natgillin/translations-raw huggingface dataset:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHROISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
Name and address of the Manufacturing Authorisation Holder responsible for batch release Intervet International B. V.
Ime in naslov imetnika dovoljenja za proizvodnjo, odgovornega za sproščanje serij Intervet International B. V.
- Dermal infections (pyoderma – superficial and deep, wounds, abscesses) caused by susceptible
- dermalne okužb (pioderma – površinska in globoka, rane, abscesi), ki jih povzročajo občutljivi
pathogens such as Staphylococcus spp., E. coli and Proteus mirabilis
mikroorganizmi, kot so Staphylococcus spp., E. coli in Proteus mirabilis
36/ 42 Ibaflin gel is indicated in cats for treatment of the following conditions:
39/ 45 Ibaflin gel je pri mačkah indiciran za zdravljenje naslednjih bolezenskih stanj:
Oral use, 15 mg ibafloxacin/ kg once daily.
Peroralno, 15 mg ibafloksacina/ kg, 1- krat na dan
15 mg per kg bodyweight = 0.5 ml of gel per kg bodyweight
15 mg / kg telesne mase = 0, 5 ml gela/ kg telesne mase
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).
Brizgo je treba nastaviti na izračunani odmerek s pomikom objemke na ustrezno mesto na batu (brizga s 15 ml – stopnje po 0, 5 ml).
In most cases, a 10 day-treatment course will be sufficient.
Večinoma zadošča 10- dnevno zdravljenje.
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN UPORABE IN DAJANJA ZDRAVILA
Oral use It is recommended that the gel is administered at the time of feeding.
Peroralno Gel je priporočljivo dajati ob času hranjenja.
If you notice any other side effect, please inform your veterinary surgeon.
Če opazite kakršnekoli druge stranske učinke, obvestite svojega veterinarja.
Ibafloxacin is a synthetic antimicrobial substance of the fluoroquinolone class.
Njegovo delovanje temelji na zaviranju bakterijske DNA - giraze.
Ibafloxacin is a broad spectrum antibiotic with bactericidal action resulting from inhibition of bacterial DNA gyrase.
Presnovek, ki nastaja v največji količini, je 8- hidroksi- ibafloksacin, ki je tudi mikrobiološko aktiven.
The most abundant metabolite is 8-hydroxy-ibafloxacin, which is also microbiologically active. lbafloxacin and 8- hydroxy-ibafloxacin act synergistically.
Ibafloksacin in 8- hidroksi- ibafloksacin delujeta sinergistično.
39/ 42 PACKAGE INSERT FOR INCLUSION WITH THE 7.5% ORAL GEL SYRINGE PACKAGES
42/ 45 NAVODILO ZA UPORABO
Ibaflin 7.5% oral gel
Ibaflin 7, 5%, peroralni gel
Ibaflin 7.5% Oral Gel:
Ibaflin 7, 5%, peroralni gel:
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHROISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
IME IN NASLOV IMETNIKA DOVOLJENJA Z APROMET Z ZDRAVILOM TER IMETNIKA DOVOLJENJA ZA PROIZVODNJO ZDRAVILA, ODGOVORNEGA ZA SPROSTITEV SERIJ V EGP, ČE STA RAZLIČNA
pathogens such as staphylococci, E. coli and Proteus mirabilis
mikroorganizmi, kot so Staphylococcus spp., E. coli in Proteus mirabilis
15 mg per kg bodyweight = 1 ml of gel per 5 kg bodyweight
15 mg/ kg telesne mase = 1 ml gela/ 5 kg telesne mase
The syringe should be adjusted to the calculated dosage by setting the ring on the appropriate place on the plunger (steps of 1 ml for the 30 ml syringe).
Brizgo je treba nastaviti na izračunani odmerek s pomikom objemke na ustrezno mesto na batu (brizga s 30 ml – stopnje po 1, 0 ml).
