natgillin/translations-raw huggingface dataset:
NAME OF THE MEDICINAL PRODUCT Luveris 75 IU powder and solvent for solution for injection.
IME ZDRAVILA Luveris 75 i.e. prašek in vehikel za raztopino za injiciranje
Presentations other than ampoules should be considered for self administration by patients.
Poleg ampul je treba razmisliti tudi o drugih oblikah zdravila, ki omogočajo bolnicam, da si lahko dajejo zdravilo same.
No teratogenic effect of Luveris has been observed in animal studies.
Študije na živalih ne kažejo teratogenih učinkov zdravila
Disodium phosphate dihydrate Sodium dihydrogen phosphate monohydrate Polysorbate 20
6.1 Seznam pomožnih snovi prašek: saharoza natrijev hidrogenfosfat dihidrat natrijev dihidrogenfosfat monohidrat polisorbat 20 fosforjeva(V) kislina, koncentrirana (za uravnavanje pH) natrijev hidroksid (za uravnavanje pH) L-metionin dušik vehikel: voda za injekcije
You may also mix Luveris and follitropin alfa as an alternative to injecting each product separately.
Kot alternativo injiciranju vsakega zdravila posebej, lahko tudi pomešate zdravilo Luveris in folitropin alfa.
Package leaflet: Information for the user Solvent in ampoules
Navodilo za uporabo vehikel v ampulah
Talk to your doctor, pharmacist or nurse before using Luveris.
Pred začetkom uporabe zdravila Luveris se posvetujte z zdravnikom, farmacevtom ali medicinsko sestro.
Other common side effects
Ostali pogosti neželeni učinki
Batch
Luveris.
Appearance of the powder: white lyophilised pellet Appearance of the solvent: clear colourless solution The pH of the reconstituted solution is 7.5-8.5.
pH rekonstituirane raztopine je 7,5-8,5.
The following adverse reactions may be observed after administration of Luveris.
Po dajanju zdravila Luveris se lahko pojavijo naslednji neželeni učinki.
Pravafenix
Jakost
5 ml l t o r
50 mg Suspenzija za vbrizg Intratekalna uporaba Viala (steklo) 5 ml o č
Suspension for injection
Embalaža Vsebina (koncentracija) Velikost pakiranja
Germany Aristo Pharma Gmbh (Art 57)
Aristo Pharma Gmbh (Art
Hungary Teva Gyógyszergyár Zrt
Teva Gyógyszergyár Zrt Adimet
Metformin Hydrochloride Morningside Healthcare
Hydrochloride Morningside Healthcare
Metformin Hydrochloride Sandoz Ltd
Hydrochloride Sandoz Ltd
Metformin Hydrochloride Arcana Arzneimittel Gmbh
Hydrochloride Arcana Arzneimittel Gmbh
France Sanofi-Aventis France
Sanofi-Aventis France Metformine Zentiva
Metformin Hydrochloride 1000mg/1117 Mg
Metformine Hcl Cf metforminijev klorid 1.000 mg/1117 Mg
Metformin Hydrochloride Generics [uk]
Generics [uk] Limited Metformin Hydrochloride Generics [uk]
Poland Zaklady FarmaceutycznePolpharma- Spolka Akcyjna
Zaklady Farmaceutyczne -Polpharma- Spolka Akcyjna
Hungary Goodwill Pharma Ltd
Goodwill Pharma Ltd Formet
Laboratórios Basi - Indústria Farmacêutica, S.A.
Laboratórios BasiIndústria Farmacêutica, S.A.
Germany Chem Affairs Deutschland Gmbh Metformdoc
Chem Affairs Deutschland Gmbh
Metformin 850mg Tablet
Metforminij 850 mg tableta
Germany Merck Serono Gmbh
Merck Serono Gmbh Glucophage
Fourrts (Uk) Pharmacare Limited Metformin Fourrts (Uk) Pharmacare
Metformin Fourrts (Uk) Pharmacare
Polpharma- Spolka Akcyjna
Zaklady Farmaceutyczne -Polpharma-Spolka Akcyjna
Metformine Arrow
Metformine Arrow Generiques
Stada Arzneimittel Ag
Stada Arzneimittel Ag Metformin Stada
Metformin Chelonia Healthcare Metformin Hydrochloride Bp 500mg
Metformin Chelonia Healthcare metforminijev klorid Bp 500 mg
Tillomed Laboratories Ltd
Tillomed Laboratories Ltd Orabet
Spain Ratiopharm Espana Sa
Ratiopharm Espana Sa Metformina Ratio
Metformin Embonate 700mg Tablet
Metforminijev embonat 700 mg tableta tableta
Metformin 1000mg Tablet
Metforminij 1.000 mg tableta
Metformin Hydrochloride Tillomed Laboratories
Tillomed Laboratories Ltd Metformin Hydrochloride Tillomed Laboratories
Bulgaria Generics [uk] Limited метформин дженерикс
Generics [uk] Limited Metformin
Metformin Hydrochloride 1g Tablet
Metformin metforminijev klorid 1 g tableta
Metformin Hydrochloride 400mg Capsule, Glibenclamide 2.5mg Capsule
Bidiab metforminijev klorid 400 mg kapsula, glibenklamid 2,5 mg kapsula kapsula
Spain Almus Farmaceutica S.A
Almus Farmaceutica S.A Metformina Almus
Metformin 500mg Tablet
Metforminij 500 mg tableta
Metformin Tillomed Laboratories
Tillomed Laboratories Ltd Metformin Tillomed Laboratories
Laboratórios Anova - Produtos Farmacêuticos Lda
Laboratórios AnovaProdutos Farmacêuticos Lda
Metformin 850mg Film
Metformina Azevedos metforminij 850 mg film
Prolonged-Release Tablet
tablete s podaljšanim sproščanjem
Metformina Galena
Metformina Galena tableta
Aurobindo Pharma (Malta) Limited Metformin Hydrochloride Aurobindo Pharma (Malta)
Metformin Hydrochloride Aurobindo Pharma (Malta) Limited
Germany Axcount Generika Gmbh
Axcount Generika Gmbh Metformin Axcount
Metformin Hydrochloride Bp 500mg
Glyformin metforminijev klorid Bp 500 mg
Metformin Hydrochloride 500mg G
Metformax metforminijev klorid 500 mg G
Coated Tablet
Metifor tableta
Denmark Stada Arzneimittel Ag
Stada Arzneimittel Ag Stadamet
Labesfal Genéricos, S.A.
Labesfal Genéricos, S.A. Metformina Labesfal
Metformin Hydrochloride 1000mg Tablet, Linagliptin 2.5mg Tablet
Jentadueto metforminijev klorid 1.000 mg tableta, linagliptin 2,5 mg tableta
Metformin Hydrochloride 850mg Tablet, Linagliptin 2.5mg Tablet
Jentadueto metforminijev klorid 850 mg tableta, linagliptin 2,5 mg tableta
Metformin Hydrochloride 850mg Tablet, Empagliflozin 12.5mg Tablet
Synjardy metforminijev klorid 850 mg tableta, empagliflozin 12,5 mg tableta
Focus Pharmaceuticals Limited Metformin Focus Pharmaceuticals
Focus Pharmaceuticals Limited
Metformin Hydrochloride 1000mg Tablet, Empagliflozin 12.5mg Tablet
Synjardy metforminijev klorid 1.000 mg tableta, empagliflozin 12,5 mg tableta
Metformin Hydrochloride 170mg/Ml
Glucoformin metforminijev klorid 170 mg/ml peroralna raztopina
Generics [uk] Limited
Generics [uk] Limited Metnova
Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Metformin/Glibenklamid Lek metforminijev klorid 500 mg tableta, glibenklamid 5 mg tableta
Metformin Hydrochloride 850mgg
Metformin-Teva metforminijev klorid 850 mgg
Metformin Lindopharm Metformin Hydrochloride 500mg Tablet
Metformin Lindopharm metforminijev klorid 500 mg tableta
Pinewood Laboratories Limited Metformin Hydrochloride Pinewood Laboratories
Pinewood Laboratories Limited
Metformin/Glibenklamid Lek Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Metformin/Glibenklamid Lek metforminijev klorid 500 mg tableta, glibenklamid 2,5 mg tableta
Metformin Lindopharm Metformin Hydrochloride 850mg Tablet
Metformin Lindopharm metforminijev klorid 850 mg tableta
Austria Merck Gesellschaft Mbh
Merck Gesellschaft Mbh Glucophage
Spain Teva Pharma S.L.U
Teva Pharma S.L.U Metformina Teva
Metformin Hydrochloride 850mg Tablet, Dapagliflozin 5mg Tablet
Ebymect metforminijev klorid 850 mg tableta, dapagliflozin 5 mg tableta
Metformin Hydrochloride 850mg Tablet, Empagliflozin 5mg Tablet
Synjardy metforminijev klorid 850 mg tableta, empagliflozin 5 mg tableta
Germany Biomo Pharma Gmbh
Biomo Pharma Gmbh Glucobon
Metformin Hydrochloride 1000mg Tablet, Dapagliflozin 5mg Tablet
Ebymect metforminijev klorid 1.000 mg tableta, dapagliflozin 5 mg tableta
Metformin Hydrochloride 1000mg Tablet, Sitagliptin 50mg Tablet
Velmetia metforminijev klorid 1.000 mg tableta, sitagliptin 50 mg tableta
Metformin Hydrochloride Ph. Eur.
Metformin Sandoz Ltd metforminijev klorid Ph. Eur.
Metformin Hydrochloride 1000mg Tablet Tablet
Metformina Ciclum metforminijev klorid 1.000 mg tableta
Metformin Hydrochloride 100mg/Ml
Metformin/Alapis metforminijev klorid 100 mg/ ml peroralna raztopina
Metformin Hydrochloride 850mg
Metformin Sandoz metforminijev klorid 850 mg
Metformina Tevagen Teva
Teva Pharma S.L.U Metformina Tevagen Teva
Metformin Hydrochloride 400mg Tablet, Glibenclamide 2.5mg Tablet
metforminijev klorid 400 mg tableta, glibenklamid 2,5 mg tableta tableta
Metformin Hydrochloride 1000mg Tablet, Empagliflozin 5mg Tablet
Synjardy metforminijev klorid 1.000 mg tableta, empagliflozin 5 mg tableta
Metformin Hydrochloride 1000mg Tablet, Glibenclamide 5mg Tablet
Glucovance metforminijev klorid 1.000 mg tableta, glibenklamid 5 mg tableta
Metwest Pharmaceuticals Limited Metformin Metwest Pharmaceuticals
Metwest Pharmaceuticals Limited
Germany Sandoz Pharmaceuticals Gmbh Metformin Sandoz
Hexal Pharma Gmbh Metformin Hexal
Metformin Hydrochloride 850mg Tablet, Sitagliptin 50mg Tablet
Ristfor metforminijev klorid 850 mg tableta, sitagliptin 50 mg tableta
Metformin Hydrochloride 1000mg Tablet, Saxagliptin 2.5mg Tablet
Komboglyze metforminijev klorid 1.000 mg tableta, saksagliptin 2,5 mg tableta
Metformin Galena
Metformin Galena tableta
Metformin-Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformin-Ratiopharm metforminijev klorid 850 mg tableta
Metformin Medley Pharma
Medley Pharma Limited Metformin Medley Pharma tableta
Metformin Hydrochloride 850mg Tablet, Saxagliptin 2.5mg Tablet
Komboglyze metforminijev klorid 850 mg tableta, saksagliptin 2,5 mg tableta
Metformin Hydrochloride 500mg
Metformin Teva metforminijev klorid 500 mg G
Austria Stada Arzneimittel Gmbh
Stada Arzneimittel Gmbh Metformin Stada
Metformin-Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformin-Ratiopharm metforminijev klorid 500 mg tableta
