FrancophonIA/ELRC3.0 huggingface dataset:
English: Common: may affect up to 1 in 10 people
Danish: Almindelige: Kan forekomme hos op til 1 ud af 10 patienter
English: The safety profile of voriconazole in young and elderly patients was similar and, therefore, no dosage adjustment is necessary for the elderly (see section 4.2).
Danish: I de kliniske studier blev der ikke foretaget dosisjusteringer på baggrund af alder. Der blev observeret en sammenhæng mellem plasmakoncentrationer og alder. Voriconazols sikkerhedsprofil var ens hos både unge og ældre patienter, hvorfor en dosisjustering hos de ældre ikke er nødvendig (se pkt.
English: Do not use this medicine after the expiry date which is stated on the label.
Danish: Brug ikke Voriconazole Accord efter den udløbsdato, der står på pakningen.
English: Oral bioavailability may be limited in paediatric patients aged 2-<12 years with malabsorption and very low body weight for age.
Danish: Hos pædiatriske patienter i alderen 2 til <12 år, med malabsorption og meget lav legemsvægt, for deres alder, kan oral biotilgængelighed være begrænset.
English: 2 In clinical studies, response to voriconazole in patients with C glabrata infections was 21% lower compared to C. albicans, C. parapsilosis and C. tropicalis.
Danish: 2 I kliniske forsøg var responset på voriconazol 21% lavere hos patienter med infektion med C.
English: Efavirenz 400 mg QD, coadministered with voriconazole 200 mg BID*
Danish: Efavirenz 400 mg QD, administreret sammen med voriconazol 200 mg BID*
English: 400 mg every 12 hours 200 mg every 12 hours
Danish: 6 mg/kg hver 12. time 400 mg hver 12. time
English: Musculoskele tal and connective tissue disorders back pain arthritis periostitis*
Danish: Knogler, led, muskler og bindevæv rygsmerter artritis periostitis*
English: Eye disorders visual impairment6 retinal haemorrhage optic nerve disorder7, papilloedema8, oculogyric crisis, diplopia, scleritis, blepharitis optic atrophy, corneal opacity
Danish: retinablødning sygdom i synsnerven7, papilødem8, okulogyrisk krise, diplopi, skleritis, blefaritis optisk atrofi, corneauklarhed
English: Endocrine disorders adrenal insufficiency, hypothyroidism hyperthyroidis m
Danish: Det endokrine system binyrebarkinsufficiens, hypotyreose hypertyreose
English: 300 mg TID (coadministered with voriconazole 400 mg single dose)
Danish: 300 mg TID (samtidig administration med voriconazol 400 mg enkeltdosis)
English: [potent CYP450 inducer; CYP3A4 inhibitor and substrate]
Danish: [potent CYP450 induktor; CYP3A4-hæmmer og substrat]
English: Uncommon: may affect up to 1 in 100 people
Danish: Ikke almindelige: Kan forekomme hos op til 1 ud af 100 patienter
English: 2 to <12.
Danish: 4.2 og 4.4.
English: Voriconazole administration induced no impairment of male or female fertility in rats at exposures similar to those obtained in humans at therapeutic doses.
Danish: Dyrestudier viste ikke nedsat fertilitet i dyreforsøg hos han- og hunrotter efter eksponeringer svarende til dem, der opnås hos mennesker efter indgift af voriconazol i terapeutiske doser.
English: Stevens-Johnson syndrome, phototoxicity, purpura, urticaria, dermatitis allergic, rash papular, rash macular, eczema toxic epidermal necrolysis, angioedema, actinic keratosis*, pseudoporphyri a erythema multiforme, psoriasis, drug eruption, drug reaction with eosinophilia and systemic symptoms (DRESS)
Danish: hududslæt, pruritus, erytem purpura, urticaria, allergisk dermatitis, papuløst hududslæt, makuløst hududslæt, eksem angioødem, aktinisk keratose*, pseudoporfyri, erythema multiforme, psoriasis, medicinudslæt, lægemiddelreakt ion med eosinofili og systemiske symptomer (DRESS)
English: • If you have any further questions, ask your doctor, pharmacist or nurse.
Danish: Er De i tvivl så spørg lægen eller apoteket.
English: [UDP-glucuronyl transferase substrate]
Danish: glucuronyltransferasesubstrat]
English: Mycophenolic acid (1 g single dose)
Danish: Mycophenolsyre (1 g enkeltdosis) [UDP
English: • inflammation)
Danish: • Feber
English: Although not studied, voriconazole may increase the plasma concentrations of coumarins that may cause an increase in prothrombin time
Danish: Selvom det ikke er undersøgt, er der mulighed for at voriconazol kan øge plasmakoncentrationerne af coumariner, der kan medføre forlænget protrombintid.
English: The species most frequently involved in causing human infections include C. albicans, C. parapsilosis, C.tropicalis, C. glabrata andC.
Danish: De arter, der oftest forårsager infektioner hos mennesker, omfatter C. albicans, C. parapsilosis, C. tropicalis, C. glabrata og C. krusei, der alle typisk har mindste hæmmende koncentration (MIC) på mindre end 1 mg/l for voriconazol.
English: Ibuprofen (400 mg single dose)
Danish: Ibuprofen (400 mg enkeltdosis) Diclofenac (50 mg enkeltdosis)
English: Efavirenz 300 mg QD, coadministered with voriconazole 400 mg BID*
Danish: Efavirenz 300 mg QD, administreret sammen med voriconazol 400 mg BID*
English: Voriconazole Cmax  49% Voriconazole AUCτ  69%
Danish: Voriconazol Cmax ↓ 49% Voriconazol AUCτ ↓ 69%
English: Cardiovascular
Danish: hyponatriæmi
English: Although not studied, voriconazole is likely to increase the plasma concentrations of sulfonylureas and cause hypoglycaemia.
Danish: Selvom det ikke er undersøgt er det sandsynligt, at voriconazol kan forøge plasmakoncentrationerne af sulfonylurinstof og forårsage hypoglykæmi.
English: For patients with IA the overall rates of global response at 6 weeks were 64.3% (9/14), the global response rate was 40% (2/5)
Danish: For patienter med IA var de samlede procentsatser for global respons efter 6 uger 64,3 % (9/14), procentsatsten for det globale respons var 40 % (2/5) for patienter på 2 til < 12 år og 77,8 % (7/9) for patienter på 12 til < 18 år.
English: Instances of hepatic reactions were noted to occur primarily in patients with serious underlying medical conditions (predominantly haematological malignancy).Transient hepatic reactions, including hepatitis and jaundice, have occurred among patients with no other identifiable risk factors.
Danish: Forbigående hepatiske reaktioner, herunder hepatitis og gulsot, er set blandt patienter uden andre erkendte risikofaktorer.
English: 100 mg twice a day
Danish: 100 mg 2 gange dagligt
English: Voriconazole Accord 200 mg film-coated tablets are supplied as white to off white, oval, approximately 15.6 mm in length and 7.8 mm in width, film-coated tablets, debossed with ‘V200' on one side and plain on the other side.
Danish: Voriconazole Accord 200 mg filmovertrukne tabletter er hvide til offwhite, ovale, filmovertrukne tabletter, ca. 15,6 mm lange og 7.8 mm brede, præget med ”V200” på den ene side og jævne på den anden side.
English: Ritonavir Cmax  25% Ritonavir AUCτ  13% Voriconazole Cmax  24% Voriconazole AUCτ  39%
Danish: Ritonavir Cmax ↓ 25% Ritonavir AUCτ ↓13% Voriconazol Cmax ↓ 24% Voriconazol AUCτ ↓ 39%
English: squamous cell carcinoma
Danish: planocellulært karcinom*
English: Voriconazole Cmax and AUCτ
Danish: Voriconazol Cmax og AUCτ ↔ Ingen dosisjustering
English: High dose (400 mg BID) Low dose (100 mg BID)*
Danish: Lav-dosis (100 mg BID)*
English: [CYP2C19 inhibitor; CYP2C19 and CYP3A4 substrate]
Danish: [CYP2C19 hæmmer; CYP2C19 og CYP3A4 substrat]
English: [CYP2C9, CYP2C19 and CYP3A4 inhibitor]
Danish: [CYP2C9, CYP2C19 og CYP3A4 hæmmer]
English: 300 mg QD (coadministered with voriconazole 350 mg BID)*
Danish: 300 mg QD (administeret samtidig med voriconazol 350 mg BID)*
English: Concomitant use of voriconazole and rifabutin should be avoided unless the benefit outweighs the risk.
Danish: voriconazol og rifabutin skal undgås, medmindre fordelen ved behandling udvejer risikoen.
English: Voriconazole Cmax  69% Voriconazole AUCτ  78%
Danish: Voriconazol Cmax ↓ 69% Voriconazol AUCτ ↓ 78%
English: [CYP3A4 substrates]
Danish: [CYP3A4 substrater]
English: Breakthrough IFI - Day Success at Day 180* * Primary endpoint of study ** Using a margin of 5%, non inferiority is demonstrated ***Difference in proportions, 95% CI obtained after adjustment for randomization Myeloablative conditioning regimens Study endpoints
Danish: * Studiets primære effektmål ** Der påvises non-inferioritet med en margin på 5% ***Forskel i andele, 95% konfidensinterval efter justering for randomisering
English: Skin and subcutaneous tissue disorders rash dermatitis exfoliative, alopecia, rash maculo-papular, pruritus, erythema
Danish: Hud og subkutane væv udslæt eksfoliativ dermatitis, alopeci, makulopapuløst
English: Pregnancy
Danish: • Udslæt
English: What Voriconazole Accord is and what it is used for What you need to know before you take Voriconazole Accord How to take Voriconazole Accord Possible side effects
Danish: Det skal De vide, før De begynder at tage Voriconazole Accord Sådan skal De tage Voriconazole Accord Bivirkninger
English: NAME OF THE MEDICINAL PRODUCT Voriconazole Accord 50 mg film-coated tablets Voriconazole Accord 200 mg film-coated tablets
Danish: LÆGEMIDLETS NAVN Voriconazole Accord 50 mg filmovertrukne tabletter Voriconazole Accord 200 mg filmovertrukne tabletter
English: hepatic failure, hepatomegaly, cholecystitis, cholelithiasis
Danish: Lever og galdeveje abnorme leverfunktionsværdier icterus, hepatitis10 leversvigt, hepatomegali, kolecystitis, cholelithiasis
English: Voriconazole AUC0-∞  59% Contraindicated (see section 4.3)
Danish: Voriconazol AUC0-∞ ↓ 59%
English: Vinca Alkaloids (e.g., vincristine and vinblastine)
Danish: Vinkaalkaloider (f.eks. vincristin og vinblastin)
English: Monitoring for voriconazoleassociated adverse reactions is recommended if voriconazole is used sequentially after fluconazole.
Danish: Hvis voriconazol anvendes sekventielt efter fluconazol anbefales det, at der monitoreres for voriconazol-relaterede bivirkninger.
English: Blood and lymphatic system disorders agranulocytosis1, pancytopenia, thrombocytopenia2
Danish: Blod og lymfesystem agranulocytose1, pancytopeni, trombocytopeni2, leukopeni, anæmi knoglemarvssvigt, lymfadenopati, eosinofili dissemineret intravaskulær koagulation
English: In an independent published study, Alfentanil AUC0-∞  6fold.
Danish: Alfentanil AUC0-∞ ↑ 6 gange
English: Voriconazole Accord 50 mg film-coated tablets Voriconazole Accord 200 mg film-coated tablets voriconazole
Danish: Voriconazole Accord 50 mg filmovertrukne tabletter Voriconazole Accord 200 mg filmovertrukne tabletter voriconazol
English: Other significant side effects whose frequency is not known, but should be reported to your doctor immediately: Skin cancer Inflammation of the tissue surrounding the bone - Red, scaly patches or ring-shaped skin lesions that may be a symptom of an autoimmune disease called cutaneous lupus erythematosus
Danish: • Betændelse i vævet omkring knoglen Røde, skællede pletter eller ringformede hudlæsioner, der kan være symptomer på den autoimmune sygdom, som kaldes kutan lupus erythematosus.
English: - Inflammation of the sinuses, inflammation of the gums, chills, weakness - Low numbers of some types, including severe, of red (sometimes immune-related) and/or white blood cells (sometimes with fever), low numbers of cells called platelets that help the blood to clot - Low blood sugar, low blood potassium, low sodium in the blood - Anxiety, depression, confusion, agitation, inability to sleep, hallucinations - Seizures, tremors or uncontrolled muscle movements, tingling or abnormal skin sensations,
Danish: • Lavt antal, herunder alvorligt, af visse typer røde (sommetider immunrelateret) og/eller hvide blodlegemer (sommetider med feber), lavt antal celler, som kaldes blodplader (trombocytter),
English: Compared to voriconazole 200 mg BID,
Danish: Sammenlignet med efavirenz 600 mg QD,
English: What Voriconazole Accord looks like and contents of the pack Voriconazole Accord 50 mg film-coated tablets are supplied as white to off white, round, approximate 7.0mm in diameter, film-coated tablets, debossed with ‘V50' on one side and plain on the other side.
Danish: Voriconazole Accord 50 mg filmovertrukne tabletter er hvide til offwhite, runde, filmovertrukne tabletter, ca. 7,0 mm i diameter, præget med ”V50” på den ene side og jævne på den anden side.
English: Voriconazole Accord 50 mg film-coated tablets voriconazole
Danish: Voriconazole Accord 50 mg filmovertrukne tabletter voriconazol
English: 300 mg QD (co-administered with voriconazole 400 mg BID)*
Danish: 300 mg QD (administeret samtidig med voriconazol 400 mg BID)*
English: Voriconazole Accord 200 mg film-coated tablets voriconazole
Danish: Voriconazole Accord 200 mg filmovertrukne tabletter voriconazol
English: How to store Voriconazole Accord
Danish: Sådan skal De tage Voriconazole Accord
English: Serious side effects - Stop taking Voriconazole Accord and see a doctor immediately - Rash - Jaundice; Changes in blood tests of liver function - Pancreatitis
Danish: Alvorlige bivirkninger - stop med at tage Voriconazole Accord og søg læge øjeblikkeligt
English: Compared to efavirenz 600 mg QD, Efavirenz Cmax ↔ Efavirenz AUCτ  17%
Danish: Efavirenz Cmax ↔ Efavirenz AUCτ ↑ 17%
English: Voriconazole Accord is an antifungal medicine.
Danish: Voriconazole Accord indeholder det aktive stof voriconazol og er et middel mod svampeinfektioner.
English: Coadministration of oral voriconazole and oral fluconazole resulted in a significant increase in Cmax and AUCτ of voriconazole in healthy subjects.
Danish: Fluconazol (CYP2C9-, CYP2C19- og CYP3A4-hæmmer) Samtidig administration af oral voriconazol og oral fluconazol hos frivillige, raske forsøgspersoner resulterede i en signifikant stigning i Cmax og AUCτ for voriconazol.
English: It is very important that you inform your doctor or pharmacist if you are taking or have taken any other medicines, even those that are obtained without a prescription, or herbal medicines.
Danish: Tal med lægen, apoteket eller sundhedspersonalet, hvis De får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel.
English: N=241
Danish: Itraconazol n=241
English: tingling or burning in the hands or feet - Problems with balance or coordination - Swelling of the brain - Double vision, serious conditions of the eye including: pain and inflammation of the eyes and eyelids, abnormal eye movement, damage to the optic nerve resulting in vision impairment,
Danish: • Dobbeltsyn, alvorlige øjentilstande, herunder smerter og betændelsestilstand i øjne og øjenlåg,
English: You may experience abnormal intolerance to light as a result of taking more Voriconazole Accord than you should.
Danish: Hvis De har taget for mange Voriconazole Accord kan De opleve abnorm intolerans over for lys.
English: Itraconazo le
Danish: • Kløe
English: N=224
Danish: Voriconazol n=224
English: Voriconazole Cmax  93% Voriconazole AUCτ  96%
Danish: Voriconazol Cmax ↓ 93% Voriconazol AUCτ ↓ 96% Kontraindiceret (se pkt.
English: 300 mg QD (coadministered with voriconazole 400 mg BID)*
Danish: 300 mg QD (samtidig administration af voriconazol 400 mg BID)*
English: However, if the combination is strictly needed, the maintenance dose of voriconazole may be increased from 200 mg to 350 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Danish: Hvis kombinationen er strengt nødvendig, kan vedligeholdelsesdosis for voriconazol øges fra 200 mg til 350 mg oralt 2 gange dagligt.
English: When voriconazole is coadministered with efavirenz the dose of voriconazole should be increased to 400 mg every 12 hours and the dose of efavirenz should be decreased to 300 mg every 24 hours (see sections 4.2, 4.3 and 4.5).
Danish: Efavirenz (potent CYP450-induktor; CYP3A4-hæmmer og -substrat) Når voriconazol anvendes samtidigt med efavirenz, bør dosis af voriconazol øges til 400 mg hver 12. time, og efavirenz-dosis bør nedsættes til 300 mg hvert 24. time (se pkt.
English: If you stop taking Voriconazole Accord
Danish: Tag ikke Voriconazole Accord
English: • The other ingredients are lactose monohydrate, pregelatinised starch, croscarmellose sodium, povidone and magnesium stearate which make up the tablet core and hypromellose, titanium dioxide (E171), lactose monohydrate and triacetin which make up the film-coat.
Danish: Filmovertræk: Hypromellose, titandioxid (E171), lactosemonohydrat og triacetin.
English: Voriconazole Cmax  104% Voriconazole AUCτ  87%
Danish: Sammenlignet med voriconazol 200 mg BID, Voriconazol Cmax ↑ 104% Voriconazol AUCτ ↑ 87%
English: [CYP450 inducer; CYP3A4 inhibitor and substrate]
Danish: [CYP-induktor; CYP3A4hæmmer og -substrat]
English: PValue
Danish: p-værdi
English: MARKETING AUTHORISATION HOLDER
Danish: NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Accord
English: The recommended dose for adults (including elderly patients) is as follows: Tablets Patients 40 kg and above Patients less than 40 kg
Danish: Den anbefalede dosis til voksne (også ældre patienter) er:
English: Reminds patients of the risk of phototoxicity and skin SCC.
Danish: • Patientadvarselskort om fototoksicitet og planocellulært karcinom: - Påminde patienter om risikoen for fototoksicitet og planocellulært hudkarcinom.
English: - Acute breathing difficulty, chest pain, swelling of the face (mouth, lips and around eyes), fluid accumulation in the lungs - Constipation, indigestion, inflammation of the lips - Jaundice, inflammation of the liver and liver injury - Skin rashes which may lead to severe blistering and peeling of the skin characterized by a flat,
Danish: • Akut vejrtrækningsbesvær, brystsmerter, hævelser i ansigtet (mund, læber og omkring øjnene),
English: [CYP3A4 inhibitor and substrate]
Danish: [CYP3A4 substrater og hæmmere]
English: Voriconazole Cmax  4% Voriconazole AUCτ  32%
Danish: Sammenlignet med voriconazol 200 mg BID, Voriconazol Cmax ↓ 4% Voriconazol AUCτ ↓ 32%
English: Phenytoin may be coadministered with voriconazole if the maintenance dose of voriconazole is increased from 200 mg to 400 mg orally, twice daily (100 mg to 200 mg orally, twice daily in patients less than 40 kg), see sections 4.4 and 4.5.
Danish: Phenytoin kan gives samtidigt med voriconazol, hvis vedligeholdelsesdosis for voriconazol øges fra 200 mg til 400 mg oralt 2 gange dagligt.
English: White to off white, oval, approximately 15.6 mm in length and 7.8 mm in width, film-coated tablets, debossed with ‘V200' on one side and plain on the other side.
Danish: Voriconazole Accord 200 mg filmovertrukne tabletter Hvide til offwhite, ovale, filmovertrukne tabletter, ca. 15,6 mm lange og 7,8 mm brede, præget med ‘V200' på den ene side og jævne på den anden side.
English: Hepatic toxicity
Danish: Levertoksicitet
English: Careful monitoring of phenytoin levels is recommended when phenytoin is coadministered with voriconazole.
Danish: Phenytoin (CYP2C9-substrat og potent CYP450-induktor) Omhyggelig monitorering af phenytoinniveauer anbefales ved samtidig administration af voriconazol.
English: White to off white, round, approximate 7.0 mm in diameter, film-coated tablets, debossed with ‘V50' on one side and plain on the other side.
Danish: Voriconazole Accord 50 mg filmovertrukne tabletter Hvide til offwhite, runde, filmovertrukne tabletter, ca. 7,0 mm i diameter, præget med ‘V50' på den ene side og jævne på den anden side.
English: increase in muscle tone, sleepiness, dizziness - Bleeding in the eye - Heart rhythm problems including very fast heartbeat, very slow heartbeat, fainting, low blood pressure, inflammation of a vein (which may be associated with the formation of a blood clot)
Danish: • Lavt blodtryk, betændelsestilstand i en vene (som kan forbindes med dannelse af blodpropper)
English: Phenytoin may be co-administered with voriconazole if the maintenance dose of voriconazole is increased to 5 mg/kg IV BID or from 200 mg to 400 mg oral BID, (100 mg to 200 mg oral BID in patients less than 40 kg) (see section 4.2).
Danish: BID eller fra 200 mg til 400 mg per-oralt BID, (100 mg til 200 mg per-oralt BID hos patienter, der vejer mindre end 40 kg) (se pkt.
English: Therefore unless your doctor instructs you to stop treatment, it is important to keep taking Voriconazole Accord correctly, as described above.
Danish: Derfor er det vigtigt, at De fortsætter med at tage Voriconazole Accord som beskrevet ovenfor, medmindre Deres læge beder Dem stoppe behandlingen.
English: Coadministration with St John's Wort (see section 4.5).
Danish: Samtidig administration af perikon (se pkt.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/06/352/001-003
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/352/001-003
English: Use Intrinsa only as long as you experience a positive effect of the treatment.
Danish: Anvend kun Intrinsa, så længe De oplever en positiv virkning af behandlingen.
English: There is no information on the safety of Intrinsa beyond 12 months.
Danish: Der foreligger ingen oplysninger om Intrinsas sikkerhed ud over 12 måneder.
English: Intrinsa is used to treat HSDD.
Danish: Intrinsa anvendes til behandling af HSDD.
English: Children and adolescents Intrinsa is not for use in children and adolescents.
Danish: Børn og unge Intrinsa er ikke beregnet til anvendelse hos børn og unge.
English: Paediatric population There is no relevant use of Intrinsa in the paediatric population.
Danish: Pædiatrisk population Der ingen relevant brug af Intrinsa i den pædiatriske population.
English: Like all medicines, Intrinsa can cause side effects, although not everybody gets them.
Danish: Intrinsa kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Intrinsa remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Danish: Baseret på data, der er blevet tilgængelige siden den første markedsføringstilladelse, anser CHMP risk/benefit-forholdet af Intrinsa for stadig at være positivt men mener, at sikkerhedsprofilen skal overvåges nøje af de følgende årsager:
English: Pregnancy Intrinsa must not be used in women who are or may become pregnant.
Danish: Graviditet Intrinsa må ikke anvendes til kvinder, som er eller kan blive gravide.
English: As the efficacy and safety of Intrinsa have not been evaluated in studies of longer duration than 1 year, it is recommended that an appraisal of the treatment is undertaken every 6 months.
Danish: Da virkningen og sikkerheden af Intrinsa ikke er blevet vurderet i forsøg af længere varighed end 1 år, anbefales det at foretage en vurdering af behandlingen hver 6. måned.
English: The mode of administration of Intrinsa makes overdose unlikely.
Danish: Måden, Intrinsa administreres på, gør overdosering usandsynlig.
English: The significance of these data for the use of Intrinsa in patients is not known.
Danish: Signifikansen af disse data for anvendelse af Intrinsa hos mennesker kendes ikke.
English: If you have not experienced a positive effect of Intrinsa within 3-6 months, you should inform your doctor, who will suggest that treatment be discontinued.
Danish: Hvis De ikke har mærket nogen positiv virkning af Intrinsa i løbet af 3-6 måneder, bør De fortælle deres læge det, og han/hun vil foreslå, at behandlingen afbrydes.
English: What Intrinsa contains
Danish: Intrinsa indeholder
English: Therefore, based on the safety profile in Intrinsa, which requires the submission of 6 monthly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Danish: Derfor, med basis i Intrinsas sikkerhedsprofil, som kræver indsendelse af PSURs hver 6. måned konkluderede CHMP, at indehaveren af markedsføringen skal indsende en yderligere ansøgning om fornyelse om 5 år.
English: The appropriate use and restrictions associated with estrogen therapy should be considered before Intrinsa therapy is initiated and during routine re-evaluation of treatment.
Danish: Relevant brug af og restriktioner forbundet med østrogenbehandling bør overvejes, før behandlingen med Intrinsa indledes og ved rutinemæssig revurdering af behandlingen.
English: Do not use Intrinsa if you are, or suspect that you may be pregnant or are able to become pregnant, because it may cause harm to the unborn child.
Danish: Anvend ikke Intrinsa, hvis De er eller har mistanke om at De er gravid eller er i stand til at blive gravid, da det kan skade det ufødte barn.