natgillin/translations-raw huggingface dataset:
How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Contents of the pack and other information
Shranjevanje cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Vsebina pakiranja in dodatne informacije
• PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should under no circumstances be administered intravascularly.
• Cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER ne smete v nobenem primeru injicirati v žilo.
• pain in the armpit
• bolečine v trebuhu,
The immunogenicity of the A/Vietnam/1203/2004 strain vaccine has been evaluated in a clinical trial in children and adolescents aged 9 to 17 years (N=288), in children aged 3 to 8 years (N=146) and in infants and children aged 6 to 35 months (N=33) following a 0, 21 day schedule.
Odziv imunskega sistema na sev A/Vietnam/1203/2004 (H5N1) Imunogenost cepiva cepilnega seva A/Vietnam/1203/2004 je bila ocenjena v kliničnem preskušanju pri otrocih in mladostnikih, starih od 9 do 17 let (N=288), pri otrocih, starih od 3 do 8 let (N=146) ter dojenčkih in otrocih, starih od 6 do 35 mesecev (N=33), po shemi cepljenja 0. in 21. dan.
What you need to know before you are vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Kaj morate vedeti preden boste cepljeni s cepivom PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
After vaccination the rate of subjects with neutralising antibody titres ≥ 20, seroconversion rate and seroconversion factor as measured by MN assay in immunocompromised subjects and patients with chronic disease conditions were as follows:
Odstotek oseb, ki imajo titer nevtralizirajočih protiteles ≥ 20, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po cepljenju preiskovancev, ki so bili imunsko kompromitirani ali bolnikov s kroničnimi bolezenskimi stanji, so bili naslednji:
Prior to administration, visually inspect the suspension for any foreign particulate matter and/or abnormal physical appearance.
Suspenzijo pred dajanjem preglejte s prostim očesom glede delcev in/ali sprememb izgleda in v takšnem primeru cepivo zavrzite.
Seroneutralization rate* Seroconversion rate** Seroconversion factor***
Odstotek seronevtralizacije* Odstotek serokonverzije**
Non-clinical studies demonstrated minor alterations in liver enzymes and calcium levels in a repeat dose toxicity study in rats.
V študiji toksičnosti pri ponavljajočih odmerkih, ki je bila izvedena na podganah, so predklinične študije pokazale manjše spremembe v vrednostih jetrnih encimov in koncentraciji kalcija.
NAME OF THE MEDICINAL PRODUCT PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Suspension for injection
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Suspenzija za injiciranje
>4 mm² *** geometric mean increase
SRH, če je začetni vzorec > 4 mm² *** geometrična sredina povečanja
The protective efficacy of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER against morbidity and mortality induced by the infection with lethal doses of highly pathogenic avian Influenza
Učinkovitost cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER pri zaščiti pred obolevnostjo in smrtnostjo zaradi okužbe s smrtonosnimi odmerki izredno patogenega virusa ptičje gripe H5N1 je bila ocenjena neklinično na dihurju.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
Druga zdravila in cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Obvestite svojega zdravnika, če jemljete ali ste pred kratkim jemali katerokoli zdravilo, tudi če ste ga dobili brez recepta, oziroma če ste bili pred kratkim cepljeni s katerimkoli drugim cepivom.
• swollen glands
• otečene žleze,
STATEMENT OF ACTIVE SUBSTANCE(S) Influenza vaccine (whole virion, inactivated) containing antigen* A/Vietnam/1203/2004 (H5N1)
Cepivo proti gripi (celi virioni, inaktivirano), ki vsebuje antigen*: A/Vietnam/1203/2004 (H5N1)
A heterologous booster vaccination with a 7.5 µg non-adjuvanted formulation of the A/Indonesia/05/2005 strain vaccine has been administered 12 months after a priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in children and adolescents aged 9 to 17 years (N=196), children aged 3 to 8 years (N=79) and infants and children aged 6 months to 35 months (N=25).
