FrancophonIA/ELRC3.0 huggingface dataset:
English: - if you have already experienced angioedema (difficulties in breathing or swallowing, or swelling of the face, hands and feet, eyes, lips and/or tongue).
Danish: - hvis du allerede har haft svært ved at trække vejret eller at synke eller har haft hævet ansigt, hænder og fødder, øjenomgivelser, læber og/eller tunge (angioødem).
English: Unit packs containing 7, 14, 28, 30, 50 or 56 tablets.
Danish: Enkeltpakninger indeholdende 7, 14, 28, 30, 50 eller 56 tabletter.
English: 90 film-coated tablets (3x30)
Danish: 90 filmovertrukne tabletter (3x30)
English: Multipacks containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets.
Danish: Multipakninger indeholdende 84 (3x28), 98 (2x49) eller 280 (20x14) tabletter.
English: Acute renal failure, renal impairment
Danish: Akut nyresvigt, nedsat nyrefunktion
English: However, since aliskiren has been shown to be a substrate for the organic anion-transporting polypeptide 1A2 (OATP1A2) (see section “Organic anion transporting polypeptide (OATP” below) inhibitors), there is a potential for aliskiren to reduce plasma torasemide exposure by an interference with the absorption process.
Danish: Aliskiren kan dog potentielt reducere plasmakoncentrationen af torasemid ved at interferere med absorptionsprocessen, da aliskiren er vist at være substrat for det organisk anion-transporterende polypeptid 1A2 (OATP1A2) (se punktet ”Interaktion med hæmmere af organisk anion-transporterende polypeptid (OATP)” nedenfor).
English: Black iron oxide (E 172) Red iron oxide (E 172)
Danish: Jernoxid, rød (E172)
English: MDR1/Mdr1a/1b (P-gp) was found to be the major efflux system involved in intestinal absorption and biliary excretion of aliskiren in preclinical studies (see section 5.2).
Danish: I prækliniske studier er det vist, at MDR1/Mdr1a/1b (P-gp) er det vigtigste efflukssystem involveret i aliskirens intestinale absorption og galdeudskillelse (se pkt.
English: In the majority of patients aged 65 years or older, the 300 mg dose of Rasilez shows no additional benefit in reducing blood pressure compared to the 150 mg dose.
Danish: Hos størstedelen af patienter på 65 år og derover giver en dosis på 300 mg af Rasilez ikke ekstra nedsat blodtryk sammenlignet med en dosis på 150 mg.
English: Co-administration of orange or apple juice with aliskiren 150 mg resulted in a 62% decrease in aliskiren AUC or in a 63% decrease in aliskiren AUC, respectively.
Danish: Indtagelse af appelsin- eller æblejuice sammen med aliskiren 150 mg resulterede i en reduktion i AUC for aliskiren på hhv. 62 % eller 63 %.
English: Rasilez 300 mg film-coated tablets are light-red, biconvex, ovaloid tablets, imprinted “IU” on one side and “NVR” on the other side.
Danish: Rasilez 300 mg filmovertrukne tabletter er lyse røde, udadbuede, ovale tabletter, præget med ”IU” på den ene side og ”NVR” på den anden side.
English: Unit packs containing 14, 28, 30, 50, 56, 90 or 98 tablets.
Danish: Enkeltpakninger indeholdende 14, 28, 30, 50, 56, 90 eller 98 tabletter.
English: 84 film-coated tablets (3x28)
Danish: 84 filmovertrukne tabletter (3x28)
English: 98 film-coated tablets (2x49)
Danish: 98 filmovertrukne tabletter (2x49)
English: In the majority of patients aged 65 years or older, the 300 mg dose of aliskiren shows no additional benefit in reducing blood pressure compared to the 150 mg dose.
Danish: Hos størstedelen af patienter på 65 år og derover giver en dosis på 300 mg af aliskiren ikke ekstra nedsat blodtryk sammenlignet med en dosis på 150 mg.
English: - Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: 4.3 Kontraindikationer - Overfølsomhed over for det aktive stof eller over for et eller flere af hjælpestofferne anført i pkt.
