FrancophonIA/ELRC3.0 huggingface dataset:
English: The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of fertility problems.
Croatian: Lijek se izdaje samo na liječnički recept, a liječenje se mora započeti pod nadzorom liječnika koji je iskusan u liječenju problema s plodnošću.
English: Rekovelle is given by injection under the skin once a day for several consecutive days during the woman's menstrual cycle starting on day 2 or 3 of the cycle and is continued until sufficient eggs have developed.
Croatian: Lijek Rekovelle primjenjuje se injekcijom pod kožu jedanput dnevno nekoliko uzastopnih dana tijekom menstrualnog ciklusa, počevši od drugog ili trećeg dana ciklusa, i nastavlja se dok se ne razvije odgovarajući broj jajnih stanica.
English: The frequency of side effects may decrease with repeated treatment cycles.
Croatian: Učestalost nuspojava može se smanjiti ponavljanjem ciklusa liječenja.
English: The study showed that Rekovelle was as effective as GONAL-f at stimulating the ovaries: around 31% of women (204 out of 665) treated with Rekovelle became pregnant compared with around 32% of women (209 out of 661) treated with GONAL-f. Implantation rates were also similar: around 35% with Rekovelle versus around 36% with GONAL-f.
Croatian: Ispitivanje je pokazalo da je lijek Rekovelle jednako djelotvoran kao lijek GONAL-f u stimulaciji jajnika: zatrudnjelo je otprilike 31 % žena (204 od 665) liječenih lijekom Rekovelle u usporedbi s otprilike 32 % žena (209 od 661) liječenih lijekom GONAL-f.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Rekovelle have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Rekovelle nalaze se u sažetku opisa svojstava lijeka i u uputi o lijeku.
English: The starting dose of Rekovelle depends on the woman's bodyweight and on the blood level of the anti-Müllerian hormone (a hormone which indicates how well the ovaries will respond to stimulation).
Croatian: Početna doza lijeka Rekovelle ovisi o tjelesnoj težini žene i o razini anti-Müllerovog hormona u krvi (hormon koji ukazuje na to kako će jajnici odgovoriti na stimulaciju).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Rekovelle's benefits are greater than its risks and recommended that it be approved for use in the EU.
Croatian: Odbor za lijekove za primjenu kod ljudi (CHMP) pri Agenciji odlučio je da koristi lijeka Rekovelle nadmašuju s njim povezane rizike te je preporučio njegovo odobrenje za primjenu u Europskoj uniji.
English: What benefits of Rekovelle have been shown in studies?
Croatian: Koje su koristi lijeka Rekovelle dokazane u ispitivanjima?
English: The most common side effects with Rekovelle (which may affect between 1 and 10 people in 100) are headache, discomfort and pain in the pelvic area which may arise from the ovaries, nausea (feeling sick) and tiredness and ovarian hyperstimulation syndrome (OHSS).
Croatian: Najčešće nuspojave lijeka Rekovelle (koje se mogu javiti u između 1 i 10 na 100 osoba) su glavobolja, nelagoda i bol u zdjelici koja može biti uzrokovana jajnicima, mučnina, umor i sindrom hiperstimulacije jajnika (OHSS).
English: The CHMP considered that Rekovelle was effective in obtaining several eggs at the same time following stimulation in women undergoing fertility treatment.
Croatian: CHMP je zaključio da je lijek Rekovelle učinkovit u istovremenom stvaranju nekoliko jajnih stanica nakon stimulacije u žena koje su podvrgnute liječenju neplodnosti.
English: OHSS is when a woman's ovaries over-respond to stimulation, causing symptoms such as vomiting, diarrhoea and pain.
Croatian: OHSS je stanje uzrokovano prevelikom reakcijom jajnika žene na stimulaciju i uzrokuje simptome poput povraćanja, proljeva i boli.
English: For more information about treatment with Rekovelle, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Croatian: Više informacija o liječenju lijekom Rekovelle pročitajte u uputi o lijeku (također dio EPAR-a), odnosno obratite se svom liječniku ili ljekarniku.
English: Rekovelle is a medicine given to women who are having fertility treatments such as in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI).
