natgillin/translations-raw huggingface dataset:
Industrieweg 23 Po Box 217, 3640 Ae Mijdrecht Holland 
Po Box 217, 3640 Ae Mijdrecht The Netherlands
Smb Laboratories 26-28 Rue De La Pastorale B-1080 Bruxelles Belgien 
Smb Laboratories 26-28 Rue De La Pastorale B-1080 Bruxelles Belgium
Samtidig brug af piroxicam med antikoagulantia bør undgås (se pkt. 
Therefore, the use of piroxicam with concomitant anticoagulant such as warfarin should be avoided.
Sopharma Ad Iliensko Shose Str. 16 1220 Sofia Bulgarien 
Sopharma Ad Iliensko Shose Str. 16 1220 Sofia Bulgaria
I produktresuméet og indlægssedlen er der tilføjet en række begrænsninger for brug, skærpede advarsler og kontraindikationer vedrørende den gastrointestinale sikkerhed og hudreaktioner. 
A number of restrictions on use, strengthened warnings and contraindications have been added to the Summary Product Characteristics and Package Leaflet in relation to gastrointestinal and skin safety.
Både korttids-og langtidsbehandling med NSAID kan give en øget risiko for alvorlige gastrointestinale bivirkninger. 
NSAID exposures of both short and long duration have an increased risk of serious GI event.
• Patienter med fortilfælde af gastrointestinale lidelser, der prædisponerer til blødningstilstande såsom colitis ulcerosa, Chrohns sygdom, gastrointestinal cancer eller diverculitis. 
• Patient history of gastrointestinal disorders that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers or diverticulitis.
Largo Boccioni, 1 21040 Origgio (Va) Italien 
Sandoz S.P.A. Largo Boccioni, 1 21040 Origgio (Va) Italy
Comuna Bragadiru Jud. 
Alexandriei 145a Comuna Bragadiru Jud.
4.2 Dosering og indgivelsesmåde 
4.2 Posology and Method of administration
CHMP konkluderede den 21. juni 2007, at epidemiologiske undersøgelser peger på, at systemiske formuleringer af piroxicam er forbundet med en større risiko for alvorlig gastrointestinal toksicitet end andre NSAID og med en højere risiko for alvorlige hudreaktioner end andre NSAID, der ikke tilhører oxicam-gruppen. 
The CHMP concluded on 21 June 2007 that epidemiological studies suggest that systemic formulations of piroxicam are associated with a higher risk of serious gastrointestinal toxicity, relative to other NSAIDs, and a higher risk of serious skin reactions (SCAR) than other non-oxicam NSAIDs.
Via Giacomo Chiesi 43100 Parma Italien 
Via Giacomo Chiesi 43100 Parma Italy
Denne meddelelse skal informere de ordinerende sundhedspersoner om de risici for gastrointestinale reaktioner og hudreaktioner, der er forbundet med piroxicam, i overensstemmelse med den af 
This communication should inform healthcare professionals of the risks of gastrointestinal and skin reactions associated with piroxicam and should be in line with the DHPC endorsed by the CHMP.
De skal især være opmærksom: - hvis De tager acetylsalicylsyre eller andre NSAID-præparater til lindring af smerter - hvis De tager binyrebarkhormoner, der er medicin til behandling af forskellige tilstande, såsom allergi og ubalance i hormonerne - hvis De tager blodfortyndende medicin for at hindre blodet i at størkne, såsom warfarin - hvis De tager visse typer medicin mod depression, de såkaldte selektive serotoningenoptagshæmmere 
It's especially important to mention: - if you are taking aspirin or other non-steroidal anti-inflammatory drugs for pain relief - if you are taking corticosteroids, which are drugs given to treat a variety of conditions such as allergies and hormone imbalances - if you are taking anticoagulants such as warfarin to prevent blood clots - if you are taking certain drugs for depression called selective serotonin re-uptake inhibitors (SSRI) - if you are taking any drugs, such as acetylsalicylic acid to prevent platelet clumping
Kortikosteroider: Øget risiko for gastrointestinalt ulcus eller blødning (se pkt. 
Corticosteroids: increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
17, Boulevards De La Plaine B-1050 Bruxelles Belgien 
17, Boulevards De La Plaine B-1050 Bruxelles Belgium
1010 Vienna Østrig 
1010 Vienna
Gastrointestinale virkninger, risiko for gastrointestinal ulceration, blødning og perforation. 
“Gastrointestinal (GI) Effects, Risk of GI Ulceration, Bleeding, and Perforation.
500 mg/50 g Creme 
500 mg/50 g Cream
Innotech International 7-9, Avenue François-Vincent Raspail Bp 32, 94111 Arcueil Cedex Frankrig 
Innotech International 7-9, Avenue François-Vincent Raspail Bp 32, 94111 Arcueil Cedex France
Bruxicam 0,5% 0.50% Øjendråber, opløsning 
Bruxicam 0,5% 0.50% Eye Drops, Solution Ocular
Ratiopharm Gmbh Graf-Arco Strasse 3 D-89070 Ulm Tyskland 
Ratiopharm Gmbh Graf-Arco Strasse 3 D-89070 Ulm Germany
Boulevard De La Plaine 17 B-1050 Brussels Belgien 
Boulevard De La Plaine 17 B-1050 Brussels Belgium
10mg/gm Creme 
10mg/gm Cream
58-500 Jelenia Gora Polen 
58-500 Jelenia Gora Poland
Trombocythæmmende midler og selektive serotoningenoptagshæmmere (SSRI): Øget risiko for gastrointestinal blødning (se pkt. 
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (see section 4.4).”
Trinity Chiesi Pharmaceuticals Ltd Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy Storbritannien 
Trinity Chiesi Pharmaceuticals Ltd Cheadle Royal Business Park Highfield, Cheadle Sk8 3gy United Kingdom
20 mg/3 mg Granulater til oral opløsning 
20 mg/3 mg Granules for oral solution
CT-Arzneimittel Gmbh Lengeder Str. 42a D-13407 Berlin Tyskland 
CT-Arzneimittel Gmbh Lengeder Str. 42a D-13407 Berlin Germany
Pfizer Aps Lautrupvang 8 Dk-2750 Ballerup Danmark 
Pfizer Aps Lautrupvang 8 Dk-2750 Ballerup Denmark
Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Danmark 
Pfizer Aps Lautrupvang 8 Dk 2750 Ballerup Denmark
11347, Post Box 23033 SE-10435 Stockholm Sverige 
11347, Post Box 23033 SE-10435 Stockholm Sweden
Maximo Aguirre, 14 48940 Lamiaco-Lejona Spanien 
Maximo Aguirre, 14 48940 Lamiaco-Lejona Spain
Deres læge vil kun udskrive piroxicam til Dem, hvis lindring af symptomerne ikke er tilfredsstillende efter brug af andre NSAID-præparater. 
Your doctor will prescribe piroxicam to you only when you have had unsatisfactory relief of symptoms with other non-steroidal anti-inflammatory medicines (NSAIDs).”
0.5g/50g - 50g Creme 
0.5g/50g - 50g Cream
Alpharma P.O. Box 158 Skøyen N-0212 Oslo Norge 
Box 158 Skøyen N-0212 Oslo Norway
Keresztúri U. 30-38 1106 Budapest Ungarn 
Keresztúri U. 30-38 1106 Budapest Hungary
De skal ikke tage dobbeltdosis som erstatning for den glemte tablet. 
Do not double the dose.
Laboratorios faes Farma Sa maximo Aguirre, 14 48940 Lamiaco-Lejona Spanien 
Laboratorios Faes Farma Sa Maximo Aguirre, 14 48940 Lamiaco-Lejona Spain
− piroxicam bør kun ordineres af læger med erfaring i diagnostisk vurdering og behandling af osteoartritis, reumatoid artritis og ankyloserende spondylitis, 
− prescription of piroxicam should only be initiated by those physicians with experience in diagnostic evaluation and treatment of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis;
D- 85737 Ismaning Tyskland 
D- 85737 Ismaning Germany
• hvis De har eller har haft fortilfælde af mave-tarm-lidelser (betændelse i maven eller tarmene), som kan føre til blødningstilstande, såsom blødende tyktarmbetændelse (colitis ulcerosa), kronisk betændelse i mave og tarm (Crohns sygdom), mave-tarmkræft eller diverticulitis (betændelse eller inficeret udposning i tyktarmen) 
• If you have or have had a history of gastrointestinal disorders (inflammation of the stomach or intestines) that predispose to bleeding disorders such as ulcerative colitis, Crohn's disease, gastrointestinal cancers, diverticulitis (inflamed or infected pouches/pockets in the colon).
Ratiopharm Gmbh Graf-Arco-Str. 3 D-89079 Ulm Tyskland 
Ratiopharm Gmbh Graf-Arco-Str. 3 D-89079 Ulm Germany
D-85737 Ismaning Tyskland 
D-85737 Ismaning Germany
− Udvalget konkluderede på baggrund af de foreliggende oplysninger, at der er større risiko for gastrointestinale og alvorlige hudreaktioner i forbindelse med piroxicam end med de øvrige NSAID i gruppen. 
− In view of the available data, the Committee concluded that there is an increased risk of gastrointestinal and serious skin reactions associated with systemic formulations of piroxicam when compared to other NSAIDs as a group.
PIROXICAMS [Særnavn] VIRKNING, OG HVAD DE SKAL BRUGE DET TIL Lægen vil vurdere fordelene ved denne medicin over for risikoen for at udvikle bivirkninger, før lægen ordinerer piroxicam. 
“Before prescribing piroxicam, your doctor will assess the benefits this medicine may give you against your risk of developing side effects.
• Fortilfælde af gastrointestinal ulceration, blødning eller perforation. 
• “History of gastro-intestinal ulceration, bleeding or perforation.
Gerakas 15344 Grækenland 
Gerakas 15344 Greece
Bivirkningerne kan minimeres ved at bekæmpe symptomerne i så kort tid og med så lav dosis som muligt. 
Undesirable effects may be minimised by using the minimum effective dose for the shortest duration necessary to control symptoms.
10 mg/1 g Creme 
10 mg/1 g Cream
• hvis De tager blodfortyndende medicin såsom warfarin 
• If you are taking anticoagulants, such as warfarin, to prevent blood clots.
− fordelene ved piroxicam opvejer risiciene til symptomlindring ved osteoartritis, reumatoid artritis og ankyloserende spondylitis, 
− the benefits of piroxicam outweigh the risks in the symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis;
Fortæl det altid til lægen, før De bruger denne medicin, hvis De har nogen medicinske problemer, eller nogen former for allergi, eller er i tvivl om, De kan bruge piroxicam. 
If you have or had any medical problems or any allergies or if you are not sure as to whether you can use piroxicam tell your doctor before using this medicine.
3ddd Pharma N.N. Diestersteenweg 349 B-3510 Hasselt Belgien 
Diestersteenweg 349 B-3510 Hasselt Belgium
D-25870 Norderfriedrichskoog Tyskland 
D-25870 Norderfriedrichskoog Germany
Epidemiologiske studier tyder på, at brugen af piroxicam kan være forbundet med stor risiko for alvorlig gastrointestinal toksicitet i forhold til andre NSAID-præparater. 
Evidence from observational studies suggests that piroxicam may be associated with a high risk of serious gastrointestinal toxicity, relative to other NSAIDs.
Dorking Road Walton-0n-The-Hill Surrey KT20 7NS Storbritannien 
Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Chiesi Farmaceutici Spa, Via Palermo, 26/A 43100 Parma Italien 
Chiesi Farmaceutici Spa, Via Palermo, 26/A 43100 Parma Italy
Av. Berlin, 38-48 7ª Planta 08029 Barcelona Spanien 
Chiesi España, S.A. Av. Berlin, 38-48 7ª Planta 08029 Barcelona Spain
Tad Pharma Gmbh Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Tyskland 
Tad Pharma Gmbh Heinz-Lohmann-Str. 5 D-27472 Cuxhaven Germany
Alvorlige hudreaktioner, som kan være fatale, er rapporteret meget sjældent i forbindelse med brugen af NSAID-præparater, omfatter bl.a. exfoliativ dermatitis, Stevens-Johnsons syndrom og toksisk epidermal nekrolyse (se pkt. 
Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8).
Manx Healthcare Taylor Group House Wedgnock Lane Warwick CV34 5YA Storbritannien 
United Kingdom Manx Healthcare Taylor Group House Wedgnock Lane
Ambachtenlaan B-3001 Heverlee Belgien 
Docpharma N.V. Ambachtenlaan B-3001 Heverlee Belgium
Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS Storbritannien 
Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS United Kingdom
Felcam20 mg/kap Kapsler, hårde 
Felcam20 mg/cap Hard capsules
Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS 
United Kingdom Pfizer Limited Walton Oaks, Dorking Road Walton-0n-The-Hill Surrey KT20 7NS
Suppositorer 
Suppository
Zerospam20 mg/cap Kapsler, hårde 
Zerospam20 mg/cap Hard capsules
Aliud Pharma Gmbh & Co.Kg Gottlieb-Daimler-Str. 19 D-89150 Laichingen Tyskland 
Aliud Pharma Gmbh & Co.Kg Gottlieb-Daimler-Str. 19 D-89150 Laichingen Germany
Aliud Pharma Gmbh &Co. Kg. Gottlieb-Daimler Str. 19 89150 Laichingen Tyskland 
Aliud Pharma Gmbh &Co. Kg. Gottlieb-Daimler Str. 19 89150 Laichingen Germany
Clonmel Healthcare Limited Waterford Road Clonmel, Co. Tipperary, Irland 
United Kingdom Clonmel Healthcare Limited Waterford Road
Gentsesteenweg 615 B-1080 Brussels Belgien 
Nycomed Belgium N.V. Gentsesteenweg 615 B-1080 Brussels Belgium
Er De i tvivl så spørg lægen eller på apoteket. 
You should check with your doctor or pharmacist if you are not sure.
Behovet for kombinationsbehandling med slimhindebeskyttende midler (f.eks. misoprostol eller protonpumpehæmmere) bør omhyggeligt overvejes (se pkt. 
The possible need for combination therapy with gastro-protective agents (e.g. misoprostol or proton pump inhibitors) should be carefully considered.
1x50 g/0,5 g Creme 
1x50 g/0,5 g Dermálny krém topical use
• hvis De tidligere har haft mavesår, sår på tarmen, mave-tarmblødning eller perforation 
• “If you previously had a stomach or intestinal ulcer, bleeding or perforation.
Granulater 
Granules
Epidemiologiske studier tyder på, at brugen af piroxicam kan være forbundet med en større risiko for alvorlige hudreaktioner i forhold til nogle andre NSAIDpræparater. 
Evidence from observational studies suggests that piroxicam may be associated with a higher risk of serious skin reactions than other non-oxicam NSAIDs.
Ud fra følgende betragtninger: 
The following indications must be deleted from this section:
For visse ikke-selektive NSAID, herunder piroxicam, blev der imidlertid fundet at være behov for en nærmere vurdering af risk/benefit-forholdet. 
However a need to further evaluate the benefit/risk balance of some non-selective NSAIDs including piroxicam was identified.
10 mg/cap Kapsler, hårde 
10 mg/cap Hard capsules
Hvis De får mavesmerter eller nogen tegn på blødning i maven eller tarmene, såsom blodig eller sort afføring eller blodigt opkast, skal De straks stoppe med at tage piroxicam. 
You should immediately stop taking piroxicam and tell your doctor if you have stomach pain, or any sign of bleeding in the stomach or intestines, such as passing black or bloodstained bowel movements, or vomiting blood.
Laboratories Fournier S.A. 42, Rue De Longvic 21300 Chenove Frankrig 
Laboratories Fournier S.A. 28, Boulevard Clemenceau 21000 Dijon
• hvis De har mavesår, sår på tarmene, mave-tarmblødning eller perforation 
• If you currently have stomach or intestinal ulcer, bleeding or perforation.
Actavis Uk Limited Whiddon Vally Barnstaple Devon Ex32 8ns Storbritannien 
United Kingdom Actavis Uk Limited Whiddon Vally
Behandling med piroxicam bør straks seponeres ved symptomer som udslæt, slimhindelæsioner eller andre tegn på overfølsomhedsreaktion. 
Piroxicam should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.”
Granulater til oral opløsning 
Granules for oral solution
St. Neots, Cambs PE19 3ET Storbritannien 
3 Howard Road, Eaton Socon St. Neots, Cambs PE19 3ET United Kingdom
Hotemin Injection 20 mg/ml -1ml Injektionsvæske, opløsning 
Hotemin Injection 20 mg/ml -1ml Solution for injection Intramuscular use
Intramuskulær anvendelse 
Solution for injection Intramuscular use
Ambachtenlaan 13e B-3001 Leuven Belgien 
Aktuapharma N.V. Ambachtenlaan 13e B-3001 Leuven Belgium
20 mg/cap Kapsler, hårde 
20 mg/cap Hard capsules
Bemærk: Dette afsnit af SPCet, er det afsnit, der var bilag til Europa-Kommissionens beslutning vedrørende denne artikel 31 arbitreringssag. 
ANNEX III AMENDMENTS TO THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET Note: These sections of the Summary of Product Characteristics are the ones that were annexed to the Commission Decision on this Article 31 referral.
Egis Pharmaceuticals Plc Kereszturi Ut 30-38 H-1106 Budapest Ungarn 
Egis Pharmaceuticals Plc Kereszturi Ut 30-38 H-1106 Budapest Hungary
Teva Pharma Bv 
Teva Pharma Bv Industrieweg 23
Via Palermo 26 A 43100, Parma Italien 
Via Palermo 26 A 43100, Parma Italy
Dermal anvendelse 
Dermal use
Dentalbehandling og i infektionsforløb Lindring af feber og smerter i forbindelse med akut øvre luftvejsinfektion Akutte muskuloskeletale lidelser (f.eks. bursitis, tendonitis) Akutte post-traumatiske lidelser 
Dental treatment and in the course of infections Relief of fever and pain associated with acute upper respiratory tract inflammation.
Følgende indikationer skal slettes fra dette afsnit: akut gigt primær dysmenoré postoperative smerter efter dentalbehandling og i infektionsforløb lindring af feber og smerter i forbindelse med akut øvre luftvejsinfektion akutte muskuloskeletale lidelserakutte posttraumatiske lidelser radiculalgia 
Following dental treatment and in the course of infections Relief of fever and pain associated with acute upper respiratory tract inflammation.
Teva Generics Belgium N.V. 
Teva Generics Belgium N.V. Laarstraat 16
Norma Hellas Ae Menandrou 54 
Norma Hellas Ae Menandrou 54 Athens 10431 Greece
Egis Pharmaceuticals Ltd. Keresztúri Út 30-38 1106 Budapest Ungarn 
Egis Pharmaceuticals Ltd. Keresztúri Út 30-38 1106 Budapest Hungary
Lyofilisat 
Lyophilisat
Ved den første forekomst af kutanreaktion eller relevant gastrointestinal hændelse skal behandlingen straks seponeres. 
The clinical benefit and tolerability should be re-evaluated periodically and treatment should be immediately discontinued at the first appearance of cutaneous reactions or relevant gastrointestinal events.”
Dispergible tabletter Oral 
Dispersible Tablet
Okulær anvendelse 
Topical use
CHMP udarbejdede desuden anbefalinger for ændringer, såkaldte "nøgleelementer", der skulle indgå i produktoplysningerne for piroxicam og visse andre ikke-selektive NSAID. 
The CHMP also made recommendations for changes, or so called “key elements”, to be included in the product information of piroxicam, as well as for some other non-selective NSAIDs which were published on the EMEA website in September 2006 (Doc ref: EMEA/CHMP/381615/2006).
4.3 og 4.4)”. 
(see section 4.3).
Resoribletter, sublinguale 
Sublingual Tablet
Via Palermo, 26/A 43100 Parma Italien 
Via Palermo, 26/A 43100 Parma Italy
Egis Pharmaceuticals Ltd. Kereszturi Ut 30-38 H-1106, Budapest Ungarn 
Egis Pharmaceuticals Ltd. Kereszturi Ut 30-38 H-1106, Budapest Hungary
1133 Budapest Ungarn 
H-1106, Budapest Hungary
Waymade Plc Sovereign House Miles Gray Road Basildon, Essex SS14 3FR Storbritannien 
Basildon, Essex SS14 3FR United Kingdom
Indikationer, der vedrører osteoarthritis, reumatoid arthritis og ankyloserende spondylitis, skal angives på følgende måde: 
Indications regarding osteoarthritis, rheumatoid arthritis and ankylosing spondylitis should read as follows: “Piroxicam is indicated for symptomatic relief of osteoarthritis, rheumatoid arthritis or ankylosing spondylitis.
Eurogenerics S.A. Esplanade Heysel B 22 B-1020 Bruxelles Belgien 
Eurogenerics N.V. Heizel Esplanade 22 B-1020 Brussels Belgium
Egis Pharmaceuticals Ltd. Keresztúri Út 30-38 H-1106 Budapest Ungarn 
Egis Pharmaceuticals Ltd. Keresztúri Út 30-38 H-1106 Budapest Hungary
Hvis et NSAID-præparat er indiceret, er piroxicam ikke førstevalgspræparat pga. dets sikkerhedsprofil (se pkt. 
Due to its safety profile (see sections 4.2, 4.3 and 4.4), piroxicam is not a first line option should an NSAID be indicated.
20 mg/ml, 1ml Injektionsvæske, opløsning 
20 mg/ml, 1ml Solution for injection Intramuscular use
Spørg lægen, hvis der noget De vil vide mere om. 
If you have any further questions on the use of this product, ask your doctor.”
Overtrukne tabletter Oral anvendelse 
Gastro resistant tablet Oral
Udvortes 
Ointment
55216, Ingelheim Am Rhein Tyskland 
55216, Ingelheim Am Rhein Germany
D-55216 Ingelheim am Rhein Tyskland 
D-55216 Ingelheim Am Rhein Germany
D-55216 Ingelheim Am Rhein Tyskland 
D-55216 Ingelheim am Rhein Germany
Hvis De får en allergisk reaktion, såsom hududslæt, hævelse i ansigtet, hvæsende vejrtrækning eller vejrtrækningsbesvær, skal De stoppe med at tage piroxicam. 
You should immediately stop taking piroxicam and tell your doctor if you have any allergic reaction such as a skin rash, swelling of the face, wheezing or difficulty breathing.
VÆR EKSTRA FORSIGTIG MED AT TAGE PIROXICAM 
HOW TO TAKE PIROXICAM
55216 Ingelheim Am Rhein Tyskland 
55216 Ingelheim Am Rhein Germany
Dispergible tabletter Oral anvendelse 
Tablet for oral solution Oral use
Pulver til oral anvendelse 
Oral powder in sachet Oral use
Injektionsvæske, opløsning 
Injekčný roztok parenteral use
20MG/ML Injektionsvæske, opløsning 
20MG/ML Solution for injection Intramuscular use
Fortæl det altid til lægen, hvis De tager anden medicin. 
Make sure you have told your doctor about any other medicines that you are taking, including those that you have bought without a prescription.”
Docpharma N.V. 
3ddd Pharma N.N.
Styrke Lægemiddelform Indgivelsesvej Emballage Pakningsstørrelse 
Strength Pharmaceutical Form Route of Administration Immediate Packaging
EU-nummer 
MA (EU) Number Name
Den gennemsnitlige forbedring var på omkring 1,4 point. 
The average improvement was about 1.4 points.
Patienterne oplevede i gennemsnit 0,08 alvorlige infektioner årligt. 
The patients had an average of 0.08 serious infections per year.
Privigen blev givet på to på hinanden følgende dage. 
Privigen was given on two consecutive days.
Andre oplysninger om Privigen 
Other information about Privigen
Privigen fik en markedsføringstilladelse med gyldighed i hele EU den 25. april 2008. 
Privigen received a marketing authorisation valid throughout the EU on 25 April 2008.
Yderligere information om Privigen findes på agenturets websted under: ema.europa.eu/medicines/human/EPAR/Privigen. 
Further information can be found on the Agency's website: ema.europa.eu/medicines/human/EPAR/Privigen.
Dosis og hyppighed af infusionerne (dvs. hvor ofte de gives) afhænger af den sygdom, der behandles. 
The dose and frequency of infusions (how often it is given) depend on the disease being treated.
Privigen blev ikke sammenlignet med andre behandlinger i studierne. 
Privigen was not compared to other treatments in the studies.
Som for alle lægemidler bliver data vedrørende brug af Privigen løbende overvåget. 
As for all medicines, data on the use of Privigen are continuously monitored.
En oversigt over Privigen, og hvorfor det er godkendt i EU 
An overview of Privigen and why it is authorised in the EU
Da dette er under den på forhånd fastlagte tærskelværdi på én alvorlig infektion årligt, tyder det på, at lægemidlet er effektivt som erstatningsbehandling. 
Since this is below the predefined threshold of one serious infection per year, this indicates that the medicine is effective as replacement therapy.
For mere information om brug af Privigen, se indlægssedlen, eller kontakt lægen eller apotekspersonalet. 
For more information about using Privigen, see the package leaflet or contact your doctor or pharmacist.
Privigen er et lægemiddel, der anvendes til at understøtte immunsystemet (kroppens naturlige forsvar) hos to hovedpatientgrupper: 
Privigen is a medicine used to support the immune system (the body's natural defences) in two main groups of patients:
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Privigen? 
What measures are being taken to ensure the safe and effective use of Privigen?
Det Europæiske Lægemiddelagentur konkluderede, at fordelene ved Privigen opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse for Privigen. 
The European Medicines Agency concluded that Privigen's benefits are greater than its risks and recommended that it be given marketing authorisation.
Det er tidligere blevet indberettet, at svær hæmolyse er lidt mere hyppig med Privigen end med enkelte andre produkter, der indeholder det samme aktive stof. 
Severe haemolysis has previously been reported to be slightly more frequent with Privigen than with some other products containing the same active substance.