FrancophonIA/ELRC3.0 huggingface dataset:
English: Certain antidepressants (selective serotonin reuptake inhibitors, selective serotonin-norepinephrine reuptake inhibitors, tricyclic or tetracyclic antidepressants) the antibiotic ciprofloxacin used against infections the cough suppressant dextromethorphan sympathomimetics such as those present in eye drops, nasal and oral decongestants and cold medicine containing ephedrine or pseudoephedrine
Danish: Spørg Deres læge til råds, inden De tager et af følgende lægemidler sammen med Rasagilin Mylan: Visse former for lægemidler til behandling af depression (selektive serotoningenoptagelseshæmmere, selektive serotonin-/noradrenalingenoptagelseshæmmere, tricykliske eller tetracykliske antidepressive lægemidler) antibiotikummet ciprofloxacin til behandling af infektioner det hostestillende middel dextromethorphan øjendråber, næsedråber/-spray og slimløsende lægemidler til næse og svælg, der indeholder sympatomimetika, samt forkølelsesmedicin, der indeholder ephedrin eller pseudoephedrin
English: In study I, 404 patients were randomly assigned to receive placebo (138 patients), rasagiline 1 mg/day (134 patients) or rasagiline 2 mg/day (132 patients) and were treated for 26 weeks, there was no active comparator.
Danish: I undersøgelse I blev 404 patienter randomiseret til behandling med enten placebo (138 patienter), rasagilin 1 mg dagligt (134 patienter) eller rasagilin 2 mg dagligt (132 patienter) i 26 uger; man sammenlignede ikke med et andet aktivt stof.
English: Rasagiline must not be administered along with other MAO inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) as there may be a risk of non-selective MAO inhibition that may lead to hypertensive crises (see section 4.3).
Danish: lægemidler og naturlægemidler i håndkøb, f.eks. perikon), da der er risiko for non-selektiv MAO hæmning, som kan medføre hypertensive kriser (se pkt.
English: Common: dystonia (2.4% vs. 0.8%), carpal tunnel syndrome (1.3% vs. 0%), balance disorder (1.6% vs. 0.3%)
Danish: Almindelig: Dystoni (2,4% vs. 0,8%), karpaltunnelsyndrom (1,3% vs. 0%), balanceforstyrrelser (1,6% vs. 0,3%)
English: How to take Rasagiline Mylan 4.
Danish: Sådan skal De tage Rasagilin Mylan 4.
English: If you forget to take Rasagiline Mylan
Danish: Hvis De har glemt at tage Rasagilin Mylan
English: Pharmacotherapeutic group: Anti-Parkinson drugs, Monoamine oxidase-B inhibitors, ATC code: N04BD02
Danish: Farmakoterapeutisk klassifikation: Antiparkinsonmiddel, monoaminooxidase-B-hæmmer.
English: Rasagiline Mylan may be taken with or without food.
Danish: Rasagilin Mylan kan tages i forbindelse med et måltid eller uden for måltiderne.
English: • fall
Danish: • Fald
English: In the post-marketing period, cases of serotonin syndrome associated with agitation, confusion, rigidity, pyrexia and myoclonus have been reported by patients treated with antidepressants/SNRI concomitantly with rasagiline.
Danish: Efter markedsføringen har patienter i samtidig behandling med antidepressiva/SNRI og rasagilin indberettet tilfælde af serotoninsyndrom, som forbindes med agitation, forvirring, rigiditet, pyreksi og myoklonus.
English: In study II, patients were randomly assigned to receive placebo (229 patients), or rasagiline 1 mg/day (231 patients) or the catechol-O-methyl transferase (COMT) inhibitor, entacapone, 200 mg taken along with scheduled doses of levodopa (LD)/decarboxylase inhibitor (227 patients), and were treated for 18 weeks.
Danish: I undersøgelse II blev patienterne randomiseret til behandling i 18 uger med enten placebo (229 patienter) eller rasagilin 1 mg dagligt (231 patienter) eller til behandling med 200 mg entakapon, en katekol-O-metyltransferase (COMT) hæmmer (227 patienter), i kombination med levodopa (LD)/decarboxylasehæmmer.
English: Česká republika Mylan Pharmaceuticals s.r.o.
Danish: Mylan Pharmaceuticals.s.r.o.
English: Renal impairment No change in dose is required for renal impairment.
Danish: Dosisjustering er ikke nødvendig ved nedsat nyrefunktion.
English: Warnings and precautions Talk to your doctor before taking Rasagiline Mylan.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, før De tager Rasagilin Mylan hvis De lider af let til moderat leverlidelse hvis De oplever mistænkelige hudforandringer.
English: In study III, patients were randomly assigned to receive placebo (159 patients), rasagiline 0.5 mg/day (164 patients), or rasagiline 1 mg/day (149 patients), and were treated for 26 weeks.
Danish: I undersøgelse III blev patienterne randomiseret til behandling i 26 uger med enten placebo (159 patienter), rasagilin 0,5 mg dagligt (164 patienter) eller rasagilin 1 mg dagligt (149 patienter).
English: In post-marketing experience, these symptoms have also been observed in Parkinson's disease patients treated with rasagiline.
Danish: Efter produktet er kommet på markedet, er disse symptomer også set hos patienter i behandling med rasagilin for Parkinsons syge.
English: • bloodshot eyes (conjunctivitis)
Danish: • Øjenbetændelse med røde øjne (conjunctivitis)
English: The concomitant use of rasagiline and fluoxetine or fluvoxamine should be avoided (see section 4.5).
Danish: Samtidig indtagelse af rasagilin og fluoxetin eller fluvoxamin bør undgås (se pkt.
English: • prolonged muscle contractions (dystonia)
Danish: • Ufrivillige bevægelser af kroppen (dystoni)
English: Uncommon: angina pectoris (0.5% vs. 0%)
Danish: Ikke almindelig: Angina pectoris (0,5% vs. 0%) Vaskulære sygdomme
English: • flu (influenza)
Danish: • Influenza
English: Common: vertigo (2.7% vs. 1.3%)
Danish: Almindelig: Vertigo (2,7% vs. 1,3%) Hjerte
English: The mean volume of distribution following a single intravenous dose of rasagiline is 243 l.
Danish: Gennemsnitlig distributionsvolumen efter en enkelt intravenøs dosis rasagilin er 243 l. Plasmaproteinbindingen efter en enkelt peroral 14C-mærket dosis rasagilin er ca. 60-70%.
English: • Very common (may affect more than 1 in 10 people)
Danish: • Meget almindelig (kan forekomme hos flere end 1 ud af 10 personer)
English: Serious adverse reactions have been reported with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors.
Danish: Der er observeret alvorlige bivirkninger ved samtidig indtagelse af SSRI'ere, SNRI'ere, tricykliske og tetracykliske antidepressiva samt MAO-hæmmere.
English: At least 14 days should elapse between discontinuation of rasagiline and initiation of treatment with fluoxetine or fluvoxamine.
Danish: Der bør gå mindst 14 dage fra seponering af rasagilin til iværksættelse af behandling med fluoxetin eller fluvoxamin.
English: Therefore, in view of the MAO inhibitory activity of rasagiline, concomitant administration of rasagiline and sympathomimetics such as those present in nasal and oral decongestants or cold medicinal products, containing ephedrine or pseudoephedrine, is not recommended (see section 4.4).
Danish: Set i lyset af rasagilins MAO-hæmmende virkning anbefales derfor ikke samtidig indgivelse af rasagilin og sympatomimetika, såsom de der findes i nasale og orale ekspektorantia, eller lægemidler mod forkølelser, der indeholder ephedrin eller pseudoephedrin (se pkt.
English: Common: depression (5.4% vs. 2%), hallucinations (1.3% vs. 0.7%) Nervous system disorders
Danish: Almindelig: Depression (5,4% vs. 2%), hallucinationer (1,3% vs. 0,7%)
English: • musculoskeletal pain
Danish: • Smerter i muskler og led
English: In vitro studies showed that rasagiline at a concentration of 1 μg/ml (equivalent to a level that is 160 times the average Cmax ~ 5.9-8.5 ng/ml in Parkinson's disease patients after 1 mg rasagiline multiple dosing), did not inhibit cytochrome P450 isoenzymes, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 and CYP4A.
