FrancophonIA/ELRC3.0 huggingface dataset:
English: Dose adjustment in patients with reduced renal function or undergoing haemodialysis is necessary (see section 4.2 Table 1).
Danish: Dosisjustering er nødvendig hos patienter med nedsat nyrefunktion eller patienter, som er i dialyse (se pkt.
English: Always take this medicine exactly as your doctor or pharmacist has told you.
Danish: Fortæl det altid til lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, The Netherlands For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Danish: Mylan B.V., Dieselweg 25, 3752 LB Bunschoten, Holland
English: Vascular disorders Uncommon
Danish: Vaskulære sygdomme Ikke almindelig
English: Oedema peripheral, oedema, gait abnormal, fall, feeling drunk, feeling abnormal, fatigue
Danish: Perifere ødemer, ødem, gangforstyrrelser, faldtendens, følelse af beruselse, føle sig unormal, træthed.
English: Pregabalin Mylan Pharma 75 mg hard capsules EU/1/15/998/016
Danish: Pregabalin Mylan Pharma 75 mg hårde kapsler EU/1/15/998/016
English: Generalised Anxiety Disorder
Danish: Generaliseret angst
English: Pregabalin Mylan Pharma with food, drink and alcohol Pregabalin Mylan Pharma capsules may be taken with or without food.
Danish: Brug af Pregabalin Mylan Pharma sammen med mad, drikke og alkohol
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 225 mg pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 225 mg pregabalin.
English: Pregabalin Mylan Pharma 150 mg hard capsules Each hard capsule contains 150 mg of pregabalin.
Danish: Pregabalin Mylan Pharma 150 mg hårde kapsler Hver hård kapsel indeholder 150 mg pregabalin.
English: Muscle cramp, arthralgia, back pain, pain in limb, cervical spasm
Danish: Muskelkramper, artralgi, rygsmerte, ekstremitetssmerter, spasmer i cervikalmuskulaturen.
English: Pregabalin Mylan Pharma 300 mg hard capsules Each hard capsule contains 300 mg of pregabalin.
Danish: Pregabalin Mylan Pharma 300 mg hårde kapsler Hver hård kapsel indeholder 300 mg pregabalin.
English: If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om dette lægemiddel, skal du henvende dig til den lokale repræsentant for indehaveren af markedsføringstilladelsen.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 75 mg pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 75 mg pregabalin.
English: Pregabalin Mylan Pharma 200 mg hard capsules Each hard capsule contains 200 mg of pregabalin.
Danish: Pregabalin Mylan Pharma 200 mg hårde kapsler Hver hård kapsel indeholder 200 mg pregabalin.
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 225 mg
Danish: INFORMATION I BRAILLE-SKRIFT Pregabalin Mylan Pharma 225 mg
English: Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 56 x 1, 84 x 1, 100 x 1 capsules.
Danish: Fås i blisterpakning med 14, 21, 56, 84 eller 100 kapsler og i perforeret enkeltdosisblisterpakning med 56 x 1, 84 x 1 eller 100 x 1 kapsler.
English: Available in blister packs containing 21, 84, 100 capsules and in perforated unit dose blister packs containing 84 x 1, 100 x 1 capsules.
Danish: Fås i blisterpakning med 21, 84 eller 100 kapsler og i perforeret enkeltdosisblisterpakning med 84 x 1 eller 100 x 1 kapsler.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 300 mg pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 300 mg pregabalin.
English: Pregabalin Mylan Pharma 200 mg hard capsules EU/1/15/998/035
Danish: Pregabalin Mylan Pharma 200 mg hårde kapsler EU/1/15/998/035
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 75 mg
Danish: INFORMATION I BRAILLE-SKRIFT Pregabalin Mylan Pharma 75 mg
English: Pregabalin Mylan Pharma 100 mg hard capsules EU/1/15/998/023
Danish: Pregabalin Mylan Pharma 100 mg hårde kapsler EU/1/15/998/023
English: - This medicine has been prescribed for you only.
Danish: Lægemidlet er receptpligtigt.
English: • Difficulty breathing, dry nose, nasal congestion
Danish: • Vejrtrækningsproblemer, tør næse, tilstoppet næse.
English: Pregabalin Mylan Pharma 100 mg hard capsules Each hard capsule contains 100 mg of pregabalin.
Danish: Pregabalin Mylan Pharma 100 mg hårde kapsler Hver hård kapsel indeholder 100 mg pregabalin.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 200 mg pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 200 mg pregabalin.
English: The 50 mg capsules are No. 3, dark peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Danish: 50 mg kapslen er en nr. 3 gelatinekapsel med hård skal, uigennemsigtig mørk ferskenfarvet overdel og uigennemsigtig hvid underdel, fyldt med hvidt/offwhite pulver.
English: Pregabalin Mylan Pharma 50 mg hard capsules Each hard capsule contains 50 mg of pregabalin.
Danish: Pregabalin Mylan Pharma 50 mg hårde kapsler Hver hård kapsel indeholder 50 mg pregabalin.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 150 mg pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 150 mg pregabalin.
English: Pregabalin Mylan Pharma 200 mg hard capsule
Danish: Pregabalin Mylan Pharma 200 mg hård kapsel
English: Pregabalin Mylan Pharma 300 mg hard capsules EU/1/15/998/045
Danish: Pregabalin Mylan Pharma 300 mg hårde kapsler EU/1/15/998/045
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 150 mg
Danish: INFORMATION I BRAILLE-SKRIFT Pregabalin Mylan Pharma 150 mg
English: 21 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Danish: 21 hårde kapsler 84 hårde kapsler 100 kapsler 84 x 1 hårde kapsler 100 x 1 hårde kapsler
English: Pregabalin Mylan Pharma 225 mg hard capsules EU/1/15/998/040
Danish: Pregabalin Mylan Pharma 225 mg hårde kapsler EU/1/15/998/040
English: Pregabalin Mylan Pharma 225 mg hard capsule
Danish: Pregabalin Mylan Pharma 225 mg hård kapsel
English: PVC/PVDC-Al perforated unit dose blister pack containing 84 x 1 and 100 x 1 hard capsules.
Danish: Perforeret PVC/PVDC-Al-enkeltdosisblisterpakning, der indeholder 84 x 1 eller 100 x 1 hårde kapsler.
English: How to store Pregabalin Mylan Pharma
Danish: Brug af anden medicin sammen med Pregabalin Mylan Pharma
English: Available in blister packs containing 14, 21, 56, 84, 100 capsules and in perforated unit dose blister packs containing 84 x 1, 100 x 1 capsules.
Danish: Fås i blisterpakning med 14, 21, 56, 84 eller 100 kapsler og i perforeret enkeltdosisblisterpakning med 84 x 1 eller 100 x 1kapsler.
English: Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 14 x 1, 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules.
Danish: Fås i blisterpakning med 14, 56 eller 100 kapsler, i perforeret enkeltdosisblisterpakning med 14 x 1, 56 x 1 eller 100 x 1 kapsler og i beholder med 200 kapsler.
English: PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1, 84 x 1 and 100 x 1 hard capsules.
Danish: Perforeret PVC/PVDC-Al-enkeltdosisblisterpakning, der indeholder 56 x 1, 84 x 1 eller 100 x 1 hårde kapsler.
English: Pregabalin Mylan Pharma 50 mg hard capsules EU/1/15/998/009
Danish: Pregabalin Mylan Pharma 50 mg hårde kapsler EU/1/15/998/009
English: Pregabalin Mylan Pharma 300 mg hard capsule
Danish: Pregabalin Mylan Pharma 300 mg hårde kapsler
English: Method of administration
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E)
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 225 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Mylan Pharma 225 mg hårde kapsler pregabalin
English: In the post-marketing experience, the most commonly reported adverse reactions observed when pregabalin was taken in overdose included somnolence, confusional state, agitation, and restlessness.
Danish: Efter markedsføring er søvnighed, konfus tilstand, agitation og rastløshed blandt de hyppigst rapporterede bivirkninger, når pregabalin tages i overdosis.
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 300 mg
Danish: INFORMATION I BRAILLE-SKRIFT Pregabalin Mylan Pharma 300 mg
English: The capsule is axially printed with MYLAN over PB225 in black ink on cap and body.
Danish: Aksialt på kapslen er der trykt MYLAN over PB225 med sort blæk på overdelen og underdelen.
English: Pregabalin Mylan Pharma 75 mg hard capsules The 75 mg capsules are No. 4, light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Danish: 75 mg kapslen er en nr. 4 gelatinekapsel med hård skal, uigennemsigtig lys ferskenfarvet overdel og uigennemsigtig lys ferskenfarvet underdel, fyldt med hvidt/offwhite pulver.
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 100 mg
Danish: INFORMATION I BRAILLE-SKRIFT Pregabalin Mylan Pharma 100 mg
English: Pregabalin Mylan Pharma 300 mg hard capsules The 300 mg capsule are No. 0, light peach opaque cap and white opaque body, hard-shell gelatin capsules filled with white to off-white powder.
Danish: 300 mg kasplen er en nr. 0 gelatinekapsel med hård skal, uigennemsigtig lys ferskenfarvet overdel og uigennemsigtig hvid underdel, fyldt med hvidt/offwhite pulver.
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 200 mg
Danish: INFORMATION I BRAILLE-SKRIFT Pregabalin Mylan Pharma 200 mg
English: PVC/PVDC-Al perforated unit dose blister pack containing 14 x 1, 56 x 1 and 100 x 1 hard capsules.
Danish: Perforeret PVC/PVDC-Al-enkeltdosisblisterpakning, der indeholder 14 x 1, 56 x 1 eller 100 x 1 hårde kapsler.
English: Pregabalin Mylan Pharma 150 mg hard capsules EU/1/15/998/028
Danish: Pregabalin Mylan Pharma 150 mg hårde kapsler EU/1/15/998/028
English: Available in blister packs containing 14, 56, 100 capsules and in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules.
Danish: Fås i blisterpakning med 14, 56 eller 100 kapsler og i perforeret enkeltdosisblisterpakning med 56 x 1 eller 100 x 1 kapsler.
English: • Liver failure.
Danish: • Leversvigt.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 75 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Mylan Pharma 75 mg hårde kapsler pregabalin
English: Pregabalin Mylan Pharma 225 mg hard capsules The 225 mg capsule are No. 1, dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsules filled with white to off-white powder.
Danish: 225 mg kapslen er en nr. 1 gelatinekapsel med hård skal, uigennemsigtig mørk ferskenfarvet overdel og uigennemsigtig mørk ferskenfarvet underdel, fyldt med hvidt/offwhite pulver.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 25 mg pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 25 mg pregabalin.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 150 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Mylan Pharma 150 mg hårde kapsler pregabalin
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 50 mg
Danish: INFORMATION I BRAILLE-SKRIFT Pregabalin Mylan Pharma 50 mg
English: INFORMATION IN BRAILLE Pregabalin Mylan Pharma 25 mg
Danish: INFORMATION I BRAILLE-SKRIFT Pregabalin Mylan Pharma 25 mg
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Danish: 14 hårde kapsler 21 hårde kapsler 56 hårde kapsler 84 hårde kapsler 100 hårde kapsler 56 x 1 hårde kapsler 84 x 1 hårde kapsler 100 x 1 hårde kapsler
English: The capsule is axially printed with MYLAN over PB200 in black ink on cap and body.
Danish: Aksialt på kapslen er der trykt MYLAN over PB200 med sort blæk på overdelen og underdelen.
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 100 mg pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 100 mg pregabalin.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 100 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Mylan Pharma 100 mg hårde kapsler pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 300 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Mylan Pharma 300 mg hårde kapsler pregabalin
English: STATEMENT OF ACTIVE SUBSTANCE Each hard capsule contains 50 mg pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver hård kapsel indeholder 50 mg pregabalin.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 200 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Mylan Pharma 200 mg hårde kapsler pregabalin
English: Pregabalin Mylan Pharma 150 mg hard capsules The 150 mg capsule are No. 2, light peach opaque cap and white opaque body, hard-shell gelatin capsules filled with white to off-white powder.
Danish: 150 mg kapslen er en nr. 2 gelatinekapsel med hård skal, uigennemsigtig lys ferskenfarvet overdel og uigennemsigtig hvid underdel, fyldt med hvidt/offwhite pulver.
English: The capsule is axially printed with MYLAN over PB150 in black ink on cap and body.
Danish: Aksialt på kapslen er der trykt MYLAN over PB150 med sort blæk på overdelen og underdelen.
English: Pregabalin Mylan Pharma 75 mg hard capsule
Danish: Pregabalin Mylan Pharma 75 mg hårde kapsler
English: Pregabalin Mylan Pharma 25 mg hard capsules EU/1/15/998/001
Danish: Pregabalin Mylan Pharma 25 mg hårde kapsler EU/1/15/998/001
English: Pregabalin Mylan Pharma 150 mg hard capsule
Danish: Pregabalin Mylan Pharma 150 mg hård kapsel
English: The capsule is axially printed with MYLAN over PB75 in black ink on cap and body.
Danish: Aksialt på kapslen er der trykt MYLAN over PB75 med sort blæk på overdelen og underdelen.
English: Urinary incontinence, dysuria Renal failure, oliguria, urinary retention
Danish: Urininkontinens, dysuri.
English: 14 hard capsules 21 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Danish: 14 hårde kapsler 21 hårde kapsler 56 hårde kapsler 84 hårde kapsler 100 hårde kapsler 84 x 1 hårde kapsler 100 x 1 hårde kapsler
English: Pregabalin Mylan Pharma 100 mg hard capsule
Danish: Pregabalin Mylan Pharma 100 mg hård kapsel
English: 14 hard capsules 56 hard capsules 100 hard capsules 200 hard capsules 14 x 1 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Danish: 14 hårde kapsler 56 hårde kapsler 100 hårde kapsler 200 hårde kapsler 14 x 1 hårde kapsler 56 x 1 hårde kapsler 100 x 1 hårde kapsler
English: Very common: may affect more than 1 in 10 people • Dizziness, drowsiness, headache
Danish: Meget almindelige: Sker hos flere end 1 ud af 10 behandlede
English: PVC/PVDC-Al perforated unit dose blister pack containing 56 x 1 and 100 x 1 hard capsules.
Danish: Perforeret PVC/PVDC-Al-enkeltdosisblisterpakning, der indeholder 56 x 1 eller 100 x 1 hårde kapsler.
English: Pregabalin Mylan Pharma 25 mg hard capsule
Danish: Pregabalin Mylan Pharma 25 mg hård kapsel
English: Pregabalin Mylan Pharma 50 mg hard capsule
Danish: Pregabalin Mylan Pharma 50 mg hård kapsel
English: • There have been reports of heart failure in some patients when taking Pregabalin Mylan Pharma; these patients were mostly elderly with cardiovascular conditions.
Danish: • Hos nogle patienter, der tager Pregabalin Mylan Pharma, er der set kronisk venstresidig hjertesvigt.
English: 14 hard capsules 56 hard capsules 100 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Danish: 14 hårde kapsler 56 hårde kapsler 100 hårde kapsler 56 x 1 hårde kapsler 100 x 1 hårde kapsler
English: As pregabalin clearance is directly proportional to creatinine clearance (see section 5.2), dose reduction in patients with compromised renal function must be individualised according to creatinine clearance (CLcr), as indicated in Table 1 determined using the following formula:
Danish: 5.2), skal dosis individuelt tilpasses patienter med nedsat nyrefunktion i henhold til kreatininclearance.
English: Light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Danish: Lys ferskenfarvet overdel og uigennemsigtig hvid underdel, hård gelatinekapsel fyldt med hvidt/offwhite pulver.
English: If you take more Pregabalin Mylan Pharma than you should Call your doctor or go to the nearest hospital emergency unit immediately.
Danish: Sådan skal du tage Pregabalin Mylan Pharma Tag altid Pregabalin Mylan Pharma nøjagtigt efter lægens eller apotekerpersonalets anvisning.
English: 14 hard capsules 56 hard capsules 100 hard capsules 200 hard capsules 56 x 1 hard capsules 100 x 1 hard capsules
Danish: 14 hårde kapsler 56 hårde kapsler 100 hårde kapsler 200 hårde kapsler 56 x 1 hårde kapsler 100 x 1 hårde kapsler
English: The capsule is axially printed with MYLAN over PB300 in black ink on cap and body.
Danish: Aksialt på kapslen er der trykt MYLAN over PB300 med sort blæk på overdelen og underdelen.
English: Available in blister packs containing 14, 56, 100 capsules, in perforated unit dose blister packs containing 56 x 1, 100 x 1 capsules and in bottles containing 200 capsules.
Danish: Fås i blisterpakning med 14, 56 eller 100 kapsler, i perforeret enkeltdosisblisterpakning med 56 x 1 eller 100 x 1 kapsler og i beholder med 200 hårde kapsler.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 25 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Mylan Pharma 25 mg hårde kapsler pregabalin
English: • Increased fluid in the abdomen
Danish: • Betændelse i bugspytkirtlen.
English: • Flushing, hot flushes
Danish: • Rødmen, hedeture.
English: • Muscle cramp, joint pain, back pain, pain in limb
Danish: • Muskelkrampe, ledsmerter, rygsmerter, smerter i arme og ben.
English: Dark peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Danish: Mørk ferskenfarvet overdel og uigennemsigtig hvid underdel, hård gelatinekapsel fyldt med hvidt/offwhite pulver.
English: The capsule is axially printed with MYLAN over PB50 in black ink on cap and body.
Danish: Aksialt på kapslen er der trykt MYLAN over PB50 med sort blæk på overdelen og underdelen.
English: The capsule is axially printed with MYLAN over PB25 in black ink on cap and body.
Danish: Aksialt på kapslen er der trykt MYLAN over PB25 med sort blæk på overdelen og underdelen.
English: Pregabalin Mylan Pharma 200 mg hard capsules The 200 mg capsule are No. 1, light peach opaque cap and light peach opaque body, hard-shell gelatin capsules filled with white to off-white powder.
Danish: 200 mg kapslen er en nr. 1 gelatinekapsel med hård skal, uigennemsigtig lys ferskenfarvet overdel og uigennemsigtig lys ferskenfarvet underdel, fyldt med hvidt/offwhite pulver.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Mylan Pharma 50 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Mylan Pharma 50 mg hårde kapsler pregabalin
English: • Disturbance in attention, clumsiness, memory impairment, loss of memory, tremor, difficulty with speaking, tingling feeling, numbness, sedation, lethargy, insomnia, fatigue, feeling abnormal
Danish: talevanskeligheder, snurrende fornemmelse, følelsesløshed, sløvhed, søvnlignende sløvhedstilstand, søvnforstyrrelser, træthed, følelse af at være unormal.
English: METHOD AND ROUTE OF ADMINISTRATION Read the package leaflet before use.
Danish: Læs indlægssedlen inden brug.
English: The capsule is axially printed with MYLAN over PB100 in black ink on cap and body.
Danish: Aksialt på kapslen er der trykt MYLAN over PB100 med sort blæk på overdelen og underdelen.
English: Pregabalin Mylan Pharma 25 mg hard capsules
Danish: Pregabalin Mylan Pharma 25 mg hårde kapsler
English: Pregabalin Mylan Pharma 50 mg hard capsules
Danish: Pregabalin Mylan Pharma 50 mg hårde kapsler
English: Pregabalin Mylan Pharma 50 mg hard capsules PVC/PVDC-Al blister pack containing 14, 21, 56, 84 and 100 hard capsules.
Danish: PVC/PVDC-Al-blisterpakning, der indeholder 14, 21, 56, 84 eller 100 hårde kapsler.
English: Pregabalin Mylan Pharma 100 mg hard capsules The 100 mg capsule are No. 3, dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsules filled with white to off-white powder.
Danish: 100 mg kapslen er en nr. 3 gelatinekapsel med hård skal, uigennemsigtig mørk ferskenfarvet overdel og uigennemsigtig mørk ferskenfarvet underdel, fyldt med hvidt/offwhite pulver.
English: Dose regimen
Danish: Rabdomyolyse.
English: Light peach opaque cap and light peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Danish: Lys ferskenfarvet overdel og uigennemsigtig lys ferskenfarvet underdel, hård gelatinekapsel fyldt med hvidt/offwhite pulver.
English: Renal failure
Danish: Nedsat nyrefunktion
English: No. 4, light peach opaque cap and white opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Danish: Uigennemsigtig lys ferskenfarvet overdel og uigennemsigtig hvid underdel, hård gelatinekapsel fyldt med hvidt/offwhite pulver.
English: 6.6 Special precautions for disposal
Danish: 6.6 Regler for bortskaffelse og anden håndtering Ingen særlige forholdsregler ved bortskaffelse.
English: Dark peach opaque cap and dark peach opaque body, hard-shell gelatin capsule filled with white to off-white powder.
Danish: Mørk ferskenfarvet overdel og uigennemsigtig mørk ferskenfarvet underdel, hård gelatinekapsel fyldt med hvidt/offwhite pulver.
English: Pregabalin is not genotoxic based on results of a battery of in vitro and in vivo tests.
Danish: På baggrund af in vitro og in vivo tests vurderes det, at pregabalin ikke er genotoksisk.
English: Packaging Content Package size Withdrawal Period
Danish: Indhold Pakningsstørrelse Tilbageholdelsestid
English: MA Numbers Invented name Strength Pharmaceutical Form
Danish: EU-nummer Særnavn Styrke Lægemiddelform
English: 120 pre-filled syringes (in a plastic bucket)
Danish: 10 ml 120 fyldte injektionssprøjter i en plastik spand
English: Target species Route of administration
Danish: Dyrearter, som lægemidlet er beregnet til
English: This summary was last updated in 02-2009.
Danish: Dette sammendrag blev sidst ajourført i 02-2009.
English: Exalief is also not recommended in children below 18 years of age.
Danish: Exalief anbefales heller ikke til børn under 18 år.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Exalief to Bial - Portela & Ca, SA on 21 April 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Exalief til Bial - Portela & Ca, SA den 21 april 2009.
English: Exalief can be taken with or without food.
Danish: Exalief kan tages med eller uden et måltid.
English: Other information about Exalief:
Danish: Andre oplysninger om Exalief:
English: The Committee recommended that Exalief be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Exalief.
English: At the start of the study, patients had around 13 seizures per month.
Danish: Ved undersøgelsens start havde patienterne ca. 13 anfald om måneden.
English: The effects of Exalief were first tested in experimental models before being studied in humans.
Danish: Virkningerne af Exalief blev først testet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
English: The main measure of effectiveness for the three studies was the reduction in the number of seizures over 12 weeks.
Danish: Det primære effektmål for de tre undersøgelser var reduktionen i antallet af anfald over en periode på 12 uger.
English: All of the patients also received other anti-epileptic medicines.
Danish: Alle patienterne fik også andre antiepileptiske lægemidler.
English: It must not be used in people with second or third degree atrioventricular block (a problem with electrical transmission in the heart).
Danish: Det må ikke anvendes af personer med 2. eller 3. grads atrioventrikulær blok (et problem med elektrisk transmission i hjertet).