FrancophonIA/ELRC3.0 huggingface dataset:
English: Croscarmellose sodium Magnesium stearate Red iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc
Danish: Croscarmellosenatrium Magnesiumstearat Jernoxid, rød (E 172) Hypromellose Titandioxid (E 171) Talcum
English: Take Starlix before meals (see section 3, “How to take Starlix”); its effect may be delayed if it is taken during or after meals.
Danish: Brug af Starlix sammen med mad, drikke og alkohol Tag Starlix inden et måltid (se afsnit 3, “Sådan skal du tage Starlix”).
English: Each film-coated tablet contains 180 mg nateglinide.
Danish: Hver filmovertrukket tablet indeholder 180 mg nateglinid.
English: EU/1/01/174/001 12 film-coated tablets EU/1/01/174/002 24 film-coated tablets EU/1/01/174/003 30 film-coated tablets EU/1/01/174/004 60 film-coated tablets EU/1/01/174/005 84 film-coated tablets EU/1/01/174/006 120 film-coated tablets EU/1/01/174/007 360 film-coated tablets
Danish: EU/1/01/174/001 12 filmovertrukne tabletter EU/1/01/174/002 24 filmovertrukne tabletter EU/1/01/174/003 30 filmovertrukne tabletter EU/1/01/174/004 60 filmovertrukne tabletter EU/1/01/174/005 84 filmovertrukne tabletter EU/1/01/174/006 120 filmovertrukne tabletter EU/1/01/174/007 360 filmovertrukne tabletter
English: Croscarmellose sodium Magnesium stearate Yellow iron oxide (E172) Hypromellose Titanium dioxide (E171) Talc
Danish: Croscarmellosenatrium Magnesiumstearat Jernoxid, gul (E 172) Hypromellose Titandioxid (E 171) Talcum
English: EU/1/01/174/008 12 film-coated tablets EU/1/01/174/009 24 film-coated tablets EU/1/01/174/010 30 film-coated tablets EU/1/01/174/011 60 film-coated tablets EU/1/01/174/012 84 film-coated tablets EU/1/01/174/013 120 film-coated tablets EU/1/01/174/014 360 film-coated tablets
Danish: EU/1/01/174/008 12 filmovertrukne tabletter EU/1/01/174/009 24 filmovertrukne tabletter EU/1/01/174/010 30 filmovertrukne tabletter EU/1/01/174/011 60 filmovertrukne tabletter EU/1/01/174/012 84 filmovertrukne tabletter EU/1/01/174/013 120 filmovertrukne tabletter EU/1/01/174/014 360 filmovertrukne tabletter
English: EU/1/01/174/015 12 film-coated tablets EU/1/01/174/016 24 film-coated tablets EU/1/01/174/017 30 film-coated tablets EU/1/01/174/018 60 film-coated tablets EU/1/01/174/019 84 film-coated tablets EU/1/01/174/020 120 film-coated tablets EU/1/01/174/021 360 film-coated tablets
Danish: EU/1/01/174/015 12 filmovertrukne tabletter EU/1/01/174/016 24 filmovertrukne tabletter EU/1/01/174/017 30 filmovertrukne tabletter EU/1/01/174/018 60 filmovertrukne tabletter EU/1/01/174/019 84 filmovertrukne tabletter EU/1/01/174/020 120 filmovertrukne tabletter EU/1/01/174/021 360 filmovertrukne tabletter
English: Patients with rare hereditary problems of galactose intolerance, of the Lapp lactase deficiency or of glucose-galactose malabsorption should not take this medicine.
Danish: Starlix indeholder lactosemonohydrat, og bør ikke anvendes til patienter med arvelig galactoseintolerans, en særlig form af arvelig lactasemangel (Lapp Lactase deficiency) eller glucose/galactosemalabsorption.
English: Each film-coated tablet contains 120 mg nateglinide.
Danish: Hver filmovertrukket tablet indeholder 120 mg nateglinid.
English: If you feel as if you are about to have a severe hypoglycaemic attack (which may lead to loss of consciousness or seizure), call for urgent medical help - or make sure that someone else does this for you.
Danish: Søg omgående læge eller få nogen til at tilkalde lægehjælp for dig hvis du kan mærke, at en kraftig hypoglykæmisk episode er på vej (som kan medføre bevidsthedstab eller kramper).
English: Nateglinide is excreted in the milk following a peroral dose to lactating rats.
Danish: Efter oral dosering til diegivende rotter udskiltes nateglinid i mælken.
English: - Inhibitors of drug metabolism such as fluconazole (used to treat fungal infection), gemfibrozil
Danish: - Medicinnedbrydningshæmmere, såsom fluconazol (anvendes til behandling af svampeinfektioner), gemfibrozil (anvendes til behandling af forstyrrelser i blodets fedt- og kolesterolindhold) og sulfipyrazon (anvendes til behandling af kronisk gigt).
English: Patients with severe renal impairment (see section 5.2) who have not undergone haemodialysis are more susceptible to the glucose-lowering effect of Starlix.
Danish: Starlix har en glukose-sænkende effekt, og patienter med svært nedsat nyrefynktion (se pkt 5.2), som ikke har været i hæmodialyse, er mere følsomme overfor denne effekt.
English: The systemic availability and half-life of nateglinide in non-diabetic subjects with mild to moderate hepatic impairment did not differ to a clinically significant degree from those in healthy subjects.
Danish: Der var ingen klinisk signifikant forskel mellem nateglinids systemiske tilgængelighed og halveringstid hos ikke-diabetikere med let til moderat nedsat leverfunktion og hos raske personer.
English: Starlix 60 mg film-coated tablets Starlix 120 mg film-coated tablets Starlix 180 mg film-coated tablets nateglinide
Danish: Starlix 60 mg filmovertrukne tabletter Starlix 120 mg filmovertrukne tabletter Starlix 180 mg filmovertrukne tabletter nateglinid
English: STARLIX 60 mg film-coated tablets STARLIX 120 mg film-coated tablets STARLIX 180 mg film-coated tablets
Danish: STARLIX 60 mg filmovertrukne tabletter STARLIX 120 mg filmovertrukne tabletter STARLIX 180 mg filmovertrukne tabletter
English: 60 mg pink, round, bevelled-edge tablets with “STARLIX” marked on one side and “60” on the other.
Danish: 60 mg lyserøde, runde tabletter med skrå kant præget med ”STARLIX” på den ene side og med ”60” på den anden side.
English: Starlix 120 mg film-coated tablets are yellow, ovaloid tablets with “STARLIX” marked on one side and “120” on the other.
Danish: Starlix 120 mg filovertrukne tabletter er gule, ovale tabletter med ”STARLIX” indprintet på én side og ”120” på den anden.
English: If you have to go to a doctor or hospital, take the pack and this leaflet with you.
Danish: Tag pakken og denne indlægssedel med, hvis du er nødt til at tage til lægen eller på hospitalet.
English: How to take Starlix
Danish: Sådan skal du tage Starlix
English: If any of these apply to you, do not take Starlix and talk to your doctor.
Danish: Hvis du oplever noget af ovenstående, må du ikke tage Starlix.
English: 180 mg red, ovaloid tablets with “STARLIX” marked on one side and “180” on the other.
Danish: 180 mg røde, ovale tabletter præget med ”STARLIX” på den ene side og med ”180” på den anden side.
English: Nateglinide did not impair fertility in male or female rats (see section 5.3).
Danish: Hos han- eller hunrotter svækkede nateglinid ikke fertiliteten (se pkt.
English: Starlix 60 mg tablets nateglinide
Danish: Starlix 60 mg tabletter nateglinid
English: Starlix 180 mg film-coated tablets are red, ovaloid tablets with “STARLIX” marked on one side and “180” on the other.
Danish: Starlix 180 mg filovertrukne tabletter er røde, ovale tabletter med ”STARLIX” indprintet på én side og ”180” på den anden.
English: 120 mg yellow, ovaloid tablets with “STARLIX” marked on one side and “120” on the other.
Danish: 120 mg gule, ovale tabletter præget med ”STARLIX” på den ene side og med ”120” på den anden side.
English: Starlix 120 mg tablets nateglinide
Danish: Starlix 120 mg tabletter nateglinid
English: Starlix 180 mg tablets nateglinide
Danish: Starlix 180 mg tabletter nateglinid
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Starlix Fortæl altid lægen eller apotekspersonalet, hvis du tager anden medicin eller har gjort det for nylig.
English: What Starlix is and what it is used for What you need to know before you take Starlix How to take Starlix
Danish: Det skal du vide, før du begynder at tage Starlix Sådan skal du tage Starlix Bivirkninger
English: STARLIX 60 mg film-coated tablets
Danish: STARLIX 60 mg filmovertrukne tabletter
English: STARLIX 180 mg film-coated tablets
Danish: STARLIX 180 mg filmovertrukne tabletter
English: STARLIX 120 mg film-coated tablets
Danish: STARLIX 120 mg filmovertrukne tabletter
English: Starlix 60 mg film-coated tablets nateglinide
Danish: Starlix 60 mg filmovertrukne tabletter nateglinid
English: Starlix 120 mg film-coated tablets nateglinide
Danish: Starlix 120 mg filmovertrukne tabletter nateglinid
English: Starlix 180 mg film-coated tablets nateglinide
Danish: Starlix 180 mg filmovertrukne tabletter nateglinid
English: The amount of Starlix that you need may change if you take other medicines as these may cause your blood sugar levels to go up or down.
Danish: Ved indtagelse af andre lægemidler kan dit behov for Starlix ændres.
English: - Beta blockers or ACE inhibitors (angiotensin-converting enzyme inhibitors) (used, for example,
Danish: - Betablokkere eller ACE-hæmmere (angiotensin konverterings-enzymhæmmere) (anvendes f.eks. til behandling af for højt blodtryk og visse hjertesygdomme).
English: What Starlix looks like and contents of the pack Starlix 60 mg film-coated tablets are pink, round tablets with “STARLIX” marked on one side and “60” on the other.
Danish: Starlix 60 mg filovertrukne tabletter er lyserøde, runde tabletter med ”STARLIX” indprintet på én side og ”60” på den anden.
English: Do not take it if you are not going to eat a main meal.
Danish: Hvis du ikke spiser et af hovedmåltiderne, skal du ikke tage Starlix.
English: It is used to treat the following groups:
Danish: Det anvendes til behandling af følgende grupper:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Ovaleap on 27 September 2013.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union den 27. september 2013.
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 dennes partner selv foretage injektionerne, hvis de er motiverede for det, har modtaget instruktion og har adgang til ekspertrådgivning.
English: This is a summary of the European public assessment report (EPAR) for Ovaleap.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Ovaleap.
English: The full EPAR for Ovaleap can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Ovaleap findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is called ‘ovarian hyperstimulation syndrome'.
Danish: Dette kaldes "ovarielt hyperstimulationssyndrom".
English: The average number of oocytes collected was 12.2 in the Ovaleap group, compared with 12.0 in the GONAL-f group.
Danish: Det gennemsnitlige antal indsamlede oocytter var 12,2 i Ovaleap-gruppen, sammenholdt med 12,0 i GONAL-f-gruppen.
English: The medicine can only be obtained with a prescription and treatment should be started under the supervision of a doctor who has experience in the treatment of fertility problems.
Danish: fås kun på recept, og behandlingen bør iværksættes under overvågning af en læge med erfaring i behandling af fertilitetsproblemer.
English: The dose of Ovaleap and how often it is given depend on why it is being used and on the patient's response to treatment.
Danish: Dosis af Ovaleap og hvor ofte det gives, afhænger af, hvorfor det anvendes, og hvordan behandlingen virker.
English: Previously, the FSH used in medicines was extracted from urine.
Danish: Tidligere blev FSH i lægemidler fremstillet ved ekstraktion af urin.
English: A risk management plan has been developed to ensure that Ovaleap is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Ovaleap anvendes så sikkert som muligt.
English: Other information about Ovaleap
Danish: Andre oplysninger om Ovaleap
English: Ovaleap is given by injection under the skin once a day.
Danish: Ovaleap gives ved injektion under huden én gang dagligt.
English: This means that Ovaleap is similar to a biological medicine (the ‘reference medicine') that is already authorised in the European Union (EU) and that Ovaleap and the reference medicine contain the same active substance.
Danish: Det betyder, at Ovaleap svarer til et biologisk lægemiddel ("referencelægemidlet"), der i forvejen er godkendt i Den Europæiske Union (EU), og at Ovaleap og referencelægemidlet indeholder samme aktive stof.
English: The main measure of effectiveness was the number of oocytes (immature eggs) collected.
Danish: Behandlingens virkning blev hovedsagelig bedømt på det indsamlede antal oocytter (umodne æg).
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 har mulighed for at virke effektivt, f.eks. til patienter, hvis æggestokke eller testikler ikke er funktionsdygtige, eller til kvinder, som af medicinske årsager bør undgå graviditet.
English: The most common side effects with Ovaleap (which may affect more than 1 in 10 people) are reactions at the injection site (pain, redness, bruising, swelling or irritation).
Danish: De hyppigste bivirkninger ved Ovaleap (som kan forekomme hos flere end 1 ud af 10 patienter) er reaktioner på injektionsstedet (smerte, rødme, blå mærker, hævelse eller irritation).
English: Ovaleap has been compared with GONAL-f in one main study involving 299 women undergoing fertility treatment.
Danish: Ovaleap er blevet sammenlignet med GONAL-f i én hovedundersøgelse med deltagelse af 299 kvinder, der var i behandling for fertilitetsproblemer.
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 regulerer FSH forplantningsfunktionen: Hos kvinder stimulerer det ægdannelsen, og hos mænd stimulerer det dannelsen af sædceller i testiklerne.
English: What is Ovaleap and what is it used for?
Danish: Hvad er Ovaleap, og hvad anvendes det til?
English: The active substance in Ovaleap, follitropin alfa, is a copy of the natural hormone FSH.
Danish: Det aktive stof i Ovaleap, follitropin alfa, er en kopi af det naturlige hormon FSH.
English: What measures are being taken to ensure the safe and effective use of Ovaleap?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Ovaleap?
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 ses desuden ovariecyster (væskeblærer i æggestokkene) og hovedpine hos mere end én ud af 10 patienter.
English: Ovaleap is given to stimulate the ovaries to produce more than one egg at a time;
Danish: Ovaleap gives for at stimulere æggestokkene til at danne flere end ét æg ad gangen.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Ovaleap, 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 Ovaleap, herunder passende forholdsregler, som patienter og sundhedspersonale bør træffe.
English: Why is Ovaleap approved?
Danish: Hvorfor er Ovaleap blevet godkendt?
English: Ovaleap is a medicine that contains the active substance follitropin alfa.
Danish: Ovaleap er et lægemiddel, der indeholder det aktive stof follitropin alfa.
English: The follitropin alfa in Ovaleap, as well as in the reference product GONAL-f, is produced by a method known as ‘recombinant DNA technology': it is made by cells into which a gene (DNA) has been introduced that makes them able to produce human FSH.
Danish: follitropin alfa i Ovaleap fremstilles ligesom for referenceproduktet GONAL-f ved "rekombinant DNA-teknologi": Det produceres ved dyrkning af celler, der har fået indsat et gen (DNA), som gør dem i stand til at producere humant FSH.
English: What are the risks associated with Ovaleap?
Danish: Hvilke risici er der forbundet med Ovaleap?
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 svulster i hypofysen eller hypothalamus eller kræft i brysterne, livmoderen eller æggestokkene.
English: Ovaleap must not be used in people who are hypersensitive (allergic) to follitropin alfa, FSH, or any of the other ingredients.
Danish: Ovaleap må ikke anvendes hos personer, der er overfølsomme (allergiske) over for follitropin alfa, FSH eller andre af indholdsstofferne.
English: Ovaleap has been shown to be comparable to the reference medicine, GONAL-f.
Danish: Ovaleap blev påvist at være sammenligneligt med referencelægemidlet, GONAL-f.
English: For more information about treatment with Ovaleap, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Ovaleap, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: It is not intended to provide practical advice on how to use Ovaleap.
Danish: Det er ikke en praktisk vejledning i, hvordan Ovaleap bør anvendes.
English: In women, Ovaleap must not be used when there is enlargement or a cyst of the ovary caused by something other than polycystic ovarian disease, or when there is unexplained bleeding from the vagina.
Danish: Ovaleap må ikke gives til kvinder med forstørret æggestok eller en cyste i æggestokken af anden årsag end polycystisk ovariesyndrom eller med blødning fra skeden af ukendt årsag.
English: For the full list of all side effects reported with Ovaleap, see the package leaflet.
Danish: Den fuldstændige liste over indberettede bivirkninger ved Ovaleap fremgår af indlægssedlen.
English: For practical information about using Ovaleap, patients should read the package leaflet or contact their doctor or pharmacist.
Danish: Hvis du ønsker praktisk vejledning om anvendelsen af Ovaleap, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
English: • women who are undergoing assisted reproductive techniques (fertility treatment) such as in-vitro fertilisation.
Danish: • kvinder, der er i behandling for barnløshed (fertilitetsbehandling) f.eks. ved hjælp af reagensglasbefrugtning.
English: How is Ovaleap used?
Danish: Hvordan anvendes Ovaleap?
English: What benefits of Ovaleap have been shown in studies?
Danish: Hvilke fordele viser undersøgelserne, at der er ved Ovaleap?
English: • women who do not produce eggs and do not respond to treatment with clomiphene citrate
Danish: • kvinder, som ikke danner æg, og hos hvem behandling med clomifencitrat ikke virker (et andet lægemiddel, der stimulerer æggestokkene til at danne æg)
English: • women with severe deficiency (very low levels) of luteinising hormone (LH) and follicle stimulating hormone (FSH).
Danish: • kvinder med svær mangel på det luteiniserende hormon (LH) og follikelstimulerende hormon (FSH) Ovaleap gives sammen med et lægemiddel indeholdende LH for at stimulere ægmodningen i æggestokkene
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Ovaleap has been shown to have a comparable quality, safety and efficacy profile to GONAL-f.
Danish: Agenturets Udvalg for Lægemidler til Mennesker (CHMP) konkluderede, at Ovaleap er påvist at være af en kvalitet, sikkerhed og virkningsprofil, der svarer til GONAL-f. CHMP fandt derfor, at fordelene ved Ovaleap ligesom ved GONAL-f opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
English: Ovaleap is available as a solution for injection.
Danish: Ovaleap leveres som injektionsvæske, opløsning.
English: The reference medicine for Ovaleap is GONAL-f. For more information on biosimilar medicines, see the question-and-answer document here.
Danish: Nærmere oplysninger om biosimilære lægemidler med spørgsmål og svar kan du finde her.
English: How does Ovaleap work?
Danish: Hvordan virker Ovaleap?
English: Ovaleap is used together with human chorionic gonadotrophin (hCG) to stimulate sperm production.
Danish: • mænd med hypogonadotrop hypogonadisme (en sjælden hormonmangelsygdom) Ovaleap anvendes sammen med humant koriongonadotropin (hCG) til at stimulere produktionen af sædceller Ovaleap er et "biosimilært" lægemiddel.
English: Revaccination is recommended after 1 year.
Danish: Revaccination anbefales efter 1 år.
English: Can be used during lactation.
Danish: Kan anvendes under laktation.
English: Date of first authorisation: 22.12.2014 Date of last renewal:
Danish: Dato for første markedsføringstilladelse: 22.12.2014 Dato for seneste fornyelse af markedsføringstilladelse:
English: The active substance being a principle of biological origin intended to produce active immunity is not in the scope of Regulation (EC) 470/2009.
Danish: Aktiv substans som principielt er af biologisk oprindelse hvis formål er at producere aktiv immunitet falder ikke indenfor anvendelsesområdet af Forordning (EF) nr. 470/2009.
English: A definitive diagnosis of persistent infection can only be established upon re-testing in blood after an interval of at least 3 weeks.
Danish: En endelig diagnose af persistent infektion kan kun stilles ved fornyet blodprøve efter et interval på mindst 3 uger.
English: Specific pharmacovigilance requirements: Periodic safety update reports are required at yearly intervals.
Danish: Krav til lægemiddelovervågning: Periodiske opdaterede sikkerhedsindberetninger er påkrævet årligt.
English: Hypersensitivity reactions, including anaphylactic-type reactions, have been reported very rarely (post-marketing safety experience).
Danish: Overfølsomhedsreaktioner, inklusive anafylaktisk lignende reaktioner, er rapporteret meget sjældent (sikkerhedserfaring efter markedsføring)
English: Duration of immunity: 1 year after immunisation.
Danish: Varighed af immunitet: 1 år efter vaccination.
English: Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the bottle after the abbreviation EXP.
Danish: Brug ikke dette veterinærlægemiddel efter den udløbsdato, der står på ydre emballage og flasken efter forkortelsen EXP.
English: Interaction with other medical products and other forms of interaction:
Danish: Interaktioner med andre lægemidler og andre former for interaktion:
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu/.
Danish: Yderligere information om dette veterinærlægemiddel er tilgængelig på Det Europæiske Lægemiddelagenturs hjemmeside (http://www.ema.europa.eu/.)
English: 12 months after primary vaccination most studied animals still had antibody titres at plateau while some animals had lower titres.
Danish: 12 måneder efter den primære vaccination havde de fleste af de dyr, i studiet, stadig antistoftitre på plateau-niveau, mens nogle dyr havde lavere titre.
English: The reconstituted vaccine is transparent and colourless.
Danish: Den rekonstituerede vaccine er gennemsigtig og farveløs.
English: The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
Danish: Hjælpestofferne (inclusive adjuvanter) som er anført i punkt 6.1 af SPC'et er enten tilladte hjælpestoffer, hvor tabel 1 i bilaget til Kommissionens forordning (EU) Nr. 37/2010 indikerer at MRL-værdier ikke er påkrævet eller som ikke anses for at være omfattet af Forordning (EF) nr. 470/2009, når de anvendes i et veterinærlægemiddel.