FrancophonIA/ELRC3.0 huggingface dataset:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Croatian: Nositelj odobrenja obavljat će zadane farmakovigilancijske aktivnosti i intervencije, detaljno objašnjene u dogovorenom Planu upravljanja rizikom (RMP), koji se nalazi u Modulu 1.8.2 Odobrenja za stavljanje lijeka u promet, te svim sljedećim dogovorenim ažuriranim verzijama
English: If you take Pioglitazone Teva Pharma with other medicines for diabetes, it is more likely that your blood sugar could fall below the normal level (hypoglycaemia).
Croatian: Ako uzimate Pioglitazon Teva Pharma s drugim lijekovima za šećernu bolest, veća je vjerojatnost da Vam šećer u krvi padne ispod normalne razine (hipoglikemija).
English: Warnings and precautions Talk to your doctor or pharmacist before taking Pioglitazone Teva Pharma (also see section 4)
Croatian: Obratite se svom liječniku ili ljekarniku prije nego što počnete uzimati Pioglitazon Teva Pharma (pogledajte također dio 4.)
English: 50 x 1 tablets in Aluminium/aluminium perforated unit dose blisters.
Croatian: 50 x 1 tableta u aluminij/aluminij blisterima djeljivima na jedinične doze.
English: Before you start taking Pioglitazone Teva Pharma you will have a blood sample taken to check your liver function.
Croatian: Prije nego što počnete uzimati Pioglitazon Teva Pharma uzet će Vam uzorak krvi da bi se provjerilo kako radi
English: - The other ingredients are mannitol, carmellose calcium, hydroxypropylcellulose and magnesium stearate.
Croatian: - Ostali sastojci su manitol, karmelozakalcij, hidroksipropilceluloza i magnezijev stearat.
English: 2 Visual disturbance has been reported mainly early in treatment and is related to changes in blood glucose due to temporary alteration in the turgidity and refractive index of the lens as seen with other hypoglycaemic treatments.
Croatian: Poremećaj vida zabilježen je uglavnom rano tijekom liječenja i povezan je s promjenama glukoze u krvi zbog privremene promjene u turgoru i indeksu loma leće kakav se vidi i kod drugih hipoglikemijskih terapija.
English: Pharmacotherapeutic group: Drugs used in diabetes, blood glucose lowering drugs, excl. insulins; ATC code: A10BG03.
Croatian: Farmakoterapijska skupina:Pripravci za liječenje šećerne bolesti, lijekovi za snižavanje glukoze u krvi, osim inzulina; ATK oznaka: A10BG03.
English: When Pioglitazone Teva Pharma is taken in combination with other medicines used to treat diabetes (such as insulin, chlorpropamide, glibenclamide, gliclazide, tolbutamide) your doctor will tell you whether you need to take a smaller dose of your medicines.
Croatian: Kad se Pioglitazon Teva Pharma uzima zajedno s drugim lijekovima za liječenje šećerne bolesti (kao što su inzulin, klorpropamid, glibenklamid, gliklazid, tolbutamid) liječnik će Vam reći trebate li te lijekove uzimati u manjim dozama.
English: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG United Kingdom
Croatian: Brampton Road, Hampden Park, Eastbourne, East Sussex, BN22 9AG
English: Your blood sugar will be checked, and your dose of Pioglitazone Teva Pharma may need to be changed.
Croatian: Provjerit će Vam šećer u krvi i nakon toga će možda biti potrebno promijeniti dozu lijeka Pioglitazon Teva Pharma.
English: Pharmachemie B.V.
Croatian: Ujedinjeno Kraljevstvo Pharmachemie B.V.
English: What Pioglitazone Teva Pharma is and what it is used for What you need to know before you take Pioglitazone Teva Pharma How to take Pioglitazone Teva Pharma Possible side effects
Croatian: Što je Pioglitazon Teva Pharma i za što se koristi Što morate znati prije nego počnete uzimati Pioglitazon Teva Pharma Kako uzimati Pioglitazon Teva Pharma
English: If you stop using Pioglitazone Teva Pharma, your blood sugar may go up.
Croatian: Ako prestanete uzimati Pioglitazon Teva Pharma, šećer u krvi Vam se može povisiti.
