natgillin/translations-raw huggingface dataset:
Dosing in in haemophilia A in children and adolescents aged ˂ 18 years is based on body weight and is therefore generally based on the same guidelines as for adults.
Odmerjanje pri hemofiliji A pri otrocih in mladostnikih, starih < 18 let, temelji na telesni masi in zato na splošno temelji na istih smernicah, kot veljajo za odrasle.
Incremental recovery (IU/mL)/(IU/kg) Half-life (h)
6-12 let postopna povrnitev aktivnosti (i.e./mL)/(i.e./kg) Half-life (h)
Powder and solvent for solution for injection/infusion.
prašek in vehikel za raztopino za injiciranje/infundiranje
-not applicable
Navedba smiselno ni potrebna
5.2 Pharmacokinetic properties von Willebrand disease
5.2 Farmakokinetične lastnosti
Pharmacotherapeutic group: antihaemorrhagics,blood coagulation factors, von Willebrand factor and coagulation factor VIII in combination, ATC code: B02BD06
Farmakoterapevtska skupina: antihemoragiki, krvni koagulacijski faktorji, kombinacija von
Exp. date
DRUGI PODATKI
Attach the syringe to the threaded, locking end of the venipuncture kit.
Pritrdite injekcijsko brizgo na navojni, zaklepalni konec kompleta za punkcijo vene.
On demand treatment
Zdravljenje po potrebi
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 pod krivuljo (area under the curve); Cmax = maksimalna koncentracija v plazmi; Cmin = minimalna koncentracija v plazmi; i,,e, = mednarodne enote; MRT = povprečni čas zadrževanja (mean residence time); N = število preiskovancev; tmax = čas do maksimalne koncentracije; Vss = volumen porazdelitve v stanju dinamičnega ravnovesja (steady state); VWF:Ag = von Willebrandov faktor: antigen; VWF:CB = von Willebrandov faktor: vezava na kolagen; VWF:RCo =
In case large volumes of Voncento are required, it is possible to pool several vials of Voncento via a commercially available infusion set (e.g. a syringe pump for intravenous application of medicinal products).
Voncento preko komercialno dostopnih infuzijskih kompletov (npr. črpalke za brizgo za intravensko aplikacijo zdravil).
1 vial with 5 ml water for injections 1 filter transfer device 20/20
1 viala s 5 ml vode za injekcije 1 priprava za prenos s filtrom 20/20
human coagulation factor VIII 1000 IU human von Willebrand factor 2400 IU
humani koagulacijski faktor VIII 1000 i.e. humani von Willebrandov faktor 2400 i.e.
Administration set
Set za dajanje
Haemorrhage
Zaviralci
The reconstituted solution should be clear to slightly opalescent, i.e. it might sparkle when held up to the light but must not contain any obvious particles.
lahko se svetlika, če jo držite proti svetlobi, vendar v njej ne sme biti vidnih delcev.
coagulation factor VIII 1000 IU von Willebrand factor 2400 IU
koagulacijski faktor VIII 1000 i.e. von Willebrandov faktor 2400 i.e.
Repeat infusion every 12 to 24 hours for at least 1 day, until the bleeding episode as indicated by pain is resolved or healing is achieved.
ur, vsaj 1 dan, dokler krvavitev, sodeč po bolečini, ne preneha ali dokler se ne zaceli.
Paediatric haemophilia A population
Pediatrična populacija s hemofilijo A
1 vial with 10 ml water for injections 1 filter transfer device 20/20
1 viala s 10 ml vode za injekcije 1 priprava za prenos s filtrom 20/20
If symptoms of hypersensitivity occur, you should stop using the medicine immediately and contact your doctor.
Če se pojavijo simptomi preobčutljivosti, nemudoma prenehajte z uporabo zdravila in pokličite svojega zdravnika.Vaš zdravnik vas bo poučil o zgodnjih znakih preobčutljivostnih reakcij.
1 disposable 10 ml syringe 1 venipuncture set 2 alcohol swabs
1 injekcijska brizga (10 ml) za enkratno uporabo 1 komplet za punkcijo vene 2 alkoholni blazinici
Talk to your doctor, nurse or pharmacist before taking Voncento.
Pred začetkom uporabe zdravila Voncento se posvetujte z zdravnikom, medicinsko sestro ali farmacevtom.
