natgillin/translations-raw huggingface dataset:
Gastrointestinal disorders
Bolezni prebavil Neznana:
Musculoskeletal, connective tissue and bone disorders
23 Bolezni mišično- skeletega sistema, vezivnega tkiva in kosti
22 Infections and infestations
Infekcijske in parazitske bolezni Neznana:
Immune system disorders
Bolezni imunskega sistema Neznana:
Metabolism and nutrition disorders
Presnovne in prehranske motnje Neznana:
Nervous system disorders
Bolezni živčevja Neznana:
Not known:
omotica
Not known:
Žilne bolezni Neznana:
Hepatobiliary disorders
24 Bolezni jeter, žolčnika in žolčevodov Neznana:
23 Symptoms:
Simptomi:
Kinzalkomb is a combination of an angiotensin II receptor antagonist, telmisartan, and a thiazide diuretic, hydrochlorothiazide.
Kinzalkomb je kombinacija antagonista receptorjev angiotenzina II telmisartana in tiazidnega diuretika hidroklorotiazida.
Telmisartan displaces angiotensin II with very high affinity from its binding site at the AT1 receptor subtype, which is responsible for the known actions of angiotensin II.
Z veliko afiniteto spodriva angiotenzin II z njegovega vezivnega mesta na podtipu receptorja
Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
25 AT1, ki je odgovoren za znane učinke angiotenzina II.
Telmisartan selectively binds the AT1 receptor.
Na receptorju AT1 nima nikakršnega delnega agonističnega učinka.
The binding is long-lasting.
Nanj se veže selektivno.
24 Upon abrupt cessation of treatment with telmisartan, blood pressure gradually returns to pre-treatment values over a period of several days without evidence of rebound hypertension.
Po nenadni ukinitvi zdravljenja s telmisartanom se krvni tlak v nekaj dneh postopno poveča na vrednosti pred zdravljenjem, ne da bi prišlo do povratne hipertenzije.
The effects of telmisartan on mortality and cardiovascular morbidity are currently unknown.
Morebitni ugodni učinki telmisartana na zmanjšanje smrtnosti in zbolevanja za srčnožilnimi boleznimi še niso raziskani.
The effects of Fixed Dose Combination of telmisartan/ HCTZ on mortality and cardiovascular morbidity are currently unknown.
Učinki fiksne kombinacije telmisartana in hidroklorotiazida na umrljivost in obolevnost zaradi srčnožilnih bolezni še niso raziskani.
Absorption:
26 Absorpcija:
Hydrochlorothiazide is 68% protein bound in the plasma and its apparent volume of distribution is 0.83 – 1.14 1/ kg.
Njegov navidezn volumen porazdelitve je 0, 83 do 1, 14 l/ kg.
25 Hydrochlorothiazide:
Hidroklorotiazid:
Based on modest experience in patients with mild to moderate renal impairment (creatinine clearance of 30 – 60 ml/ min, mean about 50 ml/ min) no dosage adjustment is necessary in patients with decreased renal function.
Redke izkušnje pri bolnikih z blago do zmerno ledvično okvaro( s kreatininskim očistkom 30 do 60 ml/ min in srednjo vrednostjo približno 50 ml/ min) kažejo, da bolnikom z zmanjšanim ledvičnim delovanjem odmerka ni treba prilagajati.
Patients with hepatic impairment:
27 Bolniki z jetrno okvaro:
26 Magnesium stearate Maize starch Meglumine Microcrystalline cellulose Povidone (K25) Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
laktoza monohidrat magnezijev stearat koruzni škrob meglumin mikrokristalna celuloza povidon (K25) rdeči železov oksid (E172) natrijev hidroksid natrijev karboksimetilškrob (vrsta A) sorbitol (E420)
6.5 Nature and contents of container
28 6. 5 Vrsta ovojnine in vsebina
Blister with 14, 28, 56, or 98 tablets or perforated unit dose blisters with 28 x 1 tablets.
Velikost pakiranja: pretisni omot po 14, 28, 56 ali 98 tablet ali perforirani pretisni omoti za enkratni odmerek po 28 x 1 tableto.
Kinzalkomb 80 mg/ 25 mg tablets
Kinzalkomb 80 mg/ 25 mg tablete
Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
Vsaka tableta vsebuje 80 mg telmisartana in 25 mg hidroklorotiazida.
Yellow and white oval shaped tablet engraved with the code'H9 '.
Tableta Rdeča in bela ovalna, dvoslojna tableta z vtisnjeno kodno številko 'H9'.
Kinzalkomb fixed dose combination (80 mg telmisartan/ 25 mg hydrochlorothiazide) is indicated in patients 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.
Kinzalkomb, fiksna kombinacija (80 mg telmisartana in 25 mg hidroklorotiazida), je indicirana za bolnike, 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.
Kinzalkomb 80 mg/ 25 mg may be administered 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.
Kinzalkomb 80 mg/ 25 mg lahko dajemo 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.
Kinzalkomb is also available at the dose strengths 40 mg/ 12.5 mg and 80 mg/ 12.5 mg
Kinzalkomb je na voljo tudi v jakosti 40 mg/ 12, 5 mg in 80 mg/ 12, 5 mg.
Periodic monitoring of renal function is advised (see section 4.4).
Priporočamo periodične kontrolne preglede ledvičnega delovanja (glejte poglavje 4. 4).
Elderly:
30 Starejši bolniki:
29 4.3 Contraindications
4. 3 Kontraindikacije
• Hypersensitivity to any of the active substances or to any of the excipients (see section 6.1). • Hypersensitivity to other sulphonamide-derived substances (since hydrochlorothiazide is a sulphonamide-derived medicinal product). • Second and third trimester of pregnancy and lactation (see sections 4.4 and 4.6). • Cholestasis and biliary obstructive disorders. • Severe hepatic impairment. • Severe renal impairment (creatinine clearance < 30 ml/ min). • Refractory hypokalaemia, hypercalcaemia.
• Preobčutljivost za eno od zdravilnih učinkovin ali pomožnih snovi (glejte poglavje 6. 1) • preobčutljivost za druge sulfonamidne derivate (ker je hidroklorotiazid sulfonamidni derivat) • drugo in tretje trimesečje nosečnosti in med dojenjem (glejte poglavji 4. 4 in 4. 6) • holestaza in obolenja z zaporo žolčevoda • huda jetrna okvara • huda ledvična okvara (kreatininski očistek < 30 ml/ min) • refraktarna hipokaliemija, hiperkalcemija.
Primary aldosteronism:
31 Primarni aldosteronizem:
30 Aortic and mitral valve stenosis, obstructive hypertrophic cardiomyopathy:
Zožitev aorte in mitralne zaklopke, obstruktivna hipertrofična kardiomiopatija:
Metabolic and endocrine effects:
Učinki na presnovo in endokrini sistem:
The risk of hypokalaemia is greater in patients with cirrhosis of liver, in patients experiencing brisk diuresis, in patients who are receiving inadequate oral intake of electrolytes and in patients receiving concomitant therapy with corticosteroids or Adrenocorticotropic hormone (ACTH) (see section 4.5).
Možnost, da se bo hipokaliemija pojavila, je večja pri bolnikih z jetrno cirozo, s povečano diurezo ali pri bolnikih, ki peroralno ne dobivajo ustreznih odmerkov elektrolitov, in pri sočasnem zdravljenju s kortikosteroidi ali adrenokortikotropnim hormonom adenokortikotropni hormon (ACTH) (glejte poglavje 4. 5).
Sorbitol and Lactose Monohydrate:
32 Sorbitol in laktoza monohidrat:
31 Ethnic differences:
Etnične razlike:
Digitalis glycosides:
33 Glikozidi digitalisa:
32 Other antihypertensive agents:
Drugi antihipertenzivi:
Dosage adjustment of the antidiabetic medicinal products may be required (see section 4.4).
Antidiabetiki (peroralni antidiabetiki in insulin): včasih je treba prilagoditi odmerek antidiabetika (glejte poglavje 4. 4).
33 4.6 Pregnancy and lactation
34 4. 6 Nosečnost in dojenje
Pregnancy (see section 4.3):
Nosečnost (glejte poglavje 4. 3):
Fixed Dose Combination The overall incidence and pattern of adverse events reported with Kinzalkomb 80 mg/ 25 mg was comparable with Kinzalkomb 80 mg/ 12.5 mg.
Fiksna kombinacija Celokupno pogostnost in vzorec (pojavljanja) neželenih učinkov zdravila Kinzalkomb 80 mg/ 25 mg so primerjali z zdravilom Kinzalkomb 80 mg/ 12, 5 mg.
A dose-relationship of undesirable effects was not established and they showed no correlation with gender, age or race of the patients.
Med neželenimi učinki in spolom, starostjo ali raso bolnikov ni bilo korelacije.
Adverse reactions have been ranked under headings of frequency using the following convention: very common (≥ 1/ 10); common (≥ 1/ 100 to < 1/ 10); uncommon (≥ 1/ 1,000 to < 1/ 100); rare (≥ 1/ 10,000 to < 1/ 1,000); very rare (< 1/ 10,000), not known (cannot be estimated from the available data).
35 Neželeni učinki so razvrščeni po pogostnosti, za katero veljajo naslednji kriteriji: zelo pogosti (≥ 1/ 10); pogosti (≥ 1/ 100 do < 1/ 10); občaseni (≥ 1/ 1. 000 do < 1/ 100); redeki (≥ 1/ 10. 000 do < 1/ 1. 000); zelo redeki (< 1/ 10. 000), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
34 Infections and infestations
Infekcijske in parazitske bolezni
Metabolism
Presnovne in prehranske motnje Občasni:
Diarrhoea, dry mouth, flatulence Abdominal pain, constipation, dyspepsia, vomiting Gastritis
driska, suha usta, napenjanje abdominalna bolečina, zaprtje, dispepsija, bruhanje gastritis
35 Investigations
Preiskave
Additional information on individual components Undesirable effects previously reported with one of the individual components may be potential undesirable effects with Kinzalkomb, even if not observed in clinical trials with this product.
Dodatni podatki o posameznih sestavinah zdravila Neželeni učinki, o katerih so poročali za posamezni sestavini zdravila, se lahko pojavijo tudi pri Kinzalkombu, čeprav jih v kliničnih preskušanjih kombinacije niso zasledili.
Upper respiratory tract infection, urinary tract infection including cystitis)
okužba zgornjih dihal, okužba sečil, tudi cistitis
Hydrochlorothiazide may cause or exacerbate hypovolaemia which could lead to electrolyte imbalance (see section 4.4).
Hidroklorotiazid Hidriklorotiazid lahko povzroči ali poslabša hipovolemijo, kar lahko privede do neravnovesja elektrolitov (glejte poglavje 4. 4).
Infections and infestations
Infekcijske in parazitske bolezni Neznana:
Not known:
38 Neznana:
37 4.9 Overdose
4. 9 Preveliko odmerjanje
Telmisartan does not exhibit any partial agonist activity at the AT1 receptor.
39 AT1, ki je odgovoren za znane učinke angiotenzina II.
38 In patients with hypertension telmisartan reduces both systolic and diastolic blood pressure without affecting pulse rate.
Telmisartan pri hipertenzivnih bolnikih znižuje sistolični in diastolični krvni tlak, ne da bi vplival na hitrost pulza.
In a double-blind controlled clinical trial (n=687 patients evaluated for efficacy) in non-responders to the 80 mg/ 12.5 mg combination, an incremental blood pressure lowering effect of the 80 mg/ 25 mg combination compared to continued treatment with the 80 mg/ 12.5 mg combination of 2.7/ 1.6 mm Hg (SBP/ DBP) was demonstrated (difference in adjusted mean changes from baseline).
V dvojno slepi, nadzorovani klinični raziskavi (n = 687 bolnikov, pri katerih so ocenili učinkovitost) pri bolnikih, ki se niso odzivali na zdravljenje s kombinacijo 80 mg/ 12, 5 mg, je kombinacija 80 mg/ 25 mg v primerjavi s stalnim zdravljenjem s kombinacijo 80 mg/ 12, 5 dodatno znižala krvni tlak za 2, 7/ 1, 6 mm Hg (SKT/ DKT) (razlika v prilagojenih srednjih spremembah glede na izhodiščno vrednost).
In a follow-up trial with the 80 mg/ 25 mg combination, blood pressure was further decreased (resulting in an overall reduction of 11.5/ 9.9 mm Hg (SBP/ DBP).
V nadaljnji raziskavi s kombinacijo 80 mg/ 25 mg se je krvni tlak nadalje znižal (skupno za 11, 5/ 9, 9 mm Hg) (AKT/ DKT).
In a pooled analysis of two similar 8 week double-blind placebo-controlled clinical trials vs. valsartan/ hydrochlorothiazide 160 mg/ 25 mg (n=2121 patients evaluated for efficacy) a significantly greater blood pressure lowering effect of 2.2/ 1.2 mm Hg (SBP/ DBP) was demonstrated (difference in adjusted mean changes from baseline, respectively) in favour of telmisartan/ hydrochlorothiazide 80 mg/ 25 mg combination.
V analizi združenih podatkov iz dveh podobnih 8- tedenskih, dvojno slepih, s placebom nadzorovanih kliničnih raziskav, v katerih je bilo primerjano zdravilo kombinacija valsartan/ hidroklorotiazid 160 mg/ 25 mg (n = 2121 bolnikov, pri katerih so ocenili učinkovitost), je bilo znižanje krvnega tlaka pri kombinaciji telmisartan/ hidroklorotiazid 80 mg/ 25 mg značilno večje, in sicer za 2, 2/ 1, 2 mm Hg (SKT/ DKT) (razlika v prilagojenih srednjih spremembah glede na izhodiščno vrednost).
Presumably through blockade of the renin- angiotensin-aldosterone system, co-administration of telmisartan tends to reverse the potassium loss associated with these diuretics.
Sočasno dajanje telmisartana deluje, predvidoma zaradi blokade renin- angiotenzin- aldosteronskega sistema,
39 Hydrochlorothiazide:
Hidroklorotiazid:
Hydrochlorothiazide is not metabolised in man and is excreted almost entirely as unchanged substance in urine.
Skoraj ves se izloči v obliki nespremenjene snovi s sečem.
About 60% of the oral dose is eliminated as unchanged substance within 48 hours.
Približno 60% peroralnega odmerka se izloči v obliki nespremenjene snovi v 48 urah.
There was a trend towards higher plasma concentrations of hydrochlorothiazide in female than in male subjects.
41 hidroklorotiazida se pri ženskah nagibajo k nekoliko večjim vrednostim.
No additional preclinical studies have been performed with the Fixed Dose Combination product 80 mg/ 25 mg.
Dodatnih predkliničnih raziskav s fiksno kombinacijo zdravila 80 mg/ 25 mg niso izvedli.
40 Toxicological findings also well known from preclinical studies with angiotensin converting enzyme inhibitors and angiotensin II receptor antagonists were: a reduction of red cell parameters (erythrocytes, haemoglobin, haematocrit), changes of renal haemodynamics (increased blood urea nitrogen and creatinine), increased plasma renin activity, hypertrophy/ hyperplasia of the juxtaglomerular cells and gastric mucosal injury.
Toksikološki izvidi, ki so znani tudi iz predkliničnih raziskav o zaviralcih angiotenzinske konvertaze in antagonistih angiotenzina II, so bili: zmanjšanje parametrov rdečih krvničk (eritrocitov, hemoglobina, hematokrita); spremembe ledvične hemodinamike (povečana vsebnost dušika v sečnini v krvi in kreatinina); povečana aktivnost renina v plazmi; hipertrofija oz. hiperplazija jukstaglomerulnih celic in poškodba želodčne sluznice.
Lactose monohydrate Magnesium stearate Maize starch Meglumine Microcrystalline cellulose Povidone (K25) Yellow ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
laktoza monohidrat magnezijev stearat koruzni škrob meglumin mikrokristalna celuloza povidon (K25) rumeni železov oksid (E172) natrijev hidroksid natrijev karboksimetilškrob (vrsta A) sorbitol (E420)
6.2 Incompatibilities
42 6. 2 Inkompatibilnosti
Pack sizes: blister with 14, 28, 56, or 98 tablets or perforated unit dose blisters with 28 x 1 tablets
Velikost pakiranja: pretisni omot po 14, 28, 56 ali 98 tablet ali perforirani pretisni omoti za enkratni odmerek po 28 x 1 tableto.
42 ANNEX II
43 DODATEK II
43 A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 6.1, 02 July 2007 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Imetnik dovoljenja za promet z zdravilom mora zagotoviti, da je sistem farmakovigilance, predstavljen v različici 3. 0 z dne 5. julija 2007 v modulu 1. 8. 1. vloge za pridobitev dovoljenja za promet, vzpostavljen in deluje, preden da zdravilo v promet in toliko časa, kolikor bo zdravilo v uporabi.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0, 30 March 2007 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Imetnik dovoljenja za promet z zdravilom se obvezuje, da bo opravil študije in druge farmakovigilančne dejavnosti, podrobno navedene v načrtu farmakovigilance, v skladu z načrtom za obvladovanje tveganja, vrazličica 1. 0 z dne 30. marca 2007, ki je predstavljen v modulu 1. 8. 2. vloge za pridobitev dovoljenja za promet, in vseh nadaljnjih posodobitvah načrta za obvladovanje tveganja, s katerim soglaša Odbor za zdravila za uporabo v humani medicini (CHMP).
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Posodobljeni načrt obvladovanja tveganja v skladu s smernicami CHMP za sisteme za obvladovanje tveganja za zdravila v humani uporabi je treba predložiti sočasno z naslednjim periodičnim poročnim poročilom o varnosti zdravila (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Poleg tega je treba posodobljen načrt za obvladovanje tveganja predložiti • ob prejemu novih podatkov, ki bi lahko vplivali na obstoječo varnostno specifikacijo, načrt farmakovigilance ali dejavnosti za zmanjšanje tveganja na minimum, • v 60 dneh od pomembne ugotovitve (pri farmakovigilanci in zmanjševanju tveganja), • na zahtevo Evropske agencije za zdravila (EMEA).
45 A.
45 DODATEK III
46 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
OZNAČEVANJE
Kinzalkomb 40 mg/ 12.5 mg tablets telmisartan/ hydrochlorothiazide
Kinzalkomb 40 mg/ 12, 5 mg tablete telmisartan / hidroklorotiazid
Read the package leaflet for further information.
Pred uporabo preberite priloženo navodilo.
14 tablets 28 tablets 28 x 1 unit dose tablets 56 tablets 98 tablets
škatla po 14 tablet škatla po 28 tablet škatla po 28 x 1 tableta škatla po 56 tablet škatla po 98 tablet
< Batch > {number}
{številka}
48 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
49 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
< Lot > {number}
{številka}
49 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
50 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
Unit dose blister (28x1 tablets pack) or any non 7 count blister
Perforiranni pretisni omot za enkratni odmerek (28 x 1 tableta) in vsi tisti pretisni omoti, ki ne vsebujejo po 7 tablet
Bayer HealthCare AG (Logo)
Bager HealthCare AG (Logo)
50 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
51 PODATKI NA ZUNANJI OVOJNINI ALI STIČNI OZ.
Kinzalkomb 80 mg/ 12.5 mg tablets telmisartan/ hydrochlorothiazide
Kinzalkomb 80 mg/ 12, 5 mg tablete telmisartan / hidroklorotiazid
Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
1 tableta vsebuje 80 mg telmisartana in 12, 5 mg hidroklorotiazida.
14 tablets 28 tablets 56 tablets 98 tablets 28 x 1 tablets
14 tablet 28 tablet 28 x 1 tableta 56 tablet 98 tablet
51 This medicinal product does not require any special storage conditions.
Za shranjevanje zdravila niso potrebna posebna navodila.
14 tablets 28 tablets 28 x 1 tablets 56 tablets 98 tablets
škatla po 14 tablet škatla po 28 tablet škatla po 28 x 1 tableta škatla po 56 tablet škatla po 98 tablet
52 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
53 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
53 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
54 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
55 PODATKI NA ZUNANJI OVOJNINI ALI STIČNI OZ.
Kinzalkomb 80 mg/ 25 mg tablets telmisartan/ hydrochlorothiazide
Kinzalkomb 80 mg/ 25 mg tablete telmisartan/ hidroklorotiazid
55 This medicinal product does not require any special storage conditions.
Za shranjevanje zdravila niso potrebna posebna navodila.
< Batch > {number}
< Lot > {številka}
56 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
57 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
< Lot > {number}
< Lot > {številka}
57 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
58 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
58 B.
59 B.
Kinzalkomb 40 mg/ 12.5 mg tablets telmisartan/ hydrochlorothiazide
Kinzalkomb 40 mg/ 12, 5 mg tablete telmisartan/ hidroklorotiazid
What Kinzalkomb is and what it is used for 2.
Kaj je zdravilo Kinzalkomb in za kaj ga uporabljamo 2.
Before you take Kinzalkomb 3.
Kaj morate vedeti, preden boste vzeli zdravilo Kinzalkomb 3.
How to take Kinzalkomb 4.
Kako jemati zdravilo Kinzalkomb 4.
How to store Kinzalkomb 6.
Shranjevanje zdravila Kinzalkomb 6.
WHAT KINZALKOMB IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO KINZALKOMB IN ZA KAJ GA UPORABLJAMO
Kinzalkomb is a combination of two active substances, telmisartan and hydrochlorothiazide in one tablet.
Kinzalkomb je kombinacija dveh zdravilnih učinkovin, telmisartana in hidroklorotiazida v eni tableti.
Both of these substances help to control high blood pressure.
Obe učinkovini pomagata uravnavati visok krvni tlak
- Telmisartan belongs to a group of medicines called angiotensin II receptor antagonists.
Telmisartan spada v skupino zdravil, ki jo imenujemo antagonisti receptorjev angiotenzina II.
- Hydrochlorothiazide belongs to a group of medicines called thiazide diuretics, which cause
•
your urine output to increase, leading to a lowering of your blood pressure.
Poveča izločanje seča, kar znižuje krvni tlak.
High blood pressure, if not treated, can damage blood vessels in several organs, which could lead sometimes to heart attack, heart or kidney failure, stroke, or blindness.
Če visokega krvnega tlaka ne zdravimo, lahko poškoduje krvne žile v različnih organih.
There are usually no symptoms of high blood pressure before damage occurs.
Posledice takšnih poškodb so lahko srčni napad, odpoved srca ali ledvic, kap ali slepota.
Kinzalkomb is used to treat high blood pressure (essential hypertension) in patients whose blood pressure is not controlled enough when either telmisartan or hydrochlorothiazide is used alone.
Kinzalkomb je namenjen za zdravljenje visokega krvnega tlaka (esencialne hipertenzije) pri bolnikih, pri katerih s samim telmisartanom in hidroklorotiazidom krvnega tlaka ne moremo dovolj uravnati.
BEFORE YOU TAKE KINZALKOMB
KAJ MORATE VEDETI, PREDEN BOSTE VZELI ZDRAVILO KINZALKOMB
• if you are allergic (hypersensitive) to telmisartan or any other ingredients included in Kinzalkomb tablets (see "Further information" for a list of other ingredients). • if you are allergic (hypersensitive) to hydrochlorothiazide or to any other sulfonamide-derived medicines. • during the last six months of pregnancy (see section Pregnancy and breast-feeding). • if you are breast-feeding. • if you have severe liver problems such as cholestasis or biliary obstruction (problems with drainage of the bile from the gall bladder) or any other severe liver disease.
Ne jemljite zdravila Kinzalkomb • če ste alergični na (preobčutljivi za) telmisartan ali katerokoli sestavino zdravila Kinzalkomb (za seznam drugih sestavin glejte Dodatne informacije), • če ste alergični na (preobčutljivi za) hidroklorotiazid ali katerokoli drugo sulfonamidno zdravilo, • zadnjih šest mesecev nosečnosti (glejte poglavje Nosečnost in dojenje), • če dojite, • če imate hude jetrne težave kot sta holestaza ali zapora žolčevoda (težave z odtekanjem žolča iz žolčnika) ali katerokoli drugo hudo jetrno bolezen,