Poživitveno cepljenje s 7,5 µg heterolognega cepilnega seva A/Indonesia/05/2005 brez adjuvansa je bilo uporabljeno pri otrocih in mladostnikih, starih od 9 do 17 let (N=196), pri otrocih, starih od 3 do 8 let (N=79), ter dojenčkih in otrocih, starih od 6 do 35 mesecev (N=25),12 mesecev po primarnem cepljenju z dvema odmerkoma cepiva s sevom A/Vietnam/1203/2004.
Once the needle is attached, the vaccine must be administered immediately.
Cepivo morate uporabiti nemudoma po namestitvi igle na brizgo.
Malaise
BOLEZNI
Trometamol Sodium chloride Water for injections Polysorbate 80
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi trometamol natrijev klorid voda za injekcije polisorbat 80
Urticaria
MedDRA
How to use PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Kako uporabljati cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
The ferrets were challenged intranasally on day 35 with a high dose of either the clade 2 H5N1 virus A/Indonesia/05/2005 or the clade 1 H5N1 virus A/Vietnam/1203/2004 and monitored for 14 days.
Na 35. dan je bil dihurjem skozi nos vbrizgan velik odmerek klada 2 virusa H5N1 A/Indonesia/05/2005 ali klada 1 virusa
- Demyelination:
- demielinizacija:
• runny nose
• izcedek iz nosu,
After vaccination, the seroprotection rate, seroconversion rate, and seroconversion factor for anti-HA antibody, as measured by SRH, in, infants, children, and adolescents aged 6 months to 17 years were as follows:
Odstotek serološke zaščite, odstotek serokonverzije in faktor serokonverzije, izmerjeni s SRH, za protitelesa proti HA po cepljenju dojenčkov, otrok in mladostnikov, starih od 6 mesecev do 17 let, so bili naslednji:
Antibody persistence after vaccination with the 7.5 µg non-adjuvanted formulation of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been evaluated in a clinical study in adults aged 18 - 59 years and subjects aged 60 years and above at 6 months, 12 - 15 months and 24 months after the start of the primary vaccination series.
H5N1 BAXTER (sev A/Vietnam/1203/2004) brez adjuvansa so ovrednotili v klinični študiji pri odraslih, starih od 18 do 59 let, in preiskovancih, starih 60 let in več, po 6 mesecih, 12-15 mesecih in 24 mesecih po začetku primarnega zaporedja cepljenja.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as other vaccines.
Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER se ne daje hkrati z drugimi cepivi.
One pack of 20 multidose vials (type I glass) of 5 ml suspension (10 x 0.5 ml doses) with a stopper (bromobutyl rubber).
Škatla po 20 večodmernih vial (iz stekla vrste I) po 5 ml suspenzije (10 odmerkov po 0,5 ml)
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as immunoglobulins.
Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER se ne sme uporabljati hkrati z imunoglobulini.
narrow SMQ “Anaphylactic reaction” and narrow SMQ “Angioedema”
ozko SMQ ”anafilaktične reakcije”
All spontaneous adverse reactions (SOC, HLT, PT) occurring in pregnant women, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Vsi spontani neželeni učinki (po organskih sistemih, HLT in PT), ki so se pojavili pri nosečnicah, razvrščeni v razrede po vrsti poročila (medicinsko ali nemedicinsko potrjenega), za obdobje, ki ga zajema poročilo, ter kumulativno.
12 Month Booster
Poživitveni odmerek po 12 mesecih
All spontaneous adverse reactions by age group, per SOC, HLT and PT, stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Vsi spontani neželeni učinki po starostnih skupinah, organskih sistemih, HLT in PT, razvrščeni v razrede po vrsti poročila (medicinsko ali nemedicinsko potrjenega), za obdobje, ki ga zajema poročilo, ter kumulativno.
• PANDEMIC INFLUENZA VACCINE H5N1 BAXTER should not be given at the same time as other vaccines.
• Cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER ne uporabljajte hkrati z drugimi cepivi.
PT “Bell's palsy”
PT ”Bellova paraliza”
MN Assay
Test MN
System Organ Class (SOC)
Razvrstitev organov po sistemu MedDRA
Microneutralisation Assay Immunocompromised subjects
Imunsko kompromitirani
Serious unlisted adverse reactions (SOC, HLT, PTs) stratified according to type of report (medically confirmed or non-medically confirmed), for the period covered by the report and cumulatively.
