FrancophonIA/ELRC3.0 huggingface dataset:
English: In post-marketing experience, anaphylaxis (including anaphylactic shock and rash generalised) has been reported very rarely following administration of tolvaptan.
Slovenian: V izkušnjah iz obdobja trženja so zelo redko po dajanju tolvaptan poročali o anafilaksi (vključno z anafilaktičnim šokom in generaliziranim izpuščanjem).
English: Tolvaptan may cause hyperglycaemia (see section 4.8).
Slovenian: Tolvaptan lahko povzroči hiperglikemijo (glejte poglavje 4.8).
English: How to take Jinarc
Slovenian: Kako jemati zdravilo Jinarc
English: • The Patient information leaflet
Slovenian: • komplet z informacijami za bolnika
English: In addition, increased use of allopurinol and other medicinal products used to manage gout were observed in the double-blind, placebo-controlled trial.
Slovenian: Poleg tega so v dvojno slepih, s placebom nadzorovanih preskušanjih opažali povečano uporabo alopurinola in drugih zdravil, ki se uporabljajo za nadzor protina.
English: The volume status of patients taking tolvaptan must be monitored to prevent dehydration (see section 4.4).
Slovenian: Zaradi preprečevanja dehidracije je treba spremljati volemijo bolnikov, ki jemljejo tolvaptan (glejte poglavje 4.4).
English: Jinarc 15 mg tablets 7 or 28 tablets in PVC/aluminium foil blister
Slovenian: Jinarc 15 mg tablete 7 ali 28 tablet v pretisnem omotu PVC/aluminijasta folija
English: Respiratory, thoracic and mediastinal disorders
Slovenian: Bolezni dihal, prsnega koša in mediastinalnega prostora dispneja
English: In a population pharmacokinetic analysis for patients with ADPKD, tolvaptan concentrations were increased, compared to healthy subjects, as renal function decreased below eGFR of 60 mL/min/1.73 m2. An eGFRCKD-EPI decrease from 72.2 to 9.79 (mL/min/1.73 m2) was associated with a 32 % reduction in total body clearance.
Slovenian: V populacijski analizi farmakokinetike pri bolnikih z ADPKD so se koncentracije tolvaptana v primerjavi z zdravimi osebami povečale, ko se je delovanje ledvic zmanjšalo pod eGFR 60 ml/min/1,73 m2.
English: The key secondary composite endpoint (ADPKD progression) was time to multiple clinical progression events of: 1) worsening kidney function (defined as a persistent [reproduced over at least 2 weeks] 25 %
Slovenian: 1) poslabšanja delovanja ledvic (opredeljenega kot trdovratnega [ponovljeno v vsaj 2 tednih] 25-%
English: OUTER CARTON (blisters in wallet card)
Slovenian: ZUNANJA ŠKATLA (pretisni omot in zgibanka)
English: • gout
Slovenian: • zgaga
English: • Healthcare professionals training material
Slovenian: • gradivo za usposabljanje zdravnikov
English: • Breast-feeding (see section 4.6)
Slovenian: • dojenje (glejte poglavje 4.6).
English: Jinarc 30 mg tablets 7 or 28 tablets in PVC/aluminium foil blister
Slovenian: Jinarc 30 mg tablete 7 ali 28 tablet v pretisnem omotu PVC/aluminijasta folija
English: This difference was maintained in the pre-specified MMRM analysis (3.15 mL/min/1.73 m2, 95 %CI 1.462 to 4.836, p = 0.0003) and with sensitivity analyses where baseline eGFR data were carried forward (2.64 mL/min/1.73 m2, 95 %CI 0.672 to 4.603, p = 0.0086).
Slovenian: 95-% interval zaupanja 1,462 do 4,836, p = 0,0003) in z analizami občutljivosti, pri čemer se podatki eGFR ob izhodišču preskušanja prenesejo naprej (2,64 ml/min/1,73 m interval zaupanja 0,672 do 4,603, p = 0,0086).
English: Patients may down-titrate to lower doses based on tolerability.
Slovenian: Na podlagi prenašanja se lahko bolnikov odmerek zmanjša na nižjega.
English: These may increase the effect of Jinarc.
Slovenian: Ta zdravila lahko povečajo učinek zdravila Jinarc.
English: Steady state digoxin concentrations were increased (1.3-fold in maximum observed plasma concentration [Cmax] and 1.2fold in area under the plasma concentration-time curve over the dosing interval [AUCτ]) when coadministered with multiple once daily 60 mg doses of tolvaptan.
Slovenian: Pri sočasnem dajanju z več odmerki tolvaptana 60 mg enkrat na dan so se koncentracije digoksina v stanju dinamičnega ravnovesja so se zvišale (1,3-kratnik največje opažene koncentracije v plazmi [Cmax] in 1,2-kratnik površine pod plazemsko koncentracijsko krivuljo v odvisnosti od časa med odmernim intervalom [AUCτ]).
English: The phase 3, multi-centre, international, randomized-withdrawal, placebo-controlled, double-blind trial 156-13-210 compared the efficacy and safety of tolvaptan (45 to 120 mg/day) to placebo in patients able to tolerate tolvaptan during a five-week titration and run-in period on tolvaptan.
Slovenian: Z multicentričnim, mednarodnim, z odtegnitvijo randomiziranim, s placebom nadzorovanim, dvojno slepim preskušanjem 3. faze št. 156-13-210 so primerjali učinkovitost in varnost tolvaptana (45
English: Jinarc is to be administered twice daily in split dose regimens of 45 mg + 15 mg, 60 mg + 30 mg or 90 mg + 30 mg.
Slovenian: Zdravilo Jinarc se daje dvakrat na dan po režimu razdeljenega odmerka 45 mg + 15 mg, 60 mg + 30 mg ali 90 mg + 30 mg. Jutranji odmerek je treba vzeti vsaj 30 minut pred jutranjim obrokom.
English: • pain in the abdomen
Slovenian: • bolečina v trebuhu
English: The active substance is tolvaptan.
Slovenian: Učinkovina je tolvaptan.
English: Jinarc 15 mg tablets: blisters with 7 or 28 tablets
Slovenian: Jinarc 15-mg tablete: pretisni omoti s 7 ali 28 tabletami
English: 2) medically significant kidney pain (defined as requiring prescribed leave, last-resort analgesics,
Slovenian: 2) medicinsko značilna bolečina ledvic (opredeljena kot bolečina, zaradi katere se predpiše bolniški stalež, analgetiki zadnjega izhoda, narkotiki in proti-nociceptivna zdravila, radiološki ali kirurški posegi)
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets Jinarc 30 mg tablets + Jinarc 60 mg tablets Jinarc 30 mg tablets + Jinarc 90 mg tablets
Slovenian: Jinarc 15 mg tablete + Jinarc 45 mg tablete Jinarc 30 mg tablete + Jinarc 60 mg tablete Jinarc 30 mg tablete + Jinarc 90 mg tablete
English: Fri.
Slovenian: • izpuščaj
English: 1,692 mL (height adjusted 972 mL/m).
Slovenian: (CKD-EPI), pri čemer jih je imelo 79 % hipertenzijo in povprečni TKV 1.692 ml (prilagojeno za višino 972 ml/m).
English: • itching of your skin
Slovenian: • srbenje kože
English: CYP3A inhibitors
Slovenian: Zaviralci CYP3A
English: Jinarc contains lactose as an excipient.
Slovenian: Zdravilo Jinarc vsebuje laktozo kot pomožno snov.
English: What Jinarc contains
Slovenian: Kaj vsebuje zdravilo Jinarc
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets Each 15 mg tablet contains 15 mg of tolvaptan.
Slovenian: Jinarc 15 mg tablete + Jinarc 45 mg tablete Ena 15-mg tableta vsebuje 15 mg tolvaptana.
English: Jinarc 30 mg tablets: blisters with 7 or 28 tablets
Slovenian: Jinarc 30-mg tablete: pretisni omoti s 7 ali 28 tabletami
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets EU/1/15/1000/005-007 (blister) EU/1/15/1000/014-016 (blister in wallet card)
Slovenian: Jinarc 15 mg tablete + Jinarc 45 mg tablete EU/1/15/1000/005-007 (pretisni omot) EU/1/15/1000/014-016 (pretisni omot in zgibanka)
English: • ADRs associated with long term use of Jinarc
Slovenian: • resnih neželenih učinkih, povezanih z dolgotrajno uporabo zdravila Jinarc
English: The expiry date refers to the last day of that month.
Slovenian: zgibanki in pretisnem omotu poleg oznake EXP. Rok uporabnosti zdravila se izteče na zadnji dan navedenega meseca.
English: At baseline, patients had average estimated glomerular filtration rate (eGFR) of 82 mL/min/1.73 m2 (CKD-EPI) with 79 % having hypertension and a mean TKV of
Slovenian: Na izhodišču so imeli bolniki povprečno ocenjeno stopnjo glomerularne filtracije (eGFR) 82 ml/min/1,73 m
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to benzazepine or benzazepine derivatives (see section 4.4)
Slovenian: • Preobčutljivost na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju 6.1,
English: • Volume depletion
Slovenian: • splošna oslabelost
English: Abdominal pain, Abdominal distension, Constipation, Dyspepsia,
Slovenian: Bolezni prebavil driska, suha usta bolečina v trebuhu, trebušna distenzija, konstipacija, dispepsija, gastroezofagealna refluksna bolezen
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets EU/1/15/1000/011-013 (blister) EU/1/15/1000/020-022 (blister in wallet card)
Slovenian: Jinarc 30 mg tablete + Jinarc 90 mg tablete EU/1/15/1000/011-013 (pretisni omot) EU/1/15/1000/020-022 (pretisni omot in zgibanka)
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets EU/1/15/1000/008-010 (blister) EU/1/15/1000/017-019 (blister in wallet card)
Slovenian: Jinarc 30 mg tablete + Jinarc 60 mg tablete EU/1/15/1000/008-010 (pretisni omot) EU/1/15/1000/017-019 (pretisni omot in zgibanka)
English: Serum sodium abnormalities
Slovenian: Nenormalnosti natrija v serumu
English: 35 % reduction in the LS means of change in eGFR of -2.34 mL/min/1.73 m in tolvaptan group relative to a -3.61 mL/min/1.73 m in placebo group observed over the course of one year.
Slovenian: Razlika v spremembi eGFR pri zdravljenju, opažena v enem letu tega preskušanja, je 1,27 ml/min/1,73 m2, kar predstavlja 35-% zmanjšanje mediane najmanjših kvadratov pri spremembi eGFR -2,34 ml/min/1,73 m v skupini, ki je prejemala tolvaptan, v primerjavi z -3,61 ml/min/1,73 m v skupini, ki je prejemala placebo.
English: Each 15 mg tablet contains approximately 35 mg lactose (as monohydrate).
Slovenian: Ena 15-mg tableta vsebuje približno 35 mg laktoze (v obliki monohidrata).
English: Jinarc 30 mg tablets
Slovenian: Jinarc 30 mg tablete
English: 45 mg tablet: blue, square (6.8 mm on a side, major axis 8.2 mm), shallow-convex, debossed with “OTSUKA” and “45” on one side
Slovenian: 45-mg tableta: modra, kvadratna (6,8 mm na stran, večja os: 8,2 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "45" na eni strani.
English: How to store Jinarc
Slovenian: Shranjevanje zdravila Jinarc
English: 30 mg tablet: blue, round, debossed with “OTSUKA” and “30” on one side.
Slovenian: 30-mg tableta: modra, okrogla z vtisnjenim napisom "OTSUKA" in "30" na eni strani.
English: Jinarc 45 mg tablets + Jinarc 15 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Slovenian: Jinarc 45-mg tablete + Jinarc 15-mg tablete: pretisni omoti z zgibanko ali brez nje s 14 (7 tablet večje jakosti + 7 tablet manjše jakosti), 28 (14 tablet večje jakosti + 14 tablet manjše jakosti) ali 56 (28 tablet večje jakosti + 28 tablet manjše jakosti) tabletami.
English: 15 mg tablet: blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Slovenian: 15-mg tableta: modra, trikotna (večja os: 6,58 mm, manjša os: 6,20 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "15" na eni strani.
English: 90 mg tablet: blue, pentagonal (major axis 9.7 mm, minor axis 9.5 mm), shallow-convex, debossed with “OTSUKA” and “90” on one side
Slovenian: 90-mg tableta: modra, peterokotna (večja os: 9,7 mm, manjša os: 9,5 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "90" na eni strani.
English: • nausea
Slovenian: • bruhanje
English: Cardiac disorders
Slovenian: Srčne bolezni palpitacije
English: Each 45 mg tablet contains 45 mg tolvaptan.
Slovenian: Ena 45-mg tableta vsebuje 45 mg tolvaptana.
English: Jinarc 15 mg tablets Jinarc 30 mg tablets Jinarc 45 mg tablets Jinarc 60 mg tablets Jinarc 90 mg tablets
Slovenian: Jinarc 15 mg tablete Jinarc 30 mg tablete Jinarc 45 mg tablete Jinarc 60 mg tablete Jinarc 90 mg tablete tolvaptan
English: Each 60 mg tablet contains 60 mg tolvaptan.
