FrancophonIA/ELRC3.0 huggingface dataset:
English: • In view of the nature of the disease and the fact that alternatives are not available in all Member States;the CHMP considers Ammonaps critical to public health; The CHMP, as a consequence, considers that the benefit-risk balance of Ammonaps remains favourable for critical use and therefore recommends that the marketing authorisations be varied and subject to the condition that the marketing authorisation holder for Ammonaps provides evidence by 30 June 2017 that the manufacturing process complies with the requirements of Commission Directive
Bulgarian: В резултат на това, CHMP счита, че съотношението полза/риск за Ammonaps остава благоприятно за критично важна употреба, и препоръчва разрешенията за употреба да бъдат изменени, като се добави условие притежателят на разрешението за употреба на Ammonaps да предостави до 30 юни 2017 г. доказателство, че производственият процес отговаря на изискванията на Директива 2003/94/ЕО на Комисията, определяща принципите и насоките на ДПП, както е предвидено в член°8, параграф°3 на Директива 2001/83/ЕО.
English: The tablets are given twice a day with or without food and usually 2 - 3 months is sufficient to control the condition although some dogs may need longer treatment.
Bulgarian: Таблетките се прилагат два пъти дневно със или без храна и 2-3 месеца обикновено са достатъчни за овладяване на състоянието, въпреки че при някои кучета е възможно да се наложи по-дълго лечение.
English: The full EPAR for Clomicalm can be found on the Agency's website: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
Bulgarian: Пълният текст на EPAR за Clomicalm може да се намери на уебсайта на Агенцията: ema.europa.eu/Find medicine/Veterinary medicines/European public assessment reports.
English: Vomiting may be reduced by giving the tablets with a small quantity of food.
Bulgarian: Повръщането може да се ограничи, като таблетките се дават с малко количество храна.
English: A neurotransmitter is a substance that relays signals from a nerve cell to another cell.
Bulgarian: Невротрансмитерът е вещество, което предава сигнали от една нервна клетка на друга.
English: It works by increasing the levels of certain neurotransmitters, serotonin and noradrenaline, in the central nervous system.
Bulgarian: Той действа, като увеличава нивата на невротрансмитерите серотонин и норадреналин в централната нервна система.
English: It is not intended to provide practical advice on how to use Clomicalm.
Bulgarian: Документът не е предназначен да предоставя практически съвети относно употребата на Clomicalm.
English: This is a summary of the European public assessment report (EPAR) for Clomicalm.
Bulgarian: Настоящият документ представлява резюме на Европейския публичен оценъчен доклад (EPAR) за Clomicalm.
English: This summary was last updated in April 2016.
Bulgarian: Дата на последно актуализиране на текста: 04-2016.
English: Clomicalm is available as tablets (5, 20 and 80 mg) and can only be obtained with a prescription.
Bulgarian: Clomicalm се предлага под формата на таблетки (5, 20 и 80 mg) и се отпуска по лекарско предписание.
English: The Agency's Committee for Medicinal Products for Veterinary Use (CVMP) concluded that Clomicalm's benefits are greater than its risks and recommended that it be approved for use in the EU.
Bulgarian: Комитетът по лекарствените продукти за ветеринарна употреба (CVMP) на Агенцията реши, че ползите от Clomicalm са по-големи от рисковете, и препоръча Clomicalm да бъде лицензиран за употреба в ЕС.
English: Other information about Clomicalm:
Bulgarian: Допълнителна информация за Clomicalm:
English: If a child accidentally swallows the medicine, this could cause serious reactions.
Bulgarian: При случайно поглъщане на продукта от дете е възможно да настъпят сериозни реакции.
English: Clomicalm must not be used in dogs with a known hypersensitivity to clomipramine and related medicines (known as tricyclic antidepressants).
Bulgarian: Clomicalm не трябва да се прилага при кучета с установена хиперчувствителност към кломипрамин и други свързани лекарства (наричани трициклични антидепресанти).
English: Clomicalm is a veterinary medicine used as an aid in the treatment of dogs with behavioural problems when separated from their owners, their home or other dogs.
Bulgarian: Clomicalm е ветеринарномедицински продукт, който се използва като помощно средство за лечение на кучета с поведенчески проблеми, причинени от раздяла със собственика, с дома или с други кучета.
English: Clomipramine is an antidepressant.
Bulgarian: Кломипрамин е антидепресант.
English: It contains the active substance clomipramine hydrochloride.
Bulgarian: Съдържа активната субстанция кломипрамин хидрохлорид (clomipramine hydrochloride).
