FrancophonIA/ELRC3.0 huggingface dataset:
English: Olanzapine Teva 5 mg orodispersible tablets A yellow, round, biconvex tablet, with 8 mm of diameter.
Norwegian Bokmål: Olanzapine Teva 5 mg smeltetabletter En gul, rund, bikonveks tablett, 8 mm i diameter.
English: Olanzapine Teva 15 mg film-coated tablets Light blue, biconvex, oval film-coated tablets, debossed ”OL 15” on one side and plain on the other.
Norwegian Bokmål: Olanzapine Teva 15 mg tablett, filmdrasjert er en lyseblå, bikonveks, oval filmdrasjert tablett, preget med ”OL 15” på en side og glatt på den andre siden.
English: Each Olanzapine Teva 20 mg orodispersible tablet contains 20 mg of the active substance.
Norwegian Bokmål: Hver Olanzapine Teva 20 mg smeltetablett inneholder 20 mg virkestoff.
English: Olanzapine Teva 15 mg orodispersible tablets A yellow, round, biconvex tablet, with 11 mm of diameter.
Norwegian Bokmål: Olanzapine Teva 15 mg smeltetabletter En gul, rund, bikonveks tablett, 11 mm i diameter.
English: Olanzapine Teva contains lactose
Norwegian Bokmål: Olanzapine Teva inneholder laktose:
English: Each orodispersible tablet contains 10 mg olanzapine.
Norwegian Bokmål: Hver smeltetablett inneholder 10 mg olanzapin.
English: EU/1/07/427/023 EU/1/07/427/024 EU/1/07/427/025 EU/1/07/427/026 EU/1/07/427/044 EU/1/07/427/054 EU/1/07/427/064
Norwegian Bokmål: EU/1/07/427/023/NO EU/1/07/427/024/NO EU/1/07/427/025/NO EU/1/07/427/026/NO EU/1/07/427/044/NO EU/1/07/427/054/NO EU/1/07/427/064/NO
English: Each Olanzapine Teva 10 mg film-coated tablet contains 10 mg of the active substance.
Norwegian Bokmål: Hver Olanzapine Teva 10 mg filmdrasjert tablett inneholder 10 mg virkestoff.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 2.5 mg film-coated tablets Olanzapine
Norwegian Bokmål: Olanzapine Teva 2,5 mg tabletter, filmdrasjerte olanzapin
English: 15 Changes in total fasting cholesterol levels from normal at baseline (<4.39 mmol/l) to high
Norwegian Bokmål: 15 Forandringer i fastende totalkolesterolverdier fra normale ved baseline (<4,39 mmol/l) til høye verdier (≥5,17 mmol/l) var vanlig observasjon.
English: Olanzapine Teva 5 mg film-coated tablets
Norwegian Bokmål: Olanzapine Teva 5 mg tabletter, filmdrasjerte
English: Olanzapine Teva 15 mg film-coated tablets are available in cartons of 28, 30, 35, 50, 56, 70 or 98 filmcoated tablets.
Norwegian Bokmål: Olanzapine Teva 15 mg tablett, filmdrasjert er tilgjengelig i pakninger med 28, 30, 35, 50, 56, 70 eller 98 filmdrasjerte tabletter.
English: EU/1/07/427/020 EU/1/07/427/021 EU/1/07/427/022 EU/1/07/427/043 EU/1/07/427/053 EU/1/07/427/063
Norwegian Bokmål: EU/1/07/427/020/NO EU/1/07/427/021/NO EU/1/07/427/022/NO EU/1/07/427/043/NO EU/1/07/427/053/NO EU/1/07/427/063/NO
English: Olanzapine Teva 15 mg orodispersible tablet is a yellow, round, biconvex tablet, with 11 mm of diameter.
Norwegian Bokmål: Olanzapine Teva 15 mg smeltetablett er en gul, rund, bikonveks tablett, 11 mm i diameter.
