natgillin/translations-raw huggingface dataset:
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 (i pridružena imena) 2000 IU (20 mg)/0,2 ml otopina za injekciju LOVENOX (i pridružena imena) 4000 IU (40 mg)/0,4 ml otopina za injekciju LOVENOX (i pridružena imena) 6000 IU (60 mg)/0,6 ml otopina za injekciju LOVENOX (i pridružena imena) 8000 IU (80 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju
LOVENOX (and associated names) 10 x 4,000 IU (10 x 40 mg) solution for injection [See Annex I - To be completed nationally]
NAZIV LIJEKA LOVENOX (i pridružena imena) 10 x 4000 IU (10 x 40 mg) otopina za injekciju
In treatment of DVT with or without PE, patients receiving enoxaparin sodium were treated with either a 100 IU/kg (1 mg/kg) SC dose every 12 hours or a 150 IU/kg (1.5 mg/kg) SC dose once a day.
Kod liječenja DVT-a praćenog PE-om ili bez njega, bolesnici su primali enoksaparinnatrij u supkutanoj dozi od 100 IU/kg (1 mg/kg) svakih
A puncture-free interval of at least 12 hours shall be kept between the last injection of enoxaparin sodium at prophylactic doses and the needle or catheter placement.
Između posljednje injekcije enoksaparinnatrija u profilaktičkim dozama i uvođenja igle ili katetera mora proći razdoblje od najmanje 12 sati bez ikakvih uboda.
• Extended prophylaxis of 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.
U dvostruko slijepom ispitivanju produljene profilakse u bolesnika podvrgnutih kirurškom zahvatu zamjene kuka, 179 bolesnika bez venske tromboembolijske bolesti, koji su prvotno (tijekom hospitalizacije) bili liječeni enoksaparinnatrijem u supkutanoj dozi od 4000 IU (40 mg),
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).
Kao i svaki drugi antikoagulans, enoksaparinnatrij mora se primjenjivati uz oprez kod stanja kod kojih postoji povećan rizik od krvarenja, kao što su: - poremećaj hemostaze - peptički ulkus u anamnezi
What is in this leaflet
Pogledajte odlomak
(20 mg) or 4,000 IU (40 mg) of LOVENOX (and associated names) each day.
(40 mg) lijeka LOVENOX (i pridružena imena).
If you get any side effects, talk to your doctor orpharmacist or nurse.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
L [to be completed nationally]
- Ispunjava država članica]
Your doctor will decide how much LOVENOX (and associated names) to give you.
Vaš će liječnik odrediti koliko ćete lijeka LOVENOX (i pridružena imena) primati.
• Your doctor will decide how much LOVENOX (and associated names) to give you.
• Vaš će liječnik odrediti koliko ćete lijeka LOVENOX (i pridružena imena) primati.
Enoxaparin sodium is to be used with extreme caution in patients with a history (>100 days) of heparin-induced thrombocytopenia without circulating antibodies.
Enoksaparinnatrij se mora primjenjivati uz osobit oprez u bolesnika koji u anamnezi (> 100 dana)
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 (i pridružena imena) 2000 IU (20 mg)/0,2 ml otopina za injekciju LOVENOX (i pridružena imena) 4000 IU (40 mg)/0,4 ml otopina za injekciju LOVENOX (i pridružena imena) 6000 IU (60 mg)/0,6 ml otopina za injekciju LOVENOX (i pridružena imena) 8000 IU (80 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju LOVENOX (i pridružena imena) 30 000 IU (300 mg)/3 ml otopina za injekciju LOVENOX (i pridružena imena) 50 000 IU (500 mg)/5 ml otopina za injekciju LOVENOX (i pridružena imena) 100 000 IU (1000 mg)/10 ml otopina za injekciju LOVENOX (i pridružena imena) 12 000 IU (120 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 15 000 IU (150 mg)/1 ml otopina za injekciju
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]
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA LOVENOX (i pridružena imena) 10 000 IU (100 mg)/10 ml otopina za injekciju
PE, treatment of unstable angina and NSTEMI, enoxaparin sodium is administered by SC
• Za liječenje nestabilne angine i NSTEMI-ja, preporučena doza enoksaparinnatrija je 100 IU/kg
Immuno-allergic thrombocytopeni a
trombocitoza β, trombocitopenija
Prevention of thrombus formation during haemodialysis The recommended dose is 100 IU/kg (1 mg/kg) of enoxaparin sodium.
