natgillin/translations-raw huggingface dataset:
Administer a single 2 ml dose orally to pigs, irrespective of body weight.
Prašičem dajte enkratni 2-mililitrski peroralni odmerek, ne glede na telesno maso.
Prevtec Microbia GmbH Geyerspergerstrasse 27 80689 München GERMANY
Prevtec Microbia GmbH Geyerspergerstrasse 27 80689 München NEMČIJA
The vaccine strains readily spread to other pigs in contact to vaccinated pigs.
Sevi cepiva se hitro razširijo na druge prašiče, ki so v stiku s cepljenimi prašiči.
As an example, for a 4-hour consumption of 22 litres and a dosing pump rate of 1%, the volume of the stock solution should be 22 litres x 0.01 = 220 ml.
Na primer pri 4-urni porabi 22 litrov in hitrosti črpalke 1 % bo volumen osnovne raztopine 22 litrov x 0,01 = 220 ml.
Type I glass vial of 11 ml containing 50 doses and type II glass vial of 50 ml containing 200 doses with a chlorobutyl rubber stopper sealed with an aluminium cap.
Viala iz stekla tipa I z 11 ml, ki vsebuje 50 odmerkov, in viala iz stekla tipa II s 50 ml, ki vsebuje 200 odmerkov, z zamaškom iz klorobutilne gume, zatesnjenim z aluminijasto zaporko.
Cardboard box of four vials of 50 doses.
Kartonska škatla s štirimi vialami po 50 odmerkov.
Administer a single dose of vaccine from 18 days of age.
Uporabite enkratni odmerek cepiva od 18. dneva starosti.
Shelf-life after reconstitution according to directions: 4 hours.
Rok uporabnosti po rekonstituciji v skladu z navodili: 4 ure.
Unvaccinated pigs in contact with vaccinated pigs will harbour and shed the vaccine strains similarly to vaccinated pigs.
Necepljeni prašiči, ki pridejo v stik s cepljenimi prašiči, bodo cepivo kolonizirali in razsejali podobno kot cepljeni prašiči.
It is not recommended to vaccinate animals undergoing immunosuppressive treatment or to vaccinate animals undergoing antibacterial treatment effective against E. coli.
Cepljenje živali, ki se zdravijo z imunosupresivi, ali živali, ki se zdravijo z antibiotiki, učinkovitimi proti E. coli, ni priporočljivo.
- For administration using bowls or tanks, dilute the reconstituted vaccine in the volume of water that the pigs will drink during a 4-hour time period.
- Če uporabljate za dajanje sklede ali cisterne, rekonstituirano cepivo razredčite v količini vode, ki jo bodo prašiči popili v 4-urnem obdobju.
CFU - colony forming units White or whitish powder.
CFU - enota, ki tvori kolonijo (colony forming units) Bel ali belkast prašek.
Vaccination schedule: administer a single dose orally from 18 days of age.
Razpored cepljenja: dajte enkratni odmerek peroralno od 18. dneva starosti.
- For administration through water lines using a dosing pump (proportioner), dilute the reconstituted vaccine in the needed volume of the dosing pump stock solution.
- Za dajanje preko vodnih cevi z uporabo črpalke za odmerjanje (dozirnik), rekonstituirano cepivo razredčite v potrebni količini osnovne raztopine v črpalki za odmerjanje.
The reconstituted vaccine is a transparent to opaque white-yellowish suspension depending on the volume of water used for dilution.
Rekonstituirano cepivo je prozorna do motna belorumenkasta suspenzija, odvisno od volumna vode, ki se uporabi za redčenje.
Shelf life after reconstitution and dilution according to directions: 4 hours.
Rok uporabnosti po rekonstituciji in redčenju v skladu z navodili: 4 ure.
Special precautions for use in animals.
Posebni previdnostni ukrepi za uporabo pri živalih
6.9 to 9.0
34 litrov od 6,9 do 9,0
Vaccination by drench application: - 50-dose presentation: Reconstitute the lyophilisate by adding 10 ml of water to the vial.
Cepljenje z drenažno aplikacijo: - pakiranje s 50 odmerki: rekonstituirajte liofilizat tako, da viali dodate 10 ml vode.
27 80689 München GERMANY
27 80689 München NEMČIJA
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCES AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
A. IZDELOVALEC BIOLOŠKIH ZDRAVILNIH UČINKOVIN IN IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
In case of spillage onto skin, rinse with water and seek medical advice immediately and show the package leaflet or the label to the physician.
V primeru razlitja po koži mesto splaknite z vodo, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali ovojnino.
Immunological properties:
Imunološke lastnosti:
4.6 to 6.8
22 litrov od 4,6 do 6,8
Reconstitute the lyophilisate by adding 10 ml (50-dose presentation) or 20 ml (200-dose presentation) of water to the vial.
Rekonstituirajte liofilizat tako, da viali dodate 10 ml (pakiranje s 50 odmerki) ali 20 ml (pakiranje z 200 odmerki) vode.
White or whitish powder.
Bel do belkast prašek.
A rectal temperature up to 41.2 °C may occur in individual animals within the first 24 hours after administration of a 10-fold overdose.
Po uporabi odmerka, ki je 10-krat večji od priporočenega, se lahko v prvih 24 urah temperatura v rektumu pri posameznih živalih dvigne na 41,2°C.
Shake well and transfer the suspension into a graduated container, mix again with water to complete to a total volume of 100 ml.
Dobro pretresite in suspenzijo prenesite v vsebnik z merilnimi oznakami; ponovno premešajte z vodo, da vsebino dopolnite do skupne prostornine 100 ml.
Special precautions to be taken by the person administering the veterinary medicinal product to animals.
Posebni previdnostni ukrepi, ki jih mora izvajati oseba, ki živalim daje zdravilo
Shake well and transfer the suspension into a graduated container, mix again with water to complete to a total volume of 400 ml.
Dobro pretresite in suspenzijo prenesite v vsebnik z merilnimi oznakami; ponovno premešajte z vodo, da vsebino dopolnite do skupne prostornine 400 ml.
Coliprotec F4/F18 lyophilisate for oral suspension for pigs
Coliprotec F4/F18 liofilizat za peroralno suspenzijo za prašiče
Pregnancy: The use is not recommended during pregnancy.
Brejost: Uporaba med brejostjo ni priporočljiva.
- reduce the incidence of moderate to severe post-weaning E. coli diarrhoea (PWD) in infected pigs; - reduce the faecal shedding of enterotoxigenic F4-positive and F18-positive E. coli from infected pigs.
- zmanjšanje incidence zmerne do hude driske zaradi E. coli po odstavitvi pri okuženih prašičih; - zmanjšanje fekalnega razsejanja enterotoksigene F4-pozitivne in F18-pozitivne E. coli iz okuženih prašičev.
Live non-pathogenic Escherichia coli O141:K94
Živa nepatogena Escherichia coli O141:K94
Live non-pathogenic Escherichia coli O8:K87
Živa nepatogena Escherichia coli O8:K87
Antibodies triggered by the vaccine provide cross-reactivity against F4ab and F4ad-positive E. coli strains.
Protitelesa, katerih nastanek sproža cepivo, zagotavljajo navzkrižno reaktivnost proti F4ab in F4ad-pozitivnim sevom E. coli.
Live E. coli O8:K87 (F4ac) and live E. coli O141:K94 (F18ac)
živa E. coli O8:K87 (F4ac) in živa E. coli O141:K94 (F18ac)
Personal protective equipment consisting of protective disposable gloves and safety glasses should be worn when handling the veterinary medicinal product.
Pri rokovanju z zdravilom nosite osebno zaščitno opremo, ki sestoji iz zaščitnih rokavic za enkratno uporabo in varnostnih očal.
The vaccine induces an intestinal immunity and a serological response against F4-positive and F18positive E. coli in pigs.
Cepivo sproži črevesno imunost in serološki odziv proti F4-pozitivni in F18-pozitivni E. coli pri prašičih.
Live non-pathogenic E. coli O141:K94 (F18ac):.................2.8x10
Živa nepatogena E. coli O141:K94 (F18ac): ...............2,8x10
PACKAGE LEAFLET FOR: Coliprotec F4/F18 lyophilisate for oral suspension for pigs
NAVODILO ZA UPORABO Coliprotec F4/F18 liofilizat za peroralno suspenzijo za prašiče
Each dose of vaccine contains: Live non-pathogenic E. coli O8:K87 (F4ac):.......................1.3x10
En odmerek cepiva vsebuje: Živa nepatogena E. coli O8:K87 (F4ac):.......................1,3x10
to 9.0x10
do 9,0x10
For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive and F18positive Escherichia coli in order to:
Za aktivno imunizacijo prašičev od 18. dneva starosti proti enterotoksigeni F4-pozitivni in F18pozitivni Escherichia coli za:
to 3.0x10
do 3,0x10
For active immunisation of pigs from 18 days of age against enterotoxigenic F4-positive and F18positive E. coli in order to:
Za aktivno imunizacijo prašičev od 18. dneva starosti proti enterotoksigeni F4-pozitivni in F18pozitivni E. coli za:
The vaccine confers cross protection against F18ab-positive E. coli, as demonstrated by challenge for both the 7-day onset of immunity and the 21-day duration of immunity.
Kot je pokazala provokacija za nastop imunosti 7. dne in trajanje imunosti 21 dni, cepivo nudi navzkrižno zaščito proti F18ab-pozitivni E. coli.
To stimulate active immunity against enterotoxigenic F4-positive and F18-positive E. coli in pigs.
Za spodbujanje aktivne imunizacije prašičev proti enterotoksigeni F4-pozitivni in F18-pozitivni E. coli.
Monosodium glutamate Purified water
6.1 Seznam pomožnih snovi dekstran 40.000 saharoza mononatrijev glutaminat prečiščena voda
Up to 4.5
200 prašičev do 4,5
- 200-dose presentation: Reconstitute the lyophilisate by adding 20 ml of water to the vial.
Prašičem dajte enkratni 2-mililitrski peroralni odmerek, ne glede na telesno maso; - pakiranje z 200 odmerki: rekonstituirajte liofilizat tako, da viali dodate 20 ml vode.
Page 2/2© EMEA 2009
Stran 2/2© EMEA 2009
This summary was last updated on May 2009.
Povzetek je bil nazadnje posodobljen 05/2009.
Other information about Masivet:
Druge informacije o zdravilu Masivet:
These reactions are usually mild to moderate and temporary, last for up to four weeks.
Te reakcije so navadno blage do zmerno hude in začasne, saj trajajo do največ štiri tedne.
It is available as round, orange tablets (50 and 150 mg).
Na voljo je v obliki okroglih, oranžnih tablet (50 in 150 mg).
The European Commission granted a marketing authorisation valid throughout the European Union, for Masivet to AB Science S.A. on 17 November 2008.
Evropska komisija je dovoljenje za promet z zdravilom Masivet, veljavno po vsej Evropski uniji, odobrila družbi AB Science S.A. dne 17. novembra 2008.
Do not eat, drink or smoke while treating a dog.
Med zdravljenjem psa ne jejte, pijte ali kadite.
What benefit has Masivet shown during the studies?
Kakšne koristi je zdravilo Masivet izkazalo med študijami?
This means that it blocks some specific enzymes known as tyrosine kinases.
To pomeni, da zavira točno določene encime, znane kot tirozin kinaze.
Four to six weeks after starting the treatment with Masivet, the veterinarian should check if the treatment is likely to be successful.
Veterinar mora štiri do šest tednov po začetku zdravljenja z zdravilom Masivet preveriti, kakšna je verjetnost, da bo zdravljenje uspešno.
These enzymes can be found in some receptors on the surface of cells, including the c-kit receptor.
Te encime lahko najdemo v nekaterih receptorjih na površini celic, med drugim tudi v receptorju c-kit.
What is the risk associated with Masivet?
Kakšna tveganja so povezana z zdravilom Masivet?
If broken tablets, or the vomit, urine or faeces of a treated dog comes into contact with the skin or eyes, rinse immediately with plenty of water.
Če pridejo zlomljene tablete, bruhanje, urin ali iztrebki zdravljenega psa v stik s kožo ali očmi, jih takoj sperite z veliko vode.
The tablets must be administered whole and should not be divided, broken or ground up.
Tablete je treba dajati cele in se ne smejo razpoloviti, lomiti ali zdrobiti.
It is only used if the presence of a mutated form of the receptor protein c-kit in the tumours has been confirmed before the start of treatment.
Uporablja se le, če je bila pred začetkom zdravljenja potrjena prisotnost mutirane oblike receptorske beljakovine c-kit v tumorjih.
The main study compared the effectiveness of Masivet at the recommended dose of 12.5 mg per kilogramme bodyweight once a day with placebo (a dummy treatment).
V glavni študiji so učinkovitost priporočenega odmerka zdravila Masivet 12,5 mg na kilogram telesne mase enkrat dnevno primerjali s placebom (zdravilom brez zdravilne učinkovine).
Because this disease is a life threatening condition and the overall number of dogs affected is expected to be low, the CVMP guidelines on “Minor-Use-Minor-Species (MUMS) data requirements” were applied when assessing the dossier.
Ker je ta bolezen življenjsko nevarna in se pričakuje majhno število prizadetih psov, so bile pri presoji dokumentacije uporabljene smernice CVMP o „zahtevah glede podatkov za manjšo uporabo pri manj pomembnih vrstah (MUMS)“.
The tablets are given by mouth, once a day.
Tablete dajemo peroralno enkrat dnevno.
A number of studies with Masivet were carried out either in laboratory dogs or in animal patients at veterinary practises in Europe and in the USA.
V veterinarskih ambulantah v Evropi in ZDA so pri laboratorijskih psih ali bolnih živalih izvedli številne študije zdravila Masivet.
In case of side effects, the veterinarian might decide to lower the dose of Masivet or to discontinue treatment.
Veterinar se lahko v primeru neželenih učinkov odloči zmanjšati odmerek zdravila Masivet ali prekiniti zdravljenje.
The most common side effects with Masivet are gastrointestinal reactions (diarrhoea and vomiting) and hair loss.
Najpogostejši neželeni učinki zdravila Masivet so gastrointestinalne reakcije (driska in bruhanje) ter izgubljanje dlake.
It should not be used in dogs that may be hypersensitive (allergic) to masitinib or any of the other ingredients.
Ne sme se uporabljati pri psih, ki utegnejo biti preobčutljivi za (alergični na) masitinib ali katero koli drugo sestavino.
The study population included dogs whose tumours contained mutated or normal (‘wild-type') c-kit receptors.
Študijska populacija je vključevala pse, katerih tumorji so imeli mutirane ali normalne („divji tip“) receptorje c-kit.
In the dogs whose tumours contained mutated c-kit receptors, it took longer for the tumour to get worse when dogs received Masivet (median of 241 days) than in those receiving placebo (median of 83 days).
Pri psih, katerih tumorji so vsebovali mutirane receptorje c-kit, se je stanje tumorjev poslabšalo kasneje, če so prejemali zdravilo Masivet (povprečni čas preživetja 241 dni), kot pri tistih, ki so prejemali placebo (povprečni čas preživetja 83 dni).
Masivet must not be used in dogs with certain kinds of liver or kidney problems, or anaemia (low red blood cell counts) or neutropenia (low white blood cell counts).
Zdravilo Masivet se ne sme uporabljati pri psih z nekaterimi vrstami jetrnih ali ledvičnih težav, anemijo (majhnim številom rdečih krvničk) ali nevtropenijo (majhnim številom belih krvničk).
Why has Masivet been approved?
Zakaj je bilo zdravilo Masivet odobreno?
It must not be used in dogs less than six months of age or less than 4 kg in weight, or bitches that are pregnant or lactating.
Zdravilo se ne sme uporabljati pri psih, starih manj kot šest mesecev ali težkih manj kot 4 kg, ali pri psicah v obdobju brejosti oziroma laktacije.
If Masivet is taken accidentally, seek medical advice immediately and show the Package Leaflet or the label to the doctor.
Če zdravilo Masivet zaužijete nenamerno, se takoj posvetujte z zdravnikom in mu pokažite navodilo za uporabo ali nalepko.
The study included dogs of various breeds and both sexes with mast-cell tumours that had come back after surgery or could not be removed with surgery.
V študijo so bili vključeni psi različnih pasem in obeh spolov z mastocitomi, ki so se ponovno pojavili po kirurškem posegu ali jih s kirurškim posegom ni bilo mogoče odstraniti.
It is used for tumours which are severe in character (grade 2 or 3) and which cannot be removed with surgery.
Uporablja se za velike tumorje (2. ali 3. stopnja malignosti), ki jih ni mogoče odstraniti s kirurškim posegom.
Masivet is used to treat dogs with mast-cell tumours (a type of cancer).
Zdravilo Masivet se uporablja za zdravljenje psov z mastocitomi (vrsta raka).
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Masivet exceed the risks for the treatment of non-resectable mast cell tumours (grade 2 or 3) that have a confirmed mutated c-kit tyrosine kinase receptor and recommended that Masivet be given a marketing authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila Masivet pri zdravljenju mastocitomov (2. ali 3. stopnje), ki jih ni mogoče odstraniti kirurško in imajo potrjeno prisoten mutiran receptor tirozin kinaze c-kit, večje od z njim povezanih tveganj, in priporočil, da se za zdravilo Masivet odobri dovoljenje za promet.
Children should not have close contact with treated dogs, or their faeces or vomit.
Otroci ne smejo priti v stik z zdravljenimi psi, njihovimi iztrebki ali bruhanjem.
The active substance in Masivet, masitinib, is a protein-tyrosine kinase inhibitor.
Zdravilna učinkovina zdravila Masivet, masitinib, je zaviralec protein tirozin kinaze.
How does Masivet work?
Kako zdravilo Masivet deluje?
Some types of mast-cell tumour are linked to a mutation that causes excessive action of c-kit and stimulates the mast cells to divide uncontrollably.
Nekatere vrste mastocitomov so povezane z mutacijo, ki povzroča čezmerno delovanje beljakovine c-kit in spodbuja mastocite k nenadzorovanemu razmnoževanju.
What is Masivet used for?
Za kaj se zdravilo Masivet uporablja?
How has Masivet been studied?
Kako je bilo zdravilo Masivet raziskano?
Masivet contains masitinib, which belongs to a class of medicines having an anticancer action.
Zdravilo Masivet vsebuje masitinib, ki spada v skupino zdravil z učinkom proti raku.
For a full list of all side-effects reported with Masivet, see the Package Leaflet.
Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Masivet, glejte navodilo za uporabo.
What is Masivet?
Kaj je zdravilo Masivet?
Dogs under Masivet treatment should be regularly monitored for side effects by the veterinarian (at least monthly).
Zaradi morebitnega pojava neželenih učinkov mora veterinar redno (vsaj enkrat mesečno) pregledovati pse, ki jih zdravimo z zdravilom Masivet.
By blocking these receptors, Masivet might help to control cell division, preventing further development of the tumours with this particular mutation.
Zdravilo Masivet lahko prepreči nadaljnji razvoj tumorjev s to mutacijo, saj z zaviranjem teh receptorjev nadzoruje razmnoževanje celic.
The dose depends on the weight of the dog being treated..
Odmerek je odvisen od mase psa, ki ga zdravimo.
2nd injection: after 3 weeks
2. injekcija: po 3 tednih
ATC vet code: QI04AA02.
Oznaka ATC vet: QI04AA02.
Aluminium hydroxide (Al3+)
aluminijev hidroksid (Al3+)
According to Article 71 of Directive 2001/82/EC of the European Parliament and of the Council as amended, a Member State may, in accordance with its national legislation, prohibit the manufacture, import, possession, sale, supply and/or use of immunological veterinary medicinal products on the whole or part of its territory if it is established that:
Skladno z 71. členom Direktive 2001/82/ES Evropskega parlamenta in Sveta, z vsemi dopolnitvami in spremembami lahko država članica, skladno z nacionalno zakonodajo, prepove izdelavo, uvoz/vnos, posedovanje, prodajo, oskrbo in/ali uporabo zdravila za uporabo imunološkega zdravila za uporabo v veterinarski medicini na svojem celotnem ozemlju ali delu ozemlja, če se ugotovi da:
EU/2/11/131/006
EU/2/11/131/001 EU/2/11/131/005 EU/2/11/131/006
*(Cycling value (Ct) ≥ 36 by a validated RT-PCR method, indicating no presence of viral genome).
*(Ciklična vrednost (Ct) ≥ 36 pri validirani metodi RT_PCR, kar kaže, da virusni genom ni prisoten)
The use of this veterinary medicinal product is only allowed under the particular conditions established by European Community legislation on the control of Bluetongue.
Uporaba tega cepiva je dovoljena le pod posebnimi pogoji zakonodaje EU o kontroli bolezni modrikastega jezika.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Podrobne informacije o tem zdravilu so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency) (http://www.ema.europa.eu/).
Date of last renewal: 18/04/2016
Datum pridobitve dovoljenja za promet: 05 avgust 2011 Datum zadnjega podaljšanja dovoljenja za promet: 18/04/2016
Administration of a two-fold overdose may be followed in most animals by a local reaction at the injection site.
Po dajanju dvakratnega prevelikega odmerka se lahko pri večini živali pojavi lokalna reakcija na mestu injiciranja.
Vaccination may be followed very commonly by a local reaction at the injection site.
Po cepljenju se zelo pogosto lahko pojavi lokalna reakcija na mestu injiciranja.
IMMUNOLOGICAL PROPERTIES Pharmacotherapeutic group: Inactivated viral vaccines - Bluetongue virus.
Farmakoterapevtska skupina: Inaktivirana virusna cepiva - virus bolezni modrikastega jezika.
A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Zato se za uporabo tega cepiva pred ali po uporabi katerega koli drugega zdravila za uporabo v veterinarski medicine odločamo od primera do primera.
Potassium dihydrogen phosphate Disodium hydrogen phosphate dodecahydrate Sodium chloride
FARMACEVTSKI PODATKI 6.1 Seznam pomožnih snovi aluminijev hidroksid saponin tiomersal kalijev klorid kalijev dihidrogenfosfat natrijev hidrogenfosfat dodekahidrat natrijev klorid voda za injekcije
Shelf-life after first opening the immediate packaging: use immediately after broaching.
Rok uporabnosti po prvem odpiranju stične ovojnine: Načeto uporabite takoj.
To stimulate active immunity against Bluetongue Virus, serotype 1 in sheep.
Za stimulacijo aktivne imunosti proti virusu bolezni modrikastega jezika, serotip 1, pri ovcah.
BATCH NUMBER Lot {number}
Lot { številka }
Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP. Once broached use immediately.
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na ovojnini po
No data is available on safety in lactating animals.
Podatkov o varnosti uporabe pri živalih v laktaciji ni na voljo.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009
Učinkovina biološkega izvora namenjena vzbujanju aktivne imunosti, ni vključena v Uredbo(ES) št.
PARTICULARS TO APPEAR ON THE OUTER PACKAGE Outer carton 1 x 20ml, 1 x 100ml and 1 x 240 ml
PODATKI NA ZUNANJI OVOJNINI Kartonska škatla 1 x 20 ml, 1 x 100 ml in 1 x 240 ml
A transient increase in rectal temperature, not exceeding 1.2 °C, may occur very commonly during the 24 hours following vaccination.
Do 24 ur po cepljenju se zelo pogosto lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 1,2 °C.
PACKAGE LEAFLET: Zulvac 1 Ovis suspension for injection for sheep
NAVODILO ZA UPORABO Zulvac 1 Ovis suspenzija za injiciranje za ovce
A transient increase in rectal temperature, not exceeding 0.6 °C, may occur during the 24 hours following administration of a two-fold overdose.
Do 24 ur po dajanju dvakratnega prevelikega odmerka se lahko pojavi prehodno povišanje rektalne temperature, ki ne presega 0,6 °C.
For active immunisation of sheep from 1 and a half months of age for the prevention* of viraemia caused by Bluetongue Virus (BTV), serotypes 1.
Za aktivno imunizacijo ovac, starejših od 1 in pol meseca starosti, za preprečitev* viremije, ki jo povzroča virus bolezni modrikastega jezika (BTV), serotip 1.
A. MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
A. PROIZVAJALEC(PROIZVAJALCI) BIOLOŠKE (BIOLOŠKIH) UČINKOVINE ( UČINKOVIN) IN PROIZVAJALEC (PROIZVAJALCI) ZDRAVILA, ODGOVOREN(ODGOVORNI) ZA SPROŠČANJE SERIJ
Inactivated Bluetongue Virus, serotype 1, strain BTV-1/ALG2006/01 E1 Aluminium hydroxide, saponin and thiomersal.
V odmerku 2 ml inaktiviran virus bolezni modrikastega jezika, serotip 1, sev BTV-1/ALG2006/01 E1 aluminijev hidroksid, saponin in tiomersal.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each 2 ml dose contains:
Vsak odmerek (2 ml) vsebuje: