natgillin/translations-raw huggingface dataset:
Lacosamide UCB 200 mg are blue, oval film-coated tablets of approximately 16.6 mm x 7.8 mm with a debossed ‘SP' on one side and ‘200' on the other side.
• Lakozamid UCB 200 mg su plave, ovalne filmom obložene tablete približnih dimenzija 16,6 mm x 7,8 mm, s utisnutim „SP“ na jednoj strani i „200“ na drugoj strani.
Adolescents and children weighing 50 kg or more and adults only When you take Lacosamide UCB on its own
Adolescenti i djeca tjelesne težine 50 kg ili više i odrasli Kada primjenjujete samo Lakozamid UCB
The most common adverse reaction resulting in discontinuation of lacosamide therapy was dizziness.
Omaglica je bila najčešća nuspojava zbog koje su bolesnici prekidali liječenje lakozamidom.
Carton 14 tablets - week 3
Kutija 14 tableta - 3. tjedan
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS TREATMENT INITIATION PACK ONLY Blister label - week 1
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP SAMO PAKIRANJE ZA POČETAK
Each vial of 20 ml solution for infusion contains 200 mg lacosamide.
Jedna bočica od 20 ml otopine za infuziju sadrži 200 mg lakozamida.
Lacosamide UCB 100 mg are dark yellow, oval film-coated tablets of approximately 13.2 mm x 6.1 mm with a debossed ‘SP' on one side and ‘100' on the other side.
• Lakozamid UCB 100 mg su tamnožute, ovalne filmom obložene tablete približnih dimenzija 13,2 mm x 6,1 mm, s utisnutim „SP“ na jednoj strani i „100“ na drugoj strani.
Carton 14 tablets - week 2
Kutija 14 tableta - 2. tjedan
The following table summarises the recommended posology in monotherapy for children and adolescents weighing less than 50 kg.
U sljedećoj je tablici sažeto prikazano preporučeno doziranje u monoterapiji za djecu i adolescente tjelesne težine manje od 50 kg.
Lacosamide UCB 10 mg/ml syrup lacosamide
Lakozamid UCB 10 mg/ml sirup lakozamid
Psychotic disorder(1) Suicide attempt (1)
Pokušaj samoubojstva(1)
Lacosamide UCB 200 mg film-coated tablets Each film-coated tablet contains 200 mg lacosamide.
Lakozamid UCB 200 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 200 mg lakozamida.
Taking Lacosamide UCB
Uzimanje lijeka Lakozamid UCB
Lacosamide UCB 200 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) indigo carmine aluminium lake (E132)
Lakozamid UCB 200 mg filmom obložene tablete poli(vinilni alkohol) polietilenglikol 3350 talk titanijev dioksid (E171) indigo carmine aluminium lake (E132)
PARTICULARS TO APPEAR ON THE OUTER PACKAGING TREATMENT INITIATION PACK ONLY Intermediate Carton
PODACI KOJI SE MORAJU NALAZITI NA VANJSKOM PAKIRANJU SAMO VIŠESTRUKA PAKIRANJA Unutarnja kutija
NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 200 mg film-coated tablets <For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 200 mg tablets lacosamide
Lakozamid UCB 200 mg filmom obložene tablete <Za 56 x 1 i 14 x 1 filmom obloženu tabletu> Lakozamid UCB 200 mg tablete lakozamid
Carton 14 tablets - week 4
Kutija 14 tableta - 4. tjedan
Lacosamide UCB 150 mg film-coated tablets Each film-coated tablet contains 150 mg lacosamide.
Lakozamid UCB 150 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 150 mg lakozamida.
NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 150 mg film-coated tablets <For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 150 mg tablets lacosamide
Lakozamid UCB 150 mg filmom obložene tablete <Za 56 x 1 i 14 x 1 filmom obloženu tabletu> Lakozamid UCB 150 mg tablete lakozamid
INFORMATION IN BRAILLE Lacosamide UCB 50 mg
16. PODACI NA BRAILLEOVOM PISMU Lakozamid UCB 50 mg
Lacosamide UCB 50 mg film-coated tablets Lacosamide UCB 100 mg film-coated tablets Lacosamide UCB 150 mg film-coated tablets Lacosamide UCB 200 mg film-coated tablets
Lakozamid UCB 50 mg filmom obložene tablete Lakozamid UCB 100 mg filmom obložene tablete Lakozamid UCB 150 mg filmom obložene tablete Lakozamid UCB 200 mg filmom obložene tablete
Lacosamide UCB 100 mg film-coated tablets Each film-coated tablet contains 100 mg lacosamide.
Lakozamid UCB 100 mg filmom obložene tablete Jedna filmom obložena tableta sadrži 100 mg lakozamida.
Lacosamide UCB 200 mg film-coated tablets
Lakozamid UCB 200 mg filmom obložene tablete
Lacosamide UCB 100 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) yellow iron oxide (E172)
Lakozamid UCB 100 mg filmom obložene tablete poli(vinilni alkohol) polietilenglikol 3350 talk titanijev dioksid (E171) željezov oksid, žuti (E172)
INFORMATION IN BRAILLE Lacosamide UCB 100 mg
16. PODACI NA BRAILLEOVOM PISMU Lakozamid UCB 100 mg
Monotherapy doses to be taken twice daily for children and adolescents from 4 years of age weighing 40 kg to under 50 kg(1) (2):
Doze u monoterapiji koje se uzimaju dvaput na dan za djecu u dobi od navršenih 4 godine života i adolescente tjelesne težine od 40 kg do manje od 50 kg(1) (2):
Maximum recommended dose in patients ≥ 20 kg to < 30 kg up to 10 mg/kg/day
Maksimalna preporučena doza u bolesnika ≥20 kg do < 30 kg do 10 mg/kg/dan
STATEMENT OF ACTIVE SUBSTANCE(S) Each ml of solution for infusion contains 10 mg lacosamide.
NAVOĐENJE DJELATNE(IH) TVARI Jedan ml otopine za infuziju sadrži 10 mg lakozamida.
This will be until you reach a maintenance dose of between 100 mg (10 ml) and 300 mg (30 ml) twice a day.
Liječnik može povećati Vašu dozu koju uzimate dvaput na dan svakih tjedan dana za 50 mg (5 ml) dok ne dosegnete dozu održavanja između 100 mg (10 ml) i 300 mg (30 ml) dvaput na dan.
When you take Lacosamide UCB on its own
Kad primjenjujete samo Lakozamid UCB
Diplopia Vision blurred
Diplopija Zamućen vid
Lacosamide UCB 50 mg film-coated tablets
Lakozamid UCB 50 mg filmom obložene tablete
Lacosamide UCB 150 mg film-coated tablets
Lakozamid UCB 150 mg filmom obložene tablete
NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 100 mg film-coated tablets <For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 100 mg tablets lacosamide
Lakozamid UCB 100 mg filmom obložene tablete <Za 56 x 1 i 14 x 1 filmom obloženu tabletu> Lakozamid UCB 100 mg tablete lakozamid
NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 10 mg/ml solution for infusion
NAZIV LIJEKA Lakozamid UCB 10 mg/ml otopina za infuziju
The 14 x 1 and 56 x 1 film-coated tablet packs are available as perforated unit dose PVC/PVDC blisters sealed with an aluminium foil, all other packs are available with standard PVC/PVDC blisters sealed with an aluminium foil.
Pakiranja od 14 x 1 i 56 x 1 tableta dostupna su u PVC/PVDC perforiranim blisterima s jediničnim dozama, zatvorenim aluminijskom folijom.
Lacosamide UCB 10 mg/ml solution for infusion lacosamide
Lakozamid UCB 10 mg/ml otopina za infuziju lakozamid
What Lacosamide UCB looks like and contents of the pack Lacosamide UCB 50 mg are pinkish, oval film-coated tablets of approximately 10.4 mm x 4.9 mm with a debossed ‘SP' on one side and ‘50' on the other side.
• Lakozamid UCB 50 mg su ružičaste, ovalne filmom obložene tablete približnih dimenzija 10,4 mm x 4,9 mm, s utisnutim „SP“ na jednoj strani i „50“ na drugoj strani.
Lacosamide UCB 150 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Lakozamid UCB 150 mg <Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma> 56 x 1 i 14 x 1 filmom obložena tableta
Lacosamide UCB 100 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Lakozamid UCB 100 mg <Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma> 56 x 1 i 14 x 1 filmom obložena tableta
Lacosamide UCB 150 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) yellow iron oxide (E172), red iron oxide (E172), black iron oxide (E172)
Lakozamid UCB 150 mg filmom obložene tablete poli(vinilni alkohol) polietilenglikol 3350 talk titanijev dioksid (E171) željezov oksid, žuti (E172), željezov oksid, crveni (E172), željezov oksid, crni (E172)
How to store Lacosamide UCB
Kako čuvati Lakozamid UCB
Hepatobiliary disorders
Hipoestezija Dizartrija
Do not use this medicine after the expiry date which is stated on the carton and vial after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i blisteru iza oznake „Rok valjanosti“ ili EXP.
Lacosamide UCB 50 mg <Justification for not including Braille accepted> 56 x 1 and 14 x 1 film-coated tablet
Lakozamid UCB 50 mg <Prihvaćeno obrazloženje za nenavođenje Brailleovog pisma> 56 x 1 i 14 x 1 filmom obložena tableta
Taking Lacosamide UCB with other antiepileptic medicines - Children above 4 years of age weighing less than 20 kg - This is for information only.
Kada se Lakozamid UCB uzima s drugim antiepileptičkim lijekovima - djeca starija od 4 godine tjelesne težine manje od 20 kg - ovo je samo informativno.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 film-coated tablet contains 150 mg lacosamide.
NAVOĐENJE DJELATNE(IH) TVARI 1 filmom obložena tableta sadrži 150 mg lakozamida.
Feeling dizzy or sick (nausea);
• osjećaj ljutnje ili uznemirenost;
Lacosamide UCB 50 mg film-coated tablets polyvinyl alcohol polyethylene glycol 3350 talc titanium dioxide (E171) red iron oxide (E172) black iron oxide (E172) indigo carmine aluminium lake (E132)
Lakozamid UCB 50 mg filmom obložene tablete poli(vinilni alkohol) polietilenglikol 3350 talk titanijev dioksid (E171) željezov oksid, crveni (E172) željezov oksid, crni (E172) indigo carmine aluminium lake (E132)
Do not use this medicine after the expiry date which is stated on the carton and bottle after EXP.
Ovaj lijek se ne smije upotrijebiti nakon isteka roka valjanosti navedenog na kutiji i boci iza oznake „Rok valjanosti“.
Lacosamide UCB 100 mg film-coated tablets
Lakozamid UCB 100 mg filmom obložene tablete
EU/1/19/1383/004 14 film-coated tablets EU/1/19/1383/005 14 x 1 film-coated tablet EU/1/19/1383/006 28 film-coated tablets EU/1/19/1383/007 56 film-coated tablets EU/1/19/1383/008 56 x 1 film-coated tablet EU/1/19/1383/009 168 film-coated tablets
EU/1/19/1383/004 14 filmom obloženih tableta EU/1/19/1383/005 14 x 1 filmom obloženih tableta EU/1/19/1383/006 28 filmom obloženih tableta EU/1/19/1383/007 56 filmom obložena tableta EU/1/19/1383/008 56 x 1filmom obložena tableta EU/1/19/1383/009 168 filmom obloženih tableta
STATEMENT OF ACTIVE SUBSTANCE(S) 1 film-coated tablet contains 200 mg lacosamide.
NAVOĐENJE DJELATNE(IH) TVARI 1 filmom obložena tableta sadrži 200 mg lakozamida.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 film-coated tablet contains 100 mg lacosamide.
NAVOĐENJE DJELATNE(IH) TVARI 1 filmom obložena tableta sadrži 100 mg lakozamida.
Monotherapy doses to be taken twice daily for children from 4 years of age weighing less than 40 kg(1):
Doze u monoterapiji koje se uzimaju dvaput na dan za djecu u dobi od navršenih 4 godine života tjelesne težine manje od 40 kg(1) :
EU/1/19/1383/022 14 film-coated tablets EU/1/19/1383/023 14 x 1 film-coated tablet EU/1/19/1383/024 28 film-coated tablets EU/1/19/1383/025 56 film-coated tablets EU/1/19/1383/026 56 x 1 film-coated tablet
EU/1/19/1383/022 14 filmom obloženih tableta EU/1/19/1383/023 14 x 1 filmom obložena tableta EU/1/19/1383/024 28 filmom obloženih tableta EU/1/19/1383/025 56 filmom obloženih tableta EU/1/19/1383/026 56 x 1 filmom obložena tableta
Drug hypersensitivity(1)
Preosjetljivost na lijek(1)
Using Lacosamide UCB with other antiepileptic medicines - Children above 4 years of age weighing less than 20 kg - This is for information only.
Kada se Lakozamid UCB upotrebljava s drugim antiepileptičkim lijekovima - djeca starija od 4 godine tjelesne težine manje od 20 kg - ovo je samo informativno.
To be taken twice daily for children from 4 years of age weighing less than 20 kg Weight
Doze koje se primjenjuju dvaput na dan za djecu od navršenih 4 godine života i tjelesne težine manje od 20 kg
Adjunctive therapy doses to be taken twice daily for children from 4 years of age weighing less than 20 kg(1):
Doze u dodatnoj terapiji koje se uzimaju dvaput na dan za djecu u dobi od navršenih 4 godine života tjelesne težine manje od 20 kg(1) :
EU/1/19/1383/010 14 film-coated tablets EU/1/19/1383/011 14 x 1 film-coated tablet EU/1/19/1383/012 28 film-coated tablets EU/1/19/1383/013 56 film-coated tablets EU/1/19/1383/014 56 x 1 film-coated tablet EU/1/19/1383/015 168 film-coated tablets
EU/1/19/1383/010 14 filmom obloženih tableta EU/1/19/1383/011 14 x 1 filmom obložena tableta EU/1/19/1383/012 28 filmom obloženih tableta EU/1/19/1383/013 56 filmom obloženih tableta EU/1/19/1383/014 56 x 1 filmom obloženih tableta EU/1/19/1383/015 168 filmom obloženih tableta
NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 10 mg/ml solution for infusion lacosamide
NAZIV LIJEKA Lakozamid UCB 10 mg/ml infuzija lakozamid
Your doctor may increase your twice daily dose every week by 50 mg.
Liječnik može povećati Vašu dozu koju uzimate dvaput na dan svakih tjedan dana za 50 mg dok ne dosegnete dozu održavanja između 100 mg i 200 mg dvaput na dan.
STATEMENT OF ACTIVE SUBSTANCE(S) 1 film-coated tablet contains 50 mg lacosamide.
NAVOĐENJE DJELATNE(IH) TVARI 1 filmom obložena tableta sadrži 50 mg lakozamida.
In particular, tell your doctor or pharmacist if you are taking any of the following medicines that affect your heart - this is because Lacosamide UCB can also affect your heart: medicines to treat heart problems; medicines which can increase the “PR interval” on a scan of the heart (ECG or electrocardiogram) such as medicines for epilepsy or pain called carbamazepine, lamotrigine or pregabalin; medicines used to treat certain types of irregular heart beat or heart failure.
Posebice obavijestite svog liječnika ili ljekarnika ako uzimate bilo koji od sljedećih lijekova koji utječu na srce - to je zato što Lakozamid UCB također može utjecati na srce:
Adjunctive therapy doses to be taken twice daily for children and adolescents from 4 years of age weighing 30 kg to under 50 kg(1):
Doze u dodatnoj terapiji koje treba uzimati dvaput na dan za djecu u dobi od navršenih 4 godine života i adolescente tjelesne težine od 30 kg do manje od 50 kg(1):
Strawberry flavour (contains propylene glycol, maltol) Masking flavour (contains propylene glycol, aspartame (E951), acesulfame potassium (E950), maltol, deionised water) purified water
6.1 Popis pomoćnih tvari glicerol (E422) karmelozanatrij sorbitol, tekući (kristalizirajući) (E420) polietilenglikol 4000 natrijev klorid citratna kiselina, bezvodna acesulfamkalij (E950) natrijev metilparahidroksibenzoat (E219) aroma jagode (sadrži propilenglikol, maltol) prekrivajuća aroma (sadrži propilenglikol, aspartam (E951), acesulfamkalij (E950), maltol, deioniziranu vodu) pročišćena voda
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1383/027
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1383/027
Adjunctive therapy doses to be taken twice daily for children and adolescents from 4 years of age weighing 20 kg to under 30 kg(1):
Doze u dodatnoj terapiji koje treba uzimati dvaput na dan za djecu u dobi od navršenih 4 godine života i adolescente tjelesne težine od 20 kg do manje od 30 kg(1):
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1383/021
12. BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1383/021
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE Any unused solution should be discarded.
OD LIJEKA, AKO JE POTREBNO Svu neiskorištenu otopinu potrebno je zbrinuti.
EU/1/19/1383/016 14 film-coated tablets EU/1/19/1383/017 14 x 1 film-coated tablet EU/1/19/1383/018 28 film-coated tablets EU/1/19/1383/019 56 film-coated tablets EU/1/19/1383/020 56 x 1 film-coated tablet
EU/1/19/1383/016 14 filmom obloženih tableta EU/1/19/1383/017 14 x 1 filmom obložena tableta EU/1/19/1383/018 28 filmom obloženih tableta EU/1/19/1383/019 56 filmom obloženih tableta EU/1/19/1383/020 56 x 1 filmom obložena tableta
Taking Lacosamide UCB with other antiepileptic medicines - Children and adolescents with a body weight of 30 kg to under 50 kg - This is for information only.
Kada se Lakozamid UCB uzima s drugim antiepileptičkim lijekovima - djeca i adolescenti tjelesne težine od 30 kg do manje od 50 kg - ovo je samo informativno.
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1383/001
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1383/001
Talk to your doctor before using Lacosamide UCB if: you have thoughts of harming or killing yourself.
Obratite se svom liječniku prije nego primite Lakozamid UCB:
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1383/028
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1383/028
Lacosamide UCB 50 mg Lacosamide UCB 100 mg Lacosamide UCB 150 mg Lacosamide UCB 200 mg film-coated tablets lacosamide
Lakozamid UCB 50 mg Lakozamid UCB 100 mg Lakozamid UCB 150 mg Lakozamid UCB 200 mg filmom obložene tablete lakozamid
Paraesthesia
Nistagmus
In children from 4 years of age with a body weight of 30 to under 50 kg: the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
U djece od navršenih 4 godine života i tjelesne težine od 30 do manje od 50 kg: • uobičajena je početna doza 1 mg (0,1 ml) na svaki kilogram (kg) tjelesne težine, dvaput na dan.
Taking Lacosamide UCB with other antiepileptic medicines - Children and adolescents with a body weight of 20 kg to under 30 kg - This is for information only.
Kada se Lakozamid UCB upotrebljava s drugim antiepileptičkim lijekovima - djeca i adolescenti tjelesne težine od 20 kg do manje od 30 kg - ovo je samo informativno.
Using Lacosamide UCB with other antiepileptic medicines - Children and adolescents with a body weight of 30 kg to under 50 kg - This is for information only.
Kada se Lakozamid UCB upotrebljava s drugim antiepileptičkim lijekovima - djeca i adolescenti tjelesne težine od 30 kg do manje od 50 kg - ovo je samo informativno.
Tel: + 48 22 696 99 20
UCB Pharma Sp. z o.o. Tel.: + 48 22 696 99 20
This will be until you reach a maintenance dose of between 100 mg and 300 mg twice a day.
Liječnik može povećati Vašu dozu koju uzimate dvaput na dan svakih tjedan dana za 50 mg dok ne dosegnete dozu održavanja između 100 mg i 300 mg dvaput na dan.
In children from 4 years of age with a body weight of under 20 kg: the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
U djece od navršenih 4 godine života i tjelesne težine manje od 20 kg: • uobičajena je početna doza 1 mg (0,1 ml) na svaki kilogram (kg) tjelesne težine, dvaput na dan.
In children from 4 years of age with a body weight of 20 kg to under 30 kg: the usual starting dose is 1 mg (0.1 ml), for each kilogram (kg) of body weight, twice a day.
U djece od navršenih 4 godine života i tjelesne težine od 20 do manje od 30 kg: • uobičajena je početna doza 1 mg (0,1 ml) na svaki kilogram (kg) tjelesne težine, dvaput na dan.
Renal impairment
Poremećaji hodanja Astenija
MARKETING AUTHORISATION NUMBER(S) EU/1/19/1383/003
BROJ(EVI) ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET EU/1/19/1383/003
Follow these steps each time you take Lacosamide UCB: Put the oral syringe into the adaptor opening (figure 4).
• Postavite štrcaljku za usta u otvor nastavka (slika 4).
Muscle spasms
Omaglica Tinitus
Excipients which may cause intolerance
OTPADNIH MATERIJALA KOJI POTJEČU
NAME OF THE MEDICINAL PRODUCT Lacosamide UCB 50 mg film-coated tablets <For 56 x 1 and 14 x 1 film-coated tablet> Lacosamide UCB 50 mg tablets lacosamide
Lakozamid UCB 50 mg filmom obložene tablete <Za 56 i 14 filmom obloženu tabletu> Lakozamid UCB 50 mg tablete lakozamid
Lacosamide UCB 50 mg 1 film-coated tablet contains 50 mg lacosamide.
1 filmom obložena tableta sadrži 50 mg lakozamida.
As the company had supplied the additional information requested, the ‘exceptional circumstances' ended on 16 December 2015.
Budući da je tvrtka dostavila dodatne zatražene informacije, „iznimne okolnosti” prestale su 16. prosinca 2015.
These were measured before and after 26 weeks of treatment.
To je izmjereno prije i nakon 26 tjedana liječenja.
This effect was maintained for up to four years.
Taj je učinak održan tijekom razdoblja do četiri godine.
It is intended for long-term use.
Namijenjen je za dugoročnu primjenu.
The effect of these on the safety and effectiveness of the medicine is not fully known.
Nije potpuno poznat njihov učinak na sigurnost i učinkovitost lijeka.
This summary was last updated in 11-2015.
Ovaj sažetak posljednji je put ažuriran u 11.2015.
Aldurazyme laronidase
Aldurazyme laronidaza
The full EPAR for Aldurazyme can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Cjeloviti EPAR za Aldurazyme nalazi se na internetskim stranicama Agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Some of these are severe, but the number of side effects tends to decrease with time.
Neke od njih su teške, ali se broj nuspojava smanjuje s vremenom.
Aldurazyme is given once a week as an infusion into a vein.
Aldurazyme se primjenjuje jednom tjedno kao infuzija u venu.
This means that substances called glycosaminoglycans (GAGs) are not broken down, so they build up in most of the organs in the body and damage them.
To znači da se tvari koje se nazivaju glikozaminoglikani (GAG-i) ne razgrađuju, pa se nakupljaju u većini organa u tijelu i oštećuju ih.
Almost all patients who receive Aldurazyme develop antibodies (proteins that are produced in response to Aldurazyme).
Gotovo svi bolesnici koji primaju Aldurazyme razviju antitijela (proteine koji se proizvode kao reakcija na Aldurazyme).
Half of the children treated had a normal size liver at the end of the study.
Polovica liječene djece po završetku ispitivanja imala je jetru normalne veličine.
Aldurazyme was originally authorised under ‘exceptional circumstances', because, as the disease is rare, limited information was available at the time of approval.
Aldurazyme je prvobitno odobren u „iznimnim okolnostima” zbog toga što su u trenutku izdavanja odobrenja bile dostupne samo ograničene informacije jer je bolest rijetka.
Aldurazyme has also been studied in 20 children below the age of five years who received Aldurazyme for a year.
Aldurazyme je također ispitan u 20 djece mlađe od pet godina koja su Aldurazyme primala jednu godinu.
The study was looking mainly at the safety of the medicine, but it also measured its ability to reduce the levels of GAGs in the urine and the size of the liver.
Ispitivanjem se uglavnom istraživala sigurnost lijeka, ali je također mjerena njegova sposobnost smanjivanja razina GAG-a u urinu i veličine jetre.
Aldurazyme should be given in a hospital or clinic where resuscitation equipment is available, and patients may need to receive some medicines before the infusion to prevent an allergic reaction.
Aldurazyme se mora primijeniti u bolnici ili klinici gdje je dostupna oprema za reanimaciju, a bolesnici će možda trebati primiti određene lijekove prije infuzije radi sprječavanja alergijske reakcije.
The European Commission granted a marketing authorisation valid throughout the European Union for Aldurazyme on 10 June 2003.
Europska komisija izdala je odobrenje za stavljanje u promet koje je za lijek Aldurazyme na snazi u Europskoj uniji od 10. lipnja 2003.
In children under five years of age, Aldurazyme reduced the levels of GAGs in the urine by about 60%.
U djece mlađe od pet godina Aldurazyme je smanjio razine GAG-a u urinu za otprilike 60 %.
Other information about Aldurazyme
Ostale informacije o lijeku Aldurazyme
Aldurazyme must not be used in people who are severely allergic to laronidase or any of the other ingredients.
Aldurazyme se ne smije koristiti u ljudi koji su izrazito alergični na laronidazu ili bilo koji drugi sastojak.
After this, the study continued for up to four years and all of the patients were treated with Aldurazyme.
Nakon toga, ispitivanje je nastavljeno tijekom razdoblja do četiri godine te su svi bolesnici liječeni lijekom Aldurazyme.
This is a summary of the European public assessment report (EPAR) for Aldurazyme.
Ovo je sažetak europskoga javnog izvješća o ocjeni dokumentacije (EPAR) o lijeku Aldurazyme.
The study showed that Aldurazyme had improved both the FVC and the walking ability of patients at 26 weeks.
Ispitivanje je pokazalo da je Aldurazyme poboljšao FVC i sposobnost hodanja bolesnika nakon 26 tjedana.