natgillin/translations-raw huggingface dataset:
The somatropin in this medicinal product is synthesised in yeast (Saccharomyces cerevisiae).
Somatropin u ovom lijeku sintetiziran je u kvascu
Antibodies
Protutijela
Vigorously swirl the vial without touching the rubber top with your fingers until the content is completely mixed.
Kružnim pokretima žustro vrtite sadržaj bočice sve dok se sav sadržaj potpuno ne pomiješa i pritom nemojte dodirivati gumeni vrh prstima.
For other doses vials with 2 or 4 mg somatropin are available.
Za druge doze dostupne su bočice s 2 ili 4 mg somatropina.
Somatropin Biopartners 20 mg should be reconstituted with 1.2 mL solvent.
Somatropin Biopartners 20 mg treba rekonstituirati s 1,2 ml otapala.
IGF-I SDS in the range of -1 to +1 and less than 1SDS increase from Baseline
IGF-I SDS u rasponu od -1 to +1 i porast manji od 1 SDS od početne vrijednosti
Your doctor will stop your treatment with this medicine if there is evidence of cancerous growth; - if you are ill due to a serious heart or stomach operation;
Vaš liječnik će zaustaviti liječenje ovim lijekom ako postoji dokaz rasta tumora; - ako ste bolesni zbog ozbiljne operacije na srcu ili želucu; - ako se liječite od više od jedne ozljede nakon ozbiljne nezgode; - ako iznenada razvijete ozbiljne tegobe s disanjem.
Gastrointestinal disorders Common: vomitting (1.1%), abdominal pain (1.1%)
Često: povraćanje (1,1%), bol u trbuhu (1,1%)
Somatropin Biopartners is a powder and solvent for prolonged-release suspension for injection.
Somatropin Biopartners je prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem.
The amino acid sequence of the active substance is identical to that of hGH of pituitary origin.
Slijed aminokiselina u djelatnoj tvari istovjetan je onome hGH iz hipofize.
For children heavier than 20 kg, Somatropin Biopartners 20 mg powder and solvent for prolonged-release suspension for injection is available.
Za djecu tjelesne težine veće od 20 kg, dostupan je Somatropin Biopartners 20 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem.
Due to the prolonged-release characteristics of this medicinal product peak levels of growth hormone can be expected approximately 15 hours after injection, see section 5.2.
Zbog toga što je ovo lijek s produljenim oslobađanjem, vršne razine hormona rasta mogu se očekivati približno 15 sati nakon injekcije, vidjeti dio 5.2. Dugotrajno predoziranje može rezultirati znakovima i simptomima gigantizma i/ili akromegalije koji su sukladni poznatim učincima prekomjerne količine hGH.
Hold the syringe upright.
Držite štrcaljku uspravno.
Put an adhesive plaster on the injection site.
Mjesto injekcije prekrijte samoljepivim flasterom.
figure
slika
Common: Haematuria, increased blood uric acid, increased blood creatinine Reproductive system and breast disorders
Često: hematurija, povećana mokraćna kiselina u krvi, povećan kreatinin u krvi
To remove any bubbles, gently tap the syringe.
Da biste uklonili eventualne mjehuriće, nježno kucnite po štrcaljki.
1 vial of powder and 1 vial of solvent.
1 bočica praška i 1 bočica otapala.
One powder vial delivers 7 mg of somatropin (21 IU).
Jedna bočica praška sadrži: 7 mg somatropina (21 IU).
Musculoskeletal and connective tissue disorders Common: arthralgia (1.1%), pain in extremities (5.1%)
Često: artralgija (1,1%), bol u ekstremitetima (5,1%)*
One powder vial delivers 20 mg of somatropin (60 IU).
Jedna bočica praška sadrži 20 mg somatropina (60 IU).
The vial should be turned upside down, with the syringe in and the tip of the needle should be placed in the solvent.
Bočicu s uvedenom štrcaljkom treba okrenuti naopako, a vršak igle treba biti postavljen u otapalo.
- Somatropin Biopartners 7 mg: One vial of powder delivers 7 mg somatropin, corresponding to 21 IU.
- Somatropin Biopartners 7 mg: Jedna bočica praška sadrži 7 mg somatropina, što odgovara 21 IU.
Reproductive system and breast disorders Very rare: gynaecomastia*
Često: bolnost bradavica Manje često: ginekomastija*
After reconstitution, 1 mL of suspension contains 20 mg (20 mg/mL).
Nakon pripreme, 1 ml suspenzije sadrži 20 mg (20 mg/ml).
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.
Bočica s 10 mg sadrži nešto više somatropin praška kako bi se omogućilo izvlačenje do 10 mg (0,5 ml suspenzije) somatropina nakon rekonstitucije.
For children up to 20 kg Somatropin Biopartners 10 mg powder and solvent for prolonged-release suspension for injection is available.
Za djecu tjelesne težine do 20 kg dostupan je Somatropin Biopartners 10 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem.
Powder and solvent for prolonged-release suspension for injection 1 vial of 10 mg powder
Prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem 1 bočica s 10 mg praška
- Somatropin Biopartners 20 mg: One vial of powder delivers 20 mg somatropin, corresponding to 60 IU.
- Somatropin Biopartners 20 mg: Jedna bočica praška sadrži 20 mg somatropina, što odgovara 60 IU.
After preparation, 1 mL of suspension contains 20 mg somatropin (20 mg/mL).
Nakon pripreme, 1 ml suspenzije sadrži 20 mg somatropina (20 mg/ml).
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
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
Conversion from required dose to injection volume and vial strength Somatropin dose vials and solvent required for preparation of
Pretvorba potrebne doze u volumen injekcije i jačinu bočice Doza somatropina (mg)
One powder vial delivers 10 mg of somatropin (30 IU).
Jedna bočica praška sadrži: 10 mg somatropina(30 IU).
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.
Nema relevantne primjene Somatropina Biopartners 7 mg u pedijatrijske populacije u indikaciji dugotrajnog liječenja zaostajanja u rastu zbog nedostatnog lučenja endogenog hormona rasta.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Solvent for Somatropin Biopartners
NAZIV LIJEKA I PUT(EVI) PRIMJENE LIJEKA Otapalo za Somatropin Biopartners NAČIN PRIMJENE LIJEKA
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
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
Shelf-life after reconstitution with solvent
Rok valjanosti nakon pripreme suspenzije s otapalom
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.
Nema relevantne primjene Somatropina Biopartners 4 mg u pedijatrijske populacije u indikaciji dugotrajnog liječenja zaostajanja u rastu zbog nedostatnog lučenja endogenog hormona rasta.
One powder vial delivers 2 mg of somatropin (6 IU).
Jedna bočica praška sadrži: 2 mg somatropina (6 IU).
- Somatropin Biopartners 10 mg: One vial of powder delivers 10 mg somatropin, corresponding to 30 IU.
- Somatropin Biopartners 10 mg: Jedna bočica praška sadrži 10 mg somatropina, što odgovara 30 IU.
- Somatropin Biopartners 2 mg: One vial of powder delivers 2 mg somatropin, corresponding to 6 IU.
- Somatropin Biopartners 2 mg: Jedna bočica praška sadrži 2 mg somatropina, što odgovara 6 IU.
None or -0.5 mg (all patients)
održavati ili sniziti kliničkom statusu nema ili -0,5 mg (svi bolesnici)
Pack size of 1 vial of powder and 1 vial of solvent and 4 vials of powder and 4 vials of solvent.
Veličina pakiranja od 1 bočice s praškom i 1 bočice s otapalom te 4 bočice s praškom i 4 bočice s otapalom.
Pack sizes of 1 vial of powder and 1 vial of solvent and 4 vials of powder and 4 vials of solvent.
Veličine pakiranja od 1 bočice s praškom i 1 bočice s otapalom te 4 bočice s praškom i 4 bočice s otapalom.
- Somatropin Biopartners 4 mg: One vial of powder delivers 4 mg somatropin, corresponding to 12 IU.
- Somatropin Biopartners 4 mg: Jedna bočica praška sadrži 4 mg somatropina, što odgovara 12 IU.
Powder and solvent for prolonged-release suspension for injection 4 vials of 7 mg powder
Prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem 4 bočice s 7 mg praška
After reconstitution, 0.5 mL of suspension contains 10 mg (20 mg/mL).
Nakon pripreme, 0,5 ml suspenzije sadrži 10 mg (20 mg/ml).
For adults
I DOHVATA DJECE
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.
Nema relevantne primjene Somatropina Biopartners 2 mg u pedijatrijske populacije u indikaciji dugotrajnog liječenja zaostajanja u rastu zbog nedostatnog lučenja endogenog hormona rasta.
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.
Bočica sadrži nešto više somatropin praška kako bi se omogućilo izvlačenje do 7 mg (0,7 ml suspenzije) somatropina nakon rekonstitucije.
After reconstitution, 0.7 mL of suspension contains 7 mg (10 mg/mL).
Nakon pripreme, 0,7 ml suspenzije sadrži 7 mg (10 mg/ml).
Immune system disorders Common: Formation of antibodies against growth hormone
Često: stvaranje protutijela na hormon rasta
One powder vial delivers 4 mg of somatropin (12 IU).
Jedna bočica praška sadrži: 4 mg somatropina(12 IU).
After preparation, 0.5 mL of suspension contains 10 mg somatropin (20 mg/mL).
Nakon pripreme, 0,5 ml suspenzije sadrži 10 mg somatropina (20 mg/ml).
1.5 mL medium chain triglycerides
SADRŽAJ PO TEŽINI, VOLUMENU ILI DOZNOJ JEDINICI LIJEKA 1,5 ml triglicerida srednje duljine lanca
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.
Bočica sadrži nešto više somatropin praška kako bi se omogućilo izvlačenje do 4 mg (0,4 ml suspenzije) somatropina nakon rekonstitucije.
After reconstitution, 0.2 mL of suspension contains 2 mg (10 mg/mL).
Nakon pripreme, 0,2 ml suspenzije sadrži 2 mg (10 mg/ml).
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.
Bočica sadrži nešto više somatropin praška kako bi se omogućilo izvlačenje do 2 mg (0,2 ml suspenzije) somatropina nakon rekonstitucije.
4 vials of powder and 4 vials of solvent.
4 bočice praška i 4 bočice otapala.
After reconstitution, 0.4 mL of suspension contains 4 mg (10 mg/mL).
Nakon pripreme, 0,4 ml suspenzije sadrži 4 mg (10 mg/ml).
Turn the vial upside down, with the syringe inside and place the tip of the needle in the solvent as seen in figure 5.
Okrenite bočicu s uvedenom štrcaljkom naopako i postavite vršak igle u otapalo kako je prikazano na slici 5. Polako izvucite potrebni volumen otapala.
After preparation, 0.7 mL of suspension contains 7 mg somatropin (10 mg/mL).
Nakon pripreme, 0,7 ml suspenzije sadrži 7 mg somatropina (10 mg/ml).
Powder and solvent for prolonged-release suspension for injection 4 vials of 4 mg powder
Prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem 4 bočice s 4 mg praška
Somatropin Biopartners 2 mg should be reconstituted with 0.4 mL solvent.
Somatropin Biopartners 2 mg treba rekonstituirati s 0,4 ml otapala.
Somatropin Biopartners 4 mg should be reconstituted with 0.6 mL solvent.
Somatropin Biopartners 4 mg treba rekonstituirati s 0,6 ml otapala.
Somatropin Biopartners 10 mg should be reconstituted with 0.7 mL solvent.
Somatropin Biopartners 10 mg treba rekonstituirati s 0,7 ml otapala.
After preparation, 0.4 mL of suspension contains 4 mg somatropin (10 mg/mL).
Nakon pripreme, 0,4 ml suspenzije sadrži 4 mg somatropina (10 mg/ml).
Somatropin Biopartners 7 mg should be reconstituted with 0.9 mL solvent.
Somatropin Biopartners 7 mg treba rekonstituirati s 0,9 ml otapala.
Pack size of 4 vials of powder and 4 vials of solvent.
Veličina pakiranja od 4 bočice s praškom i 4 bočice s otapalom.
- 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).
- 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.
Sodium hyaluronate
Za odrasle somatropin
After preparation, 0.2 mL of suspension contains 2 mg somatropin (10 mg/mL).
Nakon pripreme, 0,2 ml suspenzije sadrži 2 mg somatropina (10 mg/ml).
None
DRUGO
Each vial of powder delivers 20 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Jedna bočica s praškom sadrži 20 mg somatropina; jedna bočica otapala sadrži 1,5 ml tekućine.
Sodium dihydrogen phosphate anhydrous Disodium phosphate anhydrous.
Prašak: natrijev hijaluronat fosfolipidi jaja natrijev dihidrogenfosfat, bezvodni natrijev hidrogenfosfat, bezvodni.
- 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).
- 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.
- 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).
- 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.
- 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).
- 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.
- 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).
- 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.
INFORMATION IN BRAILLE Somatropin Biopartners 7 mg
16. PODACI NA BRAILLEOVOM PISMU Somatropin Biopartners 7 mg
After reconstitution, 0.2 mL of suspension contains 2 mg somatropin (10 mg/mL).
Nakon rekonstitucije, 0,2 ml suspenzije sadrži 2 mg somatropina (10 mg/ml).
INFORMATION IN BRAILLE Somatropin Biopartners 4 mg
16. PODACI NA BRAILLEOVOM PISMU Somatropin Biopartners 4 mg
INFORMATION IN BRAILLE Somatropin Biopartners 10 mg
16. PODACI NA BRAILLEOVOM PISMU Somatropin Biopartners 10 mg
INFORMATION IN BRAILLE Somatropin Biopartners 20 mg
TEKST NA KUTIJI SOMATROPIN BIOPARTNERS 20 MG
Each vial of powder delivers 7 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Jedna bočica praška sadrži 7 mg somatropina; jedna bočica otapala sadrži 1,5 ml tekućine.
Adrenal function
Funkcija štitne žlijezde
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL OF SOLVENT
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE
INFORMATION IN BRAILLE Somatropin Biopartners 2 mg
KUTIJA SOMATROPIN BIOPARTNERS 2 MG
Each vial of powder delivers 2 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Jedna bočica s praškom sadrži 2 mg somatropina; jedna bočica otapala sadrži 1,5 ml tekućine.
Each vial of powder delivers 4 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Jedna bočica praška sadrži 4 mg somatropina; jedna bočica otapala sadrži 1,5 ml tekućine.
Somatropin Biopartners 20 mg powder for prolonged-release suspension for injection somatropin
Somatropin Biopartners 20 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem somatropin
Each vial of powder delivers 10 mg somatropin; each vial of solvent contains 1.5 mL liquid.
Jedna bočica s praškom sadrži 10 mg somatropina; jedna bočica otapala sadrži 1,5 ml tekućine.
Egg phospholipids
(Saccharomyces cerevisiae).
Somatropin Biopartners 10 mg powder and solvent for prolonged-release suspension for injection somatropin
Somatropin Biopartners 10 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem somatropin
Pack size: 4 vials of powder and 4 vials of solvent.
Veličine pakiranja: 4 bočice praška i 4 bočice otapala.
Somatropin Biopartners 20 mg powder and solvent for prolonged-release suspension for injection
Somatropin Biopartners 20 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
Somatropin Biopartners 10 mg powder for prolonged-release suspension for injection.
Somatropin Biopartners 10 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a pink flip-off cap (aluminium and plastic).
Prašak: bočica (staklo tipa I) zatvorena gumenim (butilnim) čepom i ružičastim „flip-off“ poklopcem (aluminij i plastika).
Subcutaneous use
Potkožna primjena
Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a yellow flip-off cap (aluminium and plastic).
Prašak: bočica (staklo tipa I) zatvorena gumenim (butilnim) čepom i žutim „flip-off“ poklopcem (aluminij i plastika).
Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a green flip-off cap (aluminium and plastic).
Prašak: bočica (staklo tipa I) zatvorena gumenim (butilnim) čepom i zelenim „flip-off“ poklopcem (aluminij i plastika).
NAME OF THE MEDICINAL PRODUCT Somatropin Biopartners 7 mg powder and solvent for prolonged-release suspension for injection
Somatropin Biopartners 7 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
NAME OF THE MEDICINAL PRODUCT Somatropin Biopartners 4 mg powder and solvent for prolonged-release suspension for injection
Somatropin Biopartners 4 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
Powder: Vial (type I glass) closed with a rubber stopper (butyl) and a light-green flip-off cap (aluminium and plastic).
