natgillin/translations-raw huggingface dataset:
- Pregnancy and Lactation should be contraindicated and the appropriate wording included in sections 4.3, 4.4 and 4.6 of the SPC, and the relevant sections of the Package Leaflet.
- je treba nosečnost in dojenje kontraindicirati, v poglavja 4.3, 4.4 in 4.6 povzetka glavnih značilnosti zdravila ter ustrezna poglavja navodil za uporabo pa vnesti primerno besedilo;
Hepato-biliary disorders Rare: Hepatitis
Bolezni jeter, žolčnika in žolčevodov Redke: hepatits
Uncommon: Nervousness, paraesthesia, peripheral neuropathy, tremor, migraine, syncope
Bolezni živčevja pogoste: glavobol, omotica občasne: nervoznost, parestezija, periferna nevropatija, tremor, migrena, sinkopa
Uncommon: Anxiety, anxiety disorder, panic disorder, confusion, depression, abnormal dreams, sleep disorder, somnolence, memory impairment
Psihiatrične motnje pogoste: nespečnost občasne: anksioznost, anksiozne motnje, panične motnje, zmedenost, depresija, nenormalne sanje, motnje spanja, zaspanost, motnje spomina
Cozaar Comp 100 mg/25 mg Each tablet contains 126.26 mg lactose monohydrate.
Cozaar Comp 100 mg/25 mg Vsaka tableta vsebuje 126,26 mg laktoze monohidrata.
• Refractory hyponatraemia
• Refraktorna hiponatriemija.
When given concurrently, the following drugs may interact with thiazide diuretics:
Pri sočasni uporabi lahko na tiazidne diuretike vplivajo naslednja zdravila:
The maximum daily dose is 2 tablets per day of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets
Največji dnevni odmerek sta dve filmsko obloženi tableti losartan/hidroklorotiazid 50 mg/12,5 mg na dan ali ena filmsko obložena tableta losartan/hidroklorotiazid 100 mg/25 mg na dan.
Eye disorders Uncommon: Blurred vision, burning/stinging in the eye, conjunctivitis, decrease in visual acuity
Očesne bolezni občasne: zamegljen vid, pekoč občutek/občutek zbadanja v očesu, konjunktivitis, zmanjšana ostrina vida
• if you have had gout
• če imate protin.
Luxembourg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Luksemburg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Renal and urinary disorders Uncommon: Nocturia, urinary frequency, urinary tract infection
Bolezni sečil občasne: nokturija, pogosto uriniranje, okužba urinarnega trakta
PHARMACEUTICAL FORM AND CONTENTS 14, 15, 28, 30, 50, 56, 84, 90, 98, or 280 film coated-tablets.
FARMACEVTSKA OBLIKA IN VSEBINA 14, 15, 28, 30, 50, 56, 84, 90, 98 ali 280 filmsko obloženih tablet.
Cozaar Comp 100 mg/12.5 mg Each tablet contains 88.40 mg lactose monohydrate.
Cozaar Comp 100 mg/12,5 mg Vsaka tableta vsebuje 88,40 mg laktoze monohidrata.
• if you are diabetic
• če imate sladkorno bolezen.
Belgium Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Bruselj, Belgija
You must not take Cozaar Comp if you are breast-feeding.
Zdravila Cozaar Comp ne smete jemati, če dojite.
Please also inform your doctor when it is planned to apply iodine contrast media about taking Cozaar Comp.
Če boste imeli preiskavo z jodirnim kontrastnim sredstvom, zdravniku povejte, da jemljete zdravilo Cozaar Comp.
This can be increased to 2 tablets once daily of Losartan / Hydrochlorothiazide 50 mg/12.5 mg Film-Coated Tablets or changed to 1 tablet daily of Losartan / Hydrochlorothiazide 100 mg/25 mg Film-Coated Tablets (a stronger strength) per day.
Odmerek se lahko poveča na 2 filmsko obloženi tableti losartan/hidroklorotiazid 50 mg/12,5 mg enkrat na dan ali eno tableto losartan/hidroklorotiazid 100 mg/25 mg (večja jakost) na dan.
PHARMACEUTICAL FORM AND CONTENTS 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 film-coated tablets
FARMACEVTSKA OBLIKA IN VSEBINA 7, 14, 28, 30, 50, 56, 84, 90, 98 ali 280 filmsko obloženih tablet.
Metabolism and nutrition disorders Uncommon: Anorexia, gout
Presnovne in prehranske motnje občasne: anoreksija, protin
HOW TO TAKE COZAAR COMP
KAKO JEMATI ZDRAVILO COZAAR COMP
Cozaar Comp is contraindicated for patients with severe hepatic impairment (see section 4.3 and
Zdravilo Cozaar Comp je kontraindicirano pri bolnikih s hudo okvaro jeter (glejte poglavji 4.3 in 5.2).
some antibacterial drugs such as co-trimoxazole, ask your doctor if you are not sure)
• če ste alergični na (preobčutljivi za) druge derivate sulfonamida (npr. druge tiazide, nekatera protibakterijska zdravila, kot je ko-trimoksazol; če niste prepričani, vprašajte zdravnika).
Such conditions should be corrected before the administration of Cozaar Comp tablets (see sections 4.2. and 4.3.
Pred začetkom zdravljenja z zdravilom Cozaar Comp je treba ta stanja pozdraviti (glejte poglavji 4.2 in 4.3).
NAME OF THE MARKETING AUTHORISATION HOLDER [See Annex I - To be completed nationally] [For referral procedures]
IME IMETNIKA DOVOLJENJA ZA PROMET Z ZDRAVILOM [Glejte dodatek 1 - Izpolni država članica]
Common: Abdominal pain, nausea, diarrhoea, dyspepsia Uncommon: Constipation, dental pain, dry mouth, flatulence, gastritis, vomiting
Bolezni prebavil pogoste: bolečine v trebuhu, navzea, diareja, dispepsija občasne: zaprtje, zobobol, suha usta, flatulenca, gastritis, bruhanje
• Swelling of the face, fever.
• otekanje obraza, zvišana telesna temperatura
Hyzaar Forte 100/25 mg
Madžarska Hyzaar Forte 100/25 mg Malta
Do not take Cozaar Comp
Ne jemljite zdravila Cozaar Comp:
Uncommon: Transient blurred vision, xanthopsia Vascular disorders
Očesne bolezni občasne: prehodno zamegljen vid, ksantopsija
When clinically appropriate direct change from monotherapy to the fixed combination may be considered in patients whose blood pressure is not adequately controlled.
Če je klinično primerno, lahko pri bolnikih, pri katerih krvni tlak ni ustrezno nadzorovan, takoj preidete z zdravljenja z eno učinkovino na zdravljenje s fiksno kombinacijo.
Cozaar Comp tablets may be taken with or without food.
Zdravilo Cozaar Comp se lahko zaužije s hrano ali na tešče.
Cozaar Comp tablets should be swallowed with a glass of water Cozaar Comp may be administered with or without food.
Cozaar Comp tablete je treba pogoltniti s kozarcem vode.
Both biliary and urinary excretion contribute to the elimination of losartan and its metabolites.
K izločanju losartana in njegovih presnovkov prispevata tako izložanje z žolčem kot izločanje skozi ledvice.
Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/12.5 mgand Cozaar Comp 100 mg/25 mg contain the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinized maize starch, magnesium stearate, hydroxypropyl cellulose, hypromellose.
Cozaar Comp 50 mg/12,5 mg, Cozaar Comp 100 mg/12,5 mg in Cozaar Comp 100 mg/25 mg vsebujejo naslednje pomožne snovi: mikrokristalno celulozo, laktozo monohidrat, predgeliran koruzni škrob, magnezijev stearat, hidroksipropilcelulozo, hipromelozo.
Losartan-Hydrochlorothiazide
Losartan-hidroklorotiazid
Further, as a result of its diuretic effect, hydrochlorothiazide increases plasma renin activity, increases aldosterone secretion, decreases serum potassium, and increases the levels of angiotensin II.
Rezultat diuretičnega delovanja hidroklorotiazida je povečanje plazemske reninske aktivnosti in sekrecije aldosterona, znižanje koncentracije kalija v serumu in povečanje koncentracije angiotenzina II.
