FrancophonIA/ELRC3.0 huggingface dataset:
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological disorder (NOS), peripheral neuropathy
Danish: Ikke almindelig Status epilepticus, ekstrapyramidal lidelse, hemiparese, ataksi, nedsat kognition, dysfasi, unormal gang, hyperesthesia, hypoesthesia, neurologisk lidelse (NOS), perifer neuropati
English: Medicinal product subject to medical prescription.
Danish: Receptpligtigt lægemiddel
English: Rash, pruritus, alopecia
Danish: Udslæt, kløe, alopeci
English: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Rare
Danish: Hyppigheden er defineret i henhold til følgende konvention: Meget almindelig (≥ 1/10); almindelig (≥ 1/100 til < 1/10); ikke almindelig (≥ 1/1.000 til <1/100); sjælden (≥ 1/10.000 til< 1/1.000); meget sjælden (< 1/10.000); ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: You might be more prone to infections, bruising or bleeding.
Danish: • Hvis du er ældre end 70 år, kan du være mere modtagelig over for infektioner eller have øget tendens til at få blå mærker og bløde.
English: What you need to know before you take Temozolomide Sandoz Do not take Temozolomide Sandoz
Danish: Det skal du vide, før du begynder at tage Temozolomide Sandoz
English: Dose in Cycle 1 (monotherapy) is 150 mg/m2 once daily for
Danish: Dosis i serie 1 (monoterapi) er 150 mg/m2 én gang dagligt i 5 dage efterfulgt af 23 dage uden behandling.
English: Printing ink: shellac, black iron oxide (E 172), potassium hydroxide.
Danish: − blæk: shellac, sort jernoxid (E 172), kaliumhydroxid.
English: Pregnancy, breast-feeding and fertility
Danish: Graviditet, amning og frugbarhed
English: Dyspnoea, coughing
Danish: Dyspnø, hoste
English: Capsule shell: gelatine, titanium dioxide (E 171), water.
Danish: − kapselskal: gelatine, titandioxid (E 171), vand.
English: Each hard capsule contains 131.4 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 131,4 mg Lactose, vandfri.
English: Infections and infestations Common:
Danish: Infektioner og infestationer
English: Micturition frequency, urinary incontinence
Danish: Øget vandladningsfrekvens, urininkontinens
English: Urinary incontinence
Danish: Urininkontinens
English: Temozolomide Sandoz 5 mg hard capsules Each capsule contains 5 mg temozolomide.
Danish: Temozolomide Sandoz 5 mg hårde kapsler Hver kapsel indeholder 5 mg temozolomid.
English: Each hard capsule contains 14.6 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 14,6 mg Lactose, vandfri.
English: • haemorrhoids
Danish: • kulderystelser
English: Each hard capsule contains 73 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 73 mg Lactose, vandfri.
English: What Temozolomide Sandoz is and what it is used for
Danish: Temozolomide Sandoz er indiceret til behandling af:
English: Each hard capsule contains 20 mg temozolomide.
Danish: Hver hård kapsel indeholder 20 mg temozolomid.
English: • hair loss
Danish: • hårtab
English: Uncommon (may affect up to 1 in 100 people):
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 behandlede):
English: Titanium dioxide (E 171) Indigo carmine (E 132) Water
Danish: Titandioxid (E 171) Indigotin (E 132)* Vand
English: Fever, asthenia, rigors, malaise, pain, taste perversion
Danish: Feber, asteni, rigor, alment ubehag, smerte, smagsforstyrrelser
English: Temozolomide Sandoz 20 mg hard capsules Each capsule contains 20 mg temozolomide.
Danish: Temozolomide Sandoz 20 mg hårde kapsler Hver kapsel indeholder 20 mg temozolomid.
English: Each hard capsule contains 5 mg temozolomide.
Danish: Hver hård kapsel indeholder 5 mg temozolomid.
English: Pneumonia, upper respiratory infection, nasal congestion
Danish: Ikke almindelig Lungebetændelse, øvre luftvejsinfektion, næsetæthed
English: Based on a population pharmacokinetic analysis in patients 19-78 years of age, clearance of TMZ is not affected by age.
