FrancophonIA/ELRC3.0 huggingface dataset:
English: A total of 697 patients were randomized in a 2:1 ratio to either irbesartan/hydrochlorothiazide 150 mg/12.5 mg or to irbesartan 150 mg and systematically force titrated (before assessing the response to the lower dose) after one week to irbesartan/hydrochlorothiazide 300 mg/25 mg or irbesartan 300 mg, respectively.
Slovenian: Skupaj je bilo randomiziranih 697 bolnikov v razmerju 2: 1, bodisi na kombinacijo 150 mg irbesartana in 12,5 mg hidroklorotiazida bodisi na 150 mg irbesartana.
English: Ifirmacombi has been rarely associated with symptomatic hypotension in hypertensive patients without other risk factors for hypotension.
Slovenian: Simptomatska hipotenzija je pri bolnikih z zvišanim krvnim tlakom, ki jemljejo zdravilo Ifirmacombi, nimajo pa drugih dejavnikov tveganja za hipotenzijo, redka.
English: Given their similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers.
Slovenian: Ti izsledki so pomembni tudi za druge zaviralce ACE in antagoniste receptorjev angiotenzina II, ker so njihove farmakodinamične lastnosti podobne.
English: Additional information on individual components: in addition to the adverse reactions listed above for the combination product, other adverse reactions previously reported with one of the individual components may be potential adverse reactions with Ifirmacombi.
Slovenian: Poleg naštetih neželenih učinkov, ki se lahko pojavijo med uporabo kombiniranega zdravila, se med jemanjem zdravila Ifirmacombi utegnejo pojaviti tudi neželeni učinki, o katerih so poročali pri jemanju posamezne učinkovine.
English: While this is not documented with Ifirmacombi, a similar effect should be anticipated.
Slovenian: Podoben učinek bi lahko pričakovali pri zdravljenju z zdravilom Ifirmacombi, vendar to ni bilo dokazano.
English: The combination of 300 mg irbesartan and 12.5 mg hydrochlorothiazide resulted in an overall placebo-subtracted systolic/diastolic reductions of up to 13.6/11.5 mmHg.
Slovenian: Med kombiniranim zdravljenjem s 300 mg irbesartana in 12,5 mg hidroklorotiazida se je sistolični krvni tlak znižal za 13,6 mm Hg, diastolični pa za 11,5 mm Hg bolj kot po uporabi placeba.
English: The two active ingredients in Ifirmacombi work together to lower blood pressure further than if either was given alone.
Slovenian: Učinkovini v zdravilu Ifirmacombi znižujeta krvni tlak, in to še bolj, kot če bi jemali vsako učinkovino posebej.
English: Side effects associated with irbesartan alone
Slovenian: Po peroralni ali intravenski uporabi irbesartana
English: Do not take Ifirmacombi - if you are allergic to irbesartan or any of the other ingredients of this medicine (listed in section 6) - if you are allergic to hydrochlorothiazide or any other sulfonamide-derived medicines - if you are more than 3 months pregnant.
Slovenian: Ne jemljite zdravila Ifirmacombi - če ste alergični na irbesartan ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če ste alergični na hidroklorotiazid ali druga zdravila, ki vsebujejo sulfonamidne derivate; - če ste noseči dlje kot tri mesece (jemanju zdravila Ifirmacombi se je bolje izogniti tudi med zgodnjo nosečnostjo - glejte poglavje o nosečnosti); - če imate hudo jetrno ali ledvično okvaro; - če imate težave z odvajanjem seča; - če je zdravnik ugotovil, da imate stalno povečano koncentracijo kalcija ali zmanjšano koncentracijo kalija v krvi; - če imate sladkorno bolezen ali okvarjeno delovanje ledvic in se zdravite z zdravilom za znižanje krvnega tlaka, ki vsebuje aliskiren.
English: Calcium salts: thiazide diuretics may increase serum calcium levels due to decreased excretion.
Slovenian: Tiazidni diuretiki lahko zmanjšajo izločanje kalcija in tako povečajo njegovo serumsko koncentracijo.
English: Uncommon: flushing
Slovenian: Občasni: zardevanje
English: Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 25 mg hidroklorotiazida.
English: Ifirmacombi 300 mg/25 mg Pale pink, biconvex, capsule shaped, film-coated tablets (tablets).
Slovenian: Ifirmacombi 300 mg/25 mg Bledo roza, izbočene, filmsko obložene tablete (tablete) v obliki kapsule.
