FrancophonIA/ELRC3.0 huggingface dataset:
English: To minimise this risk, physicians should be advised that for coagulation levels testing it is recommended to draw blood samples near the time of Daptomycin Hospira trough plasma concentration.
Croatian: Kako bi se smanjio rizik od pogrešnih rezultata, potrebno je savjetovati liječnike da uzorke krvi za izvođenje testova koagulacije uzimaju približno u vrijeme kada su koncentracije lijeka Daptomicin Hospira u plazmi najniže. - kartica za doziranje treba sadržavati odgovarajuće algoritme za izračunavanje doze lijeka Daptomicin Hospira za rekonstituciju, što će pomoći u smanjenju rizika od medikacijskih pogrešaka (visoka osmolarnost, predoziranje).
English: Caution is warranted when daptomycin is co-administered with tobramycin.
Croatian: Potreban je oprez kod istodobne primjene daptomicina i tobramicina.
English: Infusion site reactions, pyrexia, asthenia
Croatian: Reakcije na mjestu primjene infuzije, vrućica, astenija
English: Safety margins for peripheral nerve effects in rats and dogs are 8- and 6-fold, respectively, based on comparison of Cmax values at the No Observed Effect Level (NOEL) with the Cmax achieved on dosing with 30-minute intravenous infusion of 6 mg/kg once daily in patients with normal renal function.
Croatian: Sigurnosne granice vezano uz učinke na periferne živce u štakora i pasa su 8 puta odnosno 6 puta veće, temeljeno na usporedbi vrijednosti Cmax za razinu pri kojoj nema uočljivih učinaka (engl.
English: • Age group 1 (n=21): 12 to 17 years treated with daptomycin dosed at 7 mg/kg or SOC comparator;
Croatian: Dobna skupina 1 (n=21): 12 do 17 godina liječeni daptomicinom u dozi od 7 mg/kg ili SOC kao komparatorom;
English: 5 mg/kg 30 minutes
Croatian: 5 mg/kg 30 minuta
English: 12 mg/kg 60 minutes
Croatian: 12 mg/kg 60 minuta
English: Daptomycin Hospira 350 mg powder for solution for injection/infusion Each vial contains 350 mg daptomycin.
Croatian: Daptomicin Hospira 350 mg prašak za otopinu za injekciju/infuziju Jedna bočica sadrži 350 mg daptomicina.
English: Comparable exposure (AUC and Cmax) was demonstrated in healthy adult subjects following administration of daptomycin as a 30-minute intravenous infusion or as a 2-minute intravenous injection.
Croatian: U zdravih je odraslih ispitanika nakon primjene daptomicina u obliku 30-minutne intravenske infuzije i 2-minutne intravenske injekcije dokazana usporediva izloženost (AUC i Cmax).
English: One vial of powder contains 350 mg daptomycin.
Croatian: Jedna bočica praška sadrži 350 mg daptomicina.
English: Daptomycin Hospira 500 mg powder for solution for injection/infusion Each vial contains 500 mg daptomycin.
Croatian: Daptomicin Hospira 500 mg prašak za otopinu za injekciju/infuziju Jedna bočica sadrži 500 mg daptomicina.
English: 10 mg/kg 60 minutes
Croatian: 10 mg/kg 60 minuta
English: • Age group 2 (n=113): 7 to 11 years treated with daptomycin dosed at 7 mg/kg or SOC;
Croatian: • Dobna skupina 2 (n=113): 7 do 11 godina liječeni daptomicinom u dozi od 7 mg/kg ili standardom skrbi
English: 7 mg/kg 30 minutes
Croatian: 7 mg/kg 30 minuta
English: Posology
Croatian: Napomene
English: Group G streptococci
Croatian: Streptokoki skupine G
English: 9 mg/kg 60 minutes
Croatian: 9 mg/kg 60 minuta
English: Use in elderly
Croatian: Primjena u starijih osoba
English: In clinical studies, 2,011 adult subjects received daptomycin.
Croatian: U kliničkim je ispitivanjima daptomicin primalo 2011 odraslih ispitanika.
English: One vial of powder contains 500mg daptomycin.
Croatian: Jedna bočica praška sadrži 500 mg daptomicina.
English: 9 mg/kg 30 minutes
Croatian: 9 mg/kg 30 minuta
English: Coagulase negative staphylococci
Croatian: Koagulaza-negativni stafilokoki
English: Renal impairment has been reported during treatment with daptomycin.
Croatian: Tijekom liječenja daptomicinom zabilježeno je oštećenje bubrega.
English: The specific cell surface component directly targeted has not been identified.
Croatian: Nije pronađena specifična struktura na površini stanice koja bi bila cilj izravnog djelovanja daptomicina.
English: Obesity In obese subjects with Body Mass Index (BMI) >40 kg/m2 but with creatinine clearance >70 ml/min, the
Croatian: Body Mass Index, BMI) > 40 kg/m2 i klirensom kreatinina > 70 ml/min, AUC0-∞ daptomicina bio je značajno povećan (u prosjeku za 42% veći) u usporedbi s kontrolnom skupinom ispitanika koji nisu bili pretili.
English: Daptomycin Hospira given as 30 or 60-minute intravenous infusion A 50 mg/ml concentration of Daptomycin Hospira for infusion is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Primjena lijeka Daptomicin Hospira kao intravenske infuzije tijekom 30 ili 60 minuta Rekonstitucijom liofiliziranog lijeka sa 7 ml otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju dobiva se lijek Daptomicin Hospira za infuziju u koncentraciji od 50 mg/ml.
English: Daptomycin Hospira given as 30 or 60-minute intravenous infusion A 50 mg/ml concentration of Daptomycin Hospira for infusion is obtained by reconstituting the lyophilised product with 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Primjena lijeka Daptomicin Hospira kao intravenske infuzije tijekom 30 ili 60 minuta Rekonstitucijom liofiliziranog lijeka sa 10 ml otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju dobiva se lijek Daptomicin Hospira za infuziju u koncentraciji od 50 mg/ml.
English: - Trembling, - Changes in heart rhythm, flushes, - Indigestion (dyspepsia), inflammation of the tongue, - Itchy rash of skin, - Muscle pain, cramping,or weakness, inflammation of the muscles (myositis), joint pain, - Kidney problems, - Inflammation and irritation of the vagina, - General pain or weakness, tiredness (fatigue), - Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactate dehydrogenase (LDH), prolonged blood clotting time or imbalance of salts, - Itchy eyes.
Croatian: Manje često: mogu se javiti u manje od 1 na 100 osoba - poremećaji krvi (npr. povećan broj krvnih pločica zvanih trombociti zbog čega se može povećati sklonost prema zgrušavanju krvi ili povišene razine nekih vrsta bijelih krvnih stanica), - smanjeni apetit, - trnci ili utrnulost ruku ili stopala, poremećaj osjeta okusa, - drhtavica, - promjene srčanog ritma, navale vrućine, - loša probava (dispepsija), upala jezika, - osip kože koji svrbi, - bol u mišićima, grčevi ili slabost mišića, upala mišića (miozitis), bol u zglobovima, - problemi s bubrezima, - upala i nadražaj rodnice, - opća bol ili slabost, umor, - nalazi krvnih pretraga koji pokazuju povišene razine šećera u krvi, kreatinina, mioglobina ili laktat dehidrogenaze (LDH) u serumu, produljeno vrijeme zgrušavanja krvi ili neravnotežu soli, - svrbež očiju.
English: 10 mg/kg once every 24 hours infused over 60 minutes
Croatian: 10 mg/kg jedanput svaka 24 sata infuzijom u trajanju od 60 minuta
English: Daptomycin Hospira 500 mg powder for solution for injection/infusion Powder for solution for injection/infusion.
Croatian: Daptomicin Hospira 500 mg prašak za otopinu za injekciju/infuziju Prašak za otopinu za injekciju/infuziju.
English: 12 mg/kg once every 24 hours infused over 60 minutes
Croatian: 12 mg/kg jedanput svaka 24 sata infuzijom u trajanju od 60 minuta
English: 7 mg/kg once every 24 hours infused over 30 minutes
Croatian: 7 mg/kg jedanput svaka 24 sata infuzijom u trajanju od 30 minuta
English: Summary of sponsor-defined clinical outcome at TOC:
Croatian: Sažetak kliničkog ishoda prema definiciji naručitelja ispitivanja kod utvrđivanja izlječenja:
English: Daptomycin Hospira 500 mg powder for solution for injection/infusion
Croatian: Daptomicin Hospira 500 mg prašak za otopinu za injekciju/infuziju
English: 9 mg/kg once every 24 hours infused over 30 minutes
Croatian: 9 mg/kg jedanput svaka 24 sata infuzijom u trajanju od 30 minuta
English: In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated with cSSTI.
Croatian: U odraslih se primjenjuje kada je bakterijemija udružena s desnostranim infektivnim endokarditisom ili s kompliciranom infekcijom kože i mekih tkiva,. dok se u pedijatrijskih bolesnika primjenjuje kada je bakterijemija udružena s kompliciranom infekcijom kože i mekih tkiva.
English: Clinically evaluable (CE)
Croatian: Klinički ocjenjiva populacija
English: Clinical Success in Paedatric SAB Daptomycin n/N (%)
Croatian: Klinički uspjeh u pedijatrijskih bolesnika s kompliciranom infekcijom kože i mekih tkiva Daptomicin n/N (%)
English: Daptomycin Hospira 500 mg powder for solution for injection/infusion daptomycin
Croatian: Daptomicin Hospira 500 mg prašak za otopinu za injekciju/infuziju daptomicin
English: Daptomycin Hospira 350 mg powder for solution for injection/infusion
Croatian: Daptomicin Hospira 350 mg prašak za otopinu za injekciju/infuziju
English: A Phase 4 study (DAP-PEDBAC-11-02) was conducted to assess safety, efficacy, and pharmacokinetics of daptomycin in paediatric patients (1 to 17 years old, inclusive) with SAB. Daptomycin pharmacokinetics inpatients in this study are summarized in Table 3.
Croatian: Pedijatrijski bolesnici s bakterijemijom izazvanom bakterijom S. aureus Ispitivanje faze 4 (DAP-PEDBAC-11-02) bilo je provedeno radi procjene sigurnosti, djelotvornosti i farmakokinetike daptomicina u pedijatrijskih bolesnika (u dobi od 1 do uključivo 17 godina) s bakterijemijom izazvanom bakterijom S. aureus.
English: 5 mg/kg once every 24 hours infused over 30 minutes
Croatian: 5 mg/kg jedanput svaka 24 sata infuzijom u trajanju od 30 minuta do 14 dana
English: Daptomycin Hospira 350 mg powder for solution for injection/infusion daptomycin
Croatian: Daptomicin Hospira 350 mg prašak za otopinu za injekciju/infuziju daptomicin
English: 9 mg/kg once every 24 hours infused over 60 minutes
Croatian: 9 mg/kg jedanput svaka 24 sata infuzijom u trajanju od 60 minuta
English: Each vial contains 500 mg daptomycin.
Croatian: Jedna bočica sadrži 500 mg daptomicina.
English: Daptomycin Hospira 350 mg powder for solution for injection/infusion Powder for solution for injection/infusion.
Croatian: Daptomicin Hospira 350 mg prašak za otopinu za injekciju/infuziju Prašak za otopinu za injekciju/infuziju.
English: A. MANUFACTURERSRESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČ(I) ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Each vial contains 350 mg daptomycin.
Croatian: Jedna bočica sadrži 350 mg daptomicina.
English: A. MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Croatian: PROIZVOĐAČI ODGOVORAN(NI) ZA PUŠTANJE SERIJE LIJEKA U PROMET
English: Draw 10 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device, then SLOWLY inject through the centre of the rubber stopper directly over the plug in the vial.
Croatian: U štrcaljku treba povući 10 ml otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju pomoću sterilne igle za prijenos od 21 G ili manjeg promjera ili pomoću uređaja bez igle, i zatim je POLAKO ubrizgati kroz središte gumenog čepa izravno u bočicu.
English: - cSSTI with concurrent SAB: daptomycin 6 mg/kg is administered once every 24 hours.
Croatian: - Komplicirane infekcije kože i mekih tkiva uz istodobnu bakterijemiju izazvanu bakterijom Staphylococcus aureus: 6 mg/kg daptomicina primjenjuje se jedanput svaka 24 sata.
English: No dosage adjustment is necessary when administering daptomycin in patients with moderate hepatic impairment.
Croatian: U bolesnika s umjerenim oštećenjem jetre nije potrebno prilagođavati dozu pri primjeni daptomicina.
English: Draw 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection into a syringe using a sterile transfer needle that is 21 gauge or smaller in diameter, or a needleless device, then SLOWLY inject through the centre of the rubber stopper directly over the product plug in the vial.
