natgillin/translations-raw huggingface dataset:
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion, which contains only 1 vial).
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Docetaxel Zentiva 160 mg/8 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
In addition, physical and chemical in-use stability of the infusion solution prepared as recommended has been demonstrated in non-PVC bags up to 48 hours when stored between 2 to 8°C.
Nadalje, fizikalna i kemijska stabilnost infuzijske otopine u uporabi, pripremljene po propisu, dokazana je do 48 sati u ne-PVC vrećici pri temperaturi od 2 do 8°C.
Docetaxel Zentiva in combination with cisplatin is indicated for the treatment of patients with unresectable, locally advanced or metastatic non-small cell lung cancer, in patients who have not previously received chemotherapy for this condition.
Docetaxel Zentiva u kombinaciji s cisplatinom indiciran je za liječenje bolesnika s neoperabilnim, lokalno uznapredovalim ili metastatskim karcinomom nemalih stanica pluća, koji nisu ranije primali kemoterapiju za tu bolest.
Docetaxel Zentiva in combination with platinum agents in chemotherapy-naïve patients
Docetaxel Zentiva u kombinaciji s derivatima platine u bolesnika koji nisu ranije primali kemoterapiju
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 20 mg/1 ml sterile concentrate docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Zentiva 20 mg/1 ml sterilni koncentrat docetaksel
In GEICAM 9805 study amenorrhoea that started during the treatment period and persisted into the follow-up period was observed to be ongoing in 18 patients (3.4 %) in TAC arm and 5 patients (1.0 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), amenorrhoea was observed to be ongoing in 7 patients (1.3%) in TAC arm, and in 4 patients (0.8%) in FAC arm.
U GEICAM 9805 studiji, amenoreja je i dalje bila prisutna u periodu praćenja (medijan vremena praćenja od 10 godina i 5 mjeseci) i zabilježena je u 18 bolesnica (3,4%) u TAC skupini i u 5 bolesnica (1,0%) u FAC skupini.
PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 160 mg/8 ml CONCENTRATE FOR SOLUTION FOR INFUSION
UPUTE ZA PRIPREMU I UPOTREBU Docetaxel Zentiva 160 mg/8 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Docetaxel Zentiva 160 mg/8 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
PARTICULARS TO APPEAR ON OUTER PACKAGING OUTER CARTON / Docetaxel Zentiva 80 mg/4 ml
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU KUTIJA / Docetaxel Zentiva 80 mg/4 ml
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion.
NAZIV LIJEKA Docetaxel Zentiva 160 mg/8 ml koncentrat za otopinu za infuziju
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion
NAZIV LIJEKA Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju
Hot flush (G3/4: 0.5%) Hypotension (G3/4: Phlebitis (G3/4: 0%)
hipotenzija (G3/4: flebitis (G3/4: 0%)
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion, which contains only 1 vial).
NEMOJTE KORISTITI druge lijekove s docetakselom, koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju, koji sadrži samo 1 bočicu).
DO NOT use other docetaxel medicinal products consisting of 2 vials (concentrate and solvent) with this medicinal product (Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion, which contains only 1 vial).
NEMOJTE KORISTITI druge lijekove s docetakselom koji sadrže 2 bočice (koncentrat i otapalo) s ovim lijekom (Docetaxel Zentiva 80 mg/4 ml koncentrat za otopinu za infuziju, koji sadržava samo 1 bočicu).
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion
NAZIV LIJEKA Docetaxel Zentiva 80 mg/4 ml koncentrat za otopinu za infuziju
Docetaxel Zentiva in combination with capecitabine is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic chemotherapy.
Docetaxel Zentiva u kombinaciji s kapecitabinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije s drugim citostaticima.