English: Ifirmacombi 300 mg/12.5 mg White, biconvex, capsule shaped, film-coated tablets (tablets).
Slovenian: Ifirmacombi 300 mg/12,5 mg Bele, izbočene, filmsko obložene tablete (tablete) v obliki kapsule.
English: Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 150 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Each film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Slovenian: Ifirmacombi 150 mg/12,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 150 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
English: Ifirmacombi 300 mg/25 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Slovenian: Ifirmacombi 300 mg/25 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 25 mg hidroklorotiazida.
English: In diabetic patients dosage adjustments of insulin or oral hypoglycemic agents may be required.
Slovenian: Bolnikom s sladkorno boleznijo je treba po potrebi prilagoditi odmerek inzulina ali peroralnih antidiabetičnih zdravil.
English: Each Ifirmacombi 150 mg/12.5 mg film-coated tablet contains 150 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Slovenian: Ena Ifirmacombi 150 mg/12,5 mg filmsko obložena tableta vsebuje 150 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
English: Each Ifirmacombi 300 mg/25 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 25 mg hydrochlorothiazide.
Slovenian: Ena Ifirmacombi 300 mg/25 mg filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 25 mg hidroklorotiazida.
English: Hepatic impairment:
Slovenian: Ledvična okvara:
English: Ifirmacombi 300 mg/25 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Slovenian: Ifirmacombi 300 mg/25 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Anti-doping test:
Slovenian: Zdravila za zdravljenje protina:
English: Ifirmacombi 150 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Slovenian: Ifirmacombi 150 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: Following oral or intravenous administration of
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN
English: Ifirmacombi 300 mg/12.5 mg tablets Irbesartan/Hydrochlorothiazide
Slovenian: Ifirmacombi 300 mg/12,5 mg tablete irbesartan/hidroklorotiazid
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Slovenian: Ifirmacombi 300 mg/12,5 mg filmsko obložene tablete Ena filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
English: Each film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
English: Each Ifirmacombi 300 mg/12.5 mg film-coated tablet contains 300 mg irbesartan (as irbesartan hydrochloride) and 12.5 mg hydrochlorothiazide.
Slovenian: Ena Ifirmacombi 300 mg/12,5 mg filmsko obložena tableta vsebuje 300 mg irbesartana (v obliki irbesartanijevega klorida) in 12,5 mg hidroklorotiazida.
English: Ifirmacombi 150 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Slovenian: Ifirmacombi 150 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Ifirmacombi 300 mg/12.5 mg film-coated tablets Irbesartan/Hydrochlorothiazide
Slovenian: Ifirmacombi 300 mg/12,5 mg filmsko obložene tablete irbesartan/hidroklorotiazid
English: Lithium:
Slovenian: EXP:
English: Renal artery stenosis - Renovascular hypertension:
Slovenian: Holestiramin in holestipol:
English: - Ifirmacombi 150 mg/12.5 mg may be administered in patients whose blood pressure is not adequately controlled with hydrochlorothiazide or irbesartan 150 mg alone; - Ifirmacombi 300 mg/12.5 mg may be administered in patients insufficiently controlled by irbesartan 300 mg or by Ifirmacombi 150 mg/12.5 mg. - Ifirmacombi 300 mg/25 mg may be administered in patients insufficiently controlled by Ifirmacombi 300 mg/12.5 mg.
Slovenian: - Zdravilo Ifirmacombi 300 mg/12,5 mg je namenjeno bolnikom, pri katerih se krvni tlak med zdravljenjem s 300 mg irbesartana ali z zdravilom Ifirmacombi 150 mg/12,5 mg ni dovolj znižal.
English: No dosage adjustment of Ifirmacombi is necessary in older people.
Slovenian: Starostniki Pri starostnikih odmerka zdravila Ifirmacombi ni treba prilagajati.
English: Colestyramine and Colestipol resins: absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Slovenian: Absorpcija hidroklorotiazida je zaradi anionskih izmenjevalnih smol motena.
English: Pregnancy:
Slovenian: Jetrna okvara:
English: Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function.
Slovenian: Pri bolnikih z okvarjenim ledvičnim delovanjem se lahko zaradi jemanja tiazidnih diuretikov pojavi azotemija.
English: What Ifirmacombi looks like and contents of the pack
Slovenian: Shranjevanje zdravila Ifirmacombi Vsebina pakiranja in dodatne informacije
English: Antigout medicinal products: dosage adjustments of antigout medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Slovenian: Hidroklorotiazid lahko poveča serumsko koncentracijo sečne kisline, zato je treba v takem primeru odmerek zdravil za zdravljenje protina prilagoditi.
English: Titanium dioxide (E171) Macrogol
Slovenian: Ifirmacombi 300 mg/12,5 mg Filmska obloga: polivinilalkohol titanov dioksid (E171) makrogol smukec
English: These lesions were not observed in macaques; - decreases in serum potassium due to hydrochlorothiazide and partly prevented when hydrochlorothiazide was given in combination with irbesartan.
Slovenian: 10 mg/kg/dan), so opazili spremembo barve želodca, razjede in fokalno nekrozo želodčne sluznice; teh lezij pri opicah ni bilo; - znižanje kalija v serumu med uporabo hidroklorotiazida, ki je bilo med kombiniranim dajanjem z irbesartanom manj izrazito.
English: These should be monitored every six months.
Slovenian: Bolnike je treba opazovati vsakih šest mesecev.
English: It is used in patients with:
Slovenian: Uporablja se pri bolnikih s:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Hepsera on 6 March 2003.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Hepsera, veljavno po vsej Evropski uniji, odobrila dne 6. marca 2003.
English: The full EPAR for Hepsera can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Hepsera je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: • decompensated liver disease (when the liver is damaged and does not function normally.
Slovenian: • dekompenzirano boleznijo jeter (jetra so poškodovana in ne delujejo normalno).
English: This is a summary of the European public assessment report (EPAR) for Hepsera.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Hepsera.
English: Other information about Hepsera
Slovenian: Druge informacije o zdravilu Hepsera
English: Hepsera adefovir dipivoxil
Slovenian: Hepsera dipivoksiladefovirat
English: Adefovir stops the virus making DNA and prevents it from multiplying and spreading.
Slovenian: Adefovir zaustavi tvorbo DNK v virusu in tako prepreči njegovo razmnoževanje in širjenje.
English: The first study included 511 patients who were ‘HBeAg positive' (infected with the common type of the hepatitis B virus) and the second included 184 patients who were ‘HBeAg negative' (infected with a virus that has mutated [changed], leading to a form of chronic hepatitis B that is more difficult to treat).
Slovenian: Prva študija je vključevala 511 bolnikov, ki so bili „HBeAg pozitivni“ (okuženi z običajno vrsto virusa hepatitisa B), druga pa 184 bolnikov, ki so bili „HBeAg negativni“ (okuženi z virusom, ki je mutiral [se spremenil], kar je privedlo do kroničnega hepatitisa B, ki ga je težje zdraviti).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that Hepsera's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Hepsera večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
English: Patients who have problems with their kidneys should take Hepsera less frequently.
Slovenian: Bolniki, ki imajo težave z ledvicami, morajo zdravilo Hepsera jemati manj pogosto.
English: What benefit has Hepsera shown during the studies?
Slovenian: Kakšne koristi je zdravilo Hepsera izkazalo med študijami?
English: Among those who took Hepsera, 53% of the HBeAg-positive and 64% of the HBeAg-negative patients had an improvement in liver damage as assessed in a biopsy, compared with 25% and 33%, respectively, in the patients who took placebo.
Slovenian: Med bolniki, ki so jemali zdravilo Hepsera, so pri 53 % HBeAg pozitivnih in 64 % HBeAg negativnih bolnikih pri biopsiji opazili izboljšanje stanja poškodb jeter, v primerjavi s 25 % HBeAg pozitivnimi in 33 % HBeAg negativnimi bolniki, ki so prejemali placebo.
English: • compensated liver disease (when the liver is damaged but functions normally), who also show signs that the virus is still multiplying, and have signs of liver damage (raised levels of the liver enzyme ‘alanine aminotransferase' [ALT] and signs of damage when liver tissue is examined under a microscope).
Slovenian: • kompenzirano boleznijo jeter (jetra so poškodovana, a delujejo normalno) pri bolnikih, ki kažejo tudi znake še vedno potekajočega razmnoževanja virusa in znake poškodb jeter (povišane ravni jetrnega encima „alanin-aminotransferaze“ [ALT] in znake poškodb, ki so vidni pod mikroskopom).
English: For more information about treatment with Hepsera, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Hepsera preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Hepsera has been studied in two main studies, in which it was compared with placebo (a dummy treatment).
Slovenian: Zdravilo Hepsera so proučevali v dveh glavnih študijah, v katerih so ga primerjali s placebom (zdravilom brez zdravilne učinkovine).