Resni nenavedeni neželeni učinki (po organskih sistemih, HLT in PT), razvrščeni v razrede po vrsti poročila (medicinsko ali nemedicinsko potrjenega), za obdobje, ki ga zajema poročilo, ter kumulativno.
Dizziness Headache Crying
draženje oči občasni
SKIN AND
INFEKCIJSKE IN
Seroneutralisation rates (MN titre ≥ 20) at 21 days after a 12 to 24 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains were as follows:
Odstotki seronevtralizacije (titer MN ≥ 20) 21 dni po poživitvenem cepljenju po 12 do 24 mesecih s 7,5 µg odmerkom cepiva s sevom A/Indonesia/05/2005, testirani proti homolognemu in heterolognemu sevu, so bili naslednji:
A minor infection such as a cold should not be a problem, but your doctor should advise whether you could still be vaccinated with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
Manjša okužba, kot je na primer prehlad, po navadi ni težava, kljub temu pa poslušajte nasvet zdravnika glede cepljenja s cepivom
2nd Dose 1st Dose
21 dni po 1. odmerku 2. odmerku 1. odmerku 2. odmerku
What PANDEMIC INFLUENZA VACCINE H5N1 BAXTER looks like and contents of the pack
Izgled cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER in vsebina pakiranja
Injection site pruritus Axillary pain
NALEPKA - ENOODMERNA NAPOLNJENA INJEKCIJSKA BRIZGA
Seroprotection rates (SRH area ≥ 25 mm²) at 21 days after a 12 months booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows:
Odstotki serološke zaščite (površina SRH ≥ 25 mm²) 21 dni po poživitvenem cepljenju po 12 mesecih s 7,5 µg odmerkom cepiva s sevom A/Indonesia/05/2005, testirani proti homolognemu in heterolognemu sevu, so bili naslednji:
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may be used in lactating women.
INFLUENZA VACCINE H5N1 BAXTER se lahko uporablja med dojenjem.
An overview for all spontaneous adverse reactions by SOC, High Level Term (HLT) and Preferred Term (PT), stratified according to type of report (medically confirmed or non-medically confirmed) and including the number of fatal reports, for the period covered by the report and cumulatively.
(High Level Term - HLT) in prednostnem terminu (Preferred Term - PT), razvrščenih v razrede po vrsti poročila (medicinsko ali nemedicinsko potrjenega), ter z navedbo števila poročil o smrtnih primerih za obdobje, ki ga zajema poročilo, in kumulativno.
A booster vaccination with a 7.5 µg heterologous A/Indonesia/05/2005 vaccine strain has been administered in a time window of 12 to 24 months after priming vaccination with two doses of the A/Vietnam/1203/2004 strain vaccine in three clinical studies in adults aged 18 to 59 years and in older aged 60 years and above.
so opravili poživitveno cepljenje s 7,5 µg heterolognega cepilnega seva A/Indonesia/05/2005 v časovnem oknu od 12 do 24 mesecev po primarnem cepljenju z dvema odmerkoma cepiva s sevom A/Vietnam/1203/2004.
The immunogenicity of PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (strain A/Vietnam/1203/2004) has been evaluated in three clinical studies in adults aged 18 - 59 years (N=961) and in older subjects aged 60 years and older (N=391) following a 0, 21 day schedule.
A/Vietnam/1203/2004) je bila ocenjena v treh kliničnih študijah pri odraslih, starih od 18 do 59 let (n=961) in pri starejših osebah, starih 60 let in več (n=391), in sicer po shemi cepljenja 0. in 21.
• Immunoglobulin is not to be given with PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
• Ni podatkov o subkutanem injiciranju cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER.
