natgillin/translations-raw huggingface dataset:
Treatment and prevention of swine dysentery
Zdravljenje in preprečevanje griže pri prašičih
44 In addition to medical treatment, good management and hygiene practices should be established on the farm in order to reduce the risk of infection and to control the build up of resistance.
45 Kot dodatek zdravljenju, bi na farmi morali uvesti dobro gospodarjenje in higienske navade, da bi tako zmanjšali tveganje infekcije in za nadzor morebitne krepitve rezistence.
Store in the original container Do not use after the expiry date stated on the label.
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na ovojnini.
Meal:
Pšenična krmna moka:
1 month Pellets:
1 mesec
The safety of Aivlosin during pregnancy and lactation has not been established in pigs.
Varnost zdravila Aivlosin v obdobju brejosti in laktacije pri prašičih ni dokazana.
45 Generally, strains of B. hyodysenteriae have higher MIC values in cases of resistance against other macrolides, such as tylosin.
46 Sevi B. hyodysenteriae imajo v primerih rezistence na druge makrolide, kakršen je tilozin, v splošnem višje vrednosti MIK.
For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Za vse nadaljnje informacije o tem zdravilu se obrnite na krajevno predstavništvo imetnika dovoljenja za promet z zdravilom
46 Danmark ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Storbritannien Tel: +44 (0) 20 84 47 8899 Email: sales@ecoanimalhealth.com
47 Danmark ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Storbritannien Tel: +44 (0) 20 8447 8899 Email: sales@ ecoanimalhealth. com
47 Ísland ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Bretland Tel: +44 (0) 20 8447 8899 Email: sales@ecoanimalhealth.com
48 Ísland ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Bretland Tel: +44 (0) 20 8447 8899 Email: sales@ ecoanimalhealth. com
48 PACKAGE LEAFLET for
49 NAVODILO ZA UPORABO
Aivlosin 8.5 mg/g Oral Powder
Aivlosin 8, 5 mg/ g peroralni prašek
Gallows Green Services Limited Cod Beck Blenders, Cod Beck Mill Dalton, Thirsk, North Yorkshire YO7 3HR United Kingdom
Izdelovalec, odgovoren za sproščanje serije Gallows Green Services Limited Cod Beck Blenders, Cod Beck Mill Dalton, Thirsk, North Yorkshire YO7 3HR Velika Britanija
Aivlosin 8.5 mg/g Oral Powder for pigs
Aivlosin 8, 5 mg/ g peroralni prašek za prašiče.
Treatment of Porcine Proliferative Enteropathy caused by Lawsonia intracellularis.
Zdravljenje prašičje proliferativne enteropatije, ki jo povzroča Lawsonia intracellularis.
Treatment of clinical outbreaks of Swine Dysentery in herds, where the disease has been diagnosed, and prevention of further clinical cases.
Zdravljenje kliničnih izbruhov griže pri prašičih, v čredah, kjer je bila diagnosticirana bolezen, in za preprečevanje nadaljnjih kliničnih primerov.
None known If you notice any side effects, please inform your veterinary surgeon
Če opazite kakršne koli stranske učinke, obvestite svojega veterinarja.
For use in individual pigs on farms where only a small number of pigs are to receive the medicine.
Za uporabo pri posameznih prašičih na farmah, kjer se zdravilo daje le majhnemu številu prašičev.
The oral powder is for use in individual pigs on farms where only a small number of pigs are to receive the medicine.
Oralni prašek je namenjen uporabi s posameznimi prašiči, kjer bo zdravilo prejelo le manjše število prašičev.
Larger groups should be treated with medicated feeding stuff containing the premix.
Večje število prašičev morate zdraviti s krmilnim sredstvom, ki vsebuje predmešanico.
For treatment of Porcine Proliferative Enteropathy (ileitis) The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
Za zdravljenje prašičje proliferativne enteropatije (ileitis) Doza znaša 4, 25 mg tylvalosina na kg telesne mase na dan s krmo 10 dni.
For treatment and prevention of Swine Dysentery The dosage is 4.25 mg tylvalosin per kg bodyweight per day for 10 consecutive days.
Za zdravljenje in preprečevanje griže pri prašičih Doza znaša 4, 25 mg tylvalosina na kg telesne mase na dan s krmo 10 dni.