METHOD AND ROUTE(S) OF ADMINISTRATION
NAČIN UOPRABE IN DAJANJA ZDRAVILA
Ibaflin 7.5% Oral Gel should not be used in cats.
Ibaflin 7, 5% peroralnega gela ne smemo uporabljati pri mačkah.
gE deleted
Inaktivirani virus IBR z gE delecijo, najmanj, 0. 75 VN. U *
Type I glass
Subkutana uporaba
5 doses
Steklenička 5 odmerkov iz stekla tipa I
10 ml
10 ml steklenička
gE deleted inactivated IBR virus, at least 0.75 VN. U*0.75 VN. U*
Inaktivirani
Emulsion for injection
Emulzija za
Type I glass bottle
Subkutana
10 doses
Steklenička 10
20 ml bottle
20 ml
gE deleted inactivated IBR virus, at least 0.75 VN. U*0.75 VN. U*
Inaktivirani virus IBR z gE delecijo, najmanj, 0. 75 VN. U *
Type I glass bottle
Subkutana uporaba
25 doses
Steklenička 25 iz stekla tipa odmerkov I
10 x 5 doses
Steklenička 10 x 5 iz stekla tipa odmerkov I
10x10ml Zero bottle
10 x 10 ml steklenička
days
Nič dni
10 x 10 doses
Steklenička 10 x 10 iz stekla tipa odmerkov I
10x 20 ml bottle
10 x 20 ml steklenička
10 x 25 doses
Steklenička 10 x 25 iz stekla tipa odmerkov I
Vironeutralising antibody titre after vaccine injection in guinea pigs.
* VN. U: vironevtralizirajoči titer protiteles po injiciranju cepiva pri morskih prašičkih.
Its purpose is to explain how the assessment done by the Committee for Medicinal Products for Veterinary Use (CVMP) on the basis of the documentation provided, led to the recommendations on the conditions of use.
Pojasnjuje, kako je Odbor za zdravila za uporabo v veterinarski medicini (CVMP) ocenil predloženo dokumentacijo, na podlagi
Each 2 ml dose of Ibraxion contains the active substance inactivated gene deleted Infectious Bovine Rhinotracheitis (IBR) virus.
En 2- ml odmerek zdravila Ibraxion vsebuje zdravilno učinkovino inaktiviran virus kužnega govejega rinotraheitisa (Infectious Bovine Rhinotracheitis, IBR) z izbrisanim genom.
To revaccinate, a booster injection should be given at 6-month intervals.
Za revakcinacijo je treba poživitvene injekcije dajati v 6 - mesečnih presledkih.
When injected, this exposure helps the calf’ s immune system to recognise and fight the IBR virus.
Ko se injicira, to izpostavljanje pomaga imunskemu sistemu teleta prepoznati IBR virus in se proti njemu bojevati.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Rezultati preizkušanj so pokazali, da je cepljenje telet, ki so bodisi stara ne manj kot 3 do 4 mesece (če imajo protitelesa za IBR, podedovana od mater) ali od drugega tedna starosti naprej (če nimajo 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(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?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 47 E- mail: mail@ emea. eu. int http: // www. emea. eu. int ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged nobenih protiteles od mater) z zdravilom Ibraxion, zagotovila zaščito pred IBR za obdobje šestih mesecev.
Ibraxion may cause a slight rise in body temperature (less than 1°C) for less than 48 hours after injection.
Zdravilo Ibraxion lahko povzroči blago povečanje telesne temperature (manj kot 1 °C) za manj kot 48 ur po injiciranju.
The European Commission granted a marketing authorisation valid throughout the European Union, for Ibraxion to Merial on 9 March 2000.
Evropska komisija je dovoljenje za promet z zdravilom Ibraxion, veljavno po vsej Evropski uniji, odobrila družbi Merial dne 9. marca 2000.
2/ 2
Page 2/ 2 ©EMEA 2007
Ibraxion emulsion for injection
Ibraxion, emulzija za injiciranje
Active substance(s) Each 2-ml dose of vaccine contains: gE deleted inactivated IBR virus, at least
Zdravilna( e) učinkovina( e):
Vironeutralising antibody titre after vaccine injection in guinea pigs.
