EN_veterinary template_v.8_final · Web view{(Invented) name of veterinary medicinal product pharmaceutical form }

[Version 8 052012732 102011]

ANNEX I

SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substanceltsgt

ltAdjuvant(ltsgt)gt

ltExcipient(ltsgt)gt

For athe full list of excipients see section 61

3 PHARMACEUTICAL FORM

4 CLINICAL PARTICULARS

41 Target species

42 Indications for use specifying the target species

43 Contraindications

ltNonegtltDo not use in hellipgtltDo not use in case of hypersensitivity to the active substance(s) lt to the adjuvant(s)gt or to any of the excipient(s)gt

44 Special warnings ltfor each target speciesgt

ltNonegt

45 Special precautions for use

Special precautions for use in animals

ltNot applicablegt

ltVaccinated species may excrete the vaccine strain up to x ltdaysgt ltweeksgt following vaccination During this time the contact of immunodepressed immunosuppressed and unvaccinated species with vaccinated species should be avoidedgt

ltThe vaccineal strain can spread to speciesSpecial precautions should be taken to avoid spreading of the vaccine strain to speciesgt

ltAppropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible speciesgt

ltSpecies and unvaccinated species in contact with vaccinated species may react to the vaccine strain presenting clinical signs such as hellipgt

Special precautions to be taken by the person administering the veterinary medicinal product to animals

ltNot applicablegt

ltIn case of accidental ltself-administrationgt ltself-injectiongt ltingestiongt ltspillage onto skingt seek medical advice immediately and show the package leaflet or the label to the physiciangt

ltPeople with known hypersensitivity to INN should ltavoid contact with the veterinary medicinal productgt ltadminister the veterinary medicinal product with cautiongtgt

ltPersonal protective equipment consisting of specify should be worn when handling the veterinary medicinal productgt

ltThe veterinary medicinal product should not be administered by pregnant womengt

ltThe ltvaccinegt ltimmunological veterinary medicinal productgt can be pathogenic for humans Since this ltvaccinegt ltimmunological veterinary medicinal productgt has been prepared with live attenuated microorganisms appropriate measures should be taken to prevent contamination of the handler and other people that collaborate in the processgt

ltVaccinated species may excrete the vaccine strain up to x ltdaysgt ltweeksgt following vaccinationgt

ltImmunocompromised persons are advised to avoid contact with the ltvaccinegt ltimmunological veterinary medicinal productgt and vaccinated animals during periodgt

ltThe vaccine strain can be found in the environment for up to x ltdaysgt ltweeksgt Personnel involved in attending vaccinated species should follow general hygiene principles (changing clothes wearing gloves cleaning and disinfection of boots) and take particular care in handling litter from recently vaccinated speciesgt

ltTo the userThis veterinary medicinal product contains mineral oil Accidental injectionself injectionself-injection may result in severe pain and swelling particularly if injected into a joint or finger and in rare cases could result in the loss of the affected finger if prompt medical attention is not given If you are accidentally injected with this veterinary medicinal product seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you If pain persists for more than 12 hours after medical examination seek medical advice again

To the physicianThis veterinary medicinal product contains mineral oil Even if small amounts have been injected accidental injection with this product can cause intense swelling which may for example result in ischaemic necrosis and even the loss of a digit Expert PROMPT surgical attention is required and may necessitate early incision and irrigation of the injected area especially where there is involvement of finger pulp or tendongt

ltThe long-term effects of the veterinary medicinal product on the population dynamics of dung beetles have not been investigated Therefore it is advisable not to treat animals on the same pasture every seasongt

46 Adverse reactions (frequency and seriousness)

lt The frequency of adverse reactions is defined using the following convention

- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals)- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports) gt

47 Use during pregnancy lactation or lay

ltThe safety of the veterinary medicinal product has not been established during ltpregnancygtltlactationgt ltlaygtgt

ltPregnancygtltCan be used during pregnancygtltThe use is not recommended (during the whole or part of the pregnancy)gtltDo not use (during the whole or part of the pregnancy)gtltThe use is not recommended during ltpregnancygt ltlactationgtgtltUse only accordingly to the benefit-risk assessment by the responsible veterinariangtltLaboratory studies in species have not produced any evidence of a ltteratogenicgt ltfoetotoxicgt ltmaternotoxicgt effectsgtltLaboratory studies in species have shown evidence of ltteratogenicgt ltfoetotoxicgt ltmaternotoxicgt effectsgt

ltLactationgtltNot applicablegt

ltLaying birdsgtltDo not use in ltbirds in laygt ltbreeding birdsgt ltandor within 4 weeks before the onset of the laying periodgtgt

ltFertilitygtltDo not use in breeding animalsgt

48 Interaction with other medicinal products and other forms of interaction

ltNone knowngtltNo data availablegt

ltNo information is available on the safety and efficacy of this ltvaccinegt ltltimmunological veterinary medicinal productgt when used with any other veterinary medicinal product A decision to use this ltvaccinegt ltimmunological veterinary medicinal productgt before or after any other veterinary medicinal product therefore needs to be made on a case by case basisgt

ltSafetygt ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be administered on the same day but not mixed with description of tested product(s)gt

ltThe ltveterinary medicinal productgt ltvaccinegt ltimmunological veterinary medicinal productgt should be given at different sitesgt

ltSafetygt ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be administered at least X number of ltdaysgt ltweeksgt ltbeforegt ltaftergt the administration of description of tested product(s) gt

ltNo information is available on the safety and efficacy of this ltvaccinegt ltimmunological veterinary medicinal productgt when used with any other veterinary medicinal product except the products mentioned above A decision to use this ltvaccinegt ltimmunological veterinary medicinal productgt before or after any other veterinary medicinal product therefore needs to be made on a case by case basisgt

ltSafety ltandgt ltefficacygt data are available which demonstrate that this ltvaccinegt ltimmunological veterinary medicinal productgt can be mixed and administered with description of tested product(s)gt

49 Amounts to be administered and administration route

ltThe ltvaccinegt ltimmunological veterinary medicinal productgt ltveterinary medicinal productgt should not be used if description of the visible signs of deteriorationgt

410 Overdose (symptoms emergency procedures antidotes) if necessary

411 Withdrawal period(s)

ltNot applicablegtltZero daysgtltMeat and offalgtltEggsgt ltMilkgt ltEggsgt X lthoursgt ltdaysgtlthoursgtltX Ddegree daysgt

ltNot authorised for use in lactating animals producing milk for human consumptiongtltDo not use in pregnant animals which are intended to produce milk for human consumption within X months of expected parturitiongtltNot authorised for use in laying birds producing eggs for human consumptiongtltDo not use within X weeks of onset of the layinggt

5 ltPHARMACOLOGICALgt ltIMMUNOLOGICALgt PROPERTIES

Pharmacotherapeutic group group ATCvet code lowest available level (eg subgroup for chemical substance)

lt51 Pharmacodynamic propertiesgt

lt52 Pharmacokinetic particularsgt

ltEnvironmental propertiesgt

6 PHARMACEUTICAL PARTICULARS

61 List of excipients

62 Incompatibilities

ltNot applicablegtltIn the absence of compatibility studies this veterinary medicinal product must not be mixed with other veterinary medicinal productsgt

ltDo not mix with any other veterinary medicinal product lt except diluent or other component ltrecommendedgt ltsuppliedgt for use with the veterinary medicinal productgtgt

ltSafety ltandgt efficacy data are available which demonstrate that this vaccine can be mixed and administered with description of tested product(s) gt

ltNone knowngt

63 Shelf life

ltShelf- life of the veterinary medicinal product as packaged for sale gtltShelf- life after first opening the immediate packaging gtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions gtltShelf life after incorporation into meal or pelleted feed gt

lt6 monthsgt lthellipgt lt1 yeargt lt18 monthsgt lt2 yearsgt lt30 monthsgt lt3 yearsgt ltuse immediatelygt

64 Special precautions for storage

ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt

ltin order to protect from ltlightgt ltandgt ltmoisturegtgt

ltProtect from lightgtltStore in a dry placegtltProtect from direct sunlightgt

ltThis veterinary medicinal product does not require any special storage conditionsgt

ltThis veterinary medicinal product does not require any special temperature storage conditions gt

[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)] Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]

65 Nature and composition of immediate packaging

ltNot all pack sizes may be marketedgt

66 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products

ltNot applicablegtltAny unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirementsgtltDispose of waste material by boiling incineration or immersion in an appropriate disinfectant approved for use by the competent authoritiesgt

ltInvented name should not enter water courses as this may be dangerous for fish and other aquatic organismsgt

7 MARKETING AUTHORISATION HOLDER

Name and addresslttTelgtltFfaxgtlteE-mailgt

8 MARKETING AUTHORISATION NUMBER(S)

9 DATE OF FIRST AUTHORISATIONRENEWAL OF THE AUTHORISATIONltDDMMYYYYgt ltDD month YYYYgthellip

ltDate of first authorisationgt ltDDMMYYYYgt ltDD month YYYYgtltDate of last renewalgt ltDDMMYYYYgt ltDD month YYYYgt

10 DATE OF REVISION OF THE TEXT

MMYYYY or ltmonth YYYYgt

ltDetailed information on this veterinary medicinal product is available on the website of the European Medicines Agency(EMEA) ((httpwwwemaeuropaeu ))gt

PROHIBITION OF SALE SUPPLY ANDOR USE

ltNot applicablegtltThe import sale supply andor use of invented name is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy Any person intending to import sell supply andor use ltinvented namegt must consult the relevant Member Statersquos competent authority on the current vaccination policies prior to the import sale supply andor usegt

ltConsideration should be given to official guidance on the incorporation of medicated premixes in final feedsgt

ANNEX II

A ltMANUFACTURERltSgt OF THE BIOLOGICAL ACTIVE SUBSTANCEltSgt ltANDgt MANUFACTURERltSgt RESPONSIBLE FOR BATCH RELEASE

B CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

C STATEMENT OF THE MRLs

ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATIONgt

ltName and address of the manufacturerltsgt of the biological active substanceltsgt

Name and addressgt

Name and address of the manufacturerltsgt responsible for batch release

Name and address

ltThe printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batchgt

ltVeterinary medicinal product subject to prescriptiongtltVeterinary medicinal product not subject to prescriptiongt

ltAccording to Article 71 of Directive 200182EC of the European Parliament and of the Council as amended a Member States may in accordance with its national legislation prohibit the manufacture import possession or may prohibit the import sale supply andor use of theimmunological veterinary medicinal products on the whole or part of their territory if it is established that

a) the administration of the veterinary medicinal product to animals will interfere with the implementation of a national programmes for the diagnosis control andor eradication of animal diseases or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals

b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory in questiongt

ltOfficial batch release (only for those vaccinesimmunological veterinary medicinal products where this is a requirement on the OMCL list)

In accordance with Article 82 of Directive 200182EC as amended a Member State may require the marketing authorisation holder for an immunological veterinary medicinal product to submit samples of batches of the buldk product andor veterinary medicinal product for control by an Official Medicines Control Laboratory before the product is put into circulation the official batch release will be undertaken by a state laboratory or a laboratory designated for that purposegt

ltNot applicablegt

[For pharmaceutical products]

The active substanceltsgt in ltname of the productgt ltisgt ltaregt ltangt allowed substanceltsgt as described in table 1 of the annex to Commission Regulation (EU) No 372010

Pharmaco-logically active substance

Marker residue

Animal species MRLs Target

tissuesOther

provisionsTherapeutic classification

ltThe excipients listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No 4702009 when used as in this veterinary medicinal productgtgt gt

[In case of MRLs not been published yet]

The Committee for Medicinal Products for Veterinary Use has recommended the inclusion of ltname of the active substance(s)gt in ltname of the productgt in table 1 (Allowed substances) of the annex to Commission Regulation (EU) No 372010 as follows

Marker residue

tissuesOther

[For immunological products]

ltThe active substance being a principle of biological origin intended to ltproducegt ltactivegt ltpassivegt ltdiagnose a state of gt immunity is not within the scope of Regulation (EC) No 4702009gt

ltThe excipients (including adjuvants) listed in section 61 of the SPC are lteithergt ltallowed substances for which table 1 of the annex to Commission Regulation (EU) No 372010 indicates that no MRLs are requiredgt ltorgt ltareconsidered as not falling within the scope of Regulation (EC) No No 4702009 when used as in this veterinary medicinal productgtgtgt

ltD OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

Pharmacovigilance system

The MAH must ensure that the system of pharmacovigilance as described in Part I of the marketing authorisation application is in place and functioning before and whilst the veterinary medicinal product is on the market

ltPSURsgt

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

ltNot applicablegtltFor use by veterinary surgeons onlygt

ltSPECIFIC OBLIGATION TO COMPLETE POST-AUTHORISATION MEASURES FOR THE MARKETING AUTHORISATION UNDER EXCEPTIONAL CIRCUMSTANCESgt

ltThis being an approval under exceptional circumstances and pursuant to Article 39(7) of Regulation (EC) No 7262004 the MAH shall conduct within the stated timeframe the following measures

Description Due date

ltOBLIGATION TO CONDUCT POST-AUTHORISATION MEASURESgt

ltThe MAH shall complete within the stated timeframe the following measures

ANNEX III

LABELLING AND PACKAGE LEAFLET

A LABELLING

ltPARTICULARS TO APPEAR ON ltTHE OUTER PACKAGEgt ltANDgt lt THE IMMEDIATE PACKAGEgtltPARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGEgt

NATURETYPE

(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgtactive substance(s)

2 STATEMENT OF ACTIVE AND OTHER SUBSTANCES

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

7 METHOD AND ROUTE(S) OF ADMINISTRATION

Read the package leaflet before use

8 WITHDRAWAL PERIOD

ltWithdrawal period gt

9 SPECIAL WARNING(S) IF NECESSARY

ltRead the package leaflet before usegt

ltAccidental injection is dangerous ndash see package leaflet before usegtltltAccidental administrationgt ltcContact with the mucosagt is dangerous ndash see package leaflet before usegt

10 EXPIRY DATE[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]

ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt ltuse byhellipgt ltuse immediatelygtgtgt

11 SPECIAL STORAGE CONDITIONS

ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 CgtgtltStore in a refrigeratorgtltStore and transport refrigeratedgtltStore in a freezergtltStore and transport frozengtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container tightly closed gt ltKeep the container in the outer carton gt

[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc)]

12 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS IF ANY

ltDispose of waste material in accordance with local requirementsgtltDisposal read package leafletgt

13 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE if applicableIF APPLICABLE

For animal treatment only lt - tTo be supplied only on veterinary prescriptiongt

ltThe import sale supply andor use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory see package leaflet for further informationgt

14 THE WORDS ldquoKEEP OUT OF THE SIGHT AND REACH AND SIGHT OF CHILDRENrdquo

Keep out of the sight and reach and sight of children

15 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

Name and addressltTtelgtltFfaxgtlteE-mailgt

EU0200000000

17 MANUFACTURERrsquoS BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]

ltBatchgt ltLotgt ltBNgt number

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS

NATURETYPE

(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt active substance(s)

2 QUANTITY OF THE ACTIVE SUBSTANCE(S)

3 CONTENTS BY WEIGHT BY VOLUME OR BY NUMBER OF DOSES

4 ROUTE(S) OF ADMINISTRATION

5 WITHDRAWAL PERIOD

6 BATCH NUMBERFor terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency website httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]

ltEXP monthyeargtltOnce ltbroachedgt ltopenedgt ltdilutedgt ltreconstitutedgt lt use byhellipgt ltuse immediatelygtgtgt

8 THE WORDS ldquoFOR ANIMAL TREATMENT ONLYrdquo

For animal treatment only

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS

NATURETYPE

2 NAME OF THE MARKETING AUTHORISATION HOLDER

ltEXP monthyeargt

4 BATCH NUMBER[For terms on Batch number and Expiry date see Appendix IV on the European Medicines Agency Wwebsite httpwwwemaeuropaeuhtmshumanqrdAppendixIVappendixIVpdf]

B PACKAGE LEAFLET

PACKAGE LEAFLET FOR(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget

speciesgt

1 NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE IF DIFFERENT

ltMarketing authorisation holder ltand manufacturer responsible for batch release gtgt

ltManufacturer responsible for the batch release gt

3 STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

- very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)- common (more than 1 but less than 10 animals in 100 animals)- uncommon (more than 1 but less than 10 animals in 1000 animals )- rare (more than 1 but less than 10 animals in 10000 animals)- very rare (less than 1 animal in 10000 animals including isolated reports)gt

If you notice any serious effects or other effects not mentioned in this package leaflet please inform your veterinary surgeon

7 TARGET SPECIES

8 DOSAGE FOR EACH SPECIES ROUTE(S) AND METHOD OF ADMINISTRATION

9 ADVICE ON CORRECT ADMINISTRATION

ltDo not use name of product if you notice description of the visible signs of deteriorationgt

10 WITHDRAWAL PERIOD

11 SPECIAL STORAGE PRECAUTIONS

ltDo not store above lt25 Cgt lt30 CgtgtltStore below lt25 Cgt lt30 Cgtgt ltStore in a refrigerator (2 C ndash 8 C)gtltStore and transport refrigerated (2 C ndash 8 C)gtltStore in a freezer temperature rangegtltStore and transport frozen temperature rangegtltDo not ltrefrigerategt ltorgt ltfreezegtgtltProtect from frostgtltStore in the original ltcontainergtltpackagegtgt ltKeep the container in the outer carton gt ltKeep the container tightly closed gt

ltThis veterinary medicinal product does not require any special storage conditionsgtltThis veterinary medicinal product does not require any special temperature storage conditionsgt

[ The stability data generated at 25 C60 RH (acc) should be taken into account when deciding whether or not transport under refrigeration is necessary The statement should only be used in exceptional cases This statement should be used only when critical Eg for containers to be stored on a farm The actual name of the container should be used (eg bottle blister etc) Depending on the pharmaceutical form and the properties of the product there may be a risk of deterioration due to physical changes if subjected to low temperatures Low temperatures may also have an effect on the packaging in certain cases An additional statement may be necessary to take account of this possibility]

Do not use after the expiry date stated on the ltlabelgt ltcartongt ltbottlegt lthellipgtltafter abbreviation used for expiry dategtDo not use this veterinary medicinal product after the expiry date which is stated on the ltlabelgt ltcartongt ltbottlegt ltgt ltafter abbreviation used for expiry dategt ltThe expiry date refers to the last day of that monthgt

ltShelf- life after first opening the container hellipgtltShelf- life after ltdilutiongt or ltreconstitutiongt according to directions hellipgt hellipgtltShelf life after incorporation into meal or pelleted feed hellip gthellip

ltDo not use name if you notice description of the visible signs of deteriorationgt

12 SPECIAL WARNING(S)

ltNonegt

ltSpecial warnings lt for each target species gt

ltSpecial precautions for usegt

ltSpecial precautions for use in animalsgt

ltSpecial precautions to be taken by the person administering the veterinary medicinal product to animalsgt

ltPregnancygt

ltLactationgt

ltLaygt

ltInteraction with other medicinal products and other forms of interactiongt

ltOverdose (symptoms emergency procedures antidotes ) gt

ltIncompatibilitiesgt

13 SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS IF ANY

ltMedicines should not be disposed of via wastewater or household wastegtltAsk your ltveterinary surgeongt ltpharmacistgt how to dispose of medicines no longer required These measures should help to protect the environmentgt

14 DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

ltDetailed information on this product is available on the website of the European Medicines Agency(EMEA) (httpwwwem e aeuropaeu )gt

lt15 OTHER INFORMATIONgt

ltFor any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holdergt

BelgieumlBelgiqueBelgienNomNaamNameltAdresseAdresAnschrift BE-0000 LocaliteacuteStadStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefoonnummerTelefonnummerlteE-mailgt

LuxembourgLuxemburgNomltAdresseL-0000 LocaliteacuteStadtgtTeacutelTel + Ndeg de teacuteleacutephoneTelefonnummerlteE-mailgt

Република БългарияНаименованиеltАдресBG Град Пощенски кодgtTeл + 359 Телефонен номерlteE-mailgt

MagyarorszaacutegNeacutevltCiacutemHU-0000 VaacuterosgtTel + TelefonszaacutemlteE-mailgt

Českaacute republikaNaacutezevltAdresaCZ městogtTel +telefonniacute čiacuteslolteE-mailgt

MaltaIsemltIndirizzMT-0000 BeltRaħalgtTel + Numru tat-telefonlteE-mailgt

DanmarkNavnltAdresseDK-0000 bygtTlf + TelefonnummerlteE-mailgt

NederlandNaamltAdresNL-0000 XX stadgtTel + TelefoonnummerlteE-mailgt

DeutschlandNameltAnschriftDE-00000 StadtgtTel + TelefonnummerlteE-mailgt

NorgeNavnltAdresseN-0000 poststedgtTlf + TelefonnummerlteE-mailgt

Eesti(Nimi)lt(Aadress)EE - (Postiindeks) (Linn)gtTel +(Telefoninumber)lteE-mailgt

OumlsterreichNameltAnschriftA-00000 StadtgtTel + TelefonnummerlteE-mailgt

ΕλλάδαΌνομαltΔιεύθυνσηGREL-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt

PolskaNazwa NazwiskoltAdresPL- ndash 00 000MiastogtTel + Numer telefonult Ee-mailgt

EspantildeaNombreltDireccioacutenES-00000 CiudadgtTel + TeleacutefonolteE-mailgt

PortugalNomeltMoradaPT-0000000 CidadegtTel + Nuacutemero de telefonelteE-mailgt

FranceNomltAdresseFR-00000 LocaliteacutegtTeacutel + Numeacutero de teacuteleacutephonelteE-mailgt

RomacircniaNumeltAdresăOraş Cod poştal ndash ROgtTel + Număr de telefonlteE-mailgt

IrelandNameltAddressIERL - Town Code for DublingtTel + Telephone numberlteE-mailgt

SlovenijaImeltNaslovSI-0000 MestogtTel + telefonska številkalteE-mailgt

IacuteslandNafnltHeimilisfangIS-000 BorgBaeligrgtSiacutemi + SiacutemanuacutemerltNetfanggt

Slovenskaacute republikaMenoltAdresaSK-000 00 MestogtTel + Telefoacutenne čiacuteslolteE-mailgt

ItaliaNomeltIndirizzoIT-00000 LocalitagravegtTel + Numero di telefonogtlteE-mailgt

SuomiFinlandNimiNamnltOsoiteAdressFIN-00000 PostitoimipaikkaStadgtPuhTel + PuhelinnumeroTelefonnummerlteE-mailgt

ΚύπροςΌνομαltΔιεύθυνσηCY-000 00 πόληgtΤηλ + Αριθμός τηλεφώνουlteE-mailgt

SverigeNamnltAdressSE-000 00 StadgtTel + TelefonnummerlteE-mailgt

LatvijaNosaukumsltAdresePilsēta LVPasta indekssgtTel + Telefona numurslteE-mailgt

United KingdomNameltAddressTown Postal code ndash UKgtTel + Telephone numberlteE-mailgt

