natgillin/translations-raw huggingface dataset:
Ikke almindelig: Varmefølelse, erythem på injektionsstedet, somnolens, utilpashed, perifert ødem, smerter, fingertryksødem, temperaturintolerans, svaghed
Feeling hot, injection site erythema, lethargy, malaise, oedema peripheral, pain, pitting oedema, temperature intolerance, weakness
Der er ingen erfaring med anvendelse af natriumporfimer til gravide.
There are no clinical data on exposed pregnancies available for porfimer sodium.
Axcan Pharma SAS Route de Bû 78550 Houdan Frankrig
78550 Houdan
Vaskulære sygdomme Ikke almindelig: Hypertension, hæmorrhagi, hedestigninger, hypotension, orthostatisk
Hypertension, haemorrhage, hot flushes, hypotension, orthostatic hypotension
Gentagen lysbehandling
Repeat light application
Lysbehandlingsudstyr Hensigt med behandling
Study day Light delivery devices Treatment intent
Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper) Ikke almindelig: Basalcellekarcinom, lentigo
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uncommon:
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN PhotoBarr 75 mg pulver til injektionsvæske, opløsning Natriumporfimer
PACKAGE LEAFLET: INFORMATION FOR THE USER PhotoBarr 75 mg powder for solution for injection Porfimer sodium
6.5 Emballagetype og pakningsstørrelse
6.5 Nature and contents of container
Ikke almindelig: Leukocytose
Leukocytosis
Kontrollér, at der er tilstrækkelige gardiner og rullegardiner i Deres hjem til at holde stærkt sollys ude, inden De tager afsted for at få Deres PhotoBarr-injektion.
Before you go to receive your PhotoBarr injection, check that there are adequate shades and curtains in your home to keep out bright sunlight.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Pulver til injektionsvæske, opløsning.
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection.
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 15 mg natriumporfimer.
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 15 mg porfimer sodium.
LISTE OVER HJÆLPESTOFFER Saltsyre, natriumhydroxyd (til pH-justering).
Hydrochloric acid, sodium hydroxide (for pH adjustment).
4.3 og
Day 3a
Spørg lægen eller på apoteket, hvis der er mere, De vil vide.
You may need to read it again If you have any further questions, please ask your doctor or pharmacist.
Fiberoptik-diffusor
Gastrointestinal disorders
Indehaver af markedsføringstilladelsen Axcan Pharma International B.V., Engelenkampstraat 72, NL-6131JJ Sittard, Holland
Pinnacle Biologics B.V., p/a Trust Company Amsterdam B.V., Crystal Tower 21st Floor, Orlyplein 10, 1043 DP Amsterdam, The Netherlands
Beskyttes mod lys og anvendes inden for 3 timer efter rekonstitution.
After reconstitution, protect from light and use within 3 hours.
DATO FOR FØRSTE MARKEDSFØRINGSTILLADELSE/FORNYELSE AF
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 25 March 2004
Medfødte, familiære og genetiske sygdomme Ikke almindelig: Pigmenteret nævus
Congenital and familial and genetic disorders Uncommon:
Navn og adresse på fremstilleren ansvarlig for batchfrigivelse
A MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
DET SKAL DE VIDE, FØR DE BEGYNDER AT BRUGE PHOTOBARR
BEFORE YOU USE PHOTOBARR
Optagelse af fotoantistof
PhotoBarr Injection
Ballonvindue længde (cm)
Balloon Window Length (cm)
Lysdoser
Light doses
Ca. 90 dage efter injektionen med PhotoBarr skal De teste hudens lysfølsomhed på følgende måde: Klip et 5 cm stort hul i en papirpose, som De lægger på Deres hånd eller Deres albue (ikke ansigtet).
Cut a 2-inch hole in a paper bag, put it on your hand or elbow (not your face).
• BETINGELSER ELLER BEGRÆNSNINGER PÅLAGT INDEHAVEREN AF MARKEDSFØRINGSTILLADELSEN VEDRØRENDE UDLEVERING OG BRUG Lægemidlet må kun udleveres efter begrænset recept (jf. bilag I: Produktresumé; pkt.
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Ikke almindelig: Løs afføring, ulcerøs øsofagitis, abdominalt ubehag, abdominal distension, nedre abdominalsmerter, erhvervet pylorusstenose, sprukne læber, colitis, flatulens, gastritis, gastrointestinal blødning, dårlig ånde, øsofagusblødning, øsofagusperforation.
Loose stools, oesophagitis ulcerative, abdominal discomfort, abdominal distension, abdominal pain lower, acquired pylori stenosis, chapped lips, colitis, flatulence, gastritis, gastrointestinal haemorrhage, halitosis, oesophageal haemorrhage, oesophageal perforation.
Meget almindelige bivirkninger
POSSIBLE SIDE EFFECTS
Pruritus, udslet, hudskørhed, misfarvning af huden, hudsår, eksfoliativ dermatitis, tør hud, varmeknopper, maculo-papuløst udslæt, papuløst udslæt, ardannelse, hyperpigmentering af huden, hudlæsion, hudnoduli, urticaria Ikke almindelig: Koldsved, dermatitis, abnorm hårvækst, øget tendens til blå mærker, keloidar, nattesved, lysfølsomt udslæt, maculøst udslæt, skællende udslæt, skorpedannelse, cikatricesmerter, vitiligo.
Uncommon side effects difficulty breathing, decrease in level of oxygen, choking, swelling of the airways, fluid in airways, shortness of breath during physical activity, wheezing, coughing up more phlegm, coughing up blood, stuffy nose lung infection, sinus infection chest pain or heart attack, high blood pressure or low blood pressure, chest discomfort abnormal blood test results, including increase in white blood cells, low potassium levels bleeding, loss of blood, increased tendency to bruise over development of breasts in men, inability to urinate, temperature intolerance, cold sweats, night sweats general swelling, general pain, musculoskeletal chest pain, stiffness of joint, inflammation of the heel shakes, restlessness, dizziness, numbness, flushes, feeling weak, feeling unwell loss of hearing, ringing in the ears, swelling of the eye, eye pain rash, redness at the injection site, nail fungal infection, skin infection, blister, itchy skin, overgrowth of tissue at the site of skin injury, scar pain, scab, presence of skin moles, abnormal hair growth
Undersøgelser
Procedure
ANGIVELSE AF AKTIVT STOF/AKTIVE STOFFER Et hætteglas indeholder 75 mg natriumporfimer.
STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 75 mg porfimer sodium
LÆGEMIDLETS NAVN PhotoBarr 15 mg pulver til injektionsvæske, opløsning
NAME OF THE MEDICINAL PRODUCT PhotoBarr 15 mg powder for solution for injection
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) PhotoBarr 75 mg pulver til injektionsvæske, opløsning Natriumporfimer
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION PhotoBarr 75 mg powder for solution for injection Porfimer sodium
Hikke, odynofagi, diarre, dyspepsi, øsofagusulcus, øvre abdominalsmerter*, abdominalsmerter, haematemese, øsofagussmerter, ructus, melæna (haematocheznia), forstyrrelser i øsophagus, føderegurgitation, abdominal défence, øsofagusspasmer, øsofagitis.
Hiccups, odynophagia, diarrhoea, dyspepsia, oesophageal ulcer, abdominal pain upper*, abdominal pain, haematemesis, oesophageal pain, eructation, melaena (haematocheznia), oesophageal disorder, regurgitation of food, abdominal rigidity, oesophageal spasm, oesophagitis.
Alarmkort
Patient alert card
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) PhotoBarr 15 mg pulver til injektionsvæske, opløsning Natriumporfimer
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION PhotoBarr 15 mg powder for solution for injection Porfimer sodium
Følsomhed i øjet
Ocular sensitivity
UBRUGTE LÆGEMIDLER ELLER AFFALD FRA SÅDANNE
OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF
LÆGEMIDLETS NAVN PhotoBarr 75 mg pulver til injektionsvæske, opløsning.
NAME OF THE MEDICINAL PRODUCT PhotoBarr 75 mg powder for solution for injection.
Brystsmerter, der ikke er hjerterelaterede
Non Cardiac Chest Pain
Øsofagusstenose
Oesophageal Stenosis
− Informationsredskaberne er udarbejdet til at hjælpe lægerne med at optimere o de har en tracheo-øsofageal eller broncho-øsofageal fistel.
o they have trachea or broncho-oesophageal fistulas.
Ballonvindue størrelse (cm)
Balloon window size (cm)
Benigne, maligne og uspecificerede tumorer (inkl.cyster og polypper) Ikke almindelig: Basalcellekarcinom, lentigo Blod og lymfesystem
Basal cell carcinoma, lentigo Blood and lymphatic system disorders Uncommon:
− Patienterne skal fortælle det til deres læge, hvis de har en svær leversygdom, før de o Bliver i kroppen i 60-90 dage efter modtagelse af injektionen.
− Patients should inform their doctor before they start treatment if they have severe o Remains in your body for 60-90 days after receiving the injection o There is an increased risk of photosensitivity (sensitivity to light) o Exposed skin will become red and cause discomfort in most cases but severe o Commercially available sun blocks are not effective in preventing sensitivity due to light
aspirationspneumoni, produktiv hoste, respirationsdepression,
Choking, dyspnoea exertional, haemoptysis, hypoxia, nasal congestion, pneumonia aspiration, productive cough, respiratory depression, respiratory
Hud og subkutane væv Meget almindelig: Lysfølsomhedsreaktion Almindelig:
Tracheo-oesophageal fistula, Gastrointestinal necrosis Skin and subcutaneous tissue disorders Very common: Photosensitivity reaction Common:
Luftveje, thorax og mediastinum
Embolism, Deep vein thrombosis, Phlebitis Respiratory, thoracic and mediastinal disorders Common:
LÆGEMIDLETS NAVN PhotoBarr 75 mg pulver til injektionsvæske, opløsning Natriumporfimer
NAME OF THE MEDICINAL PRODUCT PhotoBarr 75 mg powder for solution for injection
Sår på huden, udslæt, kløe, nældefeber, ændring i hudfarve, rifter, ar, vævsafvigelser, buler på huden, meget små cyster på huden, tør og skrøbelig hud.
Common side effects back pain, pain in arms and legs, pain due to treatment headache, feeling nervous, tingling feeling, problems sleeping abdominal stiffness, stomach pain, vomiting blood disorders of the gullet such as ulcer, irritation or constriction loose stools, passing dark tarry stool, sore throat, hiccups, belching fluid in chest, chest pain, fast heart beat, shortness of breath, shakes due to high fever, chills loss of weight, decrease in appetite, feeling tired, loss of taste skin ulcer, rash, itchiness, hives, change in skin colour, scratch, scar, abnormal tissue, bump on the skin, very small cysts in the skin, dry and fragile skin
Må ikke anvendes efter den udløbsdato, der er angivet på æsken og hætteglasset efter EXP.
Do not use after the expiry date stated on the carton and vial after the EXP. Do not store above 25°C.
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) Pulver til injektionsvæske, opløsning, 1 hætteglas.
PHARMACEUTICAL FORM AND CONTENTS Powder for solution for injection.1 vial
Kulderystelser, træthed
Post procedural pain, abrasion
Katarakt
Lactation
Ikke almindelig: Øjenirritation, øjenødem Ikke kendt:
Eye disorders Uncommon:
Brug ikke PhotoBarr hvis De er overfølsom (allergisk) over for natriumporfimer eller andre porfyriner eller et af de øvrige indholdsstoffer (anført i pkt.
Do not use PhotoBarr if you are allergic (hypersensitive) to porfimer sodium other porphyrins or to any other ingredients of PhotoBarr (listed in section 6 “What PhotoBarr contains”) if you have porphyria if you have an opening (fistula) between the oesophagus and the airways if you suffer from varices of your oesophageal veins or erosion of other major blood vessels if you have ulcers in your oesophagus if you have severe liver of kidney problems
Efter rekonstitution: anvendes straks (inden for 3 timer) Efter rekonstitution skal PhotoBarr anvendes straks (inden for 3 timer) og beskyttes mod lys.
After reconstitution: use immediately (within 3 hours).
NL-6131JJ Sittard Holland
Orlyplein 10, 1043 DP Amsterdam The Netherlands
Hætteglas 75 mg - 40 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 75 mg - 40 ml
Beskyttes mod lys og anvendes straks inden for 3 timer efter rekonstitution.
Keep the vial in the outer carton in order to protect from light After reconstitution, protect from light and use immediately within 3 hours.
Nødvendigt effekt-output fra diffusora (W)
Required Power Output from Diffuser a
Brug ikke PhotoBarr hvis De er overfølsom (allergisk) over for natriumporfimer, andre porfyriner eller et af de øvrige indholdsstoffer (anført i pkt.
Do not use PhotoBarr if you are allergic (hypersensitive) to porfimer sodium, other porphyrins or any of the other ingredients of PhotoBarr (listed in section 6, ‘What PhotoBarr contains') if you have porphyria if you have an opening (fistula) between the oesophagus and the airways if you suffer from varices of your oesophageal veins or erosion of other major blood vessels if you have ulcers in your oesophagus if you have severe liver or kidney problems
Ikke almindelig: Ledkontraktur, nedsat ledbevægelighed, muskuloskeletale brystsmerter, plantar fascitis
Joint contracture, joint range of motion decreased, musculoskeletal chest pain,
Læsioner i tarmen, unormal åbning mellem luftrøret og spiserøret Blodpropper, blokerede arterier, inflammation (betændelseslignende tilstand) i en vene Tal med lægen eller apoteket, hvis en bivirkning er generende eller bliver værre, eller De får bivirkninger, som ikke er nævnt her.
Frequency not known side effects lung infection lower number of red cells in your blood cataract lesion in intestine, abnormal opening between the wind pipe and the food pipe allergic reaction blood clots in your vessels, blockage of blood arteries, inflammation of a vein
Vægttab, nedsat appetit, træthedsfornemmelse, tab af smag.
Appetite decreased, electrolyte imbalance
Indflydelsen af nedsat nyre- og leverfunktion på eksposition for natriumporfimer er ikke evalueret (se pkt.
The influence of hepatic impairment on exposure to porfimer sodium has not been evaluated (see section 4.3 and 4.4).
Hos patienterne var den gennemsnitlige højeste plasmakoncentration (Cmax) 79,6 μg/ml (C.V.
In patients,the mean peak plasma concentration (Cmax) was 79.6 μg/ml (C.V. 61%, range 39-222), whereas in volunteers Cmax was 40 μg/ml and AUCinf was 2400 μg/h/ml.
Hætteglas 15 mg - 7 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS Vial 15 mg - 7 ml
Rygsmerter, ekstremitetssmerter
Blister, post procedural haemorrhage
Forstoppelse, dehydrering
Pleural effusion, pharyngitis, atelectasis, dyspnoea
Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for ProteqFlu den 6. marts 2003.
The European Commission granted a marketing authorisation valid throughout the European Union for ProteqFlu on 6 March 2003.
Immunogeniciteten af den aktuelle formulering af vaccinen er blevet bekræftet hos 15 føl.
The immunogenicity of the current formulation of the vaccine was confirmed in 15 foals.
Hesteinfluenza er en særdeles smitsom sygdom, der er meget almindelig hos heste, men som sjældent er dødelig.
Equine influenza is a highly contagious disease that is very common in horses but rarely causes death.
Tilbageholdelsestiden for ProteqFlu for kød og mælk er nul dage.
The withdrawal period for ProteqFlu for meat and milk is zero days.
Andre oplysninger om ProteqFlu:
Other information about ProteqFlu:
I tilfælde af forøget infektionsrisiko eller utilstrækkelig optagelse af colostrum (råmælk) kan der gives en ekstra første injektion i en alder af 4 måneder efterfulgt af det fulde vaccinationsprogram (basisvaccination og efterfølgende revaccinationer).
In case of increased risk of infection or insufficient intake of colostrum (first milk), an additional initial injection can be given at the age of 4 months, followed by the full vaccination programme (primary vaccination and following revaccinations).
Vacciner virker ved at "lære" immunsystemet (kroppens naturlige forsvar), hvordan det skal forsvare kroppen mod en sygdom.
Vaccines work by ‘teaching' the immune system (the body's natural defences) how to defend itself against diseases.
Vaccine mod hesteinfluenza
Equine influenza vaccine
I tilfælde af utilsigtet selvinjektion skal der straks søges lægehjælp, og indlægssedlen eller etiketten skal vises til lægen.
In case of accidental self-injection, medical advice should be sought immediately and the package leaflet or the label shown to the doctor.
Vaccinen gives som en intramuskulær injektion (injektion i en muskel).
The vaccine is given as an intramuscular injection (injection into a muscle).
Virkningen af ProteqFlu blev først analyseret i flere laboratorie- og feltundersøgelser.
The effectiveness of ProteqFlu was first assessed in several laboratory and field studies.
ProteqFlu indeholder et adjuvans (carbomer) til at forstærke immunresponsen.
ProteqFlu contains an adjuvant (carbomer) to enhance the immune response.
Tilbageholdelsestiden er den tid, der skal gå efter injektion af lægemidlet, før dyret kan slagtes, og kødet eller mælken kan anvendes til menneskeligt konsum.
The withdrawal period is the time allowed after administration of the medicine and before the animal can be slaughtered and the meat used for human consumption or milk used for human consumption.
Udvalget for Veterinærlægemidler (CVMP) konkluderede, at fordelene ved ProteqFlu opvejer risiciene, når det anvendes ved den godkendte indikation, og anbefalede udstedelse af markedsføringstilladelse for ProteqFlu.
The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of ProteqFlu exceed the risks for the approved indication and recommended that ProteqFlu be given a marketing authorisation.
Ved laboratorieundersøgelser blev heste udsat for (inficeret med) hesteinfluenzavirus, og de kliniske symptomer og udskillelsen af influenzavirus efter inficeringen blev sammenlignet mellem vaccinerede dyr og kontroldyr (ikke-vaccinerede dyr eller dyr vaccineret med et konkurrerende produkt).
In laboratory studies, horses were challenged (infected) with equine influenza virus and the clinical signs and the excretion of the influenza virus after the challenge were compared between vaccinated and control animals (non-vaccinated animals or those vaccinated with a competitor product).
Den beskyttende effekt holdt i 5 måneder efter basisvaccination og et år efter tredje vaccination.
The duration of protection was 5 months after primary vaccination and one year after the third vaccination.
Det betyder, at et gen fra to forskellige hesteinfluenzastammer (A/eq/Ohio/03 og A/eq/Richmond/1/07) blev indsat i hver sin levende canarypox vektorvirus, som ikke fremkalder sygdomme hos heste.
This means that a gene from two different equine influenza strains (A/eq/Ohio/03 and A/eq/Richmond/1/07) was inserted into the canarypox vector viruses, which do not produce disease in horses, allowing the vector to produce specific proteins from these influenza strains.
Heste bør have en basisvaccination ved 5-6 måneders alderen bestående af to vaccinationer med 4 - 6 ugers mellemrum.
Horses should receive a primary vaccination, consisting of two injections at 5-6 months of age, given 4-6 weeks apart.
ProteqFlu er en vaccine, der er fremstillet ved hjælp af rekombinant teknologi.
ProteqFlu is a vaccine which was produced with the use of recombinant DNA technology.
Derefter vil immunsystemet fremover kunne danne disse antistoffer hurtigere, når dyret udsættes for hesteinfluenzavirussen.
The immune system will then be able to make those protective antibodies more quickly when the animal is naturally exposed to the equine flu viruses.
Når hestene vaccineres med ProteqFlu, opfatter immunsystemet disse specifikke proteiner fra stammerne fra hesteinfluenza som "fremmede" og producerer antistoffer mod dem.
When ProteqFlu is given to horses, the animals' immune system recognises the specific proteins from the equine influenza strains as ‘foreign' and makes antibodies against them.
ProteqFlu er en vaccine til heste.
ProteqFlu is a vaccine for use in horses.
Undersøgelserne viser, at ProteqFlu er effektiv til at nedsætte kliniske symptomer og virusudskillelse efter infektion med hesteinfluenza, 14 dage efter den første vaccination.
The studies showed that ProteqFlu was effective in reducing clinical signs and virus excretion after infection with equine influenza, 14 days after primary vaccination.
ProteqFlu fås som en suspension til injektion.
ProteqFlu is available as a suspension for injection.
Hvorfor blev ProteqFlu godkendt?
Why has ProteqFlu been approved?
Hvilken risiko er der forbundet med ProteqFlu?
What is the risk associated with ProteqFlu?
Basisvaccinationen bør følges op af en revaccination 5 måneder senere og derefter af en boostervaccination én gang om året.
This should be followed by revaccination 5 months later and afterwards by yearly booster vaccinations.
Den aktuelle formulering af ProteqFlu dannede den samme mængde antistoffer mod de to influenzastrenge, der indgår i vaccinen, som dem, der sås i hovedundersøgelserne.
The current formulation of ProteqFlu produced similar antibody responses against the two flu strains included in the vaccine to those seen in the main studies.
Dette er med til at beskytte mod hesteinfluenza.
This will help to protect against equine influenza.
ProteqFlu anvendes til vaccination af heste, fra de er 4 måneder, mod hesteinfluenza.
ProteqFlu is used to vaccinate horses from 4 months of age against equine influenza.
De fleste undersøgelser blev foretaget med ProteqFlu-Te, en vaccine, der beskytter mod to hesteinfluenzastammer og mod stivkrampe.
Most of the studies were performed with ProteqFlu-Te, a vaccine that protects against two strains of equine influenza as well as against tetanus.
Den indeholder dele af to hesteinfluenzastammer, der er indsat i hver sin vektorvirus (bærervirus), som hedder canarypox.
It contains parts of two equine influenza (flu) strains, which have been inserted into two canarypox vector (carrier) viruses respectively.
Hvad er ProteqFlu?
What is ProteqFlu?
Vaccinen nedsætter de kliniske symptomer på hesteinfluenza og virusudskillelsen efter infektion.
The vaccine reduces the clinical signs of equine influenza and the excretion (shedding) of the virus after infection.
Behandlingens virkning blev i alle undersøgelserne hovedsagelig bedømt på mængden af beskyttende antistoffer mod de to influenzavaccinestammer, som blev dannet.
The measure of effectiveness in all studies was antibody levels against the two influenza vaccine strains.
Hvad anvendes ProteqFlu til?
What is ProteqFlu used for?
Hvordan blev ProteqFlu undersøgt?
How has ProteqFlu been studied?
Der kan forekomme en kortvarig hævelse på injektionsstedet (maks.
A short lived swelling at the injection site may occur (max. diameter 5 cm) which decreases within 4 days.
Hvilken fordel viser undersøgelserne, at der er ved ProteqFlu?
What benefit has ProteqFlu shown during the studies?
Hvordan virker ProteqFlu?
How does ProteqFlu work?
Der er to muligheder:
There are two options:
Se tabel 1 nedenfor.
See Table 1 below.
Dato for første markedsføringstilladelse: 25. januar 2010 Dato for seneste fornyelse: 22. august 2014
Date of first authorisation: 25 January 2010 Date of latest renewal: 22 August 2014
(Se også punkt 4.)
(See also section 4.)
Den absolutte biotilgængelighed er 58% (48-70%
The absolute bioavailability is 58% (48-70%
Dette kan fortsættes i få dage, indtil der er nok follikler af passende størrelse.
This may be continued for a few days until enough follicles of adequate size are present.
Æggene udtages fra æggestokkene 34-36 timer senere.
The eggs are collected from the ovary 34-36 hours later.
- Vask dine hænder med vand og sæbe, og tør dem, før du tager Elonva.
- Wash your hands with soap and water and dry them before you use Elonva.
Forskel [95% CI]
Difference [95% CI]
1), og den nås 44 timer (35-57 timer
1) and is reached 44 hours (35-57 hours
I tilfælde af en positiv graviditetstest skal du kontakte lægen.
In case of a positive pregnancy test, contact your doctor.
Se nedenfor for yderligere information.
See below for further explanation.
Forskellene lå dog inden for de prædefinerede ækvivalensmarginer (ENGAGE og ENSURE) eller non-inferioritetsmarginer (PURSUE).
However, the differences were within the predefined equivalence (ENGAGE and ENSURE) or non-inferiority (PURSUE) margins.
Din læge vil råde dig til, hvornår du kan starte med at tage graviditetstests.
Your doctor will advise you at what time you can start performing pregnancy tests.