English: Brampton Road, Hampden Park, Eastbourne, East Sussex - BN22 9AG United Kingdom
Croatian: Brampton Road, Hampden Park, Eastbourne, East Sussex - BN22 9AG
English: The other side effects that have been experienced by some patients taking pioglitazone are:
Croatian: Ostale nuspojave koje su osjetili neki bolesnici koji uzimaju pioglitazon su:
English: It is an anti-diabetic medicine used to treat type 2 (non-insulin dependent) diabetes mellitus in adults, when metformin is not suitable or has failed to work adequately.
Croatian: To je antidijabetički lijek koji se primjenjuje za liječenje šećerne bolesti tipa 2 (neovisne o inzulinu) kod odraslih, kada metformin nije pogodan ili nije imao odgovarajuće djelovanje.
English: Within each system organ class, adverse reactions are presented in order of decreasing incidence followed by decreasing seriousness.
Croatian: svakoj klasi organskih sustava nuspojave su prikazane slijedom prema sve manjoj incidenciji te sve manjoj ozbiljnosti.
English: common common common common common blood creatine phospho-kinase increased common increased lactic dehydro-genase uncommon alanine aminotransferase increased7
Croatian: Povišena kreatin fosfokinaza u krvi povišena laktična dehidrogenaza manje često povišena alanin aminotransferaza7
English: 1 Postmarketing reports of hypersensitivity reactions in patients treated with pioglitazone have been reported.
Croatian: 1 Nakon stavljanja lijeka u promet postoje izvještaji o reakcijama preosjetljivosti kod bolesnika liječenih pioglitazonom.
English: In patients on insulin with no pioglitazone the incidence of heart failure was 8.2% in those >65 years compared to 4.0% in patients less than 65 years.
Croatian: U bolesnika na inzulinu bez pioglitazona, incidencija srčanog zatajenja bila je 8,2% kod osoba u dobi ≥65 godina, u odnosu na 4,0% u bolesnika mlađih od 65 godina.
English: ‘15' on one side and ‘TEVA' on the other side.
Croatian: ‘TEVA' s druge strane.
English: These reactions include anaphylaxis, angioedema, and urticaria.
Croatian: Takve reakcija uključuju anafilaksiju, angioedem i urtikariju.
English: Swensweg 5, 2031 GA Haarlem The Netherlands
Croatian: Swensweg 5, 2031 GA Haarlem
English: Pioglitazone Teva Pharma may also be used in patients who are unable to take metformin, and where treatment with diet and exercise has failed to control blood sugar or may be added to insulin therapy when it fails to provide sufficient control of blood sugar.
Croatian: Pioglitazon Teva Pharma se može primjenjivati sam u bolesnika koji ne mogu uzimati metformin, a kod kojih se liječenjem dijetom i tjelovježbom nije uspjela postići kontrola šećera u krvi, ili se može dodati drugim lijekovima (kao što su metformin, sulfonilureja ili insulin) koji nisu uspjeli osigurati dostatnu kontrolu šećera u krvi.
English: Tél: +33 1 55 91 78 00
Croatian: Teva Santé Tél: +33 1 55 91 78 00
English: In this study in patients receiving pioglitazone and insulin, a higher percentage of patients with heart failure was observed in patients aged >65 years compared with those less than 65 years (9.7% compared to 4.0%).
Croatian: U ovom ispitivanju, u bolesnika koji su primali pioglitazon i inzulin zabilježen je veći postotak bolesnika sa zatajenjem srca u skupini bolesnika u dobi od ≥65 godina u odnosu na one mlađe od 65 godina (9,7% u odnosu na 4,0%).
English: Do not take Pioglitazone Teva Pharma - if you are allergic to pioglitazone or any of the other ingredients of this medicine (listed in section 6).
Croatian: Što morate znati prije nego počnete uzimati Pioglitazon Teva Pharma Nemojte uzimati Pioglitazon Teva Pharma - ako ste alergični na pioglitazon ili neki drugi sastojak ovog lijeka (naveden u dijelu 6.).
English: If you take more Pioglitazone Teva Pharma than you should If you accidentally take too many tablets, or if someone else or a child takes your medicine, talk to a doctor or pharmacist immediately.
Croatian: Ako slučajno uzmete previše tableta ili ako neka druga osoba ili dijete uzmu
English: Pioglitazone Teva Pharma contains pioglitazone.
