4.2.2. PICTURES OF DOUBLEPEN PAchemprotect.sk/wp-content/uploads/2018/10/ChemPro_catalog_Dou… · Autoinjector delivers all drugs intramuscularly to the back muscles of thigh and

ISO 9001:2015ChemProtect SK | Office Czech RepublicCukrovarnická 1071/62, 162 00 Praha [email protected] | www.chemprotect.sk

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4.2. DOUBLEPEN PA Autoinjectorisasemiautomaticinjectiondeviceforthefirstaidincaseofnerveagent(GorV)ororganophospho-

ruspesticideintoxicationdesignedforselfapplicationormutualapplication(buddyaid),afterdonningprotectivemaskandpriortothedecontaminationanddeliveryofmedicalcare.Theautoinjectorisapartofregularhealthequipmentofeachsoldier.Autoinjectordeliversalldrugsintramuscularlytothebackmusclesofthighandisabletopenetrateseverallayersofclothing.Autoinjectorisadisposabledevice,intendedforsingledosedelivery.

4.2.1. CONTENT OF THE TWO-CHAMBER AUTOINJECTOR 1st chamber Anticholinergicdrug(pralidoximechloride) 600mg/2ml 2nd chamber (contains needle) Atropinesulfate(anticholinergicdrug) 2mg/2ml

Autoinjectoriscomposedofthebody,injectingmechanismandatwo-chamberampule(bullet)withpralidoximeandatropinewhichcontainstheinjectionneedle.Theautoinjectorbodyisblackwithstripesignsforpralidoxime(brown)andatropine(yellow).Autoinjectorhastworingextensionsforforeasyrecognitionincaseofapplicationatnight.AllautoinjectorsignsareaccordingtoSTANAGrequirements.

4.2.2. PICTURES OF DOUBLEPEN PA


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4.2.3. TECHNICAL DATA Autoinjectorlength: 140mm Maximumautoinjectordiameter: 24mm Bulletlength(filledwithantidote): 70mm Maximumbulletdiameterwithclosure: 20mm Autoinjectorweight: 70g Needlelength: 20mm Applicationtime: 10s

4.2.4. LABELLING

4.2.5. USAGE 1. Removemetalsafetypin,placeautoinjectoragainstthighmuscle 2. Pushsafetyfuseforantidoteapplicationandhold10seconds 3. Removetheautoinjectorfromthemuscle


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4.2.6. PACKAGE LEAFLET

WWW.CHEMPROTECT.SK

ChemProtect.SKOffice Czech RepublicCukrovarnická 1071/62, 162 00 Praha [email protected]

CHEMISTRY4LIFE

WWW.CHEMPROTECT.SKChemProtect.SKOffice Czech RepublicCukrovarnická 1071/62, 162 00 Praha [email protected]

CHEMISTRY4LIFE2. Afterintramuscularinjectionofatropine,theonsetofeffectisin30-45minutes.Plasmaproteinbindingis

14-22%.Itcrossestheblood-brainbarrierwell.Atropineismetabolisedintheliverbymicrosomalmono-oxygenasetometabolitestropicacidandtropin(29%),estersoftropicacidandconjugateswithglucu-ronicacid.Unchangedform(30-60%)ofatropineanditsmetabolitesareexcretedrenally(94%ofthetotaldoseper24hours).Eliminationhalf-lifeis2-3hoursinadults.Thereisabigindividualvariability.

INDICATION: Antidotalmeanforthetreatmentofintoxicationswithorganophosphorusacetylcholinesteraseinhibitorsfromthegroupofnerveagentsororganophosphatepesticides.Theauto-injectorisnotdesignatedforlongtermtreatment.Auto-injectorisnottobeusedforprophylaxis.

CONTRAINDICATIONS: 1. Moreseverehepaticandrenalimpairment(pralidoximechloride).2. Closed-angleglaucoma,prostatichypertrophy,organicpylorostenosis,hyperthyroidism,mucovisci-

dosis,tachycardiaandtachyarrhythmia,increasedintracranialandintraocularpressure,severeacid/basebalanceimpairment,hypoxia(atropine).

3. Administrationiscontraindicatedinhypersensitivitytothepralidoxime,atropineorusedexcipients.Auto-injectorisnotsuitableforchildrenandpregnantorlactatingwomen.

