natgillin/translations-raw huggingface dataset:
SÅDAN OPBEVARER DU IMPRIDA
HOW TO STORE IMPRIDA
Brug ikke Imprida efter den udløbsdato, der står på æsken og blisterkortet.
Do not use Imprida after the expiry date stated on the carton and blister.
Hvad Imprida indeholder
FURTHER INFORMATION
Hver tablet
What Imprida contains − The active substances of Imprida are amlodipine (as amlodipine besylate) and valsartan.
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose; crospovidon type A; vandfri silica kolloid;
67 − The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172).
67 Impridas udseende og pakningstørrelse Imprida 5 mg/ 80 mg tabletter er runde og mørkegule, præget med ” NVR ” på den ene side og ” NV ” på den anden side.
What Imprida looks like and contents of the pack Imprida 5 mg/ 80 mg tablets are round and dark yellow with “ NVR” on one side and “ NV” on the other side.
Imprida er tilgængelig i pakninger indholdende 7, 14, 28, 30, 56, 90, 98 eller 280 tabletter og multipakninger, bestående af 4 kartoner med hver 70 tabletter.
Imprida is available in packs containing 7, 14, 28, 30, 56, 90, 98 or 280 tablets and in multipacks comprising 4 cartons, each containing 70 tablets.
Hvis du vil have yderligere oplysninger om Imprida, skal du henvende dig til den lokale repræsentant:
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
69 INDLÆGSSEDDEL:
69 PACKAGE LEAFLET:
Hvis noget af ovenstående gælder for dig, skal du ikke tage Imprida og du skal underrette din læge.
70 Take special care with Imprida − if you have been sick (vomiting or diarrhoea). − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
71 Giv din læge besked, hvis du ammer.
71 Tell your doctor if you are breast-feeding.
Hvad Imprida indeholder
What Imprida contains
- De aktive stoffer i Imprida er amlodipin (som amlodipinbesylat) og valsartan.
- The active substances of Imprida are amlodipine (as amlodipine besylate) and valsartan.
73 Impridas udseende og pakningstørrelse Imprida 5 mg/ 160 mg tabletter er ovale og mørkegule, præget med ” NVR ” på den ene side og ” ECE ” på den anden side.
What Imprida looks like and contents of the pack Imprida 5 mg/ 160 mg tablets are oval and dark yellow “ NVR” on one side and “ ECE” on the other side.
75 INDLÆGSSEDDEL:
75 PACKAGE LEAFLET:
Hvis noget af ovenstående gælder for dig, skal du ikke tage Imprida og du skal underrette din læge.
76 Take special care with Imprida − if you have been sick (vomiting or diarrhoea). − if you are taking diuretics (a type of medicine also called “ water tablets” which increases the amount of urine you produce). − if you are taking other medicines or substances that increase the level of potassium in your blood (e. g. some types of diuretics, potassium supplements or salt substitutes containing potassium). − if you have liver or kidney problems. − if you have a condition affecting the renal glands called “ primary hyperaldosteronism”. − if you have had heart failure. − if your doctor has told you that you have a narrowing of the valves in your heart (called “ aortic or mitral stenosis”) or that the thickness of your heart muscle is abnormally increased (called “ obstructive hypertrophic cardiomyopathy”).
77 Giv din læge besked, hvis du ammer.
77 Tell your doctor if you are breast-feeding.
- Øvrige indholdsstoffer: mikrokrystallinsk cellulose; crospovidon type A; vandfri silica kolloid;
79 − The other ingredients are cellulose microcrystalline; crospovidone type A; silica, colloidal anhydrous; magnesium stearate; hypromellose; macrogol 4000; talc, titanium dioxide (E171); iron oxide, yellow (E172), iron oxide, red (E172).
79 Impridas udseende og pakningstørrelse Imprida 10 mg/ 160 mg tabletter er ovale og lysegule, præget med ” NVR ” på den ene side og ” UIC ” på den anden side.
What Imprida looks like and contents of the pack Imprida 10 mg/ 160 mg tablets are oval and light yellow with “ NVR” on one side and “ UIC” on the other side.
80 France Novartis Pharma S. A. S.
France Novartis Pharma S. A. S.
BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET, DER SKAL IMPLEMENTERES AF MEDLEMSSTATERNE
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET, DER SKAL IMPLEMENTERES AF MEDLEMSSTATERNE
1/ 3 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
Medlemsstaterne skal sikre, at alle betingelser eller begrænsninger med hensyn til en sikker og virkningsfuld anvendelse af lægemidlet beskrevet herunder implementeres:
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
At alle læger, der forventes at ordinere INCRELEX, ved iværksættelsen får udleveret en “ informationspakke til læger ”, som indeholder følgende:
That at launch all physicians who are expected to prescribe INCRELEX are provided with a “ physician information pack” containing the following:
Produktinformation Information om INCRELEX til læger (informationskort, doseringsvejledning og en dosisberegner) Informationspakke til patienter
Product information Physician information about INCRELEX (information card, dosing guide, and a dose calculator) Patient information pack
Informationen om INCRELEX til læger skal indeholde følgende nøgleelementer:
The physician information about INCRELEX should contain the following key elements:
• Forældrene skal oplyses om tegn, symptomer og behandling af hypoglykæmi, herunder injektion af glukagon. • Patienterne skal have ører, næse og hals undersøgt med regelmæssige mellemrum og ved forekomst af kliniske symptomer for at udelukke sådanne potentielle komplikationer eller for at iværksætte en passende behandling. • Der skal udføres en rutinemæssig fundoskopi inden behandlingsstart og med regelmæssige mellemrum i løbet af behandlingen samt ved forekomst af kliniske symptomer. • INCRELEX er kontraindiceret ved aktiv eller mistænkt neoplasi, og behandlingen skal seponeres, hvis der udvikles tegn på neoplasi. • Forskudt caput femoralis epifyser og udvikling af scoliose kan forekomme hos patienter, som oplever hurtig vækst.
• To educate parents on the signs, symptoms and treatment of hypoglycaemia, including injection of glucagon. • That patients should have examinations of the ears, nose and throat periodically and at the occurrence of clinical symptoms to rule out such potential complications or to initiate appropriate treatment. • To perform a routine funduscopic examination prior to beginning treatment and periodically during treatment or at the occurrence of clinical symptoms. • INCRELEX is contraindicated in the presence of active or suspected neoplasia, and therapy should be discontinued if evidence of neoplasia develops. • Slipped capital femoral epiphysis and progression of scoliosis can occur in patients who experience rapid growth.
Disse tilstande skal monitoreres under behandling med INCRELEX. • Forældre og patienter skal informeres om, at allergiske reaktioner kan forekomme, og at behandlingen skal afbrydes og lægen straks kontaktes, hvis dette forekommer. • Information om immunogenicitetsprøvetagning.
These conditions should be monitored during INCRELEX treatment. • To inform parents and patients that allergic reactions are possible and that if this occurs treatment should be interrupted and prompt medical attention should be sought. • Immunogenicity sampling information.
Informationen om INCRELEX til patienter skal indeholde følgende information:
The patient information about INCRELEX should contain the following information:
• INCRELEX skal indgives umiddelbart inden eller efter et måltid eller mellemmåltid, da midlet har insulinlignende hypoglykæmiske effekter. • Tegn og symptomer på hypoglykæmi.
• That INCRELEX should be administered shortly before or after a meal or snack because it has insulin-like hypoglycaemic effects. • The signs and symptoms of hypoglycaemia.
Vejledning til behandling af hypoglykæmi.
Instructions on the treatment of hypoglycaemia.
Vejledning i indgivelse af glukagon, hvis der skulle opstå alvorlig hypoglykæmi. • INCRELEX må ikke indgives, hvis patienten af en eller anden årsag ikke kan spise.
Instructions on the administration of glucagon should severe hypoglycaemia occur. • INCRELEX should not be administered if the patient is unable to eat for any reason.
INCRELEX- dosis må aldrig fordobles for at erstatte en eller flere forsømte doser. • Patienten skal undgå høj- risiko aktiviteter (såsom voldsom fysisk aktivitet) i 2- 3 timer efter doseringen, især i begyndelsen af INCRELEX- behandlingen, indtil en godt tolereret dosis INCRELEX er fastlagt. • Vejledning i at skifte og rotere injektionssted for hver injektion for at undgå udvikling af lipohypertrofi. • Vejledning i at rapportere en forværret snorken, der kan indikere en øget vækst af mandlerne og/ eller adenoidt væv efter behandlingsstart med INCRELEX. • Rapportering af alvorlig hovedpine, sløret syn og dermed forbundet kvalme og opkastning til lægen. • Rapportering af halthed eller smerter i hoften eller knæene til lægen, så dette kan evalueres.
The dose of INCRELEX should not be doubled to make up for one or more omitted doses. • To avoid engaging in any high-risk activities (such as vigorous physical activity) within 2 - 3 hours after dosing, particularly at the initiation of INCRELEX treatment, until a well-tolerated dose of INCRELEX has been established. • Instructions to change and rotate the site of injection for each injection to avoid the development of lipohypertrophy. • Instructions to report the onset or worsening of snoring that may indicate an increase in growth of tonsils and/ or adenoids following the beginning of treatment with INCRELEX. • To report the onset of severe headache blurred vision and associated nausea and vomiting to their physician. • To report any onset of a limp or complaint of hip or knee pain to their physician so it can be evaluated.
Derudover vil der være en doseringsvejledning og en dosisberegner, som læger og patienter kan anvende til oplysninger om den individuelle dosisstigning for at minimere risikoen for fejlmedicinering og hypoglykæmi.
2/ 3 In addition there will be a dosing guide, and a dose calculator, for use by physician and patients to include information on the individualised dose escalation to minimise the risk of medication errors and hypoglycaemia.
Hvad er INCRELEX?
What is INCRELEX?
INCRELEX er en injektionsvæske (opløsning), der indeholder det aktive stof mecasermin (10 mg/ ml).
INCRELEX is a solution for injection containing the active substance mecasermin (10 mg/ ml).
Hvad anvendes INCRELEX til?
What is INCRELEX used for?
INCRELEX anvendes til langtidsbehandling af nedsat vækst hos børn og unge med primær mangel (for lav blodkoncentration) på hormonet insulinlignende vækstfaktor- 1 (IGF- 1), der er nødvendigt for normal vækst.
INCRELEX is used for the long-term treatment of growth failure in children and adolescents who have severe primary deficiency (low blood levels) of a hormone, insulin-like growth factor-1 (IGF-1), which is required for growth.
Patienter med sygdommen producerer væksthormon, men kroppen reagerer ikke på det, og de er små af vækst i forhold til alderen.
Patients with this disease produce growth hormone (GH) but their body does not respond to it, and they are short for their age.
At det er en "primær" mangel, vil sige, at der ikke er fundet nogen anden årsag til det lave indhold af IGF- 1, f. eks. fejlernæring, lavt indhold af skjoldbruskkirtelhormon eller brug af medicin, der kaldes steroider, til at afhjælpe eller forhindre inflammation.
It is a ‘ primary’ deficiency, meaning that there is no other identified cause for the low levels of IGF-1, such as malnutrition, low levels of thyroid hormone or the use of medicines called steroids to reduce or prevent inflammation.
Da IGF- 1- mangel er sjælden, blev INCRELEX udpeget som "lægemiddel til sjældne sygdomme" den 22. maj 2006.
Because the number of patients with primary IGF-1 deficiency is low, the disease is considered ‘ rare’, and INCRELEX was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 22 May 2006.
Hvordan anvendes INCRELEX?
How is INCRELEX used?
Behandlingen med INCRELEX bør overvåges af en læge med erfaring i diagnose og behandling af patienter med vækstforstyrrelser.
Treatment with INCRELEX should be supervised by doctors who have experience in the diagnosis and treatment of patients with growth disorders.
Den anbefalede startdosis er 0, 04 mg pr. kg legemsvægt to gange dagligt.
The recommended starting dose is 0.04 mg per kilogram body weight twice a day.
Dosis skal tilpasses den enkelte patient, afhængigt af væksthastigheden og visse bivirkninger.
The dose should be tailored for each patient according to the speed of growth and certain side effects.
Den maksimale dosis er 0, 12 mg pr. kg to gange dagligt.
The maximum dose is 0.12 mg per kilogram twice a day.
INCRELEX gives ved indsprøjtning under huden, idet der vælges et nyt sted til hver indsprøjtning.
INCRELEX is given by injection under the skin, and the injection site should be changed with each injection.
Det må aldrig sprøjtes ind i en vene.
It should never be injected into a vein.
Indsprøjtningen skal finde sted kort før eller efter et måltid eller mellemmåltid.
The injection should be carried out shortly before or after a meal or snack.
Behandlingen skal afbrydes, hvis patienten ikke kan spise, uanset årsagen.
Treatment should be interrupted if the patient cannot eat for any reason.
INCRELEX anbefales ikke til børn under to år på grund af manglende data om sikkerhed og effekt hos denne aldersgruppe.
INCRELEX is not recommended for children below two years of age, due to a lack of data on safety and effectiveness in this group.
Hvordan virker INCRELEX?
How does INCRELEX work?
Det aktive stof i INCRELEX, mecasermin, er en kopi af det humane hormon IGF- 1.
The active substance in INCRELEX, mecasermin, is a copy of the human hormone IGF-1.
Patienter med primær mangel på IGF- 1 har lavt indhold i blodet af IGF- 1.
Patients with primary IGF-1 deficiency have low blood levels of IGF-1.
IGF- 1 har meget stor betydning for, hvor stort barnet bliver af vækst.
IGF-1 is very important in determining how tall a child grows.
INCRELEX virker på samme måde som naturligt IGF- 1, idet det erstatter det manglende hormon og fremmer barnets vækst.
INCRELEX works in the same way as natural IGF-1, replacing the missing hormone and helping the child to grow taller.
Det produceres af bakterier, der har fået indsat et gen, som gør dem i stand til at producere IGF- 1.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Mecasermin is made using ‘ recombinant DNA technology’: it is made by bacteria that have received a gene that makes them able to produce IGF-1.
Hvordan blev INCRELEX undersøgt?
How has INCRELEX been studied?
Virkningerne af INCRELEX blev først undersøgt i forsøgsmodeller, inden de blev undersøgt hos mennesker.
The effects of INCRELEX were first tested in experimental models before being studied in humans.
Af disse havde ni fået en anden type rekombinant IGF- 1, før de deltog i disse undersøgelser.
INCRELEX has been studied in five studies involving a total of 76 children aged between 1 and 15 years with severe primary IGF-1 deficiency, nine of whom had received another type of recombinant IGF-1 before joining these studies.
På grund af sygdommens sjældenhed deltog mange af børnene i flere end én af undersøgelserne.
Because the disease is rare, many of the children were included in more than one of the studies.
I den ene undersøgelse blev INCRELEX sammenlignet med placebo (virkningsløs medicin) hos otte patienter, men i de øvrige blev INCRELEX ikke sammenlignet med anden medicin.
One study compared INCRELEX to placebo (a dummy treatment) in eight patients, but the others did not compare INCRELEX to any other treatment.
Forsøgene varede mellem 15 måneder og otte år, og behandlingens virkning blev hovedsagelig bedømt på væksthastigheden.
The studies lasted between 15 months and eight years, and the main measure of effectiveness was the speed of growth.
Hvilken fordel viser undersøgelserne, at der er ved INCRELEX?
What benefit has INCRELEX shown during the studies?
INCRELEX fik væksthastigheden til at stige væsentligt.
INCRELEX caused the speed of growth to increase significantly.
Når resultaterne af alle fire undersøgelser lægges sammen, var den gennemsnitlige væksthastighed 2, 8 cm om året inden behandlingen.
When the results of all four studies were taken together, the average growth rate was 2.8 cm per year before treatment.
I det første behandlingsår var væksthastigheden 8, 0 cm, i det andet 5, 9 cm.
This increased to 8.0 cm in the first year of treatment and 5.8 cm in the second.
4, 7 cm om året.
The growth rate stabilised at around 4.7 cm per year from the fourth year of treatment.
Nogle af undersøgelserne omfattede også børn, der havde fejl i genet for væksthormon eller havde dannet antistoffer (inhibitorer) mod væksthormon, da INCRELEX også kunne anvendes til behandling af sådanne patienter.
Some of the studies had also included children who had defects in the gene for GH and who had developed antibodies (inhibitors) against GH, as INCRELEX could also be used to treat such patients.
Firmaet ansøgte da også om godkendelse af INCRELEX til behandling af sådanne børn, men trak efter vurderingen af lægemidlet ansøgningen tilbage, da denne sygdom ikke er opført i udpegelsen som lægemiddel til sjældne sygdomme.
The company did apply for an authorisation to use INCRELEX in these children, but withdrew its application after the end of the medicine’ s assessment, as this disease is not listed in the medicine ’ s ‘ orphan’ designation.
Hvilken risiko er der forbundet med INCRELEX?
What is the risk associated with INCRELEX?
De almindeligste bivirkninger af INCRELEX (der ses hos mellem 1 og 10 ud af hver 100 patienter) er for lavt blodsukker, forstørret brissel (en kirtel, der ligger bag brystbenet og medvirker til produktion af celler, der bekæmper infektioner), hovedpine, høretab, forstørrede mandler, snorken og hævelse på indstiksstedet.
The most common side effects with INCRELEX (seen in more than 1 patient in 10) are hypoglycaemia (low blood sugar levels), thymus hypertrophy (growth of the thymus gland, a gland below the breastbone that is involved in producing infection-fighting cells), headache, hypoacusis (hearing loss), tonsillar hypertrophy (growth of the tonsils), snoring and injection site hypertrophy (lumps at the site of injection).
Den fuldstændige liste over de indberettede bivirkninger for INCRELEX fremgår af produktresuméet.
For the full list of all side effects reported with INCRELEX, see the Summary of Product Characteristics.
INCRELEX bør ikke anvendes hos patienter, der kan være overfølsomme (allergiske) over for mecasermin eller andre af indholdsstofferne.
INCRELEX should not be used in people who may be hypersensitive (allergic) to mecasermin or any of the other ingredients.
Det bør desuden ikke anvendes hos patienter, der har eller menes at have aktiv svulstdannelse.
It should also not be used in patients who have, or are thought to have active neoplasia (abnormal cell growth).
Hvis en patient får en svulst, skal behandlingen med INCRELEX standses.
Treatment with INCRELEX should be stopped if neoplasia develops.
Lægemidlet må ikke anvendes til spædbørn.
It should not be used in babies.
Hvorfor blev INCRELEX godkendt?
Why has INCRELEX been approved?
Udvalget for Humanmedicinske Lægemidler (CHMP) fandt, at fordelene ved INCRELEX opvejer risiciene ved anvendelse til langvarig behandling af væksthæmning hos børn og unge med svær primær mangel på IGF- 1.
The Committee for Medicinal Products for Human Use (CHMP) decided that INCRELEX’ s benefits are greater than its risks for the long-term treatment of growth failure in children and adolescents with severe primary IGF-1 deficiency.
Udvalget anbefalede udstedelse af markedsføringstilladelse for INCRELEX.
The Committee recommended that INCRELEX be given marketing authorisation.
INCRELEX er godkendt under "særlige omstændigheder".
INCRELEX has been authorised under “ Exceptional Circumstances”.
Det betyder, at sygdommen er så sjælden, at der ikke har kunnet skaffes fuldstændige oplysninger om INCRELEX.
This means that because the disease is rare, it has not been possible to obtain complete information about INCRELEX.
Hvilke oplysninger afventes der stadig for INCRELEX?
What information is still awaited for INCRELEX?
Det firma, der fremstiller INCRELEX, vil udføre en langtidsundersøgelse af lægemidlets sikkerhed, idet behandlingen begynder, mens patienterne er små børn, og fortsætter ind i voksenalderen.
The company that makes INCRELEX will carry out a long-term study looking at the safety of the medicine, when treatment is started in young children and continued into adulthood.
Hvilke foranstaltninger træffes der for at sikre en risikofri anvendelse af INCRELEX?
Which measures are being taken to ensure the safe use of INCRELEX?
Det firma, der fremstiller INCRELEX sørger for, at læger og patienter får udleveret sikkerhedsinformation om lægemidlet.
The company that makes INCRELEX will supply information packs for doctors and for patients explaining how the medicine is used and its side effects.
Firmaet udleverer desuden dosiskalkulatorer for at gøre det lettere for læger og patienter (eller deres omsorgsgivere) at beregne den korrekte dosis.
The company will also supply dose calculators to help doctors and patients (or their carers) to work out the appropriate dose.
Andre oplysninger om INCRELEX:
Other information about INCRELEX:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for INCRELEX til Tercica Europe Limited den 3. august 2007.
The European Commission granted a marketing authorisation valid throughout the European Union for INCRELEX to Tercica Europe Limited on 3 August 2007.
©EMEA 2007 lægemiddel til sjældne sygdomme kan ses her.
©EMEA 2007
Den fuldstændige EPAR om INCRELEX findes her.
The full EPAR for INCRELEX can be found here.
INCRELEX 10 mg/ ml injektionsvæske, opløsning.
INCRELEX 10 mg/ ml solution for injection.
1 ml indeholder 10 mg mecasermin.
Each ml contains 10 mg of mecasermin.
Mecasermin er en rekombinant, DNA- afledt, human, insulinlignende vækstfaktor- 1( IGF- 1), fremstillet i Escherichia coli.
Mecasermin is a recombinant DNA-derived human insulin-like growth factor-1(IGF-1) produced in Escherichia coli.
1 ml indeholder 9 mg benzylalkohol.
One ml contains 9 mg of benzyl alcohol.
Til langvarig behandling af vækstmangel hos børn og unge med svær primær insulinlignende vækstfaktor 1- mangel (primær IGFD).
For the long-term treatment of growth failure in children and adolescents with severe primary insulin- like growth factor-1 deficiency (Primary IGFD).