FrancophonIA/ELRC3.0 huggingface dataset:
English: Topamax 15 mgGranulat in Kapseln granuals in capsule
Danish: Topamax 15 mgGranulat in Kapseln
English: 28 film-coated tablets with desiccant
Danish: 28 filmovertrukne tabletter med tørremiddel.
English: Limb discomfort*
Danish: Ubehag i lemmerne*
English: Migraine prophylaxis in pregnancy and in women of childbearing potential if not using effective methods of contraception
Danish: Som migræneprofylakse til gravide kvinder og til fertile kvinder, der ikke bruger effektiv kontraception.
English: Topamax 25 mgGranulat in Kapseln granuals in capsule
Danish: Topamax 25 mgGranulat in Kapseln
English: Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.
Danish: Monoterapi hos voksne, unge og børn over 6 år med partielle epileptiske anfald med eller uden sekundære generaliserede anfald, og primære generaliserede tonisk-kloniske anfald.
English: • Loss of strength
Danish: • Kraftesløshed
English: UAB Johnson & Johnson - LT Šeimyniškių g.1A, LT-09312 Vilnius,
Danish: UAB Johnson & Johnson Šeimyniškių g. 1A, LT-09312 Vilnius,
English: Subsequently, at weekly or bi-weekly intervals, the dose should be increased by 25-50 mg/day and taken in two divided doses.
Danish: Herefter bør dosis en gang om ugen eller hver fjortende dag øges med 25-50 mg om dagen og tages som to separate doser.
English: When topiramate is added to glyburide therapy or glyburide is added to topiramate therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state.
Danish: Hvis topiramat gives i tillæg til glibenclamidbehandling, eller glibenclamid gives i tillæg til topiramat behandling, bør den rutinemæssige monitorering af patienternes diabetiske tilstand have særlig opmærksomhed.
English: When Topamax is added to pioglitazone therapy or pioglitazone is added to Topamax therapy, careful attention should be given to the routine monitoring of patients for adequate control of their diabetic disease state.
Danish: Hvis topiramat gives i tillæg til pioglitazonbehandling, eller pioglitazon gives i tillæg til topiramatbehandling, bør den rutinemæssige monitorering af patienternes diabetiske tilstand have særlig opmærksomhed.
English: The dosage should then be increased at 1- or 2-week intervals by increments of 25 or 50 mg/day, administered in two divided doses.
Danish: Dosis bør herefter øges hver eller hver anden uge med 25 eller 50 mg/døgn fordelt på 2 doser.
English: Hydrochlorothiazide (HCTZ)
Danish: Hydrochlorthiazid
English: 60 film-coated tablets with desiccant
Danish: 60 filmovertrukne tabletter med tørremiddel.
English: Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription, vitamins and herbal medicines.
Danish: Fortæl det altid til lægen eller på apoteket, hvis du bruger anden medicin eller har brugt det for nylig.
English: • Glaucoma which is a blockage of fluid in the eye causing increased pressure in the eye, pain and decreased vision
Danish: Det forårsager forhøjet tryk i øjet, smerte og nedsat syn.
English: Topamax 50 mgGranulat in Kapseln granuals in capsule
Danish: Topamax 50 mgGranulat in Kapseln
English: Common side effects include:
Danish: Almindelige bivirkninger:
English: PHARMACEUTICAL FORM AND CONTENTS Film-coated tablet [To be completed nationally] METHOD AND ROUTE(S) OF ADMINISTRATION Oral use.
Danish: LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Filmovertrukket tablet [Udfyldes nationalt]
English: Unless safety concerns require an abrupt withdrawal of the concomitant AED, a gradual discontinuation at the rate of approximately onethird of the concomitant AED dose every 2 weeks is recommended.
Danish: Medmindre øjeblikkelig seponering af samtidigt administrerede antiepileptika af sikkerhedshensyn er påkrævet, anbefales en gradvis nedtrapning.
English: 100 film-coated tablets with desiccant [To be completed nationally]
Danish: 6.5 Emballagetype og pakningsstørrelser [Udfyldes nationalt]
English: Adjunctive therapy in children aged 2 years and above, adolescents and adults with partial onset seizures with or without secondary generalization or primary generalized tonic-clonic seizures and for the treatment of seizures associated with Lennox-Gastaut syndrome
Danish: Adjuverende behandling af børn (fra 2 år), unge og voksne med partielle epileptiske anfald med eller uden sekundære generaliserede anfald eller primære generaliserede tonisk-kloniske anfald, og til behandling af anfald i forbindelse med Lennox-Gastaut syndrom.
English: • Tingling or numbness of the mouth
Danish: • Snurren og følelsesløshed i munden
English: Topamax and associated names (see Annex I) 15 mg hard capsules
Danish: Topimax og tilhørende navne (se bilag I) 15 mg hårde kapsler
English: Topamax and associated names (see Annex I) 25 mg hard capsules
Danish: Topimax og tilhørende navne (se bilag I) 25 mg hårde kapsler
English: Important information about some of the ingredients of Topamax
Danish: Vigtig information om nogle af de øvrige indholdsstoffer i Topimax [Udfyldes nationalt]
English: • Loss of consciousness
Danish: • Bevidstløshed
English: CHMP, the contraindication for the use of topiramate for migraine prophylaxis in pregnancy or women of child bearing potential without adequate contraception has been included by the MAH for the indication migraine prophylaxis.
Danish: Hvad angår indikationen migræneprofylakse, har indehaveren af markedsføringstilladelsen, sådan som CHMP anbefaler, medtaget kontraindikationen for brugen af topiramat til migræneprofylakse hos gravide og fertile kvinder uden passende kontraception.
English: Topamax and associated names (see Annex I) 50 mg hard capsules
Danish: Topimax og tilhørende navne (se bilag I) 50 mg hårde kapsler
English: Take special care with Topamax
Danish: Vær ekstra forsigtig med at tage Topimax
English: 50 film-coated tablets with desiccant
Danish: 50 filmovertrukne tabletter med tørremiddel.
English: • Tiredness
Danish: • Ørepine
English: • birth control pills.
Danish: • p-piller.
English: 4.2 - Posology
Danish: 4.2 - Dosering
English: • Distorted sense of taste
Danish: • Påvirket smagssans
English: When Topamax is added or withdrawn in patients on metformin therapy, careful attention should be given to the routine monitoring for adequate control of their diabetic disease state.
Danish: Hvis Topimax gives til eller seponeres hos patienter i metforminbehandling, bør den rutinemæssige monitorering af patienternes diabetiske tilstand have særlig opmærksomhed.
English: ”Adjunctive therapy for adults, adolescents and children aged 2 years and above with partial onset seizures with or without secondary generalisation or primary generalized tonic-clonic seizures……….”
Danish: “Tillægsbehandling hos voksne, unge og børn over 2 år, som lider af partielle anfald med eller uden sekundær generalisering eller primært generaliserede tonisk-kloniske anfald.”
English: Nutritional supplementation
Danish: LISTE OVER HJÆLPESTOFFER
English: “Monotherapy in adults, adolescents and children over 6 years of age with partial seizures with or without secondary generalised seizures, and primary generalised tonic-clonic seizures.”
Danish: “Monoterapi hos voksne, unge og børn over 6 år, som lider af partielle anfald med eller uden sekundær generalisering og primært generaliserede tonisk-kloniske anfald.”
English: • Dizziness
Danish: • Nyresten
English: Topiramate is contraindicated in pregnancy, and in women of childbearing potential if an effective method of contraception is not used (see section 4.3 and 4.5 Interactions with oral contraceptives).
Danish: Topiramat er kontraindiceret under graviditet og til kvinder i den fødedygtige alder, hvis der ikke anvendes effektiv kontraception (se pkt.
English: • have liver problems
Danish: • Taleproblemer
English: CNS depressants
Danish: CNS-supprimerende stoffer:
English: In patients with bipolar disorder, the pharmacokinetics of lithium were unaffected during treatment with topiramate at doses of 200 mg/day; however, there was an observed increase in systemic exposure (26% for AUC) following topiramate doses of up to 600 mg/day.
Danish: Hos patienter med bipolære sindslidelser blev farmakokinetikken af lithium ikke påvirket under behandling med topiramat 200 mg daglig.
English: • Slurred speech
Danish: • Sløret tale
English: Topamax and associated names (see Annex I) 25 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Topimax og tilhørende navne (se bilag I) 25 mg filmovertrukne tabletter.
English: Sprinkle capsule
Danish: Granulat i kapsler
English: Concomitant Drug
Danish: Samtidigt administreret lægemiddel
English: • Increase in seizures
Danish: • Flere anfald
English: • Indigestion
Danish: • Hæshed
English: WHAT TOPAMAX IS AND WHAT IT IS USED FOR:
Danish: Topimax indeholder:
English: NAME OF THE MEDICINAL PRODUCT Topamax and associated names (see Annex I) 15 mg hard capsules [See Annex I - To be completed nationally] topiramate STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally] LIST OF EXCIPIENTS
Danish: LÆGEMIDLETS NAVN Topimax og tilhørende navne (se bilag I) 15 mg hårde kapsler [Se bilag I - Udfyldes nationalt] topiramat ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER [Udfyldes nationalt] LISTE OVER HJÆLPESTOFFER
English: Marketing Authorisation Holder
Danish: Indehaver af markedsføringstilladelse Særnavn
English: Topamax and associated names (see Annex I) 100 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Topimax og tilhørende navne (se bilag I) 100 mg filmovertrukne tabletter.
English: If you take more Topamax than you should
Danish: Hvis du har taget for mange Topimax
English: Topamax and associated names (see Annex I) 200 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Topimax og tilhørende navne (se bilag I) 200 mg filmovertrukne tabletter.
English: Topamax and associated names (see Annex I) 50 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Topimax og tilhørende navne (se bilag I) 50 mg filmovertrukne tabletter.
English: Some patients may achieve efficacy with once-aday dosing.
Danish: Nogle patienter kan opnå en virkning med en dosis, der tages én gang dagligt.
English: 16% increase in AUC (TPM 50 mg q12h)
Danish: 16% øgning af AUC (TPM 50 mg hver 12. time)b a %-værdier er ændringer i behandlingens gennemsnitlige Cmax eller AUC vedr.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Topamax and associated names (see Annex I).
Danish: Produktresumé, etikettering og indlægsseddel fremgår af bilag III.
English: Topamax and associated names (see Annex I) 25 mg film-coated tablets [See Annex I - To be completed nationally] topiramate
Danish: Topimax og tilhørende navne (se bilag I) 25 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt] topiramat
English: • Joint pain
Danish: • Brystsmerter
English: PHARMACEUTICAL FORM AND CONTENTS 20 film-coated tablets with desiccant
Danish: 20 filmovertrukne tabletter med tørremiddel.
English: Topimax 25 mg tabletter, 25 milligram(s)
Danish: Topimax 200 mg tabletti, 200 milligram(s)
English: NAME OF THE MEDICINAL PRODUCT Topamax and associated names (see Annex I) 25 mg film-coated tablets [See Annex I - To be completed nationally] topiramate STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally] LIST OF EXCIPIENTS
Danish: LÆGEMIDLETS NAVN Topimax og tilhørende navne (se bilag I) 25 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt] topiramat ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER [Udfyldes nationalt] LISTE OVER HJÆLPESTOFFER
English: Topamax and associated names (see Annex I) 50 mg film-coated tablets [See Annex I - To be completed nationally] topiramate
Danish: Topimax og tilhørende navne (se bilag I) 50 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt] topiramat
English: Topamax and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally] topiramate
Danish: Topimax og tilhørende navne (se bilag I) 100 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt] topiramat
English: Topamax and associated names (see Annex I) 200 mg film-coated tablets [See Annex I - To be completed nationally] topiramate
Danish: Topimax og tilhørende navne (se bilag I) 200 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt] topiramat
English: • Inflammation of the pancreas
Danish: • Influenzalignende symptomer
English: NAME OF THE MEDICINAL PRODUCT Topamax and associated names (see Annex I) 200 mg film-coated tablets [See Annex I - To be completed nationally] topiramate STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally] LIST OF EXCIPIENTS
Danish: LÆGEMIDLETS NAVN Topimax og tilhørende navne (se bilag I) 200 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt] topiramat ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER [Udfyldes nationalt] LISTE OVER HJÆLPESTOFFER
English: • Cold extremities (e.g. hands and face)
Danish: • Kolde hænder og fødder
English: NAME OF THE MEDICINAL PRODUCT Topamax and associated names (see Annex I) 50 mg film-coated tablets [See Annex I - To be completed nationally] topiramate STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally] LIST OF EXCIPIENTS
Danish: LÆGEMIDLETS NAVN Topimax og tilhørende navne (se bilag I) 50 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt] topiramat ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER [Udfyldes nationalt] LISTE OVER HJÆLPESTOFFER
English: NAME OF THE MEDICINAL PRODUCT Topamax and associated names (see Annex I) 100 mg film-coated tablets [See Annex I - To be completed nationally] topiramate STATEMENT OF ACTIVE SUBSTANCE(S) [To be completed nationally] LIST OF EXCIPIENTS
Danish: LÆGEMIDLETS NAVN Topimax og tilhørende navne (se bilag I) 100 mg filmovertrukne tabletter [Se bilag I - Udfyldes nationalt] topiramat ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER [Udfyldes nationalt] LISTE OVER HJÆLPESTOFFER
English: Glyburide
Danish: Glibenclamid
English: • Impaired sense of smell
Danish: • Nedsat lugtesans
English: TOPAMAX 15 mg kapsule hard capsule
Danish: TOPAMAX 15 mg kapsule
English: • Renal tubular acidosis
Danish: • For meget syre i blodet (renal tubular acidose)
English: Adjunctive therapy for epilepsy in children and adults Partial onset seizures with or without secondary generalization, primary generalized tonic-clonic seizures, or
Danish: Tillægsbehandling af epilepsi hos børn og voksne Partielle anfald med eller uden sekundær generalisering, primært generaliserede tonisk-kloniske anfald eller anfald i forbindelse med Lennox-Gastauts syndrom (LGS)
English: haematuria, incontinence, micturition urgency, renal colic, renal pain
Danish: Uretral calcuri, urininkontinens, hæmaturi, inkontinens, imperiøs vandladning, nyrekolik, nyresmerter
English: [See Annex I - To be completed nationally] {Name and Address} <{tel}> <{fax}> <{e-mail}>
Danish: [Se bilag I - Udfyldes nationalt] topiramat NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN [Se bilag I - Udfyldes nationalt] {Navn }
English: • Fullness or bloating
Danish: • Mærhedsfølelse eller oppustethed
English: (furuncles).
Danish: (furunkler).
English: 20 October 2015 EMA/490629/2015
Danish: Den 20. oktober 2015 EMA/490629/2015
English: Their frequency has not been established.
Danish: Hyppigheden heraf er ikke fastlagt.
English: • as add-on treatment of irritation of the skin and areas around the anus and genitals, once serious conditions have been excluded by a doctor;
Danish: • som supplerende behandling af irritation af huden og området omkring anus og kønsdele, når læge har udelukket alvorlige sygdomme
English: Although possible beneficial effects were observed, the data were insufficient to be used as evidence, particularly because in these studies matricaria flower was not compared with any other treatment.
Danish: Selvom der i disse undersøgelser blev observeret gavnlige virkninger, var disse undersøgelser for begrænsede som dokumentation, navnlig fordi kamilleblomst i disse undersøgelser ikke blev sammenlignet med nogen anden behandling.
English: Matricaria flower is the common name for the flower heads of the plant Matricaria recutita L. (also known as chamomile).
Danish: Kamilleblomst er fællesnavnet for blomsterhovederne af planten Matricaria recutita L. (også kaldet vellugtende kamille).
English: Only some matricaria flower preparations are recommended for use in children below 12 years.
Danish: Kun visse tilberedninger af kamilleblomst anbefales til børn under 12 år.
English: • relieving the symptoms of common cold;
Danish: • lindring af symptomer på forkølelse
English: What is matricaria flower?
Danish: Hvad er kamilleblomst?
English: Herbal medicines containing matricaria flower preparations are available as herbal teas to be drunk or their steam inhaled; as infusions to be applied onto the skin or lining of the mouth; as liquid forms to be taken by mouth, used for steam inhalation, for rinsing the mouth or applied on the skin, or used as bath additives; and as semi-solid forms (such as ointments) to be applied onto the skin.
Danish: Plantelægemidler med tilberedninger af kamilleblomst fås som urtete til drikkebrug eller inhalation af dampene; til fremstilling af afkog til påføring på huden eller mundslimhinden; i flydende form til indtagelse gennem munden, til dampinhalation, til mundskylning, påføring på huden eller til anvendelse som badeadditiv; samt som halvfaste former (såsom salver) til påføring på huden.
English: For detailed information on the studies assessed by the HMPC, see the HMPC assessment report.
Danish: Nærmere oplysninger om de undersøgelser / informationer, der indgår i HMPC's vurdering, findes i HMPC's vurderingsrapport.
English: Matricaria flower can also be found in combination with other herbal substances in some herbal medicines.
Danish: Kamilleblomst findes desuden kombineret med andre droger i visse plantelægemidler.
English: Any applications for the licensing of medicines containing matricaria flower have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Danish: Ansøgninger om godkendelse af lægemidler, der indeholder kamilleblomst, skal indsendes til de nationale lægemiddelmyndigheder, som vurderer ansøgningen om plantelægemidlet og tager hensyn til HMPC's videnskabelige konklusioner.
English: Matricaria flower
Danish: Kamilleblomst
English: Information on the use and licensing of matricaria flower medicines in EU Member States should be obtained from the relevant national authorities.
Danish: Oplysninger om europæisk anvendelse og godkendelse af lægemidler, der indeholder kamilleblomst, skal indhentes fra de relevante nationale myndigheder i EU's medlemsstater.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing matricaria flower.
Danish: EU's medlemsstater tager hensyn til HMPC's konklusioner, når de vurderer ansøgninger om godkendelse af plantelægemidler, der indeholder kamilleblomst.
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of matricaria flower.
Danish: Dette er et sammendrag af Komiteen for Plantelægemidlers (HMPC) videnskabelige konklusioner angående den medicinske anvendelse af kamilleblomst.
English: Further information on the HMPC assessment of matricaria flower medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om HMPC's vurdering af lægemidler, der indeholder kamilleblomst, herunder detaljerede oplysninger om udvalgets konklusioner, findes under "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Patients with open wounds, extensive skin damage or acute (short-term) skin disease, high fever and severe infections should not have full or partial baths with matricaria flowers.
Danish: Patienter med åbne sår, udbredte hudskader eller kortvarig (akut) hudsygdom, høj feber eller svære infektioner bør ikke anvende karbade med kamilleolie til hverken dele af kroppen eller hele kroppen.
English: Further information on the risks associated with matricaria flower medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Danish: Yderligere oplysninger om risici forbundet med lægemidler, der indeholder kamilleblomst, herunder passende forholdsregler, som skal følges med henblik på sikker anvendelse, findes i monografien under fanebladet "All documents" på Det Europæiske Lægemiddelagenturs websted: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: Detailed instructions on how to take matricaria flower medicines and who can use them can be found in the package leaflet that comes with the medicine.
Danish: Detaljerede anvisninger for, hvordan lægemidler med kamilleblomst skal anvendes, og hvem der kan bruge dem, findes i indlægssedlen i lægemiddelpakningen.
English: The flowers for medicinal use are obtained either from plants that have been cultivated or found in the wild.
Danish: Blomsterne til medicinsk anvendelse fås enten fra dyrkede eller vildtvoksende planter.
English: • treating minor inflammation of the skin (sunburn) and superficial wounds and small boils
Danish: • behandling af lettere inflammation af huden (solskoldning), overfladiske sår og små bylder
English: Matricaria flower medicines are usually for use in adults and adolescents (above 12 years of age).
Danish: Lægemidler med kamilleblomst er typisk til anvendelse hos voksne og børn over 12 år.
English: Therefore, the HMPC conclusions on the use of matricaria flower medicines are based on their long-standing use.
Danish: HMPC's konklusioner om anvendelsen af lægemidler indeholdende kamilleblomst er derfor baseret på deres mangeårige anvendelse.
English: This summary is not intended to provide practical advice on how to use medicines containing matricaria flower.
Danish: Dette sammendrag er ikke en praktisk vejledning i, hvordan plantelægemidler, der indeholder kamilleblomst, anvendes.
English: Extracts are prepared using a technique to extract compounds from plant material by dissolving them in a solvent (such as ethanol).
Danish: Ekstrakterne fremstilles ved at udtrække stoffer fra plantematerialet i f.eks. ethanol.
English: Other information about matricaria flower medicines
Danish: Andre oplysninger om lægemidler, der indeholder kamilleblomst
English: How are matricaria flower medicines approved in the EU?
Danish: Hvordan godkendes lægemidler, der indeholder kamilleblomst, i EU?
English: Matricaria flower preparations are obtained by comminuting (reducing into tiny pieces) the flower, or as dry or liquid extracts.
Danish: Tilberedninger af kamilleblomst fremstilles ved findeling af blomsten eller som tørre eller flydende ekstrakter.
English: What are the risks associated with matricaria flower medicines?
Danish: Hvilke risici er der forbundet med lægemidler, der indeholder kamilleblomst?
English: • treating minor ulcers (open sores) and inflammations of the mouth and throat;
Danish: • behandling af mindre sår (åbne sår) og inflammation i mund og svælg
English: A doctor or a qualified healthcare practitioner should be consulted if symptoms persist for more than one week during treatment.
Danish: Hvis symptomerne vedvarer længere end en uge under behandlingen, bør der søges råd hos en læge eller en anden kvalificeret sundhedsmedarbejder.
English: What evidence supports the use of matricaria flower medicines?
Danish: Hvilken dokumentation underbygger den medicinske anvendelse af kamilleblomst?