FrancophonIA/ELRC3.0 huggingface dataset:
English: However, cases of alcohol intolerance and intoxication have been reported during post marketing use.
Slovenian: Kljub temu so v obdobju trženja zdravila poročali o primerih intolerance in zastrupitve z alkoholom.
English: Dasselta is indicated in adults and adolescents aged 12 years and older for the relief of symptoms associated with: - allergic rhinitis (see section 5.1), - urticaria (see section 5.1).
Slovenian: Zdravilo Dasselta je indicirano pri odraslih in mladostnikih, starih 12 let in več, za lajšanje simptomov: - alergijskega rinitisa (glejte poglavje 5.1), - urtikarije (glejte poglavje 5.1).
English: ), titanium dioxide (E171) and indigo carmine (E132).
Slovenian: ), titanov dioksid (E171) in indigotin (E132).
English: What Dasselta is and what it is used for
Slovenian: Kaj je zdravilo Dasselta in za kaj ga uporabljamo
English: Dasselta is available in carton boxes of 7, 10, 20, 30, 50, 90 and 100 film-coated tablets in blisters and in tablet container of 250 film-coated tablets.
Slovenian: Na voljo so kartonaste škatle s 7, z 10, 20, s 30, 50, z 90 in s 100 filmsko obloženimi tabletami v pretisnih omotih in vsebnik za tablete z 250 filmsko obloženimi tabletami.
English: 250 film-coated tablets
Slovenian: 250 filmsko obloženih tablet
English: Since histamine release is a causal factor in all urticarial diseases, desloratadine is expected to be effective in providing symptomatic relief for other urticarial conditions, in addition to chronic idiopathic urticaria, as advised in clinical guidelines.
Slovenian: Ker pa je vzročni dejavnik pri vseh urtikarijskih boleznih enak, to je sproščanje histamina, lahko upravičeno pričakujemo, da bi z uporabo desloratadina dosegli učinkovito lajšanje simptomov tudi pri drugih urtikarijskih stanjih razen kronične idiopatske urtikarije, saj je to priporočeno tudi v kliničnih smernicah.
English: What Dasselta is and what it is used for What you need to know before you take Dasselta How to take Dasselta
Slovenian: Kaj je zdravilo Dasselta in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Dasselta Kako jemati zdravilo Dasselta Možni neželeni učinki
English: During the marketing of desloratadine, cases of severe allergic reactions (difficulty in breathing, wheezing, itching, hives and swelling) have been reported very rarely.
Slovenian: Med trženjem zdravil, ki vsebujejo desloratadin, so zelo redko poročali o primerih hudih alergijskih reakcij (težave z dihanjem, piskanje, srbenje, koprivnica in otekanje).
English: Adverse reactions seen with desloratadine
Slovenian: Neželeni učinki, opaženi pri zdravljenju z desloratadinom
English: Suomi/Finland KRKA Finland Oy Puh/Tel: +358 20 754 5330
Slovenian: KRKA Finland Oy Puh/Tel: +358 20 754 5330
English: In clinical trials in a range of indications including allergic rhinitis and chronic idiopathic urticaria, at the recommended dose of 5 mg daily, undesirable effects with desloratadine were reported in 3 % of patients in excess of those treated with placebo.
Slovenian: V kliničnih preskušanjih pri različnih indikacijah za uporabo zdravila, vključno z alergijskim rinitisom in kronično idiopatsko urtikarijo so pri priporočenem odmerku 5 mg na dan o neželenih učinkih desloratadina poročali pri 3 % bolnikov več kot pri tistih, ki so bili zdravljeni s placebom.
English: What Dasselta is Dasselta contains desloratadine which is an antihistamine.
Slovenian: Kaj je zdravilo Dasselta Zdravilo Dasselta vsebuje desloratadin, ki je antihistaminik.
English: Desloratadine was effective in alleviating the burden of seasonal allergic rhinitis as shown by the total score of the rhino-conjunctivitis quality of life questionnaire.
Slovenian: Desloratadin je učinkovito ublažil težave, povezane s sezonskim alergijskim rinitisom, kar so pokazali skupni rezultati vprašalnika o kakovosti življenja bolnikov z rinitisom in konjunktivitisom.
English: As with other antihistamine trials in chronic idiopathic urticaria, the minority of patients who were identified as nonresponsive to antihistamines was excluded.
Slovenian: Kot pri drugih preskušanjih uporabe antihistaminikov pri bolnikih s kronično idiopatsko urtikarijo so iz raziskave izločili manjše število bolnikov, za katere je bilo ugotovljeno, da se ne odzivajo na antihistaminike.
English: When Dasselta should be used
Slovenian: Kdaj je treba uporabljati zdravilo Dasselta
English: Dasselta with food, drink and alcohol Dasselta may be taken with or without a meal.
Slovenian: Zdravilo Dasselta skupaj s hrano, pijačo in alkoholom Zdravilo Dasselta se lahko jemlje s hrano ali brez nje.
English: After oral administration, desloratadine selectively blocks peripheral histamine H1receptors because the substance is excluded from entry to the central nervous system.
Slovenian: Po peroralni uporabi selektivno zavira le periferne receptorje H1, saj učinkovina ne prehaja v osrednji živčni sistem.
English: Dasselta relieves symptoms associated with allergic rhinitis (inflammation of the nasal passages caused by an allergy, for example, hay fever or allergy to dust mites) in adults and adolescents 12 years of age and older.
Slovenian: Zdravilo Dasselta lajša simptome alergijskega rinitisa (vnetje nosnih poti zaradi alergije, na primer seneni nahod ali alergija na pršice) pri odraslih in mladostnikih, starih 12 let in več.
English: Talk to your doctor or pharmacist before taking Dasselta: - if you have poor kidney function.
Slovenian: Pred začetkom jemanja zdravila Dasselta se posvetujte z zdravnikom ali farmacevtom: - če vam ledvice slabo delujejo.
English: Dasselta is an antiallergy medicine that does not make you drowsy.
Slovenian: Zdravilo Dasselta je zdravilo proti alergiji, ki ne povzroča zaspanosti.
English: In the case of severe renal insufficiency, Dasselta should be used with caution (see section 5.2).
Slovenian: V primeru hude ledvične insuficience morate zdravilo Dasselta uporabljati previdno (glejte poglavje
English: How to take Dasselta
Slovenian: Kako jemati zdravilo Dasselta
English: - The other ingredients in the film-coating are: hypromellose (E464), macrogol, lactose monohydrate (see section 2 under »Dasselta contains lactose«.
Slovenian: - Druge sestavine zdravila v filmski oblogi so: hipromeloza (E464), makrogol, laktoza monohidrat (glejte poglavje 2 pod rubriko »Zdravilo Dasselta vsebuje laktozo«.
English: In patients with allergic rhinitis, desloratadine was effective in relieving symptoms such as sneezing, nasal discharge and itching, as well as ocular itching, tearing and redness, and itching of palate.
Slovenian: Pri bolnikih z alergijskim rinitisom desloratadin učinkovito lajša simptome, kot so kihanje, srbenje nosu in izcedek iz nosu, pa tudi srbenje oči, solzenje in vnetje očesne veznice ter srbenje ustnega neba.
English: In a clinical pharmacology trial desloratadine tablets taken concomitantly with alcohol did not potentiate the performance impairing effects of alcohol (see section 5.1).
Slovenian: V klinični farmakološki raziskavi pri sočasnem jemanju desloratadina v obliki tablet in uživanju alkohola ni bilo okrepljenih škodljivih učinkov alkohola (glejte poglavje 5.1).
English: Not known: frequency cannot be estimated from the available data - unusual weakness, - yellowing of the skin and/or eyes, - increased sensitivity of the skin to the sun, even in case of hazy sun, and to UV light, for instance to UV lights of a solarium, - changes in the way the heart beats,
Slovenian: Neznana pogostnost (pogostnosti iz razpoložljivih podatkov ni mogoče oceniti): - neobičajna šibkost, - rumeno obarvanje kože in/ali oči, - povečana občutljivost kože za sonce, tudi če gre za indirektno izpostavljenost soncu (čez oblake,
English: Dasselta 5 mg film-coated tablets Desloratadine
Slovenian: Dasselta 5 mg filmsko obložene tablete desloratadin
English: Dasselta 5 mg film-coated tablets
Slovenian: Dasselta 5 mg filmsko obložene tablete
English: Desloratadine given at a single daily dose of 7.5 mg did not affect psychomotor performance in clinical trials.
Slovenian: V kliničnih preskušanjih desloratadin v enem dnevnem odmerku 7,5 mg ni vplivalo na psihomotorične sposobnosti bolnikov.
English: During the marketing of desloratadine-containing products, the following side effects were reported as:
Slovenian: Odrasli Med trženjem zdravil, ki vsebujejo desloratadin, so poročali o naslednjih neželenih učinkih:
English: Microcrystalline cellulose (E460) Hypromellose (E464) Hydrochloric acid (E507) Sodium hydroxide (E524) Maize starch
Slovenian: Jedro tablete: mikrokristalna celuloza (E460) hipromeloza (E464) klorovodikova kislina (E507) natrijev hidroksid (E524) koruzni škrob laktoza monohidrat smukec (E553b)
English: The safety and efficacy of Dasselta 5 mg film-coated tablets in children below the age of 12 years have not been established.
Slovenian: Varnost in učinkovitost zdravila Dasselta pri otrocih, mlajših od 12 let, nista bili dokazani.
English: film-coated tablet for blister:
Slovenian: filmsko obložena tableta za pretisni omot:
English: - The other ingredients in the tablet core are: microcrystalline cellulose (E460), hypromellose (E464), hydrochloric acid (E507), sodium hydroxide (E524), maize starch, lactose monohydrate (see section 2 under »Dasselta contains lactose«.)
Slovenian: - Druge sestavine zdravila v jedru tablete so: mikrokristalna celuloza (E460), hipromeloza (E464), klorovodikova kislina (E507), natrijev hidroksid (E524), koruzni škrob, laktoza monohidrat (glejte poglavje 2 pod rubriko »Zdravilo Dasselta vsebuje laktozo«.)
English: Lactose monohydrate Titanium dioxide (E171) Indigo carmine (E132)
Slovenian: Filmska obloga: hipromeloza (E464) makrogol laktoza monohidrat titanov dioksid (E171) indigotin (E132)
English: Use caution when taking Dasselta with alcohol.
Slovenian: Pri sočasnem jemanju zdravila Dasselta in uživanju alkohola je potrebna previdnost.
English: The lack of carcinogenic potential was demonstrated in studies conducted with desloratadine and loratadine.
Slovenian: V študijah z desloratadinom in loratadinom so pokazali odsotnost kancerogenega potenciala.
English: Dasselta contains lactose
Slovenian: Zdravilo Dasselta vsebuje laktozo
English: Although most people do not experience drowsiness, it is recommended not to engage in activities requiring mental alertness, such as driving a car or operating machinery until you have established your own response to the medicinal product.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Ni pričakovati, da bi to zdravilo v priporočenem odmerku vplivalo na vašo sposobnost za vožnjo ali upravljanje strojev Čeprav se pri večini ljudi zaspanost ne pojavi, je priporočljivo, da ne opravljate dejavnosti, ki zahtevajo pozornost, kot je vožnja avtomobila ali upravljanje strojev, dokler ne ugotovite vašega odziva na zdravilo.
English: What Dasselta contains - The active substance is desloratadine.
Slovenian: Kaj vsebuje zdravilo Dasselta - Učinkovina je desloratadin.
English: Dasselta contains lactose.
Slovenian: Zdravilo Dasselta vsebuje laktozo.
English: If you are pregnant or nursing a baby, taking Dasselta is not recommended.
Slovenian: Jemanja zdravila Dasselta vam ne priporočamo, če ste noseči ali če dojite.
English: How to store Dasselta
Slovenian: Shranjevanje zdravila Dasselta
English: Weight increased
Slovenian: PRETISNI OMOT
English: TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Germany
Slovenian: KRKA, d.d., Novo mesto, Šmarješka cesta 6, 8501 Novo mesto, Slovenija TAD Pharma GmbH, Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Nemčija
English: [This wording should be inserted at the end of the section]
Slovenian: [To besedilo je treba vključiti na koncu Poglavja]
English: There is a possibility that this may lead to hypermagnesaemia.
Slovenian: Obstaja možnost, da zato pride do hipermagneziemije.
English: The amendments to the Summary of Product Characteristics, labelling and package leaflet may need to be subsequently updated by the national competent authorities, in liaison with the Reference Member State if appropriate
Slovenian: Spremembe povzetka glavnih značilnosti zdravila, označevanja in navodila za uporabo lahko pozneje posodobi pristojni nacionalni organ, v povezavi z referenčno državo članico, če je to potrebno
English: Hypermagnesaemia
Slovenian: Hipermagneziemija
English: This is especially important in those patients at increased risk of developing hypermagnesaemia including patients with impaired renal function, patients receiving other medicinal products which place them at risk of developing hypermagnesaemia or patients receiving magnesium from other sources, including neonates whose mother's recently received magnesium in the antepartum period.
Slovenian: To je posebno pomembno pri bolnikih, ki imajo povečano tveganje za razvoj hipermagneziemije, med katerimi so bolniki z okvarjenim delovanjem ledvic, bolniki, ki jemljejo druga zdravila, zaradi katerih obstaja tveganje za razvoj hipermagneziemije, ali bolniki, ki prejemajo magnezij iz drugih virov, vključno z novorojenčki, katerih matere so pred kratkim v predporodnem obdobju jemale magnezij.
English: Section 4.4 Special warnings and precautions for use Renal [This wording should be inserted]
Slovenian: 4.4 Posebna opozorila in previdnostni ukrepi Ledvice [To besedilo je treba vključiti]
English: Summary of Product Characteristics of Numeta G16%E, and associated names
Slovenian: POVZETEK GLAVNIH ZNAČILNOSTI ZDRAVILA za Numeta G16%E in povezana imena
English: Elevated levels of Magnesium in blood
Slovenian: Zvišana koncentracija magnezija v krvi
English: As signs of hypermagnesaemia may not be detected, monitoring of magnesium levels is advised at baseline and at appropriate intervals thereafter, in accordance with routine clinical practice and the needs of the individual patient.
Slovenian: Ker se znaki hipermagneziemije morda ne zaznajo, se priporoča spremljanje ravni magnezija na začetku in nato ob ustreznih presledkih, v skladu z rutinsko klinično prakso in potrebami posameznega bolnika.
English: As these signs may be difficult to detect, your child´s blood values may be monitored by their doctor, in particular if your child has risk factors for elevated levels of magnesium in blood, including impaired renal function.
Slovenian: Ker je te znake včasih težko ugotoviti, bo zdravnik lahko spremljal izvide krvi pri vašem otroku, še posebej če ima otrok dejavnike tveganja za pojav zvišane koncentracije magnezija v krvi, vključno z okvaro delovanja ledvic.
English: The signs of hypermagnesaemia include generalised weakness, hypo-reflexia, nausea, vomiting, hypocalcaemia, respiratory failure, hypotension and arrhythmias.
Slovenian: Znaki hipermagneziemije vključujejo splošno oslabelost, hiporefleksijo, navzeo, bruhanje, hipokalciemijo, odpoved dihal, hipotenzijo in aritmije.
English: If blood magnesium levels are elevated, the infusion will be stopped or reduced.
Slovenian: Če je koncentracija magnezija v krvi zvišana, mu bodo infuzijo bodisi ustavili ali pa upočasnili.
English: The signs of this could include weakness, slow reflexes, nausea, vomiting, low calcium levels in blood, breathing difficulties, low blood pressure and irregular heartbeat.
Slovenian: Med znake takšnega zvišanja sodijo na primer občutek oslabelosti, počasni refleksi, občutek slabosti ali bruhanje, nizka koncentracija kalcija v krvi, težave z dihanjem, nizek krvni tlak in nepravilen srčni utrip.
English: <Invented Name> provides 0.3 mmol/kg/d of magnesium when administered at maximum dose (see section 4.2).
Slovenian: Z največjim odmerkom zdravila Numeta G16E bolnik prejme 0,3 mmol magnezija/kg/dan (glejte poglavje 4.2).
English: If serum magnesium levels are elevated (above reference range normal values) the infusion of <Invented Name> should be stopped or infusion rate reduced as deemed clinically appropriate and safe.
Slovenian: Če je koncentracija magnezija v serumu povišana (nad normalno referenčno vrednostjo), je treba infuzijo zdravila Numeta G16%E prekiniti oziroma zmanjšati hitrost infundiranja na klinično primerno in varno vrednost.
English: Annex IV Amendments to relevant sections of the summary of product characteristics and package leaflet
Slovenian: Priloga IV Dopolnitve k posameznim poglavjem SPC in PIL
English: The amount of magnesium in <Invented Name>, may cause elevated levels of magnesium in blood.
Slovenian: Količina magnezija, ki jo vsebuje zdravilo Numeta G16%E, lahko povzroči zvišanje koncentracije magnezija v krvi.
English: Package Leaflet of Numeta G16%E, and associated names [This wording should be inserted at the top of the PL] This medicine is subject to additional monitoring.
Slovenian: Navodilo za uporabo za Numeta G16%E in povezana imena [To besedilo se vstavi na vrhu PIL]
English: [This wording should be inserted at the top of the SmPC] This medicinal product is subject to additional monitoring.
Slovenian: [To besedilo se vstavi na vrhu SmPC]
English: Severe water and electrolyte equilibration disorders, severe fluid overload states, and severe metabolic disorders should be corrected before starting the infusion.
Slovenian: Pred začetkom infundiranja zdravila je treba odpraviti morebitne hude motnje ravnovesja vode in elektrolitov, hudo preobremenitev s tekočino in hude presnovne motnje (glejte poglavje 4.3 Kontraindikacije).
English: Fluid and electrolyte status including magnesium (see Hypermagnesaemia) should be closely monitored in these patients.
Slovenian: Pri bolnikih z ledvično insuficienco je treba to zdravilo uporabljati previdno in jim skrbno spremljati ravnovesje tekočin in elektrolitov, vključno s koncentracijo magnezija (glejte poglavje Hipermagneziemija).
English: [The wording below should be added to this section]
Slovenian: Možni neželeni učinki [To besedilo spodaj, je treba dodati k temu Poglavju]
English: The tablets are to be taken at least one hour before or after a meal.
Slovenian: Tablete je treba vzeti najmanj eno uro pred obrokom ali eno uro po njem.
English: It is used for the treatment of adults and children over the age of two years with:
Slovenian: Uporablja se pri odraslih in otrocih, starejših od dveh let, za zdravljenje:
English: Patients need to receive an initial higher dose (loading dose) on the first day of treatment.
Slovenian: Bolniki morajo prejeti večji začetni odmerek (polnilni odmerek) na prvi dan zdravljenja.
English: (patients with a normal white blood cell count);
Slovenian: (bolnikih z normalnimi ravnmi levkocitov v krvi),
English: The loading dose is then followed by a maintenance dose that can be adjusted according to the patient's response.
Slovenian: Polnilnemu odmerku sledi vzdrževalni odmerek, ki se ga lahko prilagodi glede na odziv bolnika.
English: Voriconazole Accord is available as tablets (50 mg or 200 mg).
Slovenian: Zdravilo Voriconazole Accord je na voljo v obliki tablet (50 mg ali 200 mg).
English: It works by preventing the formation of ergosterol, which is an important part of fungal cell membranes.
Slovenian: Deluje s preprečevanjem tvorbe ergosterola, ki je pomembna sestavina celičnih membran glivic.
English: The full EPAR for Voriconazole Accord can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo Voriconazole Accord je na voljo na spletni strani agencije: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: This is a summary of the European public assessment report (EPAR) for Voriconazole Accord.
Slovenian: To je povzetek evropskega javnega poročila o oceni zdravila (EPAR) za zdravilo Voriconazole Accord.
English: Voriconazole Accord is also used to prevent fungal infections in patients who have had haematopoietic (blood) stem-cell transplantation (a transplant of a type of stem cells that can develop into blood cells) and are at high risk of infection.
Slovenian: Zdravilo Voriconazole Accord se uporablja tudi za preprečevanje glivičnih okužb pri bolnikih, pri katerih so opravili presaditev matičnih (krvnih) celic (presaditev vrste matičnih celic, ki se lahko razvijejo v krvne celice) in pri katerih obstaja visoko tveganje za okužbe.
English: The European Commission granted a marketing authorisation valid throughout the European Union for Voriconazole Accord on 16 May 2013.
Slovenian: Evropska komisija je dovoljenje za promet z zdravilom Voriconazole Accord, veljavno po vsej Evropski uniji, izdala 16. maja 2013.
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Voriconazole Accord has been shown to have comparable quality and to be bioequivalent to Vfend.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) pri agenciji, je zaključil, da je bilo v s skladu z zahtevami EU dokazano, da ima zdravilo Voriconazole Accord primerljivo raven kakovosti kot zdravilo Vfend ter da mu je biološko enakovredno.
English: The Committee recommended that Voriconazole Accord be approved for use in the EU.
Slovenian: Priporočil je, da se zdravilo Voriconazole Accord odobri za uporabo v EU.
English: Because Voriconazole Accord is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Slovenian: Ker je zdravilo Voriconazole Accord generično zdravilo in je biološko enakovredno referenčnemu zdravilu, so njegove koristi in tveganja enaki kot pri referenčnem zdravilu.
English: What measures are being taken to ensure the safe and effective use of Voriconazole Accord?
Slovenian: Kateri ukrepi se izvajajo za zagotovitev varne in učinkovite uporabe zdravila Voriconazole Accord?
English: • candidaemia (another type of fungal infection due to Candida) in non-neutropenic patients
Slovenian: • kandidemije (druge vrste glivične okužbe, ki jo povzroča Candida) pri nenevtropeničnih bolnikih
English: A risk management plan has been developed to ensure that Voriconazole Accord is used as safely as possible.
Slovenian: Za zagotovitev čim varnejše uporabe zdravila Voriconazole Accord je bil pripravljen načrt obvladovanja tveganj.
English: This means that Voriconazole Accord is similar to a ‘reference medicine' already authorised in the European Union (EU) called Vfend.
Slovenian: To pomeni, da je podobno „referenčnemu zdravilu“, ki je že odobreno v Evropski uniji (EU), in sicer zdravilu Vfend.
English: Voriconazole Accord is a ‘generic medicine'.
Slovenian: Voriconazole Accord je „generično zdravilo“.
English: Therefore, the CHMP's view was that, as for Vfend, the benefit outweighs the identified risks.
Slovenian: Zato je menil, da njegove koristi enako kot pri zdravilu Vfend odtehtajo znana tveganja.
English: Voriconazole Accord voriconazole
Slovenian: Voriconazole Accord vorikonazol
English: What are the benefits and risks of Voriconazole Accord?
Slovenian: Kakšne so koristi in tveganja, povezani z zdravilom Voriconazole Accord?
English: For more information about treatment with Voriconazole Accord, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravilom Voriconazole Accord preberite navodilo za uporabo (ki je prav tako del EPAR) ali se posvetujte z zdravnikom ali farmacevtom.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Voriconazole Accord, including the appropriate precautions to be followed by healthcare professionals and patients.
Slovenian: V skladu s tem načrtom so bile v povzetek glavnih značilnosti zdravila in navodilo za njegovo uporabo vključene informacije o varnosti, vključno s previdnostnimi ukrepi, ki jih morajo upoštevati zdravstveni delavci in bolniki.
English: For practical information about using Voriconazole Accord, patients should read the package leaflet or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o uporabi zdravila Voriconazole Accord naj bolniki preberejo navodilo za uporabo ali se posvetujejo z zdravnikom ali farmacevtom.
English: For full information, see the package leaflet.
Slovenian: Za več informacij glejte navodilo za uporabo.