Preporučena doza je 100 IU/kg (1 mg/kg) enoksaparinnatrija.
• LOVENOX (and associated names) can be given by injection into your vein (intravenous) after certain types of heart attack or operation.
• Nakon određenih vrsta srčanog udara ili operacija, LOVENOX (i pridružena imena) se može primijeniti injekcijom u venu (intravenski). • LOVENOX (i pridružena imena) se može dodati u cijev koja izlazi iz tijela (arterijsku liniju) na početku dijalize.
PHARMACEUTICAL FORM AND CONTENTS Solution for injection [to be completed nationally]
OBLIK I SADRŽAJ Otopina za injekciju
• For the prophylaxis of venous thrombo-embolic disease following surgery, treatment of DVT and
• Produljena profilaksa venske tromboembolije (VTE) nakon ortopedskog kirurškog zahvata
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PEN
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE BRIZGALICA
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
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju
• Prednisolone, dexamethasone or other medicines used to treat asthma, rheumatoid arthritis and other conditions
a koriste se za liječenje boli i oticanja kod artritisa i drugih bolesti • prednizolon, deksametazon ili druge lijekove koji se koriste za liječenje astme, reumatoidnog artritisa i drugih stanja • lijekove koji povisuju razinu kalija u krvi, kao što su soli kalija, tablete za izmokravanje
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
U kliničkim ispitivanjima primjene za liječenje nestabilne angine i infarkta miokarda bez Q-zupca, doza je iznosila 100 IU/kg
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 (i pridružena imena) 2000 IU (20 mg)/0,2 ml otopina za injekciju LOVENOX (i pridružena imena) 4000 IU (40 mg)/0,4 ml otopina za injekciju LOVENOX (i pridružena imena) 6000 IU (60 mg)/0,6 ml otopina za injekciju LOVENOX (i pridružena imena) 8000 IU (80 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju LOVENOX (i pridružena imena) 12 000 IU (120 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 15 000 IU (150 mg)/1 ml otopina za injekciju
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
NAZIV LIJEKA LOVENOX (i pridružena imena) 10 000 IU (100 mg)/10 ml otopina za injekciju
Intracranial haemorrhage,
Ako se provodi ručna kompresija,
Overall list of possible side effects: Very common ( may affect more than 1 in 10 people)
Vrlo česte (mogu se javiti u više od 1 na 10 osoba)
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 (i pridružena imena) 2000 IU (20 mg)/0,2 ml otopina za injekciju LOVENOX (i pridružena imena) 4000 IU (40 mg)/0,4 ml otopina za injekciju LOVENOX (i pridružena imena) 6000 IU (60 mg)/0,6 ml otopina za injekciju LOVENOX (i pridružena imena) 8000 IU (80 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju LOVENOX (i pridružena imena) 12 000 IU (120 mg)/0,8 ml otopina za injekciju LOVENOX (i pridružena imena) 15 000 IU (150 mg)/1 ml otopina za injekciju enoksaparin
All patients also received warfarin sodium (dose adjusted according to prothrombin time to achieve an International Normalized Ratio (INR) of 2.0 to 3.0), commencing within 72 hours of initiation of enoxaparin sodium or standard heparin therapy, and continuing for 90 days.
Svi su bolesnici primali i varfarinnatrij (doza se prilagođavala prema protrombinskom vremenu radi postizanja internacionalnog normaliziranog omjera (engl. international normalized ratio, INR) od
Tabulated summary list of adverse reactions
Tablični prikaz nuspojava
Enoxaparin sodium pharmacokinetics appeared similar than control population, after a single 25 IU, 50 IU or 100 IU/kg (0.25, 0.50 or 1.0 mg/kg) IV dose however, AUC was two-fold higher than control.
Nakon jednokratne intravenske doze od 25 IU (0,25 mg/kg), 50 IU (0,50 mg/kg) ili 100 IU/kg
Skin necrosis and cutaneous vasculitis have been reported with LMWHs and should lead to prompt treatment discontinuation.
