natgillin/translations-raw huggingface dataset:
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtig blister med 28 eller 2 gennemsigtige blistere med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning og PCTFE/PVCblister med aluminiumsfolie i to sekundære varmeforseglede kortpakninger indeholdende 56 x 1 mg filmovertrukne tabletter.
PCTFE/PVC blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in one secondary heat sealed card pack and PCTFE/PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 x 1 mg film-coated tablets.
PVC-blister med aluminiumsfolie, indeholdende 112 x 1 mg filmovertrukne tabletter i en karton.
PVC blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton.
CA* uge 13-24
CA* wk 15-24
N=990 n (%)
Varenicline N=990 n (%)
Varmeforseglet kortpakning, indeholdende enten 2 eller 4 blisterpakninger hver med 14 x 0,5 mg vareniclin filmovertrukne tabletter eller 2 blisterpakninger hver med 28 x 0,5 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning
Heat sealed card pack containing either 2 or 4 blister packs of 14 x 0.5 mg varenicline film-coated tablets or 2 blister packs of 28 x 0.5 mg varenicline film-coated tablets- inner and outer labelling
En blisterpakning med 28 eller 2 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS One blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets, heat sealed card
Ledstivhed, costochondritis
Silica, Colloidal Anhydrous
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 112 x 1 mg filmovertrukne tabletter i en karton.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 112 x 1 mg film-coated tablets in a carton.
Varmeforseglet kortpakning, indeholdende 1 blisterpakning med 11 x 0,5 mg vareniclin filmovertrukne tabletter og 1 blisterpakning med 14 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning
Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg varenicline film-coated tablets and 1 blister pack of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling
- Startpakning, der indeholder 2 blisterkort; 1 gennemsigtig blisterkort med 11 x CHAMPIX 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtigt blisterkort med 28 eller 2 gennemsigtige blisterkort med 14 x CHAMPIX 1 mg filmovertrukne tabletter i en kortpakning.
Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
- Startpakning, der indeholder 2 blisterkort; 1 gennemsigtigt blisterkort med 11 x CHAMPIX 0,5 mg filmovertrukne tabletter og 1 gennemsigtigt blisterkort med 14 x CHAMPIX 1 mg filmovertrukne tabletter i en karton.
Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in a carton.
PVC-blister med aluminiumsfolie, indeholdende 56 x 1 mg filmovertrukne tabletter i en karton.
PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton.
Hver filmovertrukken tablet indeholder 1 mg vareniclin (som tartrat).
Each 1 mg film-coated tablet contains 1 mg of varenicline (as tartrate).
PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtig blister med 28 meller 2 gennemsigtige blistere med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning og PVC-blister med aluminiumsfolie i to sekundære varmeforseglede kortpakninger indeholdende 56 x 1 mg filmovertrukne tabletter.
PVC blisters with aluminium foil backing containing one clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in one secondary heat sealed card pack and PVC blisters with aluminium foil backing in two secondary heat sealed card packs each containing 56 x 1 mg film-coated tablets.
PVC-blister med aluminiumsfolie, indeholdende 140 x 1 mg filmovertrukne tabletter i en karton.
PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in a carton.
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 56 x 1 mg filmovertrukne tabletter i en karton.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in a carton.
PVC-blister med aluminiumsfolie, indeholdende 28 x 1 mg filmovertrukne tabletter i en karton.
PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
Bupropion kontra placebo 2,26 (1,80, 2,85), P<0,0001 1,87 (1,46, 2,39), P<0,0001 NRT vs placebo
Varenicline vs Bupropion 1.49 (1.20, 1.85), P=0.0003
Startpakninger: EU/1/06/360/003 EU/1/06/360/008 EU/1/06/360/012 EU/1/06/360/014 EU/1/06/360/019 EU/1/06/360/023 EU/1/06/360/025 EU/1/06/360/026
EU/1/06/360/003 EU/1/06/360/008 EU/1/06/360/012 EU/1/06/360/014 EU/1/06/360/019 EU/1/06/360/023 EU/1/06/360/025 EU/1/06/360/026
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 28 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Blisterpakning med 14 x 1 mg og 28 x 1 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg and 28 x 1 mg varenicline film-coated tablets, heat sealed card
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 28 x 0,5 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 140 x 1 mg filmovertrukne tabletter i en karton.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in a carton.
Varmeforseglet kortpakning, indeholdende enten 2 eller 4 blisterpakninger hver med 14 x 1 mg vareniclin filmovertrukne tabletter eller 2 blisterpakninger hver med 28 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning
Heat sealed card pack containing either 2 or 4 blister packs of 14 x 1 mg varenicline film-coated tablets or 2 blister packs of 28 x 1 mg varenicline film-coated tablets- inner and outer labelling
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 56 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 56 x 0,5 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
PVC-blister med aluminiumsfolie, indeholdende 28 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in secondary heat sealed card packaging.
PVC-blister med aluminiumsfolie, indeholdende 56 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PVC blisters with aluminium foil backing in a pack containing 56 x 1 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 28 x 1 mg filmovertrukne tabletter i en karton.
PCTFE/PVC blisters with aluminium foil backing in a pack containing 28 x 1 mg film-coated tablets in a carton.
PVC-blister med aluminiumsfolie, indeholdende 28 x 0,5 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PVC blisters with aluminium foil backing in a pack containing 28 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
PVC-blister med aluminiumsfolie, indeholdende 56 x 0,5 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PVC blisters with aluminium foil backing in a pack containing 56 x 0.5 mg film-coated tablets in secondary heat sealed card packaging.
Resultaterne viste samme incidens af kombinerede neuropsykiatriske bivirkninger - bortset fra søvnlidelser - hos patienter, der blev behandlet med vareniclin, sammenlignet med de patienter, der fik placebo.
The results showed a similar incidence of combined neuropsychiatric adverse events, other than sleep disorders, in patients treated with varenicline compared to patients treated with placebo, with a risk ratio (RR) of 1.01 (95% CI: 0.89-1.15).
2,00 (1,54, 2,59), P<0,0001 1,77 (1,33, 2,36), P<0,0001
2.00 (1.54, 2.59), P<0.0001
Konjunktivitis, øjensmerter
Conjunctivitis, eye pain
PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtig blister med 28 eller 2 gennemsigtige blistere med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg filmovertrukne tabletter og 1 gennemsigtig blister med 14 x 1 mg filmovertrukne tabletter i en karton.
PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton.
Føler sig unormal Fjendtlighed
Feeling abnormala Hostilitya Agitationb Aggression b
PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg filmovertrukne tabletter og 1 gennemsigtig blister med 14 x 1 mg filmovertrukne tabletter i en karton.
PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister containing 14 x 1 mg film-coated tablets in a carton.
Varmeforseglet kortpakning, indeholdende 1 blisterpakning med 11 x 0,5 mg and 14 x 1 mg vareniclin filmovertrukne tabletter og 1 blisterpakning med 28 eller 2 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning
Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling
N=999 n (%)
Placebo N=999 n (%)
Tabletkerne - CHAMPIX 0,5 mg og 1 mg filmovertrukne tabletter
Tablet Core - CHAMPIX 0.5 mg and 1 mg film-coated tablets Cellulose, Microcrystalline
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg og 14 x 1 mg filmovertrukne tabletter og 1 gennemsigtig blister med 28 eller 2 gennemsigtige blistere med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg and 14 x 1 mg film-coated tablets and 1 clear blister of 28 or 2 clear blisters of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg filmovertrukne tabletter og 1 gennemsigtig blister med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Aftrapning af dosis kan overvejes i de tilfælde, hvor der er høj risiko for, at patienten vil begynde at ryge igen (se pkt.
In patients with a high risk of relapse, dose tapering may be considered (see section 4.4).
Varmeforseglet kortpakning indeholdende 1 blisterpakning med 11 x 0,5 mg og 14 x 1 mg vareniclin filmovertrukne tabletter og 1 blisterpakning med 28 eller 2 blisterpakninger med 14 x 1 mg vareniclin filmovertrukne tabletter - indre og ydre mærkning.
Heat sealed card pack containing 1 blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets and 1 blister pack of 28 or 2 blister packs of 14 x 1 mg varenicline film-coated tablets - inner and outer labelling.
PCTFE/PVC-blister med aluminiumsfolie, indeholdende 1 gennemsigtig blister med 11 x 0,5 mg filmovertrukne tabletter og 1 gennemsigtig blister med 14 x 1 mg filmovertrukne tabletter i en sekundær varmeforseglet kortpakning.
PCTFE/PVC blisters with aluminium foil backing containing 1 clear blister of 11 x 0.5 mg film-coated tablets and a second clear blister of 14 x 1 mg film-coated tablets in secondary heat sealed card packaging.
Forøget muskelspænding, talebesvær, koordinationsbesvær, nedsat smagssans, ændret søvnmønster - Synsforstyrrelser, misfarvning i øjenæblet, forstørrede pupiller, lysfølsomhed, nærsynethed, øjne der løber i vand
Rare: may affect up to 1 in 1,000 people o Excessive thirst o Feeling unwell or unhappy, slow thinking o Stroke o Increased muscle tension, difficulty with speech, difficulty with coordination, reduced sense of taste, altered sleep pattern o Disturbed vision, eyeball discolouration, dilated pupils, sensitivity to light,
Alvorlige hudreaktioner, herunder Stevens-Johnsons syndrom og erythema multiforme, angioødem Knogler, led, muskler og bindevæv Almindelig
Erythema Multiforme, angioedema Musculoskeletal and connective tissue disorders Common
Blisterpakning med 11 x 0,5 mg og 14 x 1 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg and 14 x 1 mg varenicline film-coated tablets, heat sealed card
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE)
PHARMACEUTICAL FORM AND CONTENTS Maintenance pack containing
- CHAMPIX 0,5 mg filmovertrukne tabletter er hvide, filmovertrukne, kapselformede tabletter, mærket ”Pfizer” på den ene side og ”CHX 0.5” på den anden.
What CHAMPIX looks like and contents of the pack CHAMPIX 0.5 mg film-coated tablets are white, film-coated, modified capsular shaped tablets, marked “Pfizer” and “CHX 0.5”
HDPE tabletbeholder, indeholdende 56 x 0,5 mg vareniclin filmovertrukne tabletter
PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 0.5 mg varenicline film-coated tablets
Blisterkort med 11 x 0,5 mg vareniclin filmovertrukne tabletter
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets
Blisterpakning med 11 x 0,5 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 11 x 0.5 mg varenicline film-coated tablets, heat sealed card
Hjerte Ikke almindelig
Common Uncommon
Hver tablet indeholder 0,5 mg vareniclin (som tartrat).
STATEMENT OF ACTIVE SUBSTANCE(S) Each tablet contains 0.5 mg varenicline (as tartrate).
Tabletkerne
Tablets' core
CA* uge 9-12 45,0%
CA* wk 13-24 70.6% 49.8% 20.8% CA* wk 13-52 44.0% 37.1% 6.9%
CHAMPIX 0,5 mg filmovertrukne tabletter CHAMPIX 1 mg filmovertrukne tabletter Vareniclin
Package leaflet: Information for the user CHAMPIX 0.5 mg film-coated tablets CHAMPIX 1 mg film-coated tablets Varenicline
Eller
A.
Det kan være nødvendigt både med og uden behandling med CHAMPIX.
In some cases as a result of stopping smoking, with or without CHAMPIX, an adjustment of the dose of other medicines may be necessary.
Kramperne sås både hos patienter med og uden kramper i anamnesen.
In clinical trials and post-marketing experience there have been reports of seizures in patients with or without a history of seizures, treated with CHAMPIX.
Blisterpakning med 14 x 1 mg vareniclin filmovertrukne tabletter, varmeforseglet kortpakning
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg varenicline film-coated tablets, heat sealed card
Komponenter i sammensat primært endepunkt for NPS AE, n (%): Angst Depression Føler sig unormal
NPS AE Primary Endpoint Components n Anxietya Depression a
CHAMPIX findes i følgende pakningsstørrelser: - Startpakning, der indeholder 2 blisterkort, 1 gennemsigtig blisterkort med 11 x CHAMPIX 0,5 mg filmovertrukne tabletter og 1 gennemsigtigt blisterkort med 14 x CHAMPIX 1 mg filmovertrukne tabletter i en kortpakning.
Treatment initiation pack containing 2 blisters; 1 clear blister of 11 x CHAMPIX 0.5 mg film-coated tablets and 1 clear blister of 14 x CHAMPIX 1 mg film-coated tablets in card packaging.
Blisterkort med 14 x 1 mg vareniclin filmovertrukne tabletter
MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS Blister pack of 14 x 1 mg varenicline film-coated tablets
HDPE tabletbeholder, indeholdende 56 x 1 mg vareniclin filmovertrukne tabletter
PARTICULARS TO APPEAR ON THE OUTER PACKAGING High-density polyethylene (HDPE) bottle packaging for 56 x 1 mg varenicline film-coated tablets
Odomzo tages, så længe det har en gavnlig virkning, eller indtil det ikke længere kan tages på grund af bivirkninger.
Odomzo is continued as long as it has a beneficial effect or until it can no longer be taken because of side effects.
Dette dokument er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Odomzo.
This is a summary of the European public assessment report (EPAR) for Odomzo.
Den fuldstændige EPAR og resuméet af risikostyringsplanen for Odomzo findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR and risk management plan summary for Odomzo can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
De almindeligste bivirkninger ved Odomzo (som kan påvirke mere end 1 ud af 10 personer) er muskelspasmer, hårtab, smagsforstyrrelser, træthed, kvalme, opkastning, muskel- og knoglesmerter, mavepine, hovedpine, diarré, vægttab, appetitløshed og kløe.
The most common side effects with Odomzo (which may affect more than 1 in 10 people) are muscle spasms, hair loss, taste disturbance, tiredness, nausea, vomiting, muscle and bone pain, belly ache, headache, diarrhoea, weight loss, loss of appetite, and itching.
Endvidere vil virksomheden sende en skrivelse til læger, når Odomzo er frigivet.
In addition, the company will send a letter to doctors when Odomzo is launched.
Odomzo fås som kapsler (200 mg), og den anbefalede dosis er én kapsel, taget en gang dagligt mindst to timer efter sidste måltid og en time før det næste.
Odomzo is available as capsules (200 mg) and the recommended dose is one capsule taken once a day at least two hours after the last meal and an hour before the next.
Der er udarbejdet en risikostyringsplan for at sikre, at Odomzo anvendes så sikkert som muligt.
A risk management plan has been developed to ensure that Odomzo is used as safely as possible.
Udvalget fandt, at fordelene ved Odomzo var blevet påvist for patienter med lokalt fremskreden sygdom.
The Committee considered that the benefits of Odomzo had been shown for patients with locally advanced disease.
Stoffer, der påvirker Hedgehog-signaleringsvejen, kan resultere i alvorlig skade på et ufødt barn.
Substances that affect the Hedgehog pathway can result in serious harm to an unborn baby.
Virksomheden skal også analysere tilgængeligt tumormateriale fra patienter, hvis cancer forværredes trods behandling, for at afgøre, hvorfor behandlingen ikke virkede.
The company is also required to analyse available tumour material from patients whose cancer worsened despite treatment, in order to determine why the treatment did not work.
Ved at binde sig til dette protein blokerer sonidegib Hedgehog-signaleringsvejen og reducerer derved væksten og spredningen af kræftceller.
By attaching to this protein, sonidegib blocks the Hedgehog signalling pathway and thereby reduces the growth and spread of cancer cells.
Andre oplysninger om Odomzo
Other information about Odomzo
Patienter blev startet på to forskellige doser af Odomzo: 200 eller 800 mg én gang dagligt.
Patients were started on two different doses of Odomzo: 200 or 800 mg once a day.
Endvidere skal virksomheden levere yderligere analyse fra sin hovedundersøgelse om Odomzos effektivitet og sikkerhed, herunder dets effektivitet over for hastigt voksende og langsomtvoksende basalcellekarcinom.
Furthermore, the company is to supply further analysis from its main study on the effectiveness and safety of Odomzo, including its effectiveness in rapidly growing and slow-growing basal cell carcinoma.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Odomzo opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Odomzo's benefits are greater than its risks and recommended that it be approved for use in the EU.
Det bør kun ordineres af en speciallæge med erfaring i behandling af avanceret basalcellekarcinom eller under opsyn af en sådan læge.
It should only be prescribed by a specialist doctor experienced in the treatment of advanced basal cell carcinoma or under the supervision of such a doctor.
Virksomheden vil også levere uddannelsesmateriale til læger og til patienter, herunder et oplysningskort om risiciene ved lægemidlet og især muligheden for alvorlig skade på det ufødte barn, hvis Odomzo tages under en graviditet.
It will also supply educational material to doctors and to patients, including a reminder card about the risks of the medicine and, in particular, the possibility of serious harm to the unborn baby if Odomzo is taken during pregnancy.
Odomzo indeholder det aktive stof sonidegib.
Odomzo contains the active substance sonidegib.
Ud af dem med lokalt fremskredent basalcellekarcinom reagerede ca. 56 % (37 ud af 66 patienter) på en dosis af 200 mg, og 45 % (58 ud af 128 patienter), der blev startet på en dosis af 800 mg, på behandlingen.
Of those with locally advanced basal cell carcinoma, around 56% (37 of 66 patients) on the 200-mg dose and 45% (58 of 128 patients) started on the 800-mg dose responded to treatment.
Denne signaleringsvej kontrollerer normalt et antal celleaktiviteter, herunder cellevækst og hvordan celler udvikler sig korrekt til at blive til forskellige kropsorganer hos fostre.
This pathway normally controls a number of cell activities including cell growth and how cells develop correctly to make up different body organs in unborn babies.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Odomzo?
What measures are being taken to ensure the safe and effective use of Odomzo?
Kvinder, som potentielt kan blive gravide, må ikke tage Odomzo, medmindre de følger Odomzos præventionsprogram mod graviditet.
Women who could potentially become pregnant must not take Odomzo unless they comply with the Odomzo pregnancy prevention programme.
Kvinder, der er gravide, eller som ammer, må ikke tage Odomzo.
Women who are pregnant or who are breastfeeding must not take Odomzo.
Visse kræftformer, herunder basalcellekarcinom, stammer fra overaktivitet i et specifikt sæt celleprocesser, der kaldes Hedgehog-signaleringsvejen.
Some cancers, including basal cell carcinoma, result from overactivity of a specific set of cell processes called the Hedgehog signalling pathway.
Responsrater var mindre end 20 % hos patienter med metastatisk kræft, der blev startet på enten 200 eller 800 mg Odomzo, og virksomheden trak sin ansøgning for anvendelse ved metastatisk basalcellekarcinom tilbage.
Response rates were less than 20% in patients with metastatic cancer started on either 200 or 800 mg Odomzo and the company withdrew its application for use in metastatic basal cell carcinoma.
Odomzo udleveres kun efter recept.
Odomzo can only be obtained with a prescription.