FrancophonIA/ELRC3.0 huggingface dataset:
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis De vil have yderligere oplysninger om Siklos, skal De henvende Dem til den lokale repræsentant :
English: As evaluated in a further study, in patients with a CrCl<60 ml/min the area under the curve was approximately 51% higher than in patients with a CrCl ≥60 ml/min, which suggests that a dose reduction of hydroxycarbamide by 50% may be appropriate in patients with a CrCl < 60 ml/min.
Danish: Dette blev evalueret i yderligere en undersøgelse og indikerer, at en reduktion af dosis af hydroxycarbamid på 50 % kan være hensigtsmæssig for patienter med en CrCl på < 60 ml/min.
English: Patients should be advised not to drive or operate machines, if dizziness is experienced while taking Siklos.
Danish: Siklos påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.Patienterne skal frarådes at føre motorkøretøj og betjene maskiner, hvis de oplever svimmelhed, mens de er i behandling med Siklos.
English: Impaired fertility has been observed in male rats (see section 5.3).
Danish: Nedsat fertilitet er set hos hanrotter (se pkt.
English: If you have any question, please ask your doctor or pharmacist or nurse.
Danish: Er De i tvivl, så spørg lægen eller apotekspersonalet.
English: Amenorrhea General disorders and administration site conditions: Not known:
Danish: Almene symptomer og reaktioner på administrationsstedet: Ikke kendt:
English: For severe painful crises, most patients require hospitalisation.Siklos will decrease the number of painful crises as well as the need for hospitalisation linked with the disease.
Danish: Siklos nedsætter antallet af smertefulde kriser og behovet for indlæggelse i forbindelse med sygdommen.
English: < 80,000/mm3
Danish: Thrombocytter < 80.000/mm3
English: Pharmacotherapeutic group: Antineoplastic agents, other antineoplastic agents, ATC code: L01XX05.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske midler, andre antineoplastiske midler.
English: Nervous system disorders: Common:
Danish: Lidelser i det reproduktive system og brystsygdomme: Meget almindelig :
English: Leukaemia and in elderly patients, skin cancers Blood and lymphatic system disorders: Very common: Bone marrow depression1 including neutropenia (< 2.0 x 109/L), reticulocytopenia (< 80 x 109/L), macrocytosis2
Danish: Knoglemarvshæmning1 herunder neutropeni (< 2,0 x 109/L), retikulocytopeni (< 80 x 109/L), makrocytose2
English: In paediatric and adult patients with Sickle Cell Syndrome the systemic exposure to hydroxycarbamide at steady state was similar by means of the area under the curve.
Danish: Den systemiske eksponering for hydroxycarbamid ved steady state var ens for pædiatriske og voksne patienter med seglcellesygdom målt efter AUC (Area Under the Curve).
English: Addmedica, 37 rue de Caumartin, 75009 Paris, France
Danish: Addmedica, 37 rue de Caumartin - 75009 Paris, Frankrig
English: Due to safety considerations, Siklos is contraindicated in patients with severe hepatic impairment (see sections 4.3 and 4.4).
Danish: Siklos er af sikkerhedsmæssige årsager kontraindiceret til patienter med svær leverinsufficiens (se pkt.
English: Do not throw away any medicines via wastewater or household waste.
Danish: Af hensy til miljøet må De ikke smide medicinrester i afløbet, toilettet eller skraldespanden.
English: Information sharing is especially required for - antiretroviral medicines (those that inhibit or destroy a retrovirus such as HIV), e.g. didanosine,
Danish: Udveksling af oplysninger er specielt nødvendig for - antiretroviral medicin (midler, som hæmmer eller ødelægger en retrovirus såsom HIV), fx didanosin, stavudin og indinavir (der kan opstå et fald i de hvide blodlegemer), - medicin, der hæmmer knoglemarvens blodcelle-dannende effekt (nedsætter produktionen af røde,
English: Each tablet contains 100 mg of hydroxycarbamide.
Danish: Hver tablet indeholder 100 mg hydroxycarbamid.
English: Each tablet contains 1,000 mg of hydroxycarbamide.
Danish: Hver tablet indeholder 1.000 mg hydroxycarbamid.
English: Addmedica 37 rue de Caumartin 75009 Paris France
Danish: Addmedica 37 rue de Caumartin 75009 Paris Frankrig
English: The starting dose of hydroxycarbamide is 15 mg/kg b.w.
Danish: Initialdosis af hydroxycarbamid er 15 mg/kg legemsvægt, og den normale dosis er mellem 15 mg og 30 mg/kg legemsvægt/dag.
English: Siklos 100 mg film-coated tablets.
Danish: Siklos 100 mg filmovertrukne tabletter.
English: Siklos 1000 mg film-coated tablets hydroxycarbamide
Danish: Siklos 1000 mg filmovertrukne tabletter hydroxycarbamid
English: How to take Siklos
Danish: Sådan skal De tage Siklos
English: Parvovirus B19 infection Neoplasms, benign, malignant and unspecified Not known:
Danish: Benigne, maligne og uspecificerede tumorer (inkl.
English: Possible side effects
Danish: Resumé af bivirkninger
English: Common side effects (may affect up to 1 in 10 people):
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 brugere):
English: Siklos 1000 mg film-coated tablets.
Danish: Siklos 1000 mg filmovertrukne tabletter.
English: Off-white oblong-shaped, film-coated tablet with half-scoring on both sides.
Danish: Råhvid, aflang filmovertrukken tablet med en halv delekærv på begge sider.
English: Siklos 100 mg film-coated tablets
Danish: Siklos 100 mg filmovertrukne tabletter
English: Siklos 100 mg film-coated tablets hydroxycarbamide
Danish: Siklos 100 mg filmovertrukne tabletter hydroxycarbamid
English: Treatment with Siklos should be discontinued if bone marrow function is markedly depressed.
Danish: Behandlingen med Siklos skal seponeres, hvis der foreligger markant myelosuppression (knoglemarvshæmning).
English: Siklos 1000 mg film-coated tablets
Danish: Siklos 1000 mg filmovertrukne tabletter
English: Uncommon side effects (may affect up to 1 in 100 people):
Danish: Ikke almindelige bivirkninger (kan påvirke op til 1 ud af 100 brugere):
English: Check with your doctor or pharmacist if you are not sure.
Danish: De må ikke standse Deres behandling, medmindre Deres læge har rådet Dem til det. Spørg lægen eller apoteket, hvis der er noget, De er i tvivl om eller føler Dem usikker på.
English: Siklos 100 mg film-coated tablets Each film-coated tablet contains 100 mg of hydroxycarbamide.
Danish: Siklos 100 mg filmovertrukne tabletter Hver filmovertrukne tablet indeholder 100 mg hydroxycarbamid.
English: In patients with leg ulcers, Siklos should be used with caution.
Danish: Siklos skal anvendes med forsigtighed til patienter med bensår.
English: Siklos 1000 mg film-coated tablets Each film-coated tablet contains 1,000 mg of hydroxycarbamide.
Danish: Siklos 1000 mg filmovertrukne tabletter Hver filmovertrukne tablet indeholder 1000 mg hydroxycarbamid.
English: Each Siklos 1000 mg film-coated tablet contains 1,000 mg hydroxycarbamide.
Danish: Hver filmovertrukne Siklos 1000 mg tablet indeholder 1.000 mg hydroxycarbamid.
English: Dizziness
Danish: Amenorré
English: Each Siklos 100 mg film-coated tablet contains 100 mg hydroxycarbamide.
Danish: Hver filmovertrukne Siklos 100 mg tablet indeholder 100 mg hydroxycarbamid.
English: What Siklos looks like and contents of the pack
Danish: Udseende og pakningsstørrelser
English: In patients receiving long-term hydroxycarbamide for myeloproliferative disorders, secondary leukaemia has been reported.
Danish: Sekundær leukæmi er blevet indberettet for patienter, der fik langtidsbehandling med hydroxycarbamid for myeloproliferative sygdomme.
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING BOTTLE
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE TABLETBEHOLDER
English: If you take more Siklos than you should
Danish: Hvis De har taget for meget Siklos
English: Close monitoring of blood parameters is advised in patients with hepatic impairment.
Danish: 4.3).Hos patienter med nedsat leverfunktion tilrådes nøje overvågning af blodparametrene.
English: 5 How to store Siklos Contents of the pack and other information
Danish: Pakningsstørrelser og yderligere oplysninger
English: - If you get any side effects, talk to your doctor, or pharmacist or nurse.
Danish: - Tal med lægen, apotekspersonalet eller sundhedspersonalet, hvis en bivirkning bliver værre, eller
English: Hepatobiliary disorders: Rare:
Danish: Lever og galdeveje: Sjælden:
English: In-use
Danish: I brug
English: What Siklos is and what it is used for What you need to know before you take Siklos How to take Siklos
Danish: Det skal De vide, før De begynder at tage Siklos Sådan skal De tage Siklos Bivirkninger
English: Cutaneous dryness Reproductive system and breast disorders: Very common: Oligospermia , azoospermia4 Not known:
Danish: Oligozoospermia ,azoospermia4
English: - If you have any further questions, ask your doctor, or pharmacist or nurse.
Danish: Giv Deres læge besked, hvis ét eller flere af ovenstående punkter gør sig gældende (eller har gjort sig gældende) for Dem. Spørg lægen, apoteket eller sundhedspersonalet, hvis der er mere, De vil vide.
English: MOM Park "F" Ép.
Danish: MOM Park "F" Ép., Hungary
English: List of the names, pharmaceutical form, strengths of the medicinal products, route of administration, marketing authorisation holders in the Member States
Danish: Liste over lægemidlets navne, lægemiddelformer, styrker, indgivelsesvej samt indehavere af markedsføringstilladelse i medlemsstaterne
English: Via Isonzo, 71 04100 Latina Italy
Danish: Via Isonzo, 71 04100 LatinaItaly
English: 115 28 Ilisia, Athens Greece
Danish: 115 28 Ilisia Athens,
English: Pfizer Luxembourg SARL 51, Avenue J. F. Kennedy L-1855 Luxembourg Luxembourg
Danish: Pfizer Luxembourg SARL, 51, Avenue J. F. Kennedy, L-1855 Luxembourg
English: 02-697 Warszawa Poland
Danish: Rzymowskiego 28 02-697 Warszawa Poland
English: Pharma Gyógyszerkereskedelmi Kft.
Danish: Pharma Gyógyszerkereskedel mi Kft.
English: Pfizer Ireland Pharmaceuticals, Pottery Road, Dun Laoghaire, Co Dublin
Danish: Pfizer Ireland Pharmaceuticals, Pottery Road, Dun Laoghaire, Co Dublin Ireland
English: Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain
Danish: 28108 Alcobendas, (Madrid)
English: s r.o Stroupežnického 17 150 00 Prague 5
Danish: s r.o., Stroupežnického 17, 150 00 Prague 5, Czech Republic
English: Pfizer ApS Lautrupvang 8 2750 Ballerup Denmark
Danish: Pfizer ApS, Lautrupvang 8, 2750 Ballerup,
English: Via Livornese 897 - La Vettola 56122 Pisa
Danish: Via Livornese, 897La Vettola 56010 PisaItaly
English: Pfizer Polska Sp.z o.o.ul.
Danish: Pfizer Polska Sp.z o.o.
English: Bioindustria Farmaceutici S.r.l Via Isonzo, 71
Danish: Bioindustria Farmaceutici S.r.l Via Isonzo, 71 04100 LatinaItaly
English: de Europa 20B Parque Empresarial la Moraleja 28108 Alcobendas, (Madrid) Spain
Danish: de Europa 20B Parque Empresarial la Moraleja
English: Vasút u. 11.
Danish: 2040 Budaörs Vasút u. 11.
English: 243, Messoghion Ave., 154 51 Νeo Psychiko, Athens, Greece
Danish: 154 51 Νeo Psychiko, Athens,
English: Floridsdorfer Hauptstrasse 1 A - 1210 Wien
Danish: Floridsdorfer Hauptstraße 1
English: Pfizer Holding France 23-25 Avenue du Docteur Lannelongue
Danish: Pfizer Holding France 23-25 Avenue du Docteur Lannelongue 75668 Paris Cedex 14 France
English: Pfizer Pharma GmbH Linkstraße 10
Danish: Pfizer Pharma GmbH, Linkstraße 10 10785 Berlin,
English: Pfizer Europe MA EEIG, Ramsgate Road,
Danish: Pfizer Europe MA EEIG,
English: WIN MEDICA Ltd 41 Papadiamantopoulou Street
Danish: Papadiamantopoulou Street
English: Boulevard de la Plaine 17 B-1050 Brussels Belgium
Danish: B-1050 Brussels, Belgium
English: Lagoas Park, Edifício 10 2740-271 Porto Salvo Portugal
Danish: Laboratorios Pfizer, Lda., Lagoas Park, Edifício 10, 2740-271 Porto Salvo, Portugal
English: Liprimar 10 mg 10mg
Danish: Liprimar 10 mg
English: Kent, CT13 9NJ, United Kingdom
Danish: Ramsgate Road, Sandwich, Kent, CT13 9NJ, United Kingdom
English: Liprimar 40 mg 40mg
Danish: Liprimar 40 mg
English: Liprimar 20 mg 20mg
Danish: Liprimar 20 mg
English: Liprimar 80 mg 80mg
Danish: Liprimar 80 mg
English: Atorvastatin Pfizer 10 mg
Danish: Atorvastatin 10 mg PD 10mg
English: Atorvastatin Pfizer 40 mg
Danish: Atorvastatin 40 mg PD 40mg
English: 1123 Budapest,
Danish: Pfizer KFT, 1123 Budapest, Alkotás u. 53.
English: Atorvastatin Pfizer 20 mg
Danish: Atorvastatin 20 mg PD 20mg
English: 00330 Helsinki Finland
Danish: Pfizer Oy, Tietokuja 4, 00330 Helsinki, Finland
English: Atorvastatin Pfizer 80 mg
Danish: Atorvastatin 80 mg PD 80mg
English: Sortis 20 mg filmsko obložene tablete 20mg
Danish: Sortis 20 mg filmsko obložene tablete
English: Sortis 40 mg filmsko obložene tablete 40mg
Danish: Sortis 40 mg filmsko obložene tablete
English: Pfizer KFT,
Danish: Pfizer, spol.
English: Parke-Davis - Produtos Farmaceuticos Lda.
Danish: Bioindustria Farmaceutici S.r.l.
English: Pfizer Hellas A. E.
Danish: Pfizer Hellas A. E. 243, Messoghion Ave.,
English: Farmogene - Produtos Farmacêuticos, Lda
Danish: WIN MEDICA Ltd
English: MA (EU) Number Name
Danish: MF (EU)-nummer Navn
English: EU/1/12/775/001 NovoThirteen 2500 IU Powder and solvent for solution for injection
Danish: EU/1/12/775/001 NovoThirteen 2500 IE pulver og solvens til injektionsvæske, opløsning
English: powder: 2500 IU; solvent: 3.2 ml
Danish: pulver: 2500 IE; solvens: 3,2 ml
English: 1 powder vial + 1 solvent vial + 1 vial adapter
Danish: 1 hætteglas med pulver + 1 hætteglas med solvens + 1 hætteglas adapter
English: Intravenous use powder: vial (glass); solvent: vial (glass)
Danish: Intravenøs anvendelse pulver: hætteglas (glas) solvens: hætteglas (glas)
English: 18 November 2013
Danish: Den 18. november 2013
English: September 2013 CMDh meeting
Danish: CMDh's møde i september 2013
English: Annex VI
Danish: Bilag VI Tidsplan for gennemførelse af aftalen
English: EU - number
Danish: EU-nummer
English: Target species
Danish: Indhold Pakningsstør -relse
English: It was to be available as 200 mg capsules.
Danish: Det skulle have været leveret som 200 mg-kapsler.
English: The Committee had concerns over the quality of the medicine (in particular on the choice of the starting material to make the medicine and the presence of impurities).
Danish: Udvalget havde betænkeligheder ved lægemidlets kvalitet (navnlig valget af udgangsmaterialet til fremstilling af lægemidlet og tilstedeværelsen af urenheder).
English: In addition, the CHMP had concerns about the documentation submitted in support of the effectiveness and safety of the medicine.
Danish: Desuden havde CHMP betænkeligheder ved den forelagte dokumentation af lægemidlets virkning og sikkerhed.
English: The summary of the opinion of the Committee for Orphan Medicinal Products for Ketoconazole AIDSCFM can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Danish: Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Ketoconazole AID-SCFM findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
English: In its letter notifying the Agency of the withdrawal of application, the applicant stated that it was withdrawing the application since it would require a further time extension to provide the responses to the CHMP's questions.
Danish: I brevet, hvor agenturet underrettes om tilbagetrækningen af ansøgningen, oplyste virksomheden, at ansøgningen blev trukket tilbage, fordi det ville være nødvendigt med yderligere forlængelse af fristen for at besvare CHMP's spørgsmål.
English: On 23 February 2015, Agenzia Industrie Difesa - Stabilimento Chimico Farmaceutico Militare officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ketoconazole AID-SCFM, for the treatment of Cushing's syndrome.
Danish: Den 23. februar 2015 meddelte Agenzia Industrie Difesa - Stabilimento Chimico Farmaceutico Militare officielt Udvalget for Lægemidler til Mennesker (CHMP), at virksomheden ønsker at trække sin ansøgning om markedsføringstilladelse tilbage for Ketoconazole AID-SCFM til behandling af Cushings syndrom.
English: Blocking cortisol production will help to reduce cortisol levels in the body, thereby relieving the symptoms of the disease.
Danish: Blokering af kortisolproduktionen nedsætter kortisolindholdet i kroppen og mindsker derfor symptomerne på sygdommen.
English: The active substance in Ketoconazole AID-SCFM, ketoconazole, blocks the activity of a group of enzymes involved in the production of cortisol by the adrenal glands, such as 17 alpha-hydroxylase or 11b-hydroxylase.
Danish: Det aktive stof i Ketoconazole AID-SCFM, ketoconazol, blokerer aktiviteten af en gruppe enzymer, der medvirker til binyrernes produktion af kortisol, såsom 17alfa-hydroxylase eller 11beta-hydroxylase.
English: The company also cited commercial reasons, since another medicine containing ketoconazole for Cushing's syndrome was recently authorised in the EU.
Danish: Virksomheden henviste desuden til forretningsmæssige grunde, idet et andet lægemiddel, der indeholder ketoconazol til Cushings syndrom, for nylig er blevet godkendt i EU.
English: Ketoconazole AID-SCFM was expected to be used to treat adults with Cushing's syndrome for whom surgery was not an option or had failed.
Danish: Ketoconazole AID-SCFM forventedes anvendt til behandling af voksne med Cushings syndrom, hos hvem operation ikke var mulig eller havde slået fejl.
English: Ketoconazole AID-SCFM is a medicine that contains the active substance ketoconazole.
Danish: Ketoconazole AID-SCFM er et lægemiddel, der indeholder det aktive stof ketoconazol.
English: Another medicine containing ketoconazole (Ketoconazole HRA) was recently approved in the EU to treat Cushing's syndrome.
Danish: Et andet lægemiddel, der indeholder ketoconazol, (Ketoconazole HRA), blev for nylig godkendt i EU til behandling af Cushings syndrom.
English: Ketoconazole AID-SCFM was designated an ‘orphan medicine' (a medicine to be used in rare diseases) on 9 August 2012 for Cushing's syndrome.
Danish: Ketoconazole AID-SCFM blev udpeget som »lægemiddel til sjældne sygdomme« den 9. august 2012 til Cushings syndrom.
English: Therefore, at the time of the withdrawal, the CHMP was of the opinion that the benefits of Ketoconazole AID-SCFM did not outweigh its risks.
Danish: Derfor var CHMP på tidspunktet for tilbagetrækningen af den opfattelse, at fordelene ved Ketoconazole AID-SCFM ikke opvejede risiciene.
English: Because ketoconazole is a well-known substance and its use in Cushing's syndrome is well established, the applicant presented data from the published literature to support its application for Ketoconazole AID-SCFM.
Danish: Da ketoconazol er et velkendt stof, og da dets anvendelse til Cushings syndrom er anerkendt, forelagde ansøgeren data fra den videnskabelige litteratur som dokumentation for ansøgningen for Ketoconazole AID-SCFM.
English: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom27 March 2015
Danish: 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555
English: Based on the initial review of the data, at the time of the withdrawal, the CHMP had several concerns and was of the provisional opinion that Ketoconazole AID-SCFM could not have been approved for the treatment of Cushing's syndrome.
Danish: På baggrund af gennemgangen af dataene på tidspunktet for tilbagetrækningen af ansøgningen, havde CHMP visse betænkeligheder og var af den foreløbige opfattelse, at Ketoconazole AID-SCFM ikke kunne være blevet godkendt til behandling af Cushings syndrom.
English: What is Ketoconazole AID-SCFM?
Danish: Hvad er Ketoconazole AID-SCFM?
English: What was Ketoconazole AID-SCFM expected to be used for?
Danish: Hvad forventedes Ketoconazole AID-SCFM anvendt til?
English: How is Ketoconazole AID-SCFM expected to work?
Danish: Hvordan forventes Ketoconazole AID-SCFM at virke?
English: Therefore the Committee has made a number of recommendations as outlined below.
Danish: Udvalget har derfor udarbejdet en række anbefalinger som beskrevet nedenfor.
English: You should not take this medicine if you are older than 80 years.
Danish: De må ikke tage denne medicin, hvis De er over 80 år.
English: Age over 70 years is associated with high risk of complications.
Danish: Alder over 70 år er forbundet med stor risiko for komplikationer.
English: Piroxicam is authorised in the European Union following national marketing procedures.
Danish: Piroxicam er godkendt i EU efter nationale markedsføringsprocedurer.
English: 4.5 Interaction with other Medicinal Products and other forms of Interaction
Danish: 4.5 Interaktion med andre lægemidler og andre former for interaktion
English: Under no circumstances should you change the dose without first speaking to your doctor.
Danish: De må under ingen omstændigheder ændre dosis uden først at spørge lægen.
English: It does not cure arthritis and will help you only as long as you continue to take it.
Danish: Det helbreder ikke ledbetændelse, og det hjælper Dem kun, så længe De tager det.
English: Tell your doctor immediately.”
Danish: Kontakt straks lægen.
English: Identification of at-risk subjects
Danish: Identifikation af risiko-personer
English: National Competent Authorities (NCA) shall ensure that the following conditions are fulfilled by the Marketing Authorisation Holders:
Danish: De nationale kompetente myndigheder sikrer, at indehaverne af markedsføringstilladelserne opfylder følgende vilkår:
English: These recommendations build on the previous key elements published for piroxicam in September 2006 and must be implemented in the product information.
Danish: Anbefalingerne bygger på de tidligere nøgleelementer, der blev offentliggjort for piroxicam i september 2006, og skal indarbejdes i produktoplysningerne.
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF PIROXICAM CONTAINING MEDICINAL PRODUCTS (see Annex I)
Danish: SAMLET RESUMÉ AF DEN FAGLIGE VURDERING AF LÆGEMIDLER INDEHOLDENDE PIROXICAM (se bilag I)
English: • “If any of these applies to you, you should not be given piroxicam.
Danish: Hvis noget af dette gælder for Dem, må De ikke få piroxicam.
English: The risk for developing serious GI complications increases with age.
Danish: Risikoen for udvikling af alvorlige gastrointestinale komplikationer stiger med alderen.
English: • Concomitant use with anticoagulants.
Danish: • Samtidig anvendelse af antikoagulantia.
English: 4.4 Special Warnings and Special Precautions for Use
Danish: 4.4 Særlige advarsler og forsigtighedsregler vedrørende brugen
English: The European Commission requested the CHMP to give its opinion on whether the marketing authorisations for medicinal products containing piroxicam should be maintained, varied, suspended or revoked.
Danish: EuropaKommissionen anmodede CHMP om at fremsætte en udtalelse om, hvorvidt markedsføringstilladelserne for lægemidler indeholdende piroxicam burde opretholdes, ændres, suspenderes eller tilbagekaldes.
English: 2003 RN Haarlem The Netherlands
Danish: 2003 RN Haarlem Holland
English: The administration to patients older than 80 years should be avoided.
Danish: Patienter over 80 år bør ikke behandles.
English: B-8620 Nieuwpoort Belgium
Danish: B-8620 Nieuwpoort Belgien
English: Your doctor may limit your use of piroxicam or other medicines, or you may need to take a different medicine.
Danish: Deres læge kan begrænse brugen af piroxicam eller anden medicin, eller De er måske er nødt til at tage en anden slags medicin.
English: - A Direct Healthcare Professional Communication (DHPC) must be sent to all Health Care Professionals who prescribe piroxicam according to national practice.
Danish: - Der udsendes en meddelelse (Direct Healthcare Professional Communication (DHPC)) til alle fagfolk i sundhedssektoren, der ordinerer piroxicam i henhold til national praksis.
English: − piroxicam should not be used for treatment of any acute condition due to the long half life of 50 hours and the safety profile, since equally effective and safer therapies are available;
Danish: − piroxicam bør ikke anvendes til akut behandling på grund af den lange halveringstid på 50 timer og sikkerhedsprofilen, da der findes andre lige så effektive midler, som er sikrere,