Croatian: Rekovelle je lijek koji se propisuje ženama koje se podvrgavaju postupcima liječenja neplodnosti kao što su in vitro oplodnja (IVF) i intracitoplazmatska injekcija spermija (ICSI).
English: Rekovelle must not be used in women with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary.
Croatian: Lijek Rekovelle ne smije se primjenjivati u žena s tumorom hipofize ili hipotalamusa ili rakom dojke, maternice ili jajnika.
English: Rekovelle was compared with GONAL-f (follitropin alfa), another fertility medicine, in one study involving 1,326 women who were undergoing controlled ovarian stimulation for IVF or ICSI.
Croatian: Lijek Rekovelle uspoređen je s lijekom GONAL-f (folitropin alfa), drugim lijekom za neplodnost, u jednom ispitivanju u kojem je sudjelovalo 1326 žena koje su podvrgnute kontroliranoj stimulaciji jajnika u cilju provođenja IVF-a ili ICSI-a.
English: How is Rekovelle used?
Croatian: Kako djeluje Rekovelle?
English: Giving extra stimulation with Rekovelle helps increase the number of eggs produced in the ovaries, which means that more eggs can then be collected and fertilised in the laboratory.
Croatian: Dodatna stimulacija lijekom Rekovelle pomaže u povećanju broja jajnih stanica koje se proizvode u jajnicima, što znači da se više jajnih stanica može prikupiti i oploditi u laboratoriju.
English: Rekovelle must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian syndrome, or when there is unexplained bleeding from the vagina.
Croatian: Lijek Rekovelle ne smije se primjenjivati kod povećanja jajnika ili cista na jajnicima koje nisu posljedica sindroma policističnih jajnika ili u slučaju vaginalnog krvarenja bez poznatog uzroka.
English: The active substance in Rekovelle, follitropin delta, is a copy of the natural hormone called folliclestimulating hormone (FSH) which plays a key role in fertility in women by stimulating the production of eggs in the ovaries.
Croatian: Djelatna tvar u lijeku Rekovelle, folitropin delta, kopija je prirodnog hormona naziva folikulostimulirajući hormon (FSH), koji potiče jajnike na proizvodnju jajnih stanica i ima ključnu ulogu u plodnosti žena.
English: For practical information about using Rekovelle, patients should read the package leaflet or contact their doctor or pharmacist.
Croatian: Praktične informacije o primjeni lijeka Rekovelle bolesnici trebaju pročitati u uputi o lijeku, odnosno obratiti se svom liječniku ili ljekarniku.
English: Rekovelle is available as a solution for injection, contained in a cartridge to be used with Rekovelle injection pen.
Croatian: Lijek Rekovelle dostupan je kao otopina za injekciju, a nalazi se u ulošku za Rekovelle brizgalicu za injekciju.
English: Rekovelle contains the active substance follitropin delta.
Croatian: Lijek Rekovelle sadrži djelatnu tvar folitropin delta.
English: It is used to stimulate the ovaries to produce several eggs at the time, which can then be collected and fertilised in the laboratory.
Croatian: Lijek potiče jajnike na proizvodnju više jajnih stanica istovremeno, koja se potom skupljaju i oplođuju u laboratoriju.
English: For the full list of all side effects reported with Rekovelle, see the package leaflet.
Croatian: Potpuni popis nuspojava zabilježenih pri primjeni lijeka Rekovelle potražite u uputi o lijeku.
English: How does Rekovelle work?
Croatian: Kako se Rekovelle koristi?
English: The duration of protection is of at least 6 months.
Croatian: Trajanje zaštite od najmanje 6 mjeseci.
English: Keep the boxes tightly closed.
Croatian: Držati kutije čvrsto zatvorene.
English: It is recommended to wear rubber gloves.
Croatian: Preporučuje se nositi gumene rukavice.
English: 2 years at -20°C and 2 days at +25°C.
Croatian: 2 godine na -20°C i 2 dana na +25°C.
English: The distribution rate depends on the topography and on the population of the target species.
Croatian: Distribucijska stopa ovisi o topografiji terena i populaciji ciljnih vrsta.
English: Immunocompromised/immunosuppressed individuals must not be allowed to handle this vaccine.