After vaccination, the rate of subjects with neutralizing antibody titers ≥ 20, seroconversion rate and seroconversion factor, as measured by MN assay, in infants, children, and adolescents aged 6 months to 17 years were as follows:
Odstotek oseb, ki imajo titer nevtralizirajočih protiteles enak ali večji od 20, ter odstotek serokonverzije in faktor serokonverzije, izmerjeni s testom mikronevtralizacije (MN) po cepljenju dojenčkov, otrok in mladostnikov, starih od 6 mesecev do 17 let, so bili naslednji:
Dublin 2
PRILOGA II
Vomiting Diarrhoea
BOLEZNI MIŠIČNO
Influenza-like illness
ŽILNE BOLEZNI
Very common Common Common Common Common
KAKOVOSTNA IN KOLIČINSKA SESTAVA
Injection site pain Injection site induration Injection site erythema Injection site swelling Injection site hemorrhage
utrujenost pireksija mrzlica slabo počutje gripi podobna bolezen nelagoden občutek v prsnem košu reakcije na mestu injiciranja
Pharmacotherapeutic group: Influenza vaccines, ATC Code J07BB01
Farmakoterapevtska skupina: Cepiva proti gripi, oznaka ATC: J07BB01 Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER je pridobilo dovoljenje za promet v ”izjemnih okoliščinah”.
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER is a vaccine used in individuals aged 6 months and older.
Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER je cepivo, ki se uporablja za osebe od 6. meseca starosti naprej, za preprečevanje influence (gripe) v uradno razglašenih pandemskih razmerah.
In the event of either being observed, discard the vaccine.
Če je to nujno za zagotavljanje takojšnje zaščite, pa je dovoljeno cepivo
• hardness, redness or swelling at the injection site
• otrdlina, rdečina ali oteklina na mestu injiciranja,
Immune response against the vaccine strain contained in PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (A/Vietnam/1203/2004)
H5N1 BAXTER (A/Vietnam/1203/2004) Imunogenost cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER (sev
• stuffy or runny nose
• izcedek iz nosu, • driska,
Seroneutralization rates (MN titer ≥ 20) at 21 days after a booster vaccination with the 7.5 µg dose of the A/Indonesia/05/2005 strain vaccine, tested against both the homologous and heterologous strains, were as follows:
* površina SRH ≥ 25 mm² Odstotki seronevtralizacije (titer MN ≥ 20) 21 dni po poživitvenem cepljenju s 7,5 µg odmerkom cepiva s sevom A/Indonesia/05/2005, testirani proti homolognemu in heterolognemu sevu, so bili naslednji:
EAR AND LABYRINTH DISORDERS
UŠESNE BOLEZNI, VKLJUČNO Z MOTNJAMI LABIRINTA
• Hypersensitivity reactions, including anaphylaxis, have been reported following use of a similar whole virion, Vero cell derived H1N1 influenza vaccine administered during a pandemic period.
• Po uporabi podobnega cepiva proti gripi s celimi virioni, razmnoženimi v celicah Vero,
• vertigo (motion sickness)
• omotica, • zaspanost,
Oropharyngeal pain Rhinorrhoea
nazofaringitis pogosti
How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER;
MARKETING AUTHORIZATION HOLDER
ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET
Oropharyngeal pain Cough
limfadenopatija občasni
PANDEMIC INFLUENZA VACCINE H5N1 BAXTER may make you feel dizzy or sick which may affect your ability to drive or use machines.
Cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER lahko povzroči omotico ali slabost,
• increased sweating
• povečano potenje,
• fatigue (feeling tired)
• utrujenost, • mrzlica,
How to store PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Keep this medicine out of the sight and reach of children.
Shranjevanje cepiva PANDEMIC INFLUENZA VACCINE H5N1 BAXTER Zdravilo shranjujte nedosegljivo otrokom!
