natgillin/translations-raw huggingface dataset:
Vaccinen kan anvendes til kommende æglæggere og avlsfugle, fra de er 3 uger gamle og frem via intranasal/ okulær anvendelse, grov spray eller i drikkevandet.
The vaccine can be administered to future layers and breeders from three weeks of age onwards via intranasal/ ocular route, coarse spray or drinking water.
Spraymetoden:
Spray method:
Det nødvendige antal hætteglas bør åbnes under vandoverfladen.
The appropriate number of vials should be opened under water.
Mængden af vand vil variere afhængigt af kyllingernes alder på vaccinationstidspunktet og af driftsystemet, men der foreslås 250 til 400 ml vand pr.
This will vary according to the age of the chickens being vaccinated and the management system, but 250 to 400 ml of water per 1 000 doses is suggested.
Vaccinesuspensionen bør fordeles jævnt over det korrekte antal kyllinger med en afstand på 30- 40 cm ved anvendelse af en grov forstøvning, helst når kyllingerne sidder tæt sammen i svag belysning.
The vaccine suspension should be spread evenly over the correct number of chickens, at a distance of 30-40 cm using a coarse spray, preferably when the chickens are sitting together in dim light.
Sprøjteapparatet bør være fri for aflejringer, korrosion og rester af desinfektionsmidler og skal helst udelukkende anvendes til vaccination.
The spray apparatus should be free from sediments, corrosion and traces of disinfectants and ideally should be used for vaccination purposes only.
Drikkevand:
Drinking water:
Hætteglassene bør åbnes under vandoverfladen.
The vials should be opened under water.
1. 000 doser.
For administration of the vaccine, as a general rule, dissolve 1 000 doses in one litre per age in days up to a maximum volume of 20 litres per 1 000 doses.
1. 000 doser.
For heavy breeds, or in hot weather, the quantity of water may be increased up to 40 litres per 1 000 doses.
2 g skummetmælkspulver eller 20 ml skummetmælk pr. liter vand forlænges virusaktiviteten.
By adding approximately 2 grams of skimmed milk powder or 20 ml of liquid skimmed milk per litre of water the virus retains its activity longer.
Sørg for, at al vaccinesuspension er anvendt inden for 1- 2 timer.
Ensure that all the vaccine suspension is consumed within 1-2 hours.
Det tidsrum, hvor vandforsyningen er afbrudt, afhænger i høj grad af de
The length of time of water deprivation is strongly dependent on the climatological
3/ 17 klimatiske forhold.
3/ 17 circumstances.
Intranasal/ okulær administration:
Intranasal/ ocular administration:
1. 000 doser, 75 ml pr.
Dissolve the vaccine in physiological saline solution or sterile distilled water (usually 30 ml per 1 000 doses, 75 ml per 2 500 doses) and administer by means of a standardized dropper.
2. 500 doser) og administrer ved anvendelse af en standardiseret pipette.
One drop should be applied onto one nostril or one eye.
Okulær/ intranasal administration eller grov spray giver det bedste respons, og disse bør være de foretrukne metoder, især når unge kyllinger vaccineres.
Ocular/ intranasal administration or coarse spray, give the best responses and these should be the methods of choice, especially when vaccinating young chickens.
Aktiv immunisering mod aviær Infektiøs Bronchitis virus stammevariant IB 4- 91, som forårsager infektiøs bronkitis hos kyllinger.
Active immunisation against avian Infectious Bronchitis virus variant strain IB 4-91 which causes infectious bronchitis in chickens.
Vand til injektionsvæsker.
Sorbitol, gelatine, pancreatic digest of casein, disodium phosphate, water for injections
Må ikke blandes med andre produkter.
Do not mix with any other medicinal product..
Efter opløsning:
In freeze-dried form:
9 måneder ved 2- 8°C.
9 months at 2°C to 8°C.
Vaccinen bør anvendes inden for 2 timer.
The vaccine should be used within 2 hours.
Opbevares ved 2- 8°C.
Store at 2-8°C.
Opbevares beskyttet mod lys.