Croatian: Pioglitazon Teva Pharma sadrži pioglitazon.
English: Teva Santé
Croatian: Vašeg liječnika.
English: The other side effects that have been experienced by some patients when pioglitazone is taken with other antidiabetic medicines are:
Croatian: - alergijske reakcije Druge nuspojave koje su neki bolesnici osjetili kod uzimanja pioglitazona s drugim antidijabetičkim lijekovima su:
English: Pioglitazone is contraindicated in patients with: - hypersensitivity to the active substance or to any of the excipients listed in section 6.1 - cardiac failure or history of cardiac failure (NYHA stages I to IV) - hepatic impairment - diabetic ketoacidosis - current bladder cancer or a history of bladder cancer - uninvestigated macroscopic haematuria
Croatian: Pioglitazon je kontraindiciran u bolesnika s: - preosjetljivošću na djelatnu tvar ili neku od pomoćnih tvari navedenih u dijelu 6.1 - zatajenjem srca ili anamnezom zatajenja srca (NYHA stadiji I do IV) - oštećenjem funkcije jetre - dijabetičkom ketoacidozom - postojećim ili preboljenim karcinomom mokraćnog mjehura
English: In most clinical trials, reduced total plasma triglycerides and free fatty acids, and increased HDLcholesterol levels were observed as compared to placebo, with small, but not clinically significant increases in LDL-cholesterol levels.
Croatian: U većini kliničkih ispitivanja primijećeno je sniženje ukupnih triglicerida i slobodnih masnih kiselina u plazmi te povišenje razine HDL-kolesterola u usporedbi s placebom, uz mala ali ne i klinički značajna povišenja razine LDL
English: as monotherapy - in adult patients (particularly overweight patients) inadequately controlled by diet and exercise for whom metformin is inappropriate because of contraindications or intolerance
Croatian: - u odraslih bolesnika (osobito bolesnika s prekomjernom tjelesnom težinom) u kojih se kontrola ne postiže dijetom i tjelovježbom i u kojih metformin nije prikladan zbog kontraindikacija ili nepodnošenja
English: 98, 112 or 196 tablets.
Croatian: 98 tableta 112 tableta 196 tableta
English: not known (frequency cannot be estimated from the available data) - increase in liver enzymes - allergic reactions
Croatian: - poteškoće sa spavanjem (nesanica) nepoznato (učestalost se ne može procijeniti iz dostupnih podataka) - povišenje vrijednosti jetrenih enzima
English: Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who were treated with Pioglitazone Teva Pharma and insulin experienced the development of heart failure.
Croatian: U nekih bolesnika koji su dugo imali šećernu bolest tipa 2 i srčanu bolest ili su preboljeli moždani udar, a liječili su se lijekom Pioglitazon Teva Pharma i inzulinom došlo je do zatajenja srca.
English: Other medicines and Pioglitazone Teva Pharma Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Croatian: Obavijestite svog liječnika ili ljekarnika ako uzimate ili ste nedavno uzeli ili biste mogli uzeti bilo koje druge lijekove..
English: Kaplan-Meier analysis showed shorter time to treatment failure in patients treated with gliclazide, compared with pioglitazone.
Croatian: Meierovom analizom pokazalo se da je vrijeme do prestanka odgovora na terapiju u bolesnika liječenih gliklazidom kraće nego kod liječenja pioglitazonom.
English: Metabolism and nutrition disorders hypo-glycaemia uncommon very common common appetite increased uncommon
Croatian: Poremećaji metabolizma i prehrane hipoglikemija manje često vrlo često pojačan apetit manje često
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) bladder cancer uncommon uncommon uncommon uncommon uncommon
Croatian: Dobroćudne, zloćudne i nespecificirane novotvorine (uključujući ciste i polipe)
English: Heart failure has been reported with marketing use of pioglitazone, and more frequently when pioglitazone was used in combination with insulin or in patients with a history of cardiac failure.
Croatian: Zatajenje srca uz primjenu pioglitazona zabilježeno je nakon stavljanja u promet, i bilo je češće kad se pioglitazon primjenjivao u kombinaciji s inzulinom ili u bolesnika sa zatajenjem srca u anamnezi.
English: Take Pioglitazone Teva Pharma daily as prescribed.
