natgillin/translations-raw huggingface dataset:
En 1- ml dosis af vaccinen i henhold til følgende program:
Subcutaneous use One 1-ml dose of vaccine according to the following schedule:
11.
.
EVENTUELLE SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING
Keep out of the reach and sight of children..
• Opbevares utilgængeligt for børn. • Opbevares og transporteres ved 2°C – 8°C (i køleskab), beskyttet mod lys.
Store and transport at 2°C – 8°C (in a refrigerator), protected from light.
Må ikke fryses. • Bør anvendes umiddelbart efter anbrud. • Må ikke anvendes efter den udløbsdato, som er angivet på etiketten.
Do not use after the expiry date stated on the label.
15 Ingen bivirkninger er observeret efter administration af adskillige doser, undtagen de under punktet ” Bivirkninger ” nævnte.
15 No undesirable effect has been observed after the administration of several doses except those mentioned in the “ Adverse reactions” section.
Vaccinestammen er en rekombinant canarypox virus, der afgiver env og gag generne i FeLV- A, idet det er kendt, at kun subgruppe A er infektiv under praktiske forhold, og at immunisering over for subgruppe A giver fuld beskyttelse over for A, B og C.
Under field conditions, only sub-group A is infective and immunisation against sub-group A provides full protection against A, B and C.
Æske med 20 x 1 flasker.
Box of 20 x 1 bottles.
Æske med 50 x 1 flasker.
Box of 50 x 1 bottles.
EPAR – sammendrag for offentligheden Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR).
EPAR summary for the public This document is a summary of the European Public Assessment Report.
Purevax RC er en vaccine, der indeholder følgende aktive stoffer: • svækket felin rhinotracheitis herpesvirus (FHV F2- stamme), • dræbte calicivirose antigener (FCV 431 - og G1- stammer).
Purevax RC is a vaccine containing the following active substances: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain), • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains).
Purevax RC anvendes til at vaccinere katte fra 8 uger og opefter mod følgende sygdomme: • felin viral rhinotracheitis, der er en influenzalignende sygdom, som skyldes en herpesvirus, • felin calicivirose, der er en influenzalignende sygdom med betændelse af munden forårsaget af en calicivirus.
Purevax RC is used to vaccinate cats from the age of 8 weeks against the following diseases: • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus), • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus).
Vaccinen hjælper med at reducere symptomerne på sygdommene og med at reducere virusudskillelse i tilfælde af calicivirus- infektion.
The vaccine helps to reduce the symptoms of the diseases and also helps to reduce viral excretion in case of calicivirus infection.
Efter at Purevax RC- suspensionen er klargjort, injiceres 1 ml under huden.
After Purevax RC has been made up, 1 ml is injected under the skin.
Når en kat bliver vaccineret, opfatter immunsystemet de svækkede eller dræbte vira som fremmede og danner antistoffer mod dem.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses as ‘ foreign’ and makes antibodies against them.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised provided the source is acknowledged Hvordan blev Purevax RC undersøgt?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised provided the source is acknowledged How has Purevax RC been studied?
I feltundersøgelserne af Purevax RC så forskerne nærmere på planen for basisvaccinationen (2 injektioner med 3- 4 ugers mellemrum) og boostervaccinationen (kun én injektion).
In the field, the studies of Purevax RC looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
I feltundersøgelsen af basisvaccinationen fandt man en stigning i mængden af antistoffer mod felin rhinotracheitis herpesvirus og calicivirus- infektion.
In the field study of basic vaccination there was an increase in antibodies against feline rhinotracheitis herpesvirus and calicivirus infection.
I undersøgelsen af boostervaccinationen forblev mængden af antistoffer mod rhinotracheitis herpesvirus og calicivirus- infektion på et stabilt, højt niveau eller steg lidt.
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus and calicivirus infection remained stable at a high level or increased slightly.
Der kan af og til forekomme forbigående ligegyldighed med omgivelserne og appetitløshed samt forhøjet kropstemperatur, der varer i 1- 2 dage.
Occasionally, cats will develop temporary apathy (loss of interest in surroundings) and anorexia (loss of appetite), as well as hyperthermia (elevated body temperature) lasting for one or two days.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Purevax RC.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RC exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RC be given a marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Purevax RC til MERIAL den 23. februar 2005.
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RC to MERIAL on 23 February 2005.
