natgillin/translations-raw huggingface dataset:
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.
Keď sa Kinzalkomb podáva s liekmi, ktoré ovplyvňujú poruchy sérového draslíka (digitalisové glykozidy, antiarytmiká) a liekmi vyvolávajúcimi torsade de pointes (čo zahŕňajú niektoré antiarytmiká), odporúča sa pravidelné sledovanie sérového draslíka a EKG, hypokaliémia je predispozičný faktor na torsade de pointes.
Kinzalkomb is used to treat high blood pressure (essential hypertension) in adults whose blood pressure is not adequately controlled by Kinzalkomb 80/12.5 mg or in patients who have been previously stabilised by telmisartan and hydrochlorothiazide given separately.
Kinzalkomb sa používa na liečbu vysokého krvného tlaku (esenciálna hypertenzia) u dospelých, ktorých vysoký krvný tlak nie je dostatočne kontrolovaný používaním Kinzalkombu 80/12,5mg alebo u pacientov predtým stabilizovaných podaním telmisartanu a hydrochlorotiazidu, každého samostatne.
EU/1/02/214/011 14 tablets EU/1/02/214/012 28 tablets EU/1/02/214/013 28 x 1 tablets EU/1/02/214/014 56 tablets EU/1/02/214/015 98 tablets
EU/1/02/214/011 14 tabliet EU/1/02/214/012 28 tabliet EU/1/02/214/013 28 x 1 tableta EU/1/02/214/014 56 tabliet EU/1/02/214/015 98 tabliet
Upper respiratory tract infection (e.g. sore throat, inflamed sinuses, common cold), urinary tract infections, deficiency in red blood cells (anaemia), high potassium levels, slow heart rate (bradycardia), kidney impairment including acute kidney failure, weakness, cough.
bolesť hrdla, zápal prinosových dutín, bežné prechladnutie), infekcia močových ciest, nedostatok červených krviniek (anémia), vysoké hladiny draslíka, spomalený tep srdca (bradykardia), poškodená funkcia obličiek vrátane akútneho zlyhania obličiek, slabosť, kašeľ.
EU/1/02/214/006 14 tablets EU/1/02/214/007 28 tablets EU/1/02/214/008 28 x 1 tablets EU/1/02/214/009 56 tablets EU/1/02/214/010 98 tablets
EU/1/02/214/006 14 tabliet EU/1/02/214/007 28 tabliet EU/1/02/214/008 28 x 1 tableta EU/1/02/214/009 56 tabliet EU/1/02/214/010 98 tabliet
EU/1/02/214/001 14 tablets EU/1/02/214/002 28 tablets EU/1/02/214/003 28 x 1 tablets EU/1/02/214/004 56 tablets EU/1/02/214/005 98 tablets
EU/1/02/214/001 14 tabliet EU/1/02/214/002 28 tabliet EU/1/02/214/003 28 x 1 tableta EU/1/02/214/004 56 tabliet EU/1/02/214/005 98 tabliet
Blood and lymphatic system disorders Uncommon:
Poruchy krvi a lymfatického systému Zriedkavé:
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.
Kinzalkomb fixná kombinácia dávky (80 mg telmisartanu/25 mg hydrochlorotiazidu) je indikovaná dospelým, ktorých krvný tlak nie je adekvátne kontrolovaný Kinzalkombom 80/12,5 (80 mg telmisartanu/12,5 mg hydrochlorotiazidu) alebo pacientom, ktorí boli predtým stabilizovaní na telmisartane a hydrochlorotiazide podávaných osobitne.
Medicinal products associated with potassium loss and hypokalaemia (e.g. other kaliuretic diuretics, laxatives, corticosteroids, ACTH, amphotericin, carbenoxolone, penicillin G sodium, salicylic acid and derivatives)
iné kaliuretické diuretiká, laxatíva, kortikosteroidy, ACTH, amfotericín, karbenoxolón, sodná soľ benzylpenicilínu, kyselina salicylová a jej deriváty)
- Hyponatraemia and hypochloraemic alkalosis There is no evidence that Kinzalkomb would reduce or prevent diuretic-induced hyponatraemia.
