natgillin/translations-raw huggingface dataset:
• If you have any sign of blockage of a blood vessel by a blood clot such as : - cramping pain, redness, warmth, or swelling in one of your legs - these are symptoms of deep vein thrombosis - breathlessness, chest pain, fainting or coughing up blood - these are symptoms of a pulmonary embolism
• Če imate kakršen koli znak zamašitve žile s krvnim strdkom, na primer: - krčevite bolečine, pordelost, toploto ali oteklost ene noge - to so simptomi globoke venske tromboze,
LOVENOX (and associated names) 30,000 IU (300 mg)/3 mL solution for injection LOVENOX (and associated names) 50,000 IU (500 mg)/5 mL solution for injection LOVENOX (and associated names) 100,000 IU (1,000 mg)/10 mL solution for injection
LOVENOX (in povezana imena) 30.000 i.e. (300 mg)/3 ml raztopina za injiciranje LOVENOX (in povezana imena) 50.000 i.e. (500 mg)/5 ml raztopina za injiciranje LOVENOX (in povezana imena) 100.000 i.e. (1.000 mg)/10 ml raztopina za injiciranje
Do not use LOVENOX (and associated names)
Nehajte jemati zdravilo LOVENOX (in povezana imena).
- Changing from blood thinners called vitamin-K antagonists (e.g. warfarin) to LOVENOX (and associated names)
- Prehod s sredstev za redčenje krvi, imenovanih antagonisti vitamina K (npr. varfarin) na zdravilo
[To be completed nationally] [See Annex I - To be completed nationally] [For referral procedures]
[Glejte Prilogo I - Izpolni država članica] [Za postopke predložitve, kot je ustrezno.]
Prophylaxis of venous thromboembolism in medical patients The recommended dose of enoxaparin sodium is 4,000 IU (40 mg) once daily by SC injection.
Priporočeni odmerek natrijevega enoksaparinata je 4.000 i.e. (40 mg) enkrat na dan v subkutani injekciji.
One vial contains enoxaparin sodium 30,000 IU anti-Xa activity (equivalent to 300 mg) + 45 mg benzyl alcohol in 3.0 mL water for injections.
Ena viala vsebuje 30.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 300 mg) in 45 mg benzilalkohola v 3,0 ml vode za injekcije.
LOVENOX (and associated names) 30,000 IU (300 mg) /3.0 mL solution for injection LOVENOX (and associated names) 50,000 IU (500 mg)/5.0 mL solution for injection LOVENOX (and associated names) 100,000 IU (1,000 mg)/10 mL solution for injection [See Annex I - To be completed nationally]
LOVENOX (in povezana imena) 30.000 i.e. (300 mg)/3 ml raztopina za injiciranje LOVENOX (in povezana imena) 50.000 i.e. (500 mg)/5 ml raztopina za injiciranje LOVENOX (in povezana imena) 100.000 i.e. (1.000 mg)/10 ml raztopina za injiciranje [Glejte Prilogo I - Izpolni država članica]
One vial contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 10 mL water for injections.
Ena viala vsebuje 10.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 100 mg) v 10 ml vode za injekcije.
Each prefilled syringe contains enoxaparin sodium 12,000 IU anti-Xa activity (equivalent to 120 mg) in 0.8 mL water for injections.
Ena napolnjena injekcijska brizga vsebuje 12.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 120 mg) v 0,8 ml vode za injekcije.
