natgillin/translations-raw huggingface dataset:
Voncento 250 IU FVIII / 600 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion Voncento 500 IU FVIII / 1200 IU VWF(10 ml solvent) powder and solvent for solution for injection/infusion Voncento 500 IU FVIII / 1200 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion Voncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusion human coagulation factor VIII, human von Willebrand factor
Voncento 250 IU FVIII / 600 IU VWF (5 ml otapala) prašak i otapalo za otopinu za injekciju/infuziju Voncento 500 IU FVIII / 1200 VWF (10 ml otapala) prašak i otapalo za otopinu za injekciju/infuziju Voncento 500 IU FVIII / 1200 VWF (5 ml otapala) prašak i otapalo za otopinu za injekciju/infuziju Voncento 1000 IU FVIII / 2400 VWF (10 ml otapala) prašak i otapalo za otopinu za injekciju/infuziju humani faktor zgrušavanja VIII, humani von Willebrandov faktor
Presentations with 500 IU FVIII / 1200 IU VWF (10 ml solvent) and 1000 IU FVIII / 2400 IU VWF (10 ml solvent): contain up to 29.50 mg (1.28 mmol) sodium per vial, equivalent to 1.48% of the WHO recommended maximum daily intake of 2 g sodium for an adult.
Pakiranje lijeka od 500 IU FVIII / 1200 IU VWF (10 ml otapala) i 1000 IU FVIII / 2400 IU VWF (10 ml otapala): sadrži do 29,50 mg (1,28 mmol) natrija po bočici, što odgovara 1,48 % maksimalnog dnevnog unosa od 2g natrija prema preporukama SZO za odraslu osobu.
In some cases shorter dose intervals or higher doses may be necessary.
U nekim slučajevima bi mogli biti potrebni kraći razmaci doziranja ili veće doze.
Powder and solvent for solution for injection/infusion.
Prašak i otapalo za otopinu za injekciju/infuziju.
When using a FVIII-containing VWF product, the treating physician should be aware that continued treatment may cause an excessive rise in FVIII:C. After 24 - 48 hours of treatment, in order to avoid an excessive rise in FVIII:C, reduced doses and/or prolongation of the dose interval or the use of a VWF product containing a low level of FVIII should be considered (see section 5.2).
Nakon 24-48 sati liječenja, kako bi se izbjegao prekomjerni porast u FVIII:C, potrebno je razmotriti smanjenje doze i/ili produljenje intervala doziranja ili uporabu lijeka s VWF koji sadrži niske razine FVIII (vidjeti dio
Gently swirl the product vial with the transparent adapter attached until the substance is fully dissolved.
Lagano okrećite bočicu s lijekom s pričvršćenim prozirnim nastavkom sve dok se prašak potpuno ne otopi.
500 IU FVIII and 1200 IU VWF per vial; after reconstitution with 5 ml of water for injection approx.
500 IU FVIII i 1200 IU VWF po bočici; nakon pripreme za primjenu s 5 ml vode za injekcije približno
- 500 IU* human coagulation factor VIII** (FVIII).
- 500 IU* ljudskog koagulacijskog faktora VIII** (FVIII).
Repeat infusion every 8 - 24 hours until threat is resolved.
Ponovite infuziju svakih 8 - 24
• Abnormal liver function test
Odstupanja u rezultatima testova jetrene funkcije
- 250 IU* human coagulation factor VIII** (FVIII).
- 250 IU* ljudskog koagulacijskog faktora VIII** (FVIII).
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 10 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica na bočici za otapalo 10 ml
What Voncento is and what it is used for What you need to know before you use Voncento How to use Voncento
Što morate znati prije nego počnete primjenjivati Voncento Kako primjenjivati Voncento
Paediatric population von Willebrand disease
Pedijatrijska populacija s Von Willebrandovom bolesti
Place the solvent vial on an even, clean surface and hold the vial tight.
2. Bočicu s otapalom stavite na ravnu, čistu površinu i čvrsto je uhvatite.
Attach the syringe to the threaded, locking end of the venipuncture kit.
Pričvrstite štrcaljku na navojni, blokadni kraj kompleta za venepunkciju.