English: Because the hepatitis B virus can become resistant to Hepsera, the doctor should only consider prescribing Hepsera if other treatments that are less likely to lead to resistance cannot be used;
Slovenian: Ker lahko virus hepatitisa B postane odporen na zdravilo Hepsera, naj ga zdravnik predpiše le, če drugih zdravil, pri katerih je razvoj odpornosti manj verjeten, ni mogoče uporabiti;
English: In both studies, the effectiveness was measured by looking at how the liver damage had evolved after 48 weeks of treatment using a liver biopsy (when a sample of liver tissue is taken and examined under a microscope).
Slovenian: V obeh študijah so učinkovitost zdravila ocenjevali z opazovanjem napredovanja poškodb jeter po 48 tednih zdravljenja, kar so dosegli s pomočjo biopsije jeter (odvzeti vzorec jeter se pregleda pod mikroskopom).
English: Hepsera is used to treat adults with chronic (long-term) hepatitis B (a disease of the liver due to infection with the hepatitis B virus).
Slovenian: Zdravilo Hepsera se uporablja za zdravljenje odraslih s kroničnim (dolgotrajnim) hepatitisom B (boleznijo jeter zaradi okužbe z virusom hepatitisa B).
English: 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 Hepsera.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Hepsera, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
English: Adefovir is an antiviral belonging to the class ‘nucleoside analogues'.
Slovenian: Adefovir je protivirusno sredstvo, ki spada v razred „analogov nuklezoidov“.
English: What is the risk associated with Hepsera?
Slovenian: Kakšna tveganja so povezana z zdravilom Hepsera?
English: To reduce the risk of resistance, Hepsera must be used in combination with another anti-hepatitis B medicine that does not cause resistance in the same way as Hepsera.
Slovenian: Za zmanjšanje tveganja za razvoj odpornosti se mora zdravilo Hepsera uporabljati skupaj z drugim zdravilom proti hepatitisu B, ki ne povzroča takšnega razvoja odpornosti kot zdravilo Hepsera.
English: The most common side effects with Hepsera (seen in more than 1 patient in 10) are raised creatinine (a marker of kidney problems) and asthenia (weakness).
Slovenian: Najpogostejša neželena učinka zdravila Hepsera (opažena pri več kot 1 bolniku od 10) sta zvišana raven kreatinina (označevalca težav z jetri) in astenija (šibkost).
English: Hepsera was more effective than placebo in slowing down the progression of liver disease.
Slovenian: Zdravilo Hepsera je bilo pri upočasnitvi napredovanja bolezni jeter učinkovitejše od placeba.
English: For the full list of all side effects reported with Hepsera, see the package leaflet.
Slovenian: Za celoten seznam neželenih učinkov, o katerih so poročali pri uporabi zdravila Hepsera, glejte navodilo za uporabo.
English: Why has Hepsera been approved?
Slovenian: Zakaj je bilo zdravilo Hepsera odobreno?
English: Hepsera must not be used in people who are hypersensitive (allergic) to adefovir dipivoxil or any of the other ingredients.
Slovenian: Zdravila Hepsera ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) dipivoksiladefovirat ali katero koli drugo sestavino zdravila.
English: Adefovir interferes with the action of a viral enzyme called DNA polymerase, which is involved in the formation of viral DNA.
Slovenian: Adefovir ovira delovanje virusnega encima DNK-polimeraza, ki je udeležen pri tvorbi virusne DNK.
English: The active substance in Hepsera, adefovir dipivoxil, is a ‘prodrug' that is converted into adefovir in the body.
Slovenian: Zdravilna učinkovina v zdravilu Hepsera, dipivoksiladefovirat, je predzdravilo, ki se v telesu pretvori v adefovir.
English: Treatment with Hepsera should be started by a doctor who has experience in the management of chronic hepatitis B. The recommended dose is 10 mg once a day.
Slovenian: Zdravljenje z zdravilom Hepsera mora uvesti zdravnik, ki ima izkušnje z zdravljenjem kroničnega hepatitisa B. Priporočeni odmerek je ena 10-miligramska tableta enkrat na dan. Trajanje zdravljenja je odvisno od bolnikovega stanja in odziva na zdravljenje.
English: Hepsera is a medicine that contains the active substance adefovir dipivoxil.
Slovenian: Hepsera je zdravilo, ki vsebuje zdravilno učinkovino dipivoksiladefovirat.
English: What is Hepsera?
Slovenian: Kaj je zdravilo Hepsera?
English: How has Hepsera been studied?
Slovenian: Kako je bilo zdravilo Hepsera raziskano?
English: What is Hepsera used for?
Slovenian: Za kaj se zdravilo Hepsera uporablja?
English: How is Hepsera used?
Slovenian: Kako se zdravilo Hepsera uporablja?
English: How does Hepsera work?
Slovenian: Kako zdravilo Hepsera deluje?
English: Hepsera is not recommended for use in patients with severe kidney disease or who are on dialysis (a blood clearing technique) - its use should only be considered in these patients if its potential benefits are greater than its potential risks.
Slovenian: Uporaba zdravila Hepsera ni priporočljiva pri bolnikih s hudim obolenjem ledvic ali tistih, ki so na dializi (tehniki čiščenja krvi).
English: This procedure started on 21 August 2006 and ended on 20 October 2006.
Slovenian: Ta postopek se je začel dne 21. avgusta 2006 in končal dne 20. oktobra 2006.
English: In conclusion, CVMP is of the opinion that:
Slovenian: Mnenje odbora CVMP v zaključku je:
English: (Immunisation schedules are given in the product information.)
Slovenian: (Sheme za imunizacijo so podane v informacijah o zdravilu.)
English: Cattle Intramuscular injection.
Slovenian: Govedo Intramuskularna injekcija.
English: One dose = 2 ml
Slovenian: En odmerek = 2 ml
English: 7.e.13 Hungary
Slovenian: 7.e.13 Madžarska
English: The procedure started on 13 March
Slovenian: Postopek se je začel dne 13. marca 2006.
English: Per 2 ml dose:
Slovenian: Na 2 ml odmerka:
English: On the contrary it is known that extremely high numbers of samples must be tested in order to detect a low level of defects.
Slovenian: Na drugi strani je znano, da je treba testirati izjemno veliko število vzorcev, da bi lahko zaznali majhno število okvar.
English: The first renewal procedure for the vaccine was finalised in June 2004.
Slovenian: Prvi postopek za podaljšanje dovoljenja za cepivo se je končal junija leta 2004.
English: In March 2006 Intervet then submitted an application for a marketing authorisation for this vaccine following a repeat use mutual recognition procedure, with Germany acting as Reference Member State, for Denmark, Poland, Slovakia and Slovenia.
Slovenian: Podjetje Intervet je nato marca leta 2006 vložilo prošnjo za dovoljenje za promet s tem cepivom in ponovno uporabilo postopek medsebojnega priznavanja, pri čemer je Nemčija bila referenčna država članica za Dansko, Poljsko, Slovaško in Slovenijo.
English: It is worthy of note that the first EU marketing authorisation for Bovilis BVD was granted in 1998, and the vaccine is currently authorised in 14 EU Member States.
Slovenian: Vredno je omeniti, da je bilo prvo dovoljenje za promet z zdravilom Bovilis BVD v EU odobreno leta 1998, cepivo pa je trenutno odobreno v 14 državah članicah EU.
English: DK-2740 Skovlunde Denmark
Slovenian: DK-2740 Skovlunde Danska
English: The initial mutual recognition procedure was finalised on 24 June 1999, and 11 other Member States authorised the product at this time.
Slovenian: Začetni postopek medsebojnega priznavanja se je končal dne 24. junija 1999, zdravilo pa je takrat odobrilo 11 drugih držav članic.
English: The factors which determine the safety of a product are the measures applied in the production and control procedures.
Slovenian: Faktorji, ki določajo varnost proizvoda, so merila, ki jih je treba upoštevati pri proizvodnji in nadzornih postopkih.
English: There is always a small risk of extraneous agent contamination from a variety of sources.
Slovenian: Vedno pa obstaja majhna stopnja tveganja kontaminacije s tujimi snovmi iz velikega števila virov.
English: CY-1665 Nicosia Cyprus
Slovenian: CY-1665 Nicosia Ciper
English: The production and testing of Bovilis BVD vaccine are in accordance with the relevant requirements of Directive 2001/82/EC, the relevant EU guidelines and the relevant monographs of the Ph.Eur.
Slovenian: Postopek proizvodnje in testiranje cepiva Bovilis BVD sta v skladu z ustreznimi zahtevami Direktive 2001/82/ES, ustreznimi smernicami EU in ustreznimi monografijami evropske farmakopeje.
English: B-2800 Mechelen Belgium
Slovenian: B-2800 Mechelen Belgija
English: • extraneous agents testing of raw materials are carried out according to the relevant requirements
Slovenian: • da se testiranja surovin na prisotnost tujih snovi izvaja v skladu z ustreznimi zahtevami,