English: Unit packs containing 7, 14, 28, 30, 50, 56 or 90 tablets.
Danish: Enkeltpakninger indeholdende 7, 14, 28, 30, 50, 56 eller 90 tabletter.
English: 56 x 1 film-coated tablet
Danish: 56 x 1 filmovertrukne tabletter
English: - if you are taking ciclosporin (a medicine used in transplantation to prevent organ rejection or for other conditions, e.g. rheumatoid arthritis or atopic dermatitis), itraconazole (a medicine used to treat fungal infections) or quinidine (a medicine used to correct heart rhythm).
Danish: Bruges også til andre tilstande fx gigt eller hudeksem), itraconazol (medicin, der bruges til behandling af svampeinfektioner) eller quinidin (medicin, som bruges til at korrigere hjerterytmen).
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 280 (20 packs of 14) film-coated tablets Multipack: 98 (2 packs of 49 x 1) film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 280 (20 pakninger med 14) filmovertrukne tabletter Multipakning: 98 (2 pakninger med 49 x 1) filmovertrukne tabletter
English: In a post-authorisation observational study, the co-administration of aliskiren with ACEIs or ARBs has been associated with an increased risk of angioedema.
Danish: I et observationsstudie udført efter markedsføring er der set en øget risiko for angioødem ved administration af aliskiren sammen med ACE-hæmmere eller ARB'er.
English: Concomitant intake with fruit juice and/or drinks containing plant extracts (including herbal teas) should be avoided (see section 4.5).
Danish: Indtagelse af frugtjuice og/eller drikkevarer indeholdende planteekstrakter (inklusive urteteer) sammen med Rasilez bør undgås (se pkt.
English: Arthralgia Renal and urinary disorders Uncommon:
Danish: Nyrer og urinveje Ikke almindelig:
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Rasilez 150 mg film-coated tablets Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING Rasilez 150 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 150 mg aliskiren (som hemifumarat).
English: 14 film-coated tablets 28 film-coated tablets 30 film-coated tablets 50 film-coated tablets 56 film-coated tablets 56 x 1 film-coated tablets 90 film-coated tablets 98 film-coated tablets
Danish: 14 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 50 filmovertrukne tabletter 56 filmovertrukne tabletter 56 x 1 filmovertrukne tabletter 90 filmovertrukne tabletter 98 filmovertrukne tabletter
English: Multipack: 84 (3 packs of 28) film-coated tablets Multipack: 90 (3 packs of 30) film-coated tablets Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Danish: Multipakning: 84 (3 pakninger med 28) filmovertrukne tabletter Multipakning: 90 (3 pakninger med 30) filmovertrukne tabletter Multipakning: 98 (2 pakninger med 49) filmovertrukne tabletter Multipakning: 280 (20 pakninger med 14) filmovertrukne tabletter
English: If you take more Rasilez than you should
Danish: Hvis du har taget for meget Rasilez
English: Aliskiren is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2).
Danish: Aliskiren anbefales ikke til patienter med stærkt nedsat nyrefunktion (GFR < 30 ml/min/1,73 m2).
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Rasilez Fortæl altid lægen eller apotekspersonalet, hvis du bruger anden medicin eller har gjort det for nylig.
English: What Rasilez is and what it is used for What you need to know before you take Rasilez How to take Rasilez
Danish: Det skal du vide, før du begynder at tage Rasilez Sådan skal du tage Rasilez Bivirkninger
English: Liver disorder*, jaundice, hepatitis, liver failure** Skin and subcutaneous tissue disorders Uncommon:
Danish: Leverforstyrrelser*, gulsot, hepatitis, leversvigt**
English: NAME OF THE MEDICINAL PRODUCT Rasilez 300 mg film-coated tablets aliskiren
Danish: LÆGEMIDLETS NAVN Rasilez 300 mg filmovertrukne tabletter aliskiren
English: The recommended starting dose of aliskiren in elderly patients is 150 mg. No clinically meaningful additional blood pressure reduction is observed by increasing the dose to 300 mg in the majority of elderly patients.
Danish: Hos størstedelen af de ældre patienter er der ikke set klinisk relevant ekstra blodtryksreduktion ved at øge dosis til 300 mg. Pædiatrisk population
English: Rasilez 300 mg film-coated tablets are available in the following packs: - Unit packs containing 7, 14, 28, 30, 50, 56, 90 or 98 tablets - Unit packs containing 56x1 tablets in perforated unit-dose blisters - Multipacks containing 84 (3x28), 90 (3x30), 98 (2x49) or 280 (20x14) tablets - Multipacks containing 98 (2x49x1) tablets in perforated unit-dose blisters
Danish: Enkeltpakning, der indeholder 7, 14, 28, 30, 50, 56, 90 eller 98 tabletter Enkeltpakninger, der indeholder 56x1 tabletter i perforeret enkeltdosisblister Multipakninger, der indeholder 84 (3x28), 90 (3x30), 98 (2x49) eller 280 (20x14) tabletter Multipakninger, der indeholder 98 (2x49x1) tabletter i perforeret enkeltdosisblister
English: PHARMACEUTICAL FORM AND CONTENTS Multipack: 84 (3 packs of 28) film-coated tablets Multipack: 98 (2 packs of 49) film-coated tablets Multipack: 280 (20 packs of 14) film-coated tablets
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Multipakning: 84 (3 pakninger med 28) filmovertrukne tabletter Multipakning: 98 (2 pakninger med 49) filmovertrukne tabletter Multipakning: 280 (20 pakninger med 14) filmovertrukne tabletter
English: an angiotensin converting enzyme inhibitor such as enalapril, lisinopril, ramipril or an angiotensin II receptor blocker such as valsartan, telmisartan, irbesartan.
Danish: eller en angiotensin-II receptorblokker, som fx valsartan, telmisartan, irbesartan.
English: In clinical studies aliskiren has not been investigated in hypertensive patients with severe renal impairment (serum creatinine ≥ 150 μmol/l or 1.70 mg/dl in women and ≥ 177 μmol/l or 2.00 mg/dl in men and/or estimated GFR < 30 ml/min/1.73 m2), history of dialysis, nephrotic syndrome or renovascular hypertension.
Danish: Aliskiren er ikke undersøgt i kliniske studier med hypertensive patienter, der har svært nedsat nyrefunktion (serumkreatinin ≥ 150 μmol/l eller 1,70 mg/dl hos kvinder og ≥ 177 μmol/l eller
English: NAME OF THE MEDICINAL PRODUCT Rasilez 150 mg film-coated tablets aliskiren
Danish: LÆGEMIDLETS NAVN Rasilez 150 mg filmovertrukne tabletter aliskiren
English: - The concomitant use of aliskiren with ciclosporin and itraconazole, two highly potent P-glycoprotein (P-gp) inhibitors, and other potent P-gp inhibitors (e.g. quinidine), is contraindicated (see section 4.5).
Danish: (P-gp)-hæmmere, eller andre potente P-gp-hæmmere (fx quinidin) er kontraindiceret (se pkt.
English: It is not recommended in patients with severe renal impairment (GFR < 30 ml/min/1.73 m2).
Danish: Det frarådes til patienter med stærkt nedsat nyrefunktion (GFR < 30 ml/min/1,73 m2).
English: Rasilez 150 mg film-coated tablets are available in the following packs: - Unit packs containing 7, 14, 28, 30, 50, 56, 90 or 98 tablets - Unit packs containing 56x1 tablets in perforated unit-dose blisters - Multipacks containing 84 (3x28), 98 (2x49) or 280 (20x14) tablets - Multipacks containing 98 (2x49x1) tablets in perforated unit-dose blisters
Danish: Enkeltpakning, der indeholder 7, 14, 28, 30, 50, 56, 90 eller 98 tabletter Enkeltpakninger, der indeholder 56x1 tabletter i perforeret enkeltdosisblister Multipakninger, der indeholder 84 (3x28), 98 (2x49) eller 280 (20x14) tabletter Multipakninger, der indeholder 98 (2x49x1) tabletter i perforeret enkeltdosisblister
English: Rasilez 150 mg film-coated tablets Rasilez 300 mg film-coated tablets
Danish: Rasilez 150 mg filmovertrukne tabletter Rasilez 300 mg filmovertrukne tabletter
English: You should avoid taking this medicine together with fruit juice and/or drinks containing plant extracts (including herbal teas), as it could cause a decrease in the effectiveness of this medicine.
