FrancophonIA/ELRC3.0 huggingface dataset:
English: Animal studies indicate a potential for reducing intrauterine growth at exposure levels, which are identical or slightly higher than at human exposure (see section 5.3).
Danish: Dyrestudier indikerer en potentiel mulighed for intrauterin væksthæmning ved eksponeringsniveauer, der er identiske med eller lidt højere end human eksponering (se pkt.
English: ● dextromethorphan (generally used to treat cough) and
Danish: • dextromethorfan (anvendes generelt til behandling af hoste) og
English: When patients were identified with concurrent worsening in all three domains, results showed a statistically significant effect of memantine in preventing worsening, as twice as many placebo-treated patients as memantine-treated patients showed worsening in all three domains (21% vs. 11%, p<0.0001).
Danish: Når patienterne havde fået konstateret en samtidig forværring i alle tre domæner, viste resultaterne en statistisk signifikant effekt af memantin hvad angår forebyggelse af forværring, eftersom dobbelt så mange placebobehandlede patienter som memantinbehandlede patienter udviste forværring i alle tre domæner (21% vs. 11%, p<0,0001).
English: ● if you have recently experienced a myocardial infarction (heart attack), or if you are suffering from congestive heart failure or from an uncontrolled hypertension (high blood pressure).
Danish: • hvis De for nylig har haft blodprop i hjertet (myokardieinfarkt), eller hvis De lider af dårligt hjerte eller ukontrolleret forhøjet blodtryk (hypertension).
English: These events have been reported in patients treated with memantine.
Danish: Disse hændelser er blevet beskrevet hos patienter i behandling med memantin.
English: ● if you have a history of epileptic seizures.
Danish: • hvis De tidligere har haft epileptiske anfald
English: Furthermore, Memantine ratiopharm has minor to moderate influence on the ability to drive and use machines such that outpatients should be warned to take special care.
Danish: Derudover påvirker Memantine ratiopharm i mindre til moderat grad evnen til at føre motorkøretøj og betjene maskiner, hvorfor ambulante patienter skal gøres opmærksom på at være særlig forsigtige.
English: ● if you are allergic to memantine hydrochloride, peanut or soya or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis De er allergisk over for memantinhydrochlorid, jordnødder eller soja eller et af de øvrige indholdsstoffer i Memantine ratiopharm (angivet i punkt 6).
English: Memantine ratiopharm is available in packs with 28 (7 +7 +7 + 7) film-coated tablets.
Danish: Memantine ratiopharm findes i pakninger med 28 (7 + 7 + 7 + 7) filmovertrukne tabletter.
English: The 10 mg and 20 mg tablet can be divided into equal doses.
Danish: Tabletterne med 10 mg og 20 mg kan deles i to lige store doser.
English: These compounds act at the same receptor system as memantine, and therefore adverse reactions (mainly central nervous system (CNS)-related) may be more frequent or more pronounced (see also section 4.5).
Danish: Disse forbindelser påvirker det samme receptorsystem som memantin, og der kan derfor forekomme hyppigere og mere udtalte bivirkninger (hovedsageligt i centralnervesystemet (CNS)) (se også pkt.
English: Main human metabolites are N-3,5-dimethyl-gludantan, the isomeric mixture of 4-and 6-hydroxymemantine, and 1-nitroso-3,5-dimethyl-adamantane.
Danish: Humane hovedmetabolitter er N-3,5-dimethyl-gludantan, den isomeriske blanding af 4 - og 6-hydroxy-memantin og 1-nitroso-3,5-dimethyl-adamantan.
English: Memantine ratiopharm is used for the treatment of patients with moderate to severe Alzheimer's disease.
Danish: Memantine ratiopharm anvendes til behandling af patienter med moderat til svær Alzheimers sygdom.
English: Each pack of 28 film-coated tablets for a 4 week treatment schedule contains: 7 x 5 mg and 7 x 10 mg and 7 x 15 mg and 7 x 20 mg film-coated tablets
Danish: Hver pakning med 28 filmovertrukne tabletter til et 4-ugers behandlingsprogram indeholder: 7 x 5 mg og 7 x 10 mg og 7 x 15 mg og 7 x 20 mg filmovertrukne tabletter
English: Memantine ratiopharm acts on these NMDA-receptors improving the transmission of nerve signals and the memory.
Danish: Memantine ratiopharm indvirker på disse NMDA-receptorer og forbedrer overførslen af nervesignaler samt hukommelsen.
English: ● oral anticoagulants
Danish: • orale antikoagulantia.
English: The maximum daily dose is 20 mg per day.
Danish: Den maksimale daglige dosis er 20 mg dagligt.
English: In a study using orally administered 14C-memantine, a mean of 84% of the dose was recovered within
Danish: I et studie med peroral indgivelse af 14C-memantin blev gennemsnitligt 84% af dosis udskilt inden for
English: Daily doses of 20 mg lead to steady-state plasma concentrations of memantine ranging from 70 to 150 ng/ml (0.5-1 μmol) with large interindividual variations.
Danish: Daglige doser på 20 mg giver steady-state-plasmakoncentrationer for memantin på mellem 70 og 150 ng/ml (0,5 - 1 µmol) med store interindividuelle variationer.
English: Talk to your doctor or pharmacist before taking Memantine ratiopharm:
Danish: Kontakt lægen eller apotekspersonalet, før De tager Memantine ratiopharm:
English: HDPE (high-density polyethylene) bottles with PP (polypropylene) caps Pack sizes of 100 film-coated tablets.
Danish: HDPE(højdensitets-polyethylen)-flasker med PP(polypropylen)-låg Pakningsstørrelser på 100 filmovertrukne tabletter.
English: Very Rare (affects less than 1 user in 10,000): ● Seizures
Danish: Meget sjældne (påvirker færre end 1 ud af 10.000 patienter): • Krampeanfald.
English: Soya lecithin (E 322)
Danish: Sojalecithin (E 322)
English: The study showed beneficial effects of memantine treatment in comparison to placebo at 6 months (observed cases analysis for the clinician´s interview based impression of change (CIBIC-plus): p=0.025; Alzheimer's disease cooperative study - activities of daily living (ADCS-ADLsev): p=0.003; severe impairment battery (SIB): p=0.002).
Danish: Undersøgelsen viste gavnlig effekt af memantinbehandlingen sammenlignet med placebo over en behandlingsperiode på 6 måneder (”observed cases analysis for the Clinician´s interview based impression of change” (CIBIC-plus): p=0,025; Alzheimer´s disease cooperative study - activities of daily living (ADCS-ADLsev): p=0,003; Severe impairment battery (SIB): p=0,002).
English: Common Common Uncommon Very rare
Danish: Almindelig Almindelig Ikke almindelig Meget sjælden
English: “Possible side effects”.
Danish: 4 “Bivirkninger”.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 13 June 2013
Danish: Dato for første markedsføringstilladelse: 13 juni 2013 Dato for seneste fornyelse:
English: The recommended treatment dose of 20 mg per day is achieved by a gradual increase of the Memantine ratiopharm dose during the first 3 weeks of treatment.
Danish: Den anbefalede dosis på 20 mg Memantine ratiopharm dagligt opnås ved en gradvis øgning af dosis i løbet af de første tre ugers behandling.
English: This medicine contains soya lecithin.
Danish: Denne medicin indeholder sojalecithin.
English: From the fourth week on, the usual dose is two tablets once a day (1x 20 mg).
Danish: Fra og med den fjerde uge er den normale dosis 2 tabletter én gang dagligt (1x 20 mg).
English: The use of medicinal products called
Danish: Samtidig brug af lægemidler ved navn
English: EXP Shelf life after first opening: 6 months.
Danish: EXP Opbevaringstid efter første åbning: 6 måneder.
English: If you go into hospital, let your doctor know that you are taking Memantine ratiopharm.
Danish: Hvis De kommer på hospitalet, skal De sige til lægen, at De får Memantine ratiopharm.
English: The usual starting dose is half a tablet once a day (1x 5 mg) for the first week.
Danish: Den normale startdosis er en halv tablet en gang dagligt (1x 5 mg) i den første uge.
English: In the overdose cases below 140 mg or unknown dose the patients revealed symptoms from central nervous system (confusion, drowsiness, somnolence, vertigo, agitation, aggression, hallucination, and gait disturbance) and/or of gastrointestinal origin (vomiting and diarrhoea).
Danish: I tilfælde af overdosering med doser under 140 mg eller ukendt dosis har patienterne haft symptomer, der stammede fra centralnervesystemet (forvirring, døsighed, sløvhed (søvntrang), svimmelhed, agitation, aggression, hallucinationer og gangforstyrrelser) og/eller fra mave-tarm-kanalen (opkastning og diarré).
English: Common (affects 1 to 10 users in 100):
Danish: Almindelige (påvirker 1-10 ud af 100 patienter):
English: At the beginning of treatment you will start by using 5 mg once a day.
Danish: Behandlingen startes med 5 mg én gang dagligt.
English: The patient should take two 10 mg film-coated tablets (20 mg) or one 20 mg film-coated tablet per day.
Danish: Patienten bør tage to 10 mg filmovertrukne tabletter (20 mg) eller en 20 mg filmovertrukket tablet dagligt.
English: Do not take Memantine ratiopharm:
Danish: Tag ikke Memantine ratiopharm:
English: Dizziness Balance disorders Gait abnormal Seizures
Danish: Svimmelhed Balanceforstyrrelser Unormal gang Krampeanfald
English: No cytochrome P 450 catalysed metabolism has been detected in vitro.
Danish: In vitro er der ikke fundet nogen cytokrom P 450-metabolisme.
English: At a dose of memantine of 20 mg per day the CSF levels match the ki-value (ki = inhibition constant) of memantine, which is 0.5 μmol in human frontal cortex.
Danish: Ved en dosis af memantin på 20 mg pr. dag svarer CSF-niveauerne til ki-værdien (ki = hæmningsfaktor) for memantin, som er 0,5 µmol i den humane frontale cortex.
English: Somnolence Confusion Hallucinations1
Danish: Hallucinationer1
English: Memantine-treated patients showed a statistically significantly better effect than placebo-treated patients on the primary endpoints: Alzheimer's disease assessment scale (ADAS-cog) (p=0.003) and CIBIC-plus (p=0.004) at week 24 (last observation carried forward (LOCF)).
Danish: Hos patienter behandlet med memantin sås statistisk signifikant bedre effekt på de primære effektmål end hos patienter behandlet med placebo: Alzheimer´s disease assessment scale (ADAS-cog) (p=0,003) og CIBIC-plus (p=0,004) i uge 24 (Last observation carried forward (LOCF)).
English: The recommended starting dose is 5 mg per day which is stepwise increased over the first 4 weeks of treatment reaching the recommended maintenance dose as follows:
Danish: Den anbefalede startdosis er 5 mg dagligt med trinvis dosisøgning i de første 4 uger af behandlingen, indtil den anbefalede vedligeholdelsesdosis nås, som følger:
English: Week 1 (day 1-7):
Danish: 1. uge (dag 1-7):
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (20 mg once a day) as described above.
Danish: På baggrund af de kliniske studier er den anbefalede dosis til patienter over 65 år 20 mg dagligt (20 mg én gang dagligt) som beskrevet ovenfor.
English: The use of memantine in pregnant women is not recommended.
Danish: Memantin anbefales ikke til gravide kvinder.
English: Week 2 (day 8-14):
Danish: 2. uge (dag 8-14):
English: ● If you take a large overdose of Memantine ratiopharm, contact your doctor or get medical advice,
Danish: • Hvis De tager en stor overdosis af Memantine ratiopharm, skal De søge læge, da De kan have behov for medicinsk behandling.
English: In postmarketing experience these reactions have been reported in patients treated with memantine.
Danish: Efter markedsføringen er disse hændelser rapporteret hos patienter i behandling med memantin.
English: Ocular changes were inconsistently observed in repeat dose toxicity studies in rodents and dogs, but not in monkeys.
Danish: I studier af toksicitet efter gentagne doser var der modstridende observationer af okulære forandringer hos gnavere og hunde, men ikke hos aber.
English: Women taking Memantine ratiopharm should not breast-feed.
Danish: Kvinder, der tager Memantine ratiopharm, bør ikke amme.
English: ● neuroleptics (substances used in the treatment of mental disorders)
Danish: • neuroleptika (stoffer, der bruges til behandling af sindslidelser)
English: In order to reduce the risk of side effects this dose is achieved gradually by the following daily treatment scheme.
Danish: For at mindske risikoen for bivirkninger opnås denne dosis gradvist ud fra nedenstående daglige behandlingsforløb.
English: ● anticonvulsants (substances used to prevent and relieve seizures)
Danish: • antikonvulsiva (stoffer, der bruges til at forebygge og afhjælpe krampeanfald)
English: Memantine ratiopharm contains lactose and soya lecithin This medicine contains lactose.
Danish: Memantine ratiopharm indeholder lactose og sojalecithin Denne medicin indeholder lactose.
English: The recommended dose of Memantine ratiopharm for adults and older patients is 20 mg once a day.
Danish: Den anbefalede dosis af Memantine ratiopharm til voksne og ældre patienter er 20 mg én gang dagligt.
English: PHARMACEUTICAL FORM AND CONTENTS Treatment initiation pack
Danish: LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Startpakke til behandling
English: ● barbiturates (substances generally used to induce sleep)
Danish: • barbiturater (stoffer, der generelt bruges som sovemidler)
English: Week 3 (day 15-21):
Danish: 3. uge (dag 15-21):
English: On the basis of the clinical studies, the recommended dose for patients over the age of 65 years is 20 mg per day (two 10 mg film-coated tablets or one 20 mg film-coated tablet once a day) as described above.
Danish: På baggrund af de kliniske studier er den anbefalede dosis til patienter over 65 år 20 mg dagligt (to 10 mg filmovertrukne tabletter eller en 20 mg filmovertrukket tablet én gang dagligt), som beskrevet ovenfor.
English: Week 4 (day 22-28):
Danish: 4. uge (dag 22-28):
English: PVC/PVDC-Aluminium foil blister packs Pack sizes of 28 (7 +7 +7 + 7) film-coated tablets.
Danish: 6.5 Emballagetype og pakningsstørrelser PVC/ PVDC-aluminiumsfolie-blisterpakninger Pakningsstørrelser på 28 (7 +7 +7 + 7) filmovertrukne tabletter.
English: Memantine ratiopharm should be administered orally once a day.
Danish: Memantine ratiopharm bør indtages gennem munden en gang dagligt.
English: Administration of Memantine ratiopharm is not recommended in patients with severe hepatic impairment.
Danish: Administration af Memantine ratiopharm til patienter med svært nedsat leverfunktion anbefales ikke.
English: Hypersensitivity to the active substance, peanut or soya or to any of the excipients listed in section 6.1.
Danish: Overfølsomhed over for det aktive stof, jordnødder eller soja eller over for et eller flere af hjælpestofferne anført i pkt.
English: Elevated liver function test Hepatitis
Danish: Forhøjet leverfunktionstest Hepatitis
English: 20 mg film-coated tablets
Danish: 20 mg filmovertrukne tabletter
English: In patients with mildly impaired renal function (creatinine clearance 50-80 ml/min) no dose adjustment is required.
Danish: Hos patienter med let nedsat nyrefunktion (kreatinin-clearance 50 - 80 ml/min) er dosisjustering ikke påkrævet.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 5 mg or 10 mg or 15 mg or 20 mg of memantine hydrochloride equivalent to 4.15 mg or 8.31 mg or 12.46 mg or 16.62 mg memantine.
Danish: ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver filmovertrukket tablet indeholder 5 mg eller 10 mg eller 15 mg eller 20 mg memantinhydrochlorid svarende til 4,15 mg eller 8,31 mg eller 12,46 mg eller 16,62 mg memantin.
English: The following Adverse Reactions listed in the Table below have been accumulated in clinical studies with memantine and since its introduction in the market.
Danish: Følgende bivirkninger (i nedenstående tabel) er indrapporteret i forbindelse med kliniske forsøg med memantin og efter markedsføring.
English: Dosage The recommended dose of Memantine ratiopharm for adults and older patients is 20 mg once a day.
Danish: Dosering Den anbefalede dosis af Memantine ratiopharm til voksne og ældre patienter er 20 mg én gang dagligt.
English: ● Headache, sleepiness, constipation, elevated liver function tests, dizziness, balance disorders,
Danish: • Hovedpine, søvnighed, forstoppelse, forhøjede værdier ved leverfunktionsprøver, svimmelhed,
English: Uncommon (affects 1 to 10 users in 1,000):
Danish: Ikke almindelige (påvirker 1-10 ud af 1.000 patienter):
English: Xanthan gum (E 415)
Danish: Xanthangummi (E 415)
English: Lactose anhydrous
Danish: memantinhydrochlorid
English: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg per day.
Danish: Hos patienter med moderat nedsat nyrefunktion (kreatinin-clearance 30 - 49 ml/min) er daglig dosis 10 mg pr. dag.
English: ● Tiredness, fungal infections, confusion, hallucinations, vomiting, abnormal gait, heart failure and venous blood clotting (thrombosis/thromboembolism)
Danish: • Træthed, svampeinfektioner, forvirring, hallucinationer, opkastning, unormal gang, hjertesvigt og blodprop i en blodåre (vene).
English: Memantine ratiopharm contains lactose.
Danish: Memantine ratiopharm indeholder lactose.
English: A pivotal monotherapy study in a population of patients suffering from moderate to severe Alzheimer's disease (mini mental state examination (MMSE) total scores at baseline of 3-14) included a total of 252 outpatients.
Danish: I en væsentlig monoterapiundersøgelse med en patientpopulation, der led af moderat til svær Alzheimers sygdom (med en samlet mini mental state examination (MMSE) score ved baseline på 3 - 14), indgik i alt 252 ambulante patienter.
English: If you forget to take Memantine ratiopharm
Danish: Hvis De har glemt at tage Memantine ratiopharm
English: Week 2 (day 8-14): The patient should take one 10 mg film-coated tablet (10 mg) per day for 7 days.
Danish: 2. uge (dag 8-14): Patienten bør tage én 10 mg filmovertrukket tablet (10 mg) dagligt i 7 dage.
English: Polysorbate 80 (E 433), polyvinyl alcohol (E 1203), titanium dioxide (E 171), talc (E 553b), soya lecithin (E 322), xanthan gum (E 415).
Danish: Polysorbat 80 (E 433), polyvinylalkohol (E 1203), titandioxid (E 171), talcum (E 553b), sojalecithin (E 322), xanthangummi (E 415).
English: In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg per day.
Danish: Hos patienter med svært nedsat nyrefunktion (kreatinin-clearance 5 - 29 ml/min) er daglig dosis 10 mg pr. dag.
English: Polysorbate 80 (E 433) Polyvinyl alcohol (E 1203) Titanium dioxide (E 171) Talc (E 553b) Soya lecithin (E 322) Xanthan gum (E 415)
Danish: Polysorbat 80 (E 433) Polyvinylalkohol (E 1203) Titandioxid (E 171) Talcum (E 553b) Sojalecithin (E 322) Xanthangummi (E 415)
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer packaging (Blister)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre emballage (blister)
English: LIST OF EXCIPIENTS Contains lactose and soya lecithin.
Danish: LISTE OVER HJÆLPESTOFFER Indeholder lactose og sojalecithin.
English: shortness of breath, high blood pressure and drug hypersensitivity
Danish: balanceforstyrrelser, kortåndethed, forhøjet blodtryk og overfølsomhed over for medicinen.
English: Memantine ratiopharm contains the active substance memantine hydrochloride.
Danish: Memantine ratiopharm indeholder det aktive stof memantinhydrochlorid.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/012
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/836/012
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/023
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/836/023
English: For continuation of the treatment please consult your doctor.
Danish: Kontakt lægen med henblik på at fortsætte behandlingen.
English: ● anticholinergics (substances generally used to treat movement disorders or intestinal cramps)
Danish: • antikolinergika (stoffer, der generelt bruges til behandling af lidelser i bevægeapparatet eller tarmkramper)
English: PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING Label (HDPE bottle)
Danish: MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE Etiket (HDPE-flaske)
English: Shelf life after first opening of the container: 6 months
Danish: Opbevaringstiden efter første åbning af beholderen: 6 måneder.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/13/836/022
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/13/836/022
English: 10 film-coated tablets 14 film-coated tablets 21 film-coated tablets 28 film-coated tablets 30 film-coated tablets 42 film-coated tablets 50 film-coated tablets 56 film-coated tablets 98 film-coated tablets 100 film-coated tablets 112 film-coated tablets
Danish: 10 filmovertrukne tabletter 14 filmovertrukne tabletter 21 filmovertrukne tabletter 28 filmovertrukne tabletter 30 filmovertrukne tabletter 42 filmovertrukne tabletter 56 filmovertrukne tabletter 98 filmovertrukne tabletter 100 filmovertrukne tabletter
English: To benefit from your medicine you should take it regularly every day at the same time of the day.
Danish: De bør tage tabletterne regelmæssigt hver dag på samme tidspunkt af dagen for at opnå størst mulig virkning af tabletterne.
English: Continue to take Memantine ratiopharm as long as it is of benefit to you.
Danish: Bliv ved med at tage Memantine ratiopharm, så længe De har gavn af det. Deres læge bør regelmæssigt vurdere Deres behandling.
English: Cellulose microcrystalline (E 460), starch pregelatinised (E 1404), lactose anhydrous, colloidal anhydrous silica (E 551), magnesium stearate (E 470b).
Danish: Cellulose, mikrokrystallinsk (E 460), stivelse, pregelatineret (E 1404), lactose, vandfri, kolloid vandfri silica (E 551), magnesiumstearat (E 470b).
English: Blister packs Do not store above 25°C.
Danish: Blisterpakninger Må ikke opbevares ved temperaturer over 25 °C.
English: Dosage in patients with impaired kidney function If you have impaired kidney function, your doctor will decide upon a dose that suits your condition.
Danish: Hvis De har nedsat nyrefunktion, afgør Deres læge, hvilken dosis der passer til Deres tilstand.
English: You should inform your doctor if you have recently changed or intend to change your diet substantially (e.g. from normal diet to strict vegetarian diet) or if you are suffering from states of renal tubulary acidosis (RTA, an excess of acid-forming substances in the blood due to renal dysfunction (poor kidney function)) or severe infections of the urinary tract (structure that carries urine), as your doctor may need to adjust the dose of your medicine.
Danish: De bør også informere Deres læge, hvis De lider af tilstande med renal tubulær acidose (RTA, overskud af syredannende stoffer i blodet på grund af nedsat nyrefunktion) eller alvorlige infektioner i urinvejene (som urinen udskilles igennem).
English: Week 3 (day 15-21): The patient should take one and a half 10 mg film-coated tablets (15 mg) per day for 7 days.
Danish: 3. uge (dag 15-21): Patienten bør tage halvanden 10 mg filmovertrukket tablet (15 mg) dagligt i
English: HDPE bottles
Danish: HDPE-flasker
English: B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE Medicinal product subject to restricted prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Danish: Lægemidlet må kun udleveres efter ordination på en recept udstedt af en begrænset lægegruppe (se bilag I: Produktresumé, pkt.
English: Film-coated tablet (tablet)
Danish: Filmovertrukken tablet (tablet).
English: EU/1/13/836/013 10 film-coated tablets EU/1/13/836/014 14 film-coated tablets EU/1/13/836/015 21 film-coated tablets EU/1/13/836/016 28 film-coated tablets EU/1/13/836/017 30 film-coated tablets EU/1/13/836/018 42 film-coated tablets EU/1/13/836/019 56 film-coated tablets EU/1/13/836/020 98 film-coated tablets EU/1/13/836/021 100 film-coated tablets
Danish: EU/1/13/836/013 10 filmovertrukne tabletter EU/1/13/836/014 14 filmovertrukne tabletter EU/1/13/836/015 21 filmovertrukne tabletter EU/1/13/836/016 28 filmovertrukne tabletter EU/1/13/836/017 30 filmovertrukne tabletter EU/1/13/836/018 42 filmovertrukne tabletter EU/1/13/836/019 56 filmovertrukne tabletter EU/1/13/836/020 98 filmovertrukne tabletter EU/1/13/836/021 100 filmovertrukne tabletter
English: Some factors that may raise urine pH (see section 5.2 “Elimination”) may necessitate careful monitoring of the patient.
Danish: 5.2), kan nødvendiggøre omhyggelig monitorering af patienten.