natgillin/translations-raw huggingface dataset:
Merck Sharp & Dohme Romania S.R.L.
Romunija Merck Sharp & DohmeRomania S.R.L.
Merck Sharp & Dohme PO Box 581
Islandija Merck Sharp & Dohme PO Box 581
Losartan is not recommended in children with hepatic impairment (see section 4.2).
Losartana ne priporočamo za uporabo pri otrocih z okvaro jeter (glejte poglavje 4.2).
General disorders and administration site conditions: not known: flu-like symptoms
Splošne težave in spremembe na mestu aplikacije: pogostnost ni znana: gripi podobni simptomi
One bottle of reconstituted suspension (200 ml) contains 500 mg of losartan potassium.
Ena plastenka pripravljene suspenzije (200 ml) vsebuje 500 mg kalijevega losartanata.
The antihypertensive effect of losartan was established in a clinical study involving 177 hypertensive pediatric patients 6 to 16 years of age with a body weight > 20 kg and a glomerular filtration rate > 30 ml/ min/ 1.73 m2.
Antihipertenzivni učinek losartana so dokazali v klinični študiji, ki je zajela 177 hipertenzivnih pediatričnih bolnikov, starih 6 do 16 let, s telesno maso > 20 kg in hitrostjo glomerulne filtracije > 30 ml/min/1,73 m2. Bolniki, ki so tehtali > 20 kg do < 50 kg, so prejemali bodisi 2,5, 25 ali 50 mg losartana na dan, bolniki, ki so tehtali > 50 kg, pa so prejemali bodisi 5, 50 ali 100 mg losartana na dan.
White to off-white powder.
Bel do sivo-bel prašek.
Adult Patients with high blood pressure and type 2 diabetes Treatment usually starts with 50 mg losartan (20 ml of COZAAR suspension) once a day.
Odrasli bolniki z visokim krvnim tlakom in s sladkorno boleznijo tipa 2 Zdravljenje se običajno začne s 50 mg losartana (20 ml COZAAR suspenzije) enkrat na dan. Odmerek se kasneje lahko poveča na 100 mg losartana (40 ml COZAAR suspenzije) enkrat na dan, glede na odziv krvnega tlaka.
Insert the dispenser into the adapter on the medication bottle until a tight seal is made between the bottle and the adapter.
Brizgo vstavite v nastavek na plastenki z zdravilom tako, da se nastavek in plastenka dobro držita.
affects more than 1 user in 10
se pojavijo pri več kot 1 od 10 uporabnikov pogosti:
Member State Marketing Authorisation Holder Invented name Losartan potassium
Izmišljeno ime Kalijev losartanat
Merck Sharp & Dohme GmbH Donau-City-Straße 6, 1220 Wien, Austria
Donau-City-Straße 6, 1220 Dunaj, Avstrija
COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension [See Annex I - To be completed nationally]
COZAAR in povezana imena (glejte Dodatek I) 2,5 mg/ml prašek in vehikel za peroralno suspenzijo [Glejte Dodatek I - Izpolni država članica]
Nervous system disorders: uncommon: dizziness, headache rare: paraesthesia
Bolezni živčevja: občasne: omotica, glavobol redke: parestezija
Skin and subcutaneous tissue disorders: not known: urticaria, pruritus, rash
Bolezni kože in podkožja: pogostnost ni znana: urtikarija, srbenje, izpuščaj
haemoglobin, haematocrit), a rise in urea-N in the serum and occasional rises in serum creatinine, a decrease in heart weight (without a histological correlate) and gastrointestinal changes (mucous membrane lesions, ulcers, erosions, haemorrhages).
V študijah toksičnosti pri ponavljajočih se odmerkih je uporaba losartana povzročila zmanjšanje eritrocitnih indeksov (števila eritrocitov, hemoglobina, hematokrita), povečanje količine N-sečnine v serumu in občasno zvišanje kreatinina v serumu, zmanjšanje mase srca (brez histološke povezave) in spremembe v prebavilih (poškodbe, razjede, erozije in krvavitve mukozne membrane).
Vascular disorders: common: hypotension
Žilne bolezni: pogoste: hipotenzija
Respiratory, thoracic and mediastinal disorders: not known: cough
Bolezni dihal, prsnega koša in mediastinalnega prostora: pogostnost ni znana: kašelj
Each sachet contains 500 mg of losartan potassium powder.
Ena vrečka vsebuje 500 mg praška kalijevega losartanata.
The following components are packed in a kit:
Pakiranje vsebuje naslednje komponente:
Both biliary and urinary excretions contribute to the elimination of losartan and its metabolites.
K izločanju losartana in njegovih presnovkov prispevata tako izločanje z žolčem kot izločanje preko ledvic.
Belgium Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B1180 Bruselj, Belgija
No initial dosage adjustment is necessary in patients with renal impairment and in haemodialysis patients.
Uporaba pri bolnikih z ledvično okvaro in bolnikih na hemodializi Pri bolnikih z ledvično okvaro in bolnikih na hemodializi začetnega odmerka ni treba prilagoditi.
May cause allergic reactions (possibly delayed).
Metilhidroksibenzoat in propilhidroksibenzoat Lahko povzročita alergijske reakcije (lahko zapoznele).
Luxembourg Merck Sharp & Dohme BV - Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
Luksemburg Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B-1180 Bruselj, Belgija
One ml of suspension contains 2.5 mg of losartan potassium.
En ml suspenzije vsebuje 2,5 mg kalijevega losartanata.
Shake the bottle well before use.
Pred uporabo plastenko dobro pretresite.
Nervous system disorders: not known: migraine
Bolezni živčevja: pogostnost ni znana: migrena
affects less than 1 user in 10000
se pojavijo pri manj kot 1 od 10.000 uporabnikov neznani:
Uncommon: somnolence, headache, sleep disorders
Bolezni živčevja: pogoste: omotica, vrtoglavica občasne: zaspanost, glavobol, motnje spanja
C/ Josefa Valcárcel, 38
MERCK SHARP AND DOHME DE ESPAÑA, S.A. C/ Josefa Valcárcel, 38
Luxembourg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B-1180 Brussels, Belgium
Luksemburg Therabel Pharma S.A. - Rue Egide Van Ophem 108 - B1180 Bruselj, Belgija
Belgium Merck Sharp & Dohme BV -Chaussée de Waterloo 1135 - B-1180 Brussels, Belgium
Merck Sharp & Dohme BVChaussée de Waterloo 1135 - B-1180 Bruselj, Belgija
A low dose of hydrochlorothiazide should be added and/ or the dose of losartan should be increased to 100 mg once daily based on blood pressure response.
Običajni začetni odmerek je 50 mg losartana enkrat na dan. Glede na odziv krvnega tlaka je treba dodati majhen odmerek hidroklorotiazida in/ali odmerek losartana povečati na 100 mg enkrat na dan.
affects 1 to 10 users in 1000
se pojavijo pri 1 do 10 od 1.000 uporabnikov redki:
• A single aluminum foil sachet filled with powder containing 500 mg losartan potassium The sachet material consists of the following materials, from outside to inside and product contact layer: PET/Ink/ Adhesive/ Foil/ Adhesive/PE
Vrečka je iz naslednjih materialov (od zunanje do notranje strani, ki je v stiku z zdravilom): PET/črnilo/adheziv/folija/adheziv/PE
Replace the original cap onto the bottle.
Na plastenko namestite originalni zamašek.
Hepatobiliary disorders: rare: hepatitis not known: liver function abnormalities
Bolezni jeter, žolčnika in žolčevodov: redke: hepatitis pogostnost ni znana: nenormalno delovanje jeter
Unless continued AIIRA therapy is considered essential, patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy.
Pri bolnicah, ki načrtujejo nosečnost, je treba čimprej preiti na alternativno antihipertenzivno zdravljenje z uveljavljenim varnostnim profilom za uporabo v nosečnosti; razen, če se oceni, da je nadaljnje zdravljenje z AIIRA-jem nujno.
751 Patients were treated with Losartan The objective of the study was to demonstrate a nephroprotective effect of Losartan potassium over and above the benefit of lowering blood pressure.
Namen študije je bil poleg koristi za znižanje krvnega tlaka pokazati še zaščitni učinek kalijevega losartanata na ledvice.
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS SACHET POWDER LABEL
PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
General disorders and administration site conditions: common: asthenia/fatigue
Splošne težave in spremembe na mestu aplikacije: pogoste: astenija/utrujenost
• One 10 ml oral dosing syringe
• 10 ml brizgo za peroralno odmerjanje
The dose should generally be titrated at weekly intervals (i.e. 12.5 mg daily, 25 mg daily, 50 mg daily) to the usual maintenance dose of 50 mg once daily, as tolerated by the patient.
Običajni začetni odmerek losartana pri bolnikih s srčnim popuščanjem je 12,5 mg enkrat na dan. Odmerek je običajno treba titrirati tedensko (to je 12,5 mg na dan, 25 mg na dan, 50 mg na dan) do običajnega vzdrževalnega odmerka 50 mg enkrat na dan, glede na to, kako bolnik zdravilo prenaša.
COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension Losartan potassium
COZAAR in povezana imena (glejte Dodatek I) 2,5 mg/ml prašek in vehikel za peroralno suspenzijo Kalijev losartanat
Renal and urinary disorders: not known: urinary tract infections
Bolezni sečil: pogostnost ni znana: okužbe urinarnega trakta
Add 200 ml of solvent to the 240 ml amber polyethylene terephthalate (PET) bottle provided.
200 ml vehikla dodajte v 240 ml rumeno-rjavo priloženo PET plastenko.
It is important to tell your doctor before taking COZAAR:
Preden vzamete zdravilo COZAAR, se posvetujte z zdravnikom:
See package leaflet for instructions on how to prepare COZAAR 2.5 mg/ml oral suspension.
Za navodila, kako pripraviti COZAAR 2,5 mg/ml peroralno suspenzijo, glejte Navodilo za uporabo.
Remove the dispenser and administer the medication.
Odstranite brizgo in aplicirajte zdravilo.
After reconstitution, losartan suspension is an off-white liquid.
Po pripravi je suspenzija losartana sivo-bela tekočina.
Gastrointestinal disorders: not known: diarrhoea
Bolezni prebavil: pogostnost ni znana: diareja
With the syringe, adapter, and bottle attached, turn the entire assembly upside down.
Brizgo, nastavek in plastenko skupaj obrnite na glavo.
COZAAR is used
Zdravilo COZAAR se uporablja:
Hertfordshire EN11 9BU United Kingdom
Hertford Road, Hoddesdon, Herts EN11 9BU, Velika Britanija
Each sachet of powder for oral suspension contains 500 mg of losartan potassium.
Ena vrečka s praškom za peroralno suspenzijo vsebuje 500 mg kalijevega losartanata.
Each sachet of powder for oral suspension delivers 500 mg of losartan potassium.
Iz ene vrečke s praškom za peroralno suspenzijo dobimo 500 mg kalijevega losartanata.
Take special care with COZAAR:
Bodite posebno pozorni pri jemanju zdravila COZAAR
One ml solvent contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, and 50.6 mg sorbitol.
En ml vehikla vsebuje 0,296 mg metilhidroksibenzoata, 0,041 mg propilhidroksibenzoata in 50,6 mg sorbitola.
Neither Losartan nor the active metabolite can be removed by haemodialysis.
S hemodializo ne moremo odstraniti niti losartana niti njegovega aktivnega presnovka.
affects 1 to 10 users I 10000
se pojavijo pri 1 do 10 od 10.000 uporabnikov zelo redki:
Nervous system disorders: common: dizziness
Bolezni živčevja: pogoste: omotica
One ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol,.and 1.275 mg lactose.
En ml suspenzije vsebuje 0,296 mg metilhidroksibenzoata, 0,041 mg propilhidroksibenzoata, 50,6 mg sorbitola in 1,275 mg laktoze.
LOORTAN 12,50 mg12,5mg Film-coated tabletOral use
LOORTAN 12,50 mg12,5mg Filmsko obložena tableta
One ml suspension contains 0.296 mg methylhydroxybenzoate, 0.041 mg propylhydroxybenzoate, 50.6 mg sorbitol and 1.275 mg lactose.
En ml raztopine vsebuje 0,296 mg metilhidroksibenzoata, 0,041 mg propilhidroksibenzoata, 50,6 mg sorbitola in 1,275 mg laktoze.
Heart Failure
Ledvična okvara
(It is also better to avoid COZAAR in early pregnancy
• če ste noseči več kot tri mesece (Zdravilu COZAAR se je bolje izogibati tudi v zgodnji nosečnosti - glejte poglavje "Nosečnost in dojenje"),
STATEMENT OF ACTIVE SUBSTANCE(S) One ml suspension contains 2.5 mg of losartan potassium.
NAVEDBA ENE ALI VEČ ZDRAVILNIH UČINKOVIN En ml suspenzije vsebuje 2,5 mg kalijevega losartanata.
After reconstitution, each ml suspension contains 2.5 mg of losartan potassium.
Po pripravi en ml suspenzije vsebuje 2,5 mg kalijevega losartanata.
• Severe hepatic impairment.
• Huda okvara jeter.
• One foil sachet filled with 500 mg losartan potassium powder
• Vrečko iz folije s 500 mg praška kalijevega losartanata.
Gastrointestinal disorders: uncommon: diarrhoea, nausea, vomiting
Bolezni prebavil: občasne: diareja, navzea, bruhanje
LORTAAN IC 12,5 mg Film-coated tabletOral use
LORTAAN IC 12,5 mg Filmsko obložena tableta
PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING LABEL FOR AMBER BOTTLE FOR ORAL SUSPENSION
NALEPKA ZA RUMENO-RJAVO PLASTENKO ZA PERORALNO SUSPENZIJO
LOORTAN 100 mg 100 mg Film-coated tabletOral use
LOORTAN 100 mg 100 mg Filmsko obložena tableta
General disorders and administration site conditions: Uncommon: asthenia, fatigue, oedema
Splošne težave in spremembe na mestu aplikacije: občasne: astenija, utrujenost, edem
Ear and labyrinth disorders: common: vertigo
Ušesne bolezni, vključno z motnjami labirinta: pogoste: vrtoglavica
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem, The Netherlands
Merck Sharp & Dohme BV, Postbus 581, 2003 PC, Haarlem,
Czech Republic Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39,2003 PC, Haarlem, The Netherlands
Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39,2003 PC, Haarlem, Nizozemska
Powder
Ciper
Czech Republic Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39, 2003 PC, Haarlem, The Netherlands
Merck Sharp & Dohme BV, Postbus 581, Waarderweg 39, 2003 PC, Haarlem, Nizozemska
Cozaar 12,5 mg Inicio 12,5 mg Film-coated tabletOral use
Cozaar 12,5 mg Inicio 12,5 mg Filmsko obložena tableta
With the dispenser, adapter, and bottle attached, turn the entire assembly upside down.
Celotno pripravo (brizgo, nastavek in plastenko) obrnite na glavo.
LORTAAN 100mg 100 mg Film-coated tabletOral use
LORTAAN 100mg 100 mg Filmsko obložena tableta
Strength Pharmaceutical Form
Jakost Farmacevtska oblikaPot uporabe zdravila
Losartan suspension is a white to off-white liquid when reconstituted with the supplied solution.
Po pripravi s priloženo raztopino je suspenzija losartana bela do sivo bela raztopina.
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION COZAAR and associated names (see Annex I) 2.5 mg/ml powder and solvent for oral suspension Losartan potassium.
Vehikel za Cozaar in povezana imena (glejte Dodatek I) 2,5 mg/ml prašek in vehikel za peroralno suspenzijo
• One foil sachet filled with powder equal to 500 mg losartan potassium
• vrečka iz aluminijaste folije s praškom, ki vsebuje 500 mg kalijevega losartanata.
Insert the syringe into the adaptor on the medicine bottle until a tight seal is made.
Brizgo dobro namestite v nastavek na plastenko z zdravilom.
COZAAR 12,5 mg 12,5 mg Film-coated tabletOral use
COZAAR 12,5 mg 12,5 mg Filmsko obložena tableta
Respiratory, thoracic and mediastinal disorders: uncommon: dyspnoea
Bolezni dihal, prsnega koša in mediastinalnega prostora občasne: dispneja
100 mg Film-coated tablets
100 mg Filmsko obložene tablete
Cozaar 12,5 mg 12,5mg Film-coated tabletOral use
Cozaar 12,5 mg 12,5mg Filmsko obložena tableta
COZAAR 12,5mg 12,5 mg Film-coated tabletOral use
COZAAR 12,5mg 12,5 mg Filmsko obložena tableta
BEFORE YOU TAKE COZAAR
SHRANJEVANJE ZDRAVILA COZAAR
RP*>-1 (Relative potency by a mice potency test compared to a reference vaccine that was shown efficacious in sheep)
* Relativna potenca pri testu potence pri miših v primerjavi z referenčnim cepivom, ki je bilo učinkovito pri ovcah.
240ml doses)
100 ml (50 odmerkov)
Type I glass vials with chlorobutyl stopper and aluminium seal
Viala iz stekla tipa I s klorobutilnim zamaškom in aluminijasto kapico
Pharma ceutical Form
Farmacevtska oblika
Further information on Extavia can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/extavia.
Nadaljnje informacije za zdravilo Extavia so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/extavia.
In the second study, no delay in the time to disability progression was seen.
V drugi študiji niso opazili odloga napredovanja invalidnosti.
Extavia received a marketing authorisation valid throughout the EU on 20 May 2008.
Za zdravilo Extavia je bilo 20. maja 2008 izdano dovoljenje za promet, veljavno po vsej EU.
Other information about Extavia
Druge informacije o zdravilu Extavia
What measures are being taken to ensure the safe and effective use of Extavia?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Extavia?
The European Medicines Agency decided that Extavia's benefits are greater than its risks and it can be authorised for use in the EU.
Evropska agencija za zdravila je zaključila, da so koristi zdravila Extavia večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
This medicine is the same as Betaferon, which is already authorised in the EU.
To zdravilo je enako zdravilu Betaferon, ki je že odobreno v EU.
What is Extavia and what is it used for?
Kaj je zdravilo Extavia in za kaj se uporablja?
As for all medicines, data on the use of Extavia are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Extavia stalno spremljajo.
What benefits of Extavia have been shown in studies?
Kakšne koristi zdravila Extavia so se pokazale v študijah?
• who have experienced the signs of MS for the first time, and these are severe enough to justify treatment with injected corticosteroids (anti-inflammatory medicines).
• so prvikrat doživeli znake multiple skleroze in so ti dovolj resni, da upravičujejo zdravljenje z injiciranjem kortikosteroidov (protivnetnih zdravil).
Side effects are common at the beginning of treatment but usually decrease with further treatment.
Neželeni učinki so pogosti na začetku zdravljenja, a z nadaljnjim zdravljenjem običajno izzvenijo.
Extavia must not be used in patients who have decompensated liver disease (when the liver is damaged and can no longer work adequately).
Ne smejo ga uporabljati bolniki z dekompenzirano boleznijo jeter (kadar so jetra okvarjena in ne morejo več ustrezno delovati).
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Extavia have been included in the summary of product characteristics and the package leaflet.
Priporočila in previdnostni ukrepi, ki jih morajo za varno in učinkovito uporabo zdravila Extavia upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
Extavia must not be used in patients who have severe depression or have thoughts of suicide.
Zdravila Extavia ne smejo uporabljati bolniki s hudimi depresivnimi motnjami ali samomorilnimi mislimi.
Side effects reported with Extavia are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Extavia, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
Why is Extavia authorised in the EU?
Zakaj je bilo zdravilo Extavia odobreno v EU?
What are the risks associated with Extavia?
Kakšna tveganja so povezana z zdravilom Extavia?
• who have MS of the type known as ‘relapsing-remitting', when the patient has attacks (relapses) between periods with no symptoms (remissions), and with at least two relapses within the last two years;
• imajo vrsto multiple skleroze, imenovano „recidivno-remitentna“ multipla skleroza, pri kateri bolnik doživlja napade (recidive) med obdobji brez simptomov (remisije), in sicer vsaj dva recidiva v zadnjih dveh letih;
For more information about using Extavia, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Extavia glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Extavia is used in patients:
Zdravilo Extavia se uporablja pri bolnikih, ki:
The company that makes Betaferon has agreed that its scientific data can be used for Extavia.
Podjetje, ki proizvaja zdravilo Betaferon, se strinja, da se lahko znanstveni podatki o tem zdravilu uporabijo tudi za zdravilo Extavia.
An overview of Extavia and why it is authorised in the EU
Pregled zdravila Extavia in zakaj je odobreno v EU
In both studies, Extavia showed a reduction in the number (30%) of clinical relapses.
V obeh študijah so pri uporabi zdravila Extavia ugotovili zmanjšanje števila (30 %) kliničnih recidivov.
The active substance in Extavia is the protein interferon beta-1b, one of a group of interferons that can be naturally produced by the body to help it fight against viruses and other attacks.
Učinkovina v zdravilu Extavia je beljakovina interferon beta-1b, eden od skupine interferonov, ki jih telo lahko po naravni poti proizvaja za obrambo pred okužbami, ki jih povzročajo virusi, in drugimi napadi.
Extavia is available as a powder and solvent that are made up into a solution that supplies a dose of 250 micrograms.
Zdravilo Extavia je na voljo v obliki praška in vehikla za pripravo raztopine, ki vsebuje odmerek 250 mikrogramov.
Extavia was more effective than placebo in reducing the number of annual relapses: patients receiving the medicine had on average 0.84 relapses a year, when patients on placebo had 1.27 relapses.
Zdravilo Extavia je bilo pri zmanjševanju števila letnih recidivov učinkovitejše od placeba: bolniki, ki so prejemali zdravilo, so v povprečju doživeli 0,84 recidiva letno, bolniki, zdravljeni s placebom, pa 1,27.
The most frequent side effects with Extavia are flu-like symptoms (including fever, chills, joint pain, malaise [feeling unwell], sweating, headache and muscle pain) and reactions at the site of injection.
Najpogostejši neželeni učinki zdravila Extavia so gripi podobni simptomi (vključno s povišano telesno temperaturo, mrzlico, bolečinami v sklepih, splošnim slabim počutjem, potenjem, glavobolom in bolečinami v mišicah) in reakcije na mestu injiciranja.
The exact way that Extavia works in MS is not yet known but the active substance, interferon beta-1b, seems to calm down the immune system, and prevents relapses of MS.
Natančen način delovanja zdravila Extavia pri multipli sklerozi še ni znan, vendar se zdi, da učinkovina, interferon beta-1b, pomirja imunski sistem in preprečuje redicive multiple skleroze.
• who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
• imajo sekundarno progresivno multiplo sklerozo (vrsto multiple skleroze, ki nastopi po recidivnoremitentni multipli sklerozi), pri katerih je bolezen aktivna.
Treatment should start with 62.5 micrograms (a quarter of the dose) every other day, increasing progressively over 19 days to reach the recommended dose of 250 micrograms given every other day.
Zdravljenje se začne z 62,5 mikrograma (četrtino odmerka), ki se injicira vsak drugi dan, ta odmerek pa se v naslednjih 19 dneh postopoma povečuje do priporočenega odmerka 250 mikrogramov, ki se daje vsak drugi dan. Bolniki lahko zdravilo Extavia injicirajo sami, če so bili za to ustrezno usposobljeni.
In a study involving 487 patients with a single demyelinating event, treatment with Extavia for two years was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Extavia developed MS, compared with 45% of those who received placebo.
V študiji, ki je vključevala 487 bolnikov z enkratnim demielinizacijskim dogodkom, so ugotovili, da se je v dveh letih zdravljenja z zdravilom Extavia zmanjšalo tveganje za razvoj klinično dokončne multiple skleroze: ta se je razvila pri 28 % bolnikov, ki so prejemali zdravilo Extavia, v primerjavi s 45 % tistih, ki so prejemali placebo.
MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Multipla skleroza je obolenje živcev, pri kateri vnetje poškoduje zaščitno ovojnico okrog njih (demielinizacija) in tudi same živce.
One of the two studies showed a significant delay in the time to disability progression (31% risk reduction due to Extavia) and in the time to becoming wheelchair bound (39%).
Ena od obeh študij je pokazala pomemben odlog napredovanja invalidnosti (31-odstotno zmanjšanje tveganja zaradi zdravila Extavia) in nastopa stopnje invalidnosti, pri kateri je bolnik priklenjen na voziček (39 %).