Croatian: U štrcaljku treba povući 7 ml otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju pomoću sterilne igle za prijenos od 21 G ili manjeg promjera ili pomoću uređaja bez igle, i zatim je POLAKO ubrizgati kroz središte gumenog čepa izravno u bočicu.
English: Fungal infections, urinary tract infection, candida infection Uncommon: Fungaemia Not known*: Clostridium difficile-associated diarrhoea**
Croatian: Proljev povezan s bakterijom Clostridium difficile**
English: One ml provides 50 mg of daptomycin after reconstitution with 7 ml of sodium chloride 9 mg/ml (0.9%) solution.
Croatian: Nakon rekonstitucije sa 7 ml otopine natrijevog klorida 9 mg/ml (0,9%) jedan ml sadrži 50 mg daptomicina.
English: The success rates in RIE patients are shown in the table below.
Croatian: Stope uspjeha u bolesnika s desnostranim infektivnim endokarditisom prikazane su u tablici niže.
English: One ml provides 50 mg of daptomycin after reconstitution with 10 ml of sodium chloride 9 mg/ml (0.9%) solution.
Croatian: Nakon rekonstitucije sa 10 ml otopine natrijevog klorida 9 mg/ml (0,9%) jedan ml sadrži 50 mg daptomicina.
English: RIE or cSSTI associated withSAB ≥30ml/min
Croatian: CL/wt (ml/h/kg) 12,4 (3,9)
English: • Age group 2 (n=28): 7 to 11 years treated with daptomycin dosed at 9 mg/kg or SOC;
Croatian: Dobna skupina 2 (n=28): 7 do 11 godina liječeni daptomicinom u dozi od 9 mg/kg ili SOC; Dobna skupina 3 (n=32): 1 do 6 godina liječeni daptomicinom u dozi od 12 mg/kg ili SOC.
English: Age Range
Croatian: Raspon dobi
English: Differences in Success n/N (%)
Croatian: Daptomicin Lijek usporedbe Razlike u uspjehu n/N (%)
English: A 50 mg/ml concentration of Daptomycin Hospira for injection is obtained by reconstituting the lyophilised product with 7 ml of sodium chloride 9 mg/ml (0.9%) solution for injection.
Croatian: Rekonstitucijom liofiliziranog lijeka sa 7 ml otopine natrijevog klorida 9 mg/ml (0,9%) za injekciju dobiva se lijek Daptomicin Hospira za injekciju u koncentraciji od 50 mg/ml.
English: Marketing Authorisation Holder Pfizer Europe MA EEIG Boulevard de la Plaine 17 1050 Bruxelles
Croatian: Nositelj odobrenja za stavljanje lijeka u promet Pfizer Europe MA EEIG
English: EU/1/99/122/002 Thyrogen
Croatian: Thyrogen / August 2013 / 0045 / Page 1
English: 1 vial
Croatian: Doza
English: EU Number Invented name Strength Pharmaceutical form Route of administration Packaging Content (concentration) Package size EU/1/99/122/001 Thyrogen
Croatian: (Zaštićeni ) naziv lijeka
English: 2 vials
Croatian: Proprietary and Confidential
English: 3 hours before taking the other.
Croatian: 3 sata prije uzimanja drugog.
English: After taking one of them, wait at least 2 to
Croatian: Poslije uzimanja jednog od njih pričekajte najmanje 2 do
English: • uncontrollable excessive shopping or spending.
Croatian: • nekontrolirano pretjerano kupovanje ili trošenje.
English: When Comtan is given at higher doses:
Croatian: Kad je Comtan primijenjen u visokim dozama:
English: [carton only] PC:
Croatian: [samo kutija] PC:
English: Experience with Comtan in patients under 18 years is limited.
Croatian: Iskustvo s Comtanom u bolesnika mlađih od 18 godina je ograničeno.
English: Other medicines and Comtan
Croatian: Drugi lijekovi i Comtan
English: Talk to your doctor or pharmacist before taking Comtan:
Croatian: Obratite se svom liječniku ili ljekarniku prije nego uzmete Comtan:
English: What Comtan is and what it is used for
Croatian: Što je Comtan i za što se koristi
English: • strong impulse to gamble excessively despite serious personal or family consequences.
Croatian: • snažan poriv za pretjeranim kockanjem, usprkos ozbiljnim posljedicama za Vas osobno ili za Vašu obitelj.
English: The pharmacokinetic properties of entacapone are similar in both young people and older people.
