FrancophonIA/ELRC3.0 huggingface dataset:
English: After reconstitution, 1 mL of suspension contains 20 mg (20 mg/mL).
Croatian: Nakon pripreme, 1 ml suspenzije sadrži 20 mg (20 mg/ml).
English: The 10-mg vial contains an overfill of somatropin powder to allow the withdrawal of up to 10 mg (0.5 mL suspension) of somatropin when reconstituted.
Croatian: Bočica s 10 mg sadrži nešto više somatropin praška kako bi se omogućilo izvlačenje do 10 mg (0,5 ml suspenzije) somatropina nakon rekonstitucije.
English: For children up to 20 kg Somatropin Biopartners 10 mg powder and solvent for prolonged-release suspension for injection is available.
Croatian: Za djecu tjelesne težine do 20 kg dostupan je Somatropin Biopartners 10 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem.
English: Powder and solvent for prolonged-release suspension for injection 1 vial of 10 mg powder
Croatian: Prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem 1 bočica s 10 mg praška
English: - Somatropin Biopartners 20 mg: One vial of powder delivers 20 mg somatropin, corresponding to 60 IU.
Croatian: - Somatropin Biopartners 20 mg: Jedna bočica praška sadrži 20 mg somatropina, što odgovara 60 IU.
English: After preparation, 1 mL of suspension contains 20 mg somatropin (20 mg/mL).
Croatian: Nakon pripreme, 1 ml suspenzije sadrži 20 mg somatropina (20 mg/ml).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/006 1 vial of powder and 1 vial of solvent EU/1/13/849/007 4 vials of powder and 4 vials of solvent
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/849/006 1 bočica praška i 1 bočica otapala EU/1/13/849/007 4 bočice praška i 4 bočice otapala 13. BROJ SERIJE
English: Conversion from required dose to injection volume and vial strength Somatropin dose vials and solvent required for preparation of
Croatian: Pretvorba potrebne doze u volumen injekcije i jačinu bočice Doza somatropina (mg)
English: One powder vial delivers 10 mg of somatropin (30 IU).
Croatian: Jedna bočica praška sadrži: 10 mg somatropina(30 IU).
English: There is no relevant use of Somatropin Biopartners 7 mg in the paediatric population in the indication of long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Croatian: Nema relevantne primjene Somatropina Biopartners 7 mg u pedijatrijske populacije u indikaciji dugotrajnog liječenja zaostajanja u rastu zbog nedostatnog lučenja endogenog hormona rasta.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Somatropin Biopartners
Croatian: NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za Somatropin Biopartners NAČIN PRIMJENE LIJEKA
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/004 1 vial of powder and 1 vial of solvent EU/1/13/849/005 4 vials of powder and 4 vials of solvent
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/849/004 1 bočica praška i 1 bočica otapala EU//1/13/849/005 4 bočice praška i 4 bočice otapala 13. BROJ SERIJE
English: Shelf-life after reconstitution with solvent
Croatian: Rok valjanosti nakon pripreme suspenzije s otapalom
English: There is no relevant use of Somatropin Biopartners 4 mg in the paediatric population in the indication of long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Croatian: Nema relevantne primjene Somatropina Biopartners 4 mg u pedijatrijske populacije u indikaciji dugotrajnog liječenja zaostajanja u rastu zbog nedostatnog lučenja endogenog hormona rasta.
English: One powder vial delivers 2 mg of somatropin (6 IU).
Croatian: Jedna bočica praška sadrži: 2 mg somatropina (6 IU).
English: - Somatropin Biopartners 10 mg: One vial of powder delivers 10 mg somatropin, corresponding to 30 IU.
Croatian: - Somatropin Biopartners 10 mg: Jedna bočica praška sadrži 10 mg somatropina, što odgovara 30 IU.
English: - Somatropin Biopartners 2 mg: One vial of powder delivers 2 mg somatropin, corresponding to 6 IU.
Croatian: - Somatropin Biopartners 2 mg: Jedna bočica praška sadrži 2 mg somatropina, što odgovara 6 IU.
