natgillin/translations-raw huggingface dataset:
Efter 15 ugers behandling var de gennemsnitlige serum 25hydroxyvitamin D niveauer signifikant højere (26 %) i VANTAVO (70 mg/2.800 IE) gruppen (56 nmol/l [23 ng/ml]) end i gruppen med alendronat alene (46 nmol/l [18,2 ng/ml]).
After 15 weeks of treatment, the mean serum 25-hydroxyvitamin D levels were significantly higher (26 %) in the VANTAVO (70 mg/2800 IU) group (56 nmol/l [23 ng/ml]) than in the alendronate-only group (46 nmol/l [18.2 ng/ml]).
• Mavesmerter, ubehagsfølelse i maven eller opstød efter at have spist, forstoppelse, oppustet mave, diarré, øget luftafgang fra tarmen.
• abdominal pain; uncomfortable feeling in the stomach or belching after eating; constipation; full or bloated feeling in the stomach; diarrhoea; flatulence,
Meget almindelige (kan berøre mere end 1 person ud af 10):
Very common (may affect more than 1 in 10 people):
Osteonekrose af øregangen
Osteonecrosis of the jaw
Overdosering kan forårsage hypokalcæmi, hypophosphatæmi og øvre gastrointestinale bivirkninger som mavebesvær, halsbrand, øsofagitis, gastritis eller ulcus.
Hypocalcaemia, hypophosphataemia and upper gastrointestinal adverse reactions, such as upset stomach, heartburn, oesophagitis, gastritis, or ulcer, may result from oral overdose.
VANTAVO 70 mg/5.600 IE tabletter er modificeret rektangulære, hvide/beige tabletter, der er mærket med omridset af en knogle på den ene side og ”270” på den anden side.
VANTAVO 70 mg/5,600 IU tablets are available as modified rectangle-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘270' on the other.
Almindelig Alopeci †, kløe
Common alopecia
BLISTERTEKST TIL VANTAVO 70 mg/2.800 IE
BLISTER FOR VANTAVO 70 mg/2,800 IU
• Irritation eller betændelse i spiserøret (øsofagus - det rør der forbinder din mund med maven)
• irritation or inflammation of the gullet (oesophagus - the tube that connects your mouth with your stomach) or stomach,
Ved administration af VANTAVO 70 mg/5.600 IE tabletter efter en nats faste og to timer før et måltid, var det gennemsnitlige areal under kurven for serum-koncentration-tid (AUC0-80 timer) for D3-vitamin (ikke justeret for endogene D3-vitaminniveauer) hos raske voksne forsøgspersoner (mænd og kvinder) 490,2 ngtime/ml.
In healthy adult subjects (males and females), following administration of VANTAVO 70 mg/5,600 IU after an overnight fast and two hours before a meal, the mean area under the serumconcentration-time curve (AUC0-80 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 490.2 ng•hr/ml.
VANTAVO 70 mg/2.800 IE tabletter
VANTAVO 70 mg/2,800 IU tablets
Patienter i D3-vitamin 2.800 gruppen fik VANTAVO (70 mg/2.800 IE) (n=299), og patienter i D3-vitamin 5.600 gruppen fik VANTAVO (70 mg/2.800 IE) plus yderligere
Patients in the Vitamin D3 2,800 group received VANTAVO (70 mg/2,800 IU) (n=299) and patients in the Vitamin D3 5,600 group received VANTAVO (70 mg/2,800 IU) plus an additional 2,800 IU vitamin D3 (n=309) once a week; additional vitamin D supplements were allowed.
Laboratoriefund
Laboratory test findings
Modificeret kapselformede, hvide/beige tabletter mærket med et omrids af en knogle på den ene side og ”710” på den anden.
Modified capsule-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '710' on the other.
BLISTERTEKST TIL VANTAVO 70 mg/5.600 IE
BLISTER FOR VANTAVO 70 mg/5,600 IU
Ved administration af VANTAVO 70 mg/2.800 IE tabletter efter en nats faste og to timer før et måltid, var det gennemsnitlige areal under kurven for serum-koncentration-tid (AUC0-120 timer) for D3-vitamin (ikke justeret for endogene D3-vitaminniveauer) hos raske voksne forsøgspersoner (mænd og kvinder) 296,4 ngtime/ml.
In healthy adult subjects (males and females), following administration of VANTAVO 70 mg/2,800 IU tablets after an overnight fast and two hours before a meal, the mean area under the serum-concentration-time curve (AUC0-120 hrs) for vitamin D3 (unadjusted for endogenous vitamin D3 levels) was 296.4 ng•hr/ml.
Sjældne (kan berøre op til 1 person ud af 1.000):
Rare (may affect up to 1 in 1,000 people):
Meget sjældne (kan berøre op til 1 person ud af 10.000):
Very rare (may affect up to 1 in 10,000 people):
VANTAVO 70 mg/2.800 IE tabletter er modificeret kapselformede hvide/beige tabletter mærket med omridset af en knogle på den ene side og ”710” på den anden side.
VANTAVO 70 mg/2800 IU tablets are available as modified capsule-shaped, white to off-white tablets marked with an outline of a bone image on one side and ‘710' on the other.
VANTAVO 70 mg/5.600 IE tabletter
VANTAVO 70 mg/5,600 IU tablets
• Knogle- muskel- og/eller ledsmerter, som kan være voldsomme.
• bone, muscle and/or joint pain which is severe.
EU/1/09/572/006 (2 tabletter) EU/1/09/572/007 (4 tabletter) EU/1/09/572/008 (12 tabletter)
EU/1/09/572/006 (2 tablets) EU/1/09/572/007 (4 tablets) EU/1/09/572/008 (12 tablets)
Modificeret rektangulære, hvide/beige tabletter mærket med et omrids af en knogle på den ene side og ”270” på den anden.
Modified rectangle-shaped, white to off-white tablets, marked with an outline of a bone image on one side, and '270' on the other.
EU/1/09/572/001 (2 tabletter) EU/1/09/572/002 (4 tabletter) EU/1/09/572/003 (6 tabletter) EU/1/09/572/004 (12 tabletter)
EU/1/09/572/001 (2 tablets) EU/1/09/572/002 (4 tablets) EU/1/09/572/003 (6 tablets) EU/1/09/572/004 (12 tablets)
Meget almindelig Muskuloskeletale (knogle, muskel eller led) smerter, som kan være voldsomme
Very common musculoskeletal (bone, muscle or joint) pain which is sometimes severe Common joint swelling Rare osteonecrosis of the jaw
VANTAVO 70 mg/5.600 IE tabletter EU/1/09/572/006 - 2 tabletter EU/1/09/572/007 - 4 tabletter EU/1/09/572/008 - 12 tabletter
VANTAVO 70 mg/5,600 IU tablets EU/1/09/572/006 - 2 tablets EU/1/09/572/007 - 4 tablets EU/1/09/572/008 - 12 tablets
Procentdelen af patienter med D-vitaminmangel (serum 25-hydroxyvitamin D < 37,5 nmol/l [<15 ng/ml]) var signifikant reduceret med 62,5 % med VANTAVO (70 mg/2.800 IE) versus alendronat alene (henholdsvis 12 % versus 32 %) efter uge 15.
insufficiency (serum 25-hydroxyvitamin D < 37.5 nmol/l [< 15 ng/ml]) was significantly reduced by 62.5 % with VANTAVO (70 mg/2800 IU) vs. alendronate-only (12 % vs. 32 %, respectively), through week 15.
Kroppen kan kun optage kalk ordentligt fra maden, hvis der er nok D-vitamin til stede.
The body can only absorb calcium properly from our food if it has enough vitamin D. Very few foods contain vitamin D. The main source is through exposure to summer sunlight, which makes vitamin D in our skin.
Sådan skal du tage VANTAVO
How to take VANTAVO
VANTAVO 70 mg/2.800 IE tabletter Aluminium/aluminiumblisterkort i æsker med 2, 4, 6 eller 12 tabletter.
VANTAVO 70 mg/2,800 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4, 6 or 12 tablets.
Disse omfatter kunstige fedterstatninger, mineralske olier, slankemidlet orlistat og de kolesterolsænkende lægemidler colestyramin og colestipol.
It is likely that certain medicines or food additives may prevent the vitamin D in VANTAVO from getting into your body, including artificial fat substitutes, mineral oils, the weight loss medicine, orlistat, and the cholesterol-lowering medicines, cholestyramine and colestipol.
På grund af manglende erfaring bør VANTAVO ikke gives til patienter med nedsat nyrefunktion, hvor kreatinin-clearance er <35 ml/min.
VANTAVO is not recommended for patients with renal impairment where creatinine clearance is less than 35 ml/min, due to lack of experience.
VANTAVO 70 mg/2.800 IE, tabletter VANTAVO 70 mg/5.600 IE, tabletter
VANTAVO 70 mg/2800 IU tablets VANTAVO 70 mg/5,600 IU tablets
VANTAVO 70 mg/5.600 IE tabletter Aluminium/aluminiumblisterkort i æsker med 2, 4 eller 12 tabletter.
VANTAVO 70 mg/5,600 IU tablets Aluminium/aluminium blisters, in cartons containing 2, 4 or 12 tablets.
Patienter kan opleve visse bivirkninger ved VANTAVO (f.eks. sløret syn, svimmelhed og svære knogle-, muskel- eller ledsmerter (se pkt.
Patients may experience certain adverse reactions (for example, blurred vision, dizziness and severe bone muscle or joint pain (see section 4.8)) that may influence the ability to drive and use machines.
Almindelige (kan berøre op til 1 person ud af 10):
Common (may affect up to 1 in 10 people):
5.2 Farmakokinetiske egenskaber
Pharmacokinetic properties
VANTAVO 70 mg/5.600 IE tabletter fås i pakninger med 2, 4 eller 12 tabletter.
VANTAVO 70 mg/5,600 IU tablets are available in packs containing 2, 4 or 12 tablets.
VANTAVO 70 mg/2.800 IE tabletter fås i pakninger med 2, 4, 6 eller 12 tabletter.
VANTAVO 70 mg/2,800 IU tablets are available in packs containing 2, 4, 6 or 12 tablets.
Ikke almindelige (kan berøre op til 1 person ud af 100):
Uncommon (may affect up to 1 in 100 people):
Tag 1 tablet 1 gang ugentligt
Take one tablet once a week
VANTAVO 70 mg/2.800 IE tabletter VANTAVO 70 mg/5.600 IE tabletter alendronsyre/cholecalciferol
VANTAVO 70 mg/2800 IU tabletsVANTAVO 70 mg/5,600 IU tablets Alendronic acid / colecalciferol
†, perifert ødem
Renal impairment
INDEHAVER AF MARKEDSFØRINGSTILLADELSEN
MARKETING AUTHORISATION HOLDER(S)
Denne indlægsseddel blev senest ændret
This leaflet was last revised in <{MM/YYYY}>.
Meget få fødevarer indeholder D-vitamin.
The percentage of patients with vitamin D
Hver VANTAVO 70 mg/2.800 IE tablet indeholder 70 mg alendronsyre (som natriumtrihydrat) og 70 mikrogram (2.800 IE) cholecalciferol (D3-vitamin).
Each VANTAVO 70 mg/2,800 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
Tag ikke tabletterne, hvis du mener, at noget af ovenstående passer på dig.
If you think any of these apply to you, do not take the tablets.
VANTAVO 70 mg/5.600 IE tabletter Alendronsyre/cholecalciferol
VANTAVO 70 mg/5600 IU tablets alendronic acid /colecalciferol
Hver VANTAVO 70 mg/5.600 IE tablet indeholder 70 mg alendronsyre (som natriumtrihydrat) og 140 mikrogram (5.600 IE) cholecalciferol (D3-vitamin).
Each VANTAVO 70 mg/5,600 IU tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3)
70 mg/5600 IE tabletter alendronsyre/cholecalciferol
70 mg/5600 IU tablets alendronic acid/colecalciferol
70 mg/2800 IE tabletter alendronsyre/cholecalciferol
70 mg/2800 IU tablets alendronic acid/colecalciferol
Almindelig Asteni
Common asthenia
Hver tablet indeholder 70 mg alendronsyre (som natriumtrihydrat) og 140 mikrogram (5.600 IE) cholecalciferol (D3-vitamin).
Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 140 micrograms (5,600 IU) colecalciferol (vitamin D3).
Hver tablet indeholder 70 mg alendronsyre (som natriumtrihydrat) og 70 mikrogram (2.800 IE) cholecalciferol (D3-vitamin).
Each tablet contains 70 mg alendronic acid (as sodium trihydrate) and 70 micrograms (2800 IU) colecalciferol (vitamin D3).
PRODUKTRESUME
Excipients
VANTAVO 70 mg/2.800 IE tabletter Alendronsyre/cholecalciferol
VANTAVO 70 mg/2800 IU tablets alendronic acid /colecalciferol
Det skal du vide, før du begynder at tage VANTAVO Sådan skal du tage VANTAVO Bivirkninger
What VANTAVO is and what it is used for What you need to know before you take VANTAVO How to take VANTAVO
Alendronat nedsætter risikoen for hoftebrud samt brud på rygsøjlen.
It reduces the risk of spine and hip fractures.
TI
THU
Almindelig Vertigo Meget sjælden Osteonekrose af øregangen (klassebivirkning for bisphosphonater)
Very rare osteonecrosis of the external auditory canal
Den anbefalede dosis er 400 mg én gang om måneden.
The recommended dose is 400 mg once a month.
Det må ikke gives ved injektion i en vene eller under huden.
It must not be injected into a vein or under the skin.
Den fuldstændige EPAR for Abilify Maintena findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Abilify Maintena can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Abilify Maintena den 15. november 2013.
The European Commission granted a marketing authorisation valid throughout the European Union for Abilify Maintena on 15 November 2013.
Dets nøjagtige virkningsmekanisme kendes ikke, men det bindes til en række receptorer på overfladen af nervecellerne i hjernen.
Its exact mechanism of action is unknown, but it attaches to several receptors on the surface of nerve cells in the brain.
Efter den første injektion bør den daglige behandling med 10-20 mg aripiprazol gennem munden fortsætte i to uger.
After the first injection, daily treatment with 10 to 20 mg aripiprazole by mouth should be continued for 2 weeks.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Abilify Maintena.
This is a summary of the European public assessment report (EPAR) for Abilify Maintena.
At det er et depotpræparat, betyder, at det aktive stof frigives langsomt i flere uger efter injektionen.
‘Prolonged release' means that the active substance is released slowly over a few weeks after being injected.
Behandling i over to uger med lægemidler, der fremskynder nedbrydningen af aripiprazol, bør undgås.
Treatment beyond 2 weeks with medicines that speed up the breakdown of aripiprazole should be avoided.
I én hovedundersøgelse med voksne, hvis sygdom i forvejen var blevet stabil på behandling med aripiprazol indtaget gennem munden, kom der i løbet af 26 uger tilbagefald af symptomer hos 22 (8,3 %) af de 265 patienter, der blev behandlet med Abilify Maintena, sammenholdt med 21 (7,9 %) af de 266 patienter, der var behandlet med aripiprazol taget gennem munden.
In one main study involving adults whose disease had already been stabilised on treatment with aripiprazole taken by mouth, 22 out of the 265 patients (8.3%) treated with Abilify Maintena had symptoms coming back within 26 weeks, compared with 21 out of 266 (7.9%) patients treated with aripiprazole taken by mouth.
Det anvendes til vedligeholdelsesbehandling af skizofreni hos voksne, hos hvem sygdommen i forvejen er stabiliseret ved behandling med aripiprazol indtaget gennem munden.
It is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised on treatment with aripiprazole taken by mouth.
Agenturets Udvalg for Lægemidler til Mennesker (CHMP) besluttede, at fordelene ved Abilify Maintena opvejer risiciene, og anbefalede, at det godkendes til anvendelse i EU.
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Abilify Maintena's benefits are greater than its risks and recommended that it be approved for use in the EU.
Udvalget fandt, at doseringen en gang om måneden kan gøre det lettere for patienterne at følge behandlingen.
The Committee considered that the monthly administration may help patients to adhere to their treatment.
Abilify Maintena aripiprazol
Abilify Maintena aripiprazole
Der er udarbejdet en risikostyringsplan for at sikre, at Abilify Maintena anvendes så risikofrit som muligt.
A risk management plan has been developed to ensure that Abilify Maintena is used as safely as possible.
Lægemidlet gives én gang om måneden ved langsom injektion i balderne eller deltamusklen (skulderen).
The medicine is given once a month by slow injection into the buttock or deltoid (shoulder) muscle by a doctor or nurse.
Da dopamin og 5-hydroxytryptamin er inddraget ved skizofreni, medvirker aripiprazol til at normalisere hjerneaktiviteten, så de psykotiske symptomer mindskes og ikke kommer igen.
Since dopamine and 5hydroxytryptamine are involved in schizophrenia, aripiprazole helps to normalise the activity of the brain, reducing psychotic symptoms and preventing them from returning.
Aripiprazol menes hovedsagelig at virke ved delvis stimulation (som en såkaldt “partiel agonist”) af receptorerne for neurotransmitterne dopamin og 5hydroxytryptamin (også kaldet serotonin).
Aripiprazole is thought to act mainly by being a ‘partial agonist' for the receptors for the neurotransmitters dopamine and 5-hydroxytryptamine (also called serotonin).
Det aktive stof i Abilify Maintena, aripiprazol, er et antipsykotisk lægemiddel.
The active substance in Abilify Maintena, aripiprazole, is an antipsychotic medicine.
Andre oplysninger om Abilify Maintena
Other information about Abilify Maintena
De hyppigste bivirkninger med Abilify Maintena (som kan forekomme hos 5 eller flere ud af 100 behandlede) er vægtstigning, manglende evne til at sidde stille (akatisi), søvnbesvær (insomni) og smerte på injektionsstedet.
The most common side effects with Abilify Maintena (which may affect 5 or more people in 100) are increased weight, akathisia (a constant urge to move), insomnia (difficulty sleeping) and injection site pain.
CHMP bemærkede, at Abilify Maintena er lige så effektivt som aripiprazol indtaget gennem munden og har en tilsvarende sikkerhedsprofil bortset fra smerte på injektionsstedet, som blev anset for at kunne håndteres.
The CHMP noted that Abilify Maintena is as effective as aripiprazole taken by mouth, and has a similar safety profile with the exception of injection pain, which was considered manageable.
På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og indlægssedlen for Abilify Maintena, herunder passende forholdsregler, som patienter og sundhedspersonale bør træffe.
Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Abilify Maintena, including the appropriate precautions to be followed by healthcare professionals and patients.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Abilify Maintena?
What measures are being taken to ensure the safe and effective use of Abilify Maintena?
Abilify Maintena fås som et pulver (300 mg og 400 mg) og en opløsningsvæske (et solvens), der blandes og gives som depotinjektion.
Abilify Maintena is available as a powder (300 mg and 400 mg) and solvent to be made into a prolonged-release suspension for injection.
Hvis du ønsker yderligere oplysninger om behandling med Abilify Maintena, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Abilify Maintena, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Abilify Maintena er et lægemiddel, der indeholder det aktive stof aripiprazol.
Abilify Maintena is a medicine that contains the active substance aripiprazole.
Abilify Maintena blev påvist at være lige så effektivt som aripiprazol indtaget gennem munden til at forebygge tilbagevenden af symptomerne på skizofreni.
Abilify Maintena was shown to be as effective as aripiprazole taken by mouth at preventing symptoms of schizophrenia from returning.
Skizofreni er en psykisk sygdom, der giver symptomer bl.a. i form tankeforstyrrelser og taleforstyrrelser, sansebedrag (hallucinationer), mistænksomhed og vrangforestillinger.
Schizophrenia is a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
Hvad er Atosiban Maintena, og hvad anvendes det til?
What is Abilify Maintena and what is it used for?
Det er ikke en praktisk vejledning i, hvordan Abilify Maintena bør anvendes.
It is not intended to provide practical advice on how to use Abilify Maintena.
Hvilke risici er der forbundet med Abilify Maintena?
What are the risks associated with Abilify Maintena?
Det vil sige, at aripiprazol aktiverer disse receptorer på samme måde som dopamin og 5-hydroxytryptamin, men ikke så kraftigt som neurotransmitterne.
This means that aripiprazole acts like dopamine and 5-hydroxytryptamine by activating these receptors, but less strongly than the neurotransmitters.
Hvorfor er Abilify Maintena blevet godkendt?
Why is Abilify Maintena approved?
Hvis du ønsker praktisk vejledning om anvendelsen af Abilify Maintena, kan du læse indlægssedlen eller kontakte din læge eller dit apotek
For practical information about using Abilify Maintena, patients should read the package leaflet or contact their doctor or pharmacist.
Derved afbrydes de signaler, som hjernecellerne sender til hinanden ved hjælp af signalstoffer (neurotransmittere).
This disrupts signals transmitted between brain cells by ‘neurotransmitters', chemicals that allow nerve cells to communicate with each other.
Den fuldstændige liste over indberettede bivirkninger ved Abilify Maintena fremgår af indlægssedlen.
For the full list of all side effects reported with Abilify Maintena, see the package leaflet.
I tilfælde af bivirkninger kan dosis nedsættes til 300 mg. Dosisnedsættelse kan også være nødvendig for patienter, der tager visse andre lægemidler, som hæmmer nedbrydningen af aripiprazol i kroppen.
The dose may also need to be lowered in patients who are taking certain other medicines that slow the breakdown of aripiprazole in the body.
Hvordan anvendes Abilify Maintena?
How is Abilify Maintena used?
Hvilke fordele viser undersøgelserne, at der er ved Abilify Maintena?
What benefits of Abilify Maintena have been shown in studies?
Hvordan virker Abilify Maintena?
How does Abilify Maintena work?
Pakningsstørrelse
Route of Administration
Dette sammendrag blev sidst ajourført i 09-2014.
This summary was last updated in 09/2014.
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Fortacin den 15. november 2013.
The European Commission granted a marketing authorisation valid throughout the European Union for Fortacin on 15 November 2013.
Doseringen må ikke gentages oftere end hver fjerde time, og der må højst anvendes tre doser i løbet af 24 timer.
Doses should not be repeated more frequently than every 4 hours, and no more than three doses should be used in 24 hours.
Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Fortacin.
This is a summary of the European public assessment report (EPAR) for Fortacin.
Fortacin lidocain/prilocain
Fortacin lidocaine / prilocaine
Den fuldstændige EPAR for Fortacin findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Fortacin can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Andre oplysninger om Fortacin
Other information about Fortacin
Hvad er Fortacin, og hvad anvendes det til?
What is Fortacin and what is it used for?
Hvorfor er Fortacin blevet godkendt?
Why is Fortacin approved?
Fortacin må heller ikke anvendes hos patienter, hvis partnere er overfølsomme over for disse stoffer.
Fortacin must also not be used in patients whose partners are hypersensitive to these substances.
Der er udarbejdet en risikostyringsplan for at sikre, at Fortacin anvendes så risikofrit som muligt.
A risk management plan has been developed to ensure that Fortacin is used as safely as possible.
Der var klare psykologiske fordele for patienterne og deres partnere, og bivirkningerne var lokale og kunne sædvanligvis håndteres.
There were positive psychological benefits to patients and their partners, and side effects were local and generally manageable.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Fortacin?
What measures are being taken to ensure the safe and effective use of Fortacin?
I en forlængelse af de indledende undersøgelser blev nogle af patienterne fulgt i op til 9 måneder og havde stadig samme gavnlige virkning.
Some patients were monitored for up to 9 months in an extension of the initial studies and continued to show similar benefit.
Det er ikke en praktisk vejledning i, hvordan Fortacin bør anvendes.
It is not intended to provide practical advice on how to use Fortacin.
Hvilke risici er der forbundet med Fortacin?
What are the risks associated with Fortacin?
CHMP afgjorde derfor, at fordelene ved Fortacin overstiger risiciene, og anbefalede udstedelse af markedsføringstilladelse med gyldighed i EU.
The CHMP therefore decided that Fortacin's benefits are greater than its risks and recommended that it be approved for use in the EU.