• Nekroza kože / kožni vaskulitis Kod primjene heparina niske molekulske mase prijavljeni su nekroza kože i kožni vaskulitis, koji zahtijevaju trenutačan prekid liječenja.
Although no dose adjustment is recommended in patients with moderate (creatinine clearance 3050 mL/min) and mild (creatinine clearance 50-80 mL/min) renal impairment, careful clinical monitoring is advised.
30 - 50 ml/min) i blagim (klirens kreatinina: 50 - 80 ml/min) oštećenjem bubrežne funkcije,
These are more likely to appear in the area you have been injected with LOVENOX (and associated names).
Moguće nuspojave Kako čuvati LOVENOX (i pridružena imena)
In order to assure the accuracy of the small volume to be injected, it is recommended to dilute the drug to 300 IU/mL (3 mg/mL).
Da bi se osigurala točnost malog volumena koji treba injicirati, preporučuje se razrijediti lijek do
One vial contains enoxaparin sodium 10,000 IU anti-Xa activity (equivalent to 100 mg) in 10 mL water for injections.
KVALITATIVNI I KVANTITATIVNI SASTAV Jedna bočica sadrži 10 000 IU anti-Xa aktivnosti enoksaparinnatrija (što odgovara 100 mg) u 10 ml vode za injekcije.
LOVENOX (and associated names) 10,000 IU (100 mg)/10 mL solution for injection [See Annex I - To be completed nationally]
NAZIV LIJEKA LOVENOX (i pridružena imena) 10 000 IU (100 mg)/1 ml otopina za injekciju
LOVENOX (and associated names) can be used for two different types of heart attack called STEMI (ST segment elevation myocardial infarction) or Non-STEMI (NSTEMI).
ST-segment elevation myocardial infarction, STEMI) ili infarkt miokarda bez elevacije ST-segmenta (engl. non-ST segment elevation myocardial infarction, NSTEMI).
The tablet should be swallowed whole with a little water.
Tabletu treba progutati cijelu uz malo vode.
The usual dose of Tandemact is one tablet once a day, taken just before or with the first meal of the day.
Uobičajena doza lijeka Tandemact je jedna tableta na dan, neposredno prije ili tijekom prvog dnevnog obroka.
The full EPAR for Tandemact can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Cjeloviti EPAR za lijek Tandemact nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Other information about Tandemact
Ostale informacije o lijeku Tandemact
The patients' HbA1c levels fell from a baseline of over 7.5% by between 1.22 and 1.64%.
Razina HbA1c u bolesnika pala je s osnovne vrijednosti od preko 7,5 % na 1,22 % do 1,64 %.
The European Commission granted a marketing authorisation valid throughout the EU for Tandemact on 8 January 2007.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Tandemact na snazi u Europskoj uniji od 8. siječnja 2007.
What measures are being taken to ensure the safe and effective use of Tandemact?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Tandemact?
Because pioglitazone has been approved in the European Union (EU) since 2000 under the name Actos, and glimepiride is already used in authorised medicines in the EU, the company presented data obtained in earlier studies and from the published literature.
Budući da je pioglitazon od 2000. odobren u EU-u pod nazivom Actos, a glimepirid se već koristi u odobrenim lijekovima u EU-u, tvrtka je predočila podatke iz ranijih ispitivanja i iz objavljene literature.
Tandemact pioglitazone and glimepiride
Tandemact pioglitazon i glimepirid
It is available as tablets (30 mg pioglitazone and 2 or 4 mg glimepiride, or 45 mg pioglitazone and 4 mg glimepiride).
Dostupan je u obliku tableta (30 mg pioglitazona i 2 ili 4 mg glimepirida, ili 45 mg pioglitazona i 4 mg glimepirida).
This is a summary of the European public assessment report (EPAR) for Tandemact.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Tandemact.
The company provided evidence that the levels of the active substances in the blood were the same in people taking Tandemact and people taking the separate tablets.
Tvrtka je predočila dokaze da su razine djelatnih tvari u krvi bile iste kod ljudi koji su uzimali lijek Tandemact i ljudi koji su uzimali zasebne tablete.
Tandemact contains two active substances, each of which has a different mode of action.
Lijek Tandemact sadrži dvije djelatne tvari, a svaka od njih djeluje na drugačiji način.
The most common side effects with Tandemact (seen in between 1 and 10 patients in 100) are upper respiratory tract infections (such as colds), hypoaesthesia (reduced sense of touch), bone fractures, weight gain, dizziness, flatulence (gas) and oedema (swelling).
Najčešće nuspojave pri uzimanju lijeka Tandemact (zabilježene u između 1 i 10 na 100 bolesnika) jesu infekcija gornjeg respiratornog trakta (poput prehlade), hipoestezija (smanjen osjet dodira), prijelomi kostiju, povećanje tjelesne težine, omaglica, flatulencija (nakupljanje plinova) i edem (oticanje).
For more information about treatment with Tandemact, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Tandemact pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svojem liječniku ili ljekarniku.
At least 64% of the patients treated were classified as ‘responders', since their HbA1c levels either fell by at least 0.6% from the baseline value over the course of the studies, or their HbA1c levels were 6.1% or less at the end of the studies.
Najmanje 64 % liječenih bolesnika svrstani su u skupinu koja je pozitivno odgovorila na lijek jer im je razina HbA1c tijekom ispitivanja pala s osnovne vrijednosti za najmanje 0,6 % ili im je razina HbA1c na kraju ispitivanja bila 6,1 % ili manja.
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 Tandemact.
Objašnjava kako je Odbor za lijekove za humanu uporabu (CHMP) ocijenio lijek da bi donio svoje mišljenje u korist izdavanja odobrenja za stavljanje lijeka u promet te preporuke o uvjetima za primjenu lijeka Tandemact.
Tandemact is a medicine that contains two active substances, pioglitazone and glimepiride.
Tandemact je lijek koji sadrži dvije djelatne tvari, pioglitazon i glimepirid.
Patients who are receiving pioglitazone together with another medicine in the same class as glimepiride (i.e. another sulphonylurea) should first be switched from this other sulphonylurea to glimepiride before they can transfer to Tandemact.
Bolesnici koji dobivaju pioglitazon zajedno s drugim lijekom istog razreda kao što je glimepirid (tj. drugom sulfonilurejom) trebali bi se prvo prebaciti s te druge sulfonilureje na glimepirid prije no što mogu početi uzimati Tandemact.
The CHMP concluded that the effectiveness of pioglitazone and glimepiride in type 2 diabetes had been shown, and that Tandemact simplifies treatment and improves the ability of patients to stick to their treatment when a combination of the two active substances is needed.
CHMP je zaključio da je utvrđena djelotvornost pioglitazona i glimepirida u liječenju dijabetesa tipa 2 te da lijek Tandemact pojednostavljuje liječenje i poboljšava sposobnost bolesnika da se pridržavaju liječenja kada je potrebna kombinacija tih dviju djelatnih tvari.
The studies lasted between four months and two years and measured the level of a substance in the blood called glycosylated haemoglobin (HbA1c), which gives an indication of how well the blood glucose is controlled.
Ispitivanja su trajala između četiri mjeseca i dvije godine i mjerila su koncentraciju tvari u krvi naziva glikozilirani hemoglobin (HbA1c), koja ukazuje na to koliko se uspješno kontrolira glukoza u krvi.
The company that markets Tandemact will produce educational material for doctors prescribing the medicine, which will cover the possible risk of heart failure and bladder cancer with treatments that contain pioglitazone, the criteria for selecting patients and the need to review treatment regularly and stop treatment if patients are no longer benefiting.
Tvrtka koja lijek Tandemact stavlja u promet osigurat će edukativni materijal za liječnike koji propisuju taj lijek, a koji će obuhvaćati informacije o mogućem riziku od srčanog zastoja i raka mjehura u liječenjima koja sadrže pioglitazon, kriterijima za odabir bolesnika te potrebi za redovitim procjenjivanjem liječenja i njegovim prekidom ako bolesnici od njega više nemaju koristi.
It must also not be used in patients who have or have had bladder cancer or those with blood in the urine that has not yet been investigated.
Također se ne smije primjenjivati u bolesnika koji imaju ili su imali rak mjehura ili u bolesnika koji imaju krv u mokraći koja još nije ispitana.
What is the risk associated with Tandemact?
Koji su rizici povezani s lijekom Tandemact?
Pioglitazone makes cells (fat, muscle and liver) more sensitive to insulin, which means that the body makes better use of the insulin it produces.
Pioglitazon čini stanice (masti, mišića i jetre) osjetljivijima na inzulin što znači da tijelo u većoj mjeri koristi inzulin koji proizvodi.
Tandemact is used to treat adult patients who have type 2 diabetes.
Tandemact se koristi za liječenje odraslih bolesnika koji imaju dijabetes tipa
The studies included 1,390 patients who added pioglitazone to their existing treatment with a sulphonylurea.
U ispitivanja je bilo uključeno 1 390 bolesnika kojima je pioglitazon dodan postojećem liječenju sulfonilurejom.
It is used in patients for whom metformin (a type of diabetes medicine) is not suitable and who are already being treated with a combination of tablets containing the two active substances pioglitazone and glimepiride.
Koristi se u bolesnika za koje metformin (vrsta lijeka protiv dijabetesa) nije prikladan, a koji se već liječe kombinacijom tableta koje sadrže djelatne tvari pioglitazon i glimepirid.
As a result of the action of both active substances, the blood glucose level is reduced and this helps to control type 2 diabetes.
Kao rezultat djelovanja obiju djelatnih tvari, smanjuje se razina glukoze u krvi što pomaže u kontroli dijabetesa tipa 2.
Glimepiride is a sulphonylurea: it stimulates the pancreas to produce more insulin.
Glimepirid je sulfonilureja: on potiče gušteraču da proizvodi više inzulina.
Treatment with Tandemact should be reviewed after three to six months, and discontinued in patients who are not deriving sufficient benefit.
Nakon tri do šest mjeseci liječenja potrebno je procijeniti učinke terapije lijekom Tandemact i prekinuti liječenje u bolesnika kod kojih nisu vidljive dostatne koristi.
It must not be used in patients with type 1 diabetes, patients who have complications of diabetes (diabetic ketoacidosis or diabetic coma), or women who are pregnant or breastfeeding.
Ne smije se primjenjivati u bolesnika koji imaju dijabetes tipa 1, bolesnika koji imaju komplikacije dijabetesa (dijabetičku ketoacidozu ili dijabetičku komu) niti u trudnica ili dojilja.
The Committee decided that Tandemact's benefits are greater than its risks and recommended that it be given marketing authorisation.
Odbor je odlučio da koristi lijeka Tandemact nadmašuju s njim povezane rizike te je preporučio izdavanje odobrenja za stavljanje lijeka u promet.
Patients who experience hypoglycaemia (low blood sugar levels) while taking Tandemact may need to use a lower dose of the medicine or to return to using separate tablets.
Bolesnici koji za vrijeme primjene Tandemacta dobiju hipoglikemiju (nisku razinu šećera u krvi), možda će morati smanjiti dozu lijeka ili se vratiti na primjenu zasebnih tableta.
Why has Tandemact been approved?
Zašto je Tandemact odobren?
Actos is approved for use with a sulphonylurea in type 2 diabetes patients who are not satisfactorily controlled on metformin alone.
Actos je odobren za primjenu sa sulfonilurejom u bolesnika koji imaju dijabetes tipa 2 u kojih se ne može postići zadovoljavajuća kontrola samo metforminom.
What is Tandemact?
Što je Tandemact?
These studies used pioglitazone and sulphonylureas given as separate tablets.
U tim su ispitivanjima pioglitazon i sulfonilureja primjenjivani u zasebnim tabletama.
For the full list of all side effects reported with Tandemact, see the package leaflet.
Potpuni popis svih nuspojava zabilježenih pri primjeni lijeka Tandemact potražite u uputi o lijeku.
Tandemact must not be used in patients who have heart failure, problems with their liver or severe problems with their kidneys.
Lijek Tandemact ne smije se primjenjivati u bolesnika sa zatajenjem srca ili u bolesnika koji imaju probleme s jetrom ili teške probleme s bubrezima.