Særnavn
Invented Strength
Lægemiddel - form
Content
Dyrearter, som lægemidlet er beregnet til
Package
Indgivelsesvej Emballage
Withdrawal
Indhold (koncentration)
species administration
Paknings størrelse
(concentration) size
Tilbageholdelsestid
period
Svækket felin
Lyophilisate and solvent for suspension for injection
Tørstof og
Cats
Katte
Subcutaneous use
Subkutan Type I
Type I glass bottle closed with a butyl elastomer closure and sealed with an aluminium cap
10 flasker med
10 bottles of 1 dose (lyophilisate) and 10 bottles of 1ml (solvent)
1 dosis
1 dose of lyophilis ate and 1ml of solvent
Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme): mindst 4, 9 log 10 CCID50 pr. dosis Dræbte feline calicivirose antigener (FCV 431 og FCV G1 stammer): mindst 2, 0 ELISA U pr. dosis
Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per dose Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains): at least 2.0 ELISA U per dose
Tørstof og solvens til injektionsvæsk e, suspension
Lyophilisate and solvent for suspension for injection
Type I glasflaske lukket med en butyl elastomer prop og forseglet med en aluminiums kapsel
Type I glass bottle closed with a butyl elastomer closure and sealed with an aluminium cap
50 flasker med 1 dosis (tørstof) og 50 flasker med 1 ml (solvens)
50 bottles of 1 dose (lyophilisate) and 50 bottles of 1ml (solvent)
1 dosis tørstof og 1 ml solvens
1 dose of lyophilis ate and 1ml of solvent
Purevax RCCh er en vaccine, der indeholder følgende aktive stoffer: • svækket felin rhinotracheitis herpesvirus (FHV F2- stamme), • dræbte calicivirose antigener (FCV 431 - og G1- stammer), • svækket Chlamydophila felis (905- stamme).
Purevax RCCh is a vaccine containing the following active substances: • attenuated (weakened) feline rhinotracheitis herpesvirus (FHV F2 strain), • inactivated (killed) calicivirosis antigens (FCV 431 and G1 strains), • attenuated Chlamydophila felis (905 strain).
Purevax RCCh anvendes til at vaccinere katte fra 8 uger og opefter mod følgende sygdomme: • felin viral rhinotracheitis, der er en influenzalignende sygdom, som skyldes en herpesvirus, • felin calicivirose, der er en influenzalignende sygdom med betændelse af munden forårsaget af en calicivirus, • chlamydiose, der er en influenzalignende sygdom fremkaldt af bakterien Chlamydophila felis.
Purevax RCCh is used to vaccinate cats from the age of 8 weeks against the following diseases: • feline viral rhinotracheitis (a flu-like illness caused by a herpesvirus), • feline calicivirosis (a flu-like illness with inflammation of the mouth caused by a calicivirus), • chlamydiosis (a flu-like illness caused by the bacterium C. felis).
Vaccinen hjælper med at reducere symptomerne på sygdommene og med at reducere virusudskillelse i tilfælde af calicivirus- infektion.
It also helps to reduce viral excretion in case of calicivirus infection.
Efter at Purevax RCCh- suspensionen er klargjort, injiceres 1 ml under huden.
After Purevax RCCh has been made up, 1 ml is injected under the skin.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised provided the source is acknowledged Hvordan virker Purevax RCCh?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2008 Reproduction and/ or distribution of this document is authorised provided the source is acknowledged How does Purevax RCCh work?
Når en kat bliver vaccineret, opfatter immunsystemet de svækkede eller dræbte vira og den svækkede bakterie som fremmede og danner antistoffer mod dem.
When a cat is given the vaccine, the immune system recognises the weakened or killed viruses and the weakened bacteria as ‘ foreign’ and makes antibodies against them.
I feltundersøgelser af Purevax RCCh så forskerne nærmere på planen for basisvaccinationen (2 injektioner med 3- 4 ugers mellemrum) og boostervaccinationen (kun én injektion).
In the field, the studies of Purevax RCCh looked at the basic vaccination schedule (2 injections 3-4 weeks apart) and at the booster vaccination (only one injection).
I undersøgelsen af boostervaccinationen forblev mængden af antistoffer mod rhinotracheitis herpesvirus, calicivirus- infektion og Chlamydophila felis på et stabilt, højt niveau eller steg lidt.