This is achieved by thoroughly mixing Aivlosin 8.5 mg/g Oral Powder into the daily ration for each individual pig.
To dosežemo tako, da Aivlosin 8, 5 mg/ g peroralni prašek vmešamo dnevno količino krme za vsakega prašiča posebej.
Scoops of 3 sizes are provided for measuring the correct amount of Aivlosin 8.5 mg/g Oral Powder for mixing with the daily ration, according to the schedule below.
Za odmerjanje ustreznega odmerka peroralnega praška Aivlosin 8, 5 mg/ g, ki se po spodaj navedenem razporedu vmeša v dnevni obrok, so na voljo zajemalke treh velikosti.
The feed containing the oral powder should be provided as the sole ration for the periods recommended above.
Krma, ki vsebuje peroralni prašek, morabi biti edina krma, ki jo prašiči prejemajo v trajanju, navedenem zgoraj.
The pig to be treated should be weighed and the amount of feed that the pig is likely to consume should be estimated, based on a daily feed intake equivalent to 5% of bodyweight.
Prašiča, ki ga zdravite, je treba stehtati in oceniti količino krme, ki jo bo zaužil.
The correct quantity of Aivlosin 8.5 mg/g Oral Powder should then be added to the estimated quantity of daily ration for each pig, in a bucket or similar receptacle, and thoroughly mixed.
Ustrezno količino peroralnega praška Aivlosin je treba za vsakega prašiča posebej dodati ocenjeni količini krme v vedru ali podobni posodi in temeljito premešati.
The product should only be added to dry non-pelleted feed.
51 Zdravilo se sme dodajati samo suhi nepeletirani krmi.
Swine Enzootic Pneumonia 2.125 mg/kg bodyweight
Enzootična pljučnica pri prašičih 2, 125 mg/ kg telesne mase
Number of scoops 1
Število lopatic 1
Bodyweight range (kg) 6.5-12 13-24
6. 5 - 12
Number of scoops 1 2
2 4
10 ml 10 ml 10 ml 10 ml
10 ml 1 25 - 48 10 ml
1 2 3 4
6
25-48 49-72 73-96
25 - 48
10 ml 10 ml 10 ml
10 ml 2 49 - 72 10 ml
Acute cases and severely diseased pigs with reduced food or water intake should be treated with a suitable injectable product.
Akutne primere in resno prizadete prašiče, ki manj pijejo in jedo, je treba zdraviti z ustreznim zdravilom v obliki raztopine za injiciranje.
In addition to medical treatment, good management and hygiene practices should be established on the farm in order to reduce the risk of infection and to control the potential development of resistance.
Kot dodatek zdravljenju, bi na farmi morali uvesti dobro gospodarjenje in higienske navade, da bi tako zmanjšali tveganje infekcije in za nadzor morebitne krepitve rezistence.
Because Aivlosin has been shown to cause hypersensitivity reactions in laboratory animals people with known hypersensitivity to tylvalosin tartrate should avoid any contact with the product.
Ker so pri laboratorijskih živalih opazili preobčutljivostne reakcije na Aivlosin, naj se ljudje z znano preobčutljivostjo na tylvalosin tartrat izogibajo stiku z zdravilom.
When adding the veterinary medicinal product to the individual feed ration and when handling this feed, direct contact with eyes, skin and mucous membranes should be avoided.
Pri dodajanju zdravila za uporabo v veterinarski medicini posameznim krmilnim obrokom in pri rokovanju s to krmo se je treba izogibati neposrednemu stiku z očmi, kožo in sluznicami.
Personal protective equipment should be worn when handling the veterinary medicinal product or the feed with product added: overalls, impervious gloves and either a disposable half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter to EN 143.
Pri rokovanju z zdravilom za uporabo v veterinarski medicini ali s krmo z dodanim zdravilom nosite osebno zaščitno opremo: zaščitno obleko, neprepustne rokavice in dihalno polmasko za enkratno uporabo skladno z evropskim standardom EN 149 ali dihalno masko skladno z evropskim standardom EN 140 s filtrom EN 143.
In case of accidental ingestion seek medical advice immediately and show the label to the physician.
