FrancophonIA/ELRC3.0 huggingface dataset:
English: Red opaque cap and pale yellow-brown opaque body, capsule size 0 (21.7 mm x 7.6 mm), filled with white to nearly white coloured powder.
Danish: Rød uigennemsigtig overdel og lys gulbrun uigennemsigtig underdel, kapselstørrelse 0 (21,7 mm x 7,6 mm), fyldt med hvidt eller næsten hvidt pulver.
English: 100 mg capsules:
Danish: 100 mg kapsler:
English: White opaque cap and body, capsule size 2 (18.0 mm x 6.4 mm), filled with white to nearly white coloured powder.
Danish: Hvid uigennemsigtig overdel og underdel, kapselstørrelse 2 (18,0 mm x 6,4 mm), fyldt med hvidt eller næsten hvidt pulver.
English: If you stop taking Pregabalin Sandoz
Danish: Hvis De har taget for meget Pregabalin Sandoz
English: 50 mg capsules:
Danish: 50 mg kapsler:
English: INFORMATION IN BRAILLE Pregabalin Sandoz 75 mg
Danish: INFORMATION I BRAILLESKRIFT Pregabalin Sandoz 75 mg
English: Pharmacotherapeutic group: Anti epileptics, other anti-epileptics ATC code: N03AX16 The active substance, pregabalin, is a gamma-aminobutyric acid analogue [(S)-3(aminomethyl)-5-methylhexanoic acid].
Danish: Det aktive indholdsstof, pregabalin, er en gamma-aminosmørsyre-analog [(S)-3-(aminomethyl)-5-methylhexansyre].
English: 225 mg capsules: Blisters containing 14, 56, 70, 84,100 or 120 hard capsules.
Danish: 225 mg kapsler: Blistere med 14, 56, 70, 84, 100 eller 120 hårde kapsler.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/018-029
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/018-029
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/011-017
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/011-017
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/057-062
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/057-062
English: Blisters containing 21, 28, 84 or 100 hard capsules.
Danish: Blisterpakninger: 21, 28, 84 eller 100 hårde kapsler.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/081-083
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/081-083
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/054-056
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/054-056
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/063-068
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/063-068
English: How to take Pregabalin Sandoz
Danish: Sådan skal De tage Pregabalin Sandoz
English: Unit dose blisters containing 14, 56, 84, 100 or 210 (3 x 70) hard capsules.
Danish: Blistere (enkeltdosis) med 14, 56, 84, 100 eller 210 (3 x 70) hårde kapsler.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/031-033
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/031-033
English: Tlf: + 45 6395 1000
Danish: Tel: + 39 02 96541
English: Red opaque cap and white opaque body, capsule size 4 (14.3 mm x 5.3 mm), filled with white to nearly white coloured powder.
Danish: Rød uigennemsigtig overdel og hvid uigennemsigtig underdel, kapselstørrelse 4 (14,3 mm x 5,3 mm), fyldt med hvidt eller næsten hvidt pulver.
English: INFORMATION IN BRAILLE Pregabalin Sandoz 100 mg
Danish: INFORMATION I BRAILLESKRIFT Pregabalin Sandoz 100 mg
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/001-010
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/001-010
English: INFORMATION IN BRAILLE Pregabalin Sandoz 300 mg
Danish: INFORMATION I BRAILLESKRIFT Pregabalin Sandoz 300 mg
English: 200 mg capsules Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm) filled with white to nearly white coloured powder.
Danish: 200 mg kapsler Lys orange uigennemsigtig overdel og underdel, kapselstørrelse 1 (19,4 mm x 6,9 mm), fyldt med hvidt eller næsten hvidt pulver.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 225 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hård kapsel indeholder 225 mg pregabalin.
English: Unit dose blisters containing 56, 84, 100 or 210 (3 x 70) hard capsules.
Danish: Blistere (enkeltdosis) med 56, 84, 100 eller 210 (3 x 70) hårde kapsler.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/042-052
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/042-052
English: 14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 56 x 1 hard capsules
Danish: 14 hårde kapsler 21 hårde kapsler 28 hårde kapsler 56 hårde kapsler 70 hårde kapsler 56 x 1 hårde kapsler
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 75 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hård kapsel indeholder 75 mg pregabalin.
English: Titanium dioxide (E171) Iron oxide yellow (E172) Iron oxide red (E172)
Danish: Titandioxid (E171) Jernoxid, gul (E172) Jernoxid, rød (E172)
English: 14 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules
Danish: 14 hårde kapsler 56 hårde kapsler 70 hårde kapsler 84 hårde kapsler 100 hårde kapsler 120 hårde kapsler
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/085
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/085
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/069-073
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/069-073
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/034-041
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/034-041
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/084
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/084
English: 100 mg capsules Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm) filled with white to nearly white coloured powder.
Danish: 100 mg kapsler Rød uigennemsigtig overdel og underdel, kapselstørrelse 3 (15,9 mm x 5,8 mm), fyldt med hvidt eller næsten hvidt pulver.
English: The pregabalin clinical program involved over 8,900 patients exposed to pregabalin, of whom over 5,600 were in double-blind placebo controlled trials.
Danish: Heraf har over 5.600 deltaget i dobbelt-blinde placebokontrollerede forsøg.
English: 50 mg capsules Light yellow opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm) filled with white to nearly white coloured powder.
Danish: 50 mg kapsler Lysegul uigennemsigtig overdel og underdel, kapselstørrelse 3 (15,9 mm x 5,8 mm), fyldt med hvidt eller næsten hvidt pulver.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/042-056
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/042-056
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 150 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hård kapsel indeholder 150 mg pregabalin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 300 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hård kapsel indeholder 300 mg pregabalin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 225 mg of pregabalin.
Danish: 1 hård kapsel indeholder 225 mg pregabalin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 75 mg of pregabalin.
Danish: 1 hård kapsel indeholder 75 mg pregabalin.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 200 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hård kapsel indeholder 200 mg pregabalin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 150 mg of pregabalin.
Danish: 1 hård kapsel indeholder 150 mg pregabalin.
English: 21 hard capsules 28 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Danish: 21 hårde kapsler 28 hårde kapsler 84 hårde kapsler 100 hårde kapsler 84 x 1 hårde kapsler 100 x 1 hårde kapsler
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 225 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Sandoz 225 mg hårde kapsler pregabalin
English: What Pregabalin Sandoz contains - The active substance is pregabalin.
Danish: • Aktivt stof: pregabalin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/053
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/053
English: Red opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white coloured powder.
Danish: Rød uigennemsigtig overdel og underdel, kapselstørrelse 3 (15,9 mm x 5,8 mm), fyldt med hvidt eller næsten hvidt pulver.
English: Pale orange opaque cap and white opaque body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to nearly white coloured powder.
Danish: Lys orange uigennemsigtig overdel og hvid uigennemsigtig underdel, kapselstørrelse 1 (19,4 mm x 6,9 mm), fyldt med hvidt eller næsten hvidt pulver.
English: Pale orange opaque cap and body, capsule size 1 (19.4 mm x 6.9 mm), filled with white to nearly white coloured powder.
Danish: Lys orange uigennemsigtig overdel og underdel, kapselstørrelse 1 (19,4 mm x 6,9 mm), fyldt med hvidt eller næsten hvidt pulver.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 200 mg of pregabalin.
Danish: 1 hård kapsel indeholder 200 mg pregabalin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 300 mg of pregabalin.
Danish: 1 hård kapsel indeholder 300 mg pregabalin.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/15/1011/030
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/15/1011/030
English: Pale yellow-brown opaque cap and body, capsule size 4 (14.3 mm x 5.3 mm), filled with white to nearly white coloured powder.
Danish: Lys gulbrun uigennemsigtig overdel og underdel, kapselstørrelse 4 (14,3 mm x 5,3 mm), fyldt med hvidt eller næsten hvidt pulver.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 300 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Sandoz 300 mg hårde kapsler pregabalin
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 100 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hård kapsel indeholder 100 mg pregabalin.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 200 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Sandoz 200 mg hårde kapsler pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 75 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Sandoz 75 mg hårde kapsler pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 100 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Sandoz 100 mg hårde kapsler pregabalin
English: Blisters containing 14, 21, 28, 56, 84 or 100 hard capsules.
Danish: Blisterpakninger: 14, 21, 28, 56, 84 eller 100 hårde kapsler.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 150 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Sandoz 150 mg hårde kapsler pregabalin
English: Blisters containing 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules.
Danish: Blisterpakninger: 14, 21, 28, 56, 70, 84, 100 eller 120 hårde kapsler.
English: Blister packs: 14, 21, 28, 56, 70, 84, 100 or 120 hard capsules Blister packs (unit dose): 14 x 1, 56 x 1, 84 x 1, 100 x 1 or 210 x 1 (3 x 70) hard capsules.
Danish: Blisterpakninger (enkeltdosis): 14 x 1, 56 x 1, 84 x 1, 100 x 1 eller 210 x 1 (3 x 70) hårde kapsler.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 25 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hård kapsel indeholder 25 mg pregabalin.
English: Blisters containing 14, 28, 56, 70, 84, 100 or 120 hard capsules.
Danish: Blisterpakninger: 14, 28, 56, 70, 84, 100 eller 120 hårde kapsler.
English: What you need to know before you take Pregabalin Sandoz 3.
Danish: Det skal De vide, før De begynder at tage Pregabalin Sandoz Sådan skal De tage Pregabalin Sandoz Bivirkninger
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 50 mg of pregabalin.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER 1 hård kapsel indeholder 50 mg pregabalin.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 25 mg of pregabalin.
Danish: 1 hård kapsel indeholder 25 mg pregabalin.
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 25 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Sandoz 25 mg hårde kapsler pregabalin
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 50 mg hard capsules pregabalin
Danish: LÆGEMIDLETS NAVN Pregabalin Sandoz 50 mg hårde kapsler pregabalin
English: 14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 84 hard capsules 100 hard capsules 84 x 1 hard capsules
Danish: 14 hårde kapsler 21 hårde kapsler 28 hårde kapsler 56 hårde kapsler 84 hårde kapsler 100 hårde kapsler 84 x 1 hårde kapsler
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 50 mg of pregabalin.
Danish: 1 hård kapsel indeholder 50 mg pregabalin.
English: Light yellow opaque cap and body, capsule size 3 (15.9 mm x 5.8 mm), filled with white to nearly white coloured powder.
Danish: Lysegul uigennemsigtig overdel og underdel, kapselstørrelse 3 (15,9 mm x 5,8 mm), fyldt med hvidt eller næsten hvidt pulver.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each hard capsule contains 100 mg of pregabalin.
Danish: 1 hård kapsel indeholder 100 mg pregabalin.
English: 14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 14 x 1 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Danish: 14 hårde kapsler 21 hårde kapsler 28 hårde kapsler 56 hårde kapsler 70 hårde kapsler 84 hårde kapsler 100 hårde kapsler 120 hårde kapsler 14 x 1 hårde kapsler 56 x 1 hårde kapsler 84 x 1 hårde kapsler 100 x 1 hårde kapsler
English: 14 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Danish: 14 hårde kapsler 28 hårde kapsler 56 hårde kapsler 70 hårde kapsler 84 hårde kapsler 100 hårde kapsler 120 hårde kapsler 56 x 1 hårde kapsler 84 x 1 hårde kapsler 100 x 1 hårde kapsler
English: 14 hard capsules 21 hard capsules 28 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 28 hårde kapsler 56 hårde kapsler 84 hårde kapsler 100 hårde kapsler 84 x 1 hårde kapsler 100 x 1 hårde kapsler
English: INFORMATION IN BRAILLE Pregabalin Sandoz 200 mg
Danish: Pregabalin Sandoz 200 mg
English: 14 hard capsules 21 hard capsules 28 hard capsules 56 hard capsules 70 hard capsules 84 hard capsules 100 hard capsules 120 hard capsules 56 x 1 hard capsules 84 x 1 hard capsules 100 x 1 hard capsules
Danish: 14 hårde kapsler 21 hårde kapsler 28 hårde kapsler 56 hårde kapsler 70 hårde kapsler 84 hårde kapsler 100 hårde kapsler 120 hårde kapsler 56 x 1 hårde kapsler 84 x 1 hårde kapsler 100 x 1 hårde kapsler
English: NAME OF THE MEDICINAL PRODUCT Pregabalin Sandoz 225 mg hard capsules
Danish: Pregabalin Sandoz 225 mg hårde kapsler
English: INFORMATION IN BRAILLE Pregabalin Sandoz 150 mg
Danish: Pregabalin Sandoz 150 mg
English: What Pregabalin Sandoz is and what it is used for
Danish: Pregabalin Sandoz indeholder:
English: Effective contraception must be used by women of child-bearing potential.
Danish: Hvis De er i den fødedygtige alder, skal De bruge sikker prævention.
English: Frequency cannot be estimated from the available data
Danish: Hyppigheden kan ikke estimeres ud fra de tilgængelige data
English: When taken by mouth
Danish: Ved indtagelse gennem munden
English: These medicines may change the effect of AMMONAPS and you will need more frequent blood controls.
Danish: Disse lægemidler kan ændre virkningen af AMMONAPS, og du vil have behov for hyppigere kontrol af blodet.
English: Date of first authorisation: 08/12/1999 Date of latest renewal: 08/12/2009
Danish: Dato for første markedsføringstilladelse: 08/12/1999 Dato for seneste fornyelse: 08/12/2009
English: The tablets should be taken with a large volume of water.
Danish: Tabletterne skal indtages med en stor mængde vand.
English: Immedica Pharma AB SE-113 29 Stockholm Sweden
Danish: Immedica Pharma AB SE-113 29 Stockholm Sverige
English: Evaluation of experimental animal studies has shown reproductive toxicity, i.e. effects on the development of the embryo or the foetus.
Danish: Evalueringen af eksperimentelle dyreforsøg har vist reproduktiv toksicitet, dvs. virkninger på udviklingen af embryo eller foster.
English: Your doctor will tell you how many tablets you should take.
Danish: Din læge vil fortælle dig, hvor mange tabletter du skal tage.
English: Three measuring spoons of different measures are provided.
Danish: Der medfølger tre måleskeer af forskellige størrelser.
English: Frequency is defined as 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).
Danish: Hyppigheden defineres som meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100, sjælden (1/10.000 til <1/1.000), meget sjælden (<1/10.000), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Take the solution immediately after mixing.
Danish: Tag opløsningen, straks efter at den er blandet.
English: If you are sexually active and your period stops altogether, do not assume that this is caused by AMMONAPS.
Danish: Hvis du er seksuelt aktiv, og dine menstruationer standser helt, må du ikke antage, at det skyldes AMMONAPS.
English: Common: Depression, irritability
Danish: Almindelig: Depression, irritabilitet
English: AMMONAPS may be required life-long unless orthotopic liver transplantation is elected.
Danish: AMMONAPS kan være nødvendig på livstid, medmindre ortotopisk levertransplantation vælges.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: De pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Do not use this medicine after the expiry date which is stated on the carton and the bottle label after “EXP”.
Danish: Brug ikke AMMONAPS efter den udløbsdato, der står på pakningen og flaskeetiketten efter ”EXP”.
English: Please note that the reconstituted granules will normally produce a milky white suspension.
Danish: Bemærk, at det opløste granulat normalt vil give en mælkeagtig hvid suspension.
English: The adverse reactions are listed below, by system organ class and by frequency.
Danish: De uønskede hændelser er angivet nedenfor inddelt efter systemorganklasse og hyppighed.
English: You should take AMMONAPS with each meal or feeding.
Danish: Du skal tage AMMONAPS sammen med hvert måltid eller madning.
English: In clinical trials with AMMONAPS, 56 % of the patients experienced at least one adverse event and 78 % of these adverse events were considered as not related to AMMONAPS.
Danish: I kliniske forsøg med AMMONAPS oplevede 56 % af patienterne mindst én uønsket hændelse, og det blev antaget, at 78 % af disse uønskede hændelser ikke var relateret til AMMONAPS.
English: Reversal of pre-existing neurologic impairment is not likely to occur with treatment, and neurologic deterioration may continue in some patients.
Danish: Forbedring i allerede eksisterende neurologiske defekter kan ikke forventes under behandling, og neurologisk forværring kan fortsætte hos nogle patienter.
English: More frequent monitoring of plasma ammonia levels is advised when these medications have to be used.
Danish: En hyppigere kontrol af plasmakoncentrationen af ammoniak tilrådes, når disse præparater skal anvendes.
English: If you are a woman who could get pregnant, you must use reliable contraception, during treatment with AMMONAPS.
Danish: Hvis du er kvinde, og du kan blive gravid, skal du bruge en sikker form for svangerskabsforebyggelse under behandlingen med AMMONAPS.
English: Patients with these rare disorders have a deficiency of certain liver enzymes and are therefore unable to eliminate nitrogen waste.
Danish: Patienter med disse sjældne forstyrrelser mangler nogle bestemte leverenzymer og er derfor ikke i stand til at udskille kvælstofholdige affaldsstoffer.
English: The volume of distribution of phenylbutyrate is 0.2 l/kg.
Danish: Distributionsvolumen for phenylbutyrat er 0,2 l/kg.
English: Where AMMONAPS granules need to be added to food, liquid or water, it is important that it is taken immediately after mixing.
Danish: Hvis AMMONAPS skal tilsættes mad, væske eller vand, er det vigtigt, at det bliver indtaget straks efter tilberedning.
English: • The granules left in the spoon are one spoonful
Danish: • Det granulat, der er tilbage i skeen, er en skefuld
English: The significance of these data in pregnant women is not known; therefore the use of AMMONAPS is contra-indicated during pregnancy (see section 4.3).
Danish: Betydningen af disse data med hensyn til gravide kvinder kendes ikke; derfor er brugen af AMMONAPS kontraindiceret under graviditet (se pkt.
English: Cerebral synapse maturation was retarded and the number of functioning nerve terminals in the cerebrum was reduced, which resulted in impaired brain growth.
Danish: Modningen af de cerebrale synapser var forsinket, og antallet af fungerende nerveterminaler i hjernen var nedsat, hvilket førte til hæmmet vækst af hjernen.
English: Contains sodium, see package leaflet for further information.
Danish: Indeholder natrium, se indlægssedlen for mere information.
English: You will need regular blood tests to determine the correct daily dose.
Danish: Du skal derfor regelmæssigt have taget blodprøver for at finde den rigtige daglige dosis.
English: Three spoons (one small white spoon, one medium sized yellow spoon and one large blue spoon) are included to measure your daily dose.
Danish: Tre skefulde (én lille hvid ske, én mellemstor gul ske og én stor blå ske) er vedlagt til afmåling af din daglige dosis.
English: AMMONAPS does not completely prevent the occurrence of an acute excess of ammonia in the blood and is not appropriate for treating such a condition, which is a medical emergency.
Danish: AMMONAPS forhindrer ikke fuldstændigt, at en akut tilstand med for meget ammoniak i blodet opstår, og er ikke egnet til behandling af sådan en tilstand, som er et akut tilfælde.
English: If you require laboratory tests, it is important to remind your doctor that you are taking AMMONAPS, since sodium phenylbutyrate may influence certain laboratory test results.
Danish: Hvis du skal have taget laboratorieprøver, er det vigtigt, at du fortæller det til lægen, at du tager AMMONAPS, da natriumphenylbutyrat kan påvirke resultaterne af bestemte laboratorieprøver.
English: Very common side effects: irregular menstrual periods and cessation of menstrual periods.
Danish: Meget almindelige bivirkninger: uregelmæssige menstruationer og ophør af menstruationer.
English: • Take the correct number of spoonfuls granules from the bottle
Danish: • Tag det rigtige antal skefulde granulat fra flasken
English: Common: Syncope, headache
Danish: Almindelig: Synkope, hovedpine
English: The frequency of possible side effects is listed below.
Danish: Hyppigheden af mulige bivirkninger er anført herunder:
English: • Shake the bottle lightly before opening
Danish: • Ryst flasken let, før den åbnes
English: Mix the granules with water until there are no dry granules left (stirring the solution helps to dissolve the granules).
Danish: Bland granulatet med vand, indtil der ikke er noget tørt granulat tilbage (omrøring i opløsningen hjælper til at opløse granulatet).
English: You will need to have treatment and to follow a diet throughout your life, unless you have a successful liver transplantation.
Danish: Du vil hele livet skulle have behandling og følge en særlig kostplan, medmindre du får foretaget en vellykket levertransplantation.
English: Do not use AMMONAPS if you are pregnant, because this medicine can harm your unborn baby.
Danish: Tag ikke AMMONAPS, hvis du er gravid, da denne medicin kan skade det ufødte barn.
English: Even on therapy, acute hyperammonaemic encephalopathy may occur in a number of patients.
Danish: Selv under behandling kan akut hyperammonæmisk encefalopati opstå hos nogle patienter.