One pre-filled syringe (0.2 mL) contains 2,000 IU (20 mg) enoxaparin sodium One pre-filled syringe (0.4 mL) contains 4,000 IU (40 mg) enoxaparin sodium One pre-filled syringe (0.6 mL) contains 6,000 IU (60 mg) enoxaparin sodium One pre-filled syringe (0.8 mL) contains 8,000 IU (80 mg) enoxaparin sodium One pre-filled syringe (0.8 mL) contains 12,000 IU (120 mg) enoxaparin sodium One pre-filled syringe (1 mL) contains 10,000 IU (100 mg) enoxaparin sodium One pre-filled syringe (1 mL) contains 15,000 IU (150 mg) enoxaparin sodium
Ena napolnjena injekcijska brizga (0,2 ml) vsebuje 2.000 i.e. (20 mg) natrijevega enoksaparinata Ena napolnjena injekcijska brizga (0,4 ml) vsebuje 4.000 i.e. (40 mg) natrijevega enoksaparinata Ena napolnjena injekcijska brizga (0,6 ml) vsebuje 6.000 i.e. (60 mg) natrijevega enoksaparinata Ena napolnjena injekcijska brizga (0,8 ml) vsebuje 8.000 i.e. (80 mg) natrijevega enoksaparinata Ena napolnjena injekcijska brizga (0,8 ml) vsebuje 12.000 i.e. (120 mg) natrijevega enoksaparinata Ena napolnjena injekcijska brizga (1 ml) vsebuje 10.000 i.e. (100 mg) natrijevega enoksaparinata Ena napolnjena injekcijska brizga (1 ml) vsebuje 15.000 i.e. (150 mg) natrijevega enoksaparinata
Pre-Filled Syringes:
Napolnjene injekcijske brizge:
Other medicines and LOVENOX (and associated names) Tell your doctor or pharmacist if you are taking or might take/use any other medicines.
Obvestite svojega zdravnika ali farmacevta, če uporabljate ali pa boste morda začeli uporabljati katero koli drugo zdravilo.
No dose adjustment is recommended in patients with moderate (creatinine clearance 30-50 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment.
Pri bolnikih z zmerno (očistek kreatinina 30-50 ml/min) in blago (očistek kreatinina
Very common: Haemorrhage α Rare:
Zelo pogosti: Krvavitevα
Each prefilled syringe contains enoxaparin sodium 15,000 IU anti-Xa activity (equivalent to 150 mg) in 1.0 mL water for injections.
Ena napolnjena injekcijska brizga vsebuje 15.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 150 mg) v 1,0 ml vode za injekcije.
• The maximum amount of LOVENOX (and associated names) given for the first two injections is 7,500 IU (75 mg).
• Največji odmerek zdravila LOVENOX (in povezana imena), uporabljen v prvih dveh injekcijah,
Multiple dose vials containing benzyl alcohol:
Večodmerne viale, ki vsebujejo benzilalkohol:
STEMI enoxaparin sodium regimen was a 3,000 IU (30 mg) IV bolus followed by 100 IU/kg (1 mg/kg) SC every 12 hours.
Intravenski bolus 3.000 i.e. (30 mg), ki mu je takoj sledila subkutana uporaba 100 i.e./kg (1 mg/kg) na
LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg)/0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection
- LOVENOX (in povezana imena) 2.000 i.e. (20 mg)/0,2 ml raztopina za injiciranje - LOVENOX (in povezana imena) 4.000 i.e. (40 mg)/0,4 ml raztopina za injiciranje - LOVENOX (in povezana imena) 6.000 i.e. (60 mg)/0,6 ml raztopina za injiciranje - LOVENOX (in povezana imena) 8.000 i.e. (80 mg)/0,8 ml raztopina za injiciranje - LOVENOX (in povezana imena) 10.000 i.e. (100 mg)/1 ml raztopina za injiciranje
In the clinical studies for treatment of unstable angina and non-Q-wave myocardial infarction, doses were 100 IU/kg (1 mg/kg) SC every 12 hours, and in the clinical study for treatment of acute
V kliničnih študijah za zdravljenje nestabilne angine pektoris in miokardnega infarkta brez zobca Q so bili odmerki 100 i.e./kg (1 mg/kg)
If a manual compression method is used, sheath should be removed 6 hours after the last IV/SC enoxaparin sodium injection.
morate ovojnico odstraniti 6 ur po zadnji intravenski/subkutani injekciji natrijevega enoksaparinata.
Careful clinical monitoring is advised and dose reduction might be considered in patients older than 75 years treated for STEMI (see sections 4.2 and
75 let, zdravljenih zaradi STEMI, pride v poštev zmanjšanje odmerka (glejte poglavji 4.2 in 5.2).
Subcutaneous, intravenous use.
subkutana, intravenska uporaba izventelesna uporaba (v dializnem obtoku)
Skin and subcutaneous tissue disorders
Bolezni mišično-skeletnega sistema in vezivnega tkiva
Talk to your doctor or pharmacist before using LOVENOX (and associated names) if:
Pred uporabo zdravila LOVENOX (in povezana imena) se posvetujte z zdravnikom ali farmacevtom:
LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg)/0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection LOVENOX (and associated names) 30,000 IU (300 mg)/3 mL solution for injection LOVENOX(and associated names) 50,000 IU (500 mg)/5 mL solution for injection LOVENOX(and associated names) 100,000 IU (1,000 mg)/10 mL solution for injection LOVENOX (and associated names) 12,000 IU (120 mg)/0.8 mL solution for injection LOVENOX (and associated names) 15,000 IU (150 mg)/1 mL solution for injection
LOVENOX (in povezana imena) 2.000 i.e. (20 mg)/0,2 ml raztopina za injiciranje LOVENOX (in povezana imena) 4.000 i.e. (40 mg)/0,4 ml raztopina za injiciranje LOVENOX (in povezana imena) 6.000 i.e. (60 mg)/0,6 ml raztopina za injiciranje LOVENOX (in povezana imena) 8.000 i.e. (80 mg)/0,8 ml raztopina za injiciranje LOVENOX (in povezana imena) 10.000 i.e. (100 mg)/1 ml raztopina za injiciranje LOVENOX (in povezana imena) 30.000 i.e. (300 mg)/3 ml raztopina za injiciranje LOVENOX (in povezana imena) 50.000 i.e. (500 mg)/5 ml raztopina za injiciranje LOVENOX (in povezana imena) 100.000 i.e. (1.000 mg)/10 ml raztopina za injiciranje LOVENOX (in povezana imena) 12.000 i.e. (120 mg)/0,8 ml raztopina za injiciranje LOVENOX (in povezana imena) 15.000 i.e. (150 mg)/1 ml raztopina za injiciranje
• Extended prophylaxis of venous thromboembolism (VTE) following orthopaedic surgery In a double blind study of extended prophylaxis for patients undergoing hip replacement surgery, 179 patients with no venous thromboembolic disease initially treated, while hospitalized, with enoxaparin sodium 4,000 IU (40 mg) SC, were randomized to a post-discharge regimen of either enoxaparin sodium 4,000 IU (40 mg) (n=90) once a day SC or to placebo (n=89) for 3 weeks.
bolnikov brez venske trombembolične bolezni, ki so bili med hospitalizacijo uvodoma zdravljeni z natrijevim enoksaparinatom 4.000 i.e. (40 mg) subkutano, po odpustu za 3 tedne randomizirali na shemo z natrijevim enoksaparinatom 4.000 i.e. (40 mg) subkutano enkrat na dan (n = 90) ali na placebo (n = 89).
Each ampoule contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 1.0 mL water for injections.
Ena ampula vsebuje 10.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 100 mg) v 1,0 ml vode za injekcije.
LOVENOX (and associated names) 10 x 4,000 IU (10 x 40 mg) solution for injection [See Annex I - To be completed nationally]
IME ZDRAVILA LOVENOX (in povezana imena) 10 x 4.000 i.e. (10 x 40 mg) raztopina za injiciranje
Package leaflet: Information for the user LOVENOX (and associated names) 10 x 4,000 IU (10 x 40 mg) doses solution for injection in a pen [See Annex I - To be completed nationally] enoxaparin sodium
Navodilo za uporabo LOVENOX (in povezana imena) 10 x 4.000 i.e. (10 x 40 mg) odmerkov raztopina za injiciranje v peresniku
• Your doctor or nurse will normally give you LOVENOX (and associated names).
• Običajno vam bo zdravilo LOVENOX (in povezana imena) dal zdravnik ali medicinska sestra.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LOVENOX (and associated names) 10,000 IU (100 mg)/10 mL solution for injection [See Annex I - To be completed nationally]
IME ZDRAVILA IN POT(I) UPORABE LOVENOX (in povezana imena) 10.000 i.e. (100 mg)/10 ml raztopina za injiciranje
Treatment of deep vein thrombosis with or without pulmonary embolism In a multicenter, parallel group study, 900 patients with acute lower extremity DVT with or without PE were randomized to an inpatient (hospital) treatment of either (i) enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day SC, (ii) enoxaparin sodium 100 IU/kg (1 mg/kg) every 12 hours SC, or (iii) heparin IV bolus (5,000 IU) followed by a continuous infusion (administered to achieve an aPTT of 55 to 85 seconds).
Zdravljenje globoke venske tromboze, s pljučno embolijo ali brez nje V multicentrični študiji vzporednih skupin so 900 bolnikov z akutno GVT spodnje okončine, s PE ali brez nje, randomizirali na bolnišnično zdravljenje (i) z natrijevim enoksaparinatom 150 i.e./kg
Each prefilled syringe contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 1.0 mL water for injections.
Ena napolnjena injekcijska brizga vsebuje 10.000 i.e. aktivnosti anti-Xa natrijevega enoksaparinata (to ustreza 100 mg) v 1,0 ml vode za injekcije.
No IV initial bolus, 100 IU/kg (1 mg/kg) body weight SC and then 100 IU/kg (1 mg/kg) body weight SC every 24 hours
(1 mg/kg) telesne mase subkutano, nato 100 i.e./kg (1 mg/kg) telesne mase subkutano na 24 ur
Prevention of thrombus formation during haemodialysis The recommended dose is 100 IU/kg (1 mg/kg) of enoxaparin sodium.
Priporočeni odmerek je 100 i.e./kg (1 mg/kg) natrijevega enoksaparinata.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection [See Annex I - To be completed nationally] enoxaparin
IME ZDRAVILA IN POT(I) UPORABE LOVENOX (in povezana imena) 10.000 i.e. (100 mg)/1 ml raztopina za injiciranje
PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER BOX MULTIDOSE VIAL
PODATKI NA ZUNANJI OVOJNINI ŠKATLA ZA PERESNIK
LOVENOX (and associated names) 12,000 IU (120 mg)/0.8 mL solution for injection LOVENOX (and associated names) 15,000 IU (150 mg)/1 mL solution for injection
15.000 i.e./ml (150 mg/ml) raztopina za injiciranje: - LOVENOX (in povezana imena) 12.000 i.e. (120 mg)/0,8 ml raztopina za injiciranje - LOVENOX (in povezana imena) 15.000 i.e. (150 mg)/1 ml raztopina za injiciranje
NAME OF THE MEDICINAL PRODUCT LOVENOX (and associated names) 10,000 IU (100 mg)/10 mL solution for injection [See Annex I - To be completed nationally] Enoxaparin
IME ZDRAVILA LOVENOX (in povezana imena) 10.000 i.e. (100 mg)/10 ml raztopina za injiciranje
LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg)/0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection LOVENOX (and associated names) 12,000 IU (120 mg)/0.8 mL solution for injection LOVENOX (and associated names) 15,000 IU (150 mg)/1 mL solution for injection [See Annex I - To be completed nationally]
LOVENOX (in povezana imena) 2.000 i.e. (20 mg)/0,2 ml raztopina za injiciranje LOVENOX (in povezana imena) 4.000 i.e. (40 mg)/0,4 ml raztopina za injiciranje LOVENOX (in povezana imena) 6.000 i.e. (60 mg)/0,6 ml raztopina za injiciranje LOVENOX (in povezana imena) 8.000 i.e. (80 mg)/0,8 ml raztopina za injiciranje LOVENOX (in povezana imena) 10.000 i.e. (100 mg)/1 ml raztopina za injiciranje LOVENOX (in povezana imena) 12.000 i.e. (120 mg)/0,8 ml raztopina za injiciranje LOVENOX (in povezana imena) 15.000 i.e. (150 mg)/1 ml raztopina za injiciranje [Glejte Prilogo I - Izpolni država članica]
Careful clinical monitoring is advised and dose reduction might be considered in patients older than 75 years treated for ST-segment elevation myocardial infarction (STEMI) (see section 5.2).
75 let, zdravljenih zaradi STEMI, pride v poštev zmanjšanje odmerka (glejte poglavje 5.2).
