natgillin/translations-raw huggingface dataset:
Viramune, taken alone or in combination with one or two other antiviral medicines, has also been studied in two studies including 478 children.
Zdravilo Viramune, kot samostojno zdravilo ali v kombinaciji z enim ali dvema drugima protivirusnima zdraviloma, so proučevali tudi v dveh študijah, ki sta vključevali 478 otrok.
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 Viramune.
Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo Viramune, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z njim in priporočila glede pogojev njegove uporabe.
CD4 T-cells are white blood cells that are important in helping to fight infections but which are killed by HIV.
T-celice CD4 so bele krvničke, ki imajo pomembno vlogo pri premagovanju okužb, vendar pa jih virus HIV uničuje.
EPAR summary for the public nevirapine
Povzetek EPAR za javnost
The main measures of effectiveness were the change in the level of HIV in the blood (viral load) and in the number of CD4 T-cells in the blood (CD4 cell count), and the number of patients whose disease got worse or who died.
Glavna merila učinkovitosti so bila sprememba koncentracije virusa HIV v krvi (virusno breme) in števila T-celic CD4 v krvi (koncentracije celic CD4) ter število bolnikov, pri katerih se je bolezen poslabšala ali ki so umrli.
In 151 treatment-naïve patients (who had not taken treatment for HIV infection before), viral load fell by 99% in the three-medicine group, compared with 96% in the two-medicine group after 40 to 52 weeks.
Pri 151 predhodno nezdravljenih bolnikih (ki prej še niso jemali zdravil proti okužbi s HIV) se je po 40 do 52 tednih virusno breme v skupini, ki je jemala tri zdravila, zmanjšalo za 99 % v primerjavi s 96 % v skupini, ki je jemala dve zdravili.
Immediate-release tablets release the active substance immediately, and prolonged-release tablets release it slowly over a few hours which allows it to be given less frequently.
Tablete s takojšnjim sproščanjem zdravilno učinkovino sprostijo takoj po zaužitju, tablete s podaljšanim sproščanjem pa jo sproščajo počasi v nekaj urah, kar omogoča manj pogosto jemanje zdravila.
The dose should not be increased to the maintenance dose until any rash has cleared.
Odmerek se ne sme povečati na vzdrževalni odmerek, dokler izpuščaji ne izginejo.
Viramune does not cure HIV-1 infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Zdravilo Viramune ne ozdravi okužbe z virusom HIV-1 ali aidsa, lahko pa upočasni slabšanje imunskega sistema ter razvoj okužb in bolezni, povezanih z aidsom.
Patients should be monitored closely for signs of these side effects during the first 18 weeks of treatment, and blood tests for liver problems should be carried out regularly throughout treatment.
Pri bolnikih je treba prvih 18 tednov zdravljenja skrbno nadzirati pojavljanje znakov teh neželenih učinkov, v zvezi s težavami z jetri pa je treba med zdravljenjem redno izvajati krvne teste.
Viramune, taken in combination with two other antiviral medicines, was more effective than combinations of two medicines.
Zdravilo Viramune, ki se jemlje v kombinaciji z dvema drugima protivirusnima zdraviloma, je bilo učinkovitejše od kombinacij dveh zdravil.
Adults taking three medicines also had greater rises in CD4 cell counts, and a lower risk of their disease getting worse or of dying.
Pri odraslih, ki so jemali tri zdravila, je bil tudi porast koncentracije celic CD4 večji in tveganje za poslabšanje bolezni ali smrt manjše.
In 398 treatment-experienced adults (who had taken treatment for HIV infection before), Viramune in combination with zidovudine and lamivudine led to a 38% reduction in viral load after 48 weeks, compared with a 28% rise in those taking zidovudine and lamivudine without Viramune.
Pri 398 predhodno zdravljenih odraslih (ki so že prej jemali zdravila proti okužbi s HIV) je zdravilo Viramune v kombinaciji z zidovudinom in lamivudinom po 48 tednih privedlo do 38-odstotnega zmanjšanja virusnega bremena v primerjavi z 28-odstotnim povečanjem pri bolnikih, ki so jemali samo zidovudin in lamivudin.
It is available as immediaterelease (200 mg) and prolonged-release tablets (50, 100 and 400 mg) and as an oral suspension (50 mg/5 ml).
Na voljo je v obliki tablet s takojšnjim sproščanjem (200 mg), tablet s podaljšanim sproščanjem (50, 100 in 400 mg) ter peroralne suspenzije (50 mg/5 ml).
The prolonged-released tablets are not suitable for the initial two week phase for patients starting on Viramune and should not be used until any rash has cleared.
Tablete s podaljšanim sproščanjem niso primerne za začetno dvotedensko terapijo za bolnike, ki šele začenjajo zdravljenje z zdravilom Viramune, in se ne smejo uporabljati, dokler izpuščaji ne izginejo.
For children and adolescents, the starting dose is 150 mg per square metre of body surface area (calculated using the child's height and weight) or 4 mg/kg once a day for two weeks with Viramune oral suspension, after which the dose should be increased to a maintenance dose (calculated using the patient's body surface area or weight).
Pri otrocih in mladostnikih je začetni odmerek 150 mg na kvadratni meter telesne površine (izračunane na podlagi otrokove višine in telesne mase) ali 4 mg/kg enkrat na dan v obdobju dveh tednov, ki se daje v obliki peroralne suspenzije, potem pa se odmerek poveča na vzdrževalni odmerek (ki se izračuna na podlagi bolnikove telesne površine ali telesne mase).
The Committee recommended that Viramune be given marketing authorisation.
Odbor je priporočil, da se za zdravilo Viramune odobri dovoljenje za promet.
Viramune has also been associated with serious side effects, including Stevens-Johnson syndrome and toxic epidermal necrolysis (life-threatening allergic reactions affecting the skin and mucous membranes), serious hepatitis and liver failure, and serious allergic reactions.
Z zdravilom Viramune so povezani tudi resni neželeni učinki, med drugim Stevens-Johnsonov sindrom in toksična epidermalna nekroliza (življenjsko nevarne alergijske reakcije, ki prizadenejo kožo in sluznico), hud hepatitis in jetrna odpoved ter resne alergijske reakcije.
It blocks the activity of reverse transcriptase, an enzyme produced by HIV-1 that allows it to infect cells in the body and make more viruses.
Ta zavira delovanje reverzne transkriptaze, encima, ki ga proizvaja virus HIV-1 in omogoča okužbo celic v telesu in nastajanje novih virusov.
For the full list of all side effects reported with Viramune, see the package leaflet.
Za celoten seznam vseh neželenih učinkov, o katerih so poročali pri uporabi zdravila Viramune, glejte navodilo za uporabo.
The most common side effects with Viramune (seen in between 1 and 10 patients in 100) are rash, headache, nausea (feeling sick), fatigue, abdominal pain, diarrhoea, fever, hepatitis (inflammation of the liver) and signs of liver problems in the blood.
Najpogostejši neželeni učinki zdravila Viramune (opaženi pri 1 do 10 bolnikih od 100) so izpuščaji, glavobol, slabost, utrujenost, bolečine v trebuhu, driska, povišana telesna temperatura, hepatitis (vnetje jeter) in znaki v krvi, ki kažejo na težave z jetri.
Treatment with Viramune must not be started again in patients who have had to stop taking the medicine in the past because of rash, allergic reactions or hepatitis, or who had signs of liver problems while they were taking Viramune that returned when the medicine was started again.
Zdravljenje z zdravilom Viramune se ne sme ponovno začeti pri bolnikih, ki so morali prenehati jemati zdravilo zaradi izpuščajev, alergijskih reakcij ali hepatitisa oziroma so imeli med jemanjem zdravila Viramune znake težav z jetri, ki so se ob ponovnem jemanju zdravila ponovili.
Viramune must not be used in people who are hypersensitive (allergic) to nevirapine or any of the other ingredients.
Zdravilo Viramune se ne sme uporabljati pri ljudeh, ki so preobčutljivi za (alergični na) nevirapin ali katero drugo sestavino zdravila.
If the patient cannot switch to the full dose within four weeks of starting Viramune, alternative treatments should be sought.
Če po štirih tednih zdravljenja z zdravilom Viramune bolnik ne more preiti na celotni odmerek, je treba poiskati druge možnosti zdravljenja.
They also showed that patients can be safely switched from immediate- to prolonged-release tablets.
Pokazale so tudi, da lahko bolniki varno preidejo s tablet s takojšnjim sproščanjem na tablete s podaljšanim sproščanjem.
What is the risk associated with Viramune?
Kakšna tveganja so povezana z zdravilom Viramune?
The Committee noted that most of the experience with Viramune was in combination with nucleoside reverse transcriptase inhibitors (NRTIs, a type of antiviral medicine) and that there was insufficient evidence on the use of combination treatment including a protease inhibitor (another type of antiviral medicine) after Viramune treatment.
Odbor je opozoril, da večina izkušenj z zdravilom Viramune izvira iz kombiniranega zdravljenja z zaviralci nukleozidne reverzne transkriptaze (NRTI-ji, vrsto protivirusnega zdravila) in da je na voljo premalo podatkov o kombiniranem zdravljenju z zaviralcem proteaze (drugo vrsto protivirusnega zdravila) po zdravljenju z zdravilom Viramune.
By blocking this enzyme, Viramune, taken in combination with other antiviral medicines, reduces the amount of HIV-1 in the blood and keeps it at a low level.
Zdravilo Viramune, če se jemlje v kombinaciji z drugimi protivirusnimi zdravili, z zaviranjem tega encima zmanjša koncentracijo virusa HIV-1 v krvi in jo ohranja na nizki ravni.
It must not be used in patients who have severe problems with their liver or signs of liver problems in the blood, or who are taking St John's wort (a herbal preparation used to treat depression).
Ne sme se uporabljati pri bolnikih, ki imajo resne težave z jetri ali znake v krvi, ki kažejo na težave z jetri, ali pri bolnikih, ki jemljejo šentjanževko (pripravek rastlinskega izvora za zdravljenje depresije).
The studies compared Viramune, taken in combination with zidovudine and didanosine (other antiviral medicines), with other antiviral medicines.
V študijah so zdravilo Viramune, ki se jemlje v kombinaciji z zidovudinom in didanozinom (drugima protivirusnima zdravila), primerjali z drugimi protivirusnimi zdravili.
The active substance in Viramune, nevirapine, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Zdravilna učinkovina zdravila Viramune, nevirapin, je nenukleozidni zaviralec reverzne transkriptaze (NNRTI).
Why has Viramune been approved?
Zakaj je bilo zdravilo Viramune odobreno?
For adults, treatment should start with 200 mg immediate-release tablets or oral suspension once a day for two weeks.
Pri odraslih se zdravljenje začne z 200-miligramskim odmerkom v obliki tablet s takojšnim sproščanjem ali peroralne suspenzije, in sicer enkrat na dan v obdobju dveh tednov.
Viramune is an antiviral medicine.
Zdravilo Viramune je protivirusno zdravilo.
The Committee for Medicinal Products for Human Use (CHMP) decided that Viramune's benefits are greater than its risks in combination with other antiviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age.
Odbor za zdravila za uporabo v humani medicini (CHMP) je zaključil, da so koristi zdravila Viramune v kombinaciji z drugimi protivirusnimi zdravili pri zdravljenju odraslih, mladostnikov in otrok katerekoli starosti, okuženih z virusom HIV-1, večje od z njim povezanih tveganj.
The dose should then be increased to the standard dose of 200 mg twice a day using immediate release tablets or oral suspension or to the standard dose of 400mg once a day using the prolonged-release tablets are prescribed.
Odmerek se nato poveča na standardni odmerek 200 mg dvakrat na dan, ki se daje v obliki tablet s takojšnjim sproščanjem ali peroralne suspenzije, ali na standardni odmerek 400 mg enkrat na dan, ki se daje v obliki tablet s podaljšanim sproščanjem.
Viramune is a medicine that contains the active substance nevirapine.
Viramune je zdravilo, ki vsebuje zdravilno učinkovino nevirapin.
The additional studies showed that the prolonged-release tablets were as effective as the immediaterelease tablets in HIV-infected patients.
Dodatne študije so pokazale, da so pri bolnikih, okuženih z virusom HIV, tablete s podaljšanim sproščanjem enako učinkovite kot tablete s takojšnjim sproščanjem.
Viramune is never taken on its own.
Zdravilo Viramune se nikoli ne daje kot samostojno zdravilo.
To support the use of the prolonged-release tablets, the company conducted studies to show that the immediate- and prolonged-release tablets both had adequate drug levels, and the same effect on the viral load in the body.Studies were also done to show successful switching from immediate-release tablets, twice daily to prolonged-release tablets, once daily.
V podporo uporabi tablet s podaljšanim sproščanjem je družba izvedla študije, s katerimi je želela dokazati, da tako tablete s takojšnjim sproščanjem kot tablete s podaljšanim sproščanjem zagotavljajo zadostno raven zdravila in enak učinek na virusno breme v telesu.
What is Viramune?
Kaj je zdravilo Viramune?
How has Viramune been studied?
Kako je bilo zdravilo Viramune raziskano?
What is Viramune used for?
Za kaj se zdravilo Viramune uporablja?
How does Viramune work?
Kako zdravilo Viramune deluje?
How is Viramune used?
Kako se zdravilo Viramune uporablja?
This has been shown in studies in animals and in laboratory studies.
To so pokazale študije na živalih in laboratorijske študije.
Do not exceed the recommended doses and treatment duration.
Ne prekoračite priporočenih odmerkov in trajanja zdravljenja.
Studies in animals have shown teratogenic effects (see section 5.3).
Študije na živalih so pokazale teratogene učinke (glejte poglavje 5.3).
Strictly respect the doses and duration of treatment detailed in section 3.
Strogo upoštevajte odmerke in trajanje zdravljenja, ki so podrobno opisani v 3. poglavju.
- After oral administration, total radioactivity is mainly excreted in feces (79%) while urinary excretion represents only 20%.
- Po peroralni uporabi se celotna radioaktivnost v glavnem izloči v blatu (79 %), v urinu pa se izloči le 20 %.
The dose without toxic effect was 3 mg/kg/day.
Odmerek brez toksičnega učinka je bil 3 mg/kg/dan.
4 mg/2 ml [up to 10] vials/ampoules
4 mg/2 ml [do 10] viale/ampule
The treatment duration is limited to 5 consecutive days.
Trajanje zdravljenja je omejeno na 5 zaporednih dni.
This is because the medicine passes into your breast-milk.
Zdravilo namreč prehaja v materino mleko.
Your doctor will inform you about all measures relating to an effective contraception and about the potential risk of a pregnancy.
Zdravnik vas bo seznanil z vsemi ukrepi v zvezi z učinkovito kontracepcijo in o možnih tveganjih za zanositev.
The treatment duration is limited to 7 consecutive days.
Trajanje zdravljenja je omejeno na 7 zaporednih dni.
Therefore, the potential hazards for the embryo and foetus are unknown.
Zato možna tveganja za zarodek in plod niso znana.
The carcinogenic potential was not evaluated.
Kancerogenosti niso preučili.
The corresponding values of AUC are respectively 283 and 417 ng.h/mL.
Ustrezni vrednosti AUC sta 283 in 417 ng.h/ml.
Patients should be carefully informed about the potential risk of a possible pregnancy and about effective contraception measures to be followed.
Bolnike je treba natančno seznaniti z možnimi tveganji v primeru morebitne nosečnosti in z učinkovitimi kontracepcijskimi ukrepi, ki jih je treba upoštevati.
It is used in adults and adolescents from 16 years onwards as an adjuvant treatment for painful muscular contractions.
Uporabljamo ga pri odraslih in mladostnikih od 16. leta dalje kot dodatno zdravljenje bolečih mišičnih krčev.
You should not use this medicine at higher dose or for longer than 7 days (for oral forms)/5 days (for IM forms).
Tega zdravila ne smete uporabljati v večjem odmerku ali dlje kot 7 dni (peroralne oblike) oziroma 5 dni (intramuskularne oblike).
o For the oral form 4 mg and 8 mg:
o Za peroralno obliko 4 mg in 8 mg:
There are limited data on the use of thiocolchicoside in pregnant women.
Podatkov o uporabi tiokolhikozida pri nosečnicah je malo.
This is based on laboratory studies (see section 2 “Warnings and precautions”).
Ta ugotovitev temelji na laboratorijskih študijah (glejte 2. poglavje, "Opozorila in previdnostni ukrepi").
You can also report side effects directly via {the national reporting system listed in Appendix V}*.
O neželenih učinkih lahko poročate tudi neposredno na {nacionalni center za poročanje, ki je naveden v Prilogi V}*.
Furthermore, minor abnormalities have been observed (supernumerary ribs, retarded ossification).
Poleg tega so opažali manjše nepravilnosti (nadštevilna rebra, zapoznelo osifikacijo).
Method of administration [To be completed nationally]
Način uporabe [Izpolni država članica]
[the currently approved indications should be deleted and replaced by the following]
[Trenutno odobreno besedilo je treba izbrisati in zamenjati z naslednjim besedilom]
o For intramuscular form:
o Za intramuskularno obliko:
This medicine should not be used for long-term treatment (see section 2 “Warnings and precautions”).
Tega zdravila se ne sme uporabljati za dolgotrajno zdravljenje (glejte 2. poglavje, "Opozorila in previdnostni ukrepi").
8 mg [up to 14] hard capsules [up to14] orodispersible tablets
8 mg [do 14] trde kapsule [do 14] orodisperzibilne tablete
The presence of the aglycon metabolite (3-demethylthiocolchicine-SL59.0955) after intramuscular administration has never been assessed, therefore its formation using this route of administration can not be excluded.
Prisotnost aglikonskega presnovka (3-demetiltiokolhicin - SL59.0955) po intramuskularni aplikaciji ni bila nikoli raziskana, zato njegove tvorbe z uporabo tega načina aplikacije ni mogoče izključiti.
Paediatric population <Invented name> should not be used in children and adolescents under 16 years of age because of safety concerns (see section 5.3).
Zdravila <Izmišljeno ime> se zaradi pomislekov v zvezi z varnostjo ne sme uporabljati pri otrocih in mladostnikih do 16. leta starosti (glejte poglavje 5.3).
Please discuss with your doctor if you have further questions.
Če imate dodatna vprašanja, se posvetujte z zdravnikom.
Do not give this medicine to children and adolescents below 16 years old because of safety concerns.
Tega zdravila zaradi pomislekov v zvezi z varnostjo ne smete dajati otrokom in mladostnikom do 16. leta starosti.
<Invented name> is contraindicated during pregnancy and in women of childbearing potential not using contraception (see section 4.3).
Zdravilo <Izmišljeno ime> je kontraindicirano med nosečnostjo in pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije (glejte poglavje 4.3).
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for capsules, hard /tablets/orodispersible tablets and solution for injection
PODATKI NA ZUNANJI OVOJNINI Zunanja ovojnina za trde kapsule/tablete/orodisperzibilne tablete in raztopino za injiciranje
For both metabolites, maximum plasma concentrations occur 1hour after thiocolchicoside administration.
Oba presnovka dosežeta največjo koncentracijo v plazmi 1 uro po uporabi tiokolhikozida.
For SL59.0955 these values are much lower: Cmax around 13 ng/mL and AUC ranging from 15.5 ng.h/mL (until 3h) to 39.7 ng.h/mL (until 24h).
Za presnovek SL59.0955 sta ti vrednosti veliko nižji: Cmax okoli 13 ng/ml in AUC od 15,5 ng.h/ml (do 3 ure) do 39,7 ng.h/mL (do 24 ur).
o Both for oral and for intramuscular forms:
o Za peroralno in intramuskularno obliko:
In the rat, an oral dose of 12 mg/kg/day of thiocolchicoside caused major malformations along with foetotoxicity (retarded growth, embryo death, impairment of sex distribution rate).
Pri podganah je odmerek 12 mg/kg/dan tiokolhikozida povzročil pomembne malformacije in fetotoksičnost (upočasnjeno rast, smrt zarodka, okvaro deleža spolne porazdelitve).
Do not take this medicine if: - you are pregnant, might become pregnant or think you may be pregnant - you are a woman of childbearing potential not using contraception
Ne jemljite tega zdravila: - če ste noseči, bi lahko zanosili, ali mislite, da ste noseči, - če ste ženska v rodni dobi in ne uporabljate kontracepcije.
- After oral administration, no thiocolchicoside is detected in plasma.
- Po peroralni uporabi tiokolhikozid ni zaznaven v plazmi.
Thiocolchicoside profile has been assessed in vitro, and in vivo following parenteral and oral administration.
Profil tiokolhikozida so preučili in vitro ter in vivo po parenteralni in peroralni uporabi.
This is because one of the products formed in your body when taking thiocolchicoside at high doses might cause damage to some cells (abnormal number of chromosomes).
Vzrok za to je, da lahko ena od snovi, ki v telesu nastanejo med jemanjem velikih odmerkov tiokolhikozida, okvari nekatere celice (povzroči nenormalno število kromosomov).
SL59.0955 is also demethylated into didemethyl-thiocolchicine.
SL59.0955 se tudi demetilira v didemetil-tiokolhicin.
Thiocolchicoside must not be used - in patients hypersensitive to the active substance or to any of the excipients listed in section 6.1 - during the entire pregnancy period - during lactation - in women of childbearing potential not using contraception.
Tiokolhikozida se ne sme uporabljati - pri bolnikih, preobčutljivih na zdravilno učinkovino ali katero koli pomožno snov, navedeno v poglavju - med celotno nosečnostjo - med obdobjem dojenja - pri ženskah v rodni dobi, ki ne uporabljajo kontracepcije.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
Če imate dodatna vprašanja o uporabi zdravila, se posvetujte z zdravnikom,, farmacevtom ali z medicinsko sestro.
In humans, this type of damage to cells is a risk factor for cancer, harm to the unborn child, and impairment of male fertility.
Pri človeku je takšna okvara celic dejavnik tveganja za raka, okvaro pri nerojenem otroku in okvaro plodnosti pri moškem.
This step mainly occurs by intestinal metabolism explaining the lack of circulating unchanged thiocolchicoside by this route of administration.
To se v glavnem zgodi z intestinalno presnovo; to pojasni, zakaj pri tej poti uporabe v obtoku ni nespremenjenega tiokolhikozida.
This medicine might cause problems to the male fertility due to potential damage to sperm cells (abnormal number of chromosomes).
To zdravilo lahko povzroči težave s plodnostjo pri moškem, ker lahko okvari semenčice (nenormalno število kromosomov).
No data are available for the inactive metabolite SL59.0955.
Podatkov za neaktivni presnovek SL59.0955 ni.
SL59.0955 is then glucuroconjugated into SL18.0740 which has equipotent pharmacological activity to thiocolchicoside and thus supports the pharmacological activity after oral administration of thiocolchicoside.
SL59.0955 se nato glukurokonjugira v SL18.0740, ki ima ekvipotentno farmakološko delovanje kot tiokolhikozid in tako podpira farmakološko delovanje po peroralni uporabi tiokolhikozida.
As a precautionary measure, use of the product at doses exceeding the recommended dose or long-term use should be avoided (see section 4.2).
Zaradi previdnosti se je treba izogniti uporabi zdravila v odmerkih, večjih od priporočenega odmerka in dolgotrajni uporabi (glejte poglavje 4.2).
Do not take X if: - you are allergic to thiocolchicoside or any of the other ingredients of this medicine (listed in section 6) - you are pregnant, might become pregnant or think you may be pregnant - you are a woman of childbearing potential not using contraception - you are breast feeding
Ne jemljite zdravila X: - če ste alergični na tiokolhikozid ali katero koli sestavino tega zdravila (navedeno v poglavju 6) - če ste noseči, bi lahko zanosili, ali mislite, da ste noseči - če ste ženska v rodni dobi in ne uporabljate kontracepcije - če dojite
Only two metabolites are observed: The pharmacologically active metabolite SL18.0740 and an inactive metabolite SL59.0955.
Opažali so le dva presnovka: farmakološko aktivni presnovek SL18.0740 in neaktivni presnovek SL59.0955.