Croatian: Ako ste zaboravili uzeti Pioglitazon Teva Pharma Uzimajte Pioglitazon Teva Pharma svaki dan, onako kako je propisano.
English: Pioglitazone Teva Pharma has no or negligible influence on the ability to drive and use machines.
Croatian: 4.7 Utjecaj na sposobnost upravljanja vozilima i rada sa strojevima Pioglitazon Teva Pharma ne utječe ili zanemarivo utječe na sposobnost upravljanja vozilima i rada sa strojevima.
English: - The tablets are supplied in Aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 or 196 tablets or 50 x 1 tablets in Aluminium/aluminium perforated unit dose blisters.
Croatian: - Tablete se isporučuju u aluminij/aluminij blisterima u pakiranjima sa 14, 28, 30, 50, 56, 84, 90, 98, 112 ili 196 tableta ili 50 x 1 tableta u aluminij/aluminij blisterima djeljivima na jedinične doze.
English: Monotherapy
Croatian: kao monoterapija
English: - Pioglitazone Teva Pharma 45 mg tablets are white to off white, round, convex with the number ‘45' on one side and ‘TEVA' on the other side.
Croatian: - Pioglitazon Teva Pharma 45 mg tablete su bijele do gotovo bijele boje, okrugle, konveksne, s oznakom ‘45' na jednoj strani i ‘TEVA' na drugoj.
English: 2031GA Haarlem
Croatian: Swensweg 5 2031GA Haarlem
English: 6.6 Special precautions for disposal No special requirements for disposal.
Croatian: 6.4 Posebne mjere pri čuvanju lijeka Lijek ne zahtjeva posebne uvjete čuvanja.
English: - Pioglitazone Teva Pharma 30 mg tablets are white to off white, round, convex with the number ‘30' on one side and ‘TEVA' on the other side.
Croatian: - Pioglitazon Teva Pharma 30 mg tablete su bijele do gotovo bijele boje, okrugle, konveksne, s oznakom ‘30' na jednoj strani i ‘TEVA' na drugoj.
English: NAME OF THE MARKETING AUTHORISATION HOLDER Teva B.V.
Croatian: Nositelj odobrenja za stavljanje gotovog lijeka u promet: Teva B.V.
English: If you are following a special diet for diabetes, you should continue with this while you are taking Pioglitazone Teva Pharma.
Croatian: Ako se pridržavate posebne dijete za šećernu bolest, trebate nastaviti s dijetom dok uzimate
English: What Pioglitazone Teva Pharma looks like and contents of the pack - Pioglitazone Teva Pharma 15 mg tablets are white to off white, round, convex with the number
Croatian: Kako Pioglitazon Teva Pharma izgleda i sadržaj pakiranja - Pioglitazon Teva Pharma 15 mg tablete su bijele do gotovo bijele boje, okrugle, konveksne, s oznakom ‘15' na jednoj strani i ‘TEVA' na drugoj.
English: Pioglitazone Teva Pharma 15 mg tablets Pioglitazone Teva Pharma 30 mg tablets Pioglitazone Teva Pharma 45 mg tablets
Croatian: Pioglitazon Teva Pharma 15 mg tablete Pioglitazon Teva Pharma 30 mg tablete Pioglitazon Teva Pharma 45 mg tablete pioglitazon
English: - The tablets are supplied in Aluminium/aluminium blisters in packs of 14, 28, 30, 50, 56, 84, 90,
Croatian: - Tablete se isporučuju u aluminij/aluminij blisterima u pakiranjima sa 14, 28, 30, 50, 56, 84, 90,
English: How to take Pioglitazone Teva Pharma
Croatian: Kako uzimati Pioglitazon Teva Pharma
English: Aluminium/aluminium blisters, packs of 14, 28, 30, 50, 56, 84, 90, 98, 112 and 196 tablets.
Croatian: Aluminij/aluminij blisteri, pakiranja sa 14, 28, 30, 50, 56, 84, 90, 98, 112 i 196 tableta.
English: Interactions with substances metabolised by these enzymes, e.g. oral contraceptives, cyclosporin, calcium channel blockers, and HMGCoA reductase inhibitors are not to be expected.
