FrancophonIA/ELRC3.0 huggingface dataset:
English: • if you have severe liver problems such as cholestasis or biliary obstruction (problems with the drainage of the bile from the liver and gall bladder) or any other severe liver disease.
Slovenian: • če imate hude jetrne težave, na primer holestazo ali zaporo žolčnih poti (težave z iztekanjem žolča iz jeter in žolčnika) ali katerokoli drugo hudo jetrno bolezen,
English: Micardis is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy.
Slovenian: Zdravila Micardis v zgodnji nosečnosti ne priporočajo; ne smete pa ga jemati, ko boste noseči več kot 3 mesece, ker lahko po tretjem mesecu nosečnosti resno škoduje vašemu otroku.
English: **Cases of progressive scarring of lung tissue have been reported during intake of telmisartan.
Slovenian: ** Poročali so o primerih progresivnega brazgotinjenja pljučnega tkiva med jemanjem telmisartana, vendar ni znano ali je vzrok telmisartan.
English: Angiotensin II receptor antagonists such as telmisartan, attenuate diuretic induced potassium loss.
Slovenian: Antagonisti receptorjev angiotenzina II (AIIA), kot je telmisartan, zmanjšajo izgubo kalija, ki jo povzročajo diuretiki.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Micardis 20 mg tablets
Slovenian: KAKOVOSTNA IN KOLIČINSKA SESTAVA Micardis 20 mg tablete
English: Micardis is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed, especially if your baby is newborn, or was born prematurely.
Slovenian: Če boste želeli dojiti, bo zdravnik za vas izbral drugo zdravilo, še zlasti, če je vaš otrok novorojenček ali se je prezgodaj rodil.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/98/090/021
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/98/090/021
English: PHARMACEUTICAL FORM AND CONTENTS Multipack comprising 4 packs, each containing 90 x 1 tablets
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Skupno pakiranje vsebuje 4 enote po 90 x 1 tableto.
English: What Micardis contains
Slovenian: Kaj vsebuje zdravilo Micardis
English: Micardis is available in blister packs containing 14, 28, 56, 84 or 98 tablets, in unit dose blister packs containing 28 x 1, 30 x 1 or 90 x 1 tablets or in multipacks containing 360 (4 packs of 90 x 1) tablets.
Slovenian: Zdravilo Micardis je na voljo v pretisnih omotih po 14, 28, 56, 84 ali 98 tablet, v pretisnih omotih za enkratni odmerek po 28 x 1, 30 x 1 ali 90 x 1 tableta ali v skupnih pakiranjih po 360 tablet (4 pakiranja po 90 x 1 tableta).
English: How to take Micardis
Slovenian: Kako jemati zdravilo Micardis
English: Micardis should be used only with caution in patients with mild to moderate hepatic impairment.
Slovenian: Zdravilo Micardis moramo previdno dajati bolnikom z zmerno hudo do hudo jetrno okvaro.
English: Back pain (e.g. sciatica), muscle spasms, myalgia Arthralgia, pain in extremity, tendon pain (tendinitis like symptoms)
Slovenian: bolečina v hrbtu (npr. išias), mišični krči, mialgija artralgija,bolečine v okončini, bolečina v kitah (tendinitisu podobni simptomi)
English: Micardis may also be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.
Slovenian: Zdravilo Micardis lahko jemljete tudi v kombinaciji z diuretiki, kot je hidroklorotiazid, za katerega se je pokazalo, da pri sočasnem jemanju z zdravilom Micardis dodatno znižuje krvni tlak.
English: Volume and/or sodium depletion should be corrected prior to administration of Micardis.
Slovenian: Pomanjkanje volumna ali natrija ali obe stanji moramo uravnati pred začetkom zdravljenja z zdravilom Micardis.
English: Pack sizes: Blister with 14, 28, 56, 84 or 98 tablets or perforated unit dose blisters with 28 x 1, 30 x 1 or 90 x 1 tablets; multipacks containing 360 (4 packs of 90 x 1) tablets
Slovenian: Velikost pakiranja: pretisni omot po 14, 28, 56, 84 ali 98 tablet, ali perforirani pretisni omoti za enkratni odmerek po 28 x 1, 30 x 1 ali 90 x 1 tableta; skupno pakiranje po 360 tablet (4 pakiranja po 90 x 1 tableta).
English: Some people feel dizzy or tired when taking Micardis.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Nekateri ljudje so med zdravljenjem z zdravilom Micardis omotični ali utrujeni.
English: Micardis 40 mg and 80 mg tablets 4 years
Slovenian: Micardis 40 mg in 80 mg tablete 4 leta
English: The risk may increase in case of treatment combination with other medicinal products that may also provoke hyperkalaemia (salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal antiinflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim).
Slovenian: Tveganje je lahko povečano pri kombiniranem zdravljenju z drugimi zdravili, ki lahko povzročijo hiperkaliemijo (nadomestki soli s kalijem, diuretiki, ki zadržujejo kalij, zaviralci ACE, antagonisti receptorjev angiotenzina II, nesteroidna protivnetna zdravila (tudi selektivni zaviralci ciklooksigenaze 2), heparin, imunosupresivi (ciklosporin ali takrolimus) in trimetoprim).
English: • Medicines that may increase blood potassium levels such as salt substitutes containing potassium, potassium-sparing diuretics (certain 'water tablets'), ACE inhibitors, angiotensin II receptor antagonists, NSAIDs (non steroidal anti-inflammatory medicines, e.g. aspirin or ibuprofen), heparin, immunosuppressives (e.g. cyclosporin or tacrolimus), and the antibiotic trimethoprim.
Slovenian: • zdravila, ki lahko povečajo raven kalija v krvi, na primer nadomestki soli s kalijem, diuretiki, ki zadržujejo kalij (nekatere tablete za odvajanje vode); zaviralci ACE, antagonisti receptorjev angiotenzina II, nesteroidna protivnetna zdravila (na primer acetilsalicilna kislina ali ibuprofen), heparin, imunosupresivi (na primer ciklosporin ali takrolimus) in antibiotik trimetoprim;
English: Micardis 20 mg tablets 3 years
Slovenian: Micardis 20 mg tablete 3 leta
English: Hepatic function abnormal / liver disorder
Slovenian: nenormalno delovanje jeter/jetrno obolenje
English: Povidone (K25) Meglumine Sodium hydroxide
Slovenian: 6.1 Seznam pomožnih snovi povidon (K25) meglumin natrijev hidroksid sorbitol (E420) magnezijev stearat
English: Exposure to angiotensin II receptor antagonist therapy during the second and third trimesters is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).
Slovenian: Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznelo zakostenitev lobanje) in toksične učinke pri novorojenčku (ledvično odpoved, hipotenzijo, hiperkaliemijo) (glejte poglavje 5.3).
English: Micardis 20 mg tablets EU/1/98/090/009 (14 tablets) EU/1/98/090/010 (28 tablets) EU/1/98/090/011 (56 tablets) EU/1/98/090/012 (98 tablets)
Slovenian: Micardis 20 mg tablete EU/1/98/090/009 (14 tablet) EU/1/98/090/010 (28 tablet) EU/1/98/090/011 (56 tablet) EU/1/98/090/012 (98 tablet)
English: Abdominal pain, diarrhoea, dyspepsia, flatulence, vomiting
Slovenian: trebušna bolečina, driska, dispepsija, napenjanje, bruhanje suha usta, želodčne težave, disgevzija
English: However, sometimes your doctor may recommend a lower dose of 20 mg or a higher dose of 80 mg. Alternatively, Micardis may be used in combination with diuretics ('water tablets') such as hydrochlorothiazide which has been shown to have an additive blood pressure lowering effect with Micardis.
Slovenian: Kadar s priporočenim odmerkom ne dosežemo želenega znižanja krvnega tlaka, lahko odmerek telmisartana povečamo do največ 80 mg enkrat na dan. Telmisartan lahko uporabljamo tudi v kombinaciji s tiazidnimi diuretiki, kot je npr. hidroklorotiazid, za katerega se je pokazalo, da ima v kombinaciji s telmisartanom aditivni učinek na znižanje krvnega tlaka.
English: INFORMATION IN BRAILLE Micardis 40 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Micardis 40 mg
English: At the beginning of the preventive therapy with Micardis 80 mg, blood pressure should be frequently monitored.
Slovenian: Za zmanjševanje srčnožilnih dogodkov je običajni odmerek zdravila Micardis ena tableta po 80 mg na dan. Na začetku preventivnega zdravljenja z zdravilom Micardis 80 mg je treba pogosto izmeriti krvni tlak.
English: The overall incidence of adverse reactions reported with telmisartan was usually comparable to placebo (41,4% vs 43.9 %) in controlled trials in patients treated for hypertension.
Slovenian: V s placebom nadzorovanih kliničnih preskušanjih pri bolnikih, ki so se zdravili zaradi hipertenzije, je bila skupna pogostnost neželenih dogodkov podobna pri telmisartanu in placebu (41,4 % v primerjavi s 43,9 %).
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister
Slovenian: PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
English: Talk to your doctor before taking Micardis:
Slovenian: Pred začetkom jemanja zdravila Micardis se posvetujte z zdravnikom:
English: What Micardis looks like and contents of the pack Micardis 20 mg tablets are white, round and engraved with the code number '50H' on one side and the company logo on the other side.
Slovenian: Izgled zdravila Micardis in vsebina pakiranja Tablete Micardis 20 mg so bele, okrogle tablete z vtisnjeno kodno številko 50H na eni in logom podjetja na drugi strani.
English: Prior treatment with high dose diuretics such as furosemide (loop diuretic) and hydrochlorothiazide (thiazide diuretic) may result in volume depletion, and in a risk of hypotension when initiating therapy with telmisartan.
Slovenian: Ob uvedbi telmisartana sta možni posledici predhodnega zdravljenja z visokimi odmerki diuretikov, kot sta furosemid (diuretik zanke) in hidroklorotiazid (tiazidni diuretik), izguba zunajcelične tekočine in nevarnost hipotenzije.
English: White oblong tablets of 4.6 mm engraved with the code number '52H' on one side and the company logo on the other side.
Slovenian: Bele, 4,6 mm podolgovate tablete z vtisnjeno kodno številko 52H na eni in logom podjetja na drugi strani.
English: INFORMATION IN BRAILLE Micardis 20 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Micardis 20 mg
English: White oblong tablets of 3.8 mm engraved with the code number '51H' on one side and the company logo on the other side.
Slovenian: Bele, 3,8 mm podolgovate tablete z vtisnjeno kodno številko 51H na eni in logom podjetja na drugi strani.
English: INFORMATION IN BRAILLE Micardis 80 mg
Slovenian: PODATKI V BRAILLOVI PISAVI Micardis 80 mg
English: Micardis 40 mg tablets EU/1/98/090/001 (14 tablets) EU/1/98/090/002 (28 tablets) EU/1/98/090/003 (56 tablets) EU/1/98/090/004 (98 tablets) EU/1/98/090/013 (28 x 1 tablets) EU/1/98/090/015 (84 tablets) EU/1/98/090/017 (30 x 1 tablets) EU/1/98/090/019 (90 x 1 tablets) EU/1/98/090/021 (4 x (90 x 1) tablets)
Slovenian: Micardis 40 mg tablete EU/1/98/090/001 (14 tablet) EU/1/98/090/002 (28 tablet) EU/1/98/090/003 (56 tablet) EU/1/98/090/004 (98 tablet) EU/1/98/090/013 (28 x 1 tableta) EU/1/98/090/015 (84 tablet) EU/1/98/090/017 (30 x 1 tableta) EU/1/98/090/019 (90 x 1 tableta) EU/1/98/090/021 (4 x (90 x 1) tableta)
English: Micardis 40 mg tablets
Slovenian: Micardis 40 mg tablete
English: Micardis 80 mg tablets EU/1/98/090/005 (14 tablets) EU/1/98/090/006 (28 tablets) EU/1/98/090/007 (56 tablets) EU/1/98/090/008 (98 tablets) EU/1/98/090/014 (28 x 1 tablets) EU/1/98/090/016 (84 tablets) EU/1/98/090/018 (30 x 1 tablets) EU/1/98/090/020 (90 x 1 tablets) EU/1/98/090/022 (4 x (90 x 1) tablets)
Slovenian: Micardis 80 mg tablete EU/1/98/090/005 (14 tablet) EU/1/98/090/006 (28 tablet) EU/1/98/090/007 (56 tablet) EU/1/98/090/008 (98 tablet) EU/1/98/090/014 (28 x 1 tableta) EU/1/98/090/016 (84 tablet) EU/1/98/090/018 (30 x 1 tableta) EU/1/98/090/020 (90 x 1 tableta) EU/1/98/090/022 (4 x (90 x 1) tableta)
English: There is no experience regarding the administration of Micardis in patients with recent kidney transplantation.
Slovenian: Pri bolnikih z nedavno presajeno ledvico ni izkušenj z uporabo zdravila Micardis.
English: How to store Micardis
Slovenian: Shranjevanje zdravila Micardis
English: • Low blood pressure (hypotension), likely to occur if you are dehydrated (excessive loss of body water) or have salt deficiency due to diuretic therapy ('water tablets'), low-salt diet, diarrhoea,
Slovenian: • nizek krvni tlak (hipotenzija), ki se pojavi, če ste dehidrirani (prevelika izguba vode iz telesa),
English: (It is also better to avoid Micardis in early pregnancysee pregnancy section.)
Slovenian: • če ste noseči več kot 3 mesece (zdravilu Micardis se je bolje izogibati tudi v zgodnji nosečnosti
English: Micardis 80 mg tablets
Slovenian: Micardis 80 mg tablete
English: Micardis 40 mg and 80 mg tablets
Slovenian: Micardis 40 mg in 80 mg tablete
English: NAME OF THE MEDICINAL PRODUCT Micardis 40 mg tablets telmisartan
Slovenian: IME ZDRAVILA Micardis 40 mg tablete telmisartan
English: Symptomatic hypotension, especially after the first dose of Micardis, may occur in patients who are volume and/or sodium depleted by vigorous diuretic therapy, dietary salt restriction, diarrhoea, or vomiting.
Slovenian: Pri bolnikih z zmanjšanim volumnom krvi in/ali zmanjšano količino natrija zaradi intenzivnega diuretičnega zdravljenja, omejitve količine soli v hrani, driske ali bruhanja, se zlasti po prvem odmerku zdravila Micardis lahko pojavi simptomatska hipotenzija.
English: NAME OF THE MEDICINAL PRODUCT Micardis 80 mg tablets telmisartan
Slovenian: IME ZDRAVILA Micardis 80 mg tablete telmisartan
English: NAME OF THE MEDICINAL PRODUCT Micardis 20 mg tablets telmisartan
Slovenian: IME ZDRAVILA Micardis 20 mg tablete telmisartan
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister of 7 tablets
Slovenian: Pretisni omot po 7 tablet
English: Sepsis* (often called "blood poisoning", is a severe infection with whole-body inflammatory response which can lead to death), increase in certain white blood cells (eosinophilia),low platelet count (thrombocytopenia), severe allergic reaction (anaphylactic reaction), allergic reaction (e.g. rash, itching, difficulty breathing, wheezing, swelling of the face or low blood pressure), low blood sugar levels (in diabetic patients), feeling anxious, somnolence, impaired vision, fast heart beat (tachycardia), dry mouth, upset stomach, taste disturbance (dysgeusia), abnormal liver function (Japanese patients are more likely to experience this side effect), rapid swelling of the skin and mucosa which can also lead to death (angioedema also with fatal outcome), eczema (a skin disorder), redness of skin, hives (urticaria), severe drug rash, joint pain (arthralgia), pain in extremity, tendon pain, flu-like-illness, decreased haemoglobin (a blood protein), increased levels of uric acid, increased hepatic enzymes or creatine phosphokinase in the blood.
Slovenian: Redki neželeni učinki (pojavijo se lahko pri največ 1 od 1.000 bolnikov): sepsa* (pogosto poimenovana tudi zastrupitev krvi, je huda okužba, pri kateri pride v vsem telesu do vnetnega odziva in je lahko usodna), povečanje določenih belih krvničk (eozinofilija), majhno število trombocitov (trombocitopenija), huda alergijska reakcija (anafilaktična reakcija), alergijska reakcija (npr. izpuščaj, srbež, oteženo dihanje, piskanje, otekanje obraza ali nizek krvni tlak), nizka raven krvnega sladkorja (pri bolnikih s sladkorno boleznijo), občutek tesnobe, zaspanost, motnje vida, hitro bitje srca (tahikardija), suha usta, želodčne težave, motnje okusa (disgevzija), motnje v delovanju jeter (pri japonskih bolnikih obstaja večja verjetnost pojavljanja tega neželenega učinka), hitro otekanje kože in sluznice, ki lahko povzroči tudi smrt (angioedem tudi s smrtnim izidom), ekcem (kožno obolenje), kožna rdečica, izpuščaji (urtikarija), hud medikamentni izpuščaj, bolečina v sklepih (artralgija), bolečina v okončini, bolečina v kitah, gripi podobna bolezen, znižan hemoglobin (krvna beljakovina), zvišana raven sečne kisline, zvišana raven jetrnih encimov ali kreatin fosfokinaze v krvi.
English: Micardis 20 mg tablets
Slovenian: Micardis 20 mg tablete telmisartan
English: Urinary tract infections, upper respiratory tract infections (e.g. sore throat, inflamed sinuses, common cold), deficiency in red blood cells (anaemia), high potassium levels, difficulty falling asleep, feeling sad (depression), fainting (syncope), feeling of spinning (vertigo), slow heart rate (bradycardia), low blood pressure (hypotension) in users treated for high blood pressure, dizziness on standing up (orthostatic hypotension), shortness of breath, cough, abdominal pain, diarrhoea, discomfort in the abdomen, bloating, vomiting, itching, increased sweating, drug rash, back pain, muscle cramps, muscle pain (myalgia), kidney impairment including acute kidney failure, pain in the chest, feeling of weakness, and increased level of creatinine in the blood.
Slovenian: Občasni neželeni učinki (pojavijo se pri največ 1 od 100 bolnikov) okužbe sečil, okužbe zgornjih dihal (npr. bolečine v grlu, vneti sinusi, prehlad), pomanjkanje rdečih krvničk (anemija), visoka raven kalija, težave z uspavanjem, občutek žalosti (depresija), omedlevica (sinkopa), vrtoglavica, počasen srčni utrip (bradikardija), nizek krvni tlak (hipotenzija) pri osebah, ki se zdravijo zaradi visokega krvnega tlaka, omotica pri vstajanju (ortostatska hipotenzija), zasoplost, kašelj, trebušne bolečine, driska, nelagodje v trebuhu, napenjanje, bruhanje, srbež, povečano znojenje, medikamentni izpuščaj, bolečine v hrbtu, mišični krči, mišična bolečina (mialgija), ledvična okvara, tudi akutna ledvična odpoved, bolečina v prsnem košu, občutek oslabelosti in zvišana raven kreatinina v krvi.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 80 mg
Slovenian: VMESNA OVOJNINA PRI SKUPNEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - BREZ MODREGA OKENCA - 80 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF THE MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) - WITHOUT BLUE BOX - 40 mg
Slovenian: VMESNA OVOJNINA PRI SKUPNEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - BREZ MODREGA OKENCA - 40 mg
English: What Micardis looks like and contents of the pack Micardis 40 mg tablets are white, oblong-shaped, and engraved with the code number '51H' on one side and the company logo on the other side.
Slovenian: Tablete Micardis 40 mg so bele, podolgovate tablete z vtisnjeno kodno številko 51H na eni in logom podjetja na drugi strani.
English: What Micardis looks like and contents of the pack Micardis 80 mg tablets are white, oblong-shaped and engraved with the code number '52H' on one side and the company logo on the other side.
Slovenian: Tablete Micardis 80 mg so bele, podolgovate tablete z vtisnjeno kodno številko 52H na eni in logom podjetja na drugi strani.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 80 mg
Slovenian: ZUNANJE OZNAČEVANJE PRI SKUPNEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - Z MODRIM OKENCEM - 80 mg
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER LABEL ON MULTIPACKS OF 360 (4 PACKS OF 90 x 1 TABLETS) BUNDLEDINCLUDING THE BLUE BOX - 40 mg
Slovenian: ZUNANJE OZNAČEVANJE PRI SKUPNEM PAKIRANJU PO 360 TABLET (4 PAKIRANJA PO 90 x 1 TABLETO) - Z MODRIM OKENCEM - 40 mg
English: Medicinal products or therapeutic classes of medicinal products that may provoke hyperkalaemia are salt substitutes containing potassium, potassium-sparing diuretics, ACE inhibitors, angiotensin II receptor antagonists, non steroidal anti-inflammatory medicinal products (NSAIDs, including selective COX-2 inhibitors), heparin, immunosuppressives (cyclosporin or tacrolimus), and trimethoprim.
