FrancophonIA/ELRC3.0 huggingface dataset:
English: • low blood sugar levels (hypo-glycaemia) - when taking this medicine with a sulphonylurea or insulin These are the signs of low blood sugar: - shaking, sweating, feeling very anxious, fast heart beat - feeling hungry, headache, change in vision - a change in your mood or feeling confused.
Danish: Følgende er tegn på lavt blodsukker: rysten, svedtendens, stærk angstfølelse, hurtig hjerterytme (puls) sultfornemmelse, hovedpine, synsforstyrrelser humørsvingninger eller forvirring.
English: NAME OF THE MEDICINAL PRODUCT Forxiga 10 mg tablets dapagliflozin
Danish: Forxiga 10 mg tabletter dapagliflozin
English: Elevated haematocrit
Danish: Forhøjet hæmatokrit
English: Body weight (kg) Baseline (mean) Change from baselinec Difference from glipizide + metforminc
Danish: Legemsvægt (kg) Baseline (gennemsnitlig) Ændring fra baselinec Forskel fra placebo c
English: Forxiga contains lactose
Danish: Forxiga indeholder laktose
English: • weight decreased
Danish: Nedsat leverfunktion
English: Rare disorders
Danish: Dysuri Polyuri
English: NAME OF THE MEDICINAL PRODUCT Forxiga 5 mg tablets dapagliflozin
Danish: Forxiga 5 mg tabletter dapagliflozin
English: Body weight (kg) Baseline (mean) Change from baselinec Difference from placeboc (95% CI) 1Metformin ≥ 1500 mg/day; 2sitagliptin 100 mg/day aLOCF: Last observation (prior to rescue for rescued subjects) carried forward bAll randomised subjects who took at least one dose of double-blind study medicinal product during the short-term double-blind period cLeast squares mean adjusted for baseline value *p-value < 0.0001 versus placebo + oral glucose-lowering medicinal product **p-value < 0.05 versus placebo + oral glucose-lowering medicinal product
Danish: 2sitagliptin 100 mg/dag LOCF: Last observation carried forward (før behandling med rescue-medicin) Alle randomiserede forsøgspersoner, som tog mindst én dosis af den dobbeltblinde studiemedicin i den dobbeltblinde periode i korttidsstudierne Gennemsnit beregnet efter mindste kvadraters metode justeret for baselineværdi p-værdi < 0,0001 versus placebo + oralt glucosesænkende lægemiddel p-værdi < 0,05 versus placebo + oralt glucosesænkende lægemiddel
English: In patients where DKA is suspected or diagnosed, treatment with dapagliflozin should be discontinued immediately.
Danish: Dapagliflozin skal straks seponeres hos patienter med mistænkt eller verificeret DKA.
English: Each tablet contains 50 mg of lactose anhydrous.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 50 mg vandfri lactose.
English: For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Danish: Hvis du vil have yderligere oplysninger om Forxiga, skal du henvende dig til den lokale repræsentant:
English: NAME OF THE MEDICINAL PRODUCT Forxiga 10 mg film-coated tablets
Danish: Forxiga 10 mg filmovertrukne tabletter
English: EU/1/12/795/008 98 film-coated tablets
Danish: EU/1/12/795/008 98 filmovertrukne tabletter
English: What Forxiga is and what it is used for What you need to know before you take Forxiga How to take Forxiga
Danish: Det skal du vide, før du begynder at tage Forxiga Sådan skal du tage Forxiga Bivirkninger
English: EU/1/12/795/003 98 film-coated tablets
Danish: EU/1/12/795/003 98 filmovertrukne tabletter
English: Pack sizes of 30x1 and 90x1 film-coated tablets in perforated unit dose blisters Not all pack sizes may be marketed.
Danish: Pakningsstørrelser på 14, 28 og 98 filmovertrukne tabletter i ikke-perforerede kalenderblisterkort Pakningsstørrelser på 30x1 og 90x1 filmovertrukne tabletter i perforerede enkeltdosisblisterkort
English: EU/1/12/795/001 14 film-coated tablets
Danish: EU/1/12/795/001 14 filmovertrukne tabletter
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Danish: Oversigt over bivirkninger i tabelform
English: EU/1/12/795/006 14 film-coated tablets
Danish: EU/1/12/795/006 14 filmovertrukne tabletter
English: OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
Danish: NAVN OG ADRESSE PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN
English: These conditions can cause dehydration.
Danish: I så fald kan du komme i væskeunderskud (blive dehydreret).
English: EU/1/12/795/002 28 film-coated tablets
Danish: EU/1/12/795/002 28 filmovertrukne tabletter
English: EU/1/12/795/007 28 film-coated tablets
Danish: EU/1/12/795/007 28 filmovertrukne tabletter
English: Each tablet contains 25 mg of lactose anhydrous.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver tablet indeholder 25 mg vandfri lactose.
English: 6.6 Special precautions for disposal No special requirements.
Danish: Ingen særlige forholdsregler.
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 10 mg dapagliflozin.
Danish: Hver tablet indeholder dapagliflozinpropanediolmonohydrat svarende til 10 mg dapagliflozin.
English: NAME OF THE MEDICINAL PRODUCT Forxiga 5 mg film-coated tablets
Danish: Forxiga 5 mg filmovertrukne tabletter
English: (95% CI) LOCF: Last observation (prior to rescue for rescued subjects) carried forward All randomised subjects who took at least one dose of double-blind study medication during the short-term double-blind period Least squares mean adjusted for baseline value p-value < 0.0001 versus placebo § Not evaluated for statistical significance as a result of the sequential testing procedure for secondary end points
Danish: LOCF: Last Observation Carried Forward (før behandling med rescue-medicin) Alle randomiserede forsøgspersoner, som tog mindst én dosis dobbeltblind forsøgsmedicin i den dobbeltblinde periode af korttidsstudierne
English: Gastrointestinal disorders
Danish: Laboratorieanalyser af urinprøver
English: Uncommon**
Danish: **, b
English: adverse reactions of volume depletion, most commonly reported as hypotension, were reported in 1.7% and 0.8% of dapagliflozin-treated subjects and placebo-treated subjects, respectively (see section 4.4).
Danish: Hos forsøgspersoner ≥ 65 år blev der rapporteret bivirkninger i form af volumedepletering, der almindeligvis viste sig som hypotension, hos 1,7 % og 0,8 % af de forsøgspersoner, der fik henholdsvis dapagliflozin og placebo (se pkt.
English: 0.00d
Danish: * b,c
English: NAME OF THE MEDICINAL PRODUCT Forxiga 10 mg film-coated tablets dapagliflozin
Danish: Forxiga 10 mg filmovertrukne tabletter dapagliflozin
English: Haematocrit increase was observed with dapagliflozin treatment (see section 4.8); therefore, caution in patients with already elevated haematocrit is warranted.
Danish: Der er blevet observeret forhøjet hæmatokrit relateret til behandlingen med dapagliflozin (se pkt.
English: Monotherapy and add-on combination therapy
Danish: Monoterapi og tillægsbehandling
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin.
Danish: Hver tablet indeholder dapagliflozinpropanediolmonohydrat svarende til 5 mg dapagliflozin.
English: Use in patients at risk for volume depletion, hypotension and/or electrolyte imbalances Due to its mechanism of action, dapagliflozin increases diuresis associated with a modest decrease in blood pressure (see section 5.1), which may be more pronounced in patients with very high blood glucose concentrations.
Danish: Dapagliflozins virkningsmekanisme øger diuresen, hvilket er forbundet med et moderat blodtryksfald (se pkt.
English: AstraZeneca S.p.A. Tel: +39 02 9801 1
Danish: Tel: +39 02 9801 1
English: METHOD AND ROUTE(S) OF ADMINISTRATION Read the package leaflet before use.
Danish: Læs indlægssedlen inden brug.
English: NAME OF THE MEDICINAL PRODUCT Forxiga 5 mg film-coated tablets dapagliflozin
Danish: Forxiga 5 mg filmovertrukne tabletter dapagliflozin
English: Haematocrit increasedg
Danish: Forstoppelse Mundtørhed
English: Insulin and insulin secretagogues
Danish: Insulin og ß-cellestimulerende midler
English: • Prior to initiation of dapagliflozin and at least yearly, thereafter (see sections 4.2, 4.8, 5.1 and 5.2)
Danish: • Før start på behandling med dapagliflozin og mindst én gang om året derefter (se pkt.
English: If you take more Forxiga than you should
Danish: Hvis du har taget for meget Forxiga
English: A.
Danish: *, f
English: • about what you can do to prevent dehydration
Danish: • for at få at vide, hvad du kan gøre for at forebygge dehydrering
English: Your body can also make too much sugar.
Danish: Det er også muligt, at kroppen producerer for meget sukker.
English: • Try to take it at the same time each day.
Danish: • Forsøg at tage tabletten til samme tid hver dag.
English: • Your doctor will prescribe the strength that is right for you.
Danish: • Din læge foreskriver den styrke, der passer bedst til dig.
English: If you stop taking Invokana
Danish: Hvis du holder op med at tage Invokana
English: Elderly (≥ 65 years old)
Danish: Ældre (i alderen ≥ 65 år)
English: • Swallow the tablet whole with a half glass of water.
Danish: • Synk tabletten hel med et halvt glas vand.
English: These reductions were sustained over the treatment period and near maximal after the first day of treatment.
Danish: Disse reduktioner blev opretholdt i løbet af behandlingsperioden og var nær den maksimale værdi efter den første behandlingsdag.
English: Invokana should be taken orally once a day, preferably before the first meal of the day.
Danish: Invokana skal tages oralt en gang dagligt - og helst før dagens første måltid.
English: It is best to take your tablet before the first meal of the day.
Danish: Det er bedst at tage tabletten før dagens første måltid.
English: • Do not take a double dose (two doses on the same day) to make up for a forgotten dose.
Danish: • Du må ikke tage en dobbeltdosis (to doser på samme dag) som erstatning for den glemte dosis.
English: The effect of being homozygote (UGT1A9*3/*3, frequency < 0.1%) is probably more marked, but has not been investigated.
Danish: Virkningen af at være homozygot (UGT1A9*3/*3, frekvens < 0,1 %) er sandsynligvis mere markant, men den er ikke undersøgt.
English: This reduces the amount of sugar in your blood.
Danish: Derved nedsættes mængden af sukker i blodet.
English: This may occur regardless of blood glucose level.
Danish: Dette kan forekomme uanset blodglucoseniveau.
English: Your blood sugar levels may rise if you stop taking this medicine.
Danish: Dit blodsukker kan stige, hvis du holder op med at tage dette lægemiddel.
English: • You can take your tablet with or without food.
Danish: • Du kan tage tabletten alene eller sammen med mad.
English: Tablets should be swallowed whole.
Danish: Tabletterne skal synkes hele.
English: If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.
Danish: Hvis en dosis glemmes, skal den tages, så snart patienten kommer i tanke om den. Der må dog ikke tages en dobbeltdosis på samme dag.
English: In general, elevations were transient and did not require specific treatment.
Danish: Disse forhøjelser var generelt forbigående og krævede ingen særlig behandling.
English: Do not use Invokana if the packaging is damaged or shows signs of tampering.
Danish: Brug ikke Invokana, hvis pakningen er beskadiget eller viser tegn på, at den har været åbnet.
English: This leaflet was approved in {month YYYY}.
Danish: Denne indlægsseddel blev godkendt {måned ÅÅÅÅ}.
English: Dehydration*
Danish: Dehydrering*
English: The doctor may decide to temporarily or permanently stop the treatment with Invokana.
Danish: Lægen kan beslutte at stoppe behandlingen med Invokana midlertidigt eller permanent.
English: Common (may affect up to 1 in 10 people)
Danish: Almindelige (kan berøre op til 1 ud af 10 personer)
English: Constipation, Thirstb, Nausea
Danish: Obstipation, tørstb, kvalme
English: • if you have type 1 diabetes (your body does not produce any insulin).
Danish: • hvis du har type 1-diabetes (hvor kroppen slet ikke producerer insulin).
English: Patients should be advised to report symptoms of volume depletion.
Danish: Patienterne bør opfordres til at indberette symptomer på volumendepletering.
English: • if you have severe liver problems
Danish: • hvis du har alvorlige leverproblemer
English: • If you forget to take a dose, take it as soon as you remember.
Danish: • Hvis du glemmer at tage en dosis, skal du tage den, så snart du kommer i tanke om det.
English: You may already be taking one or more of these to treat your type 2 diabetes.
Danish: Måske får du allerede et eller flere af disse midler mod type 2-diabetes.
English: However, if it is nearly time for the next dose, skip the missed dose.
Danish: Hvis det næsten er tid til næste dosis, skal du springe den glemte dosis over.
English: This medicine works by increasing the amount of sugar removed from your body in your urine.
Danish: Dette lægemiddel virker ved at øge den mængde sukker, der fjernes fra kroppen med urinen.
English: Your doctor will tell you how to treat low blood sugar levels and what to do if you have any of the signs above.
Danish: Din læge vil fortælle dig, hvordan du skal behandle lavt blodsukker, og hvad du skal gøre, hvis du bemærker et af de nævnte tegn.
English: Maternal toxicity was limited to decreased body weight gain.
Danish: Maternel toksicitet var begrænset til nedsat øgning af legemsvægten.
English: ATC code: A10BX11.
Danish: ATCkode: A10BX11.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 November 2013
Danish: Dato for første markedsføringstilladelse: 15. november 2013
English: Hypotension*, Orthostatic hypotension*
Danish: Hypotension*, ortostatisk hypotension*
English: See section 3, “Taking this medicine”.
Danish: Se punkt 3 under "Sådan skal du tage medicinen".
English: Frequency categories are defined according to the following convention: 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: Hyppighed defineres i henhold til følgende konvention: 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) og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: This was accompanied by a sustained reduction in serum uric acid concentration of approximately 20%.
Danish: Dette blev ledsaget af en vedvarende reduktion af urinsyres serumkoncentration på ca. 20 %.
English: If you forget to take Invokana
Danish: Hvis du har taget for mange Invokana
English: This will help you remember to take it.
Danish: Så kan du lettere huske at tage den.
English: For further detail, it may be advisable to contact the specific manufacturer of the 1,5-AG assay.
Danish: For yderligere oplysninger tilrådes det at kontakte producenten af den specifikke 1,5-AG-analyse.
English: c Not applicable.
Danish: c Ikke relevant.
English: 58% of patients had a body mass index (BMI) ≥ 30 kg/m2.
Danish: 58 % af patienterne havde et body mass index (BMI) på ≥ 30 kg/m2.
English: Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
Danish: Patienterne skal undersøges for ketoacidose med det samme, hvis disse symptomer opstår, uanset blodglucoseniveau.
English: The mean absolute oral bioavailability of canagliflozin is approximately 65%.
Danish: Den gennemsnitlige absolutte orale biotilgængelighed af canagliflozin er ca. 65 %.
English: The racial distribution was 72% White, 16% Asian, 4% Black, and 8% other groups.
Danish: Racemæsssigt fordelte de sig med 72 % hvide, 16 % asiater, 4 % sorte og 8 % andre grupper.
English: It is unknown whether canagliflozin and/or its metabolites are excreted in human milk.
Danish: Det er ukendt, om canagliflozin og/eller dets metabolitter udskilles i human mælk.
English: SGLT2 inhibitors should be used with caution in these patients.
Danish: SGLT2-hæmmere skal anvendes med forsigtighed til disse patienter.
English: These differences are not considered to be clinically meaningful.
Danish: Disse forskelle vurderes ikke at have klinisk relevans.
English: Your doctor may prescribe Invokana together with another glucose-lowering medicinal product.
Danish: Din læge kan foreskrive dig Invokana sammen med et andet glucosesænkende lægemiddel.
English: 16% of patients were Hispanic.
Danish: 16 % af patienterne var af latinamerikansk afstamning.
English: Approximately 58% of patients were male.
Danish: Ca. 58 % af patienterne var af hankøn.
English: Less than 1% of the dose was excreted as unchanged canagliflozin in urine.
Danish: Mindre end 1 % af dosis blev udskilt som uomdannet canagliflozin i urinen.
English: Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should.
Danish: Type 2-diabetes er en tilstand, hvor kroppen ikke producerer nok insulin, og den insulin, som kroppen faktisk producerer, ikke virker tilstrækkeligt.
English: Canagliflozin is extensively bound to proteins in plasma (99%), mainly to albumin.
Danish: Canagliflozin bindes i udstrakt grad til plasmaproteiner (99 %), især til albumin.
English: There was no notable change in heart rate.
Danish: Der sås ingen bemærkelsesværdig ændring i hjertefrekvens.
English: Remember to take all medicines as directed by your doctor to achieve the best results for your health.
Danish: Husk at tage alle lægemidler efter lægens anvisninger, så du opnår den bedste behandling af din sygdom.
English: In both cases, treatment with canagliflozin may be restarted once the patient's condition has stabilised.
Danish: I begge tilfælde kan behandlingen med canagliflozin genoptages, når patientens tilstand er stabil.
English: Placebo-controlled studies
Danish: Placebokontrollerede studier
English: b p < 0.05. c Not applicable.
Danish: b p < 0,05. c Ikke relevant.
English: • if you have severe kidney problems or are on dialysis
Danish: • hvis du har alvorlige nyreproblemer eller er i dialyse
English: • if you have ever had serious heart disease or if you have had a stroke
Danish: • hvis du nogensinde har lidt af alvorlig hjertesygdom eller har haft et slagtilfælde
English: Invokana is indicated in adults aged 18 years and older with type 2 diabetes mellitus to improve glycaemic control as:
Danish: Invokana er indiceret til voksne: 18 år og ældre med type 2-diabetes mellitus til forbedring af glykæmisk kontrol som:
English: Active-controlled studies
Danish: Aktivt kontrollerede studier
English: If interrupted, consideration should be given to more frequent glucose monitoring.
Danish: Ved afbrydning af behandlingen bør hyppigere glucosekontrol overvejes.
English: Balanitis or balanoposthitis**, h
Danish: Balanitis eller balanopostitis**, h
English: Diet and exercise
Danish: Kost og motion
English: Lactose intolerance
Danish: Lactoseintolerans
English: Invokana should not be used during pregnancy.
Danish: Invokana bør ikke anvendes under graviditeten.
English: Treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses.
Danish: Behandlingen skal afbrydes hos patienter, som hospitalsindlægges for at få foretaget større operationer eller i forbindelse med akut alvorlig sygdom.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking or continuing to take this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apotekspersonalet til råds, før du tager eller fortsætter med at tage dette lægemiddel.
English: Stop taking Invokana and see a doctor as soon as possible if you have any of the following serious side effects: Dehydration (uncommon, may affect up to 1 in 100 people)
Danish: Hold op med at tage Invokana, og kontakt lægen snarest muligt, hvis du får en af følgende alvorlige bivirkninger: Dehydrering (ikke almindelig, kan berøre op til 1 ud af 100 personer)
English: The safety and efficacy of canagliflozin in children under 18 years of age have not yet been established.
Danish: Canagliflozins sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Subsequently, the marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: Indehaveren af markedsføringstilladelsen skal derefter fremsende PSUR'er i overensstemmelse med kravene på listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: When this happens, sugar (glucose) builds up in the blood.
Danish: Når det er tilfældet, sker der en ophobning af sukker (glucose) i blodet.
English: • severe allergic reaction (may include swelling of the face, lips, mouth, tongue, or throat that may lead to difficulty breathing or swallowing).
Danish: • alvorlig allergisk reaktion (kan omfatte hævelser af ansigt, læber, mund, tunge eller svælg, som kan gøre det vanskeligt at trække vejret eller synke)
English: Tell your doctor as soon as possible if you get any of the signs of low blood sugar.
Danish: Kontakt lægen snarest muligt, hvis du bemærker tegn på lavt blodsukker.
English: More information is given below in “Other medicines and Invokana”.
Danish: Du kan finde yderligere oplysninger nedenfor under “Brug af anden medicin sammen med Invokana”.
English: In a pooled analysis of eight placebo-controlled and active-controlled studies, the safety profile in elderly patients was generally consistent with younger patients.
Danish: I en poolet analyse af otte placebokontrollerede og aktivt kontrollerede studier svarede sikkerhedsprofilen hos ældre patienter generelt til profilen hos yngre patienter.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, and genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, toksicitet efter gentagne doser og genotoksicitet.
English: Lactose anhydrous Microcrystalline cellulose Hydroxypropylcellulose Croscarmellose sodium Magnesium stearate
Danish: Lactose, vandfri Mikrokrystallinsk cellulose Hydroxypropylcellulose Croscarmellosenatrium Magnesiumstearat
English: Vulvovaginal candidiasis**, g common
Danish: Vulvovaginal candidiasis**, g
English: Moderate increases (generally < 400 mL to 500 mL) in daily urine volume were seen that attenuated over several days of dosing.
Danish: Der opstod moderate stigninger (generelt < 400 ml til 500 ml) i det daglige urinvolumen, som blev dæmpet i løbet af flere dages behandling.
English: There is no clinical experience in patients with Child-Pugh class C (severe) hepatic impairment.
Danish: Der er ingen klinisk erfaring med patienter med Child-Pugh-klasse C (svært)nedsat leverfunktion.
English: “Blood-glucose lowering drugs” are medicines used by adults to treat type 2 diabetes.
Danish: "Blodglucosesænkende midler" er lægemidler, der anvendes af voksne til at behandle type 2-diabetes.
English: • if you are on medicines to lower your blood pressure (anti-hypertensives) or have ever had low blood pressure (hypotension).
Danish: • hvis du får medicin til at sænke blodtrykket (antihypertensiva) eller nogensinde har lidt af lavt blodtryk (hypotension).
English: Older patients
Danish: Ældre patienter
English: • loss of too much fluid from your body (dehydration).
Danish: • et voldsomt væsketab fra kroppen (dehydrering).
English: There are no data from the use of canagliflozin in pregnant women.
Danish: Der foreligger ingen data fra anvendelse af canagliflozin til gravide kvinder.
English: Renal failure (mainly in the context of volume depletion)
Danish: Nyresvigt (hovedsageligt i forbindelse med volumendepletering)
English: You should not take this medicine if you are breast-feeding.
Danish: Du bør ikke tage dette lægemiddel, hvis du ammer.