Croatian: Farmakokinetička svojstva entakapona slična su i u mladih i u starijih osoba.
English: • if you are allergic to entacapone or any of the other ingredients of this medicine (listed in section 6);
Croatian: • ako ste alergični na entakapon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.);
English: • altered or increased sexual interest and behaviour of significant concern to you or to others, for example, an increased sexual drive.
Croatian: • promijenjeno ili povećano zanimanje za spolnost i spolne odnose te ponašanje koje u značajnoj mjeri zabrinjava Vas ili druge, primjerice, pojačani seksualni nagon.
English: If you stop taking Comtan Do not stop taking Comtan unless your doctor tells you to.
Croatian: Ako prestanete uzimati Comtan Comtan nemojte prestati uzimati, osim ako Vam to ne kaže liječnik.
English: • Uncontrollable movements;
Croatian: • Nekontrolirani pokreti;
English: • Uncontrollable movements with difficulty in performing voluntary movements (dyskinesias);
Croatian: • Nekontrolirani pokreti sa teškoćama u izvođenju voljnih pokreta (diskinezije);
English: However, in an interaction study in healthy volunteers, entacapone did not change the plasma levels of S-warfarin, while the AUC for R-warfarin increased on average by 18% [CI90 11-26%].
Croatian: Međutim, u jednom ispitivanju interakcija na zdravim dobrovoljcima, entakapon nije promijenio razine Svarfarina u plazmi, dok je AUC R-varfarina porastao prosječno za 18% [CI90 11-26%].
English: See Section 4 Possible side effects for the characteristics of NMS;
Croatian: Vidjeti Dio 4 Moguće nuspojave za karakteristike NMS-a;
English: What Comtan is and what it is used for What you need to know before you take Comtan How to take Comtan
Croatian: Što je Comtan i za što se koristi Što morate znati prije nego počnete uzimati Comtan Kako uzimati Comtan
English: • Agitation;
Croatian: • Uznemirenost;
English: Date of first authorisation: 22 September 1998 Date of latest renewal: 03 September 2008
Croatian: Datum posljednje obnove odobrenja: 03. rujna 2008.
English: In doses of 1,400 to 2,000 mg per day, the following side effects are more common:
Croatian: U dozama od 1400 do 2000 mg po danu, slijedeće nuspojave su češće:
English: If this happens, you should not drive or use any tools or machines (see “Driving and using machines”).
Croatian: Ako uočite da Vam se to zbiva, ne smijete voziti niti koristiti alate i strojeve (vidjeti Upravljanje vozilima i strojevima).
English: The safety and efficacy of Comtan in children below age 18 have not been established.
Croatian: Sigurnost i djelotvornost Comtana u djece u dobi do 18 godina nisu ustanovljene.
English: There are three different pack sizes (bottles containing 30, 60, or 100 tablets).
Croatian: Postoje tri različite veličine pakiranja (bočice koje sadrže 30, 60 ili 100 tableta).
English: Therefore, the use of Comtan in children or adolescents cannot be recommended.
Croatian: Stoga se ne preporučuje primjena Comtana u djece ili adolescenata.
English: What you need to know before you take Comtan
Croatian: Što morate znati prije nego počnete uzimati Comtan
English: EU/1/98/081/001 30 film-coated tablets (glass) EU/1/98/081/002 60 film-coated tablets (glass) EU/1/98/081/003
Croatian: EU/1/98/081/001 30 filmom obloženih tableta (staklo) EU/1/98/081/002 60 filmom obloženih tableta (staklo) EU/1/98/081/003
English: Elderly (≥65 years) No dosage adjustment of entacapone is required for older people.
Croatian: Stariji (≥65 godina) Starijim osobama nije potrebno posebno prilagođavati doziranje entakapona.
English: Comtan may make it harder for you to digest iron.
Croatian: Comtan može otežati probavu željeza.
English: If you forget to take Comtan
Croatian: Ako ste zaboravili uzeti Comtan
English: Do not take Comtan
Croatian: Nemojte uzimati Comtan
English: Comtan in association with levodopa may have a major influence on the ability to drive and use machines.
Croatian: Comtan udružen s levodopom može imati velik utjecaj na sposobnost upravljanja vozilima i strojevima.
English: If you experience such effects at the start of treatment with Comtan you should contact your doctor who may decide to adjust your dosage of levodopa.
Croatian: Ako osjetite te nuspojave na početku liječenja Comtanom, trebate se obratiti svom liječniku, koji može odlučiti o prilagođavanju doziranja levodope.
