natgillin/translations-raw huggingface dataset:
Hypoglykæmiske kramper, hyperglykæmi 
Very common: Hypoglycaemia Common: Hypoglycaemic seizure, hyperglycaemia
individuelle dosisstigning for at minimere risikoen for fejlmedicinering og hypoglykæmi. 
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.
ikke har været muligt at opnå fuldstændig dokumentation for lægemidlet, fordi det anvendes til en sjælden sygdom. 
This means that because of the rarity of this disease it has been impossible to get complete information on this medicine.
skal muligvis reduceres hos diabetikere, der får dette lægemiddel. 
A dose adjustment may be needed for these medicines.
Sådan skal du tage INCRELEX Tag altid lægemidlet nøjagtigt efter lægens anvisning. 
Always use this medicine exactly as your doctor has told you.
Væksthastighed SDS 
Height Velocity SDS
Bivirkningerne præsenteres efter frekvens med angivelse af de alvorligste bivirkninger først indenfor hver frekvensgruppe. 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Det anbefales, at dosis tilpasses individuelt for hver patient 
It is recommended that the dose be individualised for each patient as described under posology
EVENTUELLE ANDRE SÆRLIGE ADVARSLER 
OTHER SPECIAL WARNING(S), IF NECESSARY
Disse bivirkninger er 
Possible side effects
i løbet af behandlingen med mecasermin og ved forekomst af kliniske symptomer. 
Funduscopic examination is recommended at the initiation, periodically during the course of mecasermin therapy and at the occurrence of clinical symptoms.
til 1 ud af 10 patienter) Kramper 
Common (may affect up to 1 in 10 people) Seizures
ikke indgives. Mecasermin-dosis må aldrig øges for at erstatte en eller flere glemte doser. Der skal skiftes injektionssted ved hver injektion. 
The dose of mecasermin should never be increased to make up for one or more omitted doses.
Indberetning af formodede bivirkninger 
Reporting of suspected adverse reactions
tilfælde af hypersensitivitet, urticaria, pruritus og erytem hos patienter behandlet med INCRELEX. 
In post-marketing experience in patients treated with INCRELEX, cases of hypersensitivity, urticaria, pruritus and erythema have been reported.
LÆGEMIDDELFORM OG INDHOLD (PAKNINGSSTØRRELSE) Injektionsvæske, opløsning. 
PHARMACEUTICAL FORM AND CONTENTS Solution for injection.
Afvigelser i hjertefunktionen 
Cardiac disorders
Inden du begynder behandlingen med INCRELEX, vil lægen eller 
Before beginning treatment with INCRELEX the doctor or nurse will explain to you how to treat hypoglycaemia.
Ikke anvendt lægemiddel samt affald heraf 
Do not throw away any medicines via wastewater or household waste.
Fortykkelse af huden, modermærker og abnorm hårtekstur er blevet 
Skin and hair changes Skin thickening, moles and abnormal hair texture have been seen with mecasermin treatment.
Høretab, øresmerter og væske i mellemøret er observeret under behandling med mercasermin. 
Hypoacusis (hearing loss), ear pain and fluid in the middle ear have been observed with mecasermin treatment.
Udløbsdato 
EXPIRY DATE
Forplantningssystemet Der er blevet observeret forstørrelse af brysterne under behandling med mercasermin. 
Reproductive system Breast enlargement has been observed with mecasermin treatment.
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 
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).
Vægtøgning 
Papilloedema
ingen eller utilstrækkelige data fra anvendelse af mecasermin 
Pregnancy There are no or limited amount of data for the use of mecasermin in pregnant women.
stand til at indtage føden normalt, kan en injektion af glukagon være påkrævet. 
If a person with severe hypoglycemia is unconscious or otherwise unable to ingest food normally, an injection of glucagon may be required.
Bivirkninger rapporteret efter markedsføringen 
Reactions observed from the post-marketing environment
Pharmaswiss d.o.o Dolenjska cesta 242c SI-1000 Ljubljana Tel: + 386 1 236 47 00 
Brodišče 32 SI-1236 Trzin Tel: + 386 1 236 47 00
Hold godt fast i sprøjten og hætteglasset (se figur 3). 
Hold the syringe and vial firmly (see Figure
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. 
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.
Tidsfrist 
Due date
For højt blodsukker (hyperglykæmi) Der har også været 
Increased blood sugar (hyperglycaemia) Increased blood sugar has also been observed with mecasermin treatment.
i GH-receptoren (GHR), post-GHR signalsti og IGF-1-gendefekter; disse er 
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.
syn og dermed forbundet kvalme og opkastning til lægen. 
• To report the onset of severe headache, blurred vision and associated nausea and vomiting to their physician.
IH-associerede tegn og symptomer forsvandt efter seponering af dosis. Fundoskopi anbefales ved behandlingsstart, med regelmæssige mellemrum 
IH-associated signs and symptoms resolved after interruption of dosing.
Insulindoser og/eller andre doser af hypoglykæmiske lægemidler 
Doses of insulin and/or other hypoglycaemic medicinal products may need to be reduced for diabetic subjects using this medicinal product.
Indsprøjt aldrig direkte i en blodåre eller en muskel. Skift indgivelsessted for hver indsprøjtning. 
Never inject it into a vein or muscle.
LÆGEMIDLETS NAVN INCRELEX 10 mg/ml injektionsvæske, opløsning 
NAME OF THE MEDICINAL PRODUCT INCRELEX 10 mg/ml solution for injection
Hvis du har taget for meget INCRELEX 
If you use more INCRELEX than you should
Høretab 
Posology
skal indeholde følgende nøgleelementer: 
The physician information about INCRELEX should contain the following key elements:
Musker og knogler Smerter i led og lemmer er opstået under behandling med mercasermin. 
Musculoskeletal system Joint pains and pains in the limbs have occurred with mecasermin treatment.
Tal straks med lægen, hvis du får nogen af disse symptomer. Lægen kan kontrollere, om der er et forhøjet tryk i hjernen. 
Tell the doctor immediately if you have any of these symptoms.
Dermed kan nye sikkerhedsoplysninger hurtigt tilvejebringes. Læger og sundhedspersonale anmodes om at indberette alle formodede bivirkninger. Se i pkt. 
Healthcare professionals are asked to report any suspected adverse reactions.
LÆGEMIDLETS NAVN INCRELEX 10 mg/ml injektionsvæske, opløsning mecasermin 
NAME OF THE MEDICINAL PRODUCT INCRELEX 10 mg/ml solution for injection mecasermin
B. INDLÆGSSEDDEL 
B. PACKAGE LEAFLET
samme patienter, som afsluttede behandlingen det pågældende år, ved hjælp af parvise t-tests. 
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.
Forværret rygskævhed (skoliose) (på grund af hurtig vækst) Hvis du har en skæv ryg, skal det kontrolleres jævnligt, om din rygsøjle bliver mere krum. 
If you have scoliosis, you will need to be checked often for an increase in the curve of the spine.
Race Ingen 
Race No information is available.
30 dage ved 2C til 8C efter åbning. 
After first use, the vial may be stored for up to 30 days at 2C to 8ºC.
Hjertemislyd, takykardi 
Common: Cardiac murmur, tachycardia
Du/dit barn bør indtage væske eller føde, der indeholder sukker. 
Sugarcontaining fluids or food should be consumed.
Dosering og administration 
4.2 Posology and method of administration
skal indeholde følgende information: 
The patient information about INCRELEX should contain the following information:
Vægtøgning Der er observeret vægtøgning under behandling med mercasermin. 
Weight increase Weight increase has been observed with mecasermin treatment.
til lægen, hvis du tager insulin eller andre former for medicin mod diabetes. Det kan være nødvendigt at justere dosis af denne type medicin. 
Especially tell the doctor if you take insulin or other anti-diabetes medicines.
Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION • Periodic Safety Update Reports
som anvist af lægen. 
Inject INCRELEX as instructed by the doctor.
Hvert hætteglas indeholder 4 ml injektionsvæske. 
Each vial contains 4 ml of solution.
Amning 
Abdomen
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). 
The lowest dose that was associated with substantial growth increases on an individual basis was 0.04 mg/kg twice daily (BID).
Udslæt på injektionsstedet, hævelse på injektionsstedet, lipohypertrofi 
Uncommon: Injection site rash, injection site swelling, lipohypertrophy
Hypertrofi på injektionsstedet 
Injection site hypertrophy
snorken kan indikere en øget vækst af mandlerne og/eller adenoidt væv 
Mecasermin may enlarge your tonsils/adenoids.
væksthormon (GH)-sufficiens 
• GH sufficiency.
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. 
Do not make up the missed dose by giving two doses the next time.
Opbevar lægemidlet utilgængeligt for børn. 
Keep this medicine out of the sight and reach of children.
tilfælde af alment udslæt, besvær med at trække vejret, svimmelhed, hævelse i ansigt og/eller 
Generalised hives, difficulty in breathing, dizziness, swelling of the face and/or throat have been reported following mecasermin use.
INCRELEX bør 
How to store INCRELEX
ind for at sprøjte luft i hætteglasset (se figur 2). 
Put the needle through the rubber top of the vial and push the plunger to inject air into the vial (see Figure 2).
ikke undersøgt hos patienter under 12 år. 
Children The pharmacokinetics of INCRELEX have not been studied in subjects younger than 12 years of age.
40 mg mecasermin. 
Each vial contains 40 mg of mecasermin.
Fordøjelsessystemet Der er forekommet mavesmerter under behandling med mercasermin. 
Digestive system Pain in the belly has occurred with mecasermin treatment.
Du skal skifte indgivelsessted, hver gang du indsprøjter (rotér indgivelsesstedet). 
The injection site should be changed for each injection (rotate the injection site).
skulle opstå alvorlig hypoglykæmi. 
Instructions on the administration of glucagon should severe hypoglycaemia occur.
I dette tilfælde kan INCRELEX 
How to use INCRELEX
Papilødem 
Buttock
tydelig forskel mellem han- og hunkøn hos unge med primær IGFD og raske voksne. 
In adolescents with Primary IGFD and in healthy adults there were no apparent differences between males and females in the pharmacokinetics of INCRELEX.
Forstørrede mandler/polypper 
Enlarged tonsils/adenoids
Informationspakke 
• Patient information pack
Du eller dine pårørende kan også indberette bivirkninger direkte 
You can help by reporting any side effects you may get.
Doser på mere end 0,12 mg/kg to gange daglig er 
Doses greater than 0.12 mg/kg given twice daily have not been evaluated in children with severe Primary IGFD.
-6,9  1,8; væksthastighed (cm/år): 2,6  1,7; væksthastighed-SDS: -3,4  1,6; IGF-1 (ng/ml): 
Mean (SD) -6.9 (1.8) -6.1
i væsken 
Upper arm
Nedsat nyrefunktion 
Renal impairment
studierne på grund af bivirkninger. 
No subject discontinued the studies due to adverse events.
Der er observeret 
INSTRUCTIONS ON USE
sygdomme og om, hvordan de behandles. 
There are also links to other websites about rare diseases and treatments.
Polysorbat 20 
Benzyl alcohol Sodium chloride Polysorbate 20
ikke gives til præmature spædbørn eller nyfødte. 
As INCRELEX contains benzyl alcohol, it must not be given to premature babies or neonates.
10. Træk kanylen ud af hætteglasset og sæt beskyttelseshætten på igen. 
Remove the needle from the vial and replace the protective cap. Do not let the needle touch anything.
Основната мярка за ефективност е средното време на преживяемост. 
The main measure of effectiveness was the average survival time.
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. 
The full EPAR for Rilutek can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
За повече информация относно лечението с Rilutek, прочетете листовката (също част от EPAR) или попитайте вашия лекар или фармацевт. 
For more information about treatment with Rilutek, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Точният начин, по който действа при АЛС, не е известен. 
The exact way in which it works in ALS is not known.
Rilutek е сравнен с плацебо (сляпо лечение) в три проучвания при общо 1 282 пациенти. 
Rilutek has been compared with placebo (a dummy treatment) in three studies involving a total of 1,282 patients.
Едно от тях е при пациенти в старческа възраст (над 75 години) и при пациенти в напреднал стадий на заболяването. 
One of these studies was in older patients (over 75) and in patients with advanced disease.
Настоящият документ представлява резюме на Европейския публичен оценъчен доклад (EPAR) за Rilutek. 
This is a summary of the European public assessment report (EPAR) for Rilutek.
CHMP реши, че ползите от Rilutek са по-големи от рисковете, и препоръча да се издаде разрешение за употреба. 
The CHMP decided that Rilutek's benefits are greater than its risks and recommended that it be given marketing authorisation.
EMA/234576/2016 EMEA/H/C/000109 
EMEA/H/C/000109
Препоръчителната доза е 100 mg на ден (по една таблетка от 50 mg на всеки 12 часа). 
The recommended dose is 100 mg per day (given as one 50 mg tablet every 12 hours).
Освен това Rilutek не трябва да се предписва на бременни и кърмещи жени. 
Rilutek must also not be given to women who are pregnant or breastfeeding.
Невротрансмитерите са вещества, които нервните клетки използват, за да комуникират със съседни клетки. 
Neurotransmitters are substances that nerve cells use to communicate with neighbouring cells.
Предлага се под формата на таблетки от 50 mg. 
It is available as 50 mg tablets.
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. 
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.
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. 
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.
Средното време на преживяемост е значително по-дълго при пациентите, приемали Rilutek, в сравнение с пациентите, приемали плацебо. 
The average survival time was significantly longer for patients who received Rilutek compared with patients who received placebo.
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. 
Rilutek 50 mg/day was no more effective than placebo and 200 mg/day was no more effective than 100 mg/day.
Рилузол препятства отделянето на глутамат и това може да предотврати увреждането на нервните клетки. 
Riluzole stops the release of glutamate and this may help in preventing the nerve cells being damaged.
Какви ползи от Rilutek са установени в проучванията? 
What benefit has Rilutek shown during the studies?
Активното вещество в Rilutek, рилузол, действа върху нервната система. 
The active substance in Rilutek, riluzole, acts on the nervous system.
Счита се, че разрушаването на нервните клетки при заболявания на моторните неврони може би се причинява от прекомерно количество на невротрансмитера глутамат. 
It is thought that the destruction of nerve cells in motor neuron disease may be caused by too much of the neurotransmitter glutamate.
Какви са рисковете, свързани с Rilutek? 
What is the risk associated with Rilutek?
В проучванията Rilutek е прилаган в дози от 50, 100 или 200 mg дневно за период от максимум 18 месеца. 
Across the studies, Rilutek was given as 50, 100 or 200 mg per day, and for up to 18 months.
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. 
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.
Най-честите нежелани лекарствени реакции при Rilutek (наблюдавани при повече от 1 на 10 пациенти) са гадене (повдигане), астения (слабост) и абнормни чернодробни изследвания. 
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.
Rilutek е лекарство, съдържащо активното вещество рилузол (riluzole). 
Rilutek is a medicine containing the active substance riluzole.
Допълнителна информация за Rilutek: 
Other information about Rilutek
Rilutek се използва за удължаване живота на пациента или на времето, преди да се наложи използване на механична вентилация. 
Rilutek is used to extend the patient's life or to delay the need for mechanical ventilation.
За пълния списък на всички нежелани лекарствени реакции, съобщени при Rilutek, вижте листовката. 
For the full list of all side effects reported with Rilutek, see the package leaflet.
Лечението с Rilutek трябва да бъде започнато от лекар специалист с опит в овладяването на болести на моторните неврони. 
Treatment with Rilutek should only be started by a specialist doctor with experience in the management of motor neuron diseases.
Европейската комисия издава разрешение за употреба на Rilutek, валидно в Европейския съюз. 
The European Commission granted a marketing authorisation valid throughout the European Union for Rilutek on 10 June 1996.
В последните фази на АЛС лекарственият продукт не е по-ефективен от плацебо. 
The medicine was not more effective than placebo in the late stages of ALS.
Rilutek се използва при пациенти с амиотрофична латерална склероза (АЛС). 
Rilutek is used in patients with amyotrophic lateral sclerosis (ALS).
Rilutek не трябва да се прилага при пациенти с други заболявания на моторните неврони. 
Rilutek should not be used in patients with any other form of motor neuron disease.
Как е проучен Rilutek? 
How has Rilutek been studied?
Rilutek не трябва да се прилага при пациенти с чернодробно заболяване или при пациенти с абнормно високи нива на чернодробните ензими. 
Rilutek must not be used in patients who have liver disease or who have abnormally high levels of liver enzymes.
Защо Rilutek е разрешен за употреба? 
Why has Rilutek been approved?
Как се използва Rilutek? 
How is Rilutek used?
За какво се използва Rilutek? 
What is Rilutek used for?
Kакво представлява Rilutek? 
What is Rilutek?
Как действа Rilutek? 
How does Rilutek work?
Разрешението се основава на разрешението, издадено на Stalevo през 2003 г. („информирано съгласие“). 
This authorisation was based on the authorisation granted to Stalevo in 2003 (‘informed consent').
Ентакапон е разрешен в Европейския съюз (ЕС) под името Comtess/Comtan от 1998 г. 
Entacapone has been authorised in the European Union (EU) as Comtess/Comtan since 1998.
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. 
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.
сериозно намалена чернодробна функция; 
• severely reduced liver function;
Прилагането на комбинации от леводопа и карбидопа е добре установено и се използва от средата на 70-те години на ХХ в. 
The use of combinations of levodopa and carbidopa is well established, having been in use since the mid-1970s.
Това помага да се подобрят симптомите на болестта на Паркинсон, например сковаността и забавянето на движенията. 
This helps to improve the symptoms of Parkinson's disease, such as stiffness and slowness of movement.
Всички таблетки съдържат 200 mg ентакапон. 
All of the tablets contain 200 mg entacapone.
Те трябва да се използват с повишено внимание при пациенти с леко до умерено намалена чернодробна функция или със сериозно намалена бъбречна функция. 
They should be used with caution in patients with mild to moderately reduced liver function or severely reduced kidney function.
Таблетките не трябва да се използват при пациенти с тежки чернодробни проблеми. 
They should not be used in patients with severe liver problems.
Флуктуациите настъпват, когато действието от лекарството отслабне и симптомите се завърнат. 
Fluctuations happen when the effects of the medication wear off and symptoms re-emerge.
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. 
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.
Предлага се под формата на таблетки в седем концентрации, съдържащи от 50 до 200 mg леводопа и от 12,5 до 50 mg карбидопа. 
It is available as a range of tablets in seven strengths, containing 50 to 200 mg levodopa and 12.5 to 50 mg carbidopa.
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. 
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.
Паркинсоновата болест представлява прогресивно мозъчно нарушение, което причинява треперене, забавени движения и скованост на мускулите. 
Parkinson's disease is a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
За повече подробности вижте кратката характеристика на продукта (също част от EPAR). 
See the summary of product characteristics (also part of the EPAR) for full details.
анамнеза за малигнен невролептичен синдром (опасно неврологично нарушение, причинявано обикновено от антипсихотични лекарства) или рабдомиолиза (разрушаване на мускулните влакна). 
• a history of neuroleptic malignant syndrome (a dangerous nervous system disorder usually caused by antipsychotic medicines) or rhabdomyolysis (breakdown of muscle fibres).