FrancophonIA/ELRC3.0 huggingface dataset:
English: Before beginning treatment with INCRELEX the doctor or nurse will explain to you how to treat hypoglycaemia.
Bulgarian: Inden du begynder behandlingen med INCRELEX, vil lægen eller
English: Do not throw away any medicines via wastewater or household waste.
Bulgarian: Ikke anvendt lægemiddel samt affald heraf
English: Skin and hair changes Skin thickening, moles and abnormal hair texture have been seen with mecasermin treatment.
Bulgarian: Fortykkelse af huden, modermærker og abnorm hårtekstur er blevet
English: Hypoacusis (hearing loss), ear pain and fluid in the middle ear have been observed with mecasermin treatment.
Bulgarian: Høretab, øresmerter og væske i mellemøret er observeret under behandling med mercasermin.
English: EXPIRY DATE
Bulgarian: Udløbsdato
English: Reproductive system Breast enlargement has been observed with mecasermin treatment.
Bulgarian: Forplantningssystemet Der er blevet observeret forstørrelse af brysterne under behandling med mercasermin.
English: An increased incidence of keratoacanthoma in the skin was observed in male rats at doses of 4 and 10 mg/kg/day ( 4 times the exposure with the MRHD based on AUC).
Bulgarian: En øget forekomst af keratoacanthom i huden blev observeret hos hanrotter ved doser på 4 og 10 mg/kg/dag ( 4 gange eksponeringen med MRHD, baseret på AUC). En øget forekomst af mælkekirtelkarcinom hos både han- og hunrotter blev observeret hos dyr, der blev behandlet med 10 mg/kg/dag (7 gange eksponeringen med MRHD, baseret på AUC). En større dødelighed sekundært
English: Papilloedema
Bulgarian: Vægtøgning
English: Pregnancy There are no or limited amount of data for the use of mecasermin in pregnant women.
Bulgarian: ingen eller utilstrækkelige data fra anvendelse af mecasermin
English: If a person with severe hypoglycemia is unconscious or otherwise unable to ingest food normally, an injection of glucagon may be required.
Bulgarian: stand til at indtage føden normalt, kan en injektion af glukagon være påkrævet.
English: Reactions observed from the post-marketing environment
Bulgarian: Bivirkninger rapporteret efter markedsføringen
English: Brodišče 32 SI-1236 Trzin Tel: + 386 1 236 47 00
Bulgarian: Pharmaswiss d.o.o Dolenjska cesta 242c SI-1000 Ljubljana Tel: + 386 1 236 47 00
English: Hold the syringe and vial firmly (see Figure
Bulgarian: Hold godt fast i sprøjten og hætteglasset (se figur 3).
English: Intracranial hypertension/increased intracranial pressure This occurred in 4 subjects (0.96%); in two subjects INCRELEX was discontinued and not restarted; in two subjects the event did not recur after restarting INCRELEX at a reduced dose.
Bulgarian: Hos to patienter blev INCRELEX seponeret og ikke genstartet, hos to patienter forekom tilstanden ikke igen efter genstart af INCRELEX ved nedsat dosis. Alle 4 patienter kom sig uden sequelae.
English: Due date
Bulgarian: Tidsfrist
English: Increased blood sugar (hyperglycaemia) Increased blood sugar has also been observed with mecasermin treatment.
Bulgarian: For højt blodsukker (hyperglykæmi) Der har også været
English: Severe Primary IGFD includes patients with mutations in the GH receptor (GHR), post-GHR signaling pathway, and IGF-1 gene defects; they are not GH deficient, and therefore, they cannot be expected to respond adequately to exogenous GH treatment.
Bulgarian: i GH-receptoren (GHR), post-GHR signalsti og IGF-1-gendefekter; disse er
English: • To report the onset of severe headache, blurred vision and associated nausea and vomiting to their physician.
Bulgarian: syn og dermed forbundet kvalme og opkastning til lægen.
English: IH-associated signs and symptoms resolved after interruption of dosing.
Bulgarian: IH-associerede tegn og symptomer forsvandt efter seponering af dosis. Fundoskopi anbefales ved behandlingsstart, med regelmæssige mellemrum
English: Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced for diabetic subjects using this medicinal product.
Bulgarian: Insulindoser og/eller andre doser af hypoglykæmiske lægemidler
English: Never inject it into a vein or muscle.
Bulgarian: Indsprøjt aldrig direkte i en blodåre eller en muskel. Skift indgivelsessted for hver indsprøjtning.
English: NAME OF THE MEDICINAL PRODUCT INCRELEX 10 mg/ml solution for injection
Bulgarian: LÆGEMIDLETS NAVN INCRELEX 10 mg/ml injektionsvæske, opløsning
English: If you use more INCRELEX than you should
Bulgarian: Hvis du har taget for meget INCRELEX
English: Posology
Bulgarian: Høretab
English: The physician information about INCRELEX should contain the following key elements:
Bulgarian: skal indeholde følgende nøgleelementer:
English: Musculoskeletal system Joint pains and pains in the limbs have occurred with mecasermin treatment.
Bulgarian: Musker og knogler Smerter i led og lemmer er opstået under behandling med mercasermin.
English: Tell the doctor immediately if you have any of these symptoms.
Bulgarian: Tal straks med lægen, hvis du får nogen af disse symptomer. Lægen kan kontrollere, om der er et forhøjet tryk i hjernen.
English: Healthcare professionals are asked to report any suspected adverse reactions.
Bulgarian: Dermed kan nye sikkerhedsoplysninger hurtigt tilvejebringes. Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger. Se i pkt.
English: NAME OF THE MEDICINAL PRODUCT INCRELEX 10 mg/ml solution for injection mecasermin
Bulgarian: LÆGEMIDLETS NAVN INCRELEX 10 mg/ml injektionsvæske, opløsning mecasermin
English: B. PACKAGE LEAFLET
Bulgarian: B. INDLÆGSSEDDEL
English: The height velocities at a given year of treatment were compared by paired t-tests to the pre-treatment height velocities of the same subjects completing that treatment year.
Bulgarian: samme patienter, som afsluttede behandlingen det pågældende år, ved hjælp af parvise t-tests.
English: If you have scoliosis, you will need to be checked often for an increase in the curve of the spine.
Bulgarian: Forværret rygskævhed (skoliose) (på grund af hurtig vækst) Hvis du har en skæv ryg, skal det kontrolleres jævnligt, om din rygsøjle bliver mere krum.
English: Race No information is available.
Bulgarian: Race Ingen
English: After first use, the vial may be stored for up to 30 days at 2C to 8ºC.
Bulgarian: 30 dage ved 2C til 8C efter åbning.
English: Common: Cardiac murmur, tachycardia
Bulgarian: Hjertemislyd, takykardi
English: Sugarcontaining fluids or food should be consumed.
Bulgarian: Du/dit barn bør indtage væske eller føde, der indeholder sukker.
English: 4.2 Posology and method of administration
Bulgarian: Dosering og administration
English: The patient information about INCRELEX should contain the following information:
Bulgarian: skal indeholde følgende information:
English: Weight increase Weight increase has been observed with mecasermin treatment.
Bulgarian: Vægtøgning Der er observeret vægtøgning under behandling med mercasermin.
English: Especially tell the doctor if you take insulin or other anti-diabetes medicines.
Bulgarian: til lægen, hvis du tager insulin eller andre former for medicin mod diabetes. Det kan være nødvendigt at justere dosis af denne type medicin.
English: C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports
Bulgarian: Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er)
English: Inject INCRELEX as instructed by the doctor.
Bulgarian: som anvist af lægen.
English: Each vial contains 4 ml of solution.
Bulgarian: Hvert hætteglas indeholder 4 ml injektionsvæske.
English: Abdomen
Bulgarian: Amning
English: The lowest dose that was associated with substantial growth increases on an individual basis was 0.04 mg/kg twice daily (BID).
Bulgarian: Hvis den anbefalede dosis ikke tolereres af patienten, kan behandling med en lavere dosis overvejes. Væksthastigheder bør danne grundlag for evaluering af behandlingssucces. Den laveste dosis, der blev associeret med væsentlig individuel vækstforøgelse, var 0,04 mg/kg to gange daglig (BID).
English: Uncommon: Injection site rash, injection site swelling, lipohypertrophy
Bulgarian: Udslæt på injektionsstedet, hævelse på injektionsstedet, lipohypertrofi
English: Injection site hypertrophy
Bulgarian: Hypertrofi på injektionsstedet
English: Mecasermin may enlarge your tonsils/adenoids.
Bulgarian: snorken kan indikere en øget vækst af mandlerne og/eller adenoidt væv
English: • GH sufficiency.
Bulgarian: væksthormon (GH)-sufficiens
English: Do not make up the missed dose by giving two doses the next time.
Bulgarian: Du må ikke tage en dobbeltdosis næste gang som erstatning for den glemte dosis. Den næste dosis skal tages som sædvanligt med et måltid eller mellemmåltid.
English: Keep this medicine out of the sight and reach of children.
Bulgarian: Opbevar lægemidlet utilgængeligt for børn.
English: Generalised hives, difficulty in breathing, dizziness, swelling of the face and/or throat have been reported following mecasermin use.
Bulgarian: tilfælde af alment udslæt, besvær med at trække vejret, svimmelhed, hævelse i ansigt og/eller
English: How to store INCRELEX
Bulgarian: INCRELEX bør
English: Put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see Figure 2).
Bulgarian: ind for at sprøjte luft i hætteglasset (se figur 2).
English: Children The pharmacokinetics of INCRELEX have not been studied in subjects younger than 12 years of age.
Bulgarian: ikke undersøgt hos patienter under 12 år.
English: Each vial contains 40 mg of mecasermin.
Bulgarian: 40 mg mecasermin.
English: Digestive system Pain in the belly has occurred with mecasermin treatment.
Bulgarian: Fordøjelsessystemet Der er forekommet mavesmerter under behandling med mercasermin.
English: The injection site should be changed for each injection (rotate the injection site).
Bulgarian: Du skal skifte indgivelsessted, hver gang du indsprøjter (rotér indgivelsesstedet).
English: Instructions on the administration of glucagon should severe hypoglycaemia occur.
Bulgarian: skulle opstå alvorlig hypoglykæmi.
English: How to use INCRELEX
Bulgarian: I dette tilfælde kan INCRELEX
English: Buttock
Bulgarian: Papilødem
English: In adolescents with Primary IGFD and in healthy adults there were no apparent differences between males and females in the pharmacokinetics of INCRELEX.
Bulgarian: tydelig forskel mellem han- og hunkøn hos unge med primær IGFD og raske voksne.
English: Enlarged tonsils/adenoids
Bulgarian: Forstørrede mandler/polypper
English: • Patient information pack
Bulgarian: Informationspakke
English: You can help by reporting any side effects you may get.
Bulgarian: Du eller dine pårørende kan også indberette bivirkninger direkte
English: Doses greater than 0.12 mg/kg given twice daily have not been evaluated in children with severe Primary IGFD.
Bulgarian: Doser på mere end 0,12 mg/kg to gange daglig er
English: Mean (SD) -6.9 (1.8) -6.1
Bulgarian: -6,9  1,8; væksthastighed (cm/år): 2,6  1,7; væksthastighed-SDS: -3,4  1,6; IGF-1 (ng/ml):
English: Upper arm
Bulgarian: i væsken
English: Renal impairment
Bulgarian: Nedsat nyrefunktion
English: No subject discontinued the studies due to adverse events.
Bulgarian: studierne på grund af bivirkninger.
English: INSTRUCTIONS ON USE
Bulgarian: Der er observeret
English: There are also links to other websites about rare diseases and treatments.
Bulgarian: sygdomme og om, hvordan de behandles.
English: Benzyl alcohol Sodium chloride Polysorbate 20
Bulgarian: Polysorbat 20
English: As INCRELEX contains benzyl alcohol, it must not be given to premature babies or neonates.
Bulgarian: ikke gives til præmature spædbørn eller nyfødte.
English: Remove the needle from the vial and replace the protective cap. Do not let the needle touch anything.
Bulgarian: 10. Træk kanylen ud af hætteglasset og sæt beskyttelseshætten på igen.
English: The main measure of effectiveness was the average survival time.
Bulgarian: Основната мярка за ефективност е средното време на преживяемост.
English: The full EPAR for Rilutek can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Bulgarian: Пълният текст на EPAR за Rilutek може да се намери на уебсайта на Агенцията: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: For more information about treatment with Rilutek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Bulgarian: За повече информация относно лечението с Rilutek, прочетете листовката (също част от EPAR) или попитайте вашия лекар или фармацевт.
English: The exact way in which it works in ALS is not known.
Bulgarian: Точният начин, по който действа при АЛС, не е известен.
English: Rilutek has been compared with placebo (a dummy treatment) in three studies involving a total of 1,282 patients.
Bulgarian: Rilutek е сравнен с плацебо (сляпо лечение) в три проучвания при общо 1 282 пациенти.
English: One of these studies was in older patients (over 75) and in patients with advanced disease.
Bulgarian: Едно от тях е при пациенти в старческа възраст (над 75 години) и при пациенти в напреднал стадий на заболяването.
English: This is a summary of the European public assessment report (EPAR) for Rilutek.
Bulgarian: Настоящият документ представлява резюме на Европейския публичен оценъчен доклад (EPAR) за Rilutek.
English: The CHMP decided that Rilutek's benefits are greater than its risks and recommended that it be given marketing authorisation.
Bulgarian: CHMP реши, че ползите от Rilutek са по-големи от рисковете, и препоръча да се издаде разрешение за употреба.
English: EMEA/H/C/000109
Bulgarian: EMA/234576/2016 EMEA/H/C/000109
English: The recommended dose is 100 mg per day (given as one 50 mg tablet every 12 hours).
Bulgarian: Препоръчителната доза е 100 mg на ден (по една таблетка от 50 mg на всеки 12 часа).
English: Rilutek must also not be given to women who are pregnant or breastfeeding.
Bulgarian: Освен това Rilutek не трябва да се предписва на бременни и кърмещи жени.
English: Neurotransmitters are substances that nerve cells use to communicate with neighbouring cells.
Bulgarian: Невротрансмитерите са вещества, които нервните клетки използват, за да комуникират със съседни клетки.
English: It is available as 50 mg tablets.
Bulgarian: Предлага се под формата на таблетки от 50 mg.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Rilutek.
Bulgarian: Комитетът по лекарствените продукти за хуманна употреба (CHMP) е оценил лекарството, за да даде положително становище за разрешаване за употреба и препоръки за условията на употреба на Rilutek.
English: ALS is a form of motor neuron disease where the nerve cells responsible for sending instructions to the muscles gradually deteriorate, leading to weakness, muscle wasting and paralysis.
Bulgarian: АЛС е вид заболяване на моторните неврони, при което нервните клетки, отговорни за изпращането на инструкции до мускулите, постепенно се увреждат, което води до слабост, загуба на мускулна маса и парализа.
English: The average survival time was significantly longer for patients who received Rilutek compared with patients who received placebo.
Bulgarian: Средното време на преживяемост е значително по-дълго при пациентите, приемали Rilutek, в сравнение с пациентите, приемали плацебо.
English: Rilutek 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day.
Bulgarian: Rilutek в доза от 50 mg/ден не е показал по-голяма ефективност от плацебо, а дозата от 200 mg/ден не е по-ефективна от 100 mg/ден.
English: Riluzole stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Bulgarian: Рилузол препятства отделянето на глутамат и това може да предотврати увреждането на нервните клетки.
English: What benefit has Rilutek shown during the studies?
Bulgarian: Какви ползи от Rilutek са установени в проучванията?
English: The active substance in Rilutek, riluzole, acts on the nervous system.
Bulgarian: Активното вещество в Rilutek, рилузол, действа върху нервната система.
English: It is thought that the destruction of nerve cells in motor neuron disease may be caused by too much of the neurotransmitter glutamate.
Bulgarian: Счита се, че разрушаването на нервните клетки при заболявания на моторните неврони може би се причинява от прекомерно количество на невротрансмитера глутамат.
English: What is the risk associated with Rilutek?
Bulgarian: Какви са рисковете, свързани с Rilutek?
English: Across the studies, Rilutek was given as 50, 100 or 200 mg per day, and for up to 18 months.
Bulgarian: В проучванията Rilutek е прилаган в дози от 50, 100 или 200 mg дневно за период от максимум 18 месеца.
English: Looking at the results of the three studies together, over 18 months, patients who received Rilutek 100 mg/day had an average survival time that was about 2 months longer than the survival time for patients who received placebo.
Bulgarian: Като се вземат предвид резултатите от трите проучвания в рамките на периода от 18 месеца, средното време на преживяемост при пациентите, приемали Rilutek в доза от 100 mg/ден, е с около 2 месеца повече от времето на преживяемост при пациентите, приемали плацебо.
English: The most common side effects seen with Rilutek (in more than 1 patient in 10) are nausea (feeling sick), asthenia (weakness) and abnormal liver tests.
Bulgarian: Най-честите нежелани лекарствени реакции при Rilutek (наблюдавани при повече от 1 на 10 пациенти) са гадене (повдигане), астения (слабост) и абнормни чернодробни изследвания.
English: Rilutek is a medicine containing the active substance riluzole.
Bulgarian: Rilutek е лекарство, съдържащо активното вещество рилузол (riluzole).
English: Other information about Rilutek
Bulgarian: Допълнителна информация за Rilutek:
English: Rilutek is used to extend the patient's life or to delay the need for mechanical ventilation.
Bulgarian: Rilutek се използва за удължаване живота на пациента или на времето, преди да се наложи използване на механична вентилация.
English: For the full list of all side effects reported with Rilutek, see the package leaflet.
Bulgarian: За пълния списък на всички нежелани лекарствени реакции, съобщени при Rilutek, вижте листовката.
English: Treatment with Rilutek should only be started by a specialist doctor with experience in the management of motor neuron diseases.
Bulgarian: Лечението с Rilutek трябва да бъде започнато от лекар специалист с опит в овладяването на болести на моторните неврони.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Rilutek on 10 June 1996.
Bulgarian: Европейската комисия издава разрешение за употреба на Rilutek, валидно в Европейския съюз.
English: The medicine was not more effective than placebo in the late stages of ALS.
Bulgarian: В последните фази на АЛС лекарственият продукт не е по-ефективен от плацебо.
English: Rilutek is used in patients with amyotrophic lateral sclerosis (ALS).
Bulgarian: Rilutek се използва при пациенти с амиотрофична латерална склероза (АЛС).
English: Rilutek should not be used in patients with any other form of motor neuron disease.
Bulgarian: Rilutek не трябва да се прилага при пациенти с други заболявания на моторните неврони.
English: How has Rilutek been studied?
Bulgarian: Как е проучен Rilutek?
English: Rilutek must not be used in patients who have liver disease or who have abnormally high levels of liver enzymes.
Bulgarian: Rilutek не трябва да се прилага при пациенти с чернодробно заболяване или при пациенти с абнормно високи нива на чернодробните ензими.
English: Why has Rilutek been approved?
Bulgarian: Защо Rilutek е разрешен за употреба?
English: How is Rilutek used?
Bulgarian: Как се използва Rilutek?
English: What is Rilutek used for?
Bulgarian: За какво се използва Rilutek?
English: What is Rilutek?
Bulgarian: Kакво представлява Rilutek?
English: How does Rilutek work?
Bulgarian: Как действа Rilutek?
English: This authorisation was based on the authorisation granted to Stalevo in 2003 (‘informed consent').
Bulgarian: Разрешението се основава на разрешението, издадено на Stalevo през 2003 г. („информирано съгласие“).
English: Entacapone has been authorised in the European Union (EU) as Comtess/Comtan since 1998.
Bulgarian: Ентакапон е разрешен в Европейския съюз (ЕС) под името Comtess/Comtan от 1998 г.
English: Having all three substances in the same tablet can lower the number of tablets the patients have to take and help them stick to treatment.
Bulgarian: Събирането на всички тези три вещества в една таблетка може да намали броя на таблетките, които пациентите трябва да приемат, и да им помогне да се придържат към лечението.
English: • severely reduced liver function;
Bulgarian: сериозно намалена чернодробна функция;
English: The use of combinations of levodopa and carbidopa is well established, having been in use since the mid-1970s.
Bulgarian: Прилагането на комбинации от леводопа и карбидопа е добре установено и се използва от средата на 70-те години на ХХ в.
English: This helps to improve the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Bulgarian: Това помага да се подобрят симптомите на болестта на Паркинсон, например сковаността и забавянето на движенията.
English: All of the tablets contain 200 mg entacapone.
Bulgarian: Всички таблетки съдържат 200 mg ентакапон.
English: They should be used with caution in patients with mild to moderately reduced liver function or severely reduced kidney function.
Bulgarian: Те трябва да се използват с повишено внимание при пациенти с леко до умерено намалена чернодробна функция или със сериозно намалена бъбречна функция.
English: They should not be used in patients with severe liver problems.
Bulgarian: Таблетките не трябва да се използват при пациенти с тежки чернодробни проблеми.
English: Fluctuations happen when the effects of the medication wear off and symptoms re-emerge.
Bulgarian: Флуктуациите настъпват, когато действието от лекарството отслабне и симптомите се завърнат.
English: The full EPAR for Levodopa/Carbidopa/Entacapone Orion can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Bulgarian: Пълният текст на EPAR за Levodopa/Carbidopa/Entacapone Orion може да се намери на уебсайта на Агенцията: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: It is available as a range of tablets in seven strengths, containing 50 to 200 mg levodopa and 12.5 to 50 mg carbidopa.
Bulgarian: Предлага се под формата на таблетки в седем концентрации, съдържащи от 50 до 200 mg леводопа и от 12,5 до 50 mg карбидопа.
English: In patients with Parkinson's disease, the cells in the brain that produce dopamine (a substance used to transmit signals between nerve cells that help to control muscle movement) begin to die and the amount of dopamine in the brain decreases.
Bulgarian: При пациенти с болестта на Паркинсон мозъчните клетки, които произвеждат допамин (вещество, което се използва за предаване на сигнали между нервните клетки, което помага за контролиране на движението на мускулите), започват да загиват и количеството допамин в мозъка намалява.
English: Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Bulgarian: Паркинсоновата болест представлява прогресивно мозъчно нарушение, което причинява треперене, забавени движения и скованост на мускулите.
English: See the summary of product characteristics (also part of the EPAR) for full details.
Bulgarian: За повече подробности вижте кратката характеристика на продукта (също част от EPAR).
English: • a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).
Bulgarian: анамнеза за малигнен невролептичен синдром (опасно неврологично нарушение, причинявано обикновено от антипсихотични лекарства) или рабдомиолиза (разрушаване на мускулните влакна).