natgillin/translations-raw huggingface dataset:
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. 
Voriconazole administration induced no impairment of male or female fertility in rats at exposures similar to those obtained in humans at therapeutic doses.
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) 
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)
Er De i tvivl så spørg lægen eller apoteket. 
• If you have any further questions, ask your doctor, pharmacist or nurse.
glucuronyltransferasesubstrat] 
[UDP-glucuronyl transferase substrate]
Mycophenolsyre (1 g enkeltdosis) [UDP 
Mycophenolic acid (1 g single dose)
• Feber 
• inflammation)
Selvom det ikke er undersøgt, er der mulighed for at voriconazol kan øge plasmakoncentrationerne af coumariner, der kan medføre forlænget protrombintid. 
Although not studied, voriconazole may increase the plasma concentrations of coumarins that may cause an increase in prothrombin time
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. 
The species most frequently involved in causing human infections include C. albicans, C. parapsilosis, C.tropicalis, C. glabrata andC.
Ibuprofen (400 mg enkeltdosis) Diclofenac (50 mg enkeltdosis) 
Ibuprofen (400 mg single dose)
Efavirenz 300 mg QD, administreret sammen med voriconazol 400 mg BID* 
Efavirenz 300 mg QD, coadministered with voriconazole 400 mg BID*
Voriconazol Cmax ↓ 49% Voriconazol AUCτ ↓ 69% 
Voriconazole Cmax  49% Voriconazole AUCτ  69%
hyponatriæmi 
Cardiovascular
Selvom det ikke er undersøgt er det sandsynligt, at voriconazol kan forøge plasmakoncentrationerne af sulfonylurinstof og forårsage hypoglykæmi. 
Although not studied, voriconazole is likely to increase the plasma concentrations of sulfonylureas and cause hypoglycaemia.
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. 
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)
Forbigående hepatiske reaktioner, herunder hepatitis og gulsot, er set blandt patienter uden andre erkendte risikofaktorer. 
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.
100 mg 2 gange dagligt 
100 mg twice a day
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. 
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.
Ritonavir Cmax ↓ 25% Ritonavir AUCτ ↓13% Voriconazol Cmax ↓ 24% Voriconazol AUCτ ↓ 39% 
Ritonavir Cmax  25% Ritonavir AUCτ  13% Voriconazole Cmax  24% Voriconazole AUCτ  39%
planocellulært karcinom* 
squamous cell carcinoma
Voriconazol Cmax og AUCτ ↔ Ingen dosisjustering 
Voriconazole Cmax and AUCτ
Lav-dosis (100 mg BID)* 
High dose (400 mg BID) Low dose (100 mg BID)*
[CYP2C19 hæmmer; CYP2C19 og CYP3A4 substrat] 
[CYP2C19 inhibitor; CYP2C19 and CYP3A4 substrate]
[CYP2C9, CYP2C19 og CYP3A4 hæmmer] 
[CYP2C9, CYP2C19 and CYP3A4 inhibitor]
300 mg QD (administeret samtidig med voriconazol 350 mg BID)* 
300 mg QD (coadministered with voriconazole 350 mg BID)*
voriconazol og rifabutin skal undgås, medmindre fordelen ved behandling udvejer risikoen. 
Concomitant use of voriconazole and rifabutin should be avoided unless the benefit outweighs the risk.
Voriconazol Cmax ↓ 69% Voriconazol AUCτ ↓ 78% 
Voriconazole Cmax  69% Voriconazole AUCτ  78%
[CYP3A4 substrater] 
[CYP3A4 substrates]
* Studiets primære effektmål ** Der påvises non-inferioritet med en margin på 5% ***Forskel i andele, 95% konfidensinterval efter justering for randomisering 
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
Hud og subkutane væv udslæt eksfoliativ dermatitis, alopeci, makulopapuløst 
Skin and subcutaneous tissue disorders rash dermatitis exfoliative, alopecia, rash maculo-papular, pruritus, erythema
• Udslæt 
Pregnancy
Det skal De vide, før De begynder at tage Voriconazole Accord Sådan skal De tage Voriconazole Accord Bivirkninger 
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
LÆGEMIDLETS NAVN Voriconazole Accord 50 mg filmovertrukne tabletter Voriconazole Accord 200 mg filmovertrukne tabletter 
NAME OF THE MEDICINAL PRODUCT Voriconazole Accord 50 mg film-coated tablets Voriconazole Accord 200 mg film-coated tablets
Lever og galdeveje abnorme leverfunktionsværdier icterus, hepatitis10 leversvigt, hepatomegali, kolecystitis, cholelithiasis 
hepatic failure, hepatomegaly, cholecystitis, cholelithiasis
Voriconazol AUC0-∞ ↓ 59% 
Voriconazole AUC0-∞  59% Contraindicated (see section 4.3)
Vinkaalkaloider (f.eks. vincristin og vinblastin) 
Vinca Alkaloids (e.g., vincristine and vinblastine)
Hvis voriconazol anvendes sekventielt efter fluconazol anbefales det, at der monitoreres for voriconazol-relaterede bivirkninger. 