English: Olanzapine Teva 10 mg film-coated tablets EU/1/07/427/011 - 7 tablets, per box EU/1/07/427/083 - 7 x 1 tablets, per box EU/1/07/427/012 - 28 tablets, per box EU/1/07/427/084 - 28 x 1 tablets, per box EU/1/07/427/013 - 30 tablets, per box EU/1/07/427/085 - 30 x 1 tablets, per box EU/1/07/427/041 - 35 tablets, per box EU/1/07/427/086 - 35 x 1 tablets, per box EU/1/07/427/014 - 50 tablets, per box EU/1/07/427/087 - 50 x 1 tablets, per box EU/1/07/427/015 - 56 tablets, per box EU/1/07/427/088 - 56 x 1 tablets, per box EU/1/07/427/069 - 60 tablets, per box EU/1/07/427/051 - 70 tablets, per box EU/1/07/427/089 - 70 x 1 tablets, per box EU/1/07/427/061 - 98 tablets, per box EU/1/07/427/090 - 98 x 1 tablets, per box
Norwegian Bokmål: Olanzapine Teva 10 mg filmdrasjerte tabletter EU/1/07/427/011/NO - 7 tabletter pr. boks EU/1/07/427/083/NO - 7 x 1 tabletter pr. boks EU/1/07/427/012/NO - 28 tabletter pr. boks EU/1/07/427/084/NO - 28 x 1 tabletter pr. boks EU/1/07/427/013/NO - 30 tabletter pr. boks EU/1/07/427/085/NO - 30 x 1 tabletter pr. boks EU/1/07/427/041/NO - 35 tabletter pr. boks EU/1/07/427/086/NO - 35 x 1 tabletter pr. boks EU/1/07/427/014/NO - 50 tabletter pr. boks EU/1/07/427/087/NO - 50 x 1 tabletter pr. boks EU/1/07/427/015/NO - 56 tabletter pr. boks EU/1/07/427/088/NO - 56 x 1 tabletter pr. boks EU/1/07/427/069/NO - 60 tabletter pr. boks EU/1/07/427/051/NO - 70 tabletter pr. boks EU/1/07/427/089/NO - 70 x 1 tabletter pr. boks EU/1/07/427/061/NO - 98 tabletter pr. boks EU/1/07/427/090/NO - 98 x 1 tabletter pr. boks
English: Olanzapine Teva 20 mg orodispersible tablet is a yellow, round, biconvex tablet, with 12 mm of diameter.
Norwegian Bokmål: Olanzapine Teva 20 mg smeltetablett er en gul, rund, bikonveks tablett, 12 mm i diameter.
English: Olanzapine Teva 7.5 mg film-coated tablets EU/1/07/427/008 - 28 tablets, per box EU/1/07/427/077 - 28 x 1 tablets, per box EU/1/07/427/009 - 30 tablets, per box EU/1/07/427/078 - 30 x 1 tablets, per box EU/1/07/427/040 - 35 tablets, per box EU/1/07/427/079 - 35 x 1 tablets, per box EU/1/07/427/010 - 56 tablets, per box EU/1/07/427/080 - 56 x 1 tablets, per box EU/1/07/427/068 - 60 tablets, per box EU/1/07/427/050 - 70 tablets, per box EU/1/07/427/081 - 70 x 1 tablets, per box EU/1/07/427/060 - 98 tablets, per box EU/1/07/427/082 - 98 x 1 tablets, per box
Norwegian Bokmål: Olanzapine Teva 7,5 mg filmdrasjerte tabletter EU/1/07/427/008/NO - 28 tabletter pr. boks EU/1/07/427/077/NO - 28 x 1 tabletter pr. boks EU/1/07/427/009/NO - 30 tabletter pr. boks EU/1/07/427/078/NO - 30 x 1 tabletter pr. boks EU/1/07/427/040/NO - 35 tabletter pr. boks EU/1/07/427/079/NO - 35 x 1 tabletter pr. boks EU/1/07/427/010/NO - 56 tabletter pr. boks EU/1/07/427/080/NO - 56 x 1 tabletter pr. boks EU/1/07/427/068/NO - 60 tabletter pr. boks EU/1/07/427/050/NO - 70 tabletter pr. boks EU/1/07/427/081/NO - 70 x 1 tabletter pr. boks EU/1/07/427/060/NO - 98 tabletter pr. boks EU/1/07/427/082/NO - 98 x 1 tabletter pr. boks
English: Olanzapine Teva 20 mg orodispersible tablets A yellow, round, biconvex tablet, with 12 mm of diameter.
Norwegian Bokmål: Olanzapine Teva 20 mg smeltetabletter En gul, rund, bikonveks tablett, 12 mm i diameter.
English: Olanzapine Teva 5 mg film-coated tablets EU/1/07/427/004 - 28 tablets, per box EU/1/07/427/070 - 28 x 1 tablets, per box EU/1/07/427/005 - 30 tablets, per box EU/1/07/427/071 - 30 x 1 tablets, per box EU/1/07/427/039 - 35 tablets, per box EU/1/07/427/072 - 35 x 1 tablets, per box EU/1/07/427/006 - 50 tablets, per box EU/1/07/427/073 - 50 x 1 tablets, per box EU/1/07/427/007 - 56 tablets, per box EU/1/07/427/074 - 56 x 1 tablets, per box EU/1/07/427/049 - 70 tablets, per box EU/1/07/427/075 - 70 x 1 tablets, per box EU/1/07/427/059 - 98 tablets, per box EU/1/07/427/076 - 98 x 1 tablets, per box
Norwegian Bokmål: Olanzapine Teva 5 mg filmdrasjerte tabletter EU/1/07/427/004/NO - 28 tabletter pr. boks EU/1/07/427/070/NO - 28 x 1 tabletter pr. boks EU/1/07/427/005/NO - 30 tabletter pr. boks EU/1/07/427/071/NO - 30 x 1 tabletter pr. boks EU/1/07/427/039/NO - 35 tabletter pr. boks EU/1/07/427/072/NO - 35 x 1 tabletter pr. boks EU/1/07/427/006/NO - 50 tabletter pr. boks EU/1/07/427/073/NO - 50 x 1 tabletter pr. boks EU/1/07/427/007/NO - 56 tabletter pr. boks EU/1/07/427/074/NO - 56 x 1 tabletter pr. boks EU/1/07/427/049/NO - 70 tabletter pr. boks EU/1/07/427/075/NO - 70 x 1 tabletter pr. boks EU/1/07/427/059/NO - 98 tabletter pr. boks EU/1/07/427/076/NO - 98 x 1 tabletter pr. boks
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 7.5 mg film-coated tablets Olanzapine
Norwegian Bokmål: Olanzapine Teva 7,5 mg tabletter, filmdrasjerte olanzapin
English: Olanzapine Teva 2.5 mg film-coated tablets are available in cartons of 28, 30, 35, 56, 70 or 98 filmcoated tablets.
Norwegian Bokmål: Olanzapine Teva 2,5 mg tablett, filmdrasjert er tilgjengelig i pakninger med 28, 30, 35, 56, 70 eller 98 filmdrasjerte tabletter.
English: Olanzapine Teva 15 mg orodispersible tablets
Norwegian Bokmål: Olanzapine Teva 15 mg smeltetabletter
English: Olanzapine Teva 10 mg orodispersible tablet is a yellow, round, biconvex tablet, with 10 mm of diameter.
Norwegian Bokmål: Olanzapine Teva 10 mg smeltetablett er en gul, rund, bikonveks tablett, 10 mm i diameter.
English: 28 film-coated tablets 28 x 1 film-coated tablets 30 film-coated tablets 30 x 1 film-coated tablets 35 film-coated tablets 35 x 1 film-coated tablets 50 film-coated tablets 50 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 70 film-coated tablets 70 x 1 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets
Norwegian Bokmål: 28 tabletter, filmdrasjerte 28 x 1 tabletter, filmdrasjerte 30 tabletter, filmdrasjerte 30 x 1 tabletter, filmdrasjerte 35 tabletter, filmdrasjerte 35 x 1 tabletter, filmdrasjerte 50 tabletter, filmdrasjerte 50 x 1 tabletter, filmdrasjerte 56 tabletter, filmdrasjerte 56 x 1 tabletter, filmdrasjerte 70 tabletter, filmdrasjerte 70 x 1 tabletter, filmdrasjerte 98 tabletter, filmdrasjerte 98 x 1 tabletter, filmdrasjerte
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 7.5 mg Olanzapine.
Norwegian Bokmål: Hver filmdrasjerte tablett inneholder: 7,5 mg olanzapin.
English: Olanzapine Teva 2.5 mg film-coated tablets EU/1/07/427/001 - 28 tablets, per box
Norwegian Bokmål: Olanzapine Teva 2,5 mg filmdrasjerte tabletter EU/1/07/427/001/NO - 28 tabletter pr. boks EU/1/07/427/002/NO - 30 tabletter pr. boks EU/1/07/427/038/NO - 35 tabletter pr. boks
English: muscle stiffness and drowsiness or sleepiness.
Norwegian Bokmål: vrangforestillinger, ualminnelig mistenksomhet og tilbaketrukkenhet.
English: 28 film-coated tablets 28 x 1 film-coated tablets 30 film-coated tablets 30 x 1 film-coated tablets 35 film-coated tablets 35 x 1 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 60 film-coated tablets 70 film-coated tablets 70 x 1 film-coated tablets 98 film-coated tablets 98 x 1 film-coated tablets
Norwegian Bokmål: 28 tabletter, filmdrasjerte 28 x 1 tabletter, filmdrasjerte 30 tabletter, filmdrasjerte 30 x 1 tabletter, filmdrasjerte 35 tabletter, filmdrasjerte 35 x 1 tabletter, filmdrasjerte 56 tabletter, filmdrasjerte 56 x 1 tabletter, filmdrasjerte 60 tabletter, filmdrasjerte 70 tabletter, filmdrasjerte 70 x 1 tabletter, filmdrasjerte 98 tabletter, filmdrasjerte 98 x 1 tabletter, filmdrasjerte
English: Olanzapine Teva 10 mg orodispersible tablets A yellow, round, biconvex tablet with 10 mm of diameter.
Norwegian Bokmål: Olanzapine Teva 10 mg smeltetabletter En gul, rund, bikonveks tablett, 10 mm i diameter.
English: Each Olanzapine Teva 15 mg orodispersible tablet contains 15 mg of the active substance.
Norwegian Bokmål: Hver Olanzapine Teva 15 mg smeltetablett inneholder 15 mg virkestoff.
English: Each Olanzapine Teva 5 mg orodispersible tablet contains 5 mg of the active substance.
Norwegian Bokmål: Hver Olanzapine Teva 5 mg smeltetablett inneholder 5 mg virkestoff.
English: Olanzapine Teva 2.5 mg film-coated tablets White, biconvex, round film-coated tablets, debossed ”OL 2.5” on one side and plain on the other.
Norwegian Bokmål: Olanzapine Teva 2,5 mg tablett, filmdrasjert er en hvit, bikonveks, rund filmdrasjert tablett, preget med ”OL 2,5” på en side og glatt på den andre siden.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 20 mg orodispersible tablets Olanzapine
Norwegian Bokmål: Olanzapine Teva 20 mg smeltetabletter olanzapin
English: 28 film-coated tablets 30 film-coated tablets 35 film-coated tablets 56 film-coated tablets 70 film-coated tablets 98 film-coated tablets
Norwegian Bokmål: 28 tabletter, filmdrasjerte 30 tabletter, filmdrasjerte 35 tabletter, filmdrasjerte 56 tabletter, filmdrasjerte 70 tabletter, filmdrasjerte 98 tabletter, filmdrasjerte
English: Excipient with known effect Each film-coated tablet contains 71.3 mg lactose.
Norwegian Bokmål: Hver filmdrasjerte tablett inneholder 71,3 mg laktose.
English: Each Olanzapine Teva 15 mg film-coated tablet contains 15 mg of the active substance.
Norwegian Bokmål: Hver Olanzapine Teva 15 mg filmdrasjert tablett inneholder 15 mg virkestoff.
English: Olanzapine Teva 5 mg film-coated tablets are available in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 or 98 x 1 film-coated tablets.
Norwegian Bokmål: Olanzapine Teva 5 mg tablett, filmdrasjert er tilgjengelig i pakninger med 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 eller 98 x 1 filmdrasjerte tabletter.
English: Each Olanzapine Teva 5 mg film-coated tablet contains 5 mg of the active substance.
Norwegian Bokmål: Hver Olanzapine Teva 5 mg filmdrasjert tablett inneholder 5 mg virkestoff.
English: Olanzapine Teva 10 mg film-coated tablets White, biconvex, round film-coated tablets, debossed ”OL 10” on one side and plain on the other.
Norwegian Bokmål: Olanzapine Teva 10 mg tablett, filmdrasjert er en hvit, bikonveks, rund filmdrasjert tablett, preget med ”OL 10” på en side og glatt på den andre siden.
English: 28 film-coated tablets 30 film-coated tablets 35 film-coated tablets 50 film-coated tablets 56 film-coated tablets 70 film-coated tablets 98 film-coated tablets
Norwegian Bokmål: 28 tabletter, filmdrasjerte 30 tabletter, filmdrasjerte 35 tabletter, filmdrasjerte 50 tabletter, filmdrasjerte 56 tabletter, filmdrasjerte 70 tabletter, filmdrasjerte 98 tabletter, filmdrasjerte
English: Olanzapine Teva 5 mg film-coated tablet is a white, biconvex, round film-coated tablet, debossed ”OL 5” on one side and plain on the other.
Norwegian Bokmål: Olanzapine Teva 5 mg tablett, filmdrasjert er en hvit, bikonveks, rund filmdrasjert tablett, preget med ”OL 5” på en side og glatt på den andre siden.
English: Olanzapine Teva 20 mg film-coated tablets are available in cartons of 28, 30, 35, 56, 70 or 98 filmcoated tablets.
Norwegian Bokmål: Olanzapine Teva 20 mg tablett, filmdrasjert er tilgjengelig i pakninger med 28, 30, 35, 56, 70 eller 98 filmdrasjerte tabletter.
English: OPA/alu/PVC-alu blisters in cartons of 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 film-coated tablets per carton.
Norwegian Bokmål: OPA/Aluminium/PVC-Aluminium blistere i pakninger med 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 eller 98 x 1 filmdrasjerte tabletter per eske.
English: Olanzapine Teva 10 mg film-coated tablets are available in cartons of 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x1 film-coated tablets.
Norwegian Bokmål: Olanzapine Teva 10 mg tablett, filmdrasjert er tilgjengelig i pakninger med 7, 7 x 1, 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 eller 98 x 1 filmdrasjerte tabletter.
English: Consult your doctor if your symptoms return but do not stop taking Olanzapine Teva unless your doctor tells you to.
Norwegian Bokmål: Legen din vil fortelle deg hvor mange Olanzapine Teva tabletter du skal ta, og hvor lenge du skal fortsette å bruke dem. Daglig dose av Olanzapine Teva er mellom 5 mg og 20 mg. Ta kontakt med legen din dersom symptomene dine kommer tilbake, men du må ikke slutte å ta Olanzapine Teva uten at legen din har gitt beskjed om det.
English: OPA/alu/PVC-alu blisters in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 or 98 x 1 film-coated tablets per carton.
Norwegian Bokmål: OPA/Aluminium/PVC-Aluminium blistere i pakninger med 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 50, 50 x 1, 56, 56 x 1, 70, 70 x 1, 98 eller 98 x 1 filmdrasjerte tabletter per eske.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 5 mg orodispersible tablets Olanzapine
Norwegian Bokmål: Olanzapine Teva 5 mg smeltetabletter olanzapin
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 20 mg film-coated tablets Olanzapine
Norwegian Bokmål: Olanzapine Teva 20 mg tabletter, filmdrasjerte olanzapin
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 10 mg orodispersible tablets Olanzapine
Norwegian Bokmål: Olanzapine Teva 10 mg smeltetabletter olanzapin
English: Olanzapine Teva 7.5 mg film-coated tablets are available in cartons of 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 or 98 x 1 film-coated tablets.
Norwegian Bokmål: Olanzapine Teva 7,5 mg tablett, filmdrasjert er tilgjengelig i pakninger med 28, 28 x 1, 30, 30 x 1, 35, 35 x 1, 56, 56 x 1, 60, 70, 70 x 1, 98 eller 98 x 1 filmdrasjerte tabletter.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 15 mg orodispersible tablets Olanzapine
Norwegian Bokmål: Olanzapine Teva 15 mg smeltetabletter olanzapin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: 2.5 mg Olanzapine.
Norwegian Bokmål: Hver filmdrasjerte tablett inneholder: 2,5 mg olanzapin.
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 10 mg film-coated tablets Olanzapine
Norwegian Bokmål: Olanzapine Teva 10 mg tabletter, filmdrasjerte olanzapin
English: (≥1.467 mmol/l) and changes in fasting triglycerides from borderline at baseline
Norwegian Bokmål: (≥1,467 mmol/l) og forandringer i fastende triglyserider fra borderline ved baseline (≥1,016 mmol/l<1,467 mmol/l) til høye verdier (≥1,467 mmol/l).
English: If you suffer from any of the following illnesses tell your doctor as soon as possible: - Stroke or “mini” stroke (temporary symptoms of stroke) - Parkinson's disease - Prostate problems - A blocked intestine (Paralytic ileus) - Liver or kidney disease - Blood disorders - Heart disease - Diabetes - Seizures - If you know that you may have salt depletion as a result of prolonged severe diarrhoea and vomiting (being sick) or usage of diuretics (water tablets)
Norwegian Bokmål: • Hvis du vet at du kan ha saltmangel som følge av langvarig, alvorlig diaré og oppkast (hatt omgangssyke) eller bruk av diuretika (vanndrivende tabletter).
English: 28 orodispersible tablets 30 orodispersible tablets 35 orodispersible tablets 50 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets 98 orodispersible tablets
Norwegian Bokmål: 28 smeltetabletter 30 smeltetabletter 35 smeltetabletter 50 smeltetabletter 56 smeltetabletter 70 smeltetabletter 98 smeltetabletter
English: 28 orodispersible tablets 30 orodispersible tablets 35 orodispersible tablets 56 orodispersible tablets 70 orodispersible tablets 98 orodispersible tablets
Norwegian Bokmål: 28 smeltetabletter 30 smeltetabletter 35 smeltetabletter 56 smeltetabletter 70 smeltetabletter 98 smeltetabletter
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 5 mg film-coated tablets Olanzapine
Norwegian Bokmål: Olanzapine Teva 5 mg tabletter, filmdrasjerte olanzapin
English: Tablet coating
Norwegian Bokmål: Toksisitet ved flerdose
English: EU/1/07/427/048 - 70 tablets, per box
Norwegian Bokmål: EU/1/07/427/003/NO - 56 tabletter pr. boks EU/1/07/427/048/NO - 70 tabletter pr. boks EU/1/07/427/058/NO - 98 tabletter pr. boks
English: NAME OF THE MEDICINAL PRODUCT Olanzapine Teva 15 mg film-coated tablets Olanzapine
Norwegian Bokmål: Olanzapine Teva 15 mg tabletter, filmdrasjerte olanzapin
English: Date of first authorisation: 24 June 2016
Norwegian Bokmål: Dato for første markedsføringstillatelse: 24. juni 2016
English: This will help the doctor identify what you have taken.
Norwegian Bokmål: Dette vil hjelpe legen å identifisere hva du har tatt.
English: Follow the instructions that your doctor has given you.
Norwegian Bokmål: Følg instruksene legen har gitt deg.
English: There is no known specific antidote.
Norwegian Bokmål: Det finnes intet kjent, spesifikt antidot.
English: The magnitude of this effect is not considered to be of clinical relevance.
Norwegian Bokmål: Størrelsen på denne effekten anses ikke å være av klinisk relevans.
English: HDPE bottles: 3 years Blisters: 5 years
Norwegian Bokmål: HDPE-bokser: 3 år Blisterpakninger: 5 år
English: Caution must be exercised in patients ≥ 85 years of age as there is limited experience in this age group.
Norwegian Bokmål: Det skal utvises forsiktighet hos pasienter ≥ 85 år da det foreligger begrenset erfaring hos denne aldersgruppen.
English: Dyskinesia was the most frequently reported treatment-emergent adverse reaction (17.7%).
Norwegian Bokmål: Dyskinesi var den hyppigst rapporterte behandlingsrelaterte bivirkningen (17,7 %).
English: Note: A responder was a patient who had a reduction of at least 1 hour in absolute OFF-time (OFF-time responder)
Norwegian Bokmål: Merk: En responder var en pasient som hadde en reduksjon på minst 1 time i absolutt OFF-tid (OFFtidsresponder)
English: Children and adolescents under the age of 18 years must not take this medicine as it has not been studied in these age groups.
Norwegian Bokmål: Barn og ungdom under 18 år skal ikke ta dette legemidlet da det ikke er undersøkt i disse aldersgruppene.
English: Overall, it can be concluded that the kidney is not the primary route of excretion.
Norwegian Bokmål: Samlet kan det konkluderes med at nyrene ikke er den primære eliminasjonsveien.
English: Tell your doctor as soon as possible if you notice any of the following side effects:
Norwegian Bokmål: Informer legen så snart som mulig dersom du merker noen av følgende bivirkninger:
English: Very common: may affect more than 1 in 10 people - involuntary and uncontrollable, or difficult or painful body movements
Norwegian Bokmål: Svært vanlige: kan ramme flere enn 1 av 10 personer - ufrivillige og ukontrollerbare, vanskelige eller smertefulle kroppsbevegelser
English: There are no or limited amount of data from the use of opicapone in pregnant women.
Norwegian Bokmål: Det er ingen eller begrenset mengde data på bruk av opikapon hos gravide kvinner.
English: At screening, the mean age was similar in all treatment groups in both studies, ranging between 61.5 and 65.3 years.
Norwegian Bokmål: Ved screening var gjennomsnittsalderen lik i alle behandlingsgrupper i begge studier, og varierte fra 61,5 til 65,3 år.
English: Therefore, caution should be exercised when driving or using machines.
Norwegian Bokmål: Det bør derfor utvises forsiktighet ved bilkjøring eller bruk av maskiner.
English: Do not drive or operate machinery if you experience any of these side effects.
Norwegian Bokmål: Ikke kjør eller bruk maskiner dersom du får noen av disse bivirkningene.
English: Although embryo-foetal development was not negatively influenced in rabbits, the study is not considered predictive for human risk assessment.
Norwegian Bokmål: Selv om embryo-fosterutvikling ikke ble påvirket negativt hos kaniner, anses ikke studien å kunne brukes til risikovurdering hos mennesker.
English: Frequency categories are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000), not known (cannot be estimated from the available data).
Norwegian Bokmål: Frekvenskategorier er definert som følger: svært vanlige (≥ 1/10), vanlige (≥ 1/100 til < 1/10), mindre vanlige (≥ 1/1000 til < 1/100), sjeldne (≥ 1/10 000 til < 1/1000), svært sjeldne (< 1/10 000), ikke kjent (kan ikke anslås utifra tilgjengelige data).
English: Opicapone presents a low absorption (~20%).
Norwegian Bokmål: Opikapon har lav absorpsjon (~20 %).
English: The capsules are packaged in bottles or blisters.
Norwegian Bokmål: Kapslene er pakket i bokser eller blisterpakninger.
English: Patients should be monitored regularly for the development of impulse control disorders and review of treatment is recommended if such symptoms develop.
Norwegian Bokmål: Pasienter skal kontrolleres regelmessig for utvikling av impulskontrollforstyrrelser, og gjennomgang av behandlingen anbefales dersom slike symptomer oppstår.
English: In the table below (Table 1) all adverse reactions are presented by System Organ Class and frequency.
Norwegian Bokmål: I tabellen nedenfor (tabell 1) er alle bivirkninger presentert etter organklassesystem og frekvens.
English: The recommended dose is 50 mg once daily.
Norwegian Bokmål: Den anbefalte dosen er 50 mg, én gang daglig.
English: Table 2 - Change in absolute OFF-time and ON-time (minutes) from baseline to endpoint Treatment
Norwegian Bokmål: Tabell 2 - Endring i absolutt OFF-tid og ON-tid (minutter) fra baseline til endepunkt Behandling