1 vial with 10 ml water for injections 1 filter transfer device 20/20
1 bočica s 10 ml vode za injekcije 1 sustav za prijenos s filterom 20/20
For storage conditions after reconstitution of the medicinal product, see section 6.3.
Uvjete čuvanja nakon rekonstitucije lijeka vidjeti u dijelu 6.3. 6.5 Vrsta i sadržaj spremnika
1 vial with 5 ml water for injections 1 filter transfer device 20/20
1 bočica s 5 ml vode za injekcije 1 sustav za prijenos s filterom 20/20
- 600 IU*** human von Willebrand factor** (VWF).
- 600 IU*** ljudskog von Willebrandova faktora** (VWF).
5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
5 ml otapala u bočici (staklo tipa I), s čepom (guma), diskom (plastika) i zatvaračem (aluminij).
10 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
10 ml otapala u bočici (staklo tipa I), s čepom (guma), diskom (plastika) i zatvaračem (aluminij).
CSL Behring S.A. Tél: + 33 -(0)-1 53 58 54 00
Tél: + 33 -(0)-1 53 58 54 00
AM Mangion Ltd. Tel: +356 2397 6333
Tel: +356 2397 6333
• von Willebrand disease
• Von Willebrandova bolest
Haemorrhage
Sljedivost
- 1200 IU*** human von Willebrand factor** (VWF).
- 1200 IU*** ljudskog von Willebrandova faktora** (VWF).
- 2400 IU*** human von Willebrand factor** (VWF).
- 2400 IU*** ljudskog von Willebrandova faktora** (VWF).
Following infusion, peak concentrations of VWF markers (VWF:RCo, VWF:Ag, and VWF:CB) and FVIII:C were achieved immediately with a median IR of 0.012-0.016 (IU/mL)/(IU/kg) for VWF markers and 0.018-0.020 (IU/mL)/(IU/kg) for FVIII:C. The median elimination t1/2 of VWF markers was between 10.00 and 13.48 h whereas FVIII:C had a longer t1/2 between 11.40 and 19.54 h due to a plateau effect that may represent the net effect of decreasing levels of exogenous FVIII, combined with increasing endogenous FVIII levels.
Vršne koncentracije VWF markera (VWF:RCo, VWF:Ag, i VWF:CB) i FVIII:C postignute su odmah nakon infuzije sa medijanom IR vrijednosti od 0,012-0,016 (IU/mL)/(IU/kg) za VWF markere i 0,018-0,020
Administered intravenously, VWF binds to endogenous FVIII (which is produced normally by the patient), and by stabilising this factor, avoids its rapid degradation.
Kad se primijeni intravenski VWF se veže za endogeni FVIII (koji se inače stvara u organizmu bolesnika) te se,
If you get any side effects, talk to your doctor, nurse or pharmacist.
Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
AUC = area under the curve; Cmax = maximum plasma concentration; IU = International Unit; MRT = mean residence time; N = number of subjects; tmax = time to maximum concentration occurs; Vss = volume of distribution at steady state; VWF:Ag = von Willebrand factor: Antigen; VWF:CB = von Willebrand factor: Collagen Binding; VWF:RCo = von Willebrand factor:
AUC = površina ispod krivulje; Cmax = maksimalna koncentracija u plazmi; IU = međunarodna jedinica; MRT = srednje vrijeme zadržavanja; N = broj ispitanika; tmax = vrijeme do postizanja maksimalne koncentracije; Vss = volumen distribucije u stanju dinamičke ravnoteže; VWF:Ag = Von Willebrandov factor: Antigen; VWF:CB = Von Willebrandov factor: kolagen vezajući; VWF:RCo = Von Willebrandov factor: Ristocetin kofaktor; FVIII:C= faktor VIII:koagulans
Voncento is used for all age groups to prevent or to halt bleeding caused by the lack of VWF in von Willebrand disease (VWD) and the lack of FVIII in haemophilia A. Voncento is only used when treatment with another medicine, desmopressin, is not effective alone or cannot be given.
Voncento se koristi za sve dobne skupine za sprječavanje ili prekid krvarenja uzrokovan manjkom von Willebrandova faktora (von Willebrandova bolest) i faktora VIII (hemofilija A) u krvi.
Usually 40 - 80 IU/kg of von Willebrand factor (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended in paediatric patients to treat a bleed.