10 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
10 ml vehikla v viali (steklo tipa I), z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko
Baseline-adjusted initial PK parameters of FVIII:C in subjects <6 (N=15) and 6-12 years old (N=16) FVIII:C
(N=15) in 6-12 let (N=16)
Following infusion, peak concentrations of FVIII:C were achieved immediately with a median IR of approximately 0.016 (IU/mL)/(IU/kg) for FVIII:C. The median elimination t1/2 of FVIII:C was approximately 10 h. PK parameters from the repeat PK evaluation were similar to those from initial PK. Voncento exposure and disposition were comparable between <6-year-old and 6-12-year-old subjects.
(i.e./mL)/(i.e./kg) za FVIII:C. Mediani razpolovni čas t1/2 za FVIII:C je znašal približno 10 h.
5 ml of solvent in a vial (type I glass), with a stopper (rubber) a disc (plastic) and a cap (aluminium).
5 ml vehikla v viali (steklo tipa I), z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko
human coagulation factor VIII 250 IU human von Willebrand factor 600 IU
humani koagulacijski faktor VIII 250 i.e. humani von Willebrandov faktor 600 i.e.
Immune system disorders
MedDRA glede na organske sisteme
After reconstitution with the 5 ml water for injections provided, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF.
Po rekonstituciji s priloženimi 5 ml vode za injekcije vsebuje raztopina 50 i.e./ml FVIII in 120 i.e./ml VWF.
For children not previously treated with factor VIII medicines, inhibitor antibodies (see section
Pri otrocih, ki se predhodno še niso zdravili s faktorjem VIII, se lahko zelo pogosto (pri več kot
Carefully remove the blister package from the Mix2Vial set by holding at the rim, and pulling vertically upwards.
Mix2Vial, tako da ga primete za obod in potegnete navpično navzgor.
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:
MRT = povprečni čas zadrževanja (mean residence time); N = število preiskovancev; tmax = čas do maksimalne koncentracije; Vss = volumen porazdelitve v stanju dinamičnega ravnovesja (steady state); VWF:Ag = von Willebrandov faktor: antigen; VWF:CB = von Willebrandov faktor: vezava na kolagen; VWF:RCo = von Willebrandov faktor:
coagulation factor VIII 250 IU von Willebrand factor 600 IU
koagulacijski faktor VIII 250 i.e. von Willebrandov faktor 600 i.e.
human coagulation factor VIII 500 IU human von Willebrand factor 1200 IU
humani koagulacijski faktor VIII 500 i.e. humani von Willebrandov faktor 1200 i.e.
DATE OF FIRST AUTHORIZATION/RENEWAL OF THE AUTHORIZATION
DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM
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.
Obrnite vialo z vehiklom, na katero je pritrjen komplet Mix2Vial, in porinite konico prozornega adapterja naravnost navzdol skozi zamašek viale z zdravilom.
After reconstitution with the 10 ml water for injections provided, the solution contains 100 IU/ml of FVIII and 240 IU/ml of VWF.
Po rekonstituciji s priloženimi 10 ml vode za injekcije vsebuje raztopina 100 i.e./ml FVIII in 240 i.e./ml VWF.
Half-life (h)
razpolovni čas (h)
After filtering/withdrawal (see below) the reconstituted product should be inspected visually for particulate matter and discoloration prior to administration.
Po filtraciji/izsesanju (glejte spodaj) pred dajanjem preverite videz pripravljenega zdravila, da ne vsebuje delcev ali da ni obarvanj.
After reconstitution with the 10 ml water for injections provided, the solution contains 50 IU/ml of FVIII and 120 IU/ml of VWF.
Po rekonstituciji s priloženimi 10 ml vode za injekcije vsebuje raztopina 50 i.e./ml FVIII in 120 i.e./ml VWF.
Incremental recovery (IU/mL)/(IU/kg)
N mediana razpon postopna povrnitev aktivnosti (i.e./mL)/(i.e./kg)
Voncento 1000 IU FVIII / 2400 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusion
Voncento 1000 i.e. FVIII/ 2400 i.e. VWF (10 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje
Voncento 1000 IU FVIII / 2400 IU VWF powder for solution for injection/infusion ForIV use
Voncento 1000 i.e. FVIII/ 2400 i.e. VWF prašek in vehikel za raztopino za injiciranje/infundiranje
CSL Behring AB Puh/Tel: +46 8 544 966 70
Puh/Tel: +46 8 544 966 70
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 i.e. FVIII/600 i.e. VWF (5 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje humani koagulacijski faktor VIII/humani von Willebrandov faktor
Repeat infusion every 12-24 hours for 3 - 4 days or more until pain and acute disability are resolved.
ur, 3 - 4 dni ali dlje, dokler bolečina in akutna nezmožnost ne izzvenita.
Voncento 250 IU FVIII / 600 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion
Voncento 250 i.e. FVIII/ 600 i.e. VWF (5 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje
coagulation factor VIII 500 IU von Willebrand factor 1200 IU
koagulacijski faktor VIII 500 i.e. von Willebrandov faktor 1200 i.e.
After reconstitution with the 5 ml water for injections provided, the solution contains 100 IU/ml of FVIII and 240 IU/ml of VWF.
Po rekonstituciji s priloženimi 5 ml vode za injekcije vsebuje raztopina 100 i.e./ml FVIII in 240 i.e./ml VWF.
N median (range) N median (range) N median (range) N median (range) N median (range) N median (range) N median (range) N median (range) <6 years 6-12 years <6 years 6-12 years <6 years 6-12 years <6 years 6-12 years
N mediana razpon N mediana razpon <6 let
Fertility
Odmerek
Voncento 500 IU FVIII /1200 IU VWF (10 ml solvent) powder and solvent for solution for injection/infusion
Voncento 500 i.e. FVIII/ 1200 i.e. VWF (10 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje
CSL Behring AB Tlf: +46 8 544 966 70
Tlf: +46 8 544 966 70
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 i.e. FVIII /1200 i.e. VWF (10 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje humani koagulacijski faktor VIII/humani von Willebrandov faktor
Major surgery
Večji kirurški poseg
Usually 40 - 80 IU/kg of VWF (VWF:RCo) corresponding to 20 - 40 IU FVIII:C/kg of body weight (BW) are recommended to achieve haemostasis.
(VWF:RCo) kar ustreza 20 - 40 i.e. FVIII:C/kg telesne mase (TM).
Voncento 500 IU FVIII / 1200 IU VWF (5 ml solvent) powder and solvent for solution for injection/infusion
Voncento 500 i.e. FVIII/ 1200 i.e. VWF (5 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje
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 i.e. FVIII/1200 i.e. VWF (5 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje humani koagulacijski faktor VIII/humani von Willebrandov faktor
Voncento 250 IU FVIII / 600 IU VWF powder for solution for injection/infusion For IV use
Voncento 250 i.e. FVIII/600 i.e. VWF prašek za raztopino za injiciranje/infundiranje za i.v.
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).
Prašek (250 i.e./600 i.e.) v viali (steklo tipa I) z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko (aluminijasta).
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).
Prašek (500 i.e./1200 i.e.) v viali (steklo tipa I) z zamaškom (gumijast), okroglo ploščico (plastična) in zaporko (aluminijasta).
It may harm them, even if their signs of illness are the same as yours.
Njim bi lahko celo škodovalo, čeprav imajo znake bolezni, podobne vašim.
Posology von Willebrand disease
Odmerjanje von Willebrandova bolezen
Voncento 500 IU FVIII / 1200 IU VWF powder for solution for injection/infusion For IV use
Voncento 500 i.e. FVIII/1200 i.e. VWF prašek za raztopino za injiciranje/infundiranje za i.v.
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).
Voncento 1000 i.e. FVIII/ 2400 i.e. VWF prašek in vehikel za raztopino za injiciranje/infundiranje Ena viala s praškom vsebuje nominalno: - 1000 i.e.* humanega koagulacijskega faktorja VIII** (FVIII).
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 i.e. FVIII/2400 i.e. VWF (10 ml vehikel) prašek in vehikel za raztopino za injiciranje/infundiranje humani koagulacijski faktor VIII/humani von Willebrandov faktor prašek in vehikel za raztopino za injiciranje/infundiranje
1 disposable 10 ml syringe 1 venipuncture set
1 injekcijska brizga (10 ml) za enkratno uporabo 1 komplet za punkcijo vene
Common Very common
skupni očistek
250 IU FVIII and 600 IU VWF per vial; after reconstitution with 5 ml of water for injection approx.
250 i.e. FVIII in 600 i.e. VWF na vialo; po pripravi s 5 ml vode za injekcije vsebuje približno 50 i.e./ml FVIII in 120 i.e./ml VWF.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Solvent vial label 5 ml
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
More extensive haemarthrosis, muscle bleeding or haematoma 30 - 60
krvavitev v mišico ali hematom
1 disposable 10 ml syringe
Viala z vehiklom 10 ml
CSL Behring AB Sími: +46 8 544 966 70
Sími: +46 8 544 966 70
Presentations
uporabo
The dose and duration of the substitution therapy depend on the severity of the FVIII deficiency, on the location and extent of the bleeding and on the patient's clinical condition.
Odmerek in trajanje zdravljenja sta odvisna od kliničnega stanja bolnika ter njegovih plazemskih ravni
The following side effects have been observed commonly (may affect up to 1 in 10 people): • Increase in body temperature
Naslednji neželeni učinki so se pojavili pogosto (pojavijo se lahko pri največ 1 od 10 bolnikov):
500 IU FVIII and 1200 IU VWF per vial; after reconstitution with 5 ml of water for injection approx.
500 i.e. FVIII in 1200 i.e. VWF na vialo; po pripravi s 5 ml vode za injekcije vsebuje približno 100 i.e./ml FVIII in 240 i.e./ml VWF.
500 IU FVIII and 1200 IU VWF per vial; after reconstitution with 10 ml of water for injection approx.
500 i.e. FVIII in 1200 i.e. VWF na vialo; po pripravi s 10 ml vode za injekcije vsebuje približno 50 i.e./ml FVIII in 120 i.e./ml VWF.
CSL Behring BV Tel: + 31 85 111 96 00
Slovenská republika CSL Behring s.r.o.Tel: +421 911 653 862
--1 Per 1 ml dose: purified p45 FeLV-envelope antigen, minimum quantity 102 µg
--1 Na odmerek 1 ml: minimalna količina prečiščenega antigena ovojnice p 45FeLV 102 µg
EU (MA) number Invente d name
EU (MA) številka
The European Commission granted a marketing authorisation valid throughout the European Union for Lyxumia on 1 February 2013.
Evropska komisija je dovoljenje za promet z zdravilom Lyxumia, veljavno po vsej Evropski uniji, izdala 1. februarja 2013.
Lyxumia is injected once a day, in the hour before the same meal every day.
Zdravilo Lyxumia se injicira enkrat na dan, vsakič eno uro pred istim obrokom.
These side effects were mostly mild and usually resolved over time.
Ti neželeni učinki so bili večinoma blagi in so s časom izzveneli.
The full EPAR for Lyxumia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Lyxumia je na voljo na spletni strani 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 so bile opažene pri manj kot 1 od 100 bolnikov, ki so uporabljali zdravilo Lyxumia.
This is a summary of the European public assessment report (EPAR) for Lyxumia.
To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Lyxumia.
What measures are being taken to ensure the safe and effective use of Lyxumia?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Lyxumia?
Adding Lyxumia to metformin is not associated with this risk.
Uporaba zdravila Lyxumia skupaj z metforminom ni povezana s tem tveganjem.
Lyxumia has been studied in seven main studies involving 3,825 adults with type 2 diabetes.
Zdravilo Lyxumia so proučevali v sedmih glavnih študijah, v katere je bilo vključenih 3 825 odraslih s sladkorno boleznijo tipa 2.
For more information about treatment with Lyxumia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Lyxumia preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Other information about Lyxumia
Druge informacije o zdravilu Lyxumia
A risk management plan has been developed to ensure that Lyxumia is used as safely as possible.
Za zagotovitev čim varnejše uporabe zdravila Lyxumia je bil pripravljen načrt obvladovanja tveganj.
The CHMP concluded that the benefits of Lyxumia outweigh its risks and recommended that it be granted marketing authorisation.
CHMP je zaključil, da so koristi zdravila Lyxumia večje od z njim povezanih tveganj, in priporočil, da se zanj izda dovoljenje za promet.
What benefit has Lyxumia shown during the studies?
Kakšne koristi je zdravilo Lyxumia izkazalo med študijami?
HbA1c gives an indication of how well the blood glucose is controlled.
HbA1c kaže, kako dobro je glukoza v krvi uravnavana.
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.
V vseh študijah so merili spremembo ravni glikoziliranega hemoglobina (HbA1c), kar je odstotek hemoglobina v krvi, na katerega je vezana glukoza.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Lyxumia.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil to zdravilo, na podlagi česar je oblikoval mnenje za izdajo dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Lyxumia is started at a dose of 10 micrograms once a day which is increased to 20 micrograms once a day after 14 days.
Zdravilo Lyxumia se daje najprej enkrat na dan v 10-mikrogramskem odmerku, ki se po 14 dneh poviša na 20 mikrogramov enkrat na dan.
Lyxumia was more effective than placebo at controlling blood glucose.
