natgillin/translations-raw huggingface dataset:
Sodium citrate Citric acid, anhydrous Sodium benzoate Glycerol Sucrose Sorbitol liquid (crystallising) Propylene glycol Purified Water Natural and artificial bubble gum flavouring.
Vsebina peroralne raztopine: natrijev citrat citronska kislina, brezvodna natrijev benzoat glicerol saharoza sorbitol tekoči (kristalizirajoči) propilenglikol prečiščena voda naravna in umetna aroma za žvečilne gumije
3 years In use:
3 leta Med uporabo:
After first opening the medicinal product should be used within one month.
Zdravilo porabite v enem mesecu po prvem odpiranju.
The child-resistant cap has inner and outer polypropylene shells.
Rebetol peroralna raztopina 100 ml je pakirana v 118 ml stekleničke iz stekla jantarne barve (obarvano steklo tipa EP IV po Ph. Eur.) Za otroke varna zaporka ima notranjo in zunanjo polipropilensko plast.
The 10 ml oral dosing syringe consists of a natural polyethylene barrel, with a white polystyrene plunger rod.
10 ml brizga za peroralno odmerjanje zdravila sestoji iz valjastega dela iz naravnega polietilena in iz belega polistirenskega bata.
Calibrations are marked at 0.5 m1 increments from 1.5 ml to 10 ml.
Oznake na batu brizge so z razmiki po 0, 5 ml, v razponu od 1, 5 ml do 10 ml.
25 January 2005
25. januar, 2005
40 ANNEX II
42 DODATEK II
MANUFACTURING AUTHORISATION HOLDERS RE SPONSIBLE FOR BATCH RELEASE
IMETNIK DOVOLJENJA ZA IZDELAVO ZDRAVILA, ODGOVOREN ZA SPROŠČANJE SERIJE
Name and address of the manufacturer responsible for batch release for the hard capsules
Ime in naslov izdelovalca, odgovornega za sproščanje serije za trde kapsule
Industriepark 30 2220 Heist op den Berg Belgium
Industriepark 30 2220 Heist op den Berg Belgija
Name and address of the manufacturer responsible for batch release for the oral solution
Ime in naslov izdelovalca, odgovornega za sproščanje serije za peroralno raztopino
2, rue Louis Pasteur 14200 Hérouville St Clair France
2, rue Louis Pasteur 14200 Hérouville St Clair Francija
The holder of this marketing authorisation must submit 6-month PSURs for the medicinal product authorised by this decision until further review by CHMP.
Imetnik tega dovoljenja za promet mora predložiti 6 mesečne PSUR- e za zdravilo, za katerega se izda dovoljenje za promet s to odločbo, do nadaljnje revizije s strani CHMP.
42 ANNEX III
44 DODATEK III
43 A.
45 A.
44 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
46 PODATKI NA ZUNANJI OVOJNINI
REBETOL – 84, 112, 140, 168 hard capsules
REBETOL – 84, 112, 140, 168 trdih kapsul
Rebetol 200 mg hard capsules ribavirin
Rebetol 200 mg trde kapsule ribavirin
84 hard capsules 112 hard capsules 140 hard capsules 168 hard capsules 200 mg
84 trdih kapsul 112 trdih kapsul 140 trdih kapsul 168 trdih kapsul 200 mg
SP Europe 73, rue de Stalle B-1180 Bruxelles Belgium
SP Europe Rue de Stalle 73 B- 1180 Bruxelles Belgija
EU/1/99/107/001 (84 hard capsules) EU/1/99/107/005 (112 hard capsules) EU/1/99/107/002 (140 hard capsules) EU/1/99/107/003 (168 hard capsules)
EU/ 1/ 99/ 107/ 001 (84 trdih kapsul) EU/ 1/ 99/ 107/ 005 (112 trde kapsule) EU/ 1/ 99/ 107/ 002 (140 trdih kapsul) EU/ 1/ 99/ 107/ 003 (168 trdih kapsul)
46 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
48 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA PRETISNEM OMOTU ALI DVOJNEM TRAKU
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
49 PODATKI NA ZUNANJI OVOJNINI
Rebetol oral solution 40 mg/ml
Rebetol peroralna raztopina 40 mg/ ml
Rebetol 40 mg/ml oral solution ribavirin
Rebetol 40 mg/ ml peroralna raztopina ribavirin
Each one ml of oral solution contains 40 mg of ribavirin.
1 mililiter peroralne raztopine vsebuje 40 mg ribavirina.
Glycerol, propylene glycol, sorbitol liquid (crystallising), sucrose.
Vsebuje: glicerol, propilenglikol, tekoči sorbitol (kristalizirajoč), saharozo.
oral solution 100 ml
peroralna raztopina 100 ml
49 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
51 PODATKI, KI MORAJO BITI NAJMANJ NAVEDENI NA MANJŠIH STIČNIH OVOJNINAH
What Rebetol is and what it is used for 2.
Kaj je zdravilo Rebetol in za kaj ga uporabljamo 2.
Before you take Rebetol 3.
Kaj morate vedeti, preden boste uporabili zdravilo Rebetol 3.
How to take Rebetol 4.
Kako uporabljati zdravilo Rebetol 4.
How to store Rebetol 6.
Shranjevanje zdravila Rebetol 6.
WHAT REBETOL IS AND WHAT IT IS USED FOR
KAJ JE ZDRAVILO REBETOL IN ZA KAJ GA UPORABLJAMO
Rebetol (ribavirin) inhibits the multiplication of many types of viruses.
Rebetol (ribavirin) zavira razmnoževanje številnih vrst virusov.
Combining Rebetol and peginterferon alfa-2b or interferon alfa-2b has been shown to be a more effective treatment for hepatitis C virus infection than peginterferon alfa-2b or interferon alfa-2b alone.
Kombinacija zdravila Rebetol in peginterferona alfa- 2b ali interferona alfa- 2b je dokazano bolj učinkovita pri zdravljenju okužbe z virusom hepatitisa C kot sam peginterferon alfa- 2b ali sam interferon alfa- 2b.
Rebetol is used in combination with interferon alfa-2b to treat patients 18 years of age or older who have chronic hepatitis C.
Rebetol se uporablja v kombinaciji z interferonom alfa- 2b za zdravljenje bolnikov s kroničnim hepatitisom C, starih 18 let ali več.
The combination of Rebetol with peginterferon alfa-2b is also used to treat patients 18 years of age or older who have chronic hepatitis C, including in patients who are co- infected with clinically stable HIV.
Kombinacijo zdravila Rebetol s peginterferonom alfa- 2b uporabljamo tudi za zdravljenje bolnikov, starih 18 let ali več s kroničnim hepatitisom C, vključno s tistimi, ki imajo sočasno klinično stabilno okužbo s HIV.
Both combinations (Rebetol with peginterferon alfa-2b and Rebetol with interferon alfa-2b) can be used in previously untreated patients and patients who have previously responded to treatment with an alpha interferon, but whose condition has recurred.
Obe kombinaciji (Rebetol s peginterferonom alfa- 2b in Rebetol z interferonom alfa- 2b) se lahko uporabljata tudi za predhodno nezdravljene bolnike in za tiste, ki so se predhodno že odzvali na zdravljenje z enim od interferonov alfa, a se jim je bolezen ponovila.
Additionally, Rebetol in combination with peginterferon alfa-2b can be used for the treatment of adult patients with chronic hepatitis C who have previously relapsed following treatment with alpha interferon (pegylated or nonpegylated) and ribavirin combination therapy, or have not responded to previous treatment with alpha interferon (pegylated or nonpegylated) and ribavirin combination therapy or alpha interferon monotherapy.
Poleg tega se lahko zdravilo Rebetol v kombinaciji s peginterferonom alfa- 2b uporablja za zdravljenje odraslih bolnikov s kroničnim hepatitisom C, ki so imeli pred tem ponovitev bolezni po kombiniranem zdravljenju z interferonom alfa (pegiliranim ali nepegiliranim) in ribavirinom, ali tistih, ki se niso odzvali na predhodno kombinirano zdravljenje z interferonom alfa (pegiliranim ali nepegiliranim) in ribavirinom oziroma na monoterapijo z interferonom alfa.
Rebetol is used in combination with interferon alfa-2b for injection in children 3 years of age and older who have previously untreated chronic hepatitis C.
Zdravilo Rebetol je namenjeno uporabi v kombinaciji z interferonom alfa- 2b za injiciranje za zdravljenje otrok starih 3 leta in več, ki imajo predhodno nezdravljeni hepatitis C.
For children weighing less than 47 kg a solution formulation is available.
Za otroke, ki tehtajo manj kot 47 kg je na voljo peroralna raztopina.
Rebetol must not be used alone.
Zdravila Rebetol ne smete uporabljati samostojno.
BEFORE YOU TAKE REBETOL
KAJ MORATE VEDETI, PREDEN BOSTE UPORABILI ZDRAVILO REBETOL
- You may need to have your kidneys tested before starting your treatment, especially if you are
- Morda boste morali pred začetkom zdravljenja opraviti preiskave ledvic, še posebej če ste
older than 65 years or if you have problems with your kidneys.
starejši od 65 let ali če imate težave z ledvicami.
- Rebetol capsules are not recommended for use in children weighing less than 47 kg.
- Zdravilo Rebetol kapsule ni priporočljivo za uporabo pri otrocih ki tehtajo manj kot 47 kg.
- Tell your doctor if you have or have had any serious illness.
- Povejte svojemu zdravniku, če imate ali ste kdaj v preteklosti imeli kakršnokoli resno bolezen.
Perhaps Rebetol treatment will not
V tem primeru zdravljenje z zdravilom Rebetol morda ne bo primerno za vas.
- Tell your doctor if you ever had a heart attack or a heart problem, severe liver diseases
- Povejte svojemu zdravniku, če ste imeli kdaj v preteklosti srčni infarkt ali težave s srcem, hudo
excluding chronic hepatitis C, thyroid problems; if you have ever been treated for depression or any other psychiatric disorder, confusion, unconsciousness, or have had thoughts of suicide or have attempted suicide.
jetrno bolezen razen kroničnega hepatitisa C ali težave s ščitnico; če ste se kdaj zdravili zaradi depresije ali katere druge duševne bolezni, zmedenosti ali nezavesti ter če ste kdaj imeli samomorilne misli ali ste poskušali narediti samomor.
Be sure to read the Package Leaflet for peginterferon alfa -2b or interferon alfa-2b before you begin treatment with Rebetol and peginterferon alfa-2b or interferon alfa-2b.
Pred začetkom zdravljenja z zdravilom Rebetol in peginterferonom alfa- 2b ali interferonom alfa- 2b morate prebrati navodilo za uporabo za peginterferon alfa- 2b ali interferon alfa- 2b.
Do not take Rebetol
Ne uporabljajte zdravila Rebetol
- if you are allergic (hypersensitive) to ribavirin or any of the other ingredients of Rebetol.
- če ste alergični (preobčutljivi) na ribavirin ali katerokoli sestavino zdravila Rebetol,
- if you are pregnant or planning to become pregnant.
- če ste noseči ali načrtujete nosečnost.
Rebetol can cause harm to the unborn child
Zdravilo Rebetol lahko škoduje nerojenemu otroku, če ga
if a pregnant woman takes Rebetol herself during pregnancy or has unprotected sex (sex without using a condom) with a man who is taking Rebetol.
nosečnica jemlje sama v času nosečnosti ali če ima nezaščiten spolni odnos (spolni odnos brez uporabe kondoma) z moškim, ki jemlje Rebetol.
Rebetol can damage the sperm and the embryo (unborn child).
Zdravilo Rebetol lahko poškoduje spermo moškega in tudi zarodek (nerojenega otroka).
Therefore, if you are a female patient, it is very important to avoid becoming pregnant during treatment and during the 4 months after treatment.
Če ste ženska, je torej izredno pomembno, da preprečite zanositev med zdravljenjem s tem zdravilom in še 4 mesece po zdravljenju.
If you are a male patient, it is very important for your female partner to avoid becoming pregnant during your Rebetol treatment and during the 7 months after treatment (see “Take special care with Rebetol”).
Če ste moški, je za vašo partnerko zelo pomembno, da ne zanosi med vašim zdravljenjem z zdravilom Rebetol in še 7 mesecev po njem (glejte tudi poglavje “ Bodite posebno pozorni pri uporabi zdravila Rebetol ”),
- if you had a problem with your heart during the past six months or any previous serious heart
- če ste imeli težave s srcem v zadnjih šestih mesecih ali če ste imeli kakršnokoli resno srčno
condition.
bolezen v preteklosti,
- if you have severe medic al conditions that leave you very weak, including severe kidney
- če imate kakšno resno bolezen, zaradi katere se počutite zelo šibki, npr. hudo ledvično bolezen,
- if you have a serious problem with your liver other than chronic hepatitis C.
- če imate resno bolezen jeter (razen kroničnega hepatitisa C),
- if you have a blood disorder, including anaemia (low number of red blood cells), thalassemia
- če imate katero od krvnih bolezni ali motenj, npr. anemijo (premajhno število eritrocitov),
(Mediterranean anaemia), sickle-cell anaemia.
talasemijo (mediteransko anemijo) ali anemijo srpastih celic,
- if you have autoimmune hepatitis or any other problem with your immune system; if you are
- če imate avtoimunski hepatitis ali katero drugo motnjo imunskega sistema; če jemljete katero od
taking medicine that suppresses your immune system (Your immune system protects you against infection and some diseases).
zdravil, ki zavirajo delovanje imunskega sistema (imunski sistem ščiti telo pred okužbami in nekaterimi boleznimi).
- if you have had serious nervous or mental problems, such as severe depression or thoughts of
- če ste kdaj imeli resno živčno ali duševno bolezen, npr. hudo depresijo ali samomorilne misli.
Rebetol is also not suitable for patients with certain other past or present serious illnesses.
Zdravilo Rebetol tudi ni primerno za bolnike z nekaterimi drugimi resnimi sedanjimi ali preteklimi boleznimi.
Mention any past or present serious illness to your doctor.
Povejte svojemu zdravniku za vse svoje pretekle ali obstoječe resne bolezni.
Also, be sure to read the “Do not take” section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b.
Prebrati morate tudi poglavje “ Ne uporabljajte ” v navodilih za uporabo za peginterferon alfa- 2b ali interferon alfa- 2b.
Take special care with Rebetol • If you have had a severe or mental disorder.
Bodite posebno pozorni pri uporabi zdravila Rebetol • če ste imeli kdaj v preteklosti hudo bolezen živčevja ali duševno bolezen.
The use of Rebetol and interferon alfa -2b in children and adolescents with existence of or history of severe psychiatric conditions is contraindicated (see “Do not take Rebetol”). • If you have ever had depression or develop symptoms associated with depression (e.g. feeling of sadness, dejection, etc.) while on treatment with Rebetol (see section 4).
Uporaba zdravila Rebetol in interferona alfa- 2b je kontraindicirana pri otrocih in mladostnikih, ki imajo oziroma so imeli v preteklosti hude psihiatrične motnje (glejte “ Ne uporabljajte zdravila Rebetol ”). • če ste kdaj imeli depresijo ali če se pri vas pojavijo simptomi, povezani z depresijo (npr. žalostno razpoloženje, občutki potrtosti in malodušnosti, ipd.) med zdravljenjem z zdravilom Rebetol (glejte poglavje 4).
Rebetol can be very damaging to an unborn baby, thus both female and male patients must take special precautions in their sexual activity if there is any chance for pregnancy to occur:
Zdravilo Rebetol je lahko zelo škodljivo za nerojenega otroka, zato morajo tako bolnice kot bolniki uporabljati posebne previdnostne ukrepe pri spolnih odnosih, če obstaja kakršnakoli možnost za zanositev:
- if you are pregnant you must not take Rebetol
- če ste noseči, ne smete jemati zdravila Rebetol,
- if you are a girl or a woman of childbearing age, you must have a negative pregnancy test
- če ste dekle ali ženska v rodni dobi, mora biti nosečnostni test pri vas negativen pred
before treatment, each month during treatment, and for the 4 months after treatment is stopped.
zdravljenjem, vsak mesec med zdravljenjem in še 4 mesece po zaključku zdravljenja.
This c an be discussed with your doctor.
Pogovorite se s svojim zdravnikom o tem,
- if you are a man who is taking Rebetol, do not have sex with a pregnant woman unless you use
- če ste moški in jemljete zdravilo Rebetol, ne smete imeti spolnih odnosov z nosečo žensko brez
a condom.
uporabe kondoma.
This will lessen the chance for ribavirin to be left in the woman’s body.
Če vaša partnerka sicer trenutno ni noseča, a je v rodni dobi, mora opraviti nosečnostni test vsak
If your female partner is not pregnant now but is of childbearing age, she must be tested for pregnancy 53 each month during treatment and for the 7 months after treatment has stopped.
55 mesec med vašim zdravljenjem in še 7 mesecev po koncu zdravljenja.
If you are a male patient, you and your partner must each use an effective contraceptive during the time you are taking Rebetol and for 7 months after stopping treatment.
Če ste moški, morata tako vi kot vaša partnerka uporabljati učinkovito kontracepcijsko sredstvo v času jemanja zdravila Rebetol in še 7 mesecev po zaključku zdravljenja.
This can be discussed with your doctor (see “Do not take Rebetol”).
Pogovorite se o tem s svojim zdravnikom (glejte poglavje “ Ne uporabljajte zdravila Rebetol ”).
Standard blood tests will be taken to check your blood, kidney, and liver function.
Zdravnik vas bo napotil na običajne krvne preiskave za kontrolo krvi in spremljanje delovanja ledvic in jeter.
If you have a kidney disease, your doctor should monitor you more carefully for a decrease in red blood cell count.
Če imate ledvično bolezen, vas bo moral vaš zdravnik bolj skrbno spremljati, da ugotovi morebitno zmanjšanje števila rdečih krvničk.
Dental and gum disorders, which may lead to loss of teeth, have been reported in patients receiving Rebetol and peginterferon alfa-2b or interferon alfa-2b combination therapy.
Pri bolnikih, ki so prejemali zdravilo Rebetol in peginterferon alfa- 2b ali interferon alfa- 2b v kombinirani terapiji, so poročali o zobnih boleznih in boleznih dlesni, ki lahko vodijo do izgube zob.
In addition, dry mouth could have a damaging effect on teeth and membranes of the mouth during long-term treatment with the combination of Rebetol and peginterferon alfa-2b or interferon alfa-2b.
Poleg tega bi lahko med dolgotrajnim zdravljenjem s kombinacijo zdravila Rebetol in peginterferonom alfa- 2b ali interferonom alfa- 2b imela škodljiv vpliv na zobe in ustno sluznico tudi suha usta.
However, during the 6 months after treatment, this trend was generally reversed, although a few children did not return to their previous rate of growth within the first year after completing treatment.
V času enoletnega zdravljenja mnogi otroci niso zrasli ali pridobili toliko telesne mase, kot bi pričakovali, vendar se je v 6 mesecih po zdravljenju ta trend običajno obrnil, pri nekaj otrocih, pa se rast ni vrnila na običajni nivo tudi eno leto po prenehanju zdravljenja.
Also, be sure to read the “Take special care” section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b.
Prebrati morate tudi poglavje “ Bodite posebno pozorni pri uporabi ” v navodilih za uporabo za peginterferon alfa- 2b ali interferon alfa- 2b.
If you are also being treated for Human Immunodeficiency Virus (HIV) infection (AIDS) w ith zidovudine or stavudine, it is not certain if Rebetol will change the way these medicines work.
Če se zdravite tudi zaradi okužbe (AIDS) z virusom humane imunske pomanjkljivosti (HIV) z zdravilom zidovudin ali stavudin, ni znano, ali lahko zdravilo Rebetol spremeni delovanje teh zdravil.
If it gets worse, your doctor will decide whether or not your Rebetol treatment needs to be changed.
Če se poslabša, se bo vaš zdravnik odločil, ali je pri vas potrebna sprememba zdravljenja z zdravilom Rebetol ali ne.
Additionally, patients treated with ribavirin and zidovudine could be at increased risk of developing anaemia (low number of red blood cells).
Pri bolnikih zdravljenih z ribavirinom v kombinaciji z zidovudinom, se lahko poveča verjetnost za razvoj anemije (majhno število rdečih krvnih celic).
Co-administration of Rebetol and didanosine and/or stavudine is not recommended due to the risk of lactic acidosis (a build-up of lactic acid in the body) and pancreatitis.
Sočasno dajanje zdravila Rebetol z didanozinom in/ ali stavudinom ni priporočljivo zaradi možnosti pojava laktacidoze (nastanek mlečne kisline v telesu) in pankreatitisa.
Also, be sure to read the “Taking other medicines” section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b.
Prebrati morate tudi poglavje “ Uporaba drugih zdravil ” v navodilih za uporabo za peginterferon alfa - 2b ali interferon alfa- 2b.
Taking Rebetol with food and drink Rebetol must be taken with food.
Uporaba zdravila Rebetol skupaj s hrano in pijačo Zdravilo Rebetol morate jemati s hrano.
Pregnancy and breast-feeding Rebetol must not be used by a girl or a woman who is pregnant (see “Take special care with Rebetol”).
Nosečnost in dojenje Nosečnice ne smejo jemati zdravila Rebetol (glejte poglavje “ Bodite posebno pozorni pri uporabi zdravila Rebetol ”).
Rebetol must not be used by a woman who is breast-feeding a baby.
Zdravila Rebetol ne smejo jemati doječe matere.
Discontinue breast-feeding before starting to take Rebetol.
Pred začetkom jemanja zdravila Rebetol morate prenehati z dojenjem.
Driving and using machines Rebetol does not affect your ability to drive or use machines; however, peginterferon alfa-2b or interferon alfa-2b may have an effect.
56 Zdravilo Rebetol ne vpliva na vašo sposobnost za vožnjo ali upravljanje s stroji, medtem ko imata peginterferon alfa- 2b ali interferon alfa- 2b lahko določen vpliv.
Do not drive or use machines if you become tired from this treatment.
Če postanete zaradi tega zdravila utrujeni, ne vozite in ne delajte s stroji.
Important information about some of the ingredients of Rebetol 54 Each Rebetol capsule contains a small amount of lactose.
Pomembne informacije o nekaterih sestavinah zdravila Rebetol Vsaka kapsula zdravila Rebetol vsebuje majhno količino laktoze.
If you have been told by your doctor that you have an intolerance to some sugars, discuss with your doctor before taking this medicinal product.
Če vam je zdravnik povedal, da ne prenašate nekaterih sladkorjev, se pred jemanjem tega zdravila posvetujte z zdravnikom.
HOW TO TAKE REBETOL
KAKO UPORABLJATI ZDRAVILO REBETOL
Your doctor may adjust your dose and the length of time you take this treatment according to your response.
Zdravnik vam je določil ustrezen odmerek zdravila Rebetol na podlagi vaše telesne mase, lahko pa vam bo kasneje prilagodil odmerek in dolžino zdravljenja glede na vaš odziv nanj.
Depending upon the results of these tests, your doctor may change the number of capsules you take and prescribe a different pack size of Rebetol.
Glede na izvide teh preiskav bo lahko spremenil število kapsul, ki jih jemljete, in vam predpisal drugo velikost pakiranja zdravila Rebetol.
Rebetol hard capsules for oral use:
Rebetol trde kapsule za peroralno uporabo:
Adults who weigh
Odrasli s telesno maso:
- less than 65 kg, the usual dose is 2 capsules in the morning and 2 capsules in the evening (total
- manj kot 65 kg, običajen odmerek 2 kapsuli zjutraj in 2 kapsuli zvečer (skupaj 800 mg vsak
of 800 mg each day);
dan);
- 65 kg to 85 kg, the usual dose is 2 capsules in the morning and 3 capsules in the evening (total
- 65 kg do 85 kg, običajen odmerek 2 kapsuli zjutraj in 3 kapsule zvečer (skupaj 1. 000 mg vsak
of 1,000 mg each day);
dan);
- 86 kg to 105 kg, the usual dose is 3 capsules in the morning and 3 capsules in the evening (total
- 86 kg do 105 kg, običajen odmerek 3 kapsule zjutraj in 3 kapsule zvečer (skupaj 1. 200 mg vsak
of 1,200 mg each day);
dan);
- more than 105 kg, the usual dose is 3 capsules in the morning and 4 capsules in the evening
- več kot 105 kg, običajen odmerek 3 kapsule zjutraj in 4 kapsule zvečer (skupaj 1. 400 mg vsak
(total of 1,400 mg each day).
dan).
Children or adolescents who weigh
Otroci in mladostniki s telesno maso:
- 47 to 49 kg, the usual dose is 1 capsule in the morning and 2 capsules in the evening (total of
- 47 do 49 kg, običajen odmerek 1 kapsula zjutraj in 2 kapsuli zvečer (skupaj 600 mg vsak dan);
- 50 to 65 kg, the usual dose is 2 capsules in the morning and 2 capsules in the evening (total of
- 50 do 65 kg, običajen odmerek 2 kapsuli zjutraj in 2 kapsuli zvečer (skupaj 800 mg vsak dan);
- more than 65 kg: see adult dose.
- več kot 65 kg, glejte odmerjanje za odrasle.
Do not chew the capsules.
Kapsul ne smete žvečiti.
For children or adolescents who cannot swallow a capsule, an oral solution of ribavirin is available.
Za otroke in mladostnike, ki ne morejo pogoltniti kapsule je na voljo peroralna raztopina ribavirina.
Rebetol is used in combination with peginterferon alfa-2b (adults) or interferon alfa-2b (adults, children and adolescents).
Zdravilo Rebetol se uporablja v kombinaciji s peginterferonom alfa- 2b (odrasli) ali interferonom alfa - 2b (odrasli, otroci in mladostniki).
For complete information be sure to read the “How to take” section of the Package Leaflet for peginterferon alfa-2b or interferon alfa-2b.
Za popolnejše informacije morate prebrati tudi poglavje “ Kako uporabljati zdravilo ” v navodilih za uporabo za peginterferon alfa- 2b ali interferon alfa- 2b.
The usual dose is 1.5 microgram/kg once a week, injected subcutaneously (under the skin).
Običajen odmerek je 1, 5 mikrograma/ kg enkrat na teden s subkutano (podkožno) injekcijo.