Protect from light.
4/ 17 en kodet aluminiumskappe.
4/ 17 6.5 Nature and composition of immediate packaging
Produktet præsenteres som et enkelt hætteglas eller i multipakninger med 10 hætteglas der indeholder det samme antal doser.
The product is presented as a single vial or in multipacks of 10 vials of the same dosage.
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 products or waste materials, derived from the use of such products
Overskydende vaccine bortskaffes ved kogning, forbrænding eller nedsænkning i et egnet desinfektionsmiddel, der er godkendt til denne anvendelse af de pågældende myndigheder.
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Wim de Körverstraat 35 5831 AN BOXMEER Holland
Wim de Körverstraat 35 5831 AN BOXMEER The Netherlands
9. juni 1998
9 June 1998
Indførsel, salg, levering og/ eller anvendelse af Nobilis IB 4- 91 er eller kan i henhold til national dyresundhedspolitik være forbudt i visse medlemsstater på hele eller en del af deres område.
The import, sale, supply and/ or use of Nobilis IB 4-91 is/ or may be prohibited in certain Member States on the whole or part of its territory pursuant to national animal health policy.
Alle personer, der agter at indføre, sælge, levere og/ eller anvende Nobilis IB 4- 91, skal forinden henvende sig til de kompetente myndigheder i den pågældende medlemsstat og forhøre sig om den aktuelle vaccinationspolitik.
Any person intending to import, sell, supply and/ or use Nobilis IB 4-91 has to consult the relevant Member State’ s competent authorities on the current vaccination policies prior to the import, sale, supply and/ or use.
5/ 17 BILAG II
5/ 17 ANNEX II
FREMSTILLER( E) AF DE( T) BIOLOGISK AKTIVE STOF( FER) OG INDEHAVER( E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
FREMSTILLER( E) AF DE( T) BIOLOGISK AKTIVE STOF( FER) OG INDEHAVER AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Intervet International Wim de Körverstraat 35, 5831 AN Boxmeer, Holland
Intervet International Wim de Körverstraat 35, 5831 AN Boxmeer, The Netherlands
Må kun udleveres efter veterinærrecept.
Veterinary Medicinal product subject to medical prescription.
I henhold til artikel 71 i Europa- Parlamentets og Rådets direktiv 2001/ 82/ EF, med senere ændringer, 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 71 of Directive 2001/ 82/ EC of the European Parliament and of the Council, Member States prohibit or may prohibit the import, sale, supply and/ or use of Nobilis IB 4-91 on the whole or part of their territory if it is established that: a) the administration of the veterinary medicinal product to animals will interfere with the implementation of national programmes for the diagnosis, control and eradication of animal diseases, or will cause difficulties in certifying the absence of contamination in live animals or in foodstuffs or other products obtained from treated animals. b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
7/ 17 BILAG III
7/ 17 ANNEX III
9/ 17 OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE
9/ 17 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
Levende attenueret Infektiøs Bronchitis Virus stamme 4- 91 ≥ 3, 6 log10 EID50 *
Live attenuated Infectious Bronchitis Virus strain 4-91 ≥ 3.6 log10 EID50. *
* EID50 = 50% embryo infective dose
* EID50 = 50% Embryo infective dose
Lyofilisat til suspension
Lyophilisate for suspension.
1 x 500/ 1000/ 2500/ 5000/ 10. 000 doser 10 x 500/ 1000/ 2500/ 5000/ 10000 doser
1 x 500/ 1000/ 2500/ 5000/ 10000 doses 10 x 500/ 1000/ 2500/ 5000/ 10000 doses
Infektiøs bronkitisvaccine til fjerkræ.
Vaccine against avian Infectious Bronchitis
Til intranasal/ okulær -, spray - eller drikkevandsadministration.
For intranasal/ ocular, spray or drinking water administration.
Produktet bør udelukkende anvendes, når det er fastslået, at IBV stammevariant 4- 91 er epidemiologisk relevant i området.
The product should only be used after it has been established that IBV variant strain 4-91 is epidemiologically relevant in the area.