Monitoring for voriconazoleassociated adverse reactions is recommended if voriconazole is used sequentially after fluconazole.
Blod og lymfesystem agranulocytose1, pancytopeni, trombocytopeni2, leukopeni, anæmi knoglemarvssvigt, lymfadenopati, eosinofili dissemineret intravaskulær koagulation 
Blood and lymphatic system disorders agranulocytosis1, pancytopenia, thrombocytopenia2
Alfentanil AUC0-∞ ↑ 6 gange 
In an independent published study, Alfentanil AUC0-∞  6fold.
Voriconazole Accord 50 mg filmovertrukne tabletter Voriconazole Accord 200 mg filmovertrukne tabletter voriconazol 
Voriconazole Accord 50 mg film-coated tablets Voriconazole Accord 200 mg film-coated tablets voriconazole
• Betændelse i vævet omkring knoglen Røde, skællede pletter eller ringformede hudlæsioner, der kan være symptomer på den autoimmune sygdom, som kaldes kutan lupus erythematosus. 
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
• Lavt antal, herunder alvorligt, af visse typer røde (sommetider immunrelateret) og/eller hvide blodlegemer (sommetider med feber), lavt antal celler, som kaldes blodplader (trombocytter), 
- 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,
Sammenlignet med efavirenz 600 mg QD, 
Compared to voriconazole 200 mg BID,
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. 
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.
Voriconazole Accord 50 mg filmovertrukne tabletter voriconazol 
Voriconazole Accord 50 mg film-coated tablets voriconazole
300 mg QD (administeret samtidig med voriconazol 400 mg BID)* 
300 mg QD (co-administered with voriconazole 400 mg BID)*
Voriconazole Accord 200 mg filmovertrukne tabletter voriconazol 
Voriconazole Accord 200 mg film-coated tablets voriconazole
Sådan skal De tage Voriconazole Accord 
How to store Voriconazole Accord
Alvorlige bivirkninger - stop med at tage Voriconazole Accord og søg læge øjeblikkeligt 
Serious side effects - Stop taking Voriconazole Accord and see a doctor immediately - Rash - Jaundice; Changes in blood tests of liver function - Pancreatitis
Voriconazole Accord indeholder det aktive stof voriconazol og er et middel mod svampeinfektioner. 
Voriconazole Accord is an antifungal medicine.
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. 
Coadministration of oral voriconazole and oral fluconazole resulted in a significant increase in Cmax and AUCτ of voriconazole in healthy subjects.
Tal med lægen, apoteket eller sundhedspersonalet, hvis De får bivirkninger, herunder bivirkninger, som ikke fremgår af denne indlægsseddel. 
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.
Itraconazol n=241 
N=241
• Dobbeltsyn, alvorlige øjentilstande, herunder smerter og betændelsestilstand i øjne og øjenlåg, 
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,
Hvis De har taget for mange Voriconazole Accord kan De opleve abnorm intolerans over for lys. 
You may experience abnormal intolerance to light as a result of taking more Voriconazole Accord than you should.
• Kløe 
Itraconazo le
Voriconazol n=224 
N=224
Voriconazol Cmax ↓ 93% Voriconazol AUCτ ↓ 96% Kontraindiceret (se pkt. 
Voriconazole Cmax  93% Voriconazole AUCτ  96%
300 mg QD (samtidig administration af voriconazol 400 mg BID)* 
300 mg QD (coadministered with voriconazole 400 mg BID)*
Hvis kombinationen er strengt nødvendig, kan vedligeholdelsesdosis for voriconazol øges fra 200 mg til 350 mg oralt 2 gange dagligt. 
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.
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. 
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).
Tag ikke Voriconazole Accord 
If you stop taking Voriconazole Accord
Filmovertræk: Hypromellose, titandioxid (E171), lactosemonohydrat og triacetin. 
• 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.
Sammenlignet med voriconazol 200 mg BID, Voriconazol Cmax ↑ 104% Voriconazol AUCτ ↑ 87% 
Voriconazole Cmax  104% Voriconazole AUCτ  87%
[CYP-induktor; CYP3A4hæmmer og -substrat] 
[CYP450 inducer; CYP3A4 inhibitor and substrate]
p-værdi 
PValue
NAVN PÅ INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN Accord 
MARKETING AUTHORISATION HOLDER
Den anbefalede dosis til voksne (også ældre patienter) er: 
The recommended dose for adults (including elderly patients) is as follows: Tablets Patients 40 kg and above Patients less than 40 kg
• Patientadvarselskort om fototoksicitet og planocellulært karcinom: - Påminde patienter om risikoen for fototoksicitet og planocellulært hudkarcinom. 
Reminds patients of the risk of phototoxicity and skin SCC.
• Akut vejrtrækningsbesvær, brystsmerter, hævelser i ansigtet (mund, læber og omkring øjnene), 
- 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,
[CYP3A4 substrater og hæmmere] 
[CYP3A4 inhibitor and substrate]
Sammenlignet med voriconazol 200 mg BID, Voriconazol Cmax ↓ 4% Voriconazol AUCτ ↓ 32% 
Voriconazole Cmax  4% Voriconazole AUCτ  32%
Phenytoin kan gives samtidigt med voriconazol, hvis vedligeholdelsesdosis for voriconazol øges fra 200 mg til 400 mg oralt 2 gange dagligt. 
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.
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. 
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.
Levertoksicitet 
Hepatic toxicity
Phenytoin (CYP2C9-substrat og potent CYP450-induktor) Omhyggelig monitorering af phenytoinniveauer anbefales ved samtidig administration af voriconazol. 
Careful monitoring of phenytoin levels is recommended when phenytoin is coadministered with voriconazole.
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. 
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.
• Lavt blodtryk, betændelsestilstand i en vene (som kan forbindes med dannelse af blodpropper) 
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)
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. 
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).
Derfor er det vigtigt, at De fortsætter med at tage Voriconazole Accord som beskrevet ovenfor, medmindre Deres læge beder Dem stoppe behandlingen. 
Therefore unless your doctor instructs you to stop treatment, it is important to keep taking Voriconazole Accord correctly, as described above.
Samtidig administration af perikon (se pkt. 
Coadministration with St John's Wort (see section 4.5).
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/06/352/001-003 
MARKETING AUTHORISATION NUMBER(S) EU/1/06/352/001-003
Anvend kun Intrinsa, så længe De oplever en positiv virkning af behandlingen. 
Use Intrinsa only as long as you experience a positive effect of the treatment.
Der foreligger ingen oplysninger om Intrinsas sikkerhed ud over 12 måneder. 
There is no information on the safety of Intrinsa beyond 12 months.
Intrinsa anvendes til behandling af HSDD. 
Intrinsa is used to treat HSDD.
Børn og unge Intrinsa er ikke beregnet til anvendelse hos børn og unge. 
Children and adolescents Intrinsa is not for use in children and adolescents.
Pædiatrisk population Der ingen relevant brug af Intrinsa i den pædiatriske population. 
Paediatric population There is no relevant use of Intrinsa in the paediatric population.
Intrinsa kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger. 
Like all medicines, Intrinsa can cause side effects, although not everybody gets them.
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: 
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:
Graviditet Intrinsa må ikke anvendes til kvinder, som er eller kan blive gravide. 
Pregnancy Intrinsa must not be used in women who are or may become pregnant.
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. 
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.
Måden, Intrinsa administreres på, gør overdosering usandsynlig. 
The mode of administration of Intrinsa makes overdose unlikely.
Signifikansen af disse data for anvendelse af Intrinsa hos mennesker kendes ikke. 
The significance of these data for the use of Intrinsa in patients is not known.
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. 
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.
Intrinsa indeholder 
What Intrinsa contains
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. 
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.
Relevant brug af og restriktioner forbundet med østrogenbehandling bør overvejes, før behandlingen med Intrinsa indledes og ved rutinemæssig revurdering af behandlingen. 
The appropriate use and restrictions associated with estrogen therapy should be considered before Intrinsa therapy is initiated and during routine re-evaluation of treatment.
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. 
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.
Testosteronet i Intrinsa er det samme hormon, som mænd og kvinder producerer naturligt. 
The testosterone in Intrinsa is the same hormone as that produced naturally in men and women.
Fortsat anvendelse af Intrinsa anbefales kun, mens samtidig brug af østrogen menes at være relevant (dvs. den laveste, effektive dosis i kortest mulige tid). 
Continued use of Intrinsa is only recommended while concomitant use of estrogen is considered appropriate (i.e. the lowest effective dose for the shortest possible duration).
Der sås effekt af Intrinsa ved 4 uger efter behandlingsstart (først målte tidspunkt) og ved alle månedlige effekt-tidspunkter derefter. 
Effects of Intrinsa were observed at 4 weeks after initiation of therapy (the first measured time point) and at all monthly efficacy time points thereafter.
I tilfælde af utilsigtet eksponering under graviditet skal brugen af Intrinsa seponeres. 
In case of inadvertent exposure during pregnancy, use of Intrinsa must be discontinued.
De skal derfor drøfte østrogentypen med Deres læge, som kan rådgive om, hvilken type østrogen, det er bedst at tage sammen med Intrinsa. 
Therefore, you need to discuss your type of estrogen with your doctor, who could advise you which type of estrogen is suitable together with Intrinsa.
I den kombinerede forsøgsanalyse ved uge 24 var forskellen i gennemsnitshyppigheden af fuldstændig tilfredsstillende episoder mellem Intrinsa og placebo på 1,07 per 4 uger. 
In the combined study analysis at 24 weeks, the difference in the mean frequency of total satisfying episodes between Intrinsa and placebo was 1.07 per 4 weeks.
Trafik- og arbejdssikkerhed De kan godt køre bil og betjene maskiner, mens De anvender Intrinsa. 
Driving and using machines You can drive and use machines while using Intrinsa.
Hvis noget af ovenstående er tilfældet, skal De fortælle Deres læge det, før De begynder at anvende Intrinsa. 
If you have any of the above, tell your doctor before you start to use Intrinsa.
Intrinsas sikkerhed er ikke vurderet i dobbeltblinde, placebokontrollerede forsøg med længere varighed end 1 år. 
The safety of Intrinsa has not been evaluated in double blind placebo controlled studies of longer than 1 year duration.
Der var ingen signifikant forskel i serumøstradiol og østronniveauet hos patienter behandlet med Intrinsa i op til 52 uger sammenlignet med baseline. 
There were no significant differences in serum estradiol and estrone levels in patients treated with Intrinsa for up to 52 weeks compared to baseline.
Yderligere information om dette lægemiddel er tilgængelig på Det europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/ 
Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu
Respons på behandlingen med Intrinsa bør vurderes inden for 3-6 måneder efter behandlingsstart for at afgøre, om det er relevant at fortsætte behandlingen. 
Intrinsa treatment response should be evaluated within 3-6 months of initiation, to determine if continued therapy is appropriate.
Hvis en bivirkning forekom med større frekvens i det integrerede fase III-forsøg (Intrinsa-patienter n=1.498, placebo-patienter n=1.297), vil denne frekvens være rapporteret i tabellen. 
If an adverse reaction occurred at a higher frequency in the integrated phase III studies (Intrinsa patients n=1,498, placebo patients n=1,297), this frequency is reported in the table.
Intrinsa påvirker ikke evnen til at føre bil eller betjene maskiner. 
Intrinsa has no influence on the ability to drive and use machines.
Patienterne skal dog informeres om, at der er blevet rapporteret migræne, søvnløshed, opmærksomhedsforstyrrelser og dobbeltsyn under behandling med Intrinsa. 
However, patients should be informed that migraine, insomnia, disturbance in attention and diplopia have been reported during treatment with Intrinsa.