FrancophonIA/ELRC3.0 huggingface dataset:
English: Presence of superficial-vein thrombosis greater than 3 cm from the sapheno-femoral junction should be confirmed and concomitant DVT should be excluded by compression ultrasound or objective methods prior to initiating treatment of fondaparinux.
Slovenian: Pred začetkom zdravljenja s fondaparinuksom je treba s kompresijskim ultrazvokom ali drugimi objektivnimi metodami potrditi, da je povrhnja venska tromboza več kot 3 cm daleč od safeno femoralnega spoja in da ni sočasne globoke venske tromboze.
English: Always use this medicine exactly as your doctor or pharmacist has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila svojega zdravnika ali farmacevta.
English: Syringe with a manual needle protection system
Slovenian: Injekcijska brizga z ročnim sistemom za zaščito igle
English: Fondaparinux should not be used in patients with severe renal impairment (creatinine clearance < 30 ml/min) (See section 4.3).
Slovenian: Pri bolnikih s hudo ledvično okvaro (očistek kreatinina < 30 ml/min) fondaparinuksa ne smemo uporabljati (glejte poglavje 4.3).
English: • For prevention of VTE - Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Slovenian: • Za preprečevanje VTE - Sočasno s fondaparinuksom ne smemo uporabljati učinkovin, ki lahko povečajo tveganje za krvavitev.
English: Arixtra 1.5 mg/0.3 ml solution for injection, pre-filled syringe.
Slovenian: Arixtra 1,5 mg/0,3 ml raztopina za injiciranje, napolnjena injekcijska brizga
English: • Treatment of superficial-vein thrombosis - Fondaparinux should not be used in patients with creatinine clearance <20 ml/min (see section 4.3).
Slovenian: • Zdravljenje povrhnje venske tromboze - Fondaparinuksa se ne sme uporabljati pri bolnikih z očistkom kreatinina < 20 ml/min (glejte poglavje 4.3).
English: • syringe with a blue plunger and an automatic safety system
Slovenian: • injekcijska brizga z modrim batom in samodejnim varnostnim sistemom.
English: • headache
Slovenian: • glavobol;
English: The efficacy findings and results on major bleeding were consistent across prespecified subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines or GP IIb/IIIa inhibitors).
Slovenian: Pri v naprej določenih podskupinah, kot so starostniki, bolniki z okvaro ledvic, vrsta sočasnega zaviralca agregacije trombocitov (acetilsalicilna kislina, tienopiridini, zaviralci GP IIb/IIIa) sta bili učinkovitost in pojavnost večjih krvavitev konsistentni.
English: • feeling sick or being sick (nausea or vomiting)
Slovenian: • siljenje na bruhanje (navzea) ali bruhanje;
English: Each pre-filled syringe (0.5 ml) contains 2.5 mg of fondaparinux sodium.
Slovenian: Ena napolnjena injekcijska brizga (0,5 ml) vsebuje 2,5 mg natrijevega fondaparinuksata.
English: If you stop the treatment before your doctor told you to, the blood clot may not be treated properly and you may also be at risk of developing a new blood clot in a vein of your leg or in the lung.
Slovenian: Če prenehate uporabljati zdravilo prej, kot vam je predpisal zdravnik, zdravljenje krvnega strdka morda ne bo zadostno.
English: The difference in total VTE rates between the treatment groups, which was not statistically significant, was mainly due to a reduction of asymptomatic distal DVT.
Slovenian: Razlika v odstotku pojavnosti vseh VTE med obema skupinama ni bila statistično pomembna.
English: By Day 30, the incidence of all cause mortality was significantly reduced from 3.5% on enoxaparin to 2.9% on fondaparinux (hazard ratio 0.83, 95% CI, 0.71;0.97, p = 0.02).
Slovenian: 2,9 % pri fondaparinuksu (razmerje tveganja 0,83, 95 % interval zaupanja, 0,71;0,97, p = 0,02).
English: In subjects randomized to the “standard dose UFH” or the “low dose UFH” regimen the median dose of UFH was 85 U/kg and 50 U/kg, respectively.
Slovenian: Mediani odmerek nefrakcioniranega heparina je bil med preiskovanci, randomiziranimi na "standardni odmerek nefrakcioniranega heparina" 85 e/kg in med randomiziranimi na "nizki odmerek nefrakcioniranega heparina" 50 e/kg.
