natgillin/translations-raw huggingface dataset:
Segluromet 7.5 mg/1,000 mg film-coated tablets Each tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg metformin hydrochloride. 
Segluromet 7,5 mg/1.000 mg filmsko obložene tablete Ena tableta vsebuje 7,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 1.000 mg metforminijevega klorida.
o Each Segluromet 7.5 mg/850 mg film-coated tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride. 
o Ena filmsko obložena tableta (tableta) zdravila Segluromet 7,5 mg/850 mg vsebuje 7,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 850 mg metforminijevega klorida.
Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 850 mg of metformin hydrochloride. 
Ena tableta vsebuje 2,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 850 mg metforminijevega klorida.
Segluromet 2.5 mg/1,000 mg film-coated tablets Each tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride. 
Segluromet 2,5 mg/1.000 mg filmsko obložene tablete Ena tableta vsebuje 2,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 1.000 mg metforminijevega klorida.
Segluromet 2.5 mg/1000 mg tablets ertugliflozin/metformin hydrochloride 
Segluromet 2,5 mg/1000 mg tablete ertugliflozin/metforminijev klorid
Talk to your doctor, pharmacist, or nurse before and while taking Segluromet, if you: 
Pred začetkom jemanja zdravila Segluromet in med njegovim jemanjem se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro:
EU/1/18/1265/022 (14 film-coated tablets) EU/1/18/1265/023 (28 film-coated tablets) EU/1/18/1265/024 (30x1 film-coated tablets) EU/1/18/1265/025 (56 film-coated tablets) EU/1/18/1265/026 (60 film-coated tablets) EU/1/18/1265/027 (168 film-coated tablets) EU/1/18/1265/028 (180 film-coated tablets) EU/1/18/1265/032 (196 (4 x 49) film-coated tablets) 
EU/1/18/1265/022 (14 filmsko obloženih tablet) EU/1/18/1265/023 (28 filmsko obloženih tablet) EU/1/18/1265/024 (30 x 1 filmsko obložena tableta) EU/1/18/1265/025 (56 filmsko obloženih tablet) EU/1/18/1265/026 (60 filmsko obloženih tablet) EU/1/18/1265/027 (168 filmsko obloženih tablet) EU/1/18/1265/028 (180 filmsko obloženih tablet) EU/1/18/1265/032 (196 (4 x 49) filmsko obloženih tablet)
Change from baseline (LS mean Difference from placebo (LS mean 
Razlika v primerjavi s placebom (povprečje LS
Renal-related adverse reactions (e.g., acute kidney injury, renal impairment, acute prerenal failure) may occur in patients treated with ertugliflozin, particularly in patients with moderate renal impairment where the incidence of renal-related adverse reactions was 2.5%, 1.3%, and 0.6% in patients treated with ertugliflozin 5 mg, ertugliflozin 15 mg, and placebo, respectively. 
To velja zlasti za bolnike z zmerno okvaro ledvic, pri katerih je bila pojavnost z ledvicami povezanih neželenih učinkov za 5 mg ertugliflozina 2,5 %, za 15 mg ertugliflozina 1,3 % in za placebo 0,6 %.
