natgillin/translations-raw huggingface dataset:
Recent or latent infection with field myxoma virus seems to play a role in this to a certain extent.
Čini se da u tome do određene mjere imaju ulogu nedavne ili latentne infekcije divljim miksoma virusom.
Intervet International B.V. Wim de Körverstraat 35
Intervet International BV
Read the package leaflet before use.
Prije upotrebe pročitajte uputu na pakiranju.
No special storage conditions.
Nema posebnih uvjeta.
The vaccine strains are myxoma viruses expressing the capsid protein gene of classical or type 2 RHD viruses.
Cjepni soj su miksoma virusi, koji u kapsidisadrže proteinski gen virusa hemoragične bolesti kunića ili tip 2 RHD virusa.
{MM/YYYY}
Serija {broj}
Rabbits that have been vaccinated previously with another myxomatosis vaccine, or that have experienced natural myxomatosis infection in the field, may not develop an adequate immune response against rabbit haemorrhagic disease following vaccination.
Kunići koji su prethodno bili cijepljeni s nekim drugim cjepivom protiv miksomatoze ili koji su preboljeli miksomatozu, nakon cijepljenja, možda neće razviti odgovarajući imuni odgovor protiv hemoragijske bolesti kunića.
Pharmacotherapeutic group: Immunologicals for Leporidae, live viral vaccine for rabbits ATC-vet code: QI08AD
Farmakoterapijska grupa: Imunološki pripravak za Leporidae, živo virusno cjepivo za kuniće.
Disodium phosphate dihydrate
Dinatrij fosfat dihidrat
The vaccine is intended to stimulate immunity against myxoma virus and rabbit haemorrhagic disease viruses in rabbits.
Za poticanje imunosti protiv virusa miksomatoze i virusa hemoragične bolesti kunića.
Lyophilisate:
Docijepljivanje:
Solvent: No special precautions for storage.
Otapalo: Ne zahtijeva posebne temperaturne uvjete čuvanja.
0.5 ml and 10 ml glass vial
ETIKETA OTAPALA 0,5 ml i 10 ml staklene bočice
No safety study on the reproductive performance has been conducted in male rabbits (bucks).
Ispitivanja neškodljivosti na reprodukciju mužjaka nisu provedena.
Withdraw the reconstituted vaccine concentrate from the vial and inject it back into the solvent vial.
Rekonstituirani koncentrat cjepiva izvući iz bočice te ga injicirati u bočicu s otapalom.
A small, non-painful swelling (maximum 2 cm diameter) at the injection site is commonly observed within the first two weeks after vaccination.
U prva dva tjedna nakon cijepljenja, na mjestu injiciranja, često nastaje mala oteklina koja nije bolna (najvećeg promjera do 2 cm).
No special precautions for storage.
Ne zahtjeva posebne uvjete čuvanja.
Intervet International B.V. Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands
Wim de Körverstraat 35 NL - 5831 AN Boxmeer
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VACCINE GLASS VIAL LABEL - 1 dose / 50 doses glass vial
Cjepivo u staklenoj bočici s etiketom - 1 doza / 50 doza u staklenoj bočici
5831 AN Boxmeer
Wim de Körverstraat 35 5831 AN Boxmeer
As a consequence, rabbits are immunised against myxoma virus and both classical and type 2 RHD viruses.
Tako su kunići imunizirani protiv miksoma virusa i protiv virusa klasične hemoragične bolesti kunića i tipa2 RHD virusa.
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
KVALITATIVNI I KVANTITATIVNI SASTAV DJELATNE(IH)TVARI I DRUGIH SASTOJAKA
Live myxoma vectored RHD virus strain 009: 103.0 - 105.8 FFU* Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU*
Živi miksoma virus, vektorski RHD soj 009: ≥103,0 i ≤105,8 FFU* Živi miksoma virus, vektorski RHD soj MK1899: ≥103,0 i ≤105,8 FFU*
- Cardboard box with 10 x 50 doses vials of vaccine; and cardboard box with 10 x 10 ml vials of solvent.
Kartonska kutija s 10 bočica s 50 doza vakcine; i kartonska kutija s 10 bočica s 10 ml otapala.
Single dose vial
Bočica s jednom dozom
WITHDRAWAL PERIODS
PUTEVI PRIMJENE
Rabbits
NUSPOJAVE
Multi-dose vial (50 doses)
Bočica s 50 doza
Live myxoma vectored RHD virus strain MK1899: 103.0 - 105.8 FFU/dose.
Živi miksoma virus, vektorski RHD soj MK1899: ≥103,0 i ≤105,8 FFU/dozi.
Live myxoma vectored RHD virus strain 009: 103.0 - 105.8 FFU/dose.
Živi miksoma virus, vektorski RHD soj 009: ≥103,0 i ≤105,8 FFU/dozi.
Withdrawal period: Zero days
KARENCIJA(E) Karencija: nula dana
Subcutaneous use.
Primjena pod kožu.
- Plastic box with 25 x 1 dose vials of vaccine and 25 vials containing 0.5 ml of solvent.
Plastična kutija s 25 bočica s 1 dozom vakcine i 25 bočica s 0,5 ml otapala.
- Plastic box with 5 x 1 dose vials of vaccine and 5 vials containing 0.5 ml of solvent.
Plastična kutija s 5 bočica s 1 dozom vakcine i 5 bočica s 0,5 ml otapala.
PACKAGE LEAFLET:
Pakovanja:
5 x 1 dose of vaccine including solvent 25 x 1 dose of vaccine including solvent 10 x 50 doses of vaccine
25 x 1 doza vakcine i otapala
4.9 Amounts to be administered and administration route
4.9 Količine koje se primjenjuju i način primjene Primjena pod kožu.
Name and address of the manufacturer of the biological active substances Intervet International B.V.
Naziv i adresa proizvođača biološki djelatne tvari
In addition to the adverse reactions observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after administration of a ten-fold overdose.
4.10 Predoziranje (simptomi, hitni postupci, antidoti), ako je nužno Pored znakova uočenih nakon cijepljenja s jednom dozom, blaga oteklina lokalnih limfnih čvorova može se pojaviti unutar 3 dana nakon cijepljenja s deseterostrukom dozom.
Reconstitute a single dose vial containing lyophilisate with 0.5 ml of the supplied solvent.
Rekonstituirati bočicu s jednom dozom vakcine s 0,5 ml otapala i upotrijebiti sav sadržaj bočice.
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN I PUT(EVI) PRIMJENE Primjena pod kožu.
Multi-dose vial
Hidrolizirana želatina
The device should be cleaned after each use.
Uređaj se mora očistiti nakon svake uporabe.
Date of first authorisation: 05/02/2019
Datum prvog odobrenja: 05/02/2019
No data is available on protection of longer-lived birds such as future layers/breeders.
Na raspolaganju nisu nikakvi podaci o zaštiti dulje živućih ptica, kao što su buduće nosilice/uzgojne jedinke.
The active substances being principles of biological origin intended to produce active immunity are not within the scope of Regulation (EC) No 470/2009.
Djelatne tvari koje se sastoje od tvari biološkog podrijetla, namijenjene za stvaranje aktivne imunosti i na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
Suspension: White turbid suspension.
Suspenzija: Bijela neprozirna suspenzija.
Pharmacotherapeutic group: Immunological for Aves, live parasitic vaccines for domestic fowl.
Farmakoterapijska grupa: Imunološki proizvodi za ptice, živa parazitarna cjepiva za domaću perad.
Oral use.
Oralna uporaba.
To improve the uniformity of the vaccination, maintain the chicks inside the transportation box for at least 1 hour in order to let them ingest all the vaccine droplets.
Kako bi se poboljšala ujednačenost cijepljenja, držite piliće u transportnim kavezima najmanje 1 sat kako bi mogli probaviti sve kapljice cjepiva.
After this time, place the chicks carefully into the litter and continue with regular management practices.
Potom pažljivo smjestite piliće na stelju i nastavite s uobičajenim postupcima.
After the administration of a severe overdose (10-fold), mild, transient, clinical signs of coccidiosis were commonly observed without any consequences on the final performance.
Nakon primjene teškog predoziranja (desetostrukog), često su se uočavali blagi, prolazni klinički znakovi kokcidioze bez ikakvih posljedica na konačni učinak.
Hipra Italia S.r.l.
Italia Hipra Italia S.r.l.
* Number of sporulated oocysts derived from precocious attenuated lines of coccidia, according to in vitro procedures of the manufacturer at the time of blending.
* Broj sporuliranih oocista dobivenih iz rano zrelih atenuiranih linija kokcidija, prema in vitro postupcima proizvođača u trenutku miješanja.
Duration of immunity: 63 days post-vaccination in an environment that permits oocysts recycling.
Trajanje imunosti: 63 dana nakon cijepljenja u okolišu koji omogućuje recikliranje oocista.
België/Belgique/Belgien
B e lgië/Belgique/Belgien
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Cardboard boxes
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU Kartonske kutije
This product is intended for the vaccination of short-lived chickens only.
Ovaj proizvod je namijenjen samo za cijepljenje kratkovječnih pilića.
Potassium chloride Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Sodium chloride
Dinatrijev fosfat dodekahidrat Kalijev dihidrogenfosfat
EXP {month/year} Once diluted use within 10 hours.
Nakon razrjeđivanja upotrijebiti unutar 10 sati.
Chickens must be strictly floor-reared in the first 3 weeks after vaccination.
Pilići se prva 3 tjedna nakon cijepljenja moraju uzgajati isključivo podnim načinom.
Montanide IMS
Adjuvans: Montanid IMS
In order to reduce field infections, it is recommended that all litter should be removed and facilities and related equipment in contact with vaccinated chickens should be cleaned between production cycles.
Kako bi se smanjile terenske infekcije preporučuje se da se uklone sva legla, a prostore i opremu koji su bili u doticaju s cijepljenim pilićima treba čistiti između proizvodnih ciklusa.
Do not use in birds in lay or in breeding birds, or within 4 weeks before the start of the laying period.
Ne primjenjivati na nesilicama za vrijeme nesenja ili parenja ili unutar 4 tjedna prije početka razdoblja nesenja.
Eimeria acervulina, strain 003 ..................................... 332 - 450* Eimeria maxima, strain 013 ......................................... 196 - 265* Eimeria mitis, strain 006 .............................................. 293 - 397* Eimeria praecox, strain 007 ......................................... 293 - 397* Eimeria tenella, strain 004 ........................................... 276 - 374*
Eimeria acervulina, soj 003 ...................................... 332 - 450* Eimeria maxima, soj 013 .......................................... 196 - 265* Eimeria mitis, soj 006 .............................................. 293 - 397* Eimeria praecox, soj 007 .......................................... 293 - 397* Eimeria tenella, soj 004............................................ 276 - 374*
A purplish suspension is obtained after dilution.
Nakon razrjeđivanja dobije se purpurna suspenzija.
Dilute the content of the vial with clean, room temperature water into an appropriate container.
Razrijedite sadržaj bočice u čistoj vodi sobne temperature u odgovarajućem spremniku.
Additionally, the duration of immunity depends on an environment that permits recycling of oocysts, therefore a decision to use any anticoccidial substances in the period after 3 weeks postvaccination should be made taking into account the potential negative impact on the duration of immunity of this product.
Dodatno, trajanje imunosti ovisi o okolišu koji dopušta recikliranje oocista pa stoga odluku o uporabi antikokcidijskih tvari u razdoblju nakon 3 tjedna poslije cijepljenja treba donijeti uzimajući u obzir potencijalni negativni utjecaj na trajanje imunosti ovog proizvoda.
Eimeria acervulina, strain 003 ....................................... 332 - 450 Eimeria maxima, strain 013 ........................................... 196 - 265 Eimeria mitis, strain 006 ................................................ 293 - 397 Eimeria praecox, strain 007 ........................................... 293 - 397 Eimeria tenella, strain 004 ............................................. 276 - 374
Eimeria acervulina, soj 003 ........................................ 332 - 450 Eimeria maxima, soj 013 ............................................ 196 - 265 Eimeria mitis, soj 006 ................................................ 293 - 397 Eimeria praecox, soj 007 ............................................ 293 - 397 Eimeria tenella, soj 004.............................................. 276 - 374
Onset of immunity: 14 days post-vaccination.
Nastup imunosti: 14 dana nakon cijepljenja.
Dilute the vaccine with the relevant volumes of the solvent (HIPRAMUNE T) and water, as shown in the following table:
Razrijedite cjepivo odgovarajućim volumenima otapala (HIPRAMUNE T) i vode, kako je to prikazano u sljedećoj tablici: DOZE VODA CJEPIVO
Major incompatibilities:
Inkompatibilnosti:
Fill the reservoir of the spraying device with all the vaccine suspension prepared.
Napunite spremnik uređaja za prskanje cijelim pripremljenim sadržajem otopine za cijepljenje.
The method of administration is by coarse spray by using a suitable device (volume delivered: 28 ml/100 chicks, droplet size: 200 - 250 µm and working pressure: 1.5 to 3 bars).
Način primjene je raspršivanje velikim kapljicama koristeći odgovarajući uređaj (isporučeni volumen: 28 ml/100 pilića, veličina kapi: 200 - 250 µm i radni tlak: 1,5 do 3 bara).
No anticoccidial substances or other agents having anticoccidial activity via feed or water should be used for at least 3 weeks following the vaccination of chickens with this product otherwise the correct replication of the vaccine oocysts, and consequently the development of a solid immunity, could be hindered.
Ne smiju se upotrebljavati antikokcidijske tvari ili druge tvari koje imaju antikokcidijsku aktivnost putem hrane ili vode tijekom najmanje 3 tjedna nakon cijepljenja pilića ovim proizvodom jer će inače doći do problema s pravilnom replikacijom oocista cjepiva i posljedičnim razvojem učinkovite imunosti.
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGE Vaccine vial of 10,000 doses
PODACI KOJI SE MORAJU NALAZITI NA UNUTARNJEM PAKOVANJU Bočica cjepiva od 10,000 doza
HIPRAMUNE T solvent for oral spray for chickens
HIPRAMUNE T, otapalo za oralni sprej za piliće
LABORATORIOS HIPRA, S.A. Carretera C-63, Km 48.300 Polígono Industrial El Rieral Amer
LABORATORIOS HIPRA, S.A. Carretera C-63, Km 48.300
Vaccination schedule: One dose of vaccine (0.007 ml) from 1 day of age.
Raspored cijepljenja: Jedna doza cjepiva (0,007 ml) od 1 dana starosti.
Suspension for oral spray.
Suspenzija za oralni sprej.
Before starting to prepare the spray solution, ensure there is a clean container with sufficient capacity for preparing the diluted vaccine suspension available.
Prije početka pripreme otopine spreja provjerite je li dostupan čisti spremnik dovoljnog volumena za pripremu suspenzije razrijeđenog cjepiva.
Do not mix with any other veterinary medicinal product, except the solvent supplied for use with the veterinary medicinal product.
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom, osim s diluentom (otapalom) priloženim za primjenu s proizvodom.
Type I colourless glass vials containing 7 ml, 35 ml or 70 ml of suspension (1,000, 5,000 and 10,000 doses) closed with type I polymeric elastomer closures and aluminium caps.
I koje sadrže 7 ml, 35 ml ili 70 ml suspenzije (1.000, 5.000 i 10.000 doza) zatvorene čepovima od polimerskog elastomera tipa
Shake the vaccine (EVANT) vial and dilute the contents of it into the solvent and water solution.
Protresite bočicu cjepiva (EVANT) i razrijedite sadržaj u otapalu i vodenoj otopini.
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND
PROIZVOĐAČ<I> BIOLOŠKI DJELATNE<IH>
Brilliant Blue (E133) Red AC (E129) Vanillin
Boja, briljantno modra (E133) Boja, alurno crvena AC (E129) Vanilin
Eimeria praecox and Eimeria tenella and to reduce clinical signs (diarrhoea) associated with Eimeria acervulina, Eimeria maxima and Eimeria tenella.
Eimeria praecox te Eimeria tenella te za smanjenja kliničkih znakova (proljev) povezanih s Eimeria acervulina, Eimeria maxima i Eimeria tenella.
For the active immunisation of chicks from 1 day of age to reduce intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria maxima, Eimeria mitis,
Za aktivnu imunizaciju pilića od 1. dana života kako bi se smanjile lezije na crijevima i izlučivanja oocista povezanih s kokcidiozom uzrokovanom s Eimeria acervulina, Eimeria maxima, Eimeria mitis,
To stimulate active immunity against coccidiosis caused by Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella.
Za stimulaciju aktivne imunosti protiv kokciodioze koje uzrokuju vrste Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox i Eimeria tenella.
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari EVANT (cjepivo):
Polypropylene vials containing 50 ml, 250 ml or 500 ml of solvent closed with type I polymeric elastomer closures and aluminium caps.
Bočice od polipropilena (PP) koje sadrže 50 ml, 250 ml i 500 ml otapala zatvorene čepovima od polimerskog elastomera tipa
Maintain the diluted vaccine suspension in continuous homogenisation by using a magnetic stirrer while the vaccine is being administered via coarse spray to the chicks.
Za vrijeme raspršivanja velikim kapljicama na pilićima, neka razrijeđena suspenzija cjepiva bude uvijek homogena pomoću magnetske mješalice.
Batch {number}
(otapalo).
To be mixed with HIPRAMUNE T (solvent).
Pomiješati s HIPRAMUNE T (otapalo).
HIPRAMUNE T (solvent): Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Rok valjanosti veterinarsko-medicinskog proizvoda kada je zapakiran za prodaju: 2 godine.
For the active immunisation of chicks from 1 day of age to reduce intestinal lesions and oocysts output associated with coccidiosis caused by Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox and Eimeria tenella and to reduce clinical signs (diarrhoea) associated with Eimeria acervulina, Eimeria maxima and Eimeria tenella.
INDIKACIJE Za aktivnu imunizaciju pilića od 1. dana života kako bi se smanjile lezije na crijevima i izlučivanje oocista povezanih s kokcidiozom uzrokovanom s Eimeria acervulina, Eimeria maxima, Eimeria mitis, Eimeria praecox te Eimeria tenella te za smanjenje kliničkih znakova (proljev) povezanih s Eimeria acervulina, Eimeria mxima i Eimeria tenella.
HIPRAMUNE T (solvent): Brilliant blue (E 133) Red AC (E 129) Vanillin
Boja briljantno modra (E 133) Boja alurno crvena AC (E 129)
Each dose (0.007 ml) of undiluted vaccine contains:
Svaka doza (0,007 ml) nerazrjeđenog cjepiva sadrži
PACKAGE LEAFLET: EVANT suspension and solvent for oral spray for chickens
UPUTA O VMP: EVANT suspenzija i otapalo za oralni sprej za piliće
EVANT suspension and solvent for oral spray for chickens.
EVANT suspenzija i otapalo za oralni sprej za piliće.
Suspension and solvent for oral spray.
Suspenzija i otapalo za oralni sprej.
MINIMUM PARTICULARS TO APPEAR ON IMMEDIATE PACKAGING Solvent vial of 50 ml, 250 ml or 500 ml
Bočice otapala od 50 ml, 250 ml ili 500 ml
Each dose (0.007 ml) of undiluted vaccine contains: EVANT:
KVALITATIVNI I KVANTITATIVNI SASTAV Svaka doza (0,007 ml) nerazrijeđenog cjepiva sadrži: EVANT:
EVANT suspension and solvent for oral spray for chickens
EVANT suspenzija i otapalo za oralni sprej za piliće
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATUM PRVO G O DO BRENJA/PRODULJENJA O DOBRENJ
HIPRA BENELUX NV Tél/Tel: (+32) 09 2964464
Tél/Tel: (+32) 09 2964464
Water Vaccine HIPRAMUNE T (solvent)
Doze Voda Cjepivo HIPRAMUNE T (otapalo)
Cardboard box with one vial of EVANT containing 35 ml (5,000 doses) and one vial of HIPRAMUNE T containing 250 ml.
Kartonska kutija s jednom bočicom cjepiva EVANT koja sadrži 35 ml (5.000 doza) i jedna bočica otapala HIPRAMUNE T koja sadrži 250 ml.
17170 Amer (Girona)
17170 Ame r (Girona ) SP AIN
Solvent: Dark brownish solution.
Otapalo: Tamna smećkasta otopina.
Coarse spray
Kalijev klorid
Lay:
Primjena:
One vial of 7 ml (1,000 doses) of EVANT and one vial of 50 ml of HIPRAMUNE T (solvent).
Jedna bočica od 7 ml (1.000 doza) cjepiva EVANT i jedna bočica s 50 ml HIPRAMUNE T (otapalo).
One vial of 35 ml (5,000 doses) of EVANT and one vial of 250 ml of HIPRAMUNE T (solvent).
Jedna bočica od 35 ml (5.000 doza) cjepiva EVANT i jedna bočica s 250 ml HIPRAMUNE T
Cardboard box with one vial of EVANT containing 70 ml (10,000 doses) and one vial of HIPRAMUNE T containing 500 ml.
Kartonska kutija s jednom bočicom cjepiva EVANT koja sadrži 70 ml (10.000 doza) i jedna bočica otapala HIPRAMUNE T koja sadrži 500 ml.
Cardboard box with one vial of EVANT containing 7 ml (1,000 doses) and one vial of HIPRAMUNE T containing 50 ml.
Kartonska kutija s jednom bočicom cjepiva EVANT koja sadrži 7 ml (1000 doza) i jedna bočica otapala HIPRAMUNE T koja sadrži 50 ml.
Coarse spray.
I i aluminijskim poklopcima.
LABORATORIOS HIPRA, S.A. Paratge Lloret
LABORATORIOS HIPRA, S.A. Avda. la Selva 135
One vial of 70 ml (10,000 doses) of EVANT and one vial of 500 ml of HIPRAMUNE T (solvent).
Jedna bočica od 70 ml (10.000 doza) cjepiva EVANT i jedna bočica s 500 ml HIPRAMUNE T
Shake the solvent vial (HIPRAMUNE T).
Protresite bočicu s otapalom (HIPRAMUNE T).
Withdrawal period: Zero days.
KARENCIJA(E) Karencija: Nula dana.
Polysorbate 80
Polígono Industrial El Rieral
HIPRA UK AND IRELAND, Ltd. Tel: (+44) 0115 845 6486
Tel: (+44) 0115 845 6486
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
UVJETI ILI OGRANIČENJA U POGLEDU OPSKRBE I PRIMJENE Veterinarsko-medicinski proizvod se izdaje na veterinarski recept.
Elderly patients (older than 65 years)
Stariji bolesnici (stariji od 65 godina)
Height and weight showed similar improvements.
Visina i težina pokazale su slična poboljšanja.
DATE OF FIRST AUTHORISATION 20 November 2015
DATUM PRVOG ODOBRENJA 20. studenog 2015
The physician's educational material should contain the following key elements:
Edukacijski materijal liječnika treba sadržavati sljedeće ključne elemente:
Some of the primary defects include but are not limited to:
Neki od primarnih defekata uključuju ali nisu ograničeni na:
The study was completed on 31 July 2016.
Ispitivanje je završeno 31. srpnja 2016.
Use within 3 months of opening.
Upotrijebiti u roku od 3 mjeseca nakon otvaranja.
Once the bottle is opened, the medicinal product must be used within 3 months.
Nakon što se boca otvori, lijek se mora iskoristiti u roku od 3 mjeseca.
Never take a double dose to make up for a forgotten dose.
Nikad nemojte uzeti dvostruku dozu kako biste nadoknadili zaboravljenu dozu.
Do not take more capsules than your doctor has advised you.
Ne uzimajte više kapsula nego što Vam je liječnik savjetovao.
• oral contraceptives,
• oralni kontraceptivi,
Your doctor will tell you how many capsules you need to take, and when you should take the capsules.
Liječnik će Vas obavijestiti koliko kapsula morate uzeti, te kada morate uzeti kapsule.
If not, the next higher dose should be selected.
Ako se to nije postiglo, treba odabrati prvu sljedeću veću dozu.
Take the next dose as soon as you remember, as long as it is more than 12 hours until the next dose.
Uzmite sljedeću dozu čim se sjetite samo ukoliko do sljedeće doze preostaje više od 12 sati.
This being an approval under exceptional circumstances and pursuant to Article 14(8) of Regulation (EC) No 726/2004, the MAH shall conduct, within the stated timeframe, the following measures:
Budući je ovo odobrenje u iznimnim okolnostima, a temeljem članka 14(8) Uredbe (EZ) br. 726/2004, nositelj odobrenja će, unutar navedenog vremenskog okvira, provoditi sljedeće mjere:
Dublin 2, Ireland Tel: +353 86 803 8014 info@retrophin.com
Tel: +353 86 803 8014 info@ retrophin.com
<1/1,000), very rare (<1/10,000) and not known (cannot be estimated from the available data).
< 1/1000), vrlo rijetko (< 1/10 000), nepoznato (ne može se procijeniti iz dostupnih podataka).
Do not chew the capsule.
Ne žvačite kapsulu.
You should check with your doctor or pharmacist if you are unsure.
Provjerite s liječnikom ili ljekarnikom, ako niste sigurni.
The dose should be adjusted accordingly, as described above.
Doza se mora prilagoditi, kako je opisano ranije u tekstu.
The capsules should be swallowed whole with water.
Kapsule se moraju progutati cijele s vodom.
No data available.
Nema dostupnih podataka.
More frequent tests will be needed if you are growing fast, if you are ill (e.g., if you have liver problems) or if you are pregnant.
Češće pretrage su potrebne ako brzo rastete, ako ste bolesni (npr. ako imate problema s jetrom) ili ako ste trudni.