• Injection site pruritus
• draženje na mestu injiciranja • srbečica na mestu injiciranja
Decreased appetite
zmanjšan apetit pogosti občasni občasni
narrow SMQ “Convulsions”
ozko standardizirano iskanje po MedDRA (Standardised MedDRA Query - SMQ) ”konvulzije”
Other medicines and PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
Vsebina pakiranja in dodatne informacije Kaj vsebuje cepivo PANDEMIC INFLUENZA VACCINE H5N1 BAXTER
NERVOUS SYSTEM DISORDERS
LIMFATIČNEGA SISTEMA
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT Single dose syringe (0.5ml)
Enoodmerna injekcijska brizga (0,5 ml)
Posology
PROSTORA
Uncommon Very Common
sinkopa zelo pogosti občasni občasni pogosti občasni
• hardness, redness, swelling or bruising at the injection site
• bolečine v sklepih ali mišicah, • otrdlina, rdečina, oteklina ali podplutba na mestu injiciranja,
EYE DISORDERs
• draženje oči,
SRH assay
Test SRH Test MN
Dose
dan.
- Periodicity should be reviewed by the MAH and the (Co-)Rapporteur at 6 monthly intervals.
- Revizijo pogostnosti izvedeta imetnik dovoljenja za promet z zdravilom (MAH) in
Conjunctivitis Eye irritation
BOLEZNI ŽIVČEVJA
Revaccination: every year.
Ponovno cepljenje: enkrat letno.
ATC Vet code: QI06AJ02
Oznaka ATC vet :QI06AJ02
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http://www.emea.europa.eu/.
MARKETING AUTHORISATION NUMBER(S) EU/2/04/049/001-002
ŠTEVILKA(E) DOVOLJENJ(A) ZA PROMET EU/2/04/049/001-002
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23/02/2005
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 23/02/2005
Date of last renewal: 15/01/2010
Datum podaljšanja dovoljenja za promet: 15/01/2010
The reaction was transient If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
Če opazite kakršne koli resne stranske učinke ali druge učinke, ki niso omenjeni v teh navodilih za uporabo, obvestite svojega veterinarja.
Use only in healthy animals.
Cepite le zdrave živali.
Shelf life of the veterinary medicinal product as packaged for sale:18 months.
6.3 Rok uporabnosti Rok uporabnosti zdravila v pakiranju za prodajo : 18 mesecev.
Where high levels of maternal antibodies against R, C or Ch components are expected to be present (e.g. in kittens of 9-12 weeks of age born from queens which were vaccinated before pregnancy and/or with known or suspected previous exposure to the pathogen(s)), the primary vaccination course should be delayed until 12 weeks of age.
Kjer je pričakovati visoke titre maternalnih protiteles proti R, C ali Ch komponentam (na primer pri mladičih starih od 9 do 12 tednov, rojenih mačkam, ki so bile cepljene pred brejostjo in/ali je znano ali verjetno, da so bile predhodno izpostavljene patogenu (om)), je potrebno osnovno cepljenje odložiti do starosti 12 tednov.
EU/2/04/049/001 Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) EU/2/04/049/002 Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
EU/2/04/049/001 Liofilizat (10 stekleničk z 1 odmerkom) in vehikel (10 stekleničk po 1 ml) EU/2/04/049/002 Liofilizat (50 stekleničk z 1 odmerkom) in vehikel (50 stekleničk po 1 ml)
Per dose of 1ml:
V odmerku po 1 ml:
Name and address of the manufacturer(s) of the biological active substance(s)
Ime in naslov izdelovalcev biološke zdravilne učinkovine (zdravilnih učinkovin).
1 ml 1: cell culture infective dose 50%
1: 50% infektivni odmerek za celično kulturo
4.7 Use during pregnancy, lactation or lay
4.7 Uporaba v obdobju brejosti, laktacije ali nesnosti Ne uporabite v obdobju brejosti.
No effect other than those already mentioned in section “Adverse reactions” have been observed after the administration of several doses, except hyperthermia that may exceptionally last 5 days.
Drugi učinki, razen tistih, ki so navedeni v poglavju 4.6 »Neželeni učinki«, niso znani, razen povišane temperature , ki izjemoma lahko traja pet dni.
Active immunisation of cats aged 8 weeks and older: - against feline viral rhinotracheitis to reduce clinical signs, - against calicivirus infection to reduce clinical signs and excretion, - against Chlamydophila felis infection to reduce clinical signs.