Danish: In vitro undersøgelser viste, at rasagilin ikke hæmmede cytochrom P450 isoenzymer, CYP1A2, CYP2A6, CYP2C9, CYP2C19, CYP2D6, CYP2E1, CYP3A4 og CYP4A i en koncentration på 1g/ml (svarende til en koncentration, som er 160 gange højere end det gennemsnitlige Cmax  5,98,5 ng/ml hos patienter med Parkinsons sygdom efter indtagelse af 1 mg rasaglin som multipel dosis).
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release
Danish: Navn og adresse på den fremstiller (de fremstillere), der er ansvarlig(e) for batchfrigivelse
English: Common: orthostatic hypotension (3.9% vs. 0.8%) Gastrointestinal disorders
Danish: Almindelig: Ortostatisk hypotension (3,9% vs. 0,8%)
English: Caution should be exercised when rasagiline is administered to a breast-feeding mother.
Danish: Der bør udvises forsigtighed ved anvendelse af rasagilin til kvinder, der ammer.
English: Symptoms reported following overdose of rasagiline in doses ranging from 3 mg to 100 mg included dysphoria, hypomania, hypertensive crisis and serotonin syndrome.
Danish: Der er rapporteret om symptomer såsom dysfori, hypomani, hypertensive kriser og serotoninsyndrom efter overdosering med rasagilin i doser fra 3 mg til 100 mg.
English: Tell your doctor if you experience any of these behaviours; they will discuss ways of managing or reducing the symptoms.
Danish: Lægen vil overveje, hvordan symptomerne kan kontrolleres eller nedsættes.
English: Common: abdominal pain (4.2% vs. 1.3%), constipation (4.2% vs. 2.1%), nausea and vomiting (8.4% vs. 6.2%), dry mouth (3.4% vs. 1.8%)
Danish: Almindelig: Mavesmerter (4,2% vs. 1,3%), forstoppelse (4,2% vs. 2,1%), kvalme og opkastning (8,4%
English: At least 14 days must elapse between discontinuation of rasagiline and initiation of treatment with MAO inhibitors or pethidine.
Danish: Der skal gå mindst 14 dage fra seponering af rasagilin til iværksættelse af behandling med MAO-hæmmere eller pethidin.
English: What you need to know before you take Rasagiline Mylan
Danish: DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE Rasagilin Mylan
English: Rasagiline Mylan 1 mg tablets
Danish: LÆGEMIDLETS NAVN Rasagilin Mylan 1 mg tabletter
English: Serious adverse reactions are known to occur with the concomitant use of SSRIs, SNRIs, tricyclic/tetracyclic antidepressants and MAO inhibitors.
Danish: Det er kendt, at der kan forekomme alvorlige bivirkninger ved samtidig brug af MAO-hæmmere og SSRI'ere, SNRI'ere og tricykliske/tetracykliske antidepressiva.
English: Similar reports of ICDs have also been received post-marketing with rasagiline.
Danish: Der har også været rapporteret om tilsvarende tilfælde af impulskontrolforstyrrelser med rasagilin efter markedsføringen.
English: In a dose escalation study in patients on chronic levodopa therapy treated with 10 mg/day of rasagiline, there were reports of cardiovascular undesirable reactions (including hypertension and postural hypotension) which resolved following treatment discontinuation.
Danish: I en undersøgelse med stigende dosis til patienter i vedvarende levodopabehandling med 10 mg rasagilin dagligt blev der observeret kardiovaskulære bivirkninger (inkl.
English: Musculoskeletal and connective tissue disorders Common: musculoskeletal pain (6.7% vs. 2.6%), neck pain (2.7% vs. 0%), arthritis (1.3% vs.0.7%) Renal and urinary disorders
Danish: Almindelig: Muskuloskeletale smerter (6,7% vs. 2,6%), nakkesmerter (2,7% vs. 0%), artritis (1,3% vs.
English: • joint inflammation (arthritis)
Danish: • Ledsmerter (artralgi)
English: Common: decreased appetite (2.4% vs. 0.8%)
Danish: Almindelig: Nedsat appetit (2,4% vs. 0,8%) Psykiske forstyrrelser
English: For rasagiline no clinical data on exposed pregnancies is available.
Danish: Der er ingen erfaring med anvendelse af rasagilin til gravide.
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Common: skin carcinoma (1.3% vs. 0.7%) Blood and lymphatic system disorders Common: leucopenia (1.3% vs. 0%)
Danish: cyster og polypper) Almindelig: Hudkarcinom (1,3% vs. 0,7%) Blod og lymfesystem
English: • Very rare (may affect up to 1 in 10,000 people)
Danish: • Meget sjælden (kan forekomme hos færre end 1 ud af 10.000 personer)
English: Rasagiline may be taken with or without food.
Danish: Rasagilin kan indtages uafhængigt af måltider.
English: What Rasagiline Mylan contains - The active substance is rasagiline.
Danish: Aktivt stof: Rasagilin.
English: • decreased weight
Danish: Nedsat leverfunktion
English: Severe hepatic impairment.
Danish: Svært nedsat leverfunktion.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without prescription or if you are smoking or intend to stop smoking.
Danish: Fortæl det også, hvis De ryger eller har til hensigt at holde op med at ryge.
English: • runny nose (rhinitis)
Danish: • Løbenæse (snue)
English: • constipation
Danish: • Forstoppelse
English: Neoplasms benign, malignant and unspecified (including cysts and polyps) Uncommon: skin melanoma (0.5% vs. 0.3%)
Danish: cyster og polypper) Ikke almindelig: Hudmelanom (0,5% vs. 0,3%) Metabolisme og ernæring
English: Common: decreased weight (4.5% vs. 1.5%) Injury, poisoning and procedural complications Common: fall (4.7% vs. 3.4%)
Danish: Traumer, forgiftninger og behandlingskomplikationer Almindelig: Faldulykker (4,7% vs. 3,4%)
English: How to take Rasagiline Mylan
Danish: SÅDAN SKAL DE TAGE Rasagilin Mylan
English: Uncommon: myocardial infarction (0.7% vs. 0%) Respiratory, thoracic and mediastinal disorders Common: rhinitis (3.4% vs. 0.7%)
Danish: Almindelig: Angina pectoris (1,3% vs. 0%) Ikke almindelig: Myokardieinfarkt (0,7% vs. 0%) Luftveje, thorax og mediastinum
English: You must wait at least 14 days after stopping Rasagiline Mylan treatment and starting treatment with MAO inhibitors or pethidine.
Danish: De skal vente mindst 14 dage efter at have stoppet behandling med Rasagilin Mylan, inden De påbegynder behandling med fluoxetin eller fluvoxamin.
English: General disorders and administration site conditions Common: fever (2.7% vs. 1.3%), malaise (2% vs. 0%)
Danish: Almindelig: Pludseligt opstået vandladningstrang (1,3% vs. 0,7%) Almene symptomer og reaktioner på administrationsstedet Almindelig: Feber (2,7% vs. 1,3%), utilpashed (2% vs. 0%)
English: Tel: + 49-(0) 6172 888 01
Danish: Mylan dura GmbH Tel: + 49-(0) 6172 888 01
English: If you stop taking Rasagiline Mylan
Danish: Hvis De har taget for meget Rasagilin Mylan
English: Common: flatulence (1.3% vs.0%)
Danish: Almindelig: Leukopeni (1,3% vs. 0%) Immunsystemet
English: Very common: headache (14.1% vs. 11.9%) Uncommon: cerebrovascular accident (0.7% vs. 0%)
Danish: Meget almindelig: Hovedpine (14,1% vs. 11,9%)
English: Common: rash (1.1% vs. 0.3%)
Danish: Almindelig: Rhinitis (3,4% vs. 0,7%)
English: Keep this medicine out of the sight and reach of children.
Danish: Opbevar lægermidlet utilgængeligt for børn.
English: Common: allergy (1.3% vs. 0.7%)
Danish: Almindelig: Allergisk reaktion (1,3% vs. 0,7%) Metabolisme og ernæring
English: Concomitant treatment with other monoamine oxidase (MAO) inhibitors (including medicinal and natural products without prescription e.g. St. John's Wort) or pethidine (see section 4.5).
Danish: lægemidler og naturlægemidler i håndkøb, f.eks. perikon) eller pethidin (se pkt.
English: • Uncommon (may affect up to 1 in 100 people)
Danish: • Almindelig (kan forekomme hos mellem 1 og 10 ud af 100 personer)
English: Uncommon: cerebrovascular accident (0.5% vs. 0.3%) Cardiac disorders
Danish: Ikke almindelig: Cerebrovaskulært tilfælde (0,5% vs. 0,3%)
English: Other medicines and Rasagiline Mylan
Danish: INFORMATION I BRAILLE-SKRIFT Rasagilin Mylan
English: • Rare (may affect up to 1 in 1,000 people)
Danish: • Sjælden (kan forekomme hos mellem 1 og 10 ud af 10.000 personer)
English: Musculoskeletal and connective tissue disorders Common: arthralgia (2.4% vs. 2.1%), neck pain (1.3% vs. 0.5%)
Danish: Almindelig: Udslæt (1,1% vs. 0,3%) Knogler, led, muskler og bindevæv Almindelig: Artralgi (2,4% vs. 2,1%), nakkesmerter (1,3% vs. 0,5%) Undersøgelser
English: BLISTER
Danish: • Vægttab
English: If you are starting treatment with fluoxetine or fluvoxamine, you should wait at least 14 days after stopping Rasagiline Mylan treatment.
Danish: De skal vente mindst 5 uger efter at have stoppet behandling med fluoxetin, inden De påbegynder behandling med Rasagilin Mylan.
English: Vascular disorders
Danish: • Nakkesmerter
English: Rasagiline Mylan
Danish: Rasagilin Mylan indeholder:
English: For safety reasons:
Danish: Af sikkerhedsmæssige grunde:
English: Read other side first
Danish: Læs den anden side først
English: There is no evidence that such an interaction would be harmful.
Danish: Der er intet som tyder på at sådan interaktion vil være skadelig.
English: Date of first authorisation: April 2015
Danish: Dato for første markedsføringstilladelse: April 2015
English: Store in a refrigerator (2C - 8C).
Danish: Opbevares i køleskab (2 C - 8 C).
English: Ristempa has not been tested in pregnant women.
Danish: Ristempa er ikke blevet testet på gravide kvinder.
English: Ristempa is for use in adults aged 18 and over.
Danish: Ristempa er beregnet til voksne fra 18 år og opefter.
English: Do not warm Ristempa in any other way (for example, do not warm it in a microwave or in hot water).
Danish: Opvarm ikke Ristempa på nogen anden måde (De bør for eksempel ikke opvarme den i mikrobølgeovn eller i varmt vand).
English: Do not shake Ristempa vigorously as this may affect its activity.
Danish: Ryst ikke Ristempa kraftigt, da dette kan have negativ indflydelse på dets virkning.
English: The frequency category was estimated from a statistical calculation based upon 1576 patients receiving Ristempa in nine randomized clinical trials.
Danish: Frekvensen blev estimeret ud fra en statistisk beregning baseret på 1.576 patienter, der fik Ristempa i ni randomiserede kliniske studier.
English: The concentration is 10 mg/ml based on protein only**.
Danish: Koncentrationen er 10 mg/ml udelukkende baseret på protein**.
English: If a serious allergic reaction occurs, appropriate therapy should be administered, with close patient follow-up over several days.
Danish: Hvis der opstår en alvorlig allergisk reaktion, skal passende behandling institueras med nøje patientopfølgning i flere dage.
English: Reference Guide - Read all instructions found in the carton before use
Danish: Referencevejledning - læs alle instruktioner, der ligger i pakningen, før brug
English: Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made
Danish: 4.8, 5.1 og 5.2, men der kan ikke gives nogen anbefalinger vedrørende dosering.
English: If someone else is injecting you, they can also use the back of your arms.
Danish: Hvis en anden person giver Dem indsprøjtningen, kan bagsiden af Deres arme
English: • alcohol wipes or similar.
Danish: • afspritningsservietter eller lignende.
English: ** The concentration is 20 mg/ml if the PEG moiety is included.
Danish: ** Koncentrationen er 20 mg/ml, hvis PEG-delen er inkluderet.
English: 9/l or greater have been observed in less than 1% of patients receiving Ristempa.
Danish: 9/l eller højere er set hos mindre end 1% af patienter, behandlet med Ristempa.
English: The potency of this product should not be compared to the potency of another pegylated or nonpegylated protein of the same therapeutic class.
Danish: Dette produkts styrke bør ikke sammenlignes med et andet pegyleret eller ikke-pegyleret proteins styrke af samme terapeutiske klasse.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Accidental exposure to freezing temperatures for a single period of less than 24 hours does not adversely affect the stability of Ristempa.
Danish: Tilfældig udsættelse for frostgrader i en enkelt periode på mindre end 24 timer har ikke nogen skadelig indvirkning på stabiliteten af Ristempa.
English: • The expiry date printed on the label has passed the last day of the month shown.
Danish: • Udløbsdatoen, der er trykt på etiketten, er overskredet (den sidste dag i den viste måned
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) ) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal fremsende PSUR'er for dette lægemiddel i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: RELEASE your thumb.
Danish: GIV SLIP med tommelfingeren.
English: • Ristempa is given as an injection into the tissue just under the skin (subcutaneous injection).
Danish: • Ristempa gives som en injektion i vævet lige under huden (subkutan injektion).
English: This adverse reaction was identified through post-marketing surveillance but not observed in randomised, controlled clinical trials in adults.
Danish: Denne bivirkning er påvist i forbindelse med overvågning efter markedsføring, men ikke observeret i de randomiserede, kontrollerede kliniske studier hos voksne.
English: However, the long-term effects of Ristempa have not been established in acute myeloid leukaemia; therefore, it should be used with caution in this patient population.
Danish: Den langsigtede virkning af Ristempa er dog ikke blevet fastslået ved akut myeloid leukæmi, og skal derfor anvendes med forsigtighed i denne patientpopulation.
English: Front - Ristempa reference guide:
Danish: Forside - Ristempa referencevejledning:
English: The most frequently reported adverse reactions were bone pain (very common [≥ 1/10]) and musculoskeletal pain (common).
Danish: De hyppigst rapporterede bivirkninger var knoglesmerter (meget almindelig [≥ 1/10]) og muskuloskeletale smerter (almindelig).
English: You can use: • Upper part of your thigh.
Danish: De kan bruge: • et sted på den øverste del af
English: Ristempa may be used if it is accidentally frozen for a single period of less than 24 hours.
Danish: Ristempa kan anvendes, hvis det ved et uheld har været nedfrosset en enkelt gang i mindre end 24 timer.
English: You may notice a small air bubble in the pre-filled syringe.
Danish: Man kan se en lille luftboble i den fyldte sprøjten.
English: In animal models concomitant administration of Ristempa and 5-fluorouracil (5-FU) or other antimetabolites has been shown to potentiate myelosuppression.
Danish: I dyremodeller er samtidig administration af Ristempa og 5-fluoruracil (5-FU) eller andre antimetabolitter blevet vist at øge myelosuppression.
English: Check the appearance of Ristempa.
Danish: Kontroller udseendet af Ristempa.
English: Limited data indicate that the pharmacokinetics of pegfilgrastim in elderly subjects (> 65 years) is similar to that in adults.
Danish: Begrænsede data indikerer at farmakokinetikken for pegfilgrastim hos ældre forsøgspersoner ( 65 år) er tilsvarende den hos voksne.
English: Ristempa therapy should be initiated and supervised by physicians experienced in oncology and/or haematology.
Danish: Ristempa-terapi skal påbegyndes og overvåges af læger, der har erfaring med onkologi og/eller hæmatologi.
English: • if you are allergic to pegfilgrastim, filgrastim, E. coli derived proteins, or any of the other ingredients of this medicine.
Danish: • hvis De er allergisk over for pegfilgrastim, filgrastim, proteiner, der stammer fra E. coli, eller et af de øvrige indholdsstoffer i dette lægemiddel.
English: Do not use Ristempa
Danish: Brug ikke Ristempa
English: Single doses of 300 µg/kg have been administered subcutaneously to a limited number of healthy volunteers and patients with non-small cell lung cancer without serious adverse reactions.
Danish: Der er indgivet enkelt doser på 300 µg/kg subkutant til et begrænset antal raske frivillige og patienter med ikke-småcellet lungecancer uden alvorlige bivirkninger.