FrancophonIA/ELRC3.0 huggingface dataset:
English: - You have a history of muscle problems (e.g. myopathy or rhabdomyolysis) during treatment with cholesterol-controlling medicines called ‘statins' (such as simvastatin, atorvastatin, pravastatin or rosuvastatin) or fibrates (such as fenofibrate and bezafibrate).
Bulgarian: (kot so simvastatin, atorvastatin, pravastatin ali rosuvastatin) ali fibrati (kot sta fenofibrat in bezafibrat), težave z mišicami (npr. miopatija ali rabdomioliza).
English: Always take Pravafenix exactly as your doctor has told you.
Bulgarian: Pri jemanju zdravila Pravafenix natančno upoštevajte zdravnikova navodila.
English: Arthralgia, back pain, blood creatine phosphokinase increased, muscle spasms, musculoskeletal pain, myalgia, pain in extremity.
Bulgarian: mišični krči, mišično-skeletne bolečine, mialgija, bolečine v udih občasni
English: Musculoskeletal, connective tissue and bone disorders
Bulgarian: Bolezni mišično skeletnega sistema, vezivnega tkiva in kosti bolezen mišic (npr.
English: Rare side effects (may affect up to 1 in 1,000 people) • Decrease in haemoglobin (oxygen-carrying pigment in blood) and leukocytes (white blood cells).
Bulgarian: znižanje hemoglobina (krvnega barvila, ki prenaša kisik) in levkocitov (belih krvničk).
English: TG (mg/dl)
Bulgarian: Trigliceridi (mg/dl)
English: Immune system disorders
Bulgarian: Organski sistem Neželeni učinek
English: Tell your doctor if any of the following applies to you: - Liver or kidney problems - Thyroid problems - You are more than 70 years old - You have ever had muscle problems during a treatment with cholesterol-lowering medicines such as a statin or fibrate - You are taking or, in the last 7 days, have taken or been given a medicine called fusidic acid (a medicine for bacterial infection - You or your close family members have a hereditary muscle disorder - You have alcohol problems (regularly drinking large amounts of alcohol)
Bulgarian: imeli težave z mišicami, - če jemljete ali ste v zadnjih 7 dnevih jemali ali prejeli zdravilo, imenovano fusidna kislina (zdravilo za bakterijsko okužbo),
English: In rats and mice, liver tumours have been found at high dosages, which are attributable to peroxisome proliferation.
Bulgarian: Pri podganah in miših so pri visokih odmerkih našli
English: Muscle disorder (e.g. myositis, muscular weakness)
Bulgarian: miozitis, mišična oslabelost)
English: Diabetes mellitus aggravated, Obesity
Bulgarian: sladkorne bolezni, debelost občasni
English: See leaflet for further information
Bulgarian: Za nadaljnje informacije o tem zdravilu
English: In both healthy subjects and patients with hypercholesterolaemia, pravastatin lowers the following lipid values: total cholesterol, LDL-cholesterol, apolipoprotein B, VLDL-cholesterol and triglycerides; while HDL-cholesterol and apolipoprotein A are elevated.
Bulgarian: skupni holesterol, holesterol LDL, apolipoprotein B, holesterol VLDL in trigliceride.
English: EU/1/11/679/004 30 hard capsules
Bulgarian: EU/1/11/679/004, 30 trdih kapsul
English: It is recommended that transaminase levels be monitored every 3 months during the first 12 months of treatment and let to the appreciation of the clinician beyond this initial period.
Bulgarian: transaminaz na vsake 3 mesece, po tem začetnem obdobju pa je odločitev o tem prepuščena zdravniku.
English: Haemoglobin decreased, White blood cell count decreased
Bulgarian: Bolezni krvi in limfatičnega sistema znižanje ravni hemoglobina, zmanjšano število belih krvničk redki
English: Embryotoxic effects were observed at doses in the range of maternal toxicity.
Bulgarian: Opazili so embriotoksične učinke v odmerkih, katerih količine so bile v okviru količin toksičnosti pri materi. Pri velikih odmerkih so opazili podaljšanje gestacijske dobe in težave med porodom.
English: • Rashes, skin rash, itching, hives or reactions to sunlight or exposure to UV light (photosensitivity reactions), scalp/hair abnormality (including hair loss)
Bulgarian: izpuščaji, kožni izpuščaj, srbenje, koprivnica ali reakcija na sončno svetlobo ali izpostavljenost
English: Adverse reaction (Pravastatin)
Bulgarian: Porazdelitev Pravastatin
English: Common side effects (may affect up to 1 in 10 people)
Bulgarian: Pogosti neželeni učinki (pojavijo se lahko pri največ 1 od 10 bolnikov)
English: Hard capsule, with light green body and olive cap, containing a waxy white beige mass and a tablet.