In the study looking at booster vaccination, antibody levels against rhinotracheitis herpesvirus, calicivirus infection and C. felis remained stable at a high level or increased slightly.
Hvis en sådan person alligevel kommer til at injicere sig selv med vaccinen, skal personen straks søge lægehjælp og fortælle, at han/ hun er kommet til at injicere sig selv med en levende chlamydia- vaccine.
If self-injection does occur in these people, tell the doctor that self-injection with a living chlamydial vaccine has occurred.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Purevax RCCh.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Purevax RCCh exceed the risks for the active immunisation of cats aged eight weeks or older against the diseases listed above, and recommended that Purevax RCCh be given a marketing authorisation.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Purevax RCCh til MERIAL den 23. februar 2005.
The European Commission granted a marketing authorisation valid throughout the European Union for Purevax RCCh to MERIAL on 23 February 2005.
Emballage
Withdrawal
Paknings størrelse
size
Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme): mindst 4, 9 log 10 CCID50 pr. dosis Dræbte feline calicivirose antigener (FCV 431 og FCV G1 stammer): mindst 2, 0 ELISA U pr. dosis Svækket felin Chlamydophila felis (905 stamme): mindst 3, 0 log 10 EID50 pr. dosis
Attenuated feline rhinotracheitis herpesvirus (FVH F2 strain): at least 4.9 log 10 CCID50 per dose Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains): at least 2.0 ELISA U per dose Attenuated feline Chlamydophila felis (905 strain): at least 3.0 log 10 EID50 per dose
10 flasker med 1 dosis (tørstof) og 10 flasker med 1 ml (solvens)
10 bottles of 1 dose (lyophilisate) and 10 bottles of 1ml (solvent)
1 dosis (1 ml) indeholder:
Per 1-ml dose:
Frysetørret pille:
Freeze-dried pellet:
Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme).......................................... > 104, 9 CCID501 Dræbte feline calicivirose antigener (FCV 431 og G1 stammer).................................... > 2. 0 ELISA U.
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)..................................... ≥ 104.9 CCID501 Inactivated feline Calicivirosis antigens (FCV 431 and G1 strains)............................. ≥ 2.0 ELISA U.
Svækket Chlamydophila felis (905 stamme).................................................................... > 103, 0 EID502 Hjælpestof:
Attenuated Chlamydophila felis (905 strain).................................................................... ≥ 103.0 EID502 Excipient:
28 µg Solvens:
Gentamicin, at most........................................................................................................................ .28 µg Solvent:
Vand til injektion ……… …………………………………………………………….. ……….. q. s.
Water for injection..................................................................................................................... q. s.
1 ml 1: cellekultur infektiøs dosis 50% 2: æg infektiøs dosis 50% Se afsnit 6. 1 for en fuldstændig fortegnelse over hjælpestoffer.
1 ml 1: cell culture infective dose 50% 2: egg infective dose 50% For a full list of excipients, see section 6.1.
4.
Cats.
KLINISKE OPLYSNINGER
4.2 Indications for use
4. 1 Dyrearter, som lægemidlet er beregnet til
- against feline viral rhinotracheitis to reduce clinical signs,
Kat
- against calicivirus infection to reduce clinical signs and excretion,
4. 2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til
- against Chlamydophila felis infection to reduce clinical signs.
Aktiv immunisering af katte, der er 8 uger gamle eller ældre: • mod felin viral rhinotracheitis for at reducere kliniske tegn • mod calicivirus infektion for at reducere kliniske tegn og virusudskillelse • mod Chlamydophila felis infektion for at reducere kliniske tegn Det er vist, at immuniteten indtræder 1 uge efter basisvaccination for rhinotracheitis, calicivirus og Chlamydophila felis.
Onsets of immunity have been demonstrated 1 week after primary vaccination course for rhinotracheitis, calicivirus and Chlamydophila felis components.
Varigheden af immunitet er 1 år efter sidste (re -) vaccination.
The duration of immunity is 1 year after the last (re-)vaccination.
Anvendelse frarådes under drægtighed.
Do not use in pregnant animals.
2/ 17 4. 5 Særlige forsigtighedsregler vedrørende brugen
2/ 17 4.5 Special precautions for use
Denne vaccine bør ikke håndteres af personer, der er immundeficiente eller tager immunsuppressive lægemidler.
This vaccine should not be handled by persons who are immunodeficient or taking immunosuppressive drugs.
Hvis selv- injektion opstår ved et uheld, bør der øjeblikkeligt søges læge og lægen informeres om at selv- injektion med en levende chlamydia vaccine er sket.
If self-injection occurs, immediate medical advice should be sought and the doctor informed that self-injection with a living chlamydial vaccine has occurred.
Der foreligger oplysninger om sikkerhed og virkning der viser, at denne vaccine kan blandes med Merials vaccine uden adjuvans mod felin leukæmi og/ eller anvendes den samme dag men ikke blandes med Merials vaccine med adjuvans mod rabies..
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.
Injicer subkutant en 1 ml dosis af vaccinen efter opløsning af den frysetørrede pille i solvens, i henhold til følgende vaccinationsprogram:
Inject by subcutaneous route one 1-ml dose of vaccine after reconstitution of the lyophilisate with the solvent, according to the following vaccination scheme:
Basisvaccination: • første injektion fra 8 uger gamle • anden injektion:
- first injection: from 8 weeks of age,
3- 4 uger senere.
3 to 4 weeks later.
Ved tilstedeværelse af høje værdier af specifikke maternelle antistoffer, bør man vente med basisvaccination til killingerne er 12 uger gamle.
In the presence of high levels of maternally derived specific antibodies, the primary vaccination course should be delayed until 12 weeks of age.
3/ 17 4. 10 Overdosering (symptomer, nødforanstaltninger, modgift), om nødvendigt
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Der er ikke iagttaget andre symptomer end de, der er nævnt under sektion 4. 6 bortset fra hyperthermi, der i sjældne tilfælde kan vare op til 5 dage.
No effect other than those already mentioned in section “ Adverse reactions” have been observed, except hyperthermia that may exceptionally last 5 days.
4. 11 Tilbageholdelsestid
3/ 17 4.11 Withdrawal period(s)
ATC Vet kode:
ATC Vet code:
Stimulerer aktivt immuniteten over for felin rhinotracheitis herpesvirus, felin calici virus og Chlamydophila felis.
Stimulates active immunity against feline rhinotracheitis herpesvirus, feline calicivirus and Chlamydophila felis.
Saccharose Sorbitol Dextran 40 Casein hydrolysat Kollagen hydrolysat Salte
Sucrose Sorbitol Dextran 40 Casein hydrolysate Collagen hydrolysate Salts
4. 8 nævnte.
Do not mix with any other vaccine or immunological product, except those mentioned in section “ Interactions”.
18 måneder Bør anvendes umiddelbart efter opløsning.
Use immediately after reconstitution
Beskyttes mod lys.
Store and transport refrigerated (2 °C – 8 °C) protected from light.
Type I glasflaske indeholdende 1 dosis af tørstof og type I glasflaske indeholdende 1 ml solvens, begge lukket med en butyl elastomer prop og forseglet med en aluminiumskapsel.
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.
Ikke alle pakningsstørrelser er nødvendigvis markedsført.
Pack containing 10 bottles of 1 dose of lyophilisate and 10 bottles of 1 ml of solvent Pack containing 50 bottles of 1 dose of lyophilisate and 50 bottles of 1 ml of solvent Not all pack sizes may be marketed.
4/ 17 6. 6 Eventuelle særlige forholdsregler ved bortskaffelse af ubrugte veterinærlægemidler eller affaldsmaterialer fra brugen af sådanne
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Merial 29, avenue Tony Garnier 69007 Lyon Frankrig
MERIAL 29, avenue Tony Garnier 69007 LYON FRANCE
Navn og adresse på fremstiller( e) af de( t) biologisk aktive stof( fer) Merial Laboratory of Lyon Porte des Alpes Rue de l’ Aviation 69800 Saint- Priest Frankrig
Name and address of the manufacturer(s) of the biological active substance(s) Merial Laboratory of Lyon Porte des Alpes Rue de l’ aviation 69800 SAINT-PRIEST France
Merial Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 Lyon Frankrig
Merial Laboratory of Lyon Gerland 254, Avenue Marcel Mérieux 69007 LYON France
Merial Laboratory of Lyon Porte des Alpes Rue de l’ Aviation 69800 Saint- Priest Frankrig
Merial Laboratory of Lyon Porte des Alpes Rue de l’ aviation 69800 SAINT-PRIEST France
FHV (F2 stamme).............................................................................................................. > 104, 9 CCID50 FCV (431 og G1 stammer)............................................................................................ > 2. 0 ELISA U.
FHV (F2 strain)................................................................................................................ ≥ 104.9 CCID50 FCV (431 and G1 strains).............................................................................................. ≥ 2.0 ELISA U.
28 µg
Chlamydophila felis (905 strain)......................................................................................... ≥ 103.0 EID50 Gentamicin, at most........................................................................................................................ .28 µg
Tørstof (10 flasker à 1 dosis) + solvens (10 flasker à 1 ml) Tørstof (50 flasker à 1 dosis) + solvens (50 flasker à 1 ml)
Lyophilisate (10 bottles of 1 dose) + solvent (10 bottles of 1 ml) Lyophilisate (50 bottles of 1 dose) + solvent (50 bottles of 1 ml)
EXP {MM/ ÅÅÅÅ} Bør anvendes umiddelbart efter opløsning.
EXP (mm/ yyyy) Use immediately after reconstitution.
MERIAL 29, avenue Tony Garnier F- 69007 LYON FRANKRIG
MERIAL 29, avenue Tony Garnier F-69007 LYON FRANCE
EU/ 2/ 04/ 049/ 001 Tørstof (10 flasker à 1 dosis) + solvens (10 flasker à 1 ml) EU/ 2/ 04/ 049/ 002 Tørstof (50 flasker à 1 dosis) + solvens (50 flasker à 1 ml)
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)
Purevax RCCh tørstof til injektion.
Purevax RCCh lyophilisate for injection
Subkutan anvendelse.
Subcutaneous route
EXP
EXP (mm/ yyyy)
Purevax RCCh Tørstof og solvens til injektionsvæske, suspension.
Purevax RCCh Lyophilisate and solvent for suspension for injection.
MERIAL 29, avenue Tony Garnier F- 69007 LYON FRANKRIG
MERIAL 29, avenue Tony Garnier F-69007 Lyon France
MERIAL Laboratoires Porte des Alpes Rue de l’ Aviation F- 69800 SAINT- PRIEST FRANKRIG
MERIAL Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest France
Svækket felin rhinotracheitis herpesvirus (FHV F2 stamme).......................................... > 104, 9 CCID501 Dræbte feline calicivirose antigener (FCV 431 og G1 stammer).................................... > 2. 0 ELISA U.
Attenuated feline rhinotracheitis herpesvirus (FHV F2 strain)..................................... ≥ 104.9 CCID501 Inactivated feline Calicivirosis antigens (FCV 431 and FCV G1 strains).................... ≥ 2.0 ELISA U.
Svækket Chlamydophila felis (905 stamme).................................................................... > 103, 0 EID502 Hjælpestoffer:
Attenuated Chlamydophila felis (905 strain).................................................................... ≥ 103.0 EID502 Excipient:
28 µg Solvens:
Water for injection..................................................................................................................... q. s.
Vand til injektion ……………..................................................... …………………………… q. s 1 ml 1: cellekultur infektiøs dosis 50% 2: æg infektiøs dosis 50%
1 ml 1: cell culture infective dose 50% 2: egg infective dose 50%
I sjældne tilfælde kan der opstå lokal reaktion (let smerte ved palpering, kløe eller let hævelse), der vil forsvinde inden for højst 1 til 2 uger.
A local reaction may occur (slight pain at palpation, itching or limited oedema) that disappears within 1 or 2 weeks at most.
Reaktionen var forbigående.
In very rare cases, hyperthermia and lethargy sometimes associated with lameness has been observed one to three weeks following booster vaccination in adult cats.
Revaccination: hvert år
Revaccination:
Må ikke blandes med andre vacciner eller immunologiske lægemidler end de nedenfor nævnte.
Do not mix with any other vaccine or immunological product, except those mentioned below.
Opbevares utilgængeligt for børn Opbevares og transporteres nedkølet (2°C - 8°C).
Keep out of the reach and sight of children.
Anvendelse frarådes under drægtighed og diegivning.
The use is not recommended during lactation.
Efter administration af flere doser er der ikke iagttaget andre symptomer end de, der er nævnt under punkt 6 bortset fra hyperthermi, der i sjældne tilfælde kan vare op til 5 dage.
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.