FrancophonIA/ELRC3.0 huggingface dataset:
English: Infanrix Penta, Suspension for injection Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Danish: Infanrix Penta, injektionsvæske, suspension Difteri (D), tetanus (T), pertussis (acellulær, komponent) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inaktiveret) (IPV) vaccine (absorberet)
English: 4.5 Interaction with other medicinal products and other forms of interaction Clinical studies have demonstrated that Infanrix Penta can be administered simultaneously with Haemophilus influenzae type b vaccines.
Danish: Kliniske forsøg har vist, at Infanrix Penta kan administreres samtidigt med Haemophilus influenzae type b vacciner.
English: Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) vaccine (adsorbed)
Danish: Difteri (D), tetanus (T), pertussis (acellulær, komponent) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inaktiveret) (IPV) vaccine (absorberet).
English: Very common (these may occur with more than 1 in 10 doses of the vaccine)
Danish: Meget almindelig (disse sker ved flere end 1 ud af 10 vaccinedoser)
English: Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, hepatitis B or polio
Danish: Overfølsomhed ved tidligere indgift af difteri, tetanus, pertussis, hepatitis B, polio eller Hib vacciner.
English: Infanrix Penta should not be given if:
Danish: Dit barn må ikke blive vaccineret med Infanrix Penta hvis:
English: • temporarily stopping breathing (apnoea)
Danish: Antistof (cut-off)
English: Uncommon (these may occur in up to 1 in 100 doses of the vaccine)
Danish: Ikke almindelig (disse sker ved op til 1 ud af 100 vaccinedoser)
English: Before your child receives Infanrix Penta
Danish: DET SKAL DU VIDE, FØR DIT BARN FÅR INFANRIX PENTA
English: BEFORE YOUR CHILD RECEIVES INFANRIX PENTA
Danish: Det skal du vide, før dit barn får Infanrix Penta
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 23 October 2000
Danish: DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
English: Very rare (these may occur with up to 1 in 10,000 doses of the vaccine)
Danish: Meget sjælden (disse sker ved færre end 1 ud af 10.000 vaccinedoser)
English: Infanrix Penta is indicated for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis.
Danish: Infanrix Penta er indiceret til primær vaccination og boostervaccination af spædbørn mod difteri, tetanus,
English: Apnoea [see section 4.4 for apnoea in very premature infants (≤ 28 weeks of gestation)] General disorders and administration site conditions:
Danish: apnø hos meget tidligt fødte børn (≤ 28 uger af svangerskabet)]
English: Whooping cough can also cause ear infections, chest infections (bronchitis) which may last a long time, lung infections (pneumonia),
Danish: Kighoste kan også medføre øreinfektioner, længerevarende bronchitis, lungebetændelse, krampeanfald, hjerneskade og endda død.
English: If your child misses a dose
Danish: Ellers vil dit barn ikke være
English: Results obtained in the clinical studies for each of the components are summarised in the tables below: Percentage of subjects with antibody titres ≥ assay cut-off one month after primary vaccination months N= 55
Danish: Procentdelen af personer med en antistoftiter ≥ assay cut-off en måned efter primærvaccination måneder n = 55
English: GlaxoSmithKline Biologicals s.a. Rue de l'Institut 89
Danish: Rue de l'Institut 89
English: GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 info.produkt@gsk.com
Danish: Tel: + 46 (0)8 638 93 00info.produkt@gsk.com
English: 10 x 1 dose (0.5 ml) 20 pre-filled syringes 20 x 1 dose (0.5 ml)
Danish: 20 fyldte injektionssprøjter 20 x 1 dosis (0,5 ml)
English: There are no data with regard to the efficacy and safety of simultaneous administration of Infanrix Penta and Measles-Mumps-Rubella vaccine.
Danish: En samtidig indgift af Infanrix Penta og MFR-vaccine (Mæslinger-Fåresyge-Røde hunde) er ikke blevet
English: • your child is allergic (hypersensitive) to - Infanrix Penta, or any ingredients in Infanrix Penta (listed in Section 6) - neomycin or polymyxin (antibiotics).
Danish: - Infanrix Penta eller et af indholdsstofferne i Infanrix Penta (anført i afsnit 6) Tegn på en overfølsomhedsreaktion (allergisk reaktion) kan være kløende hududslæt, stakåndethed
English: 10 pre-filled syringes + 10 needles 10 x 1 dose (0.5 ml) 20 pre-filled syringes + 20 needles 20 x 1 dose (0.5 ml)
Danish: 10 fyldte injektionssprøjter + 10 kanyler 10 x 1 dosis (0,5 ml)
English: GlaxoSmithKline ehf.
Danish: GlaxoSmithKline AB
English: HHOW TO STORE INFANRIX PENTA
Danish: SÅDAN SKAL INFANRIX PENTA GIVES
English: Tel: + 421 (0)2 48 26 11 11
Danish: Tel: + 421 (0)2 48 26 11 11 recepcia.sk@gsk.com
English: 50 x 1 dose (0.5 ml) 1 pre-filled syringe + 1 needle 1 dose (0.5 ml)
Danish: 50 fyldte injektionssprøjter 50 x 1 dosis (0,5 ml)
English: Κύπρος
Danish: • hoste
English: GlaxoSmithKline (Cyprus) Ltd Τηλ: + 357 22 39 70 00
Danish: GlaxoSmithKline A.E.B.E Tηλ: + 30 210 68 82 100
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web
Danish: Du kan finde yderligere information om Infanrix Penta på Det Europæiske Lægemiddelagenturs (EMAs)
English: Infanrix Penta is a turbid white suspension.
Danish: Infanrix Penta er til dyb intramuskulær injektion.
English: GlaxoSmithKline S.p.A. Tel:+ 39 04 59 21 81 11
Danish: GlaxoSmithKline, S.A. Tel: + 34 902 202 700
English: Swelling of the entire injected limb*
Danish: Almene symptomer og reaktioner på administrationsstedet: Hævelse af hele armen eller benet, som er injiceret*
English: • in babies born very prematurely (at or before 28 weeks of gestation) longer gaps than normal between breaths may occur for 2-3 days after vaccination
Danish: • længere mellemrum mellem vejrtrækningerne hos meget for tidligt fødte børn (født i 28.
English: Infanrix Penta should not be given if any of the above apply to your child.
Danish: Hvis noget af ovenstående passer på dit barn, bør Infanrix Penta ikke gives.
English: • swelling, pain and redness where the injection was given Common (these may occur in with up to 1 in 10 doses of the vaccine)
Danish: • hævelse, smerte og rødme, der hvor injektionen blev givet
English: Memantine ratiopharm should be given once a day at the same time every day.
Danish: Memantine ratiopharm bør gives én gang dagligt på samme tidspunkt hver dag.
English: The full EPAR for Memantine ratiopharm can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Memantine ratiopharm findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: To prevent side effects, the dose of Memantine ratiopharm is gradually increased over the first three weeks of treatment: during the first week, the dose is 5 mg; in the second week, it is 10 mg; and during the third week, it is 15 mg. From week four onwards, the recommended maintenance dose is 20 mg once a day.
Danish: For at undgå bivirkninger øges dosis af Memantine ratiopharm gradvist i løbet af de tre første uger af behandlingen: I den første uge er dosis 5 mg, i den anden uge er den 10 mg, og i den tredje uge er den 15 mg. Fra uge fire og fremover er den anbefalede vedligeholdelsesdosis 20 mg én gang dagligt.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Memantine ratiopharm on 13 June 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Memantine ratiopharm den 13. juni 2013.
English: This is a summary of the European public assessment report (EPAR) for Memantine ratiopharm.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Memantine ratiopharm.
English: Memantine ratiopharm is available as tablets (5 mg, 10 mg, 15 mg and 20 mg) and can only be obtained with a prescription.
Danish: Memantin ratiopharm fås som tabletter (5 mg, 10 mg, 15 mg og 20 mg) og udleveres kun efter recept.
English: It is used to treat patients with moderate to severe Alzheimer's disease.
Danish: Det anvendes til behandling af moderat til svær Alzheimers sygdom.
English: The tolerance and dose should be assessed within three months after starting treatment, and from then on the benefits of continuing treatment with Memantine ratiopharm should be re-assessed on a regular basis.
Danish: Tolerance og dosis bør vurderes inden for 3 måneder efter behandlingens start, og herefter bør fordelene ved at fortsætte behandlingen med Memantine ratiopharm regelmæssigt genvurderes.
English: The Committee recommended that Memantine ratiopharm be approved for use in the EU.
Danish: Udvalget anbefalede, at Memantine ratiopharm godkendes til anvendelse i EU.
English: This means that Memantine ratiopharm is similar to a ‘reference medicine' already authorised in the European Union (EU) called Ebixa.
Danish: Det betyder, at Memantine ratiopharm er identisk med et "referencelægemiddel", der allerede er godkendt i Den Europæiske Union (EU), og som hedder Ebixa.
English: Memantine works by blocking special types of receptor called NMDA receptors, to which the neurotransmitter glutamate normally attaches.
Danish: Memantine virker ved at blokere en bestemt type receptorer kaldet NMDA-receptorer, som signalstoffet glutamat normalt binder sig til.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Memantine ratiopharm has been shown to have comparable quality and to be bioequivalent to Ebixa.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at det i overensstemmelse med EU's krav er blevet påvist, at Memantine ratiopharm er af sammenlignelig kvalitet og er bioækvivalent med Ebixa.
English: Safety information has been included in the summary of product characteristics and the package leaflet for Memantine ratiopharm, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Memantine ratiopharm, herunder passende forholdsregler, som patienter og sundhedspersonale bør følge.
English: Treatment should only be started if a caregiver is available who will regularly monitor the use of Memantine ratiopharm by the patient.
Danish: Behandlingen bør kun iværksættes, hvis en omsorgsgivende person regelmæssigt overvåger patientens indtagelse af Memantine ratiopharm.
English: Memantine ratiopharm is a ‘generic medicine'.
Danish: Memantine ratiopharm er et "generisk lægemiddel".
English: Other information about Memantine ratiopharm
Danish: Andre oplysninger om Memantine ratiopharm
English: For more information about treatment with Memantine ratiopharm, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Memantine ratiopharm, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: What measures are being taken to ensure the safe and effective use of Memantine ratiopharm?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Memantine ratiopharm?
English: The active substance in Memantine ratiopharm, memantine hydrochloride, is an antidementia medicine.
Danish: Det aktive stof i Memantine ratiopharm, memantinhydrochlorid, er et lægemiddel mod demens.
English: Memantine ratiopharm is a medicine that contains the active substance memantine hydrochloride.
Danish: Memantine ratiopharm er et lægemiddel, der indeholder det aktive stof memantinhydrochlorid.
English: What are the benefits and risks of Memantine ratiopharm?
Danish: Hvilke fordele og risici er der forbundet med Memantine ratiopharm?
English: Because Memantine ratiopharm is a generic medicine, studies in patients have been limited to tests to determine that it is bioequivalent to the reference medicine, Ebixa.
Danish: Da Memantine ratiopharm er et generisk lægemiddel, har patientundersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet Ebixa.
English: It is not intended to provide practical advice on how to use Memantine ratiopharm.
Danish: Det er ikke en praktisk vejledning i, hvordan Memantine ratiopharm bør anvendes.
English: Because Memantine ratiopharm 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 Memantine ratiopharm er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: What is Memantine ratiopharm and what is it used for?
Danish: Hvad er Memantine ratiopharm, og hvad anvendes det til?
English: By blocking NMDA receptors, memantine improves the transmission of signals in the brain and reduces the symptoms of Alzheimer's disease.
Danish: Memantine forbedrer signaloverførslen i hjernen ved at blokere NMDA-receptorerne, så symptomerne på Alzheimers sygdom mindskes.
English: For practical information about using Memantine ratiopharm, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Memantine ratiopharm, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: Why is Memantine ratiopharm approved?
Danish: Hvorfor er Memantine ratiopharm blevet godkendt?
English: Memantine ratiopharm memantine hydrochloride
Danish: EPAR - Sammendrag for offentligheden memantinhydrochlorid
English: How has Memantine ratiopharm been studied?
Danish: Hvordan er Memantine ratiopharm blevet undersøgt?
English: How is Memantine ratiopharm used?
Danish: Hvordan anvendes Memantine ratiopharm?
English: How does Memantine ratiopharm work?
Danish: Hvordan virker Memantine ratiopharm?
English: This summary was last updated in February 2017.
Danish: Dette sammendrag blev sidst ajourført i 02-2017.
English: The dose to be used depends on the weight of the dog being treated.
Danish: Dosis afhænger af den behandlede hunds vægt.
English: The full EPAR for Cytopoint can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Cytopoint findes på agenturets websted under: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Cytopoint.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Cytopoint.
English: Repeated accidental self-injection may cause an allergic reaction to the medicine.
Danish: Gentagen utilsigtet selvinjektion kan medføre en allergisk reaktion over for lægemidlet.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Cytopoint's benefits are greater than its risks and recommended that it be approved for use in the EU.
Danish: Agenturets Udvalg for Lægemidler til Dyr (CVMP) konkluderede, at fordelene ved Cytopoint opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: The most common side effects with Cytopoint (which may affect up to 1 in 1,000 animals) are allergic reactions with swelling of the face and itchy rash.
Danish: De hyppigste bivirkninger ved Cytopoint (som kan optræde hos op til 1 ud af 1 000 dyr) er allergiske reaktioner med hævelse i ansigtet og kløende udslet.
English: Once the dog's skin becomes damaged by scratching and rubbing, secondary bacterial and yeast infections may develop as well.
Danish: Når hunden kradser eller gnubber sig og dermed beskadiger huden, kan der desuden udvikle sig bakterie- og svampeinfektioner.
English: Cytopoint contains the active substance lokivetmab.
Danish: Cytopoint indeholder det aktive stof lokivetmab.
English: Other information about Cytopoint
Danish: Andre oplysninger om Cytopoint
English: It is not intended to provide practical advice on how to use Cytopoint.
Danish: Det er ikke en praktisk vejledning i, hvordan Cytopoint bør anvendes.
English: By blocking interleukin 31, lokivetmab reduces itchy skin and inflammation.
Danish: Ved at blokere interleukin 31 reducerer lokivetmab kløen og betændelsestilstanden.
English: Cytopoint is available as a solution for injection that is injected under the skin once a month.
Danish: Cytopoint fås som en opløsning til injektion, der injiceres under huden en gang månedligt.
English: Lokivetmab is a monoclonal antibody (a type of protein) that recognises and attaches to interleukin-31, a protein that plays an important role in triggering atopic dermatitits in dogs.
Danish: Lokivetmab er et monoklonalt antistof (en type protein), som genkender og binder sig til proteinet interleukin-31, der er en vigtig udløsende faktor for atopisk dermatitis hos hunde.
English: Cytopoint starts to be effective within eight hours of injection and the effect lasts for up to 28 days.
Danish: Virkningen af Cytopoint indtræder 8 timer efter injektionen og varer i op til 28 dage.
English: What is Cytopoint and what is it used for?
Danish: Hvad er Cytopoint, og hvad anvendes det til?
English: Atopic dermatitis is inflammation of the skin that is linked to allergy, often to things in the environment such as house dust mites and pollens.
Danish: Atopisk dermatitis er en betændelsestilstand i huden, som er forbundet med allergi, ofte over for ting i omgivelserne som f.eks. husstøvmider og pollen.
English: Cytopoint is a veterinary medicine used to treat atopic dermatitis in dogs.
Danish: Cytopoint er et lægemiddel til dyr, der anvendes til behandling af atopisk dermatitis hos hunde.
English: Why is Cytopoint approved?
Danish: Hvorfor blev Cytopoint godkendt?
English: The European Commission granted a marketing authorisation valid throughout the EU for Cytopoint on 25 April 2017.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele EU for Cytopoint den
English: In a field study involving dogs with atopic dermatitis, 142 dogs received Cytopoint monthly for 3 months whilst 132 were treated with ciclosporin, another medicine approved for treating atopic dermatitis.
Danish: I en feltundersøgelse hos hunde med atopisk dermatitis fik 142 hunde Cytopoint en gang månedligt i tre måneder, mens 132 blev behandlet med ciclosporin, et andet lægemiddel, der er godkendt til behandling af atopisk dermatitis.
English: What are the risks associated with Cytopoint?
Danish: Hvilke risici er der forbundet med Cytopoint?
English: Safety information has been included in the summary of product characteristics and the package leaflet for Cytopoint, including the appropriate precautions to be followed by healthcare professionals and animal owners or keepers.
Danish: Der er anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Cytopoint, herunder passende forholdsregler, som skal følges af sundhedspersoner og den, der er ejer af eller ansvarlig for dyret.
English: In a follow up study, 81 dogs of the dogs continued Cytopoint treatment for a further six months and the itchy skin score went down further to 14.
Danish: I en opfølgende undersøgelse fortsatte 81 hunde behandlingen med Cytopoint i yderligere seks måneder, og kløescoren faldt yderligere til 14.
English: Over the three months of the study pruritus score went down from a value of 74 at the start to 26 at the end in dogs given Cytopoint.
Danish: I de tre måneder, som undersøgelsen varede, faldt kløescoren hos hunde, der fik Cytopoint, fra en værdi på 74 ved starten til 26 ved afslutningen.
English: How is Cytopoint used?
Danish: Hvordan anvendes Cytopoint?
English: Cytopoint was as effective as ciclosporin in treating itchy skin; after 28 days the pruritus score (measurement of itchiness) was reduced by 52% in dogs given Cytopoint and 44% in those given ciclosporin.
Danish: Efter 28 dage var kløescoren (kløens sværhedsgrad) faldet med 52 % hos hunde, der fik Cytopoint, og 44 % hos dem, der fik ciclosporin.
English: What benefits of Cytopoint have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Cytopoint?
English: How does Cytopoint work?
Danish: Hvordan virker Cytopoint?
English: For more information about treatment with Cytopoint, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker yderligere oplysninger om behandling med Cytopoint, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: For practical information about using Cytopoint, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Danish: Hvis du som ejer eller ansvarlig for dyret ønsker praktisk vejledning om anvendelsen af Cytopoint, kan du læse indlægssedlen eller kontakte din dyrlæge eller dit apotek.
English: Cytopoint must not be given to dogs weighing less than 3 kg. For the full list of restrictions and all side effects reported with Cytopoint, see the package leaflet.
Danish: Cytopoint må ikke anvendes til hunde på under 3 kg.
English: The European Commission granted a marketing authorisation valid throughout the EU for Fosavance on 24 August 2005.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fosavance den 24. august 2005.
English: The full EPAR for Fosavance can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige EPAR for Fosavance findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: The recommended dose of Fosavance is one tablet once a week.
Danish: Den anbefalede dosis af Fosavance er én tablet én gang om ugen.
English: This is a summary of the European public assessment report (EPAR) for Fosavance.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Fosavance.
English: A risk management plan has been developed to ensure that Fosavance is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Fosavance anvendes så sikkert som muligt.
English: For more information about treatment with Fosavance, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Fosavance, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The CHMP decided that Fosavance's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Fosavance opvejer risiciene, og anbefalede udstedelse af markedsføringstilladelse.
English: What measures are being taken to ensure the safe and effective use of Fosavance?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Fosavance?
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Fosavance.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Fosavance skal anvendes.
English: Since patients with osteoporosis may not get enough vitamin D3 through exposure to sunlight, it is included in Fosavance.
Danish: Da patienter med osteoporose muligvis ikke får tilstrækkeligt med D3-vitamin via eksponering for sollys, indeholder Fosavance dette vitamin.