FrancophonIA/ELRC3.0 huggingface dataset:
English: Tadalafil Mylan 10 mg is available in blister packs containing 4, 12 and 24 tablets.
Danish: Tadalafil Mylan 10 mg fås i blisterpakninger, der indeholder 4, 12 og 24 tabletter.
English: If Tadalafil Mylan is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Danish: Hvis Tadalafil Mylan ordineres, bør en omhyggelig individuel benefit/riskvurdering foretages af den ordinerende læge.
English: The expiry date refers to the last day of that month.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på æsken efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: In a 12-week study performed in 186 patients (142 tadalafil, 44 placebo) with erectile dysfunction secondary to spinal cord injury, tadalafil significantly improved the erectile function leading to a mean per-subject proportion of successful attempts in patients treated with tadalafil 10 or 20 mg (flexible-dose, on demand) of 48% as compared to 17% with placebo.
Danish: I et 12-ugers studie med 186 patienter (142 på tadalafil, 44 på placebo) med erektil dysfunktion sekundært til læsioner i rygmarven forbedrede tadalafil signifikant den erektile funktion.
English: For once-a-day evaluation of tadalafil at doses of 2.5, 5, and 10 mg 3 clinical studies were initially conducted involving 853 patients of various ages (range 21-82 years) and ethnicities, with erectile dysfunction of various severities (mild, moderate, severe) and etiologies.
Danish: Til evaluering af tadalafil i doser på 2,5, 5 og 10 mg én gang dagligt blev der indledningsvist udført 3 kliniske studier med 853 patienter af forskellig alder (21 - 82 år) og forskellig etnisk oprindelse og med erektil dysfunktion af forskellige sværhedsgrader (let, moderat, svær) og ætiologi.
English: Uncommon (may affect up to 1 in 100 people) - dizziness, stomach ache, feeling sick, being sick (vomiting), reflux, blurred vision, eye pain, difficulty in breathing, presence of blood in urine, prolonged erection, pounding heartbeat sensation, a fast heart rate, high blood pressure, low blood pressure, nose bleeds, ringing in the ears, swelling of the hands, feet or ankles and feeling tired.
Danish: Ikke almindelige bivirkninger (kan forekomme hos op til 1 ud af 100 behandlede) - Svimmelhed, mavesmerter, kvalme, føle sig dårlig (opkastning), refluks, uklart syn, øjensmerter, , åndedrætsbesvær, blod i urinen, forlænget erektion, fornemmelse af hamrende hjerteslag, høj puls, højt blodtryk, lavt blodtryk, næseblod, ringen for ørerne (tinnitus), hævelse af hænder, fødder eller ankler og træthedsfølelse..
English: Reproductive system and breast disorders
Danish: Forstyrrelser i reproduktion og lidelser i mammae
English: Κύπρος (Cyprus) Varnavas Hadjipanayis LtdTel: + 357 222 077 23
Danish: Κύπρος (Cyprus) Varnavas Hadjipanayis Ltd Tel: + 357 22207723
English: Excipient with known effect: Each film-coated tablet contains 237.92 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukne tablet indeholder 237,92 mg laktose.
English: Tadalafil Mylan contains sodium
Danish: Tadalafil Mylan indeholder natrium
English: Tablet core: lactose anhydrous (see section 2 ‘Tadalafil Mylan contains lactose'), poloxamer 188, cellulose microcrystalline (pH101), povidone (K-25), croscarmellose sodium, magnesium stearate, sodium laurilsulfate, silica colloidal anhydrous.
Danish: Tabletkerne: lactose, vandfri (se punkt 2 ”Tadalafil Mylan indeholder lactose”), poloxamer 188, cellulose, mikrokrystallinsk (pH101), povidon (K-25), croscarmellosenatrium, magnesiumstearat, natriumlaurilsulfat; silica, kolloidal vandfri.
English: It is important to note that tadalafil does not work if there is no sexual stimulation.
Danish: Det er vigtigt at huske, at tadalafil kun virker ved seksuel stimulation.
English: However, as a formal drug-drug interaction study evaluating the effects of tadalafil and 5-alpha reductase inhibitors (5-ARIs) has not been performed, caution should be exercised when tadalafil is co-administered with 5-ARIs.
Danish: Der bør dog udvises forsigtighed, når tadalafil administeres samtidig med 5-alfa-reduktase-hæmmere, da der ikke er udført et formelt lægemiddelinteraktionsstudie til evaluering af virkningen af tadalafil plus 5-alfa-reduktase-hæmmere.
English: Excipient with known effect: Each film-coated tablet contains 29.74 mg of lactose.
Danish: Hjælpestof, som behandleren skal være opmærksom på: Hver filmovertrukken tablet indeholder 29,74 mg lactose.
English: Abdominal pain, Vomiting, Nausea,
Danish: Mavesmerter, Opkastning,
English: Musculoskeletal and connective tissue disorders Back pain,
Danish: Muskuloskeletale-, bindevævs-og knoglelidelser Rygsmerter,
English: If tadalafil is prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Danish: Hvis tadalafil ordineres, bør en omhyggelig individuel benefit/risk-vurdering foretages af den ordinerende læge.
English: For the treatment of benign prostatic hyperplasia The dose is one 5 mg tablet taken once a day at approximately the same time of the day.
Danish: Behandling af godartet forstørrelse af blærehalskirtlen Dosis er én 5 mg tablet taget én gang dagligt på omtrent samme tidspunkt hver dag.
English: Once-a-day dosing has not been evaluated in patients with hepatic impairment; therefore, if prescribed, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician (see sections 4.4 and 5.2).
Danish: Den én gang daglige dosering er ikke evalueret hos patienter med nedsat leverfunktion: derfor bør den ordinerende læge foretage en omhyggelig individuel benefit/risk-vurdering, ved ordination af tadalafil en gang dagligt (se pkt.
English: Each tablet contains 20 mg tadalafil.
Danish: Hver tablet indeholder 20 mg tadalafil.
English: Facial oedema Sudden cardiac death
Danish: Ansigtsødem Pludselig hjertedød
English: There is no relevant use of tadalafil in the paediatric population with regard to the treatment of erectile dysfunction.
Danish: Pædiatrisk population Der er ingen relevante indikationer for tadalafil i den pædiatriske population.
English: It is important to note that Tadalafil Mylan for the treatment of erectile dysfunction does not work if there is no sexual stimulation.
Danish: Det er vigtigt at huske, at Tadalafil Mylan kun virker ved seksuel stimulation.
English: In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food.
Danish: Den anbefalede dosis af tadalafil er generelt 10 mg, som tages før forventet seksuel aktivitet, enten med eller uden mad.
English: serious skin rashes, some disorders affecting blood flow to the eyes, irregular heartbeats, angina and sudden cardiac death.
Danish: uregelmæssige hjerteslag, brystkramper (angina pectoris) og pludselig hjertedød.
English: Tadalafil is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy (NAION), regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure (see section 4.4).
Danish: Tadalafil er kontraindiceret til patienter, som på grund af non-arteritis anterior iskæmisk opticusneuropati (NAION), har nedsættelse af synet på det ene øje.
English: Once-a-day dosing of 2.5 or 5 mg tadalafil both for the treatment of erectile dysfunction or benign prostatic hyperplasia is not recommended in patients with severe renal impairment (see sections 4.4 and 5.2).
Danish: En gang daglig dosering af tadalafil 2,5 eller 5 mg bør ikke anvendes til patienter med svært nedsat nyrefunktion (se pkt.
English: Common (may affect up to 1 in 10 people) - headache, back pain, muscle aches, pain in arms and legs, facial flushing, nasal congestion and indigestion.
Danish: Almindelige bivirkninger (kan forekomme hos op til 1 ud af 10 behandlede) - Hovedpine, rygsmerter, muskelsmerter, smerter i arme og ben, ansigtsrødme, tilstoppet næse og fordøjelsesbesvær.
English: Each tablet contains 2.5 mg tadalafil.
Danish: Hver tablet indeholder 2,5 mg tadalafil.
English: Rare (may affect up to 1 in 1,000 people) - fainting, seizures and passing memory loss, swelling of the eyelids, red eyes, sudden decrease or loss of hearing and hives (itchy red welts on the surface of the skin), penile bleeding, presence of blood in the semen and increased sweating.
Danish: Sjældne bivirkninger (kan forekomme hos op til 1 ud af 1.000 behandlede) - Besvimelse, kramper og forbigående hukommelsestab, hævede øjenlåg, røde øjne, pludseligt nedsat eller tab af hørelse nældefeber (kløende, rødt hududslæt), blødning fra penis, blod i sæden og øget tendens til at svede.
English: How to take Tadalafil Mylan
Danish: Sådan skal du tage Tadalafil Mylan
English: Stroke (including haemorrhagic events),
Danish: Antihpertensiva (herunder calciumantagonister)
English: If tadalafil is prescribed once-a-day, a careful individual benefit/risk evaluation should be undertaken by the prescribing physician.
Danish: Hvis tadalafil ordineres én gang dagligt, bør en omhyggelig individuel benefit/riskvurdering foretages af den ordinerende læge.
English: Each tablet contains 5 mg tadalafil.
Danish: Hver tablet indeholder 5 mg tadalafil.
English: Tadalafil Mylan 2.5 mg tablets tadalafil
Danish: Tadalafil Mylan 2,5 mg tabletter tadalafil
English: Each tablet contains 10 mg tadalafil.
Danish: Hver tablet indeholder 10 mg tadalafil.
English: Tadalafil Mylan 20 mg tablets tadalafil
Danish: Tadalafil Mylan 20 mg tabletter tadalafil
English: Rash
Danish: Batch
English: -20 mg), where nitrate administration is deemed medically necessary in a life-threatening situation, at least 48 hours should have elapsed after the last dose of tadalafil before nitrate administration is considered.
Danish: Derfor bør der hos en patient med hvilken som helst ordineret dosis af tadalafil (2,5 mg - 20 mg), hvor administration af nitrat skønnes som en medicinsk nødvendighed i en livstruende situation, mindst være gået 48 timer efter den sidste dosistadalafil, før administration af nitrat overvejes.
English: Tadalafil Mylan 5 mg tablets tadalafil
Danish: Tadalafil Mylan 5 mg tabletter tadalafil
English: A light yellow, film-coated, round, biconvex tablet (10.7 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL4' on the other side.
Danish: En lysegul, filmovertrukken, rund, bikonveks tablet (10,7 ± 0,3 mm), der er mærket med 'M' på den ene side og 'TL4' på den anden side.
English: Tadalafil Mylan 10 mg tablets tadalafil
Danish: Tadalafil Mylan 10 mg tabletter tadalafil
English: A light yellow, film-coated, round, biconvex tablet (6.3 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL over 2' on the other side.
Danish: En lysegul, filmovertrukken, rund, bikonveks tablet (6,3 ± 0,3 mm), der er mærket med 'M' på den ene side og 'TL over 2' på den anden side.
English: Tadalafil Mylan 10 mg film-coated tablets
Danish: Tadalafil Mylan 10 mg filmovertrukne tabletter
English: A light yellow, film-coated, round, biconvex tablet (8.1 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL3' on the other side.
Danish: En lysegul, filmovertrukken, rund, bikonveks tablet (8,1 ± 0,3 mm), der er mærket med 'M' på den ene side og 'TL3' på den anden side.
English: What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 20 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL4' on the other side.
Danish: Tadalafil Mylan 20 mg er en lysegul, filmovertrukken, rund, bikonveks tablet, der er mærket med 'M' på den ene side og 'TL4' på den anden side.
English: Hypertension
Danish: Migræne
English: What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 2.5 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL over 1' on the other side.
Danish: Tadalafil Mylan 2,5 mg er en lysegul, filmovertrukken, rund, bikonveks tablet, der er mærket med 'M' på den ene side og 'TL over 1' på den anden side.
English: Tadalafil Mylan 20 mg film-coated tablets
Danish: Tadalafil Mylan 20 mg filmovertrukne tabletter
English: Transient ischaemic attacks Migraine
Danish: Forbigående iskæmiske anfald
English: Tadalafil Mylan 5 mg film-coated tablets
Danish: Tadalafil Mylan 5 mg filmovertrukne tabletter
English: Tadalafil Mylan 20 mg film-coated tablets tadalafil
Danish: Tadalafil Mylan 20 mg filmovertrukne tabletter tadalafil
English: A light yellow, film-coated, round, biconvex tablet (5.1 ± 0.3 mm) debossed with ‘M' on one side of the tablet and ‘TL over 1' on the other side.
Danish: En lysegul, filmovertrukken, rund, bikonveks tablet (5,1 ± 0,3 mm), der er mærket med 'M' på den ene side og 'TL over 1' på den anden side.
English: What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 10 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL3' on the other side.
Danish: Tadalafil Mylan 10 mg er en lysegul, filmovertrukken, rund, bikonveks tablet, der er mærket med 'M' på den ene side og 'TL3' på den anden side..
English: Tadalafil Mylan 2.5 mg film-coated tablets tadalafil
Danish: Tadalafil Mylan 2,5 mg filmovertrukne tabletter tadalafil
English: Tadalafil Mylan 5 mg film-coated tablets tadalafil
Danish: Tadalafil Mylan 5 mg filmovertrukne tabletter tadalafil
English: What Tadalafil Mylan looks like and contents of the pack Tadalafil Mylan 5 mg is a light yellow, film-coated, round, biconvex tablet marked with ‘M' on one side of the tablet and ‘TL over 2' on the other side.
Danish: Tadalafil Mylan 5 mg er en lysegul, filmovertrukken, rund, bikonveks tablet, der er mærket med 'M' på den ene side og 'TL over 2' på den anden side..
English: Transient amnesia
Danish: Forbigående hukommelsestab
English: Tadalafil Mylan 10 mg film-coated tablets tadalafil
Danish: Tadalafil Mylan 10 mg filmovertrukne tabletter tadalafil
English: Vascular disorders
Danish: CYP-induktorer
English: Method of administration
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONVEJ(E)
English: If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.
Danish: Tadalafil Mylan indeholder lactose: Kontakt lægen, før du tager denne medicin, hvis lægen har fortalt dig, at du ikke tåler visse sukkerarter.
English: Tadalafil Mylan 2.5 mg film-coated tablets
Danish: Tadalafil Mylan 2,5 mg filmovertrukne tabletter.
English: What you need to know before you take Tadalafil Mylan 3.
Danish: Det skal du vide, før du begynder at tage Tadalafil Mylan Sådan skal du tage Tadalafil Mylan Bivirkninger
English: The side effect dizziness has been reported more frequently in men over 75 years of age taking tadalafil.
Danish: Hos mænd, som er over 75 år og tager tadalafil, er svimmelhed indberettet hyppigere.
English: The National Competent Authorities shall agree the details of an education programme for patients and health care professionals with the MAH, who must implement such programme nationally to ensure provision of educational material to patients and health professionals containing information:
Danish: De nationale besluttende myndigheder skal aftale detaljerne i et undervisningsprogram for patienter og behandlende personale med indehaveren af markedsføringstilladelsen, som skal implementere et sådan program på landsplan for at sikre, at uddannelsesmaterialerne til patienter og behandlere med alle informationer anskaffes:
English: • on the increased risk of vitamin deficiency in chronic kidney disease patients and the need for vitamin supplementation
Danish: • vedrørende den øgede risiko for vitaminmangel hos patienter med kronisk nyresygdom og behovet for vitamintilskud
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemsstaterne skal sikre, at alle betingelser eller begrænsninger med hensyn til sikker og effektiv anvendelse af nedenstående beskrevne lægemiddel implementer:
English: • on the risk factors for and prevention of peritonitis in PD (peritoneal dialysis) patients.
Danish: • vedrørende risikofaktorer for og forebyggelse af peritonitis hos patienter, der gennemgår PD (peritonealdialyse).
English: • on the risk factors for and prevention of arterio-venous fistula site complications in HD
Danish: • vedrørende risikofaktorer for og forebyggelse af komplikationer på stedet for arteriovenøse fistler hos patienter, der gennemgår HD (hæmodialyse)
English: 1 bottle + 1 oral syringe of 5 ml + 1 oral syringe of 10 ml + 1 bottle adaptor
Danish: 1 flaske + 1 oral sprøjte med 5 ml + 1 oral sprøjte med 10 ml + 1 flaskeadapter
English: Solution for injection
Danish: Injektions-/infusionsvæske
English: Oral use bottle (glass)
Danish: Oral opløsning Oral anvendelse flaske (glas)
English: This may help to stabilise electrical activity in the brain.
Danish: Det kan medvirke til at stabilisere den elektriske aktivitet i hjernen.
English: The full EPAR for Zonisamide Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Zonisamid Mylan findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Zonisamide Mylan.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Zonisamid Mylan.
English: The Committee recommended that Zonisamide Mylan be approved for use in the EU.
Danish: Udvalget anbefalede, at Zonisamid Mylan godkendes til anvendelse i EU.
English: Epileptic fits are caused by abnormal electrical activity in the brain.
Danish: Epileptiske anfald skyldes unormal elektrisk aktivitet i hjernen.
English: A risk management plan has been developed to ensure that Zonisamide Mylan is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Zonisamid Mylan anvendes så sikkert som muligt.
English: The usual maintenance dose is between 300 and 500 mg a day for children weighing more than 55 kg and 6 to 8 mg per kg of body weight in children weighing less than 55 kg.
Danish: Den sædvanlige vedligeholdelsesdosis er mellem 300 og 500 mg om dagen for et barn, der vejer mere end 55 kg, og 6-8 mg pr. kg legemsvægt for et barn, der vejer mindre end 55 kg.
English: It is used on its own in newly diagnosed adults and as an ‘add-on' therapy in adults and children aged six years and above already receiving other anti-epilepsy medicines.
Danish: Det anvendes alene hos nydiagnosticerede voksne eller som tillægsbehandling hos voksne og børn fra seksårsalderen, der i forvejen får andre epilepsilægemidler.
English: The medicine can only be obtained with a prescription and is available as capsules (25, 50 and 100 mg).
Danish: Zonisamid Mylan udleveres kun efter recept og fås som kapsler (25, 50 og 100 mg).
English: This means that Zonisamide Mylan is similar to a ‘reference medicine' already authorised in the European Union (EU) called Zonegran.
Danish: Det betyder, at Zonisamid Mylan svarer til et "referencelægemiddel", som allerede er godkendt i Den Europæiske Union (EU), og som hedder Abilify.
English: Before stopping Zonisamide Mylan, the dose should be decreased gradually.
Danish: Hvis behandlingen med Zonisamid Mylan skal afbrydes, bør dosen nedsættes gradvist.
English: Zonisamide is thought to work by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels, through which sodium or calcium normally enter nerve cells.
Danish: Zonisamid menes at virke ved at blokere specifikke porer på nervecellernes overflade, de såkaldte natrium- og kalciumkanaler, hvorigennem natrium og kalcium normalt trænger ind i nervecellerne.
English: Therefore, the CHMP's view was that, as for Zonegran, the benefit outweighs the identified risk.
Danish: Det var derfor CHMP's opfattelse, at fordelene opvejer de identificerede risici som for Zonegran.
English: Zonisamide Mylan is a medicine used to treat patients with partial seizures (epileptic fits starting in one part of the brain), including those who have secondary generalisation (where the seizure subsequently spreads to the whole brain).
Danish: Zonisamid Mylan anvendes til behandling af patienter med partielle anfald (epileptiske anfald, der udløses i en del af hjernen), herunder patienter med sekundær generalisering (dvs. anfald, der efterfølgende breder sig til hele hjernen).
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Zonisamide Mylan has been shown to have comparable quality and to be bioequivalent to Zonegran.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at det i overensstemmelse med EU's krav er påvist, at Zonisamid Mylan er af sammenlignelig kvalitet og er bioækvivalent med Zonegran.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Zonisamide Mylan, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Zonisamid Mylan, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: After one or two weeks, the dose may be increased to 50 mg twice a day and then further increased in steps of 100 mg every week or every other week, depending on the patient's response.
Danish: Efter én eller to uger kan dosen sættes op til 50 mg to gange dagligt og derefter sættes yderligere op med 100 mg ad gangen hver uge eller hver anden uge, afhængigt af patientens respons.
English: Zonisamide Mylan is a ‘generic medicine'.
Danish: Zonisamid Mylan er et "generisk lægemiddel".
English: The usual maintenance dose is 300 mg a day.
Danish: Den sædvanlige vedligeholdelsesdosis er 300 mg dagligt.
English: The active substance in Zonisamide Mylan, zonisamide, is an anti‑epileptic.
Danish: Det aktive stof i Zonisamid Mylan, zonisamid, er et antiepileptisk lægemiddel.
English: What measures are being taken to ensure the safe and effective use of Zonisamide Mylan?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Zonisamid Mylan?
English: For more information about treatment with Zonisamide Mylan, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Zonisamid Mylan, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: Other information about Zonisamide Mylan
Danish: Andre oplysninger om Zonisamid Mylan
English: What are the benefits and risks of Zonisamide Mylan?
Danish: Hvilken fordel og risiko er der forbundet med Zonisamid Mylan?
English: Zonisamide Mylan zonisamide
Danish: Zonisamid Mylan zonisamid
English: The usual maintenance dose is between 300 and 500 mg a day.
Danish: Den sædvanlige vedligeholdelsesdosis er mellem 300 og 500 mg dagligt.
English: After one or two weeks, the daily dose may be increased in steps of 1 mg per kilogram every one or two weeks until an appropriate dose is reached.
Danish: Efter én eller to uger kan den daglige dosis gradvist øges med 1 mg pr. kg legemsvægt hver uge eller hver anden uge, indtil en egnet dosis er nået.
English: What is Zonisamide Mylan and what is it used for?
Danish: Hvad er Zonisamid Mylan, og hvad anvendes det til?
English: Zonisamide Mylan contains the active substance zonisamide.
Danish: Zonisamid Mylan indeholder det aktive stof zonisamid.
English: Because Zonisamide Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Danish: Da Zonisamid Mylan er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: It is not intended to provide practical advice on how to use Zonisamide Mylan.
Danish: Det er ikke en praktisk vejledning i, hvordan Zonisamid Mylan bør anvendes.