natgillin/translations-raw huggingface dataset:
• Hætteglas med solvens til Docetaxel Teva 20 mg/0,72 ml hætteglas er et 6 ml klart hætteglas med brombutylgummiprop og afrivningshætte.
• The solvent for Docetaxel Teva 20 mg/0.72 ml vial is a 6 ml clear glass vial with a bromobutyl rubber stopper and a flip-off cap.
Væskeretention (alvorlig: 6,5 %) Asteni (alvorlig smerter
Fluid retention (severe: Asthenia (severe: Pain
n=221
TCF n=221
Alle andre lægemidler blev givet som intravenøs bolus på dag 1.
Docetaxel was administered as a 1-hour infusion; all other medicinal products were given as intravenous bolus on day one.
Docetaxel Teva 20 mg/0,72 ml koncentrat og solvens til infusionsvæske, opløsning docetaxel
Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion docetaxel
Docetaxel Teva 80 mg/2,88 ml koncentrat og solvens til infusionsvæske, opløsning docetaxel
Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion docetaxel
Eksfoliativt udslæt (G3/4:
Skin exfoliative (G3/4:
Diarré (G3/4: 6,4 %); Stomatitis (G3/4: 2 %)
Vomiting (G3/4: 7.6%); Diarrhoea (G3/4: 6.4%); Stomatitis (G3/4: 2%)
• Blodpropper.
• blood clots
Neutropeni (G3/4: 83,2 %); Trombocytopeni (G3/4: 8,8 %); Febril neutropeni.
Neutropenia (G3/4: 83.5%); Anaemia (G3/4: 12.4%); Thrombocytopenia (G3/4: 4.0%);
Patienter i docetaxel-armen modtog docetaxel (T) 75 mg/m2 ved intravenøs infusion på dag 1, efterfulgt af cisplatin (P) 100 mg/m2 administreret som en 30 minutter til
Patients on the docetaxel arm received docetaxel (T) 75 mg/m² by intravenous infusion on day 1 followed by cisplatin (P) 100 mg/m² administered as a 30-minute to three-hour intravenous infusion, followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 4.
Hvert hætteglas med Docetaxel Teva 80 mg/2,88 ml koncentrat indeholder 80 mg docetaxel.
Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg of docetaxel.
Dysgeusi (G3/4:
Lymphoedema (G3/4:
Anoreksi (G3/4:
Anaemia (G3/4:
H-2100 Gödöllő
H-2100 Gödöllő, Táncsics Mihály út 82
• Rødme, hudreaktioner, kløe,
• flushing, skin reactions, itching
Infektioner og parasitære sygdomme Infektion (G3/4: 3,6 %) Neutropenisk infektion
Infection (G3/4: 3.6%) Neutropenic infection
Øsofagitis/dysfagi/ odynofagi (G3/4: 0,6 %); Gastrointestinale smerter;
Esophagitis/dysphagia/odynophagia (G3/4: 12.0%);
Docetaxel-dosis bør reduceres fra 75 til 60 mg/m2, hvis der trods anvendelse af G-CSF opstår febril neutropeni, prolongeret neutropeni eller neutropenisk infektion.
If an episode of febrile neutropenia, prolonged neutropenia or neutropenic infection occurs despite G-CSF use, the docetaxel dose should be reduced from 75 to 60 mg/m2.
Neutropeni (G3/4: 32 %); Febril
Neutropenia (G3/4: 32%);
Konjunktivitis (G3/4:
Conjunctivitis (G3/4:
Hudafskalning (G3/4: 0 %).
Epistaxis (G3/4: 0%);
Beskrivelse af udvalgte bivirkninger ved behandling af gastrisk adenokarcinom med DOCETAXEL 75 mg/m² i kombination med cisplatin og 5-fluoruracil:
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil:
I de følgende tilfælde bør dosis af docetaxel reduceres fra 100 mg/m2 til 75 mg/m2 og/eller fra 75 mg/m2 til 60 mg/m2: Hos patienter, som under docetaxel-behandling har haft enten febril neutropeni, neutrofile leukocytter < 500 celler/mm i mere end en uge, alvorlige eller kumulative reaktioner eller alvorlig perifer neuropati.
In patients who experienced either febrile neutropenia, neutrophil count <500 cells/mm for more than one week, severe or cumulative cutaneous reactions or severe peripheral neuropathy during docetaxel therapy, the dose of docetaxel should be reduced from 100 mg/m2 to 75 mg/m2 and/or from
Tabel over bivirkninger ved behandling af gastrisk adenokarcinom med Docetaxel 75 mg/m² i kombination med cisplatin og 5-fluoruracil
Tabulated list of adverse reactions in gastric adenocarcinoma cancer for Docetaxel 75 mg/m² in combination with cisplatin and 5-fluorouracil
I studiet TAX316 forekom perifer sensorisk neuropati i løbet af behandlingsperioden og fortsatte ind i opfølgningsperioden hos 84 patienter (11,3 %) i TAC-armen og hos 15 patienter (2 %) i FAC-armen.
In study TAX316 peripheral sensory neuropathy started during the treatment period and persisted into the follow-up period in 84 patients (11.3%) in TAC arm and 15 patients (2%) in FAC arm. At the end of the follow-up period (median follow-up time of 8 years), peripheral sensory neuropathy was observed to be ongoing in 10 patients (1.3%) in TAC arm, and in 2 patients (0.3%) in FAC arm.
Hvis Docetaxel Tevakoncentratet, præmix-opløsningen eller infusionsvæsken skulle komme i berøring med slimhinderne, skal man straks skylle grundigt med vand.
If Docetaxel concentrate, premix solution or infusion solution should come into contact with mucous membranes, wash immediately and thoroughly with water.
Neglesygdomme (alvorlig 0,7 %);
Abdominal pain (severe 1%);
Neglesygdomme (G3/4: 0,4 %)
Constipation (G3/4: 0.4%)
Indlægsseddel: Information til patienten Docetaxel Teva 80 mg/2,88 ml koncentrat og solvens til infusionsvæske, opløsning docetaxel
NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 80 mg/2.88 ml concentrate and solvent for solution for infusion docetaxel
Alopeci (G3/4: 4,0 %) Kløende udslæt
Alopecia (G3/4: 4.0%)
Arytmi (G3/4: 2,0 %)
Lethargy (G3/4: 4.0%);
Indlægsseddel: Information til patienten Docetaxel Teva 20 mg/0,72 ml koncentrat og solvens til infusionsvæske, opløsning docetaxel
NAME OF THE MEDICINAL PRODUCT Docetaxel Teva 20 mg/0.72 ml concentrate and solvent for solution for infusion docetaxel
Opkastning (G3/4: 1,2 %)
Vomiting (G3/4: 1.2%)
Asteni (alvorlig 9,9 %); Væskeretention (alvorlig 0,7 %);
Asthenia (severe: 9.9%); Fluid retention (severe:
- Kontakt lægen hospitalsfarmaceuten eller sundhedspersonalet, hvis en bivirkning bliver værre,
Tell your doctor, hospital pharmacist or nurse if you have heart problems.
Diarré (G3/4: 19,7 %);
Stomatitis (G3/4: 20.7%);
Stomatitis (G3/4:
Dyspepsia (G3/4:
På basis af farmakokinetiske data med docetaxel givet som enkeltstof ved en dosis på 100 mg/m2, er den anbefalede dosis docetaxel 75 mg/m2 til patienter, som både har forhøjelse af transaminase
Based on pharmacokinetic data with docetaxel at 100 mg/m² as single agent, patients who have both elevations of transaminase (ALT and/or AST) greater than 1.5 times the upper limit of the normal range (ULN) and alkaline phosphatase greater than 2.5 times the ULN, the recommended dose of docetaxel is 75 mg/m2 (see sections 4.4 and 5.2).
3 timers intravenøs infusion på dag 1, efterfulgt af kontinuerlig intravenøs infusion af 5-fluoruracil(F) 1.000 mg/m2/dag fra dag 1 til dag 5.
Patients on the comparator arm received cisplatin (P) 100 mg/m² as a 30-minute to three-hour intravenous infusion on day 1 followed by the continuous intravenous infusion of 5-fluorouracil (F) 1,000 mg/m²/day from day 1 to day 5.
Neglesygdomme (G3/4: 2 %)
Nail disorders (G3/4: 2%)
Neutropeni (G3/4: 83,5 %); Anæmi (G3/4:
Neutropenia (G3/4: 83.2%); Thrombocytopenia (G3/4:
Lymfødem (G3/4:
Arrhythmia (G3/4:
Kløende udslæt (G3/4: 0,7 %); Neglesygdomme (G3/4: 0,7 %);
Nail disorders (G3/4: 0.7%); Skin exfoliation (G3/4: 0%)
Tabel over bivirkninger ved behandling af ikke-småcellet lungekræft med Docetaxel 75 mg/m²
Tabulated list of adverse reactions in non-small cell lung cancer for Docetaxel 75 mg/m² single agent MedDRA system organ classes
Hjertetoksicitet
intestinal perforation.
Ved behandling med docetaxel er der rapporteret om sclerodermi-lignende forandringer, som ofte går forud for perifer lymfødem.
Scleroderma-like changes usually preceded by peripheral lymphoedema have been reported with docetaxel.
Et hætteglas Docetaxel Teva 80 mg/2,88 ml koncentrat indeholder 80 mg docetaxel.
QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial of Docetaxel Teva 80 mg/2.88 ml concentrate contains 80 mg docetaxel.
Hvert hætteglas med Docetaxel Teva 20 mg/0,72 ml koncentrat indeholder 20 mg docetaxel.
STATEMENT OF ACTIVE SUBSTANCE(S) Each vial of Docetaxel Teva 20 mg/0.72 ml concentrate contains 20 mg docetaxel.
ETIKET TIL HÆTTEGLAS - SOLVENS TIL 20 mg/0,72 ml
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS VIAL LABEL - SOLVENT FOR 20 mg/0.72 ml
vand til injektionsvæsker 5,12 ml (påfyldningsvolumen: 6,29 ml)
5.12 ml (Fill: 6.29 ml)
Asteni (alvorlig: Væskeretention (alvorlig 1,2 %); Smerter
Abdominal pain (severe: 1%);
CF
PF).
Svimmelhed (G3/4:
Constipation (G3/4:
Asteni (G3/4: 10,0 %); Pyreksi (G3/4: NA);
Lethargy (G3/4: 4.0%); Pyrexia (G3/4: 3.6%); Fluid retention (G3/4:
C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSØFRINGSTILLADELSEN • Periodiske, opdaterede sikkerhedsindberetninger (PSUR)
Periodic Safety Update Reports
Det reproduktive system og mammae Amenorré (G3/4: NA)
Amenorrhoea (G3/4: NA)
Hudafskalning (G3/4:
Gastrointestinal haemorrhage (G3/4:
Gennemsnitlig TTP (måneder) (95 % CI)
Median TTP (months) (95% CI)
Kvalme (G3/4: 16 %);
Diarrhoea (G3/4: 6.8%);
Nedsat hørelse (G3/4: 0 %).
Weight increased (G3/4: 0%);
Diarré (G3/4: 2,9 %); Opkastning (G3/4:
Infection (G3/4: 2.4%); Neutropenic infection (G3/4: 2.6%)
Ikke almindelige bivirkninger fagi/odynofagi (G3/4: Konstipation (G3/4:
Esophagitis/dysphagia/ odynophagia (G3/4:
Vizimpro fås som tabletter (15, 30 og 45 mg).
Vizimpro is available as tablets (15, 30 and 45 mg).
Yderligere information om Vizimpro findes på agenturets websted under: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
Further information on Vizimpro can be found on the Agency's website: www.ema.europa.eu/medicines/human/EPAR/vizimpro.
Patienterne bør normalt tage en tablet à 45 mg én gang dagligt på omtrent samme tidspunkt hver dag, så længe de har gavn af den, og bivirkningerne er tålelige.
The patient should normally take a 45-mg tablet once a day, at around the same time every day, for as long as they benefit from it and the side effects are tolerable.
Før påbegyndelse af behandlingen bør tilstedeværelsen af mutationer i EGFR-genet bekræftes ved relevante test.
Before starting treatment, the presence of mutations in the EGFR gene should be confirmed by appropriate tests.
Andre oplysninger om Vizimpro
Other information about Vizimpro
Som for alle lægemidler er data vedrørende brug af Vizimpro løbende overvåget.
As for all medicines, data on the use of Vizimpro are continuously monitored.
Ved visse bivirkninger kan lægen beslutte at nedsætte dosis eller stoppe med behandlingen.
If certain side effects develop the doctor may decide to reduce the dose or stop treatment.
Vizimpro udleveres kun efter recept, og behandlingen skal påbegyndes og overvåges af en læge med erfaring i brug af kræftlægemidler.
Vizimpro can only be obtained with a prescription and treatment must be started and supervised by a doctor with experience in using cancer medicines.
Bivirkninger rapporteret for Vizimpro vurderes omhyggeligt, og der foretages nødvendige forholdsregler for at beskytte patienterne.
Side effects reported with Vizimpro are carefully evaluated and any necessary action taken to protect patients.
For mere information om brug af Vizimpro, se indlægssedlen eller kontakt lægen eller apotekspersonalet.
For more information about using Vizimpro, see the package leaflet or contact your doctor or pharmacist.
Det Europæiske Lægemiddelagentur konkluderede derfor, at fordelene ved Vizimpro opvejer risiciene, og at det kan godkendes til anvendelse i EU.
The European Medicines Agency therefore decided that Vizimpro's benefits are greater than its risks and it can be authorised for use in the EU.
Vizimpro anvendes alene og hos patienter med visse mutationer (ændringer) i genet for et protein, der kaldes epidermal vækstfaktorreceptor.
Vizimpro is used on its own and only in patients with certain mutations (changes) in the gene for a protein called epidermal growth factor receptor (EGFR).
Selv om Vizimpro forårsagede flere bivirkninger end gefitinib, blev de anset for at være håndterbare.
Although Vizimpro caused more side effects than gefitinib, these were considered manageable.
Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Vizimpro?
What measures are being taken to ensure the safe and effective use of Vizimpro?
En oversigt over Vizimpro, og hvorfor det er godkendt i EU
An overview of Vizimpro and why it is authorised in the EU
Vizimpro indeholder det aktive stof dacomitinib.
Vizimpro contains the active substance dacomitinib.
Hvad er Vizimpro, og hvad anvendes det til?
What is Vizimpro and what is it used for?
Vizimpro er et kræftlægemiddel til behandling af voksne med ikke-småcellet lungekræft (NSCLC), når sygdommen er fremskreden eller har spredt sig.
Vizimpro is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the disease is advanced or has spread.
De hyppigste bivirkninger ved Vizimpro (som optræder hos mere end 1 ud af 5 patienter) er diarré, udslæt, stomatitis (betændelse i munden), negleproblemer, tør hud, appetitløshed, conjunctivitis (rødme og ubehag i øjet), vægttab og hårtab, kløe, høje niveauer af transaminaser (tegn på leverproblemer) og kvalme.
The most common side effects with Vizimpro (which may affect more than 1 in 5 people) are diarrhoea, rash, stomatitis (inflammation of the lining of the mouth), nail disorder, dry skin, loss of appetite, conjunctivitis (redness and discomfort in the eye), weight and hair loss, itching, elevated levels of transaminases (a sign of liver problems) and nausea (feeling sick).
Ved at blokere EGFR bidrager dacomitinib til at nedsætte kræftens vækst og spredning.
By blocking EGFR, dacomitinib helps to reduce the growth and spread of the cancer.
Hvilke risici er der forbundet med Vizimpro?
What are the risks associated with Vizimpro?
De hyppigste alvorlige bivirkninger er diarré, interstitiel lungesygdom (sygdomme, der forårsager ardannelse i lungerne), udslet og appetitløshed.
The most frequent serious side effects are diarrhoea, interstitial lung disease (disorders causing scarring in the lungs), rash and loss of appetite.
Hvorfor blev Vizimpro godkendt i EU?
Why is Vizimpro authorised in the EU?
Vizimpro har vist sig at være mere effektivt end gefitinib (et andet lægemiddel mod ikke-småcellet lungekræft) ved at forlænge den tid, patienterne overlevede uden forværring af deres sygdom.
Vizimpro has been shown to be more effective than gefitinib (another medicine for non-small cell lung cancer) at prolonging the time patients lived without their disease getting worse.
Patienter, der fik Vizimpro, levede i yderligere 6 måneder uden forværring af sygdommen sammenlignet med dem, der fik gefitinib.
Patients taking Vizimpro lived for an extra 6 months without their disease getting worse compared with those taking gefitinib.
Det aktive stof i Vizimpro, dacomitinib, tilhører lægemiddelgruppen "tyrosinkinasehæmmere".
The active substance in Vizimpro, dacomitinib, belongs to a group of cancer medicine called tyrosine kinase inhibitor.
Den fuldstændige liste over bivirkninger ved og begrænsninger for Vizimpro fremgår af indlægssedlen.
For the full list of side effects and restrictions of Vizimpro, see the package leaflet.
Det er påvist, at Vizimpro markant forbedrer den tid, patienterne levede uden sygdomsprogression.
Vizimpro was shown to significantly improve the length of time patients lived without their disease getting worse.
Hvordan anvendes Vizimpro?
How is Vizimpro used?
Hvilke fordele viser studierne, at der er ved Vizimpro?
What benefits of Vizimpro have been shown in studies?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Vizimpro.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Vizimpro have been included in the summary of product characteristics and the package leaflet.
Hvordan virker Vizimpro?
How does Vizimpro work?
I et hovedstudie, som omfattede 452 patienter, levede de patienter, der fik Vizimpro, i gennemsnit ca.
involving 452 patients with EGFR mutations, patients given Vizimpro lived on average for around 15 months without their disease getting worse, compared with 9 months for those given gefitinib.
Virksomheden fremlagde resultaterne af to hovedundersøgelser.
The company submitted the results of two main studies.
Den 21. marts 2013 EMA/275106/2013 EMEA/H/C/002429
EMA/177547/2013 EMEA/H/C/002429
Hvad er Kynamro?
What is Kynamro?
Den virksomhed, der har indgivet ansøgningen, er Genzyme Europe B.V.
The company that applied for authorisation is Genzyme Europe B.V.
Dette blev anset for en vigtig begrænsning, fordi Kynamro er beregnet til langtidsbehandling.
This was considered an important limitation because Kynamro is intended for long-term treatment.
Virkningerne af Kynamro blev først afprøvet i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of Kynamro were first tested in experimental models before being studied in humans.
Derfor blev CHMP's afslag fastholdt efter den fornyede overvejelse.
Therefore, the CHMP refusal was confirmed after re-examination.
Afslag på ansøgningen om markedsføringstilladelse for Kynamro (mipomersen)
Refusal of the marketing authorisation for Kynamro (mipomersen)
Kynamro er et lægemiddel, der indeholder det aktive stof mipomersen.
Kynamro is a medicine that contains the active substance mipomersen.
Virksomheden har til CHMP oplyst, at de patienter, der får lægemidlet i kliniske undersøgelser, vil fortsætte dermed som planlagt.
The company informed the CHMP that patients receiving the medicine in clinical trials will continue to do so as planned.
Ved den fornyede overvejelse i marts 2013 var CHMP's betænkeligheder fortsat ikke afklarede og blev ikke fuldt ud afhjulpet af de foranstaltninger, virksomheden foreslog.
During the re-examination in March 2013, the CHMP's concerns remained unresolved and were not fully addressed by measures proposed by the company.
Hvad forventedes Kynamro anvendt til?
What was Kynamro expected to be used for?
CHMP var ligeledes betænkelig ved de mulige langsigtede konsekvenser af resultaterne af leverprøver, der viste fedtophobning i leveren og forhøjede enzymtal, og udvalget var ikke overbevist om, at virksomheden havde foreslået fyldestgørende foranstaltninger til at forebygge uoprettelig leverskade.
The CHMP was also concerned by the potential longterm consequences of liver test results showing a build-up of fat in the liver and increased enzyme levels, and was not convinced that the company had proposed sufficient measures to prevent the risk of irreversible liver damage.
Det aktive stof i Kynamro, mipomersen, er et "antisense-oligonukleotid", dvs. et meget kort stykke DNA, der skal blokere produktionen af proteinet apolipoprotein B ved at bindes til det genetiske materiale i de celler, der producerer det. Apolipoprotein B er hovedkomponenten i LDL-kolesterol ("low density lipoprotein"-kolesterol), der også kaldes "skadeligt kolesterol", og i de to nært beslægtede typer kolesterol IDL ("intermediate density lipoprotein"-kolesterol) og VLDL ("very low density lipoprotein"-kolesterol).
The active substance in Kynamro, mipomersen, is an ‘antisense oligonucleotide', a very short fragment of DNA designed to block the production of a protein called apolipoprotein B, by attaching to the genetic material of cells responsible for producing it. Apolipoprotein B is the main component of ‘low density lipoprotein' (LDL) cholesterol, commonly known as ‘bad cholesterol', and of two closely related types of cholesterol called ‘intermediate density lipoprotein' (IDL) and ‘very low density lipoprotein' (VLDL) cholesterol.
Patienter, der søger om at deltage i programmer med særlig udleveringstilladelse, vil fortsat blive vurderet og vil få lægemidlet, hvis de er egnede.
Patients applying for compassionate use programmes will continue to be evaluated and will receive the medicine if eligible.
Den 13. december 2012 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om markedsføringstilladelse for lægemidlet Kynamro, der er bestemt til behandling af visse former for familiær hyperkolesterolæmi.
On 13 December 2012, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Kynamro, intended for the treatment of patients with certain forms of familial hypercholesterolaemia.
Desuden var der i udvalget betænkelighed ved, at der blev indberettet flere kardiovaskulære hændelser (problemer med hjerte og blodkar) hos patienter, der fik Kynamro, end hos patienter, der fik placebo.
Moreover, the Committee was concerned that more cardiovascular events (problems with the heart and blood vessels) were reported in patients taking Kynamro than in patients taking placebo.
Hvordan forventes Kynamro at virke?
How is Kynamro expected to work?
Efter at have gennemgået begrundelsen for anmodningen foretog CHMP en fornyet overvejelse af den første udtalelse og fastholdt den 21. marts 2013 afslaget på ansøgningen om markedsføringstilladelse.
After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 21 March 2013.
CHMP fandt således på daværende tidspunkt, at fordelene ved Kynamro ikke opvejede risiciene, og anbefalede afslag på ansøgning om markedsføringstilladelse.
Therefore, at that point in time, the CHMP was of the opinion that the benefits of Kynamro did not outweigh its risks and recommended that it be refused marketing authorisation.
Det forventedes anvendt sammen med andre kolesterolsænkende lægemidler og fedtfattig diæt.
It was expected to be used together with other cholesterol-lowering medicines and a low-fat diet.
Kynamro blokerer produktionen af apolipoprotein B og forventes derfor at mindske indholdet af disse typer lipoprotein i patienternes blod.
By blocking the production of apolipoprotein B, Kynamro was expected to reduce the levels of these types of lipoproteins in the blood of patients.
Den ene omfattede 51 patienter med homozygot familiær hyperkolesterolæmi, og den anden omfattede 58 patienter med svær heterozygot familiær hyperkolesterolæmi.
One involved 51 patients with homozygous familial hypercholesterolaemia and the other involved 58 patients with severe heterozygous familial hypercholesterolaemia.
I undersøgelserne sammenlignedes virkningerne af Kynamro med placebo, når det blev anvendt som tillægsbehandling til andre kolesterolsænkende lægemidler og fedtfattig diæt i en behandlingsperiode på 26 uger.
The studies compared the effects of Kynamro with placebo when added onto treatment with other cholesterol-lowering medicines and a low-fat diet, for a treatment period of 26 weeks.
Det var meningen, at det skulle kunne fås som injektionsvæske, opløsning, til indsprøjtning under huden.
It was to be available as a solution for injection under the skin.
Patienter med homozygot familiær hyperkolesterolæmi har for højt indhold i blodet af disse typer kolesterol, hvilket øger risikoen for koronar hjertesygdom (hjertesygdom forårsaget af tilstopning af de blodkar, der forsyner hjertemusklen).
Patients with homozygous familial hypercholesterolaemia have high blood levels of these types of cholesterol, which increases the risk of coronary heart disease (heart disease caused by the obstruction of the blood vessels that supply the heart muscle).
I december 2012 var der i CHMP betænkelighed ved, at en stor del af patienterne hovedsageligt på grund af bivirkninger holdt op med at tage lægemidlet inden to år, selv i den begrænsede patientgruppe med homozygot familiær hyperkolesterolæmi.
In December 2012, the CHMP was concerned that a high proportion of patients stopped taking the medicine within two years, even in the restricted group of patients with homozygous familial hypercholesterolaemia, mainly due to side effects.
Behandlingens virkning blev hovedsagelig bedømt på reduktionen i patienternes LDL-kolesteroltal.
The main measure of effectiveness was the reduction in the patients' LDL cholesterol levels.