52 V primeru nenamernega zaužitja se takoj posvetujte z zdravnikom in mu pokažite nalepko na zunanji ovojnini.
Cross-resistance to other macrolide antibiotics cannot be excluded.
Navzkrižna odpornost na druge makrolidne antibiotike ni izključena.
Danmark ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Storbritannien Tel: +44 (0) 20 8447 8899 Email: sales@ecoanimalhealth.com
53 Danmark ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Storbritannien Tel: +44 (0) 20 8447 8899 Email: sales@ ecoanimalhealth. com
Ísland ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Bretland Tel: +44 (0) 20 8447 8899 Email: sales@ecoanimalhealth.com
54 Ísland ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Bretland Tel: +44 (0) 20 8447 8899 Email: sales@ ecoanimalhealth. com
54 PACKAGE LEAFLET FOR Aivlosin 625 mg/g Granules for use in drinking water for chickens (attached as concertina label directly to the immediate package)
Aivlosin 625 mg/ g Zrnca za uporabo v vodi za pitje za piščance (zloženo v obliki harmonike in pripeto neposredno na stično pakiranje)
Gallows Green Services Limited Cod Beck Blenders, Cod Beck Estate Dalton Lane, Dalton Thirsk, North Yorkshire YO7 3HR United Kingdom
Gallows Green Services Limited Cod Beck Blenders, Cod Beck Estate Dalton Lane, Dalton Thirsk, North Yorkshire YO7 3HR Velika Britanija
Aivlosin 625 mg/g granules for use in drinking water for chickens Tylvalosin (as tylvalosin tartrate)
Aivlosin 625 mg/ g Zrnca za uporabo v vodi za pitje za piščance tilvalozin (kot tilvalozinijev tartrat)
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
NAVEDBA ZDRAVILNE( IH) UČINKOVIN( E) IN DRUGIH SESTAVIN
White granules
bela zrnca
Treatment and prevention of respiratory disease associated with Mycoplasma gallisepticum in chickens.
Zdravljenje in preprečevanje bolezni dihal, povezanih z Mycoplasma gallisepticum pri piščancih.
For treatment of respiratory disease associated with Mycoplasma gallisepticum The dosage is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days.
Za zdravljenje bolezni dihal, povezanih z Mycoplasma gallisepticum Odmerek znaša 25 mg tilvalozina na kg telesne teže na dan v vodi za pitje 3 dni zapored.
The dosage is 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at 1 day old.
Kadar se uporablja kot pripomoček v ştrategiji preventive (kjer je verjetna infekcija in ovo z Mycoplasma gallisepticum) Odmerek znaša 25 mg tilvalozina na kg telesne teže na dan v vodi za pitje 3 dni zapored od 1. dne starosti.
This is followed by a second treatment with 25 mg tylvalosin per kg bodyweight per day in drinking water for 3 consecutive days at the period of risk, i.e. at times of management stress such as administration of vaccines (typically when birds are 2-3 weeks old).
Temu sledi drugo zdravljenje s 25 mg tilvalozina na kg telesne teže na dan v vodi za pitje 3 zaporedne dni v obdobju tveganja, t. j. v času stresa zaradi vzrejnih postopkov, na primer ob cepljenju (navadno takrat, ko so ptice stare 2- 3 tedne).
One sachet of 40 g is sufficient for a total of 1000 kg of chickens (e.g.
Ena 40- gramska vrečka zadostuje za zdravljenje skupno 1000 kg piščancev (t. j.
20,000 birds with an average bodyweight of 50 g).
20. 000 ptic s povprečno telesno težo 50 g).
2 days Not authorised for use in laying birds producing eggs for human consumption.
Uporaba pri pticah, katerih jajca so namenjena za prehrano ljudi, v obdobju nesnosti ni dovoljena.
Do not use after the expiry date, which stated on the label as “EXP”
Zdravila ne smete uporabljati po datumu izteka roka uporabnosti, navedenega na etiketi kot “ EXP ”.
Shelf-life of the medicated drinking water:
Rok uporabnosti po raztopitvi zdravila v vodi za pitje:
24 hours Only a sufficient amount of medicated drinking water should be prepared to cover the daily requirements.
Pripraviti smete le toliko pitne vode z raztopljenim zdravilom, da bo pokrila dnevne potrebe.
Medicated drinking water should be replaced every 24 hours.
Pitno vodo z raztopljenim zdravilom morate zamenjati vsakih 24 ur.
Tylvalosin has been shown to cause hypersensitivity reactions in laboratory animals; therefore, people with known hypersensitivity to tylvalosin tartrate should avoid contact with the veterinary medicinal product.
Izkazalo se je, da tilvalozin pri laboratorijskih živalih povzroča preobčutljivostne reakcije; zato naj se osebe z znano preobčutljivostjo na tilvalozin tartrat izogibajo stiku z zdravilom.
When mixing the veterinary medicinal product and handling the medicated water, direct contact, with eyes, skin and mucous membranes should be avoided.
Pri mešanju zdravila za uporabo v veterinarski medicini in rokovanju z vodo s primešanim zdravilom se izogibajte neposrednemu stiku le- teh z očmi in sluznicami.
Personal protective equipment should consisting of impervious gloves and a half-mask respirator conforming to European Standard EN 149 or a non-disposable respirator conforming to European Standard EN 140, with a filter conforming to European Standard EN 143 be worn when mixing the veterinary medicinal product.
Pri mešanju zdravila za uporabo v veterinarski medicini bi morali nositi osebno zaščitno opremo, ki jo sestavljajo delovna obleka, neprepustne rokavice in respiratorna polobrazna maska v skladu z evropskim standardom EN 149 ali respirator za večkratno uporabo v skladu z evropskim standardom EN 140 s filtrom v skladu z evropskim standardom EN 143.
Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu.
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila (European Medicines Agency, EMEA) http: // www. emea. europa. eu.
Aivlosin 625 mg/g Granules for use in drinking water for chickens is available in sachets containing 40 g or 400 g.
Aivlosin 625 mg/ g zrnca za uporabo v vodi za pitje za piščance je na voljo v vrečkah, ki vsebujejo po 40 g ali 400 g.
Ul.
59
España ESTEVE Veterinaria Laboratorios Dr.
Ελλάδα Καλορίζου Μ. - Σ. Κουρουπίδης ΟΕ Ηρώων Πολυτεχνείου 60 43100 Καρδίτσα Ελλάδα Τηλ: +3024410 41951 Email: info@ vkk. gr España ESTEVE Veterinaria Laboratorios Dr.
Portugal Esteve veterinaria-Esteve Farma, Lda.
Słoneczna 223A 05- 506 Lesznowola NIP 5262748877 Polska Tel: +4822 7376363 Portugal Esteve veterinaria- Esteve Farma, Lda.
Latvija ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Anglija Tel: +44 (0) 20 8447 8899 Email: sales@ecoanimalhealth.com
60 Latvija ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Anglija Tel: +44 (0) 20 8447 8899 Email: sales@ ecoanimalhealth. com Lietuva ECO Animal Health Ltd., The Grange, 100 The High Street, London, N14 6BN, Jungtinė Karalystė Tel: +44 (0) 20 8447 8899 Email: sales@ ecoanimalhealth. com
BTVPUR AlSap 8 is a vaccine.
BTVPUR AlSap 8 je cepivo.
It is a suspension for injection that contains inactivated (killed) bluetongue serotype 8 viruses.
Je suspenzija za injiciranje, ki vsebuje inaktivirane (uničene) viruse modrega jezika, serotip 8.
BTVPUR AlSap 8 is used in cattle and sheep to protect them against bluetongue disease.
Zdravilo BTVPUR AlSap 8 se uporablja pri govedu in ovcah za zaščito pred boleznijo modrega jezika.
Bluetongue disease is an infection that is transmitted by midges and caused by the bluetongue virus (serotype 8).
Bolezen modrega jezika je okužba, ki jo prenašajo trzače, povzroča pa jo virus modrega jezika (serotip 8).
The vaccine is used to limit viraemia (the presence of viruses in the blood) and reduce the signs of the disease.
Cepivo se uporablja za preprečitev viremije (prisotnosti virusa v krvi) in zmanjšanje znakov bolezni.
The vaccine is given to young animals as an injection under the skin.
Cepivo dajemo mladim živalim z injiciranjem pod kožo.
One injection is enough to vaccinate sheep, but cattle will need a second injection three to four weeks later.
Za cepljenje ovac zadostuje ena injekcija, govedo pa potrebuje drugo injekcijo tri do štiri tedne kasneje.
The first injection is given at one month of age in animals that have never been exposed to the disease, and at two-and-a- half months if the animal’ s mother is already immune to the disease.
Prva injekcija se da mesec starim živalim, ki še nikoli niso bile izpostavljene bolezni, in dva meseca in pol starim mladičem mater, ki so že imune na bolezen.
This is because control of bluetongue is the responsibility of national veterinary authorities in consultation with the European Commission
Cepivo se lahko uporabi le kot del odobrenega nacionalnega programa za obvladovanje bolezni, ker so za obvladovanje bolezni modrega jezika odgovorni nacionalni veterinarski organi v posvetovanju z Evropsko komisijo.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against a disease.
Cepiva delujejo tako, da imunski sistem (naravne obrambne mehanizme telesa) „ naučijo “ obrambe pred boleznijo.
When it is given to cattle and sheep, the animals’ immune systems recognise the viruses as ‘ foreign ’ and make antibodies against the virus.
Ko govedo ali ovco cepimo, imunski sistem živali prepozna viruse kot „ tujke “ proti njim izdela protitelesa.
In the future, if the animals are exposed to the bluetongue virus, the immune system will be able to produce antibodies more quickly.
Ob ponovni izpostavitvi virusu modrega jezika v prihodnosti bo imunski sistem izdelal protitelesa hitreje.
BTVPUR AlSap 8 contains bluetongue viruses of one type (‘ serotype 8’).
Zdravilo BTVPUR AlSap 8 vsebuje en tip virusov modrega jezika („ serotip 8 “).
The vaccine also contains ‘ adjuvants’ (aluminium hydroxide and saponin) to stimulate a better response.
Cepivo vsebuje tudi „ adjuvansa “ (aluminijev hidroksid in saponin) za stimulacijo boljšega odziva.
The safety of the vaccine was studied in laboratory safety studies carried out with BTVPUR AlSap 8 in cattle and sheep.
Varnost cepiva so proučili v laboratorijskih študijah varnosti, ki so jih opravili z uporabo cepiva BTVPUR AlSap 8 na govedu in ovcah.
Results from a series of laboratory safety trials performed with vaccines of similar composition but of different bluetongue serotypes were also presented in order to extrapolate safety conclusions, as the vaccine is intended for use in an emergency situation.
Predloženi so bili tudi rezultati niza laboratorijskih preskusov varnosti s cepivi s podobno sestavo, vendar drugimi serotipi virusa modrega jezika, da bi ekstrapolirali zaključke o varnosti, saj je cepivo namenjeno uporabi v nujnih primerih.
The efficacy of the vaccine in cattle was studied in a laboratory trial using the vaccine in cattle from one month of age.
Učinkovitost cepiva pri govedu so proučili v laboratorijskem preskusu uporabe cepiva na govedu, starejšemu od enega meseca.
Another laboratory study looked at the use of the vaccine in sheep aged three to four months.
V drugi laboratorijski študiji so proučili uporabo cepiva na ovcah, starih od treh do štirih mesecev.
The company also presented results from a series of studies with other vaccines that contain other serotypes of the bluetongue virus, as well as published information to show how the vaccine will also work in younger sheep.
Družba je predstavila tudi rezultate niza študij z drugimi cepivi, ki vsebujejo druge serotipe virusa modrega jezika, in objavljene podatke, s katerimi so želeli pokazati, da cepivo deluje tudi pri mlajših ovcah.
The vaccine was assessed in the context of an emergency situation which means that further studies with BTVPUR AlSap 8 are still ongoing and will be assessed.
Cepivo so ovrednotili v okviru nujnih primerov, kar pomeni, da dodatne študije cepiva BTVPUR AlSap 8 še potekajo in jih bodo še ovrednotili.
The studies showed that the vaccine is safe for sheep and cattle and that it reduces the signs of the disease and viraemia in animals from one month of age that are infected with bluetongue virus serotype 8.
Študije so pokazale, da je cepivo varno za ovce in govedo ter da zmanjša znake bolezni in viremijo pri živalih od enega meseca starosti naprej, ki so okužene z virusom modrega jezika serotipa 8.