Vsak odmerek po 2 ml cepiva vsebuje: inaktiviran virus IBR z gE delecijo, najmanj 0, 75 VN. U * * VN. U: vironevtralizirajoči titer protiteles po injiciranju cepiva pri morskih prašičkih.
Adjuvant(s) light paraffin oil
Adjuvans( i): lahko parafinsko olje
449.6 to 488.2 mg
449, 6 do 488, 2 mg
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.
Ibraxion je cepivo, ki ima delecijo specifičnega gena (gE) Je inaktivirano pomožno cepivo (o/ v emulzija), ki aktivno imunizira govedo tako, da ustvarja vironevtralizirajoča protitelesa proti kužnemu govejemu rinotreheitisu (IBR).
Ibraxion can therefore be used as a marker vaccine in association with an appropriate diagnostic test.
Ibraxion se lahko torej uporablja kot markersko cepivo v povezavi z ustreznim diagnostičnim testom.
5.2 Indications for use
5. 2 Indikacije za uporabo
The onset of immunity is 14 days and the duration of immunity is 6 months.
Imunost nastopi 14. dan po cepljenju in traja 6 mesecev.
2/ 35 5.4 Undesirable effects (frequency and seriousness)
5. 4 Neželeni učinki (pogostnost in resnost)
• 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.
Vnos cepiva lahko povzroči prehodno reakcijo tkiva na mestu injiciranja, ki lahko traja do treh tednov in le redko do pet tednov.
• 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.
2/ 35 Cepljenje lahko povzroči rahel dvig telesne temperature (manj kot 1 oC) v prehodnem obdobju (manj kot 48 ur po injiciranju) brez kakršnihkoli posledic za zdravje ali proizvodno sposobnost živali.
These are rare and an appropriate symptomatic treatment should be administered.
Lahko pride do preobčutljivostne reakcije Te so redke in jih je treba ustrezno simptomatično zdraviti.
Allow the vaccine to reach a temperature of 15°C-25°C.
Pustite, da se cepivo segreje na 15 oC do 25oC.
Ibraxion can be used in pregnant and lactating cows.
Lahko se uporablja v obdobju brejosti in laktacije pri kravah.
No information is available on the safety and efficacy from the concurrent use of this vaccine with any other.
Ni podatkov o varnosti in učinkovitosti ob sočasni uporabi tega cepiva s katerimkoli drugim, zato odsvetujemo sočasno uporabo kateregakoli cepiva s tem izdelkom.
It is therefore recommended that no other vaccines should be administered concurrently with the product.
- Pred uporabo dobro pretresite.
5.8 Posology and method of administration
- Injicirajte v predel vratu na prednjem delu rame.
• 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:
- Injicirajte en odmerek (2 ml) v podkožje po naslednjem režimu:
Basic vaccination: two injections 21 days apart.
Cepimo živali, starejše od 2 tednov, ki nimajo
For use in animals from the age of 2 weeks in the absence of maternally derived antibodies against IBR virus or from the age of 3 months in the presence of maternally derived antibodies.
maternalnih protiteles proti virusu IBR ali od 3. meseca starosti dalje, če so maternalna protitelesa prisotna,.
a booster injection should be administered at 6 month intervals.
poživitveni odmerek vsakih šest mesecev.
5.9 Overdose (symptoms, emergency procedures, antidotes)
5. 9 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če so potrebni)
No undesirable effects other than those observed and mentioned in the “ Undesirable effects” section have been observed after the administration of an overdose.
Po vnosu čezmernega odmerka niso opazili nobenih drugih neželenih učinkov razen tistih, navedenih v poglavju „ Neželeni učinki “.
5.11 Withdrawal period(s)
5. 11 Karenca( e)
3/ 35 5.12 Special precautions to be taken by the person administering the medicinal product to animals
3/ 35 5. 12 Posebni varnostni ukrepi, ki jih mora izvajati oseba, ki daje zdravilo živalim
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Zaradi pomanjkanja raziskav o združljivosti, tega cepiva ne smemo mešati z drugimi zdravili (za uporabo v veterinarski medicini).
6.2 Shelf life
6. 2 Rok uporabnosti
18 months 6 hours after first broaching the container.
18 mesecev Rok uporabnosti po prvem odpiranju vsebnika je šest ur.
Store at 2°C – 8°C, protected from light.
Shranjujte pri temperaturi 2 °C – 8 °C, zaščiteno pred svetlobo.
Nature of primary packaging elements: • Type I glass bottle. • Nitrile elastomer closure. • Aluminium cap.
Sestavni deli primarne ovojnine: steklenička iz stekla tipa I zamašek iz nitrilnega elastomera aluminijasta zaporka
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
Pakiranje: steklenička s 5. odmerki, škatla z 1 stekleničko steklenička s 5 odmerki, škatla z 10 stekleničkami steklenička s 10 odmerki, škatla z 1 stekleničko steklenička z 10 odmerki, škatla z 10 stekleničkami steklenička s 25 odmerki, škatla z 1 stekleničko steklenička s 25 odmerki, škatla z 10 stekleničkami
4/ 35 6.5 Special precautions for the disposal of unused medicinal product or waste materials, if any
6. 5 Posebni varnostni ukrepi za odstranjevanje neporabljenega zdravila ali odpadnih snovi, če obstajajo
7.
4/ 35 7.
MERIAL 29 avenue Tony Garnier F-69007 LYON FRANCE
MERIAL 29 avenue Tony Garnier F- 69007 LYON FRANCIJA
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.
Uvoz, prodaja, oskrba in/ ali uporaba je ali je lahko prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja v skladu z nacionalnim programom zdravstvenega varstva živali.
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.
Vsakdo, ki namerava uvažati, prodajati, oskrbovati in/ ali uporabljati, se mora posvetovati s pristojnimi organi posamezne države članice o veljavnih programih cepljenja še pred uvozom, prodajo, oskrbo in/ ali uporabo.
5/ 35 ANNEX II
5/ 35 DODATEK II
MANUFACTURER
POGOJI TER OMEJITVE GLEDE OSKRBE IN UPORABE
THE
D.
BIOLOGICAL
NAVEDBA
ACTIVE
NAJVIŠJIH
B.
DOVOLJENIH
C.
KOLIČIN
6/ 35 A.
6/ 35 A
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
UČINKOVIN) IN IMETNIK DOVOLJENJA ODGOVOREN ZA SPROSTITEV SERIJE
RESTRICTIONS REGARDING SUPPLY AND USE
B POGOJI DOVOLJENJA ZA PROMET Z ZDRAVILOM TER OMEJITVE GLEDE OSKRBE IN UPORABE
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:
V skladu s 4. členom Direktive 90/ 677/ EGS lahko države članice prepovejo uvoz, prodajo, oskrbo in/ ali uporabo zdravila za uporabo v veterinarski medicini na celotnem svojem ozemlju ali delu ozemlja, če se ugotovi da:
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.
a) bi uporaba zdravila za uporabo v veterinarski medicini ovirala izvajanje nacionalnih programov diagnosticiranja, nadzora ali zatiranja živalskih bolezni ali da bi povzročila težave pri zagotavljanju, da ne bi prišlo do okužbe živih živali, živil ali drugih proizvodov, ki izvirajo iz zdravljene živali
b) the disease to which the veterinary medicinal product is intended to confer immunity is largely absent from the territory.
b) bolezen, za katero se z zdravilom za uporabo v veterinarski medicini pridobi imunost, na območju skoraj ni
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.
