natgillin/translations-raw huggingface dataset:
Lot: {номер}
EXP: {month/year}
СЪСТАВ Aктивна субстанция:
QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance :
НА ЛИЦЕНЗА ЗА УПОТРЕБА VIRBAC
NAME OF THE MARKETING AUTHORISATION HOLDER VIRBAC S.A.
Притежател на лиценза за употреба и производител отговорен за освобождаване на партидата:
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
СПЕЦИАЛНИ ПРЕДУПРЕЖДЕНИЕ(Я)
SPECIAL WARNINGS
Индивидуално предпазно оборудване, състоящо се от гумени ръкавици трябва да се носи, когато се работи с ветеринарномедицинския продукт.
It is recommended to wear rubber gloves.
енотовидните кучета е бил по-голям от 3 забелязани лисици / енотовидни кучета на 10 km.
foxes / raccoon dogs seen per 10 km.
E-08950 - Esplugues de Llobregat (Barcelona) Tel: + 34 93 470 79 40
ES-8950 Esplugues de Llobregat (Barcelona) Tél.
ПАРТИДЕН НОМЕР Lot: {номер} СРОК НА ГОДНОСТ EXP : {месец/година} НАДПИСЪТ “САМО ЗА ВЕТЕРИНАРНОМЕДИЦИНСКА УПОТРЕБА”
EXPIRY DATE EXP: {month/year}
EXP
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Avenue 2065 M L.I.D 06516 Carros France
ИНФОРМАЦИЯ, КОЯТО СЕ ИЗПИСВА ВЪРХУ
PARTICULARS TO APPEAR ON BAITS
НОМЕР(А) НА ЛИЦЕНЗА ЗА УПОТРЕБА НА ВМП
MANUFACTURER'S BATCH NUMBER BN: {number}
Това е придружено с подобрение на симптомите и качеството на живот.
This was accompanied by improvements in symptoms and quality of life.
Пълният текст на EPAR относно Fabrazyme може да се намери на уебсайта на Агенцията: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
The full EPAR for Fabrazyme can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Fabrazyme се прилага веднъж на всеки две седмици като инфузия от 1 mg на килограм телесно тегло.
Fabrazyme is given once every two weeks as an infusion of 1 mg per kilogram body weight.
Инфузиите се правят в болница, но е възможно прилагането им и в домашни условия, ако е установено, че пациентът понася добре инфузиите.
The infusions are given in hospital but may be given at home if it has been shown that the patient is tolerating the infusions well.
Скоростта на инфузията може да бъде увеличавана постепенно при следващите инфузии.
The infusion rate may be increased gradually with further infusions.
Първоначалната скорост на инфузията не трябва да надвишава 0,25 mg на минута (15 mg на час), за да се сведе до минимум рискът от поява на нежелани лекарствени реакции, свързани с инфузията.
The starting infusion rate should be no more than 0.25 mg per minute (15 mg per hour) to reduce the risk of infusion-related side effects.
За повече информация относно лечението с Fabrazyme прочетете листовката (също част от EPAR) или попитайте Вашия лекар или фармацевт.
For more information about treatment with Fabrazyme, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Настоящият документ представлява резюме на Европейския публичен оценъчен доклад (EPAR) за Fabrazyme.
This is a summary of the European public assessment report (EPAR) for Fabrazyme.
Fabrazyme е проучен в три проучвания при общо 73 възрастни.
Fabrazyme has been investigated in three studies involving a total of 73 adults.
Ефективността на Fabrazyme е проучена също при 16 деца на възраст между осем и 16 години с болестта на Фабри.
The effectiveness of Fabrazyme was also tested in 16 children aged between eight and 16 years who had Fabry disease.
Децата, лекувани с Fabrazyme, също показват намаление в нивата на GL-3 в кръвта, като всички деца имат нормални нива след 20 седмици лечение.
Children treated with Fabrazyme also had decreases in levels of GL-3 in the blood, with all children having normal levels after 20 weeks of treatment.