Croatian: Ne očekuju se interakcije s tvarima koje ti enzimi metaboliziraju, npr. oralnim kontraceptivima, ciklosporinom,
English: Your doctor will ask you to have blood tests periodically during treatment with Pioglitazone Teva Pharma.
Croatian: Liječnik će tražiti da za vrijeme liječenja lijekom Pioglitazon Teva Pharma povremeno napravite krvne pretrage, da bi se provjerilo radi li Vaša jetra normalno.
English: common common uncommon macular oedema not known not known not known not known not known Ear and labyrinth disorders vertigo uncommon
Croatian: Poremećaji oka poremećaj vida manje često makularni edem nepoznato nepoznato nepoznato nepoznato nepoznato
English: How to store Pioglitazone Teva Pharma
Croatian: Kako čuvati Pioglitazon Teva Pharma
English: Pioglitazone Teva Pharma 30 mg tablets
Croatian: Pioglitazon Teva Pharma 30 mg tablete
English: common (may affect up to 1 in 10 people) - respiratory infection - abnormal vision - weight gain - numbness uncommon (may affect up to 1 in 100 people) - inflammation of the sinuses (sinusitis) - difficulty sleeping (insomnia)
Croatian: često (mogu se javiti do 1 od 10 osoba) - glavobolja - omaglica - bol u zglobovima - impotencija
English: Pioglitazone Teva Pharma 45 mg tablets
Croatian: Pioglitazon Teva Pharma 45 mg tablete
English: Each Pioglitazone Teva Pharma 30 mg tablet contains 30 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta lijeka Pioglitazon Teva Pharma od 30 mg sadrži 30 mg pioglitazona (u obliku pioglitazonklorida).
English: Pioglitazone Teva Pharma 15 mg tablets
Croatian: Pioglitazon Teva Pharma 15 mg tablete
English: prescribers should confirm at subsequent routine reviews that the benefit of pioglitazone is maintained (see section 4.4).
Croatian: S obzirom na moguće rizike produljene terapije, liječnici koji propisuju lijek trebaju i dalje rutinski procjenjivati nastavak koristi od liječenja pioglitazonom (vidjeti dio 4.4).
English: Each Pioglitazone Teva Pharma 45 mg tablet contains 45 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta lijeka Pioglitazon Teva Pharma od 45 mg sadrži 45 mg pioglitazona (u obliku pioglitazonklorida).
English: Carmellose calcium Hydroxypropylcellulose Magnesium stearate
Croatian: FARMACEUTSKI PODACI 6.1 Popis pomoćnih tvari manitol karmelozakalcij hidroksipropilceluloza magnezijev stearat
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/758/001-010
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/758/001-010
English: Pioglitazone Teva Pharma should be used every day to work properly.
Croatian: Ako prestanete uzimati Pioglitazon Teva Pharma Da bi Pioglitazon Teva Pharma ispravno djelovao, treba ga uzimati svaki dan.
English: Each Pioglitazone Teva Pharma 15 mg tablet contains 15 mg of pioglitazone (as hydrochloride).
Croatian: Jedna tableta lijeka Pioglitazon Teva Pharma od 15 mg sadrži 15 mg pioglitazona (u obliku pioglitazonklorida).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/12/758/011-020
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/758/011-020
English: Tablet
Croatian: 14 tableta
English: 31-546, Krakow Poland
Croatian: Teva Operations Poland Sp z.o.o. ul. Mogilska 80. 31-546, Krakow
English: Hepatic impairment
Croatian: - abnormalni vid
English: You can usually continue to take other medicines whilst you are being treated with Pioglitazone Teva Pharma.
Croatian: Za vrijeme liječenja lijekom Pioglitazon Teva Pharma obično možete nastaviti uzimati druge lijekove.
English: The tablets are white to off-white, round, convex and debossed with the number ‘45' on one side and ‘TEVA' on the other side.
Croatian: Tablete su bijele do gotovo bijele boje, okrugle, konveksne i imaju oznaku ‘45' s jedne strane i
English: The tablets are white to off-white, round, convex and debossed with the number ‘15' on one side and ‘TEVA' on the other side.
Croatian: Tablete su bijele do gotovo bijele boje, okrugle, konveksne i imaju oznaku ‘15' s jedne strane i
English: nausea or vomiting).