Croatian: Imunokompromitiranim/imunosupresivnim osobama nije dopušteno rukovati ovim cjepivom.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/
Croatian: Detaljne informacije o ovom veterinarsko-medicinskom proizvodu su dostupne na web stranici Europske agencije za lijekove http://www.ema.europa.eu/.
English: Vaccine :
Croatian: Vakcina:
English: The administration of the vaccine at 10 times the recommended dosage induced no undesirable effects.
Croatian: Doza cjepiva 10 puta veća od preporučene doze ne izaziva neželjene učinke.
English: Restricted to duly designated competent administrative authorities.
Croatian: Ograničeno na propisno određena nadležna upravna tijela.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance :
Croatian: KVALITATIVNI I KVANTITATIVNI SASTAV Djelatna tvar:
English: Store in a freezer at -40°C to -20°C.
Croatian: Čuvati u zamrzivaču na -40°C do -20°C.
English: Baits shall not be distributed in inhabited areas, roads and watery areas.
Croatian: Mamci se ne smiju postavljati u naseljenim mjestima, uz ceste i vodene površine.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, if applicable
Croatian: 12. RIJEČI “SAMO ZA PRIMJENU NA ŽIVOTINJAMA” I UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE, ako je primjenjivo
English: The baits are successively packed in boxes of: - 200 units (4x50) - 400 units (2x200)
Croatian: Mamci su zasebno pakirani u kutijama: - 200 komada (4x50) - 400 komada (2x200)
English: Virbac Danmark A/S Filial Sverige, c/o Incognito AB, Box 1027,
Croatian: Virbac Danmark A/S Filial Sverige, c/o Incognito AB,
English: However rabies virus and attenuated rabies vaccine viruses do not usually accumulate in reproductive organs and are not known to directly affect reproductive functions.
Croatian: No, virus bjesnoće i atenuirani virus bjesnoće iz cjepiva, se ne nakupljaju u reproduktivnim organima i nije poznato da imaju direktni utjecaj na reproduktivne funkcije.
English: The import, sale, supply and/or 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 insert for further information.
Croatian: Uvoz, prodaja, opskrba i/ili primjena ovog veterinarsko-medicinskog proizvoda je ili može biti zabranjena u određenim državama članicama na cijelom teritoriju ili na jednom njegovom dijelu, vidi uputu o VMP za daljnje informacije.
English: THE WORDS “KEEP OUT OF THE REACH AND SIGHT OF CHILDREN” Keep out of the reach and sight of children.
Croatian: Čuvati izvan dosega i pogleda djece.
English: Disodium phosphate - Potassium dihydrogen phosphate - Glutamic acid - Saccharose - GelatinTryptone - Lactalbumin hydrolysate - Sodium chloride - Water for injection
Croatian: Dinatrij fosfat - kalij dihidrogen fosfat - glutaminska kiselina - saharoza - želatina - triptonlaktalbumin hidrolizat - natrijev klorid - voda za injekcije.
English: 02-819 Warszawa
Croatian: Puławska 314 02-819 Warszawa
English: Dispose of waste material and any unplaced baits at the end of the day of distribution by boiling or incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Croatian: Otpad i neiskorištene mamce potrebno je na kraju dana inaktivirati uranjanjem u kipuću vodu, spaljivanjem ili uranjanjem u odgovarajuće dezinfekcijsko sredstvo odobreno od strane nadležnih tijela.
English: Rhodor 7046R antifoam - Tetracycline (Hcl) HD - EVA (Ethyl Vinyl Acetate) - White soft paraffinParaffin 50/52° C - Seah Saur - Natural fish aroma
Croatian: Rhodor 7046R antifoam - tetraciklin (HCl) HD - EVA (vinil acetat etil) - bijeli meki parafin - parafin 50/52°C - seah saur - prirodna aroma ribe.
English: Any person intending to import, sell, supply and/or use the veterinary medicinal product must consult the relevant Member State's Competent Authority on the current vaccination policies prior to the import, sale, supply and/or use.
Croatian: Tko namjerava uvesti, prodavati, opskrbljivati i/ili primjenjivati Rabigen SAG2 mora konzultirati nadležno tijelo odnosne države članice u pogledu važećih odredbi o cijepljenju prije uvoza, prodaje, opskrbe i/ili primjene.
English: EU/2/00/021/001 EU/2/00/021/002
Croatian: EU/2/00/021/002
English: As this vaccine presentation contains traces of gentamicin and contains tetracycline as biomarker, occasional hypersensitivity reactions may be observed in domestic animals that have accidentally ingested the bait.
Croatian: Kako ovo cjepivo sadrži tragove gentamicina i tetraciklin kao biomarkera, primijećene su povremene reakcije preosjetljivosti kod domaćih životinja koje su slučajno progutale mamac.
English: PHARMACEUTICAL FORM Oral suspension.
Croatian: Peroralna suspenzija.
English: They are intended to be eaten by foxes and raccoon dogs.
Croatian: Namijenjeni su da ih pojede lisica ili kunopas.
English: 06516 Carros - France tel: + 33 4 92 08 73 04 fax: + 33 4 92 08 73 48 e-mail: darprocedure@virbac.com
Croatian: 06516 Carros - Francuska tel: + 33 4 92 08 73 04 fax: + 33 4 92 08 73 48 e-mail: darprocedure@virbac.com
English: The baits are distributed by land or by air within the framework of vaccination campaigns against rabies.
Croatian: Mamci se raspoređuju krećući se kopnom ili iz zraka, u okviru kampanje cijepljenja protiv bjesnoće.
English: Liquid vaccine contained within an aluminium/PVC sachet coated with an appetising matrix.
Croatian: Tekuća vakcina nalazi se u aluminijskom/PVC omotaču obložena s ukusnim mamcem.
English: In the event of human exposure to the active ingredient of the vaccine, seek medical advice immediately and show the package leaflet or the label to the physician.
Croatian: U slučaju izloženosti osoba djelatnom sastojku cjepiva, odmah potražiti pomoć liječnika i pokažite mu uputu o VMP ili etiketu.
English: The intake of a single bait is sufficient to ensure active immunisation to prevent infection by rabies virus.
Croatian: Unos jednog mamca je dovoljan kako bi se osiguralo aktivno cijepljenje koje će spriječiti infekciju virusom bjesnoće.
English: foxes / raccoon dogs seen per 10 km.
Croatian: lisice/kunopasa na 10 km.
English: Name and address of the manufacturer of the biological active substance
Croatian: Naziv i adresa proizvođača biološki aktivne tvari VIRBAC S.A.
English: The import, sale, supply and/or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Croatian: Uvoz, prodaja, opskrba i/ili primjena Rabigen SAG2 je ili može biti zabranjena u određenim državama članicama na cijelom teritoriju ili na jednom njegovom dijelu sukladno nacionalnim odredbama zaštite zdravlja životinja.
English: Palatable matrix (bait) containing a tetracycline biomarker
Croatian: Ukusna obloga (mamac) koja sadrži tetraciklin biomarker.
English: RABIES VACCINE DO NOT TOUCH Informative phone number: + 33 4 92 08 73 04
Croatian: VAKCINA PROTIV BJESNOĆE - NE DIRATI Telefon za informacije: + 33 4 92 08 73 04
English: Appetent matrix (bait) :
Croatian: Obloga koja izaziva apetit (mamac):
English: EXP: {month/year}
Croatian: EXP : {mjesec/godina}
English: People handling and distributing this vaccine should be vaccinated against rabies.
Croatian: Osobe koje rukuju ovim cjepivom trebaju biti cijepljene protiv bjesnoće.
English: Live attenuated rabies virus, SAG2 strain
Croatian: Živi atenuirani virus bjesnoće, soj SAG2
English: Rabigen SAG2 is a live modified rabies vaccine for oral administration to red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).
Croatian: Rabigen SAG2 je živo modificirano cjepivo protiv bjesnoće za peroralnu primjenu kod lisica (Vulpes vulpes) i kunopasa (Nyctereutes procyonoides).
English: PHARMACEUTICAL FORM Oral suspension
Croatian: Peroralna suspenzija
English: 8 log10 - CCID50*/dose
Croatian: 8 log 10 - CCID50*/po dozi
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 400 UNIT BOX
Croatian: PODACI NA VANJSKOM PAKOVANJU Kutija s 400 komada
English: Pharmacotherapeutic group: Live viral vaccines ATCvet code: QI07BD.
Croatian: ATCvet code: QI07BD.
English: * CCID50: Cell Culture Infective Dose 50%
Croatian: *CCID50: 50% infektivna doza za staničnu kulturu
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGE 200 UNIT BOX
Croatian: PODACI NA VANJSKOM PAKOVANJU kutija s 200 komada
English: Manufacturing Authorisation issued on December 22 santé et de la protection sociale - Direction de la Pharmacie et du médicament - République Française.
Croatian: Odobrenje za proizvodnju izdala je 22. prosinca 1997. Agence Nationale du Médicaments Vétérinaire
English: * CCID50: Cell Culture Infective Dose 50% Excipients:
Croatian: *CCID50: 50% infektivna doza za staničnu kulturu Pomoćne tvari:
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES Active substance:
Croatian: NAVOĐENJE DJELATNIH I DRUGIH TVARI Djelatna tvar:
English: PACKAGE SIZE 400 (2 x 200) vaccinal baits.
Croatian: 400 (2 x 200) cjepnih mamaca
English: The active ingredient is a double low virulence mutant isolated from the SAD Bern strain of rabies virus by two successive selection steps in order to avoid natural reversion to the parental strain.
Croatian: Djelatna tvar je mutirani virus bjesnoće izoliran u SAD-u, soj Bern, kojem je dvostruko smanjena virulentnost i koji onemogućava prirodni povratak virulentnosti na virulentnost roditeljskog soja.
English: For the active immunisation of red foxes and raccoon dogs to prevent infection by rabies virus.
Croatian: Za aktivnu imunizaciju lisica i kunopasa u cilju sprječavanja infekcije virusom bjesnoće.
English: - 20 baits per square km over the areas where fox / raccoon dog density indexes were more than 3
Croatian: − 20 mamca po kvadratnom kilometru na području na kojem je viđenost lisica/kunopasa veća od 3
English: Red foxes (Vulpes vulpes) and raccoon dogs (Nyctereutes procyonoides).
Croatian: Lisica (Vulpes vulpes) i kunopsi (Nyctereutes procyonoides).
English: It is used for the active immunisation of foxes and raccoon dogs characterised by the induction of rabies specific antibodies.
Croatian: Korištenje za aktivnu imunizaciju lisica i kunopasa obilježava pojava specifičnih antitijela protiv bjesnoće kod ciljnih vrsta životinja.
English: MANUFACTURER'S BATCH NUMBER BN: {number}
Croatian: BROJ PROIZVODNE SERIJE Lot: {broj}
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE U PROMET I NOSITELJA ODOBRENJA ZA PROIZVODNJU ODGOVORNOG ZA PUŠTANJE PROIZVODNE SERIJE, AKO JE RAZLIČITO
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION WITH REGARD TO SAFE AND EFFECTIVE USE
Croatian: UVIJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU NEŠKODLJIVE I DJELOTVORNE PRIMJENE
English: CONDITIONS OR RESTRICTIONS OF THE MARKETING AUTHORISATION REGARDING SUPPLY OR USE
Croatian: UVIJETI ILI OGRANIČENJA ODOBRENJA ZA STAVLJANJE U PROMET U POGLEDU OPSKRBE I PRIMJENE
English: 8 log10 CCID50*/dose
Croatian: minimum 8 log 10CCID50*/po dozi
English: The minimum distribution rate is: - 13 baits per square km over the areas where fox /raccoon dog density indexes were equal or less than 3 foxes / raccoon dogs seen per 10 km.
Croatian: − 13 mamca po kvadratnom kilometru na području na kojem je viđenost lisica/kunopasa jednaka ili manja od 3 lisice/kunopasa na 10 km.
English: The safety of the vaccine in pregnant and lactating animals has not been investigated.
Croatian: Neškodljivost cjepiva u graviditetu i tijekom laktacije nije ispitivana.
English: Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
Croatian: Rabigen SAG2 peroralna suspenzija za lisice i kunopse.
English: PACKAGE SIZE 200 (4 x 50) vaccinal baits.
Croatian: 200 (4 x 50) cjepnih mamaca
English: NAME OF THE VETERINARY MEDICINAL PRODUCT Rabigen SAG2 oral suspension, for red foxes and raccoon dogs.
Croatian: NAZIV VETERINARSKO-MEDICINSKOG PROIZVODA Rabigen SAG2 peroralna suspenzija za lisice i kunopse.
English: MARKETING AUTHORISATION NUMBER EU/2/00/021/001
Croatian: BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/00/021/001
English: Vomiting due to gastric intolerance (potentially due to the aluminium/PVC sachet as part of the bait vaccine), in dogs which have accidentally ingested the bait, has been reported.
Croatian: Kod pasa koji su slučajno progutali mamac može doći do povraćanja koje je posljedica želučane netolerancije (vjerojatno zbog aluminijske/PVC vrećice koja je dio mamca za cijepljenje).
English: 1ère avenue 2065 m LID 06516 Carros
Croatian: 1ère avenue 2065 m LID 06516 Carros France
English: 1ère Avenue - 2065 m 06516 Carros,
Croatian: L.I.D.1ère Avenue - 2065m 06516 Carros,
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE
Croatian: 13. POSEBNE MJERE PREDOSTROŽNOSTI ZA ODLAGANJE NEUPOTREBLJENOG PROIZVODA ILI OTPADNIH MATERIJALA, AKO IH IMA
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) BIOLOŠKI DJELATNE(IH) TVARI I> NOSITELJ(I) ODOBRENJA ZA PROIZVODNJU ODGOVORAN(I) ZA PUŠTANJE SERIJE U PROMET
English: MARKETING AUTHORISATION NUMBER EU/2/00/021/002
Croatian: 15. BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/00/021/002
English: 06516 Carros France
Croatian: 06516 Carros,
English: Avenue 2065 M L.I.D 06516 Carros France
Croatian: L.I.D.1ère Avenue - 2065m 06516 Carros, Francuska
English: MINIMUM PARTICULARS TO APPEAR ON SACHETS
Croatian: OSNOVNI PODACI NAPISANI NA VREĆICI
English: 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
Croatian: F-06516 Carros Tel: 33 (0) 4 92 08 73 00
English: PACKAGE LEAFLET
Croatian: VELIČINA PAKOVANJA
English: 1ère
Croatian: DATUM PRVOG ODOBRENJA/PRODULJENJA ODOBRENJA
English: Live attenuated rabies virus, SAG2 strain minimum 8 log10 CCID50*/dose
Croatian: minimum 8 log 10CCID50*/ po dozi
English: Suomi/Finland VIRBAC S.A. 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: 33 (0) 4 92 08 73 00
Croatian: Suomi/Finland VIRBAC S.A. 1ère avenue 2065 m - L.I.D
English: No adverse events have been reported in the target species.
Croatian: Rabigen SAG2 nije pokazao neželjene efekte kod ciljnih vrsta životinja.
English: Name and address of the manufacturer responsible for batch release
Croatian: Nazivi adresa proizvođača odgovornog za puštanje serije u promet VIRBAC S.A.
English: Lietuva
Croatian: KARENCIJA
English: România VIRBAC S.A. 1ère avenue 2065 m - L.I.D F-06516 Carros Tel: + 33 (0) 4 92 08 73 00
Croatian: F-06516 Carros Tel: + 33 (0) 4 92 08 73 00
English: EU/1/12/751/001
Croatian: EU/1/12/751/001 Zelboraf
English: Zelboraf
Croatian: Jačina
English: 240 mg Film-coated tablet
Croatian: 240 mg filmom obložena tableta peroralno blister(alu/alu) 56 tableta
English: (Invented) name
Croatian: (Zaštićeno) ime lijeka
English: Packaging Package size
Croatian: Farmaceutski oblik Način primjene Pakovanje Veličina pakovanja
English: The user must not smoke, eat or drink while handling Stronghold.
Croatian: Korisnik ne smije pušiti, jesti niti piti dok rukuje proizvodom
English: This causes the paralysis or death of the parasites.
Croatian: Time se uzrokuje paraliza ili smrt parazita.
English: Stronghold must not be used in animals under six weeks of age.
Croatian: Stronghold se ne smije koristiti u životinja mlađih od šest tjedana.