FrancophonIA/ELRC3.0 huggingface dataset:
English: - The active substance is Human hepatitis B immunoglobulin.
Slovak: - Liečivo je ľudský imunoglobulín proti hepatitíde B.
English: There is reassuring clinical experience regarding the lack of hepatitis A or parvovirus B19 transmission with immunoglobulins and it is also assumed that the antibody content makes an important contribution to
Slovak: A alebo parvovírusu B19 imunoglobulínmi, pričom sa predpokladá, ţe obsah protilotok významne prispieva k zväčšeniu bezpečnosti
English: Human hepatitis B immunoglobulin should be administrated three to four weeks after vaccination with such a live attenuated vaccine; in case administration of human hepatitis B immunoglobulin is essential within three to four weeks after vaccination, then revaccination should be performed three months after the administration of
Slovak: B sa má podávať tri aţ štyri týţdne po očkovaní takouto vakcínou so ţivými oslabenými vírusmi; v prípade, ţe je nevyhnutné podávanie ľudského imunoglobulínu proti hepatitíde
English: Each ml contains 312 IU Human Hepatitis B Immunoglobulin corresponding to a protein content of 30-70 mg/ml with at least 96% Immunoglobulin G (IgG).
Slovak: B, čo zodpovedá obsahu bielkovín 30 - 70 mg/ml, s minimálne 96 % imunoglobulínu G (IgG).
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Slovak: VÝROBCA BIOLOGICKÉHO LIEČIVA A DRŢITEĽ POVOLENIA NA VÝROBU
English: ImmunoGam provides protection against hepatitis B virus for a short period of time and it is used to treat the
Slovak: ImmunoGam poskytuje ochranu proti vírusu hepatitídy
English: - In the newborn of a hepatitis B virus carrier-mother.
Slovak: U novorodencov, ktorých matka je nosičom vírusu hepatitídy B.
English: • Immunoglobulins in general may cause adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and moderate low back pain.
Slovak: horúčka, vracanie, alergické reakcie, nevoľnosť, artralgia (bolesť kĺbov), nízky krvný tlak a stredne ťaţká
English: Each ml contains 312 IU Human hepatitis B immunoglobulin, corresponding to a protein content of 30-70 mg/ml of which 96% is Immunoglobulin G (IgG).
Slovak: B, čo zodpovedá obsahu bielkovín 30 - 70 mg/ml, z ktorých minimálne 96 % predstavuje imunoglobulín G (IgG).
English: Undesirable effects reported during clinical trials with ImmunoGam, that was administered intramuscularly (injected into a muscle), were uncommon (affects 1 to 10 users in 1,000).
Slovak: ImmunoGamom, a ktoré sa povaţovali za súvisiace s ImmunoGamom, boli menej časté (postihujú 1 aţ 10 pouţívateľov z 1 000).
English: The solution should be clear to slightly opalescent and colourless or pale yellow.
Slovak: Roztok má byť číry aţ slabo opaleskujúci, bezfarebný alebo svetloţltý.
English: MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE
Slovak: VÝROBCA BIOLOGICKÉHO LIEČIVA A DRŢITEĽ
English: ImmunoGam is supplied in a Type 1 glass vial with a siliconized bromobutyl rubber stopper, aluminum seal and
Slovak: I so silikonizovanou zátkou z brómobutylovej gumy, hliníkovým tesniacim uzáverom a plastovým vyklápacím viečkom.
English: - Prevention of hepatitis B in the newborn, of a hepatitis B virus carrier-mother, at birth or as soon as
Slovak: B u novorodencov, ktorých matka je nosičom vírusu hepatitídy B, pri pôrode alebo 30 - 100 IU/kg.
English: Patients who have an IgA deficiency may develop an allergic reaction to this medicine.
Slovak: Tieto symptómy môţu predstavovať prvotné príznaky alergickej reakcie.
English: - Immunoprophylaxis of hepatitis B in haemodialysed patients:
Slovak: Ľudský imunoglobulín proti hepatitíde B
English: ADR frequency category*
Slovak: Kategória frekvencie neţiad.
English: SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
Slovak: ŠPECIÁLNE UPOZORNENIA NA LIKVIDÁCIU NEPOUŢITÝCH LIEKOV
English: ImmunoGam 312 IU/ml solution for injection.
Slovak: 1 ml obsahuje 312 IU ľudského imunoglobulínu proti hepatitíde
English: Consideration should also be given to dose and dose schedules for human hepatitis B immunoglobulin for intramuscular use recommended in other official guidance.
Slovak: Treba tieţ uváţiť dávku a dávkovací reţim pre ľudský imunoglobulín proti hepatitíde
English: - Newborn of a hepatitis B virus carrier-mother.
Slovak: B a vírus hepatitídy C.
English: (Portugal), S.A.
Slovak: (Portugalsko), S.A.
English: CAPSULE
Slovak: KAPSULE
English: Teva Pharma Belgium N.V.-S.A
Slovak: Teva Pharma Belgicko N.V.-S.A
English: ORAL USE
Slovak: ÚSTNÝ POUŽITIE
English: Pfizer Healthcare Ireland
Slovak: Pfizer Healthcare Írsko
English: Fresenius Kabi Hungary Kft.
Slovak: Fresenius Kabi Maďarsko Kft.
English: Teva Gyógyszergyár Zrt
Slovak: Teva Gyógyszergyár
English: DIRECT INTRAVENOUS INJECTION
Slovak: PRIAMY INTRAVENNÉ INJEKCIE
English: Fresenius Kabi Pharma Portugal Lda.
Slovak: Fresenius Kabi Pharma Portugalsko Lda.
English: United Kingdom Laboratorio Reig Jofre, S.A.
Slovak: Spojené kráľovstvo Laboratorio Reig Jofre, S.A.
English: Pharmaserve-Lilly Saci
Slovak: Pharmaserve-Lilly
English: United Kingdom Nrim Limited
Slovak: Nrim Limited
English: INJECTION
Slovak: INJEKCIE
English: United Kingdom Co-Pharma Limited Vancomycin CoPharma
Slovak: Spojené kráľovstvo Co-Pharma Limited Vancomycin CoPharma
English: CAPSULE, HARD ORAL USE
Slovak: ORALNE KAPSULE ÚSTNÝ POUŽITIE
English: Vancomycin Pfizer Healthcare Ireland
Slovak: Vancomycin Pfizer Healthcare Írsko
English: Mip Pharma Polska Sp. Z O.O.
Slovak: Mip Pharma Polska Sp.
English: Hikma Farmacêutica (Portugal), S.A.
Slovak: Hikma Farmacêutica (Portugalsko), S.A.
English: United Kingdom Flynn Pharma Ltd.
Slovak: Spojené kráľovstvo Flynn Pharma Ltd.
English: Labesfal Laboratorios Almiro, S.A.
Slovak: Laboratorios Almiro, S.A.
English: Trading
Slovak: Pharmaceutical Trading
English: Fresenius Kabi Romania S.R.L.
Slovak: Fresenius Kabi Rumunsko S.R.L.
English: United Kingdom Hikma Farmacêutica (Portugal), S.A.
Slovak: Spojené kráľovstvo Hikma Farmacêutica (Portugalsko), S.A.
English: Mip Pharma Austria Gmbh
Slovak: Mip Pharma Rakúsko Gmbh
English: Hospira Benelux Bvba
Slovak: Hospira Benelux
English: POWDER FOR CONCENTRATE FOR
Slovak: PRAŠEK ZA KONCENTRAT
English: POWDER FOR
Slovak: RAZTOPINE ZA
English: Vancomycin Morningside Healthcare
Slovak: Vancomycin Morningside
English: Pfizer Luxembourg Sarl
Slovak: Pfizer Luxembursko
English: Mcdermott Laboratories Ltd
Slovak: Mcdermott Laboratories
English: United Kingdom Actavis Group Ptc Ehf.
Slovak: Spojené kráľovstvo Actavis Group Ptc Ehf.
English: Teva Denmark A-S Vancomycin Teva VANCOMYCIN HYDROCHLORIDE
Slovak: Teva Dánsko A-S Vancomycin Teva VANCOMYCIN HYDROCHLORIDE
English: VANCOMYCIN 1G VIAL POWDER FOR ORAL SOLUTION, POWDER
Slovak: VANCOMYCIN 1G VIAL ORAL SOLUTION, POWDER FOR
English: Fresenius Kabi Ab Vancomycin Fresenius Kabi
Slovak: Kabi Ab Vancomycin Fresenius
English: VANCOMYCIN 500MG POWDER FOR
Slovak: VANCOMYCIN 500MG PRAŠEK ZA
English: Sandoz Gmbh
Slovak: Sandoz Gmbh Edicin
English: Mylan Pharmaceuticals, S.L.
Slovak: Pharmaceuticals, S.L.
English: Vancomicina Kern Pharma
Slovak: Vancomicina Kern
English: POWDER FOR ORAL SOLUTION, SOLUTION FOR INFUSION
Slovak: PRAŠEK ZA PRIPRAVO ORÁLNE RIEŠENIE, SOLUTION FOR INFUSION
English: United Kingdom Teva Uk Limited Vancomycin Teva Uk VANCOMYCIN 1000MG VIAL
Slovak: Spojené kráľovstvo Teva Uk Limited Vancomycin Teva Uk VANCOMYCIN 1000MG VIAL
English: Generics Pharma Hellas Ltd
Slovak: Generics Pharma Hellas
English: INHALATION USE
Slovak: POUŽITIE INHALÁCIE
English: POWDER FOR ORAL SOLUTION
Slovak: PRAŠEK ZA PRIPRAVO ORÁLNE RIEŠENIE
English: Eli Lilly Italia S.P.A. Vancocina A.P.
Slovak: Eli Lilly Italia S.P.A.
English: VANCOMYCIN HYDROCHLORIDE 128.15MG CAPSULE
Slovak: VANCOMYCIN HYDROCHLORIDE 128.15MG ORALNE KAPSULE
English: United Kingdom Xellia Pharmaceuticals Aps
Slovak: Spojené kráľovstvo Xellia Pharmaceuticals Aps
English: 512.6 - 520.1MG VIAL
Slovak: HYDROCHLORIDE 512.6 - 520.1MG VIAL
English: Vancomycine Teva VANCOMYCIN 1000MG/20 ML
Slovak: Vancomycine Teva VANCOMYCIN 1000MG/20
English: VANCOMYCIN HYDROCHLORIDE 1025MG/1025 MG
Slovak: VANCOMYCIN HYDROCHLORIDE 1025MG/1025
English: Hikma Italia S.P.A. Vancomicina
Slovak: Hikma Italia S.P.A.
English: United Kingdom Teva Uk Limited Vancomycin Teva Uk VANCOMYCIN 500MG VIAL
Slovak: Spojené kráľovstvo Teva Uk Limited Vancomycin Teva Uk VANCOMYCIN 500MG
English: 1025.2 - 1040.2MG VIAL
Slovak: HYDROCHLORIDE 1025.2 - 1040.2MG VIAL
English: Actavis Group Ptc Vancomycin Actavis VANCOMYCIN 500MG POWDER FOR
Slovak: Actavis Group Ptc Vancomycin Actavis VANCOMYCIN 1000MG PRAŠEK ZA
English: POWDER FOR SOLUTION FOR INFUSION / POWDER FOR ORAL SOLUTION
Slovak: PRAŠEK ZA PRIPRAVO RAZTOPINE ZA INFUNDIRANJE / PRAŠEK ZA PRIPRAVO ORÁLNE RIEŠENIE
English: Ratiopharm Gmbh Vancomycin
Slovak: Ratiopharm Gmbh Vancomycin Ratiopharm
English: United Kingdom Sandoz Ltd
Slovak: Sandoz Ltd
English: Fresenius Kabi France S.A.S.