Prašak: bočica (staklo tipa I) zatvorena gumenim (butilnim) čepom i svijetlozelenim „flip-off“ poklopcem (aluminij i plastika).
Somatropin Biopartners 2 mg powder for prolonged-release suspension for injection somatropin
Somatropin Biopartners 2 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem
MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/002 4 vials of powder and 4 vials of solvent
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/13/849/002 4 bočice praška i 4 bočice otapala 13. BROJ SERIJE
QUALITATIVE AND QUANTITATIVE COMPOSITION One vial delivers 2 mg of somatropin* (corresponding to 6 IU).
Jedna bočica osigurava 2 mg somatropina* (što odgovara 6 IU).
Solvent: Vial (Type I glass) closed with a rubber stopper (butyl) and a flip-off cap (aluminium and plastic).
Otapalo: bočica (staklo tipa I) zatvorena gumenim (butilnim) čepom i „flip-off“ poklopcem (aluminij i plastika).
Somatropin Biopartners 7 mg powder and solvent for prolonged-release suspension for injection Somatropin
Somatropin Biopartners 7 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem somatropin za odrasle
MARKETING AUTHORISATION NUMBER(S) EU/1/13/849/003 4 vials of powder and 4 vials of solvent
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU//1/13/849/003 4 bočice praška i 4 bočice otapala 13. BROJ SERIJE
Somatropin Biopartners 4 mg powder for prolonged-release suspension for injection somatropin
Somatropin Biopartners 4 mg prašak i otapalo za suspenziju za injekciju s produljenim oslobađanjem somatropin za odrasle
Gently pinch the skin that has been cleaned, to make a fold.
Nježno uhvatite nabor očišćene kože prstima.
It is available as 20-mg tablets.
Dostupan je u obliku tableta od 20 mg.
Further information on Doptelet can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/doptelet.
Više informacija o lijeku Doptelet dostupno je na internetskim stranicama Agencije: ema.europa.eu/medicines/human/EPAR/doptelet.
Treatment with Doptelet should start at least 10 days before the procedure.
Terapiju lijekom Doptelet treba započeti najmanje 10 dana prije postupka.
What is Doptelet and what is it used for?
Što je Doptelet i za što se koristi?
Other information about Doptelet
Ostale informacije o lijeku Doptelet
What measures are being taken to ensure the safe and effective use of Doptelet?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Doptelet?
The dose is 2 or 3 tablets (depending on the platelet count at the start of treatment), daily for 5 days.
Doza je 2 ili 3 tablete (ovisno o broju trombocita na početku liječenja) dnevno tijekom razdoblja od 5 dana.
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).
Lijek se primjenjuje u bolesnika koji će biti podvrgnuti invazivnom postupku (medicinskom postupku koji podrazumijeva rezanje ili punkciju kože ili uvođenje instrumenata u tijelo).
The European Medicines Agency decided that Doptelet's benefits are greater than its risks and it can be authorised for use in the EU.
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.
Side effects reported with Doptelet are carefully evaluated and any necessary action taken to protect patients.
Nuspojave prijavljene za lijek Doptelet pažljivo se procjenjuju i poduzimaju se potrebne mjere za zaštitu bolesnika.
Doptelet can only be obtained with a prescription.
Doptelet se izdaje samo na recept.
The most common side effect with Doptelet (which may affect up to 1 in 10 people) is tiredness.
Najčešća nuspojava lijeka Doptelet (koja se može javiti u najviše 1 na 10 osoba) je umor.
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.
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.
An overview of Doptelet and why it is authorised in the EU
Pregled informacija o lijeku Doptelet i zašto je odobren u EU-u
What are the risks associated with Doptelet?
Koji su rizici povezani s lijekom Doptelet?
A blood test on the day of the procedure is necessary to ensure that the platelet count is adequate and not unexpectedly high.
Na dan postupka potrebno je obaviti krvnu pretragu kako bi se zajamčilo da je broj trombocita primjeren, a ne neočekivano visok.
Why is Doptelet authorised in the EU?
Zašto je lijek Doptelet odobren u EU-u?