Slovenian: Ena 60-mg tableta vsebuje 60 mg tolvaptana.
English: Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate).
Slovenian: Ena 45-mg tableta vsebuje približno 12 mg laktoze (v obliki monohidrata).
English: Each 30 mg tablet contains 30 mg tolvaptan.
Slovenian: Ena 30-mg tableta vsebuje 30 mg tolvaptana.
English: Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate).
Slovenian: Ena 60-mg tableta vsebuje približno 16 mg laktoze (v obliki monohidrata).
English: Each 15 mg tablet contains 15 mg tolvaptan.
Slovenian: Ena 15-mg tableta vsebuje 15 mg tolvaptana.
English: • vomiting
Slovenian: • zasoplost
English: Jinarc 30 mg tablets tolvaptan
Slovenian: Jinarc 30 mg tablete tolvaptan
English: Jinarc 15 mg tablets
Slovenian: Jinarc 15 mg tablete
English: Each 90 mg tablet contains 90 mg tolvaptan.
Slovenian: Ena 90-mg tableta vsebuje 90 mg tolvaptana.
English: Blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Slovenian: Modra, trikotna (večja os: 6,58 mm, manjša os: 6,20 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "15" na eni strani.
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
Slovenian: Jinarc 30 mg tablete + Jinarc 60 mg tablete Ena 30-mg tableta vsebuje 30 mg tolvaptana.
English: Jinarc 60 mg tablets + Jinarc 30 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Slovenian: Jinarc 60-mg tablete + Jinarc 30-mg tablete: pretisni omoti z zgibanko ali brez nje s 14 (7 tablet večje jakosti + 7 tablet manjše jakosti), 28 (14 tablet večje jakosti + 14 tablet manjše jakosti) ali 56 (28 tablet večje jakosti + 28 tablet manjše jakosti) tabletami.
English: Age Clearance of tolvaptan is not significantly affected by age.
Slovenian: Starost Starost nima značilnega vpliva na očistek tolvaptana.
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets
Slovenian: Jinarc 15 mg tablete + Jinarc 45 mg tablete
English: Each 30 mg tablet contains approximately 70 mg lactose (as monohydrate).
Slovenian: Ena 30-mg tableta vsebuje približno 70 mg laktoze (v obliki monohidrata).
English: Jinarc 15 mg tablets tolvaptan
Slovenian: Jinarc 15 mg tablete tolvaptan
English: 60 mg tablet: blue, modified rectangular (major axis 9.9 mm, minor axis 5.6 mm), shallow-convex, debossed with “OTSUKA” and “60” on one side
Slovenian: 60-mg tableta: modra, modificiran pravokotnik (večja os: 9,9 mm, manjša os: 5,6 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "60" na eni strani.
English: Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate).
Slovenian: Ena 90-mg tableta vsebuje približno 24 mg laktoze (v obliki monohidrata).
English: Jinarc 90 mg tablets + Jinarc 30 mg tablets: blisters with or without wallet card with 14 (7 tablets of the higher strength + 7 tablets of the lower strength), 28 (14 tablets of the higher strength + 14 tablets of the lower strength) or 56 (28 tablets of the higher strength + 28 tablets of the lower strength) tablets.
Slovenian: Jinarc 90-mg tablete + Jinarc 30-mg tablete: pretisni omoti z zgibanko ali brez nje s 14 (7 tablet večje jakosti + 7 tablet manjše jakosti), 28 (14 tablet večje jakosti + 14 tablet manjše jakosti) ali 56 (28 tablet večje jakosti + 28 tablet manjše jakosti) tabletami.
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
Slovenian: Jinarc 30 mg tablete + Jinarc 90 mg tablete Ena 30-mg tableta vsebuje 30 mg tolvaptana.
English: 7 × 15 mg tablets and 7 × 45 mg tablets 14 × 15 mg tablets and 14 × 45 mg tablets 28 × 15 mg tablets and 28 × 45 mg tablets
Slovenian: 7 × 15 mg tablete in 7 × 45 mg tablete 14 × 15 mg tabletein 14 × 45 mg tablete 28 × 15 mg tablete in 28 × 45 mg tablete
English: 30 but greater than 15 mL/min/1.73 m
Slovenian: 3b 45 % (eGFR 30-45 ml/min/1,73 m
English: Jinarc 15 mg tablets Jinarc 45 mg tablets tolvaptan
Slovenian: Jinarc 15 mg tablete Jinarc 45 mg tablete tolvaptan
English: WALLET CARD
Slovenian: ZUNANJA ŠKATLA
English: • weight loss
Slovenian: • izguba telesne mase
English: • constipation
Slovenian: • utrujenost
English: Each tablet contains 15 mg tolvaptan.
