natgillin/translations-raw huggingface dataset:
Kinzalkomb 80 mg/25 mg tablets are yellow and white, oval-shaped, two-layer tablets engraved with the code 'H9'.
Izgled zdravila Kinzalkomb in vsebina pakiranja Tablete zdravila Kinzalkomb 80 mg/25 mg so rumene in bele, ovalne, dvoslojne, z vtisnjeno kodno številko 'H9'.
Patients were randomized to one of the three following treatment groups: telmisartan 80 mg (n = 8542), ramipril 10 mg (n = 8576), or the combination of telmisartan 80 mg plus ramipril 10 mg (n = 8502), and followed for a mean observation time of 4.5 years.
8576) ali kombinacijo telmisartana po 80 mg in ramiprila po 10 mg (n =
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.
Redki neželeni učinki (pojavijo se pri največ 1 od 1.000 bolnikov): majhno število trombocitov (trombocitopenija), povečano število nekaterih belih krvničk (eozinofilija), resne alergijske reakcije (npr. preobčutljivost, anafilaktična reakcija, medikamentni izpuščaj), nizka raven krvnega sladkorja (pri bolnikih s sladkorno boleznijo), želodčne težave, ekcem (kožna bolezen), artroza, vnetje kit, znižana raven hemoglobina (krvne beljakovine), zaspanost.
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to medical prescription.
Predpisovanje in izdaja zdravila je le na recept.
- Diabetes.
Nephropathy in Diabetes).
Posology
Preiskave
NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/25 mg tablets telmisartan/hydrochlorothiazide
IME ZDRAVILA Kinzalkomb 80 mg/25 mg tablete telmisartan/hidroklorotiazid
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).
Druge sestavine zdravila so laktoza monohidrat, magnezijev stearat, koruzni škrob, meglumin, mikrokristalna celuloza, povidon (K25), rumen železov oksid (E172), natrijev hidroksid, natrijev karboksimetilškrob (vrsta
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
PRILOGA II A. IZDELOVALEC (IZDELOVALCI), ODGOVOREN (ODGOVORNI)
Eye disorders Rare:
Očesne bolezni Redki:
Stomach discomfort Skin and subcutaneous tissue disorders Rare:
Bolezni kože in podkožja Redki:
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.
Neželeni učinki neznane pogostnosti (ni mogoče oceniti iz razpoložljivih podatkov): vnetje žleze slinavke, kožni rak in rak ustnice (nemelanomski kožni rak), zmanjšanje števila (ali celo pomanjkanje) krvnih celic, tudi majhno število rdečih in belih krvničk; resne alergijske reakcije (npr. preobčutljivost, anafilaktična reakcija), zmanjšan tek ali izguba teka, nemir, vrtoglavica, zamegljen vid ali rumenkasta obarvanost, poslabšan vid in očesna bolečina (možna znaka akutne miopije ali akutnega glavkoma zaprtega zakotja), vnetje žil (nekrotizirajoči vaskulitis), vnetje trebušne slinavke, želodčne težave, porumenelost kože ali oči (zlatenica), lupusu podoben sindrom (bolezensko stanje, ki je podobno sistemskemu eritematoznemu lupusu, pri kateri telo napade človekov lastni imunski sistem), kožne motnje, kot so vnetje žil v koži; povečana občutljivost za sončno svetlobo, izpuščaj, pordelost kože, pojav mehurčkov na ustnicah, očeh ali v ustih, luščenje kože, povišana telesna temperatura (možen znak za multiformni eritem), oslabelost, vnetje ledvic ali okvara ledvičnega delovanja, sladkor v urinu (glikozurija), zvišana telesna temperatura, moteno elektrolitsko ravnovesje, visoka raven holesterola, zmanjšan krvni volumen, povečana raven glukoze v krvi, težave pri uravnavanju ravni glukoze v krvi ali urinu pri bolnikih s sladkorno boleznijo, ali maščob v krvi.
Adverse reactions known to occur with each component given singly but which have not been seen in clinical trials may occur during treatment with Kinzalkomb.
Neželeni učinki, o katerih so poročali za posamezni sestavini zdravila, se lahko pojavijo tudi pri zdravilu Kinzalkomb, čeprav jih v kliničnih preskušanjih kombinacije niso zasledili.
Common:
Občasni:
• Cholestasis and biliary obstructive disorders.
• holestaza in obolenja z zaporo žolčevoda,
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
x 1 tableta EU/1/02/214/014 56 tablet EU/1/02/214/015 98 tablet
Angioedema (also with fatal outcome), erythema, pruritus, rash, hyperhidrosis, urticaria
angioedem (lahko povzroči tudi smrt), eritem, pruritus, izpuščaj, hiperhidroza, urtikarija Bolezni mišično-skeletega sistema, vezivnega tkiva in kosti Občasni:
Therefore, the use of Kinzalkomb is not recommended.
Sočasno dajanje litija in zdravila Kinzalkomb ne priporočamo.
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.
Občasni neželeni učinki (pojavijo se pri največ 1 od 100 bolnikov): znižana raven kalija v krvi, tesnoba, omedlevanje (sinkopa), ščemenje, mravljinci (parestezija), vrtoglavica, hiter srčni utrip (tahikardija), motnje srčnega ritma, nizek krvni tlak, nenadno znižanje krvnega tlaka med vstajanjem, zasoplost (dispneja), driska, suha usta, napenjanje, bolečina v hrbtu, mišični krč, bolečina v mišicah, erektilna disfunkcija (nezmožnost erekcije ali vzdrževanja erekcije), bolečina v prsnem košu, povečana raven sečne kisline v krvi.
NAME OF THE MEDICINAL PRODUCT Kinzalkomb 40 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
IME ZDRAVILA Kinzalkomb 40 mg/12,5 mg tablete telmisartan / hidroklorotiazid
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.
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)
Kinzalkomb is not recommended for mothers who are breast-feeding, and your doctor may choose another treatment for you if you wish to breast-feed.
Zdravila Kinzalkomb ne priporočajo materam, ki dojijo.
Renal impairment and kidney transplantation
Motnje reprodukcije in dojk
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.
Posledice takšnih poškodb so lahko srčni infarkt, popuščanje srca ali odpoved ledvic, možganska kap ali slepota.
Adverse reactions occurred with similar frequency in placebo and telmisartantreated patients.
Pojavnost neželenih učinkov je bila enako pogosta kot pri placebu.
Renal impairment
Ledvična okvara
Meglumine
vrtoglavica
Feeling sick (nausea), low blood magnesium level.
zvišana raven sečne kisline v krvi
Dizziness or drowsiness may occasionally occur when taking Kinzalkomb.
Zdravilo Kinzalkomb lahko včasih povzroči omotico ali dremavost.
Dyspnoea
omotica
Restlessness
anksioznost
Inflammation of the lung (bronchitis), activation or worsening of systemic lupus erythematosus (a disease where the body's immune system attacks the body, which causes joint pain, skin rashes and fever); sore throat, inflamed sinuses, feeling sad (depression), difficulty falling asleep (insomnia), impaired vision, difficulty breathing, abdominal pain, constipation, bloating (dyspepsia), feeling sick (vomiting), inflammation of the stomach (gastritis), abnormal liver function (Japanese patients are more likely to experience this side effect), redness of the skin (erythema), allergic reactions such as itching or rash, increased sweating, hives (urticaria), joint pain (arthralgia) and pain in extremities, muscle cramps, flu-like-illness, pain, low levels of sodium, increased levels of creatinine, hepatic enzymes or creatine phosphokinase in the blood.
