natgillin/translations-raw huggingface dataset:
De hyppigste tegn og symptomer på systemiske infusionsreaktioner er: urticaria, dyspnø, rødme, hyperhidrose, ubehag eller smerter i brystet, kulderystelser og hypertension. 
The most common signs and symptoms of systemic infusion reactions are: urticaria, dyspnoea, flushing, hyperhidrosis, chest discomfort or pain, chills, and hypertension.
De hyppigste tegn og symptomer på lokale infusionsreaktioner er: erytem, pruritus og udslæt. 
The most common signs and symptoms of local infusion reactions are: erythema, pruritus, and rash.
Brug af anden medicin sammen med KRYSTEXXA 
Other medicines and KRYSTEXXA
Hvert hætteglas indeholder 8 mg pegloticase (koncentrat, 8/mg/ml). 
Each vial contains 8 mg of pegloticase (8 mg/ml concentrate).
• sammensnøring af halsen, hæs stemme eller synkebesvær 
• tightness of the throat, hoarse voice or trouble swallowing
Den læge eller sygeplejerske, der behandler dig med KRYSTEXXA, bør have erfaring fra et behandlingscenter i behandling af svær kronisk urinsyregigt. 
KRYSTEXXA should be given to you by a doctor or nurse experienced in the treatment of severe chronic gout in a healthcare centre.
Derfor anbefales nøje overvågning af patienter, der efter forudgående afbrydelse af behandlingen får gentaget infusion med KRYSTEXXA. 
It is therefore recommended that patients given repeat infusions of KRYSTEXXA after a treatment interruption be monitored carefully.
I de kliniske undersøgelser udvikledes anti-pegloticase-antistoffer (IgM og IgG) hos 89 % af de patienter, der blev behandlet med KRYSTEXXA, 8 mg hver 2. uge, og hos 15 % i placebogruppen. 
In clinical trials, anti-pegloticase antibodies (IgM and IgG) developed in 89% of patients treated with KRYSTEXXA 8 mg every 2 weeks and 15% in the placebo group.
Af de patienter, der fik KRYSTEXXA, 8 mg hver 2. uge, i de kliniske undersøgelser, var 34 % (29 af 85) over 65 år, og 12 % (10 af 85) var over 75 år. 
In the clinical studies, 34% (29 of 85) of patients treated with KRYSTEXXA 8 mg every 2 weeks were 65 years of age and older and 12% (10 of 85) were 75 years of age and older.
Dinatriumhydrogenphosphatdihydrat, natriumdihydrogenphosphatdihydrat, natriumklorid, vand til injektionsvæsker. 
Disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride, water for injections
Lægen vil muligvis ordinere medicin, der mindsker sandsynligheden for, at du får akutte anfald af urinsyregigt, efter at du er begyndt at få KRYSTEXXA. 
Your doctor may prescribe medicines to reduce the likelihood of gout flares after starting KRYSTEXXA.
Som det ses af tabel 3, var der i måned 6 fuldstændig tophus-respons hos 29,0 % af de patienter, der fik KRYSTEXXA, 8 mg hver 2. uge, sammenholdt med 6,9 % hos patienter på placebo (idet der ved fuldstændig tophus-respons forstås 100 % opløsning af mindst én mål-tophus uden dannelse af nye tophi eller progression af eksisterende tophi). 
As shown in Table 3 at Month 6, the percentage of patients who achieved complete tophus response (defined as 100% resolution of at least one target tophus, without the appearance of any new tophi or any progression of existing tophi) was 29.0% in patients treated with 8 mg pegloticase every 2 weeks compared to 6.9% in placebo patients excluding patients with missing data, who were considered as a failure.
De fleste infusionsrelaterede reaktioner er iagttaget efter tab af behandlingsrespons forårsaget af udvikling af anti-pegloticase-antistoffer, dvs. ved serumurinsyre over 0,360 mmol/l (6 mg/dl) Serumurinsyre skal derfor kontrolleres før hver infusion. 
Most infusion-related reactions have been observed after loss of therapeutic response due to the development of anti-pegloticase antibodies, i.e. when serum uric acid values were above 6 mg/dl (360 µmol/L).
Indlægsseddel: Information til brugeren KRYSTEXXA, 8 mg, koncentrat til infusionsvæske, opløsning pegloticase 
Package Leaflet: Information for the user KRYSTEXXA 8 mg concentrate for solution for infusion
Begrundelser for at anbefale ændring af betingelserne for markedsføringstilladelsen 
Grounds recommending the variation to the terms of the Marketing Authorisation
Almindelige bivirkninger (forekommer hos op til 1 ud af 10 behandlede): forhøjet blodsukker, opkastning, hævede led, influenzalignende symptomer. 
Common side effects (may affect up to 1 in 10 people): high blood sugar levels, vomiting, joint swelling, flu-like symptoms
I de kliniske forsøg faldt den gennemsnitlige plasmaurinsyre (PUA) til 0,041 mmol/l (0,7 mg/dl) ca. 24 timer efter den første dosis af pegloticase hos patienter, der fik KRYSTEXXA, 8 mg hver 2. uge, sammenholdt med en gennemsnitlig PUA på 0,48 mmol/l (8,2 mg/dl) hos placebobehandlede patienter. 
In clinical trials, the mean plasma uric acid (PUA) levels fell to 0.7 mg/dl approximately 24 hours following the first dose of pegloticase in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with a mean PUA of 8.2 mg/dl in the placebo-treated patients.
Der var ingen indvirkning på fertiliteten at han- eller hunrotter. 
There were no effects on the fertility of male or female rats.
Virknings- og sikkerhedsprofilen af pegloticase er den samme hos patienter med kreatininclearance under og over 50 ml/min. 
Based on similar efficacy and safety profiles of pegloticase in patients with creatinine clearance below and above 50 ml/min, no dose adjustment is required for patients with renal impairment (see section 5.2).
Der er ikke udført formelle undersøgelser af virkningerne af leverinsufficiens. 
No formal studies were conducted to examine the effects of hepatic impairment.
Efter markedsføring blev der indberettet et tilfælde, hvor indholdet af to hætteglas (16 mg) KRYSTEXXA blev administreret uden optræden af uønskede reaktioner. 
The maximum dose that has been administered as a single intravenous dose during clinical studies was 12 mg. A post-marketing report documented administration of the contents of 2 vials (16 mg) without any adverse reaction related to KRYSTEXXA administration.
Andre svandt med støttende behandling med intravenøs væske, supplerende glukokortikoider eller antihistaminer eller efter ophør af infusionen samt med adrenalin mod anafylaktiske reaktioner. 
fluids, additional glucocorticoids or antihistamines, or following discontinuation of the infusion and with epinephrine for anaphylactic reactions.
Hæmolyse og/eller methæmoglobinæmi 
Haemolysis and/or Methemoglobinemia
De mest almindelige tegn og symptomer på lokale infusionsreaktioner var: rødme på injektionsstedet, kløe og udslæt. 
The most common signs and symptoms of local infusion reactions were: redness at the injection site, itching, and rash.
Efter fortynding af KRYSTEXXA med 250 ml natriumkloridopløsning 4,5 mg/ml (0,45 %) eller 9 mg/ml (0,9 %) administreres det som en intravenøs infusion i løbet af mindst 2 timer med en infusionshastighed på ca. 2 ml/minut. 
KRYSTEXXA, once diluted with 250 ml of sodium chloride solution, 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%), is administered as an intravenous infusion over no less than 2 hours, at a flow rate of approximately 2 ml/minute.
Denne indlægsseddel blev senest godkendt i {MM/ÅÅÅÅ\}. 
This leaflet was last revised in {MM/YYYY} Other sources of information
KRYSTEXXA bør seponeres, hvis der to på hinanden følgende gange måles over 0,360 mmol/l 
KRYSTEXXA should be discontinued if 2 consecutive levels above 6 mg/dl have been measured.
Før hver dosis vil lægen undersøge dit blod for indholdet af urinsyre for at sikre, at du skal fortsætte med at få KRYSTEXXA. 
Your doctor will test your blood to measure uric acid levels before each dose to make sure that you should continue receiving KRYSTEXXA.
KRYSTEXXA, 8 mg, koncentrat til infusionsvæske, opløsning pegloticase 
KRYSTEXXA 8 mg concentrate for solution for infusion pegloticase
Hos responderende patienter var PUA-værdien < 0,360 mmol/l (< 6 mg/dl) i hele den 6 måneders behandlingsperiode. 
Responders maintained PUA values < 6 mg/dl throughout the 6-month treatment period.
KRYSTEXXA indeholder 4,2 mg natrium pr. dosis. 
KRYSTEXXA contains 4.2 mg sodium per dose which means it is essentially sodium free.
I de efterfølgende tre måneder forekom akutte artritis urica-anfald hos 41 % og 67 % i de samme grupper, og hos patienter, der fik pegloticase, 8 mg hver 2. uge, i over et år, var sådanne anfald ikke almindelige. 
This compared with flare rates of 41%and 67% in the same groups in the subsequent 3 months, and gout flares were infrequent in patients that received pegloticase 8 mg every 2 weeks for over one year.
Ikke kendt: hæmolyse 
Not known: Haemolysis
Som vist i tabel 2 var responsandelen større hos patienter, der fik KRYSTEXXA, 8 mg hver 2. uge, end i placebogruppen. 
As shown in Table 2, a greater proportion of patients treated with KRYSTEXXA 8 mg every 2 weeks were responders as compared to patients receiving placebo.
• 1 ml KRYSTEXXA injiceres i en enkelt 250 ml pose med natriumklorid, 4,5 mg/ml (0,45 %) eller 9 mg/ml (0,9 %) injektionsvæske eller infusionsvæske. 
• 1 ml of KRYSTEXXA should be injected into a single 250 ml bag of sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) solution for injection or infusion.
Hvis du holder op med at få KRYSTEXXA og derefter genoptager behandlingen, kan der være øget risiko for infusionsreaktioner, herunder svære akutte overfølsomhedsreaktioner (anafylaksi). 
If you stop taking KRYSTEXXA, and then are treated again, you may be at increased risk of infusion reactions, including severe acute allergic reactions (anaphylaxis) so your doctor will monitor you carefully when you restart treatment.
Dinatriumhydrogenphosphatdihydrat Natriumdihydrogenphosphatdihydrat Natriumklorid 
Disodium hydrogen phosphate dihydrate Sodium dihydrogen phosphate dihydrate Sodium chloride
KRYSTEXXA, 8 mg, koncentrat til infusionsvæske, opløsning 
KRYSTEXXA 8 mg concentrate for solution for infusion
Følgende oplysninger er tiltænkt læger og sundhedspersonale: 
The following information is intended for healthcare professionals only: KRYSTEXXA must be prepared as follows:
I de kliniske undersøgelser forekom akutte anfald af artritis urica i de første tre måneder hos 75 % af de patienter, der blev behandlet med KRYSTEXXA, 8 mg hver 2. uge, sammenholdt med 54 % af de placebobehandlede. 
In clinical trials, the percentage of patients that had flares in the first 3 months was 75% in patients treated with KRYSTEXXA 8 mg every 2 weeks compared with 54% in placebo-treated patients.
6.6 er KRYSTEXXA påvist at være fysisk og kemisk stabil ved fortynding i 250 ml natriumklorid, 4,5 mg/ml (0,45 %) og 9 mg/ml (0,9 %), gennem 4 timer ved 2 °C til 8 °C samt ved rumtemperatur (7 °C til 25 °C). 
Physical and chemical stability of KRYSTEXXA diluted in 250 ml sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) has been demonstrated for 4 hours at 2°C to 8°C and at room temperature (20°C to 25°C), if the solution is prepared as described in section 6.6.
Behandlingen med KRYSTEXXA behøver ikke afbrydes ved akutte anfald af artritis urica. 
KRYSTEXXA does not need to be discontinued because of a gout flare.
Hvordan KRYSTEXXA gives 
How KRYSTEXXA is administered
Før behandlingen påbegyndes og især før kontrol af urinsyreniveauerne i serum, bør oral uratsænkende medicin være seponeret. 
Before starting the treatment and especially before monitoring the serum uric acid levels, patients should discontinue oral urate-lowering medication and not institute therapy with oral urate-lowering medication while taking KRYSTEXXA (see section 4.4).
- Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning bliver værre, 
- If you get any side effects, talk to your doctor, pharmacist or nurse.
De ikke-kliniske undersøgelser viser, at pegloticase udskilles renalt. 
From the nonclinical studies, the elimination of pegloticase is via renal/urinary excretion.
Akutte anfald af artritis urica 
Acute gouty attacks (gout flare)
Brug ikke KRYSTEXXA, hvis den fortyndede opløsning indeholder partikler eller er misfarvet. 
Do not use this medicine if you notice any particles or discolouration in the diluted solution.
Videnskabelige konklusioner og begrundelser, der anbefaler en ændring af betingelserne for 
Annex IV Scientific conclusions and grounds recommending the variation to the terms of the Marketing Authorisation
Hvert hætteglas indeholder 8 mg pegloticase (koncentrat, 
Each vial contains 8 mg of pegloticase (8 mg/ml concentrate)
Spørg lægen eller på apoteket eller sundhedspersonalet, hvis du er i tvivl om brugen af lægemidlet. 
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
I denne vægtgruppe var der desuden tendens til øget forekomst af høj titer af anti-pegloticase-antistoffer og infusionsrelaterede reaktioner (se pkt. 
Also, high titres of anti-pegloticase antibodies and infusion-related reactions showed a tendency to occur in a greater proportion of patients in this weight group (see section 4.8).
Sådan virker KRYSTEXXA 
How KRYSTEXXA works
Smertescore på en visuel analog skala var 44,2 ved baseline mod 28,4 i uge 25 for patienter behandlet med pegloticase, 8 mg hver 2. uge. 
The Pain scores using a visual analogue scale were 44.2 at baseline vs. 28.4 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 53.9 vs. 57.2 in the placebo group (p≤0.001).
Ved enkeltdoser på 8 mg og 12 mg iagttoges et vedholdende (mere end 12 dage) fald i plasmaurinsyre til under opløseligheden på 0,360 mmol/l (6 mg/dl). 
Sustained decrease in plasma uric acid below the solubility concentration of 6 mg/dl was observed for more than 12 days with single doses of 8 mg and 12 mg.
• 1 ml KRYSTEXXA injiceres i en enkelt 250 ml pose med natriumklorid, 4,5 mg/ml (0,45 %) 
• 1 ml of KRYSTEXXA should be injected into a single 250 ml bag of sodium chloride 4.5 mg/ml (0.45%) or 9 mg/ml (0.9%) solution for injection for infusion.
HAQ-PGA-scoren var 42,4 ved baseline mod 27,1 i uge 25 for patienter behandlet med pegloticase, 8 mg hver 2. uge. 
The HAQ-PGA scores were 42.4 at baseline vs. 27.1 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 51.6 vs. 53.4 in the placebo group (p≤0.001).
Før hver infusion skal serumurinsyre måles. 
Monitoring of serum uric acid level is required prior to each infusion.
• De øvrige indholdsstoffer er dinatriumhydrogenphosphatdihydrat, 
• The other ingredients are disodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate dihydrate, sodium chloride and water for injections.
HAQ-DI-scoren var 1,1 ved baseline mod 0,84 i uge 25 for patienter behandlet med KRYSTEXXA, 8 mg hver 2. uge. 
The HAQ-DI scores were 1.1 at baseline vs. 0.84 at Week 25 in patients treated with pegloticase 8 mg every 2 weeks compared to 1.2 vs. 1.3 in the placebo group (p≤0.01).
Almindelig: hævede led 
Common: Vomiting
Ualmindelige bivirkninger (forekommer hos op til 1 ud af 100 behandlede): forværring af hjertesvigt med væskeophobning, hudinfektioner, forhøjet kaliumindhold i blodet. 
Uncommon side effects: (may affect up to 1 in 100 people): worsening of a type of heart disease called congestive heart failure, skin infection, elevated potassium levels in the blood Frequency not known (cannot be estimated from available data): destruction of red blood cells If you get any side effects, talk to your doctor, pharmacist or nurse.
71 % af patienterne havde tophi ved baseline. 
The mean PUA at baseline was 9.8 mg/dl. Seventy-one percent (71%) of patients had baseline tophi.
pværdi2 
p-Value2
Meget almindelig: akutte anfald af artritis urica 
Very common: Gout flare
Ikke almindelig: hyperkaliæmi 
Metabolism and nutrition disorders Common: Hyperglycaemia Cardiac disorders
Mave-tarmkanalen 
Breast-feeding
Injektionsvæske, pløsning 
Solution for infusion
100 IE/ml 
vials (glass)
EU/1/97/030/095 Insuman Rapid 100 IE/ml 
EU/1/97/030/053 Insuman Infusat 100 IU/ml
EU/1/97/030/054 Insuman Infusat 
EU/1/97/030/203 Insuman Implantable
Filamentøs hæmagglutinin, adsorberet 25 mikrogram Pertactin, adsorberet 
Filamentous haemagglutinin, adsorbed 25 micrograms Pertactin, adsorbed
Pertussistoksoid, adsorberet 
Pertussis toxoid, adsorbed
1 fyldt injektionssprøjte + 2 separate kanyler 
1 pre-filled syringe + 2 separate needles
Rekombinant hepatitis B overfladeantigen (S protein), adsorberet 
Recombinant Hepatitis B surface antigen (S protein), adsorbed Inactivated type 1 Poliovirus Inactivated type 2 Poliovirus Inactivated type 3 Poliovirus
Styrke Lægemiddelform Indgivelsesvej Emballage 
Invented name Strength Pharmaceutical
Tetanustoksoid, adsorberet 
Diphtheria toxoid, adsorbed Tetanus toxoid, adsorbed
1 fyldt injektionssprøjte + 1 separat kanyle 
1 pre-filled syringe (glass) + 1 separate needle
r l g 
Content
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Copalia den 16. januar 2007. 
The European Commission granted a marketing authorisation valid throughout the EU for Copalia on 16 January 2007.
Andre oplysninger om Copalia 
Other information about Copalia
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Copalia. 
This is a summary of the European public assessment report (EPAR) for Copalia.
Den fuldstændige EPAR for Copalia findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Copalia can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Copalia tages oralt som en tablet en gang dagligt med vand. 
Copalia is taken by mouth as one tablet once a day with some water.
Copalia amlodipin/valsartan 
Copalia amlodipine / valsartan
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, hvordan Copalia skal anvendes. 
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 Copalia.
Hvis du ønsker yderligere oplysninger om behandling med Copalia, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Copalia, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
CHMP besluttede, at fordelene ved Copalia opvejer risiciene, og anbefalede udstedelse af en markedsføringstilladelse for Copalia. 
The CHMP decided that Copalia's benefits are greater than its risks and recommended that it be given marketing authorisation.
Hvilken risiko er der forbundet med Copalia? 
What is the risk associated with Copalia?
De hyppigste bivirkninger ved Copalia (sm optræder hos mellem 1 og 10 patienter ud af 100) er hovedpine, betændelse i næse og hals (nasopharyngitis), influenza, lavt kaliumindhold i blodet (hypokaliæmi), forskellige former for hævelser (ødemer), træthed, rødmen, kraftesløshed (asteni) og hedeture. 
The most common side effects with Copalia (seen in between 1 and 10 patients in 100) are headache, nasopharyngitis (inflammation of the nose and throat), influenza (flu), hypokalaemia (low blood potassium levels), various types of oedema (swelling), fatigue (tiredness), flushing (reddening), asthenia (weakness) and hot flushes.
Virksomheden fremlagde desuden dokumentation for, at blodets indhold af amlodipin og valsartan er den samme hos personer, der får Copalia, som hos dem, der får lægemidlerne hver for sig. 
The company also presented evidence that the levels of amlodipine and valsartan in the blood were the same in people taking Copalia and people taking the separate medicines.
Den fuldstændige liste over indberettede bivirkninger ved Copalia fremgår af indlægssedlen. 
For the full list of all side effects reported with Copalia, see the package leaflet.
Copalia må ikke anvendes til patienter med svær lever- eller galdeblæresygdom, patienter med visse hjerteproblemer eller patienter med svær hypotension (lavt blodtryk). 
Copalia must not be used in patients who have severe liver or bile problems, patients with certain heart problems and patients with severe hypotension (low blood pressure).
Copalia må heller ikke anvendes i kombination med lægemidler, der indeholder aliskiren (som også anvendes til behandling af essentiel hypertension), hos patienter med type 2-diabetes eller patienter med moderat eller svær nyresygdom. 
Copalia must also not be used in combination with aliskiren-containing medicines (also used to treat essential hypertension) in patients with type 2 diabetes or in patients with moderate or severe kidney impairment.
Den dosis Copalia, der skal anvendes, afhænger af, hvilken dosis amlodipin eller valsartan patienten fik tidligere. 
The dose of Copalia to be used depends on the doses of amlodipine or valsartan that the patient was taking before.
Hvorfor blev Copalia godkendt? 
Why has Copalia been approved?
Copalia må ikke anvendes til patienter, der er overfølsomme (allergiske) over for amlodipin eller andre lægemidler i gruppen af "dihydropyridinderivater", valsartan eller andre af indholdsstofferne. 
Copalia must not be used in patients who are hypersensitive (allergic) to amlodipine or other medicines in the ‘dihydropyridine derivatives' class, to valsartan, or to any of the other ingredients.
Hvad er Copalia? 
What is Copalia?
Copalia indeholder to aktive stoffer, amlodipin og valsartan. 
Copalia contains two active substances, amlodipine and valsartan.
Copalia anvendes til patienter med essentiel hypertension (forhøjet blodtryk), når blodtrykket ikke kan kontrolleres tilstrækkeligt med amlodipin eller valsartan alene. 
Copalia is used in patients who have essential hypertension (high blood pressure) that is not adequately controlled on either amlodipine or valsartan taken alone.
Copalia er et lægemiddel, der indeholder de to aktive stoffer amlodipin og valsartan. 
Copalia is a medicine that contains two active substances, amlodipine and valsartan.
Hos de patienter, der fik amlodipin alene, faldt blodtrykket med 10,0 mmHg, sammenlignet med 11,8 mmHg hos dem, der desuden fik 160 mg valsartan. 
Patients taking amlodipine alone had a fall of 10.0 mmHg, compared with 11.8 mmHg in the patients adding 160 mg valsartan.
Hvad anvendes Copalia til? 
What is Copalia used for?
Hvordan blev Copalia undersøgt? 
How has Copalia been studied?
Hvilken fordel viser undersøgelserne, at der er ved Copalia? 
What benefit has Copalia shown during the studies?
Hvordan anvendes Copalia? 
How is Copalia used?
Hvordan virker Copalia? 
How does Copalia work?
Bilag I Fortegnelse over lægemidlernes navne, lægemiddelform(er), styrke(r), indgivelsesvej(e), indehaver(e) af markedsføringstilladelse(r) i medlemsstaterne 
Annex I List of the names, pharmaceutical form(s), strength(s) of the medicinal product(s), route(s) of administration, marketing authorisation holder(s) in the member states
Storbritannien Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road 
Napp Pharmaceuticals Ltd. Cambridge Science Park Milton Road
Oxycodonhydrochlorid / Naloxonhydrochlorid 
Oxycodone hydrochloride/ Naloxone hydrochloride
Norpharma A/S Slotsmarken 15, Hørsholm 
Norpharma A/S Slotsmarken 15, Horsholm
13, Othellos Street, Dhali Industrial Zone, Nicosia Cypern 
Mundipharma Pharmaceuticals Ltd. 13, Othellos Street, Dhali Industrial Zone, Nicosia Cyprus
Via G. Serbelloni 4, Milano 
Mundipharma Pharmaceuticals Srl Via G. Serbelloni 4, Milano
Millbank House, Arkle Road Sandyford, Dublin 18 Irland 
Mundipharma Pharmaceuticals Ltd. Millbank House, Arkle Road Sandyford, Dublin 18 Ireland
Luxemborg Mundipharma Comm. VA Blarenberglaan 3C Mechelen 
Luxembourg Mundipharma Comm. VA Blarenberglaan 3C
Norpharma A/S Slotsmarken 15 Hørsholm 2970 Danmark 
Denmark Norpharma A/S Slotsmarken 15, Horsholm
Luxemborg Mundipharma Comm. VA Blarenberglaan 3C, Mechelen 
Luxembourg Mundipharma Comm. VA Blarenberglaan 3C,
Yderligere information om Rizmoic findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/rizmoic 
Further information on Rizmoic can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/rizmoic