Nie sú dôkazy o tom, že Kinzalkomb znižuje alebo predchádza diuretikami vyvolanú hyponatrémiu.
INFORMATION IN BRAILLE Kinzalkomb 80 mg/12.5 mg
INFORMÁCIE V BRAILLOVOM PÍSME Kinzalkomb 80 mg/12,5 mg
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, red iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420).
Ďalšie zložky sú monohydrát laktózy, magnéziumstearát, kukuričný škrob, meglumín, mikrokryštalická celulóza, povidón, červený oxid železitý (E172), hydroxid sodný, sodná soľ karboxymetylškrobu (typ A), sorbitol (E420).
The other ingredients are lactose monohydrate, magnesium stearate, maize starch, meglumine, microcrystalline cellulose, povidone, yellow iron oxide (E172), sodium hydroxide, sodium starch glycollate (type A), sorbitol (E420).
Ďalšie zložky sú monohydrát laktózy, magnéziumstearát, kukuričný škrob, meglumín, mikrokryštalická celulóza, povidón, žltý oxid železitý (E172), hydroxid sodný, sodná soľ karboxymetylškrobu (typ A), sorbitol (E420).
There is no clinical experience with Kinzalkomb in patients with hepatic impairment.
U pacientov s poruchou funkcie pečene nie sú žiadne klinické skúsenosti s Kinzalkombom.
6.1 List of excipients
6.1 Zoznam pomocných látok
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)].
V predšpecifikovanom sekundárnom kompozitnom koncovom ukazovateli: kardiovaskulárna smrť, nefatálny infarkt myokardu a nefatálna mozgová príhoda sa dokázal prínos telmisartanu v porovnaní s placebom [0,87 (95 % CI 0,76 - 1,00, p = 0,048)].
Uncommon: Rare:
Menej časté: Veľmi zriedkavé:
Ear and labyrinth disorders Uncommon:
Poruchy ucha a labyrintu Menej časté:
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).
- lieky, ktoré môžu zvýšiť hladiny draslíka v krvi, ako sú draslík šetriace diuretiká, náhrady draslíka, náhrady soli obsahujúce draslík, ACE inhibítory, cyklosporín (imunosupresívum) a iné liečivá, ako je sodná soľ heparínu (antikoagulancium).
Kinzalkomb 80 mg/25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the code 'H9'.
Kinzalkomb 80 mg/25 mg tablety sú žlto-biele, dvojvrstvové oválne tablety s vyrytým logom spoločnosti a kódom 'H9'.
Kinzalkomb 40 mg/12.5 mg tablets Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
Kinzalkomb 40 mg/12,5 mg tablety Každá tableta obsahuje 40 mg telmisartanu a 12,5 mg hydrochlorotiazidu.
2: For further description, please see sub-section”Description of selected adverse reactions” Additional information on individual components
3: Pre ďalší popis, prosím, pozri časť „Popis vybraných nežiaducich reakcií“
Kinzalkomb 80 mg/12.5 mg tablets
Kinzalkomb 40 mg/12,5 mg tablety Kinzalkomb 80 mg/12,5 mg tablety
Kinzalkomb 80 mg/12.5 mg tablets Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
Kinzalkomb 80 mg/12,5 mg tablety Každá tableta obsahuje 80 mg telmisartanu a 12,5 mg hydrochlorotiazidu.
cyamemazine, sulpiride, sultopride, amisulpride, tiapride, pimozide, haloperidol, droperidol) - others (e.g. bepridil, cisapride, diphemanil, erythromycin IV, halofantrin, mizolastin,
cyamemazín, sulpirid, sultoprid, amisulprid, tiaprid, pimozid haloperidol, droperidol) - iné (napr.
Inflammation of the salivary gland, skin and lip cancer (non-melanoma skin cancer), decreases in the number (or even lack) of cells in the blood, including low red and white blood cell count, , serious allergic reactions (e.g. hypersensitivity, anaphylactic reaction), decreased or loss of appetite, restlessness, light-headedness, blurred or yellowing of vision, decrease in vision and eye pain (possible signs of acute myopia or acute-angle closure glaucoma), inflammation of blood vessels (vasculitis necrotising), inflamed pancreas, upset stomach, yellowing of the skin or eyes (jaundice), lupus-like syndrome (a condition mimicking a disease called systemic lupus erythematosus where the body's immune system attacks the body); skin disorders such as inflamed blood vessels in the skin, increased sensitivity to sunlight, rash, redness of the skin, blistering of the lips, eyes or mouth, skin peeling, fever (possible signs of erythema multiforme), weakness, kidney inflammation or impaired kidney function, glucose in the urine (glycosuria), fever, impaired electrolyte balance, high blood cholesterol levels, decreased blood volume, increased blood levels of glucose, difficulties in controlling blood/ urine levels of glucose in patients with a diagnosis of diabetes mellitus, or fat in the blood.
precitlivenosť, anafylaktická reakcia), zníženie alebo strata chuti do jedla, nepokoj, mierny závrat, rozmazané alebo žltkasté videnie, zhoršené videnie a bolesť oka (možné príznaky akútnej krátkozrakosti alebo akútneho glaukómu s uzavretým uhlom), zápal krvných ciev (nekrotizujúca vaskulitída), zápal pankreasu, žalúdočné ťažkosti, zožltnutie pokožky alebo očí (žltačka), príznaky podobné lupusu (príznaky podobné ochoreniu nazývanému systémový lupus erythematosus, pri ktorom imunitný systém organizmu napáda vlastné telo), poruchy kože ako zápal žíl v koži, zvýšenú citlivosť na slnečné svetlo, vyrážka, sčervenanie kože, pľuzgiere na perách, očiach alebo v ústach, olupovanie kože, horúčka (možné prejavy multiformného erytému), slabosť, zápal obličiek alebo narušená funkcia obličiek, glukóza v moči (glykozúria), horúčka, narušená rovnováha elektrolytov, vysoké hladiny cholesterolu v krvi, znížený objem krvi, zvýšená hladina glukózy, ťažkosti s regulovaním hladiny glukózy v krvi/moči u pacientov s diagnózou cukrovky alebo tukov v krvi.
Cytotoxic agents (e.g. cyclophosphamide, methotrexate)
cyklofosfamid, metotrexát)
Medicines associated with low blood potassium (hypokalaemia) such as other diuretics, ('water tablets'), laxatives (e.g. castor oil), corticosteroids (e.g. prednisone), ACTH (a hormone), amphotericin (an antifungal medicine), carbenoxolone (used to treat mouth ulcers), penicillin G sodium (an antibiotic), and salicylic acid and derivatives.
prednisón), ACTH (hormón), amfotericín (liek proti plesniam), karbenoxolón (používal sa na liečbu vredov v ústach), sodná soľ benzylpenicilínu (antibiotikum), kyselina salicylová a jej deriváty.
Kinzalkomb 40 mg/12.5 mg tablets Red and white oval shaped two layer tablet of 5.2 mm engraved with the code number 'H4'.
Kinzalkomb 40 mg/12,5 mg tablety Červeno-biele oválne 5,2 mm dvojvrstvové tablety s vyrytým číselným kódom 'H4'.
Pack sizes: - Blister with 14, 28, 56, or 98 tablets or - Perforated unit dose blisters with 28 x 1 tablets.
Veľkosti balenia: - blister so 14, 28, 56 alebo 98 tabletami alebo - perforovaný blister s jednotlivými dávkami 28 x 1 tableta.
Kinzalkomb 80 mg/12.5 mg tablets Red and white oval shaped two layer tablet of 6.2 mm engraved with the code number 'H8'.
Kinzalkomb 80 mg/12,5 mg tablety Červeno-biele oválne 6,2 mm dvojvrstvové tablety s vyrytým číselným kódom 'H8'.
Infections and infestations Uncommon:
Infekcie a nákazy Neznáme:
• Kinzalkomb 40 mg/12.5 mg may be administered once daily in patients whose blood pressure is not adequately controlled by Kinzalmono 40 mg
Kinzalkomb 40 mg/12,5 mg sa môže podávať jedenkrát denne pacientom, ktorých krvný tlak nie je náležite kontrolovaný Kinzalmonom 40 mg Kinzalkomb 80mg/12,5mg sa môže podávať jedenkrát denne pacientom, ktorých krvný tlak nie je náležite kontrolovaný Kinzalmonom 80mg
Decreased blood potassium levels, anxiety fainting (syncope), sensation of tingling, pins and needles (paraesthesia), feeling of spinning (vertigo), fast heart beat (tachycardia), heart rhythm disorders, low blood pressure, a sudden fall in blood pressure when you stand up, shortness of breath (dyspnoea), diarrhoea, dry mouth, flatulence, back pain, muscle spasm, muscle pain, erectile dysfunction (inability to get or keep an erection), chest pain; increased blood uric acid levels.
Menej časté vedľajšie účinky (môžu postihovať menej ako 1 zo 100 osôb): znížené hladiny draslíka v krvi, úzkosť, mdloba (náhle prechodné bezvedomie), pocit brnenia, mravčenia a pichania (parestézia), pocit závratu (vertigo), rýchly tep srdca (tachykardia), poruchy srdcového rytmu, nízky tlak krvi, náhly pokles tlaku krvi pri vstávaní, skrátený dych (dýchavičnosť), hnačka, sucho v ústach, plynatosť, bolesť chrbta, svalové kŕče, bolesť svalov, erektilná dysfunkcia (neschopnosť mať alebo udržať erekciu), bolesť v hrudníku a zvýšené hladiny kyseliny močovej v krvi.
Marketing Authorisation Holder Bayer AG
DRŽITEĽ ROZHODNUTIA O REGISTRÁCII Bayer AG
Kinzalkomb 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number 'H8'.
Kinzalkomb 80 mg/12,5 mg tablety sú červeno-biele, dvojvrstvové oválne tablety s vyrytým logom spoločnosti a kódom 'H8'.
Low platelet count (thrombocytopenia), increase in certain white blood cells (eosinophilia), serious allergic reaction (e.g. hypersensitivity, anaphylactic reaction, drug rash), low blood sugar levels (in diabetic patients), upset stomach, eczema (a skin disorder), arthrosis, inflammation of the tendons, decreased haemoglobin (a blood protein), somnolence.
precitlivenosť, anafylaktická reakcia, lieková vyrážka), nízka hladina cukru v krvi (u diabetických pacientov), žalúdočné ťažkosti, ekzém (ochorenie kože), artróza, zápal šliach, znížený hemoglobín (krvná bielkovina), ospalosť.
Talk to your doctor before taking Kinzalkomb:
Predtým, ako začnete užívať Kinzalkomb, obráťte sa na svojho lekára:
Jaundice hepatocellular, jaundice cholestatic Skin and subcutaneous tissue disorders Not known:
Poruchy kože a podkožného tkaniva Neznáme:
Kinzalkomb 40 mg/12.5 mg tablets are red and white, oval-shaped two-layer tablets engraved with the code number 'H4'.
Kinzalkomb 40 mg/12,5 mg tablety sú červeno-biele, dvojvrstvové oválne tablety s vyrytým logom spoločnosti a kódom 'H4'.
NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
NÁZOV LIEKU Kinzalkomb 80 mg/25 mg tablety telmisartan/hydrochlorotiazid
Vascular disorders Not known:
Poruchy ciev Neznáme:
Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
Červený oxid železitý (E172) Hydroxid sodný
Pressor amines (e.g. noradrenaline)
noradrenalín)
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
LIEČIVO (LIEČIVÁ) Každá tableta obsahuje 40 mg telmisartanu a 12,5 mg hydrochlorotiazidu.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
LIEČIVO (LIEČIVÁ) Každá tableta obsahuje 80 mg telmisartanu a 25 mg hydrochlorotiazidu.
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
LIEČIVO (LIEČIVÁ) Každá tableta obsahuje 80 mg telmisartanu a 12,5 mg hydrochlorotiazidu.
- class Ia antiarrythmics (e.g. quinidine, hydroquinidine, disopyramide) - class III antiarrythmics (e.g. amiodarone, sotalol, dofetilide, ibutilide) - some antipsychotics (e.g. thioridazine, chlorpromazine, levomepromazine, trifluoperazine,
bepridil, cisaprid, difemanil, erytromycín i.v., halofantrín, mizolastín, pentamidín, sparfloxacín, terfenadín, vinkamín i. v.).
Excretion Following administration of an oral [
Izločanje Po dajanju peroralnega odmerka [
Never take two doses on the same day.
Nikoli ne vzemite isti dan dveh odmerkov.
• have or have had a disease of the pancreas.
• imate ali ste imeli bolezen trebušne slinavke.
The safety and efficacy of linagliptin in children and adolescents has not yet been established.
Varnost in učinkovitost linagliptina pri otrocih in mladostnikih še nista bili dokazani.
• have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood.
• ste imeli alergijske reakcije na nekatera druga zdravila, ki jih jemljete za urejanje količine sladkorja v krvi.
This was achieved with a stable insulin dose (40.1 IU).
Ta izid je bil dosežen ob stabilnem odmerku insulina (40,1 i.e.).
Children and adolescents Trajenta is not recommended for children and adolescents under 18 years.
Zdravilo Trajenta ni primerno za otroke in mladostnike, mlajše od 18 let.
Effects on plasma lipids were negligible.
Učinki na lipide v plazmi so bili zanemarljivi.
They work by helping the body reduce the level of sugar in your blood.
Delujejo tako, da telesu pomagajo znižati raven sladkorja v krvi.
The tablets can be taken with or without a meal at any time of the day.
Tablete lahko bolniki jemljejo s hrano ali brez nje ob kateri koli uri dneva.
A double dose should not be taken on the same day.
Isti dan ne smejo vzeti dvojnega odmerka.
There was no difference between groups in severe hypoglycaemic events.
Med skupinama ni bilo razlik v pojavnosti hudih hipoglikemičnih dogodkov.
If you have symptoms of acute pancreatitis, like persistent, severe stomach ache (abdominal pain), you should consult your doctor.
Če imate simptome akutnega pankreatitisa, kot je persistentna, huda bolečina v trebuhu, se posvetujte z zdravnikom.
Therefore, it is preferable to avoid using Trajenta if you are pregnant.
Zato je priporočljivo, da zdravila Trajenta ne uporabljate, če ste noseči.
Doses of background antidiabetic medicinal products were kept stable during the first 12 weeks, after which adjustments were permitted.
Prvih 12 tednov so bili odmerki osnovnih antidiabetikov stabilni, nato so bila dovoljena prilagajanja.
In particular, you should tell your doctor if you are using medicines containing any of the following active substances:
Še zlasti pomembno je, da zdravniku poveste, če uporabljate zdravila, ki vsebujejo katero od naštetih zdravilnih učinkovin:
What Trajenta is and what it is used for
Kaj je zdravilo Trajenta in za kaj ga uporabljamo
Frequencies are defined as 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) or not known (cannot be estimated from the available data).
Po pogostnosti so opredeljeni kot zelo pogosti (≥ 1/10), pogosti (≥ 1/100 do < 1/10), občasni (≥ 1/1.000 do < 1/100), redki (≥ 1/10.000 do < 1/1.000), zelo redki (< 1/10.000) ali neznana (ni mogoče oceniti iz razpoložljivih podatkov).
However, if it is nearly time for the next dose, skip the missed dose.
Če je blizu čas za naslednji odmerek, pozabljenega izpustite.
STOP taking Trajenta and contact a doctor immediately if you notice any of the following serious side effects:
Takoj PRENEHAJTE jemati zdravilo Trajenta in se posvetujte z zdravnikom, če opazite katerega od naslednjih resnih neželenih učinkov:
• Rare: blistering of skin (bullous pemphigoid).
• Redki: mehurjavost kože (bulozni pemfigoid).
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 August 2011
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 24. avgust 2011 Datum zadnjega podaljšanja: 22. marec 2016
Your doctor may ask you to stop Trajenta.
Vaš zdravnik vam bo morda naročil, da zdravilo Trajenta prenehate jemati.
There was a significant difference in reduction in HbA1c between Asian patients (0.8%) and White patients (0.5%) in the pooled studies.
Pomembna razlika v zmanjšanju HbA1c je bila med azijskimi bolniki (0,8 %) in bolniki belci (0,5 %) v združenih študijah.
• If you forget to take a dose of Trajenta, take it as soon as you remember it.
• Če ste pozabili vzeti odmerek zdravila Trajenta, ga vzemite takoj, ko se spomnite.
It is unknown if Trajenta is harmful to the unborn child.
Ni znano, ali lahko zdravilo Trajenta škoduje nerojenemu otroku.
Thus, full efficacy of linagliptin in combination with strong P-gp inducers might not be achieved, particularly if these are administered long-term.
Polna učinkovitost linagliptina pri kombiniranju z močnimi induktorji P-glikoproteina torej morda ne bo dosežena, zlasti pri dolgotrajni uporabi.
Other medicines and Trajenta
Druga zdravila in zdravilo Trajenta
The MAH shall perform the pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
For any information about this medicine, please contact the local representatives of the Marketing Authorisation Holder:
Za vse morebitne nadaljnje informacije o tem zdravilu se lahko obrnete na predstavništva imetnika dovoljenja za promet z zdravilom:
If you experience any of the signs of illness mentioned above, stop taking Trajenta and call your doctor right away.
Če se pojavijo, katerikoli od zgoraj omenjenih znakov bolezni, zdravilo Trajenta prenehajte jemati in takoj pokličite zdravnika.
In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring and institute clinical measures if required.
V primeru prevelikega odmerjanja so smiselni običajni podporni ukrepi, npr. odstranitev neabsorbiranega zdravila iz prebavil, klinično spremljanje in po potrebi podporno zdravljenje.
Body weight did not differ significantly between the groups.
Med skupinama ni bilo pomembnih razlik v telesni masi.
Of these, 4.0% were mild and 0.9% were moderate and 0.1% were classified as severe in intensity.
Od tega je bilo po intenzivnosti opredeljenih 4,0 % kot blagi, 0,9 % kot zmerni in 0,1 % kot hudi.
Do not stop taking Trajenta without first consulting your doctor.
Zdravila Trajenta ne prenehajte jemati, ne da bi se posvetovali z zdravnikom.
• Severe and persistent pain in the abdomen (stomach area) which might reach through to your back, as well as nausea and vomiting, as it could be a sign of an inflamed pancreas
• huda in persistentna trebušna bolečina (v predelu želodca), ki se lahko širi v hrbet; tudi slabost in bruhanje, ker so vsi lahko tudi znaki vnetja trebušne slinavke (pankreatitisa).
If you take more Trajenta than you should, talk to a doctor immediately.
Če ste vzeli več zdravila Trajenta, kot bi smeli, se takoj posvetujte z zdravnikom.
A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from linagliptin therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Odločiti se je treba med prenehanjem dojenja in prenehanjem/prekinitvijo zdravljenja z linagliptinom, pri čemer je treba pretehtati prednosti dojenja za otroka in prednosti zdravljenja za mater.
You can take Trajenta with or without food.
Zdravilo Trajenta lahko jemljete s hrano ali brez nje.
Oral anti-diabetics are used to treat high blood sugar levels.
Peroralni antidiabetiki se uporabljajo za zdravljenje visoke ravni sladkorja v krvi.
Skin and subcutaneous tissue disorders Angioedema*
Bolezni kože in podkožja angioedem*
Diabetic skin lesions are a common complication of diabetes.
Diabetične okvare kože so pogost zaplet sladkorne bolezni.
The use of linagliptin has not been studied in pregnant women.
Uporabe linagliptina pri nosečnicah niso preučevali.
Elderly No dose adjustment is necessary based on age.
Starejši Prilagoditev odmerka glede na starost ni potrebna.
A dose reduction of the sulphonylurea or insulin may be considered (see section 4.2).
Morda bo treba odmerek sulfonilsečnine ali insulina zmanjšati (glejte poglavje 4.2).
• Common: level of lipase in the blood increased.
• Pogosti: zvišana raven lipaze v krvi.
The European Medicines Agency has deferred the obligation to submit the results of studies with linagliptin in one or more subsets of the paediatric population in Type 2 diabetes (see section 4.2 for information on paediatric use).
Evropska agencija za zdravila je začasno odložila zahtevo za predložitev rezultatov študij z linagliptinom za eno ali več podskupin pediatrične populacije s sladkorno boleznijo tipa 2 (za podatek o uporabi pri pediatrični populaciji glejte poglavje 4.2).