Redki neželeni učinki (pojavijo se pri največ 1 od 1.000 bolnikov): pljučno vnetje (bronhitis), aktiviranje ali poslabšanje sistemskega eritematoznega lupusa (bolezni, pri kateri telo napade človekov lastni imunski sistem, kar povzroči bolečine v sklepih, kožni izpuščaj in vročino), angina, vnetje sinusov, občutek žalosti (depresija), težave z uspavanjem (nespečnost), motnje vida, težave z dihanjem, trebušna bolečina, zaprtje, spahovanje (dispepsija), slabo počutje (bruhanje), želodčno vnetje (gastritis), motnje v delovanju jeter (pri japonskih bolnikih obstaja večja verjetnost pojavljanja tega neželenega učinka), rdečica na koži (eritem), alergijske reakcije, na primer srbenje ali izpuščaj; povečano znojenje, urtikarija, bolečine v sklepih (artralgija) in v okončinah, mišični krči, gripi podobna bolezen, bolečina,, nizka raven natrija, zvišane ravni kreatinina, jetrnih encimov ali kreatinfosfokinaze v krvi.
Kinzalkomb 80 mg/12.5 mg tablets are red and white, oval-shaped, two-layer tablets engraved with the code number 'H8'.
Izgled zdravila Kinzalkomb in vsebina pakiranja Tablete zdravila Kinzalkomb 80 mg/12,5 mg so rdeče in bele, ovalne, dvoslojne, z vtisnjeno kodno številko 'H8'.
Hypomagnesaemia
Hipomagneziemija
NAME OF THE MEDICINAL PRODUCT Kinzalkomb 80 mg/12.5 mg tablets telmisartan/hydrochlorothiazide
IME ZDRAVILA Kinzalkomb 80 mg/12,5 mg tablete telmisartan / hidroklorotiazid
Diabetes mellitus inadequate control
neurejenost sladkorne bolezni
Thiazide diuretic-associated azotaemia may occur in patients with impaired renal function.
Pri bolnikih z zmanjšanim delovanjem ledvic se lahko pojavi azotemija, ki jo povzročajo tiazidni diuretiki.
Infections and infestations Uncommon:
Infekcijske in parazitske bolezni Občasni:
Nervous system disorders Common:
Bolezni živčevja Pogosti:
Psychiatric disorders Uncommon:
Psihiatrične motnje Občasni:
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 40 mg telmisartan and 12.5 mg hydrochlorothiazide.
NAVEDBA ENE ALI VEČ UČINKOVIN 1 tableta vsebuje 40 mg telmisartana in 12,5 mg hidroklorotiazida.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 80 mg telmisartan and 25 mg hydrochlorothiazide.
NAVEDBA ENE ALI VEČ UČINKOVIN 1 tableta vsebuje 80 mg telmisartana in 25 mg hidroklorotiazida.
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Unit dose blister (28x1 tablets pack) or any non 7 count blister
x 1 tableta) ali vsi tisti pretisni omoti, ki ne vsebujejo po 7 tablet
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
14 tablet EU/1/02/214/002 28 tablet EU/1/02/214/003 28
4.9 Overdose
Preveliko odmerjanje
Red ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
Seznam pomožnih snovi laktoza monohidrat magnezijev stearat koruzni škrob meglumin mikrokristalna celuloza povidon (K25) rdeči železov oksid (E172) natrijev hidroksid natrijev karboksimetilškrob (vrsta A) sorbitol (E420)
Microcrystalline cellulose Povidone (K25)
Študija ALTITUDE (Aliskiren
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 80 mg telmisartan and 12.5 mg hydrochlorothiazide.
NAVEDBA ENE ALI VEČ UČINKOVIN 1 tableta vsebuje 80 mg telmisartana in 12,5 mg hidroklorotiazida.
Kinzalkomb 40 mg/12.5 mg tablets are red and white, oval-shaped two-layer tablets engraved with the code number 'H4'.
Izgled zdravila Kinzalkomb in vsebina pakiranja Tablete zdravila Kinzalkomb po 40 mg/12,5 mg so rdeče in bele, ovalne, dvoslojne, z vtisnjeno kodno številko 'H4'.
Lithium
Leverkusen
Headache
kašelj
Abnormal hepatic function/liver disorder Skin and subcutaneous tissue disorders Rare:
Bolezni jeter, žolčnika in žolčevodov Redki:
Yellow ferric oxide (E172) Sodium hydroxide Sodium starch glycollate (type A) Sorbitol (E420).
Seznam pomožnih snovi laktoza monohidrat magnezijev stearat koruzni škrob meglumin mikrokristalna celuloza povidon (K25) rumeni železov oksid (E172) natrijev hidroksid natrijev karboksimetilškrob (vrsta A) sorbitol (E420)
Although clinically significant hyperkalaemia has not been documented with Kinzalkomb, risk factors for the development of hyperkalaemia include renal insufficiency and/or heart failure, and diabetes mellitus.
Dejavniki tveganja za njen razvoj so zmanjšano delovanje ledvicali srčno popuščanje ali obe obolenji in diabetes mellitus.
Marketing Authorisation Holder Bayer AG
Imetnik dovoljenja za promet z zdravilom Bayer AG
MARKETING AUTHORISATION HOLDER Bayer AG
IMETNIK DOVOLJENJA ZA PROMET Z ZDRAVILOM Bayer AG
Kinzalkomb should be taken in patients whose blood pressure is not adequately controlled by telmisartan alone.
Zdravilo Kinzalkomb je namenjeno za zdravljenje visokega krvnega tlaka (esencialne hipertenzije) pri odraslih, pri katerih s samim telmisartanom krvnega tlaka ne moremo dovolj uravnavati.
Lactose monohydrate Magnesium stearate Maize starch
hepatocelularna zlatenica, holestazna zlatenica
Date of latest renewal: 22 March 2016
Dátum posledného predĺženia registrácie: 22. marec 2016
• have or have had a disease of the pancreas.
• máte alebo ste mali ochorenie podžalúdkovej žľazy.
(pancreatitis).
(pankreatitídy).
Trajenta should not be used to treat these conditions.
Trajenta sa nemá používať na liečbu týchto stavov.
This was achieved with a stable insulin dose (40.1 IU).
Toto sa dosiahlo stabilnou dávkou inzulínu (40,1 IU).
• Rifampicin.
• rifampicín.
In particular, you should tell your doctor if you are using medicines containing any of the following active substances:
Predovšetkým máte povedať svojmu lekárovi ak užívate lieky, ktoré obsahujú ktorékoľvek z nasledovných liečiv:
• have had allergic reactions to any other medicines that you take to control the amount of sugar in your blood.
• ak ste mali alergické reakcie na akékoľvek iné lieky, ktoré užívate na kontrolu množstva cukru v krvi.
What Trajenta is and what it is used for What you need to know before you take Trajenta How to take Trajenta
Čo je Trajenta a na čo sa používa Čo potrebujete vedieť predtým, ako užijete Trajentu Ako užívať Trajentu
Children and adolescents Trajenta is not recommended for children and adolescents under 18 years.
Deti a dospievajúci Trajenta sa neodporúča pre deti a dospievajúcich do 18 rokov.
Your doctor may ask you to stop Trajenta.
Váš lekár vás môže požiadať, aby ste prestali užívať liek Trajenta.
Lipase increased**
Zvýšená hladina lipázy**
Adverse reaction observed in combination with insulin
Nežiaduca reakcia pozorovaná v kombinácii s inzulínom
• Carbamazepine, phenobarbital or phenytoin.
• karbamazepín, fenobarbital alebo fenytoín.
• 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
• silná a pretrvávajúca bolesť brucha (v oblasti žalúdka), ktorá sa môže šíriť do vášho chrbta, ako aj nevoľnosť a vracanie, pretože to môžu byť prejavy zápalu podžalúdkovej žľazy
The clinical trials before marketing authorisation have been performed up to a BMI equal to 40 kg/m
Klinické štúdie pred registráciou sa vykonali do BMI zodpovedajúcemu 40 kg/m
• Common: level of lipase in the blood increased.
• časté: zvýšená hladina lipázy v krvi
Skin and subcutaneous tissue disorders Angioedema*
Poruchy kože a podkožného tkaniva Angioedém*
• If you forget to take a dose of Trajenta, take it as soon as you remember it.
Ak zabudnete užiť dávku Trajenty, užite ju hneď ako si spomeniete.
Some symptoms need immediate medical attention You should stop taking Trajenta and see your doctor immediately if you experience the following symptoms of low blood sugar: trembling, sweating, anxiety, blurred vision, tingling lips, paleness, mood change or confusion (hypoglycaemia).
Niektoré príznaky si vyžadujú okamžitý lekársky zásah Trajentu máte prestať užívať a okamžite máte navštíviť lekára, ak máte nasledovné príznaky nízkej hladiny cukru v krvi: tras, potenie, úzkosť, rozmazané videnie, tŕpnutie pier, bledosť, zmenu nálady alebo zmätenosť (hypoglykémia).
• Rare: blistering of skin (bullous pemphigoid).
• zriedkavé: tvorba pľuzgierov na pokožke (bulózny pemfigoid).
Table 2 Cardiovascular and renal outcomes by treatment group in the CARMELINA study
Tabuľka 2 Kardiovaskulárne a renálne výsledky podľa liečebnej skupiny v štúdii CARMELINA
Some patients have had the following side effects while taking Trajenta alone or in combination with other medicinal products for the treatment of diabetes:
Niektorí pacienti mali počas užívania Trajenty samostatne alebo v kombinácii s inými liekmi na liečbu cukrovky nasledovné vedľajšie účinky:
Pharmacokinetic studies suggest that no dose adjustment is required for patients with hepatic impairment but clinical experience in such patients is lacking.
Farmakokinetické štúdie naznačujú, že u pacientov s poruchou funkcie pečene nie je potrebná žiadna úprava dávky, no s takýmito pacientmi chýbajú klinické skúsenosti.
The reductions in glycosylated haemoglobin A1c (HbA1c) were similar across different subgroups including gender, age, renal impairment and body mass index (BMI).
Zníženie glykozylovaného hemoglobínu A1c (HbA1c) bolo v rámci rôznych podskupín zahŕňajúcich pohlavie, vek, porucha funkcie obličiek a index telesnej hmotnosti (body mass index, BMI) podobné.
Trajenta is used for ‘type 2 diabetes' in adults, if the disease cannot be adequately controlled with one oral anti-diabetic medicine (metformin or sulphonylureas) or diet and exercise alone.
Trajenta sa používa u dospelých s „cukrovkou typu 2”, ak ochorenie nemožno dostatočne kontrolovať jedným perorálnym antidiabetikom (metformínom alebo sulfonylmočovinou) alebo samotnou diétou a pohybovou aktivitou.
• Uncommon: inflamed nose or throat (nasopharyngitis), cough, constipation (in combination with insulin), level of amylase in the blood increased.
• menej časté: zápal nosa alebo hrdla (nazofaryngitída), kašeľ, zápcha (v kombinácii s inzulínom), zvýšenie hladiny amylázy v krvi.
Linagliptin should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
Linagliptín nemajú používať pacienti s diabetom mellitus typu 1 alebo na liečbu diabetickej ketoacidózy.
• are taking an anti-diabetic medicine known as a ‘sulphonylurea'(e.g. glimepiride, glipizide), your doctor may want to reduce your dose of sulphonylurea when you take it together with Trajenta in order to avoid your blood sugar going too low.
• ak užívate antidiabetikum známe ako „sulfonylmočovina” (napr. glimepirid, glipizid), váš lekár môže chcieť znížiť dávku sulfonylmočoviny, ak ju užívate spolu s Trajentou, aby sa zabránilo príliš veľkému poklesu hladiny cukru v krvi.
Pancreatitis was reported more often in patients randomized to linagliptin (7 events in 6,580 patients receiving linagliptin versus 2 events in 4,383 patients receiving placebo).
Pankreatitída sa hlásila častejšie u pacientov randomizovaných na linagliptín (7 udalostí u 6580 pacientov dostávajúcich linagliptín verzus 2 udalosti u 4383 pacientov dostávajúcich placebo).
After a median follow up of 2.2 years, linagliptin, when added to usual care, did not increase the risk of major adverse cardiovascular events or renal outcome events.
Po období sledovania s mediánom 2,2 roka linagliptín po pridaní k obvyklej starostlivosti nezvyšoval riziko závažných nežiaducich kardiovaskulárnych udalostí ani renálnych udalostí.
Immune system disorders Hypersensitivity (e.g. bronchial hyperreactivity)
Poruchy imunitného systému Precitlivenosť (napríklad hyperreaktivita priedušiek)
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 24 August 2011
Dátum prvej registrácie: 24. august 2011
After a median follow up of 6.25 years, linagliptin did not increase the risk of major adverse cardiovascular events (see table 3) as compared to glimepiride.
Po období sledovania s mediánom 6,25 roka linagliptín nezvyšoval riziko závažných nežiaducich kardiovaskulárnych udalostí (pozri tabuľku 3) v porovnaní s glimepiridom.
Pharmacotherapeutic group: Drugs used in diabetes, dipeptidyl peptidase 4 (DPP-4) inhibitors, ATC code: A10BH05
Antidiabetiká, inhibítory dipeptidyl 4 (DPP-4) peptidázy, ATC kód: A10BH05.
The renal composite endpoint was defined as renal death or sustained end stage renal disease or sustained decrease of 40% or more in eGFR.
Renálny kombinovaný koncový ukazovateľ bol definovaný ako renálne úmrtie alebo trvalé terminálne štádium ochorenia obličiek (end stage renal disease, ESRD) alebo trvalé zníženie eGFR o 40 % alebo viac.
- monotherapy with short-term duration of up to 4 weeks - monotherapy with ≥ 12 week duration - add-on to metformin - add-on to metformin + sulphonylurea - add on to metformin and empagliflozin - add-on to insulin with or without metformin
- monoterapia s krátkodobým trvaním do 4 týždňov - monoterapia s trvaním ≥ 12 týždňov - prídavná liečba k metformínu - prídavná liečba k metformínu a sulfonylmočovine - prídavná liečba k metformínu a empagliflozínu - prídavná liečba k inzulínu s metformínom alebo bez neho
Do not use Trajenta if the package is damaged or shows signs of tampering.
Trajentu, ak je obal poškodený, alebo vykazuje známky použitia.
In moderate renal impairment, a moderate increase in exposure of about 1.7 fold was observed compared with control.
Pri stredne závažnej poruche funkcie obličiek sa pozoroval mierny vzostup expozície asi o 1,7-násobok v porovnaní s kontrolou.
Therefore, clinically relevant interactions would not be expected with other Pglycoprotein/CYP3A4 inhibitors.
Preto sa nepredpokladajú klinicky významné interakcie s inými inhibítormi P-glykoproteínu/CYP3A4.
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Táto písomná informácia bola naposledy aktualizovaná v Podrobné informácie o tomto lieku sú dostupné na internetovej stránke Európskej agentúry pre lieky http://www.ema.europa.eu.
Table 3 Major adverse cardiovascular events (MACE) and mortality by treatment group in the
Tabuľka 3 Závažné nežiaduce kardiovaskulárne udalosti (MACE) a úmrtnosť podľa liečebnej skupiny v štúdii CAROLINA
There were also 1,238 patients with mild renal impairment, and 143 patients with moderate renal impairment on linagliptin.
Bolo tu aj 1238 pacientov s miernou poruchou funkcie obličiek a 143 pacientov so stredne závažnou poruchou funkcie obličiek, ktorí sa liečili linagliptínom.