FrancophonIA/ELRC3.0 huggingface dataset:
English: 15 mg tablet: blue, triangular, debossed with “OTSUKA” and “15” on one side.
Latvian: 15 mg tablete: zila, trīsstūraina, ar vienā pusē iegravētu „OTSUKA” un „15”.
English: The healthcare professional training material shall contain the following key elements
Latvian: Veselības aprūpes speciālistu apmācības materiālam jāaptver šādas pamattēmas:
English: Dose reduction of tolvaptan is recommended for patients while taking moderate or strong CYP3A inhibitors (see section 4.2).
Latvian: Lietojot mērenus vai spēcīgus CYP3A inhibitorus, ieteicams samazināt tolvaptāna devu (skatīt 4.2. apakšpunktu).
English: Dose adjustment for patients taking moderate CYP3A inhibitors In patients taking moderate CYP3A inhibitors, tolvaptan doses have to be reduced as follows:
Latvian: Devas pielāgošana pacientiem, kuri lieto mērenus CYP3A inhibitorus Pacientiem, kuri lieto mērenus CYP3A inhibitorus, tolvaptāna deva jāsamazina šādi: Tolvaptāna dalītā dienas deva Samazināta dalītā deva 90+30 mg
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)
Latvian: Jinarc 30 mg tabletes + Jinarc 90 mg tabletes EU/1/15/1000/011-013 (blisteris) EU/1/15/1000/020-022 (blisteris maciņā)
English: Each 15 mg tablet contains approximately 35 mg lactose (as monohydrate).
Latvian: Katra 15 mg tablete satur aptuveni 35 mg laktozes (monohidrāta veidā).
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)
Latvian: Jinarc 30 mg tabletes + Jinarc 60 mg tabletes EU/1/15/1000/008-010 (blisteris) EU/1/15/1000/017-019 (blisteris maciņā)
English: Each Jinarc 30 mg tablet contains 30 mg tolvaptan.
Latvian: Katra Jinarc 30 mg tablete satur 30 mg tolvaptāna.
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
Latvian: 7 × 15 mg tabletes un 7 × 45 mg tabletes 14 × 15 mg tabletes un 14 × 45 mg tabletes 28 × 15 mg tabletes un 28 × 45 mg tabletes
English: Jinarc 30 mg tablets
Latvian: Jinarc 30 mg tabletes
English: Tolvaptan
Latvian: Izkliede
English: Each Jinarc 15 mg tablet contains 15 mg tolvaptan.
Latvian: Katra Jinarc 15 mg tablete satur 15 mg tolvaptāna.
English: Muscle spasms
Latvian: Muskuļu krampji
English: Jinarc 30 mg tablets Blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Latvian: Jinarc 30 mg tabletes Zila, apaļa (diametrs: 8 mm), viegli izliekta tablete ar vienā pusē iegravētu „OTSUKA” un „30”.
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
Latvian: 60 mg tablete: zila, modificēta taisnstūra (lielākā ass: 9,9 mm, mazākā ass: 5,6 mm), viegli izliekta, ar vienā pusē iegravētu „OTSUKA” un „60”.
English: Jinarc 15 mg tablets
Latvian: Jinarc 15 mg tabletes
English: Each Jinarc 60 mg tablet contains 60 mg tolvaptan.
Latvian: Katra Jinarc 60 mg tablete satur 60 mg tolvaptāna.
English: Each Jinarc 45 mg tablet contains 45 mg tolvaptan.
Latvian: Katra Jinarc 45 mg tablete satur 45 mg tolvaptāna.
English: How to take Jinarc
Latvian: Kā lietot Jinarc
English: Jinarc 15 mg tablets Jinarc 45 mg tablets tolvaptan
Latvian: Jinarc 15 mg tabletes Jinarc 45 mg tabletes tolvaptan
English: Each 60 mg tablet contains approximately 16 mg lactose (as monohydrate).
Latvian: Katra 60 mg tablete satur aptuveni 16 mg laktozes (monohidrāta veidā).
English: Each 45 mg tablet contains approximately 12 mg lactose (as monohydrate).
Latvian: Katra 45 mg tablete satur aptuveni 12 mg laktozes (monohidrāta veidā).
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
Latvian: 45 mg tablete: zila, četrstūraina (6,8 mm sānā, lielākā ass: 8,2 mm), viegli izliekta tablete ar vienā pusē iegravētu „OTSUKA” un „45”.
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.
Latvian: Jinarc 45 mg tabletes + Jinarc 15 mg tabletes: blisteri ar maciņu, kurā ir 14 (7 lielākā stipruma tabletes + 7 mazākā stipruma tabletes), 28 (14 lielākā stipruma tabletes + 14 mazākā stipruma tabletes) vai 56 (28 lielākā stipruma tabletes + 28 mazākā stipruma tabletes) tabletes, vai bez maciņa.
English: Hepatic impairment
Latvian: Akūta aknu mazspēja
English: Each 15 mg tablet contains 15 mg tolvaptan.
Latvian: Katra 15 mg tablete satur 15 mg tolvaptāna.
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.
Latvian: 15 mg tablete: zila, trīsstūraina (lielākā ass: 6,58 mm, mazākā ass: 6,20 mm), viegli izliekta tablete ar vienā pusē iegravētu „OTSUKA” un „15”.
English: Each 90 mg tablet contains approximately 24 mg lactose (as monohydrate).
Latvian: Katra 90 mg tablete satur aptuveni 24 mg laktozes (monohidrāta veidā).
English: Jinarc 15 mg tablets Jinarc 30 mg tablets Jinarc 45 mg tablets Jinarc 60 mg tablets Jinarc 90 mg tablets
Latvian: Jinarc 15 mg tabletes Jinarc 30 mg tabletes Jinarc 45 mg tabletes Jinarc 60 mg tabletes Jinarc 90 mg tabletes tolvaptan
English: Jinarc 15 mg tablets + Jinarc 45 mg tablets
Latvian: Jinarc 15 mg tabletes + Jinarc 45 mg tabletes
English: 30 mg tablet: blue, round, debossed with “OTSUKA” and “30” on one side.
Latvian: 30 mg tablete: zila, apaļa, ar vienā pusē iegravētu „OTSUKA” un „30”.
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
Latvian: 7 × 15 mg tabletes un 7 × 45 mg tabletes maciņa iepakojumā 14 × 15 mg tabletes un 14 × 45 mg tabletes maciņa iepakojumā 28 × 15 mg tabletes un 28 × 45 mg tabletes maciņa iepakojumā
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
Latvian: 90 mg tablete: zila, piecstūraina (lielākā ass: 9,7 mm, mazākā ass: 9,5 mm), viegli izliekta tablete ar vienā pusē iegravētu „OTSUKA” un „90”.
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
Latvian: Jinarc 30 mg tabletes + Jinarc 60 mg tabletes Katra 30 mg tablete satur 30 mg tolvaptāna (Tolvaptan).
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
Latvian: Jinarc 15 mg tabletes + Jinarc 45 mg tabletes 14 tabletes vienā PVH/alumīnija folijas blisterī ar 7 × 15 mg un 7 × 45 mg tabletēm 28 tabletes divos PVH/alumīnija folijas blisteros ar 7 × 15 mg un 7 × 45 mg tabletēm 56 tabletes četros PVH/alumīnija folijas blisteros ar 7 × 15 mg un 7 × 45 mg tabletēm
English: Each Jinarc 90 mg tablet contains 90 mg tolvaptan.
Latvian: Katra Jinarc 90 mg tablete satur 90 mg tolvaptāna.
English: Age Clearance of tolvaptan is not significantly affected by age.
Latvian: Vecums Vecumam nav būtiskas ietekmes uz tolvaptāna klīrensu.
English: Jinarc 30 mg tablets tolvaptan
Latvian: Jinarc 30 mg tabletes tolvaptan
English: Jinarc 15 mg tablets tolvaptan
Latvian: Jinarc 15 mg tabletes tolvaptan
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets Each 30 mg tablet contains 30 mg of tolvaptan.
Latvian: Jinarc 30 mg tabletes + Jinarc 90 mg tabletes Katra 30 mg tablete satur 30 mg tolvaptāna (Tolvaptan).