Metformina Mylan Generics Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformine Hcl Mylan metforminijev klorid 1.000 mg tableta disperzibilna tableta
Crescent Pharma Limited
Crescent Pharma Limited Metformin Crescent Pharma
Metformina Mylan Generics Metformin Hydrochloride 500mg Tablet
Metformine Hcl Mylan metforminijev klorid 500 mg tableta
Metformin Hydrochloride 1000mg Tablet, Canagliflozin 50mg Tablet
Vokanamet metforminijev klorid 1.000 mg tableta, kanagliflozin 50 mg tableta
Metformina Labesfal
Metformina Amneal
Metformine Hcl Usv Europe Metformin Hydrochloride 500mg Tablet
Metformin Hydrochloride Glenmark Generics Europe metforminijev klorid 500 mg/5 ml peroralna raztopina
Metformin Relonchem Metformin Hydrochloride 500mg Tablet
Relon Chem Limited Metformin Relonchem metforminijev klorid 500 mg tableta
Norway Rosemont Pharmaceuticals Limited Metformin Rosemont
Rosemont Pharmaceuticals Limited
Metformin Hydrochloride 1000mg Tablet Prolonged-Release Tablet
Metformin Actavis Ptc metforminijev klorid 1.000 mg tableta tablete s podaljšanim sproščanjem
Metformin Hydrochloride 500mg Tablet, Glibenclamide 2.5mg Tablet
Glucovance metforminijev klorid 500 mg tableta, glibenklamid 2,5 mg tableta
Metformina Mylan Generics Metformin Hydrochloride 850mg Tablet
Metformine Hcl Mylan metforminijev klorid 850 mg tableta
Normell
Norveška
Metformin Relonchem Metformin Hydrochloride 850mg Tablet
Metformin Heumann metforminijev klorid 850 mg tableta
Dispersible Tablet
Glucostop šumeča tableta
Metformin Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformin Ratiopharm metforminijev klorid 500 mg tableta
Metformin Hydrochloride 1000mg Tablet, Canagliflozin 150mg Tablet
Vokanamet metforminijev klorid 1.000 mg tableta, kanagliflozin 150 mg tableta
Metformin Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformin Ratiopharm metforminijev klorid 850 mg tableta
Metformin Wockhardt Uk Ltd Metformin Hydrochloride 500mg Tablet
Metformin Wockhardt Uk Ltd obložena tableta
Metformin Hydrochloride 500mg/5 Ml
Metformin Glenmark metforminijev klorid 500 mg/5 ml peroralna raztopina
Metformin Crescent Pharma Metformin Hydrochloride 850mg Tablet
Metformin Aaa-Pharma metforminijev klorid 850 mg tableta
Metformin Hydrochloride 500mg Tablet, Glibenclamide 5mg Tablet
Glucovance metforminijev klorid 500 mg tableta, glibenklamid 5 mg tableta
Metformin Crescent Pharma Metformin Hydrochloride 500mg Tablet
Metformin Aaa-Pharma metforminijev klorid 500 mg tableta
Rosemont Pharmaceuticals Limited Metformin Hydrochloride Rosemont Pharmaceuticals
Generics [uk] Limited Metformin Hydrochloride Arcana Arzneimittel Gmbh
Germany Aliud Pharma Gmbh
Aliud Pharma Gmbh Metformin
Metformine Arrow Generiques Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformine Arrow Lab metforminijev klorid 1.000 mg tableta
Metformin Hydrochloride 850mg Tablet, Canagliflozin 50mg Tablet
Vokanamet metforminijev klorid 850 mg tableta, kanagliflozin 50 mg tableta
Metformin Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformin Ratiopharm metforminijev klorid 1.000 mg tableta
Metformina Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformina Ratiopharm metforminijev klorid 500 mg tableta
Metformina Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformina Ratiopharm metforminijev klorid 850 mg tableta
Metformina Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformina Ratiopharm metforminijev klorid 1.000 mg tableta
Metformin Hydrochloride 500ml/5 Ml
Metformin Hydrochloride Rosemont metforminijev klorid 500 ml/5 ml peroralna raztopina
Metformine Ratiopharm Metformin Hydrochloride 850mg Tablet
Metformine Ratiopharm metforminijev klorid 850 mg tableta
Metformine Ratiopharm Metformin Hydrochloride 1000mg Tablet Film-Coated Tablet
Metformine Ratiopharm metforminijev klorid 1.000 mg tableta
Metformine Ratiopharm Metformin Hydrochloride 500mg Tablet
Metformine Ratiopharm metforminijev klorid 500 mg tableta
Metformin Hydrochloride 850mg Tablet, Canagliflozin 150mg Tablet
Vokanamet metforminijev klorid 850 mg tableta, kanagliflozin 150 mg tableta
Metformin Hydrochloride 500mg Sachet Powder For Oral Solution In Sachet
metforminijev klorid 500 mg vrečica prašek za peroralno raztopino v vrečici
Metformin Hydrochloride 850mg Tablet, Alogliptin 25mg Tablet
Takeda Pharma A-S Vipdomet metforminijev klorid 850 mg tableta, alogliptin 25 mg tableta
Metformin Hydrochloride 500mg Film Film-Coated Tablet
500 mg tableta filmsko obložena tableta
Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution In Sachet
metforminijev klorid 1.000 mg vrečica prašek za peroralno raztopino v vrečici
Metformin Hydrochloride 850mg Sachet Powder For Oral Solution
metforminijev klorid 850 mg vrečica prašek za peroralno raztopino
Metformin Hydrochloride 1000mg Sachet Powder For Oral Solution
metforminijev klorid 1.000 mg vrečica prašek za peroralno raztopino
Metformin Hydrochloride 850mg Tablet, Alogliptin 12.5mg Tablet
Takeda Pharma A-S Vipdomet metforminijev klorid 850 mg tableta, alogliptin 12,5 mg tableta
Metformin Hydrochloride 500mg Sachet Powder For Oral Solution
metforminijev klorid 500 mg vrečica prašek za peroralno raztopino
Metformin Wockhardt Uk Ltd Metformin Hydrochloride 850mg Tablet
Metformin Sandoz Ltd metforminijev klorid 850 mg tableta
It is available as capsules (100 mg).
Na voljo je v obliki kapsul (100 mg).
Some patients were treated for up to five and a half years.
Nekateri bolniki so bili zdravljeni pet let in pol.
• Gaucher disease;
• Gaucherjeva bolezen;
As the company had supplied the additional information requested, the exceptional circumstances ended on 23 August 2012.
Ker je družba predložila zahtevane dodatne informacije, so „izjemne okoliščine“ prenehale veljati 23. avgusta 2012.
EPAR summary for the public miglustat
Povzetek EPAR za javnost miglustat
The European Commission granted a marketing authorisation valid throughout the European Union for Zavesca on 20 November 2002.
Evropska komisija je dovoljenje za promet z zdravilom Zavesca, veljavno po vsej Evropski uniji, odobrila dne 20. novembra 2002.
There were also small improvements in blood counts: on average, the levels of haemoglobin increased by 0.26 g per decilitre and platelet counts increased by 8.29 million per millilitre.
Prav tako je prišlo do manjšega izboljšanja krvnih parametrov: v povprečju se je raven hemoglobina povečala za 0,26 grama na deciliter, število trombocitov pa za 8,29 milijona na mililiter.
The recommended starting dose for type 1 Gaucher disease is one capsule three times a day.
Priporočeni začetni odmerek pri Gaucherjevi bolezni tipa 1 je ena kapsula trikrat na dan.
What benefit has Zavesca shown during the studies?
Kakšne koristi je zdravilo Zavesca izkazalo med študijami?
The company also presented the results of a survey of 66 patients treated with Zavesca.
Družba je predstavila tudi rezultate ankete pri 66 bolnikih, ki so prejemali zdravilo Zavesca.
What is the risk associated with Zavesca?
Kakšna tveganja so povezana z zdravilom Zavesca?
• Niemann-Pick type C disease.
• Niemann-Pickova bolezen tipa C.
Zavesca is used to treat the neurological symptoms of the disease (symptoms affecting the brain and nerves).
Zdravilo Zavesca se uporablja za zdravljenje nevroloških simptomov bolezni (simptomov, ki prizadenejo možgane in živce).
The main measure of effectiveness was the change in the speed at which the patients made saccadic horizontal eye movements after a year, but the study also looked at other neurological symptoms such as the patients' ability to swallow and their intellectual function.
Glavno merilo učinkovitosti je bila sprememba hitrosti, s katero je bolnik delal sunkovite vodoravne gibe z očmi po enem letu, v študiji pa so opazovali tudi druge nevrološke simptome, kot je bolnikova sposobnost požiranja in njegova intelektualna zmožnost.
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 Zavesca.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Zavesca, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
Zavesca is used to treat the following patients:
Zdravilo Zavesca se uporablja za zdravljenje naslednjih bolnikov:
The summaries of the opinions of the Committee for Orphan Medicinal Products for Zavesca on the Agency's website ema.europa.eu/Find medicine/Human medicines/Rare disease designations:
Povzetki mnenj Odbora za zdravila sirote o zdravilu Zavesca so na voljo na spletni strani agencije na naslovu ema.europa.eu/Find medicine/Human medicines/Rare disease designation:
This document is a summary of the European Public Assessment Report (EPAR) for Zavesca.
Ta dokument je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Zavesca.
The CHMP decided that Zavesca's benefits are greater than its risks and recommended that it be given marketing authorisation.
CHMP je zaključil, da so koristi zdravila Zavesca večje od z njim povezanih tveganj, in priporočil, da se zanj odobri dovoljenje za promet.
Other information about Zavesca:
Druge informacije o zdravilu Zavesca:
In the study of type 1 Gaucher disease, there were moderate reductions in the size of the liver (12% reduction) and the spleen (19% reduction) after a year.
V študiji Gaucherjeve bolezni tipa 1 je po enem letu prišlo do zmernega zmanjšanja velikosti jeter (12odstotno zmanjšanje) in vranice (19-odstotno zmanjšanje).
Zavesca was originally authorised under ‘exceptional circumstances' because, as the diseases are rare, limited information was available at the time of approval.
Zdravilo Zavesca je pridobilo dovoljenje za promet v „izjemnih okoliščinah“, saj so bile zaradi redkosti bolezni ob odobritvi dovoljenja na voljo le omejene informacije.
The dose should also be reduced temporarily in patients who develop diarrhoea.
Odmerek je treba začasno zmanjšati tudi pri bolnikih, pri katerih se pojavi driska.
The study compared the effects of adding Zavesca to standard care with the effects of standard care alone.
V študiji so učinke dodajanja zdravila Zavesca standardnemu zdravljenju primerjali z učinki samostojnega standardnega zdravljenja.
Because the number of patients with these diseases is low, they are considered ‘rare', and Zavesca was designated an ‘orphan medicine' (a medicine used in rare diseases) on 18 October 2000 for type 1 Gaucher disease and on 16 February 2006 for Niemann-Pick type C disease.
Ker je bolnikov s tema boleznima malo, veljata bolezni za redki, zato je bilo zdravilo Zavesca dne 18. oktobra 2000 določeno kot „zdravilo sirota“ (zdravilo za zdravljenje redkih bolezni) za zdravljenje Gaucherjeve bolezni tipa 1 in dne 16. februarja 2006 za zdravljenje Niemann-Pickove bolezni tipa C.
The study looked at the effect of Zavesca on the size of the liver and spleen, and at blood counts, such as the levels of haemoglobin (a protein found in red blood cells that carries oxygen around the body) and platelets (components that help the blood to clot).
V študiji so proučevali učinek zdravila Zavesca na velikost jeter in vranice ter krvne parametre, kot so ravni hemoglobina (proteina, ki se nahaja v rdečih krvnih celicah in prenaša kisik po telesu) ter trombocitov (celic, ki pomagajo pri strjevanju krvi).
These include loss of co-ordination, problems with ‘saccadic' (rapid) eye movements that can lead to impaired vision, delayed development, difficulty swallowing, decreased muscle tone, fits and learning difficulties.
Mednje spadajo izguba koordinacije, težave s hitrim, sunkovitim premikanjem oči, ki lahko vodi do okvare vida, zaostalost v razvoju, težave pri požiranju, zmanjšan tonus mišic, krči in težave pri učenju.
The full EPAR for Zavesca 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 Zavesca je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
For more information about treatment with Zavesca, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Za več informacij o zdravljenju z zdravilom Zavesca preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
Zavesca is intended for long-term use.
Zdravilo Zavesca je predvideno za dolgotrajno uporabo.
• adults (aged 18 years and above) with mild to moderate type 1 Gaucher disease.
• odraslih (starejših od 18 let) z blago do zmerno obliko Gaucherjeve bolezni tipa 1.
This enzyme is involved in the first step of the production of glycosphingolipids.
Ta encim sodeluje v prvi fazi izdelave glikosfingolipidov.
• patients of all ages with Niemann-Pick type C disease, a potentially fatal disease in which glycosphingolipids build up within cells in the brain and elsewhere in the body.
• bolnikih vseh starosti z Niemann-Pickovo boleznijo tipa C, ki je lahko smrtna, pri kateri se glikosfingolipidi kopičijo v celicah v možganih in drugje v telesu.
Zavesca must not be used in people who are hypersensitive (allergic) to miglustat or any of the other ingredients.
Zdravila Zavesca ne smejo uporabljati osebe, ki so preobčutljive za (alergične na) miglustat ali katero koli drugo sestavino zdravila.
Zavesca is used to treat two inherited diseases that affect the way the body handles fats.
Zdravilo Zavesca se uporablja za zdravljenje dveh prirojenih bolezni, ki vplivata na to, kako telo presnavlja maščobe.
Why has Zavesca been approved?
Zakaj je bilo zdravilo Zavesca odobreno?
For Niemann-Pick type C disease, it is two capsules three times a day for patients aged 12 years and over; in younger patients, the dose depends on their weight and height.
Pri NiemannPickovi bolezni tipa C je priporočeni odmerek za bolnike, starejše od 12 let, dve kapsuli trikrat na dan, pri mlajših bolnikih pa je odmerek odvisen od njihove telesne mase in višine.
For Niemann-Pick type C disease, Zavesca was studied in one main study involving 31 patients, 12 of whom were less than 12 years old.
Zdravilo Zavesca so za zdravljenje Niemann-Pickove bolezni tipa C proučevali v eni glavni študiji, v katero je bilo vključenih 31 bolnikov, od katerih jih je 12 bilo mlajših od 12 let.
This is expected to slow down or prevent the development of the symptoms of type 1 Gaucher disease and to reduce the symptoms of Niemann-Pick type C disease.
S tem naj bi bil razvoj simptomov Gaucherjeve bolezni tipa 1 upočasnjen ali preprečen, simptomi Niemann-Pickove bolezni tipa C pa ublaženi.