Danish: Du skal undgå at tage dette lægemiddel sammen med frugtjuice og/eller drikkevarer, der indeholder planteekstrakt (inkl.
English: aliskiren at doses of 75 mg, 150 mg and 300 mg provided statistically significant superior reduction in blood pressure (both systolic and diastolic) when compared to placebo.
Danish: I et 8-ugers studie med 754 hypertensive ældre patienter (≥ 65 år) og gamle patienter (30 % ≥ 75 år) gav aliskiren i doser på 75 mg, 150 mg og 300 mg statistisk signifikant større blodtryksreduktioner (både systolisk og diastolisk) sammenlignet med placebo.
English: Rasilez 300 mg film-coated tablets
Danish: Rasilez 300 mg filmovertrukne tabletter
English: It is not recommended in patients with severe renal impairment (glomerular filtration rate (GFR) < 30 ml/min/1.73 m2).
Danish: Aliskiren anbefales ikke til patienter med stærkt nedsat nyrefunktion (glomerulær filtrationsrate (GFR) < 30 ml/min/1,73 m2).
English: - The concomitant use of Rasilez with an angiotensin converting enzyme inhibitor(ACEI) or an angiotensin II receptor blocker (ARB) is contraindicated in patients with diabetes mellitus or renal impairment (GFR < 60 ml/min/1.73 m2) (see sections 4.5 and 5.1).
Danish: eller en angiotensin-receptorblokker (ARB) er kontraindiceret hos patienter med diabetes mellitus eller nedsat nyrefunktion (GFR < 60 ml/min/1,73 m2) (se pkt.
English: Rasilez 150 mg film-coated tablets - Each tablet contains 150 mg aliskiren (as hemifumarate).
Danish: Rasilez 150 mg filmovertrukne tabletter - Hver tablet indeholder 150 mg aliskiren (som hemifumarat).
English: What Rasilez looks like and contents of the pack Rasilez 150 mg film-coated tablets are light-pink, biconvex round tablets, imprinted “IL” on one side and “NVR” on the other side.
Danish: Rasilez 150 mg filmovertrukne tabletter er lyse pink, udadbuede, runde tabletter, præget med ”IL” på den ene side og ”NVR” på den anden side.
English: No overall clinically relevant adverse impact on paediatric patients aged 6 to 17 years was observed after treatment with aliskiren for up to one year based on physical development, assessed in patients with primary or secondary hypertension, and neurocognitive development assessed only in patients with secondary hypertension (19 patients: 9 previously treated with aliskiren and 10 previously treated with enalapril) (see section 4.2, 4.8, 5.1 and 5.2).
Danish: Ud fra en vurdering af fysisk udvikling hos patienter med primær eller sekundær hypertension og en vurdering af neurokognitiv udvikling udelukkende hos patienter med sekundær hypertension (19 patienter: 9 tidligere behandlet med aliskiren og 10 tidligere behandlet med enalapril) blev der ikke observeret en overordnet klinisk relevant negativ indvirkning på pædiatriske patienter i alderen 6 til 17 år efter behandling med aliskiren i op til et år (se pkt.
English: Rasilez 150 mg film-coated tablets
Danish: Rasilez 150 mg filmovertrukne tabletter
English: (95.4% Confidence Interval: 0.987, 1.218, 2-sided p=0.0787).
Danish: De endelige resultater fra studiet indikerede en hazard ratio for det primære endepunkt på 1,097 til fordel for placebo (95,4 % konfidensinterval: 0,987-1,218; 2-sidet p=0,0787).