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
Latvian: Sākotnēji pacientiem vidējais aprēķinātais glomerulārās filtrācijas ātrums (eGFĀ) bija 82 ml/min/1,73 m
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.
Latvian: Ārstēšanas starpība šajā pētījumā novērotajās eGFĀ izmaiņās ir 1,27 ml/min/1,73 m2, kas viena novērojumu gada laikā parāda samazinājumu par 35 %, salīdzinot mazākās kvadrātsaknes vidējo atšķirību tolvaptāna grupā (eGFĀ - -2,34 ml/min/1,73 m un placebo grupā (eGFĀ - -3,61 ml/min/1,73 m2).
English: United Kingdom Otsuka Pharmaceuticals (UK) Ltd. Tel: +44 (0)203 747 5300
Latvian: Tel: +44 (0)203 747 5300
English: Each 30 mg tablet contains approximately 70 mg lactose (as monohydrate).
Latvian: Katra 30 mg tablete satur aptuveni 70 mg laktozes (monohidrāta veidā).
English: Each 30 mg tablet contains 30 mg tolvaptan.
Latvian: Katra 30 mg tablete satur 30 mg tolvaptāna.
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.
Latvian: Jinarc 60 mg tabletes + Jinarc 30 mg tabletes: blisteri ar maciņu, kurā ir 14 (7 lielākā stipruma tabletes + 7 mazākā stipruma tabletes), 28 (14 lielākā stipruma tabletes + 14 mazākā stipruma tabletes) vai 56 (28 lielākā stipruma tabletes + 28 mazākā stipruma tabletes) tabletes, vai bez maciņa.
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.
Latvian: Jinarc 90 mg tabletes + Jinarc 30 mg tabletes: blisteri ar maciņu, kurā ir 14 (7 lielākā stipruma tabletes + 7 mazākā stipruma tabletes), 28 (14 lielākā stipruma tabletes + 14 mazākā stipruma tabletes) vai 56 (28 lielākā stipruma tabletes + 28 mazākā stipruma tabletes) tabletes, vai bez maciņa.
English: Anaphylactic shock,
Latvian: Anafilaktiskais šoks, ģeneralizēti izsitumi
English: Sun.
Latvian: Lot.
English: Jinarc may cause your liver to not work properly.
Latvian: Jinarc var izraisīt aknu darbības traucējumus.
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
Latvian: 7 × 30 mg tabletes un 7 × 90 mg tabletes 14 × 30 mg tabletes un 14 × 90 mg tabletes 28 × 30 mg tabletes un 28 × 90 mg tabletes
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
Latvian: 7 × 30 mg tabletes un 7 × 60 mg tabletes 14 × 30 mg tabletes un 14 × 60 mg tabletes 28 × 30 mg tabletes un 28 × 60 mg tabletes
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets
Latvian: Jinarc 30 mg tabletes + Jinarc 60 mg tabletes
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets
Latvian: Jinarc 30 mg tabletes + Jinarc 90 mg tabletes
English: Jinarc 30 mg tablets Jinarc 90 mg tablets tolvaptan
Latvian: Jinarc 30 mg tabletes Jinarc 90 mg tabletes tolvaptan
English: Jinarc 30 mg tablets Jinarc 60 mg tablets tolvaptan
Latvian: Jinarc 30 mg tabletes Jinarc 60 mg tabletes tolvaptan
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 %
Latvian: Galvenais sekundārais saliktais mērķa kritērijs (ADNP progresēšana) bija laiks līdz vairāku klīnisko notikumu progresēšanai:
English: What Jinarc looks like and contents of the pack
Latvian: Jinarc ārējais izskats un iepakojums
English: • vomiting
Latvian: • aizcietējumi;
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)
Latvian: EU/1/15/1000/005 14 tabletes (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/006 28 tabletes (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/007 56 tabletes (28 × 15 mg + 28 × 45 mg)
English: Each 45 mg tablet contains 45 mg tolvaptan.
Latvian: Katra 45 mg tablete satur 45 mg tolvaptāna.
English: Each 60 mg tablet contains 60 mg tolvaptan.
Latvian: Katra 60 mg tablete satur 60 mg tolvaptāna.
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)
Latvian: EU/1/15/1000/014 14 tabletes (7 × 15 mg + 7 × 45 mg) EU/1/15/1000/015 28 tabletes (14 × 15 mg + 14 × 45 mg) EU/1/15/1000/016 56 tabletes (28 × 15 mg + 28 × 45 mg)
English: Serum sodium abnormalities
Latvian: Nātrija līmeņa novirzes serumā
English: Approximately 5 %, 75 % and 20 % had an eGFR 60 mL/min/1.73 m or greater (CKD stage 2), or less than 60 and greater than 30 mL/min/1.73 m
Latvian: (HNS-epidemioloģijas formula), un vidējais vēsturiskais KNT, kas bija pieejams 318 (23 %) pacientiem, bija 2026 ml. Aptuveni 5 %, 75 % un 20 % pacientu eGFĀ bija attiecīgi 60 ml/min/1,73 m vai lielāks (HNS 2. stadija), mazāks nekā 60 un lielāks par
English: Each tablet contains 15 mg tolvaptan.
Latvian: Katra tablete satur 15 mg tolvaptāna.
English: Each tablet contains 30 mg tolvaptan.
Latvian: Katra tablete satur 30 mg tolvaptāna.
English: Gastroesophageal reflux disease
Latvian: Kuņģa-zarnu trakta traucējumi
English: Each 90 mg tablet contains 90 mg tolvaptan.
Latvian: Katra 90 mg tablete satur 90 mg tolvaptāna.
English: Each 90 mg tablet contains 90 mg of tolvaptan.
Latvian: Katra 90 mg tablete satur 90 mg tolvaptāna (Tolvaptan).
English: Each 60 mg tablet contains 60 mg of tolvaptan.
Latvian: Katra 60 mg tablete satur 60 mg tolvaptāna (Tolvaptan).
English: • Volume depletion
Latvian: • ķermeņa masas samazināšanās.
English: Each 45 mg tablet contains 45 mg of tolvaptan.
Latvian: Katra 45 mg tablete satur 45 mg tolvaptāna (Tolvaptan).
English: Some people may feel dizzy, weak or tired after being given Jinarc.
Latvian: Transportlīdzekļu vadīšana un mehānismu apkalpošana Dažiem cilvēkiem Jinarc lietošana var izraisīt reiboni, vājumu vai nogurumu.
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
Latvian: 14 tabletes vienā PVH/alumīnija folijas blisterī maciņā ar 7 × 15 mg un 7 × 45 mg tabletēm 28 tabletes divos PVH/alumīnija folijas blisteros maciņā ar 7 × 15 mg un 7 × 45 mg tabletēm 56 tabletes četros PVH/alumīnija folijas blisteros maciņā ar 7 × 15 mg un 7 × 45 mg tabletēm
English: • find it difficult to urinate.
Latvian: • ir urinācijas grūtības;
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
Latvian: 7 × 30 mg tabletes un 7 × 90 mg tabletes maciņa iepakojumā 14 × 30 mg tabletes un 14 × 90 mg tabletes maciņa iepakojumā 28 × 30 mg tabletes un 28 × 90 mg tabletes maciņa iepakojumā
English: Blue, triangular (major axis: 6.58 mm, minor axis: 6.20 mm), shallow-convex, debossed with “OTSUKA” and “15” on one side.
Latvian: Jinarc 15 mg tabletes Zila, trīsstūraina (lielākā ass: 6,58 mm, mazākā ass: 6,20 mm), viegli izliekta tablete ar vienā pusē iegravētu „OTSUKA” un „15”.
English: Jinarc 30 mg tablets + Jinarc 90 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 90 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 90 mg tablets
Latvian: Jinarc 30 mg tabletes + Jinarc 90 mg tabletes 14 tabletes vienā PVH/alumīnija folijas blisterī ar 7 × 30 mg un 7 × 90 mg tabletēm28 tabletes divos PVH/alumīnija folijas blisteros ar 7 × 30 mg un 7 × 90 mg tabletēm 56 tabletes četros PVH/alumīnija folijas blisteros ar 7 × 30 mg un 7 × 90 mg tabletēm
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
Latvian: 7 × 30 mg tabletes un 7 × 60 mg tabletes maciņa iepakojumā 14 × 30 mg tabletes un 14 × 60 mg tabletes maciņa iepakojumā 28 × 30 mg tabletes un 28 × 60 mg tabletes maciņa iepakojumā
English: Jinarc 30 mg tablets + Jinarc 60 mg tablets 14 tablets in 1 PVC/aluminium foil blister with 7 × 30 mg and 7 × 60 mg tablets 28 tablets in 2 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets 56 tablets in 4 PVC/aluminium foil blisters with 7 × 30 mg and 7 × 60 mg tablets
Latvian: Jinarc 30 mg tabletes + Jinarc 60 mg tabletes 14 tabletes vienā PVH/alumīnija folijas blisterī ar 7 × 30 mg un 7 × 60 mg tabletēm 28 tabletes divos PVH/alumīnija folijas blisteros ar 7 × 30 mg un 7 × 60 mg tabletēm 56 tabletes četros PVH/alumīnija folijas blisteros ar 7 × 30 mg un 7 × 60 mg tabletēm
English: Dose titration
Latvian: Devas titrēšana
English: • liver function abnormal
Latvian: Aknu funkcijas traucējumi
English: • nausea
Latvian: • grēmas;
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)
Latvian: EU/1/15/1000/008 14 tabletes (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/009 28 tabletes (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/010 56 tabletes (28 × 30 mg + 28 × 60 mg)
English: 30 mg tablet: blue, round (diameter: 8 mm), shallow-convex, debossed with “OTSUKA” and “30” on one side.
Latvian: 30 mg tablete: zila, apaļa (diametrs: 8 mm), viegli izliekta tablete ar vienā pusē iegravētu „OTSUKA” un „30”.
English: België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V. Tél/Tel: +31 (0) 20 85 46 555
Latvian: België/Belgique/Belgien Otsuka Pharmaceutical Netherlands B.V.
English: Otsuka Pharmaceutical Netherlands B.V. Tel: +31 (0) 20 85 46 555
Latvian: Tél/Tel: +31 (0) 20 85 46 555
English: Diuretics
Latvian: Uzsūkšanās
English: • The Summary of product Characteristics
Latvian: • zāļu aprakstu;
English: Otsuka Pharmaceutical Netherlands B.V. Teл: +31 (0) 20 85 46 555
Latvian: Teл: +31 (0) 20 85 46 555
English: • weight loss
Latvian: • elpas trūkums;
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)
Latvian: EU/1/15/1000/020 14 tabletes (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/021 28 tabletes (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/022 56 tabletes (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)
Latvian: EU/1/15/1000/011 14 tabletes (7 × 30 mg + 7 × 90 mg) EU/1/15/1000/012 28 tabletes (14 × 30 mg + 14 × 90 mg) EU/1/15/1000/013 56 tabletes (28 × 30 mg + 28 × 90 mg)
English: Each tablet contains 15 mg of tolvaptan.
Latvian: Katra tablete satur 15 mg tolvaptāna (Tolvaptan).
English: Each tablet contains 30 mg of tolvaptan.
Latvian: Katra tablete satur 30 mg tolvaptāna (Tolvaptan).
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)
Latvian: EU/1/15/1000/017 14 tabletes (7 × 30 mg + 7 × 60 mg) EU/1/15/1000/018 28 tabletes (14 × 30 mg + 14 × 60 mg) EU/1/15/1000/019 56 tabletes (28 × 30 mg + 28 × 60 mg)
English: • belly pain
Latvian: • ādas nieze;
English: 14 tablets in 1 PVC/aluminium foil blister in wallet card with 7 × 30 mg and 7 × 90 mg tablets 28 tablets in 2 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets 56 tablets in 4 PVC/aluminium foil blisters in wallet card with 7 × 30 mg and 7 × 90 mg tablets
Latvian: 14 tabletes vienā PVH/alumīnija folijas blisterī maciņā ar 7 × 30 mg un 7 × 90 mg tabletēm 28 tabletes divos PVH/alumīnija folijas blisteros maciņā ar 7 × 30 mg un 7 × 90 mg tabletēm 56 tabletes četros PVH/alumīnija folijas blisteros maciņā ar 7 × 30 mg un 7 × 90 mg tabletēm
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
Latvian: 14 tabletes vienā PVH/alumīnija folijas blisterī maciņā ar 7 × 30 mg un 7 × 60 mg tabletēm 28 tabletes divos PVH/alumīnija folijas blisteros maciņā ar 7 × 30 mg un 7 × 60 mg tabletēm 56 tabletes četros PVH/alumīnija folijas blisteros maciņā ar 7 × 30 mg un 7 × 60 mg tabletēm
English: OUTER CARTON
Latvian: Sirdsklauves
English: Dyspnoea
Latvian: Astēnija
English: • muscle spasms
Latvian: • muskuļu krampji;
English: • dizziness
Latvian: • Anūrija.
English: • itching
Latvian: Ltd.
English: Otsuka Pharmaceutical Netherlands B.V. Thλ: +31 (0) 20 85 46 555
Latvian: Thλ: +31 (0) 20 85 46 555
English: Uncommon: may affect up to 1 in 100 people • increase of bilirubin (a substance that can cause yellowing of skin or eyes) in the blood
Latvian: • bilirubīna (vielas, kas izraisa ādas vai acu iekrāsošanos dzeltenā krāsā) līmeņa paaugstināšanās asinīs.
English: • heartburn
Latvian: (ADNP).
English: • The Patient information leaflet
Latvian: • lietošanas instrukciju pacientam;
English: The incidences of the Adverse Drug Reactions (ADRs) associated with tolvaptan therapy are tabulated below.
Latvian: Ar tolvaptāna lietošanu saistīto nevēlamo blakusparādību biežums ir parādīts zemāk esošajā tabulā.
English: • ADRs associated with long term use of Jinarc
Latvian: • nevēlamām blakusparādībām, kas saistītas ar Jinarc lietošanu.
English: EMEA Number
Latvian: ES Numurs nosaukums
English: Name
Latvian: Stiprums
English: This summary was last updated in 07-2017.
Latvian: Šo kopsavilkumu pēdējo reizi atjaunināja 7.2017.
English: The full EPAR for Clopidogrel TAD can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Latvian: Pilns Clopidogrel TAD EPAR teksts ir atrodams aģentūras tīmekļa vietnē: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Therefore, the Agency's view was that, as for Plavix, the benefit outweighs the identified risk.
Latvian: Tāpēc aģentūra uzskatīja, ka, tāpat kā Plavix gadījumā, ieguvumi pārsniedz identificēto risku.
English: The standard dose is one 75-mg tablet once a day.
Latvian: Standartdeva ir viena 75 mg tablete vienu reizi dienā.
English: This is a summary of the European public assessment report (EPAR) for Clopidogrel TAD.
Latvian: Šis ir Eiropas Publiskā novērtējuma ziņojuma (EPAR) kopsavilkums par Clopidogrel TAD.
English: • recently had a myocardial infarction (heart attack).
Latvian: • nesen bijis miokarda infarkts (sirdslēkme).
English: clopidogrel
Latvian: klopidogrels
English: This means that Clopidogrel TAD is similar to a ‘reference medicine' already authorised in the European Union (EU) called Plavix.
Latvian: Tas nozīmē, ka Clopidogrel TAD ir līdzīgas "atsauces zālēm", kas jau ir reģistrētas Eiropas Savienībā (ES) ar nosaukumu Plavix.
English: What measures are being taken to ensure the safe and effective use of Clopidogrel TAD?
Latvian: Kas tiek darīts, lai garantētu drošu un efektīvu Clopidogrel TAD lietošanu?
English: This is then followed by the standard 75-mg dose once a day for at least four weeks (in ‘ST segment elevation' myocardial infarction) or for up to 12 months (in unstable angina or ‘non-Q-wave' myocardial infarction).
Latvian: Tai seko 75 mg standartdeva vienreiz dienā vismaz četras nedēļas (miokarda infarkta ar ST segmenta pacēlumu pacientiem) vai līdz 12 mēnešiem (nestabilas stenokardijas un miokarda infarkta bez Q zoba pacientiem).
English: It is not intended to provide practical advice on how to use Clopidogrel TAD.
Latvian: Tas nav paredzēts kā praktiski ieteikumi par Clopidogrel TAD lietošanu.