FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information on the use of Hulio in all conditions, including when it can be used in children, see the package leaflet or contact your doctor or pharmacist.
Bulgarian: За повече информация относно употребата на Hulio при всички заболявания, включително кога може да се прилага при деца, вижте листовката или се свържете с Вашия лекар или фармацевт.
English: Other rare serious side effects (which may affect up to 1 in 1,000 people) include failure of bone marrow to produce blood cells, disorder of the nerves, lupus and lupus-like conditions (where the immune system attacks the patient's own tissues, causing inflammation and organ damage), and Stevens-Johnson syndrome (life-threatening reaction with flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).
Bulgarian: Другите редки сериозни нежелани реакции (които може да засегнат не повече от 1 на 1 000 души) включват неспособност на костния мозък да произвежда кръвни клетки, увреждане на нервите, лупус и лупус-подобни състояния (при които имунната система атакува собствените тъкани на пациента, като причинява възпаление и увреждане на органите), синдром на StevensJohnson (животозастрашаваща реакция с грипоподобни симптоми и болезнен обрив, засягащ кожата, устата, очите и гениталиите).
English: For more information about using Hulio, see the package leaflet or contact your doctor or pharmacist.
Bulgarian: За повече информация относно употребата на Hulio вижте листовката или се свържете с лекаря или фармацевта си.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Hulio have also been included in the summary of product characteristics and the package leaflet.
Bulgarian: Препоръките и предпазните мерки за безопасната и ефективна употреба на Hulio, които следва да се спазват от медицинските специалисти и пациентите, са включени в кратката характеристика на продукта и в листовката.
English: TNF is involved in causing inflammation and is found at high levels in patients with the diseases that Hulio is used to treat.
Bulgarian: TNF причинява възпаление и се среща във високи концентрации при пациенти, страдащи от заболяванията, за чието лечение се използва Hulio.
English: Hulio can only be obtained with a prescription and treatment must be started and supervised by a doctor who has experience in the treatment of the diseases for which Hulio is used.
Bulgarian: Hulio се отпуска с рецепта, а лечението трябва да бъде започнато и да се проследява от лекар с опит в лечението на заболяванията, за които се използва Hulio.
English: Eye specialists treating uveitis should also take advice from doctors who have experience of using adalimumab.
Bulgarian: Офталмолозите, лекуващи увеит, следва да се посъветват и с лекари с опит в прилагането на адалимумаб.
English: The most common side effects with adalimumab (seen in more than 1 patient in 10) are infections (including in the nose, throat and sinuses), injection site reactions (redness, itching, bleeding, pain or swelling), headache and muscle and bone pain.
Bulgarian: Най-честите нежелани реакции при адалимумаб (които може да засегнат повече от 1 на 10 пациенти) са инфекции (включително на носа, гърлото и синусите), реакции на мястото на инжектиране (зачервяване, сърбеж, кървене, болка или подуване), главоболие и болки в мускулите и костите.
English: Studies have also shown that giving Hulio produces similar levels of the active substance in the body to giving Humira.
Bulgarian: Проучванията показват също, че приемът на Hulio води до сходни нива на активното вещество в организма като Humira.
English: • polyarticular juvenile idiopathic arthritis and active enthesitis-related arthritis (both rare diseases causing inflammation in the joints);
Bulgarian: полиартикуларен ювенилен идиопатичен артрит и активен артрит, свързан с ентезит (и двете са редки заболявания, които причиняват възпаления на ставите);
English: Laboratory studies comparing Hulio with the reference medicine Humira have shown that the active substance in Hulio is highly similar to that in Humira in terms of structure, purity and biological activity.
Bulgarian: Hulio с референтното лекарство Humira, показват, че активното вещество в Hulio е много подобно на това в Humira по структура, чистота и биологична активност.
English: Like other medicines of its class, Hulio may affect the ability of the immune system to fight off infections and cancer, and there have been some cases of serious infections and blood cancers in patients using adalimumab.
Bulgarian: Подобно на други лекарства от същия клас, Hulio може да повлияе на способността на имунната система да се бори с инфекции и рак.
English: After training, patients or their carers may inject Hulio if their doctor considers it appropriate.
Bulgarian: Ако лекуващият лекар прецени, че е подходящо, пациентите или лицата, които полагат грижи за тях, могат да поставят сами инжекцията с Hulio, след като са били обучени за целта.
English: How is Hulio used?
Bulgarian: Как се използва Hulio?
English: All these data were considered sufficient to conclude that Hulio will behave in the same way as Humira in terms of effectiveness and safety in its approved uses.
Bulgarian: Всички тези данни се считат за достатъчни, за да се заключи, че по отношение на ефективността и безопасността
English: How does Hulio work?
Bulgarian: Как действа Hulio?
English: • axial spondyloarthritis (inflammation of the spine causing back pain), including ankylosing spondylitis and when X-ray does not show disease but there are clear signs of inflammation;
Bulgarian: включително анкилозиращ спондилит, когато заболяването не е установено с рентгенови изследвания, но има ясни признаци на възпаление;
English: In addition, Hulio was as effective as Humira in a study involving 730 patients with rheumatoid arthritis that was not adequately controlled with the medicine methotrexate.
Bulgarian: Освен това в проучване при 730 пациенти с ревматоиден артрит, недостатъчно контролиран с лекарството метотрексат, Hulio е бил също толкова ефективен, колкото и Humira.
English: • Crohn's disease (a disease causing inflammation of the gut);
Bulgarian: болест на Крон (заболяване, което причинява възпаление на червата);
English: • plaque psoriasis (a disease causing red, scaly patches on the skin);
Bulgarian: псориазис с плаки (заболяване, което причинява червени, люспести плаки по кожата);
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Hulio has a highly similar structure, purity and biological activity to Humira and is distributed in the body in the same way.
Bulgarian: Hulio има много подобна на Humira структура, чистота и биологична активност и се разпределя в организма по същия начин.
English: • rheumatoid arthritis (a disease causing inflammation of the joints);
Bulgarian: ревматоиден артрит (заболяване, което причинява възпаление на ставите);
English: Therefore, the Agency's view was that, as for Humira, the benefit of Hulio outweighs the identified risk and it can be authorised.
Bulgarian: Поради това Агенцията счита, че както при Humira, ползите от
English: • psoriatic arthritis (a disease causing red, scaly patches on the skin with inflammation of the joints);
Bulgarian: псориатичен артрит (заболяване, което причинява червени, люспести плаки по кожата и възпаление на ставите);
English: • hidradenitis suppurativa (acne inversa), a long-term skin disease that causes lumps, abscesses (collections of pus) and scarring on the skin;
Bulgarian: гноен хидраденит (акне инверса), хронично кожно заболяване, което причинява подутини,
English: Annex II
Bulgarian: Bilaga II
English: Ethanol
Bulgarian: Etanol
English: Therefore the risk of medication error was considered to be a potential serious risk to public health.
Bulgarian: Därför ansågs risken för medicineringsfel vara en potentiellt allvarlig risk för folkhälsan.
English: However this was not accepted due to the risk of dosing errors.
Bulgarian: Detta godkändes emellertid inte på grund av risken för doseringsfel.
English: Chronic under-dosing has consequences to normal brain development of children.
Bulgarian: Stadigvarande underdosering har följder för barns normala hjärnutveckling.
English: 2 (Pediatrics Vol. 79 No. 4 April 1987)(2)
Bulgarian: 4 April 1987)(2)
English: Harmful for those suffering from alcoholism.
Bulgarian: som lider av alkoholism.
English: Scientific conclusions and grounds for refusal
Bulgarian: Vetenskapliga slutsatser och skäl till avslag
English: Overall summary of the scientific evaluation of Levothyroxine Alapis and associated names (see Annex I)
Bulgarian: Övergripande sammanfattning av den vetenskapliga utvärderingen av Levothyroxine Alapis och associerade namn (se bilaga I)
English: The decentralised marketing authorisation application for the medicinal product Levothyroxine is a well-established use application according to Article 10(a) of Directive 2001/83/EC.
Bulgarian: Den decentraliserade ansökan om godkännande för försäljning för läkemedlet Levothyroxine är en ansökan om väletablerad användning enligt artikel 10 a i direktiv 2001/83/EG.
English: • The Committee reviewed all the data that was available to address the potential serious risk to public health, in particular with regard to the safety of Levothyroxine Alapis 100 microgram/ml oral drops solution.
Bulgarian: Kommittén har granskat alla tillgängliga data för hantering av den potentiellt allvarliga risken för folkhälsan, särskilt beträffande säkerheten av Levothyroxine Alapis 100 mikrogram/ml oral dropplösning.
English: There was a significant difference in the occurrence of clinical seizures (P = .021).
Bulgarian: skillnad i antalet kliniska anfall (P = ,021).
English: This represents an impractical means of dosing babies and small infants, and will result in further variability in dosing volumes associated with use of a second administration device.
Bulgarian: Detta är ett opraktiskt sätt att ge doser till spädbarn och små barn, och kommer att ge ytterligare variationer i doseringsvolymerna som är förknippade med användningen av en andra administreringsenhet.
English: Despite the shortcomings of this study the data suggest a dose-dependent trend towards a higher incidence of seizures with higher doses of propylene glycol.
Bulgarian: Trots bristerna hos denna studie tyder uppgifterna på en dosberoende tendens mot en högre incidens av anfall med högre doser av propylenglykol.
English: The dosing errors due to the difficulty in accurately counting a large number of drops per dose (up to 20 drops) of Levothyroxine Alapis solution also remain a concern.
Bulgarian: Doseringsfelen på grund av svårigheten att exakt räkna ett stort antal droppar per dos (upp till 20 droppar) av Levothyroxine Alapis lösning är även fortsättningsvis ett problem.
English: To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.'
Bulgarian: Ska uppmärksammas av gravida eller ammande kvinnor, barn och högriskgrupper såsom patienter med leversjukdom eller epilepsi.”
English: • The Committee concluded that the risk-benefit balance of Levothyroxine Alapis is therefore not considered to be favourable.
Bulgarian: Kommittén drog slutsatsen att nytta-riskförhållandet för Levothyroxine Alapis därför inte anses vara gynnsamt.
English: In light of the Applicant's failure to provide responses to the CHMP list of questions during the Article 29(4) referral procedure, the assessment was carried out on the data made available during the decentralised procedure and the CMDh referral procedure.
Bulgarian: Med anledning av att sökanden inte lämnade in svar på CHMP:s frågelista under hänskjutningen enligt artikel 29.4, utfördes bedömningen med de data som gjordes tillgängliga under det decentraliserade förfarandet och CMDh:s hänskjutningsförfarande.
English: Grounds for refusal
Bulgarian: Skäl till avslag
English: The active substance levothyroxine, is an established active substance described in the European Pharmacopoeia.
Bulgarian: Den aktiva substansen levotyroxin är en erkänd aktiv substans som beskrivs i Europeiska farmakopén.
English: • The Committee considered the notification of the referral triggered by the United Kingdom under Article 29(4) of l Directive 2001/83/EC.
Bulgarian: som inleddes av Storbritannien enligt artikel 29.4 i direktiv 2001/83/EG.
English: More seizures occurred with the higher dose of propylene glycol, where 33% of the infants had seizures, vs only 14% of infants who received the lower dose of propylene glycol.
Bulgarian: inträffade med den högre dosen av propylenglykol, där 33 procent av spädbarnen drabbades av anfall, mot bara 14 procent av spädbarnen
English: The possible medication errors caused by the dropper insert were discussed by the CHMP:
Bulgarian: till följd av droppanordningen diskuterades av CHMP:
English: Levothyroxine Alapis is an oral drop solution containing levothyroxine sodium as active substance (100 mcg/ml).
Bulgarian: Levothyroxine Alapis är en oral dropplösning som innehåller levotyroxinnatrium som aktiv substans (100 μg/ml).
English: As there is limited information on safe ethanol concentrations in paediatric formulations intended for chronic use, there are concerns with regard to chronic use of Levothyroxine Alapis in neonates/children, as ethanol represents an additional insult to brain development that is already compromised by congenital hypothyroidism.
Bulgarian: Eftersom det finns begränsad information om säkra etanolkoncentrationer i pediatriska beredningar avsedda för stadigvarande användning finns det farhågor över stadigvarande användning av Levothyroxine Alapis hos nyfödda/barn, eftersom etanol utgör ännu en attack på en hjärnutveckling som redan är nedsatt
English: Medication errors caused by the administration device (dropper insert) Initially two different dropper inserts resulting in different drop sizes that would count up to 40 drops was proposed by the Applicant.
Bulgarian: Medicineringsfel orsakade av administreringsenheten (droppanordning) Först föreslog sökanden två olika droppanordningar med olika droppstorlekar vilka skulle räkna upp till 40 droppar.
English: The proposed patient populations are: adults, children over 12 years (in the treatment of diffuse non-toxic goitre), and neonates and infants (with congenital hypothyroidism).
Bulgarian: De föreslagna patientpopulationerna är vuxna, barn över 12 år (vid behandling av diffus atoxisk struma), samt nyfödda och spädbarn (med medfödd hypotyreos).
English: The absence of robust user testing with representative members of the general public provides no reassurance that this dropper device will prove manageable and accurate in practice.
Bulgarian: Till följd av bristen på robusta användartester med representativa personer ur allmänheten kan det inte med säkerhet förväntas att denna droppanordning visar
English: Levothyroxine Alapis is a solution with low viscosity, which gives a fast drop rate.
Bulgarian: Levothyroxine Alapis är en lågviskös lösning som ger en hög dropphastighet.
English: As ethanol is used to solubilise levothyroxine, its use is not considered to be essential in this formulation, based on the relatively poor solubility of levothyroxine in ethanol when compared to propylene glycol.
Bulgarian: Eftersom etanol används för att göra levotyroxin lösligt, anses dess användning vara avgörande i denna beredning, baserat på levotyroxins relativt låga löslighetsgrad i etanol vid jämförelse med propylenglykol.
English: Inaccuracy due to the miscounting of the large number of drops administered also contributes to the risk of medication error.
Bulgarian: stora antalet administrerade droppar bidrar även till risken för medicineringsfel.
English: Although propylene glycol is widely used as an excipient in oral and injectable medicines, literature data on its safety in children when administered chronically is sparse.
Bulgarian: Trots att propylenglykol har en omfattande användning som hjälpämne i orala och injicerbara läkemedel, finns det bara sparsamma litteraturuppgifter om dess säkerhet för barn vid stadigvarande administrering.
English: Combination of ethanol and propylene glycol
Bulgarian: Kombination av etanol och propylenglykol
English: Therefore, co-administration of ethanol and propylene glycol can lead to raised and potentially toxic levels of the latter.
Bulgarian: Därför kan samtidig administrering av etanol och propylenglykol leda till förhöjda och potentiellt
English: Inaccuracies due to miscounting
Bulgarian: Felaktigheter till följd av felräkning
English: The proposed indications for Levothyroxine Alapis are for: the treatment of hypothyroidism (congenital or acquired, including diffuse non-toxic goiter), hypothyroidism forms of Hashimoto's thyroiditis and thyroid carcinoma.
Bulgarian: De föreslagna indikationerna för Levothyroxine Alapis är för behandling av hypotyreos (medfödd eller förvärvad, däribland diffus atoxisk struma), hypotyreosformer av Hashimotos tyreoidit och sköldkörtelcarcinom.
English: Inaccuracies due to improper dropper orientation
Bulgarian: Felaktigheter till följd av olämplig dropporientering
English: It is also noted that the proposed package leaflet (PL) recommends that the drops are not administered directly to the patient, but should first be delivered to a spoon.
Bulgarian: Det noteras även att den föreslagna bipacksedeln rekommenderar att dropparna inte administreras direkt
English: In addition there are concerns in vulnerable adults such as those suffering from alcoholism, as well as in patients with hepatic impairment and epilepsy.
Bulgarian: Dessutom finns det farhågor för utsatta vuxna patienter, t.ex. de som lider av alkoholism, liksom för patienter med leverinsufficiens och epilepsi.
English: Nunn et al; Journal of Clinical Pharmacy and Therapeutics (2004) 29, 521-529
Bulgarian: (1) An assessment of dose-uniformity of samples delivered from paediatric oral droppers, A.J. Nunn et al; Journal of Clinical Pharmacy and Therapeutics (2004) 29, 521-529
English: • The Committee was of the opinion that there was an unacceptable risk of medication error due to the dropper insert, where the inappropriate orientation of the dropper insert would result in inaccurate and variable drop volume.
Bulgarian: Kommittén anser att droppanordningen gav upphov till en oacceptabel risk för medicineringsfel, där droppanordningens olämpliga orientering skulle leda till en felaktig och varierande droppvolym. Felaktigheter till följd av felräkningen av det
English: Deviation from a vertical position is more likely in situations where the patient / carer is attempting to manage / slow the drop rate to enable a relatively high number of drops to be counted.
Bulgarian: patienten/vårdaren försöker påverka/sakta ner dropphastigheten för att möjliggöra räkningen av ett relativt stort antal droppar.
English: Therefore there are major safety concerns due to the chronic use of the combination of ethanol and propylene glycol in neonates/children.
Bulgarian: stora säkerhetsproblem vid stadigvarande användning av kombinationen etanol och propylenglykol hos nyfödda/barn.
English: The excipients are glycerol, propylene glycol, ethanol and purified water, which comply with the respective Ph.Eur monographs.
Bulgarian: Hjälpämnena är glycerol, propylenglykol, etanol och renat vatten, vilket uppfyller kraven i respektive monografier i Europeiska farmakopén.
English: This is a bibliographic application that refers to literature concerning several levothyroxin tablet formulations and solutions and thus no reference is made to a single unique formulation.
