natgillin/translations-raw huggingface dataset:
Hvis De har glemt at tage Ratiograstim De må ikke tage en dobbeltdosis som erstatning for en glemt indsprøjtning.
If you forget to use Ratiograstim Do not use a double dose to make up for a forgotten injection.
Hvis De holder op med at bruge Ratiograstim Tal med lægen, før De stopper behandlingen.
If you stop using Ratiograstim Before you stop using Ratiograstim, talk to your doctor.
Ratiograstim kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
Like all medicines, Ratiograstim can cause side effects, although not everybody gets them.
Stop omgående indsprøjtning af Ratiograstim og søg lægehjælp, hvis De mener, at De oplever denne type reaktion.
If you think you are having this type of reaction, stop your Ratiograstim injection and get medical help immediately.
53 Der er indberettet forstørret milt og meget sjældne tilfælde af miltruptur.
56 Increased spleen size and very rare cases of spleen ruptures have been reported.
SÅDAN OPBEVARER DE RATIOGRASTIM
HOW TO STORE Ratiograstim
Brug ikke Ratiograstim efter den udløbsdato, der står på den ydre karton og på den fyldte injektionssprøjte efter EXP.
Do not use Ratiograstim after the expiry date which is stated on the outer carton and on the pre-filled syringe after EXP.
Brug ikke Ratiograstim, hvis opløsningen er uklar eller indeholder partikler.
Do not use Ratiograstim if you notice it is cloudy or there are particles in it.
Medicinen må ikke tilføres spildevand eller husholdningsaffald.
57 Medicines should not be disposed of via wastewater or household waste.
Hvad Ratiograstim indeholder
What Ratiograstim contains
En fyldt injektionssprøjte indeholder 30 millioner internationale enheder [mio.
Ratiograstim 30 MIU/ 0.5 ml:
IE/ 0, 8 ml:
Ratiograstim 48 MIU/ 0.8 ml:
Nærmere oplysninger om indholdsstoffet sorbitol (en sukkerart) er angivet i afsnit 2 under "Vigtige oplysninger om visse af indholdsstofferne i Ratiograstim".
You will find detailed information about the ingredient sorbitol (a sugar) in section 2. under the heading “ Important information about some of the ingredients of Ratiograstim”.
Ratiograstims udseende og pakningsstørrelse Ratiograstim er en injektions - og infusionsvæske i en fyldt injektionssprøjte.
What Ratiograstim looks like and contents of the pack Ratiograstim is a solution for injection or infusion in a pre-filled syringe.
Ratiograstim leveres i pakker á 1, 5 eller 10 fyldte injektionssprøjter eller multipakker á 10 (2 pakker á 5) fyldte injektionssprøjter.
Ratiograstim are supplied in packs of 1, 5 or 10 pre-filled syringes or multipacks of 10 (2 packs of 5) pre-filled syringes.
Deutschland ratiopharm GmbH
Deutschland ratiopharm GmbH Tel: +49 731 402 02
55
Norge ratiopharm AS Tlf: +47 66 77 55 90
Dette afsnit indeholder oplysninger om, hvordan De kan give Dem selv indsprøjtninger med Ratiograstim.
59 This section contains information on how to give yourself an injection of Ratiograstim.
56 De skal give indsprøjtningen i væv lige under huden.
You will need to give yourself the injection into the tissue just under the skin.
- en fyldt medicinsprøjte med Ratiograstim
- a pre-filled syringe of Ratiograstim,
Sådan gør De Dem klar til at give Dem selv en subkutan injektion af Ratiograstim 1.
1.
Find et bekvemt og veloplyst sted og anbring udstyret, hvor De let kan nå det (den fyldte sprøjte med Ratiograstim, spritservietter og beholderen til affald).
Find a comfortable, well-lit place and put everything you need where you can reach them (the Ratiograstim pre-filled syringe, alcohol wipes and the puncture-proof container).
