FrancophonIA/ELRC3.0 huggingface dataset:
English: MEPACT 4 mg powder for concentrate for dispersion for infusion
Danish: MEPACT 4 mg pulver til koncentrat til infusionsvæske, dispersion.
English: Powder for concentrate for dispersion for infusion Pack of 1 vial of powder, 1 sterile filter
Danish: Pakke med 1 hætteglas pulver, 1 sterilt filter
English: The cap of the vial should be removed and the stopper cleaned using an alcohol pad.
Danish: Fjern hætteglassets låg, og rens proppen med en spritpude.
English: Fever, Chills, Fatigue, Hypothermia, Pain, Malaise, Asthenia, Chest pain
Danish: Feber, kulderystelser, træthed, hypotermi, smerter, utilpashed, asteni, brystsmerter
English: Each vial contains 4 mg mifamurtide*.
Danish: Hvert4 mg hætteglas indeholder 4 mg mifamurtid*.
English: Each vial should be reconstituted with 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Hvert hætteglas skal blandes med 50 ml natriumklorid 9 mg/ml (0,9 %) injektionsopløsning.
English: Therefore, the SmPC of mifamurtide should be updated with the inclusion of pericardial effusion as an ADR in section 4.8 under SOC Cardiac disorders.
Danish: Derfor bør produktresuméet for mifamurtid opdateres med indsættelse af perikardieekssudat som bivirkning i pkt.
English: Therefore, MEPACT should not be used during pregnancy and in women of childbearing potential not using effective contraception.
Danish: Derfor må hverken gravide eller kvinder i den fødedygtige alder, der ikke bruger sikker prævention, behandles med MEPACT.
English: - The other ingredients are 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) and 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS).
Danish: - Øvrige indholdsstoffer: 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) og 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine mononatriumsalt (OOPS), se pkt.
English: Post-procedural pain
Danish: Smerter efter indgreb
English: The 100 mL sodium chloride 9 mg/mL (0.9%) solution for injection bag, needle and syringe should be unpacked (not provided in the pack).
Danish: Pak 100 ml natriumklorid 9 mg/ml (0,9 %) opløsning til injektionsposen, kanyle og sprøjte ud (følger ikke med pakken).
English: Peripheral oedema, Oedema, Mucosal inflammation, Infusion site erythema, Infusion site reaction, Catheter site pain, Chest discomfort, Feeling cold
Danish: Perifert ødem, ødem, slimhindebetændelse, erythema på infusionsstedet, reaktion på infusionsstedet, smerte på kateterstedet, brystsmerter, kuldefølelse
English: Cancer pain
Danish: Cancersmerte
English: Powder for concentrate for dispersion for infusion
Danish: Pulver til koncentrat til infusionsvæske, dispersion.
English: Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med MEPACT Fortæl det altid til lægen, hvis du bruger anden medicin, har gjort det for nylig, eller overvejer at gøre det.
English: However, as the variability in pharmacokinetics of mifamurtide is greater in subjects with moderate hepatic impairment (see section 5.2), and safety data in patients with moderate hepatic impairment is limited, caution when administering mifamurtide to patients with moderate hepatic impairment is recommended.
Danish: 5.2), og da der er begrænsede sikkerhedsdata for patienter med moderat leverinsufficiens, anbefales forsigtighed ved administration af mifamurtid til patienter med moderat leverinsufficiens.
English: Using the needle and syringe, 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection should be withdrawn from the bag.
Danish: Ved hjælp af kanylen og sprøjten trækkes injektionsopløsningen med 50 ml natriumklorid 9 mg/ml (0,9 %) ud af posen.
English: Vomiting, Diarrhoea, Constipation, Abdominal pain, Nausea
Danish: Opkastning, diarré, obstipation, mavesmerter, kvalme
English: Dyspnoea, Tachypnoea, Cough
Danish: Dyspnø, takypnø, hoste
English: If you use more MEPACT than you should
Danish: Hvis du har brugt for meget MEPACT
English: Patient identification, time and date should be added to the label on the bag containing the reconstituted, filtered and diluted liposomal suspension.
Danish: Patientidentifikation, tid og dato påføres på posens etiket.
English: Myalgia, Arthralgia, Back pain, Pain in extremity
Danish: Myalgi, artralgi, rygsmerter, smerter i ekstremiteterne
English: Muscle spasms, Neck pain, Groin pain, Bone pain, Shoulder pain, Chest wall pain, Musculoskeletal stiffness
Danish: Muskelspasmer, nakkesmerter, lyskesmerter, knoglesmerter, skuldersmerter, smerter i thoraxvæg, muskuloskeletal stivhed
English: You should use effective contraception if you are being treated with MEPACT.
Danish: Hvis du behandles med MEPACT, skal du bruge sikker prævention.
English: What MEPACT is and what it is used for What you need to know before you use MEPACT How to use MEPACT
Danish: Det skal du vide, før du begynder at bruge MEPACT Sådan skal du bruge MEPACT Bivirkninger
English: Each mL reconstituted suspension contains 0.08 mg mifamurtide.
Danish: Hver ml opløst suspension indeholder 0,08 mg/ml mifamurtid.
English: The site of the sodium chloride 9 mg/mL (0.9%) solution for injection bag where the needle is going to be inserted should be swabbed with an alcohol pad.
Danish: Rens det sted på posen med den 100 ml natriumklorid 9 mg/ml (0,9 %) injektionsopløsning, hvor kanylen skal indføres med en spritpude.
English: Phlebitis, Flushing, Pallor
Danish: Flebitis, rødmen, bleghed
English: What MEPACT is and what it is used for
Danish: MEPACT leveres i en pakning, der indeholder
English: The spike should then be inserted into the vial septum firmly until seated.
Danish: Indfør derefter spidsen i hætteglassets skillevæg, indtil den sidder fast.
English: After reconstitution, each mL suspension in the vial contains 0.08 mg mifamurtide.
Danish: Efter rekonstitution indeholder hver ml suspension i hætteglasset 0,08 mg mifamurtid.
English: After reconstitution, each mL of suspension contains 0.08 mg of mifamurtide.
Danish: Efter blanding indeholder hver ml opløsning 0,08 mg mifamurtid.
English: How MEPACT is given
Danish: Sådan bliver du behandlet med MEPACT
English: LIST OF EXCIPIENTS
Danish: Perikardieekssudat
English: The European Commission granted a marketing authorisation valid throughout the European Union for GONAL-f to Merck Serono Europe Ltd. on 20 October 1995.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for GONAL-f til Merck Serono Europe Ltd. den 20. oktober 1995.
English: It has also been studied as part of assisted reproductive techniques in 470 women.
Danish: Det er også blevet undersøgt som en del af kunstig befrugtning hos 470 kvinder.
English: The dose of GONAL-f and how often it is given depend on why it is being used and on the patient's response to treatment.
Danish: Dosen af GONAL-f og den hyppighed, hvormed det gives, afhænger af, hvorfor det anvendes, og af patientens respons på behandlingen.
English: This is called ‘ovarian hyperstimulation syndrome'.
Danish: Dette kaldes ”ovarielt hyperstimulationssyndrom”.
English: After the first injection, the patient or their partner may give the injections themselves, if they are well motivated, have been trained and have access to expert advice.
Danish: Efter den første injektion kan patienten eller patientens partner selv foretage injektionerne, hvis de er motiverede for det og har adgang til ekspertrådgivning.
English: This document is a summary of the European public assessment report (EPAR) for GONAL-f.
Danish: Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for GONAL-f.
English: Because these conditions are rare, GONAL-f was not compared with any other treatments in these studies, and the low number of patients in the studies was considered to be acceptable.
Danish: Da disse sygdomme er sjældne, blev GONAL-f ikke sammenlignet med andre behandlinger i forbindelse med disse undersøgelser, og det lave antal patienter i undersøgelserne blev betragtet som værende acceptabelt.
English: In men, the studies looked at the number of men who started to produce sperm within the first 18 months of treatment.
Danish: I undersøgelsen af mænd så man på antallet af mænd, som begyndte at danne sæd inden for de første 18 måneders behandling.
English: GONAL-f is given by injection under the skin once a day.
Danish: GONAL-f gives ved injektion under huden én gang om dagen.
English: It must not be used when it would not be possible for the patient to have an effective response, such as in patients whose ovaries or testicles do not work or in women who should not get pregnant for medical reasons.
Danish: Det må ikke anvendes, når det ikke er muligt for patienten at opnå en effektiv respons, f.eks. til patienter, hvis æggestokke eller testikler ikke er funktionsdygtige, eller til kvinder, som af medicinske årsager ikke bør blive gravide.
English: GONAL-f is used to treat the following groups:
Danish: GONAL-f anvendes til behandling af følgende grupper:
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 GONAL-f.
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 anvendelsesbetingelserne for GONAL-f.
English: In some women, the ovaries can over-respond to stimulation.
Danish: Hos nogle kvinder kan æggestokkene undertiden overreagere på stimulation.
English: Other information about GONAL-f:
Danish: Andre oplysninger om GONAL-f:
English: For more information about treatment with GONAL-f, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med GONAL-f, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: If the powder is being used, it should be mixed with the solvent provided just before use.
Danish: Hvis pulveret anvendes, skal det blandes med solvensen (opløsningsvæsken) umiddelbart før brug.
English: In the studies of women, the main measures of effectiveness were the number of eggs collected, the number of women who released eggs and the number of follicles produced in the ovaries (small sacs that hold the eggs).
Danish: I undersøgelserne af kvinder var det primære effektmål antallet af indsamlede æg, antallet af kvinder, som løste æg, og antallet af follikler produceret i æggestokkene (små sække, som indeholder æggene).
English: The most common side effects with GONAL-f (seen in more than 1 patient in 10) are reactions at the injection site (pain, redness, bruising, swelling or irritation).
Danish: De hyppigste bivirkninger ved GONAL f (set hos flere end 1 ud af 10 patienter) er reaktioner på injektionsstedet (smerte, rødme, blå mærker, hævelse eller irritation).
English: Previously, the FSH used in medicines was extracted from urine.
Danish: Tidligere blev FSH til brug i lægemidler udvundet af urin.
English: The CHMP decided that GONAL-f's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved GONAL-f er større end risiciene, og anbefalede udstedelse af markedsføringstilladelse for GONAL-f.
English: • adult men who have hypogonadotrophic hypogonadism (a rare hormone deficiency disease).
Danish: • Voksne mænd med hypogonadotropisk hypogonadisme (en sjælden hormondefektsygdom).
English: The full EPAR for GONAL-f can be found here.
Danish: Den fuldstændige EPAR for GONAL-f findes her.
English: • adult women (aged 18 years or over) who do not produce eggs and do not respond to treatment with clomiphene citrate (another medicine that stimulates the ovaries to produce eggs);
Danish: • Voksne kvinder (18 år eller derover), som ikke danner æg, og som ikke reagerer på behandling med clomifencitrat (et andet lægemiddel, der stimulerer æggestokkene til at danne æg).
English: Treatment with GONAL-f should be carried out by a doctor who has experience in the treatment of fertility problems.
Danish: Behandling med GONAL-f skal foretages af en læge med erfaring i fertilitetsbehandling.
English: GONAL-f has been studied in 222 women who do not produce eggs or respond to clomiphene citrate.
Danish: GONAL-f er blevet undersøgt hos 222 kvinder, som ikke producerer æg eller reagerer på clomifencitrat.
English: GONAL-f was as effective as human FSH in women who did not produce eggs or respond to clomiphene citrate: 84% of the women receiving GONAL-f produced eggs, compared with 91% of those receiving human FSH.
Danish: GONAL-f var lige så effektivt som humant FSH til kvinder, som ikke dannede æg eller reagerede på clomifencitrat: 84 % af de kvinder, der fik GONAL-f, dannede æg, sammenlignet med 91 % af de kvinder, der fik humant FSH.
English: In the body, FSH controls reproductive function: in women, it stimulates the production of eggs; and in men, it stimulates the production of sperm in the testicles.
Danish: I kroppen kontrollerer FSH forplantningsevnen: Hos kvinder stimulerer det dannelsen af æg, og hos mænd stimulerer det dannelsen af sæd i testiklerne.
English: GONAL-f should not be used in people who may be hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients.
Danish: GONAL f må ikke anvendes af personer, der kan være overfølsomme (allergiske) over for follitropin alfa, FSH eller andre af de øvrige indholdsstoffer.
English: • adult women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH).
Danish: • Voksne kvinder med svær mangel på (meget lave niveauer af) luteiniserende hormon (LH) og follikelstimulerende hormon (FSH).
English: The active substance in GONAL-f, follitropin alfa, is a copy of the natural hormone FSH.
Danish: Det aktive stof i GONAL-f, follitropin alfa, er en kopi af det naturlige hormon FSH.
English: It is available as a solution for injection in a prefilled pen and as a powder and solvent that are made up into a solution for injection.
Danish: Det leveres som injektionsvæske, opløsning, i en fyldt pen og som et pulver og en solvens, der blandes til en injektionsvæske, opløsning.
English: It must not be used in patients with tumours of the pituitary gland or hypothalamus, or cancer of the breast, womb or ovary.
Danish: Det må ikke anvendes til patienter med tumorer i hypofysen eller hypothalamus eller kræft i brysterne, livmoderen eller æggestokkene.
English: GONAL-f, in combination with LH, has also been studied in 38 women with severe LH and FSH deficiency, and in combination with hCG in 19 men with hypogonadotrophic hypogonadism.
Danish: GONAL-f, i kombination med LH, er desuden blevet undersøgt hos 38 kvinder med svær LH- og FSHmangel og, i kombination med hGC, hos 19 mænd med hypogonadotropisk hypogonadisme.
English: GONAL-f is a medicine that contains the active substance follitropin alfa.
Danish: GONAL-f er et lægemiddel, der indeholder det aktive stof follitropin alfa.
English: In the study in men, GONAL-f, used in combination with hCG, was effective in stimulating sperm production, with 63% of the men starting to produce sperm.
Danish: I undersøgelsen af mænd var GONAL-f anvendt i kombination med hCG effektivt til at stimulere sæddannelsen, idet 63 % af mændene begyndte at danne sæd.
English: • adult women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation.
Danish: • Voksne kvinder, der modtager kunstig befrugtning (fertilitetsbehandling) såsom in vitrobefrugtning.
English: In women, GONAL-f must not be used when there is enlargement of an ovary or a cyst that is caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina.
Danish: GONAL-f må ikke gives til kvinder, hvis de har en forstørret æggestok eller en cyste, der skyldes andet end polycystisk ovariesyndrom, eller når der forekommer blødning fra vagina af ukendt årsag.
English: What is the risk associated with GONAL-f?
Danish: Hvilken risiko er der forbundet med GONAL-f?
English: GONAL-f is given to stimulate the ovaries to produce more than one egg at a time;
Danish: GONAL-f gives for at stimulere æggestokkene til at danne flere end ét æg ad gangen.
English: In women, ovarian cysts (sacs of fluid within the ovaries) and headache are also seen in more than 1 patient in 10.
Danish: Hos kvinder ser man desuden, at der opstår cyster (væskeblærer) i æggestokkene og hovedpine hos 1 ud af 10 patienter.
English: GONAL-f was effective in triggering egg development in women with severe LH and FSH deficiency.
Danish: GONAL-f var effektivt til at fremkalde ægmodning hos kvinder med svær mangel på LH og FSH.
English: In these studies, GONAL-f was compared with human FSH that had been extracted from urine.
Danish: I undersøgelserne blev GONAL-f sammenlignet med humant FSH udvundet af urin.
English: GONAL-f is used together with human chorionic gonadotrophin (hCG) to stimulate sperm production.
Danish: GONAL-f anvendes sammen med humant koriongonadotropin (hCG) til at stimulere sæddannelsen.
English: Why has GONAL-f been approved?
Danish: Hvorfor blev GONAL-f godkendt?
English: For the full list of all side effects reported with GONAL-f, see the package leaflet.
Danish: En fuldstændig liste over de indberettede bivirkninger ved GONAL-f fremgår af indlægssedlen.
English: What is GONAL-f?
Danish: Hvad er GONAL-f?
English: GONAL-f is given together with a medicine containing LH to stimulate the eggs to mature in the ovaries;
Danish: GONAL-f gives sammen med et lægemiddel indeholdende LH for at stimulere ægmodningen i æggestokkene.
English: GONAL-f was also as effective as human FSH at stimulating the ovaries during assisted reproductive techniques.
Danish: GONAL-f var også lige så effektivt som humant FSH til at stimulere æggestokkene i forbindelse med kunstig befrugtning.
English: How has GONAL-f been studied?
Danish: Hvordan er GONAL-f blevet undersøgt?
English: What is GONAL-f used for?
Danish: Hvad anvendes GONAL-f til?
English: The follitropin alfa in GONAL-f is produced by a method known as ‘recombinant DNA technology': it is made by a cell that has received a gene (DNA), which makes it able to produce human FSH.
Danish: Follitropin alfa i GONAL-f fremstilles ved hjælp af en metode kaldet ”rekombinant dna-teknologi”.
English: What benefit has GONAL-f shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved GONAL-f?
English: How is GONAL-f used?
Danish: Hvordan anvendes GONAL-f?
English: How does GONAL-f work?
Danish: Hvordan virker GONAL-f?
English: This dose may need to be increased after one or two weeks.
Danish: Det kan være nødvendigt at forhøje dosis efter en eller to uger.
English: The dose is adjusted to give the best control.
Danish: Doseringen justeres for at give den bedste kontrol.
English: Repaglinide Teva is taken before meals, normally up to 15 minutes before each main meal.
Danish: Repaglinid Teva indtages før måltiderne, normalt op til 15 minutter før hvert hovedmåltid.
English: It is available as round tablets (blue: 0.5 mg; yellow: 1 mg; peach: 2 mg).
Danish: Det fås som runde tabletter (blå: 0,5 mg, gule: 1 mg; ferskenfarvede: 2 mg).
English: If patients are transferred from another anti-diabetes medicine, the recommended starting dose is 1 mg.
Danish: Hvis patienten er skiftet fra et andet lægemiddel mod diabetes, er den anbefalede startdosis 1 mg.
English: Other information about Repaglinide Teva:
Danish: Andre oplysninger om Repaglinid Teva:
English: This means that Repaglinide Teva is similar to a ‘reference medicine' already authorised in the European Union (EU) called NovoNorm.
Danish: Det betyder, at Repaglinid Teva er identisk med et ‘referencelægemiddel', der allerede er godkendt i Den Europæiske Union (EU), og som hedder NovoNorm.
English: Repaglinide Teva repaglinide EPAR summary for the public
Danish: Repaglinid Teva repaglinid EPAR - sammendrag for offentligheden
English: Repaglinide Teva is a medicine that contains the active substance repaglinide.
Danish: Repaglinid Teva er et lægemiddel, der indeholder det aktive stof repaglinid.
English: The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Repaglinide Teva has been shown to have comparable quality and to be bioequivalent to NovoNorm.
Danish: Udvalget for Humanmedicinske Lægemidler (CHMP) konkluderede, at Repaglinid Teva i overensstemmelse med EU's krav har vist sig at være af sammenlignelig kvalitet og er bioækvivalent med NovoNorm.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Repaglinide Teva to Teva Pharma B.V. on 29 June 2009.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Repaglinid Teva til Teva Pharma B.V.
English: Because Repaglinide Teva is a generic medicine, studies have been limited to tests to determine that it is bioequivalent to the reference medicine (this means that the two medicines produce the same levels of the active substance in the body).
Danish: Da Repaglinid Teva er et generisk lægemiddel, har undersøgelserne været begrænset til at påvise, at det er bioækvivalent med referencelægemidlet (dvs. at de to lægemidler producerer samme mængde af det aktive stof i kroppen).
English: The full EPAR for Repaglinide Teva can be found here.
Danish: Den fuldstændige EPAR for Repaglinid Teva findes her.
English: The Committee recommended that Repaglinide Teva be given marketing authorisation.
Danish: Udvalget anbefalede udstedelse af markedsføringstilladelse for Repaglinid Teva.
English: Repaglinide Teva is a ‘generic medicine'.
Danish: Repaglinid Teva er et ‘generisk lægemiddel'.
English: It is used together with diet and exercise to lower blood glucose (sugar) levels in patients whose hyperglycaemia (high blood glucose levels) cannot be controlled by diet, weight reduction and exercise.
Danish: Det anvendes sammen med diæt og motion til at sænke blodglukoseniveauet (sukker) hos patienter, hvis hyperglykæmi (højt blodglukoseniveau) ikke kan kontrolleres med diæt, vægttab og motion.
English: Therefore, the CHMP's view was that, as for NovoNorm, the benefit outweighs the identified risk.
Danish: CHMP var derfor af den opfattelse, at fordelene opvejer de identificerede risici som for NovoNorm.
English: What are the benefit and risk of Repaglinide Teva?
Danish: Hvilken fordel og risiko er der forbundet med Repaglinid Teva?
English: Type 2 diabetes is a disease in which the pancreas does not make enough insulin to control the level of glucose in the blood or when the body is unable to use insulin effectively.
Danish: Type 2-diabetes er en sygdom, hvor bugspytkirtlen enten ikke danner tilstrækkeligt insulin til at regulere glukoseniveauet i blodet, eller når kroppen ikke er i stand til at udnytte insulinet effektivt.
English: Repaglinide Teva is used in patients who have type 2 diabetes (non-insulin-dependent diabetes).
Danish: Repaglinid Teva anvendes til patienter, som lider af type 2-diabetes (ikke-insulinkrævende diabetes).
English: Because Repaglinide Teva is a generic medicine and is bioequivalent to the reference medicine, its benefit and risk are taken as being the same as those of the reference medicine.
Danish: Da Repaglinid Teva er et generisk lægemiddel, som er bioækvivalent med referencelægemidlet, anses benefit/risk-forholdet for at være det samme som for referencelægemidlet.
English: Repaglinide Teva helps the pancreas to produce more insulin at mealtimes and is used to control type 2 diabetes.
Danish: Repaglinid Teva får bugspytkirtlen til at producere mere insulin i forbindelse med måltider og anvendes til at holde type 2- diabetes under kontrol.
English: Why has Repaglinide Teva been approved?
Danish: Hvorfor blev Repaglinid Teva godkendt?