Хората с болестта на Фабри могат да имат много на брой признаци и симптоми, включително тежки състояния като бъбречна недостатъчност, сърдечни проблеми и удар.
People with Fabry disease may have a wide range of signs and symptoms, including severe conditions such as kidney failure, heart problems and stroke.
Fabrazyme е предназначен за продължителна употреба.
Fabrazyme is intended for long-term use.
При основното проучване Fabrazyme е сравнен с плацебо (сляпо лечение) при 58 пациенти.
In the main study, Fabrazyme was compared with placebo (a dummy treatment) in 58 patients.
Най-честите нежелани лекарствени реакции при Fabrazyme (наблюдавани при повече от 1 на 10 пациенти) са причинени по-скоро от инфузията, отколкото от лекарството.
The most common side effects with Fabrazyme (seen in more than 1 patient in 10) are caused by the infusion rather than the medicine.
Ако ензимът отсъства, GL-3 не може да бъде разграден и се натрупва в клетките, например в бъбречните клетки.
If the enzyme is not present, GL-3 cannot be broken down and it builds up in the body's cells, such as kidney cells.
Активното вещество във Fabrazyme, алагзидаза бета, е една от формите на човешкия ензим, произвеждан по метод, познат като „рекомбинантна ДНК технология” от клетки, получили ген (ДНК), който ги прави способни да произведат ензима.
The active substance in Fabrazyme, agalsidase beta, is a copy of the human enzyme, produced by a method known as ‘recombinant DNA technology': it is made by cells that have received a gene (DNA), which makes them able to produce the enzyme.
При основното проучване Fabrazyme предизвиква значим и почти пълен бъбречен клирънс на GL3 в бъбречните клетки след 20-седмично лечение: 69% от пациентите, лекувани с Fabrazyme, имат най-добрите резултати по отношение на клирънса в сравнение с нито един от пациентите от групата, получавала плацебо.
In the main study, Fabrazyme produced a highly significant and almost complete clearance of GL-3 in the kidney cells after 20 weeks of treatment: 69% of the patients treated with Fabrazyme had the best score for clearance, compared with none of the patients in the placebo group.
Ензимозаместващата терапия осигурява на пациентите ензима, който им липсва.
Enzyme replacement therapies provide patients with the enzyme they are lacking.
Резюме на EPAR за обществено ползване agalsidase beta
EPAR summary for the public agalsidase beta
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 Fabrazyme.
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 Fabrazyme.
Допълнителна информация за Fabrazyme:
Other information about Fabrazyme
Fabrazyme не трябва да се прилага при хора, които са свръхчувствителни (алергични) към агалзидаза бета или към някоя от останалите съставки.
Fabrazyme must not be used in people who are hypersensitive (allergic) to agalsidase beta or any of the other ingredients.
Fabrazyme е предназначен да замени човешкия ензим алфагалактозидаза A, който липсва при хората с болестта на Фабри.
Fabrazyme is designed to replace the human enzyme alpha galactosidase A, which is lacking in patients with Fabry disease.
Проучването разглежда ефекта от лекарството върху бъбречния клирънс на GL-3.
The study looked at the effects of the medicine on clearing GL-3 from the kidney.
Fabrazyme е лекарство, което съдържа активното вещество агалсидаза бета (agalsidase beta).
Fabrazyme is a medicine that contains the active substance agalsidase beta.
Какви ползи от Fabrazyme са установени в проучванията?
What benefit has Fabrazyme shown during the studies?
Заместващият ензим помага да се разгради GL-3 и да се спре натрупването му в клетките.
The replacement enzyme helps to break down GL-3 and stops it building up in the patient's cells.
Fabrazyme е ензимозаместваща терапия.
Fabrazyme is an enzyme replacement therapy.
Тези реакции включват повишена температура, студени тръпки, главоболие, парестезия (ненормални усещания, като вцепеняване или изтръпване на крайниците), гадене (позиви за повръщане), повръщане и усещане за студ.
These include fever, chills, headache, paraesthesia (abnormal sensations like pins and needles), nausea (feeling sick), vomiting and feeling cold. For the full list of all side effects reported with Fabrazyme, see the package leaflet.
