natgillin/translations-raw huggingface dataset:
Mave-tarmkanalen Ikke almindelig: Sialoadenitis, spasmer, maveirritation, kvalme, opkastning, diarré, forstoppelse. 
Gastrointestinal disorders Uncommon: Sialoadenitis, spasms, stomach irritation, nausea, vomiting, diarrhoea, constipation
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 7, 14, 28, 30, 50, 56, 84, 90, 98 eller 280 filmovertrukne tabletter. 
PHARMACEUTICAL FORM AND CONTENTS 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 film-coated tablets
• hvis De tidligere har haft hævelse af ansigt, læber, svælg eller tunge 
Take special care with Cozaar Comp • if you have previously suffered from swelling of the face, lips, throat or tongue
Ikke almindellig: Faciale ødemer, feber. 
Uncommon: Facial oedema, fever
COZAAR COMP. filmovertrukne tabletter losartankalium og hydrochlorthiazid 
COZAAR COMP film-coated Tablets losartan potassium and hydrochlorothiazide
Cozaar Comp. 50 mg/12,5 mg og Cozaar Comp. 100 mg/25 mg indeholder også titandioxid (E171), quinolingult (E104) og carnaubavoks (E903). 
Cozaar Comp 50 mg/12.5 mg and Cozaar Comp 100 mg/25 mg also contain titanium dioxide (E171), quinoline yellow aluminum lake (E104) and carnauba wax (E903).
Cozaar Comp. 50 mg/12,5 mg indeholder 4,24 mg (0,108 mEq) kalium. 
Cozaar Comp 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium.
Cozaar Comp. 50 mg/12,5 mg indeholder 50 mg losartankalium og 12,5 mg hydrochlorthiazid som aktive indholdsstoffer. 
Cozaar Comp 50 mg/12.5 mg> contains 50 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp. 100 mg/25 mg indeholder 100 mg losartankalium og 25 mg hydrochlorthiazid som aktive indholdsstoffer. 
Cozaar Comp 100 mg/25 mg> contains 100 mg of losartan potassium and 25 mg of hydrochlorothiazide as the active ingredients.
CHMP fandt, at der ikke var et positivt benefit/risk-forhold for indikationen for initial behandling af hypertension med fastdosiskombinationen. 
The CHMP concluded that the indication for the initial therapy of hypertension with the fixed dose combination (FDC) does not have a positive benefit-risk ratio, and therefore is not acceptable.
Refraktær hyponatriæmi. 
• Refractory hyponatraemia
FORTZAAR® 100 mg/25 mg, comprimate filmate 
FORTZAAR® 100/25 mg, comprimate filmate
Nyrer og urinveje Ikke almindelig: Nykturi, hyppig vandladning, urinvejsinfektion. 
Renal and urinary disorders Uncommon: Nocturia, urinary frequency, urinary tract infection
Hver tablet indeholder 100 mg losartan (som kaliumsalt) og 25 mg hydrochlorthiazid som de aktive indholdsstoffer. 
Each tablet contains 100 mg of losartan (as potassium salt) and 25 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Cozaar Comp. 100 mg/12,5 mg og Cozaar Comp. 100 mg/25 mg indeholder 8,48 mg (0,216 mEq) kalium. 
Cozaar Comp 100 mg/12.5 mg mg and Cozaar Comp 100 mg/25 mg contain 8.48 mg (0.216 mEq) of potassium.
• hvis De tager vanddrivende medicin 
• if you take diuretics (water pills)
Cozaar Comp. 100 mg/25 mg indeholder også: Titandioxid (E171), quinolingult (E104) og carnaubavoks (E903). 
Cozaar Comp 100 mg/25 mg also contain:, Titanium dioxide (E171), Quinoline yellow aluminum lake (E104), and Carnauba wax (E903)
Cozaar Comp. 100 mg/12,5 mg indeholder 100 mg losartankalium og 12,5 mg hydrochlorthiazid som aktive indholdsstoffer. 
Cozaar Comp100 mg/12.5 mg mg contains 100 mg of losartan potassium and 12.5 mg of hydrochlorothiazide as the active ingredients.
Cozaar Comp. bør ikke anvendes til patienter med svær leverinsufficiens (se pkt. 
Cozaar Comp is contraindicated for patients with severe hepatic impairment (see section 4.3 and
Hver tablet indeholder 50 mg losartan (som kaliumsalt) og 12,5 mg hydrochlorthiazid som de aktive indholdsstoffer. 
Each tablet contains 50 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Hver tablet indeholder 100 mg losartan (som kaliumsalt) og 12,5 mg hydrochlorthiazid som de aktive indholdsstoffer. 
Each tablet contains 100 mg of losartan (as potassium salt) and 12.5 mg of hydrochlorothiazide (HCTZ) as the active ingredients.
Almindelig: Hoste, øvre luftvejsinfektion, stoppet næse, sinuitis, sinuslidelser. 
• Cough, upper airway infection, congestion in the nose, sinusitis, sinus disorder,
Og Cozaar Comp. 100 mg/25 mg indeholder 8,48 mg (0,216 mEq) kalium. 
and Cozaar Comp 100 mg/25 mg contains 8.48 mg (0.216 mEq) of potassium.
Hjerte 
Forte
6.6 Regler for destruktion og anden håndtering 
6.6 Special precautions for disposal <and other handling> No special requirements.
FORTZAAR (Losartan/Hydrochlorthiazide) 
FORTZAAR (Losartan/Hydrochlorothiazide)
Cozaar Comp. 100 mg/25 mg fås som filmovertrukne tabletter uden delekærv. 
Cozaar Comp 100 mg/25 mg is supplied as unscored film-coated tablets.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar Comp. 100 mg/25 mg filmovertrukne tabletter 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar Comp 100 mg/25 mg film-coated tablets
- Graviditet og amning skal kontraindiceres, og den relevante ordlyd skal inkluderes i afsnit 4.3, 4.4 og 4.6 i produktresuméet samt i de relevante afsnit af indlægssedlen anbefaler CHMP ændring af den/de markedsføringstilladelse(r), hvis produktresuméer, etikettering og indlægsseddel er anført i bilag III til Cozaar Comp. og tilknyttede navne (se bilag I). 
the CHMP has recommended the amendment of the Marketing Authorisation(s) for which the Summary of Product Characteristics, labelling and package leaflet are set out in Annex III for Cozaar Comp. and associated names (see Annex I).
LÆGEMIDLETS NAVN Cozaar Comp. 100 mg/25 mg Losartan og hydrochlorthiazid 
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg Losartan and hydrochlorothiazide
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar Comp. 50 mg/12,5 mg filmovertrukne tabletter 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar Comp 50 mg/12.5 mg film-coated tablets
Ikke almindelig: Konstipation, tandsmerter, tør mund, flatulens, gastritis, opkastning. 
Common: Abdominal pain, nausea, diarrhoea, dyspepsia Uncommon: Constipation, dental pain, dry mouth, flatulence, gastritis, vomiting
Kombinationen af losartan og hydrochlorthiazid kan have tilbøjelighed til at dæmpe diuretikainduceret hyperurikæmi. 
Hydrochlorothiazide has been shown to cause modest increases in uric acid; the combination of losartan and hydrochlorothiazide tends to attenuate the diuretic-induced hyperuricemia.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 100 mg losartan og 25 mg hydrochlorthiazid. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium and 25 mg hydrochlorothiazide.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTERKORT ELLER BLISTERSTRIPS Blister til Cozaar Comp. 100 mg/12,5 mg filmovertrukne tabletter 
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister for Cozaar Comp 100 mg/12.5 mg film-coated tablets
Cosaar Plus - Filmtabletten 50 mg losartankalium 
Cosaar Plus - Filmtabletten 50 mg losartan potassium12.5 mg hydrochlorothiazide
Korrektion af væske- og elektrolytbalance, hepatisk koma og hypotension behandles henhold til gældende procedurer. 
Suggested measures include induction of emesis if ingestion is recent, and correction of dehydration, electrolyte imbalance, hepatic coma and hypotension by established procedures.
Ikke almindelig: Lille stigning i urinstof og serumkreatininkoncentration. 
Common: Hyperkalaemia, mild reduction of haematocrit and haemoglobin Uncommon: Mild increase in urea and creatinine serum levels Very rare: Increase in hepatic enzymes and bilirubin.
LÆGEMIDLETS NAVN Cozaar Comp. 50 mg/12,5 mg Losartan og hydrochlorthiazid 
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 50 mg/12.5 mg Losartan and hydrochlorothiazide
HYZAAR (Losartan/Hydrochlorthiazide) 
HYZAAR (Losartan/Hydrochlorothia zide)
Cozaar Comp. 100 mg/25 mg Lysegule, ovale filmovertrukne tabletter mærket 747 på den ene side og glatte på den anden side. 
Light yellow, oval film-coated tablets marked 747 on one side and plain on the other.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 50 mg losartan og 12,5 mg hydrochlorthiazid. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 50 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Cozaar Comp. 100 mg/12,5 mg indeholder 8,48 mg (0,216 mEq) kalium. 
Cozaar Comp 100 mg/12.5 mg mg contains 8.48 mg (0.216 mEq) of potassium.
LÆGEMIDLETS NAVN Cozaar Comp. 100 mg/12,5 mg Losartan og hydrochlorthiazid 
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/12.5 mg Losartan and hydrochlorothiazide
Cozaar Comp. 100 mg/12,5 mg fås som filmovertrukne tabletter uden delekærv. 
Cozaar Comp 100 mg/12.5 mg mg is supplied as unscored film-coated tablets.
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar Comp. 100 mg/25 mg filmovertrukne tabletter - blister 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 100 mg/25 mg film-coated tablets blister
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Hver tablet indeholder 100 mg losartan og 12,5 mg hydrochlorthiazid. 
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 100 mg losartan potassium and 12.5 mg hydrochlorothiazide.
Cozaar Comp. 100 mg/25 mg filmovertrukne tabletter Losartan og hydrochlorthiazid 
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/25 mg mg film-coated tablets Losartan and hydrochlorothiazide
Knogler, led, muskler og bindevæv Ikke almindelig: Muskelkramper. 
Musculoskeletal and connective tissue disorders Uncommon: Muscle cramps
MSD BV Waarderweg 39 2031 BN Haarlem Holland 
Norway MSD BV Waarderweg 39
Ikke almindelig: Gener i svælget, pharyngitis, laryngitis, dyspnø, bronkitis, epistaksis, rhinitis, respiratorisk kongestion. 
Common: Cough, upper respiratory infection, nasal congestion, sinusitis, sinus disorder Uncommon: Pharyngeal discomfort, pharyngitis, laryngitis, dyspnoea, bronchitis, epistaxis, rhinitis, respiratory congestion
Cozaar Comp. 50 mg/12,5 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98 eller 280 tabletter. 
Cozaar Comp 50 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 4, 7, 10, 14, 20, 28, 30, 50, 56, 84, 98, or 280 tablets.
Cozaar Comp. 50 mg/12,5 mg filmovertrukne tabletter Losartan og hydrochlorthiazid 
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 50 mg/12.5 mg mg film-coated tablets Losartan and hydrochlorothiazide
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar Comp. 50 mg/12,5 mg filmovertrukne tabletter - blister 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 50 mg/12.5 mg film-coated tablets blister
Via G. Fabbroni 6, 00191 Rom, Italien 
Merck Sharp & Dohme Italia S.p.A. via G Fabbroni 6 , 00191 Rome Italy
Cozaar Comp. 100 mg/12,5 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tabletter. 
Cozaar Comp 100 mg/12.5 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 14, 15, 28, 30, 50, 56, 84, 90, 98, 280 tablets.
Medlemsstat Indehaver af markedsføringstilladelse 
Marketing Authorisation Holder Invented name
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar Comp. 100 mg/12,5 mg filmovertrukne tabletter - blister 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 100 mg/12.5 mg film-coated tablets blister
Cozaar Comp. 50 mg/12,5 mg fås som filmovertrukne tabletter med eller uden delekærv. 
What Cozaar Comp looks like and contents of the pack Cozaar Comp 50 mg/12.5 mg is supplied as scored or unscored film-coated tablets.
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar Comp. 100 mg/25 mg filmovertrukne tabletter - HDPE-beholder 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 100 mg/25 mg film-coated tablets HDPE bottle
Cozaar Comp. 100 mg/25 mg - PVC/PE/PVDC blisterpakninger med aluminiumsfolie i pakninger à 7, 14, 28, 30, 50, 56, 84, 90, 98 eller 280 tabletter. 
Cozaar Comp 100 mg/25 mg - PVC/PE/PVDC blister packages with aluminum foil lidding in packs of 7, 14, 28, 30, 50, 56, 84, 90, 98, or 280 tablets.
Cozaar Comp. 100 mg/12,5 mg filmovertrukne tabletter Losartan og hydrochlorthiazid 
NAME OF THE MEDICINAL PRODUCT Cozaar Comp 100 mg/12.5 mg mg film-coated tablets Losartan and hydrochlorothiazide
Sådan skal De tage Cozaar Comp. 
HOW TO TAKE COZAAR COMP
DET SKAL DE VIDE, FØR DE BEGYNDER AT TAGE COZAAR COMP. 
BEFORE YOU TAKE COZAAR COMP
Cozaar Comp. og tilhørende navne (se bilag I) 100 mg/12,5 mg filmovertrukne tabletter. 
NAME OF THE MEDICINAL PRODUCT Cozaar Comp and associated names (see Annex I) 50 mg/12.5 mg film-coated tablets Cozaar Comp and associated names (see Annex I) 100 mg/12.5 mg film-coated tablets Cozaar Comp and associated names (see Annex I) 100 mg/25 mg film-coated tablets [To be implemented nationally]
Derfor bør Cozaar Comp. ikke gives til patienter med svær leverinsufficiens (se pkt. 
Therefore Cozaar Comp is contraindicated in patients with severe hepatic impairment (see sections 4.2, 4.3 and 5.2).
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar Comp. 50 mg/12,5 mg filmovertrukne tabletter - HDPE-beholder 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 50 mg/12.5 mg film-coated tablets HDPE Bottle
Immunsystemet Sjælden: Anafylaktiske reaktioner, angioødem, urticaria. 
Anaphylactic reactions, angioedema, urticaria
MINDSTEKRAV TIL MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre karton for Cozaar Comp. 100 mg/12,5 mg filmovertrukne tabletter - HDPE-beholder 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton for Cozaar Comp 100 mg/12.5 mg film-coated tablets HDPE bottle
Cozaar Comp.'s virkning og hvad De skal bruge det til 2. 
What Cozaar Comp is and what it is used for Before you take Cozaar Comp How to take Cozaar Comp Possible side effects
SÅDAN OPBEVARER DE COZAAR COMP. 
HOW TO STORE COZAAR COMP
Angiotensin-II stimulerer også formeringen af celler i den glatte muskulatur. 
and elicits several important biological actions, including vasoconstriction and the release of aldosterone.Angiotensin II also stimulates smooth-muscle cell proliferation.
Tal med lægen eller apoteket, hvis en bivirkning bliver værre, eller De får bivirkninger, som ikke er nævnt her. 
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
• Lægen har ordineret Cozaar Comp. til Dem personligt. 
• This medicine has been prescribed for you.
Bilag III Ændringer til relevante afsnit i produktresumeer og indlægssedler 
Annex III Amendments to relevant sections of the summaries of product characteristics and package leaflets
• Akutte retinopatier af vaskulær oprindelse 
• Acute retinopathies of vascular origin
• Symptomatisk behandling af kroniske, patologiske, kognitive og neurosensoriske svækkelser hos ældre (ekskl. 
• Symptomatic treatment of chronic pathological cognitive and neurosensorial impairment in elderly (excluding Alzheimer's disease and other dementia)
• Supplerende behandling af synsnedsættelse og synsfeltforstyrrelser, formentlig af vaskulær oprindelse 
• Ancillary treatment of visual acuity decrease and visual field disturbances presumably of vascular origin
Alle henvisninger til ovennævnte indikationer skal slettes i de øvrige afsnit i produktresuméerne. 
All references to the above mentioned indications should be deleted from the remaining relevant sections of the summaries of product characteristics.
Lægemidlet har en acceptabel sikkerhedsprofil. 
The medicine has an acceptable safety profile.
Intrarosa prasteron 
Intrarosa prasterone
I begge undersøgelser blev 6,5 mg Intrarosa givet én gang dagligt i 12 uger. 
In both studies, 6.5 mg Intrarosa was given once a day for 12 weeks.
Den fuldstændige EPAR for Intrarosa findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports. 
The full EPAR for Intrarosa can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Intrarosa. 
This is a summary of the European public assessment report (EPAR) for Intrarosa.
Andre oplysninger om Intrarosa 
Other information about Intrarosa
Virksomheden, der markedsfører Intrarosa, skal gennemføre en undersøgelse af, hvordan lægemidlet anvendes i klinisk praksis, herunder om det anvendes i overensstemmelse med den godkendte produktinformation. 
The company that markets Intrarosa is required to conduct a study on how the medicine is used in clinical practice, including whether it is used according to the authorised product information.
Intrarosa må ikke anvendes hos patienter med følgende sygdomme: blødning i skeden (hvor årsagen ikke er klarlagt), diagnosticeret brystkræft eller mistanke derom eller østrogen-afhængig kræft, tidligere brystkræft, ubehandlet endometriehyperplasi (fortykkelse af slimhinden i livmoderen), akut leversygdom, tidligere leversygdom (hvor leverfunktionstallene stadig ikke er normale), tidligere eller aktuel venøs tromboemboli (dannelse af blodpropper i venerne), trombofile sygdomme (unormal blodstørkning), aktiv eller nylig arteriel tromboemboli (dannelse af blodpropper i arterierne), porfyri (manglende evne til at nedbryde et kemisk stof, der hedder porfyriner). 
Intrarosa must not be used in patients with the following conditions: genital bleeding where the cause has not been diagnosed, known or suspected breast cancer or oestrogen-dependent cancer, previous breast cancer, untreated endometrial hyperplasia (thickening of the lining of the womb), acute (shortterm) liver disease, previous liver disease where liver function tests are still abnormal, previous or current venous thromboembolism (formation of blood clots in the veins), thrombophilic disorders (abnormal blood clotting), active or recent arterial thromboembolic disease (disease caused by blood clots in the arteries), porphyria (inability to break down chemicals called porphyrins).
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Intrarosa? 
What measures are being taken to ensure the safe and effective use of Intrarosa?
Smerter under samleje blev vurderet af patienterne selv ved hjælp af en standardskala fra 0 (ingen smerter) til 3 (kraftige smerter). 
Pain during sexual intercourse was self-assessed by patients using a standard scale ranging from 0 (no pain) to 3 (severe pain).
Hvorfor blev Intrarosa godkendt? 
Why is Intrarosa approved?
Det Europæiske lægemiddelagentur konkluderede derfor, at fordelene ved Intrarosa opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU. 
The European Medicines Agency therefore considered that Intrarosa's benefits are greater than its risks and recommended that it be approved for use in the EU.
Hvad er Intrarosa, og hvad anvendes det til? 
What is Intrarosa and what is it used for?
Den mest almindelige bivirkning ved Intrarosa (som kan forekomme hos op til 1 ud af 10 personer) er vaginalt udflåd. 
The most common side effect with Intrarosa (which may affect up to 1 in 10 people) is vaginal discharge.
Intrarosa fås som en 6,5 mg-stikpille. 
Intrarosa is available as a 6.5 mg pessary.
Intrarosa indeholder det aktive stof prasteron (også kendt som dehydroepiandrosteron). 
Intrarosa contains the active substance prasterone, also known as dehydroepiandrosterone (DHEA).
Virkningen i placebo-gruppen blev forklaret med hjælpestoffets smørende virkning. 
The effect seen in the placebo group was explained by the lubricant effect of the excipient.
Det er ikke en praktisk vejledning i, hvordan Intrarosa bør anvendes. 
It is not intended to provide practical advice on how to use Intrarosa.
Hvis du ønsker yderligere oplysninger om behandling med Intrarosa, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek. 
For more information about treatment with Intrarosa, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Smerterne faldt med 1,3 og 1,4 point med Intrarosa sammenholdt med 0,9 og 1,1 point med placebo. 
The pain reduced by 1.3 and 1.4 points with Intrarosa compared with 0.9 and 1.1 points with placebo.
Patienter, der tog Intrarosa, oplevede en moderat reduktion af smerter under samleje, hvilket er det samme som eller bedre end den virkning, som patienter på placebo oplevede. 
Patients taking Intrarosa had a modest reduction in pain during sexual intercourse, which was similar or better to the effect seen in patients taking placebo.
Hvilke risici er der forbundet med Intrarosa? 
What are the risks associated with Intrarosa?
Det er i to undersøgelser af 813 postmenopausale kvinder med vulvær og vaginal atrofi påvist, at behandling med Intrarosa er mere effektivt end placebo (ikke-aktivt stof) til at reducere tegn på tyndere væv i skeden (atrofi). 
Two studies involving 813 post-menopausal women with vulvar and vaginal atrophy found that treatment with Intrarosa was more effective than placebo (a dummy treatment) at reducing signs of thinning (atrophy) of vaginal tissues.
Kvinden bør indføre stikpillen i skeden én gang dagligt ved sengetid. 
Women should insert the pessary into their vagina, once daily, at bedtime.
Hos kvinder med vulvær og vaginal atrofi bliver skedevæggen og de omkringliggende væv tyndere og kan forårsage symptomer som f.eks. tørhed, irritation og ømhed i skeden samt smerter ved samleje. 
In women with vulvar and vaginal atrophy, the wall of the vagina and surrounding tissues become thinner and can cause symptoms such as dryness, irritation and soreness around the genital area, and painful sexual intercourse.
Det aktive stof i Intrarosa, prasteron, omdannes til kønshormonerne østrogen og androgen, når stikpillen indføres i skeden. 
The active substance of Intrarosa, prasterone, is converted into the sex hormones oestrogens and androgens when inserted into the vagina.
Som følge af stigningen i østrogen-niveauet stiger antallet af overfladeceller i vævene i og omkring skeden og dermed lindres symptomerne på vaginal atrofi. 
As a result of increasing oestrogen levels, the number of superficial cells in the tissues in and around the vagina increases thus relieving the symptoms of vaginal atrophy.
Det er påvist, at Intrarosa forbedrer strukturen i vævene i skeden, og at det har en besked virkning på smerter under samleje. 
Intrarosa has been shown to improve the structure of the vaginal tissues and to have a modest effect on pain during sexual intercourse.
Hvis du ønsker praktisk vejledning om anvendelsen af Intrarosa, kan du læse indlægssedlen eller kontakte din læge eller dit apotek. 
For practical information about using Intrarosa, patients should read the package leaflet or contact their doctor or pharmacist.
Der sås også et fald i antallet af parabasale celler (der normalt stiger ved atrofi) på 42 % og 47 % ved behandling med Intrarosa sammenholdt med ca. 2 % og 12 % ved behandling med placebo. 
There was also a decrease in the number of parabasal cells (which normally increase with atrophy) of 42% and 47% with Intrarosa compared with 2% and 12% with placebo.
Den fuldstændige liste over indberettede bivirkninger ved Intrarosa fremgår af indlægssedlen. 
For the full list of side effects reported with Intrarosa, see the package leaflet.
Hvordan anvendes Intrarosa? 
How is Intrarosa used?
Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Intrarosa. 
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Intrarosa have also been included in the summary of product characteristics and the package leaflet.
Hvilke fordele viser undersøgelserne, at der er ved Intrarosa? 
What benefits of Intrarosa have been shown in studies?