Bulgarian: som gäller flera tablettberedningar och lösningar av levotyroxin, varför ingen hänvisning görs till en enda unik beredning.
English: Levothyroxine Alapis, which is a highly concentrated solution of a highly potent medicinal product, is associated with adverse events with chronic over-dosing - particularly cardiovascular events.
Bulgarian: Levothyroxine Alapis, som är en högkoncentrerad lösning av ett mycket potent läkemedel, är förknippat med oönskade händelser med stadigvarande överdosering - särskilt kardiovaskulära sådana.
English: In addition there are also concerns in patients with hepatic impairment, epilepsy and in vulnerable adults such as those suffering from alcoholism.
Bulgarian: genom medfödd hypotyreos. Dessutom finns det farhågor för patienter med leverinsufficiens, epilepsi och utsatta vuxna, t.ex. de som lider av alkoholism.
English: Levothyroxine Alapis, which is formulated as a highly concentrated solution of a very potent active substance, is associated with adverse events with chronic over-dosing - particularly cardiovascular.
Bulgarian: Levothyroxine Alapis, som har beretts som en högkoncentrerad lösning av en mycket potent aktiv substans, är förknippat med oönskade händelser vid stadigvarande överdosering - särskilt kardiovaskulära sådana.
English: Based on the above, the CHMP considers that the safety concerns relating to Levothyroxine Alapis that were raised during the decentralised procedure and the CMDh referral procedure have not been sufficiently addressed.
Bulgarian: som är förknippade med Levothyroxine Alapis och som togs upp under det decentraliserade förfarandet och CMDh:s hänskjutningsförfarande inte är tillräckligt utredda.
English: The applicant then proposed to use: - a dropper insert for doses between 12.5 µg and 50 µg (5 to 20 drops) and - a 3 mL oral syringe for doses between 50 µg and 200 µg (0.5 to 2 mL) According to the proposed Summary of Product Characteristics (SmPC), the dropper insert will be mainly used for administration to paediatric patients as well as for initial dosing of adults and children over 12 years.
Bulgarian: Sökanden föreslog då användning av - en droppanordning för doser mellan 12,5 µg och 50 µg (5 till 20 droppar) och - en 3 ml oral
English: Newborn infants, and children are not able to metabolize ethanol as efficiently as adults; as a consequence, they may be at higher risk of both acute and chronic alcohol-related toxicities.
Bulgarian: som vuxna, varför de kan löpa högre risk för både akuta och kroniska alkoholrelaterade förgiftningar.
English: As mentioned previously, both ethanol and propylene glycol are initially metabolised by alcohol dehydrogenase.
Bulgarian: Som tidigare nämnts metaboliseras initialt både etanol och propylenglykol av alkoholdehydrogenas. Alkoholdehydrogenas metaboliserar företrädesvis etanol
English: The guidance “Guideline on the excipients in the label and the package leaflet of medicinal products for human use” states that if the content of ethanol is 100 mg - 3g per dose, the following should be stated in the PL: ‘This medicinal product contains < > vol % ethanol (alcohol), i.e. up to < > mg per dose, equivalent to < > ml beer, < > ml wine per dose.
Bulgarian: ”Detta läkemedel innehåller < > vol% etanol (alkohol), dvs. upp till < > mg per dos, motsvarande < > ml öl, < > ml vin per dos.
English: Two groups of infants were treated with two doses of propylene glycol; 0.3 g/day and 3 g/day in an IV multivitamin solution, during two consecutive 19month periods in a retrospective design.
Bulgarian: i en av studiearmarna studerades dagliga doser av propylenglykol liknande vad som kan förväntas av Levothyroxine Alapis. Två spädbarnsgrupper behandlades med två doser propylenglykol på 0,3 g/dag respektive 3 g/dag i en intravenös multivitaminlösning under
English: In conclusion given that Levothyroxine Alapis is a highly concentrated solution containing 100 mcg/ml the dropper device is considered to be unsuitable due to inaccuracies resulting from improper dropper orientation and miscounting, especially for paediatric initial doses less than 25 mcg.
Bulgarian: Sammanfattningsvis anses det, då Levothyroxine Alapis är en högkoncentrerad lösning innehållande 100 μg/ml, att droppanordningen är olämplig till följd av felaktigheter som uppstår
English: Both ethanol and propylene glycol are initially metabolised by alcohol dehydrogenase.
Bulgarian: Både etanol och propylenglykol metaboliseras initialt av alkoholdehydrogenas. Alkoholdehydrogenas metaboliserar företrädesvis etanol