English: Since low levels of these neurotransmitters can be linked to depression and anxiety, increasing them can help the dogs feel calmer so improving the behavioural signs in dogs with separation related problems.
Bulgarian: Тъй като ниските нива на тези невротрансмитери могат да бъдат свързани с депресия и тревожност, повишаването им може да помогне на кучетата да
English: Clomicalm may very rarely cause vomiting, changes in appetite, lethargy (lack of energy) or an elevation in liver enzymes which is reversible when treatment is stopped.
Bulgarian: Много рядко Clomicalm може да причини повръщане, промени в апетита, летаргия (липса на енергия) или завишени чернодробни ензими.
English: What benefits of Clomicalm have been shown in studies?
Bulgarian: Какви ползи от Clomicalm са установени в проучванията?
English: What is Clomicalm and what is it used for?
Bulgarian: Какво представлява Clomicalm и за какво се използва?
English: Liver effects have been reported particularly in dogs with existing liver problems.
Bulgarian: Съобщено е за чернодробни реакции, по-конкретно при кучета със съществуващи чернодробни проблеми.
English: What are the risks associated with Clomicalm?
Bulgarian: Какви са рисковете, свързани с Clomicalm?
English: For practical information about using Clomicalm, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Bulgarian: За практическа информация относно употребата на Clomicalm собствениците на животни или животновъдите следва да прочетат листовката или да се свържат с ветеринарен лекар или фармацевт.
English: to be effective in reducing behavioural problems in dogs associated with separation anxiety and was more effective than behavioural therapy alone on the basis of a broad spectrum of behavioural signs of anxiety including signs of high attachment to the owner.
Bulgarian: Практическите проучвания, проведени в САЩ и Европа, показват, че Clomicalm, прилаган в комбинация с поведенческа терапия, е ефективен за намаляване на свързаните с тревожност от раздяла поведенчески проблеми при кучета и е по-ефективен от самостоятелно приложена поведенческа терапия въз основа на широк кръг от поведенчески признаци на тревожност, включително признаци на силна привързаност към собственика.
English: For more information about treatment with Clomicalm, animal owners or keepers should read the package leaflet or contact their veterinarian or pharmacist.
Bulgarian: За повече информация относно третирането с Clomicalm собствениците на животни или животновъдите следва да прочетат листовката или да попитат ветеринарен лекар или фармацевт.
English: Such problems may include destruction of property and inappropriate defaecation and urination in the home. Clomicalm should only be given in combination with behavioural therapy.
Bulgarian: Подобни проблеми могат да включват разрушаване на собственост, неуместна дефекация или уриниране в дома.
English: How is Clomicalm used?
Bulgarian: Как се използва Clomicalm?
English: The European Commission granted a marketing authorisation valid throughout the EU for Clomicalm on 1 April 1998.
Bulgarian: Европейската комисия издава разрешение за употреба на Clomicalm, валидно в Европейския съюз.
English: How does Clomicalm work?
Bulgarian: Как действа Clomicalm?
English: Why is Clomicalm approved?
Bulgarian: Защо Clomicalm е лицензиран за употреба?
English: These measures should help to protect the environment.
Bulgarian: Tato opatření napomáhají chránit životní prostředí.
English: This veterinary medicinal product contains mineral oil.
Bulgarian: Tento veterinární léčivý přípravek obsahuje minerální olej.
English: ANNEX II
Bulgarian: PŘÍLOHA II
English: Keep the bottle in the outer carton in order to protect from light.
Bulgarian: Uchovávejte lahvičku ve vnějším kartonu, aby byla chráněna před světlem.
English: These local reactions gradually reduce and disappear without need for treatment
Bulgarian: Tyto lokální reakce se budou postupně zmenšovat a zmizí bez nutnosti léčby.
English: 10 DATE OF REVISION OF THE TEXT
Bulgarian: 10. DATUM REVIZE TEXTU
English: No available data.
Bulgarian: Žádná data nejsou k dispozici.
English: Vaccinate healthy animals only.
Bulgarian: Vakcinovat pouze zdravá zvířat.
English: 4.6 Adverse reactions (frequency and seriousness)
Bulgarian: 4.6 Nežádoucí účinky (frekvence a závažnost)
English: Do not use this veterinary medicinal product after the expiry date which is stated on the label after EXP..
Bulgarian: Nepoužívejte tento veterinární léčivý přípravek po uplynutí doby použitelnosti uvedené na etiketě po EXP.
English: Onset of immunity: 1 week.
Bulgarian: Nástup imunity: 1 týden.
English: OTHER INFORMATION
Bulgarian: DALŠÍ INFORMACE
English: If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
Bulgarian: Jestliže zaznamenáte kterýkoliv z nežádoucích účinků, a to i takové, které nejsou uvedeny v této příbalové informaci, nebo si myslíte, že léčivo nefunguje, oznamte to, prosím, vašemu veterinárnímu lékaři.
English: No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product.
Bulgarian: Nejsou dostupné informace o bezpečnosti a účinnosti této vakcíny při souběžném podání jiného veterinárního léčivého přípravku.
English: Special warnings for each target species:
Bulgarian: Zvláštní upozornění pro každý cílový druh:
English: If pain persists for more than 12 hours after medical examination, seek medical advice again.
Bulgarian: Pokud bolest přetrvává více než 12 hodin po lékařské prohlídce, obraťte se na lékaře znovu.
English: IMMUNOLOGICAL PROPERTIES
Bulgarian: IMUNOLOGICKÉ VLASTNOSTI
English: Pregnant does should be handled with special care to avoid stress and risk of abortion
Bulgarian: se zvláštní péčí, aby se zabránilo stresu a riziku potratu.
English: 6.2 Major incompatibilities
Bulgarian: 6.2 Inkompatibility
English: Each dose of 0.5 ml contains:
Bulgarian: Každá 0,5 ml dávka obsahuje:
English: Protect from light.
Bulgarian: Chraňte před světlem.
English: MANUFACTURER'S BATCH NUMBER
Bulgarian: ČÍSLO ŠARŽE OD VÝROBCE
English: Interaction with other medicinal products and other forms of interaction:
Bulgarian: s dalšími léčivými přípravky a další formy interakce:
English: For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.
Bulgarian: Pokud chcete získat informace o tomto veterinárním léčivém přípravku, kontaktujte prosím příslušného místního zástupce držitele rozhodnutí o registraci.
English: {MM/YYYY}
Bulgarian: {MM/RRRR}
English: Very common: nodules or swelling (< 2 cm) can be observed in the injection site, which may last 24 hours.
Bulgarian: Velmi časté: V místě vpichu mohou být pozorovány uzliny nebo otok (< 2 cm), které mohou přetrvávat 24 hodin.
English: Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency (http://www.ema.europa.eu)
Bulgarian: Podrobné informace o veterinárním léčivém přípravku jsou k dispozici na webové stránce Evropské lékové agentury http://www.ema.europa.eu/.
English: Marketing authorisation holder and manufacturer responsible for batch release: LABORATORIOS HIPRA, S.A.
Bulgarian: Držitel rozhodnutí o registraci a výrobce odpovědný za uvolnění šarže: Laboratorios Hipra, S.A.
English: Pharmacotherapeutic group: Inactivated viral vaccines for Leporidae, inactivated viral vaccine for rabbits.
Bulgarian: Farmakoterapeutická skupina: Inaktivované virové vakcíny pro zajícovité, inaktivované virové vakcíny pro králíky.
English: Rabbits
Bulgarian: Králíci
English: A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.
Bulgarian: Rozhodnutí o použití vakcíny v době před podáním libovolného veterinárního přípravku nebo po něm je proto třeba učinit na základě posouzení konkrétního případu.
English: Before use allow the vaccine to reach room temperature.
Bulgarian: Před použitím nechejte vakcínu vytemperovat na pokojovou teplotu.
English: ATCvet code: QI08AA
Bulgarian: QI08AA
English: DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
Bulgarian: DÁVKOVÁNÍ PRO KAŽDÝ DRUH, CESTA(Y) A ZPŮSOB PODÁNÍ
English: PROHIBITION OF SALE, SUPPLY AND/OR USE
Bulgarian: ZÁKAZ PRODEJE, VÝDEJE A/NEBO POUŽITÍ Neuplatňuje se.
English: Revaccination: 9 months after vaccination.
Bulgarian: 9 měsíců po vakcinaci.
English: Vaccination of rabbits induced the production of hemagglutination inhibition antibodies that persisted for at least 12 months.
Bulgarian: Vakcinace králíků vyvolala produkci hemaglutinačně-inhibičních protilátek přetrvávajících minimálně 12 měsíců.
English: 4.7 Use during pregnancy, lactation or lay
Bulgarian: 4.7 Použití v průběhu březosti, laktace nebo snášky
English: - 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).
Bulgarian: - 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).
English: CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
Bulgarian: PODMÍNKY REGISTRACE NEBO OMEZENÍ TÝKAJÍCÍ SE VÝDEJE A POUŽITÍ
English: Store and transport refrigerated (2 °C - 8 °C).
Bulgarian: Uchovávejte a přepravujte chlazené (2 °C - 8 °C).
English: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
Bulgarian: Všechen nepoužitý veterinární léčivý přípravek nebo odpad, který pochází z tohoto přípravku, musí být likvidován podle místních právních předpisů.
English: THE WORDS “FOR ANIMAL TREATMENT ONLY” AND CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE, IF APPLICABLE
Bulgarian: OZNAČENÍ „POUZE PRO ZVÍŘATA“ A PODMÍNKY NEBO OMEZENÍ TÝKAJÍCÍ SE VÝDEJE A POUŽITÍ, POKUD JE JICH TŘEBA
English: The vaccine provides protection only against RHDV2, cross protection against classical RHDV has not been demonstrated.
Bulgarian: Vakcína poskytuje ochranu pouze proti RHDV2, zkřížená ochrana proti původnímu viru RHDV nebyla prokázána.
English: ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS
Bulgarian: PŘÍLOHA I SOUHRN ÚDAJŮ O PŘÍPRAVKU
English: Sodium chloride
Bulgarian: Chlorid sodný
English: Date of first authorisation: 22 September 2016
Bulgarian: DATUM REGISTRACE/ PRODLOUŽENÍ REGISTRACE Datum registrace:22/09/2016
English: C. STATEMENT OF THE MRLs
Bulgarian: C. DEKLARACE HODNOT MRL
English: 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.
Bulgarian: 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.
English: Laboratory studies in doe rabbits in the last third of gestation have not produced any evidence of a teratogenic, foetotoxic and maternotoxic effects.
Bulgarian: Laboratorní studie u králičích samic v poslední třetině březosti nepodaly důkaz o teratogenním, fetotoxickém účinku a maternální toxicitě.
English: La Selva, 135 17170 Amer SPAIN
Bulgarian: La Selva, 135 17170 Amer Španělsko
English: Name and address of the manufacturer of the biological active substance
Bulgarian: Jméno a adresa výrobce biologicky účinné látky
English: 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.
Bulgarian: 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.
English: Excipients:
Bulgarian: Excipiens:
English: NAME OF THE VETERINARY MEDICINAL PRODUCT
Bulgarian: NÁZEV VETERINÁRNÍHO LÉČIVÉHO PŘÍPRAVKU
English: Read the package leaflet before use.
Bulgarian: Před použitím čtěte příbalovou informaci.
English: Sorbitan mono-oleate Polysorbate 80
Bulgarian: Polysorbát 80
English: 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.
Bulgarian: 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.
English: STATEMENT OF THE MRLs
Bulgarian: DEKLARACE HODNOT MRL
English: Accidental injection is dangerous.
Bulgarian: Náhodné sebepoškození injekčně aplikovaným přípravkem je nebezpečné.
English: Potassium chloride Disodium phosphate dodecahydrate Potassium dihydrogen phosphate Water for injections
Bulgarian: Dodekahydrát hydrogenfosforečnanu sodného Dihydrogenfosforečnan draselný Voda na injekci
English: 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.
Bulgarian: Podejte 1 dávku (0,5 ml) veterinárního léčivého přípravku subkutánní injekcí do boční hrudní stěny králíkům od 30 dnů věku.
English: SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCTS OR WASTE MATERIALS, IF ANY
Bulgarian: ZVLÁŠTNÍ OPATŘENÍ PRO ZNEŠKODŇOVÁNÍ NEPOUŽITÝCH PŘÍPRAVKŮ NEBO ODPADU, POKUD JE JICH TŘEBA
English: 4.8 Interaction with other medicinal products and other forms of interaction
Bulgarian: s dalšími léčivými přípravky a další formy interakce
English: THE WORDS “KEEP OUT OF THE SIGHT AND REACH OF CHILDREN”
Bulgarian: OZNAČENÍ „UCHOVÁVAT MIMO DOHLED A DOSAH DĚTÍ“ Uchovávat mimo dohled a dosah dětí.
English: Subcutaneous use.
Bulgarian: Podkožní podání.
English: 4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Bulgarian: 4.10 Předávkování (symptomy, první pomoc, antidota), pokud je to nutné Žádná data nejsou k dispozici.
English: Whitish emulsion.
Bulgarian: Bělavá emulze.
English: To be supplied only on veterinary prescription.
Bulgarian: Veterinární léčivý přípravek je vydáván pouze na předpis.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Bulgarian: PŘÍLOHA III OZNAČENÍ NA OBALU A PŘÍBALOVÁ INFORMACE
English: 6.5 Nature and composition of immediate packaging
Bulgarian: 6.5 Druh a složení vnitřního obalu
English: Shake well before administration.
Bulgarian: Před podáním dobře protřepejte.
English: CLINICAL PARTICULARS 4.1 Target species
Bulgarian: 4.1 Cílové druhy zvířat
English: Special precautions for use in animals Vaccination is recommended where RHDV2 is epidemiologically relevant.
Bulgarian: Vakcinace se doporučuje tam, kde je riziko nákazy RHDV2 epizootologicky relevantní.
English: 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.
Bulgarian: Pomocné látky (včetně adjuvancií) uvedené v SPC v bodě 6.1 jsou povolenými látkami, pro které buď tabulka 1 přílohy nařízení Komise (EU) č.
English: STATEMENT OF ACTIVE AND OTHER SUBSTANCES
Bulgarian: OBSAH LÉČIVÝCH A OSTATNÍCH LÁTEK
English: 1 x 40 doses (20 ml).
Bulgarian: 1 x 40 dávek (20 ml).
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Bulgarian: JMÉNO A ADRESA DRŽITELE ROZHODNUTÍ O REGISTRACI A DRŽITELE POVOLENÍ K VÝROBĚ ODPOVĚDNÉHO ZA UVOLNĚNÍ ŠARŽE, POKUD SE NESHODUJE
English: 4.3 Contraindications
Bulgarian: 4.2 Indikace
English: 6.6 Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Bulgarian: Zvláštní opatření pro zneškodňování nepoužitého veterinárního léčivého přípravku nebo odpadu, který pochází z tohoto přípravku
English: 4.9 Amounts to be administered and administration route
Bulgarian: 4.9 Podávané množství a způsob podání
English: Medicines should not be disposed of via wastewater or household waste.
Bulgarian: Léčivé přípravky se nesmí likvidovat prostřednictvím odpadní vody či domovního odpadu. O možnostech likvidace nepotřebných léčivých přípravků
English: 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.
Bulgarian: I když bylo injekčně aplikované malé množství, náhodná injekce tohoto přípravku může vyvolat intenzivní otok, který může např.
English: Very common: a transient temperature increase slightly above 40 ºC might occur between two or three days following vaccination.
Bulgarian: 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 .
English: For active immunisation of rabbits from the age of 30 days to reduce mortality caused by the rabbit haemorrhagic disease type 2 virus (RHDV2).
Bulgarian: K aktivní imunizaci králíků od věku 30 dní ke snížení mortality způsobené virem hemoragického onemocnění králíků typu 2 (RHDV2).
English: PHARMACEUTICAL PARTICULARS 6.1 List of excipients
Bulgarian: 6.1 Seznam pomocných látek
English: 17170 Amer (Girona) SPAIN
Bulgarian: 17170 Amer (Girona) ŠPANĚLSKO
English: Store and transport refrigerated.
Bulgarian: ZVLÁŠTNÍ PODMÍNKY PRO UCHOVÁVÁNÍ Uchovávejte a přepravujte chlazené.
English: Do not use in case of hypersensitivity to the active substance, to the adjuvant or to any of the excipients.
Bulgarian: Nepoužívat v případě přecitlivělosti na léčivou látku, nebo na některou z pomocných látek.
English: Mineral oil: ………………..104.125 mg
Bulgarian: Tekutý parafin………………104,125 mg
English: The vials are closed with a rubber stopper and aluminium cap.
Bulgarian: typu. Injekční lahvičky jsou uzavřeny pryžovou zátkou a hliníkovou čepičkou.
English: Name and address of the manufacturer responsible for batch release
Bulgarian: Jméno a adresa výrobce odpovědného za uvolnění šarže
English: To stimulate active immunity against the rabbit haemorrhagic disease type 2 virus (RHDV2).
Bulgarian: Ke stimulaci aktivní imunity proti virovému hemoragickému onemocnění králíků typu 2 (RHDV2).
English: Shelf life after first opening the immediate packaging: Use immediately.
Bulgarian: DATUM EXSPIRACE EXP: {měsíc/rok} Po otevření ihned spotřebujte.
English: 1 x 10 doses (5 ml).
Bulgarian: 1 x 10 dávek (5 ml).
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
Bulgarian: VÝROBCE BIOLOGICKY ÚČINNÉ LÁTKY A VÝROBCE ODPOVĚDNÝ
English: For animal treatment only.
Bulgarian: Pouze pro zvířata.
English: Type I colourless glass vials with 0.5 ml (1 dose), 5 ml (10 doses) and 20 ml (40 doses).
Bulgarian: Injekční lahvičky 0,5 ml (1 dávka), 5 ml (10 dávek) a 20 ml (40 dávek) z bezbarvého skla I.