FrancophonIA/ELRC3.0 huggingface dataset:
English: The no observed adverse effect levels (NOAELs) for foetal toxicity in mice (5 mg/kg/day) as well as maternal and foetal toxicity in rats (2.5 mg/kg/day) were associated with tedizolid plasma area under the curve (AUC) values approximately equivalent to the tedizolid AUC value associated with the oral human therapeutic dose.
Bulgarian: Нивата, при които не се наблюдават нежелани реакции (NOAEL), свързани с токсичност за плода при мишки (5 mg/kg/ден), както и с токсичност за майката и плода при плъхове (2,5 mg/kg/ден), съответстват на тези стойности на площта под кривата плазмена концентрация/време (AUC), които са приблизително равни на стойностите на AUC след приложение на перорална терапевтична доза тедизолид при хора.
English: In Phase 3 studies, subjects taking serotonergic agents including antidepressants such as selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants, and serotonin 5-hydroxytryptamine (5-HT1) receptor agonists (triptans), meperidine, or buspirone were excluded.
Bulgarian: В проучвания фаза 3 са изключени участниците, приемащи серотонинергични средства, включително антидепресанти като селективни инхибитори на обратното захващане на серотонина (SSRI), трициклични антидепресанти и серотонин 5-хидрокситриптаминови (5-HT1) рецепторни агонисти (триптани), меперидин или буспирон.
English: • The active substance is tedizolid phosphate.
Bulgarian: Активното вещество е тедизолидов фосфат.
English: Therefore, orally administered tedizolid phosphate can result in inhibition of BCRP at the intestinal level.
Bulgarian: Поради това, перорално приложен, тедизолидовият фосфат може да доведе до инхибиране на BCRP на чревно ниво.
English: If you forget to take Sivextro
Bulgarian: Ако сте пропуснали да приемете Sivextro
English: Tedizolid phosphate is converted by endogenous plasma and tissue phosphatases to the microbiologically active moiety, tedizolid.
Bulgarian: Тедизолидов фосфат се превръща от ендогенните фосфатази в плазмата и тъканите до микробиологично активната група тедизолид.
English: Reproductive system and breast disorders
Bulgarian: Нарушения на възпроизводителната система и гърдите
English: This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Bulgarian: Този лекарствен продукт не трябва да се смесва с други лекарствени продукти, с изключение на посочените в точка 6.6. Sivextro е несъвместим с разтвори, съдържащи двувалентни катиони (напр. Ca
English: Hyperhidrosis Pruritus
Bulgarian: Хиперхидроза Пруритус
English: If less than 8 hours remains before the next dose, then wait until the next scheduled dose.
Bulgarian: Ако остават по-малко от 8 часа преди следващата доза, изчакайте до следващата планирана доза.
English: There is no Phase 3 clinical experience in patients with co-administration of tedizolid phosphate with serotonergic agents such as selective serotonin re-uptake inhibitors [SSRI], serotonin norepinephrine reuptake inhibitors (SNRI), tricyclic antidepressants, MAO inhibitors, triptans, and other medicines with potential adrenergic or serotonergic activity.
Bulgarian: Няма клиничен опит при пациенти фаза 3, при които тедизолидов фосфат е прилаган едновременно със серотонинергични средства като селективни инхибитори на обратното захващане на серотонина [SSRI], ихибитори на обратното захващане на серотонина и норепинефрина (SNRI), трициклични антидепресанти, MAO инхибитори, триптани и други лекарства с потенциално адренергично или серотонинергично действие.
English: Acute bacterial skin and skin structure infections
Bulgarian: Остри бактериални инфекции на кожата и меките тъкани
English: Monoamine oxidase inhibition
Bulgarian: Инхибиране на моноаминооксидазата
English: Aseptic technique must be followed when preparing the infusion solution.
Bulgarian: При приготвяне на инфузионния разтвор трябва да се спазва асептична техника.
English: The Cmax and AUC of tedizolid increased approximately dose proportionally within the single oral dose range of 200 mg to 1,200 mg and across the intravenous dose range of 100 mg to 400 mg. Steady-state concentrations are achieved within 3 days and indicate modest active substance accumulation of approximately 30%
Bulgarian: Cmax и AUC на тедизолид нарастват, приблизително пропорционално на дозата, в рамките на диапазон на единичната перорална доза от 200 mg до 1 200 mg и при диапазон на интравенозната доза от 100 mg до 400 mg.
English: How to store Sivextro
Bulgarian: Как да съхранявате Sivextro
English: Sivextro 200 mg film-coated tablets
Bulgarian: Sivextro 200 mg филмирани таблетки
English: • Fungal infections of skin , mouth and vagina (oral / vaginal thrush)
Bulgarian: Гъбични инфекции на кожата, устата и влагалището (млечница на устата/влагалището)
English: If less than 8 hours remains before the next dose, then the physician should wait until the next scheduled dose.
Bulgarian: Ако остават по-малко от 8 часа преди следващата доза, лекарят трябва да изчака до следващата планирана доза.
English: If less than 8 hours remains before the next dose, then the patient should wait until the next scheduled dose.
Bulgarian: Ако остават по-малко от 8 часа преди следващата доза, пациентът трябва да изчака до следващата планирана доза.
English: How to take Sivextro
Bulgarian: Как да приемате Sivextro
English: For administration, the reconstituted solution must be further diluted in 250 mL 0.9% sodium chloride.
Bulgarian: Преди приложение, приготвеният разтвор трябва допълнително да се разреди в 250 ml натриев хлорид 0,9 %.
English: If you take more Sivextro than you should
Bulgarian: Ако сте приели повече от необходимата доза Sivextro
English: Antibacterial activity against other relevant pathogens
Bulgarian: Антибактериално действие срещу други, подобни патогени
English: Serotonergic effects at doses of tedizolid phosphate up to 30-fold above the human equivalent dose did not differ from vehicle control in a mouse model that predicts brain serotonergic activity.
Bulgarian: В модел с мишка, който прогнозира мозъчното серотонинергично действие, серотонинергичните ефекти в дози на тедизолидовия фосфат до 30 пъти над еквивалентната доза при хора, не се различават от тези при прием на контролния разтворител.
English: Uncommon reactions (phlebitis)
Bulgarian: Реакции на мястото на инфузия (флебит)
English: In a clinical study comparing the single dose (2 mg) pharmacokinetics of midazolam (CYP3A4 substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose for 10 days), midazolam AUC and Cmax when co-administered with tedizolid phosphate were 81% and 83% of midazolam AUC and Cmax when administered alone, respectively.
Bulgarian: В клинично проучване, сравняващо фармакокинетиката на единична доза (2 mg) мидазолам (субстрат на CYP3A4), приложена самостоятелно или в комбинация с тедизолидов фосфат (200 mg перорална доза веднъж дневно за 10 дни), AUC и Cmax на мидазолам, прилаган едновременно с тедизолидов фосфат, са съответно 81 % и 83 % от AUC и Cmax на мидазолам, когато се прилага самостоятелно.
English: • Acid reflux disease (heartburn, pain or difficulty swallowing), flatulence/passing wind
Bulgarian: Рефлуксна болест (киселини, болка или трудно преглъщане), подуване на корема/
English: Recommended dose and duration The recommended dosage is 200 mg once daily for 6 days.
Bulgarian: Препоръчителната дозировка е 200 mg веднъж дневно в продължение на 6 дни.
English: After reconstitution each ml contains 50 mg tedizolid phosphate.
Bulgarian: След реконституиране всеки ml съдържа 50 mg тедизолидов фосфат.
English: If you forget to take your medicine, take the dose as soon as possible anytime up to 8 hours prior to the next scheduled dose.
Bulgarian: Вашето лекарство, приемете дозата възможно най-скоро, до 8 часа преди следващата планирана доза.
English: If you stop taking Sivextro
Bulgarian: Ако сте спрели приема на Sivextro
English: Sivextro 200 mg powder for concentrate for solution for infusion
Bulgarian: Sivextro 200 mg прах за концентрат за инфузионен разтвор
English: In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (BCRP substrate) alone or in combination with the oral administration of tedizolid phosphate 200 mg, rosuvastatin AUC and Cmax increased by approximately 70% and 55%, respectively, when coadministered with Sivextro.
Bulgarian: В клинично проучване, сравняващо фармакокинетиката на единична доза (10 mg) розувастатин (субстрат на BCRP), самостоятелно или в комбинация с перорално приложение на тедизолидов фосфат 200 mg, AUC и Cmax на розувастатин се повишават съответно с приблизително 70 % и 55 %, когато се прилага едновременно със Sivextro.
English: Talk to a doctor if you do not feel better, or if you feel worse after 6 days.
Bulgarian: Ако след 6 дни не се почувствате по-добре или състоянието Ви се влоши, трябва да потърсите лекарска помощ.
English: IV
Bulgarian: В
English: Diabetes mellitus inadequate control
Bulgarian: Незадоволителен контрол на захарния диабет Хиперкалиемия
English: In a clinical study comparing the single dose (10 mg) pharmacokinetics of rosuvastatin (Breast Cancer Resistant Protein [BCRP] substrate) alone or in combination with tedizolid phosphate (once-daily 200 mg oral dose), rosuvastatin AUC and Cmax increased by approximately 70% and 55%, respectively, when coadministered with tedizolid phosphate.
Bulgarian: В клинично проучване, сравняващо фармакокинетиката на единична доза (10 mg) розувастатин (субстрат на протеина на резистентност към рака на гърдата [Breast Cancer Resistant Protein, BCRP]), приложена самостоятелно или в комбинация с тедизолидов фосфат (200 mg перорална доза веднъж дневно), AUC и Cmax на розувастатин се повишават съответно с приблизително 70 % и 55 %, когато се прилага едновременно с тедизолидов фосфат.
English: Somnolence
Bulgarian: Безсъние
English: Lymphadenopathy
Bulgarian: Хематохезия
English: For administration, the reconstituted solution must be further diluted in 250 mL of sodium chloride 0.9% solution for injection.
Bulgarian: Преди приложение, приготвеният разтвор трябва допълнително да се разреди в 250 ml инжекционен разтвор натриев хлорид 0,9 %.
English: The highest single dose administered in clinical studies was 1,200 mg. All adverse reactions at this dose level were mild or moderate in severity.
Bulgarian: Всички нежелани реакции при тази доза са леки или умерени по тежест.
English: Each film-coated tablet contains 200 mg tedizolid phosphate.
Bulgarian: Всяка филмирана таблетка съдържа 200 mg тедизолидов фосфат.
English: imipramine, isocarboxazid, lofepramine, moclobemide, paroxetine, phenelzine, selegiline and sertraline (used to treat depression)
Bulgarian: флувоксамин, имипрамин, изокарбоксазид, лофепрамин, моклобемид, пароксетин,
English: If possible, an interruption of the coadministered BCRP substrate medicinal product (such as imatinib, lapatinib, methotrexate, pitavastatin, rosuvastatin, sulfasalazine, and topotecan) should be considered during the 6 days of treatment with oral tedizolid phosphate.
Bulgarian: Ако е възможно, по време на 6-дневния период на лечение с перорален тедизолидов фосфат трябва да се обмисли преустановяване на едновременно прилагания лекарствен продукт, който е субстрат на BCRP (като иматиниб, лапатиниб, метотрексат, питавастатин, розувастатин, сулфасалазин и топотекан).
English: Tedizolid is a reversible inhibitor of MAO in vitro; however, no interaction is anticipated when comparing the IC50 and the anticipated plasma exposures in man. No evidence of MAO-A inhibition was observed in Phase 1 studies specifically designed to investigate the potential for this interaction.
Bulgarian: Въпреки това не се очаква взаимодействие, при сравнението на IC50 за MAO-A инхибирането с очакваните плазмени експозиции при човека.
English: Adrenergic agents
Bulgarian: Адренергични средства
English: Monoamine oxidase inhibitors
Bulgarian: Инхибитори на моноаминооксидазата
English: How you will be given Sivextro
Bulgarian: Как ще Ви бъде приложен Sivextro
English: After reconstitution each mL contains 50 mg tedizolid phosphate.
Bulgarian: След разтваряне всеки ml съдържа 50 mg тедизолидов фосфат.
English: Sivextro 200 mg tablets tedizolid phosphate
Bulgarian: Sivextro 200 mg таблетки тедизолидов фосфат
English: Hepatic impairment
Bulgarian: Коремен дискомфорт
English: Vulvovaginal mycotic infection Fungal infection Vulvovaginal candidiasis Abscess
Bulgarian: Вулвовагинална микотична инфекция
English: Each vial of powder contains disodium tedizolid phosphate which is equal to 200 mg of tedizolid phosphate.
Bulgarian: Всеки флакон прах съдържа динатриев тедизолидов фосфат, който съответства на 200 mg тедизолидов фосфат.
English: Nasal dryness Pulmonary congestion
Bulgarian: Сухота в носа Белодробен застой
English: Abdominal discomfort Dry mouth
Bulgarian: Сухота в устата Диспепсия
English: Infusion site pain
Bulgarian: Болка на мястото на инфузия
English: Each vial contains disodium tedizolid phosphate corresponding to 200 mg tedizolid phosphate.
Bulgarian: Всеки флакон съдържа динатриев тедизолидов фосфат (disodium tedizolid phosphate), съответстващ на 200 mg тедизолидов фосфат (tedizolid phosphate).
English: Sivextro 200 mg film-coated tablets tedizolid phosphate
Bulgarian: Sivextro 200 mg филмирани таблетки тедизолидов фосфат (tedizolid phosphate)
English: Sivextro 200 mg powder for concentrate for solution for infusion tedizolid phosphate
Bulgarian: Sivextro 200 mg прах за концентрат за инфузионен разтвор тедизолидов фосфат
English: The Cmax and AUC of tedizolid increased approximately dose proportionally within the single oral dose range of 200 mg to 1,200 mg and across the intravenous dose range of 100 mg to 400 mg. Steady-state concentrations are achieved within 3 days and indicate modest active substance accumulation of approximately 30% following multiple once-daily oral or intravenous administration as predicted by a half-life of approximately 12 hours.
Bulgarian: Стационарните концентрации се достигат в рамките на 3 дни и показват умерена кумулация на активното вещество приблизително 30 %, след многократни перорални или интравенозни приложения веднъж дневно, както е прогнозирано при полуживот приблизително 12 часа.
English: Do not shake the bag.
Bulgarian: Не разклащайте сака.
English: Decreased platelets, decreased haemoglobin and decreased neutrophils have been observed in a few subjects during treatment with tedizolid phosphate.
Bulgarian: При лечение с тедизолидов фосфат при няколко пациенти са наблюдавани понижени тромбоцити, понижен хемоглобин и понижени неутрофили.
English: Abdominal pain upper Flatulence
Bulgarian: Болка в горната част на корема Флатуленция
English: Sivextro 200 mg powder for concentrate tedizolid phosphate
Bulgarian: Sivextro 200 mg прах за концентрат тедизолидов фосфат i.v.
English: Rash erythematous Rash generalised Acne
Bulgarian: Еритематозен обрив Генерализиран обрив Акне
English: Vision blurred Vitreous floaters
Bulgarian: Замъглено зрение, мътнини в зрителното поле
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Bulgarian: Препоръчителна доза и продължителност
English: • Infusion site pain or swelling.
Bulgarian: Болка или подуване на мястото на инфузия.
English: Dilution
Bulgarian: Разтваряне
English: The following quality, efficacy and safety issues were addressed:
Bulgarian: Bylo poukázáno na tyto otázky týkající se kvality, účinnosti a bezpečnosti:
English: Keep the tube tightly closed.
Bulgarian: Tubu uchovávejte dobře uzavřenou.
English: Section on contraindications remained unchanged.
Bulgarian: Oddíl týkající se kontraindikací zůstal nezměněn.
English: No special requirements.
Bulgarian: s ním Žádné zvláštní požadavky.
English: Undesirable effects
Bulgarian: Nežádoucí účinky
English: QUALITATIVE AND QUANTITATIVE COMPOSITION
Bulgarian: KVALITATIVNÍ A KVANTITATIVNÍ SLOŽENÍ
English: Benefit/Risk considerations
Bulgarian: Posouzení přínosu/rizika
English: The remaining 1% is present in the intra- and extracellular fluids.
Bulgarian: Zbývající 1 % je přítomno v intra a extracelulární tekutině.
English: Effects on ability to drive and use machines
Bulgarian: Účinky na schopnost řídit a obsluhovat stroje
English: DATE OF REVISION OF THE TEXT
Bulgarian: 10. DATUM REVIZE TEXTU
English: Physicochemical and biological aspects relevant to the uniform clinical performance of the product have been investigated and are controlled in a satisfactory way.
Bulgarian: Fyzikálně-chemické a biologické aspekty týkající se jednotného klinického použití přípravku byly zjišťovány a jsou kontrolovány uspokojivým způsobem.
English: There is no information of relevance to the safety assessment in addition to what is stated in other parts of the SmPC.
Bulgarian: Neexistují žádné jiné informace vztahující se k hodnocení bezpečnosti než informace uvedené v jiných částech SPC.
English: SCIENTIFIC CONCLUSIONS
Bulgarian: VĚDECKÉ ZÁVĚRY
English: Classification and terminology were amended according to the MedDRA system organ class.
Bulgarian: Klasifikace a terminologie byly změněny na základě roztřídění podle orgánu podle MedDRA.
English: Not all pack sizes may be marketed.
Bulgarian: Na trhu nemusí být všechny velikosti balení.
English: 1800 VILVOORDE Belgium
Bulgarian: 1800 VILVOORDE Belgie
English: During pregnancy, the daily intake of calcium should not exceed 1500 mg.
Bulgarian: V průběhu těhotenství by neměl denní příjem kalcia překročit 1500 mg.
English: Av. Poeta Mistral n°2-2°, 1069-172 Lisboa, Portugal
Bulgarian: Poeta Mistral n°2-2° 1069-172 Lisboa,
English: uncommon (>1/1,000, <1/100), rare (>1/10,000, <1/1,000) or very rare (<1/10,000), including isolated reports.
Bulgarian: Na základě četnosti jsou nežádoucí účinky děleny na méně časté (>1/1000, <1/100), vzácné (>1/10000, <1/1000) nebo velmi vzácné (<1/10,000), mezi které jsou řazeny i ojedinělé případy.
English: In the case of an intoxication, treatment should be stopped immediately and the fluid deficiency should be corrected.
Bulgarian: V případě intoxikace je třeba ihned ukončit léčbu a korigovat deficit tekutin.
English: Ms Eeva Liisa Kärkkäinen
Bulgarian: & pí Eeva Liisa Kärkkäinen
English: Lyngbyvej 172,
Bulgarian: A/S, Lyngbyvej 172,
English: Postboks 237 Økern 0510 Oslo, Norway
Bulgarian: Postboks 237 Økern 0510 Oslo
English: DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION
Bulgarian: DATUM PRVNÍ REGISTRACE / PRODLOUŽENÍ REGISTRACE Doplní
English: The threshold for calcium intoxication is from supplementation in excess of 2000 mg per day, taken for several months.
Bulgarian: Hraniční hodnota pro intoxikaci kalciem je při suplementaci více než 2000 mg za den, užívaných po dobu několika měsíců.
English: The remaining 45% of serum calcium is bound to proteins, principally albumin.
Bulgarian: Zbývajících 45 % sérového kalcia je navázáno na proteiny, převážně na albumin.
English: Largo U. Boccioni, 1 21040 Origgio (VA), Italy
Bulgarian: Boccioni, 1 21040 Origgio (VA), Itálie
English: There have been literature reports alluding to possible increased absorption of aluminium with citrate salts.
Bulgarian: Byly publikovány zprávy, které zmiňují možné zvýšení absorpce hliníku při podávání se solemi citrátu.
English: Special precautions for storage
Bulgarian: Zvláštní opatření pro uchovávání
English: The mineral component of bones and teeth contains 99% of the body's calcium.
Bulgarian: složka kostí a zubů obsahje 99 % kalcia obsaženého v těle.
English: Patients with rare hereditary problems of fructose intolerance or glucose-galactose malabsorption should not take this medicine.
Bulgarian: Pacienti se vzácnou vrozenou vadou - intolerancí fruktózy nebo malabsorpcí glukózy-galaktózy - by neměli tento lék užívat.
English: Distribution and metabolism:
Bulgarian: Distribuce a metabolismus:
English: Urinary excretion depends on glomerular filtration and tubular reabsorption.
Bulgarian: Vylučování močí je závislé na glomerulární filtraci a tubulární reabsorpci.
English: Attn: Mr Pieter De Pourcq
Bulgarian: Kontakt: P. Pieter De Pourcq
English: Calcium Sandoz has no influence on the ability to drive and use machines.
Bulgarian: Přípravek Calcium Sandoz nijak neovlivňuje schopnost řídit motorová vozidla a obsluhovat stroje.
English: Emelet Postacím: 1525 Budapest, Pf. 118 Hungary
Bulgarian: 1525 Budapest, Pf. 118
English: Special warnings and precautions for use
Bulgarian: Zvláštní upozornění a zvláštní opatření pro použití
English: ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES
Bulgarian: SEZNAM NÁZVŮ, LÉKOVÝCH FOREM, OBSAHŮ LÉČIVÝCH LÁTEK V LÉČIVÝCH PŘÍPRAVCÍCH, ZPŮSOBU PODÁNÍ A DRŽITELŮ ROZHODNUTÍ O REGISTRACI V ČLENSKÝCH STÁTECH
English: The quality of this product is considered to be acceptable when used in accordance with the conditions defined in the SPC.
Bulgarian: − Kvalita Kvalita přípravku je považována za přijatelnou, jestliže je používán za podmínek stanovených v souhrnu údajů o přípravku.
English: The effervescent tablets should be dissolved in a glass of water (approx. 200 ml) and drunk immediately.
Bulgarian: Šumivé tablety se rozpustí ve sklenici vody (přibližně 200 ml), doporučuje se roztok ihned vypít.
English: Attn: P. Miko
Bulgarian: Kontakt: P. Miko
English: PHARMACEUTICAL FORM
Bulgarian: Léková forma
English: If necessary, the calcium dose should be reduced or therapy should be discontinued.
Bulgarian: V případě potřeby lze snížit dávku kalcia nebo přerušit léčbu.
English: Attn: J. Lam
Bulgarian: J. Lam
English: Calcium is an essential mineral, necessary for bone formation and maintenance, for electrolyte equilibrium in the body and for the proper functioning of numerous regulatory mechanisms.
Bulgarian: Kalcium je základním minerálem nezbytným pro utváření a výživu kostí, pro elektrolytovou rovnováhu v těle a pro správnou funkci řady regulačních mechanismů.
English: Horvát u. 14-24.
Bulgarian: 1027 Budapest Horvát u. 14-24.
English: vomiting, thirst, polydipsia, polyuria, dehydration and constipation.
Bulgarian: zvracení, žízeň, polydipsie, polyurie, dehydratace a zácpa.
English: The scope of the procedure were the necessary measures to achieve an harmonised Summary of Product Characteristics (SPC), and the harmonisation of module 3 of the dossier, for which the Marketing Authorisation Holder proposed to replace all existing formulas with a single formula in two strengths, and to optimize the manufacturing process for this formula.
Bulgarian: Obsahem řízení byla nezbytná opatření k dosažení harmonizovaného souhrnu údajů o přípravku (SPC) a harmonizaci modulu 3 souboru dokumentace, pro které držitel rozhodnutí o registraci navrhl nahradit všechny stávající formy přípravku jedinou formou o dvou různých obsazích léčivých látek, a k optimalizaci výrobního procesu pro tuto formu.
English: Divison Consumer
Bulgarian: Division Consumer Health
English: Some 25-50% of the ingested dose of calcium is absorbed, predominantly in the proximal part of the small intestine, and delivered to the exchangeable calcium pool.
Bulgarian: Přibližně 25-50 % požité dávky kalcia je absorbováno, převážně v proximální části tenkého střeva, a předáno do poolu volně dostupného kalcia.
English: Significant amounts of calcium are secreted in milk during lactation but do not cause any adverse effects to the neonate.
Bulgarian: V období kojení je významné množství kalcia secrenováno do mateřského mléka, ale u novorozence nezpůsobuje žádné nežádoucí účinky.
English: Czech Republic Novartis s.r.o.
Bulgarian: Česká republika Novartis s.r.o.
English: the CHMP has recommended the amendment of the Marketing Authorisations for which the Summary of Product Characteristics is set out in Annex III of this opinion.
Bulgarian: Výbor pro humánní a léčivé přípravky doporučil úpravu rozhodnutí o registraci, pro něž je souhrn údajů o přípravku uveden v příloze III tohoto stanoviska.
English: Wimblehurst Road, Horsham,
Bulgarian: Wimblehurst Road,
English: Attn: J. Grevsen
Bulgarian: J. Grevsen
English: OVERALL SUMMARY OF THE SCIENTIFIC EVALUATION OF CALCIUM SANDOZ EFFERVESCENT TABLETS (AND ASSOCIATED NAMES - SEE ANNEEX 1)
Bulgarian: CELKOVÝ PŘEHLED VĚDECKÉHO HODNOCENÍ LÉČIVÉHO PŘÍPRAVKU CALCIUM SANDOZ ŠUMIVÉ TABLETY (A SOUVISEJÍCÍCH NÁZVŮ - VIZ PŘÍLOHA 1)
English: Member State
Bulgarian: Členský stát
English: Sodium hydrogen carbonate
Bulgarian: Hydrogenuhličitan sodný