{måned / år}
{month/ year}
Batch, Lot
Lot
11/ 17 MINDSTEKRAV TIL OPLYSNINGER PÅ SMÅ INDRE PAKNINGER
11/ 17 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
≥ 3, 6 log10 EID50 IBV pr. dosis
> 3.6 log10 EID50 IBV per dose
500/ 1000/ 2500/ 5000/ 10. 000 doser
500/ 1000/ 2500/ 5000/ 10000 doses
INDGIVELSESVEJ( E)
ROUTES OF ADMINISTRATION
Intranasal/ okulær, spray eller drikkevand
intranasal/ ocular, spray or drinking water
UDL. D
EXP.
13/ 17 INDLÆGSSEDDEL
13/ 17 PACKAGE LEAFLET FOR:
Nobilis IB 4- 91
Nobilis IB4-91, lyophilisate for suspension
Levende attenueret aviær Infektiøs Bronchitis Virus stammevariant 4- 91 ≥ 3, 6 log10 EID50 *
Live attenuated Infectious Bronchitis Virus variant strain 4-91 ≥ 3.6 log10 EID50. *
* EID50 = 50% embryo infective dose: den virustiterværdi, som er nødvendig for at forårsage infektion i 50% af de inokulerede embryoer.
* EID50 = 50% Embryo infective dose: the titre required to infect 50% of the embryos inoculated with the virus.
Aktiv immunisering af kyllinger for at reducere de respiratoriske symptomer på infektiøs bronkitis, som forårsages af stammevarianten IB 4- 91.
Active immunisation of chickens to reduce the respiratory signs of Infectious Bronchitis caused by the variant strain IB 4-91.
Vaccination af daggamle kyllinger med Nobilis IB 4- 91 kan have negativ indflydelse på effekten af vaccine mod Turkey Rhinotracheitis (TRT), der er givet inden for 7 dage, hvorfor dette vaccinationsprogram er kontraindiceret.
Nobilis IB 4-91 given at day-old can adversely affect the efficacy of Turkey Rhinotracheitis (TRT) vaccine given within 7 days; therefore this vaccination scheme is contraindicated.
Vaccination med Nobilis IB 4- 91 kan inducere milde respirationssymptomer, som kan vare i et par dage afhængigt af kyllingernes helbred og tilstand.
Vaccination with Nobilis IB 4-91 may induce mild respiratory signs which may persist for a few days depending on the health and condition of the chickens.
Mindst 3, 6 log10 EID50 (1 dosis) pr. kylling enten ved sprayvaccination, drikkevand eller intranasal/ okulær administration.
At least 3.6 log10 EID50 (1 dose) per animal by either spray vaccination, drinking water or intranasal/ ocular administration.
Såfremt antallet af kyllinger ligger imellem standard- doseringerne, bør næste højere dosis anvendes.
Where the number of chickens is between the standard dosages, the next higher dosage should be used.
Det nødvendige antal hætteglas bør åbnes under vandoverfladen.
The appropriate number of vials should be opened under the water.
2 g skummetmælkspulver eller 20 ml skummetmælk pr. liter vand forlænges virusaktiviteten væsentligt.
By adding approximately 2 grams of skimmed milk powder or 20 ml of liquid skimmed milk per litre of water the virus retains its activity longer.
Man skal sikre sig, at al vaccinesuspension er drukket inden for 1- 2 timer.
Ensure that all the vaccine suspension is consumed within 1-2 hours.
Okulær/ intranasal administration eller grov spray giver det bedste respons, og disse bør være de foretrukne metoder, især når unge kyllinger vaccineres.
Ocular/ intranasal administration or coarse spray give the best responses and these should be the methods of choice, especially when vaccinating young chickens.
Der bør kun anvendes skummetmælk, da fedtet i sødmælk kan tilstoppe det automatiske drikkevandssystem samt reducere
Only skimmed milk should be used, since fat in whole milk may block the automatic drinking systems as well as reduce vaccine virus efficacy.
15/ 17 vaccinens virkning.