Slovak: Fresenius Kabi Francúzsko S.A.S.
English: Vancomycin Actavis VANCOMYCIN 125MG CAPSULE
Slovak: Vancomycin Actavis VANCOMYCIN 125MG ORALNE KAPSULE
English: Vancomycin Xellia VANCOMYCIN 125MG CAPSULE
Slovak: Vancomycin Xellia VANCOMYCIN 125MG ORALNE KAPSULE
English: United Kingdom Mip Pharma Gmbh Vancomycin Mip Pharma Gmbh
Slovak: Spojené kráľovstvo Mip Pharma Gmbh Vancomycin Mip Pharma Gmbh
English: VANCOMYCIN 1G VIAL POWDER FOR CONCENTRATE FOR SOLUTION FOR
Slovak: VANCOMYCIN 1G VIAL PRAŠEK ZA KONCENTRAT
English: VANCOMYCIN 125MG CAPSULE
Slovak: VANCOMYCIN 125MG ORALNE KAPSULE
English: Fresenius Kabi Bulgaria Eood ванкомицин каби VANCOMYCIN 1000MG VIAL
Slovak: Kabi Bulharsko Eood ванкомицин каби VANCOMYCIN 1000MG VIAL
English: Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE
Slovak: Uk Ltd Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE
English: VANCOMYCIN HYDROCHLORIDE 512.5MG/512.5 MG
Slovak: VANCOMYCIN HYDROCHLORIDE 512.5MG/512.5
English: Vancomycine Fresenius Kabi
Slovak: Vancomycine Fresenius
English: Vancomycine Teva VANCOMYCIN 500MG/10 ML
Slovak: Vancomycine Teva VANCOMYCIN 500MG/10
English: Flynn Pharma Limited Vancocin
Slovak: Flynn Pharma Limited
English: POWDER FOR ORAL INTRAVENOUS USE,
Slovak: INTRAVENNÉ POUŽITIE, ÚSTNÝ
English: VANCOMYCIN HYDROCHLORIDE 125MG CAPSULE
Slovak: VANCOMYCIN HYDROCHLORIDE 125MG ORALNE KAPSULE
English: Hikma Farmacêutica Vancomycin Hikma VANCOMYCIN
Slovak: Vancomicina Hikma VANCOMYCIN
English: Vancomycin Actavis VANCOMYCIN 250MG CAPSULE
Slovak: Vancomycin Actavis VANCOMYCIN 250MG
English: VANCOMYCIN HYDROCHLORIDE 1000MG/1000 MG
Slovak: VANCOMYCIN HYDROCHLORIDE 1000MG/1000
English: Vancomycin Mylan VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR
Slovak: Vancomycin Mylan VANCOMYCIN 1G VIAL PRAŠEK ZA PRIPRAVO RAZTOPINE
English: Vancomycin Fresenius Kabi
Slovak: Vancomycin Fresenius
English: United Kingdom Hospira Uk Ltd Vancomycin Hydrochloride
Slovak: Spojené kráľovstvo Hospira Uk Ltd Vancomycin Hydrochloride
English: Fresenius Kabi Bulgaria Eood ванкомицин каби VANCOMYCIN 500MG VIAL
Slovak: Kabi Bulharsko Eood ванкомицин каби VANCOMYCIN 500MG
English: Wockhardt Uk Ltd Vancomycin Wockhardt Uk Ltd
Slovak: Uk Ltd Vancomycin Wockhardt
English: VANCOMYCIN HYDROCHLORIDE 0.5G VIAL
Slovak: VANCOMYCIN HYDROCHLORIDE 0.5G
English: POWDER FOR ORAL SOLUTION, POWDER FOR SOLUTION FOR INJECTION
Slovak: PRAŠEK ZA PRIPRAVO ORÁLNE RIEŠENIE, PRAŠEK ZA PRIPRAVO RAZTOPINE ZA INJEKCIE
English: Mylan Hospital As Vancomycin Mylan VANCOMYCIN 500MG VIAL
Slovak: Mylan Hospital As Vancomycin Mylan VANCOMYCIN 500MG
English: VANCOMYCIN HYDROCHLORIDE 500MG/500 MG
Slovak: VANCOMYCIN HYDROCHLORIDE 500MG/500
English: Vancomycin Xellia VANCOMYCIN 250MG CAPSULE
Slovak: Vancomycin Xellia VANCOMYCIN 250MG
English: Vancomycin Xellia VANCOMYCIN 500MG VIAL
Slovak: Vancomycin Xellia VANCOMYCIN 500MG
English: United Kingdom Morningside Healthcare Ltd
Slovak: Healthcare Ltd
English: VANCOMYCIN HYDROCHLORIDE 500000 I.U.
Slovak: VANCOMYCIN HYDROCHLORIDE 500000
English: Vancomycin Farmaplus 1000 Mg
Slovak: Vancomycin Farmaplus 1000
English: VANCOMYCIN HYDROCHLORIDE 256MG CAPSULE
Slovak: VANCOMYCIN HYDROCHLORIDE 256MG
English: Hospira Uk Ltd Vancomycin Hydrochloride
Slovak: Uk Ltd Vancomycin Hydrochloride
English: Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE
Slovak: Sandoz Gmbh Vancomycin Sandoz VANCOMYCIN HYDROCHLORIDE
English: Fresenius Kabi S.R.O Vancomycin Kabi
Slovak: Fresenius Kabi S.R.O
English: Dr. Friedrich Eberth Arzneimittel Gmbh
Slovak: Dr. Friedrich Eberth
English: Hospira Uk Ltd Vancomycin Hospira VANCOMYCIN 50MG/ML
Slovak: Uk Ltd Vancomycin Hospira VANCOMYCIN 50MG/ML
English: VANCOMYCIN HYDROCHLORIDE 250MG CAPSULE
Slovak: VANCOMYCIN HYDROCHLORIDE 250MG
English: Pharma Regulatory Solutions Ltd.
Slovak: Pharma Regulatory Solutions
English: Mylan Dura Gmbh Vancomycin Mylan VANCOMYCIN 1000MG VIAL
Slovak: Mylan Dura Gmbh Vancomycin Mylan VANCOMYCIN 1000MG PRAŠEK ZA
English: Arzneimittel Gmbh Eberth
Slovak: Arzneimittel Gmbh
English: Vancomycin Actavis VANCOMYCIN HYDROCHLORIDE
Slovak: Vancomycin Actavis VANCOMYCIN
English: Mip Pharma Gmbh Vancomycine Mip VANCOMYCIN HYDROCHLORIDE
Slovak: Mip Pharma Gmbh Vancomycine Mip VANCOMYCIN
English: Vancomicina Hospira VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR
Slovak: Vancomicina Hospira VANCOMYCIN 1G VIAL PRAŠEK ZA PRIPRAVO RAZTOPINE ZA
English: Hospira Portugal Lda Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE
Slovak: Hospira Portugalsko Vancomycin Hospira VANCOMYCIN
English: Vancomycin Cp VANCOMYCIN HYDROCHLORIDE
Slovak: Vancomycin Cp VANCOMYCIN
English: VANCOMYCIN HYDROCHLORIDE 1000000 I.U.
Slovak: VANCOMYCIN HYDROCHLORIDE 1000000
English: POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION, POWDER FOR ORAL SOLUTION
Slovak: ZA PRIPRAVO RAZTOPINE ZA INFUNDIRANJE , PRAŠEK ZA PRIPRAVO ORÁLNE RIEŠENIE
English: Vancomicina Hospira VANCOMYCIN HYDROCHLORIDE
Slovak: Vancomicina Hospira VANCOMYCIN
English: Vancomycin Mip VANCOMYCIN HYDROCHLORIDE
Slovak: Vancomycin Mip VANCOMYCIN
English: Vancomicina Sala VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR
Slovak: Vancomicina Sala VANCOMYCIN 1G VIAL PRAŠEK ZA PRIPRAVO RAZTOPINE ZA
English: Vancomycin Vocate VANCOMYCIN 500MG VIAL
Slovak: Vancomycin Vocate VANCOMYCIN 500MG
English: Vancomycine Sandoz VANCOMYCIN HYDROCHLORIDE 1G VIAL
Slovak: Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 1G VIAL
English: Vancomycin Hydrochloride Pharmaceutical
Slovak: VANCOMYCIN HYDROCHLORIDE
English: VANCOMYCIN 1G VIAL ORAL SOLUTION,
Slovak: VANCOMYCIN 1G VIAL PRAŠEK ZA PRIPRAVO ORÁLNE RIEŠENIE,
English: Ratiopharm HYDROCHLORIDE 512.5MG VIAL
Slovak: HYDROCHLORIDE 512.5MG VIAL
English: Vancomycine Pfizer VANCOMYCIN
Slovak: Pfizer Luxembursko Vankomicin Pfizer VANKOMICIN
English: Vancomycin Farmaplus 500 Mg
Slovak: Vancomycin Farmaplus 500
English: Fresenius Kabi Nv-Sa Vancomycine Fresenius Kabi
Slovak: Fresenius Kabi NvSa
English: Vancomycin Xellia VANCOMYCIN HYDROCHLORIDE
Slovak: Vancomycin Xellia VANCOMYCIN HYDROCHLORIDE 500MG
English: Gmbh
Slovak: MG
English: Cnp Pharma Gmbh Vancomycine Cnp VANCOMYCIN
Slovak: Cnp Pharma Gmbh Vancomycin "cnp"
English: United Kingdom Flynn Pharma Limited Vancocin Matrigel
Slovak: Spojené kráľovstvo Flynn Pharma Limited
English: VANCOMYCIN 250MG CAPSULE
Slovak: VANCOMYCIN 250MG
English: Vankomicin Actavis VANCOMYCIN 500MG VIAL
Slovak: Vankomicin Actavis VANKOMICIN 500 MG VIALA
English: Vancomycin Mylan VANCOMYCIN HYDROCHLORIDE
Slovak: Vancomycin Mylan VANCOMYCIN HYDROCHLORIDE 500MG
English: Vancomycin Nrim VANCOMYCIN 500MG VIAL
Slovak: Vancomycin Nrim VANCOMYCIN 500MG
English: VANCOMYCIN Hydrochloride 1000MG VIAL
Slovak: Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 1000MG vial
English: Vancomicina Labesfal VANCOMYCIN Hydrochloride 500MG vial
Slovak: Vancomycin Hospira VANCOMYCIN HYDROCHLORIDE 500MG
English: United Kingdom Pfizer Limited
Slovak: Pfizer Europe
English: Vancomicina Generis VANCOMYCIN HYDROCHLORIDE
Slovak: Vancomicina Generis VANCOMYCIN HYDROCHLORIDE 1000 mg
English: Hospira Enterprise Bv Vancomycin Hospira VANCOMYCIN 1G VIAL POWDER FOR SOLUTION FOR
Slovak: Vancomycin Hospira VANCOMYCIN 1G VIAL PRAŠEK ZA PRIPRAVO RAZTOPINE
English: MA (EU) number (Invented) name
Slovak: MA (EU) číslo (Invented) name Sila Lieková forma
English: Route of Administration
Slovak: Febuxostat
English: The dose in children depends on their age.
Slovak: Dávkovanie u detí závisí od ich veku.
English: EMA/628776/2014 EMEA/H/C/000314
Slovak: EMEA/H/C/000314
English: Adults and adolescents can use any form of the medicine.
Slovak: Dospelí a dospievajúci môžu užívať ktorúkoľvek liekovú formu.
English: The side effects seen in children are similar.
Slovak: U detí sa vyskytli podobné vedľajšie účinky.
English: The full EPAR for Neoclarityn can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Slovak: Úplné znenie správy EPAR o lieku Neoclarityn sa nachádza na webovej stránke agentúry: ema.europa.eu/Find medicine/Human medicines/European
English: Neoclarityn has also been studied in 416 patients with urticaria.
Slovak: Neoclarityn sa skúmal aj u 416 pacientov s urtikáriou.
English: This is a summary of the European public assessment report (EPAR) for Neoclarityn.
Slovak: Tento dokument je súhrn Európskej verejnej hodnotiacej správy (EPAR) o lieku Neoclarityn.
English: In all studies, the effectiveness of Neoclarityn was compared with that of placebo (a dummy treatment).
Slovak: Vo všetkých štúdiách sa účinnosť lieku Neoclarityn porovnávala s účinnosťou placeba (zdanlivého lieku).
English: Additional studies were presented to show that the syrup, oral solution and orodispersible tablets are treated by the body in the same way as the tablets, and to show that they can be used safely in children.
Slovak: V predložených dodatočných štúdiách sa preukázalo, že sirup, perorálny roztok a orodispergovateľné tablety sa v tele spracúvajú rovnakým spôsobom ako tablety a že sa môžu bezpečne používať u detí.
English: 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 Neoclarityn.
Slovak: Vysvetľuje, akým spôsobom Výbor pre lieky na humánne použitie (CHMP) vyhodnotil liek a dospel k stanovisku v prospech vydania povolenia na uvedenie na trh, ako aj k odporúčaniam, ako používať liek Neoclarityn.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Neoclarityn on 15 January 2001.
Slovak: Európska komisia vydala povolenie na uvedenie lieku Neoclarityn na trh platné v celej Európskej únii.
English: Neoclarityn is a medicine containing the active substance desloratadine.
Slovak: Neoclarityn je liek obsahujúci účinnú látku desloratadín.
English: Neoclarityn has been studied in a total of eight studies involving about 4,800 adult and adolescent patients with allergic rhinitis (including four studies in seasonal allergic rhinitis, and two studies in patients who also had asthma).
Slovak: Neoclarityn bol skúmaný celkovo v ôsmich štúdiách, na ktorých sa zúčastnilo približne 4 800 dospelých a dospievajúcich pacientov s alergickou nádchou (vrátané štyroch štúdií skúmajúcich sezónnu alergickú nádchu a dvoch štúdií s pacientmi, ktorí mali aj astmu).
English: It is available as a 5 mg tablet, 2.5 mg and 5 mg orodispersible tablets (tablets that dissolve in the mouth), a 0.5 mg/ml syrup and a 0.5 mg/ml oral solution.
Slovak: Je dostupný vo forme 5 mg tablety, vo forme 2,5 mg a 5 mg orodispergovateľných tabliet (tabliet rozpustných v ústach), vo forme 0,5 mg/ml sirupu a 0,5 mg/ml perorálneho roztoku.
English: For more information about treatment with Neoclarityn, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovak: Ak potrebujete ďalšie informácie o liečbe liekom Neoclarityn, prečítajte si písomnú informáciu pre používateľov (súčasť správy EPAR) alebo sa obráťte na svojho ošetrujúceho lekára, resp. lekárnika.
English: Neoclarityn must not be used in people who are hypersensitive (allergic) to desloratadine, loratadine or any of the other ingredients.
Slovak: Neoclarityn nesmú užívať osoby, ktoré môžu byť precitlivené (alergické) na desloratadín, loratadín alebo na iné zložky lieku.
English: The active substance in Neoclarityn, desloratadine, is an antihistamine.
Slovak: Účinná látka lieku Neoclarityn, desloratadín, je antihistaminikum.
English: What is the risk associated with Neoclarityn?
Slovak: Aké riziká sa spájajú s používaním lieku Neoclarityn?
English: It works by blocking the receptors to which histamine, a substance in the body that causes allergic symptoms, normally attaches itself.
Slovak: Účinkuje tak, že blokuje receptory, na ktoré sa za normálnych okolností viaže histamín, látka v tele, ktorá spôsobuje alergické príznaky.
English: The CHMP decided that Neoclarityn's benefits are greater than its risks for the relief of symptoms associated with allergic rhinitis or urticaria and recommended that it be given marketing authorisation.
Slovak: Výbor CHMP rozhodol, že prínos lieku Neoclarityn je väčší než riziká spojené s jeho užívaním na zmiernenie príznakov alergickej nádchy alebo urtikárie a odporučil udeliť povolenie na uvedenie na trh.
English: In allergic rhinitis, looking at the results of all studies taken together, two weeks of treatment with 5 mg Neoclarityn led to an average decrease in symptom score of 25 to 32%, compared with a decrease of 12 to 26% in the patients receiving placebo.
Slovak: Pri zohľadnení celkových výsledkov všetkých štúdií sa u alergickej nádchy zistilo, že dvojtýždňová liečba liekom Neoclarityn v dávke 5 mg viedla k zmierneniu príznakov v priemere o 25 % až 32 % v porovnaní so zmiernením o 12 % až 26 % u pacientov liečených placebom.
English: Neoclarityn is used to relieve the symptoms of allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) or urticaria (a skin condition caused by an allergy, with symptoms including itching and hives).
Slovak: Neoclarityn sa používa na zmiernenie príznakov alergickej nádchy (zápal nosových ciest spôsobený alergiou, napr. sennou nádchou alebo alergiou na roztoče v prachu) alebo urtikárie (kožné ochorenie spôsobené alergiou a s príznakmi ako sú svrbenie a vyrážky).
English: The effectiveness was measured by looking at the change in the symptoms (itching, number and size of hives, interference with sleep and daytime function) before and after six weeks of treatment.
Slovak: Účinnosť lieku sa merala ako zmena príznakov (svrbenie, počet a veľkosť vyrážok, narušenie spánku a činnosti počas dňa) pred liečbou a šesť týždňov po liečbe.
English: Why has Neoclarityn been approved?
Slovak: Prečo bol liek Neoclarityn povolený?
English: For children from one to five years of age, the dose is 1.25 mg once a day, taken as 2.5 ml syrup or oral solution.
Slovak: Deťom vo veku od jedného do piatich rokov sa podáva dávka 1,25 mg jedenkrát denne užívaná vo forme 2,5 ml sirupu alebo perorálneho roztoku.
English: In the two studies in urticaria, the decrease in symptom score after six weeks of treatment with Neoclarityn was 58 and 67%, compared with 40 and 33% in placebo-treated patients.
Slovak: Neoclarityn zmiernili o 58 % a 67 % v porovnaní so 40 % a 33 % u pacientov liečených placebom.
English: How has Neoclarityn been studied?
Slovak: Ako bol liek Neoclarityn skúmaný?
English: For children from six to 11 years of age, the dose is 2.5 mg once a day, taken either as 5 ml of the syrup or oral solution, or as one 2.5 mg orodispersible tablet.
Slovak: Deťom vo veku od šesť do 11 rokov sa podáva dávka 2,5 mg jedenkrát denne užívaná buď vo forme 5 ml sirupu alebo perorálneho roztoku alebo vo forme jednej 2,5 mg orodispergovateľnej tablety.
English: For the full list of all side effects reported with Neoclarityn, see the package leaflet.
Slovak: Zoznam všetkých vedľajších účinkov pozorovaných pri používaní lieku Neoclarityn sa nachádza v písomnej informácii pre používateľov.