2309/ 93, dopolnjene dne 22. julija 1993
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:
2377/ 90 v skladu z naslednjo tabelo:
Pharmacologically active substance(s)
Mineralni hidrokarboni; nizke do
Animal species
Vse proizvodne
Other provisions
aromatične
Mineral hydrocarbons, low to All food producing species high viscosity, including microcrystalline waxes, approximately C10-C60, aliphatic, branched aliphatic and alicyclic compounds
visoke viskoznosti; vključno z mikrokristalnimi voski; približno C10- C60; alifatski; razvejene alifatske in aciklične sestavine
Excludes aromatic and unsaturated compounds
nenasičene sestavine
8/ 35 ANNEX III
8/ 35 DODATEK III
10/ 35 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
10/ 35 PODATKI NA ZUNANJI OVOJNINI
Per dose of 2 ml:. gE deleted inactivated IBR virus, at least 0.75 VN. U*. light paraffin oil 449.6 to 488.2 mg * VN. U:
V odmerku po 2 ml: inaktivirani virus IBR z delecijo gE, najmanj lahko parafinsko olje 449, 6 do 488, 2 mg
Vironeutralising antibody titre after vaccine injection in guinea pigs
* VN. U: vironevtralizirajoči titer protiteles po injiciranju cepiva pri morskih prašičkih.
Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
Aktivna imunizacija goveda za ublažitev kliničnih znakov kužnega govejega rinotraheitisa (IBR) in zmanjšanje izločanja virusov v okolje.
Read the package insert before use Subcutaneous use
Subkutana uporaba
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, see package insert for further information.
Za nadaljnje informacije preberite priložena navodila.
Store at 2°C – 8°C (in a refrigerator), protected from light.
Shranjujte pri temperaturi 2 °C – 8 °C (v hladilniku), zaščiteno pred svetlobo.
Due to lack of space, these requirements are contained in the sentence “ Read the package insert before use ”, see paragraph 7 above
Zaradi pomanjkanja prostora te zahteve vsebuje stavek » Pred uporabo preberite priložena navodila. « Glejte odstavek 7 zgoraj.
THE WORDS “ KEEP OUT OF THE REACH AND SIGHT OF CHILDREN”
BESEDILO “ ZDRAVILO SHRANJUJTE IZVEN DOSEGA IN POGLEDA OTROK ”
Marketing authorisation holder MERIAL 29 avenue Tony Garnier F-69007 LYON France
Imetnik dovoljenja za promet MERIAL 29 avenue Tony Garnier F- 69007 LYON Francija
12/ 35 Manufacturing authorisation holder responsible for batch release Merial Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest
12/ 35 Imetnik dovoljenja za proizvodnjo, odgovoren za sprostitev serije Merial Laboratoire Porte des Alpes Rue de l' Aviation F- 69800 Saint Priest Francija
France Due to lack of space, these requirements are contained in the sentence “ Read the package insert before use ”, see paragraph 7 above
Zaradi pomanjkanja prostora te zahteve vsebuje stavek » Pred uporabo preberite priložena navodila. « Glejte odstavek 7 zgoraj.
NUMBER(S) IN THE COMMUNITY REGISTER OF MEDICINAL PRODUCTS
ŠTEVILKA( E) V REGISTRU SKUPNOSTI ZDRAVIL
13/ 35 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
13/ 35 PODATKI NA ZUNANJI OVOJNINI
Ibraxion emulsion for injection
Ibraxion emulzija za injiciranje
10 x 5 doses (10 x 10 ml)
10 x 5 odmerkov (10 x 10 ml)
Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
Aktivna imunizacija goveda za ublažitev kliničnih znakov kužnega govejega rinotraheitisa (IBR) in zmanjšanje izločanja virusov v naravo.
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, see package insert for further information.
Uvoz, prodaja, oskrba ali uporaba tega zdravila za uporabo v veterinarski medicini je, ali je lahko, prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja, za nadaljnje informacije preberite priložena navodila.
Keep out of the reach and sight of children.
Zdravilo shranjujte izven dosega in pogleda otrok..
15/ 35 Manufacturing authorisation holder responsible for batch release Merial Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest
15/ 35 Imetnik dovoljenja za proizvodnjo, odgovoren za sprostitev serije Merial Laboratoire Porte des Alpes Rue de l' Aviation F- 69800 Saint Priest Francija
16/ 35 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
16/ 35 PODATKI NA ZUNANJI OVOJNINI
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, see package insert for further information.
Uvoz, prodaja, oskrba in/ ali uporaba tega zdravila za uporabo v veterinarski medicini je, ali je lahko, prepovedana v nekaterih državah članicah na njihovem celotnem ozemlju ali delu ozemlja, za nadaljnje informacije preberite priložena navodila.
18/ 35 Manufacturing authorisation holder responsible for batch release Merial Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest
18/ 35 Imetnik dovoljenja za proizvodnjo, odgovoren za sprostitev serije Merial Laboratoire Porte des Alpes Rue de l' Aviation F- 69800 Saint Priest Francija
France Due to lack of space, these requirements are contained in the sentence “ Read the package insert before use ”, see paragraph 7 above
Zaradi pomanjkanja prostora so te zahteve vključene v stavek » pred uporabo preberite priložena navodila «, glej odstavek 7 zgoraj.
19/ 35 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
19/ 35 PODATKI NA ZUNANJI OVOJNINI
Per dose of 2 ml:. gE deleted inactivated IBR virus, at least 0.75 VN. U*. light paraffin oil 449.6 to 488.2 mg * VN. U:
V odmerku po 2 ml: inaktiviran virus IBR z elecijogE d, najmanj 0, 75 VN. U * lahko parafinsko olje
10 x 10 doses (10 x 20 ml)
10 x 10 odmerkov (10 x 20 ml)
Active immunisation of cattle to reduce the clinical signs of infectious bovine rhinotracheitis (IBR) and field virus excretion.
Aktivna imunizacija goveda za ublažitev kliničnih znakov infekcioznega govejega rinotraheitisa (IBR) in zmanjšanje izločanja virusov v okolje.
21/ 35 Manufacturing authorisation holder responsible for batch release Merial Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest
21/ 35 Imetnik dovoljenja za proizvodnjo, odgovoren za sprostitev serije Merial Laboratoire Porte des Alpes Rue de l' Aviation F- 69800 Saint Priest Francija
22/ 35 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
22/ 35 PODATKI NA ZUNANJI OVOJNINI
Per dose of 2 ml:. gE deleted inactivated IBR virus, at least 0.75 VN. U*. light paraffin oil 449.6 to 488.2 mg * VN. U:
V odmerku po 2 ml: inaktivirani virus IBR z delecijo gE, najmanj 0, 75 VN. U * lahko parafinsko olje
Vironeutralising antibody titre after vaccine injection in guinea pigs
* VN. U vironevtralizirajoči titer protiteles po injiciranju cepiva pri morskih prašičkih.
Keep out of the reach and sight of children.
Zdravilo shranjujte izven dosega in pogleda.
24/ 35 Manufacturing authorisation holder responsible for batch release Merial Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest
24/ 35 Imetnik dovoljenja za proizvodnjo, odgovoren za sprostitev serije Merial Laboratoire Porte des Alpes Rue de l' Aviation F- 69800 Saint Priest Francija
25/ 35 PARTICULARS TO APPEAR ON THE OUTER PACKAGE
25/ 35 PODATKI NA ZUNANJI OVOJNINI
27/ 35 Manufacturing authorisation holder responsible for batch release Merial Laboratoire Porte des Alpes Rue de l'Aviation F-69800 Saint Priest
27/ 35 Imetnik dovoljenja za proizvodnjo, odgovoren za sprostitev serije Merial Laboratoire Porte des Alpes Rue de l' Aviation F- 69800 Saint Priest Francija
28/ 35 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
28/ 35 PODATKI, KI OVOJNINAH
Per dose of 2 ml: gE deleted inactivated IBR virus, at least
V odmerku po 2 ml: inaktivirani virus IBR z delecijo gE, najmanj