LOVENOX (and associated names) 2,000 IU (20 mg)/0.2 mL solution for injection LOVENOX (and associated names) 4,000 IU (40 mg /0.4 mL solution for injection LOVENOX (and associated names) 6,000 IU (60 mg)/0.6 mL solution for injection LOVENOX (and associated names) 8,000 IU (80 mg)/0.8 mL solution for injection LOVENOX (and associated names) 10,000 IU (100 mg)/1 mL solution for injection LOVENOX (and associated names) 12,000 IU (120 mg)/0.8 mL solution for injection LOVENOX (and associated names) 15,000 IU (150 mg)/1 mL solution for injection
LOVENOX (in povezana imena) 2.000 i.e. (20 mg)/0,2 ml raztopina za injiciranje LOVENOX (in povezana imena) 4.000 i.e. (40 mg)/0,4 ml raztopina za injiciranje LOVENOX (in povezana imena) 6.000 i.e. (60 mg)/0,6 ml raztopina za injiciranje LOVENOX (in povezana imena) 8.000 i.e. (80 mg)/0,8 ml raztopina za injiciranje LOVENOX (in povezana imena) 10.000 i.e. (100 mg)/1 ml raztopina za injiciranje LOVENOX (in povezana imena) 12.000 i.e. (120 mg)/0,8 ml raztopina za injiciranje LOVENOX (in povezana imena) 15.000 i.e. (150 mg)/1 ml raztopina za injiciranje enoksaparin
All Treated DVT Patients with or without PE Total VTE (%)
Vse VTE (%) Samo GVT (%) Proksimalne GVT PE (%)
6.6 Special precautions for disposal and other handling [To be completed nationally]
4.4 Posebna opozorila in previdnostni ukrepi • Splošno
PACKAGE LEAFLET
Odmerna shema
NAME OF THE MEDICINAL PRODUCT LOVENOX 10 x 4,000 IU (10 x 40 mg) Pen Enoxaparin STATEMENT OF ACTIVE SUBSTANCE(S) 1 pen contains 3.0 mL corresponding to 10 single doses of 4,000 IU (40 mg) enoxaparin sodium.
1 peresnik vsebuje 3,0 ml, kar ustreza 10 enkratnim odmerkom 4.000 i.e. (40 mg) natrijevega enoksaparinata.
Thrombocytopenia and thrombocytosis System
Trombocitopenija in trombocitoza
100 IU/kg (1 mg/kg) body weight SC once daily
i.e./kg (1,5 mg/kg) enkrat na dan 0,19 i.e./ml.
Volume to be injected through IV line after dilution is completed at a concentration of 300 IU (3 mg) /mL.
Količina, ki jo je treba injicirati v intravensko linijo po dokončanem razredčenju na koncentracijo
Enoxaparin sodium, as with any other anticoagulant therapy, should be used with caution in conditions with increased potential for bleeding, such as: - impaired haemostasis, - history of peptic ulcer, - recent ischemic stroke, - severe arterial hypertension, recent diabetic retinopathy, - neuro- or ophthalmologic surgery, - concomitant use of medications affecting haemostasis (see section 4.5).
Med takšna zdravila spadajo na primer: - sistemski salicilati, acetilsalicilna kislina v protivnetnih odmerkih in NSAID, vključno s ketorolakom, - drugi trombolitiki (npr. alteplaza, reteplaza, streptokinaza, tenekteplaza, urokinaza) in antikoagulansi (glejte poglavje 4.2).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS MULTIPLE DOSE VIALS
V dvojno slepi, multicentrični študiji vzporednih skupin so natrijev enoksaparinat v odmerkih
Immune system disorders
Imuno-alergijska trombocitopenija
Rare (may affect up to 1 in 1,000 people)
Redki (pojavijo se lahko pri največ 1 od 1.000 bolnikov) • Huda alergijska reakcija.
• Sudden severe headache.
• Pogosti: Glavobol* Žilne bolezni
- The active substance(s) is enoxaparin sodium
- Zdravilna učinkovina je natrijev enoksaparinat.
some medicines for heart problems.
priloženem v pakiranju zdravila.
After repeated SC administration of the 100 IU/kg (1 mg/kg) twice daily regimen, the steady-state is reached from day 3 to 4 with mean exposure about 65% higher than after a single dose and mean maximum and trough anti-Xa activity levels of about 1.2 and 0.52 IU/mL, respectively.
Povprečna izpostavljenost je približno 65 % večja kot po enkratnem odmerku, povprečna največja raven aktivnosti anti-Xa je približno 1,2 i.e./ml in povprečna najmanjša raven okoli 0,52
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT [To be completed nationally]
[Glejte Prilogo I - Izpolni država članica] KAKOVOSTNA IN KOLIČINSKA SESTAVA
Major bleeding were respectively 1.7% in the enoxaparin sodium 150 IU/kg (1.5 mg/kg) once a day group, 1.3% in the enoxaparin sodium 100 IU/kg (1mg/kg) twice a day group and 2.1% in the heparin group.
Večjih krvavitev je bilo v skupini s 150 i.e./kg (1,5 mg/kg) natrijevega enoksaparinata enkrat na dan
Most cases were mild and none were severe.
Večinoma so bili blagi, nobeden pa ni bil resen.
The European Commission granted a marketing authorisation valid throughout the European Union for Trajenta on 24 August 2011.
Evropska komisija je dovoljenje za promet z zdravilom Trajenta, veljavno po vsej Evropski uniji, odobrila dne 24. avgusta 2011.
Other information about Trajenta
Druge informacije o zdravilu Trajenta
The recommended dose of Trajenta is one tablet once a day.
Priporočeni odmerek zdravila Trajenta je ena tableta enkrat dnevno.
EPAR summary for the public linagliptin
Povzetek EPAR za javnost linagliptin
The full EPAR for Trajenta can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Trajenta je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
This is a summary of the European public assessment report (EPAR) for Trajenta.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Trajenta.
• metformin and a sulphonylurea;
• metformin in sulfonilsečnina;
For more information about treatment with Trajenta, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Trajenta preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
What benefit has Trajenta shown during the studies?
Kakšne koristi je zdravilo Trajenta izkazalo med študijami?
• insulin, either on its own or together with metformin.
• insulin, bodisi kot samostojno zdravilo bodisi skupaj z metforminom.
In all studies, the main measure of effectiveness was the change in blood levels of a substance called glycosylated haemoglobin (HbA1c) after 24 weeks of treatment.
V vseh študijah je bilo glavno merilo učinkovitosti sprememba ravni snovi v krvi, imenovane glikozilirani hemoglobin (HbA1c), po 24 tednih zdravljenja.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Trajenta.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Trajenta, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
However the benefit of adding Trajenta to pioglitazone treatment was not considered to have been sufficiently established.
Koristi dodajanja zdravila Trajenta zdravljenju s pioglitazonom pa niso bile zadostno dokazane.
Together, these processes reduce blood glucose levels and help to control type 2 diabetes.
Ti procesi skupaj znižajo raven glukoze v krvi in pripomorejo k vzpostavitvi nadzora nad sladkorno boleznijo tipa 2.
Trajenta must not be used in people who are hypersensitive (allergic) to linagliptin or to any of the other ingredients.
Zdravila Trajenta ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) linagliptin ali katero koli drugo sestavino zdravila.
Trajenta is a medicine that contains the active substance linagliptin.
Trajenta je zdravilo, ki vsebuje zdravilno učinkovino linagliptin.
What is the risk associated with Trajenta?
Kakšna tveganja so povezana z zdravilom Trajenta?
The most frequently reported side effect, seen in around 6 out of 100 patients taking Trajenta, was hypoglycaemia.
Najpogostejši neželeni učinek jemanja zdravila Trajenta, o katerem so poročali pri približno 6 bolnikih od 100, je bila hipoglikemija.
The active substance in Trajenta, linagliptin, is a dipeptidyl peptidase 4 (DPP-4) inhibitor.
Zdravilna učinkovina v zdravilu Trajenta, linagliptin, je zaviralec dipeptidil peptidaze 4 (DPP-4).
The Committee therefore concluded that the benefits of Trajenta outweigh its risks and recommended that it be granted marketing authorisation.
CHMP je zato zaključil, da koristi zdravila Trajenta odtehtajo z njim povezana tveganja, in priporočil, da se zanj odobri dovoljenje za promet.
Hypoglycaemia was seen in around 15 out of 100 patients treated with the triple combination of Trajenta with metformin and a sulphonylurea (around twice as many as the placebo group).
Hipoglikemijo so opazili pri okoli 15 bolnikih od 100, ki so jih zdravili s trojno kombinacijo zdravila Trajenta, metformina in sulfonilsečnine (okoli dvakrat več primerov kot v skupini, ki je prejemala placebo).
Trajenta was shown to be more effective than placebo at reducing HbA1c levels in all combinations studied:
Zdravilo Trajenta je bilo pri zniževanju ravni HbA1c učinkovitejše od placeba v vseh proučevanih kombinacijah: