natgillin/translations-raw huggingface dataset:
Vakcinace králíků vyvolala produkci hemaglutinačně-inhibičních protilátek přetrvávajících minimálně 12 měsíců.
Vaccination of rabbits induced the production of hemagglutination inhibition antibodies that persisted for at least 12 months.
4.7 Použití v průběhu březosti, laktace nebo snášky
4.7 Use during pregnancy, lactation or lay
- časté (u více než 1, ale méně než 10 ze 100 ošetřených zvířat) - neobvyklé (u více než 1, ale méně než 10 z 1000 ošetřených zvířat) - vzácné (u více než 1, ale méně než 10 z 10000 ošetřených zvířat) - velmi vzácné (u méně než 1 z 10000 ošetřených zvířat, včetně ojedinělých hlášení).
- very common (more than 1 in 10 animals treated displaying adverse reactions) - common (more than 1 but less than 10 animals in 100 animals treated) - uncommon (more than 1 but less than 10 animals in 1,000 animals treated) - rare (more than 1 but less than 10 animals in 10,000 animals treated) - very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
PODMÍNKY REGISTRACE NEBO OMEZENÍ TÝKAJÍCÍ SE VÝDEJE A POUŽITÍ
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Uchovávejte a přepravujte chlazené (2 °C - 8 °C).
Store and transport refrigerated (2 °C - 8 °C).
Všechen nepoužitý veterinární léčivý přípravek nebo odpad, který pochází z tohoto přípravku, musí být likvidován podle místních právních předpisů.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
OZNAČENÍ „POUZE PRO ZVÍŘATA“ A PODMÍNKY NEBO OMEZENÍ TÝKAJÍCÍ SE VÝDEJE A POUŽITÍ, POKUD JE JICH TŘEBA
THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Vakcína poskytuje ochranu pouze proti RHDV2, zkřížená ochrana proti původnímu viru RHDV nebyla prokázána.
The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated.
PŘÍLOHA I SOUHRN ÚDAJŮ O PŘÍPRAVKU
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Chlorid sodný
Sodium chloride
DATUM REGISTRACE/ PRODLOUŽENÍ REGISTRACE Datum registrace:22/09/2016
Date of first authorisation: 22 September 2016
C. DEKLARACE HODNOT MRL
C. STATEMENT OF THE MRLs
Pokud u vás došlo k náhodné injekci veterinárního léčivého přípravku, vyhledejte lékařskou pomoc, i když šlo jen o malé množství, a vezměte příbalovou informaci s sebou.
If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you.
Laboratorní studie u králičích samic v poslední třetině březosti nepodaly důkaz o teratogenním, fetotoxickém účinku a maternální toxicitě.
Laboratory studies in doe rabbits in the last third of gestation have not produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
La Selva, 135 17170 Amer Španělsko
La Selva, 135 17170 Amer SPAIN
Jméno a adresa výrobce biologicky účinné látky
Name and address of the manufacturer of the biological active substance
Odborná a RYCHLÁ chirurgická péče je nutná a může vyžadovat včasné chirurgické otevření a výplach místa, kam byla injekce podána, zvláště tam, kde je zasažena pulpa prstu nebo šlacha.
Expert, prompt, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Excipiens:
Excipients:
NÁZEV VETERINÁRNÍHO LÉČIVÉHO PŘÍPRAVKU
NAME OF THE VETERINARY MEDICINAL PRODUCT
Před použitím čtěte příbalovou informaci.
Read the package leaflet before use.
Polysorbát 80
Sorbitan mono-oleate Polysorbate 80
silné bolesti a otok, zvláště po injekčním podání do kloubu nebo prstu, a ve vzácných případech může vést k ztrátě postiženého prstu, pokud není poskytnuta rychlá lékařská péče.
Accidental injection/self-injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.
DEKLARACE HODNOT MRL
STATEMENT OF THE MRLs
Náhodné sebepoškození injekčně aplikovaným přípravkem je nebezpečné.
Accidental injection is dangerous.
Dodekahydrát hydrogenfosforečnanu sodného Dihydrogenfosforečnan draselný Voda na injekci
Potassium chloride Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Water for injections
Podejte 1 dávku (0,5 ml) veterinárního léčivého přípravku subkutánní injekcí do boční hrudní stěny králíkům od 30 dnů věku.
Administer 1 dose (0.5 ml) of the veterinary medicinal product to rabbits from the age of 30 days by subcutaneous injection in the lateral thoracic wall.
ZVLÁŠTNÍ OPATŘENÍ PRO ZNEŠKODŇOVÁNÍ NEPOUŽITÝCH PŘÍPRAVKŮ NEBO ODPADU, POKUD JE JICH TŘEBA
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
s dalšími léčivými přípravky a další formy interakce
4.8 Interaction with other medicinal products and other forms of interaction
OZNAČENÍ „UCHOVÁVAT MIMO DOHLED A DOSAH DĚTÍ“ Uchovávat mimo dohled a dosah dětí.
THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Podkožní podání.
Subcutaneous use.
4.10 Předávkování (symptomy, první pomoc, antidota), pokud je to nutné Žádná data nejsou k dispozici.
4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Bělavá emulze.
Whitish emulsion.
Veterinární léčivý přípravek je vydáván pouze na předpis.
To be supplied only on veterinary prescription.
PŘÍLOHA III OZNAČENÍ NA OBALU A PŘÍBALOVÁ INFORMACE
ANNEX III LABELLING AND PACKAGE LEAFLET
6.5 Druh a složení vnitřního obalu
6.5 Nature and composition of immediate packaging
Před podáním dobře protřepejte.
Shake well before administration.
4.1 Cílové druhy zvířat
CLINICAL PARTICULARS 4.1 Target species
Vakcinace se doporučuje tam, kde je riziko nákazy RHDV2 epizootologicky relevantní.
Special precautions for use in animals Vaccination is recommended where RHDV2 is epidemiologically relevant.
Pomocné látky (včetně adjuvancií) uvedené v SPC v bodě 6.1 jsou povolenými látkami, pro které buď tabulka 1 přílohy nařízení Komise (EU) č.
The excipients (including adjuvants) listed in section 6.1 of the SPC are either allowed substances for which table 1 of the annex to Commission Regulation (EU) No 37/2010 indicates that no MRLs are required or are considered as not falling within the scope of Regulation (EC) No 470/2009 when used as in this veterinary medicinal product.
OBSAH LÉČIVÝCH A OSTATNÍCH LÁTEK
STATEMENT OF ACTIVE AND OTHER SUBSTANCES
1 x 40 dávek (20 ml).
1 x 40 doses (20 ml).
JMÉNO A ADRESA DRŽITELE ROZHODNUTÍ O REGISTRACI A DRŽITELE POVOLENÍ K VÝROBĚ ODPOVĚDNÉHO ZA UVOLNĚNÍ ŠARŽE, POKUD SE NESHODUJE
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
4.2 Indikace
4.3 Contraindications
Zvláštní opatření pro zneškodňování nepoužitého veterinárního léčivého přípravku nebo odpadu, který pochází z tohoto přípravku
6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
4.9 Podávané množství a způsob podání
4.9 Amounts to be administered and administration route
Léčivé přípravky se nesmí likvidovat prostřednictvím odpadní vody či domovního odpadu. O možnostech likvidace nepotřebných léčivých přípravků
Medicines should not be disposed of via wastewater or household waste.
I když bylo injekčně aplikované malé množství, náhodná injekce tohoto přípravku může vyvolat intenzivní otok, který může např.
Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit.
Velmi časté: dva nebo tři dny po vakcinaci může dojít k přechodnému zvýšení teploty mírně nad 40 °C. Toto zvýšení samovolně a bez léčby vymizí do pátého dne po vakcinaci .
Very common: a transient temperature increase slightly above 40 ºC might occur between two or three days following vaccination.
K aktivní imunizaci králíků od věku 30 dní ke snížení mortality způsobené virem hemoragického onemocnění králíků typu 2 (RHDV2).
For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2).
6.1 Seznam pomocných látek
PHARMACEUTICAL PARTICULARS 6.1 List of excipients
17170 Amer (Girona) ŠPANĚLSKO
17170 Amer (Girona) SPAIN
ZVLÁŠTNÍ PODMÍNKY PRO UCHOVÁVÁNÍ Uchovávejte a přepravujte chlazené.
Store and transport refrigerated.
Nepoužívat v případě přecitlivělosti na léčivou látku, nebo na některou z pomocných látek.
Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Tekutý parafin………………104,125 mg
Mineral oil: ………………..104.125 mg
typu. Injekční lahvičky jsou uzavřeny pryžovou zátkou a hliníkovou čepičkou.
The vials are closed with a rubber stopper and aluminium cap.
Jméno a adresa výrobce odpovědného za uvolnění šarže
Name and address of the manufacturer responsible for batch release
Ke stimulaci aktivní imunity proti virovému hemoragickému onemocnění králíků typu 2 (RHDV2).
To stimulate active immunity against the rabbit haemorrhagic disease type 2 virus (RHDV2).
DATUM EXSPIRACE EXP: {měsíc/rok} Po otevření ihned spotřebujte.
Shelf life after first opening the immediate packaging: Use immediately.
1 x 10 dávek (5 ml).
1 x 10 doses (5 ml).
VÝROBCE BIOLOGICKY ÚČINNÉ LÁTKY A VÝROBCE ODPOVĚDNÝ
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Pouze pro zvířata.
For animal treatment only.
Injekční lahvičky 0,5 ml (1 dávka), 5 ml (10 dávek) a 20 ml (40 dávek) z bezbarvého skla I.
Type I colourless glass vials with 0.5 ml (1 dose), 5 ml (10 doses) and 20 ml (40 doses).
INDIKACE
CONTRAINDICATIONS
Luxembourg HIPRA BENELUX NV Tel: (+32) 9 324 21 58
HIPRA BENELUX NV Tel: (+32) 9 324 21 58
REGISTRAČNÍ ČÍSLO(A)
MARKETING AUTHORISATION NUMBER(S)
Zvláštní opatření určené osobám, které podávají veterinární léčivý přípravek zvířatům Pro uživatele:
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Předávkování (symptomy, první pomoc, antidota):
Overdose (symptoms, emergency procedures, antidotes): No available data.
JMÉNO A ADRESA DRŽITELE ROZHODNUTÍ O REGISTRACI
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
CÍLOVÝ DRUH ZVÍŘAT Králíci
TARGET SPECIES
Pro lékaře:
To the physician:
DRŽITEL ROZHODNUTÍ O REGISTRACI
MARKETING AUTHORISATION HOLDER
OZNAČENÍ „POUZE PRO ZVÍŘATA“ Pouze pro zvířata.
THE WORDS “FOR ANIMAL TREATMENT ONLY”
ZVLÁŠTNÍ UPOZORNĚNÍ, POKUD JE (JSOU) NUTNÉ(Á) Před použitím čtěte příbalovou informaci.
SPECIAL WARNING(S), IF NECESSARY
LÉKOVÁ FORMA Injekční emulze.
Emulsion for injection.
FARMACEUTICKÉ ÚDAJE
PHARMACEUTICAL FORM
4.11 Ochranné lhůty
4.11 Withdrawal period(s)
OCHRANNÁ LHŮTA Ochranná lhůta: Bez ochranných lhůt.
Withdrawal period: Zero days.
Lepenková krabička s 1 skleněnou injekční lahvičkou o 40 dávkách (20 ml).
Cardboard box of 1 glass vial of 40 doses (20 ml).
imunity nespadají do působnosti nařízení (ES) č.
The active substance being a principle of biological origin intended to produce active immunity is not within the scope of Regulation (EC) No 470/2009.
Šarže {číslo}
Batch{number}
CESTA(Y) PODÁNÍ
ROUTE(S) OF ADMINISTRATION
PODROBNÉ ÚDAJE UVÁDĚNÉ NA VNĚJŠÍM OBALU A VNITŘNÍM OBALU KARTON
PARTICULARS TO APPEAR ON THE OUTER PACKAGE AND THE IMMEDIATE PACKAGE
s jiným veterinárním léčivým přípravkem.
Do not mix with any other veterinary medicinal products.
Zvláštní opatření pro použití
4.5 Special precautions for use
ERAVAC injekční emulze pro králíky.
ERAVAC emulsion for injection for rabbits.
9 měsíců prokázáno čelenží
Duration of immunity: 9 months demonstrated by challenge
Thiomersal………………0,05 mg
Thiomersal: ………………..0.05 mg Whitish emulsion.
cELISA40* (*) ≥70 % vakcinovaných králíků má mít titr protilátek stanovených cELISOU minimálně 40. Adjuvans:
(*) ≥70 % of vaccinated rabbits shall give cELISA antibody titres equal to or higher than 40.
Léčivá látka:
Active substance:
Březost
Pregnancy
VELIKOST BALENÍ 10 x 1 dávka (0,5 ml).
10 x 1 dose (0.5 ml).
čtěte příbalovou informaci.
Disposal: read the package leaflet.
Lepenková krabička obsahující 10 skleněných injekčních lahviček po 1 dávce (0,5 ml).
Cardboard box of 10 glass vials of 1 dose (0.5 ml).
B. PŘÍBALOVÁ INFORMACE
B. PACKAGE LEAFLET
Velikosti balení:
Pack sizes:
NEŽÁDOUCÍ ÚČINKY
Not applicable.
ŠPANĚLSKO
SPAIN
Lepenková krabička s 1 skleněnou injekční lahvičkou o 10 dávkách (5 ml).
Cardboard box of 1 glass vial of 10 doses (5 ml).
Calicivirus septicemiae haemorrhagiae cuniculi inactivatum, typ 2 (RHDV2),kmen V-1037……≥70%
Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037 ….
Injekční emulze pro králíky
ERAVAC Emulsion for injection for rabbits
Fax: +34 972 430661
Tel. +34 972 430660 Fax +34 972 430661 E-mail: hipra@hipra.com
Calicivirus septicemiae haemorrhagiae cuniculi inactivatum, typ 2 (RHDV2), kmen V-1037 ……≥70% cELISA40* (*) ≥70 % vakcinovaných králíků má mít titr protilátek stanovených cELISOU minimálně 40.
Inactivated rabbit haemorrhagic disease type 2 virus (RHDV2), strain V-1037: ……≥70% cELISA40*
ZVLÁŠTNÍ UPOZORNĚNÍ
ADVERSE REACTIONS
Doba použitelnosti veterinárního léčivého přípravku v neporušeném obalu: 2 roky Doba použitelnosti po prvním otevření vnitřního obalu:
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Úplný seznam pomocných látek viz bod 6.1.
Thiomersal…………0.05 mg For the full list of excipients, see section 6.1.
MNOŽSTVÍ LÉČIVÉ(ÝCH) LÁTKY(EK) Inaktivovaný RHDV2, kmen V-1037: ≥70% cELISA40 ≥70 % očkovaných králíků bude mít titr protilátek dle cELISA minimálně 40.
Inactivated RHDV2, strain V-1037: ……… ≥70% cELISA40*
MINIMÁLNÍ ÚDAJE UVÁDĚNÉ NA VNITŘNÍM OBALU MALÉ VELIKOSTI Lahvičky (1 dávka, 10 dávek nebo 40 dávek)
Vial label (1, 10 or 40 doses)
Chraňte před mrazem.
Do not freeze.
………………..104,125 mg Excipiens:
Mineral oil…………104.125 mg
DATUM EXSPIRACE EXP: {měsíc/rok} Po 1.
EXP {month/year} Once broached use immediately.
OBSAH VYJÁDŘENÝ HMOTNOSTÍ, OBJEMEM NEBO POČTEM DÁVEK 10 x 1 dávka (0,5 ml).
CONTENTS BY WEIGHT, BY VOLUME OR BY NUMBER OF DOSES
Това означава, че въпреки недостатъчните доказателства от клинични изпитвания, ефективността на тези растителни лекарствени продукти е приемлива и има доказателства, че са използвани безопасно по този начин от поне 30 години (от които най-малко 15 години в ЕС).
This means that, although there is insufficient evidence from clinical studies, the effectiveness of these herbal medicines is plausible and there is evidence that they have been used safely in this way for at least 30 years (including at least 15 years within the EU).
05 април 2016 г.
5 April 2016 EMA/154066/2016
Пациенти с отворени рани, кожни проблеми, висока температура, тежки инфекции и тежки проблеми със сърцето и кръвообращението, не трябва вземат вани с лекарствени продукти от масло от валериана.
Patients with open wounds, skin problems, high fever, severe infections and severe heart and circulation problems should not have baths with valerian essential oil medicines.
Лекарствените продукти, съдържащи масло от валериана, трябва да се използват само при възрастни и юноши на възраст над 12 години.
Valerian essential oil medicines should be used only in adults and adolescents over the age of 12 years.
Ако симптомите продължават по време на употребата на лекарствения продукт, трябва да се потърси консултация с лекар или квалифицирано медицинско лице.
If symptoms continue during the use of the medicine, a doctor or a healthcare practitioner should be consulted.
Маслото от валериана е общоприетото наименование за етеричното масло, извлечено от подземните части на растението Valeriana officinalis L.
Valerian essential oil is the common name for the essential oil extracted from the underground parts of the plant Valeriana officinalis L.
Маслото от валериана може да се предлага и в комбинация с други растителни вещества в някои растителни лекарствени продукти.
Valerian essential oil may also be found in combination with other herbal substances in some herbal medicines.
Заключенията на HMPC относно използването на лекарствени продукти, съдържащи масло от валериана, за облекчаване на леки симптоми на психически стрес и за подпомагане на съня се основават на тяхната „традиционна употреба”.
The HMPC conclusions on the use of these valerian essential oil medicines for the relief of mild symptoms of mental stress and to aid sleep are based on their ‘traditional use'.
HMPC отбелязва, че липсват клинични проучвания с масло от валериана, но взема предвид добре документираната употреба на този растителен лекарствен продукт.
The HMPC noted the lack of clinical studies with valerian essential oil medicines, but took into account the well documented use of this herbal medicine.
Допълнителна информация относно оценката на HMPC за лекарствените продукти, съдържащи масло от валериана, включително подробности за заключенията на Комитета, може да се намери в раздел „Всички документи” на уебсайта на Агенцията: ema.europa.eu/Find medicine/Herbal medicines for human use.
Further information on the HMPC assessment of valerian essential oil medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Настоящото резюме не е предназначено да предоставя практически съвети за използването на лекарствените продукти, съдържащи масло от валериана.
This summary is not intended to provide practical advice on how to use medicines containing valerian essential oil.
Допълнителна информация за рисковете, свързани с лекарствените продукти, съдържащи масло от валериана, включително съответните предпазни мерки за безопасната им употреба, могат да се намерят в монографията, в раздел „Всички документи” на уебсайта на Агенцията: ema.europa.eu/Find medicine/Herbal medicines for human use.
Further information on the risks associated with these valerian essential oil medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Въз основа на дългогодишната употреба HMPC заключи, че маслото от валериана може да се използва за облекчаване на леки симптоми на психически стрес и за подпомагане на съня.
The HMPC concluded that, on the basis of its long-standing use, valerian essential oil can be used for relief of mild symptoms of mental stress and to aid sleep.
Маслото от валериана се получава чрез прокарване на пара през подземните части на растението.
Valerian essential oil is obtained by directing steam through the underground parts of the plant.
Всички заявления за регистрация на лекарствените продукти, съдържащи масло от валериана, се подават в националните органи, отговорни за лекарствените продукти, които оценяват заявлението за растителния лекарствен продукт, като вземат предвид научните заключения на HMPC.
Any applications for the licensing of medicines containing valerian essential oil have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
За информация относно приложението и регистрацията на лекарствени продукти, съдържащи масло от валериана, в държавите членки на ЕС следва да се допитате до съответните национални органи.
Information on the use and licensing of valerian essential oil medicines in EU Member States should be obtained from the relevant national authorities.
Подробни указания как да прилагате лекарствените продукти, съдържащи масло от валериана, както и кой може да ги използва, могат да се намерят в листовката към лекарствения продукт.
Detailed instructions on how to take valerian essential oil medicines and who can use them can be found in the package leaflet that comes with the medicine.
Растителните лекарствени продукти, съдържащи масло от валериана, обикновено се предлагат в течни форми за перорално приложение или за употреба като добавки за вана.
Herbal medicines containing valerian essential oil are usually available in liquid forms to be taken by mouth or used as bath additives.
Държавите членки вземат предвид заключенията на HMPC при оценяване на заявленията за разрешаване за употреба на растителни лекарствени продукти, съдържащи масло от валериана.
The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing valerian essential oil.
Настоящият документ представлява резюме на научните заключения на Комитета по растителните лекарствени продукти (HMPC) за употребата на масло от валериана в медицината.
This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of valerian essential oil.
За повече информация относно лечението с лекарствените продукти, съдържащи масло от валериана, прочетете листовката към лекарствения продукт или попитайте Вашия лекар или фармацевт.
For more information about treatment with valerian essential oil medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
За практическа информация относно употребата на лекарствените продукти, съдържащи масло от валериана, пациентите следва да прочетат листовката към лекарствения продукт или да попитат своя лекар или фармацевт.
For practical information about using valerian essential oil medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Как са разрешени лекарствените продукти, съдържащи масло от валериана, в ЕС?
How are valerian essential oil medicines approved in the EU?
Какво представлява маслото от валериана?
What is valerian essential oil?
Допълнителна информация за лекарствените продукти, съдържащи масло от валериана:
Other information about valerian essential oil medicines
Какви са доказателствата, които подкрепят употребата на лекарствени продукти, съдържащи масло от валериана?
What evidence supports the use of valerian essential oil medicines?
Какви са рисковете, свързани с лекарствените продукти, съдържащи масло от валериана?
What are the risks associated with valerian essential oil medicines?
Какви са заключенията на HMPC за употребата на масло от валериана в медицината?
What are the HMPC conclusions on its medicinal uses?
При лекарствените продукти, съдържащи масло от валериана, се съобщават нежелани реакции.
Side effects have been reported with valerian essential oil medicines.
Приложение I Списък на лекарствените продукти техните разновидности
Annex I List of medicinal products and presentations
Великобритания Medimpex UK LTD 127 Shirland road,
United Kingdom Medimpex UK LTD 127 Shirland road,
Таблеткаka 1500 mikrogramów
Escapelle tabletka 1500 mikrogramów
28 x 1 таблетка (календарна опаковка)
28 x 1 tablets (calendar pack)
84 tablets
50 tablet
таблетка о а
l t o r
Основната мярка за ефективност е общата преживяемост (колко дълго живеят пациентите).
The main measure of effectiveness was overall survival (how long the patients lived).
Какви мерки се предприемат, за да се гарантира безопасната и ефективна употреба на Onivyde?
What measures are being taken to ensure the safe and effective use of Onivyde?
Както при всички лекарства, данните във връзка с употребата на Onivyde непрекъснато се проследяват.
As for all medicines, data on the use of Onivyde are continuously monitored.
Европейската агенция по лекарствата реши, че ползите от Onivyde са по-големи от рисковете, и препоръча този лекарствен продукт да бъде разрешен за употреба в ЕС.
The European Medicines Agency decided that Onivyde's benefits are greater than its risks and recommended that it be approved for use in the EU.
Допълнителна информация за „лекарства сираци“ можете да намерите тук: ema.europa.eu/medicines/human/orphandesignations/eu311933.
Further information on the orphan designation can be found here: ema.europa.eu/medicines/human/orphan-designations/eu311933.