Fabrazyme се използва за лечение на пациенти с болестта на Фабри, рядко наследствено заболяване.
Fabrazyme is used to treat patients who have Fabry disease, a rare inherited disorder.
Какви са рисковете, свързани с Fabrazyme?
What is the risk associated with Fabrazyme?
Европейската комисия издава разрешение за употреба на Fabrazyme, валидно в Европейския съюз.
The European Commission granted a marketing authorisation valid throughout the European Union for Fabrazyme on 3 August 2001.
Предлага се под формата на разтвор за приготвяне на венозен инфузионен разтвор (вливане).
It is available as a powder to be made into a solution for infusion (drip) into a vein.
Лечението с Fabrazyme трябва да се извършва единствено от лекар, притежаващ опит в лечението на пациенти с болестта на Фабри или други наследствени метаболитни заболявания.
Only a doctor who has experience in treating patients with Fabry disease or other inherited metabolic diseases should give Fabrazyme.
Този ензим обикновено разгражда мастното вещество глоботриаозилцерамид (GL3 или Gb3).
Patients with Fabry disease do not have enough of an enzyme called alpha-galactosidase A. This enzyme normally breaks down a fatty substance called globotriaosylceramide (GL-3 or Gb3).
Какво представлява Fabrazyme?
What is Fabrazyme?
CHMP реши, че при пациентите с болестта на Фабри лечението с Fabrazyme може да доведе до дългосрочни клинични ползи. CHMP реши, че ползите от Fabrazyme са по-големи от рисковете, и препоръча да се издаде разрешение за употреба.
The CHMP decided that Fabrazyme's benefits are greater than its risks and recommended that it be given marketing authorisation.
Как е проучен Fabrazyme?
How has Fabrazyme been studied?
За какво се използва Fabrazyme?
What is Fabrazyme used for?
Как се използва Fabrazyme?
How is Fabrazyme used?
Защо Fabrazyme е разрешен за употреба?
Why has Fabrazyme been approved?
Как действа Fabrazyme?
How does Fabrazyme work?
EU/1/12/751/001 Zelboraf
EU/1/12/751/001
Перорално приложение блистер (alu/alu)
Oral use blister (alu/alu) 56 tablets
240 mg
240 mg Film-coated tablet
Търговско име Концентрация Лекарствена форма
Strength Pharmaceutical Form Route of Administration
Брой в опаковка
Packaging Package size
Опаковка
Zelboraf
Начина на приложение
(Invented) name
Tento postup je považován za přijatelný.
This approach is considered acceptable.
Váš lékař bude vědět, zda-li jste ohroženi.
Your doctor will know if you are at risk.
Potenciální riziko pro člověka není známé.
The potential risk for humans is unknown.
Možnými příčinami tohoto zvýšení či snížení jsou:
The possible reasons for an increase or decrease are:
Léčbu lze v případě potřeby opakovat.
The treatment can be repeated if required.
Alergická reakce může způsobit kterýkoliv z následujících příznaků:
An allergic reaction can cause any of the following symptoms:
Nebyl zaznamenán žádný důkaz o lokální nesnášenlivosti.
No evidence of local intolerability was noted.
o Závazek varovat národní kompetentní úřady, pokud by došlo k významné změně v počtu hlášených případů.
o Commitment to alert the National Competent Authorities if there is a significant change in reporting rate.
Z mikrobiologického hlediska má být přípravek použit okamžitě.
From a microbiological point of view, the product should be used immediately.
o Hodnocení rozšířených reakcí, zejména v rámci příštích studií.
o Evaluation of the spread reactions, specifically as part of future studies.
Mezi oběma léčenými skupinami nebyly zjištěny statistické rozdíly.
No statistical differences were found between both treatment groups.
Obvykle se nedosahuje žádného dalšího prospěchu tím, že se léčba provádí častěji než každé tři měsíce.
Normally, no additional benefit is conferred by treating more frequently than every three months.
s žádnými jinými léčivými přípravky vyjma těch, které jsou uvedeny v bodu 6.6.
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Ovlivněné osoby se proto musí vyhnout těmto úkolům, dokud se jejich schopnosti plně neobnoví.
Consequently affected persons should avoid these tasks until their faculties are fully recovered.
Váš lékař poté přijme dodatečná opatření;
Your doctor will then take additional precautions.
Vzhledem k těmto informacím by další rozsáhlý program zaměřený na rozsah dávkování nebyl z etického hlediska dostatečně odůvodněn.
Against this background a further extensive dose-ranging program would not have been justifiable from an ethical point of view.
Vzhledem k velmi nízkému počtu jedinců v jednotlivých skupinách se závěry této studie fáze II nepovažují z hlediska bezpečnosti za užitečné.
Due to the very low number in each group, results of this Phase II study were not considered to be useful from a safety point a view.
Prášek je bílý.
The powder is white.
Studie na zvířatech prokázaly reprodukční toxicitu (viz bod 5.3).
Studies in animals have shown reproductive toxicity (see section 5.3).
Jestliže se neobjeví žádný léčebný účinek během jednoho měsíce po první injekci, je nutné přijmou následující opatření:
If no treatment effect occurs within a month after the initial injection, the following measures should be taken:
0,5 ml 1,0 ml 2,0 ml 4,0 ml 8,0 ml
0.5 ml 1.0 ml 2.0 ml 4.0 ml
Velmi časté: bolest, místní slabost
Very common: pain, local weakness
Účinek každé léčby trvá obecně 3 až 4 měsíce, ovšem může trvat významně délší nebo kratší dobu.
The effect of each treatment generally lasts approximately 3-4 months, however, it may last significantly longer or shorter.
Frekvence výskytu podle různých indikací
Frequency by different indications
Bezpečnostní profil
Safety profile
jestliže máte nebo jste měli polykací obtíže;
• if you have or have had swallowing difficulties
V průběhu postupu vzájemného uznávání nebyly otázky kvality předmětem sporu.
No quality aspects were the subject of disagreement during the Mutual Recognition procedure.
Xeomin obsahuje albumin, derivát lidské krve.
Xeomin contains albumin, a derivative of human blood.
Elektromyografické zavádění není nezbytné.
Electromyographic guidance is not necessary.
CELKOVÉ SHRNUTÍ VĚDECKÉHO HODNOCENÍ PŘÍPRAVKU XEOMIN <(viz příloha I)> - Otázky kvality
OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF XEOMIN <(see Annex I)> - Quality issues
Incidence závažných nežádoucích příhod byla ve všech studiích nízká a jejich frekvence byla v obou léčených skupinách podobná.
The incidence of Serious Adverse Events was low in all studies, with a similar frequency in both treatment groups.
Použití Xeominu u dětí a dospívajících nebylo dosud zkoumáno, a proto se nedoporučuje.
The use of Xeomin in children and adolescents has not yet been investigated and is therefore not recommended.
V případě předávkování musí být pacient několik dnů pod lékařským dohledem.
In case of an overdose the patient must be monitored medically for several days.
Tento přípravek byl předepsán Vám.
• This medicine has been prescribed for you.
ZVLÁŠTNÍ UPOZORNĚNÍ, ŽE LÉČIVÝ PŘÍPRAVEK MUSÍ BÝT UCHOVÁVÁN MIMO DOSAH A DOHLED DĚTÍ
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
Při opakovaných léčebných sezeních lze dávku zvyšovat až dvojnásobně, pokud odezva na počáteční léčbu bude považována za nedostatečnou - obvykle je definována jako účinek, který netrvá déle než dva měsíce.
At repeat treatment sessions, the dose may be increased up to two-fold if the response to the initial treatment is considered insufficient - usually defined as an effect that does not last longer than two months.
Interval mezi léčebnými sezeními by měl být nejméně 10 týdnů.
The period between each treatment session should be at least 10 weeks.
Okamžitě se obraťte na svého lékaře nebo odejděte na oddělení pro akutní případy do nejbližší nemocnice, jestliže se objeví jakýkoliv z těchto příznaků.
