FrancophonIA/ELRC3.0 huggingface dataset:
English: DK-6000 Kolding, Tlf: + 45 7552 1244
Croatian: Profilvej 1, DK-6000 Kolding, Tlf: + 45 7552 1244
English: One size of unit-dose pipette only per box.
Croatian: Kutija sadrži samo jednu pipetu s jediničnom dozom.
English: The absorbed indoxacarb and permethrin are extensively metabolised by the liver to a variety of metabolites.
Croatian: Apsorbirani indoksakarb i permetrin se opsežno metaboliziraju u jetri do raznih metabolita.
English: VIRBAC Danmark A/S, Profilvej 1,
Croatian: Danmark: VIRBAC Danmark A/S,
English: Spot-on use
Croatian: Spot-on primjena
English: ж.к.Люлин 10, бл.145, ergon-m@mbox.contact.bg
Croatian: Ергон-Миланова ЕООД, Р България, гр.София, ж.к.Люлин 10, бл.145, ergon-m@mbox.contact.bg
English: Laboratory studies in rats, mice and rabbits with indoxacarb and permethrin have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.
Croatian: Laboratorijska ispitivanja na štakorima, miševima i zečevima s indoksakarbom i permetrinom nisu dala nikakve dokaze o teratogenim i fetotoksičnim ili maternotoksičnim učincima.
English: Signs of poisoning are severe tremors, muscle cramp and ataxia.
Croatian: Znakovi trovanja su jak tremor, grčenje mišića i ataksia.
English: Permethrin belongs to the Type I class of pyrethroids, which are acaricides and insecticides with repellent activity.
Croatian: I skupini piretroida, koji su akaricidi i insekticidi s repelentnom aktivnosti.
English: One treatment provides repellent (anti-feeding) activity against sand flies (Phlebotomus perniciosus) for up to 3 weeks.
Croatian: Jedna primjena pruža repelentni (sprečava hranjenje) učinak protiv papatača (Phlebotomus perniciosus) do 3 tjedna.
English: Signs related to the nervous system can be treated with e.g. atropine (salivation) and diazepam (muscle tremors/fasciculation/cramp).
Croatian: Simptomi povezani sa nervnim sustavom mogu biti tretirani npr. atropinom (slinjenje) ili diazepaminom ( tremor mišića/grčevi).
English: Following a single administration, the veterinary medicinal product will prevent further flea infestation for 4 weeks and prevent tick re-infestation (through an acaricidal effect) with I. ricinus and R. sanguineus for 5 and 3 weeks, respectively; repellent (anti-feeding) activity against sand flies will last for 3 weeks.
Croatian: Nakon pojedine administracije, veterinarsko medicinski proizvod će prevenirati daljnju infestaciju buhama 4 tjedna te ponovnu infestaciju krpeljima (akaridni učinak) s I. ricinus i R. sanguineus za 5 i
English: THE WORDS “FOR ANIMAL TREATMENT ONLY”
Croatian: RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” Samo za primjenu na životinjama.
English: Stored pipettes must be kept in the child-resistant sachet.
Croatian: Čuvane pipete moraju se držati u vrećici otpornoj na otvaranje od strane djece.
English: Manufacturer responsible for batch release: Intervet Productions SA Rue de Lyons
Croatian: Proizvođač odgovoran za puštanje proizvodne serije: Intervet Productions SA
English: Do not use in cats.
Croatian: Ne primjenjivati na mačkama.
English: 13ο χλμ.
Croatian: Rögen 20,
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER (pipette label)
Croatian: ILI TRAKAMA BLISTER (naljepnica na pipetama)
English: Keep out of the sight and reach of children.
Croatian: Držati izvan pogleda i dosega djece.
English: The application of the veterinary medicinal product may produce a local, temporary oily appearance or hair clumping at the application site.
