natgillin/translations-raw huggingface dataset:
27/ 46 8.
24/ 42 8.
8 uger
(Month/ year) Once opened use within 8 weeks
EVENTUELLE SÆRLIGE FORHOLDSREGLER VED BORTSKAFFELSE UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
TEKSTEN "TIL DYR"
THE WORDS "FOR ANIMAL TREATMENT ONLY"
NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN OG PÅ DEN INDEHAVER AF VIRKSOMHEDSGODKENDELSE, SOM ER ANSVARLIG FOR BATCHFRIGIVELSE, HVIS FORSKELLIG HERFRA
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IN THE EEA IF DIFFERENT
28/ 46 Navn og adresse på den indehaver af virksomhedsgodkendelse, som er ansvarlig for batchfrigivelse
25/ 42 Name and address of the Manufacturing Authorisation Holder responsible for batch release
29/ 46 MINIMUMS OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE PAKNING.
26/ 42 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
MÆNGDE AF AKTIV( E) STOF( FER)
QUANTITY OF THE ACTIVE SUBSTANCE
VÆGT, VOLUME ELLER ANTAL DOSER
CONTENTS BY WEIGHT, BY VOLUME OR NUMBER OF DOSES
Oral anvendelse, 15 mg pr. kg legemsvægt én gang dagligt (dvs.
Oral use, 15 mg per kg bodyweight once daily (i. e.
0, 5 ml gel pr. kg legemsvægt).
0.5 ml of gel per kg body weight).
8 uger.
EXP {month/ year} > Once opened use within 8 weeks.
30/ 46 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
27/ 42 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
KARTONÆSKE TIL 1 SPRØJTE IBAFLIN 7, 5% ORAL GEL / KARTONÆSKE TIL 5 SPRØJTER IBAFLIN 7, 5% ORAL GEL
CARTON BOX FOR 1 SYRINGE IBAFLIN 7.5% ORAL GEL / CARTON BOX FOR 5 SYRINGES IBAFLIN 7.5% ORAL GEL
Ibaflin 7, 5% oral gel til hunde
Ibaflin 7.5% oral gel for dogs.
Kartonæske indeholdende 1 justerbar præfyldt multidosissprøjte, indeholdende 30 ml Ibaflin 7, 5% oral gel. / Kartonæske indeholdende 5 justerbare præfyldte multidosissprøjter, hver indeholdende 30 ml Ibaflin 7, 5% oral gel.
Carton box containing 1 adjustable pre-filled multidose syringe, containing 30 ml Ibaflin 7.5% oral gel. / Carton box containing 5 adjustable pre-filled multidose syringes, containing 30 ml Ibaflin 7.5% oral gel.
Læs indlægsseddel inden brug.
15 mg per kg bodyweight = 1 ml of gel per 5 kg bodyweight Read the package insert before use.
31/ 46 9.
28/ 42 9.
8 uger.
(Month/ year) Once opened use within 8 weeks.
32/ 46 Navn og adresse på den indehaver af virksomhedsgodkendelse, som er ansvarlig for batchfrigivelse
29/ 42 Name and address of the Manufacturing Authorisation Holder responsible for batch release
33/ 46 MINIMUMS OPLYSNINGER, DER SKAL ANFØRES PÅ DEN INDRE PAKNING
30/ 42 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
IBAFLIN 7, 5% ORAL GEL, JUSTÉRBAR MULTIDOSISSPRØJTE
IBAFLIN 7.5% ORAL GEL ADJUSTABLE MULTIDOSE SYRINGE
Ibaflin 7, 5% oral gel til hunde
Ibaflin 7.5% oral gel for dogs
5 kg legemsvægt).
1 ml of gel per 5 kg body weight).
34/ 46 B.
31/ 42 B.
35/ 46 INDLÆGSSEDDEL
32/ 42 PACKAGE INSERT
Intervet GesmbH Siemensstrasse 107 A1210 Wien Østrig
Intervet GesmbH Siemensstrasse 107 A 1210 Vienna Austria
36/ 46 6.
33/ 42 6.
DOSERING FOR HVER DYREART
DOSAGE FOR EACH SPECIES
Ibaflin Ibaflin 30 mg 150 mg 0, 5 1 1, 5 2 0, 5 1 1, 5
Ibaflin Ibaflin 30 mg 150 mg 0.5 1 1.5 2 0.5 1 1.5
Ibaflin 300 mg 1 2
Ibaflin 300mg 1 2
Ibaflin 900 mg 0, 5 1
Ibaflin 900 mg 0.5 1
Oral anvendelse.
Oral
Må ikke anvendes i kombination med nonsteroide antiinflammatoriske lægemidler (NSAID’ s) til hunde, der tidligere har haft krampe.
Do not use in combination with nonsteroidal anti-inflammatory drugs (NSAIDs) in dogs with a history of seizures.
37/ 46 11.
34/ 42 11.
EVENTUELLE, SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING
SPECIAL STORAGE CONDITIONS, IF ANY
BORTSKAFFELSE AF
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
DATO FOR SENESTE ÆNDRING AF INDLÆGSSEDLEN
DATE ON WHICH THE PACKAGE INSERT WAS LAST REVISED
Dets virkning er opnået ved hæmning af bakteriel DNA- gyrase.
Its action results from inhibition of bacterial DNA gyrase.
Efter oral indgift til hunde optages ibafloxacin hurtigt med maksimal koncentration i plasma af mikrobiologiske aktive forbindelser 1- 2 timer efter indgift.
After oral administration in dogs, ibafloxacin is rapidly absorbed with maximum plasma levels of microbiologically active compounds obtained at 1-2 hours after administration.
4- 5 timer.
Terminal plasma half-life is approximately 4-5 hours.
Sikkerhedsstudier udført på 8 måneder gamle beagle hunde viste, at ved oral indgift af 45 mg/ kg/ dag (tre gange den anbefalede dosis) i 90 dage, gav ibafloxacin ikke anledning til erkendelige uønskede reaktioner.
Target animal safety studies in beagle dogs of 8 months of age demonstrated that, when administered orally at 45 mg/ kg/ day (three times the recommended dose) for a period of 90 days, ibafloxacin produced no observable adverse effects.
38/ 46 INDLÆGSSEDDEL TIL PAKNINGER MED SPRØJTER MED 3% ORAL GEL
35/ 42 PACKAGE INSERT FOR INCLUSION WITH THE 3% ORAL GEL SYRINGE PACKAGES
Ibaflin 3% oral gel
Ibaflin 3% oral gel
ANGIVELSE AF AKTIV( E) STOF( FER)
STATEMENT OF THE ACTIVE AND OTHER SUBSTANCE(S)
30 mg ibafloxacin pr. g gel (svarende til 30, 9 mg/ ml).
30 mg of ibafloxacin per g of gel (equivalent to 30.9 mg/ ml);
Methylparahydroxybenzoat (0, 125%)
Methyl parahydroxybenzoate (0.125%)
Intervet International B. V.
Name and address of the Manufacturing Authorisation Holder responsible for batch release Intervet International B. V.
39/ 46 5.
5.
som Staphylococcus spp., E. coli og Proteus mirabilis.
pathogens such as Staphylococcus spp., E. coli and Proteus mirabilis
Ibaflin oral gel er indikeret til behandling af katte for følgende tilstande:
36/ 42 Ibaflin gel is indicated in cats for treatment of the following conditions:
Oral anvendelse, 15 mg ibafloxacin/ kg én gang dagligt.
Oral use, 15 mg ibafloxacin/ kg once daily.
15 mg pr. kg legemsvægt = 0, 5 ml gel pr. kg legemsvægt.
15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight
Sprøjten indstilles til den beregnede dosering ved at placere ringen på det korrekte sted på stemplet (trin af 0, 5 ml for 15 ml sprøjten).
The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger (steps of 0.5 ml for the 15 ml syringe).
Oral anvendelse Det anbefales at give gelen ved fodringstid.
Oral use It is recommended that the gel is administered at the time of feeding.
40/ 46 9.
9.
For de fleste racer er anvendelse af ibafloxacin kontraindikeret for hunde, der er yngre end 8 måneder og for de tungeste racer, der yngre end 18 måneder.
For the majority of breeds, the use of ibafloxacin is contra-indicated in dogs less than 8 months of age, and in giant breeds less than 18 months.
Hvis du bemærker andre bivirkninger, bedes du venligst informere dyrlægen herom.
If you notice any other side effect, please inform your veterinary surgeon.
SÆRLIGE FORHOLDSREGLER VEDRØRENDE OPBEVARING
SPECIAL STORAGE CONDITIONS
Sprøjter, der indeholder rester, bør smides væk, så snart behandlingen er afsluttet.
Any syringes containing unused product should be disposed of once a course of treatment has been completed.
SÆRLIGE FORHOLDSREGLER VED
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIAL, IF ANY
Ibafloxacin er et bredspektret antibiotikum med baktericid virkning grundet hæmning af bakteriel DNA- gyrase.
Ibafloxacin is a broad spectrum antibiotic with bactericidal action resulting from inhibition of bacterial DNA gyrase.
Ibafloxacin og 8- hydroxy- ibafloxacin har synergistisk effekt.
The most abundant metabolite is 8-hydroxy-ibafloxacin, which is also microbiologically active. lbafloxacin and 8- hydroxy-ibafloxacin act synergistically.
3- 5 timer.
Terminal plasma half- life is approximately 3-5 hours.
Ved gentagen oral indgift opnås steady state efter første dosering, og der forekommer ikke akkumulation hos hunde, hvorimod moderat akkumulation er set hos katte.
After multiple oral administration, steady state is reached after the first dosing and no accumulation occurs in dogs whereas modest accumulation is observed in cats.
42/ 46 INDLÆGSSEDDEL TIL PAKNINGER MED SPRØJTER MED 7, 5% ORAL GEL
39/ 42 PACKAGE INSERT FOR INCLUSION WITH THE 7.5% ORAL GEL SYRINGE PACKAGES
Ibaflin 7, 5% oral gel
Ibaflin 7.5% oral gel
Ibaflin 7, 5% oral gel:
Ibaflin 7.5% Oral Gel:
75 mg ibafloxacin pr. g gel (svarende til 78, 8 mg/ ml);
75 mg of ibafloxacin per g of gel (equivalent to 78.8 mg/ ml)
som Staphylococcus spp., E. coli og Proteus mirabilis.
pathogens such as staphylococci, E. coli and Proteus mirabilis
43/ 46 6.
40/ 42 6.
5 kg legemsvægt.
15 mg per kg bodyweight = 1 ml of gel per 5 kg bodyweight
Ibaflin oral gel er sikkert at anvende under drægtighed hos hunde.
Ibaflin gel can be used during pregnancy in dogs.
Denne periode raceafhængig.
This period depends on the breed.
For de fleste racer er anvendelse af ibafloxacin kontraindikeret for hunde, der er yngre end 8 måneder og for de tungeste racer, der yngre end 18 måneder.
For the majority of breeds the use of ibafloxacin is contra-indicated in dogs less than 8 months of age, and in giant breeds less than 18 months.
44/ 46 10.
10.
11.
41/ 42 11.
45/ 46 16.
16.
Ved gentagen oral indgift opnås steady state efter første dosering, og der forekommer ikke akkumulation hos hunde.
After multiple oral administration, steady state is reached after the first dosing and no accumulation occurs in dogs.
Ved oral administration af en dosis på 75 mg/ kg/ dag (fem gange den anbefalede dosis) til hunde i en periode på 90 dage, blev ibafloxacin tolereret godt.
When administered orally at 75 mg/ kg/ day (five times the recommended dose) for a period of 90 days in dogs, ibafloxacin was well tolerated.
46/ 46
42/ 42
EU NUMMER
EU Number
Handelsn avn
Trade name
Salgspakninger
Package Size
Ibraxion
Ibraxion
gE deleted inaktiveret IBR virus, min.
gE deleted
Injektionsvæske, emulsion
Emulsion for
Type I glas flaske
Type I glass
10 ml flaske
10 ml
0 dage
bottle
0. 75 VN. U* 0. 75 VN. U *
gE deleted inactivated IBR virus, at least 0.75 VN. U*0.75 VN. U*
Type I glas flaske
Type I glass bottle
gE deleted
gE deleted inactivated IBR virus, at least 0.75 VN. U*0.75 VN. U*
Type I glas
Type I glass bottle
10 x 5
10 x 5 doses
flaske
10x10ml Zero bottle
doser
days
10 x 10
10 x 10 doses
10 x 20 ml flaske
10x 20 ml bottle
emulsion
Zero days
10 x 25
10 x 25 doses
* VN. U:
* VN. U:
Virusneutraliserende antistof titer efter vaccination af marsvin.
Vironeutralising antibody titre after vaccine injection in guinea pigs.
Hvis De vil have yderligere oplysninger om grundlaget for CVMP' s anbefalinger, henvises De til den videnskabelige diskussion (også en del af EPAR).
If you want more information on the basis of the CVMP recommendations, read the Scientific Discussion (also part of the EPAR).
Hver 2 ml dosis Ibraxion indeholder det aktive stof inaktiveret infektiøs bovin rhinotracheitis- virus (IBR- virus), hvor det specifikke gE- gen er fjernet.
Each 2 ml dose of Ibraxion contains the active substance inactivated gene deleted Infectious Bovine Rhinotracheitis (IBR) virus.
Denne fjernelse af gE- genet gør det muligt at skelne vaccinerede dyr fra inficerede dyr, så sygdommen bedre kan kontrolleres.
This deletion allows to differentiate vaccinated animals from infected animals allowing a better management of the disease.
Der gives 2 injektioner med 21 dages mellemrum hos dyr i alderen 2 uger og derover, som ikke har antistoffer mod IBR- virus fra moderen.
Two injections are given 21 days apart in animals from the age of 2 weeks where there are no antibodies against IBR virus from the mother.
Hvis der findes antistoffer, skal vaccinen gives fra 3 - måneders- alderen.
If there are antibodies, the vaccine should be given from the age of 3 months.
Ved revaccination skal der gives en booster- injektion med 6 måneders mellemrum.
To revaccinate, a booster injection should be given at 6-month intervals.
Ibraxion indeholder et inaktiveret IBR- virus, hvor det specifikke gE- gen er fjernet.
Ibraxion contains a gene deleted IBR virus, which is inactivated.
Når lægemidlet injiceres, er denne eksponering med til at få kalvens immunsystem til at genkende og bekæmpe IBR - virusset.
When injected, this exposure helps the calf’ s immune system to recognise and fight the IBR virus.
Når kalven senere i livet eksponeres for IBR- virusset, vil den enten ikke blive inficeret eller få en langt mindre alvorlig infektion.
When exposed to IBR virus later in life, the calf will either not become infected or have a much less serious infection.
Ibraxion har også til formål at reducere spredningen af IBR - virusset ved at nedsætte mængden af virus, der udskilles af dyrene.
Ibraxion is also intended to reduce the spread of the IBR virus by reducing the amount of virus excreted by the animals.
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvilken fordel viser undersøgelserne, at der er ved Ibraxion?
(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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged What benefit has Ibraxion shown during the studies?
Resultaterne af undersøgelserne viste, at vaccination med Ibraxion hos kalve, der enten var ældre end 3- 4 måneder (hvis de havde antistoffer mod IBR, som var blevet overført fra moderen) eller over 2 uger gamle (hvis de ikke havde antistoffer fra moderen), ydede beskyttelse mod IBR i 6 måneder.
The results of the trials showed that vaccination by Ibraxion of calves either not less than 3 to 4 months of age (if they have antibodies to IBR that have been passed on from their mother) or from 2-week of age (if they have no maternal antibodies). provided protection from IBR for six months.
I undersøgelserne bekræftedes også virkningen af en booster- injektion 15 måneder efter den første vaccination (booster- vaccination med Ibraxion anbefales hver 6. måned).
The studies also confirmed the effect of a booster injection at 15 months after the first vaccination (the booster for Ibrax is recommended every 6 months).
Endelig blev det påvist, at vaccination med Ibraxion ikke inducerede antistoffer mod gE, hvilket giver mulighed for at skelne disse dyr fra de dyr, som er inficeret med IBR- virus.
Finally, it was shown that vaccination with Ibraxion did not induced antibodies against gE, allowing differentation between those animals and IBR infected ones.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ibraxion til Merial den 9. marts 2000.
The European Commission granted a marketing authorisation valid throughout the European Union, for Ibraxion to Merial on 9 March 2000.
Ibraxion, emulsion til injektion.
Ibraxion emulsion for injection
Per dosis à 2 ml vaccine: gE- deleted, inaktiveret IBR- virus, min.
Active substance(s) Each 2-ml dose of vaccine contains: gE deleted inactivated IBR virus, at least
0, 75 VN. U *
0.75 VN. U*
* VN. U: vironeutraliserende antistoftiter efter vaccination af marsvin
Vironeutralising antibody titre after vaccine injection in guinea pigs.
