natgillin/translations-raw huggingface dataset:
Preclinical data for metformin reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, toxicity to reproduction.
Neklinički podaci za metformin ne ukazuju na poseban rizik za ljude na temelju konvencionalnih ispitivanja sigurnosne farmakologije, toksičnosti ponovljenih doza, genotoksičnosti, kancerogenosti i reproduktivne toksičnosti.
If you stop taking Competact
Ako prestanete uzimati Competact,
Competact should not be used during pregnancy.
Competact se ne smije primjenjivati tijekom trudnoće.
Both pioglitazone and metformin have been shown to be present in the milk of lactating rats.
Pokazalo se da su i pioglitazon i metformin prisutni u mlijeku ženki štakora tijekom laktacije.
Blurred vision due to swelling (or fluid) at the back of the eye (macular oedema) has been reported (frequency cannot be estimated from available data).
Zabilježen je zamagljen vid zbog oticanja (ili nakupljanja tekućine) u stražnjem segmentu oka (makularni edem) (učestalost se ne može procijeniti iz dostupnih podataka).
The recommended dose of Competact is 30 mg/day pioglitazone plus 1,700 mg/day of metformin hydrochloride (this dose is achievable with one tablet of Competact 15 mg/850 mg, taken twice a day).
Preporučena doza lijeka Competact je 30 mg pioglitazona na dan plus 1700 mg metforminklorida na dan (ova se doza može postići jednom tabletom lijeka Competact 15 mg/850 mg, koja se uzima dvaput na dan).
These findings were observed across species at plasma concentrations ≤ 4 times the clinical exposure.
Ovi su nalazi opaženi u svih životinjskih vrsta kod koncentracije u plazmi koja je ≤ 4 puta veća od izloženosti kod kliničke primjene.
common common macular oedema not known not known
često često makularni edem nepoznato nepoznato
At two years, glycaemic control (defined as HbA1c < 8.0%) was sustained in 69% of patients treated with pioglitazone, compared with 50% of patients on gliclazide.
Nakon dvije godine, kontrola glikemije (definirane kao HbA1c <8,0%) bila je održana u 69% bolesnika liječenih pioglitazonom u usporedbi s 50% bolesnika liječenih gliklazidom.
4 Gastrointestinal disorders occur most frequently during initiation of therapy and resolve spontaneously in most cases.
4 Poremećaji probavnog sustava češće nastaju u početku liječenja i u većine se slučajeva spontano povlače.
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EU/1/06/354/001 14 tableta EU/1/06/354/002 28 tableta EU/1/06/354/003 30 tableta EU/1/06/354/004 50 tableta EU/1/06/354/005 56 tableta EU/1/06/354/006 60 tableta EU/1/06/354/007 90 tableta EU/1/06/354/008 98 tableta EU/1/06/354/010 112 tableta EU/1/06/354/009 180 tableta EU/1/06/354/012 60 x 1 tableta
A large overdose of metformin (or coexisting risks of lactic acidosis) may lead to lactic acidosis which is a medical emergency and must be treated in hospital.
Teško predoziranje metforminom (ili istovremeno prisutnim rizikom od laktacidoze) može dovesti do laktacidoze, koja je hitno medicinsko stanje i mora se liječiti u bolnici.
If you need to have major surgery you must stop taking Competact during and for some time after the procedure.
Ako se morate podvrgnuti velikom kirurškom zahvatu, morate prestati uzimati lijek Competact tijekom i još neko vrijeme nakon zahvata.
Stop taking Competact and contact a doctor or the nearest hospital immediately if you experience some of the symptoms of lactic acidosis, as this condition may lead to coma.
Prestanite uzimati Competact i odmah se obratite liječniku ili otiđite u najbližu bolnicu ako osjetite neke od simptoma laktacidoze, jer to stanje može dovesti do kome.
However, the incidence of oedema, weight gain and heart failure were increased.
Ipak, incidencija edema, porasta tjelesne težine i zatajenja srca je bila povećana.