Cozaar Comp 50 mg/12.5 mg, Cozaar Comp 100 mg/12.5 mg and Cozaar Comp 100 mg/25 mg: Each tablet contains the following inactive ingredients: microcrystalline cellulose(E460), lactose monohydrate, pregelatinized maize starch, magnesium stearate (E572), hydroxypropyl cellulose (E463), hypromellose(E464).
Cozaar Comp 50 mg/12,5 mg, Cozaar Comp 100 mg/12,5 mg in Cozaar Comp 100 mg/25 mg: Vsaka tableta vsebuje naslednje pomožne snovi: mikrokristalno celulozo (E460), laktozo monohidrat, predgelirani koruzni škrob, magnezijev stearat (E572), hidroksipropilcelulozo (E463), hipromelozo (E464).
There was no clinically significant effect on the plasma concentration profile of losartan when the drug was administered with a standardized meal.
Zaužitje zdravila med standardiziranim obrokom ni imelo nobenega klinično pomembnega vpliva na plazemski koncentracijski profil losartana.
Metabolism and nutrition disorders Uncommon: Anorexia, hyperglycaemia, hyperuricaemia, hypokalaemia, hyponatraemia
Presnovne in prehranske motnje občasne: anoreksija, hiperglikemija, hiperurikemija, hipokaliemija, hiponatriemija Psihiatrične motnje občasne: nespečnost
Increases in cholesterol and triglyceride levels may be associated with thiazide diuretic therapy.
Diuretično zdravljenje s tiazidi lahko povzroči dvig koncentracije holesterola in trigliceridov.
Uncommon: Alopecia, dermatitis, dry skin, erythema, flushing, photosensitivity, pruritus, rash, urticaria, sweating
Bolezni kože in podkožja občasne: alopecija, dermatits, suha koža, eritem, zardevanje, fotosenzitivnost, srbenje, izpuščaj, koprivnica, znojenje
Cases of thrombocytopenia in neonates and fetal or neonatal jaundice were reported after treating the mothers with thiazides.
Po zdravljenju mater s tiazidi v nosečnosti so poročali o primerih trombocitopenije pri novorojenčkih ter o fetalni in neonatalni zlatenici.
• Some antipsychotics (eg thioridazine, chlorpromazine, levomepromazine, trifluoperazine, cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol).
• nekateri antipsihotiki (npr. tioridazin, klorpromazin, levomepromazin, trifluoperazin,
Therefore, serum lithium levels should be monitored carefully if lithium salts are to be coadministered with angiotensin II receptor antagonists.
Zato je treba v primeru, ko mora bolnik sočasno z antagonisti receptorjev angiotenzina II jemati litijeve soli, pozorno spremljati količino litija v serumu.
Take special care with Cozaar Comp • if you have previously suffered from swelling of the face, lips, throat or tongue
• če so vam kdaj otekali obraz, ustnice, žrelo ali jezik.
COZAAR COMP film-coated Tablets losartan potassium and hydrochlorothiazide
COZAAR COMP filmsko obložene tablete kalijev losartanat in hidroklorotiazid
Anaphylactic reaction
Redke: anafilaktična reakcija
Common: Cough, upper respiratory infection, nasal congestion, sinusitis, sinus disorder Uncommon: Pharyngeal discomfort, pharyngitis, laryngitis, dyspnoea, bronchitis, epistaxis, rhinitis, respiratory congestion
Bolezni dihal, prsnega koša in mediastinalnega prostora pogoste: kašelj, okužba zgornjih dihal, zamašen nos, sinuzitis, težave s sinusi občasne: nelagodje v žrelu, faringitis, laringitis, dispneja, bronhitis, krvavitev iz nosu, rinitis, respiratorna kongestija
Cozaar Comp 50 mg/12.5 mg and Cozaar Comp 100 mg/25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).
Cozaar Comp 50 mg/12,5 mg in Cozaar Comp 100 mg/25 mg vsebujeta tudi titanov dioksid (E171), kinolinsko rumeno (E104) in karnauba vosek (E903).
Cozaar Comp 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.
Cozaar Comp 50 mg/12,5 mg vsebuje 4,24 mg (0,108 mEq) kalija.