Sådan forbereder De indsprøjtningen af Ratiograstim Før injektion af Ratiograstim skal De foretage følgende:
Before you inject Ratiograstim you must do the following:
Tryk stemplet i til det antal millimeter (ml), der svarer til den ordinerede dosis Ratiograstim.
Push the plunger up to the number (ml) on the syringe that matches the dose of Ratiograstim that your doctor prescribed.
58 6
6
Ratiograstim bør ikke fortyndes i natriumklorid.
Ratiograstim should not be diluted with sodium chloride solution.
Ved et slutvolumen til injektion på 20 ml bør totaldoser af filgrastim på mindre end 30 mio.
In a final injection volume of 20 ml, total doses of filgrastim less than 30 MIU (300 μ g) should be given with 0.2 ml of 200 mg/ ml (20%) human albumin solution added.
IE (300 μg) gives efter tilsætning af 0, 2 ml 20 mg/ ml (20%) human serumalbuminopløsning.
When diluted in glucose 50 mg/ ml (5%) solution for
Ved fortynding i 50 mg/ ml (5%) glucose infusionsvæske er Ratiograstim kompatibelt med glas og flere plastmaterialer inklusive PVC, polyolefin (et copolymer af polypropylen og polyethylen) og polypropylen.
62 infusion, Ratiograstim is compatible with glass and a variety of plastics including PVC, polyolefin (a co-polymer of polypropylene and polyethylene) and polypropylene.
59
63
Rebetol er et lægemiddel, der indeholder det aktive stof ribavirin.
Rebetol is a medicine containing the active substance ribavirin.
Det leveres som kapsler (200 mg) og som oral opløsning (40 mg/ ml).
It is available as capsules (200 mg) and as an oral solution (40 mg/ ml).
Rebetol anvendes til behandling af voksne og børn over tre år med kronisk hepatitis C (langvarig leverbetændelse forårsaget af hepatitis C- virus).
Rebetol is used to treat adults and children aged 3 years and older who have chronic (long term) hepatitis C (a disease of the liver due to an infection by the hepatitis C virus).
Rebetol må aldrig anvendes alene, men kun sammen med et interferon (en anden type medicin, der anvendes ved hepatitis).
Rebetol must never be used on its own but only together with an interferon (another type of medicine used in hepatitis).
Hos voksne kan Rebetol anvendes hos ikke tidligere behandlede patienter eller hos patienter, der har fået tilbagefald efter behandling med interferon, idet Rebetol kombineres enten med interferon alfa- 2b eller peginterferon alfa- 2b (herunder også patienter, der desuden er smittet med hiv (human immundefektvirus)).
In adults, Rebetol can be used in ‘ naïve’ patients (who have not been treated before) or in patients who have relapsed after treatment with interferon, either in combination with interferon alfa-2b or peginterferon alfa-2b (including for patients also infected with human immunodeficiency virus [HIV]).
Hos børn og unge kan Rebetol kun anvendes kombineret med interferon alfa- 2b hos ikke tidligere behandlede patienter.
In children and adolescents, Rebetol can only be used in combination with interferon alfa-2b to treat naïve patients.
Behandling med Rebetol bør iværksættes og overvåges af en læge med erfaring i behandling af kronisk hepatitis C.
Treatment with Rebetol should be initiated and monitored by a doctor who has experience in the management of chronic hepatitis C.
Dosis af Rebetol beregnes efter patientens legemsvægt og er mellem 3 og 6 kapsler dagligt hos patienter, der vejer over 47 kg.
The dose of Rebetol is based on the patient’ s body weight, and ranges from 3 to 6 capsules a day in patients weighing more than 47 kg.
Til patienter med lavere vægt anvendes den orale opløsning i en dosis svarende til 15 mg pr. kg legemsvægt pr. dag.
For patients of a lower weight, the oral solution is used to provide a dose of 15 mg per kilogram body weight a day.
Rebetol tages sammen med måltiderne hver dag, fordelt på to doser (morgen og aften).
Rebetol is taken with food each day in two divided doses (morning and evening).
Behandlingens varighed afhænger af patientens tilstand og reaktion på behandlingen og er mellem 24 uger og ét år.
The duration of treatment depends on the patient’ s condition and response to treatment, and ranges from 24 weeks to a year.
Det aktive stof i Rebetol, ribavirin, er et antiviralt middel, der tilhører gruppen af nukleosidanaloger.
The active substance in Rebetol, ribavirin, is an antiviral belonging to the class ‘ nucleoside analogues’.
Rebetol menes at gribe ind i produktionen eller virkningen af viralt DNA og RNA, som er nødvendige for virusets overlevelse og formering.
Rebetol is thought to interfere with the production or action of viral DNA and RNA, which are needed for viruses to survive and multiply.
Anvendt alene er Rebetol uden virkning med hensyn til at udrydde hepatitis C- virus i kroppen.
Rebetol on its own has no effect on eliminating the hepatitis C virus from the body.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Hvordan blev Rebetol undersøgt?
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Rebetol been studied?
Hos voksne blev Rebetol sammen med interferon alfa- 2b anvendt i fire hovedundersøgelser, hvoraf de to tilsammen omfattede 1 744 ikke tidligere behandlede patienter, mens de andre to tilsammen omfattede 345 patienter, der havde fået tilbagefald efter tidligere behandling med interferon.
In adults, the use of Rebetol with interferon alfa-2b has been studied in four main studies, two in a total of 1,744 treatment-naïve patients and two in a total of 345 patients who had relapsed after previous treatment with interferon.
I alle disse undersøgelser blev virkningen af at tilføje enten Rebetol eller placebo (virkningsløs behandling) til interferon alfa- 2b sammenlignet med anvendelse af interferon alene.
All of these studies compared the effectiveness of adding either Rebetol or placebo (a dummy treatment) to interferon alfa-2b with using the interferon alone.
Sammenligningsbehandlingen var Rebetol i kombination med interferon alfa- 2b.
The use of Rebetol with peginterferon alfa-2b has been studied in 1,580 treatment-naïve patients, comparing two schedules of Rebetol added to peginterferon alfa-2b with Rebetol added to interferon alfa-2b.
Det blev her anvendt i kombination med enten interferon alfa- 2b eller peginterferon alfa- 2b.
In addition, a further two studies have looked at its use in 565 patients also infected with HIV, where it was used in combination with either interferon alfa-2b or peginterferon alfa-2b.
Rebetol i kombination med interferon alfa- 2b blev desuden anvendt hos 70 ikke tidligere behandlede børn i alderen 3 til 16 år.
Rebetol used in combination with interferon alfa-2b has also been studied in 70 treatment-naïve children aged 3 to 16 years.
I størstedelen af undersøgelserne blev behandlingens virkning bedømt på indholdet af virus- RNA i blodet før og efter 24 eller 48 ugers behandling og ved opfølgningen (24 uger senere).
In most studies, the main measure of effectiveness was the level of viral RNA circulating in the blood before and after 24 or 48 weeks of treatment, and at follow up (24 weeks later).
Desuden er der gennemført en række undersøgelser af tegn på bedring i leverens tilstand.
Some studies also looked at signs of improvement of the condition of the liver.
Rebetol i kombination med interferon alfa- 2b var mere effektivt end interferon alfa- 2b anvendt alene.
Rebetol used with interferon alfa-2b was more effective than interferon alfa-2b used on its own.
Hos ikke tidligere behandlede voksne patienter viste den opfølgende kontrol efter 48 uger, at behandlingen havde virket hos 41%, sammenholdt med 16% af dem, der kun havde fået interferon alfa- 2b.
In treatment-naïve adult patients, 41% had responded to treatment when checked at follow up (48 weeks) compared with 16% of those who received only interferon alfa-2b.
Hos patienter, der havde haft tilbagefald, viste det opfølgende besøg, at behandlingen havde virket hos 37% af de patienter, der havde fået kombinationen, sammenholdt med 3, 5% af dem, der kun havde fået interferon alfa- 2b.
In relapsed patients, the responder rates at the follow up visit were 37% in the patients who received the combination, compared with 3.5% of the patients who only received interferon alfa-2b.
Rebetol i kombination med peginterferon alfa- 2b (i en dosis af 1, 5 µg pr. kg legemsvægt én gang ugentligt) var mere effektivt end i kombination med interferon alfa - 2b.
The effectiveness of Rebetol used with peginterferon alfa-2b (as a once weekly 1.5 micrograms per kg bodyweight) was more effective than the combination with interferon alfa-2b.
Kombinationen af Rebetol med peginterferon alfa- 2b var også effektiv til behandling af hepatitis C hos patienter, der desuden var smittet med hiv.
Rebetol used in combination with peginterferon alfa-2b has also shown its effectiveness in the treatment of hepatitis C infection inpatients also infected with HIV.
Hos børn var Rebetol i kombination med interferon alfa- 2b effektivt hos 49% af de patienter, hos hvilke medicinen havde virket ved opfølgningsbesøget efter 48 uger.
In children, Rebetol combined with interferon alfa-2b was effective with 49% of the patients having responded to treatment at the 48-week follow-up visit.
De hyppigste bivirkninger af Rebetol anvendt i kombination med interferon alfa- 2b eller peginterferon alfa- 2b (som ses hos mere end 1 ud af hver 10 patienter) er virusinfektioner, ondt i halsen, anæmi (for lavt antal røde blodlegemer), neutropeni (for lavt antal hvide blodlegemer), hypotyreose (for lavt indhold af skjoldbruskkirtelhormon), appetitløshed, depression, søvnbesvær, humørsvingninger, angst, mundtørhed, hovedpine, svimmelhed, nedsat koncentrationsevne, hoste, stakåndethed, kvalme, diarré, mavesmerter, opkastninger, hårtab, kløe, tør hud, udslæt, muskelsmerter, ledsmerter, smerter i muskler og knogler, reaktioner på indstiksstedet, herunder inflammation, træthed, feber, kulderystelser, influenzalignende symptomer, kraftesløshed, ubehag, irritabilitet, vægttab og nedsat væksthastighed.
The most common side effects with Rebetol used in combination with interferon alfa-2b or peginterferon alfa-2b (seen in more than 1 patient in 10) are viral infections, pharyngitis (sore throat), anaemia (low red blood cell counts), neutropenia (low white blood cell counts), hypothryroidism (underactive thyroid gland), anorexia (loss of appetite), depression, insomnia (difficulty sleeping), emotional lability (mood swings), anxiety, dry mouth, headache, dizziness, impaired concentration, cough, dyspnoea (difficulty breathing), nausea, diarrhoea, abdominal (tummy) pain, vomiting, alopecia (hair loss), pruritus (itching), dry skin, rash, myalgia (muscle pain), arthralgia (joint pain), musculoskeletal pain (pain in the muscles and bones), reactions at the site of the injection including inflammation, fatigue (tiredness), fever, rigors (shaking chills), flu-like symptoms, asthenia (weakness), malaise (feeling unwell), irritability, weight loss and decreased growth rate.
Den fuldstændige liste over de indberettede bivirkninger ved Rebetol fremgår af indlægssedlen.
For the full list of all side effects reported with Rebetol, see the Package Leaflet.
Rebetol bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for ribavirin eller andre af indholdsstofferne.
Rebetol should not be used in people who may be hypersensitive (allergic) to ribavirin or any of the other ingredients.
Rebetol må ikke anvendes hos: • gravide kvinder, • kvinder, der ammer, • patienter med svær hjertesygdom, • patienter med svær sygdom, herunder nyresvigt og svær leversygdom, • patienter med visse blodsygdomme, der påvirker hæmoglobinindholdet, • patienter, der tidligere har haft bestemte immunsygdomme eller tager medicin, der dæmper immunsystemet, • børn og unge med tidligere svære psykiske sygdomme, især svær depression, selvmordstanker eller selvmordsforsøg.
Rebetol should not be used in: • pregnant women, • women who are breast-feeding, • patients with severe heart disease, • patients with a severe medical condition, including kidney failure and severe liver disease. • patients with certain blood disorder that affect haemoglobin, • patients with a history of certain disorders of the immune system, or are taking medicine that suppress the immune system, • children and adolescents with a history of severe mental illness, particularly severe depression, suicidal thoughts or suicide attempts.
Den fuldstændige liste over begrænsninger fremgår af indlægssedlen.
For the full list of all restrictions, see the Package Leaflet.
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Rebetol opvejer risiciene til behandling af kronisk hepatitis C, når det anvendes i kombination med peginterferon alfa - 2b til voksne, herunder ikke tidligere behandlede patienter med samtidig klinisk stabil hiv- infektion,
The Committee for Medicinal products for Human Use (CHMP) decided that Rebetol’ s benefits are greater than its risks for treatment of chronic hepatitis C, as part of a combination regimen with peginterferon alfa-2b (adults) including naïve patients with clinically stable HIV co-infection, or
eller i kombination med interferon alfa- 2b til voksne, børn over 3 år og unge.
interferon alfa-2b (adults, children of 3 years and older and adolescents).
Udvalget anbefalede udstedelse af markedsføringstilladelse for Rebetol.
The Committee recommended that Rebetol be given marketing authorisation.
Andre oplysninger om Rebetol:
Other information about Rebetol:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Rebetol til SP Europe den 7. maj 1999.
The European Commission granted a marketing authorisation valid throughout the European Union for Rebetol to SP Europe on 7 May 1999.
Denne tilladelse blev fornyet den 7. maj 2004.
The marketing authorisation was renewed on 7 May 2004.
Den fuldstændige EPAR om Rebetol findes her.
The full EPAR for Rebetol is available here.
Blister (PVC/ PE/ PVDC)
blister (PVC/ PE/ PVDC)
oral opløsning
Oral solution
Hver Rebetol kapsel indeholder 200 mg ribavirin.
Each Rebetol capsule contains 200 mg of ribavirin.
Rebetol indeholder 40 mg laktosemonohydrat.
Rebetol contains 40 mg of lactose monohydrate.
Hård kapsel Hvide, uigennemsigtige og mærket med blåt tryk.
Hard capsule White, opaque and imprinted with blue ink.
Rebetol er indiceret til behandling af kronisk hepatitis C og skal udelukkende anvendes som en del af en kombinationsbehandling med peginterferon alfa- 2b (voksne) eller interferon alfa- 2b (voksne, børn (3 år eller ældre) og unge).
Rebetol is indicated for the treatment of chronic hepatitis C and must only be used as part of a combination regimen with peginterferon alfa-2b (adults) or interferon alfa-2b (adults, children (3-years of age or older), and adolescents).
Rebetol må ikke anvendes som monoterapi.
Rebetol monotherapy must not be used.
Der er ingen information om sikkerhed eller effekt ved anvendelse af Rebetol med andre former for interferon (det vil sige foruden alfa- 2b) eller ved brug af Rebetol med peginterferon alfa- 2b hos børn og unge.
There is no safety or efficacy information on the use of Rebetol with other forms of interferon (i. e., not alfa-2b), or on the use of Rebetol with peginterferon alfa-2b in children or adolescents.
Se venligst også produktresume (SPC) for peginterferon alfa- 2b eller interferon alfa- 2b for foreskreven information specielt for dette lægemiddel.
Please refer also to the peginterferon alfa-2b or interferon alfa-2b Summary of Product Characteristics (SPC) for prescribing information particular to that product.
