natgillin/translations-raw huggingface dataset:
EU/1/16/1124/001 1 pre-filled pen EU/1/16/1124/009 4 pre-filled pens (4 packs of 1) EU/1/16/1124/010 6 pre-filled pens (6 packs of 1) EU/1/16/1124/057 4 pre-filled pens (1 pack of 4) EU/1/16/1124/058 12 pre-filled pens (3 packs of 4)
EU/1/16/1124/001 1 napolnjen injekcijski peresnik EU/1/16/1124/009 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/010 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/057 4 napolnjeni injekcijski peresniki (1 pakiranje po 4) EU/1/16/1124/058 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
EU/1/16/1124/006 1 pre-filled pen 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/1/16/1124/067 4 pre-filled pens (1 pack of 4) EU/1/16/1124/068 12 pre-filled pens (3 packs of 4)
EU/1/16/1124/006 1 napolnjen injekcijski peresnik 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/1/16/1124/067 4 napolnjeni injekcijski peresniki (1 pakiranje po 4) EU/1/16/1124/068 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
Multipack: 6 (6 packs of 1) pre-filled syringes (1.0 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (1,0 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
Nordimet 25 mg solution for injection in pre-filled pen methotrexate
Nordimet 25 mg raztopina za injiciranje v napolnjeni injekcijski brizgi metotreksat
EU/1/16/1124/040 1 pre-filled syringe EU/1/16/1124/041 4 pre-filled syringes (4 packs of 1) EU/1/16/1124/042 6 pre-filled syringes (6 packs of 1) EU/1/16/1124/054 12 pre-filled syringes (12 packs of 1)
EU/1/16/1124/040 1 napolnjena injekcijska brizga 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)
EU/1/16/1124/007 1 pre-filled pen 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/1/16/1124/069 4 pre-filled pens (1 pack of 4) EU/1/16/1124/070 12 pre-filled pens (3 packs of 4)
EU/1/16/1124/007 1 napolnjen injekcijski peresnik 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/1/16/1124/069 4 napolnjeni injekcijski peresniki (1 pakiranje po 4) EU/1/16/1124/070 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
EU/1/16/1124/017 4 pre-filled pens (4 packs of 1) EU/1/16/1124/018 6 pre-filled pens (6 packs of 1) EU/1/16/1124/066 12 pre-filled pens (3 packs of 4)
EU/1/16/1124/017 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/018 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/066 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
1 pre-filled syringe (1 ml) with pre-assembled needle with needle guard and 2 alcohol swabs Multipack: 4 (4 packs of 1) pre-filled syringes (1.0 ml) with pre-assembled needle with needle guard and alcohol swabs
1 napolnjena injekcijska brizga (1,0 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici Skupno pakiranje: 4 (4 pakiranja po 1) napolnjene injekcijske brizge (1,0 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
EU/1/16/1124/009 4 pre-filled pens (4 packs of 1) EU/1/16/1124/010 6 pre-filled pens (6 packs of 1) EU/1/16/1124/058 12 pre-filled pens (3 packs of 4)
EU/1/16/1124/009 4 napolnjeni injekcijski peresniki (4 pakiranja po 1) EU/1/16/1124/010 6 napolnjenih injekcijskih peresnikov (6 pakiranj po 1) EU/1/16/1124/058 12 napolnjenih injekcijskih peresnikov (3 pakiranja po 4)
4 pre-filled pens (0.6 ml) with pre-assembled needle and 4 alcohol swabs.
4 napolnjeni injekcijski peresniki (0,6 ml) s pritrjeno injekcijsko iglo in 4 alkoholnimi blazinicami.
EU/1/16/1124/052 - 12 pack
EU/1/16/1124/052 - pakiranje po 12
1 pre-filled syringe (0.9 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
1 napolnjena injekcijska brizga (0,9 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici.
Multipack: 12 (12 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,7 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
EU/1/16/1124/033 - 6 pack
EU/1/16/1124/033 - pakiranje po 6
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
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
Multipack: 12 (12 packs of 1) pre-filled syringes (0.5 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,5 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
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
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
1 pre-filled syringe (0.4 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
1 napolnjena injekcijska brizga (0,4 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici.
1 pre-filled syringe (0.6 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
1 napolnjena injekcijska brizga (0,6 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici.
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)
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)
Multipack: 6 (6 packs of 1) pre-filled syringes (0.5 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,5 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
EU/1/16/1124/065 - 4 pack (1 pack of 4) EU/1/16/1124/066 - 12 pack
EU/1/16/1124/065 - pakiranje po 4 (1 pakiranje po 4) EU/1/16/1124/066 - pakiranje po 12
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)
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)
Nervous system disorders
imate oslabljen imunski sistem.
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)
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)
Please refer to the patient information leaflet for instructions on how to use the pre-filled pen or prefilled syringe.
Za uporabo napolnjenega injekcijskega peresnika ali napolnjene injekcijske brizge glejte navodilo za uporabo.
Multipack: 6 (6 packs of 1) pre-filled syringes (0.7 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,7 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
4 pre-filled pens (0.3 ml) with pre-assembled needle and 4 alcohol swabs.
4 napolnjeni injekcijski peresniki (0,3 ml) s pritrjeno injekcijsko iglo in 4 alkoholnimi blazinicami.
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)
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)
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)
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)
EU/1/16/1124/030 - 6 pack
EU/1/16/1124/030 - pakiranje po 6
4 pre-filled pens (0.4 ml) with pre-assembled needle and 4 alcohol swabs.
4 napolnjeni injekcijski peresniki (0,4 ml) s pritrjeno injekcijsko iglo in 4 alkoholnimi blazinicami.
Very common: Abnormal liver function tests (increased ALAT, ASAT, alkaline phosphatase and bilirubin).
Bolezni jeter, žolčnika in žolčevodov (glejte poglavje 4.4) Zelo pogosti: nenormalni testi jetrne funkcije (zvišane vrednosti ALAT, ASAT, alkalne fosfataze in bilirubina)
Multipack: 6 (6 packs of 1) pre-filled syringes (0.9 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,9 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
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)
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)
Nordimet 20 mg solution for injection in pre-filled pen methotrexate
Nordimet 20 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku metotreksat
Multipack: 12 (12 packs of 1) pre-filled syringes (0.9 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,9 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
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)
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)
1 pre-filled pen (0.3 ml) with pre-assembled needle and 1 alcohol swab.
1 napolnjen injekcijski peresnik (0,3 ml) s pritrjeno injekcijsko iglo in 1 alkoholna blazinica.
EU/1/16/1124/061 - 4 pack (1 pack of 4) EU/1/16/1124/062 - 12 pack
EU/1/16/1124/061 - pakiranje po 4 (1 pakiranje po 4) EU/1/16/1124/062 - pakiranje po 12
Multipack: 12 (12 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,3 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
Multipack: 6 (6 packs of 1) pre-filled syringes (0.3 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,3 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
Multipack: 12 (12 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,4 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
1 pre-filled syringe (0.3 ml) with pre-assembled needle with needle guard and 2 alcohol swabs.
1 napolnjena injekcijska brizga (0,3 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici.
Multipack: 6 (6 packs of 1) pre-filled syringes (0.4 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,4 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
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
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
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
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
Multipack: 12 (12 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,6 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
Multipack: 6 (6 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,8 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
Multipack: 12 (12 packs of 1) pre-filled syringes (0.8 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 12 (12 pakiranj po 1) napolnjenih injekcijskih brizg (0,8 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
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)
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)
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
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
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)
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)
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
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
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)
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)
Nordimet 10 mg solution for injection in pre-filled pen methotrexate
Nordimet 10 mg raztopina za injiciranje v napolnjenem injekcijskem peresniku metotreksat
Multipack: 6 (6 packs of 1) pre-filled syringes (0.6 ml) with pre-assembled needle with needle guard and alcohol swabs
Skupno pakiranje: 6 (6 pakiranj po 1) napolnjenih injekcijskih brizg (0,6 ml) s pritrjeno injekcijsko iglo s ščitnikom in alkoholne blazinice
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
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
How to give yourself an injection of Nordimet If you have difficulty handling the syringe, ask your doctor or pharmacist.
Če imate težave pri ravnanju z brizgo, se posvetujte z zdravnikom ali farmacevtom.
Not known: Proteinuria.
Občasni: omotica
Rare: Renal failure, oliguria, anuria, electrolyte disturbances.
Občasni: vnetje in razjeda sečnega mehurja, okvara ledvic, moteno uriniranje Redki: ledvična odpoved, oligurija, anurija, motnje elektrolitskega ravnotežja Neznana pogostnost: proteinurija
1 pre-filled syringe (0.8 ml) with pre-assembled needle and needle guard and 2 alcohol swabs.
1 napolnjena injekcijska brizga (0,8 ml) s pritrjeno injekcijsko iglo s ščitnikom in 2 alkoholni blazinici.
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)
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)
For Orlistat 60 mg capsules:
Orlistat 60 mg kapsule:
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.”
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.
The capsule should be swallowed with water.”
Kapsulo vzemite z vodo. "
“[Product name] can be taken immediately before, during a meal or up to one hour after a meal.
"Zdravilo [ime zdravila] lahko vzamete tik pred obroki, med njimi ali največ eno uro po njih.
“Other medicines and [Product name]”
"Druga zdravila in zdravilo [ime zdravila] "
Section 4.8 “Hepatitis that may be serious”
"hepatitis, ki je lahko resen"
• “oxalate nephropathy (build up of calcium oxalate which may lead to kidney stones).
• oksalatna nefropatija (nalaganje kalcijevega oksalata, ki lahko vodi do ledvičnih kamnov).
• “Hepatitis (inflammation of the liver).
• "hepatitis (vnetje jeter).
SECTION 4 - POSSIBLE SIDE EFFECTS
MOŽNI NEŽELENI UČINKI
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).”
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. "
See Chapter 2, take extra care with [Product name]”
Glejte poglavje 2, Bodite posebno pozorni pri jemanju zdravila [ime zdravila]. "
[Product name] is not recommended for people taking acarbose.”
Zdravilo [ime zdravila] ni priporočljivo za ljudi, ki jemljejo akarbozo. "
ANNEX III AMENDMENTS TO BE INCLUDED IN THE RELEVANT SECTIONS OF THE SUMMARY OF PRODUCTS CHARACTERISTICS AND PACKAGE LEAFLET
SPREMEMBE ZA VKLJUČITEV V USTREZNO POGLAVJE POVZETKA GLAVNIH ZNAČILNOSTI ZDRAVILA IN NAVODILA ZA UPORABO
• “- acarbose (an anti-diabetic drug used to treat type 2 diabetes mellitus).
• "akarbozo (zdravilo za zdravljenje sladkorne bolezni tipa 2).
The following wording should be included in the package leaflet of the marketing authorisations to be varied, as relevant:
V navodilo za uporabo zdravila v sklopu dovoljenja za promet z zdravilom, ki bo spremenjeno, se vključi naslednje besedilo, kot je ustrezno:
SECTION 3 - HOW TO TAKE [PRODUCT NAME]
KAKO JEMATI ZDRAVILO [IME ZDRAVILA]
SECTION 2 - BEFORE YOU TAKE [PRODUCT NAME]
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO [IME ZDRAVILA]
Temozolomide Sandoz 5 mg
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)
The European Commission issued a decision on 27 February 2017.
Evropska komisija je sklep izdala 27. februarja 2017.
What is gentamicin?
Kaj je gentamicin?
Outcome of a referral procedure under Article 35 of Directive 2001/82/EC (EMEA/V/A/117)
Izid napotitvenega postopka v skladu s členom 35 Direktive 2001/82/ES (EMEA/V/A/117)
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).
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).
Questions and answers on veterinary medicinal products containing gentamicin presented as solutions for injection to be administered to cattle and pigs EMA/144816/2017
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