English: Rasilez 300 mg film-coated tablets - Each tablet contains 300 mg aliskiren (as hemifumarate).
Danish: Rasilez 300 mg filmovertrukne tabletter - Hver tablet indeholder 300 mg aliskiren (som hemifumarat).
English: Rasilez 300 mg film-coated tablets Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Danish: Rasilez 300 mg filmovertrukne tabletter Hver filmovertrukken tablet indeholder 300 mg aliskiren (som hemifumarat).
English: - an angiotensin II receptor blocker or an angiotensin converting enzyme inhibitor (see sections
Danish: - en angiotensin-II receptorblokker eller en angiotensin-konverteringsenzym (ACE)-hæmmer (se punkterne ”Tag ikke Rasilez” og ”Advarsler og forsigtighedsregler”.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 150 mg aliskiren (as hemifumarate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 150 mg aliskiren (som hemifumarat).
English: P-gp interactions
Danish: Interaktioner med P-glykoprotein
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PCTFE/PVC BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL MULTPAKNING (INKLUSIV BLÅ BOKS) MED PCTFE/PVCBLISTERKORT
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON OF MULTIPACKS (INCLUDING BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE YDRE KARTON TIL MULTPAKNING (INKLUSIV BLÅ BOKS) MED PA/ALU/PVCBLISTERKORT
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR UNIT PACK CONTAINING PA/ALU/PVC BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL ENKELTPAKNING MED PA/ALU/PVC-BLISTERKORT
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON FOR UNIT PACK CONTAINING PCTFE/PVC BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL ENKELTPAKNING MED PCTFE/PVC-BLISTERKORT
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 300 mg aliskiren (as hemifumarate).
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukken tablet indeholder 300 mg aliskiren (som hemifumarat).
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PCTFE/PVC BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL DELPAKNING (UDEN BLÅ BOKS) MED PCTFE/PVC-BLISTERKORT
English: Manufacturer Noden Pharma DAC D'Olier Chambers 16A D'Olier Street Dublin 2
Danish: Fremstiller Noden Pharma DAC D'Olier Chambers
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING INTERMEDIATE CARTON OF MULTIPACKS (WITHOUT BLUE BOX) CONTAINING PA/ALU/PVC BLISTERS
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE KARTON TIL DELPAKNING (UDEN BLÅ BOKS) MED PA/ALU/PVC-BLISTERKORT
English: After the first 52 week extension study, eligible male and female paediatric patients aged 6 to 17 years with primary or secondary hypertension, were enrolled in a 52 to 104 week off-therapy noninterventional observational extension study designed to evaluate the LT growth and development,
Danish: Efter det første 52-ugers forlængelsesstudie blev egnede pædiatriske patienter (drenge og piger) i alderen fra 6 til 17 år med primær eller sekundær hypertension tilmeldt et 52 til 104 uger langt ikkeinterventionelt forlængelsesobservationsstudie uden behandling, som havde til formål at evaluere langsigtet vækst og udvikling ved måling af højde og vægt med yderligere neurokognitive evalueringer og vurderinger af nyrefunktion som opfølgende tiltag, der kun foretages hos patienter med sekundær hypertension (19 patienter: 9 tidligere behandlet med aliskiren og 10 tidligere behandlet med enalapril).
English: No adjustment of the initial dosage of treatment is required in patients with mild to moderate renal impairment (see sections 4.2 and 4.4).
Danish: Det er ikke nødvendigt at justere initialdosen af behandlingen hos patienter med let til moderat nedsat nyrefunktion (se pkt.
English: If co-administration with an agent affecting the level of serum potassium is considered necessary, routine monitoring of potassium levels would be advisable.
Danish: Regelmæssig kontrol af kaliumniveauer tilrådes, hvis samtidig administration af et stof, som påvirker serumkalium, skønnes nødvendig.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/039
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/405/039
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/405/001
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/017
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/405/017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/031
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/405/031
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/029
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/405/029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/011
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/405/011
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/007
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/405/007
English: MARKETING AUTHORISATION NUMBER(S) EU/1/07/405/021
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/07/405/021
English: The effect of drinks containing plant extracts (including herbal teas) on the absorption of aliskiren has not been investigated.