Croatian: Infekcije i infestacije
English: The tablets are white to off-white, round, convex and debossed with the number ‘30' on one side and ‘TEVA' on the other side.
Croatian: Tablete su bijele do gotovo bijele boje, okrugle, konveksne i imaju oznaku ‘30' s jedne strane i
English: Pioglitazone Teva Pharma 45 mg tablets EU/1/12/758/021-030
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/12/758/021-030
English: There may be an increased possibility of becoming pregnant because you may ovulate again when you take Pioglitazone Teva Pharma.
Croatian: Kad uzimate Pioglitazon Teva Pharma, možete ponovno imati ovulaciju pa mogućnost trudnoće može biti povećana.
English: This medicine does not require any special storage precautions.
Croatian: Nema posebnih zahtjeva za zbrinjavanje.
English: Mannitol
Croatian: Monoterapija
English: common (may affect up to 1 in 10 people) - headache - dizziness - joint pain - impotence - back pain - shortness of breath - small reduction in red blood cell count - flatulence uncommon (may affect up to 1 in 100 people) - sugar in urine, proteins in urine - increase in enzymes - spinning sensation (vertigo) sweating tiredness increased appetite
Croatian: - šećer u mokraći, proteini u mokraći - povišenje enzima - osjećaj vrtnje (vrtoglavica)
English: Nervous system disorders hypo-aesthesia common common common common common headache common uncommon
Croatian: Poremećaji živčanog sustava hipoestezija glavobolja manje često omaglica nesanica manje često manje često manje često manje često manje često
English: How to store Pioglitazone Teva Pharma Contents of the pack and other information
Croatian: Sadržaj pakiranja i druge informacije Što Pioglitazon Teva Pharma sadrži
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 30 mg pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 30 mg pioglitazona (u obliku pioglitazonklorida).
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 45 mg pioglitazone (as hydrochloride).
Croatian: Jedna tableta sadrži 45 mg pioglitazona (u obliku pioglitazonklorida).
English: The recommended starting dose is 2.5 mg once a week for 4 weeks.
Croatian: Preporučena početna doza je 2,5 mg jednom tjedno tijekom četiri tjedna.
English: Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu309708.
Croatian: Više informacija o statusu lijeka za rijetku bolest nalazi se ovdje: ema.europa.eu/medicines/human/orphan-designations/eu309708.
English: The medicine can only be obtained with a prescription and treatment should be started and supervised by a doctor who has experience in treating PKU.
Croatian: Lijek se izdaje samo na liječnički recept, a liječenje mora započeti i nadzirati liječnik s iskustvom u liječenju PKU-a.
English: Palynziq (pegvaliase)
Croatian: Palynziq (pegvaliaza)
English: Further information on Palynziq can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Palynziq.
Croatian: Više informacija o lijeku Palynziq nalazi se na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/Palynziq.
English: The dose and frequency of injection are then increased gradually (up to a maximum dose of 60 mg once a day) to achieve adequate control of phenylalanine blood levels.
Croatian: Doza i učestalost injekcija zatim se postupno povećava (do maksimalne doze od 60 mg jednom dnevno) kako bi se postigla odgovarajuća kontrola razine fenilalanina u krvi.
English: The most significant allergic reactions include acute systemic allergic reaction, angioedema (swelling under the skin in areas such as the face, throat, arms and legs), and serum sickness (allergic reaction caused by animal proteins or serum).
Croatian: Najznačajnije alergijske reakcije uključuju akutnu sistemsku reakciju preosjetljivosti, angioedem (oticanje ispod kože u područjima poput lica, grla, ruku i nogu) te serumsku bolest (alergijsku reakciju uzrokovanu životinjskim proteinima ili serumom).
English: During the first part, all patients were given Palynziq at a dose of 20 or 40 mg for up to 13 weeks.
Croatian: Tijekom prvog dijela svi su bolesnici primili Palynziq u dozi od 20 ili 40 mg u trajanju do 13 tjedana.
English: Palynziq is available as pre-filled syringes (2.5, 10 and 20 mg) for injection under the skin.
Croatian: Palynziq je dostupan kao napunjena štrcaljka (2,5; 10 i 20 mg) za injektiranje pod kožu.
English: Palynziq is intended for long-term use.
Croatian: Palynziq je namijenjen za dugoročnu primjenu.