Zdravilo Lyxumia je bilo učinkovitejše od placeba pri uravnavanju glukoze v krvi.
It works by attaching to glucagon-like peptide 1 (GLP-1) receptors that are found on the surface of the cells in the pancreas and that cause the production of insulin by the pancreas.
Deluje tako, da se veže na receptorje glukagonu podobnih peptidov 1 (GLP-1), ki se nahajajo na površini celic trebušne slinavke in ki sprožajo proizvodnjo insulina v njej.
For the full list of all side effects and restrictions with Lyxumia, see the package leaflet.
Za celoten seznam vseh neželenih učinkov in omejitev pri uporabi zdravila Lyxumia glejte navodilo za uporabo.
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.
Na voljo je v obliki raztopine za injiciranje v predhodno napolnjenih peresnikih, ki v vsakem odmerku vsebujejo 10 ali 20 mikrogramov liksisenatida.
When Lyxumia is injected, lixisenatide reaches the receptors in the pancreas and activates them.
Pri injiciranju zdravila Lyxumia liksisenatid doseže receptorje v trebušni slinavki in jih sproži.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Lyxumia, including the appropriate precautions to be followed by healthcare professionals and patients.
V skladu s tem načrtom so bile v povzetek glavnih značilnosti tega zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
The most common side effects with Lyxumia (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea and headache.
Najpogostejši neželeni učinki zdravila Lyxumia (opaženi pri 1 bolniku od 10) so navzeja (slabost), bruhanje, driska in glavobol.
Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Sladkorna bolezen tipa 2 je bolezen, pri kateri trebušna slinavka ne tvori dovolj insulina za uravnavanje ravni glukoze v krvi ali pri kateri telo insulina ne more učinkovito izrabiti.
The study comparing Lyxumia with exenatide (added to metformin) showed reduced HbA1c levels by 0.79% after 24 weeks treatment with Lyxumia compared to 0.96% with exenatide twice daily.
Študija, v kateri so primerjali zdravilo Lyxumia z eksenatidom, dodanim metforminu, je pokazala, da se je raven HbA1c znižala za 0,79 % po 24 tednih zdravljenja z zdravilom Lyxumia v primerjavi z 0,96 % pri zdravljenju z eksenatidom, dajanim dvakrat na dan.
What is the risk associated with Lyxumia?
Kakšna tveganja so povezana z zdravilom Lyxumia?
Lyxumia is a diabetes medicine that contains the active substance lixisenatide.
Lyxumia je zdravilo za sladkorno bolezen, ki vsebuje zdravilno učinkovino liksisenatid.
It is used together with diabetes medicines taken by mouth and/or basal insulin (long-acting insulin) in patients whose blood glucose levels are not adequately controlled by these medicines together with diet and exercise.
Uporablja se skupaj z zdravili za zdravljenje sladkorne bolezni, ki se jemljejo peroralno in/ali bazalnim insulinom (insulin z dolgotrajnim delovanjem) pri bolnikih, pri katerih ravni glukoze v krvi niso zadostno nadzorovane s temi zdravili, v kombinaciji z ustrezno prehrano in telesno dejavnostjo.
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).
Če bolnik že prejema sulfonilsečnino (drugo zdravilo proti sladkorni bolezni) ali bazalni insulin, mora zdravnik njun odmerek zmanjšati, ker obstaja tveganje za pojav hipoglikemije (nizke ravni sladkorja v krvi).
It is given as an injection under the skin in the abdominal wall (at the front of the waist), upper arm or thigh.
Injicira se pod kožo v trebušno steno (sprednji del pasu), nadlaket ali stegno.
Lyxumia should not be given with a combination of both, basal insulin and a sulphonylurea.
Zdravila Lyxumia naj ne bi dajali skupaj s kombinacijo obeh drugih zdravil, bazalnega insulina in sulfonilsečnine.
Six of the studies compared Lyxumia with placebo (a dummy treatment), used alone or when added to metformin, a sulphonylurea, basal insulin, or a combination of two of these medicines, in patients in whom previous treatment had failed.
V šestih študijah so zdravilo Lyxumia primerjali s placebom (zdravilom brez zdravilne učinkovine), kadar se je to uporabljalo kot samostojno zdravilo ali kot dodatek metforminu, sulfonilsečnini ali bazalnemu insulinu, ali kombinaciji dveh od teh zdravil, pri bolnikih, pri katerih predhodno zdravljenje ni bilo uspešno.