LietuvapavadinimasltadresasLT -pašto indeksas miestasgtTel +370 telefono numerislteEl -mailpaštasgt

(Invented) name of veterinary medicinal product ltstrengthgt pharmaceutical form lttarget speciesgt

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Active substanceltsgt

ltAdjuvant(ltsgt)gt

ltExcipient(ltsgt)gt

For athe full list of excipients see section 61

4 CLINICAL PARTICULARS

41 Target species

42 Indications for use specifying the target species

43 Contraindications

ltNonegtltDo not use in hellipgtltDo not use in case of hypersensitivity to the active substance(s) lt to the adjuvant(s)gt or to any of the excipient(s)gt

44 Special warnings ltfor each target speciesgt

ltNonegt

45 Special precautions for use

Special precautions for use in animals

ltNot applicablegt

ltVaccinated species may excrete the vaccine strain up to x ltdaysgt ltweeksgt following vaccination During this time the contact of immunodepressed immunosuppressed and unvaccinated species with vaccinated species should be avoidedgt

ltThe vaccineal strain can spread to speciesSpecial precautions should be taken to avoid spreading of the vaccine strain to speciesgt

ltAppropriate veterinary and husbandry measures should be taken to avoid spread of the vaccine strain to susceptible speciesgt

ltSpecies and unvaccinated species in contact with vaccinated species may react to the vaccine strain presenting clinical signs such as hellipgt

ltNot applicablegt

ltNone knowngt

63 Shelf life

ANNEX II

Name and addressgt

Name and address

ltNot applicablegt

Marker residue

tissuesOther

Marker residue

tissuesOther

ltPSURsgt

ANNEX III

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

ltNot applicablegt

ltNone knowngt

63 Shelf life

ANNEX II

Name and addressgt

Name and address

ltNot applicablegt

Marker residue

tissuesOther

Marker residue

tissuesOther

ltPSURsgt

ANNEX III

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

ltNone knowngt

63 Shelf life

ANNEX II

Name and addressgt

Name and address

ltNot applicablegt

Marker residue

tissuesOther

Marker residue

tissuesOther

ltPSURsgt

ANNEX III

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

ltNone knowngt

63 Shelf life

ANNEX II

Name and addressgt

Name and address

ltNot applicablegt

Marker residue

tissuesOther

Marker residue

tissuesOther

ltPSURsgt

ANNEX III

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

ltNone knowngt

63 Shelf life

ANNEX II

Name and addressgt

Name and address

ltNot applicablegt

Marker residue

tissuesOther

Marker residue

tissuesOther

ltPSURsgt

ANNEX III

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

ANNEX II

Name and addressgt

Name and address

ltNot applicablegt

Marker residue

tissuesOther

Marker residue

tissuesOther

ltPSURsgt

ANNEX III

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

ANNEX II

Name and addressgt

Name and address

ltNot applicablegt

Marker residue

tissuesOther

Marker residue

tissuesOther

ltPSURsgt

ANNEX III

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

Name and addressgt

Name and address

ltNot applicablegt

Marker residue

tissuesOther

Marker residue

tissuesOther

ltPSURsgt

ANNEX III

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

Marker residue

tissuesOther

ltPSURsgt

ANNEX III

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

ANNEX III

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

ANNEX III

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

A LABELLING

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

NATURETYPE

4 PACKAGE SIZE

5 TARGET SPECIES

6 INDICATION(S)

8 WITHDRAWAL PERIOD

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

EU0200000000

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

NATURETYPE

5 WITHDRAWAL PERIOD

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

NATURETYPE

ltEXP monthyeargt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

B PACKAGE LEAFLET

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

speciesgt

4 INDICATION(S)

5 CONTRAINDICATIONS

6 ADVERSE REACTIONS

7 TARGET SPECIES

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

ltNonegt

ltPregnancygt

ltLactationgt

ltLaygt

ltPregnancygt

ltLactationgt

ltLaygt

Documents

EN_veterinary template_v.8_final · Web view{(Invented) name of veterinary medicinal product pharmaceutical form }