English: None or -0.5 mg (all patients)
Croatian: održavati ili sniziti kliničkom statusu nema ili -0,5 mg (svi bolesnici)
English: Pack size of 1 vial of powder and 1 vial of solvent and 4 vials of powder and 4 vials of solvent.
Croatian: Veličina pakiranja od 1 bočice s praškom i 1 bočice s otapalom te 4 bočice s praškom i 4 bočice s otapalom.
English: Pack sizes of 1 vial of powder and 1 vial of solvent and 4 vials of powder and 4 vials of solvent.
Croatian: Veličine pakiranja od 1 bočice s praškom i 1 bočice s otapalom te 4 bočice s praškom i 4 bočice s otapalom.
English: - Somatropin Biopartners 4 mg: One vial of powder delivers 4 mg somatropin, corresponding to 12 IU.
Croatian: - Somatropin Biopartners 4 mg: Jedna bočica praška sadrži 4 mg somatropina, što odgovara 12 IU.
English: Powder and solvent for prolonged-release suspension for injection 4 vials of 7 mg powder
Croatian: Prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem 4 bočice s 7 mg praška
English: After reconstitution, 0.5 mL of suspension contains 10 mg (20 mg/mL).
Croatian: Nakon pripreme, 0,5 ml suspenzije sadrži 10 mg (20 mg/ml).
English: For adults
Croatian: I DOHVATA DJECE
English: There is no relevant use of Somatropin Biopartners 2 mg in the paediatric population in the indication of long-term treatment of growth failure due to insufficient secretion of endogenous growth hormone.
Croatian: Nema relevantne primjene Somatropina Biopartners 2 mg u pedijatrijske populacije u indikaciji dugotrajnog liječenja zaostajanja u rastu zbog nedostatnog lučenja endogenog hormona rasta.
English: The vial contains an overfill of somatropin powder to allow the withdrawal of up to 7 mg (0.7 mL suspension) of somatropin when reconstituted.
Croatian: Bočica sadrži nešto više somatropin praška kako bi se omogućilo izvlačenje do 7 mg (0,7 ml suspenzije) somatropina nakon rekonstitucije.
English: After reconstitution, 0.7 mL of suspension contains 7 mg (10 mg/mL).
Croatian: Nakon pripreme, 0,7 ml suspenzije sadrži 7 mg (10 mg/ml).
English: Immune system disorders Common: Formation of antibodies against growth hormone
Croatian: Često: stvaranje protutijela na hormon rasta
English: One powder vial delivers 4 mg of somatropin (12 IU).
Croatian: Jedna bočica praška sadrži: 4 mg somatropina(12 IU).
English: After preparation, 0.5 mL of suspension contains 10 mg somatropin (20 mg/mL).
Croatian: Nakon pripreme, 0,5 ml suspenzije sadrži 10 mg somatropina (20 mg/ml).
English: 1.5 mL medium chain triglycerides
Croatian: SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1,5 ml triglicerida srednje duljine lanca
English: The vial contains an overfill of somatropin powder to allow the withdrawal of up to 4 mg (0.4 mL suspension) of somatropin when reconstituted.
Croatian: Bočica sadrži nešto više somatropin praška kako bi se omogućilo izvlačenje do 4 mg (0,4 ml suspenzije) somatropina nakon rekonstitucije.
English: After reconstitution, 0.2 mL of suspension contains 2 mg (10 mg/mL).
Croatian: Nakon pripreme, 0,2 ml suspenzije sadrži 2 mg (10 mg/ml).
English: The vial contains an overfill of somatropin powder to allow the withdrawal of up to 2 mg (0.2 mL suspension) of somatropin when reconstituted.
Croatian: Bočica sadrži nešto više somatropin praška kako bi se omogućilo izvlačenje do 2 mg (0,2 ml suspenzije) somatropina nakon rekonstitucije.
English: 4 vials of powder and 4 vials of solvent.
