natgillin/translations-raw huggingface dataset:
Derved øges risikoen for alvorlige arytmier forårsaget af disse lægemidler (se pkt.
Thereby, increasing the risk of serious arrhythmias from these agents (see section 4.5).
Delamanid (100 mg 2 gange dagligt)
Delamanid (100 mg BID)
Kaletra 100 mg/25 mg filmovertrukne tabletter
Kaletra 100 mg/25 mg film-coated tablets
(80 mg lopinavir/20 mg ritonavir pr. ml)**
Volume of oral solution twice daily taken with food (80 mg lopinavir/20 mg ritonavir per ml)**
Antiretroviral-erfarne patienter
Patients with prior antiretroviral therapy
b. Bivirkninger i tabelform
b. Tabulated list of adverse reactions
Lopinavir/ritonavir 400/100 mg 2 gange dagligt
Lopinavir/ritonavir 400/100 mg BID
Ætiologien anses dog for at være multifaktoriel (omfattende anvendelse af kortikosteroider, alkoholforbrug, svær immunosuppression, højere Body Mass Index (BMI)).
Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART).
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Ydre emballage af multipakning a 120 (3 æsker a 40 filmovertrukne tabletter) - inklusive blue box, Æske, som indeholder 120 200/50 mg filmovertrukne tabletter
PARTICULARS TO APPEAR ON THE OUTER PACKAGING Outer carton of multipacks of 120 (3 cartons of 40 film-coated 200 mg/50 mg film-coated tablets) - including the blue box
Kombination af bedaquilin og Kaletra bør undgås på grund af risikoen for bedaquilinrelaterede bivirkninger.
Due to the risk of bedaquiline related adverse events, the combination of bedaquiline and Kaletra should be avoided.
Anvendelse af vardenafil med Kaletra er kontraindiceret (se pkt.
The use of vardenafil with Kaletra is contraindicated (see section 4.3).
På grund af lopinavir/ritonavirs CYP3A-hæmning forventes koncentrationen af lurasidon at stige.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of lurasidone are expected to increase.
Forhøjede plasmakoncentrationer af avanafil (se pkt.
Increased plasma concentrations of avanafil (see sections 4.4 and 4.5).
Gennemsnitsbaseline CD4+ T-celletal var 216 celler/mm3 (interval: 20 til 775 celler/mm3) og gennemsnitsbaseline plasma-hiv-1-RNA var 5,0 log10 kopier/ml (interval: 1,7 til 7,0 log10 kopier/ml).
Mean baseline CD4+ T-cell count was 216 cells/mm3 (range: 20 to 775 cells/mm3) and mean baseline plasma HIV-1 RNA was 5.0 log10 copies/ml (range: 1.7 to 7.0 log10 copies/ml).
AUC: ↑ 13-gange På grund af lopinavir/ritonavirs hæmning af CYP3A.
AUC: ↑ 13-fold Due to CYP3A inhibition by lopinavir/ritonavir.
4.5), er resulterne af dette studie måske ikke direkte ekstrapolerbare, når andre basis-regime bruges med Kaletra.
Given the pharmacokinetic interaction between Kaletra and tenofovir (see section 4.5), the results of this study might not be strictly extrapolable when other backbone regimens are used with Kaletra.
Hver ml Kaletra oral opløsning indeholder 80 mg lopinavir og 20 mg ritonavir.
Each ml of Kaletra oral solution contains 80 mg of lopinavir and 20 mg of ritonavir.
Interaktionstabel
Interaction table
MÆRKNING, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE 100/25 mg tabletter- æske med 1 beholder
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 100 mg/ 25 mg tablets - Carton of 1 bottle
Brug doseringssprøjten på 2 ml til at klargøre en dosis.
Use the 2 ml oral dosing syringe to prepare a dose.
Udskillelse af lopinavir i mælk er vist i rottestudier.
Studies in rats revealed that lopinavir is excreted in the milk.
Rifabutin (moderstof og den aktive 25-O-desacetyl metabolit): AUC: ↑5,7-gange Cmax: ↑3,5-gange
Rifabutin, 150 mg QD Rifabutin (parent drug and active 25-O-desacetyl metabolite):
Midler mod angina pectoris Ranolazin
Antianginal Ranolazine
Koncentrationerne kan være nedsat.
Voriconazole: Concentrations may be decreased.
Samtidig administration af Kaletra og pimozid er kontraindiceret, idet risikoen for alvorlige hæmatologiske stige.
Concomitant administration of Kaletra and quetiapine is contraindicated as it may increase quetiapine-related toxicity.
Det er også rapporteret, at autoimmune sygdomme (såsom Graves sygdom og autoimmun hepatitis) kan forekomme i tilfælde af immunrekonstitution.
Autoimmune disorders (such as Graves' disease and autoimmune hepatitis) have also been reported to occur in the setting of immune reconstitution; however, the reported time to onset is more variable and can occur many months after initiation of treatment.
hiv-RNA < 400 kopier/ml (ITT)* hiv-RNA < 50 kopier/ml (ITT)*
HIV RNA < 400 copies/ml (ITT)*
NC= Fejl Observerede data
Observed data
Cmax: ↑ 4,7 gange Cmin: ↑ 14,4 gange
AUC: ↑ 7.2-fold Cmax: ↑ 4.7-fold Cmin: ↑ 14.4-fold
AUC: ↑ 13-gange
AUC: ↑ 13-fold
• Hvis ”ml" markering på den sorte ”O” ring er mindre end den ordinerede dosis, træk mere opløsning op til du rammer den ordinerede dosis.
• If the ‘ml' mark on the black ‘O' ring is less than the prescribed dose, draw up more solution to the prescribed dose.
På grund af lopinavir/ritonavirs CYP3A-hæmning forventes koncentrationen af ranolazin at stige.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of ranolazine are expected to increase.
Kaletra tabletter skal synkes hele og ikke tygges, deles eller knuses.
Kaletra tablets must be swallowed whole and not chewed, broken or crushed.
Hver ml af Kaletra indeholder 80 mg lopinavir og 20 mg ritonavir.
Each ml of Kaletra contains 80 mg of lopinavir and 20 mg of ritonavir.
Kaletra 200 mg/50 mg filmovertrukne tabletter
Kaletra 200 mg/50 mg film-coated tablets
P=0,015 (kohorte I); P< 0,001 (kohorte II).
Overall failure rate combining the treatment differences across age strata, weighted by the precision of the estimate within each age stratum p=0.015 (Cohort I); p< 0.001 (Cohort II)
Dosis til voksne af Kaletra tabletter (400/100 mg to gange dagligt) kan anvendes til børn på 40 kg eller derover eller med en legemsverflade (BSA)* større end 1,4 m2 .
The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2. For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, refer to the dosing guideline tables below.
Filmovertrukne tabletter Lysegule med præget [Abbott logo] og “KC”.
Film-coated tablet Pale yellow debossed with [Abbott logo] and “KC”.
Gennemsnitsbaseline for CD4+ celletæling var 254 celler/mm3 (interval: 4 til 952 celler/mm3) og gennemsnitsbaseline for plasma hiv-1-RNA var 4,3 log10 kopier/ml (interval: 1,7 til 6,6 log10 kopier/ml).
Mean baseline CD4+ T-cell count was 254 cells/mm3 (range: 4 to 952 cells/mm3) and mean baseline plasma HIV-1 RNA was 4.3 log10 copies/ml (range: 1.7 to 6.6 log10 copies/ml).
MÆRKNING, DER SKAL ANFØRES PÅ DEN INDRE EMBALLAGE 100/25 mg tabletter- beholderetiket
PARTICULARS TO APPEAR ON THE ON THE IMMEDIATE PACKAGING 100 mg/25 mg tablets - bottle label
Udslæt inklusive makulopapuløst udslæt, dermatit/udslæt inklusive eksem og seboreisk dermatit, nattesved, pruritus Ikke almindelig Alopeci, kapillarit, vaskulit Ikke kendt
Rash including maculopapular rash, dermatitis/rash including eczema and seborrheic dermatitis, night sweats, pruritus
Øgede plasmakoncentrationer af neratinib, som kan øge risikoen for alvorlige og livstruende reaktioner (se pkt.
Increased plasma concentrations of neratinib which may increase the potential for serious and/or life-threatening reactions (see section
• hjertemedicin, herunder: digoxin; calciumantagonister (f.eks. felodipin, nifedipin, nicardipin);
− calcium channel antagonists (e.g. felodipine, nifedipine, nicardipine);
Samtidig administration af encorafenib og Kaletra bør undgås.
Co-administration of encorafenib and Kaletra should be avoided.
b. Bivirkninger i tableform
B. PACKAGE LEAFLET
(Lopinavir/ritonavir 400/100 mg 2 gange dagligt fler-dosis)
(Lopinavir/ritonavir 400/100 mg BID, multiple dose)
Se produktresuméet for colchicin.
Refer to colchicine prescribing information.
Serumkoncentrationen kan øges på grund af ritonavirs hæmning af CYP3A.
Serum concentrations may be increased due to CYP3A inhibition by ritonavir.
Samtidig administration af Kaletra og simeprevir anbefales ikke
It is not recommended to co-administer Kaletra and simeprevir.
Serumkoncentrationen af apalutamid kan øges på grund af lopinavir/ritonavirs CYP3Ahæmning.
Serum concentrations of apalutamide may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Gennemsnitlig baseline CD4+ T-celletal var 259 celler/mm3 (interval: 2 til 949 celler/ mm3) og gennemsnitlig baseline plasma hiv-1-RNA var 4,9 log10 kopier/ml (interval: 2,6 til 6,8 log10 kopier/ml).
Mean baseline CD4+ T-cell count was 259 cells/mm3 (range: 2 to 949 cells/ mm3) and mean baseline plasma HIV-1 RNA was 4.9 log10 copies/ml (range: 2.6 to 6.8 log10 copies/ml).
På grund lopinavir/ritonavirs hæmning af CYP3A og P-gp.
Due to CYP3A and P-gp inhibition by lopinavir/ritonavir.
Gennemsnitlig stigning i CD4+ T-celletal (celler/mm3) fra baseline
Mean increase from baseline in CD4+ T-cell count (cells/mm3)
Nevirapin, 200 mg to gange dagligt
Nevirapine, 200 mg BID
Risiko for nedsat plasmakoncentration og klinisk effekt af lopinavir og ritonavir (se pkt.
Herbal preparations containing St John's wort (Hypericum perforatum) due to the risk of decreased plasma concentrations and reduced clinical effects of lopinavir and ritonavir (see section 4.5).
Hver ml indeholder: 80 mg lopinavir og 20 mg ritonavir .
Each ml contains: lopinavir 80 mg and ritonavir 20 mg.
På grund af lopinavir/ritonavirs CYP3A-hæmning, forventes koncentrationen af alfuzosin at stige.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of alfuzosin are expected to increase.
Derved øges risikoen for alvorlige arytmier forårsaget af dette lægemiddel (se pkt.
Thereby, increasing the risk of serious arrhythmias from this agent (see section 4.5).
På grund af lopinavir/ritonavirs CYP3A-hæmning forventes koncentrationen af lomitapid at stige.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of lomitapide are expected to increase.
Forhøjede plasmakoncentrationer af lurasidon som kan forøge risikoen for alvorlige og/eller livstruende reaktioner (se pkt.
Increased plasma concentrations of lurasidone which may increase the potential for serious and/or lifethreatening reactions (see section 4.5).
Serumkoncentrationen kan øges på grund af lopinavir/ritonavirs hæmning af CYP3A og P-gp.
Serum concentrations may be increased due to CYP3A and P-gp inhibition by lopinavir/ritonavir.
HMG-CoA-reduktasehæmmere
Lipid-modifying agents HMG Co-A Reductase Inhibitors
+ 4% (95% CI: -1, 9) (n=19) *Andel af forsøgspersoner som havde hiv-1 < 400 kopier/ml og fortsatte på studie-behandling
*Proportion of subjects who had HIV-1 < 400 copies/ml and had remained on study treatment
Fluticasonpropionat, 50 µg intranasalt 4 gange dagligt: Plasmakoncentrationer ↑ Kortisolniveauer ↓ 86%
Fluticasone propionate, 50 µg intranasal 4 times daily:
Forhøjede plasmakoncentrationer af vardenafil (se pkt.
Increased plasma concentrations of vardenafil (see sections 4.4 and 4.5)
Øget koncentration forventes på grund af lopinavir/ritonavirs hæmning af CYP3A.
Concentrations are expected to increase due to CYP3A inhibition by lopinavir/ritonavir.
Lopinavir-ritonavir-niveauerne kan stige ved stop af behandling med perikon.
Lopinavir and ritonavir levels may increase on stopping St John's wort.
På grund af lopinavir/ritonavirs CYP3A-hæmning af pimozid forventes koncentrationen at stige.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of pimozide are expected to increase.
På grund af lopinavir/ritonavirs hæmning af CYP3A4.
Due to CYP3A4 inhibition by lopinavir/ritonavir.
• Hvis ”ml" markering på kraven er mindre end den ordinerede dosis, træk mere opløsning op,
• If the ‘ml' mark on the collar is less than the prescribed dose, draw up more solution to the prescribed dose.
− 120 ml (2 flasker x 60 ml) med 2 x 2 ml sprøjter med 0,1 ml inddeling til voluminer op til 2 ml.
Two pack sizes are available for Kaletra oral solution: - 120 ml (2 bottles x 60 ml) with 2 x 2 ml syringes with 0.1 ml graduations
Glecaprevir/pibrentasvir Serumkoncentrationen kan øges på grund af lopinavir/ritonavirs hæmning af P-glycoprotein,
Glecaprevir/pibrentasvir Serum concentrations may be increased due to P-glycoprotein, BCRP and OATP1B inhibition by lopinavir/ritonavir.
På grund af lopinavir/ritonavirs hæmning af CYP3A forventes koncentrationen af quetiapin at stige.
Due to CYP3A inhibition by lopinavir/ritonavir, concentrations of quetiapine are expected to increase.
Forhøjede plasmakoncentrationer af ranolazin, som kan forøge risikoen for alvorlige og/eller livstruende reaktioner (se pkt.
Increased plasma concentrations of ranolazine which may increase the potential for serious and/or lifethreatening reactions (see section 4.5).
• betændelse i galdegangen;
• inflammation of the pancreas;
Brug af dosering en gang dagligt bør forbeholdes de voksne patienter, som kun har meget få proteasehæmmer(PI)-associerede mutationer ( f.eks. færre end 3 PI-mutationer i tråd med resultaterne fra et klinisk studie, se pkt.
The use of a once-daily dosing should be limited to those adult patients having only very few protease inhibitor (PI) associated mutations (i.e. less than 3 PI mutations in line with clinical trial results, see section 5.1 for the full description of the population) and should take into account the risk of a lesser sustainability of the virologic suppression (see section 5.1) and higher risk of diarrhoea (see section 4.8) compared to the recommended standard twice-daily dosing.
Sekalealkaloider
Ergot alkaloids
På grund af lopinavir/ritonavirs hæmning af CYP3A.
Due to CYP3A inhibition by lopinavir/ritonavir.
Koncentrationerne kan øges på grund af lopinavir/ritonavirs hæmning af CYP3A.
Concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
• forstoppelse;
• constipation;
Alvorlig nedsat leverfunktion.
Severe hepatic insufficiency.
Administration af Kaletra i kombination med efavirenz eller nevirapin til patienter under 6 måneder anbefales ikke.
BSA (m2) = √ (Height (cm) X Weight (kg) / 3600) It is recommended that Kaletra not be administered in combination with efavirenz or nevirapine in patients less than 6 months of age.
(Lopinavir/ritonavir 400/100 mg 2 gange dagligt)
(Lopinavir/ritonavir 400/100 mg BID)
Til børn som vejer mindre end 40 kg eller med en legemsoverflade (BSA) på mellem 0,5 og 1,4 m2 , og som er i stand til at synke tabletter, se produktresuméet for Kaletra 100 mg/25 mg tabletter.
The adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2. For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, please refer to the Kaletra 100 mg/25 mg tablets Summary of Product Characteristics.
Opioider
Opioids
Pakningsstørrelser og yderligere oplysninger Kaletra indeholder:
Other side effects that have been reported with Kaletra:
Påbegyndt behandling med perikon bør stoppes, og hvis det er mulig bør de virale-niveauer kontrolleres.
If a patient is already taking St John's wort, stop St John's wort and if possible check viral levels.
4.3) idet alfuzosin-relateret toksicitet, inklusive hypotension, kan være forøget.
Concomitant administration of Kaletra and alfuzosin is contraindicated (see section 4.3) as alfuzosin-related toxicity, including hypotension, may be increased.
Præventionsmidler
Contraceptives
Lovastatin, simvastatin: Markant forøgede plasmakoncentrationer på grund af lopinavir/ritonavirs hæmning af CYP3A.
Markedly increased plasma concentrations due to CYP3A inhibition by lopinavir/ritonavir.
AUC: ↑ 153% Cmax: ↑ 55%
AUC: ↑ 153%
Samtidig administration af riociguat og Kaletra anbefales ikke (se pkt.
The co-administration of riociguat with Kaletra is not recommended (see section 4.4 and refer to riociguat SmPC).
Serumkoncentrationen kan øges på grund af lopinavir/ritonavirs hæmning af CYP3A
Serum concentrations may be increased due to CYP3A inhibition by lopinavir/ritonavir.
Samtidig administration af øgede fosamprenavir-doser (1400 mg to gange dagligt med Kaletra (533/133 mg to gange dagligt) til proteasehæmmer-erfarne patienter resulterede i en højere forekomst af gastrointestinale bivirkninger og stigninger i triglycerider med kombinationsregimet uden stigning i den virologiske effekt ved sammenligning med standarddoser af fosamprenavir/ritonavir.
protease inhibitor-experienced patients resulted in a higher incidence of gastrointestinal adverse events and elevations in triglycerides with the combination regimen without increases in virological efficacy, when compared with standard doses of fosamprenavir/ritonavir.
Samtidig administration af vorapaxar og Kaletra anbefales ikke (se pkt.
The co-administration of vorapaxar with Kaletra is not recommended (see section 4.4 and refer to the vorapaxar SmPC).
Midler mod urinsyregigt
Renal and urinary disorders
Se produkresuméet for Kaletra 100 mg/25 mg filmovertrukne tabletter.
Please refer to the Kaletra 100 mg/25 mg film-coated tablets Summary of Product Characteristics.
Samtidig administration af Kaletra og quetiapin er kontra-indiceret (se pkt.
Co-administration of Kaletra with sildenafil is contraindicated (see section 4.3).
hiv-RNA < 400 kopier/ml hiv-RNA < 50 kopier/ml
HIV RNA < 50 copies/ml
Derved øges risikoen for myopati, inklusive rabdomyolyse (se pkt.
Increased plasma concentrations of lovastatin and simvastatin; thereby, increasing the risk of myopathy including rhabdomyolysis (see section
Lopinavir giver Kaletra dets antivirale effekt.
Lopinavir provides the antiviral activity of Kaletra.
EU/1/04/276/036 Abilify 7,5 mg/ml Injektionsvæske, opløsning
7.5 mg/ml Solution for injection
Hætteglas (glas)
Intramuscular use vial (glass)
Resultat af en indbringelsesprocedure i henhold til artikel 6, stk. 12, i forordning (EF) nr. 1084/2003 med senere ændringer
Outcome of a procedure under Article 6(12) of Regulation (EC) 1084/2003 as amended
Udvalget så på de undersøgelser, som virksomheden havde fremlagt til støtte for den nye indikation.
The Committee looked at the studies presented by the company to support the new indication.
Europa-Kommissionen traf en afgørelse den 02. september 2010.
The European Commission issued a decision on 02 September 2010.
1 I alle andre EU-medlemsstater har lægemidlet opnået markedsføringstilladelse på nationalt plan.
1 In all other Member States of the EU, the medicine has received a marketing authorisation at national level.
Hvad er Genotropin?
What is Genotropin?
Disse nationale markedsføringstilladelser berøres ikke af denne indbringelsesprocedure.
These national marketing authorisations are not affected by this referral.
Udvalget konkluderede, at ændringen i markedsføringstilladelsen ikke kan godkendes.
The Committee concluded that the change to the marketing authorisation cannot be granted.
Frankrig, Tyskland, Grækenland, Irland, Italien, Luxembourg, Nederlandene, Portugal, Spanien, Sverige og Det Forenede Kongerige ("de berørte medlemsstater").
This variation was to be recognised in Austria, Belgium, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, the Netherlands, Portugal, Spain, Sweden and the United Kingdom
Hvorfor blev Genotropin vurderet igen?
Why was Genotropin reviewed?
Hvilke konklusioner nåede CHMP frem til?
What are the conclusions of the CHMP?
Den virksomhed, der fremstiller lægemidlet, er Pfizer.
The company that makes the medicine is Pfizer.
Da det ikke lykkedes medlemsstaterne at opnå enighed, indbragte Nederlandene sagen for CHMP med henblik på voldgift den 28. oktober 2009.
Because the Member States were not able to reach an agreement, the Netherlands referred the matter to the CHMP for arbitration on 28 October 2009.
Genotropin, der også markedsføres under særnavnet Genotonorm, kan fås i hele Den Europæiske Union (EU).
Genotropin, also marketed under the trade name Genotonorm, is available throughout the European Union (EU).
Det Europæiske Lægemiddelagentur har gennemført en voldgiftsprocedure for Genotropin og relaterede navne.
The European Medicines Agency has completed an arbitration procedure for Genotropin and associated names.
I 15 EU-medlemsstater er Genotropin godkendt efter en gensidig anerkendelsesprocedure på baggrund af den første markedsføringstilladelse, der blev udstedt af Danmark den 7. maj 19871.
In 15 Member States of the EU, Genotropin is authorised under a mutual recognition procedure on the basis of the initial authorisation granted by Denmark on 7 May 19871.
25. januar 2010, 3. maj 2010 og 24. maj 2010
25 January 2010, 3 May 2010 and 24 May 2010
På grundlag af vurderingen af de tilgængelige data og den faglige drøftelse i udvalget konkluderede CHMP, at ændringen af markedsføringstilladelsen for Genotropin ikke kan godkendes i Danmark og i alle de berørte medlemsstater.
Based on the evaluation of the currently available data and the scientific discussion within the Committee, the CHMP concluded that the variation to the marketing authorisation for Genotropin cannot be approved in Denmark as well as in all concerned Member States.
I juli 2008 ansøgte Pfizer om en ændring af markedsføringstilladelsen med henblik på at medtage en ny indikation i Danmark ("referencemedlemsstaten").
In July 2008, Pfizer applied for a change (variation) to the marketing authorisation to add a new indication in Denmark (the ‘reference Member State').
Genotropin er et lægemiddel, der indeholder somatropin, som er en kopi af naturligt væksthormon.
Genotropin is a medicine that contains somatropin, which is a copy of natural growth hormone.
Væksthormon fremmer væksten i barndommen og ungdommen og indvirker også på den måde, som kroppen håndterer protein, fedt og kulhydrat på.
Growth hormone promotes growth during childhood and adolescence, and also acts on the way the body handles proteins, fat and carbohydrates.
Udvalget undersøgte ligeledes den offentliggjorte information om brugen af væksthormon hos patienter med JIA, og det indkaldte til et ekspertmøde, som omfattede eksperter i både behandlingen af hormonelle sygdomme (endokrinologer) og behandlingen af ledsygdomme (reumatologer).
It also looked at published information on the use of growth hormone in patients with JIA, and convened a meeting of experts, which included experts both in the treatment of hormonal disorders (endocrinologists) and in the treatment of joint diseases (rheumatologists).
Somatropin fremstilles ved hjælp af en metode, der kaldes "rekombinant dna-teknologi", dvs. ved hjælp af en organisme, der har fået indsat et gen (dna), som gør den i stand til at producere væksthormon.
Somatropin is produced by a method known as ‘recombinant DNA technology': it is made by an organism that has received a gene (DNA), which makes it able to produce growth hormone.
Startdato for indbringelse:
Procedure start date:
Det anvendes ligeledes til at korrigere lav højde hos børn, der lider af de genetiske sygdomme Turners syndrom og Prader Willis syndrom, samt hos børn, der i længere tid har haft nyreproblemer.
It is also used to correct short height in children who have the genetic diseases Turner syndrome and Prader Willi syndrome, and in children who have longstanding kidney problems.
Genotropin anvendes som erstatningsbehandling hos børn og voksne, der mangler væksthormon.
Genotropin is used as replacement therapy in children and adults who have a growth hormone deficiency.
24. juni 2010
24 June 2010
EMA's Udvalg for Lægemidler til Mennesker (CHMP) var blevet anmodet om at træffe afgørelse ved voldgift om en ændring af markedsføringstilladelsen for Genotropin med henblik på at medtage en ny indikation for behandlingen af lav vækst som følge af langvarig brug af steroider hos børn med juvenil idiopatisk arthritis.
The Agency's Committee for Medicinal Products for Human Use (CHMP) had been asked to arbitrate on a change to the marketing authorisation for Genotropin to include a new indication for the treatment of stunted growth caused by the long-term use of steroids in children with juvenile idiopathic arthritis.