English: Arixtra 2.5 mg/0.5 ml solution for injection, pre-filled syringe.
Slovenian: Arixtra 2,5 mg/0,5 ml raztopina za injiciranje, napolnjena injekcijska brizga
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.6 ml) contains 7.5 mg fondaparinux sodium.
Slovenian: Ena napolnjena injekcijska brizga (0,6 ml) vsebuje 7,5 mg natrijevega fondaparinuksata.
English: NAME OF THE MEDICINAL PRODUCT Arixtra 1.5 mg/0.3 ml solution for injection fondaparinux sodium
Slovenian: Arixtra 1,5 mg/0,3 ml raztopina za injiciranje natrijev fondaparinuksat
English: • low number of platelets (blood cells necessary for blood clotting)
Slovenian: • zmanjšanje števila trombocitov (krvnih celic, pomembnih za strjevanje krvi);
English: The syringe needle shield may contain latex that has the potential to cause allergic reactions in latex sensitive individuals.
Slovenian: Ščitnik igle na injekcijski brizgi lahko vsebuje lateks, ki lahko osebam, občutljivim na lateks, povzroči resno alergijsko reakcijo.
English: Day 30 was significantly reduced from 15% for the control group to 12.1% for the fondaparinux group (hazard ratio 0.79, 95% CI, 0.65;0.97, p = 0.023).
Slovenian: Pri bolnikih, pri katerih ni bila opravljena začetna reperfuzija, je fondaparinuks pomembno zmanjšal smrtnost/pojavnost re-MI do 30. dne iz 15 % v kontrolni skupini na 12,1 % (razmerje tveganja 0,79, 95 % interval zaupanja, 0,65;0,97, p = 0,023).
English: Each pre-filled syringe (0.3 ml) contains 1.5 mg of fondaparinux sodium.
Slovenian: Ena napolnjena injekcijska brizga (0,3 ml) vsebuje 1,5 mg natrijevega fondaparinuksata.
English: May cause severe allergic reactions.
Slovenian: Redki: alergijske reakcije
English: Treatment of ST segment elevation myocardial infarction (STEMI) The recommended dose of fondaparinux is 2.5 mg once daily.
Slovenian: Zdravljenje miokardnega infarkta z dvigom segmenta ST (STEMI) Priporočeni odmerek fondaparinuksa je 2,5 mg enkrat na dan. Prvi odmerek fondaparinuksa mora bolnik prejeti intravensko, nadaljnje odmerke pa subkutano.
English: The efficacy findings and results on severe haemorrhage were consistent across prespecified subgroups such as elderly, renally impaired patients, type of concomitant platelet aggregation inhibitors (aspirin, thienopyridines).
Slovenian: Pri v naprej določenih podskupinah, kot so starostniki, bolniki z okvaro ledvic, vrsta sočasnega zaviralca agregacije trombocitov (acetilsalicilna kislina, tienopiridini) sta bili učinkovitost in pojavnost hujših krvavitev konsistentni.
English: Arixtra 5 mg/0.4 ml solution for injection, pre-filled syringe.
Slovenian: Arixtra 5 mg/0,4 ml raztopina za injiciranje, napolnjena injekcijska brizga
English: • syringe with a magenta plunger and an automatic safety system
Slovenian: • injekcijska brizga z vijoličastim batom in samodejnim varnostnim sistemom.
English: NAME OF THE MEDICINAL PRODUCT Arixtra 7.5 mg/0.6 ml solution for injection fondaparinux sodium
Slovenian: Arixtra 7,5 mg/0,6 ml raztopina za injiciranje natrijev fondaparinuksat
English: The syringe needle shield contains latex that has the potential to cause allergic reactions in latex sensitive individuals.
Slovenian: Ščitnik igle na injekcijski brizgi vsebuje lateks, ki lahko osebam, občutljivim na lateks, povzroči resno alergijsko reakcijo.
English: Package leaflet: Information for the user Arixtra 2.5 mg/0.5 ml solution for injection fondaparinux sodium
Slovenian: Navodilo za uporabo Arixtra 2,5 mg/0,5 ml raztopina za injiciranje natrijev fondaparinuksat
English: B.
Slovenian: ② Bat
English: NAME OF THE MEDICINAL PRODUCT Arixtra 2.5 mg/0.5 ml solution for injection fondaparinux sodium
Slovenian: Arixtra 2,5 mg/0,5 ml raztopina za injiciranje natrijev fondaparinuksat
English: • syringe with yellow plunger and a manual safety system.
Slovenian: • injekcijska brizga z rumenim batom in ročnim varnostnim sistemom.
English: → Tell your doctor if any of these applies to you.
Slovenian: → Če se karkoli od navedenega nanaša na vas, o tem obvestite svojega zdravnika.
English: • syringe with blue plunger and a manual safety system.
Slovenian: • injekcijska brizga z modrim batom in ročnim varnostnim sistemom.
English: • increase in some chemical (enzymes) produced by the liver
Slovenian: • povečane vrednosti bilirubina (snovi, ki nastaja v jetrih) v krvi;
English: EU/1/02/206/031 - 2 pre-filled syringes with a manual safety system EU/1/02/206/032 - 10 pre-filled syringes with a manual safety system EU/1/02/206/035 - 20 pre-filled syringes with a manual safety system
Slovenian: EU/1/02/206/031 - 2 napolnjeni injekcijski brizgi z ročnim varnostnim sistemom EU/1/02/206/032 - 10 napolnjenih injekcijskih brizg z ročnim varnostnim sistemom EU/1/02/206/035 - 20 napolnjenih injekcijskih brizg z ročnim varnostnim sistemom
English: Clinical experience is limited in patients with body weight <50 kg. Fondaparinux should be used with caution at a daily dose of 5 mg in this population (see sections 4.2 and 5.2).
Slovenian: V tej skupini je treba fondaparinuks previdno uporabljati v dnevnem odmerku 5 mg (glejte poglavji 4.2 in 5.2).
English: EU/1/02/206/005- 2 pre-filled syringes with an automatic safety system EU/1/02/206/006 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/007 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/008 - 20 pre-filled syringes with an automatic safety system
Slovenian: EU/1/02/206/005 - 2 napolnjeni injekcijski brizgi s samodejnim varnostnim sistemom EU/1/02/206/006 - 7 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom EU/1/02/206/007 - 10 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom EU/1/02/206/008 - 20 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom
English: STATEMENT OF ACTIVE SUBSTANCE(S) One pre-filled syringe (0.4 ml) contains 5 mg fondaparinux sodium.
Slovenian: Ena napolnjena injekcijska brizga (0,4 ml) vsebuje 5 mg natrijevega fondaparinuksata.
English: EU/1/02/206/015 - 2 pre-filled syringes with an automatic safety system EU/1/02/206/016 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/017 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/020 - 20 pre-filled syringe with an automatic safety system
Slovenian: EU/1/02/206/015 - 2 napolnjeni injekcijski brizgi s samodejnim varnostnim sistemom EU/1/02/206/016 - 7 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom EU/1/02/206/017 - 10 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom EU/1/02/206/020 - 20 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom
English: This dose may be reduced to 7.5 mg once a day if you have moderate kidney disease.
Slovenian: Če imate zmerno okvaro ledvic, se lahko ta odmerek zmanjša na 7,5 mg enkrat na dan.
English: NAME OF THE MEDICINAL PRODUCT Arixtra 5 mg/0.4 ml solution for injection fondaparinux sodium
Slovenian: Arixtra 5 mg/0,4 ml raztopina za injiciranje natrijev fondaparinuksat
English: EU/1/02/206/027 - 2 pre-filled syringes with a manual safety system EU/1/02/206/028 - 10 pre-filled syringes with a manual safety system EU/1/02/206/033 - 20 pre-filled syringes with a manual safety system
Slovenian: EU/1/02/206/027- 2 napolnjeni injekcijski brizgi z ročnim varnostnim sistemom EU/1/02/206/028- 10 napolnjenih injekcijskih brizg z ročnim varnostnim sistemom EU/1/02/206/033- 20 napolnjenih injekcijskih brizg z ročnim varnostnim sistemom
English: MI or TVR at Day 30
Slovenian: 30. dan
English: EU/1/02/206/012- 2 pre-filled syringes with an automatic safety system EU/1/02/206/013 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/014 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/019 - 20 pre-filled syringe with an automatic safety system
Slovenian: EU/1/02/206/012 - 2 napolnjeni injekcijski brizgi s samodejnim varnostnim sistemom EU/1/02/206/013 - 7 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom EU/1/02/206/014 - 10 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom EU/1/02/206/019 - 20 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom
English: EU/1/02/206/001 - 2 pre-filled syringes with an automatic safety system EU/1/02/206/002 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/003 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/004 - 20 pre-filled syringes with an automatic safety system
Slovenian: EU/1/02/206/001 - 2 napolnjeni injekcijski brizgi s samodejnim varnostnim sistemom EU/1/02/206/002 - 7 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom EU/1/02/206/003 - 10 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom EU/1/02/206/004 - 20 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom
English: The needle protection system of the Arixtra pre-filled syringes have been designed with a safety system to protect from needle stick injuries following injection.
Slovenian: Arixtra napolnjene injekcijske brizge so opremljene s sistemom za zaščito igle.
English: EU/1/02/206/009- 2 pre-filled syringes with an automatic safety system EU/1/02/206//010 - 7 pre-filled syringes with an automatic safety system EU/1/02/206/011 - 10 pre-filled syringes with an automatic safety system EU/1/02/206/018 - 20 pre-filled syringe with an automatic safety system
Slovenian: EU/1/02/206/009 - 2 napolnjeni injekcijski brizgi s samodejnim varnostnim sistemom EU/1/02/206/010 - 7 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom EU/1/02/206/011 - 10 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom EU/1/02/206/018 - 20 napolnjenih injekcijskih brizg s samodejnim varnostnim sistemom
English: Parts of the syringes: 1 Needle shield 2 Plunger 3 Finger-grip 4 Security sleeve
Slovenian: ② Bat ③ Držalo za prste ④ Varnostni tulec
English: Hepatobiliary disorders Uncommon: hepatic enzymes increased, hepatic function abnormal
Slovenian: Občasni: povečana aktivnost jetrnih encimov, motnje v delovanju jeter Redki: bilirubinemija
English: Haemorrhage
Slovenian: Žilne bolezni
English: Common: bleeding (haematoma, haematuria, haemoptysis, gingival bleeding) Uncommon: anaemia
Slovenian: Pogosti: krvavitve (hematom, hematurija, hemoptiza, krvavitve dlesni)
English: EU/1/02/206/029 - 2 pre-filled syringes with a manual safety system EU/1/02/206/030 - 10 pre-filled syringes with a manual safety system EU/1/02/206/034 - 20 pre-filled syringes with a manual safety system
Slovenian: EU/1/02/206/029- 2 napolnjeni injekcijski brizgi z ročnim varnostnim sistemom EU/1/02/206/030- 10 napolnjenih injekcijskih brizg z ročnim varnostnim sistemom EU/1/02/206/034- 20 napolnjenih injekcijskih brizg z ročnim varnostnim sistemom
English: • indigestion
Slovenian: • kašljanje;
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni jeter, žolčnika in žolčevodov
English: Contents of the pack and other information
Slovenian: 5 Shranjevanje zdravila Arixtra Vsebina pakiranja in dodatne informacije
English: • drowsiness or tiredness
Slovenian: • kožni izpuščaj ali srbenje;
English: Fondaparinux 5 mg (body weight < 50 kg), 7.5 mg (body weight ≥ 50kg, ≤ 100 kg) or 10 mg (body weight >100 kg) SC once daily was compared to unfractionated heparin IV bolus (5,000 IU) followed by a continuous IV infusion adjusted to maintain 1.5-2.5 times aPTT control value.
Slovenian: (telesna masa < 50 kg), 7,5 mg (telesna masa > 50 kg, ≤ 100 kg) ali 10 mg (telesna masa > 100 kg) s.c. enkrat na dan z i.v.
English: Aspen Pharma Trading Limited Tel.: 008001211566/+44 (0)1423 852 859 aspenmedinfo@professionalinformation.co.uk
Slovenian: Aspen Pharma Trading Limited Tél/Tel: 0035 227861279 aspenmedinfo@professionalinformation.co.uk
English: Aspen Pharma Trading Limited Tlf: 80010093/+44 (0)1423 852 995 aspenmedinfo@professionalinformation.co.uk
Slovenian: Aspen Pharma Trading Limited Tel: 0039 0687502429 aspenmedinfo@professionalinformation.co.uk
English: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) OASIS 5 was a double-blind, randomised, non-inferiority study with fondaparinux 2.5 mg subcutaneously once daily versus enoxaparin 1 mg/kg subcutaneously twice daily in approximately 20,000 patients with UA/NSTEMI.
Slovenian: Pri približno 20.000 bolnikih z UA/NSTEMI je primerjala uporabo fondaparinuksa v odmerku 2,5 mg subkutano enkrat na dan in enoksaparina v odmerku 1 mg/kg subkutano dvakrat na dan.
English: For prevention of VTE- Agents that may enhance the risk of haemorrhage should not be administered concomitantly with fondaparinux.
Slovenian: Pri preprečevanju VTE - Sočasno s fondaparinuksom se ne sme uporabljati učinkovin, ki lahko povečajo tveganje za krvavitev.
English: Peri-PCI major bleeding or death,
Slovenian: Večja krvavitev ali smrt v času okrog PCI, MI ali TVR
English: B. PACKAGE LEAFLET
Slovenian: vredn ost p
English: • chest pain
Slovenian: • bolečine v prsih;
English: Outcome of re-examination
Slovenian: Izid ponovne presoje
English: EMA/CHMP/896315/2011 EMEA/H/C/002140
Slovenian: 17. november 2011 EMA/907378/2011 EMEA/H/C/002140
English: The additional measures proposed by the company were still considered insufficient.
Slovenian: Dodatni ukrepi, ki jih je predlagala družba, so se še vedno šteli kot nezadostni.
English: The applicant requested a re-examination of the negative opinion.
Slovenian: Predlagatelj je zahteval ponovno presojo negativnega mnenja.
English: What did the company present to support its application?
Slovenian: Kaj je družba predložila v podporo svoji vlogi?
English: It was to be available as 50 mg tablets.
Slovenian: Na voljo naj bi bilo v obliki 50 mg tablet.
English: This will stop the symptoms of migraine: headache, sickness and sensitivity to light.
Slovenian: To ustavi simptome migrene: glavobol, slabost in občutljivost za svetlobo.
English: What were the CHMP's main concerns that led to the refusal?
Slovenian: Kateri so bili glavni zadržki odbora CHMP za zavrnitev?
English: During the re-examination in November 2011, the CHMP's main concerns were not resolved.
Slovenian: Med ponovno presojo novembra 2011 glavni zadržki odbora CHMP niso bili odpravljeni.
English: The CHMP therefore confirmed its initial negative opinion.
Slovenian: Zato je Odbor potrdil svoje prvotno negativno mnenje.
English: This leads to a widening of blood vessels in the brain which can lead to a migraine attack.
Slovenian: Posledično se razširijo krvne žile v možganih, kar lahko privede do migrenskega napada.
English: Sumatriptan will help blood vessels to return to their normal size.
Slovenian: Sumatriptan pomaga, da se krvne žile vrnejo v normalno velikost.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 17 November 2011.
Slovenian: Po proučitvi podlage za to zahtevo je odbor CHMP ponovno pregledal prvotno mnenje in 17. novembra 2011 potrdil zavrnitev vloge za dovoljenje za promet z zdravilom.
English: The company presented the results of a study carried out to investigate whether it is ‘bioequivalent' to the reference medicine and data in support of its use in the non-prescription setting.
Slovenian: Družba je predložila rezultate študije, ki je bila izvedena, da bi raziskali, ali je zdravilo „biološko enakovredno“ referenčnemu zdravilu, in podatke v podporo uporabi brez recepta.
English: The CHMP felt that the measures proposed by the company to reduce these risks were insufficient.
Slovenian: Odbor je menil, da so bili ukrepi za zmanjšanje teh tveganj, ki jih je predlagala družba, nezadostni.
English: Migraine attacks occur when the level of 5hydroxytryptamine in the brain becomes low.
Slovenian: Migrenski napadi se pojavijo, ko se zniža raven 5-hidroksitriptamina v možganih.
English: This was because a lack of medical supervision and monitoring of the patient would increase the risk for cerebrovascular (brain) and cardiovascular (heart) side effects and potential misuse and overuse.
Slovenian: Pomanjkanje zdravniškega nadzora in spremljanja bolnika bi namreč povečalo tveganje za cerebrovaskularne (možganske) in kardiovaskularne (srčne) neželene učinke ter za morebitno zlorabo in čezmerno uporabo zdravila.
English: Refusal of the marketing authorisation for Sumatriptan Galpharm 50 mg tablets
Slovenian: Zavrnitev dovoljenja za promet z zdravilom Sumatriptan Galpharm 50 mg tablete
English: that allow nerve cells to communicate with one another.
Slovenian: kemične snovi, ki omogočajo medsebojno sporazumevanje živčnih celic.
English: On 21 July 2011, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Sumatriptan Galpharm, intended for the relief of migraine attacks in people who have been diagnosed with migraine.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je 21. julija 2011 sprejel negativno mnenje, v katerem je priporočil zavrnitev vloge za dovoljenje za promet z zdravilom Sumatriptan Galpharm, namenjenim lajšanju migrenskih napadov pri ljudeh z diagnozo migrene.
English: Neurotransmitters are chemicals
Slovenian: Živčni prenašalci so
English: The active substance in Sumatriptan Galpharm and Imigran, sumatriptan, works by mimicking the action of the neurotransmitter 5-hydroxytryptamine (serotonin) in the brain.
Slovenian: Zdravilna učinkovina v zdravilih Sumatriptan Galpharm in Imigran, sumatriptan, deluje tako, da posnema delovanje živčnega prenašalca 5-hidroksitriptamina (serotonina) v možganih.
English: The CHMP also remained concerned about the safety of Sumatriptan Galpharm, in particular the potential for misuse and overuse as well as the risk of misdiagnosis of migraine and lack of medical follow-up when used in the non-prescription setting.
Slovenian: Odbor je prav tako obdržal zadržke glede varnosti zdravila Sumatriptan Galpharm, še zlasti glede morebitne zlorabe in čezmerne uporabe ter tveganja za napačno diagnozo migrene in pomanjkanje zdravniškega nadzora, kadar se zdravilo izdaja brez recepta.
English: Sumatriptan Galpharm was intended to be similar to a ‘reference medicine' already authorised in the European Union called Imigran.
Slovenian: Zdravilo Sumatriptan Galpharm naj bi bilo podobno „referenčnemu zdravilu“ Imigran, ki je že odobreno v Evropski uniji.
English: Refusal of the marketing authorisation for Sumatriptan Galpharm 50 mg tablets EMA/CHMP/896315/2011
Slovenian: Zavrnitev dovoljenja za promet z zdravilom Sumatriptan Galpharm 50 mg tablete EMA/159017/2012
English: The company that applied for authorisation is Galpharm Healthcare Ltd.
Slovenian: Vlogo za dovoljenje je predložila družba Galpharm Healthcare Ltd.
English: Sumatriptan Galpharm is a medicine that contains the active substance sumatriptan.
Slovenian: Sumatriptan Galpharm je zdravilo, ki vsebuje zdravilno učinkovino sumatriptan.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Sumatriptan Galpharm did not outweigh its risks and recommended that it be refused marketing authorisation.
Slovenian: Posledično je tedaj menil, da koristi zdravila Sumatriptan Galpharm ne odtehtajo z njim povezanih tveganj, in priporočil zavrnitev dovoljenja za promet s tem zdravilom.
English: What is Sumatriptan Galpharm?
Slovenian: Kaj je zdravilo Sumatriptan Galpharm?
English: In addition the CHMP felt that Sumatriptan Galpharm in the non-prescription setting is not appropriate because migraine as a condition changes over time as well as the patient's cardiovascular and cerebrovascular status, and monitoring is therefore essential.
Slovenian: Odbor je menil, da izdajanje zdravila Sumatriptan Galpharm brez recepta ni primerno tudi zato, ker se migrensko obolenje sčasoma spreminja, tako kot tudi kardio- in cerebrovaskularni status bolnika.
English: Sumatriptan Galpharm was expected to be used to relieve migraine attacks in people who had been diagnosed with migraine.
Slovenian: Zdravilo Sumatriptan Galpharm naj bi se uporabljalo za lajšanje migrenskih napadov pri ljudeh z diagnozo migrene.