Segluromet 7.5 mg/1000 mg film-coated tablets ertugliflozin/metformin hydrochloride 
Segluromet 7,5 mg/1000 mg filmsko obložene tablete ertugliflozin/metforminijev klorid
EU/1/18/1265/008 (14 film-coated tablets) EU/1/18/1265/009 (28 film-coated tablets) EU/1/18/1265/010 (30x1 film-coated tablets) EU/1/18/1265/011 (56 film-coated tablets) EU/1/18/1265/012 (60 film-coated tablets) EU/1/18/1265/013 (168 film-coated tablets) EU/1/18/1265/014 (180 film-coated tablets) EU/1/18/1265/030 (196 (4 x 49) film-coated tablets) 
EU/1/18/1265/008 (14 filmsko obloženih tablet) EU/1/18/1265/009 (28 filmsko obloženih tablet) EU/1/18/1265/010 (30 x 1 filmsko obložena tableta) EU/1/18/1265/011 (56 filmsko obloženih tablet) EU/1/18/1265/012 (60 filmsko obloženih tablet) EU/1/18/1265/013 (168 filmsko obloženih tablet) EU/1/18/1265/014 (180 filmsko obloženih tablet) EU/1/18/1265/030 (196 (4 x 49) filmsko obloženih tablet)
Segluromet 7.5 mg/850 mg film-coated tablets ertugliflozin/metformin hydrochloride 
Segluromet 7,5 mg/850 mg filmsko obložene tablete ertugliflozin/metforminijev klorid
Segluromet 2.5 mg/1000 mg film-coated tablets ertugliflozin/metformin hydrochloride 
Segluromet 2,5 mg/1000 mg filmsko obložene tablete ertugliflozin/metforminijev klorid
Segluromet 2.5 mg/850 mg film-coated tablets ertugliflozin/metformin hydrochloride 
Segluromet 2,5 mg/850 mg filmsko obložene tablete ertugliflozin/metforminijev klorid
Monitor for signs and symptoms after initiating therapy. 
Po uvedbi zdravljenja spremljajte znake in simptome.
EU/1/18/1265/015 (14 film-coated tablets) EU/1/18/1265/016 (28 film-coated tablets) EU/1/18/1265/017 (30x1 film-coated tablets) EU/1/18/1265/018 (56 film-coated tablets) EU/1/18/1265/019 (60 film-coated tablets) EU/1/18/1265/020 (168 film-coated tablets) EU/1/18/1265/021 (180 film-coated tablets) EU/1/18/1265/031 (196 (4 x 49) film-coated tablets) 
EU/1/18/1265/015 (14 filmsko obloženih tablet) EU/1/18/1265/016 (28 filmsko obloženih tablet) EU/1/18/1265/017 (30 x 1 filmsko obložena tableta) EU/1/18/1265/018 (56 filmsko obloženih tablet) EU/1/18/1265/019 (60 filmsko obloženih tablet) EU/1/18/1265/020 (168 filmsko obloženih tablet) EU/1/18/1265/021 (180 filmsko obloženih tablet) EU/1/18/1265/031 (196 (4 x 49) filmsko obloženih tablet)
EU/1/18/1265/001 (14 film-coated tablets) EU/1/18/1265/002 (28 film-coated tablets) EU/1/18/1265/003 (30x1 film-coated tablets) EU/1/18/1265/004 (56 film-coated tablets) EU/1/18/1265/005 (60 film-coated tablets) EU/1/18/1265/006 (168 film-coated tablets) EU/1/18/1265/007 (180 film-coated tablets) EU/1/18/1265/029 (196 (4 x 49) film-coated tablets) 
EU/1/18/1265/001 (14 filmsko obloženih tablet) EU/1/18/1265/002 (28 filmsko obloženih tablet) EU/1/18/1265/003 (30 x 1 filmsko obložena tableta) EU/1/18/1265/004 (56 filmsko obloženih tablet) EU/1/18/1265/005 (60 filmsko obloženih tablet) EU/1/18/1265/006 (168 filmsko obloženih tablet) EU/1/18/1265/007 (180 filmsko obloženih tablet) EU/1/18/1265/029 (196 (4 x 49) filmsko obloženih tablet)
How to store Segluromet 
Shranjevanje zdravila Segluromet
o Each Segluromet 7.5 mg/1,000 mg film-coated tablet contains 7.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride. 
o Ena filmsko obložena tableta (tableta) zdravila Segluromet 7,5 mg/1.000 mg vsebuje 7,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 1.000 mg metforminijevega klorida.
OUTER CARTON FOR SEGLUROMET 2.5 mg/850 mg 
ZUNANJA ŠKATLA ZA ZDRAVILO SEGLUROMET 2,5 mg/850 mg
General disorders and administration site conditions Common 
Splošne težave in spremembe na mestu aplikacije pogosti žeja
OUTER CARTON FOR SEGLUROMET 7.5 mg/850 mg 
ZUNANJA ŠKATLA ZA ZDRAVILO SEGLUROMET 7,5 mg/850 mg
o Each Segluromet 2.5 mg/1,000 mg film-coated tablet contains 2.5 mg ertugliflozin (as ertugliflozin L-pyroglutamic acid) and 1,000 mg of metformin hydrochloride. 
o Ena filmsko obložena tableta (tableta) zdravila Segluromet 2,5 mg/1.000 mg vsebuje 2,5 mg ertugliflozina (v obliki ertugliflozin L-piroglutaminske kisline) in 1.000 mg metforminijevega klorida.
OUTER CARTON FOR SEGLUROMET 2.5 mg/1000 mg 
ZUNANJA ŠKATLA ZA ZDRAVILO SEGLUROMET 2,5 mg/1.000 mg
Genital mycotic infections 
Glivične okužbe spolovil
OUTER CARTON FOR SEGLUROMET 7.5 mg/1000 mg 
ZUNANJA ŠKATLA ZA ZDRAVILO SEGLUROMET 7,5 mg/1.000 mg
N = 248 N = 247 
n = 248
• feeling sick (nausea) 
• občutek slabosti (siljenje na bruhanje),
Dark brown, 18 x 10 mm oval, film-coated tablet debossed with “7.5/850” on one side and plain on the other side. 
Segluromet 7,5 mg/850 mg filmsko obložene tablete temno rjava, ovalna, filmsko obložena tableta, velikosti 18 x 10 mm, na eni strani z vtisnjeno oznako "7.5/850" in brez oznake na drugi strani
Red, 19.1 x 10.6 mm oval, film-coated tablet debossed with “7.5/1000” on one side and plain on the other side. 
Segluromet 7,5 mg/1.000 mg filmsko obložene tablete rdeča, ovalna, filmsko obložena tableta, velikosti 19,1 x 10,6 mm, na eni strani z vtisnjeno oznako "7.5/1000" in brez oznake na drugi strani
• dry mouth 
• srbenje nožnice,
You should not use Segluromet if you are breast-feeding. 
Če dojite, ne uporabljajte zdravila Segluromet.
Pink, 19.1 x 10.6 mm oval, film-coated tablet debossed with “2.5/1000” on one side and plain on the other side. 
Segluromet 2,5 mg/1.000 mg filmsko obložene tablete rožnata, ovalna, filmsko obložena tableta, velikosti 19,1 x 10,6 mm, na eni strani z vtisnjeno oznako "2.5/1000" in brez oznake na drugi strani
Segluromet 
Odmerjanje
The European Commission granted a marketing authorisation valid throughout the European Union for Epivir on 8 August 1996. 
Evropska komisija je dovoljenje za promet z zdravilom Epivir, veljavno po vsej Evropski uniji, izdala 8. avgusta 1996.
The study measured how long the patients lived without their disease getting worse. 
V njej so opazovali, kako dolgo so bolniki živeli, ne da bi se bolezen poslabšala.
The combination also reduced viral loads in all studies after two to four weeks of treatment, but this effect was temporary. 
Kombinacija je v vseh študijah po dveh do štirih tednih zdravljenja zmanjšala tudi virusno obremenitev, vendar pa je bil ta učinek le začasen.
The full EPAR for Epivir can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Epivir je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Similar results were seen in HIV-infected patients aged under 15 years. 
Podobni rezultati so bili opaženi pri bolnikih, mlajših od 15 let.
It is available as tablets (150 and 300 mg) and as an oral solution (10 mg/ml). 
Na voljo je v obliki tablet (150 in 300 mg) in peroralne raztopine (10 mg/ml).
The recommended dose of Epivir for adults and children weighing at least 25 kg is 300 mg a day. 
Priporočeni odmerek zdravila Epivir za odrasle in otroke, ki tehtajo vsaj 25 kg, je 300 mg na dan.
What measures are being taken to ensure the safe and effective use of Epivir? 
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Epivir?
This can be taken either as a single daily dose or divided into 150 mg twice a day. 
Ta odmerek se lahko vzame naenkrat ali razdeli na dva 150-miligramska odmerka dvakrat na dan.
