FrancophonIA/ELRC3.0 huggingface dataset:
English: Therefore, aripiprazole should be used with caution in patients who have a history of seizure disorder or have conditions associated with seizures (see section 4.8).
Danish: Aripiprazol skal dog anvendes med forsigtighed til patienter, der tidligere har haft krampeanfald, eller som lider af tilstande forbundet med krampeanfald (se pkt.
English: Extrapyramidal disorder Akathisia Tremor
Danish: Ekstrapyramidal e forstyrrelser Akatisi
English: • muscle rigidity, muscle spasms, muscle twitching, muscle tightness, mucle pain (myalgia), pain in extremity
Danish: • Muskelstivhed, muskelspasmer, muskeltrækninger, muskelspændinger, muskelsmerter (myalgi),
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial solvent
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglas med solvens
English: Step 3: Injection procedure a) Twist and pull off Over-cap and Tip-cap.
Danish: Trin 3: Forberedelser inden injektionen a) Overhætten drejes og tages af, og spidshætten drejes og tages af.
English: Intramuscular use only
Danish: Kun til intramuskulær anvendelse.
English: Proportion of subjects free of impending relapse
Danish: Andelen af patienter uden imminent recidiv
English: • antidepressants or herbal remedy used to treat depression and anxiety (such as fluoxetine,
Danish: • antidepressiva eller naturmedicin mod depression og angst (fx fluoxetin, paroxetin eller perikon)
English: PANSS Total Score - Change From Baseline to Week 38-LOCF: Randomised Efficacy Samplea, b
Danish: Samlet PANSS-score - ændring fra baseline til uge 38 (LOCF): Analyse baseret på effektpopulationena, b
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - Single pack 300 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton - enkeltpakning 300 mg
English: Powder and solvent for prolonged-release suspension for injection
Danish: Pulver og solvens til depotinjektionsvæske, suspension, i fyldt injektionssprøjte
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton - Single pack 400 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton - enkeltpakning 400 mg
English: • experience a combination of fever, sweating, faster breathing, muscle stiffness and drowsiness or sleepiness (may be signs of neuroleptic malignant syndrome)
Danish: svedtendens, hurtig vejrtrækning, muskelstivhed og sløvhed eller søvnighed (kan være tegn på malignt neuroleptikasyndrom)
English: • frequent bowel movement
Danish: • Hyppig afføring
English: The injections will not be given intravenously.
Danish: Injektionen indgives ikke i en blodåre.
English: Liver function test abnormal Hepatic enzyme increased Alanine aminotransferase increased
Danish: Unormal leverfunktionstest Forhøjede leverenzymer Øget alaninaminotransferase Øget gammaglutamyltransferase Forhøjet bilirubin i blodet Øget aspartataminotransferase
English: Carmellose sodium
Danish: Pulver Carmellosenatrium
English: • during tests your doctor may find higher amounts alkaline phosphatase fluctuating results during tests to measure glucose in your blood
Danish: højere niveau af basisk fosfatase svingende resultater under måling af dit blodsukker
English: Visually confirm that the needle is fully engaged into the needle protection sheath, and discard.
Danish: Tjek, at nålen er ført helt ind i sikkerhedshylsteret, og kassér kanylen.
English: Care should be taken to avoid inadvertent injection into a blood vessel.
Danish: Man skal omhyggeligt sikre sig, at injektionen ikke gives i et blodkar.
English: In clinical trials of one year or less duration, there were uncommon reports of treatment emergent dyskinesia during treatment with aripiprazole.
Danish: I kliniske studier af op til et års varighed blev der under behandling med aripiprazol rapporteret behandlingsrelateret dyskinesi med en hyppighed svarende til ikke almindelig.
English: Each single pack containing one vial of powder, 2 ml vial of solvent, one 3 ml luer lock syringe with pre-attached 38 mm (1.5 inch) 21 gauge, hypodermic safety needle with needle protection device, one 3 ml disposable syringe with luer lock tip, one vial adapter and three hypodermic safety needles: one 25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.
Danish: Hver pakning indeholder et hætteglas med pulver, et hætteglas med 2 ml solvens, en 3 ml sprøjte med luer lock og påsat hypodermisk sikkerhedskanyle på 38 mm og 21 gauge med nålebeskyttelse, en 3 ml engangssprøjte med luer lock-spids, en hætteglasadapter samt tre hypodermiske sikkerhedskanyler: én på 25 mm og 23 gauge, én på 38 mm og 22 gauge og én på 51 mm og 21 gauge.
English: Strong CYP2D6 or strong CYP3A4 inhibitors
Danish: Potente CYP2D6-hæmmere eller potente CYP3A4-hæmmere
English: CYP2D6 poor metabolisers
Danish: Langsomme CYP2D6-omsættere
English: Parkinsonism events followed in frequency of 6.9 % for Abilify Maintena, 4.15 % for oral aripiprazole 10-30 mg tablets and 3.0 % for placebo, respectively.
Danish: Maintena-gruppen, 4,15 % for den gruppe, der fik oralt aripiprazol 10-30 mg, og 3,0 % for placebogruppen.
English: Excess amount of gastric juice flowing back (refluxes) into the esophagus (gullet or the tube that goes from mouth to stomach through which food passes),
Danish: For store mængder mavesaft flyder tilbage (refluks) i spiserøret
English: Each single pack containing one pre-filled syringe and three hypodermic safety needles: one 25 mm (1 inch) 23 gauge, one 38 mm (1.5 inch) 22 gauge and one 51 mm (2 inch) 21 gauge.
Danish: Hver pakning indeholder én fyldt injektionssprøjte og tre hypodermiske sikkerhedskanyler: én på 25 mm og 23 gauge, én på 38 mm og 22 gauge og én på 51 mm og 21 gauge.
English: d) If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours.
Danish: h) Hvis der ikke foretages injektion straks efter rekonstitutionen, kan hætteglasset opbevares ved temperaturer under 25 °C i op til 4 timer.
English: If the injection is not performed immediately after reconstitution, the syringe can be kept below 25 °C for up to 2 hours.
Danish: Hvis injektionen ikke gives straks efter rekonstitutionen, kan sprøjten opbevares < 25 °C i op til 2 timer.
English: Strong CYP2D6 and strong CYP3A4 inhibitors
Danish: Potente CYP2D6-hæmmere og potente CYP3A4-hæmmere
English: Akathisia was the most frequently observed symptom (8.2 %) and typically started around day 10 after first injection, and lasted a median of 56 days.
Danish: Akatisi startede typisk omkring dag 10 efter den første injektion og havde en median varighed på 56 dage.
English: How to store Abilify Maintena
Danish: Sådan får du Abilify Maintena
English: c) Use the luer lock syringe to remove the vial adapter from the package and discard the vial adapter package.
Danish: c) Tag hætteglasadapteren ud af dens emballage ved hjælp af luer lock-sprøjten, og kassér emballagen.
English: Diabetic hyperosmolar coma Diabetic ketoacidosis
Danish: Diabetisk hyperosmolær koma
English: Powder and solvent for prolonged-release suspension for injection Multipack: Three single packages, each containing:
Danish: Pulver og solvens til depotinjektionsvæske, suspension, i fyldt injektionssprøjte Multipakning: Tre enkeltpakninger, der hver indeholder Én fyldt injektionssprøjte, der indeholder pulver i forkammeret og solvens i bagkammeret.
English: Abilify Maintena comes as a pre-filled syringe.
Danish: Abilify Maintena leveres i en fyldt sprøjte.
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Each vial contains 300 mg aripiprazole.
Danish: Abilify Maintena 300 mg pulver og solvens til depotinjektionsvæske, suspension Hvert hætteglas indeholder 300 mg aripiprazol.
English: These medicines may increase the risk of side effects or reduce the effect of Abilify Maintena; if you get any unusual symptom taking any of these medicines together with Abilify Maintena, you should see your doctor.
Danish: Disse typer medicin kan øge risikoen for bivirkninger eller reducere virkningen af Abilify Maintena.
English: Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Each vial contains 400 mg aripiprazole.
Danish: Abilify Maintena 400 mg pulver og solvens til depotinjektionsvæske, suspension Hvert hætteglas indeholder 400 mg aripiprazol.
English: Abilify Maintena 300 mg Vial
Danish: Abilify Maintena 300 mg-hætteglas
English: Frequent bowel movement Salivary hypersecretion
Danish: Hyppig afføring Øget spytsekretion
English: And then, rotate plunger rod until the rod stops rotating to release diluent.
Danish: Skru derefter stemplet så langt ned, det kan, så solvens frigives.
English: Dysphoria Sleep disorder Bruxism
Danish: Søvnforstyrrelser Bruksisme
English: Concomitant oral aripiprazole should be restarted for 14 days with next administered injection.
Danish: Samtidig med den næste injektion skal der administreres oralt aripiprazol i 14 dage.
English: Abilify Maintena 300 mg injection aripiprazole
Danish: Abilify Maintena 300 mg injektionsvæske aripiprazol i.m.
English: Injection site pain
Danish: Injektionssted Nålestørrelse
English: • thirstiness more than usual, need to urinate more than usual, feel very hungry, feel weak or tired, feel sick, feel confused or your breath smells fruity, since this may be a sign of diabetes.
Danish: • Usædvanlig tørst, hyppigere vandladning, stor sultfølelse, svagheds- eller træthedsfølelse, kvalme, forvirring eller frugtagtig ånde.
English: Thrombocytopenia Neutrophil count decreased White blood cell count decreased
Danish: Trombocytopeni Nedsat neutrofiltal Nedsat leukocyttal
English: Abilify Maintena 400 mg injection aripiprazole
Danish: Abilify Maintena 400 mg injektionsvæske aripiprazol i.m.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe - 300 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Fyldt injektionssprøjte - 300 mg
English: Abilify Maintena 400 mg Vial
Danish: Abilify Maintena 400 mg-hætteglas
English: The SmPC for Abilify Maintena prolonged-release suspension for injection lists oculogyric crisis in section 4.8 and the PIL lists fixation of eye balls in one position as an uncommon side effect.
Danish: 4.8, og i indlægssedlen nævnes fiksering af øjenæblerne i en fast position som en ikke-almindelig bivirkning.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial powder 300 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglas med pulver 300 mg
English: In case of adverse reactions despite dose adjustments of Abilify Maintena, the necessity of concomitant use of CYP2D6 or CYP3A4 inhibitor should be reassessed.
Danish: Hvis der opstår bivirkninger, selv om Abilify Maintena-dosis justeres, bør nødvendigheden af samtidig brug af
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Pre-filled syringe - 400 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Fyldt injektionssprøjte - 400 mg
English: It is important not to miss your scheduled dose.
Danish: Det er vigtigt, at du får alle de planlagte injektioner.
English: MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial Powder 400 mg
Danish: MINDSTEKRAV TIL MÆRKNING PÅ SMÅ INDRE EMBALLAGER Hætteglas med pulver 400 mg
English: If you are given more Abilify Maintena than you should
Danish: Hvis du har fået for meget Abilify Maintena
English: No cases of overdose associated with adverse reactions were reported in clinical studies with Abilify Maintena.
Danish: Neutropeni er rapporteret i kliniske programmer med Abilify Maintena.
English: 300 mg vial:
Danish: 300 mg-hætteglas:
English: When used concomitantly with strong CYP3A4 inhibitors the dose should be reduced to 200 mg (see section 4.5).
Danish: Hos langsomme CYP2D6-omsættere skal start- og vedligeholdelsesdosis være 300 mg. Ved samtidig administration af potente CYP3A4-hæmmere skal dosis reduceres til 200 mg (se pkt.
English: Gently press the sheath against a flat surface until the needle is firmly engaged in the needle protection sheath.
Danish: Tryk sikkerhedshylsteret forsigtigt mod en plan flade, indtil nålen er ført helt ind i det.
English: Drooling
Danish: Hudinduration
English: • high blood sugar (characterised by symptoms such as excessive thirst, passing of large amounts of urine, increase in appetite and feeling weak) or family history of diabetes
Danish: • forhøjet blodsukker (kendetegnet ved symptomer som fx ekstrem tørst, stor urinproduktion,
English: Dispose of the needle and pre-filled syringe appropriately after injection.
Danish: Efter injektionen skal nålen og injektionssprøjten bortskaffes i henhold til lokale retningslinjer.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer label (with blue box) - Multipack 300 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre mærkning (med blå boks) - multipakning 300 mg
English: Neutropenia
Danish: Ugidelighed
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer label (with blue box) - Multipack 400 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre mærkning (med blå boks) - multipakning 400 mg
English: • delusion
Danish: • Besvimelse
English: • injection site reactions such as redness, swelling discomfort and injection site itching
Danish: • Reaktioner på injektionsstedet, fx rødme, hævelse og kløe
English: abnormal reading (ECG) of the heart
Danish: Unormalt ekg Ekg: inversion af T-takken
English: Each vial contains 400 mg aripiprazole.
Danish: Hvert hætteglas indeholder 400 mg aripiprazol.
English: Abdominal pain upper Abdominal discomfort Constipation
Danish: Smerter i øvre del af maven Ubehag i maven Forstoppelse
English: Each vial contains 300 mg aripiprazole.
Danish: Hvert hætteglas indeholder 300 mg aripiprazol.
English: • muscle stiffness
Danish: • Muskelstivhed
English: Dry mouth Gastrooesophageal reflux disease
Danish: Gastroøsofageal reflukssygdom Dyspepsi
English: The incidence of weight loss of ≥ 7 % from baseline to last visit was 10.2 % for Abilify Maintena and 4.5 % for oral aripiprazole tablets 10-30 mg. During the Doubleblind, Placebo-controlled Phase of the 52-week long-term trial, the incidence of weight gain of ≥ 7 % from baseline to last visit was 6.4 % for Abilify Maintena and 5.2 % for placebo.
Danish: I den dobbeltblinde placebokontrollerede fase i det langvarige studie på 52 uger var incidensen af en vægtøgning ≥ 7 % fra baseline til sidste besøg på 6,4 % for Abilify Maintena-gruppen og 5,2 % for placebo-gruppen.
English: 400 mg vial:
Danish: 400 mg-hætteglas:
English: - higher amounts of gamma-glutamyl transferase
Danish: - højere niveau af gammaglutamyltransferase
English: Needle cap d) Then pull needle-cap straight up.
Danish: Nålehætte d) Træk derefter nålehætten opad i en lige bevægelse.
English: • inflammation of the liver
Danish: • Betændelse i leveren
English: Each pre-filled syringe contains 400 mg aripiprazole.
Danish: Hver fyldt injektionssprøjte indeholder 400 mg aripiprazol.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton (without blue box) - component of multipack 300 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske (uden blå boks) - indgår i multipakning 300 mg
English: Each pre-filled syringe contains 300 mg aripiprazole.
Danish: Hver fyldt injektionssprøjte indeholder 300 mg aripiprazol.
English: • feeling anxious
Danish: • Angstfølelse
English: - Vial of powder.
Danish: Lever og galdeveje
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton (without blue box) - component of multipack 400 mg
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Æske (uden blå boks) - indgår i multipakning 400 mg
English: Haemodialysis
Danish: Glutealmusklen
English: b) Using the vial adapter package to handle the vial adapter, attach the pre-packaged luer lock syringe to the vial adapter.
Danish: b) Tag fat om hætteglasadapterens emballage, og fastgør den medfølgende luer lock-sprøjte til hætteglasadapteren.
English: Cover
Danish: Tildæk
English: It is not possible to re-suspend after the air in the syringe is expelled.
Danish: Når luften er presset ud af sprøjten, kan suspensionen ikke længere omrystes.
English: Deltoid injections should be alternated between the two deltoid muscles.
Danish: Injektion i deltoidmusklen skal ske på skift mellem højre og venstre side.
English: • gait disturbance
Danish: • Gangforstyrrelser
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe
Danish: Abilify Maintena 300 mg pulver og solvens til depotinjektionsvæske, suspension Abilify Maintena 400 mg pulver og solvens til depotinjektionsvæske, suspension Abilify Maintena 300 mg pulver og solvens til depotinjektionsvæske, suspension, i fyldt injektionssprøjte
English: • weight loss
Danish: • Vægtøgning
English: Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection aripiprazole
Danish: Abilify Maintena 400 mg pulver og solvens til depotinjektionsvæske, suspension aripiprazol
English: In clinical trials, uncommon cases of seizure were reported during treatment with aripiprazole.
Danish: Der har i kliniske studier været rapporteret om krampeanfald under behandling med aripiprazol med en hyppighed svarende til ikke almindelig.
English: • altered mood
Danish: • Humørsvingninger
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection aripiprazole
Danish: Abilify Maintena 300 mg pulver og solvens til depotinjektionsvæske, suspension aripiprazol
English: Investigations Blood creatine phosphokinase increased
Danish: Øget kreatinkinase i blodet
English: Sluggishness
Danish: Nålehætte
English: Abilify Maintena 400 mg powder for prolonged-release injection aripiprazole
Danish: Abilify Maintena 400 mg pulver til depotinjektionsvæske aripiprazol i.m.
English: Abilify Maintena 300 mg powder for prolonged-release injection aripiprazole
Danish: Abilify Maintena 300 mg pulver til depotinjektionsvæske aripiprazol i.m.
English: • grinding of teeth or clenching of the jaw
Danish: • Tænderskæren eller sammenbidte kæber
English: Rosacea Eczema Skin induration
Danish: Rosacea Eksem
English: Blood cholesterol decreased Blood triglycerides decreased
Danish: Øget taljemål Nedsat kolesterolniveau i blodet
English: 25 mm (1 inch) 23 gauge
Danish: Ikke-overvægtig Deltoidmusklen 25 mm og 23 gauge Glutealmusklen 38 mm og 22 gauge
English: • thoughts about suicide
Danish: • Selvmordstanker
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection
Danish: Abilify Maintena 300 mg pulver og solvens til depotinjektionsvæske, suspension Abilify Maintena 400 mg pulver og solvens til depotinjektionsvæske, suspension
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection aripiprazole
Danish: Abilify Maintena 300 mg pulver og solvens til depotinjektionsvæske, suspension Abilify Maintena 400 mg pulver og solvens til depotinjektionsvæske, suspension aripiprazol
English: • stomach discomfort
Danish: • Ubehag i maven
English: Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe aripiprazole
Danish: Abilify Maintena 400 mg pulver og solvens til depotinjektionsvæske, suspension, i fyldt injektionssprøjte aripiprazol
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe aripiprazole
Danish: Abilify Maintena 300 mg pulver og solvens til depotinjektionsvæske, suspension, i fyldt injektionssprøjte aripiprazol
English: • inflammation of the pancreas
Danish: • Betændelse i bugspytkirtlen
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe aripiprazole
Danish: Abilify Maintena 300 mg pulver og solvens til depotinjektionsvæske, suspension, i fyldt injektionssprøjte Abilify Maintena 400 mg pulver og solvens til depotinjektionsvæske, suspension, i fyldt injektionssprøjte aripiprazol
English: Abilify Maintena 400 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe
Danish: Abilify Maintena 400 mg pulver og solvens til depotinjektionsvæske, suspension, i fyldt injektionssprøjte
English: Abilify Maintena 300 mg powder and solvent for prolonged-release suspension for injection in pre-filled syringe
Danish: Abilify Maintena 300 mg pulver og solvens til depotinjektionsvæske, suspension, i fyldt injektionssprøjte
English: The recommended needle for gluteal administration is a 38 mm (1.5 inch), 22 gauge hypodermic safety needle; for obese patients (Body mass index > 28 kg/m2), a 51 mm (2 inch), 21 gauge hypodermic safety needle should be used.
Danish: Injektionssted Nålestørrelse Ikke-overvægtig Deltoidmusklen 25 mm og 23 gauge Glutealmusklen 38 mm og 22 gauge Overvægtig Deltoidmusklen 38 mm og 22 gauge Glutealmusklen 51 mm og 21 gauge c) Tag fat om nålehætten og giv den et tryk, så det sikres, at nålen sidder rigtigt i sikkerhedsmekanismen.
English: • sleepiness
Danish: • Søvnighed
English: • cardiovascular diseases (diseases of the heart and circulation), family history of cardiovascular disease, stroke or "mini" stroke, abnormal blood pressure
Danish: • hjerte-kar-sygdom, hjerte-kar-sygdom i familien, slagtilfælde eller mini-slagtilfælde, unormalt blodtrykhar uregelmæssig hjerterytme, eller hvis nogen i din familie tidligere har haft uregelmæssig hjerterytme (herunder såkaldt QT-forlængelse, der kan ses på et hjertediagram (ekg)
English: Joint range of motion decreased
Danish: Nedsat bevægelighed i leddene
English: - One 25 mm (1 inch) 23 gauge hypodermic safety needle with needle protection device.
Danish: Til administration i deltoidmusklen anbefales en hypodermisk sikkerhedskanyle på 25 mm og 23 gauge.
English: Body type
Danish: Hoste Hikke
English: Deltoid
Danish: Dysfori
English: - One 3 ml luer lock syringe with pre-attached 38 mm (1.5 inch) 21 gauge hypodermic safety needle with needle protection device.
Danish: - Én 3 ml-sprøjte med luer lock og påsat hypodermisk sikkerhedskanyle på 38 mm og 21 gauge med nålebeskyttelse - Én 3 ml-engangssprøjte med luer lock-spids - Én hætteglasadapter - Én hypodermisk sikkerhedskanyle på 25 mm og 23 gauge med nålebeskyttelse - Én hypodermisk sikkerhedskanyle på 38 mm og 22 gauge med nålebeskyttelse - Én hypodermisk sikkerhedskanyle på 51 mm og 21 gauge med nålebeskyttelse - Sprøjte/kanyle-anvisninger
English: Mekinist received a marketing authorisation valid throughout the EU on 30 June 2014.
Danish: Mekinist fik en markedsføringstilladelse med gyldighed i hele EU den 30. juni 2014.
English: Further information on Mekinist can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Yderligere information om Mekinist findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Other information about Mekinist
Danish: Andre oplysninger om Mekinist
English: Mekinist is available as tablets (0.5 and 2 mg).
Danish: Mekinist fås som tabletter (0,5 mg og 2 mg).
English: This leads cancers to develop by allowing uncontrolled division of cells.
Danish: Dette medfører udviklingen af kræft gennem ukontrolleret deling af cellerne.
English: Response to treatment was assessed using body scans and patients' clinical data.
Danish: Responset på behandlingen blev bedømt ud fra kropsscanninger og patienternes kliniske data.
English: As for all medicines, data on the use of Mekinist are continuously monitored.
Danish: Som for alle lægemidler bliver data vedrørende brug af Mekinist løbende overvåget.
English: It is used for the treatment of:
Danish: Mekinist anvendes til behandling af: