natgillin/translations-raw huggingface dataset:
Anvend ikke Nifedipine Pharmamatch retard efter udløbsdatoen, som er angivet på etiketten efter “Anv.
Do not use Nifedipine Pharmamatch retard after the expiry date which is stated on the label carton after “Expiry date” or “exp.”.
Nifedipins virkningstid kan forkortes.
The duration of action of nifedipine can be shortened.
Pulmonært ødem Gastrointestinale lidelser: - Almindelig:
pulmonary oedema Gastrointestinal disorders: - Common:
Pulmonært ødem, synkope, hjerteblok.
pulmonary oedema, syncope, heart block.
Hvis De er i nyredialyse, skal De konsultere Deres læge før De tager dette lægemiddel.
If you are on kidney dialysis please consult your doctor before taking this medicine.
Svimmelhed, træthed.
dizziness, tiredness.
Der foreligger kun begrænsede data fra brug af nifedipin til gravide.
There are no adequate data from the use of nifedipine in pregnant women.
En effekt på spædbarnet kan ikke udelukkes.
It cannot be excluded that the newborn may be affected.
Neozipine XL 30/60 mg 30 mg / 60 mg Depottablet
Neozipine XL 30/60 mg 30 mg / 60 mg prolonged-release tablets
Samtidig administration af cisaprid og nifedipin kan medføre forøgede plasmakoncentrationer af nifedipin.
Simultaneous administration of cisapride and nifedipine may lead to increased plasma concentrations of nifedipine.
Tabletterne bør ikke tygges eller knækkes over.
You should not chew or break the tablets.
Hos patienter med diarre, vil tablettens ophold i tarmsystemet være kortere, og som et resultat heraf vil effekten være reduceret.
In patients with diarrhoea, the residence time of the tablet in the gastrointestinal tract, and as a result thereof, the duration of action are decreased.
Vær særlig forsigtig med at anvende Nifedipine Pharmamatch retard - Hvis De lider af nedsat blodomløb i fingre og/eller tæer pga. en forsnævring af venerne
Take special care with Nifedipine Pharmamatch retard - if you suffer from decreased blood flow to the fingers and/or toes, caused by a narrowing of the veins (ischemia).
Når begge lægemidler administreres samtidigt, bør den kliniske respons på nifedipin monitoreres og, om nødvendigt bør man overveje en forøgelse af nifedipin-dosen.
When both medicines are concomitantly administered, the clinical response to nifedipine should be monitored and, if necessary, an increase of the nifedipine dose considered.
Kardiovaskulære lidelser:
Cardiovascular disorders:
3930 EB Woudenberg Holland
3930 EB Woudenberg The Netherlands
- Almindelig:
- Common:
- fugt i lungerne (pulmonært ødem) - besvimelse (synkop) - hjerteblok - afskalning af huden (exfoliativ dermatitis) - alvorlige blegner på huden og/eller slimhinderne på læber, øjne, mund, næse eller kønsorganerne (tegn på Steven-Johnson syndrom) - hududslæt (erythema multiform, nældefeber, ikke-flygtig medikamentelt udslæt, nældefeber) - nedsat produktion af røde blodceller (aplastisk anæmi) - forøgelse af blodkaliumnivauerne (når de bruges sammen med andre lægemidler kaldet propranolol)
- moisture in lungs (pulmonary oedema) - fainting (syncope) - heart block - peeling or flaking of skin (exfoliative dermatitis) - severe blistering of the skin and/or mucous membranes of the lips, eyes, mouth, nasal passages or genitals (signs of Steven-Johnson syndrome) - skin rashes (erythema multifome, pemphigus, fixed drug eruption, urticaria) - reduced production of red blood cells (aplastic anaemia) - increase in blood potassium levels (when used together with another medicine called propranolol)
Sjældne (mere end 1 ud af 10.000, men mindre end 1 ud af 1.000 patienter): - hududslæt - muskelkramper - tandkødsbetændelse - en masse fremmede materialer i maven (bezoar) - en mindre udvikling af brystvævet hos ældre mænd (gynaecomasti)
Rare (more than 1 out of 10.000, but less than 1 out of 1.000 patients): - skin rash - muscle cramps - inflammation of the gums - a mass of foreign material found in the stomach (bezoar) - a slight development in breast tissue in older men (gynaecomastia)
Nogle stoffer har vist sig at påvirke plasmakoncentrationen af den strukturelt relaterede calcium-antagonist nimodipin, enten ved enzyminduktion (carbamazepin, phenobarbiton) eller enzymhæmning (valproesyre).
Carbamazepine, phenobarbitone and valproic acid Some substances have been shown to influence the plasma concentration of the structurally related calcium antagonist nimodipine, either by enzyme induction (carbamazepine, phenobarbitone) or enzyme inhibition (valproic acid).
Ved samtidig administration af begge medikamenter bør tacrolimus plasmakoncentrationerne monitoreres og tacrolimus-dosis bør om nødvendigt nedsættes.
Upon co-administration of both medicines, the tacrolimus plasma concentrations should be monitored and, if necessary, a reduction in the tacrolimus dose considered.
exfoliativ dermatit, Steven-Johnsons syndrom, erythema multiform, nældefeber, ikke-flygtig medikamentelt udslæt,
exfoliative dermatitis, Steven-Johnsons syndrome, erythema multifome, urticaria, fixed drug eruption, pemphigus, phototoxicity.
Nifedipine Pharmamatch tablets leveres i blisterpakninger af 28.
Nifedipine Pharmamatch tablets are supplied in blister packs of 28.
Nifedipin kan forværre det nedsatte blodomløb.
Nifedipine can worsen the decreased blood flow.
Hvordan Nifedipine Pharmamatch retard ser ud og pakningsindhold Nifedipine Pharmamatch retard er depottabletter, som er runde, bikonvekse tabletter med en blegrød farve.
What Nifedipine Pharmamatch retard looks like and contents of the pack Nifedipine Pharmamatch retard are prolonged-release tablets, which appear as round, biconvex tablets with a pale red colour.
Stoffer, der fremkalder CYP3A4
Substances that induce CYP3A4
LÆGEMIDDELFORM OG INDHOLDSMÆNGDE (PAKNINGSSTØRRELSE) 28 depottabletter.
PHARMACEUTICAL FORM AND CONTENTS 28 prolonged-release tablets.
Nederlandene Pharmamatch BV, Stationsweg Oost 281-D, 3931 ER
Pharmamatch BV, Stationsweg Oost 281-D, 3931 ER Woudenberg, The Netherlands
4.7 Virkninger på evnen til at føre motorkøretøj eller betjene maskiner Hos patienter, der oplever svimmelhed, hovedpine, træthed eller kvalme, nedsat reaktionsevne, kan det påvirke evnen til at føre bil eller betjene maskiner.
4.7 Effects on ability to drive and use machines In patients that experience dizziness, headache, fatigue or nausea, impaired reaction time may effect ability to drive or to operate machinery This occurs especially at the beginning of treatment, in case of a change in medication or in case of concomitant use of alcohol.
5.3 Prækliniske data
5.3 Preclinical safety data
- Meget sjældne:
- Very rare:
Den anbefalede begyndelsesdosis er 1 tablet a 30 mg om dagen.
The recommended initial dose is one 30mg tablet once-daily.
Den normale indledende dosis er en 30 mg tablet en gang daglig.
The usual initial dose is one 30mg tablet once-daily.
Phenytoin fremmer CYP3A4-systemet.
Phenytoin induces the CYP3A4 system.
Grapefrugtjuice hæmmer CYP3A4-systemet.
Grapefruit juice inhibits the CYP3A4 system.
Lidelser i nervesystemet: - Ualmindelige:
Nervous system disorders: - Uncommon:
Der foreligger kun begrænsede data, som viser, at nifedipine udskilles i små mænger i modermælken.
There are limited data showing that nifedipine is excreted into human breast milk at low levels.
Samtidig indtagelse af grapefrugtjuice med nifedipin medfører forhøjet plasmakoncentrationer af nifedipin pga. et reduceret first-pass metabolisme.
Co-administration of grapefruit juice with nifedipine causes elevated plasma concentrations of nifedipine, due to a decreased first pass metabolism.
Hud og subkutane-vævsforstyrrelser: - Sjældne:
Skin and subcutaneous tissue disorders: - Rare:
- Hvis De tager andre lægemidler for højt blodtryk, da disse lægemidler kan øge effekten af
- if you use other medicines for high blood pressure, since these medicines may increase the effect of Nifedipine Pharmamatch retard on blood pressure.
En lille del af nifedipin udskilles i modermælken.
A small fraction of nifedipine passes into the breast milk.
UDLØBSDATO Må ikke bruges efter: SÆRLIGE OPBEVARINGSBETINGELSER Opbevares i den originale emballage.
SPECIAL STORAGE CONDITIONS Store in the original packaging.
Efter oral indtagelse indikeres ventrikelskylning, om nødvendigt i kombination med skylning af tyndtarmen.
After oral ingestion, gastric lavage is indicated, if necessary in combination with irrigation of the small intestine.
Nifedipin kan reducere chancen for befrugtning.
Nifedipine can lower the chance of conception.
Titandioxid (E171):
Titanium dioxide (E172): colouring aid Red iron oxide (E172):
Rifampicin virker stærkt fremmende på CYP3A4-systemet.
Rifampicin strongly induces the CYP3A4 system.
Almindelige (mere end 1 ud af 100, men mindre end 1 ud af 10 patienter): - angina (ved pludselig seponering af nifedipin) - uregelmæssigt hjerteslag (palpitationer) - hjertestop - træthed - konstipation - svimmelhed - kvalme - øget hyppighed eller forværring af angina - øget iltmangel i hjertet, inkl.
Common (more than 1 out of 100, but less than 1 out of 10 patients): - angina (upon sudden withdrawal of nifedipine) - irregular heart beat (palpitations) - heart failure - tiredness - constipation - dizziness - nausea - increased frequency or worsening of angina - increased shortage of oxygen in the heart, including a heart attack - low blood pressure (hypotension) - sudden low blood pressure that occurs when a assuming a standing position (orthostatic hypotension).
- Sjældne:
- Rare:
anbefaler CPMP, at der udstedes markedsføringstilladelser for Nifedipine Pharmamatch Retard 30/60 mg og de tilknyttede navne (se bilag I).
The CHMP has recommended the granting of the Marketing Authorisation(s) for which the Summaries of Product Characteristics, labelling and package leaflet are set out in Annex III for Nifedipinr Pharmamatch Retard 30/60 mg and associated names (see Annex I).
Nifedipin udskilles i små mængder i modermælken.
Nifedipine is excreted into breast milk in small amounts.
Perifert ødem, ansigtsrødne (flushing).
- Very common: peripheral oedema, flushing (facial reddening).
Hver tablet indeholder: 30 mg nifedipin
Each tablet contains: 30 mg nifedipine
Hver tablet indeholder: 60 mg nifedipin
Each tablet contains: 60 mg nifedipine
Høre- og labyrinthforstyrrelser: - Meget sjældne:
Ear and labyrinth disorders: - Very rare:
Stoffer, der hæmmer CYP3A4
Substances that inhibit CYP3A4
Muskuloskeletale- og bindevævslidelser: - Sjældne:
Musculoskeletal and connective tissue disorders: - Rare:
Pharmachemie B.V.
Pharmamatch B.V. Postbus 82
Hvad Nifedipine Pharmamatch retard indeholder
What Nifedipine Pharmamatch retard contains
30 mg / 60 mg Depottablet
30 mg / 60 mg prolonged-release tablets
I tilfælde af samtidig brug af begge lægemidler, bør blodtrykket monitoreres og dosis af nifedipin bør om nødvendigt nedsættes.
In case of concomitant use of both medicines, blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered.
- blegner på huden, hvor den bliver udsat for sollys (fototoksicitet) - pludselig forværring af nyrefunktion hos patienter med kroniske nyreproblemer - hævelser omkring øjnene (periorbitalt ødem) - støj i ørerne (tinnitus).
Very rare (Les than 1 out of 10.000 patients): - bedwetting - depression - blistering of the skin when exposed to sunlight (phototoxicity) - sudden worsening of kidney function in patients with chronic kidney problems - swelling around the eyes (periorbital oedema) - noise in the ear (tinnitus).
Baseret på resultaterne af bioækvivalensundersøgelser kan Nifedipine Pharmamatch retard tabletter på 30 mg og 60 mg betragtes som værende bioækvivalente med referenceproduktet Adalat OROS under faste- og mæthedsforhold.
The pharmacokinetic properties of nifedipine in the Nifedipine Pharmamatch retard tablet are linear in a dose range of 30-180 mg. Based on the results of the bioequivalence studies, Nifedipine Pharmamatch retard tablets 30 mg and 60 mg can be considered to be bioequivalent to the reference product Adalat OROS under fasting and fed conditions.
Der kan forekomme forstoppelse.
Constipation (obstruction) can occur.
pludselig død), hjertestop eller død som følge af andre kardiovaskulære årsager (sammensat gennembrud).
The primary end-point was the combination of stroke, MI (including sudden death), heart failure or death from any other cardiovascular cause (composite end-point).
Ved samtidig brug bør blodtrykket monitoreres, og dosis af nifedipin bør om nødvendigt nedsættes.
In case of concomitant use, blood pressure should be monitored and, if necessary, a reduction in the nifedipine dose considered.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) RVG 31822 - Nifedipine Pharmamatch retard 30 mg, depottabletter
RVG 31822 - Nifedipine Pharmamatch retard 30 mg, prolonged-release tablets
INDLÆGSSEDDEL: INFORMATION TIL BRUGEREN Nifedipine Pharmamatch retard 30 mg depottabletter
PACKAGE LEAFLET: INFORMATION FOR THE USER Nifedipine Pharmamatch retard 30 mg prolonged-release tablets
Meget almindelige (mere end 1 ud af 10 patienter): - hovedpine - rødme - hævelse, især af ankler og ben - svimmelhed - ørhed - følelsen af tryk i hovedet.
Very common (more than 1 out of 10 patients): - headache - flushing - swelling, particularly of the ankles and legs
Nifedipine Pharmamatch retard bør altid tages i nøje overensstemmelse med Deres læges instruktioner.
Always take Nifedipine Pharmamatch retard exactly as your doctor has told you.
- De øvrige indholdsstoffer er: Carbomer, colloidal siliciumdioxid (E551), hypromellose (E464), lactose monohydrat, magnesiumstearat (E572), methacrylsyre copolymer, macrogol, povidon (E1201), rød jernoxid (E172), talcum (E553b) og titaniumdioxid (E171).
- The other ingredients are: carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E533b) and titanium dioxide (E171).
Specielt ved depotprodukter (Nifedipine Pharmamatch retard) skal udskillelsen være så komplet som muligt, inkl.
Especially for prolonged-release products (Nifedipine Pharmamatch retard) elimination must be as complete as possible, including the small intestine, to prevent the otherwise inevitable subsequent absorption of the active substance.
Hvordan De opbevarer Nifedipine Pharmamatch retard Yderligere oplysninger
How to store Nifedipine Pharmamatch retard Further information
Nifedipine Pharmamach retard tabletter leveres i en kalenderpakning med 28 tabletter (2 blisterpakninger med hver 14 tabletter).
Nifedipine Pharmamach retard tablets come in a calendar packing of 28 tablets (2 blisters of 14 tablets each).
Biotilgængeligheden er ca. 40-60%.
Bioavailability is approximately
Carbomer, colloidal siliciumdioxid (E551), hypromellose (E464), lactose monohydrat, magnesiumstearat (E572), methacrylsyre copolymer, macrogol, povidon (E1201), rød jernoxid (E172), talcum (E553b), titandioxid (E171)
Carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E533b), titanium dioxide (E171)
Lidelser i luftveje, thorax og mediastinum: - Meget sjældne:
Respiratory, thoracic and mediastinal disorders: - Very rare:
Carbomer, colloidal siliciumdioxid (E551), hypromellose (E464), lactose monohydrat, magnesiumstearat (E572), methacrylsyre copolymer, macrogol, povidon (E1201), rød jernoxid (E172), talcum (E553b) og titaniumdioxid (E171).
Carbomer, colloidal silicon dioxide (E551), hypromellose (E464), lactose monohydrate, magnesium stearate (E572), methacrylic acid copolymer, macrogol, povidone (E1201), red iron oxide (E172), talc (E553b) and titanium dioxide (E171).
- Hvis De har en alvorlig forsnævring i tarmsystemet.
- if you have a severe narrowing of the gastrointestinal tract.
angina ved pludselig seponering af nifedipin, øget hyppighed eller forværring af angina, aggravation af myokardial iskæmi inkl.
angina upon abrupt withdrawal of nifedipine, increased frequency or worsening of angina, aggravation of myocardial ischemia including myocardial infarction, palpitations (tachycardia - accelerated pulse rate), congestive heart failure, hypotension, orthostatic hypotension.
Om nødvendigt kan dosen øges i henhold til det individuelle behov, dog op til maks.
If necessary the dosage can be increased according to individual requirements up to a maximum of 90mg once-daily.
Muskelkramper.
muscle cramps.
Forstyrrelser i reproduktion og lidelser i mammae: - Ualmindelige:
Reproductive system and breast disorders: - Uncommon:
embryotoksicitet og teratogenisk effekt ved maternelt toksiske doser.
Studies in animals have shown reproductive toxicity, consisting of embryotoxicity and teratogenic effects at maternally toxic doses.
BILAG III PRODUKTRESUME
SUMMARY OF PRODUCT CHARACTERISTICS
- trækninger i fingrene - feber de første par dage efter behandlingens start - forbigående forøgelse af leverenzymer - oesophageal reflux - allergisk leverinfektion - øget blodtryk i portalvenen hos patienter med alkoholinduceret cirrhose - degradering af livmoderens slimhinde (endometriatrofi) - nedsat blodgennemstrømning til fingre og tæer (reduktion af blodgennemstrømningen) hos patienter med Raynaud's syndrom
Uncommon (more than 1 out of 1.000, but less than 1 out of 100 patients): - heart rhythm disturbances - increased sensitivity, particularly in arms and legs - eye reactions such as eye pain, temporary vision disturbances - finger twitching - fever in the first few days after start of therapy - transient increase in liver enzymes - oesophageal reflux - allergic liver infection - increased blood pressure in the portal vein in patients with alcoholic cirrhosis - degradation of the mucous membrane of the uterus (atrophic endometrium) - reduction in blood flow to the fingers and toes (digital blood flow reduction) in patients with
Nifedipine Pharmamatch 60 mg tabletter findes som depottabletter i en kalenderpakning af 28 tabletter (2 blisterpakninger med 14 tabletter).
Nifedipine Pharmamatch 60 mg tablets are available as prolonged-release tablets in a calendar packaging of 28 tablets (2 blisters of 14 tablets).
Nifedipine Pharmamatch 30 mg tabletter findes som depottabletter i en kalenderpakning af 28 tabletter (2 blisterpakninger med 14 tabletter).
Nifedipine Pharmamatch 30 mg tablets are available as prolonged-release tablets in a calendar packaging of 28 tablets (2 blisters of 14 tablets).
Nifedipine Pharmamatch retard 30 mg, depottabletter indeholder 30 mg nifedipin pr. tablet.
Nifedipine Pharmamatch retard 30 mg, prolonged-release tablets contain 30 mg nifedipine per tablet.
Depottabletter.
Prolonged-release tablets.
Nifedipine Pharmamatch retard 60 mg, depottabletter indeholder 60 mg nifedipin pr. tablet.
Nifedipine Pharmamatch retard 60 mg, prolonged-release tablets contain 60 mg nifedipine per tablet.
HVORDAN DE TAGER NIFEDIPINE PHARMAMATCH RETARD
HOW TO TAKE NIFEDIPINE PHARMAMATCH RETARD
hovedpine, svimmelhed, ørhed, følelsen af tryk i hovedet.
- giddiness - light headedness - feeling of pressure in the head.
Lidelser i blod og lymfe: - Meget sjældne:
Blood and lymphatic system disorders: - Very rare:
HVORDAN DE OPBEVARER NIFEDIPINE PHARMAMATCH RETARD
HOW TO STORE NIFEDIPINE PHARMAMATCH RETARD
HVAD DE SKAL GØRE, FØR DE BEGYNDER AT TAGE NIFEDIPINE PHARMAMATCH
BEFORE YOU TAKE NIFEDIPINE PHARMAMATCH
Hvordan De tager lægemidlet
How to take
4.2 Dosering og indgivelsesmåde
4.2 Posology and method of administration For oral administration.
som ikke er nævnt i denne indlægsseddel, bør De fortælle det til Deres læge eller apotek.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
LÆGEMIDLETS NAVN Nifedipine Pharmamatch retard 60 mg depottabletter Nifedipin.
NAME OF THE MEDICINAL PRODUCT Nifedipine Pharmamatch retard 60 mg prolonged-release tablets Nifedipine.
FORTEGNELSE OVER HJÆLPESTOFFER
colouring aid
Der savnes oplysninger om en farmakologisk effekt hos spædbarnet pga. dette.
It is not known if a pharmacological effect in the infant can occur because of this; however, it is recommended to cease breast feeding as a precautionary measure.
LÆGEMIDLETS NAVN Nifedipine Pharmamatch retard 30 mg depottabletter Nifedipin.
NAME OF THE MEDICINAL PRODUCT Nifedipine Pharmamatch retard 30 mg prolonged-release tablets Nifedipine.
Nifedipine Pharmamatch retard 60 mg depottabletter Nifedipin
Nifedipine Pharmamatch retard 60 mg prolonged-release tablets Nifedipine
Der savnes oplysninger om risiko for det ammende barn.
It is not known if this can lead to an effect in the infant.
Nifedipine Pharmamatch retard 30 mg depottabletter Nifedipin
Nifedipine Pharmamatch retard 30 mg prolonged-release tablets Nifedipine
6.5 Emballage
6.5 Nature and contents of container
Vigtige oplysninger om visse af indholdsstofferne i Nifedipine Pharmamatch retard Nifedipine Pharmamatch retard indeholder lactose.
Important information about some of the ingredients of Nifedipine Pharmamatch retard
Dosen kan øges i henhold til det individuelle behov, dog op til maks.
The dosage can be increased according to individual requirements up to a maximum of 90 mg once-daily.
- rødme - hævelse, især af ankler og ben - svimmelhed - ørhed - følelsen af tryk i hovedet.
General disorders and administration site conditions: - Very common: headache, giddiness, light headedness, feeling of pressure in the head.
MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) RVG 31823 - Nifedipine Pharmamatch retard 60 mg, depottabletter
RVG 31823 - Nifedipine Pharmamatch retard 60 mg, prolonged-release tablets DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 29 November 2004
ETIKETTERING OG INDLÆGSSEDDEL
QUALITATIVE AND QUANTITATIVE COMPOSITION
myokardial infarkt, palpitationer (tachykardia - accelereret puls),
Cardiovascular disorders: - Very common: peripheral oedema, flushing (facial reddening).
Den anbefalede dosis er 350 mg én gang hver tredje uge.
The recommended dose is 350 mg once every 3 weeks.
Studiet omfattede imidlertid et lille antal patienter, og der er behov for yderligere data.
However, the study involved a small number of patients and additional data are required.
Yderligere information om Libtayo findes på agenturets websted under: www.ema.europa.eu/medicines/human/EPAR/libtayo.
Further information on Libtayo can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/libtayo.
Det anvendes hos patienter, der ikke kan gennemgå en operation eller en behandling med stråling for at helbrede deres sygdom.
It is used in patients who cannot have surgery or treatment with radiation to cure their disease.
Libtayo har fået en "betinget godkendelse".
Libtayo has been given ‘conditional authorisation'.
Hvad angår lægemidlets sikkerhed, er bivirkningerne håndterbare og svarer til dem, der ses ved andre kræftbehandlinger af denne type.
As for the medicine's safety, its side effects are manageable and similar to those seen in other cancer treatments of this type.
I et hovedstudie, hvori der indgik i alt 193 patienter, blev kræften mindre hos ca. 39 % af de patienter med metastatisk sygdom, som fik 350 mg Libtayo hver 3. uge i ca. et år.
In a main study involving a total of 193 patients, the cancer shrank in around 39% of patients with metastatic disease who received 350 mg Libtayo every 3 weeks for around one year.
Virksomheden vil også undersøge, om lægemidlet virker anderledes, afhængigt af niveauet af PD-L1, som produceres af kræftcellerne.
The company will also investigate whether the medicine works differently depending on the levels of PD-L1 produced by the cancer cells.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Libtayo opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency therefore decided that Libtayo's benefits are greater than its risks and it can be authorised for use in the EU.
Som for alle lægemidler er data vedrørende brug af Libtayo løbende overvåget.
As for all medicines, data on the use of Libtayo are continuously monitored.
Behandlingen kan fortsætte, så længe sygdommen er stabil, og patienten kan tolerere bivirkningerne.
Treatment can continue for as long as the disease remains stable and the patient does not experience unacceptable side effects.
Libtayo indeholder det aktive stof cemiplimab.
Libtayo contains the active substance cemiplimab.