Croatian: Primjenom veterinarsko-medicinskog proizvoda može doći do lokaliziranog, privremeno masnog izgleda dlake ili gubitka veće količine dlake na mjestu primjene.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET
Croatian: OSNOVNI DIJELOVI NAPISANI NA MALIM JEDINICAMA UNUTARNJIH PAKOVANJA VREĆICE
English: Apply the product only to the skin surface and on intact skin.
Croatian: Primijeniti proizvod na površinu netaknute kože.
English: PACKAGE LEAFLET: Activyl Tick Plus spot-on solution for dogs
Croatian: UPUTA O VMP: Activyl Tick Plus spot-on otopina za pse
English: Veterinary medicinal product not subject to prescription.
Croatian: Veterinarsko-medicinski proizvod se izdaje na veterinarski recept.
English: Transitory erythema (redness of skin), hair loss or itching at the application site were commonly (13 of 359 dogs) observed in clinical studies.
Croatian: U kliničkim ispitivanjima često se uočava prolazni eritem (crvenilo kože), gubitak dlake ili svrbež na mjestu aplikacije ( kod 13 od 359 pasa).
English: The major route of excretion is in faeces for indoxacarb and both in urine and faeces for permethrin.
Croatian: Glavni put izlučivanja za indoksakarb je fecesom, a za permetrin u jednakoj mjeri mokraćom i fecesom.
English: VIRBAC BELGIUM NV, Esperantolaan 4, BE-3001 Leuven, Tél/Tel: + 32 (0) 16 38 72 60
Croatian: Esperantolaan 4, BE-3001 Leuven, Tél/Tel: + 32 (0) 16 38 72 60
English: Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Croatian: Posebne predostrožnosti za osobe koje primjenjuju veterinarsko medicinski proizvod na životinjama:
English: 4.9 Amounts to be administered and administration route
Croatian: 4.9 Količine koje se primjenjuju i put primjene Doziranje:
English: DANGER - Do not use in cats as adverse reactions and even death can occur (see also section Special precautions for use in animals).
Croatian: OPREZ - Ne primjenjivati na mačkama jer se mogu pojaviti nuspojave uključujući uginuće (pogledati pod posebna upozorenja kod primjene)
English: The recommended dose for dogs is 15 mg indoxacarb and 48 mg permethrin per kg bodyweight, equivalent to 0.1 ml/kg bodyweight.
Croatian: Preporučena doza za pse je 15 mg indoksakarba i 48 mg permetrina na 1 kg tjelesne težine, što je ekvivalent od 0,1 ml/kg tjelesne težine.
English: Dosage schedule:
Croatian: Raspored tretiranja:
English: Danger - Do not use in cats.
Croatian: OPREZ - ne upotrebljavati na mačkama.
English: Step 1: Hold the pipette in an upright position away from your face.
Croatian: Korak 1: Jednom rukom, držite pipetu u uspravnom položaju dalje od lica i otvorite ju savijajući vrh te ga vratite u početni položaj.
English: Do not use in cases of known hypersensitivity to the active substances or to any of the excipients.
Croatian: Ne primjenjivati u slučaju preosjetljivosti na djelatnu tvari ili na bilo koju od pomoćnih tvari.
English: However, a reproductive toxicity study conducted in the dog at three times the recommended therapeutic dose did reveal a significant reduction in the live pup ratio; the clinical significance of this latter finding is unknown as no studies were carried out in dogs using the recommended therapeutic dose.
Croatian: Međutim, ispitivanja reproduktivne toksičnosti provedena na psu s tri puta većim terapijskim dozama od preporučenih je otkrila značajno smanjenje broja živorođene štenadi.
English: For application to the dog's skin only.
Croatian: Samo za primjenu na kožu.
English: Indoxacarb and permethrin may have harmful effects on aquatic organisms.
Croatian: Indoksakarb i permetrin mogu biti opasni za vodene organizme.
English: Keep the pipettes in the original packaging until ready to use.
Croatian: Čuvati pipete u originalnom pakovanju do upotrebe.
English: Keep treated animals separately until the application site is dry.
Croatian: Izdvojiti životinju dok se mjesto aplikacije ne osuši.
English: Indoxacarb (mg/kg)
Croatian: Indoksakarb (mg/kg)
English: Gastrointestinal signs (e.g. emesis (vomiting), diarrhoea or anorexia (loss of appetite), reversible neurological signs (e.g. tremor (shakiness) or ataxia (unsteady movement)) or lethargy (drowsiness) have been observed in very rare cases.
Croatian: Gastrointestinalni simptomi (npr. povraćanje, proljev ili manjak apetita), privremeni neurološki simptomi (npr. tremor (tresavica) ili ataksija (nestabilni pokreti) ) ili letargija (nezainteresiranost) se mogu pojaviti u rijetkim slučajevima.
English: Care should be taken to apply the product to intact skin.
Croatian: Paziti da se upotrebi na intaktnoj koži.
English: VIRBAC Tierarzneimittel GmbH, Rögen 20,
Croatian: Deutschland: VIRBAC Tierarzneimittel GmbH,
English: Dogs 1.2 - 5 kg Dogs 5.1 - 10 kg Dogs 10.1 - 20 kg Dogs 20.1 - 40 kg Dogs 40.1 - 60 kg
Croatian: Psi 1,2 - 5 kg Psi 5,1 - 10 kg Psi 10,1 - 20 kg Psi 20,1 - 40 kg Psi 40,1 - 60 kg
English: It is important to ensure that cats do not groom the site of application on a dog which has been treated with this product.
Croatian: Važno je da mačke ne dodiruju tretirano mjesto na psu.
English: The sachet is child-resistant.
Croatian: Vrećica je otporna na otvaranje od strane djece.
English: STATEMENT OF ACTIVE SUBSTANCES
Croatian: NAVOĐENJE DJELATNIH TVARI
English: VIRBAC DE PORTUGAL, LABORATÓRIOS LDA, R.do Centro Empresarial, Ed13-Piso 1- Esc.3, Quinta da Beloura, PT-2710-693 Sintra, Tel: + 351 219 245 020
Croatian: Ed13-Piso 1- Esc.3, Quinta da Beloura, PT-2710-693 Sintra, Tel: + 351 219 245 020
English: Do not apply an excessive amount of solution at any one spot in order to prevent run-off. Should run-off occur, re-application is not necessary.
Croatian: Ne aplicirati preveliku količinu na jednom mjestu da bi se izbjeglo curenje.
English: Lactation: Do not use in lactating dogs
Croatian: Laktacija: Ne koristiti kod kuja u laktaciji.
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Croatian: I POGLEDA DJECE” Čuvati izvan pogleda i dosega djece.
English: The recommended minimum dose is 15 mg indoxacarb/kg bodyweight and 48 mg/kg permethrin, equivalent to 0.1 ml spot-on solution per kg bodyweight.
Croatian: Minimalna preporučena doza je 15 mg indoksakarba/kg tjelesne težine i 48 mg/kg permetrina što odgovara 0,1 ml otopine po kg tjelesne težine.
English: SPECIAL STORAGE CONDITIONS
Croatian: 11. POSEBNI UVJETI ČUVANJA
English: Pharmacotherapeutic group: Ectoparasiticides for topical use, incl.
Croatian: FARMAKOLOŠKA SVOJSTVA Farmakoterapijska grupa: ektoparazitik za vanjsku upotrebu, insekticidi; permetrin, kombinacija.
English: Method of administration:
Croatian: Način primjene:
English: Indoxacarb (mg)
Croatian: Indoksakarb (mg)
English: Very small dogs (1.2 - 5 kg) Small dogs (5.1 - 10 kg) Medium dogs (10.1 - 20 kg) Large dogs (20.1 - 40 kg) Extra large dogs (40.1 - 60 kg)
Croatian: Jako mali psi (1,2 -5 kg) Mali psi (5,1 -10 kg) Srednje veliki psi (10,1 - 20 kg) Veliki psi (20,1 -40 kg) Jako veliki psi (40,1 -60 kg)
English: Pregnancy:
Croatian: Graviditet:
English: Gastrointestinal signs (e.g. emesis, diarrhoea or anorexia), reversible neurological signs (e.g. tremor or ataxia) or lethargy have been observed in very rare cases.