English: [carton only]
Croatian: [samo kutija]
English: Do not use Comtan during pregnancy or if you are breast-feeding.
Croatian: Comtan nemojte koristiti tijekom trudnoće i dojenja.
English: Comtan 200 mg [carton only]
Croatian: Comtan 200 mg [samo kutija]
English: Neuroleptic Malignant Syndrome (NMS) is a serious but rare reaction to certain medicines, and may occur especially when Comtan and other medicines to treat Parkinson's disease are suddenly stopped or the dose is suddenly reduced.
Croatian: Neuroleptički maligni sindrom (NMS) je ozbiljna ali rijetka reakcija na neke lijekove, i može se javiti naročito kada se naglo prekine uzimanje Comtana i drugih lijekova za terapiju Parkinsonove bolesti, ili se njihova doza naglo smanji.
English: If you forget to take the Comtan tablet with your levodopa dose, you should continue the treatment by taking the next Comtan tablet with your next levodopa dose.
Croatian: Ako uz dozu levodope zaboravite uzeti Comtan, nastavite Vaše liječenje uzimanjem sljedeće Comtan tablete s Vašom sljedećom dozom levodope.
English: Comtan and iron supplements at the same time.
Croatian: Zbog toga ne uzimajte Comtan i preparate željeza u isto vrijeme.
English: Comtan has no effect on relieving the symptoms of Parkinson's disease unless taken with levodopa.
Croatian: Comtan nema učinak ublažavanja simptoma Parkinsonove bolesti ako nije uzet s levodopom.
English: Comtan taken together with levodopa may lower your blood pressure, which may make you feel light-headed or dizzy.
Croatian: Comtan uzet zajedno s levodopom može sniziti Vaš krvni tlak, zbog čega možete osjetiti laganu ošamućenost ili omaglicu.
English: • if you have ever suffered from a rare reaction to antipsychotic medicines called neuroleptic malignant syndrome (NMS).
Croatian: • ako ste bilo kada imali rijetku reakciju na antipsihotike zvanu neuroleptički maligni sindrom
English: Therefore, patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Croatian: Stoga, bolesnici s rijetkim nasljednim poremećajem nepodnošenja fruktoze, malapsorpcijom glukoze i galaktoze ili insuficijencijom sukraze-izomaltaze ne bi trebali uzimati ovaj lijek.
English: It is characterised by stiffness, muscle twitching, shaking, agitation, confusion, coma, high body temperature, increased heart rate and unstable blood pressure;
Croatian: Karakteriziran je ukočenošću, trzanjem mišića, drhtavicom, uznemirenošću, smetenošću, komom, visokom tjelesnom temperaturom, povećanom brzinom otkucaja srca i nestabilnim krvnim tlakom;
English: • discolouration of the skin, hair, beard and nails.
Croatian: • promjena boje kože, kose, brade i noktiju.
English: Uncommon (may affect up to 1 in 100 people): • Heart attack.
Croatian: Manje često (mogu se javiti u manje od 1 na 100 osoba): • Srčani udar.
English: • if you experience increasing loss of appetite, weakness, exhaustion and weight loss within a relatively short period of time, a general medical evaluation including liver function should be considered.
Croatian: • ako imate povećani gubitak apetita, slabost, iscrpljenost i gubitak tjelesne težine unutar relativno kratkog vremenskog perioda, potrebno je razmisliti o općem liječničkom pregledu,
English: The maximum recommended dose is 10 tablets per day, i.e. 2,000 mg of Comtan.
Croatian: Najveća preporučena doza je 10 tableta na dan, odnosno 2000 mg Comtana.
English: As Comtan tablets will be taken together with other levodopa medicines, please also read the package leaflets of these medicines carefully.
Croatian: S obzirom da se Comtan tablete uzimaju zajedno s lijekovima na bazi levodope, molimo da pažljivo pročitate upute o lijeku i tih drugih lijekova.
English: 30 film-coated tablets 60 film-coated tablets 100 film-coated tablets
Croatian: 30 filmom obloženih tableta 60 filmom obloženih tableta 100 filmom obloženih tableta
English: Comtan tablets contain entacapone and are used together with levodopa to treat Parkinson's disease.
Croatian: Comtan tablete sadrže entakapon i primjenjuju se zajedno s levodopom za liječenje Parkinsonove bolesti.