FrancophonIA/ELRC3.0 huggingface dataset:
English: Hepatic impairment
Slovak: glavobol omotica
English: MARKETING AUTHORISATION NUMBER(S) Kinzalkomb 40 mg/12.5 mg tablets EU/1/02/214/001-005
Slovak: Kinzalkorb 40 mg/12,5 mg tablete EU/1/02/214/001-005
English: 6.2 Incompatibilities
Slovak: Inkompatibilnosti
English: Beta-blockers and diazoxide
Slovak: Zaviralci adrenergičnih receptorjev beta in diazoksid
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA
Slovak: EDINSTVENA OZNAKA - V BERLJIVI OBLIKI
English: Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
Slovak: Na receptorju AT1 nima nikakršnega delnega agonističnega učinka.
English: Based on available data from epidemiological studies, cumulative dose-dependent association between HCTZ and NMSC has been observed.
Slovak: Na podlagi obstoječih podatkov epidemioloških študij so ugotovili, da obstaja razmerje med kumulativnim odmerkom hidroklorotiazida in nemelanomskim kožnim rakom.
English: Each 80 mg/12.5 mg tablet contains 112 mg of lactose monohydrate and 338 mg sorbitol (E420).
Slovak: Ena 80 mg/12,5 mg tableta vsebuje 112 mg laktoze monohidrata in 338 mg sorbitola (E420).
English: 5.3 Preclinical safety data
Slovak: Predklinični podatki o varnosti
English: If these effects are not treated they could be fatal.
Slovak: Brez zdravljenja so lahko usodni za bolnika.
English: The hyperglycaemic effect of beta-blockers and diazoxide may be enhanced by thiazides.
Slovak: Tiazidi lahko povečano hiperglikemični učinek zaviralcev adrenergičnih receptorjev beta in diazoksida.
English: Telmisartan showed no evidence of mutagenicity and relevant clastogenic activity in in vitro studies and no evidence of carcinogenicity in rats and mice.
Slovak: Telmisartan v in vitro študijah pri podganah in miših ni imel mutagenih učinkov ali pomembnejšega klastogenega delovanja in ni deloval kancerogeno.
English: Kinzalkomb should be kept in the sealed blister due to the hygroscopic property of the tablets.
Slovak: Zdravilo Kinzalkomb je treba shranjevati v zaprtem pretisnem omotu, ker so tablete higroskopične.
English: 6.4 Special precautions for storage
Slovak: POSEBNA NAVODILA ZA SHRANJEVANJE
English: The overall incidence of adverse reactions reported with Kinzalkomb was comparable to those reported with telmisartan alone in randomised controlled trials involving 1471 patients randomised to receive telmisartan plus hydrochlorothiazide (835) or telmisartan alone (636).
Slovak: V kliničnih preskušanjih je sodelovalo 1471 bolnikov, ki so bili naključno razvrščeni v skupini, od katerih je ena prejemala telmisartan in hidroklorotiazid (835), druga pa samo telmisartan (636).
English: If this combination proves essential, careful monitoring of serum lithium level is recommended during concomitant use.
Slovak: Če je kombinirano zdravljenje nujno potrebno, je priporočljivo pazljivo spremljanje serumske ravni litija.
English: Tell your doctor if you are breast-feeding or about to start breast-feeding.
Slovak: Povejte zdravniku, če dojite ali nameravate začeti dojiti.
English: Vasculitis necrotizing
Slovak: nekrotizirajoči vaskulitis
English: Pregnancy and breast-feeding
Slovak: Nosečnost in dojenje
English: Digoxin.
Slovak: Digoksin
English: Pharmacokinetic properties
Slovak: Farmakokinetične lastnosti
English: C-labelled telmisartan the glucuronide represents approximately 11 % of the measured radioactivity in plasma.
Slovak: C označenega telmisartana odpade na glukuronid približno 11
English: Based on their pharmacological properties it can be expected that the following medicinal products may potentiate the hypotensive effects of all antihypertensives including telmisartan: Baclofen, amifostine.
Slovak: Zdravili, ki lahko zaradi svojih farmakoloških lastnosti povečata hipotenzivne učinke vseh antihipertenzivov, tudi telmisartana, sta baklofen in amifostin.
English: General
Slovak: Splošno
English: Absorption of hydrochlorothiazide is impaired in the presence of anionic exchange resins.
Slovak: V prisotnosti anionskih izmenjalnih smol je motena absorpcija hidroklorotiazida.
English: Individual dose titration with each of the two components is recommended before changing to the fixed dose combination.
Slovak: Pred prehodom na zdravljenje s fiksno kombinacijo je priporočljivo, da najprej individualno prilagodimo odmerka posameznih sestavin kombinacije.
English: A cumulative dose-response relationship was demonstrated with an adjusted OR 2.1 (95% CI: 1.7-2.6) increasing to OR 3.9 (3.0-4.9) for high use (~25,000 mg) and OR 7.7 (5.7-10.5) for the highest cumulative dose (~100,000 mg) (see also section 4.4).
Slovak: Razmerje med kumulativnim odmerkom in odzivom so dokazali s tem, da se je prilagojeni OR z 2,1 (95odstotni IZ: 1,7-2,6), zvišal na 3,9 (3,0-4,9) pri velikih odmerkih (~
English: There is no experience regarding the administration of Kinzalkomb in patients with recent kidney transplantation.
Slovak: Z uporabo zdravila Kinzalkomb pri bolnikih z nedavno presajeno ledvico ni izkušenj.
English: Kinzalkomb must not be used in patients with severe renal impairment (creatinine clearance <30 ml/min) (see section 4.3).
Slovak: Zdravila Kinzalkomb ne smemo dajati bolnikom z močno zmanjšanim delovanjem ledvic (kreatininskim očistkom < 30 ml/min)
English: Lupus-like syndrome, photosensitivity reactions, skin vasculitis, toxic epidermal necrolysis, erythema multiforme Musculoskeletal, connective tissue and bone disorders Not known:
Slovak: lupusu podoben sindrom, fotosenzibilne reakcije, kožni vaskulitis, toksična epidermalna nekroliza, multiformni eritem
English: 4.4 Special warnings and precautions for use
Slovak: Posebna opozorila in previdnostni ukrepi
English: Hydrochlorothiazide is a thiazide diuretic.
Slovak: Hidroklorotiazid je zdravilo iz skupine tiazidnih diuretikov.
English: Hydrochlorothiazide exhibits linear pharmacokinetics.
Slovak: Hidroklorotiazid kaže linerano farmakinetiko.
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).
Slovak: Znano je, da izpostavljenost antagonistom angiotenzina II v drugem in tretjem trimesečju nosečnosti lahko povzroči fetotoksične učinke pri človeku (zmanjšano delovanje ledvic, oligohidramnij, zapoznela zakostenitev lobanje) in toksične učinke pri novorojenčku (ledvična odpoved, hipotenzija, hiperkaliemija).
English: Cardiovascular death and stroke were both numerically more frequent in the aliskiren group than in the placebo group and adverse events and serious adverse events of interest (hyperkalaemia, hypotension and renal dysfunction) were more frequently reported in the aliskiren group than in the placebo group.
Slovak: Tudi resni interesantni neželeni učinki (hiperkaliemija, hipotenzija in disfunkcija ledvic) so bili v skupini, ki je prejemala aliskiren, pogostejši kot v skupini, ki je prejemala placebo.
English: Cytotoxic agents (e.g. cyclophosphamide, methotrexate)
Slovak: Citotoksična zdravila (npr. ciklofosfamid, metotreksat)
English: After a single dose of
Slovak: Po enkratnem odmerku s
English: Pancreatitis, stomach discomfort
Slovak: navzea pankreatitis, želodčne težave
English: Adverse reactions reported with one of the individual components may be potential adverse reactions with Kinzalkomb, even if not observed in clinical trials with this product.
Slovak: Neželeni učinki, o katerih so poročali za eno od posameznih sestavin, se lahko pojavijo tudi pri zdravilu Kinzalkomb, četudi jih v kliničnem preskušanju tega zdravila niso zasledili.
English: NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/25 mg tablets
Slovak: IME ZDRAVILA Kinzalkomb 80 mg/25 mg tablete
English: Japanese patients are more likely to experience these adverse reactions.
Slovak: Preobčutljivostne reakcije so verjetnejše pri bolnikih, ki imajo omenjena obolenja v anamnezi.
English: Thiazide-induced hypokalaemia or hypomagnesaemia favours the onset of digitalis-induced arrhythmia (see section 4.4).
Slovak: Hipokaliemija ali hipomagneziemija, ki jo povzročajo tiazidi, poveča možnost nastanka aritmije, inducirane z digitalisom (glejte poglavje 4.4
English: 1: Based on post-marketing experience 2: For further description, please see sub-section “Description of selected adverse reactions”
Slovak: znižan hemoglobin 3: Za podrobnejši opis glejte podpoglavje »Opis izbranih neželenih učinkov«
English: Co-administration of lithium and Kinzalkomb is not recommended (see section 4.4).
Slovak: Sočasno dajanje litija in zdravila Kinzalkomb ne priporočamo (glejte poglavje 4.4).
English: Coadministration of thiazide may increase the incidence of hypersensitivity reactions of allopurinol.
Slovak: Sočasno dajanje tiazida lahko poveča pogostnost preobčutljivostnih reakcij na alopurinol.
English: Sialadenitis Neoplasms benign, malignant and unspecified (incl cysts and polyps) Not known:
Slovak: Benigne, maligne in neopredeljene novotvorbe (vključno s cistami in polipi)
English: Hypokalaemia Hyperuricaemia, hyponatraemia
Slovak: hiperurikemija, hiponatriemija
English: Common side effects (may affect up to 1 in 10 people): Feeling sick (nausea), low blood magnesium level.
Slovak: Pogosti neželeni učinki (lahko se pojavijo pri največ 1 od 10 bolnikov): slabost (navzea), nizka raven magnezija v krvi.
English: Thiazides may decrease urinary calcium excretion and cause an intermittent and slight elevation of serum calcium in the absence of known disorders of calcium metabolism.
Slovak: Tiazidi lahko zmanjšajo izločanje kalcija s sečem in občasno blago povečajo njegovo raven v serumu, kadar ni znanih motenj njegove presnove.
English: Reduction in blood platelets, which increases risk of bleeding or bruising (small purple-red marks in skin or other tissue caused by bleeding), high blood calcium level, headache.
Slovak: Redki neželeni učinki (lahko se pojavijo pri največ 1 od 1.000 bolnikov): zmanjšanje števila trombocitov, kar poveča tveganje za krvavitve ali nastanek modric (majhne vijoličnordeče lise na koži ali drugih tkivih, ki jih povzroča krvavitev), visoka raven kalcija v krvi, glavobol.
English: Yellow and white oval shaped tablet of 6.2 mm engraved with the code 'H9'.
Slovak: Rdeča in bela ovalna, dvoslojna 6,2 mm tableta z vtisnjeno kodno številko 'H9'.
English: Periodic monitoring of serum potassium and ECG is recommended when Kinzalkomb is administered with medicinal products affected by serum potassium disturbances (e.g. digitalis glycosides, antiarrhythmics) and the following torsades de pointes inducing medicinal products (which include some antiarrhythmics), hypokalaemia being a predisposing factor to torsades de pointes.
Slovak: Priporočamo periodično spremljanje ravni kalija v serumu in EKG, kadar dajemo zdravilo Kinzalkomb hkrati z zdravili, na delovanje katerih vplivajo motnje serumskega kalija (npr. z glikozidi digitalisa ali antiaritmiki).
English: Possible side effects of Kinzalkomb:
Slovak: Možni neželeni učinki zdravila Kinzalkomb so:
English: Immune system disorders Not known:
Slovak: Bolezni imunskega sistema Neznana:
English: A clear cumulative dose response relationship was observed for both BCC and SCC.
Slovak: Pokazalo se je jasno razmerje med kumulativnim odmerkom in odzivom nanj, tako pri bazalnoceličnem karcinomu kot pri ploščatoceličnem karcinomu.
English: • Kinzalkomb 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Kinzalmono 40 mg
Slovak: Zdravilo Kinzalkomb 40 mg/12,5 mg lahko dajemo enkrat na dan bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati z zdravilom Kinzalmono 40 mg
English: - Hypokalaemia
Slovak: hipokaliemija
English: Photosensitizing actions of HCTZ could act as a possible mechanism for NMSC.
Slovak: Učinki hidroklorotiazida, ki povzročajo občutljivost na svetlobo, bi lahko delovali kot potencialni mehanizem za nemelanomski kožni rak.
English: 6.6 Special precautions for disposal and other handling
Slovak: Posebni varnostni ukrepi za odstranjevanje in ravnanje z zdravilom
English: Blood and lymphatic system disorders Uncommon:
Slovak: Bolezni krvi in limfatičnega sistema Redki:
English: Latent diabetes mellitus may become manifest during thiazide therapy.
Slovak: Med zdravljenjem s tiazidi se lahko razvijejo klinični znaki latentnega diabetesa mellitusa.
English: Furthermore, orthostatic hypotension may be aggravated by alcohol, barbiturates, narcotics or antidepressants.
Slovak: Poleg tega alkohol, barbiturati, narkotiki ali antidepresivi poslabšajo ortostatsko hipotenzijo.
English: ACE-inhibitors and angiotensin II receptor blockers should therefore not be used concomitantly in patients with diabetic nephropathy.
Slovak: Zato se pri bolnikih z diabetično nefropatijo zaviralcev ACE in blokatorjev receptorjev angiotenzina II ne sme uporabljati sočasno.
English: PHARMACEUTICAL PARTICULARS
Slovak: FARMAKOLOŠKE LASTNOSTI
English: Thiazide diuretics may increase serum calcium levels due to the decreased excretion.
Slovak: Tiazidni diuretiki lahko zaradi manjšega izločanja povečajo raven kalcija v serumu.
English: Serious angioedema may occur rarely (≥1/10,000 to <1/1,000).
Slovak: 1/1.000) se lahko pojavi resen angioedem.
English: Two large randomised, controlled trials (ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) and VA NEPHRON-D (The Veterans Affairs Nephropathy in Diabetes)) have examined the use of the combination of an ACE-inhibitor with an angiotensin II receptor blocker.
Slovak: Uporabo zaviralca ACE v kombinaciji z blokatorjem receptorjev angiotenzina II so raziskali v dveh velikih randomiziranih, kontroliranih preskušanjih: ONTARGET (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial) in VA NEPHRON-D (The Veterans Affairs
English: Kinzalkomb fixed dose combination (80 mg telmisartan/25 mg hydrochlorothiazide) is indicated in adults whose blood pressure is not adequately controlled on Kinzalkomb 80 mg/12.5 mg (80 mg telmisartan/12.5 mg hydrochlorothiazide) or patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Slovak: Zdravilo Kinzalkomb, fiksna kombinacija (80 mg telmisartana in 25 mg hidroklorotiazida), je indicirano za odrasle, pri katerih krvnega tlaka ne moremo ustrezno uravnati z zdravilom Kinzalkomb 80 mg/12,5 mg (80 mg telmisartana in 12,5 mg hidroklorotiazida) ali za bolnike, ki jemljejo telmisartan in hidroklorotiazid posebej in imajo ustaljen krvni tlak.
English: What Kinzalkomb contains
Slovak: Kaj vsebuje zdravilo Kinzalkomb
English: INFORMATION IN BRAILLE Kinzalkomb 80 mg/25 mg
Slovak: Kinzalkomb 80 mg/25 mg
English: Infections and infestations Rare:
Slovak: Infekcijske in parazitske bolezni Redki:
English: Psychiatric disorders Not known:
Slovak: Psihiatrične motnje Neznana:
English: Amantadine
Slovak: Amantadin
English: - Heart trouble.
Slovak: želodčne težave
English: Weakness
Slovak: oslabelost
English: Non-melanoma skin cancer (Basal cell carcinoma and Squamous cell carcinoma) Blood and lymphatic system disorders Rare:
Slovak: nemelanomski kožni rak (bazalnocelični karcinom in ploščatocelični karcinom)
English: 2: For further description, please see sub-section”Description of selected adverse reactions” Additional information on individual components
Slovak: Za podrobnejši opis glejte podpoglavje »Opis izbranih neželenih učinkov«
English: There was evidence for a benefit of telmisartan compared to placebo in the pre-specified secondary composite endpoint of cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke [0.87 (95 % CI 0.76 - 1.00, p = 0.048)].
Slovak: Podatki dokazujejo korist zdravljenja s telmisartanom v primerjavi s placebom na podlagi njegovega učinka na vnaprej opredeljen sekundarni, sestavljeni opazovani dogodek, ki je zajemal srčnožilno smrt, neusodni miokardni infarkt in neusodno možgansko kap [0,87 (95-odstotni IZ 0,76 do 1,00, p =
English: ACE-inhibitors and angiotensin II receptor blockers should not be used concomitantly in patients with diabetic nephropathy.
Slovak: Pri bolnikih z diabetično nefropatijo se zaviralcev ACE in blokatorjev receptorjev angiotenzina II ne sme uporabljati sočasno.
English: Exacerbation or activation of systemic lupus erythematosus has been reported with the use of thiazide diuretics, including hydrochlorothiazide.
Slovak: Pri uporabi tiazidnih diuretikov vključno z hidroklorotiazidom poročajo o poslabšanju ali aktiviranju sistemskega eritematoznega lupusa.
English: Renovascular hypertension
Slovak: Ledvičnožilna hipertenzija
English: The absolute bioavailability of telmisartan at 40 mg and 160 mg was 42 % and 58 %, respectively.
Slovak: Njegova absolutna biološka uporabnost je bila po dajanju odmerkov po 40 mg in 160 mg 42- oz.
English: How to store Kinzalkomb
Slovak: Shranjevanje zdravila Kinzalkomb
English: Hepatic function abnormal / liver disorder
Slovak: Nenormalno delovanje jeter ali jetrna bolezen
English: Kinzalkomb 80 mg/25 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Kinzalkomb 80 mg/12.5 mg or in patients who have been previously stabilised on telmisartan and hydrochlorothiazide given separately.
Slovak: Zdravilo Kinzalkomb 80 mg/25 mg lahko dajemo enkrat na dan bolnikom, pri katerih krvnega tlaka ne moremo ustrezno uravnati z zdravilom Kinzalkomb 80 mg/12,5 mg, ali bolnikom, ki jemljejo telmisartan in hidroklorotiazid posebej in imajo ustaljen krvni tlak.
English: The overall incidence and pattern of adverse reactions reported with Kinzalkomb 80 mg/25 mg was comparable with Kinzalkomb 80 mg/12.5 mg. A dose-relationship of adverse reactions was not established and they showed no correlation with gender, age or race of the patients.
Slovak: Celokupno pogostnost in vzorec (pojavljanja) neželenih učinkov zdravila Kinzalkomb 80 mg/25 mg so primerjali z zdravilom Kinzalkomb 80 mg/12,5 mg. Vpliva velikosti odmerka na neželene učinke niso ugotavljali.
English: Nervous system disorders Rare:
Slovak: Bolezni živčevja Redki:
English: Pregnancy
Slovak: Nosečnost
English: General disorders and administration site conditions Uncommon:
Slovak: Splošne težave in spremembe na mestu aplikacije Neznana:
English: Given their similar pharmacodynamic properties, these results are also relevant for other ACE-inhibitors and angiotensin II receptor blockers.
Slovak: Ti izsledki so pomembni tudi za druge zaviralce ACE in blokatorje receptorjev angiotenzina II, ker so njihove farmakodinamične lastnosti podobne.
English: - Hyponatraemia and hypochloraemic alkalosis There is no evidence that Kinzalkomb would reduce or prevent diuretic-induced hyponatraemia.
Slovak: Ni podatkov, ki bi kazali, da zdravilo Kinzalkomb zmanjša ali prepreči hiponatriemijo, ki jo povzročajo diuretiki.
English: The hazard ratio for telmisartan vs. ramipril was 1.01 (97.5 % CI 0.931.10, p (non-inferiority) = 0.0019 at a margin of 1.13).
Slovak: Pri zdravljenju s telmisartanom je bilo razmerje ogroženosti v primerjavi z ramiprilom 1,01 (97,5-odstotni IZ 0,93 do 1,10, p (enakovrednost) =
English: PHARMACEUTICAL FORM
Slovak: NAČIN IZDAJANJA ZDRAVILA
English: Nondepolarizing skeletal muscle relaxants (e.g. tubocurarine) The effect of nondepolarizing skeletal muscle relaxants may be potentiated by hydrochlorothiazide.
Slovak: Hidroklorotiazid lahko poveča učinek nedepolarizirajočih relaksantov skeletnih mišic.
English: METHOD AND ROUTE(S) OF ADMINISTRATION Oral use
Slovak: POSTOPEK IN POT(I)
English: Immune system disorders Rare:
Slovak: Bolezni imunskega sistema Redki:
English: Not applicable.
Slovak: Ukrepati ni potrebno.
English: 6.5 Nature and contents of container
Slovak: Vrsta ovojnine in vsebina
English: Hypotension, orthostatic hypotension Respiratory, thoracic and mediastinal disorders Uncommon: Rare:
Slovak: hipotenzija, ortostatska hipotenzija Bolezni dihal, prsnega koša in mediastinalnega prostora Občasni:
English: Pack sizes: - Blister with 14, 28, 56, or 98 tablets or - Perforated unit dose blisters with 28 x 1 tablets.
Slovak: Velikost pakiranja: pretisni omot po 14, 28, 56 ali 98 tablet ali perforirani pretisni omoti za enkratni odmerek po 28 x 1 tableto.
English: Anaemia Eosinophilia, thrombocytopenia
Slovak: eozinofilija, trombocitopenija
English: Blood uric acid increased
Slovak: zvišanaraven sečne kisline v krvi
English: • Kinzalkomb 80 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Kinzalmono 80 mg
Slovak: Zdravilo Kinzalkomb 80 mg/12,5 mg lahko dajemo enkrat na dan bolnikom, pri katerih krvnega tlaka ne moremo ustrezno nadzorovati z zdravilom Kinzalmono 80 mg Ledvična okvara
English: Kinzalkomb 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Slovak: Kinzalkomb 40 mg/12,5 mg tablete Ena tableta vsebuje 40 mg telmisartana in 12,5 mg hidroklorotiazida.
English: Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Slovak: Ena tableta vsebuje 80 mg telmisartana in 25 mg hidroklorotiazida.
English: Telmisartan does not inhibit angiotensin converting enzyme (kininase II), the enzyme which also degrades bradykinin.
Slovak: Ne zavira angiotenzinske konvertaze (kininaze II) - encima, ki tudi razgrajuje bradikinin, zato predvidoma ne poveča neželenih učinkov, katere povzroča bradikinin.
English: Medicines that may increase blood potassium levels such as potassium-sparing diuretics, potassium supplements, salt substitutes containing potassium, ACE inhibitors, cyclosporin (an immunosuppressant drug) and other medicinal products such as heparin sodium (an anticoagulant).
Slovak: Zdravila, ki lahko povečajo raven kalija ali povzročijo hiperkaliemijo (npr. zaviralci ACE; diuretiki, ki varčujejo s kalijem; kalijevi pripravki; nadomestki soli, ki vsebujejo kalij; ciklosporin ali druga zdravila, kot je natrijev heparinat)
English: Most cases of hepatic function abnormal / liver disorder from post-marketing experience with telmisartan occurred in Japanese patients.
Slovak: O večini primerov nenormalnega delovanja jeter ali jetrne bolezni so v obdobju po začetku trženja telmisartana poročali pri japonskih bolnikih, pri katerih tudi sicer obstaja večja verjetnost teh neželenih reakcij.
English: Pack sizes: -Blister with 14, 28, 56, or 98 tablets or -Perforated unit dose blisters with 28 x 1 tablets
Slovak: Velikost pakiranja: pretisni omot po 14, 28, 56, 98 tablet ali perforirani pretisni omoti za enkratni odmerek po 28 x 1 tableto.
English: C-labelled telmisartan most of the administered dose (>97 %) was eliminated in faeces via biliary excretion.
Slovak: 97 %) izločila z blatom po biliarni poti.
English: Kinzalkomb 80 mg/12.5 mg tablets
Slovak: Kinzalkomb 80 mg/12,5 mg
English: Aplastic anaemia, haemolytic anaemia, bone marrow failure, leukopenia, neutropenia, agranulocytosis,
Slovak: trombocitopenija (včasih s purpuro) aplastična anemija, hemolitična anemija, odpoved kostnega mozga, levkopenija, nevtropenija, agranulocitoza
English: Always take this medicine exactly as your doctor has told you.
Slovak: Pri jemanju tega zdravila natančno upoštevajte navodila zdravnika.
English: Reporting of side effects
Slovak: Poročanje o neželenih učinkih
English: Hydrochlorothiazide crosses the placenta.
Slovak: Hidroklorotiazid prehaja skozi posteljico.
English: Although hypokalaemia may develop with the use of thiazide diuretics, concurrent therapy with telmisartan may reduce diuretic-induced hypokalaemia.
Slovak: Sočasno jemanje telmisartana in tiazidnih diuretikov zmanjšuje možnost razvoja hipokaliemije, ki jo povzročajo tiazidni diuretiki.
English: Talk to your doctor before taking Kinzalkomb:
Slovak: Pred začetkom jemanja zdravila Kinzalkomb se posvetujte z zdravnikom:
English: Kinzalkomb 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Slovak: Kinzalkomb 80 mg/12,5 mg tablete Ena tableta vsebuje 80 mg telmisartana in 12,5 mg hidroklorotiazida