Cozaar Comp 100 mg/25 mg is supplied as unscored film-coated tablets.
Cozaar Comp 100 mg/25 mg je na voljo v obliki filmsko obloženih tablet brez razdelilne zareze.
Despite the significant decrease in blood pressure, administration of Cozaar Comp had no clinically significant effect on heart rate.
Zdravljenje z zdravilom Cozaar Comp ni imelo klinično pomembnega vpliva na srčno frekvenco kljub pomembnemu znižanju krvnega tlaka.
Hungary Merck Sharp & Dohme Hungary Ltd 50, Alkotas str.
Madžarska Merck Sharp & Dohme Hungary Ltd
There was no evidence of teratogenicity in rats or rabbits treated with the losartan/hydrochlorothiazide combination.
Pri podganah ali kuncih, ki so prejemali kombinacijo losartan/hidroklorotiazid, niso odkrili teratogenosti.
Cozaar Plus 100/12,5 100 mg losartan potassium12.5 mg hydrochlorothiazide
Cozaar Plus 100/12,5 100 mg kalijev losartanat
Cozaar Comp 100 mg/25 mg> contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 100 mg/25 mg kot zdravilni učinkovini vsebuje 100 mg kalijevega losartanata in 25 mg hidroklorotiazida.
Ear and labyrinth disorders Uncommon: Vertigo, tinnitus
Ušesne bolezni in motnje labirinta Občasne: vrtoglavica, tinitus
Norway MSD BV Waarderweg 39
MSD BV Waarderweg 39 2031 BN Haarlem Nizozemska
Cozaar Comp 100 mg/12.5 mg mg and Cozaar Comp 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.
Cozaar Comp 100 mg/12,5 mg in Cozaar Comp 100 mg/25 mg vsebujeta 8,48 mg (0,216 mEq) kalija.
HYZAAR (Losartan/Hydrochlorothia zide)
HYZAAR (Losartan/Hidroklorotiazid)
• if you have ‘aortic or mitral valve stenosis' (narrowing of the valves of the heart) or
• če imate stenozo aortne ali mitralne zaklopke (zožitev srčnih zaklopk) ali hipertrofično kardiomiopatijo (bolezen, ki povzroča zadebelitev srčne mišice).
Cozaar Comp 100 mg/12.5 mg mg is supplied as unscored film-coated tablets.
Cozaar Comp 100 mg/12,5 mg je na voljo v obliki filmsko obloženih tablet brez razdelilne zareze.
Cosaar Plus - Filmtabletten 50 mg losartan potassium12.5 mg hydrochlorothiazide
Cosaar Plus - Filmtabletten 50 mg kalijev losartanat
Fortzaar 100 mg/25 mg 100 mg losartan potassium25 mg hydrochlorothiazide
Fortzaar 100 mg/25 mg 100 mg kalijev losartanat
Anaphylactic reactions, angioedema, urticaria
Bolezni imunskega sistema redke: anafilaktične reakcije, angioedem, koprivnica
Cozaar Comp 50 mg/12.5 mg> contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 50 mg/12,5 mg kot zdravilni učinkovini vsebuje 50 mg kalijevega losartanata in 12,5 mg hidroklorotiazida.
Unless continued Losartan/HTCZ therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost, je treba čim prej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen, če se oceni, da je nadaljnje zdravljenje s kombinacijo losartan/HCTZ nujno.
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg mg film-coated tablets Losartan and hydrochlorothiazide
Cozaar Comp 100 mg/25 mg filmsko obložene tablete losartan in hidroklorotiazid
Cozaar Comp100 mg/12.5 mg mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp 100 mg/12,5 mg kot zdravilni učinkovini vsebuje 100 mg kalijevega losartanata in 12,5 mg hidroklorotiazida.
Marketing Authorisation Holder and Manufacturer <To be completed nationally>
Imetnik dovoljenja za promet z zdravilom in izdelovalec [Izpolni država članica]
The efficacy and safety are established for the indication “treatment of essential hypertension in patients whose blood pressure is not adequately controlled on hydrochlorothiazide or losartan monotherapy”.
- Zdravljenje esencialne hipertenzije pri bolnikih, katerih krvnega tlaka ni mogoče primerno nadzorovati z monoterapijo s hidroklorotiazidom ali losartanom Učinkovitost in varnost sta bili ugotovljeni za indikacijo „zdravljenje esencialne hipertenzije pri bolnikih, katerih krvnega tlaka ni mogoče primerno nadzorovati z monoterapijo s hidroklorotiazidom ali losartanom“.
Hyzaar Forte 100/25 mg 100 mg losartan potassium25 mg hydrochlorothiazide
Hyzaar Forte 100/25 mg 100 mg kalijev losartanat
The CHMP concluded that the indication for the initial therapy of hypertension with the fixed dose combination (FDC) does not have a positive benefit-risk ratio, and therefore is not acceptable.
-Kot prvi korak pri zdravljenju bolnikov z zmerno do hudo hipertenzijo in pri bolnikih s hudo ali zelo hudo hipertrofijo levega ventrikla CHMP je zaključil, da indikacija za začetno zdravljenje hipertenzije s fiksno kombinacijo odmerkov nima pozitivnega razmerja med koristnimi učinki in tveganjem, zaradi česar ni sprejemljiva.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 50 mg kalijevega losartanata in 12,5 mg hidroklorotiazida.
Hepato-biliary disorders Not known: Liver function abnormalities
Bolezni jeter, žolčnika in žolčevodov Pogostnost ni znana: nenormalno delovanje jeter
Diuretic agents reduce the renal clearance of lithium and add a high risk of lithium toxicity; concomitant use is not recommended.
Diuretiki zmanjšajo ledvični očistek litija in s tem zelo povečajo tveganje za toksičnost litija.
and Cozaar Comp 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.
Cozaar Comp 100 mg/25 mg vsebuje 8,48 mg (0,216 mEq) kalija.
• Symtomatic hyperuricaemia/gout
• Simptomatska hiperurikemija/protin.
Each tablet contains 100 mg of losartan (as potassium salt) and 25 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Vsaka tableta kot zdravilni učinkovini vsebuje 100 mg losartana (v obliki kalijeve soli) in 25 mg hidroklorotiazida (HCTZ).
COZAAR-COMP Forte 100 mg losartan potassium25 mg hydrochlorothiazide
COZAAR-COMP Forte 100 mg kalijev losartanat
HYZAAR 50 mg/12,5 mg 50 mg losartan potassium12.5 mg hydrochlorothiazide
HYZAAR 50 mg/12,5 mg; 50 mg kalijev losartanat
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg Losartan and hydrochlorothiazide
Cozaar Comp 100 mg/25 mg losartan in hidroklorotiazid
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 100 mg kalijevega losartanata in 25 mg hidroklorotiazida.
• Severe hepatic impairment; Cholestasis and biliary obstructive disorders
• Huda okvara jeter, holestaza, obstrukcija žolča.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN Vsaka tableta vsebuje 100 mg kalijevega losartanata in 12,5 mg hidroklorotiazida.
Cozaar Comp 100 mg/12.5 mg mg contains 8.48 mg (0.216 mEq) of potassium.
Cozaar Comp 100 mg/12,5 mg vsebuje 8,48 mg (0,216 mEq) kalija.
• Anuria
• Anurija.
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 50 mg/12.5 mg Losartan and hydrochlorothiazide
Cozaar Comp 50 mg/12,5 mg losartan in hidroklorotiazid
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 50 mg/12.5 mg mg film-coated tablets Losartan and hydrochlorothiazide
Cozaar Comp 50 mg/12,5 mg filmsko obložene tablete losartan in hidroklorotiazid
What Cozaar Comp contains
Kaj vsebuje zdravilo Cozaar Comp
Hydrochlorothiazide has been shown to cause modest increases in uric acid; the combination of losartan and hydrochlorothiazide tends to attenuate the diuretic-induced hyperuricemia.
Tako kombinacija losartana in hidroklorotiazida teži k zniževanju z diuretikom povzročene hiperurikemije.
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/12.5 mg Losartan and hydrochlorothiazide
Cozaar Comp 100 mg/12,5 mg losartan in hidroklorotiazid
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/12.5 mg mg film-coated tablets Losartan and hydrochlorothiazide
Cozaar Comp 100 mg/12,5 mg filmsko obložene tablete losartan in hidroklorotiazid
Liver function impairment
Okvara jeter
Merck Sharp & Dohme Italia S.p.A. via G Fabbroni 6 , 00191 Rome Italy
Via G. Fabbroni 6, 00191 Rim, Italija
Each tablet contains 50 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Vsaka tableta kot zdravilni učinkovini vsebuje 50 mg losartana (v obliki kalijeve soli) in 12,5 mg hidroklorotiazida (HCTZ).
Each tablet contains 100 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Vsaka tableta kot zdravilni učinkovini vsebuje 100 mg losartana (v obliki kalijeve soli) in 12,5 mg hidroklorotiazida (HCTZ).
• Diarrhoea, abdominal pain, nausea, indigestion,
• driska, bolečine v trebuhu, siljenje na bruhanje, slaba prebava
Cozaar Comp 50 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets.
Cozaar Comp 50 mg/12,5 mg: PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 ali 280 tablet.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 100 mg/12.5 mg film-coated tablets HDPE bottle
PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti za Cozaar Comp 100 mg/12,5 mg filmsko obložene tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 50 mg/12.5 mg film-coated tablets HDPE Bottle
PODATKI NA ZUNANJI OVOJNINI Škatla s pretisnimi omoti za Cozaar Comp 50 mg/12,5 mg filmsko obložene tablete
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 100 mg/25 mg film-coated tablets HDPE bottle
PODATKI NA ZUNANJI OVOJNINI Škatla za Cozaar Comp 100 mg/25 mg filmsko obložene tablete
Cozaar Comp 100 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets.
Cozaar Comp 100 mg/12,5 mg - PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablet.
Skin and subcutaneous tissue disorders
Holestiraminske in kolestipolne smole
Nervous system disorders
Bolezni imunskega sistema
Cozaar Comp 100 mg/25 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Cozaar Comp 100 mg/25 mg: PVC/PE/PVDC pretisni omoti s prevleko iz aluminijaste folije v pakiranjih po 7, 14, 28, 30, 50, 56, 84, 90, 98 ali 280 tablet.
Latent diabetes mellitus may become manifest during thiazide therapy.
Med zdravljenjem s tiazidi se lahko prikaže do tedaj prikrita sladkorna bolezen.
Heart failure:
Srčno popuščanje
In general, the antihypertensive effect is attained within three to four weeks after initiation of therapy.
Antihipertenzivni učinek traja do 24 ur.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar Comp 100 mg/25 mg film-coated tablets
Nalepka za HDPE plastenko za Cozaar Comp 100 mg/25 mg filmsko obložene tablete
[the below currently approved indications should be deleted (specific wording of the indication may vary from product to product)]
[spodaj navedene trenutno odobrene indikacije je treba izbrisati (specifično besedilo indikacije se lahko razlikuje od izdelka do izdelka)]
• Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
• Simptomatsko zdravljenje kroničnih patoloških kognitivnih in nevrosenzoričnih motenj pri starostnikih (razen Alzheimerjeve bolezni in drugih demenc)
• Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
• Pomožno zdravljenje zmanjšanja vidne ostrine in motenj vidnega polja, ki so domnevno žilnega izvora
All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Vse navedbe zgoraj navedenih indikacij je treba izbrisati iz preostalih ustreznih poglavij povzetkov glavnih značilnosti zdravila.
All references to the above mentioned indications should be deleted from the relevant sections of the package leaflets.
Vse navedbe zgoraj navedenih indikacij je treba izbrisati iz ustreznih poglavij navodil za uporabo.
Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Spremembe ustreznih poglavij povzetkov glavnih značilnosti zdravila in navodil za uporabo
The medicine has an acceptable safety profile.
Zdravilo ima sprejemljiv varnostni profil.
In both studies, 6.5 mg Intrarosa was given once a day for 12 weeks.
V obeh študijah so dajali 6,5 mg zdravila Intrarosa enkrat dnevno 12 tednov.
What measures are being taken to ensure the safe and effective use of Intrarosa?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Intrarosa?
The full EPAR for Intrarosa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Intrarosa je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.