Danish: På baggrund af en analyse af populationsfarmakokinetikken for patienter mellem 19-78 år er TMZclearance ikke afhængig af alder. Ældre patienter (> 70 år) ser dog ud til at have øget risiko for udviklingen af neutropeni og trombocytopeni (se pkt.
English: Each hard capsule contains 250 mg temozolomide.
Danish: Hver hård kapsel indeholder 250 mg temozolomid.
English: Your doctor will work out your dose of Temozolomide Sandoz.
Danish: Dosis og varighed af behandlingen Din læge vil fastsætte den præcise dosis Temozolomide Sandoz til dig.
English: Capsule shell
Danish: Kapselskal:
English: Skin and subcutaneous tissue disorders Common:
Danish: Hud og subkutane væv Almindelig
English: Temozolomide Sandoz 250 mg hard capsules Each capsule contains 250 mg temozolomide.
Danish: Temozolomide Sandoz 250 mg hårde kapsler Hver kapsel indeholder 250 mg temozolomid.
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Danish: Kontakt lægen, før du tager dette lægemiddel, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Treatment-emergent events during concomitant and monotherapy treatment phases in patients with newly-diagnosed glioblastoma multiforme System organ class
Danish: Bivirkninger fremkommet hos patienter med ny diagnosticeret glioblastoma multiforme under behandlingsfaserne med konkomitant behandling og monoterapi Systemorganklasse
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance
Danish: Hemiparese, ataksi, nedsat koordinationsevne, unormal gang, hyperestesi, føleforstyrrelse
English: How to take Temozolomide Sandoz
Danish: Sådan tages Temozolomide Sandoz
English: Respiratory, thoracic and mediastinal disorders Common:
Danish: Luftveje, thorax og mediastinum Almindelig
English: Asthenia, flushing, hot flushes, condition aggravated, rigors, tongue discolouration, parosmia, thirst
Danish: Ikke almindelig Asteni, rødmen, hedestigninger, forværret tilstand, rigor, misfarvet tunge, parosmi, tørst
English: Temozolomide Sandoz 140 mg hard capsules Each capsule contains 140 mg temozolomide.
Danish: Temozolomide Sandoz 140 mg hårde kapsler Hver kapsel indeholder 140 mg temozolomid.
English: Renal and urinary disorders Common:
Danish: Nyrer og urinveje Almindelig
English: Convulsions were reported very commonly in the newly-diagnosed glioblastoma multiforme patients receiving monotherapy, and rash was reported very commonly in newly-diagnosed glioblastoma multiforme patients receiving TMZ concurrent with RT and also as monotherapy, and commonly in recurrent glioma.
Danish: Hos patienter med nyligt diagnosticeret glioblastoma multiforme, der fik TMZ samtidig med strålebehandling eller som monoterapi, blev udslæt rapporteret som værende meget almindeligt.
English: • wound infection
Danish: • sårinfektion
English: Cerebral haemorrhage, hypertension Embolism pulmonary, oedema, oedema peripheral
Danish: Ikke almindelig Hjerneblødning, hypertension Lungeemboli, ødem, perifert ødem
English: Common (may affect up to 1 in 10 people):
Danish: Almindelig (kan forekomme hos op til 1 ud af 10 behandlede):
English: Temozolomide Sandoz 100 mg hard capsules pink
Danish: Temozolomide Sandoz 100 mg hårde kapsler pink
English: Vomiting, nausea, constipation
Danish: Opkastning, kvalme, forstoppelse
English: Hemiplegia, ataxia, coordination abnormal, gait abnormal, hyperesthesia, sensory disturbance disorder (NOS), peripheral neuropathy
Danish: Hemiparese, ataksi, nedsat koordinationsevne, unormal gang, hyperæstesi, føleforstyrrelse hypoesthesia, neurologisk lidelse (NOS), perifer neuropati
English: Temozolomide Sandoz 180 mg hard capsules Each capsule contains 180 mg temozolomide.
Danish: Temozolomide Sandoz 180 mg hårde kapsler Hver kapsel indeholder 180 mg temozolomid.
English: Temozolomide Sandoz 140 mg hard capsules blue
Danish: Temozolomide Sandoz 140 mg hårde kapsler blå
English: Myopathy, back pain, musculoskeletal pain, myalgia
Danish: Ikke almindelig Myopati, rygsmerte, muskuloskeletal smerte, myalgi
English: Very common:
Danish: Meget almindelig
English: Each hard capsule contains 102.2 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 102,2mg Lactose, vandfri.
English: Each hard capsule contains 180 mg temozolomide.
Danish: Hver hård kapsel indeholder 180 mg temozolomid.
English: • vaginal bleeding
Danish: • vaginal blødning
English: Capsule shell: gelatine, titanium dioxide (E 171), indigo carmine (E 132), water.
Danish: − kapselskal: gelatine, titandioxid (E 171), indigotin (E 132), vand.
English: • pneumonia
Danish: • lungebetændelse
English: Hyperglycaemia, weight decreased
Danish: Hyperglykæmi, vægttab
English: At the start of Cycle 2, the dose is escalated to 200 mg/m2 if the CTC non-haematological toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia,
Danish: Ved begyndelsen af serie 2 øges dosis til 200 mg/m2, hvis CTC ikke-hæmatologisk toksicitet for serie 1 er Grad ≤ 2 (undtagen alopeci, kvalme og opkastning), det absolutte neutrofiltal (ANC) er ≥ 1,5 x 109/l og trombocyttallet er ≥ 100 x 109/l.
English: • infection of the middle ear
Danish: • mellemørebetændelse
English: Vascular disorders Common:
Danish: Vaskulære sygdomme Almindelig
English: Titanium dioxide (E 171) Red iron oxide (E 172) Water
Danish: Titandioxid (E 171) Rød jernoxid (E 172) Vand
English: Temozolomide Sandoz 5 mg hard capsules
Danish: Temozolomide Sandoz 5 mg hårde kapsler
English: Temozolomide Sandoz 250 mg hard capsules white
Danish: Temozolomide Sandoz 250 mg hårde kapsler hvid
English: Men being treated with TMZ should be advised not to father a child up to 6 months after receiving the last dose and to seek advice on cryoconservation of sperm prior to treatment (see section 4.6).
Danish: Mænd, der behandles med TMZ, bør derfor frarådes at gøre nogen gravid i op til 6 måneder efter at have modtaget den sidste dosis.
English: Blood and lymphatic system disorders Common:
Danish: Blod og lymfesystem Almindelig
English: Each hard capsule contains 168 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 168 mg Lactose, vandfri.
English: Each hard capsule contains 140 mg temozolomide.
Danish: Hver hård kapsel indeholder 140 mg temozolomid.
English: Temozolomide Sandoz 5 mg hard capsules green
Danish: Temozolomide Sandoz 5 mg hårde kapsler grøn
English: Status epilepticus, extrapyramidal disorder, hemiparesis, ataxia, cognition impaired, dysphasia, gait abnormal, hyperesthesia, hypoesthesia, neurological
Danish: Ikke almindelig Status epilepticus, ekstrapyramidal lidelse, hemiparese, ataksi, nedsat kognition, dysfasi, unormal gang, hyperesthesia,
English: • bruising, shaking
Danish: Myopati, rygsmerte
English: Each hard capsule contains 182.5 mg of anhydrous lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver hård kapsel indeholder 182,5 mg Lactose, vandfri.
English: • seizures (convulsions),
Danish: • anfald (kramper)
English: • dizziness
Danish: • udslæt
English: Temozolomide Sandoz 250 mg hard capsules
Danish: Temozolomide Sandoz 250 mg hårde kapsler
English: Bottle Do not store above 25 °C.
Danish: Brev Må ikke opbevares ved temperaturer over 25 °C.
English: Each hard capsule contains 100 mg temozolomide.
Danish: Hver hård kapsel indeholder 100 mg temozolomid.
English: Temozolomide Sandoz 100 mg hard capsules Each capsule contains 100 mg temozolomide.
Danish: Temozolomide Sandoz 100 mg hårde kapsler Hver kapsel indeholder 100 mg temozolomid.
English: Temozolomide Sandoz is indicated for the treatment of: adult patients with newly-diagnosed glioblastoma multiforme concomitantly with radiotherapy (RT) and subsequently as monotherapy treatment, children from the age of three years, adolescents and adult patients with malignant glioma, such as glioblastoma multiforme or anaplastic astrocytoma, showing recurrence or progression after standard therapy.
Danish: − børn fra 3 år, unge og voksne med malignt gliom, såsom glioblastoma multiforme eller anaplastisk astrocytom, der får recidiv eller progression efter standardbehandling.
English: Temozolomide Sandoz 140 mg hard capsules
Danish: Temozolomide Sandoz 140 mg hårde kapsler
English: Temozolomide Sandoz 20 mg hard capsules
Danish: Temozolomide Sandoz 20 mg hårde kapsler
English: Stomatitis, diarrhoea, dyspepsia, dysphagia, mouth dry
Danish: Stomatitis, diarré, dyspepsi, dysfagi, mundtørhed
English: Temozolomide Sandoz 20 mg capsules temozolomide
Danish: Temozolomide Sandoz 20 mg kapsler temozolomid
English: The hard capsules have a white coloured body, a transparent blue coloured cap, and are imprinted with black ink.
Danish: De hårde kapsler har en hvid krop og, en gennemsigtig blå hætte og er præget med sort blæk.
English: Temozolomide Sandoz 140 mg capsules temozolomide
Danish: Temozolomide Sandoz 140 mg kapsler temozolomid
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Indigo carmine (E132) Water
Danish: Titandioxid (E 171) Gul jernoxid (E 172) Indigotin (E 132)* Vand
English: Temozolomide Sandoz 20 mg hard capsules temozolomide
Danish: Temozolomide Sandoz 20 mg hårde kapsler temozolomid
English: Temozolomide Sandoz 5 mg hard capsules temozolomide
Danish: Temozolomide Sandoz 5 mg hårde kapsler temozolomid
English: Temozolomide Sandoz 100 mg hard capsules
Danish: Temozolomide Sandoz 100 mg hårde kapsler
English: Temozolomide Sandoz 20 mg hard capsules yellow
Danish: Temozolomide Sandoz 20 mg hårde kapsler gul
English: • earache
Danish: • ørepine
English: Temozolomide Sandoz 180 mg hard capsules
Danish: Temozolomide Sandoz 180 mg hårde kapsler
English: • headache
Danish: • hedeture
English: Capsule shell: gelatine, titanium dioxide (E 171), red iron oxide (E 172), water.
Danish: − kapselskal: gelatine, titandioxid (E 171), rød jernoxid (E 172), vand.
English: Once escalated, the dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs.
Danish: Når dosis en gang er steget, bibeholdes den på 200 mg/m2 per dag i de første
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Red iron oxide (E 172) Water
Danish: Titandioxid (E 171) Gul jernoxid (E 172) Rød Jernoxid (E 172) Vand
English: Temozolomide Sandoz 250 mg hard capsules temozolomide
Danish: Temozolomide Sandoz 250 mg hårde kapsler temozolomid
English: Temozolomide Sandoz 140 mg hard capsules temozolomide
Danish: Temozolomide Sandoz 140 mg hårde kapsler temozolomid
English: Temozolomide Sandoz 100 mg capsules temozolomide
Danish: Temozolomide Sandoz 100 mg kapsler temozolomid
English: Weight decreased
Danish: Nedsat hørelse
English: • stomach or abdominal pain
Danish: • mave- eller underlivssmerter
English: If you take more Temozolomide Sandoz than you should
Danish: Hvis du har taget for meget Temozolomide Sandoz
English: Diarrhoea, abdominal pain, dyspepsia
Danish: Diarré, mavesmerte, dyspepsi
English: Titanium dioxide (E 171) Yellow iron oxide (E 172) Water
Danish: Titandioxid (E 171) Gul jernoxid (E 172) Vand
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), indigo carmine (E 132), water.
Danish: − kapselskal: gelatine, titandioxid (E 171), gul jernoxid (E 172), indigotin (E 132), vand.
English: Temozolomide Sandoz 100 mg hard capsules temozolomide
Danish: Temozolomide Sandoz 100 mg hårde kapsler temozolomid
English: Temozolomide Sandoz 180 mg hard capsules temozolomide
Danish: Temozolomide Sandoz 180 mg hårde kapsler temozolomid
English: The hard capsules have a white coloured body, a yellow coloured cap, and are imprinted with black ink.
Danish: De hårde kapsler har en hvid krop og en gul hætte og er præget med sort blæk.
English: Your dose of Temozolomide Sandoz may need to be adjusted.
Danish: • Hvis du har problemer med leveren eller nyrerne, skal din dosis af Temozolomide Sandoz muligvis justeres.
English: Capsule content Anhydrous lactose Colloidal anhydrous silica Sodium starch glycolate type A Tartaric acid
Danish: Kolloid vandfri silica Natriumstivelsesglycolat (type A) Vinsyre
English: Skin and subcutaneous tissue disorders Very common:
Danish: Hud og subkutane væv Meget almindelig Udslæt, alopeci
English: In patients treated with TMZ, whether used in combination with RT or as monotherapy following RT for newly-diagnosed glioblastoma multiforme, or as monotherapy in patients with recurrent or progressive glioma, the reported very common adverse reactions were similar: nausea, vomiting, constipation, anorexia, headache and fatigue.
Danish: Dette er gældende for patienter med nyligt diagnosticeret glioblastoma multiforme, der behandles i kombination med strålebehandling, eller som behandles med monoterapi efterfulgt af strålebehandling, samt for patienter med recidiv eller progressivt gliom, der behandles med monoterapi.
English: Eye disorders Common:
Danish: Øjne Almindelig
English: Adult and paediatric patients 3 years of age or older with recurrent or progressive malignant glioma A treatment cycle comprises 28 days.
Danish: Voksne og børn fra 3 år med tilbagevendende eller progressivt malignt gliom:
English: • oral infections
Danish: • infektioner i munden
English: • vomiting
Danish: • opkastning
English: Constipation, nausea, vomiting Constipation, nausea, vomiting
Danish: Meget almindelig Forstoppelse, kvalme, opkastning Forstoppelse, kvalme,
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), red iron oxide (E 172), water.
Danish: − kapselskal: gelatine, titandioxid (E 171), gul jernoxid (E 172), rød jernoxid (E 172), vand.
English: The hard capsules have a white coloured body, a pink coloured cap, and are imprinted with black ink.
Danish: De hårde kapsler har en hvid krop og en lyserød hætte og er præget med sort blæk.
English: Otitis media, tinnitus, hyperacusis, earache Deafness, vertigo, earache
Danish: Ikke almindelig Mellemørebetændelse, tinnitus, lydoverfølsomhed, ørepine
English: The hard capsules have a white coloured body, a green coloured cap, and are imprinted with black ink.
Danish: De hårde kapsler har en hvid krop og en grøn hætte og er præget med sort blæk.
English: Gastrointestinal disorders Very common:
Danish: Mave-tarm-kanalen Meget almindelig
English: Anti-emetic therapy
Danish: Antiemetisk behandling
English: • sleepiness
Danish: • søvnighed
English: Capsule shell: gelatine, titanium dioxide (E 171), yellow iron oxide (E 172), water.
Danish: − kapselskal: gelatine, titandioxid (E 171), gul jernoxid (E 172), vand.
English: The hard capsules have a white coloured body, a white coloured cap, and are imprinted with black ink.
Danish: De hårde kapsler har en hvid krop og en hvid hætte og er præget med sort blæk.
English: INSTRUCTIONS ON USE
Danish: INSTRUKTIONER VEDRØRENDE ANVENDELSEN 16.
English: Palpitation
Danish: Trombocyttal
English: Uncommon:
Danish: Ikke almindelig:
English: They generally do not get worse after this time.
Danish: Almindeligvis vil de ikke blive værre efter dette tidspunkt.
English: • It is best to use Fuzeon at the same time each day.
Danish: • Det er bedst, at Fuzeon bruges på samme tidspunkt hver dag.
English: What to do if you are left-handed
Danish: Hvad du skal gøre, hvis du er venstrehåndet
English: If you are left-handed, do what comes naturally to you.
Danish: Hvis du er venstrehåndet, skal du gøre det, som falder dig naturligt.
English: # Last value carried forward.
Danish: # Seneste værdi fremført.
English: To reduce the risk of infection, it is important that you follow the instructions provided in Section 7.
Danish: For at reducere risikoen for infektion er det vigtigt, at du følger instruktionen, der gives i Afsnit 7.
English: You will probably find it most comfortable to:
Danish: Du vil sikkert finde det nemmest at:
English: Please contact your doctor if this occurs.
Danish: Kontakt din læge, hvis dette sker
English: Typically, such reactions have been observed within the first few weeks or months of initiation of CART.
Danish: Typisk er sådanne reaktioner observeret inden for de første få uger eller måneder efter påbegyndelsen af CART.
English: 2Based on GSS score.
Danish: 2Baseret på GSS-score.
English: Take the medicine pack with you.
Danish: Tag pakken med medicin med dig
English: As per the judgment of the investigator.
Danish: I henhold til investigators skøn.
English: Interaction studies have only been performed in adults.
Danish: Interaktionsstudier er kun udført på voksne.
English: Passing HIV to others
Danish: Overførsel af hiv til andre
English: This is less likely if you use it regularly and without gaps in treatment.
Danish: Dette er mindre sandsynligt, hvis du bruger det regelmæssigt og uden pauser i behandlingen.
English: • Keep using your medicine until your doctor tells you to stop.
Danish: • Bliv ved med at tage din medicin, indtil lægen siger, du skal stoppe.
English: This will reduce the risk of bacterial infections.
Danish: Dette vil nedsætte risikoen for infektion med bakterier.
English: This improvement enables the body to fight infections that may have been present with no obvious symptoms.
Danish: Denne forbedring gør kroppen i stand til at bekæmpe infektioner, der kan have været til stede uden tydelige symptomer.
English: - you will hear a click.
Danish: - Du vil kunne høre et klik.
English: Includes discontinuations from loss to follow-up, treatment refusal, and other reasons.
Danish: Inkluderer tabt for follow-up, afvisning af behandling og andre årsager.
English: 27 May 2003
Danish: 27. maj 2003
English: You will probably have one or more of the following mild to moderate reactions:
Danish: Sandsynligvis vil du få en eller flere af følgende lette til middelsvære reaktioner:
English: 27 May 2008
Danish: 27. maj 2008
English: MARKETING AUTHORISATION NUMBER(S) EU/1/03/252/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/03/252/001
English: Fuzeon helps by preventing this.
Danish: Fuzeon virker ved at forhindre dette.
English: The pictures in this leaflet show people who are right-handed.
Danish: Billederne i indlægssedlen viser personer, som er højrehåndede.
English: • changes shown in blood tests (increased blood fat)
Danish: • ændringer i blodprøver (stigning i fedt i blodet)
English: Precautions to prevent transmission should be taken in accordance with national guidelines.
Danish: Der skal tages forholdsregler til at forebygge transmission i overensstemmelse med nationale retningslinjer.
English: This may feel like lumps under the skin.
Danish: Det kan føles som knuder under huden.
English: Solvent 4 years
Danish: Solvens 4 år
English: This may result in a false positive HIV test with the anti-HIV ELISA test.
Danish: Det kan resultere i en falsk positiv hiv-test med ELISA-testen.
English: The severity of the pain and discomfort did not increase with treatment duration.
Danish: Sværhedsgraden af smerte og ubehag blev ikke øget ikke med behandlingsvarigheden.
English: The clinical relevance of these findings is unknown.
Danish: Den kliniske relevans af disse fund kendes ikke.
English: 4.8 Undesirable effects a. Summary of the safety profile
Danish: 4.8 Bivirkninger a. Resumé af sikkerhedsprofil
English: Long-term animal carcinogenicity studies have not been performed.
Danish: Der er ikke udført langtidsstudier på dyr for karcinogenicitet.
English: Ecchymosis g g aAny severity grade.
Danish: Ecchymosis g g aEnhver sværhedsgrad.
English: No case of overdose has been reported.
Danish: Der er ikke indberettet tilfælde af overdosering.
English: From a microbiological point of view, the product should be used immediately.
Danish: Fra et mikrobiologisk synspunkt skal præparatet anvendes straks.
English: • hold the syringe in your left hand and
Danish: • holde sprøjten i venstre hånd og
English: System organ class Frequency
Danish: System-organklasse Hyppighed
English: They may also be worse when the injection is given deeper than intended (for example, into a muscle).
Danish: De kan også forværres, hvis indsprøjtningerne gives dybere end beregnet (for eksempel i en muskel).