This document is a summary of the European Public Assessment Report (EPAR) for Epivir. 
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Epivir.
Epivir has also been studied in 615 patients aged between nine months and 15 years. 
Zdravilo Epivir so proučevali tudi pri 615 bolnikih, starih od devet mesecev do 15 let.
Other information about Epivir 
Druge informacije o zdravilu Epivir
A risk management plan has been developed to ensure that Epivir is used as safely as possible. 
Za zagotovitev čim varnejše uporabe zdravila Epivir je bil pripravljen načrt obvladovanja tveganj.
This study looked at how many patients had developed an illness associated with AIDS or had died after a year's treatment. 
V tej študiji so proučevali, pri koliko bolnikih se je razvila bolezen, povezana z aidsom, ali koliko jih je umrlo po enoletnem zdravljenju.
The CHMP decided that Epivir's benefits are greater than its risks and recommended that it be given marketing authorisation. 
CHMP je zaključil, da so koristi zdravila Epivir večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
In the fifth adult study, adding Epivir to existing treatment reduced the risk of disease progression or death: after a year, 9% of the patients taking Epivir had developed an AIDS-related illness or died (128 out of 1,369), compared with 20% of those taking placebo (95 out of 471). 
V peti študiji pri odraslih je dodajanje zdravila Epivir obstoječemu zdravljenju zmanjšalo tveganje poslabšanja bolezni ali smrti: po enem letu se je pri 9 % bolnikov, ki so jemali zdravilo Epivir, razvila bolezen, povezana z aidsom, ali pa so ti umrli (128 od 1 369), v primerjavi z 20 % tistih, ki so jemali placebo (95 od 471).
In children weighing less than 25 kg the recommended dose depends on their weight. 
Pri otrocih, ki tehtajo manj kot 25 kg, je priporočeni odmerek odvisen od telesne mase.
All of the studies found that combinations including Epivir were more effective than the comparator medicines. 
V vseh študijah so ugotovili, da so bile kombinacije z zdravilom Epivir učinkovitejše od primerjalnih zdravil.
Epivir has been studied in five main studies involving almost 3,000 adults (aged 18 years or over). 
Zdravilo Epivir so proučevali v petih glavnih študijah, v katere je bilo vključenih skoraj 3 000 odraslih (starejših od 18 let).
For more information about treatment with Epivir, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. 
Za več informacij o zdravljenju z zdravilom Epivir preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
The most common side effects with Epivir (seen in between 1 and 10 patients in 100) are diarrhoea, nausea (feeling sick), vomiting, headache, insomnia (difficulty sleeping), cough, nasal symptoms, rash, muscle disorders, arthralgia (joint pain), alopecia (hair loss), fever, abdominal pain (stomach ache) or cramps, malaise (feeling unwell) and fatigue (tiredness). 
Najpogostejši neželeni učinki zdravila Epivir (opaženi pri 1 do 10 bolnikih izmed 100) so driska, slabost, bruhanje, glavobol, nespečnost (težave s spanjem), kašelj, nazalni simptomi, izpuščaji, mišična obolenja, artralgija (bolečine v sklepih), alopecija (izpadanje las), povišana telesna temperatura, bolečine ali krči v trebuhu, neugodje (slabo počutje) in utrujenost.
Epivir, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level. 
Zdravilo Epivir, uporabljeno v kombinaciji z drugimi protivirusnimi zdravili, zmanjša količino virusa HIV v krvi in jo ohranja na nizki ravni.
CD4 T-cells are white blood cells that are important in helping to fight infections, but which are killed by HIV. 
T-celice CD4 so bele krvničke, ki so pomembne za obrambo pred okužbami, vendar pa jih virus HIV uničuje.
Treatment with Epivir should be started by a doctor who has experience in the management of HIV infection. 
Zdravljenje z zdravilom Epivir mora uvesti zdravnik, ki ima izkušnje z zdravljenjem okužb z virusom HIV.
Patients who cannot swallow tablets should use the oral solution, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it. 
Bolniki, ki ne morejo pogoltniti celih tablet, naj uporabijo peroralno raztopino ali pa naj tablete zdrobijo in jih tik pred zaužitjem zmešajo z majhno količino hrane ali pijače.
Epivir is a medicine containing the active substance lamivudine. 
Epivir je zdravilo, ki vsebuje zdravilno učinkovino lamivudin.
The studies examined the effects of Epivir on the levels of HIV in the blood (viral load) and the number of CD4 T-cells in the blood (CD4 cell count). 
V študijah so proučevali učinke zdravila Epivir na ravni virusa HIV v krvi (virusno obremenitev) in število T-celic CD4 v krvi (število celic CD4).
What benefit has Epivir shown during the studies? 
Kakšne koristi je zdravilo Epivir izkazalo med študijami?
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Epivir. 
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Epivir, including the appropriate precautions to be followed by healthcare professionals and patients. 
V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
Epivir is used in combination with other antiviral medicines to treat patients infected with human immunodeficiency virus (HIV), the virus that causes acquired immune deficiency syndrome (AIDS). 
Zdravilo Epivir se uporablja v kombinaciji z drugimi protivirusnimi zdravili za zdravljenje bolnikov, ki so okuženi z virusom humane imunske pomanjkljivosti (HIV), tj. virusom, ki povzroča sindrom pridobljene imunske pomanjkljivosti (aids).
The fifth study compared the effects of adding Epivir or placebo (a dummy treatment) to existing treatment for HIV infection in 1,895 adults who had been taking antiviral medicines for at least four weeks. 
V peti študiji so primerjali učinke dodajanja zdravila Epivir ali placeba (zdravila brez zdravilne učinkovine) obstoječemu zdravljenju okužbe z virusom HIV pri 1 895 odraslih, ki so vsaj štiri tedne jemali protivirusna zdravila.
For the full list of all side effects and restrictions with Epivir, see the package leaflet. 
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Epivir glejte navodilo za uporabo.
It does not cure HIV infection or AIDS, but it can hold off damage to the immune system and avoid the development of infections and diseases associated with AIDS. 
Zdravilo Epivir ne ozdravi okužbe z virusom HIV ali aidsa, vendar pa lahko upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
What is the risk associated with Epivir? 
Kakšna tveganja so povezana z zdravilom Epivir?
Four of these studies compared Epivir in combination with zidovudine (another antiviral medicine) to either Epivir or zidovudine alone, or to the combination of Epivir and zalcitabine (another antiviral medicine). 
V štirih od teh študij so zdravilo Epivir v kombinaciji z zidovudinom (drugim protivirusnim zdravilom) primerjali bodisi samo z zdravilom Epivir ali samo z zidovudinom oziroma s kombinacijo zdravila Epivir in zalcitabina (drugega protivirusnega zdravila).
The oral solution can be used to achieve the appropriate dose. 
Ustrezen odmerek se lahko doseže z uporabo peroralne raztopine.
In the first four studies in adults, Epivir, taken in combination with zidovudine, increased CD4 cell counts more than the comparator medicines after 24 weeks of treatment. 
V prvih štirih študijah z odraslimi je po 24 tednih zdravljenja zdravilo Epivir, dajano v kombinaciji z zidovudinom, bolj povečalo število celic CD4 kot primerjalna zdravila.
Why has Epivir been approved? 
Zakaj je bilo zdravilo Epivir odobreno?
The study compared the effects of Epivir taken with zidovudine to didanosine (another antiviral medicine) taken alone. 
V študiji so učinke zdravila Epivir, uporabljenega v kombinaciji z zidovudinom, primerjali z didanozinom (drugim protivirusnim zdravilom), vzetim samostojno.
The active substance in Epivir, lamivudine, is a nucleoside reverse transcriptase inhibitor (NRTI).It works by blocking the activity of reverse transcriptase, an enzyme needed by HIV to produce the genetic instructions for making more viruses once it has infected the cell. 
Deluje tako, da zavira delovanje reverzne transkriptaze, tj. encima, ki ga virus HIV potrebuje za izdelavo genskih navodil za tvorbo še več virusov, potem ko je okužil celico.
What is Epivir used for? 
Za kaj se zdravilo Epivir uporablja?
How has Epivir been studied? 
Kako je bilo zdravilo Epivir raziskano?
How is Epivir used? 
Kako se zdravilo Epivir uporablja?
What is Epivir? 
Kaj je zdravilo Epivir?
The dose of Epivir needs to be adjusted in patients who have severe kidney problems. 
Pri bolnikih, ki imajo resne težave z ledvicami, je treba odmerek zdravila Epivir prilagoditi.
How does Epivir work? 
Kako zdravilo Epivir deluje?
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. 470/2009.
Annual. 
Letno.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of the first authorisation: 17/12/2010 
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Datum pridobitve dovoljenja za promet: 17/12/2010
a) the administration of the product to animals will interfere with the implementation of a national programme for the diagnosis, control or 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 ovirala izvajanje nacionalnega programa za diagnozo, nadzor ali zatiranje živalskih bolezni ali da bi povzročila težave pri zagotavljanju odsotnosti okuženosti pri živih živalih ali živilih ali drugih proizvodih, pridobljenih iz zdravljenih živali.
(**) Haemolytic units For the full list of excipients, see section 6.1. 
(**) Hemolizne enote Za celoten seznam pomožnih snovi, glejte poglavje 6.1.
Detailed information on this product is available on the website of the European Medicines Agency http://www.ema.europa.eu/. 
Podrobne informacije o tem zdravilu za uporabo v veterinarski medicini so na voljo na spletni strani Evropske agencije za zdravila http://www.ema.europa.eu/.
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 zdravila za uporabo v veterinarski medicini je dovoljena samo pod posebnimi pogoji, ki jih za nadzor nad boleznijo modrega jezika predpisuje zakonodaja Evropske skupnosti.
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ United Kingdom 
MERIAL Animal Health Limited Biological Laboratory, Ash Road, Pirbright, Woking, Surrey GU24 0NQ Združeno Kraljestvo
- Second injection: after 3-4 weeks 
- Drugi odmerek: po 3-4 tednih
The duration of immunity for cattle and sheep is 1 year after the primary vaccination course. 
Trajanje imunosti pri ovcah in govedu je 1 leto po osnovnem cepljenju.
b) the disease to which the product is intended to confer immunity is largely absent from the territory in question. 
b) bolezen, za katero se pridobi imunost, na območju skoraj ni prisotna.
Onset of immunity has been demonstrated 3 weeks after the primary vaccination course. 
Imunost nastopi 3 tedne po osnovnem cepljenju.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary Very rare and transient apathy can be observed after the administration of a double-dose of the vaccine. 
4.10 Preveliko odmerjanje (simptomi, nujni ukrepi, protistrupi) (če je potrebno) Zelo redko se lahko po dajanju dvakratnega odmerka cepiva pojavi prehodna apatija.
Incompatibilities: Do not mix with any other veterinary medicinal product. 
Inkompatibilnosti: Ne mešajte z drugimi zdravili za uporabo v veterinarski medicini.
Pharmacotherapeutic group: bluetongue virus vaccine, ATCvet code QI04AA02 (sheep) and QI02AA08 (cattle). 
Farmakoterapevtska skupina: cepivo proti virusu bolezni modrikastega jezika; Oznaka ATC vet QI04AA02 (ovce) in QI02AA08 (govedo).
PHARMACEUTICAL FORM Homogeneous milky white suspension for injection. 
FARMACEVTSKA OBLIKA Homogena mlečno bela suspenzija za injiciranje.
50 doses (50 ml) 
50 odmerkov (50 ml)
No other adverse reactions except those mentioned in section ‘Adverse Reactions' were observed. 
Drugi neželeni učinki, razen tistih, ki so navedeni v ‘Neželeni učinki', niso bili opaženi.
Date of the last renewal: 
Datum zadnjega podaljšanja dovoljenja za promet:
TARGET SPECIES Sheep and cattle 
CILJNE ŽIVALSKE VRSTE Ovce in govedo