FrancophonIA/ELRC3.0 huggingface dataset:
English: Each film-coated tablet contains 12 mg of lactose and 13.2 mg of hydrogenated castor oil.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukket tablet indeholder 12 mg lactose og 13,2 mg hydrogeneret ricinusolie.
English: Aluminium perforated unit-dose blisters in cardboard cartons containing 4x1, 10x1, 30x1 and 100x1 film-coated tablets.
Danish: Clopidogrel Zentiva 300 mg filmovertrukne tabletter Perforerede enkeltdosisblistere af aluminium i kartonæsker der indeholder 4x1, 10x1, 30x1 og 100x1 filmovertrukne tabletter.
English: Zentiva Portugal, Lda Tel: +351210601360
Danish: Zentiva Portugal, Lda Tel: +351210601360 PV-Portugal@zentiva.com
English: Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171), Polishing agent: carnauba wax.
Danish: Tabletkernen: Mannitol (E421), hydrogeneret ricinusolie, mikrokrystallinsk cellulose, macrogol 6000, lavsubstitueret hydroxypropylcellulose Tabletovertræk: Lactosemonohydrat (mælkesukker), hypromellose (E464), triacetin (E1518), rød jernoxid (E172) og titandioxid (E171)
English: What you need to know before you take Clopidogrel Zentiva Do not take Clopidogrel Zentiva:
Danish: Det skal du vide, før du begynder at tage Clopidogrel Zentiva Sådan skal du tage Clopidogrel Zentiva Bivirkninger
English: In all aluminium blisters, this medicinal product does not require any special storage conditions.
Danish: Blisterkort kun i aluminium kræver ingen særlige forholdsregler vedrørende opbevaringen.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS BLISTER 4x1, 10x1, 30x1 or 100x1 tablets
Danish: BLISTER 4x1, 10x1, 30x1 eller 100x1 tabletter
English: Clopidogrel Zentiva 75 mg film-coated tablets Pink, round, biconvex, engraved with «75» on one side and «1171» on the other side.
Danish: Clopidogrel Zentiva 75 mg filmovertrukne tabletter Lyserøde, runde og bikonvekse, med tallet "75" præget på den ene side og tallet "1171" på den anden side.
English: Clopidogrel Zentiva 75-mg film-coated tablets (tablets) are round, biconvex, pink, engraved on one side with the number ‘75' and on the other side with the number ‘1171'.
Danish: Clopidogrel Zentiva 75 mg filmovertrukne tabletter (tabletter) er runde, bikonvekse, lyserøde, og er præget på den ene side med tallet "75" og på den anden side med tallet "1171".
English: Each film-coated tablet contains 3 mg of lactose and 3.3 mg of hydrogenated castor oil.
Danish: Hjælpestoffer, som behandleren skal være opmærksom på: Hver filmovertrukket tablet indeholder 3 mg lactose og 3,3 mg hydrogeneret ricinusolie.
English: Clopidogrel Zentiva 300-mg film-coated tablets (tablets) are oblong, pink, engraved on one side with the number ‘300' and on the other side with the number ‘1332'.
Danish: Clopidogrel Zentiva 300 mg filmovertrukne tabletter (tabletter) er aflange, lyserøde, og er præget på den ene side med tallet '300' og på den anden side med tallet "1332".
English: In PVC/PVDC/aluminium blisters, store below 30°C.
Danish: Blisterkort af PVC/PVDC/aluminium skal opbevares ved temperaturer under 30 ºC.
English: Clopidogrel Zentiva 75 mg film-coated tablets Clopidogrel Zentiva 300 mg film-coated tablets
Danish: Clopidogrel Zentiva 75 mg filmovertrukne tabletter Clopidogrel Zentiva 300 mg filmovertrukne tabletter
English: The active substance is clopidogrel.
Danish: Clopidogrel Zentiva indeholder Det aktive stof er clopidogrel.
English: Tablet core: mannitol (E421), hydrogenated castor oil, microcrystalline cellulose, macrogol 6000 and low-substituted hydroxypropylcellulose, Tablet coating: lactose monohydrate (milk sugar), hypromellose (E464), triacetin (E1518), red iron oxide (E172) and titanium dioxide (E171), Polishing agent: carnauba wax.
Danish: Øvrige indholdsstoffer (se afsnit 2 'Clopidogrel Zentiva indeholder lactose' og Clopidogrel Zentiva indeholder hydrogeneret ricinusolie'): - Tabletkernen: Mannitol (E421), hydrogeneret ricinusolie, mikrokrystallinsk cellulose, macrogol 6000, lavsubstitueret hydroxypropylcellulose - Tabletovertræk: Lactosemonohydrat (mælkesukker), hypromellose (E464), triacetin (E1518), rød jernoxid (E172), titandioxid (E171) - Polérmiddel: Carnaubavoks
English: In CLARITY, there was an overall increase in bleeding in the clopidogrel plus ASA group vs. the placebo plus ASA group .The incidence of major bleeding was similar between groups.
Danish: I CLARITY var der en generel stigning i antallet af blødninger i clopidrogrel plus ASA-gruppen versus placebo plus ASA-gruppen.
English: Bleeding may occur as bleeding in the stomach or bowels, bruising, haematoma (unusual bleeding or bruising under the skin), nose bleed, blood in the urine.
Danish: Den almindeligste bivirkning, der er set med Clopidogrel Zentiva, er blødning Blødning kan forekomme i form af blødninger fra mave eller tarm, blå mærker, hæmatom (usædvanlig blødning eller blodudtrædning i underhuden), næseblod, blod i urinen, I nogle enkelte tilfælde er der indberettet blødning i øjne, hoved, lunger eller led.
English: Clopidogrel Zentiva 300 mg film-coated tablets Pink, oblong, engraved with «300» on one side and «1332» on the other side.
Danish: Clopidogrel Zentiva 300 mg filmovertrukne tabletter Lyserøde, aflange, med tallet "300" præget på den ene side og tallet "1332" på den anden side.
English: In a dose escalation study of 86 neonates or infants up to 24 months of age at risk for thrombosis (PICOLO), clopidogrel was evaluated at consecutive doses of 0.01, 0.1 and 0.2 mg/kg in neonates and infants and 0.15 mg/kg only in neonates.
Danish: (PICOLO) blev clopidogrel evalueret ved konsekutive doser på 0,01, 0,1 og 0,2 mg/kg til nyfødte og spædbærn og ved 0,15 mg/kg alene til nyfødte.
English: Check with your doctor or pharmacist if you are not sure.
Danish: Spørg lægen eller apotekespersonalet, hvis der er noget du er i tvivl om.
English: You should specifically tell your doctor if you take - medicines that may increase your risk of bleeding such as: o oral anticoagulants, medicines used to reduce blood clotting, o a non-steroidal anti-inflammatory medicine, usually used to treat painful and/or inflammatory conditions of muscle or joints, o heparin or any other injectable medicine used to reduce blood clotting, o ticlopidine, other antiplatelet agent, o a selective serotonin reuptake inhibitor (including but not restricted to fluoxetine or fluvoxamine), medicines usually used to treat depression,
Danish: - medicin, der kan øge risikoen for blødning, såsom: o blodfortyndende medicin, der tages gennem munden for at nedsætte dannelse af blodpropper o en type smertestillende medicin (nonsteroide antiinflammatoriske lægemidler, NSAID'er), som normalt gives til behandling af smertefulde og/eller betændelseslignende tilstande i muskler eller led o heparin eller anden medicin til indsprøjtning for at nedsætte dannelse af blodpropper o ticlopidin, der er anden medicin mod blodpropper o selektive serotoningenoptagelseshæmmere (inklusive, men ikke begrænset til fluoxetin og fluvoxamin), der normalt anvendes mod depression - omeprazol eller esomeprazol til behandling af for meget mavesyre - fluconazol eller voriconazol, der anvendes til behandling af svampeinfektioner - efavirenz, eller andre antiretrovirale lægemidler (anvendt til behandling af hiv-infektion) - carbamazepin, der anvendes mod bestemte former for epilepsi - moclobemid, mod depression.
English: - omeprazole or esomeprazole, medicines to treat upset stomach, - fluconazole or voriconazole, medicines to treat fungal infections, - efavirenz, or other anti-retroviral medicines (used to treat HIV infections), - carbamazepine, a medicine to treat some forms of epilepsy, - moclobemide, medicine to treat depression, - repaglinide, medicine to treat diabetes, - paclitaxel, medicine to treat cancer, - opioids: while you are treated with clopidogrel, you should inform your doctor before being prescribed any opioids (used to treat severe pain).
Danish: - repaglinid, medicin til nehandling af diabetes - paclitaxel, medicin til behandling af kræft - opioider: mens du er i behandling med clopidogrel, bør du fortælle det til lægen, før du får ordineret enhver form for behandling med opioider (anvendes til behandling af svære smerter).
English: Clopidogrel Zentiva 300 mg tablets clopidogrel
Danish: Clopidogrel Zentiva 300 mg tabletter clopidogrel
English: Clopidogrel Zentiva 75 mg tablets clopidogrel
Danish: Clopidogrel Zentiva 75 mg tabletter clopidogrel
English: Clopidogrel Zentiva 75 mg film-coated tablets Clopidogrel should be given as a single daily dose of 75 mg.
Danish: Clopidogrel Zentiva-tablet på 75 mg dagligt på samme tidspunkt hver dag.
English: The number of patients experiencing the co-primary endpoint (CV death, MI, stroke or refractory ischaemia) was 1,035 (16.5%) in the clopidogrel-treated group and 1,187 (18.8%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the clopidogrel-treated group.
Danish: Antallet af patienter, som oplevede det primære endepunkt [kardiovaskulært dødsfald, MI, apopleksi eller refraktær iskæmi] var 1035 (16,5 %) i clopidogrelgruppen og 1187 (18,8 %) i placebogruppen,
English: - Clopidogrel Zentiva 300 mg film-coated tablets
Danish: - Clopidogrel Zentiva 300 mg filmovertrukne tabletter
English: Clopidogrel Zentiva 300 mg film-coated tablets clopidogrel
Danish: Clopidogrel Zentiva 300 mg filmovertrukne tabletter clopidogrel
English: Luxembourg/Luxemburg
Danish: Luxembourg/Luxemburg Zentiva, k.s.
English: The incidence of severe cases was similar for clopidogrel and ASA.
Danish: Forekomsten af svære tilfælde var 1,4% for clopidogrel og 1,6% for ASA.
English: Clopidogrel Zentiva 75 mg film-coated tablets clopidogrel
Danish: Clopidogrel Zentiva 75 mg filmovertrukne tabletter clopidogrel
English: - Clopidogrel Zentiva 75 mg film-coated tablets
Danish: - Clopidogrel Zentiva 75 mg filmovertrukne tabletter
English: EU/1/08/465/010 - Cartons of 84 film-coated tablets in all aluminium blisters EU/1/08/465/011 - Cartons of 90 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/012 - Cartons of 90 film-coated tablets in all aluminium blisters EU/1/08/465/013 - Cartons of 100 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/014 - Cartons of 100 film-coated tablets in all aluminium blisters EU/1/08/465/018 - Cartons of 7 film-coated tablets in PVC/PVDC/Alu blisters EU/1/08/465/019 - Cartons of 7 film-coated tablets in all aluminium blisters EU/1/08/465/021 - Cartons of 50 film-coated tablets in PVC/PVDC/Alu blisters
Danish: Clopidogrel Zentiva 75 mg filmovertrukne tabletter EU/1/08/465/001 - Pakning med 14 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/465/002 - Pakning med 14 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/465/003 - Pakning med 28 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/465/004 - Pakning med 28 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/465/005 - Pakning med 30 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/465/006 - Pakning med 30 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/465/007 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/465/008 - Pakning med 50x1 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/465/009 - Pakning med 84 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/465/010 - Pakning med 84 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/465/011 - Pakning med 90 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/465/012 - Pakning med 90 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/465/013 - Pakning med 100 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/465/014 - Pakning med 100 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/465/018 - Pakning med 7 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium EU/1/08/465/019 - Pakning med 7 filmovertrukne tabletter i blisterkort af aluminium EU/1/08/465/021 - Pakning med 50 filmovertrukne tabletter i blisterkort af PVC/PVDC/aluminium
English: EU/1/08/465/015 - Cartons of 4x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/465/016 - Cartons of 30x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/465/017 - Cartons of 100x1 film-coated tablets in all aluminium perforated unit-dose blisters EU/1/08/465/020 - Cartons of 10x1 film-coated tablets in all aluminium perforated unit-dose blisters
Danish: EU/1/08/465/016 - Pakning med 30x1 filmovertrukne tabletter i perforerede enkeltdosisblistere af aluminium
English: Paediatric population
Danish: Vaskulære sygdomme
English: Clopidogrel Zentiva 75 mg film-coated tablets
Danish: Clopidogrel Zentiva 75 mg filmovertrukne tabletter
English: Zentiva, a.s.
Danish: Slovenská republika Zentiva, a.s.
English: SN: {number} [serial number]
Danish: SN: {number} [serienummer]
English: There are also links to other websites about rare diseases and treatments.
Danish: Der er også links til andre hjemmesider vedrørende sjældne sygdomme og behandling.
English: Tmax was similar with both formulations.
Danish: Tmax var sammenlignelig i de to formuleringer.
English: Glucose may be harmful to the teeth.
Danish: Glukose kan være skadelig for tænderne.
English: Povidone (K29/32)
Danish: Povidon (K29/32)
English: It is important that your child takes this medicine regularly at the same time each day.
Danish: Det er vigtigt, at Deres barn tager dette lægemiddel regelmæssigt på samme tidspunkt hver dag.
English: • a low number of a type of white blood cells.
Danish: • et lavt antal af en type hvide blodlegemer.
English: Growth rate of children
Danish: Børns vækstrate
English: A dose adjustment may be necessary.
Danish: En dosisjustering kan være påkrævet.
English: These studies in mice and rabbits were undertaken prior to the introduction of Good Laboratory Practice requirements.
Danish: Disse undersøgelser på mus og kaniner blev gennemført, inden kravene til Good Laboratory Practice blev introduceret.
English: • sensitivity to light;
Danish: • følsomhed over for lys;
English: The 95% CI of the difference was 42.2-85.7.
Danish: Det 95% CI for forskellen var 42,2-85,7.
English: AT/BE/BG/CY/DK/EE/EL/ES/FR/HR/HU/IE/IS/IT/LT/LU/LV/MT/NL/PL/PT/SI/UK Biocodex
Danish: AT/BE/BG/CY/DK/EE/EL/ES/FR/HU/IE/IS/IT/LT/LU/LV/MT/NL/PL/PT/SI/UK Biocodex
English: The data were best fitted with a one compartment model with first order absorption and elimination processes.
Danish: De mest anvendelige data var med en 1-compartment model med 1. ordens absorbering og eliminationsproces.
English: However, the situation is different if the vomiting occurs more than one hour after medicine intake because stiripentol is quickly absorbed.
Danish: Situationen er dog anderledes, hvis opkastningen sker over en time efter indtagelse af medicinen, fordi stiripentol absorberes hurtigt.
English: Patients aged ≥ 18 years of age
Danish: Patienter i en alder af ≥ 18 år
English: - Statins (atorvastatin, simvastatin, etc.)
Danish: - Statiner (atorvastatin, simvastatin osv.)
English: Substances interfering with CYP enzymes
Danish: Stoffer som interfererer med CYP enzymer
English: Many of these interactions have been partially confirmed by in vitro studies and in clinical trials.
Danish: Mange af disse interaktioner er blevet delvist bekræftet ved forsøg in vitro og i kliniske forsøg.
English: NN: {number} [national reimbursement number or other national number identifying the medicinal product]
Danish: NN: {number} [nationalt godtgørelsesnummer eller andet nationale nummer, der identificerer lægemidlet]>
English: Clinical efficacy and safety
Danish: Klinisk virkningsfuldhed og sikkerhed
English: It may harm them, even if their symptoms are the same as your child's.
Danish: Det kan være skadeligt for andre, selv om de har de samme symptomer, som Deres barn har.
English: Treatment should be continued for as long as efficacy is observed.
Danish: Behandlingen bør fortsættes, så længe der observeres en virkning.
English: Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335 Hamburg Germany
Danish: Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335 Hamburg Tyskland
English: 4.8 Undesirable effects
Danish: 4.8 Undesirable effectsBivirkninger
English: A past history of psychoses in the form of episodes of delirium.
Danish: Tidligere tilfælde af psykoser i form af episoder med delirium.
English: No clinical data are available, potential risk for human is unknown.
Danish: Der foreligger ingen kliniske data, den mulige risiko for mennesker er ukendt.
English: By reporting side affects you can help provide more information on the safety of this medicine.
Danish: Ved at indrapportere bivirkninger kan De hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: Treatment is supportive (symptomatic measures in intensive care units).
Danish: Behandling er supportiv (symptomatiske foranstaltninger på intensivafdeling).
English: The two formulations were bioequivalent in terms of AUC but not in terms of Cmax.
Danish: De to formuleringer var bioækvivalente med hensyn til AUC, men ikke med hensyn til Cmax.
English: Long-term data has not been collected in a sufficient number of adults to confirm maintenance of effect in this population.
Danish: Der er ikke blevet indsamlet et tilstrækkeligt antal data fra voksne for at bekræfte opretholdelsen af effekten i denne gruppe.
English: • if your child has ever experienced attacks of delirium (a mental state with confusion,
Danish: • hvis barnet nogensinde har haft episoder med delirium (en mental tilstand med konfusion,
English: Effect of formulation
Danish: Virkninger af formuleringen
English: Mechanism of action
Danish: Handlingsmekanisme
English: Patients then received stiripentol in an open fashion.
Danish: Patienterne fik derefter stiripentol i et åbent design.
English: Read all of this leaflet carefully before your child starts taking this medicine because it contains important information for you.
Danish: Læs denne indlægsseddel grundigt, inden Deres barn begynder at tage dette lægemiddel, da den indeholder vigtige oplysninger.
English: • Your child should not take Diacomit after the expiry date, which is stated on the label.
Danish: • Anvend ikke Diacomit efter udløbsdatoen, som er angivet på etiketten.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorization: 04 January 2007
Danish: DATO FOR FØRSTE TILLADELSE/FORNYELSE AF TILLADELSEN Dato for første tilladelse: 4. januar 2007
English: Adverse reactions encountered most often are 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).
Danish: De bivirkninger, der oftest opstår, er som følger: 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); hyppighed ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: - If your child takes medicines containing:
Danish: - Hvis Deres barn tager lægemidler, der indeholder:
English: Therefore, it may be harmful for people with phenylketonuria.
Danish: Det kan derfor være skadeligt for personer med fenylketonuri.
English: In the treated population, an increase in malformations has been noted with polytherapy.
Danish: I den behandlede population er en stigning i misdannelser observeret ved polyterapi.
English: This finding is considered to be an adaptive response to a high metabolic burden on the liver.
Danish: Disse fund anses for at være en adaptiv reaktion på en høj metabolisk belastning af leveren.
English: Stiripentol, the active ingredient of Diacomit, belongs to a group of medicines called antiepileptics.
Danish: Stiripentol, den aktive ingrediens i Diacomit, tilhører en gruppe lægemidler, der kaldes for antiepileptika.
English: Carcinogenicity studies gave negative results in the rat.
Danish: Undersøgelser af karcinogeniciteten gav negative resultater hos rotter.
English: It is well absorbed by the oral route since the majority of an oral dose is excreted in urine.
Danish: Det absorberes godt ved oral indgivelse, da størstedelen af en oral dosis udskilles i urin.
English: Use in combination with stiripentol is not recommended.
Danish: Anvendelse i kombination med stiripentol anbefales ikke.
English: Thus, there would be no need for a new intake or for an adjustment of the next dose.
Danish: Derfor er det ikke nødvendigt at tage en ny dosis eller justere den næste dosis.
English: Combinations requiring precautions
Danish: Kombinationer, hvor forsigtighed er påkrævet
English: Your child should not take a double dose to make up for a forgotten individual dose.
Danish: Deres barn må ikke tage en dobbeltdosis som erstatning for en glemt enkeltdosis.
English: However, effective anti-epileptic therapy should not be interrupted during pregnancy, since the aggravation of the illness may be detrimental to both the mother and the foetus.
Danish: En effektiv antiepileptisk behandling bør dog ikke afbrydes under graviditet, da en forværring af sygdommen kan være skadelig for både kvinde og foster.
English: excitement, restlessness and hallucinations).
Danish: ophidselse, rastløshed og hallucinationer).
English: System Organ Class (MedDRA terminology)
Danish: Systemorgan-klasse (MedDRAterminologi)
English: Likewise, the effect of stiripentol on their metabolism is not known.
Danish: Virkningen af stiripentol på deres metabolisme kendes ligeledes ikke.
English: The capsules should not be chewed.
Danish: Kapslerne må ikke tygges.
English: Although other factors, e.g. the epilepsy, can contribute, available evidence suggests that this increase, to a large extent, is caused by the treatment.
Danish: Selvom andre faktorer, fx epilepsien, kan være bidragende, tyder den tilgængelige evidens på, at denne stigning i stor udstrækning skyldes behandlingen.
English: 41 children with SMEI were included in a randomised, placebo-controlled, add-on trial.
Danish: 41 børn med SMEI deltog i et randomiseret, placebokontrolleret add-on-forsøg.
English: It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.
Danish: Det kan være skadeligt, hvis De har phenylketonuria (PKU), en sjælden genetisk forstyrrelse, hvor phenylalanin ophobes, fordi kroppen ikke kan fjerne det korrekt.
English: Neither non-clinical nor clinical data are available to assess aspartame use in infants below 12 weeks of age.
Danish: Hverken ikke-kliniske eller kliniske data er tilgængelige til at vurdere aspartam-brug til børn under 12 uger.
English: Patients with rare glucosegalactose malabsorption should not take this medicine, as the formulation contains glucose.
Danish: Patienter med glucose-galactosemalabsorption bør ikke tage dette lægemiddel, da formuleringen indeholder glucose.
English: Breast-feeding is not recommended during treatment with this medicine.
Danish: Amning anbefales ikke under behandling med dette lægemiddel.
English: Genotoxicity studies have not detected any mutagenic or clastogenic activity.
Danish: Undersøgelser af genotoksiciteten har ikke påvist nogen mutagen eller clastogen aktivitet.
English: Caution should be exercised when prescribing to pregnant women and use of efficient methods of contraception is advisable.
Danish: Der bør udvises forsigtighed ved ordinering til gravide kvinder, og det tilrådes at anvende effektive antikonceptionsmetoder.
English: Sachets are made with a composite paper/aluminium/polyethylene film.
Danish: Brevene er fremstillet med en film af papir/aluminium/polyethylen.
English: The main metabolic processes are demethylenation and glucuronidation, although precise identification of the enzymes involved has not yet been achieved.
Danish: De vigtigste metaboliske processer er demethylation og glucuronidation, selvom de involverede enzymer endnu ikke er nøjagtigt identificeret.