natgillin/translations-raw huggingface dataset:
LÆGEMIDLETS NAVN Instanyl 100 mikrogram næsespray Fentanyl 
NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms nasal spray Fentanyl
100 mikrogram/dosis: 1 ml indeholder fentanylcitrat svarende til 1000 mikrogram fentanyl. 
100 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 1,000 micrograms fentanyl.
INFORMATION I BRAILLE-SKRIFT Instanyl 100, endosis 
INFORMATION IN BRAILLE Instanyl 100, single-dose
• For flerdosisnæsesprayen og flerdosisnæsespray DoseGuard skal alle ubrugte næstesprays eller tomme beholdere returneres ifølge de lokale retningslinjer. 
• For the multi-dose nasal spray and multi-dose nasal spray DoseGuard all unused devices or empty containers should be returned systematically according to the local regulation.
Transportsyge 
Motion sickness
Instanyl 200 mikrogram/dosis, næsespray, opløsning EU/1/09/531/007-009 
Instanyl 200 micrograms/dose nasal spray, solution EU/1/09/531/007-009
HÆNGELÅS-symbol 
LOCK symbol
200 mikrogram: 1 dosis (100 mikroliter) indeholder fentanylcitrat svarende til 200 mikrogram fentanyl. 
200 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 200 micrograms fentanyl.
Instanyl 50 mikrogram/dosis, næsespray, opløsning EU/1/09/531/022-025 
Instanyl 50 micrograms/dose nasal spray, solution EU/1/09/531/022-025
50 mikrogram/dosis: 1 ml indeholder fentanylcitrat svarende til 500 mikrogram fentanyl. 
50 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 500 micrograms fentanyl.
Mave-tarm-kanalen Kvalme, opkastning Obstipation, stomatitis, mundtørhed 
Nausea, vomiting Constipation, stomatitis, dry mouth
1,8 ml indeholder 0,90 mg fentanyl som sikrer levering af 10 doser af 50 mikrogram 2,9 ml indeholder 1,45 mg fentanyl som sikrer levering af 20 doser af 50 mikrogram 5,0 ml indeholder 2,50 mg fentanyl som sikrer levering af 40 doser af 50 mikrogram 
1.8 ml containing 0.90 mg fentanyl ensuring the delivery of 10 doses of 50 micrograms 2.9 ml containing 1.45 mg fentanyl ensuring the delivery of 20 doses of 50 micrograms 5.0 ml containing 2.50 mg fentanyl ensuring the delivery of 40 doses of 50 micrograms
Instanyl 200 mikrogram/dosis, næsespray, opløsning. 
Instanyl 200 micrograms/dose nasal spray, solution.
Instanyl 100 mikrogram, næsespray, opløsning, enkeltdosisbeholder EU/1/09/531/014-017 
Instanyl 100 micrograms nasal spray, solution in single-dose container EU/1/09/531/014-017
Kør ikke bil eller motorcykel og lad være med at cykle. 
You should not drive or use machinery whilst being treated with Instanyl.
2,0 ml indeholder 1,00 mg fentanyl som sikrer levering af 10 doser af 50 mikrogram 3,2 ml indeholder 1,60 mg fentanyl som sikrer levering af 20 doser af 50 mikrogram 4,3 ml indeholder 2,15 mg fentanyl som sikrer levering af 30 doser af 50 mikrogram 5,3 ml indeholder 2,65 mg fentanyl som sikrer levering af 40 doser af 50 mikrogram 
2.0 ml containing 1.00 mg fentanyl ensuring the delivery of 10 doses of 50 micrograms 3.2 ml containing 1.60 mg fentanyl ensuring the delivery of 20 doses of 50 micrograms 4.3 ml containing 2.15 mg fentanyl ensuring the delivery of 30 doses of 50 micrograms 5.3 ml containing 2.65 mg fentanyl ensuring the delivery of 40 doses of 50 micrograms
Instanyl 50 mikrogram/dosis, næsespray, opløsning EU/1/09/531/001-003 
Instanyl 50 micrograms/dose nasal spray, solution EU/1/09/531/001-003
Instanyl DoseGuard er en næsespray, opløsning. 
What Instanyl looks like and contents of the pack Instanyl DoseGuard is a nasal spray, solution.
1 dosis af 100 mikroliter svarer til 200 mikrogram fentanyl. 
1 dose of 100 microlitres equals 200 micrograms fentanyl.
• Tal med apotekspersonalet, hvis næsesprayen stadig ikke fungerer, som den skal. 
• If your nasal spray is still not working properly, talk to your pharmacist.
Øvrige indholdsstoffer: Natriumdihydrogenphosphatdihydrat, dinatriumphosphatdihydrat, renset vand. 
The other ingredients are sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, and purified water.
50 mikrogram: 1 dosis (100 mikroliter) indeholder fentanylcitrat svarende til 50 mikrogram fentanyl. 
50 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 50 micrograms fentanyl.
100 mikrogram: 1 dosis (100 mikroliter) indeholder fentanylcitrat svarende til 100 mikrogram fentanyl. 
100 micrograms: 1 dose (100 microlitres) contains fentanyl citrate equivalent to 100 micrograms fentanyl.
Kontakt din læge, hvis du oplever flere end 4 tilfælde af gennembrudssmerter i løbet af en dag, da din sædvanlige behandling af cancersmerter måske skal ændres. 
If you experience more than four episodes of breakthrough pain per day, contact your doctor, as your usual cancer pain treatment may have to be changed.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Instanyl 50 mikrogram/dosis næsespray, opløsning Fentanyl 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 50 micrograms/dose nasal spray
LÆGEMIDLETS NAVN Instanyl 50 mikrogram/dosis næsespray, opløsning Fentanyl 
NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms/dose nasal spray, solution Fentanyl
Hvis der er gået mere end 7 dage siden Instanyl har været brugt, skal næsesprayen klargøres med et enkelt pump, inden næste dosis tages. 
If the product has not been used for a period of more than 7 days, the nasal spray must be primed again by actuating once before the next dose is taken.
Instanyl 100 mikrogram/dosis, næsespray, opløsning EU/1/09/531/026-029 
Instanyl 100 micrograms/dose nasal spray, solution EU/1/09/531/026-029
200 mikrogram/dosis: 1 ml indeholder fentanylcitrat svarende til 2000 mikrogram fentanyl. 
200 micrograms/dose: 1 ml contains fentanyl citrate equivalent to 2,000 micrograms fentanyl.
Luk altid næsesprayen efter brug ved at sætte den børnesikrede hætte på igen 
Keep out of the sight and reach of children Always close after use by putting the child-resistant cap back on to the nasal spray.
2,0 ml indeholder 4,00 mg fentanyl som sikrer levering af 10 doser af 200 mikrogram 3,2 ml indeholder 6,40 mg fentanyl som sikrer levering af 20 doser af 200 mikrogram 4,3 ml indeholder 8,60 mg fentanyl som sikrer levering af 30 doser af 200 mikrogram 5,3 ml indeholder 10,60 mg fentanyl som sikrer levering af 40 doser af 200 mikrogram 
3.2 ml containing 6.40 mg fentanyl ensuring the delivery of 20 doses of 200 micrograms 4.3 ml containing 8.60 mg fentanyl ensuring the delivery of 30 doses of 200 micrograms 5.3 ml containing 10.60 mg fentanyl ensuring the delivery of 40 doses of 200 micrograms
1 dosis (100 mikroliter) indeholder 200 mikrogram fentanyl. 
1 dose (100 microlitres) contains 200 micrograms fentanyl.
Instanyl 50 mikrogram/dosis, næsespray, opløsning 3 år. 
Instanyl 50 micrograms/dose nasal spray, solution 3 years
1 dosis af 100 mikroliter svarer til 100 mikrogram fentanyl. 
1 dose of 100 microlitres equals 100 micrograms fentanyl.
Instanyl 50 mikrogram, næsespray, opløsning, enkeltdosisbeholder Hver enkeltdosisbeholder indeholder en dosis (100 mikroliter) fentanylcitrat svarende til 50 mikrogram fentanyl. 
Instanyl 50 micrograms nasal spray, solution in single-dose container Each single-dose container contains one dose (100 microlitres) of fentanyl citrate equivalent to 50 micrograms fentanyl.
1 dosis af 100 mikroliter svarer til 50 mikrogram fentanyl. 
1 dose of 100 microlitres equals 50 micrograms fentanyl.
Instanyl 100 mikrogram/dosis, næsespray, opløsning EU/1/09/531/004-006 
Instanyl 100 micrograms/dose nasal spray, solution EU/1/09/531/004-006
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Instanyl 200 mikrogram/dosis næsespray, opløsning Fentanyl 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 200 micrograms/dose nasal spray
1 dosis (100 mikroliter) indeholder 50 mikrogram fentanyl. 
1 dose (100 microlitres) contains 50 micrograms fentanyl.
Det skal du vide, før du begynder at bruge Instanyl Sådan skal du bruge Instanyl Bivirkninger 
What Instanyl is and what it is used for What you need to know before you use Instanyl How to use Instanyl
Instanyl 100 mikrogram/dosis, næsespray, opløsning. 
Instanyl 100 micrograms/dose nasal spray, solution.
Abstinenssymptomer 
Hyperhidrosis
Instanyl 50 mikrogram, næsespray, opløsning, enkeltdosisbeholder EU/1/09/531/010-013 
Instanyl 50 micrograms nasal spray, solution in single-dose container EU/1/09/531/010-013
LÆGEMIDLETS NAVN Instanyl 200 mikrogram/dosis næsespray, opløsning Fentanyl 
NAME OF THE MEDICINAL PRODUCT Instanyl 200 micrograms/dose nasal spray, solution Fentanyl
Instanyl 200 mikrogram, næsespray, opløsning, enkeltdosisbeholder Hver enkeltdosisbeholder indeholder en dosis (100 mikroliter) fentanylcitrat svarende til 200 mikrogram fentanyl. 
Instanyl 200 micrograms nasal spray, solution in single-dose container Each single-dose container contains one dose (100 microlitres) of fentanyl citrate equivalent to 200 micrograms fentanyl.
LÆGEMIDLETS NAVN Instanyl 100 mikrogram/dosis næsespray, opløsning Fentanyl 
NAME OF THE MEDICINAL PRODUCT Instanyl 100 micrograms/dose nasal spray, solution Fentanyl
Instanyl 50 mikrogram næsespray, opløsning, enkeltdosisbeholder Instanyl 100 mikrogram næsespray, opløsning, enkeltdosisbeholder Instanyl 200 mikrogram næsespray, opløsning, enkeltdosisbeholder fentantyl 
Instanyl 50 micrograms nasal spray, solution in single-dose container Instanyl 100 micrograms nasal spray, solution in single-dose container Instanyl 200 micrograms nasal spray, solution in single-dose container fentanyl
1 dosis (100 mikroliter) indeholder 100 mikrogram fentanyl. 
1 dose (100 microlitres) contains 100 micrograms fentanyl.
Instanyl 50 mikrogram/dosis, næsespray, opløsning 1 ml opløsning indeholder fentanylcitrat svarende til 500 mikrogram fentanyl. 
Instanyl 50 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 500 micrograms fentanyl.
Instanyl 200 mikrogram/dosis, næsespray, opløsning 4 år. 
Instanyl 200 micrograms/dose nasal spray, solution 4 years
LISTE OVER HJÆLPESTOFFER Natriumdihydrogenphosphatdihydrat, dinatriumphosphatdihydrat, vand til injektion 
Also contains: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, water for injections
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Instanyl 100 mikrogram/dosis næsespray, opløsning Fentanyl 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 100 micrograms/dose nasal spray
Instanyl 100 mikrogram, næsespray, opløsning, enkeltdosisbeholder Hver enkeltdosisbeholder indeholder en dosis (100 mikroliter) fentanylcitrat svarende til 100 mikrogram fentanyl. 
Instanyl 100 micrograms nasal spray, solution in single-dose container Each single-dose container contains one dose (100 microlitres) of fentanyl citrate equivalent to 100 micrograms fentanyl.
Instanyl 50 mikrogram/dosis, næsespray, opløsning 
Instanyl 50 micrograms/dose nasal spray, solution.
1 pust (100 mikroliter) indeholder 200 mikrogram fentanyl. 
1 puff (100 microlitres) contains 200 micrograms fentanyl.
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Instanyl 50 mikrog næsespray 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 50 mcg nasal spray
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Instanyl 100 mikrog næsespray 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 100 mcg nasal spray
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Instanyl 200 mikrog næsespray 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Instanyl 200 mcg nasal spray
Instanyl 50 mikrogram/dosis, næsespray, opløsning DoseGuard 
Instanyl 50 micrograms/dose nasal spray, solution
Brug altid Instanyl nøjagtigt efter lægens eller apotekspersonalets anvisning. 
Always use this medicine exactly as your doctor has told you.
1 pust (100 mikroliter) indeholder 50 mikrogram fentanyl. 
1 puff (100 microlitres) contains 50 micrograms fentanyl.
Instanyl 100 mikrogram/dosis, næsespray, opløsning 1 ml opløsning indeholder fentanylcitrat svarende til 1000 mikrogram fentanyl. 
Instanyl 100 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 1,000 micrograms fentanyl.
1 pust (100 mikroliter) indeholder 100 mikrogram fentanyl. 
1 puff (100 microlitres) contains 100 micrograms fentanyl.
Klargøring af Instanyl næsespray 
Preparing the Instanyl nasal spray
Instanyl 200 mikrogram/dosis, næsespray, opløsning 1 ml opløsning indeholder fentanylcitrat svarende til 2000 mikrogram fentanyl. 
Instanyl 200 micrograms/dose nasal spray, solution Each ml of solution contains fentanyl citrate equivalent to 2,000 micrograms fentanyl.
LISTE OVER HJÆLPESTOFFER Natriumdihydrogenphosphatdihydrat, dinatriumphosphatdihydrat, renset vand 
LIST OF EXCIPIENTS Also contains: sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, purified water
Instanyl 100 mikrogram/dosis, næsespray, opløsning DoseGuard 
Instanyl 100 micrograms/dose nasal spray, solution
Instanyl anvendes via næsen. 
Instanyl is for nasal use.
Instanyl 50 mikrogram næsespray, opløsning, enkeltdosisbeholder Fentanyl 
NAME OF THE MEDICINAL PRODUCT Instanyl 50 micrograms nasal spray, solution in single-dose container Fentanyl
100 mikrogram er lilla. 
100 micrograms labelling is purple.
Sådan bruges Instanyl næsespray 
How to use Instanyl nasal spray
ETIKET/ENKELTDOSIS NÆSESPRAY 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS LABEL / SINGLE-DOSE NASAL SPRAY
Hvis du vil have yderligere oplysninger om Instanyl, skal du henvende dig til den lokale repræsentant: 
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Både brugte og ubrugte næsesprays skal kasseres efter lokale bestemmelser eller returneres til apoteket i den børnesikrede æske. 
Any used or unused nasal spray should be returned systematically and suitably in the child-resistant outer box and discarded according to local requirements or returned to the pharmacy.
Instanyl 200 mikrogram næsespray, opløsning, enkeltdosisbeholder Fentanyl 
NAME OF THE MEDICINAL PRODUCT Instanyl 200 micrograms nasal spray, solution in single-dose container Fentanyl
− Et uddannelseskursus for neurokirurger, der har til formål at minimere risikoen og understøtte en sikker og virkningsfuld anvendelse af produktet. 
− A training course for neurosurgeons which is aimed at risk minimisation and to support safe and effective use for the product.
IV); - neurofysiologiske monitoreringsteknikker til kirurgiske indgreb i elokvente hjerneområder. 
IV); - Neurophysiological monitoring techniques for surgery in eloquent brain regions.
Medlemslandene skal sørge for, at alle betingelser eller begrænsninger, som er beskrevet nedenfor, med hensyn til en sikker og virkningsfuld anvendelse af lægemidlet bliver implementeret: 
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Minimumskravene til et kompetent undervisningscenter er: - mikroskop, der er tilpasset fluorescens-ledt resektion; - tilstrækkelig casemængde (mindst 10 patienter pr. år) af maligne gliomer (WHO-grad III og 
Minimum requirements for a qualified training centre are: - Microscope modified for fluorescence-guided resection; - Sufficient case load (at least 10 patients per year) of malignant gliomas (WHO grade III and
forsøget; - erfaring med Gliolan-fluorescencs-ledt kirurgi i form af mindst 20 cases. 
III trial; - Experience with Gliolan-fluorescence-guided surgery in at least 20 cases.
- kommissionsgodkendelse som neurokirurg i henhold til lokale, nationale krav; - tidligere vellykket deltagelse i et uddannelseskursus eller tilsvarende kursus under fase III 
Minimum requirements for a qualified trainer are: - Board-certification as neurosurgeon according to local, national requirements; - Previous successful participation at a training course, or equivalent course during the phase
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Ziagen den 8. juli 1999. 
The European Commission granted a marketing authorisation valid throughout the European Union for Ziagen on 8 July 1999.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ziagen. 
This document is a summary of the European Public Assessment Report (EPAR) for Ziagen.
Den fuldstændige EPAR for Ziagen findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Ziagen can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Det kan enten tages som en enkelt daglig dosis eller opdelt i 300 mg to gange dagligt. 
This can be taken either as a single daily dose or divided into 300 mg twice a day.
Der er udarbejdet en risikostyringsplan for at sikre, at Ziagen anvendes så sikkert som muligt. 
A risk management plan has been developed to ensure that Ziagen is used as safely as possible.
Det fås som tabletter (300 mg) og som oral opløsning (20 mg/ml). 
It is available as tablets (300 mg) and as an oral solution (20 mg/ml).
Hos børn på under 25 kg afhænger den anbefalede dosis af legemsvægten. 
In children weighing less than 25 kg the recommended dose depends on body weight.
Den anbefalede dosis af Ziagen til voksne og børn, der vejer mindst 25 kg er 600 mg dagligt. 
The recommended dose of Ziagen for adults and children weighing at least 25 kg is 600 mg daily.
Overfølsomhedsreaktioner (allergiske reaktioner) opstår hos patienter, der tager Ziagen, normalt inden for de første seks uger af behandlingen, og de kan være livstruende. 
Hypersensitivity reactions (allergic reactions) occur in patients taking Ziagen, usually within the first six weeks of treatment, and can be life-threatening.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ziagen? 
What measures are being taken to ensure the safe and effective use of Ziagen?
Det kurerer ikke hivinfektion eller aids, men det kan udsætte beskadigelsen af immunsystemet og hindre udvikling af infektioner og sygdomme, der er forbundet med aids. 
It does not cure HIV infection or AIDS, but it can hold off the damage to the immune system and avoid the development of infections and diseases associated with AIDS.
Det var mere effektivt end placebo og lige så effektivt som andre antivirale lægemidler til at reducere den virale belastning hos alle aldersgrupper. 
It was more effective than placebo, and was as effective as other antiviral medicines in reducing viral loads in all age groups.
Patienter, der fik Ziagen, havde også stigninger i deres CD4-celletal. 
Patients receiving Ziagen also had increases in their CD4 cell counts.
Behandling med Ziagen skal stoppes øjeblikkeligt, hvis patienten har overfølsomhedsreaktioner. 
Treatment with Ziagen should be stopped promptly if the patient has a hypersensitivity reaction.
Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om anvendelsesbetingelserne for Ziagen. 
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 Ziagen.
CHMP bemærkede, at den påviste fordel ved Ziagen var baseret på resultaterne af undersøgelser, der hovedsagelig blev udført, hvor lægemidlet blev taget to gange om dagen i kombination med andre lægemidler af voksne, som ikke tidligere havde været i hivbehandling. 
The CHMP noted that the demonstration of the benefit of Ziagen was based on the results of studies mainly carried out with the medicine taken twice a day in combination with other medicines in adults who had not taken HIV treatment before.
Ziagen er et lægemiddel, der indeholder det aktive stof abacavir. 
Ziagen is a medicine that contains the active substance abacavir.
I alle undersøgelserne forårsagede Ziagen et fald i viral belastning, især når det blev taget sammen med andre antivirale lægemidler. 
In all of the studies, Ziagen caused a decrease in viral loads, particularly when taken with other antiviral medicines.
Virksomheden, der markedsfører Ziagen, udleverer desuden undervisningsmateriale til læger vedrørende overfølsomhedsreaktioner med lægemidlet, herunder at det er nødvendigt at teste patienter for HLA-B (type 5701)-genet og at minde patienterne om, at de skal kontakte deres læge omgående, hvis de udvikler symptomer, der tyder på overfølsomhed. 
In addition, the company that markets Ziagen provides educational materials for doctors about hypersensitivity reactions with the medicine, including the need to test patients for the HLA-B (type 5701) gene and to remind patients to contact their doctor immediately if they develop symptoms suggestive of hypersensitivity.
Inden behandlingen med abacavir indledes, skal alle patienter undersøges for, om de har et bestemt gen kaldet »HLA-B (type 5701)«. 
Before starting treatment with abacavir, all patients should have a test to find out if they have a gene called ‘HLA-B (type 5701)'.
Der blev desuden gennemført undersøgelser med én daglig dosis og to daglige doser hos børn. 
In addition, studies were carried out to examine once daily versus twice daily dosing in children.
Andre oplysninger om Ziagen 
Other information about Ziagen:
Patienter, der ikke kan sluge tabletter, bør anvende den orale opløsning, eller alternativt knuse tabletterne og komme dem i lidt mad eller drikke, umiddelbart inden de synker det. 
Patients who cannot swallow tablets should use the oral solution, or alternatively they may crush the tablets and add them to a small amount of food or drink immediately before swallowing it. For more information, see the package leaflet.
Hvis du ønsker yderligere oplysninger om behandling med Ziagen, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Ziagen, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
På baggrund af gennemgangen af kvaliteten, sikkerheden og virkningen af lægemidlet fandt udvalget, at fordelene ved Ziagen opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse. 
Based on its review of the quality, safety and effectiveness of the medicine, the Committee decided that Ziagen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Det aktive stof i Ziagen, abacavir, er en nukleosid revers transkriptasehæmmer (NRTI). 
The active substance in Ziagen, abacavir, is a nucleoside reverse transcriptase inhibitor (NRTI).
I en af undersøgelserne af voksne patienter havde 77 % (67 af 87) af de patienter, der tog Ziagen sammen med lamivudin og zidovudin, virale belastninger på under 400 kopier/ml efter 16 uger, sammenlignet med 38 % (33 af 86) af de voksne, der tog lamivudin og zidovudin uden Ziagen. 
In one of the studies in adults, 77% of the patients taking Ziagen with lamivudine and zidovudine had viral loads below 400 copies/ml after 16 weeks (67 out of 87), compared with 38% of the adults taking lamivudine and zidovudine without Ziagen (33 out of 86).
Symptomerne omfatter næsten altid feber eller udslæt, men også meget ofte kvalme, opkast, diarré, mavesmerter, dyspnø (vejrtrækningsbesvær), hoste, feber, apati, utilpashed, hovedpine, tegn på leverskade i blodet og muskelsmerter. 
Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain (stomach ache), dyspnoea (difficulty breathing), cough, fever, lethargy, malaise (feeling unwell), headache, signs of liver damage in the blood and myalgia (muscle pain).
Patienter med dette gen har øget risiko for overfølsomhed over for abacavir og skal derfor ikke have Ziagen. 
Patients with this gene are at an increased risk of having an allergic reaction to abacavir, so they should not take Ziagen.
Hvilken risiko er der forbundet med Ziagen? 
What is the risk associated with Ziagen?