15/ 17 Only healthy chickens should be vaccinated.
Nobilis IB 4- 91 er udelukkende beregnet til beskyttelse af kyllinger mod respiratoriske symptomer på sygdom der er forårsaget af IBV stammevariant 4- 91, og bør ikke anvendes som erstatning for andre IBV vacciner.
Nobilis IB 4-91 is intended to protect chickens against respiratory signs of disease caused by IBV variant strain 4-91 only and should not be used as a replacement for other IBV vaccines.
Kyllinger bør vaccineres mod andre prævalente IBV serotyper (f. eks.
Chickens should be vaccinated against other prevalent IBV serotypes (e. g.
Må ikke blandes eller administreres sammen med andre produkter.
Do not mix or administer with other products.
Vask og desinficér hænder og udstyr efter vaccination.
Wash and disinfect hands and equipment after vaccinating.
Vaccinen bør anvendes inden for 2 timer efter opløsning og bør ikke gemmes.
The vaccine should be used within 2 hours after reconstitution and should not be stored.
Der skal drages omsorg for at undgå at sprede vaccinevirus fra vaccinerede kyllinger til fasaner.
Care should be taken to avoid spread of a vaccine virus from vaccinated chickens to pheasants.
16/ 17 14.
16/ 17 14.
Aktiv immunisering af kyllinger for at reducere de respiratoriske symptomer på infektiøs bronkitis, som forårsages af stammevarianten IB 4- 91.
Active immunisation against avian Infectious Bronchitis virus variant strain IB 4-91 which causes infectious bronchitis in chickens.
1/ 10 x 500/ 1000/ 2500/ 5000/ 10000 doser
1/ 10 x 500/ 1000/ 2500/ 5000/ 10000 doses Not all pack sizes my be marketed.
Nobivac Bb er en vaccine, der indeholder en levende Bordetella bronchiseptica bakteriestamme B- C2.
Nobivac Bb is a vaccine that contains a live bacterium Bordetella bronchiseptica strain B-C2.
Kattene vaccineres med en 0, 2 ml dosis ind i det ene næsebor.
Cats are vaccinated by giving a 0.2-ml dose into one nostril.
Vacciner virker ved, at de ‘ lærer ’ immunsystemet (kroppens naturlige forsvarssystem), hvordan det skal forsvare sig selv imod sygdomme.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
Nobivac Bb indeholder en type levende B. bronchiseptica, der kaldes stamme B- C2.
Nobivac Bb contains a type of live B. bronchiseptica called strain B-C2.
Når en kat får vaccinen, genkender immunsystemet bakterierne som ‘ fremmede ’ og danner en særlig type anstistoffer imod dem.
When a cat is given the vaccine, the immune system recognises the bacteria as ‘ foreign’ and makes a special type of antibodies against them.
I fremtiden vil immunsystemet være i stand til at producere disse antistoffer hurtigere, når det igen udsættes for bakterierne.
In the future, the immune system will be able to produce these antibodies more quickly when it is again exposed to the bacteria.
(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 Hvordan blev Nobivac Bb 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 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Nobivac Bb been studied?
Kattene blev vaccineret med Nobivac Bb, inden de med vilje blev udsat for en ” vildtype ” B. bronchiseptica.
The cats were vaccinated with Nobivac Bb before being challenged by being exposed to wild-type B. bronchiseptica.
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Nobivac Bb til Intervet International B. V. den 10. september 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for Nobivac Bb to Intervet International B. V. on 10 September 2002.
Oplysninger om udleveringsbestemmelserne for lægemidlet findes på etiketten/ den ydre emballage.
Information on the prescription status of this product may be found on the label/ outer package.
≥106. 3 og ≤108.. 3 Pulver og solvens, Katte CFU af levende nasal suspension Bordetella bronchiseptica bakteriestamme B- C2 pr. dosis
Powder and solvent for suspension for nasal administration
5 hætteglas 5 hætteglas
5 vials 5 vials
SPECIALITETENS NAVN
NAME OF THE VETERINARY MEDICINAL PRODUCT
Nobivac Bb til katte.
Nobivac Bb for cats
Aktive stoffer: > 106, 3 og < 108, 3 CFU af levende Bordetella bronchiseptica bakterie stamme B- C2, pr. dosis af 0, 2 ml opløst suspension.
Active substance ≥ 106,3 and ≤ 108,3 CFU of live Bordetella bronchiseptica bacteria strain B-C2, per 0.2 ml dose of reconstituted suspension.
Vand til injektionsvæsker.
Solvent Water for injections
Se afsnit 6. 1 for en fuldstændig fortegnelse over hjælpestoffer.
For a list of excipients, see section 6.1.
Lyofilisat og solvens, suspension til nasal administration.
Lyophilisate and solvent for suspension for nasal administration.
4. 1 Dyreart
4.1 Target species
Hos 8 uger gamle katte indtræder immuniteten allerede 72 timer efter vaccination.
Onset of immunity was established in 8 week old cats as early as 72 hours after vaccination.
2 4. 4 Særlige advarsler for hver enkelt dyreart, som lægemidlet er beregnet til
4.4 Special warnings for each target species
Vaccinerede dyr kan sprede vaccinestammen Bordetella bronchiseptica i seks uger; i enkelte tilfælde i mindst et år.
Vaccinated animals can spread the Bordetella bronchispetica vaccine strain for six weeks; in individual cases for at least one year.
Periodisk forekommende spredning kan også forekomme.
Intermittent spreading is possible as well.
4. 5 Særlige forsigtighedsregler vedrørende brugen
2 4.5 Special precaution(s) for use
At katte nyser efter vaccination påvirker ikke i negativ grad produktets effekt.
Sneezing by cats after administration does not adversely affect the efficacy of the product.
Må ikke anvendes samtidigt med antibiotisk behandling eller sammen med andre intranasale produkter.
Do not administer during antibiotic treatment or in conjunction with any other intranasal products.
Hunde, svin og ikke- vaccinerede katte kan reagere på vaccinestammen med milde og forbigående luftvejssymptomer.
Dogs, pigs and unvaccinated cats may react to the vaccine strain with mild and transient respiratory signs.
Anvend en passende desinfektionsmetode, efter brug af denne levende bakterievaccine.
Appropriate disinfection procedures should be used following use of this live bacterial vaccine.
Lejlighedsvis nysen, hosten, let og forbigående flåd fra øjne og næse.
Occasionally sneezing, coughing, mild and transient discharge from the eyes or nose.
For dyr, der viser mere alvorlige symptomer, kan det være indiceret at give passende antibiotisk behandling.
In animals, which show more severe signs, appropriate antibiotic treatment may be indicated.
Der findes ingen tilgængelig information vedrørende sikkerhed og effekt ved samtidig brug af denne og anden vaccine.
No information is available on the safety and efficacy from the use of this vaccine with any other.
Det anbefales derfor, at der ikke anvendes nogen anden vaccine inden for 14 dage før og efter vaccination med dette produkt.
It is therefore recommended that no other vaccine should be administered within 14 days before or after vaccination with the product.
1 dosis af 0, 2 ml opløst vaccine gives mindst 72 timer før forventet risikoperiode.
One dose, of 0.2 ml of reconstituted vaccine at least 72 hours prior to period of anticipated risk.
Lad solvensen opnå stuetemperatur (15- 25°C).
Allow the solvent to reach room temperature (15 - 25°C).
Opløs aseptisk den frysetørrede vaccine i 0, 3 ml af den medfølgende sterile solvens.
Aseptically reconstitute the freeze-dried vaccine with 0.3 ml of the sterile solvent provided.
Tag 0, 2 ml af den opløste vaccine op med en 1 ml eller 2 ml sprøjte, fjern kanylen og indgiv sprøjtens indhold i det ene af kattens næsebor.
Withdraw 0.2 ml of reconstituted vaccine into a 1 ml or 2 ml syringe, remove the needle and administer the whole contents of the syringe into one of the cat’ s nostrils.
Kattens hoved holdes, så næsen peger opad, og munden er lukket, således at katten tvinges til at trække vejret gennem næsen.
3 The head of the cat should be held with its nose pointing upwards and its mouth closed, so that it is forced to breathe through its nostrils.
Lejlighedsvis nysen, hoste, let og forbigående flåd fra øjne og næse, især hos meget unge modtagelige killinger.
Occasionally sneezing, coughing, mild and transient discharge from the eyes or nose, particularly in very young susceptible kittens.
For dyr, der viser mere alvorlige symptomer, kan det være indikeret at give passende antibiotisk behandling.
In animals, which show more severe signs, appropriate antibiotic treatment may be indicated.
QI 06AE02
QI 06AE02.
Gelatine, sorbitol, fosfatbuffer.
Gelatin, sorbitol, phosphate buffers.
Da der ikke er foretaget uforligelighedsstudier, bør produktet ikke blandes med andre produkter end den medfølgende solvens.
In the absence of incompatibility studies, do not mix with any other product except the solvent supplied for use with the vaccine.
Efter opløsning bør præparatet anvendes inden for 4 timer.
After reconstitution the product should be used within 4 hours.
Opbevares ved 2- 8°C.
Store at 2 - 8°C.
Et 3 ml én- dosis hætteglas (glas Type I) med lyofilisat lukket med en halogenobutyl gummiprop og en aluminiumhætte sampakket med et hætteglas (glas Type I) med 0, 5 ml sterilt solvens.
One 3 ml unit-dose vial (glass Type I) of lyophilisate sealed with a halogenobutyl rubber stopper and an aluminium cap, supplied with a vial (glass Type I) of 0.5 ml sterile solvent.
Fem én- dosis hætteglas med lyofilisat og 5 hætteglas med solvens pr. karton.
5 unit-dose vials of lyophilisate and 5 vials of solvent per carton.
Wim de Körverstraat 35 NL- 5831 AN Boxmeer Holland
Wim de Körverstraat 35 PO Box 31 NL - 5830 AA Boxmeer The Netherlands
Nærmere oplysninger om dette veterinærlægemiddel er tilgængelige på webstedet for Det Europæiske Lægemiddelagentur (EMEA) http: // www. emea. europa. eu /.
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (EMEA), http: / /www. emea. europa. eu/.
Import, salg, levering og/ eller anvendelse af Nobivac Bb til katte er forbudt eller kan forbydes i visse medlemslande i hele eller dele af landets territorium som følge af national dyresundhedspolitik.
The import, sale, supply and/ or use of Nobivac Bb for cats is or may be prohibited in certain Member States on the whole or part of their territory pursuant to national animal health policy.
Enhver, der påtænker at indføre, sælge, levere og/ eller anvende Nobivac Bb til katte, skal rådføre sig hos rette myndighed i det pågældende medlemsland om gældende vaccinationsregler forud for import, salg, levering og/ eller anvendelse.
Any person intending to import, sell, supply and/ or use Nobivac Bb for cats must consult the relevant Member State’ s competent authority on the current vaccination policies prior to the import, sale, supply and/ or use.
FREMSTILLER( E) AF DE( T) BIOLOGISK AKTIVE STOF( FER) OG > INDEHAVER( E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
FREMSTILLER( E) AF DE( T) BIOLOGISK AKTIVE STOF( FER) OG INDEHAVER( E) AF VIRKSOMHEDSGODKENDELSE ANSVARLIG FOR BATCHFRIGIVELSE
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Navn og adresse på fremstilleren (fremstillerne) af de( t) biologisk aktive stof( fer)
Manufacturer of the biological active substance
Wim sw Körverstraat 35 PO Box 31 NL- 5830 AA Boxmeer Holland
Wim de Körverstraat 35 PO Box 31 NL - 5830 AA Boxmeer The Netherlands
Wim de Körverstraat 35 PO Box 31 NL- 5830 AA Boxmeer
Wim de Körverstraat 35 PO Box 31 NL - 5830 AA Boxmeer The Netherlands