Danish: Virkningen af drikkevarer indeholdende planteekstrakter (inklusive urteteer)
English: (× 0.85 for female patients)
Danish: (× 0,85 for kvinder)
English: Date of first authorisation: 17 July 2015.
Danish: Dato for første markedsføringstilladelse: 17. juli 2015
English: Do not use this medicine after the expiry date which is stated on the blister and carton after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på blisteren og pakningen efter ”Exp”.
English: Pregabalin may potentiate the effects of ethanol and lorazepam.
Danish: Pregabalin kan potensere virkningerne af ethanol og lorazepam.
English: The active substance is pregabalin.
Danish: Det aktive indholdsstof er pregabalin.
English: If you are an elderly patient (over 65 years of age), you should take Pregabalin Zentiva normally except if you have problems with your kidneys.
Danish: Hvis du er ældre (over 65 år), skal du tage Pregabalin Zentiva som normalt, medmindre du har nyreproblemer.
English: Pregabalin Zentiva and certain other medicines may influence each other (interaction).
Danish: Pregabalin Zentiva og anden medicin kan påvirke hinanden (interaktion).
English: It is advised not to drink alcohol while taking Pregabalin Zentiva.
Danish: Det tilrådes ikke at drikke alkohol, når du tager Pregabalin Zentiva.
English: 1.23 × [140 - age (years)] × weight (kg) serum creatinine (µmol/l)
Danish: 1,23 × [140 - alder (år)] × vægt (kg) serumkreatinin (µmol/l)
English: Pregabalin Zentiva is not intended to be used alone, but should always be used in combination with other anti-epileptic treatment.
Danish: Pregabalin Zentiva er ikke beregnet til at blive brugt alene, men skal altid anvendes i kombination med anden behandling mod epilepsi.
English: Your doctor will tell you to take Pregabalin Zentiva either twice or three times a day.
Danish: Din læge vil fortælle, at du enten skal tage Pregabalin Zentiva 2 gange eller 3 gange dagligt.
English: If you have the impression that the effect of Pregabalin Zentiva is too strong or too weak, talk to your doctor or pharmacist.
Danish: Hvis du har indtryk af, at virkningen af Pregabalin Zentiva er for stærk eller alt for svag, skal du tale med din læge eller apoteket.
English: Pregabalin Zentiva is for oral use only.
Danish: Pregabalin Zentiva er kun til oral anvendelse.
English: Pregabalin Zentiva may be taken with or without food.
Danish: Pregabalin Zentiva kan tages med eller uden mad.
English: The AUC was lower by 30% in paediatric patients below a weight of 30 kg due to an increased body weight adjusted clearance of 43% for these patients in comparison to patients weighing ≥30 kg.
Danish: AUC var 30% lavere hos pædiatriske patienter med en vægt under 30 kg på grund af en øgning i kropsvægtjusteret clearance på 43% hos disse patienter sammenlignet med patienter, der vejede ≥30 kg.
English: It is important to take your Pregabalin Zentiva hard capsules regularly at the same time each day.
Danish: Det er vigtigt, at du tager dine Pregabalin Zentiva kapsler regelmæssigt og på samme tid hver dag.
English: Your doctor will prescribe Pregabalin Zentiva for you to help treat your epilepsy when your current treatment is not controlling your condition.
Danish: Din læge vil udskrive Pregabalin Zentiva til behandling af din epilepsi, hvis din nuværende behandling ikke kan kontrollere din tilstand.
English: Continue taking Pregabalin Zentiva until your doctor tells you to stop.
Danish: Fortsæt med at tage Pregabalin Zentiva, indtil din læge beder dig om at stoppe.
English: Pregabalin Zentiva with food, drink and alcohol Pregabalin Zentiva hard capsules may be taken with or without food.
Danish: Brug af Pregabalin Zentiva sammen med mad, drikke og alkohol Pregabalin Zentiva hårde kapsler kan tages både sammen med eller uden mad.