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Product Compendium (Ireland) 2012 AN IRISH OWNED COMPANY SUPPORTING LOCAL JOBS

Product_Compendium_Ire_Collated_29-03-2012-reduced

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Page 1: Product_Compendium_Ire_Collated_29-03-2012-reduced

Product Compendium (Ireland) 2012

AN IRISH OWNED COMPANY SUPPORTING LOCAL JOBS

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2

Contents

Foreward 3

Product Guide 4-11

Product Datasheets 12-119

Index of Products 120-121

Bimeda Sales Team 122

Product Compendium (Ireland)

This compendium is up to date and accurate as of the date of issue (April 2012). To ensure accuracy of information subsequent to the issue date, please consult the SPC on www.imb.ie

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Foreword

Founded in Ireland in 1967, Bimeda® has become one of the leading manufacturers and distributors of veterinary pharmaceuticals and animal health products in Ireland. We are the market originator and leader in teat seal products. Our original teat seal brand, Boviseal, is now widely used on Irish dairy farms. This technology has fundamentally changed mastitis control programs in the Irish dairy industry. The use of Boviseal will be critical for Irish dairy farmers to meet the Food Harvest 2020 target of a 50% increase in milk production by the end of the decade. It is a good example of how an Irish company can be at the forefront of innovation to drive our Agri-food sector to be best the best in the world.

Headquartered in Dublin, our company employs over 130 people in Ireland and over 500 worldwide. We have seven manufacturing facilities in Ireland, USA, Canada, UK and Brazil. We also distribute

in Mexico and Kenya. We have a state of the art R & D/Regulatory Laboratory in Shijiazhuang, China.

Our organisation develops and manufactures a wide range of veterinary products including; antibiotics, anti-inflammatories, intramammaries, scour treatments, ecto & endo parasiticides together with a comprehensive equine health portfolio.

Our mission is to be recognized as a market leader in the commercial and companion animal health sectors across the globe, through our people, products, and customers. We are committed to improving health and wellness of pets and livestock around the world, by providing innovative, high quality products and solutions through excellence in research and development, manufacturing and above all customer service.

Together with our customers, we aim to make the difference!

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Code Description Product Size

Species

Cattle Sheep Equine

1ABI001 ABINEX FORTE(Abamectin 10mg/ml)

400ml, 1L, 2.5L

1BIL001 BILOSIN 200 INJECTION(Tylosin 200mg/ml)

100ml

1BIM003 BIMADINE PDR(Sulfadimidine 25g)

100 X 25g

1BIM018 BIMOTRIM CO. INJECTION(Sulphadoxine 200mg/ml/ Trimethoprim 40mg/ml)

100ml

1BIM027 BIMOXYL LA INJECTION(150mg/ml Amoxicillin)

100ml

1BIM052 BIMASTAT(Sulphadiazine 150mg/ml,Neomycin 25mg/ml)

250ml, 1L

1BIM068 BIMECTIN INJECTION( Ivermectin 10mg/ml)

50ml, 250ml, 500ml

1BIM098 BIMECTIN HORSE WORMER( Ivermectin 18.7 mg/g)

6.42g Syringe

1BIM123BIMECTIN POUR ON( Ivermectin 5mg/ml) Bimectin 0.5% Cattle Pour On Solution

2.5L, 5L

1BIM156 BIMECTIN PLUS INJECTION ( Ivermectin 10mg/ml, Clorsulon 100mg/ml)

50ml, 250ml, 500ml

1BIO001 BIOCOLOST B(Colostrum from selected and controlled herds)

100ml

1BOV024BOVISAL PEARLS(Calcium supplement for downer cows with added phosphorous and energy)

600g

1BOV010 BOVISEAL NA(Bismuth Subnitrate 2.6g)

120 syringes per container

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LMDo not use on non-lactating cows or within 60 days of calving.

35 days 12

POM Nil 21 Days 14

POM N/A 28 Days 16

POM 48 hours 5 Days 18

POM 72 hoursCattle 18 days Sheep 21 days Pigs 11 days

20

POM Nil 28 Days 22

LMDo not use on lactating cows or within 60 days of calving.

Cattle 49 days Sheep 42 days Pigs 28 days

24

LM N/A 34 days 26

LMNot for use in animals producing milk for human consumption

28 Days IMB 31 days 28

LM Not for use in lactating cows or in-calf dairy stock

66 Days 30

N/A Nil Nil 32

N/A Nil Nil 34

LM Nil Nil 36

ctd. Withdrawal Period Milk

Withdrawal Period Meat Page

Pig Dog Cat Poultry Categ.

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Code Description Product Size

Species

Cattle Sheep Equine

1BOV011 BOVIMAST DC(Cloxacillin 500mg)

120 syringes per container

1BOV021

BOVIFERM PLUS (Electrolytes, dextrose, Buffering agents, lactic acid bacteria, vegetable mucins and mineral bulking agents)

24 x 115g Sachets

1BOV022 CALCIUM BOVISAL(Minerals containing calcium, magnesium, phosphorous)

500ml

1EQU001 CONVITAL EQUILYTES(Contains potassium, magnesium and calcium ions concentrated in an amino acid chelate)

3 X 60g

1CON007 CONVITAL R(Contains 7 essential vitamins and 11 vital minerals & trace elements in a balanced ratio)

4.5L

1CRO003 CRONYXIN INJECTION(Flunixin 50mg/ml)

50ml, 100ml

1CYC002 CYCLOSOL SPRAY(chlorotetracycline 200mg/ml)

211ml

1CYC001 CYCLOSOL LA INJECTION (Oxytetracycline 200mg/ml)

100ml

1CYP003CYPERGUARD(Cypermethrin High Cis 10% w/w per ml)

1L, 2L

1DIP010 DIPEN(Procaine Penicillin 200mg& Dihydrostreptomycin 200mg/ml)

100ml

TBCD-MITEProcaine Penicillin 200mg & Dihydrostreptomycin 200mg/m

2 x 5L

1ECT001ECTOSPEC(Cypermethrin Technical 2.5% w/v)

500ml, 2.5L

1ECT003 ECTOFLITS(Diazinon 60% w/w)

3L

8ECT008 ECTOFLY(Cypermethrin)

5L

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ctd. Withdrawal Period Milk

Withdrawal Period Meat Page

Pig Dog Cat Poultry Categ.

POM 28 Days + 120 Hours 28 Days 38

N/A Nil Nil 40

N/A Nil Nil 42

LM N/A Nil 44

LM N/A Nil 46

POM 36 Hours7 days. Not to be used in horses intended for human consumption.

48

POM Nil Nil 50

POM 12 daysCattle 30 days Pigs 30 days 52

LM N/A 14 days 54

POM Nil 72hrsPigs and Cattle 21 days 56

TBC TBC TBC 58

LM Nil 10 days 60

LM N/A 35 days 62

64

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Code Description Product Size

Species

Cattle Sheep Equine

1EFI001 EFICUR(Ceftiofur 50mg/ml)

100ml

1EMB001 EMBOTAPE HORSE WORMER(Pyrantel embonate 400mg/g)

28.5g

1END009ENDOSPEC 2.5% SC(Albendazole 25 mg, Selenium 0.27mg, Cobalt 0.24mg/ml)

2.5L, 5L

1END002 ENDOSPEC 10% SC(Albendazole 100 mg/ml)

1L, 2.5L, 5L

1END023 ENDOFLUKE 10(Triclabendazole 100mg/ml)

1L, 2.5L

1EQU005 EQUIBACTIN(Trimethoprim 66.7mg, Sulfadiazine 333.3mg/g)

45g Syringe

1FLE003 FLEE(Flee Household Flea Spray)

400ml

1HEL002HELODIP(Ammonium Lauryl Sulphate 3.1 % w/v)

5L, 20L

1HYS002 HYSPAN 400 MG ORAL POWDER(Neomycin Sulphate 4mg/g)

100g Sachets

1KEF002KEFAMAST DRY COW(Anhydrous Cefalexin 500 mg Dihydrostreptomycin 500mg/syringe)

120 syringes per container

1KEF010KEFAMAST LACTATING COW(Cephalexin 500mg Dihydrostreptomycin 500mg/10ml)

24 syringes per container

1MUL004MULTIMAST DRY COW(Neomycin Sulphate 100mg Penethamate Hydriodide 100mg Procaine Benzylpenecillin 400mg/4.5g syringe)

120 syringes per container

TBCNEFOTEK(Nefotek 100 mg/ml solution for injection)

100ml, 250ml

1OSM004OSMODEX(Contains 1.99% w/w of available Iodine)

5L, 25L

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ctd. Withdrawal Period Milk

Withdrawal Period Meat Page

Pig Dog Cat Poultry Categ.

POM NilPigs and Cattle 2 days 8 days 66

LM N/A 7 Days 68

LM 60 HoursSheep 4 Days Cattle 14 days 70

LM 60 hoursCattle: 14 daysSheep: 4 days 72

LM Not permitted for use in lactating cows.

56 days 74

POM N/A 14 Days 76

POM N/A N/A 78

LM Nil Nil 80

POM N/A 28 Days 82

POM 40 Days + 60 hours 28 days 84

POM 96 hours 7 days 86

POM 50 days + 96 hours 28 days 88

LM N/A N/A 90

92

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Code Description Product Size

Species

Cattle Sheep Equine

1OXY003OXYCOMPLEX NS INJECTION(Oxytetracycline hydrochloride equivalent to Oxytetracycline 10mg. Flunixin Meglumine equivelant to Flunixin 20mg/ml)

100ml

1OXY037 OXYTOCIN INJECTION(synthetic) 10 I.U. per ml

50ml

1RAP001 RAPIDEXON 2MG INJECTION(Dexamethasone 2mg/ml)

100ml

1SED001SEDAXYLAN INJECTION(Xylazine 20mg Equivelant to 23.32mg xylazine hydrochloride/ml)

25ml

1SEL001SELECTAN INJECTION(Florfenicol 300mg/ml)

100ml

1SUL003 SULPHADIMIDINE PDR(Sulfadimidine Sodium 1000mg/g)

25g Sachets

1TET015 TETROXY LA INJECTION(Oxytetracycline Ph. Eur. 200 mg/ml)

100ml

1TON002 TONAVET(Multivitamin tracel element tonic for animals)

500ml, 2.5L

1TYL009 TYLOVET 20% INJECTION(Tylosin 200mg/ml)

100ml

1UNI001 UNISOL(Enrofloxacin 100mg/ml)

100ml

1VET005 VETRISUL(Trimethoprim 40g, Sulphamethoxazole 200mg/ml)

100ml

1VIT001VITAMIN B1 INJECTION(Thiamine Hydrochloride Ph. Eur. 100 mg/ml)

50ml

1VIT014VITAMIN K1 INJECTION(Phytomenadione 10mg/ml)

50ml

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11

ctd. Withdrawal Period Milk

Withdrawal Period Meat Page

Pig Dog Cat Poultry Categ.

POM 5 Days 28 days 94

POM Nil Nil 96

POM 72 hoursCattle 7 days Pig 2 days Horse 11 days

98

POM Nil 1 day 100

POMNot permitted for use in lactating animals producing milk for human consumption

Cattle 30 days Pigs 18 days 102

POM 5 DaysCattle 21 days Poultry 14 days 104

POM 7 daysCattle & Sheep 28 Days Pigs 21 days

106

N/A Nil Nil 108

POM 4 days 21 days 110

POM Cattle Subcut. 84 hrs, Intraven. 72 hrs

Cattle Subcut. 13 days, Intraven. 4 days Pigs intramus. 10 days

112

POM Cattle 5 days Cattle 35 days 114

POM Nil Nil 116

POM 7 days 28 days 118

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%,0(&7,1�+256(�3$67(PRESENTATIONA yellow gel-like, apple flavoured, paste of uniform consistency, containing 1.87% w/w Ivermectin.

USESBimectin Horse Paste is indicated for the treatment nematodeor arthropod infestations in horses due to:Large strongyles: Strongylus vulgaris (adults and 4th larval [arterial] stages),S. edentatus (adults & 4th larval [tissue] stages), S. equinus (adults),Triodontophorus spp. (adults),Triodontophorus brevicauda,Triodontophorus serratus. Small Strongyles: Adult and immatures (fourth stage larvae) small strongyles or cyathostomes unless otherwise stated. Ivermectin is not effective against the encysted larval stages of the small strongyles.: Coronocyclus spp., Cyathostomum spp., Cylicocyclus spp., Cylicostephanus spp., Cylicodontophorus spp., , Parapoteriostomum spp.,Petrovinema spp., Poteriostomum spp. Lungworms (adult andinhibited fourth stage larvae): Dictyocaulus arnfieldi Pinworms (adult and inhibited fourth stage larvae): Oxyuris equi Ascarids (adults and third & fourth stage larvae): Parascaris equorum Hairworms (adults): Trichostrongylus axei Large-mouth stomach worms (adults): Habronema muscae Neck threadworms (microfilariae):Onchocerca spp. Intestinal threadworms (adults): Strongyloides westeriStomach bots: Oral and gastric stages of Gasterophilus spp.

DOSAGE AND ADMINISTRATIONAdminister orally as a single dose rate to horses at the recommended dose level of 0.2mg ivermectin per kilogram of bodyweight. Each syringe delivers 120mg ivermectin, sufficient to treat 600kg of bodyweight. Single administration.Bodyweight and dosage should beaccurately determined prior to treatment.

DOSING INSTRUCTIONSEach weight marking on the syringeplunger will deliver sufficient paste to treat 100kg bodyweight. Unlock the knurled ring by making ! turn and slide the knurled ring up the plunger shaft so that the side nearest the barrel is at the prescribed weight

marking. Turn the knurled ring ! turn to lock in place. Make sure the horse’s mouth contains no feed. Remove the plastic cap from the tip of the nozzle. Insert the syringe into the horse’s mouth at the inter-dental space. Advance the plunger as far as it will go, depositing the medication on the base of the tongue. Immediately raise the horse’s head for a few seconds after dosing. The treatment schedule should be based on the local epidemiological situation.

CONTRA-INDICATIONS, WARNINGS, ETCSpecial warning for non-target species: The product has been formulated for use in horses only. Cats, Dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also turtles and tortoises may be adversely affected by the concentration of ivermectin in this product if they are allowed to ingest spilled paste or have access to used syringes. Do not use in mares producing milk for human consumption.Studies performed in laboratory animals showed no teratogenic or embryotoxic affect of ivermectin at the recommended doses during therapy. The safety of the veterinary medicinal product has not been established during pregnancy and lactation. Use only according to risk/benefit analysis by the responsible veterinary surgeon. Some horses carrying heavy infection of Onchocerca microfilariae have experienced oedema and pruritus following dosing, assumed to be the result of death of large numbers of microfilariae. These signs resolve within a few days but symptomatic treatment may be advisable. Ivermectin is extremely dangerous to fish and aquatic life. Treated animals should not have direct access to surface waters and ditches during treatment. Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

OVERDOSEMild transitory signs (slowedpupillary light response anddepression) have been seen at a dose of 1.8mg/kg (9 times the recommended dose level). Other signs seen at higher doses

includes mydriasis, ataxia, tremors, stupor,coma and death. The less severe signs have been transitory. No antidote has been identified; however, symptomatic therapy may be beneficial.

WITHDRAWAL PERIODSMeat and offal 34 days.Not permitted for use in maresproducing milk for human consumption.

OPERATOR WARNINGSDo not eat, drink or smoke whilehandling the product.Avoid contact with skin and eyes.If accidental skin contact occurs,wash the affected area immediatelywith soap and water.If accidental eye exposure occurs, flush the eyes immediately with water and, if necessary, get medical attention. Wash hands after use.Extremely dangerous to fish and aquatic life. Do not contaminate surface waters or ditches with product or used containers.Any unused product or waste material should be disposed of in accordance with national requirements.

PHARMACEUTICAL PRECAUTIONSFollowing intensive exposure to sunlight photolytic degradation of ivermectin may occur.This is a single dose product.Discard after use.Keep out of reach and sight of children.

LEGAL CATEGORY LM

PACKAGE QUANTITIESHigh density polyethylene pre-filleddose-graduated disposable syringecontaining 6.42 g of product.

VPA 10960/48/1

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PRESENTATIONCronyxin Injection is a clear, sterile, aqueous solution for injection.Each ml contains Flunixin 50mg (as Flunixin Meglumine), Phenol 5mg(preservative), Sodium Formaldehyde Sulfoxylate (antioxidant) and Propylene Glycol (co-solvent).

USESCattleFor the control of acute inflammation associated with respiratory disease. For use as adjunctive therapy in the treatment of acute mastitis.HorsesFor the alleviation of inflammation and pain associated with musculoskeletal disorders. For the alleviation of visceral pain associated with colic.

DOSAGE AND ADMINISTRATIONCattleThe recommended dose is 2ml Cronyxin injection per 45kg bodyweight (equivalent to 2.2mg flunixin per kg) injected intravenously and repeated as necessary at 24 hour intervals for up to 5 consecutive days.The cause of the acute inflammatory condition should be determined and treated with concomitant therapy.HorsesFor use in equine musculoskeletal disorders, the recommended doseis 1ml Cronyxin Injection per 45kg bodyweight (equivalent to 1.1mg flunixin per kg) injected intravenously and repeated as necessary at 24 hour intervals for up to 5 consecutive days according to response.For use in equine colic, the recommended dose is 1ml Cronyxin Injection per 45kg bodyweight (equivalent to 1.1mg flunixin per kg) injected intravenously and repeated once or twice if signs of colic recur. The cause of colic should be determined and treated with concomitant therapy.

CONTRAINDICATIONS, WARNINGS ETC.Do not exceed the recommended dose or treat animals for more than 5 consecutive days. Use is contra-indicated in animals suffering from cardiac, hepatic or renal disease, where there is the possibility of gastrointestinal ulceration or bleeding, where there is evidence of a blood dyscrasia or hypersensitivity to the product. Avoid intra-arterial injection. Avoid use in dehydrated, hypovolemic or hypotensive animals as there is a potential risk of increased renal toxicity. Not to be used in animals with known hypersensitivity to the active ingredient. For animal treatment only.

UNDESIRABLE EFFECTS (GENERAL)Prolonged use of NSAIDs, including flunixin, may predispose or lead to gastro-intestinal irritation, and in severe cases, ulceration.

SPECIAL PRECAUTIONS FOR USENSAIDs can cause inhibition of phagocytosis and hence in the treatment of inflammatory conditions associated with bacterial infections appropriate concurrent antimicrobial therapy should be instigated. Some NSAIDs may be highly bound to plasma proteins and compete with other highly bound drugs to produce an increase in non-bound pharmacologically active concentrations, which can lead to toxic effects. Use in any animal less than 6 weeks of age or

in aged animals may involve additional risk. If such use cannot be avoided animals may require a reduced dosage and careful clinical management. It is preferable that flunixin is not administered to animals undergoing general anaesthesia until fully recovered. Concurrent administration of potentially nephrotoxic drugs should be avoided..

USE DURING PREGNANCY AND LACTATIONDo not administer to pregnant mares. Studies to demonstrate safety in pregnant mares have not been conducted.

DRUG INTERACTIONSDo not mix Cronyxin with other medicaments prior to administration. Monitor drug compatibility closely where adjunctive therapy is required. Cronyxin may potentiate the effects of warfarin and other such drugs. Do not administer other NSAIDs concurrently or within 24 hours of each other. Due to their common mode of action, flunixin may potentiate and be potentiated by other NSAIDs which act by interfering with prostaglandin synthesis.

WITHDRAWAL PERIOD(S)Milk from lactating cows should be discarded during treatment and may only be taken for human consumption after 36 hours following treatment. Animals may not be slaughtered for human consumption during treatment. Animals may be slaughtered for human consumption only after 7 days from the last treatment. Not for horses intended for human consumption.

PHARMACEUTICAL PRECAUTIONSKeep out of reach and sight of children.Do not store above 25°C. Following withdrawal of the first dose, use the product within 28 days.Avoid the introduction of contamination during use. Should any apparent growth or discolouration occur, the product should be discarded.

LEGAL CATEGORY� 320

PACKAGE QUANTITIES250ml and 1 litre

FUTHER INFORMATIONNon-steroidal anti-inflammatory drugs are not permitted substancesunder the Rules of Racing and under rules covering other competitive events.

Veterinary surgeons administering NSAIDs to racehorses should refer to Section 4.4 of the RCVS Guide to Professional Conduct. Section 4.4.7 states ‘If a veterinarian recommends the discontinuance of anysubstance…….. not less than eight days before racing (even though such period may be longer than is necessary in many instances) he should be able to feel that he has catered for all but the most exceptionalcases’.

VPA 10126/064/001

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TARGET SPECIES&DWWOH��VKHHS�DQG�SLJV�

USES7UHDWPHQW�RI�VXSHU¿FLDO�WUDXPDWLF�RU�VXUJLFDO�ZRXQGV�FRQWDPLQDWHG�ZLWK�FKORURWHWUDF\FOLQH�VHQVLWLYH�DJHQWV�7KH�SURGXFW�FDQ�EH�XVHG�DV�SDUW�RI�D�WUHDWPHQW�IRU�VXSHU¿FLDO�VNLQ�DQG�FODZ�KRRI�LQIHFWLRQV��LQ�SDUWLFXODULQWHUGLJLWDO�GHUPDWLWLV��IRRW�URW�DQG�IRXO�LQ�WKH�IRRW��DQG�GLJLWDO�GHUPDWLWLV�FDXVHG�E\�PLFUR�RUJDQLVPV�VHQVLWLYH�WRFKORURWHWUDF\FOLQH��6XLWDEOH�IRU�XVH�GXULQJ�SUHJQDQF\�ODFWDWLRQ�

CONTRAINDICATIONS, WARNINGS ETC'R�QRW�XVH�LQ�FDVH�RI�K\SHUVHQVLWLYLW\�WR�WHWUDF\FOLQHV�RU�WR�RWKHU�LQJUHGLHQWV�RI�WKH�SURGXFW��'R�QRW�XVH�RQ�WKH�XGGHU�RI�ODFWDWLQJ�DQLPDOV�LI�PLON�LV�LQWHQGHG�IRU�KXPDQ�FRQVXPSWLRQ�8VH�RI�WKH�SURGXFW�GHYLDWLQJ�IURP�WKH�LQVWUXFWLRQV�JLYHQ�LQ�WKH�63&�PD\�LQFUHDVH�WKH�SUHYDOHQFH�RI�EDFWHULD�UHVLVWDQW�WR�FKORURWHWUDF\FOLQH�DQG�PD\�GHFUHDVH�WKH�HIIHFWLYHQHVV�RI�WUHDWPHQW�ZLWK�RWKHU�WHWUDF\FOLQHV��GXH�WR�WKH�SRWHQWLDO�IRU�FURVV�UHVLVWDQFH�

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',3(1PRESENTATIONThe product is a white to off-white sterile aqueous suspension for injection.Each ml contains: Procaine Penicillin 200 mg (equivalent of 200,000 IU) Dihydrostreptomycin sulphate 200 mg Methylhydroxybenzoate 1.0 mg

USESFor the treatment of infections caused by bacteria sensitive to penicillin and dihydrostreptomycin in cattle, sheep and pigs.

DOSAGE AND ADMINISTRATIONThe recommended dose is 4 ml per 100 kg bodyweight i.e. 8,000 IU procaine penicillin and 10 mg dihydrostreptomycin sulphate per kg. Dipen is to be administered by sterile intramuscular administration only. Clean the area of injection and swab with spirit.Dose Rate per Species (ml) kg Bodyweight Cattle 4.0 100 Sheep 1.0 25 Sow 3.0 75 Piglet 0.2 5 Do not exceed the stated dose�CONTRAINDICATIONS AND WARNINGSDo not administer to animals known to be sensitive to penicillin. Do not use when it is known that penicillinase-producing staphylococcus organisms are present.Occasionally in sucking and fattening pigs, administration of products containing procaine penicillin may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. In pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported. The maximum dose volume recommended at any one site for cattle is 20 ml.

WITHDRAWAL PERIODSWithdrawal Period(s):Cattle: Meat : 21 days. Milk: 72 hours. Sheep: Meat: 21 daysMilk: Not to be used in lactating ewes producing milk for human consumption. Pigs: Meat: 21 days. Animals are not to be slaughtered to produce meat for human consumption during treatment. Milk for human consumption is not to be taken from cows during treatment.

PHARMACEUTICAL INFORMATION AND PRECAUTIONSContraindications: Do not administer to animals known to be sensitive to penicillin. Do not use when it is known that penicillinase-producing staphylococcus organisms are

present. Special warnings: Occasionally in sucking and fattening pigs, administration of products containing procaine penicillin may cause a transient pyrexia, vomiting, shivering, listlessness and incoordination. In pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported. The maximum dose volume recommended at any one site for cattle is 20ml.

SPECIAL PRECAUTIONS FOR USE IN ANIMALS:Not for use in lactating ewes producing milk for human consumption.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING THE VETERINARY MEDICINAL PRODUCT TO ANIMALS Penicillin and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillin may lead to cross sensitivity to cephalosporins and vice versa. Allergic reaction to those substances can occasionally be serious. Do not handle this product if you know you are sensitised or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions. If you develop symptoms following exposure, such as a skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips and eyes or difficulty with breathing are more serious symptoms and require urgent medical attention.Adverse reactions: Occasional allergies to penicillins have been observed but these are very rare. Hypersensitivity (allergic) reactions to penicillins can vary from localised swelling to anaphylaxis and death. Occasionally in sucking and fattening pigs administration of products containing procaine penicillin may cause transient pyrexia, vomiting, shivering, listlessness and incoordination. In pregnant sows and gilts a vulval discharge which could be associated with abortion has been reported. Procaine penicillin G can, under certain circumstances, be toxic and even lethal to pigs and this is thought to be due to a sudden release of toxic amounts of free procaine. The symptoms include shivering, lassitude, inappetence, vomiting, cyanosis of the extremities and pronounced pyrexia (40°C and over). A vulval discharge may appear and some animals may abort. Alarming side-effects are most likely to occur when pigs with erysipelas are injected with an older and, or,

heat-affected procaine penicillin formulation. Treatment with 5 mg dexamethasone will result in rapid recovery.

USE DURING PREGNANCY, LACTATION OR LAY:Procaine penicillin and dihydrostreptomycin are safe for use in pregnant animals. Not for use in lactating ewes producing milk for human consumption. Interaction with other medicinal products and other forms of interaction: Tetracyclines are bacteriostatic antibiotics that presumably may interfere with a bactericidal agent such as penicillin. Since penicillin acts by inhibiting cell wall synthesis, agents such as tetracyclines, which inhibit protein synthesis, could mask the bactericidal effect of penicillin. If penicillin is used with a tetracycline, it would be prudent to observe the following points when possible: Be sure that adequate amounts of each agent are given; antagonism is most likely to occur when barely sufficient amounts of each agent are given. Begin administration of the penicillin at least a few hours before the administration of tetracycline.

SHELF-LIFE�The shelf life is two years from the date of manufacture. Once a vial is broached, use the contents within four weeks.

SPECIAL PRECAUTIONS FOR STORAGE�Do not store above 25°C. Do not freeze.

NATURE AND COMPOSITION OF IMMEDIATE PACKAGING:Type II, Siliconised clear glass, 100 ml vials containing closed with rubber stoppers and sealed with aluminium seals. Special precautions for the disposal of unused veterinary medicinal products or waste materials: Unused product or waste material should be disposed of in accordance with current practice for pharmaceutical waste under national disposal regulations.

LEGAL CATEGORY� POM

MARKETING AUTHORISATION HOLDERCrossVetpharm Ltd (trading as Bimeda),Broomhill Road, Tallaght, Dublin 24.

MARKETING AUTHORISATION NUMBERVPA: 10960/062/001

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FLEEWhen this is sprayed on a flea, it evaporates off after 20 minutes, leaving a gum/glue on the outer skin of the parasite. Staining on household surfaces is minimal and the ‘wet look’ usually fades once dry. FLEE does not feel sticky to touch. It is non-insecticidal andnon-pesticidal. It is effective against adults, larvae, eggs and pupae.

As a result, adults and mobile larvae are ‘glued up’ (adults within 1 min, larvae in 10mins) and eventually die of starvation. Eggs and Pupae are coated in sticky layer and continue to physically develop but cannot emerge from their chitin sac. FLEE also ‘Glues’ adult dust mites and their integumentary material (debris and faeces). Due to its non-insecticidal mode of action, resistance is not an issue. The adhesive effects of FLEE persist for 6 days in deep carpet, immobilising all adults and larvae for 6 days after application. It is not orally toxic to pets. FLEE has very low toxic levels in general. It is not absorbed following oral/dermal exposure. FLEE reduces dust mite allergens (Thornton & Ross). This product is effective for at least 6 weeks (reapply every 6 weeks at the most). Vacuuming is NOT required after application. You do not need to treat the whole house, merely the areas in contact with your Pet.

DIRECTIONS FOR USE:Shake can well before use. Direct nozzle approximately 40 cm from the surface you want to treat and away from your body. Using a sweeping motion to ensure uniform delivery, apply a 14 second spray per square metreon carpets, upholstered furniture and pet bedding. If spraying large areas shake can occasionally to maintain an even distribution of product. Wash your hands after use.

You may notice slightly darker shading on sprayed surfaces. This is normal and will disappear as the product dries off completely. Hard non-porous surfaces should not normally require application. If sprayed such surfaces will appear wet for approximately 30 minutes after treatment and may present a slip hazard until dry.

YOU DO NOT need to ventilate the room after application. Not orally toxic to pets. Very low toxic levels in general. Not absorbed following oral/dermal exposure. FLEE reduces dust mite allergens (Thornton & Ross). FLEE is effective for at least 6 weeks (re-apply every 6 weeks at the most). Vacuuming is NOT required after application. Does not need to treat whole house, merely areas in contact with Pet. DO NOT need to ventilate the room after application

PRECAUTIONS:Keep away from food and drinks. Avoid eye contact. If your eyes are accidentally affected, flush with plenty of clean water. Seek medical advice if irritation persists.

Due to the oily nature of the ingredients, some surfaces could be slightly slippery before they dry. Take necessary precautions if this is the case. FLEE can be used on most surfaces.However, before use on large surfaces or potentially delicate fabrics such as leather, we recommend that you test a small, out-of-sight area to check the suitability of the product with the material.

WARNINGS:Pressurised container: protect from sunlight and do not expose to temperatures exceeding 50°C. Do not pierce or burn even after use. Do not spray on or near a naked flame, electrical equipment or any incandescent material. Keep away from sources of ignition – No smoking. Keep can out of the reach and sight of children. Use only as directed. Please recycle when empty. FLEE contains a patented combination of silicones. Due totheir mechanical mode of action, these active ingredients are considered exempt under the Biocides Directive.

Special precautions for the disposal of unused veterinary medicinal product or waste material derived from the use of such products:Any unused veterinary medicinal product or waste material derived from such veterinary medicinal products should be disposed of inaccordance with local requirements.

Distributed in Ireland by Bimeda in partnership with Excella-tec,a division of Cross Vetpharm Group Ltd., Broomhill Road, Tallaght,Dublin 24, Ireland

Distributed in UK by Bimeda in partnership with Excella-tec,Bryn Cefni Industrial Park, Llangefni,Anglesey,LL77 7XA, Wales

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1()27(.����PJ�PO�VROXWLRQ�IRU�LQMHFWLRQTARGET SPECIESCattle, pigs and horses

INDICATIONSCattle:Anti-inflammatory and analgesic treatment of diseases in the musculoskeletal system and theudder.Pigs:Anti-inflammatory and antipyretic treatment of Mastitis Metritis Agalactia Syndrome and respiratory diseases.Horses:Anti-inflammatory and analgesic treatment of diseases in the musculature, joints and the skeleton. Symptomatic analgesic treatment for colic. Postoperative pain and swelling.

BENEFITSSuitable for pigs, cattle and horses. Wide range of indications. Excellent analgesic, anti-inflammatory and antipyretic propertiesShort meat and no milk withdrawal periods. Suitable for symptomatic colic treatment in horses. Suitable for treatment of postoperative pain and swelling.

PRESENTATIONClear solution for injectionOne ml contains:Active substanceKetoprofen 100 mg

EXCIPIENTSBenzyl alcohol

USESCattle:Anti-inflammatory and analgesic treatment of diseases in the musculoskeletal systemand the udder.This can include- the supportive treatment of parturient paresis associated with calving;- reducing the pyrexia and distress associated with bacterial respiratory disease when used in conjunction with antimicrobial therapy as appropriate;- improving the recovery rate in acute clinical mastitis, including acute endotoxin mastitis, caused by gram negative micro-organisms, in conjunction with antimicrobial therapy.- reducing oedema of the udder associated with calving.Pigs:Anti-inflammatory and antipyretic treatment of Mastitis Metritis Agalactia Syndromeand respiratory diseases.This can include; reducing the pyrexia and respiratory rate associated with bacterial or viral respiratory disease when used in conjunction with antimicrobial therapy as appropriate. The supportive treatment of Mastitis Metritis Agalactia Syndrome in sows, in conjunction with antimicrobial therapy as appropriateHorses:Anti-inflammatory and analgesic treatment of diseases in the musculature, joints and

the skeletonThis can include- Diseases affecting the osteoarticular andmuscular-skeletal system associated with acute pain and inflammation:- Lameness of traumatic origin- Arthritis- Osteitis, spavin- Tendinitis, bursitis- Naviculitis- Laminitis- MyositisSymptomatic analgesic treatment for colic.Postoperative pain and swelling.

DOSAGE AND ADMINISTRATIONCattle:3 mg ketoprofen/kg b.w., equivalent to 3 mlof NEFOTEK /100 kg b.w. intravenously orintramuscularly once a day for 3 to 5 days.Pigs:3 mg ketoprofen/kg b.w., equivalent to 3 ml of NEFOTEK /100 kg b.w. intramuscularly once a day for 3 to 5 days.Horses:2.2 mg ketoprofen/kg b.w, equivalent to 1 ml of NEFOTEK /45 kg b.w. Intravenously once per day for 3 to 5 days. In thecase of colic, treatment should not be repeated until a clinical re-examination has been carried out.

CONTRAINDICATIONS AND WARNINGSDo not use in severe renal failure.Do not use in conditions with a tendency to increased bleeding. Do not use in case of known hypersensitivity to ketoprofen. In the absence of specific tolerance data for veryyoung foals, foals less than 15 days old should not be treated. Avoid intra-arterial injection. Do not exceed the stated dose or duration of treatment. Use with caution in dehydrated animals and animalswith low blood pressure. In the case of colic a supplementary dose may only be given after a thorough clinical examination. Special precautions to be taken by the person administering the veterinary medicinal product to animals. Avoid splashes on the skin and eyes. Irrigate thoroughly with water should this occur.

ADVERSE REACTIONS (frequency and seriousness) Repeated intramuscular injections can cause temporary irritation. Due to its mechanism of action including inhibition of prostaglandin synthesis, ketoprofen can cause gastric and intestinal irritation or ulceration. Use during pregnancy, lactation or lay. Studies of the effect of ketoprofen in pregnant laboratory animals and cattle have not produced any evidence of adverse effects. The effect on pregnant mares or sows has not been established. Concurrent administration with other non-steroidal anti-inflammatory drugs and steroids is to be avoided. Ketoprofen can counteract the diuretic effect of

loop diuretics. Concurrent treatment with anticoagulants should be avoided because of the increased risk of haemorrhage.

WITHDRAWAL PERIODSMeat and offal: Cattle 4 days, pigs 4 days, horses4 days,Milk: Zero days.NOTE Ketoprofen, in common with other non-steroidal anti-inflammatorys is not permitted by Racing Authorities of Great Britain and Ireland to be used at the time of racing. Ketoprofen orits conjugates can be detected in urinefor up to 10 days after treatment (analyticalsensitivity of 50ng/ml). An interval of 15 days from cessation of treatment should ensure that the drug is undetectable in most horses.

PHARMACEUTICAL INFORMATION AND PRECAUTIONS:Non-steroidal anti-inflammatory/antirheumatic agent (NSAID). The active component of NEFOTEK is ketoprofen, a substance belonging to the group non-steroidal anti-inflammatory drugs (NSAIDs). Ketoprofen has anti-inflammatory, analgesic and antipyretic properties. Not all aspects of its mechanism of action are known. Effects are obtained partially by the inhibition of prostaglandin and leukotriene synthesis by ketoprofen, acting on cyclooxygenase and lipoxygenase respectively. The formation of bradykinin is also inhibited. Ketoprofen inhibits thrombocyte aggregation.List of excipientsL Arginine, Benzyl alcohol, Citric acid monohydrate, Water for injectionsIn the absence of compatibility studies, NEFOTEK must not be mixed with other medicinal products. Shelf life of the veterinary medicinal product as packaged for sale: 1 year.Shelf life after first opening the immediate packaging: 28 days. Special precautions for storage. Store below 25�C. Store in the original package. Protect from light.

6.5 Nature and composition ofimmediate packagingNEFOTEK is packaged in amber type II glass vialsof 100 ml and 250 ml.Any unused veterinary medicinal product or wastematerials derived from such Veterinary Medicinalproduct should be disposed of in accordance withlocal requirements

LEGAL CATEGORY:�� POM

MARKETING AUTHORISATION HOLDER:Bimeda Chemicals Ltd., Broomhill Road, Tallaght, Dublin 24, Ireland.

MARKETING AUTHORISATION NUMBER:Vm:

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OXYCOMPLEX NSOxytetracycline hydrochlorideFlunixin Meglumine

PRESENTATIONA clear yellow to amber aqueous solutionfor injection. Each ml contains 100mgOxyteracycline (as oxytetracycline hydrochloride) and 20mg Flunixin ( as flunixinmeglumine)

TARGET SPECIESCattle.

INDICATIONS FOR USEFor the control and treatment of infectiousdiseases of cattle caused by or associated withorganisms sensitive to oxytetracycline, where concurrent analgesic, anti-inflammatory, anti-endotoxic or antipyretic therapy is desired.The product is especially indicated for thetreatment of respiratory disease (particularlythat associated with Mannheimia andPasteurella infection) and acute mastitis (inconjunction with appropriate intramammarytherapy)

CONTRAINDICATIONSDo not administer other NSAIDs concurrentlyor within 24 hours of each other.Use is contra-indicated in animals sufferingfrom cardiac, hepatic or renal disease, wherethere is the possibility of gastro-intestinalulceration or bleeding, where there is evidenceof a blood dyscrasia or hypersensitivity to theproduct.

SPECIAL WARNINGS FOR EACH TARGET SPECIESSome NSAIDs may be highly bound to plasmaproteins and compete with other highly bounddrugs to produce an increase in non-boundpharmacologically active concentrations,which can lead to toxic effects.Rapid intraveneous injection in cattle mayoccasionally cause cardiovascular collapse.Use in any animal less than 6 weeks of ageor in aged animals may involve additional risk.If such use cannot be avoided animals mayrequire a reduced dosage and careful clinicalmanagement.Avoid use in any dehydrated, hypovolaemicor hypotensive animal as there is a potential risk of renal toxicity. It is preferable that flunixinis not administered to animals undergoinggeneral anaesthesia until fully recovered. Concurrent administration of methoxyflurane anaesthesia or other potentially nephrotoxicdrugs should be avoided.

SPECIAL PRECAUTIONS FOR USEi. Special precautions for use in animalsDo not exceed the stated dose orduration of treatment.ii. Special precautions to be taken by theperson administering the veterinarymedicinal product to animalsAvoid eye contact and direct contact with skin.To avoid possible sensitisation reactions,avoid contact with skin. Gloves should be wornduring application. Wash hands after use.In case of accidental contact with eyes, rinseimmediately with plenty of water and seekmedical advice. The product may cause reactions in sensitive individuals. If you have known hypersensitivity for non-steroidal anti-inflammatory products, do not handle the product. Reactions may be serious. Avoid accidental self-injection.

ADVERSE REACTIONSProlonged use of NSAIDs, including flunixin,may predispose or lead to gastrointestinalulceration.

USE DURING PREGNANCY,LACTATION OR LAYReports of teratogenicity, effects on breedingperformance, or gestation lengths have not been noted following use of flunixin.Use with care in pregnant animals. The use of tetracyclines during the period of tooth development, including late pregnancy,may lead to tooth discolouration.

INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OFINTERACTIONSThe product may potentiate the effects ofWarfarin and related drugs. Because of their common mode of action, flunixin may potentiate and be potentiated by other NSAIDs which act by interfering with prostaglandin synthesis.

AMOUNTS TO BE ADMINISTERED ANDADMINISTRATION ROUTE1 ml per 10 kg bodyweight (equivalent to 10 mg oxytetracycline and 2 mg flunixin per kgbodyweight) daily for up to 5 days. The first injection should be administered intravenously, slowly, with subsequent injections given intramuscularly. Do not inject more than 20 ml intramuscularly at a single site. Where the dose exceeds 20 ml it should be divided between two or more sites, as appropriate.

OVERDOSE

Overdosing by intramuscular injectionmay give rise to swellings at the site ofinjection. Treatment should be symptomatic.

WITHDRAWAL PERIODSMeat: Animals must not be slaughtered forhuman consumption during treatment. Cattlemay be slaughtered for human consumptiononly after 28 days following the last treatment.Milk: Do not use in cattle producing milk forhuman consumption.

INCOMPATIBILITIESNone.

SHELF LIFE(a) Shelf-Life – of the veterinary medicinalproduct as packaged for sale: 2 years(b) Shelf-Life - after first opening theimmediate packaging: 28 days

SPECIAL PRECAUTIONS FOR STORAGEDo not store above 25°C. Protect from light. Following withdrawal of the first dose, usethe product within 28 days. Discard unusedmaterial.

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED MEDICINAL PRODUCT OR WASTE MATERIALS, IF ANYAny unused veterinary medicinal product orwaste materials derived from such veterinarymedicinal products should be disposed of inaccordance with local requirements.

MARKETING AUTHORISATION HOLDERCross Vetpharm Group Limited, BroomhillRoad, Tallaght, Dublin 24, Ireland

MARKETING AUTHORISATION NUMBERVPA 10126/063/001

LEGAL CATEGORY POM

PACKAGE QUANTITIES100ML MULTIDOSE VIALS

A full product SPC is available on request fromBimeda or alternatively can be found on theIMB website

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68/3+$',0,',1(62',80�32:'(5)25�25$/�62/87,21PRESENTATIONA white or creamy white odourless powder. Sulphadimidine Sodium 1000 mg.

TARGET SPECIESCattle and poultry.

USESFor the treatment of infections caused by micro-organisms (both bacteria and Coccidia) susceptible to Sulphadimidine.

CONTRAINDICATIONS, WARNINGS ETC.Do not use in animals with serious liver and renal disturbances or in animals with diseases accompanied with a decreased intake of fluids or a decreased urine production or in casesof aciduria.Do not use in animals with damage to the haematopoietic system.Do not administer to laying hens.Do not use in case of hypersensitivity to the active ingredient.After administration of this product to ruminants, sometimes a temporary interference with ruminal function andmicrofloral activity may occur. However, spontaneous recovery is likely.Monitor water intake in poultry and calves during treatment.

OPERATOR WARNINGSAvoid skin contact with the powder and avoid inhalationof the dust.pronounced in cases of decreased diuresis).

USE DURING PREGNANCY, LACTATION OR LAYThe safety of the veterinary medicinal product has not been established during pregnancy, lactation or lay.Use only accordingly to the benefit/risk assessment by the responsible veterinarian.

Interaction with other medicinal productsSimultaneous administration with para-aminobenzoic acid, its esters (e.g. procaine, tetracaine) and methenamine must be avoided.

DOSES AND ADMINISTRATIONFor oral administration via the drinking water.Calves: 100 mg per kg bodyweight.Dosage interval: 12-24 hours.Duration: 3-5 days.Poultry (non laying hens and broilers):100 mg per kg bodyweight (1 g powder per 1 – 2 litres drinking water, depending on actual water intake)Acute Coccidiosis:Administration during 3 consecutive days; after 2 days of no treatment, another 3 day treatment.Subclinical Coccidiosis:Administration for 3 consecutive days.

OVERDOSEAcute overdose:Following an overdose a clear drop in water intake will occur in poultry. Administration to calves via the artificialmilk may lead to a retarded uptake of water and to diarrhoea.Chronic overdose:Haemorrhagic symptoms have been reported after long term administration of sulphonamides. A certain degree ofimmunosupression may occur making the animals more susceptible to secondary bacterial infections (especially gangrenous dermatitis in poultry). All undesirable effects documented under 4.6 may also occur following chronic overdosing.

WITHDRAWAL PERIOD(S)Poultry: Meat & offal: 14 days. Do not administer to laying hens.Cattle: Meat & offal: 21 daysMilk: 5 days (i.e. 11th milking)

SHELF-LIFEShelf-life of the veterinary medicinalproduct as packaged for sale: 2 yearsShelf-life after dilution or reconstitution according to directions: 24 hours

STORAGEDo not store above 25°C.Protect from light.

PACKAGINGLDPE bags of 1kg, 5kg, 10kg, 25 kg and 50kg. Sealed 4 layer sachet (clay-coated paper/polyethylene/aluminium foil/ionised) of 25g. Not all pack sizes may be marketed

DISPOSALAny unused product or waste material should be disposed of in accordance with national requirements.

LEGAL CATEGORY� POM

PACKAGING200 x 25 sachets

VPA 10989/50/1

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CATTLERespiratory infections caused by Pasteurella spp. or Mycoplasma spp. Alimentary tract infections caused by E. coli. Treatment of local signs (inflammation, milk qualityand yield) associated with peracute/acute mastitis in lactating dairy cattle caused by E. coli.

PIGSRespiratory infections caused by of Pasteurellaspp. or Mycoplasma spp.Alimentary tract infections caused by E. coli.Enrofloxacin should be used where clinical experience, supported where possible bysensitivity testing of the causal organism, indicates enrofloxacin as the drug of choice.

PRESENTATIONSolution for injectionClear slightly yellowish solutionEach 1 ml of solution contains:

2.1 Active Constituents Enroloxacin 100.0 mg

2.2 Relevant Constituents of the Excipients Benzyl alcohol 7.8mg Disodium edetate 10.0mg

LIST OF EXCIPIENTS Benzyl alcohol Disodium edetate Potassium hydroxide Glacial acetic acid Water for injections

USESFor the treatment of diseases in cattle and pigsinvolving organisms sensitive to Enrofloxacin,including Respiratory infections caused byPasteurella spp. or Mycoplasma spp. Mastitic andAlimentary tract infections caused by E. coli.Fluoroquinolones should be reserved for thetreatment of clinical conditions which haveresponded poorly, or are expected to respondpoorly, to other classes of antimicrobials.

DOSAGE AND ADMINISTRATIONTo ensure correct dosage, bodyweight should be determined as accurately aspossible to avoid underdosing.

Cattle:For respiratory and alimentary infections in cattleand secondary bacterial infections: administer bysubcutaneous injection.• 2.5 mg enrofloxacin per kg bodyweight dailyby subcutaneous injection for 3 days (2.5 ml per100 kg bodyweight). This rate may be doubled to 5mg/kg bodyweight (5 ml per 100 kg) for 5 days forcomplicated respiratory disease.Not more than 10 ml should be administered at anyone subcutaneous injection site.For E. coli mastitis: administer by slow intravenousinjection.• 5.0 ml per 100 kg bodyweight (5 mgenrofloxacin per kg bodyweight) daily for 2 daysPigs:

For respiratory and alimentary infections in pigsand secondary bacterial infections: administer byintramuscular injection.2.5 mg enrofloxacin per kg bodyweight daily by intramuscular injection for 3 days (2.5 ml per 100kg bodyweight). This rate may be doubled to 5mg/kg bodyweight (5 ml per 100 kg) for 5 days forcomplicated respiratory disease.Not more than 2.5 ml should be administered atany one intramuscular injection site.The stopper should not be punctured more than20 times.

CONTRAINDICATIONS AND WARNINGSi. Special precautions for use in animalsThe safety of the product has not beenestablished in pigs or calves when administeredby the intravenous route and use of this route ofadministration is not recommended in these animalgroups.Do not exceed the recommended dose.Repeat injections should be administered atdifferent sites.Enrofloxacin should be used with caution inepileptic animals or animals affected by renaldysfunction.Official and local antimicrobial policies should betaken into account when the product is used.Fluoroquinolones should be reserved for thetreatment of clinical conditions which haveresponded poorly, or are expected to respondpoorly, to other classes of antimicrobials.Whenever possible, fluoroquinolones should onlybe used based on susceptibility testing.Use of the product deviating from the instructionsgiven in the SPC may increase the prevalenceof bacteria resistant to the fluoroquinolones andmay decrease the effectiveness of treatment withother quinolones due to the potential for crossresistance.ii. Special precautions to be taken by theperson administering the veterinary medicinal product to animalsThe product is an alkaline solution. Wash anysplashes from skin or eyes immediately with water.Do not eat, drink or smoke whilst using the product.Care should be taken to avoid accidental selfinjection.If accidental self injection occurs seekmedical advice immediately.Direct contact with the skin should be avoidedbecause of sensitisation, contact dermatitis andpossible hypersensitivity reactions. Wear gloves.iii. Other precautionsNone knownAdverse reactions (frequency and seriousness)Local tissue reactions may occasionally occur atthe injection site. Normal sterile precautions shouldbe taken.Rarely, anaphylactic reactions may occur followingintravenous administration.In cattle, gastrointestinal disturbances mayoccasionally occur.Use during pregnancy, lactation or layThere is no restriction on the use ofthis product during pregnancy and lactation.

Interactions with other medicinal products and other form of interactionAntagonistic effects due to concurrentadministration of macrolides, and tetracyclinesmay occur Enrofloxacin may interfere withthe metabolism of theophylline, decreasingtheophylline clearance resulting in increasedplasma levels of theophylline.

WITHDRAWAL PERIODSCattle: Subcutaneous UseMeat and offal: 13 daysMilk: 84 hours

Cattle: Intravenous UseMeat and offal: 4 daysMilk: 72 hours

Pigs: Intramuscular UseMeat and offal: 10 days

PHARMACEUTICAL PRECAUTIONS:In the absence of compatibility studies, thisveterinary medicinal product must not be mixed with other veterinary medicinal products.

SHELF LIFE:Shelf life of the veterinary medicinal product as packaged for sale: 2 years.Shelf life after first opening the immediatepackaging: 28 days.

SPECIAL PRECAUTIONS FOR STORAGE:Protect from light.Do not freeze

SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED VETERINARY MEDICINAL PRODUCT OR WASTE DERIVED FROM THE USE OF SUCH PRODUCTSAny unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance withlocal requirements.

LEGAL CATEGORY: POM

PACKAGE QUANTITIES: Multi-dose glass vials

MARKETING AUTHORISATION HOLDER:Bimeda Chemicals Ltd.,Unit 2, Bryn Cefni Industrial Park, Llangefni,Anglesey, Wales, LL777XA

MARKETING AUTHORISATION NUMBER:VPA 10516/001/001

100 mg/ml solution for injection for cattle and pigs

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Index

A-M

AABINEX FORTE POUR-ON 12, 13

BBICOLOST B 32, 33BILOSIN 200 INJECTION 14, 15BIMADINE POWDER 16, 17BIMASTAT 22, 23BIMECTIN INJECTION 24, 25BIMECTIN ORAL PASTE 26, 27BIMECTIN PLUS 30, 31BIMECTIN POUR-ON 28, 29BIMOTRIM CO INJECTION 18, 19BIMOXYL LA INJECTION 20, 21BOVIFERM PLUS 40, 41BOVIMAST DC 38, 39BOVISAL PEARLS 34, 35BOVISEAL NA 36, 37

CCALCIUM BOVISAL 42, 43CONVITAL EQUILYTES 44, 45CONVITAL R 46, 47CRONYXIN INJECTION 48, 49CYCLOSOL LA 52, 53CYCLO SPRAY 50, 51CYPERGUARD 54, 55

DDIPEN 56, 57D-MITE 58, 59

EECTOFLITS 60, 61ECTOFLY 62, 63ECTOSPEC 64, 65EFICUR 50 mg/ml 66, 67EMBOTAPE 68, 69ENDOSPEC 2.5% SC 70, 71ENDOSPEC 10% 72, 73ENDOFLUKE 10% 74, 75EQUIBACTIN VET. 76, 77

FFLEE 78, 79

HHELODIP 80, 81HYSPAN 82, 83

KKEFAMAST DC 84, 85KEFAMAST LACTATING COW 86, 87

MMULTIMAST DRY COW 88, 89

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Index

O-Z

NNEFOTEK 90, 91

OOSMODEX 92, 93OXYCOMPLEX NS 94, 95OXYTOCIN Pro Injection 96, 97

RRAPIDEXON 98, 99

SSEDAXYLAN 100, 101SELECTAN 102, 103SODIUM POWDER 104, 105

TTETROXY LA 106, 107TONAVET 108, 109TYLOVET 20% 110, 111

UUNISOL 112, 113

VVETRUSIL INJECTION 114, 115VITAMIN B1 INJECTION 116, 117VITAMIN K1 INJECTION 118, 119

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Andrew Glynn,Sales Manager for Ireland(Veterinary and Co Operatives)[email protected] 2525110

Denis Carney,Veterinary sales Representative(South East Ireland),[email protected] 2576925

John Reynolds,Veterinary Sales Representative(Dublin, Midlands and West of Ireland)[email protected] 8097059

John SheerinVeterinary Sales Representative(Munster)[email protected] 2576926

Shane Kinsella,Co Operative Sales Representative(Munster & Leinster)[email protected] 0493960

Morgan Lane,Co Operative Sales Representative(West of Ireland & Midlands)[email protected] 2568346

Paudie HylandBimeda Commercial [email protected] 0433388

Your Local Representative

from Bimeda

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