natgillin/translations-raw huggingface dataset:
Amendments to be included in the relevant sections of the summary of product characteristics for multivalent measles, mumps, rubella and varicella containing vaccines
Popravki, ki morajo biti vključeni v ustrezna poglavja povzetka glavnih značilnosti zdravila za večvalentna cepiva, ki vsebujejo ošpice, mumps, rdečke in norice
Therefore, inadvertent vaccination of unknowingly pregnant women with mumps containing vaccines should not be a reason for termination of pregnancy.
Zato nenamerno cepljenje nosečnice s cepivi, ki vsebujejo virus mumpsa, ne sme biti razlog za prekinitev nosečnosti.
Therefore, inadvertent vaccination of unknowingly pregnant women with measles containing vaccines should not be a reason for termination of pregnancy.
Zato nenamerno cepljenje nosečnice s cepivi, ki vsebujejo virus ošpic, ne sme biti razlog za prekinitev nosečnosti.
Amendments to be included in the relevant sections of the package leaflet for multivalent measles and rubella containing vaccines
Popravki, ki morajo biti vključeni v ustrezna poglavja navodila za uporabo za večvalentna cepiva, ki vsebujejo ošpice in rdečke
Amendments to be included in the relevant sections of the package leaflet for multivalent measles, mumps, rubella and varicella containing vaccines 2.
Popravki, ki morajo biti vključeni v ustrezna poglavja navodila za uporabo za večvalentna cepiva, ki vsebujejo ošpice, mumps, rdečke in norice 2.
Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
Popravki ustreznih poglavij v povzetku glavnih značilnosti zdravila in navodilu za uporabo
However, fetal damage has not been documented when measles vaccines have been given to pregnant women.
Vendar pri uporabi cepiva proti ošpicam pri nosečnicah, niso zabeležili poškodb ploda.
Amendments to be included in the relevant sections of the summary of product characteristics for monovalent measles containing vaccines
Popravki, ki morajo biti vključeni v ustrezna poglavja povzetka glavnih značilnosti zdravila za enovalentna cepiva, ki vsebujejo ošpice
Amendments to be included in the relevant sections of the summary of product characteristics for multivalent measles and rubella containing vaccines
Popravki, ki morajo biti vključeni v ustrezna poglavja povzetka glavnih značilnosti zdravila za večvalentna cepiva, ki vsebujejo ošpice in rdečke
However, fetal damage has not been documented when rubella vaccines have been given to pregnant women.
Vendar pri uporabi cepiva proti noricam pri nosečnicah, niso zabeležili poškodb ploda.
However, fetal damage has not been documented when measles or rubella vaccines have been given to pregnant women.
Vendar pri uporabi cepiva proti ošpicam ali rdečkam pri nosečnicah, niso zabeležili poškodb ploda.
Amendments to be included in the relevant sections of the package leaflet for monovalent measles containing vaccines
Popravki, ki morajo biti vključeni v ustrezna poglavja navodila za uporabo za enovalentna cepiva, ki vsebujejo ošpice
Therefore, inadvertent vaccination of unknowingly pregnant women with measles and rubella containing vaccines should not be a reason for termination of pregnancy.
Zato nenamerno cepljenje nosečnice s cepivi, ki vsebujejo virusa ošpic in rdečk, ne sme biti razlog za prekinitev nosečnosti.
Amendments to be included in the relevant sections of the package leaflet for monovalent rubella containing vaccines
Popravki, ki morajo biti vključeni v ustrezna poglavja navodila za uporabo za enovalentna cepiva, ki vsebujejo rdečke
Therefore, inadvertent vaccination of unknowingly pregnant women with rubella containing vaccines should not be a reason for termination of pregnancy.
Zato nenamerno cepljenje nosečnice s cepivi, ki vsebujejo virus rdečk, ne sme biti razlog za prekinitev nosečnosti.
Amendments to be included in the relevant sections of the summary of product characteristics for monovalent rubella containing vaccines
Popravki, ki morajo biti vključeni v ustrezna poglavja povzetka glavnih značilnosti zdravila za enovalentna cepiva, ki vsebujejo rdečke
Further information on Betaferon can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/betaferon.
Nadaljnje informacije o zdravilu Betaferon so na voljo na spletni strani agencije: ema.europa.eu/medicines/human/EPAR/betaferon.
What measures are being taken to ensure the safe and effective use of Betaferon?
Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Betaferon?
In the other study, no delay in the time to disability progression was seen.
V drugi študiji do odloga napredovanja invalidnosti ni prišlo.
Other information about Betaferon
Druge informacije o zdravilu Betaferon
The European Medicines Agency decided that Betaferon'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 Betaferon večje od z njim povezanih tveganj in da se lahko odobri za uporabo v EU.
Betaferon is used in patients:
Zdravilo Betaferon se uporablja pri bolnikih:
Betaferon received a marketing authorisation valid throughout the EU on 30 November 1995.
Za zdravilo Betaferon je bilo 30. novembra 1995 izdano dovoljenje za promet, veljavno po vsej EU.
Side effects are common at the beginning of treatment but usually decrease with further treatment.
Neželeni učinki so pogosti na začetku zdravljenja, vendar se z nadaljevanjem zdravljenja običajno zmanjšajo.
As for all medicines, data on the use of Betaferon are continuously monitored.
Tako kot za vsako zdravilo se tudi podatki o uporabi zdravila Betaferon stalno spremljajo.
What are the risks associated with Betaferon?
Kakšna tveganja so povezana z zdravilom Betaferon?
What benefits of Betaferon have been shown in studies?
Kakšne koristi zdravila Betaferon so se pokazale v študijah?
• who have MS of the type known as ‘relapsing-remitting', when the patient has attacks (relapses) between periods with no symptoms (remissions), in patients with at least two relapses within the last two years;
• ki imajo vrsto multiple skleroze, znano kot „recidivno-remitentna“, pri kateri ima bolnik napade (recidive) med obdobji brez simptomov (remisije), in sicer pri bolnikih z vsaj dvema recidivoma v zadnjih dveh letih;
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Betaferon 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 Betaferon upoštevati zdravstveni delavci in bolniki, so vključeni v povzetek glavnih značilnosti zdravila in navodilo za uporabo.
In both studies, Betaferon showed a reduction (30%) in the number of clinical relapses.
V obeh študijah je zdravilo Betaferon pokazalo (30-odstotno) zmanjšanje števila kliničnih recidivov.
• who have experienced the signs of MS for the first time, and these are severe enough to need treatment with injected corticosteroids (anti-inflammatory medicines).
• pri katerih so se znaki multiple skleroze pojavili prvič, pri čemer so ti dovolj resni, da jih je treba zdraviti z injiciranjem kortikosteroidov (protivnetnih zdravil).
Why is Betaferon authorised in the EU?
Zakaj je bilo zdravilo Betaferon odobreno v EU?
Betaferon must not be used in patients who have severe depression or have thoughts of suicide.
Zdravilo Betaferon se ne sme uporabljati pri bolnikih, ki imajo hudo depresijo ali samomorilne misli.
Betaferon treatment should be stopped in patients whose condition does not improve.
Zdravljenje z zdravilom Betaferon je treba prekiniti pri bolnikih, katerih stanje se ne izboljšuje.
An overview of Betaferon and why it is authorised in the EU
Pregled zdravila Betaferon in zakaj je odobreno v EU
Side effects reported with Betaferon are carefully evaluated and any necessary action taken to protect patients.
Neželeni učinki, o katerih so poročali pri zdravilu Betaferon, se skrbno ovrednotijo in po potrebi se sprejmejo ukrepi za zaščito bolnikov.
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 je treba začeti z odmerkom 62,5 mikrogramov (četrtina odmerka) vsak drug dan, ki se 19 dni postopoma povečuje, da se doseže priporočeni odmerek 250 mikrogramov vsak drugi dan. Bolniki si lahko po opravljenem ustreznem usposabljanju zdravilo Betaferon injicirajo sami.
Betaferon must not be used in patients who have decompensated liver disease (when the liver is damaged and can no longer work adequately).
Ne sme uporabljati pri bolnikih, ki imajo dekompenzirano bolezen jeter (poškodovana jetra, ki ne morejo več ustrezno delovati).
For more information about using Betaferon, see the package leaflet or contact your doctor or pharmacist.
Za več informacij glede uporabe zdravila Betaferon glejte navodilo za uporabo ali se posvetujte z zdravnikom ali farmacevtom.
Betaferon is a medicine used to treat adults who have multiple sclerosis (MS).
Betaferon je zdravilo, ki se uporablja za zdravljenje odraslih z multiplo sklerozo (MS).
The active substance in Betaferon 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 Betaferon je beljakovina interferon beta-1b, ki je ena od skupin interferonov, ki jih lahko telo naravno ustvari v boju proti virusom in drugim napadom.
The most frequent side effects with Betaferon 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 Betaferon so gripi podobni simptomi (vključno s povišano telesno temperaturo, mrzlico, bolečinami v sklepih, slabim počutjem, potenjem, glavobolom in bolečinami v mišicah) in reakcije na mestu injiciranja.
• who have secondary progressive MS (the type of MS that comes after relapsing-remitting MS), when their disease is active.
• s sekundarno progresivno multiplo sklerozo (vrsto multiple skleroze, ki nastopi po recidivnoremitentni multipli sklerozi), če je njihova bolezen aktivna.
The exact way that Betaferon 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 Betaferon še ni znan, vendar se zdi, da učinkovina, interferon beta-1b, umirja imunski sistem in preprečuje recidive multiple skleroze.
What is Betaferon and what is it used for?
Kaj je zdravilo Betaferon in za kaj se uporablja?
In MS, the immune system (the body's natural defences) malfunctions and attacks parts of the central nervous system (the brain, spinal cord and optic nerve [nerve that sends signals from the eye to the brain]), causing inflammation that damages the nerves and the insulation around them.
Pri multipli sklerozi imunski sistem (naravni obrambni mehanizmi telesa) ne deluje pravilno in napada dele osrednjega živčnega sistema (možgane, hrbtenjačo in optični živec [živec, ki pošilja signale od očesa do možganov]), kar povzroča vnetje, ki poškoduje živce in njihovo ovojnico.
Betaferon 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.
Zdravilo Betaferon je bilo pri zmanjševanju števila recidivov na leto učinkovitejše od placeba: bolniki, ki so prejemali zdravilo Betaferon, so imeli povprečno 0,84 recidiva na leto, medtem ko so jih bolniki, ki so prejemali placebo, imeli 1,27.
It is given by injection under the skin.
Zdravilo se injicira v podkožje.
MS is a disease in which inflammation damages the protective insulation around nerves (demyelination) as well as the nerves themselves.
Multipla skleroza je bolezen, pri kateri zaradi vnetja pride do poškodbe zaščitne ovojnice okoli živcev (demielinizacije) in samih živcev.
One of the two studies showed a significant delay in the time to disability progression (31% risk reduction due to Betaferon) and in the time to becoming wheelchair bound (39%).
Ena od obeh študij je pokazala znaten odlog napredovanja invalidnosti (31-odstotno zmanjšanje tveganja ob jemanju zdravila Betaferon) in nastopa stopnje invalidnosti, pri kateri bolnik potrebuje invalidski voziček (39 %).
Betaferon can only be obtained with a prescription and treatment should be started by a doctor who has experience in the treatment of MS.
Predpisovanje in izdaja zdravila Betaferon je le na recept, zdravljenje z njim pa mora uvesti zdravnik, ki ima izkušnje z zdravljenjem multiple skleroze.
Betaferon is available as a powder and solvent that are made up into a solution that supplies a dose of 250 micrograms.
Zdravilo Betaferon je na voljo v obliki praška in vehikla za pripravo raztopine, ki vsebuje 250mikrogramski odmerek učinkovine.
For the full list of side effects and restrictions with Betaferon, see the package leaflet.
Za celoten seznam neželenih učinkov in omejitev pri uporabi zdravila Betaferon glejte navodilo za uporabo.
Betaferon was also studied in 487 patients with a single demyelinating event, who received either Betaferon or placebo for two years.
Zdravilo Betaferon so proučevali tudi pri 487 bolnikih z enim samim demielinezacijskim dogodkom, ki so dve leti prejemali bodisi zdravilo Betaferon bodisi placebo.
Betaferon was shown to reduce the risk of developing clinically defined MS: 28% of the patients who received Betaferon developed MS, compared with 45% of those who received placebo.
Zdravilo Betaferon dokazano zmanjšuje tveganje za razvoj klinične multiple skleroze: multipla skleroza se je razvila pri 28 % bolnikov, ki so prejemali zdravilo Betaferon, in pri 45 % bolnikov, ki so prejemali placebo.
Betaferon contains the active substance interferon beta-1b.
Zdravilo Betaferon vsebuje učinkovino interferon beta-1b.
How is Betaferon used?
Kako se zdravilo Betaferon uporablja?
Betaferon has also been studied in 1,657 patients in two studies of secondary progressive MS patients who were able to walk, where it was compared with placebo.
Zdravilo Betaferon so proučevali tudi v dveh študijah sekundarne progresivne multiple skleroze pri 1 657 bolnikih, ki so lahko hodili, in ga primerjali s placebom.
Betaferon was studied over a two-year period in 338 patients with relapsing remitting MS who were able to walk unaided, where it was compared with placebo (a dummy treatment).
Zdravilo Betaferon so dve leti proučevali pri 338 bolnikih z recidivno-remitentno multiplo sklerozo, ki so lahko hodili brez pomoči, in ga primerjali s placebom (zdravilom brez učinkovine).
Betaferon is used when the patient is considered to be at high risk of developing MS. Before using Betaferon, doctors need to exclude other causes for the symptoms;
Pred uporabo zdravila Betaferon morajo zdravniki izključiti druge možne vzroke za opažene simptome;
• an examination to check the nerves in your arms and legs
• pregled živcev v vaših rokah in nogah
Take the next capsule at the usual time.
Kapsulo vzemite ob običajnem času.
A relevance of these findings to humans cannot be excluded.
Pomembnosti teh ugotovitev za človeka ni mogoče izključiti.
You should swallow the whole capsule with a glass of water.
Kapsulo morate pogoltniti celo s kozarcem vode.
• measurement of vitamin B12 levels
• meritev ravni vitamina B12
ATC Code: A16AX06
Oznaka ATC: A16AX06.
The tremor often disappears without needing to stop the treatment.
Tremor pogosto izgine brez potrebe prekinitve zdravljenja.
Hard capsule 84 capsules 84x1 capsules
trda kapsula 84 kapsul 84 x 1 kapsula
The greatest prevalence was observed between 6 and 12 months.
Največjo prevalenco so opazili med 6
- if you are allergic to miglustat or any of the other ingredients of this medicine (listed in section 6).
- če ste alergični na miglustat ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
Thirteen patients discontinued treatment due to an adverse event.
Trinajst bolnikov je zdravljenje zaključilo zaradi neželenega dogodka.
A No Observed Effect Level (NOEL) was not established and the effect was not dose dependent.
Ravni brez opaženega učinka (NOEL - No Observed Effect Level) niso ugotovili, učinek ni bil odvisen od odmerka.
The apparent volume of distribution of miglustat is 83 L. Miglustat does not bind to plasma proteins.
Navidezni volumen porazdelitve miglustata je 83 l. Miglustat se ne veže na beljakovine v plazmi.
Most patients get one or more of these side effects mentioned above, usually at the start of treatment or at intervals during treatment.
Pri večini bolnikov se pojavi eden ali več teh neželenih učinkov, običajno na začetku zdravljenja ali občasno med zdravljenjem.
Miglustat Dipharma has negligible influence on the ability to drive and use machines.
Zdravilo Miglustat Dipharma ima zanemarljiv vpliv na sposobnost vožnje in upravljanja strojev.
• monitoring growth if you are a child or adolescent with Niemann-Pick type C disease
• nadziranje rasti, če ste otrok ali mladostnik z Niemann-Pickovo boleznijo tipa C
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Znotraj vsake pogostnostne skupine so neželeni učinki navedeni po padajoči resnosti.
for an average duration of 2.1 years.
Povprečno zdravljenje je trajalo 2.1 leto.
Liver volume (primary efficacy variable) was unchanged from baseline to the end of treatment.
Jetrni volumen (primarna spremenljivka učinkovitosti) se od izhodišča do konca zdravljenja ni spremenil.
Among the 41 patients enrolled in the trial 14 patients were treated with miglustat for more than 3 years.
Med 41 bolniki, vključenimi v preskušanje, je bilo 14 bolnikov zdravljenih z zdravilom miglustat več kot 3 leta.
The tests will help the doctor decide whether these effects are due to your disease or other existing conditions, or due to side effects of Miglustat Dipharma (see section 4 for further details).
Te preiskave bodo zdravniku v pomoč pri presoji, ali so ti učinki posledica vaše bolezni ali drugega obstoječega stanja ali posledica neželenih učinkov zdravila Miglustat Dipharma (za dodatne informacije glejte poglavje 4).
Tell your doctor if you are taking medicines containing imiglucerase, which are sometimes used at the same time as Miglustat Dipharma.
Obvestite zdravnika, če jemljete zdravila, ki vsebujejo imiglucerazo, ki se včasih jemljejo skupaj z zdravilom Miglustat Dipharma.
The kinetics of miglustat appears to be dose linear and time independent.
Kinetika miglustata je videti linearno odvisna od odmerka in neodvisna od časa.
Tabulated list of adverse reactions Adverse reactions from clinical trials and spontaneous reporting, occurring in >1% of patients, are listed in the table below by system organ class and frequency (very common: ≥ 1/10, common: ≥ 1/100 < 1/10, uncommon: ≥1/1,000 to <1/100, rare: ≥1/10,000 to <1/1,000, very rare: <1/10,000).
Neželeni učinki zdravila iz kliničnih preskušanj in spontanega poročanja, ki so se pojavili pri > 1 % bolnikov, so navedeni v spodnji preglednici, razvrščeni po organskem sistemu in pogostnosti (zelo pogosti: ≥ 1/10, pogosti: ≥ 1/100 < 1/10, občasni: ≥1/1.000 do <1/100, redki: ≥1/10.000 do <1/1.000,
This study also indicated that miglustat has no or limited effect on the pharmacokinetics of imiglucerase.
Ta študija je tudi pokazala, da miglustat nima učinka ali ima le majhen učinek na farmakokinetiko imigluceraze.
Of these, 18 patients at baseline were within established therapeutic goals for liver and spleen volume, haemoglobin levels, and platelet counts, and 16 patients remained within all these therapeutic goals at month 24.
Med njimi je bilo 18 bolnikov ob izhodišču znotraj uveljavljenih terapevtskih ciljev za volumen jeter in vranice, ravni hemoglobina in število trombocitov, 16 bolnikov pa je ostalo znotraj vseh teh terapevtskih ciljev v 24. mesecu.
They may lower the amount of Miglustat Dipharma in your body.
Ta zdravila lahko znižajo količino zdravila Miglustat Dipharma v vašem telesu.
The efficacy and safety of miglustat has not been specifically evaluated in patients with severe Gaucher disease.
Učinkovitost in varnost miglustata nista bili specifično ocenjeni pri bolnikih s hudo Gaucherjevo boleznijo.
Your doctor may reduce your dose, e.g., to one capsule (100 mg) once or twice a day, if you suffer from diarrhoea when taking Miglustat Dipharma (see section 4).
Vaš zdravnik lahko zmanjša vaš odmerek, npr. na eno kapsulo (100 mg) enkrat ali dvakrat dnevno, če imate med jemanjem zdravila Miglustat Dipharma drisko (glejte poglavje 4).
This study was conducted over a 6-month randomised comparison period followed by 18 months extension where all patients received miglustat monotherapy.
To študijo so izpeljali prek 6-mesečnega randomiziranega primerjalnega obdobja, ki mu je sledilo 18-mesečno podaljšanje, v katerem so vsi bolniki prejemali monoterapijo z miglustatom.
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreeed subsequent updates of the RMP.
• Načrt za obvladovanje tveganj (RMP) Imetnik dovoljenja za promet z zdravilom bo izvedel zahtevane farmakovigilančne aktivnosti in ukrepe, podrobno opisane v sprejetem RMP, predloženem v modulu 1.8.2 dovoljenja za promet z zdravilom, in vseh nadaljnjih sprejetih posodobitvah RMP.
Miglustat is mainly eliminated by renal excretion, with urinary recovery of unchanged substance accounting for 70-80% of the dose.
Miglustat se pretežno izloča skozi ledvice, pri čemer znaša rekuperacija nespremenjenega zdravila v urinu 70-80 % odmerka.
A second open, controlled study randomised 36 patients who had received a minimum of 2 years of treatment with ERT, into three treatment groups: continuation with imiglucerase, imiglucerase in combination with miglustat, or switch to miglustat.
V drugi odprti kontrolirani študiji so 36 bolnikov, ki so se že vsaj 2 leti zdravili z ERT, naključno razporedili v tri skupine zdravljenja: nadaljevanje zdravljenja z imiglucerazo, kombinacija imigluceraze in miglustata ali prehod na miglustat.
Data to support safety and efficacy of miglustat in Niemann-Pick type C disease come from a prospective open-label clinical trial and a retrospective survey.
Podatki, ki podpirajo varnost in učinkovitost zdravila miglustat pri Niemann-Pickovi bolezni tipa C so bili zbrani v prospektivnem odprtem kliničnem preskušanju in v retrospektivni analizi.
When compared to the measurements at 6 months, disease control was unchanged after 18 and 24 months of miglustat monotherapy (20 and 6 patients, respectively).
V primerjavi z meritvami pri 6 mesecih je bil nadzor bolezni po 18 in 24 mesecih monoterapije z miglustatom nespremenjen (20 oz. 6 bolnikov).
Miglustat Dipharma can be taken with or without food.
Zdravilo Miglustat Dipharma se lahko jemlje s hrano ali brez nje.
PCTFE/PVC and Aluminium blister containing 12 (perforated unit dose) or 21 (non-perforated) capsules.
Pretisni omot PCTFE/PVC in aluminija, ki vsebuje 12 (perforiranih, s posameznimi odmerki) ali 21 (neperforiranih) kapsul.
In a pooled analysis of uncontrolled data, bone mineral density Z-scores at the lumbar spine and femoral neck increased by more than 0.1 units from baseline in 27 (57%) and 28 (65%) of the patients with longitudinal bone density measurements.
V zbrani analizi nekontroliranih podatkov so se vrednosti Z mineralne gostote kosti ledvene hrbtenice in vratu stegnenice povečale za več kot 0.1 enoto od izhodišča pri 27 (57 %) in 28 (65 %) bolnikov pri vzdolžni smeri merjenja gostote kosti.
Approximately 37% of patients in clinical trials in type 1 Gaucher disease, and 58% of patients in a clinical trial in Niemann-Pick type C disease reported tremor on treatment.
Približno 37 % bolnikov v kliničnih preskušanjih z Gaucherjevo boleznijo tipa 1 in 58 % bolnikov v kliničnih preskušanjih z Niemann-Pickovo boleznijo tipa C je poročalo o tremorju med zdravljenjem.
Do not stop taking Miglustat Dipharma without talking to your doctor.
Ne prenehajte jemati zdravila Miglustat Dipharma, ne da se o tem pogovorite z zdravnikom.