Slovenian: Ena tableta vsebuje 15 mg tolvaptana.
English: • Hypernatraemia
Slovenian: • hipernatriemija.
English: Skin and subcutaneous tissue disorders
Slovenian: Bolezni kože in podkožja izpuščaj, pruritus
English: 7 × 15 mg tablets and 7 × 45 mg tablets in card packaging 14 × 15 mg tablets and 14 × 45 mg tablets in card packaging 28 × 15 mg tablets and 28 × 45 mg tablets in card packaging
Slovenian: 7 × 15 mg tablete in 7 × 45 mg tablete v zgibanka 14 × 15 mg tablete in 14 × 45 mg tablete v zgibanka 28 × 15 mg tablete in 28 × 45 mg tablete v zgibanka
English: Jinarc 30 mg tablets Jinarc 60 mg tablets tolvaptan
Slovenian: Jinarc 30 mg tablete Jinarc 60 mg tablete tolvaptan
English: EU/1/15/1000/005 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tablets (28 × 15 mg + 28 × 45 mg)
Slovenian: EU/1/15/1000/005 14 tablet (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tablet (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tablet (28 × 15 mg + 28 × 45 mg)
English: • Obligation to conduct post-authorisation measures
Slovenian: • Obveznosti izvajanja ukrepov po pridobitvi dovoljenja za promet Imetnik dovoljenja za promet z zdravilom mora v določenem časovnem okvirju izvesti naslednje ukrepe:
English: Each tablet contains 30 mg tolvaptan.
Slovenian: Ena tableta vsebuje 30 mg tolvaptana.
English: Each Jinarc 15 mg tablet contains 15 mg tolvaptan.
Slovenian: Ena 15-mg tableta zdravila Jinarc vsebuje 15 mg tolvaptana.
English: Each Jinarc 30 mg tablet contains 30 mg tolvaptan.
Slovenian: Ena 30-mg tableta zdravila Jinarc vsebuje 30 mg tolvaptana.
English: Jinarc 30 mg tablets Jinarc 90 mg tablets tolvaptan
Slovenian: Jinarc 30 mg tablete Jinarc 90 mg tablete tolvaptan
English: EU/1/15/1000/014 14 tablets (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tablets (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tablets (28 × 15 mg + 28 × 45 mg)
Slovenian: EU/1/15/1000/014 14 tablet (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tablet (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tablet (28 × 15 mg + 28 × 45 mg)
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets
Slovenian: Jinarc 30 mg tablete + Jinarc 60 mg tablete
English: 15 mg tablet: blue, triangular, debossed with “OTSUKA” and “15” on one side.
Slovenian: 45-mg tableta: modra, kvadratna z vtisnjenim napisom "OTSUKA" in "45" na eni strani.
English: 7 × 30 mg tablets and 7 × 90 mg tablets 14 × 30 mg tablets and 14 × 90 mg tablets 28 × 30 mg tablets and 28 × 90 mg tablets
Slovenian: 7 × 30 mg tablete in 7 × 90 mg tablete 14 × 30 mg tablete in 14 × 90 mg tablete 28 × 30 mg tablete in 28 × 90 mg tablete
English: Each Jinarc 45 mg tablet contains 45 mg tolvaptan.
Slovenian: Ena 45-mg tableta zdravila Jinarc vsebuje 45 mg tolvaptana.
English: Each Jinarc 60 mg tablet contains 60 mg tolvaptan.
Slovenian: Ena 60-mg tableta zdravila Jinarc vsebuje 60 mg tolvaptana.
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets
Slovenian: Jinarc 30 mg tablete + Jinarc 90 mg tablete
English: 30 mg tablet: blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Slovenian: 30-mg tableta: modra, okrogla (premer: 8 mm), plitko konveksna z vtisnjenim napisom "OTSUKA" in "30" na eni strani.
English: Each Jinarc 90 mg tablet contains 90 mg tolvaptan.
Slovenian: Ena 90-mg tableta zdravila Jinarc vsebuje 90 mg tolvaptana.
English: 7 × 30 mg tablets and 7 × 60 mg tablets 14 × 30 mg tablets and 14 × 60 mg tablets 28 × 30 mg tablets and 28 × 60 mg tablets
Slovenian: 7 × 30 mg tablete in 7 × 60 mg tablete 14 × 30 mg tablete in 14 × 60 mg tablete 28 × 30 mg tablete in 28 × 60 mg tablete
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 15 mg and 7 × 45 mg tablets
Slovenian: 14 tablet v 1 pretisnem omotu PVC/aluminijasta folija v zgibanki s 7 × 15 mg in 7 × 45 mg tabletami 28 tablet v 2 pretisnih omotih PVC/aluminijasta folija v zgibanki s 7 × 15 mg in 7 × 45 mg tabletami 56 tablet v 4 pretisnih omotih PVC/aluminijasta folija v zgibanki s 7 × 15 mg in 7 × 45 mg tabletami
English: EU/1/15/1000/008 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tablets (28 × 30 mg + 28 × 60 mg)
Slovenian: EU/1/15/1000/008 14 tablet (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tablet (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tablet (28 × 30 mg + 28 × 60 mg)
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 15 mg and 7 × 45 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 15 mg and 7 × 45 mg tablets
Slovenian: 14 tablet v 1 pretisnem omotu PVC/aluminijasta folija s 7 × 15 mg in 7 × 45 mg tabletami 28 tablet v 2 pretisnih omotih PVC/aluminijasta folija s 7 × 15 mg in 7 × 45 mg tabletami 56 tablet v 4 pretisnih omotih PVC/aluminijasta folija s 7 × 15 mg in 7 × 45 mg tabletami
English: Anaphylactic shock,
Slovenian: Bolezni imunskega sistema anafilaktični šok, generalizirani izpuščaj
English: 7 × 30 mg tablets and 7 × 90 mg tablets in card packaging 14 × 30 mg tablets and 14 × 90 mg tablets in card packaging 28 × 30 mg tablets and 28 × 90 mg tablets in card packaging
Slovenian: 7 × 30 mg tablete in 7 × 90 mg tablete v zgibanka 14 × 30 mg tablete in 14 × 90 mg tablete v zgibanka 28 × 30 mg tablete in 28 × 90 mg tablete v zgibanka
English: Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Slovenian: Tél/Tel: +31 (0) 20 85 46 555
English: EU/1/15/1000/020 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tablets (28 × 30 mg + 28 × 90 mg)
Slovenian: EU/1/15/1000/020 14 tablet (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tablet (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tablet (28 × 30 mg + 28 × 90 mg)
English: EU/1/15/1000/011 14 tablets (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tablets (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tablets (28 × 30 mg + 28 × 90 mg)
Slovenian: EU/1/15/1000/011 14 tablet (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tablet (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tablet (28 × 30 mg + 28 × 90 mg)
English: • heartburn
Slovenian: • srbečica
English: Otsuka Pharmaceutical Netherlands B.V. Teл: +31 (0) 20 85 46 555
Slovenian: Teл: +31 (0) 20 85 46 555
English: 7 × 30 mg tablets and 7 × 60 mg tablets in card packaging 14 × 30 mg tablets and 14 × 60 mg tablets in card packaging 28 × 30 mg tablets and 28 × 60 mg tablets in card packaging
Slovenian: 7 × 30 mg tablete in 7 × 60 mg tablete v zgibanka 14 × 30 mg tablete in 14 × 60 mg tablete v zgibanka 28 × 30 mg tablete in 28 × 60 mg tablete v zgibanka
English: EU/1/15/1000/017 14 tablets (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tablets (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tablets (28 × 30 mg + 28 × 60 mg)
Slovenian: EU/1/15/1000/017 14 tablet (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tablet (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tablet (28 × 30 mg + 28 × 60 mg)
English: Jinarc 15 mg tablets EU/1/15/1000/001-002 (blister)
Slovenian: Jinarc 15 mg tablete EU/1/15/1000/001-002 (pretisni omot) Jinarc 30 mg tablete EU/1/15/1000/001-004 (pretisni omot)
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 60 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 60 mg tablets
Slovenian: 14 tablet v 1 pretisnem omotu PVC/aluminijasta folija v zgibanki s 7 × 30 mg in 7 × 60 mg tabletami 28 tablet v 2 pretisnih omotih PVC/aluminijasta folija v zgibanki s 7 × 30 mg in 7 × 60 mg tabletami 56 tablet v 4 pretisnih omotih PVC/aluminijasta folija v zgibanki s 7 × 30 mg in 7 × 60 mg tabletami