Slovenian: Zdravila ali terapevtske skupine zdravil, ki lahko povzročijo hiperkaliemijo so nadomestki soli s kalijem, diuretiki, ki zadržujejo kalij; zaviralci ACE,
English: White round tablets of 2.5 mm engraved with the code number '50H' on one side and the company logo on the other side.
Slovenian: Micardis 20 mg tablete Bele, 2,55 mm okrogle tablete z vtisnjeno kodno številko 50H na eni in logom podjetja na drugi strani.
English: NAME OF THE MEDICINAL PRODUCT Micardis 20 mg tablets
Slovenian: IME ZDRAVILA Micardis 20 mg tablete Micardis 40 mg tablete Micardis 80 mg tablete
English: - are 65 years of age or older.
Slovenian: - ste stari 65 let ali več.
English: Date of first authorisation: 18 December 2013 Date of latest renewal: 20 November 2018
Slovenian: Datum prve odobritve: 18. december 2013 Datum zadnjega podaljšanja: 20. november 2018
English: The absolute bioavailability is 75%.
Slovenian: Absolutna biološka uporabnost je 75 %.
English: EXP {MM-YYYY}
Slovenian: EXP{MM-LLLL}
English: Do this even if there are no signs of discomfort.
Slovenian: To storite tudi, če ni znakov nelagodja.
English: A risk to the breastfeeding child cannot be excluded.
Slovenian: Tveganje za dojenega otroka ne moremo izključiti.
English: Treatment should be continued for at least 6 months after you feel well again.
Slovenian: Zdravljenje je potrebno nadaljevati vsaj še 6 mesecev po tem, ko se spet dobro počutite.
English: Take one tablet with a glass of water.
Slovenian: Vzemite eno tableto s kozarcem vode.
English: Impact on human fertility has not been observed so far.
Slovenian: Vpliv na plodnost pri človeku doslej še ni bil opažen.
English: Belgique/België/Belgien
Slovenian: België/Belgique/Belgien
English: Pack of 1 glass bottle.
Slovenian: Pakiranje z 1 steklenico.
English: Tell your doctor if you are taking any of the following medicines:
Slovenian: Povejte svojemu zdravniku, če jemljete katerokoli izmed naslednjih zdravil:
English: * Based on post-marketing cases
Slovenian: * Na podlagi primerov po začetku trženja.
English: For information on undesirable effects, see section 4.8.
Slovenian: Za informacije o neželenih učinkih glejte poglavje 4.8.
English: - have low sodium level in the blood.
Slovenian: - imate nizko raven natrija v krvi.
English: Component of a multipack, can't be sold separately.
Slovenian: Sestavni del večkratnega pakiranja; se ne sme prodajati ločeno.
English: The mean volume of distribution (Vss) is 2,600 L, indicating extensive extravascular distribution.
Slovenian: Povprečen volumen porazdelitve (VSS) je 2.600 L, kar kaže na obsežno ekstravaskularno porazdelitev.
English: In the majority of instances, such complications began immediately or soon (<24 hours) after delivery.
Slovenian: V večini primerov do zapletov pride takoj ali kmalu (< 24 ur) po rojstvu.
English: The requirements for submission of periodic safety reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Slovenian: Zahteve za predložitev posodobljenih poročil o varnosti zdravila za to zdravilo so določene v seznamu referenčnih datumov Unije (seznamu EURD), opredeljenem v členu 107c(7) Direktive 2001/83/ES in vseh nadaljnjih posodobitvah, objavljenih na evropskem spletnem portalu o zdravilih.
English: The list is based on information from clinical trials and post-marketing experience.
Slovenian: Seznam temelji na podatkih iz kliničnih preskušanj in izkušenj po začetku trženja.
English: - have had mania.
Slovenian: - ste kdaj imeli manijo.
English: Thoughts of suicide and worsening of your depression
Slovenian: Misli na samomor in poslabšanje depresije
English: Doses of 5 to 15 mg showed no difference to placebo.
Slovenian: Odmerki od 5 do 15 mg ne kažejo nobene razlike od placeba.
English: Medical follow-up in a specialised environment is recommended.
Slovenian: Priporočljivo je zdravniško spremljanje v specializirani enoti.
English: Abnormal dreams
Slovenian: Nenormalne sanje