natgillin/translations-raw huggingface dataset:
49 Ελλάδα JANSSEN- CILAG Φαρµακευτική Α. Ε. Β. Ε.
Ελλάδα JANSSEN-CILAG Φαρ µακευτική Α .Ε .Β .Ε.
VEJLEDNING I INJEKTION
50 INSTRUCTIONS FOR ADMINISTRATION
Tag hætteglasset/ hætteglassene ud af køleskabet og kontroller hætteglasset / hætteglassene, så du er sikker på • at antallet af hætteglas og styrken er korrekt o Hvis din dosis er 90 mg, får du et hætteglas med 90 mg STELARA. • at det er den rigtige medicin • at den ikke har overskredet udløbsdatoen • at hætteglasset ikke er beskadiget, og at forseglingen ikke er brudt • at opløsningen ikke er misfarvet, uklar eller indeholder fremmedlegemer • at opløsningen ikke er frossen
Take the vial(s) out of the refrigerator and check the vial(s) to make sure • the number of vials and strength is correct o If your dose is 90 mg you will get one 90 mg vial of STELARA. • it is the right medicine • it has not passed its expiry date • the vial is not damaged and the seal is not broken • the solution is not discoloured, cloudy or contains any foreign particles • the solution is not frozen.
51 2.
51 3.
• Fjern nålen fra hætteglasset. • Hold sprøjten, sådan at nålen peger opad, for at se, om der er luftbobler i sprøjten.
• Remove the needle from the vial • Hold the syringe with the needle pointing up to see if it has any air bubbles inside • If there are air bubbles, tap the side gently until the air bubbles go to the top of the syringe
52 • Hvis der er luftbobler, skal du banke forsigtigt på siden af sprøjten, indtil luftboblerne befinder sig øverst i sprøjten.
• Then press the plunger until all of the air (but none of the liquid) has been removed • Do not lay the syringe down or allow the needle to touch anything.
EU/ 1/ 99/ 111/ 005 EU/ 1/ 99/ 111/ 006 EU/ 1/ 99/ 111/ 007 EU/ 1/ 99/ 111/ 008 EU/ 1/ 99/ 111/ 009 EU/ 1/ 99/ 111/ 010 EU/ 1/ 99/ 111/ 011
EU Number EU/ 1/ 99/ 111/ 001 EU/ 1/ 99/ 111/ 002 EU/ 1/ 99/ 111/ 003 EU/ 1/ 99/ 111/ 004 EU/ 1/ 99/ 111/ 005 EU/ 1/ 99/ 111/ 006 EU/ 1/ 99/ 111/ 007 EU/ 1/ 99/ 111/ 008 EU/ 1/ 99/ 111/ 009 EU/ 1/ 99/ 111/ 010 EU/ 1/ 99/ 111/ 011
Stocrin Stocrin Stocrin Stocrin Stocrin Stocrin Stocrin
Invented name Stocrin Stocrin Stocrin Stocrin Stocrin Stocrin Stocrin Stocrin Stocrin Stocrin Stocrin
30 mg/ ml 300 mg 300 mg 600 mg 600 mg 50 mg 200 mg
Strength 50 mg 100 mg 200 mg 200 mg 30 mg/ ml 300 mg 300 mg 600 mg 600 mg 50 mg 200 mg
Oral opløsning Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet Filmovertrukken tablet
Pharmaceutical form Hard capsule Hard capsule Hard capsule Hard capsule Oral Solution Film-coated tablets Film-coated tablets Film-coated tablets Film-coated tablets Film-coated tablet Film-coated tablet
Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse Oral anvendelse
Route of administration Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use Oral use
flaske (HDPE) flaske (HDPE) blister (alu) flaske (HDPE) blister (alu) flaske (HDPE) flaske (HDPE)
Packaging Bottle (HDPE) Bottle (HDPE) Bottle (HDPE) Blister (Alu) Bottle (HDPE) Bottle (HDPE) Blister (Alu) Bottle (HDPE) Blister (Alu) bottle (HDPE) bottle (HDPE)
1 flaske + 1 sprøjte 60 tabletter 60 tabletter 30 tabletter 30 tabletter 30 tabletter 90 tabletter
Package size 30 capsules 30 capsules 90 capsules 42 capsules 180 ml oral solution 60 tablets 60 tablets 30 tablets 30 tablets 30 tablets 90 tablets
Det leveres som kapsler (gule og hvide:
It is available as capsules (yellow and white:
50 mg, hvide:
50 mg; white:
100 mg, gule:
100 mg; yellow:
200 mg), som gule, kapselformede tabletter (600 mg), som runde, gule tabletter (50 og 200 mg) og som oral opløsning (30 mg/ ml).
200 mg), as yellow, capsule-shaped tablets (600 mg), as round, yellow tablets (50 and 200 mg), and as an oral solution (30 mg/ ml).
Dette virus er årsag til erhvervet immundefektsyndrom (aids).
It is used together with other antiviral medicines to treat adults and children aged three years or older infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Behandling med Stocrin bør indledes af en læge med erfaring i behandling af hivinfektion.
Treatment with Stocrin should be started by a doctor who has experience in the management of HIV infection.
Stocrin skal gives sammen med anden antiviral medicin.
Stocrin must be given in combination with other antiviral medicines.
Patienter, der tager rifampicin (et antibiotikum) kan være nødt til at tage en højere dosis Stocrin.
Patients taking rifampicin (an antibiotic) may need to take a higher dose of Stocrin.
Stocrin indeholder det aktive stof efavirenz, der er en non- nukleosid revers transkriptase hæmmer (NNRTI).
The active substance in Stocrin, efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Ved at blokere dette enzym reducerer Stocrin, i kombination med andre antivirale lægemidler, hivmængden i blodet og holder den nede.
By blocking this enzyme, Stocrin, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Stocrin helbreder ikke hivinfektion eller aids, men kan sinke den skade på immunsystemet og de infektioner og sygdomme, der er forbundet med aids.
Stocrin does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Stocrin var genstand for tre hovedundersøgelser hos voksne, hvori der deltog over 1 100 patienter:  I den første undersøgelse blev Stocrin, i kombination med lamivudin og zidovudin eller med indinavir (andre antivirale lægemidler), sammenlignet med kombinationen indinavir, lamivudin og zidovudin.  I den anden undersøgelse sammenlignedes Stocrin i kombination med nelfinavir og to andre antivirale lægemidler med den samme kombination uden Stocrin.  I den tredje undersøgelse blev Stocrin sammenlignet med placebo (et virkningsløst præparat) som tillægsbehandling til en kombination af antivirale lægemidler, herunder indinavir og to andre antivirale lægemidler, hos patienter, der i forvejen var blevet behandlet for hivinfektion.
Stocrin has been studied in three main studies involving over 1,100 adults:  in the first study, Stocrin in combination with lamivudine and zidovudine or with indinavir (other antiviral medicines) was compared with the combination of indinavir, lamivudine and zidovudine;  the second study compared Stocrin in combination with nelfinavir and two other antiviral medicines with the same combination without Stocrin;  the third study compared adding Stocrin or placebo (a dummy treatment) to a combination of antiviral medicines that included indinavir and two other antiviral medicines, in patients who had already been receiving treatment for HIV infection.
I alle undersøgelserne blev behandlingens virkning hovedsagelig bedømt på det antal patienter, hos hvem der ikke kunne påvises hiv- 1 i blodet efter 24 eller 48 ugers behandling.
In all of the studies, the main measure of effectiveness was the number of patients who had undetectable levels of HIV-1 in their blood (viral loads) after 24 or 48 weeks of treatment.
De tilsvarende tal var 54% for de patienter, der blev behandlet med Stocrin og indinavir, og 45% for de patienter, der blev behandlet med indinavir, lamivudin og zidovudin.  I den anden undersøgelse virkede Stocrin i kombination med nelfinavir bedre end kombinationen uden Stocrin:
All of the studies showed that combinations including Stocrin were at least as effective as the comparator medicines:  the first study showed that 67% of the adults treated with Stocrin in combination with zidovudine and lamivudine had viral loads below 400 copies/ ml after 48 weeks, compared with 54% of the patients treated with Stocrin and indinavir, and 45% of the patients treated with indinavir, lamivudine and zidovudine;  in the second study, Stocrin in combination with nelfinavir was superior to the combination without Stocrin:
Hos henholdsvis 70% og 30% af patienterne var indholdet af virus under 500 kopier/ ml efter 48 ugers behandling.  Den tredje undersøgelse viste, at der var flere patienter i Stocrin- gruppen end i placebogruppen, der havde et virusindhold på under 400 kopier/ ml efter 24 uger.
70% and 30% of the patients, respectively, had viral loads below 500 copies/ ml after 48 weeks;  the third study showed that more patients receiving Stocrin had viral loads below 400 copies/ ml than those taking placebo after 24 weeks.
Stocrin er desuden forbundet med symptomer fra nervesystemet, f. eks. svimmelhed, søvnløshed, søvntrang, nedsat koncentrationsevne og unormale drømme, og med psykiske lidelser, herunder svær depression, selvmordstanker, selvmordsforsøg og aggressiv adfærd, navnlig hos patienter med tidligere psykisk sygdom.
Stocrin is also associated with nervous system symptoms, such as dizziness, insomnia (difficulty sleeping), somnolence (sleepiness), impaired concentration and abnormal dreaming, and with psychiatric disorders, including severe depression, suicidal thoughts, suicide attempts and aggressive behaviour, especially in patients with a history of mental illness.
Den fuldstændige liste over alle de indberettede bivirkninger ved Stocrin fremgår af indlægssedlen.
For a more complete list of side effects reported with Stocrin, see the Package Leaflet.
Stocrin bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for efavirenz eller andre af indholdsstofferne.
Stocrin should not be used in patients who may be hypersensitive (allergic) to efavirenz or any of the other ingredients.
Det må ikke anvendes af patienter med svær leversygdom eller af patienter, der er i behandling med nogen af følgende lægemidler:  astemizol og terfenadin (anvendes til behandling af allergisymptomer – kan fås uden recept)  dihydroergotamin, ergotamin, ergonovin, methylergonovin (anvendes mod migræne)  midazolam, triazolam (anvendes mod angst og søvnbesvær)  pimozid (anvendes ved psykiske sygdomme)  cisaprid (anvendes til lindring af visse maveproblemer)  bepridil (anvendes ved angina pectoris)  perikum (en drogetilberedning til behandling af depression).
It must not be used in patients with severe liver disease or who are taking any of the following medicines:  astemizole, terfenadine (commonly used to treat allergy symptoms - these medicines may be available without prescription);  dihydroergotamine, ergotamine, ergonovine, methylergonovine (used to treat migraine headache);  midazolam, triazolam (used to relieve anxiety or difficulty sleeping);  pimozide (used to treat mental illnesses);  cisapride (used to relieve certain stomach problems);  bepridil (used to treat angina);  St John ’ s wort (a herbal preparation used to treat depression).
Også når Stocrin anvendes sammen med andre lægemidler, bør forsigtighed udvises.
Caution is also needed when Stocrin is taken at the same time as other medicines.
Som med anden hivmedicin kan patienter, der får Stocrin, få lipodystrofi (forandringer i kropsfedtets fordeling), osteonekrose (knoglevævsdød) eller immunreaktiveringssyndrom (infektionslignende symptomer, der skyldes, at immunsystemet genvinder sin funktion).
As with other anti-HIV medicines, patients taking Stocrin may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Patienter med leverproblemer (herunder hepatitis B eller C) kan have forhøjet risiko for leverskade, når de får Stocrin.
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Stocrin.
2/ 3 Hvorfor blev Stocrin godkendt?
2/ 3 Why has Stocrin been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at fordelene ved Stocrin opvejer risiciene til antiretroviral kombinationsbehandling af hivsmittede voksne, unge og børn på tre år og derover.
The Committee for Medicinal Products for Human Use (CHMP) decided that Stocrin’ s benefits are greater than its risks in antiviral combination treatment of HIV-infected adults, adolescents, and children three years of age and older.
Udvalget konstaterede, at Stocrin ikke er blevet tilstrækkelig undersøgt hos patienter med fremskreden sygdom (CD4- celletal under 50 celler/ mm3) eller patienter, hos hvem proteasehæmmere (en anden type antiviral medicin) ikke har virket.
The Committee noted that Stocrin has not been studied adequately in patients with advanced disease (CD4 cell counts below 50 cells/ mm3) or after treatment with protease inhibitors (another type of antiviral medicine) that was not working.
Der er dog ikke resultater, der tyder på, at proteasehæmmere ikke virker hos sådanne patienter.
The Committee also noted that there is little information on the benefits of treatment including a protease inhibitor in patients who have been treated with Stocrin in the past but which stopped working, although there is no evidence to suggest that protease inhibitors may not work in these patients.
Udvalget anbefalede udstedelse af markedsføringstilladelse for Stocrin.
The Committee recommended that Stocrin be given marketing authorisation.
Andre oplysninger om Stocrin:
Other information about Stocrin:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Stocrin til Merck Sharp & Dohme Limited den 28. maj 1999.
The European Commission granted a marketing authorisation valid throughout the European Union for Stocrin to Merck Sharp & Dohme Limited on 28 May 1999.
Markedsføringstilladelsen blev fornyet den 28. maj 2004 og den 28. maj 2009.
The marketing authorisation was renewed on 28 May 2004 and on 28 May 2009.
Den fuldstændige EPAR for Stocrin findes her.
The full EPAR for Stocrin can be found here.
Dette sammendrag blev sidst ajourført i 05- 2009.
This summary was last updated in 05-2009.
Hver hård kapsel indeholder 28, 5 mg lactosemonohydrat.
Excipient: each hard capsule contains 28.5 mg of lactose monohydrate.
Mørkegule og hvide, præget med ” 3805 ”.
Dark yellow and white, printed with “ 3805”.
STOCRIN er indiceret til antiviral kombinationsbehandling af humant immundefekt virus- 1 (HIV- 1) - inficerede voksne, unge og børn fra 3 år og opefter.
STOCRIN is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.
STOCRIN er ikke tilstrækkeligt undersøgt hos patienter med fremskreden HIV- sygdom, det vil sige patienter med CD4 tal < 50 celler/ mm3, eller efter svigtende effekt af proteasehæmmerregimer (PI).
STOCRIN has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/ mm3, or after failure of protease inhibitor (PI) containing regimens.
Selvom der ikke er dokumenteret krydsresistens mellem efavirenz og PI' ere, er der i øjeblikket ikke tilstrækkelige data med hensyn til effekten af efterfølgende brug af PI- baseret kombinationsbehandling efter svigtende effekt af regimer, der inkluderer STOCRIN.
Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing STOCRIN.
5. 1.
For a summary of clinical and pharmacodynamic information, see section 5.1.
Behandlingen bør initieres af læger med erfaring i behandling af HIV- infektion.
Therapy should be initiated by a physician experienced in the management of HIV infection.
Samtidig antiretroviral behandling:
Concomitant antiretroviral therapy:
4. 5).
STOCRIN must be given in combination with other antiretroviral medicines (see section 4.5).
4. 4 og 5. 2).
The increased efavirenz concentrations observed following administration of STOCRIN with food may lead to an increase in frequency of adverse reactions (see sections 4.4 and 5.2).
4. 8).
In order to improve the tolerability of nervous system undesirable effects, bedtime dosing is recommended (see section 4.8).
4. 5) er 600 mg oralt 1 gang dagligt.
Adults: the recommended dosage of STOCRIN in combination with nucleoside analogue reverse transcriptase inhibitors (NRTIs) with or without a PI (see section 4.5) is 600 mg orally, once daily.
Den anbefalede dosis af STOCRIN i kombination med en PI' er og/ eller NRTI’ ere til patienter i alderen 3 - 17 år er beskrevet i tabel 1.
Paediatric patients (3 to 17 years): the recommended dose of STOCRIN in combination with a PI and/ or NRTIs for patients between 3 and 17 years of age is described in Table 1.
STOCRIN bør ikke
STOCRIN hard capsules must only be administered to children who are able to reliably swallow hard capsules.
5. 1 og 5. 2).
2 STOCRIN is not recommended for use in children below the age of 3 years or weighing less than 13 kg due to a lack of data on safety and efficacy in that age group (see sections 5.1 and 5.2).
Tabel 1 Pædiatrisk dosis til indgivelse 1 gang daglig.
Table 1 Paediatric dose to be administered once daily
Legemsvægt kg 13 til < 15 15 til < 20 20 til < 25 25 til < 32, 5 32, 5 < 40 ≥ 40
Body Weight kg 13 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40 ≥ 40
STOCRIN Dosis (mg) 200 250 300 350 400 600
STOCRIN Dose (mg) 200 250 300 350 400 600
Hvis STOCRIN administreres sammen med voriconazol, bør voriconazol vedligeholdelsesdosis øges til 400 mg hver 12. time, og STOCRIN dosis bør reduceres med 50%, dvs. til 300 mg en gang dagligt.
Dosage adjustment: if STOCRIN is coadministered with voriconazole, the voriconazole maintenance dose must be increased to 400 mg every 12 hours and the STOCRIN dose must be reduced by 50%, i. e., to 300 mg once daily.
4. 5).
When treatment with voriconazole is stopped, the initial dosage of efavirenz should be restored (see section 4.5).
4. 5).
If STOCRIN is coadministered with rifampicin, an increase in the dose of STOCRIN to 800 mg/ day may be considered (see section 4.5).
4. 4).
Renal impairment: the pharmacokinetics of efavirenz have not been studied in patients with renal insufficiency; however, less than 1% of an efavirenz dose is excreted unchanged in the urine, so the impact of renal impairment on efavirenz elimination should be minimal (see section 4.4).
Patienter med mild til moderat leversygdom kan behandles med den normalt anbefalede dosis efavirenz.
Hepatic impairment: patients with mild to moderate liver disease may be treated with their normally recommended dose of efavirenz.
4. 3 og 4. 4).
Patients should be monitored carefully for dose-related adverse reactions, especially nervous system symptoms (see sections 4.3 and 4.4).
5. 2).
Efavirenz must not be used in patients with severe hepatic impairment (Child Pugh Grade C) (see section 5.2).
4. 5).
Efavirenz must not be administered concurrently with terfenadine, astemizole, cisapride, midazolam, triazolam, pimozide, bepridil, or ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) because competition for CYP3A4 by efavirenz could result in inhibition of metabolism and create the potential for serious and/ or life-threatening undesirable effects [for example, cardiac arrhythmias, prolonged sedation or respiratory depression] (see section 4.5).
4. 5).
John’ s wort (Hypericum perforatum) must not be used while taking efavirenz due to the risk of decreased plasma concentrations and reduced clinical effects of efavirenz (see section 4.5).
Efavirenz må ikke bruges som eneste lægemiddel til behandling af HIV eller som eneste lægemiddel føjes til et svigtende regime.
Efavirenz must not be used as a single agent to treat HIV or added on as a sole agent to a failing regimen.
Som med alle andre non- nukleosid reverse transkriptasehæmmere (NNRTI’ ere) forekommer der hurtigt resistent virus, når efavirenz administreres som monoterapi.
As with all other non-nucleoside reverse transcriptase inhibitors (NNRTIs), resistant virus emerges rapidly when efavirenz is administered as monotherapy.
5. 1).
The choice of new antiretroviral agent(s) to be used in combination with efavirenz should take into consideration the potential for viral cross-resistance (see section 5.1).
3 Efavirenz og den faste kombinationstablet indeholdende efavirenz, emtricitabin og tenofovirdisoproxilfumarat, bør ikke administreres samtidigt.
3 Co-administration of efavirenz with the fixed combination tablet containing efavirenz, emtricitabine, and tenofovir disoproxil fumarate, is not recommended.
Ved ordinering af medicin til brug sammen med STOCRIN, bør læger konsultere det pågældende produktresumé.
When prescribing medicinal products concomitantly with STOCRIN, physicians should refer to the corresponding Summary of Product Characteristics.
Patienterne bør informeres om, at det ikke er bevist, at nuværende antiretroviral behandling, inklusive efavirenz, udelukker risiko for overførsel af HIV til andre via seksuel kontakt eller blod.
Patients should be advised that current antiretroviral therapy, including efavirenz, has not been proven to prevent the risk of transmission of HIV to others through sexual contact or blood contamination.
Der er rapporteret mildt til moderat udslæt i kliniske undersøgelser med efavirenz, og dette forsvinder sædvanligvis ved fortsat behandling.
Rash: mild-to-moderate rash has been reported in clinical studies with efavirenz and usually resolves with continued therapy.
Relevante antihistaminer og/ eller kortikosteroider kan forbedre tolerabiliteten og fremskynde udslættets forsvinden.
Appropriate antihistamines and/ or corticosteroids may improve the tolerability and hasten the resolution of rash.
Der er rapporteret svært udslæt, ledsaget af blæredannelse, fugtig afskalning eller ulceration hos færre end 1% af de patienter, der er behandlet med efavirenz.
Severe rash associated with blistering, moist desquamation or ulceration has been reported in less than 1% of patients treated with efavirenz.
4. 8).
If therapy with efavirenz is discontinued, consideration should also be given to interrupting therapy with other antiretroviral agents to avoid development of resistant virus (see section 4.8).
Der rapporteredes udslæt hos 26 ud af 57 børn (46%), der er behandlet med efavirenz i løbet af en periode på 48 uger; udslættet var alvorligt hos tre patienter.
Rash was reported in 26 of 57 children (46%) treated with efavirenz during a 48-week period and was severe in three patients.
Profylakse med passende antihistaminer forud for påbegyndelse af behandling med efavirenz hos børn kan overvejes.
Prophylaxis with appropriate antihistamines prior to initiating therapy with efavirenz in children may be considered.
Patienter som seponerede behandling med andre NNRTI’ ere på grund af udslæt, kan have højere risiko for at udvikle udslæt under behandling med efavirenz.
Patients who discontinued treatment with other NNRTIs due to rash may be at higher risk of developing rash during treatment with efavirenz.
Der er indberettet psykiatriske bivirkninger hos patienter, der er behandlet med efavirenz.
Psychiatric symptoms: psychiatric adverse reactions have been reported in patients treated with efavirenz.
Efter markedsføring har der ligeledes været indberetninger vedrørende svær depression, selvmord, vrangforestillinger og psykose- lignende opførsel.
There have also been post-marketing reports of severe depression, death by suicide, delusions and psychosis-like behaviour.
4. 8).
Patients should be advised that if they experience symptoms such as severe depression, psychosis or suicidal ideation, they should contact their doctor immediately to assess the possibility that the symptoms may be related to the use of efavirenz, and if so, to determine whether the risks of continued therapy outweigh the benefits (see section 4.8).
4. 8).
Nervous system symptoms: symptoms including, but not limited to, dizziness, insomnia, somnolence, impaired concentration and abnormal dreaming are frequently reported undesirable effects in patients receiving efavirenz 600 mg daily in clinical studies (see section 4.8).