Bulgarian: Trda kapsula s svetlozelenim spodnjim in olivno zelenim zgornjim delom.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLES FOR 60 AND 90 HARD CAPSULES
Bulgarian: PLASTENKE ZA 60 IN 90 TRDIH KAPSUL
English: No modification of posology should be necessary in patients with mild renal impairment.
Bulgarian: Prilagoditev odmerjanja pri bolnikih z blago okvarno lednic ni potrebna.
English: Some severe cases of reversible renal function impairment have been reported during concomitant administration of fenofibrate and ciclosporin.
Bulgarian: Pri sočasni uporabi fenofibrata in ciklosporina poročajo o nekaj resnih primerih reverzibilne okvare ledvične funkcije.
English: If treatment with fusidic acid is necessary, pravastatin treatment should be discontinued throughout the duration of the fusidic acid treatment.
Bulgarian: s pravastatinom za celotno obdobje zdravljenja s fusidno kislino.
English: Tel: +40 21 211 71 83
Bulgarian: Solartium Group S.r.l. Tel: +40 21 211 71 83
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BLISTERS
Bulgarian: PODATKI, KI MORAJO BITI NAVEDENI NA STIČNIH OVOJNINAH PLASTENKA
English: The plasma elimination half-life of fenofibric acid is approximately 20 hours.
Bulgarian: Plazemska razpolovna doba izločanja fenofibratne kisline
English: OTHER
Bulgarian: in
English: and/or AST ≥ 3 times the ULN, < 5 times the ULN) was 0.83% for patients treated with Pravafenix.
Bulgarian: ZMN < 5-kratnika ZMN) znašala 0,83 %.
English: Respiratory, thoracic and mediastinal disorders
Bulgarian: Bolezni dihal, prsnega koša in mediastinalnega prostora intersticijske pnevmopatije neznana
English: The incremental benefit of Pravafenix 40 mg/160 mg on main lipid parameters versus Pravastatin 40 mg and Fenofibrate 160 mg monotherapy was also established.
Bulgarian: s pravastatinom 40 mg in fenofibratom 160 mg dodatno koristno za uravnavanje glavnih parametrov lipidov.
English: - Your doctor should do a blood test before you start taking Pravafenix.
Bulgarian: - Preden začnete jemati zdravilo Pravafenix, mora zdravnik opraviti preiskavo vaše krvi.
English: LDL-C (mg/dl)
Bulgarian: Holesterol LDL (mg/dl)
English: In the FIELD study, a statistically significant increase was reported in the incidence of pulmonary embolism (0.7% in the placebo group versus 1.1% in the fenofibrate group; p=0.022) and a statistically non significant increase in deep vein thrombosis (placebo 1.0% 48/4,900 patients) versus fenofibrate 1.4% (67/4,895); p=0.074.
Bulgarian: Venski tromboembolični dogodki V študiji FIELD so poročali o statistično pomembnem povečanju pogostosti pojavljanja pljučne embolije (0,7 % v skupini, ki je prejemala placebo, v primerjavi z 1,1 % v skupini, ki je prejemala fenofibrat; p = 0,022) in o statistično nepomembnem povečanju pogostosti globoke venske tromboze
English: Pancreatitis has been reported in patients taking fenofibrate or pravastatin (see sections 4.3).
Bulgarian: Pri bolnikih, ki so jemali fenofibrat ali pravastatin, so poročali o pankreatitisu (glejte poglavje 4.3). To lahko kaže na neučinkovitost zdravila pri bolnikih
English: HDL-C (mg/dl)
Bulgarian: Holesterol HDL (mg/dl)
English: How to take pravafenix
Bulgarian: KAKO JEMATI ZDRAVILO PRAVAFENIX
English: Pravafenix is used if you are an adult with an elevated risk for heart disease and need to improve cholesterol and triglycerides fat levels in your blood when your ‘bad' cholesterol levels are being adequately controlled with pravastatin alone (a statin, a cholesterol-lowering medicine).
Bulgarian: in če je vaš „slabi“ holesterol ustrezno nadzorovan samo s pravastatinom (statinom, zdravilom za zniževanje ravni holesterola).
English: Clinically important elevation (CK ≥ 10 times the ULN without muscular symptoms) was seen in 0.06% of the patients treated with Pravafenix.
Bulgarian: simptomov v mišicah) je prišlo pri 0,06 % bolnikov, ki so prejemali zdravilo Pravafenix (glejte poglavje 4.4).
English: SMB Technology s.a. rue du Parc Industriel 39 B-6900 Marche en Famenne Belgium
Bulgarian: Ime in naslov izdelovalca, odgovornega za sproščanje serije: SMB Technology s.a. rue du Parc Industriel 39
English: Do not pass it on to others.
Bulgarian: - Zdravilo je bilo predpisano vam osebno in ga ne smete dajati drugim.
English: • Diabetes.
Bulgarian: s hemodializo.
English: The name of your medicine is Pravafenix.
Bulgarian: se imenuje Pravafenix.
English: Hepatic impairment
Bulgarian: Bolezni sečil
English: In some patients, however, the increase in pravastatin exposure may be larger.
Bulgarian: Pri nekaterih bolnikih pa je povečanje
English: Metabolism and nutrition disorders
Bulgarian: Presnovne in prehranske motnje poslabšanje
English: Clinically important elevations in serum transaminases (ALT and/or AST ≥ 5 times the ULN) were seen in 0.38% of the patients treated with Pravafenix.
Bulgarian: Do klinično pomembnih zvišanj serumskih transaminaz (ALT in/ali AST ≥ 5-kratnika ZMN) je prišlo pri
English: Oral use.
Bulgarian: peroralna uporaba
English: EU/1/11/679/002 60 hard capsules
Bulgarian: EU/1/11/679/002, 60 trdih kapsul
English: Skin and subcutaneous tissue disorders
Bulgarian: Bolezni kože in podkožja pruritus, urtikarija občasni
English: • Periodic Safety Update Reports
Bulgarian: ZA PROMET Z ZDRAVILOM • Redno posodobljena poročila o varnosti zdravila (PSUR)
English: If a patient plans to become pregnant or becomes pregnant, the physician has to be informed immediately and pravastatin should be discontinued because of the potential risk to the foetus.
Bulgarian: Če bolnica načrtuje nosečnost ali če zanosi, mora biti zdravnik o tem
English: If confirmed, the treatment should definitively not be initiated (see section 4.3).
Bulgarian: s hudo okvaro jeter pa je kontraindicirano (glejte poglavje 4.3).
English: Treatment discontinuation should also be considered if the muscular symptoms are severe and cause daily discomfort (whatever CK levels).
Bulgarian: Če je zaznana in potrjena izrazito zvišana vrednost kreatin-fosfokinaze (večja od petkratne ZMN), je treba zdravljenje z zdravilom Pravafenix prekiniti. O prekinitvi zdravljenja je treba razmisliti tudi v primeru, če so simptomi v mišicah hudi in motijo dnevne dejavnosti (ne glede na to, kakšne so vrednosti kreatin-fosfokinaze).
English: - If you have any further questions, ask your doctor or pharmacist - This medicine has been prescribed for you.
Bulgarian: - Če imate dodatna vprašanja, se posvetujte z zdravnikom ali farmacevtom.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/005 60 hard capsules
Bulgarian: ZA PROMET EU/1/11/679/005, 60 trdih kapsul
English: Capsule shell Gelatine
Bulgarian: Ovojnica kapsule želatina, indigo karmin,
English: In line with several formulations for fenofibrate, the fixed combination is recommended to be taken with food because the bioavailability of fenofibrate is increased when administered with food and the lipid-lowering efficacy of pravastatin is not altered.
Bulgarian: s hrano poveča, učinkovitost pravastatina pri zniževanju koncentracije lipidov pa se ne spremeni.
English: No clinically significant pharmacokinetic interaction was seen when fenofibrate was coadministered with pravastatin.
Bulgarian: Pri sočasni uporabi fenofibrata in pravastatina niso opazili nobenih pomembnih farmakokinetičnih interakcij.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/001 30 hard capsules
Bulgarian: ZA PROMET EU/1/11/679/001, 30 trdih kapsul
English: Clinically important elevations in creatine phosphokinase (CK ≥ 5 times the ULN, < 10 times the ULN without muscular symptoms) were seen in 0.38% of the patients treated with Pravafenix.
Bulgarian: simptomov v mišicah) pri 0,38 % bolnikov, ki so prejemali zdravilo Pravafenix. Do klinično pomembnih zvišanj (KF ≥ 10kratnika
English: • Digestive effects: gastric or intestinal disorders (abdominal pain, nausea, vomiting, diarrhoea and flatulence, constipation, dry mouth, upper abdominal pain with bloating (dyspepsia), burping
Bulgarian: bruhanje, driska in flatulenca, zaprtje, suha usta, bolečina v zgornjem delu trebuha z napihnjenostjo (dispepsija), spahovanje), • učinki na jetra: zvišane vrednosti serumskih transaminaz.
English: 5.1 Pharmacodynamic properties
Bulgarian: FARMAKOLOŠKE LASTNOSTI 5.1 Farmakodinamične lastnosti
English: Pravafenix with food, drink and alcohol - Always take Pravafenix with food as Pravafenix is less well absorbed from an empty stomach.
Bulgarian: - Zdravilo Pravafenix vedno vzemite skupaj s hrano, saj se na tešče
English: Jaundice, fulminant hepatic necrosis
Bulgarian: Interakcije, pomembne za pravastatin Holestiramin/holestipol
English: Skin rash, Scalp/hair abnormality (including alopecia)
Bulgarian: Bolezni kože in podkožja kožni izpuščaj, bolezenska sprememba na lasišču/laseh (vključno z alopecijo)
English: Asthenia, fatigue, influenza like illness
Bulgarian: Splošne težave in spremembe na mestu aplikacije astenija, utrujenost, gripi podobno bolezensko stanje občasni
English: Distribution
Bulgarian: Odmerjanje
English: NAME OF THE MEDICINAL PRODUCT Pravafenix 40 mg/160 mg hard capsules Pravastatin/Fenofibrate
Bulgarian: NAVODILO ZA UPORABO Pravafenix 40 mg/160 mg trde kapsule pravastatin/fenofibrat
English: EU/1/11/679/003 90 hard capsules
Bulgarian: EU/1/11/679/003, 90 trdih kapsul
English: Additional information on the individual active substances of the fixed dose combination Pravafenix contains pravastatin and fenofibrate.
Bulgarian: VSEBINA PAKIRANJA IN DODATNE INFORMACIJE Kaj vsebuje zdravilo Pravafenix
English: MARKETING AUTHORISATION NUMBER(S) EU/1/11/679/007 14 hard capsules
Bulgarian: ZA PROMET EU/1/11/679/007, 14 trdih kapsul
English: There are no data on fertility from the combined use of fenofibrate and pravastatin
Bulgarian: Pri kombinirani uporabi fenofibrata in pravastatina ni podatkov o vplivu na plodnost.
English: In interaction studies, no statistically significant differences in bioavailability were observed when pravastatin was administered with acetylsalicylic acid, antacids (when given one hour prior to pravastatin), nicotinic acid or probucol.
Bulgarian: so bili vzeti eno uro pred pravastatinom), nikotinsko kislino ali probukolom, v študijah medsebojnega delovanja niso opazili statistično pomembnih razlik v biološki uporabnosti.
English: Other medicines and Pravafenix
Bulgarian: SHRANJEVANJE ZDRAVILA PRAVAFENIX
English: Hepatic pain, gammaglutamyl transferase increased.
Bulgarian: Bolezni jeter, žolčnika in žolčevodov zvišana vrednost transaminaz pogosti bolečina v jetrih, zvišana gama-glutamiltransferaza občasni
English: EU/1/11/679/006 90 hard capsules
Bulgarian: EU/1/11/679/006, 90 trdih kapsul
English: Rare
Bulgarian: občasni
English: Check with your doctor or pharmacist if you are not sure.
Bulgarian: se posvetujte z zdravnikom ali farmacevtom.
English: Pharmacotherapeutic group: Lipid modifying agents, HMG CoA reductase inhibitors in combination with other lipid modifying agents, ATC code: C10BA03
Bulgarian: Učinkovine, ki vplivajo na lipide, zaviralci reduktaze hidroksimetilglutaril koencima A v kombinaciji z drugimi učinkovinami, ki vplivajo na lipide, oznaka
English: Posology
Bulgarian: ŠKATLA
English: In clinical studies, the incidence of important elevations in creatine phosphokinase (CK ≥ 3 times the ULN, < 5 times the ULN) was 1.92% for patients treated with Pravafenix.
Bulgarian: ki so v kliničnih študijah prejemali zdravilo Pravafenix, je incidenca pomembnih zvišanj kreatin fosfokinaze (KF ≥ 3-kratnika
English: Reproductive system and breast disorders
Bulgarian: Motnje reprodukcije in dojk motnje na področju spolnosti motnje na področju spolnosti občasni
English: Pravafenix is not recommended in patients with moderate hepatic impairment and is contraindicated in patients with severe hepatic impairment (see section 4.3.).
Bulgarian: Zdravilo Pravafenix se ne priporoča pri bolnikih z zmerno okvaro jeter, pri bolnikih
English: MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Bulgarian: IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI)
English: Hs-CRP (mg/L) a Number of patients b Mean percent change (least square mean ± standard error) between baseline measured after 8 weeks on Pravastatin 40 mg and 12 additional weeks with Pravafenix 40 mg/160 mg or Pravastatin 40 mg c Pairwise p-value is significant if <0.05
Bulgarian: Apoprotein B/apoprotein A1 Fibrinogen (g/l) Hs-CRP (mg/l) a Število bolnikov b Povprečna sprememba v odstotkih (povprečje najmanjših kvadratov ± standardna napaka) med izhodiščno vrednostjo, izmerjeno po 8
English: Hypersensitivity reactions
Bulgarian: Bolezni imunskega sistema preobčutljivostne reakcije občasni
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR BOTTLES
Bulgarian: PODATKI NA ZUNANJI OVOJNINI ŠKATLA
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTERS
Bulgarian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: - Keep this leaflet.
Bulgarian: PRETISNI OMOTI
English: Pruritus, urticaria
Bulgarian: ZA PRETISNE OMOTE
English: D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Bulgarian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE C. DRUGI POGOJI IN ZAHTEVE DOVOLJENJA
English: Uncommon
Bulgarian: s kombinirano
English: Your doctor can measure your cholesterol with a simple blood test. Visit your doctor regularly to keep track of your cholesterol level.
Bulgarian: svojega zdravnika, da boste spremljali raven holesterola.
English: Rare * In the FIELD-study (fenofibrate study), a randomised placebo-controlled trial performed in 9,795 patients with type 2 diabetes mellitus, a statistically significant increase in pancreatitis cases was observed in patients receiving fenofibrate versus patients receiving placebo (0.8% versus 0.5%; p = 0.031).
Bulgarian: Preiskave povečana količina sečnine v krvi redki * V študiji FIELD (študiji o fenofibratu), randomiziranem, s placebom nadzorovanem preskušanju, ki je bilo izvedeno pri 9795 bolnikih
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each capsule contains 40 mg of pravastatin sodium and 160 mg of fenofibrate.
Bulgarian: NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Ena kapsula vsebuje 40 mg natrijevega pravastatinata in 160 mg fenofibrata.
English: Lot
Bulgarian: ZA
English: Sexual dysfunction
Bulgarian: tveganjem za bolezni
English: The most commonly reported adverse reactions (ADRs) during Pravafenix therapy are increased transaminase and gastrointestinal disorders.
Bulgarian: Najpogosteje navedeni neželeni učinki med terapijo z zdravilom Pravafenix
English: 56 Eirinis Ave., 151 21, Pefki,
Bulgarian: 56 Eirinis Ave., 151 21, Pefki, Greece
English: 92787 ISSY-LESMOULINEAUX Cedex 9 France
Bulgarian: 92787 ISSY-LESMOULINEAUX Cedex
English: Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B
Bulgarian: Janssen-Cilag Pharma GmbH, 1020 Vienna, Vorgartenstraße 206B Austria
English: Janssen-Cilag Kft. 1123 Budapest, Nagyenyed utca 8 -14 Magyarország Hungary
Bulgarian: 1123 Budapest, Nagyenyed utca 8 -14 Magyarország Hungary
English: Czech Republic Janssen-Cilag s.r.o., Karla Engliše 3201/6, Prague 5, 150 00
Bulgarian: Чешка република Janssen-Cilag s.r.o., Karla Engliše 3201/6,
English: Dr. Paul Janssenweg 150 5026 RH Tilburg PO Box 90240
Bulgarian: 5026 RH Tilburg PO Box 90240
English: Queluz de Baixo 2734-503 Barcarena Portugal
Bulgarian: Estrada Consiglieri Pedroso, 69 A Queluz de Baixo 2734-503 Barcarena Portugal
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES
Bulgarian: СПИСЪК НА ИМЕНАТА, ЛЕКАРСТВЕНИ ФОРМИ, КОЛИЧЕСТВО НА АКТИВНОТО ВЕЩЕСТВО
English: Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse
Bulgarian: Janssen-Cilag International NV Turnhoutseweg 30 B-2340 Beerse Belgium
English: 20093 COLOGNO MONZESE (MI), Italy
Bulgarian: JANSSEN-CILAG SpA Via M. Buonarroti, 23 20093 COLOGNO MONZESE (MI), Italy
English: Oreškovićeva 6H, 10010 Zagreb,
Bulgarian: d.o.o. Oreškovićeva 6H,
English: Belgium Janssen-Cilag N.V. Antwerpseweg 15-17
Bulgarian: Janssen-Cilag N.V. Antwerpseweg 15-17 B-2340 Beerse Belgium
English: Janssen-Cilag Limited 50-100 Holmers Farm Way High Wycombe Buckinghamshire HP12 4EG
Bulgarian: Janssen-Cilag Limited 50-100 Holmers Farm Way
English: Janssen-Cilag B.V.
Bulgarian: Janssen-Cilag Kft.
English: Durogesic Matrix 12 µg/h
Bulgarian: Durogesic Matrix 12 µг/ч
English: Durogesic Matrix 100 µg/h
Bulgarian: Durogesic Matrix 100 µг/ч
English: Durogesic 12 microgrammes/h eure, dispositif transdermique
Bulgarian: Durogesic 12 microgrammes/he ure, dispositif transdermique
English: d.o.o.
Bulgarian: 4EG
English: Durogesic Matrix 75 µg/h
Bulgarian: Durogesic Matrix 75 µг/ч
English: Durogesic Matrix 25 µg/h
Bulgarian: Durogesic Matrix 25 µг/ч
English: Durogesic 100 microgrammes/h eure, dispositif transdermique
Bulgarian: Durogesic 100 microgrammes/he ure, dispositif transdermique
English: Durogesic 75 microgrammes/h eure, dispositif transdermique
Bulgarian: Durogesic 75 microgrammes/he ure, dispositif transdermique
English: Durogesic Matrix 50 µg/h
Bulgarian: Durogesic Matrix 50 µг/ч
English: JANSSEN-CILAG, S.A. Paseo de Las Doce Estrellas, 5-7 28042, Madrid
Bulgarian: Paseo de Las Doce Estrellas, 5-7
English: Durogesic 25 microgrammes/h eure, dispositif transdermique
Bulgarian: Durogesic 25 microgrammes/he ure, dispositif transdermique
English: Durogesic 50 microgrammes/h eure, dispositif transdermique
Bulgarian: Durogesic 50 microgrammes/he ure, dispositif transdermique
English: The valid summary of product characteristics, labelling and package leaflet are the final versions achieved during the Coordination group procedure.
Bulgarian: Валидната кратка характеристика на продукта, означенията върху опаковката и листовката са последните версии одобрени от Координационната група по време на процедурата.
English: Summary of product characteristics, labelling and package leaflet
Bulgarian: Кратка характеристика на продукта,означения върху опаковката и листовката
English: It increases the range of available vaccine options.
Bulgarian: Тя увеличава обхвата на наличните варианти за ваксина.
English: The marketing authorisations in Spain and Italy were suspended by the national competent authorities on 11 and 20 April 2011, respectively.
Bulgarian: Лицензите за употреба в Испания и Италия са временно спрени от националните компетентни органи съответно на 11 и 20 април 2011 г.
English: Additionally, in Spain where approximately half of the total EU-product sales are recorded, two adverse events have been reported to date.
Bulgarian: В допълнение в Испания, където са регистрирани приблизително половината от всички продажби на продукта в ЕС, към момента са съобщени две нежелани събития.
English: The national competent authorities, coordinated by the reference Member State, shall ensure that the following conditions are fulfilled by the marketing authorisation holder:
Bulgarian: Националните компетентни органи, координирани от референтната държава-членка, трябва да гарантират, че следните условия са изпълнени от притежателя на лиценза за употреба:
English: The frequency of events reported varies across Member States and does not appear to directly reflect the amount of product sold.
Bulgarian: Честотата на събитията варира сред държавитечленки и не изглежда да отразява пряко продаденото количество от продукта.
English: The greatest number of adverse events was reported in France.
Bulgarian: Най-голям брой нежелани събития е съобщен във Франция.
English: Based on post-authorisation safety data, there is no evidence that the product poses a risk to the user, the consumer or the environment.
Bulgarian: На базата на данни за безопасността след лицензирането, няма доказателства, че продуктът представлява риск за потребителя, консуматора или околната среда.