Aktivna imunizacija 8 tednov starih mačk in starejših: - Proti kužnemu rinotraheitisu mačk, za ublažitev kliničnih znamenj - Proti okužbam s kalicivirusi, za ublažitev kliničnih znamenj in zmanjšanje izločanja virusov,
Shelf life after reconstitution: use immediately after reconstitution
Rok uporabnosti po razredčenju ali rekonstituciji v skladu z navodili : uporabite takoj po rekonstituciji
QUALITATIVE AND QUANTITATIVE COMPOSITION Per dose of 1 ml
KAKOVOSTNA IN KOLIČINSKA SESTAVA
SPECIAL STORAGE CONDITIONS Store and transport refrigerated (2 °C - 8 °C) Protect from light.
POSEBNA NAVODILA ZA SHRANJEVANJE Shranjujte in prevažajte pri temperaturi 2°C - 8°C (v hladilniku).
Water for injection ....................................................................................................................... q.s.
Vehikel: Voda za injiciranje......................................................................................................................... q.s.
In very rare cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.
V zelo redkih primerih sta se en teden do tri tedne po ponovnem cepljenju pri odraslih mačkah pojavili prehodna hipertermija in letargičnost, včasih tudi v povezavi s šepanjem.
The duration of immunity is 1 year after the last (re-)vaccination.
Živali so odporne eno leto po zadnjem cepljenju.
If self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.
V primeru samo-injiciranja se takoj posvetujte z zdravnikom in mu povejte, da je prišlo do samo-injiciranja z živim cepivom, ki vsebuje klamidijo.
Store and transport refrigerated (2 °C - 8 °C) Protect from light.
Shranjujte in prevažajte pri temperaturi 2°C - 8°C (v hladilniku).
Type I glass bottle containing 1 dose of lyophilisate and type I glass bottle containing 1 ml of solvent, both closed with a butyl elastomer closure and sealed with an aluminium cap.
Prebodna steklenička iz stekla tipa 1, ki vsebuje 1 odmerek liofilizata, in prebodna steklenička iz stekla tipa I, ki vsebuje vehikel; obe zaprti z gumijastim zamaškom in zaščiteni z aluminijasto zaporko.
This vaccine should not be handled by persons who are immunodeficient or taking immunosuppressive medicinal products.
Oseba, ki daje zdravilo živalim, ne sme imeti oslabljenega imunskega sistema ali uživati zdravila, ki slabijo imunski sistem.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administrated with Merial non-adjuvanted vaccine against feline leukaemia
Podatki o varnosti in učinkovitosti so pokazali, da se to cepivo lahko meša in daje z Merialovim neadjuviranim cepivom proti levkemiji mačk.
PHARMACEUTICAL FORM Lyophilisate and solvent for suspension for injection.
FARMACEVTSKA OBLIKA Liofilizat in vehikel za suspenzijo za injiciranje.
ROUTE(S) OF ADMINISTRATION Subcutaneous use
POT(I) UPORABE ZDRAVILA Subkutana uporaba
Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus and Chlamydophila felis.
Vzpodbuja aktivno imunost proti herpesvirusu kužnega rinotraheitisa, kalicivirusu in Chlamydophila felis.
EXPIRY DATE EXP (mm/yyyy)
DATUM IZTEKA ROKA UPORABNOSTI ZDRAVILA EXP (mesec/leto)
2: egg infective dose 50%
2: 50% infektivni odmerek za embrionirana kokošja jajca
Safety and efficacy data are available which demonstrate that this vaccine can be mixed with Merial non-adjuvanted vaccine against feline leukaemia and/or administered the same day but not mixed with Merial adjuvanted vaccine against rabies.
Podatki o varnosti in učinkovitosti so pokazali, da je to cepivo varno mešati z Merialovim neadjuviranim cepivom proti levkemiji mačk in/ali dati isti dan, vendar ne zmešano z Merialovim cepivom proti steklini.
Lyophilisate and solvent for suspension for injection.
Liofilizat in vehikel za suspenzijo za injiciranje
Manufacturer for the batch release: MERIAL
Izdelovalec, odgovoren za sprostitev serije MERIAL