Croatian: 4 bočice praška i 4 bočice otapala.
English: After reconstitution, 0.4 mL of suspension contains 4 mg (10 mg/mL).
Croatian: Nakon pripreme, 0,4 ml suspenzije sadrži 4 mg (10 mg/ml).
English: Turn the vial upside down, with the syringe inside and place the tip of the needle in the solvent as seen in figure 5.
Croatian: Okrenite bočicu s uvedenom štrcaljkom naopako i postavite vršak igle u otapalo kako je prikazano na slici 5. Polako izvucite potrebni volumen otapala.
English: After preparation, 0.7 mL of suspension contains 7 mg somatropin (10 mg/mL).
Croatian: Nakon pripreme, 0,7 ml suspenzije sadrži 7 mg somatropina (10 mg/ml).
English: Powder and solvent for prolonged-release suspension for injection 4 vials of 4 mg powder
Croatian: Prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem 4 bočice s 4 mg praška
English: Somatropin Biopartners 2 mg should be reconstituted with 0.4 mL solvent.
Croatian: Somatropin Biopartners 2 mg treba rekonstituirati s 0,4 ml otapala.
English: Somatropin Biopartners 4 mg should be reconstituted with 0.6 mL solvent.
Croatian: Somatropin Biopartners 4 mg treba rekonstituirati s 0,6 ml otapala.
English: Somatropin Biopartners 10 mg should be reconstituted with 0.7 mL solvent.
Croatian: Somatropin Biopartners 10 mg treba rekonstituirati s 0,7 ml otapala.
English: After preparation, 0.4 mL of suspension contains 4 mg somatropin (10 mg/mL).
Croatian: Nakon pripreme, 0,4 ml suspenzije sadrži 4 mg somatropina (10 mg/ml).
English: Somatropin Biopartners 7 mg should be reconstituted with 0.9 mL solvent.
Croatian: Somatropin Biopartners 7 mg treba rekonstituirati s 0,9 ml otapala.
English: Pack size of 4 vials of powder and 4 vials of solvent.
Croatian: Veličina pakiranja od 4 bočice s praškom i 4 bočice s otapalom.
English: - Somatropin Biopartners 20 mg: 20 mg (60 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a green flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
Croatian: - Somatropin Biopartners 20 mg: 20 mg (60 IU) somatropina u prašku u staklenoj bočici zatvorenoj gumenim čepom (butil) i zelenim „flip-off“ poklopcem (aluminij i plastika) i 1,5 ml otapala (trigliceridi srednje duljine lanca) u staklenoj bočici s gumenim (butilnim) čepom.
English: Sodium hyaluronate
Croatian: Za odrasle somatropin
English: After preparation, 0.2 mL of suspension contains 2 mg somatropin (10 mg/mL).
Croatian: Nakon pripreme, 0,2 ml suspenzije sadrži 2 mg somatropina (10 mg/ml).
English: None
Croatian: DRUGO
English: Each vial of powder delivers 20 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Croatian: Jedna bočica s praškom sadrži 20 mg somatropina; jedna bočica otapala sadrži 1,5 ml tekućine.
English: Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous.
Croatian: Prašak: natrijev hijaluronat fosfolipidi jaja natrijev dihidrogenfosfat, bezvodni natrijev hidrogenfosfat, bezvodni.
English: - Somatropin Biopartners 4 mg: 4 mg (12 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a pink flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
Croatian: - Somatropin Biopartners 4 mg: 4 mg (12 IU) somatropina u prašku u staklenoj bočici zatvorenoj gumenim čepom (butil) i ružičastim „flip-off“ poklopcem (aluminij i plastika) i 1,5 ml otapala (trigliceridi srednje duljine lanca) u staklenoj bočici s gumenim (butilnim) čepom.
English: - Somatropin Biopartners 2 mg: 2 mg (6 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a yellow flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in a glass vial with a rubber stopper (butyl).
Croatian: - Somatropin Biopartners 2 mg: 2 mg (6 IU) somatropina u prašku u staklenoj bočici zatvorenoj gumenim čepom (butil) i žutim „flip-off“ poklopcem (aluminij i plastika) i 1,5 ml otapala (trigliceridi srednje duljine lanca) u staklenoj bočici s gumenim (butilnim) čepom.
English: - Somatropin Biopartners 7 mg: 7 mg (21 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a light-blue flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
Croatian: - Somatropin Biopartners 7 mg: 7 mg (21 IU) somatropina u prašku u staklenoj bočici zatvorenoj gumenim čepom (butil) i svijetloplavim „flip-off“ poklopcem (aluminij i plastika) i 1,5 ml otapala (trigliceridi srednje duljine lanca) u staklenoj bočici s gumenim (butilnim) čepom.
English: - Somatropin Biopartners 10 mg: 10 mg (30 IU) somatropin as powder in a glass vial closed with a rubber stopper (butyl) and a light-green flip-off cap (aluminium and plastic) and 1.5 mL solvent (medium chain triglycerides) in glass vial with a rubber stopper (butyl).
Croatian: - Somatropin Biopartners 10 mg: 10 mg (30 IU) somatropina u prašku u staklenoj bočici zatvorenoj gumenim čepom (butil) i svijetlozelenim „flip-off“ poklopcem (aluminij i plastika) i 1,5 ml otapala (trigliceridi srednje duljine lanca) u staklenoj bočici s gumenim (butilnim) čepom.
English: INFORMATION IN BRAILLE Somatropin Biopartners 7 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Somatropin Biopartners 7 mg
English: After reconstitution, 0.2 mL of suspension contains 2 mg somatropin (10 mg/mL).
Croatian: Nakon rekonstitucije, 0,2 ml suspenzije sadrži 2 mg somatropina (10 mg/ml).
English: INFORMATION IN BRAILLE Somatropin Biopartners 4 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Somatropin Biopartners 4 mg
English: INFORMATION IN BRAILLE Somatropin Biopartners 10 mg
Croatian: 16. PODACI NA BRAILLEOVOM PISMU Somatropin Biopartners 10 mg
English: INFORMATION IN BRAILLE Somatropin Biopartners 20 mg
Croatian: TEKST NA KUTIJI SOMATROPIN BIOPARTNERS 20 MG
English: Each vial of powder delivers 7 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Croatian: Jedna bočica praška sadrži 7 mg somatropina; jedna bočica otapala sadrži 1,5 ml tekućine.
English: Adrenal function
Croatian: Funkcija štitne žlijezde
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL OF SOLVENT
Croatian: PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
English: INFORMATION IN BRAILLE Somatropin Biopartners 2 mg
Croatian: KUTIJA SOMATROPIN BIOPARTNERS 2 MG
English: Each vial of powder delivers 2 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Croatian: Jedna bočica s praškom sadrži 2 mg somatropina; jedna bočica otapala sadrži 1,5 ml tekućine.
English: Each vial of powder delivers 4 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Croatian: Jedna bočica praška sadrži 4 mg somatropina; jedna bočica otapala sadrži 1,5 ml tekućine.
English: Somatropin Biopartners 20 mg powder for prolonged-release suspension for injection somatropin
Croatian: Somatropin Biopartners 20 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem somatropin
English: Each vial of powder delivers 10 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Croatian: Jedna bočica s praškom sadrži 10 mg somatropina; jedna bočica otapala sadrži 1,5 ml tekućine.
English: Egg phospholipids
Croatian: (Saccharomyces cerevisiae).
English: Somatropin Biopartners 10 mg powder and solvent for prolonged-release suspension for injection somatropin
Croatian: Somatropin Biopartners 10 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem somatropin
English: Pack size: 4 vials of powder and 4 vials of solvent.
Croatian: Veličine pakiranja: 4 bočice praška i 4 bočice otapala.
English: Somatropin Biopartners 20 mg powder and solvent for prolonged-release suspension for injection
Croatian: Somatropin Biopartners 20 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
English: Somatropin Biopartners 10 mg powder for prolonged-release suspension for injection.
Croatian: Somatropin Biopartners 10 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a pink flip-off cap (aluminium and plastic).
Croatian: Prašak: bočica (staklo tipa I) zatvorena gumenim (butilnim) čepom i ružičastim „flip-off“ poklopcem (aluminij i plastika).
English: Subcutaneous use
Croatian: Potkožna primjena
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a yellow flip-off cap (aluminium and plastic).
Croatian: Prašak: bočica (staklo tipa I) zatvorena gumenim (butilnim) čepom i žutim „flip-off“ poklopcem (aluminij i plastika).
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a green flip-off cap (aluminium and plastic).
Croatian: Prašak: bočica (staklo tipa I) zatvorena gumenim (butilnim) čepom i zelenim „flip-off“ poklopcem (aluminij i plastika).
English: NAME OF THE MEDICINAL PRODUCT Somatropin Biopartners 7 mg powder and solvent for prolonged-release suspension for injection
Croatian: Somatropin Biopartners 7 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
English: NAME OF THE MEDICINAL PRODUCT Somatropin Biopartners 4 mg powder and solvent for prolonged-release suspension for injection
Croatian: Somatropin Biopartners 4 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
English: Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a light-green flip-off cap (aluminium and plastic).
Croatian: Prašak: bočica (staklo tipa I) zatvorena gumenim (butilnim) čepom i svijetlozelenim „flip-off“ poklopcem (aluminij i plastika).
English: Somatropin Biopartners 2 mg powder for prolonged-release suspension for injection somatropin
Croatian: Somatropin Biopartners 2 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/002 4 vials of powder and 4 vials of solvent
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/849/002 4 bočice praška i 4 bočice otapala 13. BROJ SERIJE
English: QUALITATIVE AND QUANTITATIVE COMPOSITION One vial delivers 2 mg of somatropin* (corresponding to 6 IU).
Croatian: Jedna bočica osigurava 2 mg somatropina* (što odgovara 6 IU).
English: Solvent: Vial (Type I glass) closed with a rubber stopper (butyl) and a flip-off cap (aluminium and plastic).
Croatian: Otapalo: bočica (staklo tipa I) zatvorena gumenim (butilnim) čepom i „flip-off“ poklopcem (aluminij i plastika).
English: Somatropin Biopartners 7 mg powder and solvent for prolonged-release suspension for injection Somatropin
Croatian: Somatropin Biopartners 7 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem somatropin za odrasle
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/003 4 vials of powder and 4 vials of solvent
Croatian: 12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU//1/13/849/003 4 bočice praška i 4 bočice otapala 13. BROJ SERIJE
English: Somatropin Biopartners 4 mg powder for prolonged-release suspension for injection somatropin
Croatian: Somatropin Biopartners 4 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem somatropin za odrasle
English: Gently pinch the skin that has been cleaned, to make a fold.
Croatian: Nježno uhvatite nabor očišćene kože prstima.
English: It is available as 20-mg tablets.
Croatian: Dostupan je u obliku tableta od 20 mg.
English: Further information on Doptelet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/doptelet.
Croatian: Više informacija o lijeku Doptelet dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/doptelet.
English: Treatment with Doptelet should start at least 10 days before the procedure.
Croatian: Terapiju lijekom Doptelet treba započeti najmanje 10 dana prije postupka.
English: What is Doptelet and what is it used for?
Croatian: Što je Doptelet i za što se koristi?
English: Other information about Doptelet
Croatian: Ostale informacije o lijeku Doptelet
English: What measures are being taken to ensure the safe and effective use of Doptelet?
Croatian: Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Doptelet?
English: The dose is 2 or 3 tablets (depending on the platelet count at the start of treatment), daily for 5 days.
Croatian: Doza je 2 ili 3 tablete (ovisno o broju trombocita na početku liječenja) dnevno tijekom razdoblja od 5 dana.
English: The medicine is for use in patients having an invasive procedure (a medical procedure that involves cutting into or puncturing the skin or inserting instruments into the body).
Croatian: Lijek se primjenjuje u bolesnika koji će biti podvrgnuti invazivnom postupku (medicinskom postupku koji podrazumijeva rezanje ili punkciju kože ili uvođenje instrumenata u tijelo).
English: The European Medicines Agency decided that Doptelet's benefits are greater than its risks and it can be authorised for use in the EU.
Croatian: Europska agencija za lijekove zaključila je da koristi od lijeka Doptelet nadmašuju s njim povezane rizike te da lijek može biti odobren za primjenu u EU-u.
English: Side effects reported with Doptelet are carefully evaluated and any necessary action taken to protect patients.
Croatian: Nuspojave prijavljene za lijek Doptelet pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
English: Doptelet can only be obtained with a prescription.
Croatian: Doptelet se izdaje samo na recept.
English: The most common side effect with Doptelet (which may affect up to 1 in 10 people) is tiredness.
Croatian: Najčešća nuspojava lijeka Doptelet (koja se može javiti u najviše 1 na 10 osoba) je umor.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Doptelet have been included in the summary of product characteristics and the package leaflet.
Croatian: Preporuke i mjere opreza kojih se zdravstveni radnici i bolesnici trebaju pridržavati u cilju sigurne i učinkovite primjene lijeka Doptelet nalaze se u sažetku opisa svojstava i u uputi o lijeku.
English: An overview of Doptelet and why it is authorised in the EU
Croatian: Pregled informacija o lijeku Doptelet i zašto je odobren u EU-u
English: What are the risks associated with Doptelet?
Croatian: Koji su rizici povezani s lijekom Doptelet?
English: A blood test on the day of the procedure is necessary to ensure that the platelet count is adequate and not unexpectedly high.
Croatian: Na dan postupka potrebno je obaviti krvnu pretragu kako bi se zajamčilo da je broj trombocita primjeren, a ne neočekivano visok.
English: Why is Doptelet authorised in the EU?
Croatian: Zašto je lijek Doptelet odobren u EU-u?
English: As for all medicines, data on the use of Doptelet are continuously monitored.
Croatian: Kao i za sve lijekove, podatci o primjeni lijeka Doptelet kontinuirano se prate.
English: In these studies, 88% of patients who received Doptelet 40 mg daily did not require a transfusion or rescue procedure compared with 36% of patients who were given placebo (a dummy treatment).
Croatian: U tim ispitivanjima 88 % bolesnika koji su primali lijek Doptelet u dozi od 40 mg dnevno nije trebalo transfuziju ni terapiju spasa, u odnosu na 36 % bolesnika koji su primali placebo (prividno liječenje).
English: Among patients with more severe thrombocytopenia, 67% of those given Doptelet 60 mg daily did not require a transfusion or rescue procedure compared with 29% of those who received placebo.
Croatian: Među bolesnicima s težim oblikom trombocitopenije, 67 % onih koji su primali lijek Doptelet u dozi od 60 mg dnevno nije trebalo transfuziju ni terapiju spasa, u odnosu na 29 % onih koji su primali placebo.
English: Patients with thrombocytopenia have reduced number of platelets (components in the blood that help it to clot), which can cause excessive bleeding.
Croatian: Bolesnici s trombocitopenijom imaju smanjen broj trombocita (krvna tjelešca koja pospješuju zgrušavanje krvi), što može dovesti do prekomjernog krvarenja.
English: Doptelet is a medicine used to prevent excessive bleeding in adults with thrombocytopenia due to long-standing liver disease.
Croatian: Doptelet je lijek za sprječavanje prekomjernog krvarenja u odraslih osoba s trombocitopenijom uzrokovanom kroničnom bolešću jetre.
English: For more information about using Doptelet, see the package leaflet or contact your doctor or pharmacist.
Croatian: Više informacija o primjeni lijeka Doptelet pročitajte u uputi o lijeku odnosno obratite se liječniku ili ljekarniku.