Croatian: Gastrointestinalni simptomi (npr. povraćanje, proljev ili manjak apetita), privremeni neurološki simptomi (npr. tremor ili ataksija) ili letargija u vrlo rijetkim slučajevima.
English: VIRBAC SP. Z O.O., Ul.
Croatian: VIRBAC SP.
English: Following a single spot-on application of the product, indoxacarb and permethrin can still be detected in both skin and hair coat after 4 weeks post-treatment.
Croatian: Nakon jedne spot-on primjene proizvoda, indoksakarb i permetrin može biti otkriven u koži i dlakama
English: VIRBAC HELLAS A.E.,
Croatian: VIRBAC HELLAS A.E., 13ο χλμ.
English: VIRBAC NEDERLAND BV, Hermesweg 15, NL-3771 ND Barneveld, Tel: + 31 (0) 342 427 127
Croatian: NL-3771 ND Barneveld, Tel: + 31 (0) 342 427 127
English: VIRBAC ESPAÑA S.A., Angel Guimerá 179-181, ES-8950 Esplugues de Llobregat, infocliente@virbac.es
Croatian: ES-8950 Esplugues de Llobregat, infocliente@virbac.es
English: Keep pipettes in the original packaging until ready to use.
Croatian: Držati pipete u originalnom pakovanju do primjene.
English: NAME OF THE MARKETING AUTHORISATION HOLDER
Croatian: NAZIV NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET
English: Special precautions for use in animals
Croatian: Posebne mjere predostrožnost za primjenu na životinjama:
English: Local and/or systemic reactions have been observed in some people after exposure to the product such as: local skin reactions; nasal or throat/mouth irritation; neurological signs; respiratory signs; gastrointestinal signs or other systemic signs.
Croatian: kožne reakcije, nazalne ili iritacije grla/usta, neurološki znakovi, respiratorni znakovi,
English: SPECIAL STORAGE PRECAUTIONS
Croatian: 11. POSEBNE MJERE PREDOSTROŽNOSTI ZA ČUVANJE
English: 1.2 - 5 Very small dogs
Croatian: Jako mali psi
English: If clinical signs of poisoning occur, seek veterinary advice immediately and show this package leaflet to your veterinarian.
Croatian: Kod slučajnog izlaganja na mačkama: Ukoliko se pojave znakovi trovanja, odmah potražiti veterinarsku pomoć te pokazati uputu.
English: − rare (more than 1 but less than 10 animals in 10,000 animals treated)
Croatian: Učestalost nuspojava je određena prema sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojave) - česte (više od jedne ali manje od 10 tretiranih životinja na 100 životinja) - manje česte (više od 1 ali manje od 10 tretiranih životinja na 1000 životinja) - rijetke (više od 1 ali manje od 10 životinja na 10 000 tretiranih životinja) - vrlo rijetke (manje od 1 životinje na 10 000 tretiranih životinja, uključujući izolirane slučajeve).
English: Permethrin (mg/kg)
Croatian: Permetrin (mg/kg)
English: METHOD AND ROUTE(S) OF ADMINISTRATION For spot-on use.
Croatian: NAČIN I PUT(EVI) PRIMJENE
English: A. MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
English: Pyrethroids affect the voltage-gated sodium channels in vertebrates and non- vertebrates.
Croatian: Piretroidi djeluju na naponski regulirane natrijeve kanale kralježnjaka i beskralježnjaka.
English: Weight of dog (kg) Pipette size to be used
Croatian: Veličina pipeta za korištenje
English: QUANTITY OF THE ACTIVE SUBSTANCE(S)
Croatian: KOLIČINA DJELATNE(IH) TVARI
English: VIRBAC Österreich GmbH, Hildebrandgasse 27, A-1180 Wien, Tel: + 43 (0) 1 21 834 260
Croatian: A-1180 Wien, Tel: + 43 (0) 1 21 834 260
English: Excipients:
Croatian: Predoziranje:
English: A dry white residue may be also observed.
Croatian: Suho-bijeli ostatak proizvoda može biti vidljiv.
English: - BP 27, FR-06517 Carros, service-conso@virbac.fr
Croatian: - BP 27, FR-06517 Carros,
English: 4.5 Special precautions for use
Croatian: 4.5 Posebne mjere predostrožnost za primjenu Posebne mjere predostrožnost za primjenu na životinjama
English: Ticks
Croatian: Buhe
English: Snap the tip open by bending it and folding it back on itself.
Croatian: Korak 1: Držite pipetu u uspravnom položaju dalje od lica i otvorite ju savijajući vrh te ga vratite u početni položaj.
English: Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs (1.2 - 5 kg) Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs (5.1 - 10 kg) Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs (10.1 - 20 kg) Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs (20.1 - 40 kg) Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large dogs (40.1 - 60 kg)
Croatian: Activyl Tick Plus 75 mg + 240 mg spot-on otopina za jako male pse (1,2 - 5 kg) Activyl Tick Plus 150 mg + 480 mg spot-on otopina za male pse (5,1 - 10 kg) Activyl Tick Plus 300 mg + 960 mg spot-on otopina za srednje velike pse ( 10,1 - 20 kg) Activyl Tick Plus 600 mg + 1920 mg spot-on otopina za velike pse ( 20,1 - 40 kg) Activyl Tick Plus 900 mg + 2880 mg spot-on otopina za jako velike pse (40,1 - 60 kg)
English: Indoxacarb 75 mg + permethrin 240 mg Indoxacarb 150 mg + permethrin 480 mg Indoxacarb 300 mg + permethrin 960 mg Indoxacarb 600 mg + permethrin 1920 mg Indoxacarb 900 mg + permethrin 2880 mg
Croatian: Indoksakarb 75 mg + permetrin 240 mg Indoksakarb 150 mg + permetrin 480 mg Indoksakarb 300 mg + permetrin 960 mg Indoksakarb 600 mg + permetrin 1920 mg Indoksakarb 900 mg + permetrin 2880 mg
English: 6.4 Special precautions for storage
Croatian: 4.4 Posebna upozorenja
English: One unit-dose pipette holds 0.5 ml, 1 ml, 2 ml, 4 ml, or 6 ml spot-on solution.
Croatian: Jedna pipeta s jediničnom dozom sadrži 0,5 ml, 1 ml, 2 ml, 4 ml ili 6 ml otopine za nakapavanje.
English: Intravenous infusion of electrolytes should be provided to stabilize vital functions if clinical signs of poisoning occur (e.g. hypersalivation, tremor, muscle cramp).
Croatian: ukoliko se pojave klinički znakovi trovanja (npr. pretjerano slinjenje, tremor, grčenje mišića).
English: Fleas
Croatian: Krpelji
English: Sand flies
Croatian: Rue de Lyons
English: Τηλ: + 30 210 6219520, info@virbac.gr
Croatian: Τηλ: + 30 210 6219520,
English: Fertility: Do not use in breeding dogs.
Croatian: Ne koristiti kod pasa za rasplod.
English: Cardboard box of 1 pipette of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Croatian: Kartonska kutija s 1 pipetom od 0,5 ml, 1 ml, 2 ml, 4 ml ili 6 ml.
English: Cardboard box of 4 pipettes of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Croatian: Kartonska kutija s 4 pipete od 0,5 ml, 1 ml, 2 ml, 4 ml ili 6 ml.
English: Activyl Tick Plus 75 mg + 240 mg spot-on solution for very small dogs Activyl Tick Plus 150 mg + 480 mg spot-on solution for small dogs Activyl Tick Plus 300 mg + 960 mg spot-on solution for medium dogs Activyl Tick Plus 600 mg + 1920 mg spot-on solution for large dogs Activyl Tick Plus 900 mg + 2880 mg spot-on solution for extra large dogs
Croatian: Activyl Tick Plus 75 mg + 240 mg spot-on otopina za jako male pse Activyl Tick Plus 150 mg + 480 mg spot-on otopina za male pse Activyl Tick Plus 300 mg + 960 mg spot-on otopina za srednje velike pse Activyl Tick Plus 600 mg + 1920 mg spot-on otopina za velike pse Activyl Tick Plus 900 mg + 2880 mg spot-on otopina za jako velike pse
English: Cardboard box of 6 pipettes of 0.5 ml, 1 ml, 2 ml, 4 ml or 6 ml.
Croatian: Kartonska kutija s 6 pipeta od 05 ml, 1 ml, 2 ml, 4 ml ili 6 ml.
English: 10.1 - 20 Medium dogs 20.1 - 40 Large dogs
Croatian: 5,1 -10 Mali psi 10,1 -20 Srednje veliki psi 20,1 - 40 Veliki psi 40,1 -60 Jako veliki psi treba upotrijebiti odgovarajuću kombinaciju pipeta
English: Indoxacarb + permethrin
Croatian: info@virbac.gr
English: Ергон-Миланова ЕООД, Р България, гр.София,
Croatian: Luxembourg/Luxemburg: VIRBAC BELGIUM NV,
English: MARKETING AUTHORISATION NUMBER(S)
Croatian: 16. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET
English: 4.11 Withdrawal period(s)
Croatian: 4.11 Karencija
English: Permethrin (mg)
Croatian: Permetrin (mg)
English: Batch {number}
Croatian: (mg)
English: BATCH NUMBER
Croatian: BROJ PROIZVODNE SERIJE
English: Before having an operation
Croatian: Prije operacije
English: If he/she is unavailable seek emergency assistance.
Croatian: Ako on/ona nije dostupan/na, potražite hitnu medicinsku pomoć.
English: Recovery usually takes place over a period of time.
Croatian: Oporavak obično nastupa nakon nekog vremena.
English: You may need urgent medical treatment.
Croatian: Može Vam biti potrebno hitno medicinsko liječenje.
English: This can be due to the high dosages usually used in this population.
Croatian: Razlog tomu mogu biti visoke doze obično primjenjivane u toj populaciji.
English: Injections should be repeated as required to maintain good function and minimise pain.
Croatian: Injekcije treba ponavljati prema potrebi da bi se održala dobra funkcija i smanjila bol.
English: n = 38 n = 39 n = 36 n = 36 n = 37
Croatian: n = 36 n = 36 n = 37
English: Restricted to hospital use only.
Croatian: Ograničeno samo na bolničku upotrebu.
English: The risks, which can include death, may outweigh the potential benefits.
Croatian: Rizici, uključujući i smrt, mogu prevagnuti nad potencijalnim koristima.
English: The risk of spreading of effect is greater than in adults, and more frequently severe.
Croatian: Rizik od širenja učinka veći je nego u odraslih, a češće je i težeg oblika.
English: The dose resulting in death was 2400 U/kg.
Croatian: Doza koja je rezultirala smrću bila je 2400 U/kg.
English: TWSTRS-Total
Croatian: TWSTRS - ukupno
English: You may feel pain at the place where you had the injection, but this should wear off after a few minutes.
Croatian: Možda ćete osjetiti bol na mjestu uboda injekcije, ali to bi trebalo proći nakon nekoliko minuta.
English: They may happen days to weeks after you have had the injection.
Croatian: Mogu se dogoditi danima ili tjednima nakon što ste primili injekciju.
English: On these scales, scores of 50 indicate no change, 0 much worse, and 100 much better.
Croatian: Na tim ljestvicama 50 bodova pokazuje da nema promjene, 0 veliko pogoršanje, a 100 veliko poboljšanje.
English: If this happens, do not drive or use any tools or machines.