The studies also showed that the vaccine can be used in pregnant sheep.
Študije so pokazale tudi, da se cepivo lahko uporabi pri brejih ovcah.
The safety of the vaccine in pregnant cows is not yet fully established, but results to date show that the vaccine can be used safely at least during the last three months of pregnancy.
Varnost cepiva pri brejih kravah še ni popolnoma ugotovljena, vendar rezultati dosedaj kažejo, da se lahko cepivo varno uporabi najmanj v zadnjih treh mesecih brejosti.
After vaccination, there can be a small swelling at the injection site lasting up to two weeks.
Po cepljenju lahko se lahko na mestu injiciranja pojavi manjša oteklina, ki izgine v največ 14 dneh.
Animals may also show a temporary increase in body temperature, usually of no more than 1ºC, in the 24 hours after vaccination.
V 24 urah po cepljenju je možno prehodno zvišanje telesne temperature, navadno ne za več kot 1 °C.
The withdrawal period for both sheep and cattle is zero days.
Karenca za ovce in govedo je nič dni.
Milk can be taken after zero days for both sheep and cattle.
Mleko ovc in goveda se lahko pomolze po nič dneh.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of BTVPUR AlSap 8 exceed the risks for active immunisation of sheep and cattle to prevent infection, viraemia and clinical signs caused by the bluetongue virus serotype 8, and recommended that BTVPUR AlSap 8 should be given a Marketing Authorisation.
Odbor za zdravila za uporabo v veterinarski medicini (CVMP) je zaključil, da so koristi zdravila BTVPUR AlSap 8 za aktivno imunizacijo ovac in goveda za preprečevanje okužbe, viremije in kliničnih znakov bolezni, ki jo povzroča virus modrega jezika, serotip 8, večje od z njim povezanih tveganj, in priporočil, da se za zdravilo BTVPUR AlSap 8 odobri dovoljenje za promet.
BTVPUR AlSap 8 has been authorised under ‘ Exceptional Circumstances’.
Zdravilo BTVPUR AlSap 8 je bilo odobreno „ izjemnih okoliščinah “.
This means that it has not been possible to obtain complete information about BTVPUR AlSap 8.
To pomeni, da ni bilo mogoče pridobiti vseh informacij o zdravilu BTVPUR AlSap 8.
Page 2/ 3 Medicines Agency (EMEA) will review additional information that will become available according to an agreed timetable and this summary will be updated as necessary.
Evropska agencija za zdravila (EMEA) bo vsako leto po dogovorjenem časovnem razporedu pregledala vse razpoložljive nove informacije in po potrebi posodobila ta povzetek.
What information is still awaited for BTVPUR Alsap 8?
2/ 3 Katere informacije o zdravilu BTVPUR Alsap 8 še pričakujemo?
The company that makes BTVPUR Alsap 8 will submit an action plan together with timelines for all of the issues that need to be resolved before the authorisation can revert to normal status.
Družba, ki izdeluje zdravilo BTVPUR Alsap 8, bo predložila načrt ukrepov s časovnimi okviri za vsa vprašanja, ki jih je še treba rešiti, da dobi dovoljenje za promet normalni status.
It will also supply regular updates on the use and the safety of the vaccine.
Redno bo pošiljala posodobljene podatke o uporabi in varnosti cepiva.
Other information about BTVPUR Alsap 8:
Druge informacije o zdravilu BTVPUR Alsap 8:
The European Commission granted a marketing authorisation valid throughout the EU for BTVPUR AlSap 8 to Merial on 17 March 2009.
Evropska komisija je dovoljenje za promet z zdravilom BTVPUR AlSap 8, veljavno po vsej Evropski uniji, odobrila družbi Merial dne 17. marca 2009.
This summary was last updated on 17 March 2009.
Povzetek je bil nazadnje posodobljen 17. marca 2009.
Cattle, Sheep
stekleničko s
Subcutaneous use
(govedo)
Polyproylene bottle with chlorobutyl rubber stopper and aluminium cap
klorobutilno gumijasto zaporko
100 ml
100 odmerki Ni smiselno (ovce)
Cattle, Sheep
ska plastenka s
Subcutaneous use
stekleničkami (govedo)
100 ml
s 100 odmerki Ni smiselno (ovce)