Multipack of 196 (2 packs of 98) tablets and aluminium/aluminium perforated unit dose blisters in pack of 60 x 1 tablets.
Višestruko pakiranje od 196 (2 pakiranja od 98) tableta i aluminij/aluminij perforirani blisteri djeljivi na jedinične doze u pakiranju od 60 x 1 tablete.
Skin and subcutaneous tissue disorders erythema very rare very rare pruritis very rare very rare urticaria very rare very rare
Poremećai kože i potkožnog tkiva eritem vrlo rijetko vrlo rijetko pruritis vrlo rijetko vrlo rijetko urtikarija vrlo rijetko vrlo rijetko
Broken bones have been reported commonly (may affect up to 1 in 10 people) in female patients taking Competact and have also been reported in male patients (frequency cannot be estimated from the available data) taking Competact.
Prijelomi kostiju su često prijavljivani (mogu se pojaviti u do 1 na 10 osoba) u žena koje su uzimale Competact, a također su prijavljivani i u muškaraca (učestalost se ne može procijeniti iz dostupnih podataka) koji su uzimali Competact.
Although the study failed regarding its primary endpoint, which was a composite of all-cause mortality, non-fatal myocardial infarction, stroke, acute coronary syndrome, major leg amputation, coronary revascularisation and leg revascularisation, the results suggest that there are no long-term cardiovascular concerns regarding use of pioglitazone.
Iako studija nije uspjela u pogledu njene primarne mjere ishoda, koja je bila kompozitna mjera sastavljena od mortaliteta svih uzroka; ne-fatalnog infarkta miokarda, moždanog udara, akutnog koronarnog sindroma, amputacije noge, koronarne revaskularizacije i revaskularizacije noge, rezultati ukazuju da nema kardiovaskularne opasnosti pri dugotrajnoj primjeni pioglitazona.
The following statements reflect the pharmacokinetic properties of the individual active substances of Competact.
Sljedeće tvrdnje odnose se na farmakokinetička svojstva pojedine djelatne tvari u lijeku Competact.
- if you are allergic to pioglitazone, metformin or any of the other ingredients of this medicine (listed in section 6).
- ako ste alergični na pioglitazon, metformin ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.). - ako imate ili ste ranije imali zatajenje srca.
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); not known (cannot be estimated from the available data).
< 1/100); rijetko (≥ 1/10000 i < 1/1000); vrlo rijetko (< 1/10000); nepoznato (ne može se procijeniti iz dostupnih podataka).
Bioequivalence studies in healthy volunteers have shown Competact to be bioequivalent to the administration of pioglitazone and metformin given as separate tablets.
Ispitivanja bioekvivalencije u zdravih dobrovoljaca pokazala su da je Competact bioekvivalentan primjeni pioglitazona i metformina kad se daju kao zasebne tablete.
- The other ingredients are microcrystalline cellulose, povidone (K30), croscarmellose sodium magnesium stearate, hypromellose, macrogol 8000, talc and titanium dioxide (E171).
- Drugi sastojci su mikrokristalična celuloza, povidon (K 30), umrežena karmelozanatrij, magnezijev stearat, hipromeloza, makrogol 8000, talk i titanijev dioksid (E171).
If this happens you must stop taking Competact and contact a doctor or the nearest hospital immediately, as lactic acidosis may lead to coma.
Ako Vam se to dogodi, morate prestati uzimati lijek Competact i odmah se obratiti liječniku ili otići u najbližu bolnicu, jer laktacidoza može dovesti do kome.
Avoid excessive alcohol intake while taking Competact since this may increase the risk of lactic acidosis (see section “Risk of lactic acidosis”).
Izbjegavajte prekomjerni unos alkohola dok uzimate lijek Competact jer to može povećati rizik od laktacidoze (vidjeti dio “Rizik od laktacidoze”).
An increased incidence in bone fractures in women was seen in a pooled analysis of adverse reactions of bone fracture from randomised, controlled, double blind clinical trials (see section 4.8)
Povećana incidencija prijeloma kostiju u žena opažena je u analizi objedinjenih podataka o prijelomima kostiju kao nuspojava u randomiziranim, kontroliranim, dvostruko slijepim kliničkim ispitivanjima (vidjeti dio 4.8).
As metformin is excreted via the kidney, and elderly patients have a tendency to decreased renal function, elderly patients taking Competact should have their renal function monitored regularly (see sections 4.3 and 4.4).
Budući da se metformin izlučuje putem bubrega, a funkcija bubrega u starijih bolesnika može biti smanjena, potrebno je redovito provjeravati funkciju bubrega u starijih bolesnika koji uzimaju Competact (vidjeti dijelove 4.3 i 4.4).
In combination trials pioglitazone added to metformin resulted in mean weight increase over one year of 1.5 kg.
U kombiniranim ispitivanjima dodavanje pioglitazona metforminu rezultiralo je prosječnim povećanjem tjelesne težine tijekom jedne godine za 1,5 kg.
Date of first authorisation: 28/07/2006 Date of latest renewal: 25/04/2016
Datum prvog odobrenja: 28.07.2006.
This study showed an increase in reports of heart failure; however this did not lead to an increase in mortality in this study.
U ovom je ispitivanju zabilježen povećani broj slučajeva zatajenja srca; ali bez povećanja smrtnosti.
If a patient wishes to become pregnant, treatment with Competact should be discontinued.
Ako bolesnica želi zatrudnjeti, liječenje lijekom Competact treba prekinuti.
If you have taken more Competact that you should have, you may experience lactic acidosis (see section “Risk of lactic acidosis”).
Ako uzmete više lijeka Competact nego što ste trebali možete iskusiti laktacidozu (vidjeti dio “Rizik od laktacidoze”).
Following initiation of therapy with Competact, it is recommended that liver enzymes be monitored periodically according to clinical judgement.
Nakon početka terapije lijekom Competact preporučuje se povremeno određivati jetrene enzime na temelju kliničke procjene.
comprising 2 packs, each containing 98 film-coated tablets.
Sastavni dio višestrukog pakiranja koje se sastoji od 2 pakiranja, od kojih svako sadrži 98 filmom obloženih tableta.
Competact is indicated as second line treatment of type 2 diabetes mellitus adult patients, particularly overweight patients, who are unable to achieve sufficient glycaemic control at their maximally tolerated dose of oral metformin alone.
Competact je indiciran kao druga linija liječenja šećerne bolesti tipa 2 u odraslih bolesnika, osobito onih s prekomjernom tjelesnom težinom, koji ne mogu postići zadovoljavajuću kontrolu glikemije samo peroralnim metforminom u najvišim podnošljivim dozama.
No animal studies have been conducted with the combined products in Competact.
Nisu provedena ispitivanja na životinjama kombinacije lijekova u lijeku Competact.
A clinical trial of pioglitazone vs. gliclazide as monotherapy was extended to two years in order to assess time to treatment failure (defined as appearance of HbA1c ≥ 8.0% after the first six months of therapy).
Kliničko ispitivanje pioglitazona u usporedbi s gliklazidom u obliku monoterapije bilo je produženo na dvije godine kako bi se procijenilo vrijeme do neuspjeha liječenja (definirano kao vrijednosti HbA1c ≥ 8,0% nakon prvih šest mjeseci terapije).
Competact combines two antihyperglycaemic active substances with complementary mechanisms of action to improve glycaemic control in patients with type 2 diabetes mellitus: pioglitazone, a member of the thiazolidinedione class and metformin hydrochloride, a member of the biguanide class.
Competact je kombinacija dvije antihiperglikemijske djelatne tvari s komplementarnim mehanizmom djelovanja koje poboljšavaju kontrolu glikemije u bolesnika sa šećernom bolešću tipa 2: pioglitazonom iz klase tiazolidindiona i metforminkloridom iz klase bigvanida.
After 24 weeks of treatment, the primary endpoint of mean change from baseline in HbA1c was -1.83% in the combination group versus -0.96% in the pioglitazone group (p< 0.0001) and -0.99% in the metformin group (p< 0.0001).
Nakon 24 tjedna liječenja, primarni ishod bila je prosječna promjena u odnosu na početnu vrijednost HbA1c i iznosila je -1,83% u skupini koja je primala kombinaciju nasuprot -0,96% u skupini koja je primala pioglitazon (p< 0,0001) i -0,99% u skupini koja je primala metformin (p< 0,0001).
Competact may cause a very rare (may affect up to 1 in 10,000), but very serious side effect called lactic acidosis (see section “Risk of lactic acidosis”).
Competact može uzrokovati vrlo rijetku (može se javiti u manje od 1 korisnika na 10 000), ali vrlo ozbiljnu nuspojavu koja se naziva laktacidoza (vidjeti dio “Rizik od laktacidoze”).
How to take Competact
Kako čuvati Competact
- by reduction of hepatic glucose production by inhibiting gluconeogenesis and glycogenolysis - in muscle, by modestly increasing insulin sensitivity, improving peripheral glucose uptake and utilisation - by delaying intestinal glucose absorption.
- smanjenjem sinteze glukoze u jetri inhibicijom glukoneogeneze i glikogenolize - u mišićima, umjerenim povećavanjem osjetljivosti na inzulin, poboljšava periferni unos i iskorištenje glukoze - usporavanjem intestinalne apsorpcije glukoze.
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EU/1/06/354/006 EU/1/06/354/007 EU/1/06/354/008 EU/1/06/354/009 EU/1/06/354/010 EU/1/06/354/011 EU/1/06/354/012
Since insulin and pioglitazone are both associated with fluid retention, concomitant administration of insulin and Competact may increase the risk of oedema.
Budući da se i inzulin i pioglitazon povezuju sa zadržavanjem tekućine, istovremena primjena inzulina i lijeka Competact može povećati rizik od edema.
Patients receiving pioglitazone in dual oral therapy with a sulphonylurea may be at risk for dose-related hypoglycaemia, and a reduction in the dose of the sulphonylurea may be necessary.
U bolesnika koji u sklopu dvostruke peroralne terapije primaju pioglitazon sa sulfonilurejom može postojati rizik od hipoglikemije povezane s dozom pa može biti potrebno sniziti dozu sulfonilureje.
Competact should not be used in patients with hepatic impairment (see sections 4.3 and 4.4).
Competact se ne smije primjenjivati u bolesnika s oštećenjem funkcije jetre (vidjeti dijelove 4.3 i 4.4).
Cases of bladder cancer were reported more frequently in a meta-analysis of controlled clinical trials with pioglitazone (19 cases from 12,506 patients, 0.15%) than in control groups (7 cases from 10,212 patients, 0.07%) HR=2.64 (95% CI 1.11-6.31, p=0.029).
U meta-analizi kontroliranih kliničkih ispitivanja, slučajevi karcinoma mokraćnog mjehura češće su zabilježeni u skupinama koje su primale pioglitazon (19 slučajeva na 12 506 bolesnika, 0,15%) nego u kontrolnim skupinama (7 slučajeva na 10 212 bolesnika, 0,07%) HR = 2,64 (95% CI 1,11-6,31,
For Competact no preclinical or clinical data on exposed pregnancies or lactation are available.
Nema dostupnih pretkliničkih ili kliničkih podataka o izloženosti lijeku Competact tijekom trudnoće ili dojenja.
Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked.
Obavijestite svog liječnika čim prije ako razvijete simptome koji ukazuju na tegobe s jetrom (poput neobjašnjive mučnine, povraćanja, boli u trbuhu, umora, gubitka apetita i/ili tamne mokraće), jer tada treba provjeriti funkciju jetre.
Liver enzymes should be checked prior to the initiation of therapy with Competact in all patients.
Jetrene enzime treba provjeriti u svih bolesnika prije početka liječenja lijekom Competact.
Competact should be used every day to work properly.
Da bi Competact valjano djelovao, treba ga uzimati svaki dan.
112 tablets
112 tableta
Hepatobiliary disorders hepatitis5
Poremećaji jetre i žuči hepatitis5
Pioglitazone
Pioglitazona
If ALT levels are increased to 3 x upper limit of normal during Competact therapy, liver enzyme levels should be reassessed as soon as possible.
Ako se tijekom terapije lijekom Competact vrijednosti ALT povise na vrijednosti koje su 3 puta više od gornje granice normale, razine jetrenih enzima treba čim prije ponovno provjeriti.
6 A pooled analysis was conducted of adverse reactions of bone fractures from randomised, comparator controlled, double blind clinical trials in over 8,100 patients in the pioglitazone-treated groups and 7,400 in the comparator-treated groups of up to 3.5 years duration.
6 Provedena je analiza objedinjenih podataka o prijelomima kostiju kao nuspojavi u randomiziranim, dvostruko slijepim kliničkim ispitivanjima kontroliranima komparatorom u više od 8100 bolesnika liječenih pioglitazonom i 7400 bolesnika liječenih komparatorima u trajanju do najviše 3,5 godine.
A study conducted in seven normal healthy volunteers showed that cimetidine, administered as 400 mg twice daily, increased metformin systemic exposure (AUC) by 50% and Cmax by 81%.
Ispitivanje provedeno u sedam normalnih zdravih dragovoljaca pokazalo je da je cimetidin, primijenjen u dozi od 400 mg dvaput na dan, povećao sistemsku izloženost (AUC)
A cardiovascular outcome study of pioglitazone has been performed in patients under 75 years with type 2 diabetes mellitus and pre-existing major macrovascular disease.
Utjecaj pioglitazona na kardiovaskularni ishod ispitan je u bolesnika mlađih od 75 godina sa šećernom bolešću tipa 2 i postojećom teškom makrovaskularnom bolešću.
- Acute conditions with the potential to alter renal function such as: Dehydration Severe infection Shock - Intravascular administration of iodinated contrast agents (see section 4.4) - Breast-feeding (see section 4.6)
- akutna stanja koja mogu promijeniti funkciju bubrega kao što su: - dehidracija - teška infekcija - šok - intravaskularna primjena kontrastnih sredstava s jodom (vidjeti dio 4.4) - dojenje (vidjeti dio 4.6)
Interaction studies have shown that pioglitazone has no relevant effect on either the pharmacokinetics or pharmacodynamics of digoxin, warfarin, phenprocoumon and metformin.
Ispitivanja interakcija pokazala su da pioglitazon nema važnih učinaka niti na farmakokinetiku niti na farmakodinamiku digoksina, varfarina, fenoprokumona i metformina.
Clinical trials have been conducted with Competact tablets and co-administered pioglitazone and metformin (see section 5.1).
Sažetak sigurnosnog profila Klinička ispitivanja provedena su s tabletama Competact i istovremeno primijenjenima pioglitazonom i metforminom (vidjeti dio 5.1).
When clinically appropriate, direct change from metformin monotherapy to Competact may be considered.
U klinički opravdanim slučajevima može se razmotriti izravna zamjena monoterapije metforminom s lijekom Competact.
- you must tell your doctor if you are pregnant, think you may be pregnant or are planning to have a baby.
Ako ste trudni, mislite da biste mogli biti trudni ili planirate imati dijete, morate o tome obavijestiti svog liječnika.
In one year clinical trials, pioglitazone consistently gave a statistically significant reduction in the albumin/creatinine ratio compared to baseline.
U kliničkim ispitivanjima u trajanju od jedne godine, pioglitazon je dosljedno izazivao statistički značajno sniženje omjera albumina i kreatinina u usporedbi s početnim vrijednostima.
In light of age- related risks (especially bladder cancer, fractures and heart failure), the balance of benefits and risks should be considered carefully both before and during treatment in the elderly.
Kod procjene rizika povezanih sa životnom dobi (osobito karcinoma mokraćnog mjehura, prijeloma kostiju i zatajenja srca), potrebno je pažljivo razmotriti ravnotežu između koristi i rizika kako prije,
The decision whether to continue the patient on therapy with Competact should be guided by clinical judgement pending laboratory evaluations.
Odluku o nastavku liječenja lijekom Competact treba donijeti na temelju kliničke procjene i ovisno o laboratorijskim nalazima.
Investigations weight increased8
Pretrage povećana tjelesna težina8
OTHER SPECIAL WARNING(S), IF NECESSARY EXPIRY DATE
DRUGA POSEBNA UPOZORENJA, AKO JE POTREBNO ROK VALJANOSTI
Competact contains pioglitazone and metformin.
Competact sadrži pioglitazon i metformin.
PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON (WITHOUT BLUE BOX) MULTIPACKS ONLY (98 TABLETS)
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU UNUTARNJA KUTIJA (BEZ PLAVOG OKVIRA) SAMO VIŠESTRUKA PAKIRANJA (98 TABLETA)
Post-marketing cases of peripheral oedema and cardiac failure have also been reported in patients with concomitant use of pioglitazone and nonsteroidal anti-inflammatory drugs, including selective COX-2 inhibitors.
Nakon stavljanja lijeka u promet prijavljeni su slučajevi perifernih edema i zatajenja srca kod bolesnika koji su istodobno uzimali pioglitazon s nesteroidnim protuupalnim lijekovima, uključujući i selektivne COX-2 inhibitore.
Adverse reactions reported in double-blind studies and post-marketing experience are listed below as MedDRA preferred term by system organ class and absolute frequency.
Nuspojave zabilježene u dvostruko slijepim ispitivanjima i nakon stavljanja lijeka u promet navedene su niže prema MedDRA klasifikaciji organskih sustava i apsolutnoj učestalosti.
Since there is a potential for an increase in dose-related adverse events, a decrease in the dose of pioglitazone may be needed when gemfibrozil is concomitantly administered.
Budući da postoji povećana mogućnost nuspojava povezanih s dozom, možda će trebati sniziti dozu pioglitazona kod istovremene primjene gemfibrozila.
Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
U klasifikaciji organskih sustava nuspojave su prikazane u padajućem nizu prema sve manjoj incidenciji i padajućoj ozbiljnosti.
Risk related to pioglitazone
Trudnoća Rizik povezan s pioglitazonom
The pioglitazone dose may need to be increased when rifampicin is concomitantly administered.
Dozu pioglitazona možda će trebati povisiti kod istovremene primjene rifampicina.
If you forget to take Competact
Ako ste zaboravili uzeti lijek Competact
The fixed dose combination tablet of pioglitazone 15 mg/metformin 850 mg BID (N=201), pioglitazone 15 mg BID (N=189), and metformin 850 mg BID (N=210) were evaluated in type 2 diabetes mellitus patients with mean baseline HbA1c of 9.5% in a randomised double-blind, parallel-group study.
Fiksna kombinacija pioglitazona u dozi od 15 mg i metformina u dozi od 850 mg dvaput na dan u tableti (N = 201), pioglitazon u dozi od 15 mg dvaput na dan (N = 189) i metformin u dozi od 850 mg dvaput na dan (N = 210) ispitana je u randomiziranom, dvostruko slijepom ispitivanju na usporednim skupinama bolesnika sa šećernom bolešću tipa 2 i prosječnim početnim HbA1c od 9,5%.
Women of childbearing potential / Contraception in males and females Competact is not recommended in women of childbearing potential not using contraception.
Competact se ne preporučuje u žena reproduktivne dobi koje ne koriste kontracepciju.
In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDL-cholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
U većini kliničkih ispitivanja opaženo je sniženje ukupnih triglicerida i slobodnih masnih kiselina u plazmi te povišenje razine HDL-kolesterola u usporedbi s placebom, uz malo, ali ne i klinički značajno povišenje razine
8 In active comparator controlled trials mean weight increase with pioglitazone given as monotherapy was 2-3 kg over one year.
8 U ispitivanima kontroliranima aktivnim komparatorom, prosječno povećanje tjelesne težine monoterapijom pioglitazonom iznosilo je 2-3 kg tijekom jedne godine.