Alopecia; Skin reaction (G3/4:
Poremećaji kože i potkožnog tkiva alopecija; kožna reakcija (G 3/4:
Skin reaction (G3/4:
Manje česte nuspojave kožna reakcija (G3/4:
Peripheral sensory neuropathy (≥G3: 2%)a
Poremećaji živčanog sustava periferna senzorna neuropatija (≥G3: 2%)
Description of selected adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab
Opis odabranih nuspojava kod karcinoma dojke za Docetaxel Zentiva 100 mg/m² u kombinaciji s trastuzumabom
(75 mg/m2 on day 1) in combination with cisplatin (C) (75 mg/m2 on day 1) and 5-fluorouracil (F) (750 mg/m2 per day for 5 days) or cisplatin (100 mg/m2 on day 1) and 5-fluorouracil (1000 mg/m2 per day for 5 days).
u kombinaciji sa cisplatinom (C) (75 mg/m prvi dan) i 5-fluorouracilom (F) (750 mg/m dnevno kroz
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Docetaxel Zentiva 80 mg/4 ml sterile concentrate docetaxel
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Docetaxel Zentiva 80 mg/4 ml sterilni koncentrat docetaksel
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 160 mg/8 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE / Docetaxel Zentiva 160 mg/8 ml
Patients should be retreated with docetaxel when neutrophils recover to a level  1,500 cells/mm3 (see section 4.2).
Bolesnici se mogu ponovno liječiti docetakselom kad se broj neutrofila oporavi na razinu ≥ 1500 stanica/mm
Docetaxel Zentiva in combination with doxorubicin is indicated for the treatment of patients with locally advanced or metastatic breast cancer who have not previously received cytotoxic therapy for this condition.
Docetaxel Zentiva u kombinaciji s doksorubicinom indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke koji nisu ranije liječeni citostaticima za tu bolest.
Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion requires NO prior dilution with a solvent and is ready to add to the infusion solution.
Docetaxel Zentiva 80 mg/4 ml koncentrat za otopinu za infuziju NE zahtijeva prethodno razrjeđivanje otapalom te se može odmah dodati u infuzijsku otopinu.
PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 20 mg/1 ml CONCENTRATE FOR SOLUTION FOR INFUSION
UPUTE ZA PRIPREMU I UPOTREBU Docetaxel Zentiva 20 mg/1 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² in combination with trastuzumab
Tablični popis nuspojava kod karcinoma dojke za Docetaxel Zentiva 100 mg/m² u kombinaciji s trastuzumabom
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 20 mg/1 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE / Docetaxel Zentiva 20 mg/1 ml
PREPARATION GUIDE FOR USE WITH DOCETAXEL ZENTIVA 80 mg/4 ml CONCENTRATE FOR SOLUTION FOR INFUSION
UPUTE ZA PRIPREMU I UPOTREBU Docetaxel Zentiva 80 mg/4 ml KONCENTRATA ZA OTOPINU ZA INFUZIJU
1060 patients were randomised to receive either Docetaxel Zentiva 75 mg/m2 administered 1-hour after doxorubicin 50 mg/m2 and cyclophosphamide 500 mg/m2 (539 patients in TAC arm), or doxorubicin 50 mg/m2 followed by fluorouracil 500 mg/m2 and cyclophosphamide 500 mg/m2 (521 patients in FAC arm), as adjuvant treatment of operable node-negative breast cancer patients with high risk of relapse according to 1998 St. Gallen criteria (tumour size >2 cm and/or negative ER and PR and/or high histological/nuclear grade (grade 2 to 3) and /or age <35 years).
(521 bolesnik u FAC skupini), kao adjuvantnu terapiju za operabilni karcinom dojke s negativnim limfnim čvorovima i visokim rizikom povrata bolesti prema kriterijima iz St. Gallena iz 1998.g. (veličina tumora >2 cm i/ili negativni ER i PR i/ili visoki histološki/nuklearni gradus (gradus 2 do 3) i/ili dob <35 godina).
In GEICAM 9805 study alopecia that started during the treatment period and persisted into the followup period was observed to be ongoing in 49 patients (9.2 %) in TAC arm and 35 patients (6.7 %) in FAC arm. Alopecia related to study drug started or worsened during the follow-up period in 42 patients (7.9 %) in TAC arm and 30 patients (5.8 %) in FAC arm. At the end of the follow-up period (median follow-up time of 10 years and 5 months), alopecia was observed to be ongoing in 3 patients (0.6%) in TAC arm, and in 1 patient (0.2%) in FAC arm.