Tell your doctor immediately or go to the casualty department at your nearest hospital if you suffer from any of these symptoms.
Výchozí dávka by neměla překročit 25 jednotek na oko.
The initial dose should not exceed 25 U per eye.
nulová odezva/selhání terapie v průběhu léčby.
• non-response/therapy failure during the course of treatment.
Pouze pro použití v nemocnici
For hospital use only
Tato zjištění je nutno interpretovat opatrně, jelikož všichni pacienti nebyli systematicky testováni na přítomnost protilátek proti botulinovému toxinu.
These findings must be interpreted cautiously because all patients were not systematically tested for Botulinum toxin antibodies.
Předložený program klinických zkoušek sestával ze:
The submitted clinical trial programme consisted of:
různé postupy při přípravě léčivého přípravku vaším lékařem
• different techniques of preparation of the product by your doctor
Všechny indikace
All indications
DALŠÍ INFORMACE
FURTHER INFORMATION
Při poskytování vědeckého poradenství v roce 2000 Evropská agentura pro léčivé přípravky nevyžadovala ani nedoporučovala, aby před zahájením studí fáze III byly provedeny další studie fáze II.
During a Scientific Advice procedure in 2000, the EMEA did not require or recommend that further Phase II studies be conducted before the Phase III studies were performed.
Doporučené jednotlivé dávky Xeominu by se neměly překračovat a intervaly mezi injekcemi by neměly být zkracovány.
The recommended single doses of Xeomin should not be exceeded and the intervals between injections should not be shortened.
Program klinického rozvoje sestával z 5 studií uvedených v následující tabulce:
The clinical development program was composed by 5 studies provided in the following table:
Svalová hmota a stupeň hypertrofie či atrofie jsou faktory, které je nutno vzít v úvahu při volbě vhodné dávky.
The muscle mass and the degree of hypertrophy or atrophy are factors to be taken into consideration when selecting the appropriate dose.
Xeomin se používá k léčbě následujících onemocnění u dospělých:
Xeomin is used for the treatment of the following conditions in adults:
• v cílových svalech, které vykazují značnou slabost nebo atrofii.
• in targeted muscles which display pronounced weakness or atrophy.
Je možné, že se tyto nežádoucí účinky mohou vyskytnout i u Xeominu.
It is possible that these undesirable effects may also occur with Xeomin.
Informujte, prosím, svého lékaře před jakoukoliv léčbou o tom, že:
Please inform your doctor prior to any treatment, if you:
4.1 Terapeutické indikace
4.1 Therapeutic indications
Tato příbalová informace byla naposledy schválena
This leaflet was last approved in
jestliže trpíte onemocněním nazývaným amyotrofická laterální skleróza.
• if you suffer from a disease called amyotrophic lateral sclerosis.
- Otázky účinnosti
- Efficacy issues
OBSAH UDANÝ JAKO HMOTNOST, OBJEM NEBO POČET 100 LD50 jednotek
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 100 LD50 units
b) Distribuce léčivé látky v organismu pacienta:
b) Distribution of the active substance in patients:
Výsledná dávka v jednotkách na 0,1 ml
Resulting dose in units per 0.1 ml
Podobně jako u každého léčivého přípravku, může se u Xeominu objevit alergická reakce.
As with any medicine, an allergic reaction may occur with Xeomin.
velmi časté více než 1 z 10 léčených lidí časté méně než 1 z 10, ale více než 1 ze 100 léčených lidí méně časté méně než 1 ze 100, ale více než 1 z 1 000 léčených lidí vzácné méně než 1 z 1 000, ale více než 1 z 10 000 léčených lidí velmi vzácné méně než 1 z 10 000 léčených lidí včetně izolovaných případů
very common more than 1 per 10 treated people common less than 1 per 10, but more than 1 per 100 treated people uncommon less than 1 per 100, but more than 1 per 1,000 treated people rare less than 1 per 1,000, but more than 1 per 10,000 treated people very rare less than 1 per 10,000 treated people, incl.
DALŠÍ ZVLÁŠTNÍ UPOZORNĚNÍ, POKUD JE POTŘEBNÉ
OTHER SPECIAL WARNING(S); IF NECESSARY
Optimální počet míst vpichu závisí na velikosti svalu, který má být chemicky denervován.
The optimum number of injection sites is dependent upon the size of the muscle to be chemically denervated.
s Xeominem u pediatrické populace nebyly prováděny, a proto se jeho používání nedoporučuje ve skupině pacientů pediatrického věku, dokud nebudou známy další údaje.
Xeomin has not been studied in the paediatric population and is therefore not recommended in the paediatric age group until further data become available.
Proto se musíte vyhnout řízení dopravních prostředků a obsluze strojů, dokud se vaše schopnosti plně neobnoví.
Consequently you should avoid driving and operating machinery until your faculties are fully recovered.
s botulinovým toxinem je nutno používat u těchto pacientů za dohledu specialisty a měl by se používat pouze v případě, že prospěch z léčby převáží nad riziky.
The Botulinum toxin product should be used under specialist supervision in these patients and should only be used if the benefit of treatment is considered to outweigh the risk.
Zvláštní opatrnosti je zapotřebí, když jsou místa vpichu v blízkosti citlivých struktur, například karotid a plicních vrcholů.
Extra caution is required when injecting at sites close to sensitive structures such as the carotid artery and lung apices.
Protilátky mohou snižovat účinnost přípravku.
Antibodies may reduce the therapeutic effectiveness of the product.
trapezius. Tento seznam není vyčerpávající, protože jakýkoliv sval odpovídající za kontrolu pozice hlavy může být postižen a tím i vyžadovat léčbu.
This list is not exhaustive as any of the muscles responsible for controlling head position may be involved and therefore require treatment.
injekce do jiného svalu
• injections into another muscle
S léčbou dosud neléčených pacientů a s dlouhodobou léčbou jsou omezené zkušenosti.
There is limited experience in treatment-naïve patients and long-term treatment.
jestliže užíváte látky, které brání srážení krve (antikoagulační léčba)
• if you receive substances that prevent the blood from clotting (anticoagulant therapy)
otok rukou, nohou, kotníků, obličeje, rtů, úst nebo hrdla.
• swelling of the hands, feet, ankles, face, lips, mouth or throat.
Obnovení přenosu impulsů se dosáhne vytvořením nových nervových zakončení a koncových motorických plotének.
Recovery of impulse transmission is re-established by the formation of new nerve terminals and motor endplates.
Zotavení po injekci normálně nastává během 3-4 měsíců, když nervová zakončení vyrostou a znovu se spojí
Recovery after injection normally takes place within 3-4 months as nerve terminals sprout and reconnect with the endplate.
Doporučená naředění jsou uvedena v následující tabulce:
The recommended dilutions are indicated in the following table:
Zvýšení či snížení dávky Xeominu je možné podáním menšího či většího injekčního objemu.
A decrease or increase in the Xeomin dose is possible by administering a smaller or larger injection volume.
Jestliže vzniknou obtíže při izolaci jednotlivých svalů, injekce je zapotřebí provádět za pomocí elektromyografického vyšetření.
If difficulties arise isolating single muscles, injections should be performed using electromyographic guidance.
různé intervaly léčby
• different treatment intervals
Na základě těchto výsledků lze shrnout, že farmakologický účinek přípravků Xeomin a Botox je u zvířat téměř srovnatelný.
Based on the results, it could be concluded that pharmacological effect of Xeomin and Botox are almost comparable in animals.
Tři pacienti předčasně ukončili léčbu v rámci studie z důvodu nežádoucích příhod, které byly vyhodnoceny jako nesouvisející se zkoumanou léčivou látkou.
Three patients discontinued the studies prematurely due to adverse events considered as unrelated to study drug.
Při léčbě blefarospasmu by celková dávka neměla překročit 100 jednotek každých 12 týdnů.
In the management of blepharospasm, total dosing should not exceed 100 U every 12 weeks.