Von Willebrandov factor (VWF:RCo) od 40-80 IU/kg koji odgovara 20 - 40 IU FVIII:C/kg tjelesne težine su obično preporučeni za liječenje krvarenja kod pedijatrijskih bolesnika.
AUC = area under the curve; Cmax = maximum plasma concentration; Cmin = minimum plasma concentration; IU = International Unit; MRT = mean residence time; N = number of subjects; tmax = time to maximum concentration; Vss = volume of distribution at steady state; FVIII:C = Factor VIII: Coagulant
AUC = površina ispod krivulje; Cmax = maksimalna plazmatska koncentracija; Cmin = minimalna plazmatska koncentracija; IU = međunarodna jedinica; MRT = prosječno vrijeme zadržavanja; N = broj ispitanika; Tmax = vrijeme do postizanja maksimalne koncentracije; Vss = volumen distribucije u stanju dinamičke ravnoteže; FVIII:C= faktor VIII:koagulans
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 5 ml
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Naljepnica na bočici za otapalo 5 ml
• Headache
• Glavobolja.
Total clearance (mL/(h*kg))
Ukupni klirens (mL/(h*kg))
Inject air into the product vial.
Istisnite zrak u bočicu s lijekom.
For long term prophylaxis in patients with VWD, a dose of 25 - 40 IU VWF:RCo /kg body weight should be considered at a frequency of 1 to 3 times per week.
25 - 40 IU VWF:RCo/kg tjelesne težine 1 do 3 puta tjedno.
This is equivalent to 0.74 % of the recommended maximum daily dietary intake of sodium for an adult.
preporučenog maksimalnog dnevnog unosa soli za odraslu osobu.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 1000 IU/2400 IU
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica s praškom 1000 IU/2400 IU
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 250 IU/600 IU
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica s praškom 250 IU/600 IU
Total clearance (mL/(h*kg)
Ukupni klirens (mL/(h*kg)
coagulation factor VIII 1000 IU von Willebrand factor 2400 IU
faktor zgrušavanja VIII 1000 IU von Willebrandov faktor 2400 IU
Now that the solution has been transferred into the syringe, firmly hold on to the barrel of the syringe (keeping the syringe plunger facing down) and disconnect the transparent Mix2Vial adapter from the syringe by unscrewing counterclockwise.
Kad je otopina prenesena u štrcaljku čvrsto uhvatite tijelo štrcaljke (dok je klip štrcaljke okrenut prema dolje) i odspojite prozirni nastavak
Please contact your doctor immediately if: • you notice symptoms of allergic reactions
Odmah se obratite liječniku ako:
Invert the solvent vial with the Mix2Vial set attached and push the spike of the transparent adapter end straight down through the product vial stopper.
Preokrenite bočicu s otapalom s pričvršćenim kompletom Mix2Vial i gurnite šiljak na kraju prozirnog nastavka ravno prema dolje kroz čep bočice s lijekom.
After reconstitution with the 5 ml water for injections provided, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF.
Nakon rekonstitucije s 5 ml vode za injekcije koja je priložena, otopina sadrži 50 IU/ml FVIII i 120 IU/ml VWF.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Powder vial 500 IU/1200 IU
PODACI KOJE MORA NAJMANJE SADRŽAVATI MALO UNUTARNJE PAKIRANJE Bočica s praškom 500 IU/1200 IU
• Keep this medicine out of the sight and reach of children.
Kako čuvati Voncento • Lijek čuvajte izvan pogleda i dohvata djece.
After reconstitution with the 10 ml water for injections provided, the solution contains 100 IU/ml of FVIII and 240 IU/ml of VWF.
Nakon rekonstitucije s 10 ml vode za injekcije koja je priložena, otopina sadrži 100 IU/ml FVIII i 240 IU/ml VWF.
Administration set
Set za primjenu
The pharmacokinetics of Voncento have been evaluated in VWD patients in the non-bleeding state.
Voncenta procijenjena je u bolesnika s von Willebrandovom bolešću u stanju bez krvarenja.
Solvent Water for injections
Trometamol Otapalo voda za injekcije
AUC = area under the curve; Cmax = maximum plasma concentration; Cmin = minimum plasma concentration; IU = International Unit; MRT = mean residence time; N = number of subjects;tmax = time to maximum concentration; Vss = volume of distribution at steady state; VWF:Ag = von Willebrand factor: Antigen; VWF:CB = von Willebrand factor:
AUC = površina ispod krivulje; Cmax = maksimalna plazmatska koncentracija; Cmin = minimalna plazmatska koncentracija; IU = međunarodna jedinica; MRT = prosječno vrijeme zadržavanja; N = broj ispitanika; Tmax = vrijeme do postizanja maksimalne koncentracije; Vss = volumen distribucije u stanju dinamičke ravnoteže; VWF:Ag = von Willebrandov faktor: antigen; VWF:CB = von Willebrandov faktor: vezni kolagen; VWF:RCo = von Willebrandov faktor: ristocetin kofaktor, FVIII:C = faktor VIII: koagulans.
After reconstitution with the 10 ml water for injections provided, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF.
Nakon rekonstitucije s 10 ml vode za injekcije koja je priložena, otopina sadrži 50 IU/ml FVIII i 120 IU/ml VWF.
coagulation factor VIII 250 IU von Willebrand factor 600 IU
faktor zgrušavanja VIII 250 IU von Willebrandov faktor 600 IU
Name and address of the manufacturer(s) of the biological active substances
Naziv i adresa proizvođača bioloških djelatnih tvari CSL Behring AG
human coagulation factor VIII 1000 IU human von Willebrand factor 2400 IU
ljudski koagulacijski faktor VIII 1000 IU ljudski von Willebrandov faktor 2400 IU
von Willebrand disease
Von Willebrandova bolest
Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Mix2Vial držeći ga za rub i povlačeći ga okomito prema gore.
Usually 40 - 80 IU/kg of von Willebrand factor (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended to achieve haemostasis.
Obično se za postizanje hemostaze preporučuje 40 - 80 IU/kg von Willebrandova faktora (VWF:RCo), što odgovara 20 - 40 IU FVIII:C po kg tjelesne težine.
human coagulation factor VIII 250 IU human von Willebrand factor 600 IU
ljudski koagulacijski faktor VIII 250 IU ljudski von Willebrandov faktor 600 IU
Cmax (IU/mL)
Cmax (IU/mL) Tmax (sati) Cmin (IU/mL)
human coagulation factor VIII 500 IU human von Willebrand factor 1200 IU
ljudski koagulacijski faktor VIII 500 IU ljudski von Willebrandov faktor 1200 IU
CSL Behring GmbH, 35041 Marburg, Germany
11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET CSL Behring GmbH, 35041 Marburg, Njemačka
After filtering/withdrawal (see below) the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.
rekonstituirani lijek treba vizualno pregledati na prisutnost čestica i promjenu boje prije same primjene.
powder and solvent for solution for injection/infusion 1 vial with powder
prašak i otapalo za injekciju/infuziju
• If you get any side effects talk to your doctor, nurse or pharmacist.
• Ako primijetite bilo koju nuspojavu, potrebno je obavijestiti liječnika, ljekarnika ili medicinsku sestru.
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products, diluents or solvents except those mentioned in section 6.1.
Zbog nedostatka ispitivanja kompatibilnosti, ovaj lijek se ne smije miješati s drugim lijekovima,
Voncento 1000 IU FVIII / 2400 IU VWF powder for solution for injection/infusion ForIV use
Voncento 1000 IU FVIII / 2400 IU VWF prašak i otapalo za otopinu za injekciju/infuziju
coagulation factor VIII 500 IU von Willebrand factor 1200 IU
faktor zgrušavanja VIII 500 IU von Willebrandov faktor 1200 IU
Posology von Willebrand disease
Doziranje von Willebrandova bolest
Voncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusionhuman coagulation factor VIII/human von Willebrand factor
Voncento 1000 IU FVIII / 2400 IU VWF (10 ml otapala) prašak i otapalo za otopinu za injekciju/infuziju ljudski koagulacijski faktor VIII/ljudski von Willebrandov faktor
Voncento 250 IU FVIII / 600 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion human coagulation factor VIII/human von Willebrand factor
Voncento 250 IU FVIII / 600 IU VWF(5ml otapala) prašak i otapalo za otopinu za injekciju/infuziju ljudski koagulacijski faktor VIII/ljudski von Willebrandov faktor
Voncento 250 IU FVIII / 600 IU VWF powder for solution for injection/infusion For IV use
Voncento 250 IU FVIII / 600 IU VWF prašak za otopinu za injekciju/infuziju Za i.v. primjenu
The presentations 250 IU FVIII /600 IU VWF (5 ml solvent) and 500 IU FVIII /1200 IU VWF (5 ml solvent) contain up to 14.75 mg sodium per vial (main component of cooking/table salt).
Pakiranja 250 IU FVIII /600 IU VWF (5 ml otapala) i 500 IU FVIII / 1200 IU VWF (5 ml otapala)
CSL Behring AB Puh/Tel: +46 8 544 966 70
Suomi/Finland CSL Behring AB Puh/Tel: +46 8 544 966 70
Voncento 500 IU FVIII / 1200 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusionhuman coagulation factor VIII/human von Willebrand factor
Voncento 500 IU FVIII /1200 IU VWF (5 ml otapala) prašak i otapalo za otopinu za injekciju/infuziju ljudski koagulacijski faktor VIII/ljudski von Willebrandov faktor
Voncento 500 IU FVIII / 1200 IU VWF(10 ml solvent) powder and solvent for solution for injection/infusion human coagulation factor VIII/human von Willebrand factor
Voncento 500 IU FVIII / 1200 IU VWF (10 ml otapala) prašak i otapalo za otopinu za injekciju/infuziju ljudski koagulacijski faktor VIII/ljudski von Willebrandov faktor
Prophylaxis treatment
Farmakokinetika
• you notice any symptoms of an impaired perfusion in your extremities (e.g. cold and pale extremities) or vital organs (e.g. severe chest pain)
• primijetite bilo kakve simptome oslabljenog protoka krvi u udovima (na primjer hladne i blijede ruke i noge) ili vitalnim ogranima (npr. jaka bol u prsnom košu) Postoji i rizik od nastanka krvnih ugrušaka (tromboza), posebice u bolesnika s poznatim čimbenicima rizika (vidjeti također dio 2.) Sljedeće nuspojave opažene su vrlo često (mogu se javiti u više od 1 na 10 osoba):
Voncento 250 IU FVIII / 600 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion
Voncento 250 IU FVIII / 600 IU VWF prašak i otapalo za otopinu za injekciju/infuziju
Other medicines and Voncento
Izvlačenje lijeka i primjena
Paediatric haemophilia A population
Pedijatrijska populacija s hemofilijom A
Voncento 500 IU FVIII / 1200 IU VWF powder for solution for injection/infusion For IV use
Voncento 500 IU FVIII / 1200 IU VWF prašak za otopinu za injekciju/infuziju Za i.v. primjenu
Voncento 500 IU FVIII /1200 IU VWF powder for solution for injection/infusion For IV use
Voncento 500 IU FVIII /1200 IU VWF prašak za otopinu za injekciju/infuziju Za i.v. primjenu
Voncento 250 IU FVIII / 600 IU VWF powder and solvent for solution for injection/infusion Powder (250 IU/600 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Prašak (250 IU/600 IU) u bočici (staklo tipa I), s čepom (guma), diskom (plastika) i zatvaračem
Voncento 500 IU FVIII / 1200 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion
Voncento 500 IU FVIII / 1200 IU VWF prašak i otapalo za otopinu za injekciju/infuziju
After reconstitution with the 5 ml water for injections provided, the solution contains 100 IU/ml of FVIII and 240 IU/ml of VWF.
Nakon rekonstitucije s 5 ml vode za injekcije koja je priložena, otopina sadrži 100 IU/ml FVIII i 240
Voncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusion
1 nesterilni flaster Voncento 1000 IU FVIII / 2400 IU VWF prašak i otapalo za otopinu za injekciju/infuziju
1 disposable 10 ml syringe
1 bočica s 5 ml vode za injekcije
Voncento 500 IU FVIII / 1200 IU VWF powder and solvent for solution for injection/infusion Powder (500 IU/1200 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Prašak (500 IU/1200 IU) u bočici (staklo tipa I), s čepom (guma), diskom (plastika) i zatvaračem
Voncento 1000 IU FVIII / 2400 IU VWF powder and solvent for solution for injection/infusion Powder (1000 IU/2400 IU) in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
Prašak (1000 IU/1200IU) u bočici (staklo tipa I), s čepom (guma), diskom (plastika) i zatvaračem
--1 Per 1 ml dose: purified p45 FeLV-envelope antigen, minimum quantity 102 µg
--1 Po dozi 1 ml: najmanja količina pročišćenog antigena omotača p45 FeLV 102 µg
EU (MA) number Invente d name
Izmišljeno ime
This summary was last updated in 08-2014.
Ovaj sažetak je posljednji put ažuriran u 08.2014.
Lyxumia is injected once a day, in the hour before the same meal every day.
Lyxumia se injektira jednom na dan u satu prije istog obroka svaki dan.
The full EPAR for Lyxumia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjelovito europsko javno izvješće o ocjeni dokumentacije o lijeku Lyxumia (EPAR) može se naći na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Allergic reactions have been reported in less than 1 in 100 patients using Lyxumia.
Alergijske reakcije prijavljene su kod manje od 1 na 100 bolesnika koji su koristili lijek Lyxumia.
The European Commission granted a marketing authorisation valid throughout the European Union for Lyxumia on 1 February 2013.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Lyxumia na snazi u Europskoj uniji od 1. veljače 2013.
Adding Lyxumia to metformin is not associated with this risk.
Dodavanje lijeka Lyxumia metforminu nije povezano s ovim rizikom.
These side effects were mostly mild and usually resolved over time.
Te su nuspojave najčešće bile blage i obično su se povukle s vremenom.
This is a summary of the European public assessment report (EPAR) for Lyxumia.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Lyxumia.
What measures are being taken to ensure the safe and effective use of Lyxumia?
Koje se mjere poduzimaju kako bi se osigurala sigurna i učinkovita primjena lijeka Lyxumia?
It is available as a solution for injection in a pre-filled pen that provides either 10 micrograms or 20 micrograms of lixisenatide in each dose.
Dostupan je kao otopina za injekciju u napunjenoj štrcaljki koja isporučuje 10 mikrograma ili 20 mikrograma liksisenatida u svakoj dozi.
Lyxumia has been studied in seven main studies involving 3,825 adults with type 2 diabetes.
Lyxumia je ispitivana u sedam glavnih ispitivanja koja su uključivala 3 825 odraslih bolesnika s dijabetesom tipa 2.
Lyxumia lixisenatide
Lyxumia liksisenatid
Other information about Lyxumia
Ostale informacije o lijeku Lyxumia
When Lyxumia is injected, lixisenatide reaches the receptors in the pancreas and activates them.
Kad se Lyxumia injektira liksisenatid doseže receptore u gušterači i aktivira ih.
Lyxumia is started at a dose of 10 micrograms once a day which is increased to 20 micrograms once a day after 14 days.
Terapija lijekom Lyxumia počinje s dozom od 10 mikrograma jednom na dan što se povećava na 20 mikrograma jednom na dan nakon 14 dana.
For more information about treatment with Lyxumia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Više informacija o terapiji lijekom Lyxumia pročitajte u uputi o lijeku (također dio EPAR-a) ili se obratite svom liječniku ili ljekarniku.
If the patient is already taking a sulphonylurea (another diabetes medicine) or basal insulin, the doctor may need to reduce the dose of the sulphonylurea or basal insulin because there is a risk of hypoglycaemia (low blood sugar levels).
Ako bolesnik već uzima sulfonilureju (drugi lijek protiv dijabetesa) ili bazalni inzulin, liječnik će možda morati smanjiti dozu sulfonilureje ili bazalnog inzulina jer postoji rizik od hipoglikemije (niskih razina šećera u krvi).
Lyxumia was more effective than placebo at controlling blood glucose.
Lyxumia se pokazala djelotvornijom od placeba prilikom kontrole glukoze u krvi.
All of the studies measured the change in the level of glycosylated haemoglobin (HbA1c), which is the percentage of haemoglobin in the blood that has glucose attached.
Sva su ispitivanja mjerila promjenu u razini glikoliziranog hemoglobina (HbA1c) što je postotak hemoglobina u krvi koji veže glukozu.