FrancophonIA/ELRC3.0 huggingface dataset:
English: EU/1/09/570/041 90 film-coated tablets
Slovenian: EU/1/09/570/041 90 filmsko obloženih tablet
English: EU/1/09/570/054 98 film-coated tablets
Slovenian: EU/1/09/570/054 98 filmsko obloženih tablet
English: EU/1/09/570/049 14 film-coated tablets
Slovenian: EU/1/09/570/049 14 filmsko obloženih tablet
English: Imprida HCT 5 mg/160 mg/25 mg film-coated tablets: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Slovenian: Imprida HCT 5 mg/160 mg/25 mg filmsko obložene tablete: Ena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 25 mg hidroklorotiazida.
English: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 320 mg of valsartan and 25 mg of hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 320 mg valsartana in 25 mg hidroklorotiazida.
English: EU/1/09/570/027 30 film-coated tablets
Slovenian: EU/1/09/570/027 30 filmsko obloženih tablet
English: Imprida HCT 10 mg/160 mg/25 mg film-coated tablets: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan, and 25 mg hydrochlorothiazide.
Slovenian: Imprida HCT 10 mg/160 mg/25 mg filmsko obložene tablete: Ena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 25 mg hidroklorotiazida.
English: What Imprida HCT looks like and contents of the pack Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets are white, oval tablets with “NVR” on one side and “VCL” on the other side.
Slovenian: Izgled zdravila Imprida HCT in vsebina pakiranja Imprida HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete so bele ovalne tablete z oznako “NVR” na eni strani in “VCL” na drugi.
English: EU/1/09/570/025 14 film-coated tablets
Slovenian: EU/1/09/570/025 14 filmsko obloženih tablet
English: EU/1/09/570/026 28 film-coated tablets
Slovenian: EU/1/09/570/026 28 filmsko obloženih tablet
English: White, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VCL” on the other side.
Slovenian: Bele ovalne bikonveksne tablete z zaobljenim robom in oznako “NVR” na eni strani in “VCL” na drugi.
English: Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Slovenian: Imprida HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete: Ena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 12,5 mg hidroklorotiazida.
English: Absorption of thiazide diuretics, including hydrochlorothiazide, is decreased by cholestyramine or colestipol.
Slovenian: Holestiramin in holestipol zmanjšujeta absorpcijo tiazidnih diuretikov, vključno s hidroklorotiazidom.
English: EU/1/09/570/029 90 film-coated tablets
Slovenian: EU/1/09/570/029 90 filmsko obloženih tablet
English: EU/1/09/570/003 30 film-coated tablets
Slovenian: EU/1/09/570/003 30 filmsko obloženih tablet
English: • nausea
Slovenian: • zadah
English: • inflammation of blood vessels
Slovenian: • vnetje krvnih žil
English: Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets: Each film-coated tablet contains 10 mg amlodipine (as amlodipine besylate),160 mg valsartan, and 12.5 mg hydrochlorothiazide.
Slovenian: Imprida HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete: Ena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 12,5 mg hidroklorotiazida.
English: • decrease of potassium in the blood
Slovenian: • znižanje ravni kalija v krvi
English: EU/1/09/570/053 90 film-coated tablets
Slovenian: EU/1/09/570/053 90 filmsko obloženih tablet
English: • skin discoloration
Slovenian: • sprememba barve kože
English: EU/1/09/570/005 90 film-coated tablets
Slovenian: EU/1/09/570/005 90 filmsko obloženih tablet
English: Thiazide diuretics may precipitate azotaemia in patients with chronic kidney disease.
Slovenian: Pri bolnikih s kronično boleznijo ledvic lahko tiazidni diuretiki izzovejo azotemijo.
English: EU/1/09/570/014 28 film-coated tablets
Slovenian: EU/1/09/570/014 28 filmsko obloženih tablet
English: Muscular weakness
Slovenian: • mišični krči
English: EU/1/09/570/037 14 film-coated tablets
Slovenian: EU/1/09/570/037 14 filmsko obloženih tablet
English: What Imprida HCT looks like and contents of the pack Imprida HCT 5 mg/160 mg/25 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “VEL” on the other side.
Slovenian: Izgled zdravila Imprida HCT in vsebina pakiranja Imprida HCT 5 mg/160 mg/25 mg filmsko obložene tablete so rumene ovalne tablete z oznako “NVR” na eni strani in “VEL” na drugi.
English: Imprida HCT is contraindicated in patients with severe renal impairment, anuria or undergoing dialysis (see section 4.3).
Slovenian: Pri bolnikih s hudo okvaro ledvic, z anurijo in pri bolnikih na dializi je uporaba zdravila Imprida HCT kontraindicirana (glejte poglavje 4.3).
English: EU/1/09/570/051 30 film-coated tablets
Slovenian: EU/1/09/570/051 30 filmsko obloženih tablet
English: EU/1/09/570/015 30 film-coated tablets
Slovenian: EU/1/09/570/015 30 filmsko obloženih tablet
English: What Imprida HCT looks like and contents of the pack Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets are pale yellow, oval tablets with “NVR” on one side and “VDL” on the other side.
Slovenian: Izgled zdravila Imprida HCT in vsebina pakiranja Imprida HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete so bledo rumene ovalne tablete z oznako “NVR” na eni strani in “VDL” na drugi.
English: Reproductive toxicology
Slovenian: Toksičen vpliv na sposobnost razmnoževanja
English: EU/1/09/570/002 28 film-coated tablets
Slovenian: EU/1/09/570/002 28 filmsko obloženih tablet
English: EU/1/09/570/039 30 film-coated tablets
Slovenian: EU/1/09/570/039 30 filmsko obloženih tablet
English: • high level of uric acid in the blood
Slovenian: • zvišana raven sečne kisline v krvi
English: EU/1/09/570/017 90 film-coated tablets
Slovenian: EU/1/09/570/017 90 filmsko obloženih tablet
English: • constipation
Slovenian: • zadihanost
English: EU/1/09/570/013 14 film-coated tablets
Slovenian: EU/1/09/570/013 14 filmsko obloženih tablet
English: EU/1/09/570/044 56 x 1 film-coated tablet (unit dose) EU/1/09/570/045 98 x 1 film-coated tablet (unit dose) EU/1/09/570/046 280 x 1 film-coated tablet (unit dose)
Slovenian: EU/1/09/570/044 56 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/570/045 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/570/046 280 x 1 filmsko obložena tableta (za enkratni odmerek)
English: Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VFL” on the other side.
Slovenian: Rjavo rumene ovalne bikonveksne tablete z zaobljenim robom in oznako “NVR” na eni strani in “VFL” na drugi.
English: Rash
Slovenian: Horsham
English: Imprida HCT 5 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Slovenian: Imprida HCT 5 mg/160 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
English: EU/1/09/570/032 56 x 1 film-coated tablet (unit dose) EU/1/09/570/033 98 x 1 film-coated tablet (unit dose) EU/1/09/570/034 280 x 1 film-coated tablet (unit dose)
Slovenian: EU/1/09/570/032 56 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/570/033 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/570/034 280 x 1 filmsko obložena tableta (za enkratni odmerek)
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous; magnesium stearate; hypromellose, macrogol 4000, talc, titanium dioxide (E171).
Slovenian: Pomožne snovi so mikrokristalna celuloza, krospovidon, brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza, makrogol 4000, smukec, titanov dioksid (E171).
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, yellow iron oxide (E172).
Slovenian: Pomožne snovi so mikrokristalna celuloza, krospovidon, brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza, makrogol 4000, smukec, rumeni železov oksid (E172).
English: • diarrhoea
Slovenian: • zaspanost
English: EU/1/09/570/028 56 film-coated tablets
Slovenian: EU/1/09/570/028 56 filmsko obloženih tablet
English: EU/1/09/570/050 28 film-coated tablets
Slovenian: EU/1/09/570/050 28 filmsko obloženih tablet
English: Pale yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VDL” on the other side.
Slovenian: Bledo rumene ovalne bikonveksne tablete z zaobljenim robom in oznako “NVR” na eni strani in “VDL” na drugi.
English: • dizziness
Slovenian: • otekanje
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Slovenian: Ena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 25 mg hidroklorotiazida.
English: EU/1/09/570/008 56 x 1 film-coated tablet (unit dose) EU/1/09/570/009 98 x 1 film-coated tablet (unit dose) EU/1/09/570/010 280 x 1 film-coated tablet (unit dose)
Slovenian: EU/1/09/570/008 56 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/570/009 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/570/010 280 x 1 filmsko obložena tableta (za enkratni odmerek)
English: Imprida HCT 10 mg/160 mg/25 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Slovenian: Imprida HCT 10 mg/160 mg/25 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Imprida HCT 10 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Slovenian: Imprida HCT 10 mg/160 mg/12,5 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
English: Each tablet contains 10 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Slovenian: Ena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 12,5 mg hidroklorotiazida.
English: What Imprida HCT looks like and contents of the pack Imprida HCT 10 mg/160 mg/25 mg film-coated tablets are brown-yellow, oval tablets with “NVR” on one side and “VHL” on the other side.
Slovenian: Izgled zdravila Imprida HCT in vsebina pakiranja Imprida HCT 10 mg/160 mg/25 mg filmsko obložene tablete so rjavo rumene ovalne tablete z oznako “NVR” na eni strani in “VHL” na drugi.
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 25 mg hydrochlorothiazide.
Slovenian: Ena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 25 mg hidroklorotiazida.
English: EU/1/09/570/056 56 x 1 film-coated tablet (unit dose) EU/1/09/570/057 98 x 1 film-coated tablet (unit dose) EU/1/09/570/058 280 x 1 film-coated tablet (unit dose)
Slovenian: EU/1/09/570/056 56 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/570/057 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/570/058 280 x 1 filmsko obložena tableta (za enkratni odmerek)
English: Each tablet contains 5 mg amlodipine (as amlodipine besylate), 160 mg valsartan and 12.5 mg hydrochlorothiazide.
Slovenian: Ena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 12,5 mg hidroklorotiazida.
English: Imprida HCT 5 mg/160 mg/12.5 mg film-coated tablets amlodipine/valsartan/hydrochlorothiaziade
Slovenian: Imprida HCT 5 mg/160 mg/12,5 mg filmsko obložene tablete amlodipin/valsartan/hidroklorotiazid
English: if you have a high level of calcium in your blood (with or without symptoms such as nausea, vomiting, constipation, stomach pain, frequent urination, thirst, muscle weakness and twitching).
Slovenian: Bodite posebno pozorni pri uporabi zdravila Imprida HCT če imate v krvi nizke ravni kalija ali magnezija (s simptomi, kot so šibkost mišic, mišični krči in nepravilen srčni ritem, ali brez teh simptomov); če imate v krvi nizke ravni natrija (s simptomi, kot so utrujenost, zmedenost, trzanje mišic in napadi krčev, ali brez teh simptomov); če imate v krvi visoko raven kalcija (s simptomi, kot so slabost, bruhanje, zapeka, bolečine v trebuhu, pogosto uriniranje, žeja, šibkost in trzanje mišic, ali brez teh simptomov); če jemljete zdravila ali snovi, ki zvečajo količino kalija v krvi; med njimi so kalijevi nadomestki ali soli, ki vsebujejo kalij, zdravila, ki varčujejo s kalijem in heparin.
English: The other ingredients are cellulose microcrystalline; crospovidone; silica, colloidal anhydrous, magnesium stearate, hypromellose, macrogol 4000, talc, titanium dioxide (E171), yellow iron oxide (E172).
Slovenian: Pomožne snovi so mikrokristalna celuloza, krospovidon, brezvoden koloidni silicijev dioksid, magnezijev stearat, hipromeloza, makrogol 4000, smukec, titanov dioksid (E171), rumeni železov oksid (E172).
English: Yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VEL” on the other side.
Slovenian: Rumene ovalne bikonveksne tablete z zaobljenim robom in oznako “NVR” na eni strani in “VEL” na drugi.
English: EU/1/09/570/020 56 x 1 film-coated tablet (unit dose) EU/1/09/570/021 98 x 1 film-coated tablet (unit dose) EU/1/09/570/022 280 x 1 film-coated tablet (unit dose)
Slovenian: EU/1/09/570/020 56 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/570/021 98 x 1 filmsko obložena tableta (za enkratni odmerek) EU/1/09/570/022 280 x 1 filmsko obložena tableta (za enkratni odmerek)
English: EU/1/09/570/036 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/035 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Slovenian: EU/1/09/570/036 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/570/035 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za
English: • stomach discomfort
Slovenian: • nelagodje v želodcu
English: if you are allergic (hypersensitive) to amlodipine, valsartan, hydrochlorothiazide, sulphonamide-derived medicines (medicines used to treat chest or urinary infections), or any of the other ingredients of Imprida HCT (see section 6, “What Imprida HCT contains”).
Slovenian: (Zdravilu Imprida HCT se je bolje izogibati tudi v zgodnji nosečnosti - glejte poglavje Nosečnost); če ste alergični (preobčutljivi) na amlodipin, valsartan, hidroklorotiazid, zdravila sulfonamidne vrste (zdravila za zdravljenje okužb v prsnem košu in okužb sečil) ali katerokoli sestavino zdravila Imprida HCT (glejte poglavje 6 “Kaj vsebuje zdravilo Imprida HCT”); Če domnevate, da bi lahko bili alergični, ne vzemite zdravila Imprida HCT in se posvetujte z zdravnikom; če imate bolezen jeter, poškodbe manjših žolčnih izvodil v jetrih (biliarno cirozo), kar povzroča zastoj žolča v jetrih (holestazo); če imate hude težave z ledvicami ali se zdravite z dializo;
English: Back pain
Slovenian: • bolečine v hrbtu
English: EU/1/09/570/048 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/047 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Slovenian: EU/1/09/570/048 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/570/047 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za
English: Hypromellose Macrogol 4000
Slovenian: Obloga hipromeloza makrogol 4000 smukec rumeni železov oksid (E172)
English: EU/1/09/570/060 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/059 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Slovenian: EU/1/09/570/060 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/570/059 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za
English: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 25 mg hidroklorotiazida.
English: EU/1/09/570/012 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/011 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Slovenian: EU/1/09/570/012 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/570/011 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za
English: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 12,5 mg hidroklorotiazida.
English: Each film-coated tablet contains 5 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 25 mg of hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 5 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 25 mg hidroklorotiazida.
English: Brown-yellow, ovaloid, biconvex tablets with bevelled edge, debossed “NVR” on one side and “VHL” on the other side.
Slovenian: Rjavo rumene ovalne bikonveksne tablete z zaobljenim robom in oznako “NVR” na eni strani in “VHL” na drugi.
English: Each film-coated tablet contains 10 mg of amlodipine (as amlodipine besylate), 160 mg of valsartan, and 12.5 mg of hydrochlorothiazide.
Slovenian: Ena filmsko obložena tableta vsebuje 10 mg amlodipina (v obliki amlodipinijevega besilata), 160 mg valsartana in 12,5 mg hidroklorotiazida.
English: HOW TO STORE IMPRIDA HCT
Slovenian: SHRANJEVANJE ZDRAVILA IMPRIDA HCT
English: • vomiting
Slovenian: • bruhanje
English: EU/1/09/570/024 280 film-coated tablets (multipack, 20 cartons of 14 tablets) EU/1/09/570/023 280 film-coated tablets (multipack, 4 cartons of 70 tablets) (unit dose)
Slovenian: EU/1/09/570/024 280 filmsko obloženih tablet (skupno pakiranje, 20 škatel po 14 tablet) EU/1/09/570/023 280 filmsko obloženih tablet (skupno pakiranje, 4 škatle po 70 tablet) (za
English: • pain
Slovenian: • bolečina
English: • hot flushes
Slovenian: • navali vročine
English: • low level of sodium in the blood
Slovenian: • znižana raven natrija v krvi
English: Dose adjustment of uricosuric medicinal products may be necessary as hydrochlorothiazide may raise the level of serum uric acid.
Slovenian: Ker hidroklorotiazid lahko zviša koncentracijo sečne kisline v serumu, je včasih treba prilagoditi odmerjanje urikozurikov.
English: • weight decrease
Slovenian: • zmanjšana telesna masa
English: • muscle spasm
Slovenian: • suha usta
English: • skin reddening
Slovenian: • rdečina kože
English: Renal failure acute
Slovenian: Akutni glavkom zaprtega zakotja
English: Imprida HCT should be discontinued if hypercalcaemia develops during treatment.
Slovenian: Če pride med zdravljenjem do razvoja hiperkalciemije, je treba uporabo zdravila Imprida HCT prekiniti.
English: • chest pain
Slovenian: • bolečina v prsih
English: This will help protect the environment.
Slovenian: Taki ukrepi pomagajo varovati okolje.
English: Sucralose (E955)
Slovenian: Sukraloza (E955)
English: In this population, efficacy has not been established.
Slovenian: Pri tej populaciji učinkovitost ni bila dokazana.
English: Routine Monitoring:
Slovenian: Rutinsko spremljanje:
English: It can be used in adults, adolescents and children of at least 2 years of age.
Slovenian: Uporablja se lahko pri odraslih, mladostnikih in otrocih, starih vsaj 2 leti.
English: In addition, monitoring of plasma concentrations should be considered.
Slovenian: Poleg tega je treba razmisliti o spremljanju plazemskih koncentracij.
English: Take the next dose at your regular time.
Slovenian: Naslednji odmerek vzemite ob običajnem času.
English: Subgroup analyses were conducted on multiple factors, including cAEDs.
Slovenian: Analize podskupin so bile izvedene z več dejavniki, vključno s cAED.
English: Continue to use the medicine as normal.
Slovenian: Normalno nadaljujte z uporabo zdravila.
English: The medicine may be harmful for those suffering from alcoholism.
Slovenian: Zdravilo lahko škoduje osebam z alkoholizmom.
English: - you notice unusual changes in your mood or behaviour or have thoughts of harming or killing yourself.
Slovenian: - opazite neobičajne spremembe razpoloženja ali vedenja ali začnete razmišljati o samopoškodovanju ali samomoru.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1389/001
Slovenian: ŠTEVILKA (ŠTEVILKE) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/19/1389/001
English: You may start on a low dose that your doctor gradually increases over time.
Slovenian: Začnete lahko z majhnim odmerkom, ki vam ga zdravnik postopoma povečuje.
English: Increased appetite
Slovenian: Povečan apetit
English: The pack contains the following items
Slovenian: Pakiranje vsebuje naslednje sestavine:
English: Biotransformation and elimination
Slovenian: Biotransformacija in izločanje
English: Use within 8 weeks after first opening the bottle.
Slovenian: Uporabite v 8 tednih po odprtju steklenice.
English: Do not use this medicine after the expiry date shown on the bottle.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na steklenici.
English: The mechanism of this risk is not known, and the available data do not exclude the possibility of an increased risk for cannabidiol.
Slovenian: Mehanizem tveganja še ni znan, vendar razpoložljivi podatki ne izključujejo možnosti povečanega tveganja pri uporabi kanabidiola.
English: The increase was reversible in healthy adults.
Slovenian: Pri zdravih odraslih je bilo zvišanje reverzibilno.
English: No effect
Slovenian: Brez vpliva
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation:
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve:
English: The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100).
Slovenian: Pogostnosti so določene kot sledi: zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10) in občasni (≥ 1/1.000 do < 1/100).
English: Dosing should be resumed at the existing treatment schedule.
Slovenian: Odmerjanje je treba nadaljevati po obstoječem načrtu zdravljenja.
English: Suicidal behaviour and ideation
Slovenian: Samomorilno vedenje in razmišljanje
English: - if your doctor determines that you have certain abnormal liver blood tests.
Slovenian: - če zdravnik ugotovi, da imate nenormalne rezultate določenih krvnih preiskav jeter.
English: In this case, keep careful track of how many times you have filled the syringe (e.g., by marking off each 5 ml dose, respectively) so that you take the right dose.
Slovenian: V takem primeru si skrbno beležite, kolikokrat ste napolnili brizgo (npr. tako, da odkljukate za vsak 5-mililitrski odmerek), da boste vzeli ustrezen odmerek.
English: Experience with doses higher than the recommended therapeutic dose is limited.
Slovenian: Izkušenj z odmerki, večjimi od priporočenega terapevtskega odmerka, je malo.
English: Somnolence and sedation
Slovenian: Somnolenca in sedacija
English: Early identification of elevated transaminase may decrease the risk of a serious outcome.
Slovenian: Zgodnje odkritje zvišanih vrednosti transaminaz lahko zmanjša tveganje za resen izid.
English: If you have any solution left in the bottle more than 8 weeks after it was first opened, you should not use it.
Slovenian: Če je v steklenici več kot 8 tednov po prvem odprtju ostalo kaj raztopine, je ne smete uporabiti.
English: Patients with prolonged elevations of serum transaminases should be evaluated for other possible causes.
Slovenian: Bolnike z dolgotrajno zvišanimi vrednostmi serumskih transaminaz je treba oceniti glede drugih možnih vzrokov.
English: Tell your doctor if you are taking any of the following medicines, as your dose may need to be adjusted: - other epilepsy medicines, such as carbamazepine, clobazam, lamotrigine, lorazepam,
Slovenian: Zdravniku povejte, če jemljete katero od naslednjih zdravil, saj bo morda potrebna prilagoditev odmerka: - druga zdravila za epilepsijo, kot so karbamazepin, klobazam, lamotrigin, lorazepam,