Croatian: Ako se to dogodi, nemojte voziti niti rukovati alatima ili strojevima.
English: However, the pharmacological characteristics do not indicate any need to adjust the dose.
Croatian: Međutim, farmakološke značajke ne pokazuju potrebu za prilagodbom doze.
English: Store in a refrigerator at 2oC-8oC.
Croatian: Čuvati u hladnjaku na 2oC-8oC.
English: The safety of NeuroBloc outside the approved indication has not been established.
Croatian: Sigurnost NeuroBloca izvan odobrenih indikacija nije ustanovljena.
English: Do not shake.
Croatian: Nemojte tresti.
English: Very common (may affect more than 1 in 10 people) dry mouth difficulty swallowing headache
Croatian: Vrlo česte (mogu se pojaviti u više od 1 na 10 osoba) suha usta otežano gutanje glavobolja
English: The following information is intended for healthcare professionals only: INSTRUCTIONS FOR USE, HANDLING AND DISPOSAL
Croatian: Sljedeće informacije namijenjene su samo zdravstvenim radnicima: UPUTE ZA PRIMJENU, RUKOVANJE I ZBRINJAVANJE
English: Animal reproduction studies are insufficient with respect to effects on pregnancy and embryonal/foetal development.
Croatian: Ispitivanja provedena na životinjama nedostatna su s obzirom na učinke na trudnoću i embrionalni/fetalni razvoj.
English: Spread of toxin effect
Croatian: Širenje učinka toksina
English: Cases of overdose (some with signs of systemic toxicity) have been reported.
Croatian: Zabilježeni su slučajevi predoziranja (neki uz znakove sistemske toksičnosti).
English: This is where you have contractions of your neck or shoulder muscles that you cannot control.
Croatian: To je stanje u kojem imate stezanja (kontrakcije) mišića vrata ili ramena koja ne možete kontrolirati.
English: There were 77 subjects enrolled into the first study and 109 subjects into the second.
Croatian: U prvo ispitivanje bilo je uključeno 77 ispitanika, u drugo 109 ispitanika.
English: The available reports indicate that the product has been used in the paediatric population.
Croatian: Dostupna izvješća pokazuju da se ovaj lijek primjenjivao u pedijatrijskoj populaciji.
English: General precaution:
Croatian: Opće mjere opreza:
English: Date of first authorisation: 22 January 2001 Date of latest renewal: 29 November 2010
Croatian: Datum posljednje obnove odobrenja: 29. studeni 2010.
English: You may get a dry mouth and it might become difficult to swallow.
Croatian: Možda ćete osjetiti da su Vam suha usta i može Vam postati teško gutati.
English: In rare cases difficulty in swallowing may be severe and choking is possible.
Croatian: U rijetkim slučajevima teškoće s gutanjem mogu postati teške pa je moguće gušenje.
English: You must not be given NeuroBloc if any of the above applies to you.
Croatian: Ne smijete primiti NeuroBloc ako se bilo što od gore navedenog odnosi na Vas.
English: Elderly No dose adjustment is required in older people ≥ 65 years of age.
Croatian: Nije potrebna prilagodba doze u starije populacije u dobi od 65 ili više godina.
English: Luxembourg
Croatian: Luksemburg
English: The medicinal product is ready to use and no reconstitution is required.
Croatian: Lijek je spreman za upotrebu i rekonstitucija nije potrebna.
English: This warning includes use in children and in any other indication besides cervical dystonia.
Croatian: Ovo upozorenje uključuje primjenu u djece i svaku drugu indikaciju osim cervikalne distonije.
English: Contents of the pack and other information What NeuroBloc contains
Croatian: Sadržaj pakiranja i druge informacije Što NeuroBloc sadrži
English: The dosing frequency should therefore be adapted based on the clinical assessment/response of an individual patient.
Croatian: Stoga učestalost doziranja treba prilagoditi na temelju kliničke procjene/odgovora svakog pojedinog bolesnika.