FrancophonIA/ELRC3.0 huggingface dataset:
English: The active metabolite of clopidogrel selectively inhibits the binding of adenosine diphosphate (ADP) to its platelet P2Y12 receptor and the subsequent ADP-mediated activation of the glycoprotein GPIIb/IIIa complex, thereby inhibiting platelet aggregation.
Danish: Clopidogrels aktive metabolit hæmmer selektivt bindingen af adenosindiphosphat (ADP) til dets trombocyt P2Y12-receptor og den efterfølgende ADP-medierede aktivering af glykoprotein (GP)IIbIIIa-komplekset, hvorved trombocytaggregationen hæmmes.
English: In patients with non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction): The optimal duration of treatment has not been formally established.
Danish: - Hos patienter med akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina pectoris eller myokardieinfarkt uden forekomst af Q-takker): Den optimale varighed af behandlingen er ikke endeligt fastslået.
English: • This medicinal product must be administered under close medical supervision in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency due to risk of haemolysis (see section
Danish: • På grund af risiko for hæmolyse skal dette lægemiddel administreres under omhyggelig medicinsk supervision til patienter med glucose-6-phosphatdehydrogenase (G6PD)-mangel (se pkt.
English: DuoPlavin contains lactose.
Danish: DuoPlavin indeholder lactose.
English: Do not take DuoPlavin
Danish: Tag ikke DuoPlavin
English: Sanofi Winthrop Industrie 1 rue de la Vierge Ambarès et Lagrave F-33565 Carbon Blanc Cedex France
Danish: Sanofi Winthrop Industrie 1, rue de la Vierge Ambarès & Lagrave F-33565 Carbon Blanc cedex Frankrig
English: While you are taking DuoPlavin:
Danish: Mens du er i behandling med DuoPlavin:
English: Common side effects (may affect up to 1 in 10 people): Diarrhoea, abdominal pain, indigestion or heartburn.
Danish: Almindelige bivirkninger (kan påvirke op til 1 ud af 10 patienter): Diaré, mavesmerter, fordøjelsesbesvær eller halsbrand.
English: Colitis (including ulcerative or lymphocytic colitis), stomatitis, acute pancreatitis in the context of a hypersensitivity reaction due to acetylsalicylic acid*
Danish: Colitis (inklusive colitis ulcerosa og lymfocytisk colitis), stomatitis, akut pankreatitis i forbindelse med en overfølsomhedsreaktion på grund af acetylsalicylsyre*
English: Driving and using machines DuoPlavin should not affect your ability to drive or to use machines.
Danish: Trafik- og arbejdssikkerhed Det er usandsynligt, at DuoPlavin vil påvirke din evne til at køre bil eller betjene maskiner.
English: DuoPlavin contains lactose
Danish: DuoPlavin indeholder lactose
English: Acute liver failure, liver injury, mainly hepatocellular*, hepatitis, elevation of hepatic enzymes*, abnormal liver function test, chronic hepatitis*
Danish: Akut leversvigt, leverskader, primært hepatocellulær*, hepatitis, forhøjede leverenzymer*, unormal leverfunktionstest, kronisk hepatitis*
English: • valproic acid, valproate or carbamazepine, medicines to treat some forms of epilepsy,
Danish: • valproinsyre, valproat eller carbamazepin, medicin til behandling af bestemte typer epilepsi.
English: Contact your doctor or the nearest hospital emergency department because of the increased risk of bleeding.
Danish: Hvis du har taget for mange DuoPlavin Kontakt din læge eller tag på den nærmeste skadestue på grund af den øgede blødningsrisiko.
English: Patients should be counseled about the risks of gastrointestinal injury and bleeding while taking clopidogrel plus ASA with alcohol, especially if alcohol consumption is chronic or heavy.
Danish: Patienter skal vejledes vedrørende risikoen for skader og blødning i mave-tarm-kanalen, hvis de drikker alkohol under behandlingen med clopidogrel plus ASA, især hvis alkoholforbruget er kronisk eller stort (se pkt.
English: • repaglinide, medicine to treat diabetes,
Danish: • repaglinid, medicin til behandling af sukkersyge (diabetes).
English: As a dual antiplatelet agent, DuoPlavin should be used with caution in patients who may be at risk of increased bleeding from trauma, surgery or other pathological conditions and in patients receiving treatment with other NSAIDs including Cox-2 inhibitors, heparin, glycoprotein IIb/IIIa inhibitors, selective serotonin reuptake inhibitors (SSRIs), thrombolytics, or other medicinal products associated with bleeding risk such as pentoxifylline (see section 4.5).
Danish: Som dobbelt antitrombotisk middel skal DuoPlavin anvendes med forsigtighed til patienter med øget risiko for blødning pga. traumer, kirurgi eller andre patologiske tilstande samt til patienter, der samtidigt behandles med andre NSAID'er inklusive Cox-2-hæmmere, heparin, glykoprotein IIb/IIIa-hæmmere, selektive serotoningenoptagelseshæmmere (SSRI'er), trombolytika, eller andre lægemidler forbundet med risiko for blødning, såsom pentoxifyllin (se pkt.
English: Fifteen percent (15.0%) of patients in the clopidogrel plus ASA group and 21.7% in the group treated with ASA alone reached the primary endpoint, representing an absolute reduction of 6.7% and a 36% odds reduction in favor of clopidogrel (95% CI: 24, 47%; p <0.001), mainly related to a reduction in occluded infarct-related arteries.
Danish: 15,0 % af patienterne i clopidogrel plus ASA-gruppen og 21,7 % i gruppen behandlet med ASA alene opnåede det primære endepunkt, hvilket viste en absolut reduktion på 6,7 % og en odds-reduktion på 36 % til fordel for clopidogrel (9 5 % CI: 24; 47 %; p < 0,001), der hovedsagligt var relateret til en reduktion af infarkt-relaterede okkluderede arterier.
English: Bullous dermatitis (toxic epidermal necrolysis, Stevens Johnson Syndrome, erythema multiforme, acute generalised exanthematous pustulosis (AGEP)), angioedema, drug-induced hypersensitivity syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), rash erythematous or exfoliative, urticaria, eczema, lichen planus, fixed eruption*
Danish: Bulløs dermatitis (toksisk epidermal nekrolyse, StevensJohnsons syndrom, erythema multiforme, akut generaliseret eksantematøs pustulose (AGEP)), angioødem, lægemiddelinduceret overfølsomhed, medikamentelt udslæt med eosinofili og systemiske symptomer (DRESS), erytematøst eller eksfoliativt udslæt, urticaria, eksem, lichen planus, fixed drug eruption*
English: Jaundice (yellowing of skin and/or eyes); burning in stomach and/or esophagus (gullet); severe abdominal pain with or without back pain; fever, breathing difficulties sometimes associated with cough; generalised allergic reactions (for example, overall sensation of heat with sudden general discomfort until fainting); swelling in the mouth; blisters of the skin; skin allergy; sore mouth (stomatitis); decrease in blood pressure; confusion; hallucinations; joint pain; muscular pain; changes in taste or loss of taste of foods, inflammation of small vessels.
Danish: Gulsot (gulfarvning af hud og/eller øjne); brændende fornemmelse i maven og/eller spiserøret; alvorlige mavesmerter med eller uden rygsmerter; feber, åndedrætsbesvær indimellem i ledsaget af hoste; generelle allergiske reaktioner (f.eks. varmefølelse over hele kroppen med pludselig almen utilpashed og eventuelt besvimelse); hævelse i munden; blærer på huden; allergiske hudreaktioner; ømhed i munden (stomatitis); blodtryksfald; forvirring; hallucinationer; ledsmerter; muskelsmerter; smagsforstyrrelser eller mangel på smagssans, betændelse i små kar.
English: The safety and efficacy of clopidogrel plus ASA have been evaluated in three double-blind studies involving over 61,900 patients: the CURE, CLARITY and COMMIT studies, comparing clopidogrel plus ASA to ASA alone, both treatments given in combination with other standard therapy.
Danish: Sikkerheden og virkningen af clopidrogrel plus ASA er blevet evalueret i 3 dobbeltblindede studier, der omfattede mere end 61.900 patienter i CURE-, CLARITY- og COMMIT-undersøgelserne, hvor clopidogrel plus ASA sammenlignes med ASA alene.
English: Physicians should remain alert for signs of GI ulceration and bleeding, even in the absence of previous GI symptoms.
Danish: Lægen bør fortsat være opmærksom på tegn på GI-ulceration og -blødning, også hvis patienten ikke tidligere har haft gastrointestinale symptomer.
English: • ST segment elevation acute myocardial infarction in medically treated patients eligible for thrombolytic therapy
Danish: - akut myokardieinfarkt (MI) med elevation af ST-segmentet hos medicinsk behandlede patienter, der er egnede til trombolytisk behandling.
English: Thrombotic thrombocytopenic purpura (TTP) (see section 4.4), bone marrow failure*, aplastic anaemia, pancytopenia, bicytopenia*, agranulocytosis, severe thrombocytopenia, acquired haemophilia A, granulocytopenia, anaemia, haemolytic anaemia in patients with glucose-6-phosphate dehydrogenase (G6PD) deficiency* (see section 4.4)
Danish: Trombotisk trombocytopenisk purpura (TTP) (se afsnit 4.4), knoglemarvssvigt*, aplastisk anæmi, pancytopeni, bicytopeni*, agranulocytose, alvorlig trombocytopeni, erhvervet hæmofili A, granulocytopeni, anæmi, hæmolytisk anæmi hos patienter med glucose-6phosphatdehydrogenase (G6PD)-mangel* (se pkt.
English: In patients concomitantly receiving nicorandil and NSAIDs including ASA and LAS, there is an increased risk for severe complications such as gastrointestinal ulceration, perforation and haemorrhage (see section 4.5).
Danish: Hos patienter, der samtidig får nicorandil og NSAID'er, herunder ASA og LAS, er der en øget risiko for alvorlige komplikationer i form af gastrointestinal blødning, perforation og blødning (se pkt.
English: If any of the situations mentioned below apply to you, you should tell your doctor before taking DuoPlavin:
Danish: Advarsler og forsigtighedsregler Hvis nogen af følgende situationer gælder for dig, skal du oplyse det til lægen, før du tager DuoPlavin:
English: The number of patients experiencing the primary endpoint [cardiovascular (CV) death, myocardial infarction (MI), or stroke] was 582 (9.3%) in the clopidogrel plus ASA group and 719 (11.4%) in the ASA group, a 20% relative risk reduction (RRR) (95% CI of 10%-28%; p=0.00009) for the clopidogrel plus ASA group [17% relative risk reduction when patients were treated conservatively, 29% when they underwent percutaneous transluminal coronary angioplasty (PTCA) with or without stent and 10% when they underwent coronary artery bypass graft (CABG)].
Danish: Antallet af patienter, som oplevede det primære endepunkt [kardiovaskulær død (CV), myokardieinfarkt (MI) eller apopleksi] var 582 (9,3 %) i clopidogrel plus ASA-gruppen og 719 (11,4 %) i ASA-gruppen, hvilket giver en relativ risikoreduktion på 20 % (95 % CI: 10 %-28 %; p=0,00009) for clopidogrel plus ASA-gruppen (en relativ risikoreduktion (RR) på 17 %, når patienterne fik konservativ behandling, 29 %, når de fik ballonudvidelse (perkutan transluminal koronar angioplastik (PTCA)) med eller uden stent, og 10%, når de fik koronar bypassoperation (CABG).
English: Due to the presence of ASA, methotrexate used at doses higher than 20 mg/week should be used with caution with DuoPlavin as it can inhibit renal clearance of methotrexate, which may lead to bone marrow toxicity.
Danish: Methotrexatdoser over 20 mg ugentligt bør anvendes med forsigtighed, da ASA kan hæmme den renale clearance af methotrexat, hvilket kan føre til knoglemarvstoksicitet.
English: Store below 25C.
Danish: Opbevares ved temperaturer under 25º C.
English: The safety of the concomitant administration of DuoPlavin with other thrombolytic agents has not been formally established and should be undertaken with caution (see section 4.4).
Danish: Sikkerheden ved samtidig administration af DuoPlavin og andre trombolytika er ikke fastlagt, og der skal derfor udvises forsigtighed (se pkt.
English: • You should tell your doctor - if a surgery (including dental) is planned.
Danish: • skal du fortælle lægen, at du er i behandling med DuoPlavin: hvis du skal have foretaget en planlagt operation (også hos tandlægen).
English: The concomitant administration of DuoPlavin with oral anticoagulants is not recommended since it may increase the intensity of bleeding (see section 4.5).
Danish: Samtidig administration af DuoPlavin og orale antikoagulantia kan ikke anbefales, da det kan øge blødningsintensiteten (se pkt.
English: Respiratory tract bleeding (haemoptysis, pulmonary haemorrhage), bronchospasm, interstitial pneumonitis, non-cardiogenic pulmonary edema with chronic use and in the context of a hypersensitivity reaction due to acetylsalicylic acid*, eosinophilic pneumonia.
Danish: Blødning i luftvejene (hæmoptyse, pulmonal blødning), bronkospasmer, interstitiel pneumoni, ikke-kardiogent lungeødem ved kronisk brug eller i forbindelse med en overfølsomhedsreaktion på grund af acetylsalicylsyre*, eosinofil pneumoni
English: DATE OF REVISION OF THE TEXT Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/
Danish: Denne indlægsseddel blev senest ændret MM/ÅÅÅÅ Du kan finde yderligere oplysninger om dette lægemiddel på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/
English: Patients received clopidogrel (75 mg/day, n=22,961) plus ASA (162 mg/day), or ASA alone (162 mg/day) (n=22,891), for 28 days or until hospital discharge.
Danish: Patienterne fik clopidogrel (75mg/dag, n=22.961) plus ASA (162 mg/dag) eller ASA alene (162 mg/dag) (n=22.891) i 28 dage eller indtil udskrivelse fra hospitalet.
English: This benefit was mostly driven by the statistically significant reduction in the incidence of MI [287 (4.6%) in the clopidogrel plus ASA group and 363 (5.8%) in the ASA group].
Danish: Fordelen må hovedsageligt tilskrives den statistisk signifikante reduktion i forekomsten af myokardieinfarkt [287 (4,6 %) i clopidogrel plus
English: Pharmacotherapeutic group: Antithrombotic agents, platelet aggregation inhibitors excl. Heparin, ATC Code: B01AC30.
Danish: Farmakoterapeutisk klassifikation: Blodplade-aggregationshæmmere excl. Heparin.
English: DuoPlavin should be used with caution in patients who receive concomitant glycoprotein IIb/IIIa inhibitors (see section 4.4).
Danish: DuoPlavin skal anvendes med forsigtighed til patienter i samtidig behandling med glykoprotein IIb/IIIa-hæmmere (se pkt.
English: • fluconazole or voriconazole, medicines to treat fungal infections,
Danish: • fluconazol eller voriconazol, der anvendes til behandling af svampeinfektioner.
English: Hydrogenated castor oil Stearic acid
Danish: Hydrogeneret ricinusolie Stearinsyre
English: - a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,
Danish: o ticlopidin, der er anden medicin mod blodpropper o selektive serotoningenoptagelseshæmmere (inklusive, men ikke begrænset til fluoxetin og fluvoxamin), der normalt anvendes mod depression
English: • Non-ST segment elevation acute coronary syndrome (unstable angina or non-Q-wave myocardial infarction) including patients undergoing a stent placement following percutaneous coronary intervention
Danish: - akut koronarsyndrom uden elevation af ST-segmentet (ustabil angina eller myokardieinfarkt uden forekomst af Q-takker) inklusive patienter, som får indsat stent efter perkutan koronar intervention.
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel plus ASA group and 1,187 (18.8%) in the ASA group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel plus ASA group.
Danish: Antallet af patienter, som oplevede det primære sammensatte endepunkt [kardiovaskulær død, myokardieinfarkt, apopleksi eller refraktær iskæmi] var 1.035 (16,5 %) i clopidogrel plus ASAgruppen og 1.187 (18,8 %) i ASA-gruppen, hvilket giver en relativ risikoreduktion på 14 % (95 % CI: 6 %-21 %; p=0,00005) for clopidogrel plus ASA-gruppen.
English: Ulcer perforation, ringing in the ears, hearing loss, sudden life-threatening allergic or hypersensitivity reactions with chest or abdominal pain, kidney disease, low blood sugar, gout (a condition of painful, swollen joints caused by uric acid crystals) and worsening of food allergies, a particular form of anaemia (low number of red blood cells) (see section 2 ‘Warnings and precautions'), swelling.
Danish: Bivirkninger med ikke kendt hyppighed (kan ikke vurderes ud fra forhåndenværende data): Perforeret mavesår, ringen for ørerne, nedsat hørelse, pludselige, livstruende allergiske reaktioner eller overfølsomhedsreaktioner med bryst- eller mavesmerter, nyresygdom, lavt blodsukker, urinsur gigt (en tilstand med smertefulde, hævede led forårsaget af urinsyrekrystaller), forværring af madallergi og en særlig form for anæmi (lavt antal røde blodceller) (se afsnit 2 ‘Advarsler og forsigtighedsregler'), hævelse.
English: DuoPlavin 75 mg/75 mg film-coated tablets Aluminium blisters in cardboard cartons containing 14, 28, 30 and 84 film-coated tablets.
Danish: DuoPlavin 75 mg/75 mg filmovertrukne tabletter Blisterkort af aluminium i kartonæsker der indeholder 14, 28, 30 og 84 filmovertrukne tabletter.
English: If a dose is missed: - Within less than 12 hours after regular scheduled time: patients should take the dose immediately and then take the next dose at the regular scheduled time.
Danish: Inden for mindre end 12 timer efter planlagt dosering: Patienten bør straks tage den planlagte dosis og derefter tage den næste dosis ved næste planlagte dosering.
English: Patients were randomised to clopidogrel (300 mg loading dose followed by 75 mg/day, N=6,259) plus ASA (75-325 mg once daily) or ASA alone (N=6,303), (75-325 mg once daily) and other standard therapies.
Danish: Patienterne blev randomiseret til clopidogrel (300 mg initial støddosis efterfulgt af 75 mg/dag, N=6.259) plus ASA (75-325 mg en gang daglig) eller ASA alene (N=6.303), (75-325 mg en gang daglig) i kombination anden standardbehandling.
English: DuoPlavin 75 mg/100 mg film-coated tablets DuoPlavin should be given as a single daily 75 mg/100 mg dose.
Danish: DuoPlavin 75 mg/100 mg filmovertrukne tabletter DuoPlavin bør gives som en enkelt daglig dosis på 75 mg/100 mg.
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablet 50x1 film-coated tablet 84 film-coated tablets 90x1film-coated tablet 100x1 film-coated tablet
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30x1 filmovertrukne tabletter 50x1 filmovertrukne tabletter 84 filmovertrukne tabletter 90x1 filmovertrukne tabletter 100x1 filmovertrukne tabletter
English: Patients received clopidogrel (300 mg loading dose, followed by 75 mg/day, n=1,752) plus ASA or ASA alone (n=1,739), (150 to 325 mg as a loading dose, followed by 75 to 162 mg/day), a fibrinolytic agent and, when appropriate, heparin.
Danish: Patienterne fik clopidogrel (300 mg støddosis efterfulgt af 75 mg daglig, n=1.752) plus ASA eller ASA alene (n=1.739) (150-325 mg som støddosis, herefter 75-162 mg daglig), et fibrinolytisk middel samt når det var hensigtsmæssigt heparin.
English: 14 film-coated tablets 28 film-coated tablets 30x1 film-coated tablet 50x1 film-coated tablet 84 film-coated tablets 90x1film-coated tablet 100x1 film-coated tablet 30 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30x1 filmovertrukne tabletter 50x1 filmovertrukne tabletter 84 filmovertrukne tabletter 90x1 filmovertrukne tabletter 100x1 filmovertrukne tabletter 30 filmovertrukne tabletter
English: The other ingredients are: - Tablet core: mannitol (E421), macrogol 6000, microcrystalline cellulose, low substituted hydroxypropylcellulose, maize starch, hydrogenated castor oil (see section 2 ‘DuoPlavin contains hydrogenated castor oil'), stearic acid and colloidal anhydrous silica - Tablet coating: lactose monohydrate (see section 2 ‘DuoPlavin contains lactose'), hypromellose (E464), titanium dioxide (E171), triacetin (E1518), red iron oxide (E172) - Polishing agent: carnauba wax
Danish: Øvrige indholdsstoffer: - Tabletkernen: mannitol (E421), macrogol 6000, mikrokrystallinsk cellulose, lavsubstitueret hydroxypropylcellulose, majsstivelse, hydrogeneret ricinusolie (se afsnit 2 ‘DuoPlavin indeholder hydrogeneret ricinusolie'), stearinsyre og kolloid vandfri silica.
English: DuoPlavin 75 mg/100 mg film-coated tablets Aluminium blisters in cardboard cartons containing 14, 28 and 84 film-coated tablets.
Danish: DuoPlavin 75 mg/100 mg filmovertrukne tabletter Blisterkort af aluminium i kartonæsker der indeholder 14, 28 og 84 filmovertrukne tabletter.
English: Co-administration of heparin had no effect on the inhibition of platelet aggregation induced by clopidogrel.
Danish: Samtidig indgift af heparin havde ingen virkning på den hæmning af trombocytaggregationen, som DuoPlavin inducerer.
English: DuoPlavin contains hydrogenated castor oil This may cause stomach upset or diarrhoea.
Danish: DuoPlavin indeholder hydrogeneret ricinusolie DuoPlavin indeholder hydrogeneret ricinusolie, der kan forårsage mavetilfælde eller diaré.
English: Anaphylactic shock*, serum sickness, anaphylactoid reactions, cross-reactive drug hypersensitivity among thienopyridines (such as ticlopidine, prasugrel) (see section 4.4)**,insulin autoimmune syndrome, which can lead to severe hypoglycemia, particularly in patients with HLA DRA4 subtype (more frequent in the Japanese population)**, aggravation of allergic symptoms of food allergy*
Danish: 4.4)**, insulin autoimmun syndrom, som kan føre til alvorlig hypoglykæmi, især hos patienter med HLA DRA4 subtype (hyppigere i den japanske befolkning) **, forværring af symptomer på fødeallergi*
English: This was consistent across subgroups of patients defined by baseline characteristics, and type of fibrinolytic or heparin therapy.
Danish: Forekomsten af større blødninger var ens i de to grupper Dette var konsistent blandt undergrupperne af patienter, defineret ved baseline-karakteristika og typen af fibrinolytikaeller heparinbehandling.
English: Upper gastrointestinal disorders (oesophagitis, oesophageal ulceration, perforation, erosive gastritis, erosive duodenitis; gastro-duodenal ulcer/perforations)*; lower gastrointestinal disorders (small [jejunum and ileum] and large [colon and rectum] intestinal ulcers, colitis and intestinal perforation)*; upper gastro-intestinal symptoms* such as gastralgia (see section 4.4); these ASArelated GI reactions may or may not be associated with haemorrhage, and may occur at any dose of acetylsalicylic acid and in patients with or without warning symptoms or a previous history of serious GI events*.
Danish: Øvre gastrointestinale lidelser (øsofagitis, øsofageal ulceration, perforation, erosiv gastritis, erosiv duodenitis; gastroduodenalt ulcus/perforationer)*; nedre gastrointestinale lidelser (små [jejunum og ileum] og store [tyktarm og endetarm] tarmsår, colitis og intestinal perforation)*; øvre gastrointestinale symptomer* såsom gastralgi (se pkt.
English: DuoPlavin must not be used in patients with severe renal impairment (see section 4.3).
Danish: DuoPlavin må ikke anvendes hos patienter med stærkt nedsat leverfunktion (se pkt.
English: • the varicella vaccine, a medicine used to prevent chickenpox or shingles, within 6 weeks of taking DuoPlavin, or if you have active chickenpox or shingles infection (see section 2
Danish: • bliver vaccineret mod skoldkopper eller helvedesild indenfor 6 uger efter brug af DuoPlavin, eller hvis du har/får skoldkopper eller helvedsild (se afsnit 2 ”Børn og unge”).
English: Retroperitoneal haemorrhage
Danish: Retroperitonea l blødning
English: • the foetus to: - cardiopulmonary toxicity (with premature closure of the ductus arteriosus and pulmonary hypertension); - renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;
Danish: Kardiopulmonal toksicitet (med præmatur lukning af ductus arteriosus og pulmonal hypertension);
English: Hypoglycaemia*, gout* (see section 4.4)
Danish: Hypoglykæmi*, urinsur gigt* (se pkt.
English: Gastrointestinal haemorrhage, diarrhoea, abdominal pain, dyspepsia
Danish: Mave-tarm-kanalen Gastrointestinal blødning, diaré, mavesmerter, dyspepsi