U ispitivanju GEICAM 9805, alopecija koja je počela tijekom perioda liječenja i dalje bila prisutna tijekom perioda praćenja zabilježena je u 49 bolesnika (9,2%) u TAC skupini i u 35 bolesnika (6,7%) u FAC skupini.
Dizziness
Raspodjela
Peripheral sensory neuropathy (G3/4:
Poremećaji živčanog sustava periferna senzorna neuropatija (G3/4:
Docetaxel Zentiva monotherapy is indicated for the treatment of patients with locally advanced or metastatic breast cancer after failure of cytotoxic therapy.
Docetaxel Zentiva kao monoterapija indiciran je za liječenje bolesnika s lokalno uznapredovalim ili metastatskim karcinomom dojke nakon neuspjeha terapije drugim citostaticima.
In Docetaxel Zentiva 80 mg/4 ml vial the concentration of docetaxel is 20 mg/ml.
U bočici Docetaxel Zentiva 80 mg/4 ml, koncentracija docetaksela iznosi 20 mg/ml.
Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
proljev (G3/4: 6,4%); stomatitis (G3/4: 2%)
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin
Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Docetaxel Zentiva 75 mg/m² u kombinaciji s cisplatinom
Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with doxorubicin
Tablični popis nuspojava kod karcinoma dojke za Docetaxel Zentiva 75 mg/m² u kombinaciji s doksorubicinom
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 160 mg/8 ml concentrate for solution for infusion docetaxel
Docetaxel Zentiva 160 mg/8 ml koncentrat za otopinu za infuziju docetaksel
Nausea (G3/4: 9.6%);
proljev (G3/4: 6,2%);
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL / Docetaxel Zentiva 80 mg/4 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE NALJEPNICA BOČICE / Docetaxel Zentiva 80 mg/4 ml
Tabulated list of adverse reactions in breast cancer for Docetaxel Zentiva 75 mg/m² in combination with capecitabine
Tablični popis nuspojava kod karcinoma dojke za Docetaxel Zentiva 75 mg/m² u kombinaciji s kapecitabinom
Description of selected adverse reactions in gastric adenocarcinoma cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Opis odabranih nuspojava za Docetaxel Zentiva 75 mg/m² u kombinaciji s cisplatinom i 5fluorouracilom u terapiji adenokarcinoma želuca
The recommended dose of docetaxel is 75 mg/m2.
Standard liječenja + docetaksel 75 mg/m
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 20 mg/1 ml concentrate for solution for infusion docetaxel
Docetaxel Zentiva 20 mg/1 ml koncentrat za otopinu za infuziju docetaksel
NAME OF THE MEDICINAL PRODUCT Docetaxel Zentiva 80 mg/4 ml concentrate for solution for infusion docetaxel
Docetaxel Zentiva 80 mg/4 ml koncentrat za otopinu za infuziju docetaksel
Weight decreased (G3/4: 0.2%)
abdominalna bol (G3/4: 0,4%)
Patients on the comparator arm received cisplatin (P) 100 mg/m2 followed by 5-fluorouracil (F)
Bolesnici u docetaksel skupini primali su docetaksel (T) 75 mg/m nakon čega je slijedio cisplatin (P)
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel Zentiva 75 mg/m² single agent
Tablični popis nuspojava kod karcinoma nemalih stanica pluća za Docetaxel Zentiva 75 mg/m² u monoterapiji
Description of selected adverse reactions in breast cancer for Docetaxel Zentiva 100 mg/m² single agent
Opis odabranih nuspojava kod karcinoma dojke za Docetaxel Zentiva 100 mg/m u monoterapiji
Vomiting (G3: 1%)
a promjene na noktima (G3: 1%)
In Docetaxel Zentiva 20 mg/1 ml vial the concentration of docetaxel is 20 mg/ml.
U bočici lijeka Docetaxel Zentiva 20 mg/1 ml, koncentracija docetaksela iznosi 20 mg/ml.
Peripheral sensory neuropathy (G3: 4.1%); Peripheral motor neuropathy (G3/4: 4%); Dysgeusia (severe:
Poremećaji živčanog sustava periferna senzorna neuropatija (G 3: periferna motorna neuropatija (G 3/4: disgeuzija (teška:
If you get any side effects , talkto your doctor, hospital pharmacist or nurse.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
Number of metastatic prostate cancer patients
Broj bolesnika s metastatskim karcinomom prostate Medijan ukupnog preživljenja (mjeseci)
In Docetaxel Zentiva 20 mg /1 ml vial the concentration of docetaxel is 20 mg/ml.
U bočici Docetaxel Zentiva 20 mg/l ml, koncentracija docetaksela iznosi 20 mg/ml.
Febrile neutropenia (G3/4: NA)
Manje česte nuspojave povraćanje (G3/4: konstipacija
95% CI p-value*
95% CI p- vrijednost
Tabulated list of adverse reactions in head and neck cancer for Docetaxel Zentiva 75 mg/m² in combination with cisplatin and 5-fluorouracil
Tablični popis nuspojava za Docetaxel Zentiva 75 mg/m u kombinaciji s cisplatinom i 5
Dizziness (G3/4: Peripheral motor neuropathy (G3/4:
omaglica (G3/4:2,0%) periferna motorna neuropatija (G3/4:0,4%)
2 years
Neotovorena bočica 2 godine
Infection associated with G4 neutropenia
infekcije udružene s G4 neutropenijom (G3/4:
Infusion site reaction
Opći poremećaji i reakcije na mjestu primjene
These scabs usually disappear within 2 weeks.
Kraste obično nestanu nakon dva tjedna.
Pregnancy: Can be used during pregnancy.
Može se primjenjivati tijekom graviditeta.
Not applicable.
Nije primijenjivo.
Each dose (0.2 ml or 0.5 ml) of reconstituted vaccine contains:
Svaka doza (0,2 ml ili 0,5 ml) rekonstituirane vakcine sadržava:
The excipients listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Pomoćne tvari navedene u dijelu 6.1 SPC su ili dozvoljene tvari za koje je u tablici 1, Dodatka Uredbe Komisije (EU) br. 37/2010 naznačeno da određivanje MRL nije nužno, ili se smatra da se na njih ne primjenjuju odredbe Uredbe (EK) br. 470/2009 kada se primjenjuju u tom veterinarsko-medicinskim proizvodu.
The scabs are only observed in animals with active immunity and have no influence on the general health, appetite or behaviour of the rabbit.
Kraste se uočavaju u životinja s aktivnim imunitetom i nemaju utjecaj na opće zdravstveno stanje, apetit ili ponašanje kunića.
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
SADRŽAJ PO TEŽINI, VOLUMENU ILI BROJU DOZA 1 doza
High levels of maternally derived antibodies against myxoma virus and/or RHD virus can potentially reduce the efficacy of the product.
Visoka razina stečenih antitijela od majke protiv miksoma virusa i/ili RHD virusa, može potencijalno smanjiti učinkovitost proizvoda.
The active substances being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Djelatna tvar koja se sastoji od tvari biološkog podrijetla i namijenjena je za poticanje aktivne imunosti, na koje se ne primjenjuju odredbe Uredbe (EK) br. 470/2009.
Any reconstituted vaccine remaining at the end of this time should be discarded.
Preostalo rekonstituirano cjepivo, nakon tog vremena, treba baciti.
After infection with virulent field myxoma virus some vaccinated animals may develop a few very small swellings, especially on hairless places of the body, which quickly form scabs.
Nakon infekcije s virulentnim divljim miksoma virusom u nekih cijepljenih životinja moguć je razvoj nekoliko vrlo malih oteklina, posebno na mjestima bez dlake, koje brzo formiraju kraste.
Any unused veterinary medicinal product or waste materials derived from such medicinal product should be disposed of in accordance with local requirements.
Bilo koji neupotrebljeni veterinarsko-medicinski proizvod ili otpadni materijali dobiveni primjenom tih veterinarsko-medicinskih proizvoda trebaju se odlagati u skladu s lokalnim propisima.
EXP {month/year} Once reconstituted use within 4 hours.
EXP {mjesec/godina} Rekonstituirano cjepivo upotrijebiti unutar 4 sata.
Shelf life after reconstitution according to directions: 4 hours.
Rok valjanosti nakon rekonstitucije prema uputi: 4 sata.
A transient temperature increase of 1 - 2 °C can commonly occur.
Može doći do prolaznog porasta temperature od 1 - 2 °C.
For proper reconstitution of the multidose vial, use the following procedure:
Za pravilnu rekonstituciju višedozne bočice, koristiti sljedeći postupak:
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Stoga se odluka o primjeni ovog cjepiva prije, odnosno nakon primjene bilo kojeg drugog veterinarsko-medicinskog proizvoda mora donositi od slučaja do slučaja.
Live myxoma vectored RHD viruses
Živi miksoma vektorski RHD virusi
Do not mix with any other veterinary medicinal product, except solvent supplied for use with the veterinary medicinal product.
Ne miješati s bilo kojim drugim veterinarsko-medicinskim proizvodom osim s otapalom koje je priloženo za primjenu s veterinarsko-medicinskim proizvodom.
Revaccination: Revaccinate annually.
Ddocijepljivanje: Nadocijepiti svake godine.
Ensure that the lyophilisate is completely reconstituted before use.
Prije primjene liofilizat se mora potpuno rekonstituirati.
Hydrolysed gelatine Pancreatic digest of casein Sorbitol
Pankreasni digest kazeina Sorbitol
For active immunisation of rabbits from 5 weeks of age onwards to reduce mortality and clinical signs of myxomatosis and rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV1) and RHD type 2 virus (RHDV2).
Za aktivnu imunizaciju kunića u dobi od 5 tjedana i više, za smanjenje smrtnosti i kliničkih znakova miksomatoze i za sprječavanje smrtnosti zbog hemoragične bolesti kunića (RHD) uzrokovane klasičnim RHD virusom (RHDV1) i RHD tip 2 virusa (RHDV2).
CLINICAL PARTICULARS 4.1 Target species
KLINIČKE POJEDINOSTI 4.1 Ciljne vrste životinja Kunići.
In pet rabbits, local reactions at the injection site such as necrosis, scabs, crusts or hair loss may occur in very rare cases.
U vrlo rijetkim slučajevima, kod kućnih kunića mogu se javiti lokalne reakcije kao što je nekroza, krasta, kora ili gubitak dlake.
10 x 10 ml
10 ml
1 dose 50 doses
50 doza
*Focus Forming Units For the full list of excipients, see section 6.1.
Pomoćne tvari: Potpuni popis pomoćnih tvari vidi u odjeljku 6.1.
Use the vaccine suspension within 4 hours of reconstitution.
Suspenziju cjepiva primijeniti u roku od 4 sata nakon rekonstitucije.
0.5 ml 10 ml
0,5 ml
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX (SOLVENT ONLY)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU KUTIJA (OTAPALO)
EU/2/19/244/001-003
BROJ(EVI) ODOBRENJA ZA STAVLJANJE U PROMET EU/2/19/244/001-003
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
PROIZVOĐAČ BIOLOŠKI DJELATNE TVARI I PROIZVOĐAČ ODGOVORAN ZA PUŠTANJE SERIJE U PROMET
The appearance of mild clinical signs of myxomatosis may occur within 3 weeks of vaccination in very rare cases.
U vrlo rijetkim slučajevima mogu se javiti blagi klinički znakovi miksomatoze unutar 3 tjedna nakon cijepljenja.
Nobivac Myxo-RHD PLUS lyophilisate and solvent for suspension for injection for rabbits
Nobivac Myxo-RHD PLUS liofilizat i otapalo za suspenziju za injekciju za kuniće
Lyophilisate: off-white or cream-coloured pellet.
Liofilizat: peleta bjelkaste ili krem boje.
Reconstituted product: off-pink or pink coloured suspension.
Rekostituirani liofilizat: suspenzija roskaste ili ružičaste boje.
To be supplied only on veterinary prescription.
Samo za primjenu na životinjama - izdaje se samo na veterinarski recept.
Shelf life of the veterinary medicinal product (lyophilisate) as packaged for sale: 2 years.
Rok valjanosti liofilizata kad je zapakiran za prodaju: 2 godine.
To ensure the full duration of immunity, vaccination from 7 weeks of age is advised in this case.
Savjetuje se cijepljenje kunića od 7 tjedna starosti kako bi se osiguralo potpuno trajanje imuniteta.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SOLVENT LABEL
OSNOVNI PODACI KOJI SE MORAJU NALAZITI NA MALIM UNUTARNJIM PAKOVANJIMA
In addition to the signs observed after single dose vaccination, a mild swelling of the local lymph nodes may be observed within the first 3 days after the administration of a ten-fold overdose.
Pored znakova uočenih nakon cijepljenja s jednom dozom, blaga oteklina lokalnih limfnih čvorova može se pojaviti unutar 3 dana nakon cijepljenja s deseterostrukom dozom.
Solvent for Nobivac Myxo-RHD PLUS
Otapalo za Nobivac Myxo-RHD PLUS
TARGET SPECIES
CILJNE VRSTE ŽIVOTINJA Kunići
Plastic box with 5 x 1 dose vials of vaccine and 5 x 0.5 ml solvent vials (glass) Plastic box with 25 x 1 dose vials of vaccine and 25 x 0.5 ml solvent vials (glass) Cardboard box with 10 x 50 doses of vaccine
Plastična kutija s 5 x 1 doza vakcine i 5 x 0,5 ml otapala u staklenoj bočici Plastična kutija s 25 x 1 doza vakcine i 25 x 0,5 ml otapala u staklenoj bočici Kartonska kutija s 10 x 50 doza vakcine
Lyophilisate: Type I clear glass vial of 1 or 50 doses closed with a chlorobutyl rubber stopper and aluminium cap.
Staklena bočica od 1 ili 50 doza zatvorena s klorbutilnim gumenim čepom i aluminijskom kapicom.
Add 1 -2 ml of solvent to the 50-dose vaccine vial and ensure that the lyophilisate is fully dissolved.
Dodati 1 - 2 ml otapala u bočicu s 50 doza cjepiva i paziti da se liofilizat potpuno otopi.
Cardboard box with 10 x 10 ml solvent vials (glass)
Kartonska kutija s 10 x 10 ml otapala (staklena bočica)
− rare (more than 1 but less than 10 animals in 10,000 animals treated)
Učestalost nuspojava je određena prema sljedećim pravilima: - vrlo česte (više od 1 na 10 tretiranih životinja pokazuju nuspojavu(e) ) - česte (više od 1 ali manje od 10 životinja na 100 tretiranih životinja) - manje česte (više od 1 ali manje od 10 životinja na 1.000 tretiranih 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).
PARTICULARS TO APPEAR ON THE OUTER PACKAGE BOX
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKOVANJU
Serious hypersensitivity reactions, which may be fatal, may occur after vaccination in very rare cases.
U vrlo rijetkim slučajevima nakon cijepljenja se mogu javiti ozbiljne reakcije preosjetljivosti koje mogu biti fatalne.
Primary vaccination: Administer one dose to rabbits from 5 weeks of age onwards.
Prvo cijepljenje: Nakon rekonstitucije, 1 dozu cjepiva dati subkutano kunićima od 5. tjedna starosti nadalje.
Ensure that the resulting vaccine suspension in the solvent vial is properly mixed.
3. Paziti da se nastala suspenzija cjepiva u bočici s otapalom dobro promiješa.