SIDE EFFECTS: 1. PralidoximechloridecanslightlyincreaseASTactivity,gamma-GTactivity,creatinineandurobilinogen

inurine.Thosealleffectscorrespondtoslighteffectofpralidoximetohepaticandrenalfunctions.2. Atropinecancausedrynessofthemouthandnose,mydriasis,decreasedaccommodation,increase

ofintraocularpressure,photophobia,tachycardiaorarrhythmia,urinaryretention,headache,consti-pation.Afterhigherdoses:temperatureregulationblockingwithhyperthermia,excitation,twitchingevenmuscleseizures,hallucinationsevenlossofconsciousness.

DOSAGE:Auto-injectorshouldbeadministeredintramuscularlyafterintoxication(signsandsymptomsarepresent)priortothedecontaminationanddeliveryofmedicalcare.Ifseveresignsandsymptomsarepresent,threeauto-injectorsshouldbeadministeredinrapidsuccession.Benzodiazepines(diazepam)canbeco-administeredincaseofexcitationorseizures.

Instructions for application1. Removecotterpin,placeauto-injectoragainstthighmuscle.2. Pushsafetyfuseforantidoteapplicationandhold10seconds.3. Removeauto-injectorfrommuscle.

STORAGE: Storeinadryanddarkplace,attemperature5-25oC,donotrefrigerateorfreeze.

Manufacturer:FarmáciaMartina.s.forChemProtect.SK s.r.o.,Staničná1119/8,03901TurčianskeTeplice,SlovakRepublic,IDnumber:44397526Office–Cukrovarnická1071/62,16200Prague6,CzechRepublic,www.chemprotect.sk

Lastrevision:May2015

PACKAGE LEAFLET – SUMMARY OF PRODUCT CHARACTERISTICS DOUBLEPEN PA | PRALIDOXIME – ATROPINE AUTO-INJECTORTwo-chamberedauto-injector(DOUBLEPENPA)containingPRALIDOXIMEchloride(600mg),ATROPINEsulfatemonohydrate(2mg).Sterilesolutionsforintramuscularuseonly.

COMPOSITION:Oneauto-injectordeliversatropinesulfatemonohydrate2mginwaterforinjections(2ml,firstchamber)andpralidoximechloride600mginwaterforinjections(2ml,secondchamber).Theproductispyrogenfreeandcontainsexcipients(sodiumchloride,disodiumedetate,benzylalcohol,glycine)toimprovethestabilityofsolution.

DESCRIPTION:Prefilledtwo-chamberedauto-injectorforfirstaid(self-orbuddy-aid)inthecaseofpoisoningwithace-tylcholinesteraseinhibitorsfromthegroupoforganophosphoruscompounds(nerveagents,organophos-phatepesticides).Thissingle-usedeviceprovidesautomaticintramuscularadministrationofpralidoxime(1)andatropine(2). Indication groups: 1. Antidoteagainstnerveagentpoisoning,acetylcholinesterasereactivator.2. Parasympatholyticdrug.

CHARACTERISTIC: 1. Pralidoximechlorideisasyntheticacetylcholinesterasereactivatorthatisabletosplitthechemical

bondbetweennerveagentorpesticideandtheenzyme,restoringthenormalfunctionofnervoussys-temintheintoxicatedperson.Peripheralantimuscarinicandantinicotiniceffects,blockingofcentralcholinergicreceptors,moderateperipheralanticholinergiceffectandstimulationofbloodpressureandrespiratorycenterswereobservedafteritsadministration.Alltheseeffectsarefavorableintreat-mentoftheintoxication.Therecoveryofspontaneousrespirationandreturnofconsciousnessareacceleratedwhenpralidoximeisadministeredtogetherwithparasympatholyticdrug.

2. AtropineisanaturalalkaloidofSolanaceae.Itantagonizestheacetylcholinemuscariniceffectsthrou-ghdifferentdegreeM-receptorsblocking. Iteffectsspasmolyticallyonsmoothmuscles,decreasessalivation,sweatingandrespiratorysecretion.

PHARMACOKINETICS: 1. Theplasmapralidoximetherapeuticconcentrationafter i.m.administration isachievedapprox.16

minafterapplicationandpersists2-3hours.Pralidoxime isdistributed toalltissues.Approx.55%ofthesubstanceisexcretedbythekidneysunchangedin24hours.Thebloodpressure,heartrate,respirationfrequency,ECGparameters,behaviorandvisionarenotinfluenced.


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4.2.7. STORAGE CONDITIONS 5–25°C(41–77°F)

4.2.8. WARRANTY 3years

4.2.9. PACKAGING Cartonwith50pcs

Photoforexampleofpackagingonly.

Documents

4.2.2. PICTURES OF DOUBLEPEN PAchemprotect.sk/wp-content/uploads/2018/10/ChemPro_catalog_Dou… · Autoinjector delivers all drugs intramuscularly to the back muscles of thigh and