Adjuvans: tynd paraffinolie
Adjuvant(s) light paraffin oil
449, 6 - 488, 2 mg
449.6 to 488.2 mg
Vaccinen virker ved en aktiv immunisering af kvæg, ved dannelse af Infektiøs Bovin Rhinotracheitis (IBR) vironeutraliserende antistoffer.
Ibraxion is a gene specific deleted (gE), inactivated and adjuvanted (o/ w emulsion) vaccine which acts by the active immunisation of cattle characterised by the production of Infectious Bovine Rhinotracheitis (IBR) vironeutralising antibodies.
Fjernelsen af gE genet muliggør differentiering mellem dyr vaccineret med gE- negative vacciner (anti gE antistof negative, IBR vironeutraliserende antistof positive) og naturligt inficerede dyr (positive over for både IBR vironeutraliserende antistof og anti gE antistof).
The gE gene deletion allows differentiation between animals vaccinated with gE-negative vaccines (anti gE antibody negative, IBR vironeutralising antibody positive) and naturally infected animals (positive to both IBR vironeutralising antibody and anti gE antibody).
Ibraxion kan anvendes som en markør vaccine i forbindelse med en passende diagnostisk testmetode.
Ibraxion can therefore be used as a marker vaccine in association with an appropriate diagnostic test.
5. 2 Terapeutiske indikationer med angivelse af dyrearter, som lægemidlet er beregnet til >
5.2 Indications for use
Immuniteten indtræder efter 14 dage og varer i 6 måneder.
The onset of immunity is 14 days and the duration of immunity is 6 months.
2/ 35 5. 4 Bivirkninger (hyppighed og sværhedsgrad)
2/ 35 5.4 Undesirable effects (frequency and seriousness)
• Injektion med vaccinen kan forårsage forbigående vævsreaktion på injektionsstedet, der kan persistere i tre uger, i sjældne tilfælde op til 5 uger.
• The injection of the vaccine may cause a transient tissue reaction at the site of injection, which may persist for three weeks and rarely up to five weeks.
• Vaccinationen kan forårsage en let temperaturforhøjelse (mindre end 1oC) i en forbigående periode (inden for 48 timer efter injektionen) uden nogen betydning for dyrets sundhed og ydelse.
• The vaccination may cause a slight rise in body temperature (less than 1°C) for a transient period (less than 48 hours after injection) without any consequence to the health or performance of the animal.
• Vaccinationen kan undtagelsesvis give anledning til overfølsomhedsreaktion.
• A hypersensitivity reaction may occur.
Vaccinen skal have en temperatur på 15oC- 25oC før ibrugtagning.
Allow the vaccine to reach a temperature of 15°C-25°C.
Anvend sterile sprøjter og nåle.
Use sterile syringes and needles.
Kan anvendes til drægtige og lakterende køer.
Ibraxion can be used in pregnant and lactating cows.
5. 7 Interaktion med andre lægemidler og andre former for interaktion
5.7 Interaction with other medicinal products and other forms of interaction
Da der ikke foreligger nogen data vedr. sikkerhed og effekt ved samtidig anvendelse af en anden vaccine og denne vaccine, anbefales det ikke at anvende anden vaccine samtidig med denne vaccine.
It is therefore recommended that no other vaccines should be administered concurrently with the product.
• Omrystes før brug. • Injektion skal foregå i halsregionen foran skulderen. • 1 dosis på 2 ml vaccine injiceres subkutant i henhold til følgende program:
• Shake well prior to use. • Injection in the neck at the front of the shoulder. • Inject one 2-ml dose of vaccine by subcutaneous route, according to the following regimen:
Tilstedeværelsen af maternelle antistoffer over for infektiøs bovin rhinotracheitis kan interferere med vaccinationen og kræver nøjagtig udført vaccinationsprogram.
Revaccination:
5. 9 Overdosering (symptomer, nødforanstaltninger, modgift)
a booster injection should be administered at 6 month intervals.
Ingen bivirkninger, andre end de under administration af en overdosis.
5.9 Overdose (symptoms, emergency procedures, antidotes)
5. 4 “ Bivirkninger ” nævnte, er blevet observeret efter
No undesirable effects other than those observed and mentioned in the “ Undesirable effects” section have been observed after the administration of an overdose.
5. 11 Tilbageholdelsestid
5.11 Withdrawal period(s)
3/ 35 5. 12 Særlige forsigtighedsregler for personer, som indgiver lægemidlet til dyr
3/ 35 5.12 Special precautions to be taken by the person administering the medicinal product to animals
Uforsætlig injektion/ selvinjektion kan medføre alvorlige smerter og hævelser, navnlig ved injektion i led eller fingre, og kan i sjælne tilfælde medføre tab af den pågældende finger, hvis den ikke behandles omgående.
Accidental injection/ self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
18 måneder 6 timer efter anbrud.
18 months 6 hours after first broaching the container.
6. 3 Særlige opbevaringsforhold
Special precautions for storage
Opbevares ved 2°C – 8°C, beskyttet mod lys.
Store at 2°C – 8°C, protected from light.
Pakningsmateriale: • Flaske type I glas. • Nitril elastomer prop. • Aluminiumshætte.
Nature of primary packaging elements: • Type I glass bottle. • Nitrile elastomer closure. • Aluminium cap.
Ubrugte lægemidler eller affald fra sådanne skal destrueres i overensstemmelse med de lokale krav.
Packaging: • 5-dose bottle, box of 1 bottle. • 5-dose bottle, box of 10 bottles. • 10-dose bottle, box of 1 bottle. • 10-dose bottle, box of 10 bottles. • 25-dose bottle, box of 1 bottle. • 25-dose bottle, box of 10 bottles
4/ 35 7.
4/ 35 6.5 Special precautions for the disposal of unused medicinal product or waste materials, if any
NAVN ELLER FIRMANAVN OG ADRESSE ELLER INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
FOR
7.
29 avenue Tony Garnier F- 69007 Lyon Frankrig
MERIAL 29 avenue Tony Garnier F-69007 LYON FRANCE
Import, salg, lagerhold og/ eller anvendelse af dette veterinære lægemiddel er forbudt eller kan forbydes i visse medlemsstater på hele eller dele af deres territorium som følge af national dyrevelfærdspolitik.
The import, sale, supply and/ or use of this veterinary medicinal product is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Enhver person, som har til hensigt at importere, sælge, lagerføre og/ eller anvende dette veterinære lægemiddel, skal henvende sig til den relevante medlemsstats kompetente myndighed vedrørende den aktuelle vaccinationspolitik forud for import, salg, lagerhold og/ eller anvendelse.
Any person intending to import, sell, supply and/ or use the veterinary medicinal product must consult the relevant Member State’ s Competent Authority on the current vaccination policies prior to the import, sale, supply and/ or use.
5/ 35 BILAG II
5/ 35 ANNEX II
FREMSTILLER AF DE( T) BIOLOGISK AKTIVE STOF( FER) OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER
BETINGELSER
BIOLOGICAL
FOR
ACTIVE
MARKEDSFØRINGSTILLADELSEN,
SUBSTANCE(S) AND THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
HERUNDER BEGRÆNSNINGER FOR UDLEVERING OG BRUG
CONDITIONS OF THE MARKETING AUTHORISATION INCLUDING RESTRICTIONS REGARDING SUPPLY AND USE
FREMSTILLER AF DE( T) BIOLOGISK AKTIVE STOF( FER) OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MERIAL Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux F- 69007 LYON Frankrig
MERIAL Laboratoire Lyon Gerland 254, Avenue Marcel Mérieux F-69007 LYON FRANCE
MERIAL Laboratoire 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
I henhold til artikel 71 i Europa- Parlamentets og Rådets direktiv 2001/ 82/ EF kan en medlemsstat forbyde indførsel, salg, levering og/ eller anvendelse af veterinærlægemidlet på hele eller en del af sit område, hvis det godtgøres:
According to Article 4 of Council Directive 90/ 677/ EEC Member States prohibit or may prohibit the import, sale, supply and/ or use of the veterinary medicinal product on the whole or part of their territory if it is established that:
3, litra b), i Rådets forordning (EØF) nr.
which are/ may be accepted in accordance with Council Regulation (EEC) No 2377/ 90 and in accordance with Article 31 (3b) of Council Regulation (EEC) No 2309/ 93 of 22 July 1993, as amended.
2377/ 90 i overensstemmelse med nedenstående tabel:
7/ 35 The Committee for Veterinary Medicinal Products has recommended the inclusion of mineral oil in Annex II of Council Regulation (EEC) No 2377/ 90 in accordance with the following table:
De( t) farmakologisk aktive stof( fer)
Pharmacologically active substance(s)