FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 pre-filled syringe (0.9 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Slovenian: 1 napolnjena injekcijska brizga (0,9 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici.
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,7 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: EU/1/16/1124/033 - 6 pack
Slovenian: EU/1/16/1124/033 - pakiranje po 6
English: 1 pre-filled syringe (0.9 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.9 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: 1 napolnjena injekcijska brizga (0,9 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici Skupno pakiranje: 4 (4 pakiranja po 1) napolnjene injekcijske brizge (0,9 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.5 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,5 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: 1 pre-filled syringe (0.8 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: 1 napolnjena injekcijska brizga (0,8 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici Skupno pakiranje: 4 (4 pakiranja po 1) napolnjene injekcijske brizge (0,8 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: 1 pre-filled syringe (0.4 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Slovenian: 1 napolnjena injekcijska brizga (0,4 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici.
English: 1 pre-filled syringe (0.6 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Slovenian: 1 napolnjena injekcijska brizga (0,6 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici.
English: EU/1/16/1124/021 4 pre-filled pens (4 packs of 1) EU/1/16/1124/022 6 pre-filled pens (6 packs of 1) EU/1/16/1124/070 12 pre-filled pens (3 packs of 4)
Slovenian: EU/1/16/1124/021 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/022 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/070 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.5 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,5 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: EU/1/16/1124/065 - 4 pack (1 pack of 4) EU/1/16/1124/066 - 12 pack
Slovenian: EU/1/16/1124/065 - pakiranje po 4 (1 pakiranje po 4) EU/1/16/1124/066 - pakiranje po 12
English: EU/1/16/1124/044 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/045 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/055 12 pre-filled syringes (12 packs of 1)
Slovenian: EU/1/16/1124/044 4 napolnjene injekcijske brizge (4 pakiranja po 1) EU/1/16/1124/045 6 napolnjenih injekcijskih brizg (6 pakiranj po 1) EU/1/16/1124/055 12 napolnjenih injekcijskih brizg (12 pakiranj po 1)
English: Nervous system disorders
Slovenian: imate oslabljen imunski sistem.
English: EU/1/16/1124/041 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/042 6 pre-filled syinges (6 packs of 1) EU/1/16/1124/054 12 pre-filled syringes (12 packs of 1)
Slovenian: EU/1/16/1124/041 4 napolnjene injekcijske brizge (4 pakiranja po 1) EU/1/16/1124/042 6 napolnjenih injekcijskih brizg (6 pakiranj po 1) EU/1/16/1124/054 12 napolnjenih injekcijskih brizg (12 pakiranj po 1)
English: Please refer to the patient information leaflet for instructions on how to use the pre-filled pen or prefilled syringe.
Slovenian: Za uporabo napolnjenega injekcijskega peresnika ali napolnjene injekcijske brizge glejte navodilo za uporabo.
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,7 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: 4 pre-filled pens (0.3 ml) with pre-assembled needle and 4 alcohol swabs.
Slovenian: 4 napolnjeni injekcijski peresniki (0,3 ml) s pritrjeno injekcijsko iglo in 4 alkoholnimi blazinicami.
English: EU/1/16/1124/023 4 pre-filled pens (4 packs of 1) EU/1/16/1124/024 6 pre-filled pens (6 packs of 1) EU/1/16/1124/072 12 pre-filled pens (3 packs of 4)
Slovenian: EU/1/16/1124/023 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/024 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/072 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
English: EU/1/16/1124/002 1 pre-filled pen EU/1/16/1124/011 4 pre-filled pens (4 packs of 1) EU/1/16/1124/012 6 pre-filled pens (6 packs of 1) EU/1/16/1124/059 4 pre-filled pens (1 pack of 4) EU/1/16/1124/060 12 pre-filled pens (3 packs of 4)
Slovenian: EU/1/16/1124/002 1 napolnjen injekcijski peresnik EU/1/16/1124/011 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/012 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/059 4 napolnjeni injekcijski peresniki (1 pakiranje po 4) EU/1/16/1124/060 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
English: EU/1/16/1124/030 - 6 pack
Slovenian: EU/1/16/1124/030 - pakiranje po 6
English: 4 pre-filled pens (0.4 ml) with pre-assembled needle and 4 alcohol swabs.
Slovenian: 4 napolnjeni injekcijski peresniki (0,4 ml) s pritrjeno injekcijsko iglo in 4 alkoholnimi blazinicami.
English: Very common: Abnormal liver function tests (increased ALAT, ASAT, alkaline phosphatase and bilirubin).
Slovenian: Bolezni jeter, žolčnika in žolčevodov (glejte poglavje 4.4) Zelo pogosti: nenormalni testi jetrne funkcije (zvišane vrednosti ALAT, ASAT, alkalne fosfataze in bilirubina)
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.9 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,9 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: EU/1/16/1124/019 4 pre-filled pens (4 packs of 1) EU/1/16/1124/020 6 pre-filled pens (6 packs of 1) EU/1/16/1124/068 12 pre-filled pens (3 packs of 4)
Slovenian: EU/1/16/1124/019 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/020 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/068 12 napolnjenih injekcijskih peresnikov (3 pakiranj po 4)
English: Nordimet 20 mg solution for injection in pre-filled pen methotrexate
Slovenian: Nordimet 20 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku metotreksat
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.9 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,9 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: EU/1/16/1124/004 1 pre-filled pen EU/1/16/1124/015 4 pre-filled pens (4 packs of 1) EU/1/16/1124/016 6 pre-filled pens (6 packs of 1) EU/1/16/1124/063 4 pre-filled pens (1 pack of 4) EU/1/16/1124/064 12 pre-filled pens (3 packs of 4)
Slovenian: EU/1/16/1124/004 1 napolnjen injekcijski peresnik EU/1/16/1124/015 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/016 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/063 4 napolnjeni injekcijski peresniki (1 pakiranje po 4) EU/1/16/1124/064 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
English: 1 pre-filled pen (0.3 ml) with pre-assembled needle and 1 alcohol swab.
Slovenian: 1 napolnjen injekcijski peresnik (0,3 ml) s pritrjeno injekcijsko iglo in 1 alkoholna blazinica.
English: EU/1/16/1124/061 - 4 pack (1 pack of 4) EU/1/16/1124/062 - 12 pack
Slovenian: EU/1/16/1124/061 - pakiranje po 4 (1 pakiranje po 4) EU/1/16/1124/062 - pakiranje po 12
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,3 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,3 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,4 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: 1 pre-filled syringe (0.3 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
Slovenian: 1 napolnjena injekcijska brizga (0,3 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici.
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,4 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: 1 pre-filled syringe (0.6 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: 1 napolnjena injekcijska brizga (0,6 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici Skupno pakiranje: 4 (4 pakiranja po 1) napolnjene injekcijske brizge (0,6 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: 1 pre-filled syringe (0.3 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: 1 napolnjena injekcijska brizga (0,3 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici Skupno pakiranje: 4 (4 pakiranja po 1) napolnjene injekcijske brizge (0,3 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,6 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,8 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: Multipack: 12 (12 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,8 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: EU/1/16/1124/015 4 pre-filled pens (4 packs of 1) EU/1/16/1124/016 6 pre-filled pens (6 packs of 1) EU/1/16/1124/064 12 pre-filled pens (3 packs of 4)
Slovenian: EU/1/16/1124/015 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/016 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/064 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
English: Nordimet 7.5 mg solution for injection in pre-filled syringe Nordimet 10 mg solution for injection in pre-filled syringe Nordimet 12.5 mg solution for injection in pre-filled syringe Nordimet 15 mg solution for injection in pre-filled syringe Nordimet 17.5 mg solution for injection in pre-filled syringe Nordimet 20 mg solution for injection in pre-filled syringe Nordimet 22.5 mg solution for injection in pre-filled syringe Nordimet 25 mg solution for injection in pre-filled syringe methotrexate
Slovenian: Nordimet 7,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 10 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 12,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 15 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 17,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 20 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 22,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 25 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku metotreksat
English: EU/1/16/1124/003 1 pre-filled pen EU/1/16/1124/013 4 pre-filled pens (4 packs of 1) EU/1/16/1124/014 6 pre-filled pens (6 packs of 1) EU/1/16/1124/061 4 pre-filled pens (1 pack of 4) EU/1/16/1124/062 12 pre-filled pens (3 packs of 4)
Slovenian: EU/1/16/1124/003 1 napolnjen injekcijski peresnik EU/1/16/1124/013 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/014 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/061 4 napolnjeni injekcijski peresniki (1 pakiranje po 4) EU/1/16/1124/062 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
English: 1 pre-filled syringe (0.4 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: 1 napolnjena injekcijska brizga (0,4 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici Skupno pakiranje: 4 (4 pakiranja po 1) napolnjene injekcijske brizge (0,4 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: EU/1/16/1124/011 4 pre-filled pens (4 packs of 1) EU/1/16/1124/012 6 pre-filled pens (6 packs of 1) EU/1/16/1124/060 12 pre-filled pens (3 packs of 4)
Slovenian: EU/1/16/1124/011 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/012 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/060 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
English: Nordimet 10 mg solution for injection in pre-filled pen methotrexate
Slovenian: Nordimet 10 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku metotreksat
English: Multipack: 6 (6 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle guard and alcohol swabs
Slovenian: Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,6 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
English: Nordimet 7.5 mg solution for injection in pre-filled syringe Nordimet 10 mg solution for injection in pre-filled syringe Nordimet 12.5 mg solution for injection in pre-filled syringe Nordimet 15 mg solution for injection in pre-filled syringe Nordimet 17.5 mg solution for injection in pre-filled syringe Nordimet 20 mg solution for injection in pre-filled syringe Nordimet 22.5 mg solution for injection in pre-filled syringe Nordimet 25 mg solution for injection in pre-filled syringe
Slovenian: Nordimet 7,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 10 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 12,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 15 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 17,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 20 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 22,5 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku Nordimet 25 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku
English: How to give yourself an injection of Nordimet If you have difficulty handling the syringe, ask your doctor or pharmacist.
Slovenian: Če imate težave pri ravnanju z brizgo, se posvetujte z zdravnikom ali farmacevtom.
English: Not known: Proteinuria.
Slovenian: Občasni: omotica
English: Rare: Renal failure, oliguria, anuria, electrolyte disturbances.
Slovenian: Občasni: vnetje in razjeda sečnega mehurja, okvara ledvic, moteno uriniranje Redki: ledvična odpoved, oligurija, anurija, motnje elektrolitskega ravnotežja Neznana pogostnost: proteinurija
English: 1 pre-filled syringe (0.8 ml) with pre-assembled needle and needle guard and 2 alcohol swabs.
Slovenian: 1 napolnjena injekcijska brizga (0,8 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici.
English: EU/1/16/1124/013 4 pre-filled pens (4 packs of 1) EU/1/16/1124/014 6 pre-filled pens (6 packs of 1) EU/1/16/1124/062 12 pre-filled pens (3 packs of 4)
Slovenian: EU/1/16/1124/013 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/014 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/062 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
English: For Orlistat 60 mg capsules:
Slovenian: Orlistat 60 mg kapsule:
English: Symptoms can include yellowing skin and eyes, itching, dark coloured urine, stomach pain and liver tenderness (indicated by pain under the front of the rib cage on your right hand side), sometimes with loss of appetite.”
Slovenian: Simptomi lahko vključujejo porumenelost kože in oči, srbenje, temno obarvan urin, bolečine v trebuhu in otrdela jetra (kar se kaže z bolečino pod prsnim košem na desni strani), včasih z izgubo apetita.
English: The capsule should be swallowed with water.”
Slovenian: Kapsulo vzemite z vodo. "
English: “[Product name] can be taken immediately before, during a meal or up to one hour after a meal.
Slovenian: "Zdravilo [ime zdravila] lahko vzamete tik pred obroki, med njimi ali največ eno uro po njih.
English: “Other medicines and [Product name]”
Slovenian: "Druga zdravila in zdravilo [ime zdravila] "
English: Section 4.8 “Hepatitis that may be serious”
Slovenian: "hepatitis, ki je lahko resen"
English: • “oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).
Slovenian: • oksalatna nefropatija (nalaganje kalcijevega oksalata, ki lahko vodi do ledvičnih kamnov).
English: • “Hepatitis (inflammation of the liver).
Slovenian: • "hepatitis (vnetje jeter).
English: SECTION 4 - POSSIBLE SIDE EFFECTS
Slovenian: MOŽNI NEŽELENI UČINKI
English: For Orlistat 120 mg capsules: “[Product name] is not recommended for people taking acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).”
Slovenian: Orlistat 120 mg kapsule: "Uporaba zdravila [ime zdravila] pri ljudeh, ki jemljejo akarbozo (zdravilo, ki se uporablja pri zdravljenju sladkorne bolezni tipa 2), ni priporočljiva. "
English: See Chapter 2, take extra care with [Product name]”
Slovenian: Glejte poglavje 2, Bodite posebno pozorni pri jemanju zdravila [ime zdravila]. "
English: [Product name] is not recommended for people taking acarbose.”
Slovenian: Zdravilo [ime zdravila] ni priporočljivo za ljudi, ki jemljejo akarbozo. "
English: ANNEX III AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS AND PACKAGE LEAFLET
Slovenian: SPREMEMBE ZA VKLJUČITEV V USTREZNO POGLAVJE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
English: • “- acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
Slovenian: • "akarbozo (zdravilo za zdravljenje sladkorne bolezni tipa 2).
English: The following wording should be included in the package leaflet of the marketing authorisations to be varied, as relevant:
Slovenian: V navodilo za uporabo zdravila v sklopu dovoljenja za promet z zdravilom, ki bo spremenjeno, se vključi naslednje besedilo, kot je ustrezno:
English: SECTION 3 - HOW TO TAKE [PRODUCT NAME]
Slovenian: KAKO JEMATI ZDRAVILO [IME ZDRAVILA]
English: SECTION 2 - BEFORE YOU TAKE [PRODUCT NAME]
Slovenian: KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO [IME ZDRAVILA]
English: Temozolomide Sandoz 5 mg
Slovenian: EU/1/10/617/034 Temozolomid Sandoz 180 mg kapsula, trda peroralna uporaba vrečica (PET/alu/PE) 20 x 1 kapsula (odmerek enote) EU/1/10/617/035 Temozolomid Sandoz 250 mg kapsula, trda peroralna uporaba vrečica (PET/alu/PE) 5 x 1 kapsula (odmerek enote) EU/1/10/617/036 Temozolomid Sandoz 250 mg kapsula, trda peroralna uporaba vrečica (PET/alu/PE) 20 x 1 kapsula (odmerek enote)
English: The European Commission issued a decision on 27 February 2017.
Slovenian: Evropska komisija je sklep izdala 27. februarja 2017.
English: What is gentamicin?
Slovenian: Kaj je gentamicin?
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 February 2017
Slovenian: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27.
English: Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/117)
Slovenian: Izid napotitvenega postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/117)
English: The CVMP was requested to review all available residue depletion data and recommend withdrawal periods for cattle (meat and milk) and pigs (meat and offal).
Slovenian: Odbor CVMP je bil zaprošen, da pregleda vse razpoložljive podatke o izločanju ostankov ter priporoči karence za govedo (meso in mleko) in prašiče (meso in organe).
English: Questions and answers on veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs EMA/144816/2017
Slovenian: Vprašanja in odgovori o zdravilih za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje za dajanje govedu in prašičem EMA/144816/2017
English: On 8 January 2016, Belgium initiated a procedure under Article 35 of Directive 2001/82/EC for veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs, due to concerns related to the withdrawal periods set for the aforementioned products.
Slovenian: Belgija je 8. januarja 2016 sprožila postopek v skladu s členom 35 Direktive 2001/82/ES za zdravila za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje za dajanje govedu in prašičem, in sicer zaradi pomislekov glede karenc, določenih za zgoraj navedene
English: Belgium noted that there are different approved withdrawal periods for cattle and pigs for veterinary medicinal products containing gentamicin presented as solutions for injection across the European Union, e.g. cattle meat and offal from 28 days to 210 days; cattle milk from 2 to 7 days, with some of the products stating ‘do not use in cows whose milk is intended for human consumption'; and pig meat and offal from 28 days to 150 days.
Slovenian: Na primer karenca za goveje meso in organe je od 28 do 210 dni, za kravje mleko od 2 do 7 dni, pri čemer je za nekatera zdravila navedeno „ne uporabljajte pri kravah, katerih mleko je namenjeno za prehrano ljudi“, za prašičje meso in organe pa od 28 do 150 dni.
English: On 10 November 2016, the European Medicines Agency (the Agency) completed a review of the consumer safety of the withdrawal periods for cattle (meat and milk) and pigs (meat and offal) for veterinary medicinal products containing gentamicin presented as solutions for injection.
Slovenian: Evropska agencija za zdravila (agencija) je 10. novembra 2016 zaključila pregled varnosti potrošnikov glede karenc za govedo (meso in mleko) in prašiče (meso in organi) za zdravila za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje.
English: Why were veterinary medicinal products containing gentamicin presented as solutions for injection reviewed?
Slovenian: Zakaj so bila pregledana zdravila za uporabo v veterinarski medicini, ki vsebujejo gentamicin in so v obliki raztopine za injiciranje?