Naive patienter Voksne patienter:
Naïve patients Adult patients:
4. 4).
Rebetol is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA (see section 4.4).
4. 4).
Additionally, Rebetol is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for serum HCV-RNA, including patients with clinically stable HIV co-infection (see section 4.4).
Rebetol er beregnet til anvendelse, i kombination med interferon alfa- 2b, til behandling af børn og unge i alderen 3 år eller ældre, som lider af tidligere ubehandlet kronisk hepatitis C uden leverdekompensation, og som er positive med hensyn til serum HCV- RNA.
Rebetol is intended for use, in a combination regimen with interferon alfa- 2b, for the treatment of children and adolescents 3 years of age and older, who have chronic hepatitis C, not previously treated, without liver decompensation, and who are positive for serum HCV-RNA.
Beslutningen om at behandle bør tages individuelt fra patient til patient under hensyntagen til tegn på sygdomsprogression såsom leverinflammation og fibrose, såvel som prognostiske faktorer for respons, HCV genotype og virusmængde.
The decision to treat should be made on a case by case basis, taking into account any evidence of disease progression such as hepatic inflammation and fibrosis, as well as prognostic factors for response, HCV genotype and viral load.
Patienter i tidligere mislykket behandling Voksne patienter:
Previous treatment failure patients Adult patients:
Rebetol er indiceret i kombination med interferon alfa- 2b til behandling af voksne patienter med kronisk hepatitis C, der tidligere har responderet (med normalisering af ALT ved behandlingsafslutningen) på interferon alfa monoterapi, men som efterfølgende har fået relaps.
Rebetol is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.
Rebetol er ydermere indiceret i kombination med peginterferon alfa- 2b til behandling af voksne patienter med kronisk hepatitis C, hvor tidligere behandling med interferon alfa (pegyleret eller non -
Additionally, Rebetol is indicated, in combination with peginterferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have failed previous treatment with interferon alpha (pegylated or nonpegylated) and ribavirin combination therapy or interferon alpha monotherapy (see section 5.1).
4. 2 Dosering og indgivelsesmåde
2 4.2 Posology and method of administration
Dosis, der skal indgives Dosis af Rebetol er baseret på patientens kropsvægt (Tabel 1).
Dose to be administered The dose of Rebetol is based on patient body weight (Table 1).
Rebetol kapsler skal indtages oralt hver dag fordelt på to doser (morgen og aften) samtidig med et måltid.
Rebetol capsules are to be administered orally each day in two divided doses (morning and evening) with food.
Rebetol skal anvendes i kombination med enten peginterferon alfa- 2b (1, 5 mikrogram/ kg/ uge) eller interferon alfa- 2b (3 millioner internationale enheder [MIE] tre gange om ugen).
Rebetol must be used in combination with either peginterferon alfa-2b (1.5 micrograms/ kg/ week) or interferon alfa-2b (3 million international units [MIU] three times a week).
Valg af kombinationsbehandling er baseret på patientens karakteristika.
The choice of combination regimen is based on the characteristics of the patient.
5. 1).
The regimen administered should be selected based on the anticipated efficacy and safety of the combination treatment for an individual patient (see section 5.1).
Rebetol dosis baseret på kropsvægt
Rebetol dose based on body weight
Patientvægt (kg) < 65 65 – 85 86 - 105 > 105
86 - 105 > 105
Daglig Rebetol dosis 800 mg 1. 000 mg 1. 200 mg 1. 400 mg
1,200 mg 1,400 mg
Antal 200 mg kapsler 4a 5b 6c 7d
6c 7d
Rebetol kapsler i kombination med pegyleret interferon alfa- 2b:
Rebetol Capsules in combination with pegylated interferon alfa-2b:
Behandlingsvarighed – Naive patienter Forudsigelighed for vedvarende virologisk respons:
Duration of treatment – Naïve patients Predictability of sustained virological response: