FrancophonIA/ELRC3.0 huggingface dataset:
English: 1 multidose cartridge with 9 pen injection needles
Slovenian: 1 večodmerni vložek s 9 injekcijskimi iglami za peresnik
English: REKOVELLE 72 micrograms/2.16 mL solution for injection One multidose cartridge contains 72 micrograms follitropin delta* in 2.16 mL solution.
Slovenian: REKOVELLE 72 mikrogramov/2,16 ml raztopina za injiciranje En večodmerni vložek vsebuje 72 mikrogramov folitropina delta*v 2,16 ml raztopine.
English: Table 3 Ongoing pregnancy rate and ongoing implantation rate in ESTHER-1 trial REKOVELLE in an individualised dosing regimen (N=665)
Slovenian: Preglednica 3 Delež nosečnosti in delež vsaditev v študiji ESTHER-1 Zdravilo
English: REKOVELLE 36 micrograms/1.08 mL solution for injection 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber).
Slovenian: REKOVELLE 36 mikrogramov/1,08 ml raztopina za injiciranje 3 ml večodmerni vložek (steklo tipa I) z batom (halobutilna guma) in objemno zaporko (aluminij) z notranjo prevleko (guma).
English: REKOVELLE is a clear and colourless solution for injection (injection).
Slovenian: Izgled zdravila REKOVELLE in vsebina pakiranja Zdravilo REKOVELLE je bistra in brezbarvna raztopina za injiciranje (injekcija).
English: • Do not use the pen if the medicine contains particles or if the medicine is not clear.
Slovenian: Peresnika ne uporabljajte, če zdravilo v vložku vsebuje delce ali ni bistro.
English: REKOVELLE 72 micrograms/2.16 mL solution for injection One pre-filled multidose pen delivers 72 micrograms follitropin delta* in 2.16 mL solution.
Slovenian: REKOVELLE 72 mikrogramov/2,16 ml raztopina za injiciranje En večodmerni napolnjen injekcijski peresnik vsebuje 72 mikrogramov folitropina delta*v 2,16 ml raztopine.
English: 1 multidose cartridge with 6 pen injection needles
Slovenian: 1 večodmerni vložek s 6 injekcijskimi iglami za peresnik
English: REKOVELLE 12 micrograms/0.36 mL solution for injection 3 mL multidose cartridge (Type I glass) with a plunger (halobutyl rubber) and a crimp cap (aluminium) with an inlay (rubber).
Slovenian: REKOVELLE 12 mikrogramov/0,36 ml raztopina za injiciranje 3 ml večodmerni vložek (steklo tipa I) z batom (halobutilna guma) in objemno zaporko (aluminij) z notranjo prevleko (guma).
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 72 micrograms/2.16 mL injection follitropin delta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE REKOVELLE 72 mikrogramov/2,16 ml injekcija folitropin delta s.c.
English: Twisting of ovaries
Slovenian: Zasuk jajčnikov
English: • are vomiting
Slovenian: • bruhanje,
English: Step 14:
Slovenian: 14. korak:
English: 1 multidose cartridge with 3 pen injection needles
Slovenian: 1 večodmerni vložek s 3 injekcijskimi iglami za peresnik
English: • Pelvic pain and discomfort, including of ovarian origin
Slovenian: • bolečina in nelagodje v medenici, vključno z bolečino, ki izvira iz jajčnikov, • utrujenost.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection One multidose cartridge contains 12 micrograms follitropin delta* in 0.36 mL solution.
Slovenian: REKOVELLE 12 mikrogramov/0,36 ml raztopina za injiciranje En večodmerni vložek vsebuje 12 mikrogramov folitropina delta* v 0,36 ml raztopine.
English: EU/1/16/1150/006
Slovenian: EU/1/16/1150/004 EU/1/16/1150/005 EU/1/16/1150/006
English: Pack size of 1 cartridge and 9 injection needles (stainless steel) to be used with the REKOVELLE injection pen.
Slovenian: Zdravilo je na voljo v pakiranju z 1 vložkom in 9 injekcijskimi iglami (nerjavno jeklo) za uporabo z injekcijskim peresnikom REKOVELLE.
English: Each multidose cartridge contains 36 micrograms of follitropin delta in 1.08 millilitre of solution.
Slovenian: En večodmerni vložek vsebuje 36 mikrogramov folitropina delta v 1,08 mililitra raztopine.
English: Each multidose cartridge contains 72 micrograms of follitropin delta in 2.16 millilitre of solution.
Slovenian: En večodmerni vložek vsebuje 72 mikrogramov folitropina delta v 2,16 mililitra raztopine .
English: REKOVELLE 36 micrograms/1.08 mL solution for injection One multidose cartridge contains 36 micrograms follitropin delta* in 1.08 mL solution.
Slovenian: REKOVELLE 36 mikrogramov/1,08 ml raztopina za injiciranje En večodmerni vložek vsebuje 36 mikrogramov folitropina delta*v 1,08 ml raztopine.
English: Pack size of 1 cartridge and 6 injection needles (stainless steel) to be used with the REKOVELLE injection pen.
Slovenian: Zdravilo je na voljo v pakiranju z 1 vložkom in 6 injekcijskimi iglami (nerjavno jeklo) za uporabo z injekcijskim peresnikom REKOVELLE.
English: The following symptoms may be observed in severe cases of OHSS: abdominal pain, discomfort and distension, severe ovarian enlargement, weight gain, dyspnoea, oliguria and gastrointestinal symptoms including nausea, vomiting and diarrhoea.
Slovenian: V hudih primerih SHSJ lahko opazimo naslednje simptome: bolečina v trebuhu, neprijeten občutek in napihnjenost, močno povečanje jajčnikov, povečanje telesne mase,
English: Pack size of 1 cartridge and 3 injection needles (stainless steel) to be used with the REKOVELLE injection pen.
Slovenian: Zdravilo je na voljo v pakiranju z 1 vložkom in 3 injekcijskimi iglami (nerjavno jeklo) za uporabo z injekcijskim peresnikom REKOVELLE.
English: REKOVELLE 72 micrograms/2.16 mL solution for injection follitropin delta
Slovenian: REKOVELLE 72 mikrogramov/2,16 ml raztopina za injiciranje folitropin delta
English: REKOVELLE 36 micrograms/1.08 mL solution for injection follitropin delta
Slovenian: REKOVELLE 36 mikrogramov/1,08 ml raztopina za injiciranje folitropin delta
English: • Discomfort of the abdomen
Slovenian: • nelagodje v trebuhu,
English: Each multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of solution.
Slovenian: En večodmerni vložek vsebuje 12 mikrogramov folitropina delta v 0,36 mililitra raztopine.
English: • Use a new injection site for each injection to lower the risk of skin reactions as redness and irritation.
Slovenian: • Da bi znižali tveganje za kožne reakcije v obliki rdečice in razdraženosti, zdravilo vsakič injicirajte na drugo mesto.
English: One mL of solution contains 33.3 micrograms of follitropin delta* *recombinant human follicle-stimulating hormone (FSH) produced in a human cell line (PER.C6) by recombinant DNA technology.
Slovenian: *rekombinantni humani folikle stimulirajoči hormon (FSH), pridobljen iz človeške celične linije
English: Occurrence of ovarian torsion has been reported for ART cycles.
Slovenian: V ciklih zdravljenja v postopku asistirane reprodukcije so poročali o pojavu torzije jajčnikov.
English: • Firmly replace the pen cap on the pen for protection between injections.
Slovenian: • Za zaščito med posameznimi injiciranji trdno namestite pokrovček peresnika na injekcijski peresnik.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection follitropin delta
Slovenian: REKOVELLE 12 mikrogramov/0,36 ml raztopina za injiciranje folitropin delta
English: REKOVELLE 36 micrograms/1.08 mL solution for injection One pre-filled multidose pen delivers 36 micrograms follitropin delta* in 1.08 mL solution.
Slovenian: REKOVELLE 36 mikrogramov/1,08 ml raztopina za injiciranje En večodmerni napolnjen injekcijski peresnik vsebuje 36 mikrogramov folitropina delta*v 1,08 ml raztopine.
English: Vaginal haemorrhage Breast pain Breast tenderness
Slovenian: bolečina v medenici bolečina v materničnih priveskih nelagodje v medenici vaginalna krvavitev bolečina v dojkah občutljivost dojk
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 36 micrograms/1.08 mL injection follitropin delta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE REKOVELLE 36 mikrogramov/1,08 ml injekcija folitropin delta s.c.
English: • Keep pressing the injection button in and when you see the number ‘0' lined up with the dose indicator, wait for 5 seconds (slowly count to 5).
Slovenian: • Gumb za injiciranje držite pritisnjen in ko se številka »0« poravna s kazalnikom odmerka,
English: REKOVELLE 72 micrograms/2.16 mL solution for injection in a pre-filled pen follitropin delta
Slovenian: REKOVELLE 72 mikrogramov/2,16 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin delta
English: In general, you will be given a single injection of a medicine called human chorionic gonadotrophin (hCG) at a dose of 250 micrograms or 5,000 IU for final development of the follicles.
Slovenian: Dali vam bodo enkratno injekcijo zdravila, ki se imenuje človeški horionski gonadotropin (hCG), v odmerku
English: • Carefully replace the outer needle cap over the needle with a firm push (A).
Slovenian: • Z močnim pritiskom (A) previdno namestite zunanji zaščitni pokrovček na iglo.
English: REKOVELLE 36 micrograms/1.08 mL solution for injection in a pre-filled pen follitropin delta
Slovenian: REKOVELLE 36 mikrogramov/1,08 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin delta
English: Each pre-filled pen with multidose cartridge contains 36 micrograms of follitropin delta in 1.08 millilitre of solution.
Slovenian: En napolnjen injekcijski peresnik z večodmernim vložkom vsebuje 36 mikrogramov folitropina delta v 1,08 mililitra raztopine.
English: Somnolence Dizziness
Slovenian: OVOJNINAH VLOŽEK
English: • Write down the dose that is left in your pen in column B. Give the injection using the rest of the medicine that is left in your pen.
Slovenian: • V stolpec B si zabeležite, koliko odmerka je še ostalo v vašem injekcijskem peresniku.
English: The apparent clearance for follitropin delta is low, i.e. 0.6 L/h after multiple subcutaneous administration, leading to high exposure.
Slovenian: Navidezni očistek folitropina po večkratnih subkutanih odmerkih je nizek, t.j.
English: Each pre-filled pen with multidose cartridge contains 12 micrograms of follitropin delta in 0.36 millilitre of solution.
Slovenian: En napolnjen injekcijski peresnik z večodmernim vložkom vsebuje 12 mikrogramov folitropina delta v 0,36 mililitra raztopine.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION REKOVELLE 12 micrograms/0.36 mL injection follitropin delta
Slovenian: IME ZDRAVILA IN POT(I) UPORABE REKOVELLE 12 mikrogramov/0,36 ml injekcija folitropin delta s.c.
English: Each pre-filled pen with multidose cartridge contains 72 micrograms of follitropin delta in 2.16 millilitre of solution.
Slovenian: En napolnjen injekcijski peresnik z večodmernim vložkom vsebuje 72 mikrogramov folitropina delta v 2,16 mililitra raztopine .
English: The table below (Table 2) displays the adverse reactions in patients treated with REKOVELLE in the pivotal clinical trials according to MedDRA system organ class and frequency as follows: common
Slovenian: Neželeni učinki iz ključnih kliničnih preskušanj bolnic, zdravljenih z zdravilom REKOVELLE, so navedeni v spodnji preglednici (Preglednica 2).
English: After first use (in-use period): • The pen may be stored for up to 28 days at 2°C to 25°C.
Slovenian: • Injekcijski peresnik lahko shranjujete do 28 dni pri temperaturi od 2 °C do 25 °C.
English: When undergoing assisted reproductive technology treatment, you are more likely to have a miscarriage than if you conceive naturally.
Slovenian: Pri zdravljenju s postopki oploditve z biomedicinsko pomočjo je verjetnost za spontani splav večja kot pri naravnem spočetju.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection One pre-filled multidose pen delivers 12 micrograms follitropin delta* in 0.36 mL solution.
Slovenian: REKOVELLE 12 mikrogramov/0,36 ml raztopina za injiciranje En večodmerni napolnjen injekcijski peresnik vsebuje 12 mikrogramov folitropina delta* v 0,36 ml raztopine.
English: REKOVELLE 12 micrograms/0.36 mL solution for injection in a pre-filled pen follitropin delta
Slovenian: REKOVELLE 12 mikrogramov/0,36 ml raztopina za injiciranje v napolnjenem injekcijskem peresniku folitropin delta
English: Always use this medicine exactly as your doctor has told you and at the dose your doctor has told you.
Slovenian: Pri uporabi tega zdravila natančno upoštevajte navodila zdravnika in predpisani odmerek.
English: It is available in packs of 1 cartridge and 6 pen injection needles.
Slovenian: Na voljo je v pakiranjih z 1 vložkom in 6 injekcijskimi iglami za peresnik.
English: Pack size of 1 pre-filled pen and 9 injection needles (stainless steel).
Slovenian: Zdravilo je na voljo v pakiranju z 1 napolnjenim injekcijskim peresnikom in 9 injekcijskimi iglami (nerjavno jeklo).
English: It is available in packs of 1 cartridge and 9 pen injection needles.
Slovenian: Na voljo je v pakiranjih z 1 vložkom in 9 injekcijskimi iglami za peresnik.
English: Pack size of 1 pre-filled pen and 3 injection needles (stainless steel).
Slovenian: Zdravilo je na voljo v pakiranju z 1 napolnjenim injekcijskim peresnikom in 3 injekcijskimi iglami (nerjavno jeklo).
English: Pack size of 1 pre-filled pen and 6 injection needles (stainless steel).
Slovenian: Zdravilo je na voljo v pakiranju z 1 napolnjenim injekcijsim peresnikom in 6 injekcijskimi iglami (nerjavno jeklo).
English: The instructions for using the pre-filled pen must be followed carefully.
Slovenian: Skrbno upoštevajte navodila za uporabo napolnjenega injekcijskega peresnika.
English: It is available in packs of 1 cartridge and 3 pen injection needles.
Slovenian: Na voljo je v pakiranjih z 1 vložkom in 3 injekcijskimi iglami za peresnik.
English: It is available in packs of 1 pre-filled pen and 9 pen injection needles.
Slovenian: Na voljo je v pakiranjih z 1 napolnjenim injekcijskim peresnikom in 9 injekcijskimi iglami za peresnik.
English: It is available in packs of 1 pre-filled pen and 6 pen injection needles.
Slovenian: Na voljo je v pakiranjih z 1 napolnjenim injekcijskim peresnikom in 6 injekcijskimi iglami za peresnik.
English: Step 2: • Pull off the pen cap.
Slovenian: 4. korak: • Iglo pritisnite na injekcijski peresnik.
English: • leak-resistant, and
Slovenian: • omotica,
English: NAME OF THE MEDICINAL PRODUCT REKOVELLE 72 micrograms/2.16 mL solution for injection follitropin delta
Slovenian: Navodilo za uporabo REKOVELLE 72 mikrogramov/2,16 ml raztopina za injiciranje folitropin delta
English: It is available in packs of 1 pre-filled pen and 3 pen injection needles.
Slovenian: Na voljo je v pakiranjih z 1 napolnjenim injekcijskim peresnikom in 3 injekcijskimi iglami za peresnik.
English: A.
Slovenian: V
English: NAME OF THE MEDICINAL PRODUCT REKOVELLE 12 micrograms/0.36 mL solution for injection follitropin delta
Slovenian: Navodilo za uporabo REKOVELLE 12 mikrogramov/0,36 ml raztopina za injiciranje folitropin delta
English: NAME OF THE MEDICINAL PRODUCT REKOVELLE 36 micrograms/1.08 mL solution for injection follitropin delta
Slovenian: Navodilo za uporabo REKOVELLE 36 mikrogramov/1,08 ml raztopina za injiciranje folitropin delta
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/002
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/002
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/005
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/005
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/006
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/006
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/004
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/004
English: Needles
Slovenian: Igle
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/001
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/001
English: Constipation Abdominal discomfort
Slovenian: Psihiatrične motnje nihanja razpoloženja
English: Nervous system disorders
Slovenian: Bolezni živčevja glavobol somnolenca omotica
English: • Unscrew the needle in counter-clockwise direction to remove the needle from the pen (B+C).
Slovenian: • Odvijte iglo v nasprotni smeri urinega kazalca, da jo odstranite iz injekcijskega peresnika
English: Step 4:
Slovenian: 3. korak:
English: What REKOVELLE looks like and contents of the pack
Slovenian: Vsebina pakiranja in dodatne informacije Kaj vsebuje zdravilo REKOVELLE
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1150/003
Slovenian: ŠTEVILKA(E) DOVOLJENJA (DOVOLJENJ) ZA PROMET EU/1/16/1150/003
English: REKOVELLE may be removed from the refrigerator, without being refrigerated again, and stored at or below 25 °C for up to 3 months including the period after first use.
Slovenian: Zdravilo REKOVELLE se lahko vzame iz hladilnika in se shranjuje zunaj njega pri temperaturi do
English: Within the therapeutic dose range, exposure to follitropin delta increases proportionally with the dose.
Slovenian: Navidezni volumen porazdelitve znaša približno 25 l po subkutani uporabi, volumen porazdelitve v stanju dinamičnega ravnovesja po intravenski uporabi pa znaša 9 l. V razponu terapevtskih odmerkov se izpostavljenost folitropinu delta povečuje sorazmerno z odmerkom.
English: Write down your prescribed dose in column A.
Slovenian: V stolpec A si zabeležite svoj predpisani odmerek.
English: The main measure of effectiveness in all the studies was based on the number of relapses the patients experienced each year.
Slovenian: Glavno merilo učinkovitosti v vseh študijah je bilo število recidivov, ki so se pri bolnikih pojavili vsako leto.
English: Further information on Gilenya can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Gilenya.
Slovenian: Nadaljnje informacije o zdravilu Gilenya so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/Gilenya.
English: Gilenya is available as capsules (0.25 mg and 0.5 mg).
Slovenian: Zdravilo Gilenya je na voljo v obliki kapsul (0,25 mg in 0,5 mg).
English: In addition, the Agency concluded that all patients should have their heart activity closely monitored after the first dose.
Slovenian: Poleg tega je sklenila, da je treba pri vseh bolnikih po prvem odmerku natančno spremljati srčni utrip.
English: The recommended dose for adults is one 0.5 mg capsule taken once a day by mouth, the recommended dose for children depends on body weight.
Slovenian: Priporočeni odmerek za odrasle je ena 0,5-miligramska kapsula, ki se jemlje peroralno enkrat na dan, priporočeni odmerek za otroke pa je odvisen od njihove telesne mase.
English: Gilenya received a marketing authorisation valid throughout the EU on 17 March 2011.
Slovenian: Za zdravilo Gilenya je bilo 17. marca 2011 izdano dovoljenje za promet, veljavno po vsej EU.
English: What measures are being taken to ensure the safe and effective use of Gilenya?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Gilenya?
English: Details on the recommendations for monitoring patients are found in the summary of product characteristics.
Slovenian: Podrobna priporočila o spremljanju bolnikov so na voljo v povzetku glavnih značilnosti zdravila.
English: An overview of Gilenya and why it is authorised in the EU
Slovenian: Pregled zdravila Gilenya in zakaj je odobreno v EU
English: It must also ensure that all doctors who prescribe Gilenya receive an information pack containing important safety information, including a checklist of the risks with Gilenya and the situations where its use is not recommended.
Slovenian: Zagotoviti mora tudi, da bodo vsi zdravniki, ki predpisujejo zdravilo Gilenya, prejeli informativno gradivo, ki bo vsebovalo pomembne varnostne informacije, vključno s kontrolnim seznamom tveganj, povezanih z zdravilom Gilenya, in primeri, pri katerih njegova uporaba ni priporočena.
English: Other information about Gilenya
Slovenian: Druge informacije o zdravilu Gilenya
English: ‘Relapsing-remitting' means that the patient has flare-ups of symptoms (relapses) followed by periods of recovery (remissions).
Slovenian: „Recidivnoremitentna“ pomeni, da ima bolnik poslabšanja (recidive), ki jim sledijo obdobja izboljšanja (remisij).
English: As for all medicines, data on the use of Gilenya are continuously monitored.
Slovenian: Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Gilenya stalno spremljajo.
English: Why is Gilenya authorised in the EU?
Slovenian: Zakaj je zdravilo Gilenya odobreno v EU?
English: Gilenya contains the active substance fingolimod.
Slovenian: Zdravilo Gilenya vsebuje učinkovino fingolimod.
English: Side effects reported with Gilenya are carefully evaluated and any necessary action taken to protect patients.
Slovenian: Neželeni učinki, o katerih so poročali pri zdravilu Gilenya, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
English: It does this by blocking the action of a receptor (target) on the T cells called the sphingosine-1phosphate receptor, which is involved in controlling the movement of these cells in the body.
Slovenian: Deluje tako, da zavira delovanje receptorja (tarče) na celicah T, imenovanega receptor za sfingozin-1-fosfat, ki sodeluje pri uravnavanju premikanja teh celic po telesu.
English: Gilenya must not be used in patients at risk of infections due to a weakened immune system, patients with a severe infection or a long-term active infection such as hepatitis, and patients with cancer or severe liver problems.
Slovenian: Zdravila Gilenya ne smejo uporabljati bolniki, pri katerih obstaja nevarnost okužb zaradi oslabljenega imunskega sistema, bolniki s hudimi okužbami ali dolgotrajnimi aktivnimi okužbami, kot je hepatitis, in bolniki z rakom ali hudimi težavami z jetri.
English: The Agency decided that Gilenya's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Zato je sklenila, da so koristi zdravila Gilenya večje od z njim povezanih tveganj, in priporočila, da se zanj izda dovoljenje za promet.
English: Gilenya is a type of medicine known as a ‘disease-modifying therapy' that is used to treat adults and children over 10 years of age with highly active relapsing-remitting multiple sclerosis (MS), a disease of the nerves in which inflammation destroys the protective sheath surrounding the nerve cells.
Slovenian: Gilenya je vrsta zdravila, znana kot „zdravilo za spreminjanje poteka bolezni“, ki se uporablja za zdravljenje odraslih in otrok, starejših od 10 let, z zelo aktivno recidivno-remitentno multiplo sklerozo (MS), tj. boleznijo živcev, pri kateri vnetje uniči zaščitno ovojnico, ki obdaja živčne celice.
English: The European Medicines Agency concluded that there is clear evidence of the benefit of Gilenya in relapsing-remitting multiple sclerosis in both adults and children and noted that it had the benefit of being taken by mouth while most other medicines for this disease are given by injection.
Slovenian: Evropska agencija za zdravila je zaključila, da obstajajo jasni dokazi o koristih zdravila Gilenya pri recidivno-remitentni multipli sklerozi pri odraslih in tudi otrocih, in ugotovila, da je koristno, če se jemlje peroralno, saj se večina drugih zdravil za to bolezen daje z injiciranjem.
English: For more information about using Gilenya, see the package leaflet or contact your doctor or pharmacist.
Slovenian: Za več informacij glede uporabe zdravila Gilenya glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
English: What benefits of Gilenya have been shown in studies?
Slovenian: Kakšne koristi je zdravilo Gilenya izkazalo v študijah?
English: The pack will also include information on a registry to collect data on babies born to women treated with Gilenya, as well as a patient reminder card for patients or their carers with key safety information.
Slovenian: Gradivo bo prav tako vključevalo informacije o registru za zbiranje podatkov o dojenčkih, ki so se rodili ženskam, zdravljenim z zdravilom Gilenya, ter opozorilno kartico za bolnike s ključnimi informacijami o varnosti zdravila.
English: In multiple sclerosis, the immune system (the body's defences) incorrectly attacks the protective sheath around the nerves in the brain and spinal cord.
Slovenian: Pri multipli sklerozi imunski sistem (obrambni mehanizem telesa) nepravilno napade zaščitno ovojnico, ki obdaja živce v možganih in hrbtenjači.
English: What are the risks associated with Gilenya?
Slovenian: Kakšna tveganja so povezana z zdravilom Gilenya?