FrancophonIA/ELRC3.0 huggingface dataset:
English: Weight and levels of blood lipids and glucose may increase during antiretroviral therapy.
Slovenian: Med protiretrovirusnim zdravljenjem se lahko poveča telesna masa ter zviša koncentracija lipidov in glukoze v krvi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains: efavirenz 600 mg.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena filmsko obložena tableta vsebuje 600 mg efavirenza.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains: efavirenz 100 mg.
Slovenian: NAVEDBA ENE ALI VEČ UČINKOVIN Ena kapsula vsebuje 100 mg efavirenza.
English: SUSTIVA
Slovenian: Odmerek
English: You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with SUSTIVA.
Slovenian: V primeru izpuščaja se posvetujte z zdravnikom, ker so nekateri izpuščaji lahko resni.
English: You should not breast feed your baby if you are taking SUSTIVA.
Slovenian: Če jemljete zdravilo SUSTIVA, ne smete dojiti.
English: Cmin: ↓ 32% (↓ 15 to ↓ 46) (CYP3A4 and CYP2B6 induction)
Slovenian: AUC: ↓ 26 % (↓ 15 do ↓ 36) Cmax: ↓ 20 % (↓ 11 do ↓ 28) Cmin: ↓ 32 % (↓ 15 do ↓ 46) (indukcija CYP3A4 in CYP2B6)
English: Darunavir:
Slovenian: rifabutin:
English: Cmax: ↑ 21% (↑ 10 to ↑ 33)
Slovenian: AUC: ↑ 20 % (↑ 8 do ↑ 34) Cmax : ↑ 21 % (↑ 10 do ↑ 33) Kombinacijo so na splošno dobro prenašali.
English: SUSTIVA may reduce the amount of posaconazole in your blood.
Slovenian: Zdravilo SUSTIVA lahko zmanjša količino posakonazola v krvi.
English: Tell your doctor immediately.
Slovenian: Takoj obvestite svojega zdravnika.
English: In particular, tell your doctor if you have:
Slovenian: Še posebej obvestite svojega zdravnika, če imate:
English: Patients with pre-existing risk factors
Slovenian: Bolniki z obstoječimi dejavniki tveganja
English: These are used to treat conditions where the body's defence system against disease is not working properly.
Slovenian: Uporabljajo se za zdravljenje stanj, pri katerih obrambni sistem telesa proti boleznim ne deluje pravilno.
English: (See section 4.8.)
Slovenian: (Glejte poglavje 4.8.)
English: There are five groups:
Slovenian: Obstaja pet skupin:
English: There are two alternative treatment schedules:
Slovenian: Na voljo sta dva alternativna režima zdravljenja:
English: It is worth considering that these 2 subjects contributed to the higher frequency of infusions with reactions in this group.
Slovenian: Upoštevanja vredno je, da sta ta 2 bolnika prispevala k večji pogostnosti infuzij z reakcijami v tej skupini.
English: ● Coombs test positive
Slovenian: ● pozitiven Coombov test,
English: • Guillain Barré syndrome, where the immune system damages the nerves and hinders them from working properly.
Slovenian: • Guillain Barréjev sindrom, pri katerem imunski sistem poškoduje živce in ovira njihovo pravilno delovanje.
English: Use in children of more than 2 years old
Slovenian: Uporaba pri otrocih, starih 2 leti in več
English: Produced from the plasma of human donors.
Slovenian: Izdelano iz humane plazme.
English: IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.
Slovenian: IgG in kompleksi z IgG se razgradijo v celicah retikuloendotelijskega sistema.
English: There are two groups:
Slovenian: Obstajata dve skupini:
English: The treatment can be repeated if relapse occurs.
Slovenian: Zdravljenje lahko ponovite, če pride do ponovitve bolezni.
English: The following information is intended for healthcare professionals only (see section 3 for further information):
Slovenian: Naslednje informacije so namenjene samo zdravstvenemu osebju (za dodatne informacije glejte poglavje 3):
English: All other patients should be observed for at least 20 minutes after administration
Slovenian: Vse ostale bolnike pa nadzorujte vsaj še 20 minut po infundiranju.
English: The recommended infusion rate given under section 4.2 must be closely followed.
Slovenian: Priporočene hitrosti infundiranja v poglavju 4.2 se je treba natančno držati.
English: It is usually prepared from pooled plasma from not fewer than 1000 donors.
Slovenian: Običajno ga pripravijo iz združene plazme najmanj 1.000 darovalcev.
English: This is equivalent to 1.5% of the recommended maximum daily dietary intake of sodium for an adult.
Slovenian: To je enako 1,5 % priporočenega največjega dnevnega vnosa natrija s hrano za odrasle osebe.
English: Your doctor will consider your risk factors and take measures such as to decrease the rate of infusion or to stop the treatment.
Slovenian: Zdravnik bo upošteval dejavnike tveganja pri vas in uvedel ukrepe, kot sta zmanjšanje hitrosti infundiranja ali prekinitev zdravljenja.
English: ● general physical health deterioration
Slovenian: ● poslabšanje splošnega telesnega zdravja,
English: Assessment of vital signs in clinical trials of the paediatric population did not indicate any pattern of clinically relevant changes.
Slovenian: Ocenjevanje vitalnih znakov v kliničnih preskušanjih pediatrične populacije ni pokazalo nikakršnega vzorca klinično pomembnih sprememb.
English: Tell your doctor or pharmacist immediately and follow his/her instructions.
Slovenian: Takoj obvestite svojega zdravnika ali farmacevta in upoštevajte navodila.
English: Allergic reactions are rare.
Slovenian: Alergijske reakcije so redke.
English: Date of latest renewal: 24 April 2017
Slovenian: Datum prve odobritve: 23. avgust 2007 Datum zadnjega podaljšanja: 24. april 2017
English: It is expected that the same interactions than those mentioned for the adults may be presented by the paediatric population.
Slovenian: Pričakovati je, da se bodo iste interakcije, ki so omenjene pri odraslih, pojavile tudi pri pediatrični populaciji.
English: TRALI is a potentially life-threatening condition requiring immediate intensive-care-unit management.
Slovenian: TRALI je potencialno življenjsko nevarno stanje, ki zahteva takojšnjo obravnavo na oddelku za intenzivno nego.
English: Effects on blood tests
Slovenian: Učinki na krvne preiskave
English: Certain side effects may occur more frequently:
Slovenian: Določeni neželeni učinki se lahko pojavijo pogosteje:
English: - The other ingredients are sorbitol and water for injections (see section 2 for further information about ingredients).
Slovenian: - Drugi sestavini zdravila sta sorbitol in voda za injekcije (za nadaljnje informacije o sestavinah glejte poglavje 2).
English: No evidence is available to require a dose adjustment.
Slovenian: Ni dokazov, da je potrebna prilagoditev odmerka.
English: Maintenance dose:
Slovenian: Vzdrževalni odmerek:
English: It is distributed relatively rapidly between plasma and extravascular fluid, after approximately 3 - 5 days equilibrium is reached between the intra- and extravascular compartments.
Slovenian: Sorazmerno hitro se porazdeli med plazmo in zunajžilnimi tekočinami, po približno 3-5 dneh nastopi ravnovesje med znotrajžilnimi in zunajžilnimi razdelki.
English: This could particularly happen when you are a patient at risk, e.g. an elderly patient or a patient having problems with your heart or your kidneys.
Slovenian: To se lahko zgodi predvsem, če ste bolnik s tveganjem, npr. starejša oseba ali bolnik s težavami s srcem ali ledvicami.
English: The dosing and intervals may have to be adapted according to the individual course of the disease.
Slovenian: Odmerjanje in intervale bo morda treba prilagoditi glede na individualni potek bolezni.
English: 08150 Barcelona - Spain
Slovenian: 08150 Barcelona - Španija
English: The treatment required depends on the nature and severity of the adverse reaction.
Slovenian: Potrebno zdravljenje je odvisno od narave in intenzivnosti neželenega učinka.
English: ● photophobia (excessive sensitivity to light)
Slovenian: ● fotofobija (pretirana občutljivost na svetlobo),
English: • Cases of temporary reduction in the number of the red cells in the blood (reversible haemolytic anaemia/haemolysis).
Slovenian: • Primeri prehodnega zmanjšanja števila rdečih krvničk v krvi (reverzibilna hemolitična anemija/hemoliza).
English: This also applies to unknown or emerging viruses and other pathogens.
Slovenian: To velja tudi za neznane ali nove viruse in druge patogene.
English: This medicine belongs to the group of medicines called intravenous immunoglobulins.
Slovenian: To zdravilo spada v skupino zdravil, ki jih imenujemo intravenski imunoglobulini.
English: Additional side effects in children and adolescents
Slovenian: Dodatni neželeni učinki pri otrocih in mladostnikih
English: Single dose toxicity studies were carried out in rats and mice.
Slovenian: Študije toksičnosti po enkratnem odmerku so izvedli na podganah in miših.
English: This applies to any unknown or emerging viruses or other types of infections.
Slovenian: To velja za vse neznane ali nove viruse in druge vrste okužb.
English: Patients should receive concomitant treatment with acetylsalicylic acid.
Slovenian: Bolnike morate sočasno zdraviti z acetilsalicilno kislino.
English: You must not be given a double dose to make up for a forgotten dose.
Slovenian: Ne smejo vam dati dvojnega odmerka, če so vam pozabili dati prejšnji odmerek.
English: This half-life may vary from patient to patient, in particular in primary immunodeficiency.
Slovenian: Ta razpolovni čas se lahko razlikuje glede na bolnika, še posebej pri primarni imunski pomanjkljivosti.
English: In order to improve the traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
Slovenian: Za izboljšanje sledljivosti bioloških zdravil je treba natančno zabeležiti ime in številko serije uporabljenega zdravila.
English: - very common (>1/10) - common (>1/100 to <1/10) - uncommon (>1/1,000 to <1/100) - rare (>1/10,000 to <1/1,000) - very rare (<1/10,000) - not known (cannot be estimated from the available data)
Slovenian: - zelo pogosti (>1/10) - pogosti (>1/100 do <1/10) - občasni (>1/1.000 do <1/100) - redki (>1/10.000 do <1/1.000) - zelo redki (<1/10.000)
English: In case of shock, standard medical treatment for shock should be implemented.
Slovenian: Če se pojavi šok, ga je treba zdraviti po standardnih metodah zdravljenja šoka.
English: Infusion rates during the initial infusions should be slow.
Slovenian: Pri začetnih infuzijah mora biti infundiranje počasno.
English: See leaflet for further information.
Slovenian: Glejte navodilo za uporabo za več informacij.
English: For intravenous use.
Slovenian: Za intravensko uporabo.
English: Patients with rare hereditary problems of fructose intolerance must not take this medicine.
Slovenian: Bolniki z redko dedno intoleranco za fruktozo ne smejo jemati tega zdravila.
English: Neutropenia/Leukopenia
Slovenian: Nevtropenija/levkopenija
English: Adequate doses of this medicinal product may restore abnormally low immunoglobulin G levels to the normal range.
Slovenian: Primerno odmerjanje tega zdravila lahko poviša nenormalno nizke ravni imunoglobulina G na normalne vrednosti.
English: To reduce the rate of bacterial infections, it may be necessary to increase the dosage and aim for higher trough levels.
Slovenian: Da bi zmanjšali pogostnost bakterijskih okužb, bo morda potrebno povečati odmerek, da bi dosegli višje ravni.
English: Patients may experience reactions (for example dizziness or nausea) during treatment, which might affect the ability to drive and use machines.
Slovenian: Bolniki lahko med zdravljenjem doživijo neželene učinke (na primer omotica ali slabost), kar lahko vpliva na sposobnost vožnje in upravljanja strojev.
English: No dose adjustment unless clinically warranted, see section 4.4.
Slovenian: Brez prilagoditve odmerka, razen če je ta klinično utemeljena; glejte poglavje 4.4.
English: For safety information with respect to transmissible agents, see section 4.4.
Slovenian: Za informacije o varnosti v zvezi s prenosljivimi povzročitelji bolezni glejte poglavje 4.4.
English: Secondary immunodeficiencies (as defined in 4.1)
Slovenian: Sekundarne imunske pomanjkljivosti (kot so opredeljene v poglavju 4.1)
English: Please tell your doctor if you have any other condition and/or illness, as control is required in patients with pre-existing risk factors for thrombotic events (formation of blood clots inside your blood).
Slovenian: Obvestite svojega zdravnika, če imate katerokoli stanje in/ali bolezen, saj je potreben nadzor pri bolnikih z obstoječimi dejavniki tveganja za trombotične dogodke (nastajanje krvnih strdkov v krvi).
English: Fructose intolerance (see section 4.4).
Slovenian: Intoleranca za fruktozo (glejte poglavje 4.4).
English: Distribution of the IgG subclasses (approx. values): IgG1 66.6%
Slovenian: Odstotki podrazredov IgG (približne vrednosti): IgG1 66,6 %
English: If there are no adverse reactions, the infusion rate for subsequent infusions can be slowly increased to the maximum rate.
Slovenian: Če neželenih učinkov ni, se lahko hitrost infundiranja pri nadaljnjih infuzijah počasi povečuje do največje hitrosti.
English: Cyanosis (lack of oxygen in the blood) was reported in one child but not in adults.
Slovenian: O cianozi (pomanjkanju kisika v krvi) so poročali pri enem otroku, pri odraslih pa ne.
English: Pack size of 1 vial.
Slovenian: Velikost pakiranja: 1 viala.
English: The safety results for 29 paediatric patients (those ≤ 17 years old) included in the PID studies were evaluated.
Slovenian: Ovrednotili so rezultate varnosti pri 29 pediatričnih bolnikih (starih ≤ 17 let), ki so sodelovali v študijah PID.
English:  Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.
Slovenian: • Obvestite zdravnika ali farmacevta, če jemljete, ste pred kratkim jemali ali pa boste morda začeli jemati katero koli drugo zdravilo.
English: • the inclusion of steps in the processing of the blood or plasma that can inactivate or remove viruses.
Slovenian: • vključitev postopkov pri obdelovanju krvi ali plazme, ki lahko onemogočijo ali odstranijo viruse.
English: Repeated dose toxicity testing and embryo-foetal toxicity studies are impracticable due to induction of, and interference with antibodies.
Slovenian: Preizkusi toksičnosti pri ponavljajočih odmerkih in študije embrio-fetalne toksičnosti so zaradi indukcije nastanka protiteles in interferenc s protitelesi neizvedljivi.
English: However, as in adult population, overdose may lead to fluid overload and hyperviscosity as with any other intravenous immunoglobulins.
Slovenian: Vendar pa lahko tako kot pri odraslih preveliko odmerjanje povzroči tekočinsko preobremenitev in hiperviskoznost, kot pri vseh intravensko danih imunoglobulinih.
English: Symptoms of TRALI typically develop during or within 6 hours of a transfusion, often within 1 - 2 hours.
Slovenian: Simptomi TRALI se ponavadi razvijejo med infundiranjem ali do 6 ur po njem, pogosto v 1-2 urah.
English: The percentage of IgG subclasses is approximately 66.6% IgG1, 28.5% IgG2, 2.7% IgG3 and 2.2% IgG4.
Slovenian: Odstotki podrazredov IgG znašajo približno 66,6 % IgG1, 28,5 % IgG2, 2,7 % IgG3 in 2,2 % IgG4.
English: ● influenza (flu)
Slovenian: ● influenca (gripa),
English: In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a state laboratory or a laboratory designated for that purpose.
Slovenian: Uradna sprostitev serije: V skladu s členom 114 Direktive 2001/83/ES z vsemi dopolnitvami in spremembami, serijo uradno sprosti državni laboratorij ali laboratorij, določen v ta namen.
English: ● fever (body temperature increased)
Slovenian: ● vročina (zvišana telesna temperatura),
English: Frequency per patient
Slovenian: Pogostnost na bolnika
English: • the testing of each donation and pools of plasma for signs of virus/infections,
Slovenian: • preiskovanje vsake darovane enote ter združene plazme za pokazatelje virusov/okužb,
English: MedDRA System Organ Class (SOC)
Slovenian: Razvrstitev po organskem sistemu (SOC) MedDRA
English: There were no other subjects with more than 1 infusion with adverse reactions in both groups.
Slovenian: V nobeni od teh dveh skupin ni bilo drugih bolnikov z več kot 1 infuzijo z neželenimi učinki.
English: Patients must be closely monitored and carefully observed for any symptoms throughout the infusion period.
Slovenian: Bolnike je treba ves čas infundiranja natančno spremljati in skrbno opazovati glede kakršnih koli simptomov.
English: In the case of measles, this impairment may persist for up to 1 year.
Slovenian: V primeru ošpic lahko zmanjšanje učinkovitosti traja tudi do 1 leta.
English: - If you are allergic to human normal immunoglobulin or any of the other ingredients of this medicine (listed in section 6).
Slovenian: - Če ste alergični na humani polispecifični imunoglobulin ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: • abnormal behaviour
Slovenian: • nenormalno vedenje,
English: Interferences with determination of blood glucose levels are not expected.
Slovenian: Motnje pri določanju ravni glukoze v krvi se ne pričakujejo.
English: The dose may need to be individualised for each patient dependent on the clinical response.
Slovenian: Odmerek bo morda treba prilagoditi posameznemu bolniku na podlagi kliničnega odziva.
English: • Multifocal motor neuropathy (MMN), a rare disease causing slow progressive asymmetric limb weakness without sensory loss.
Slovenian: • Multifokalna motorična nevropatija (MMN), redka bolezen, ki povzroča počasi napredujočo asimetrično oslabelost okončin brez izgube zaznave.
English: Guillain Barré syndrome
Slovenian: Guillain-Barréjev sindrom
English: Effects of the product on the immune system of the newborn have not been studied.
Slovenian: Študij učinkov zdravila na imunski sistem novorojenčkov niso izvedli.
English: Special safety warning
Slovenian: Posebno varnostno opozorilo
English: After the administration of immunoglobulin the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.
Slovenian: Po dajanju imunoglobulina lahko začasni porast različnih pasivno prenesenih protiteles v krvi bolnika povzroči lažno pozitivne rezultate seroloških preiskav.
English: Patients exhibiting such signs and symptoms should receive a thorough neurological examination, including CSF studies, to rule out other causes of meningitis.
Slovenian: Pri bolnikih s tovrstnimi znaki in simptomi je treba opraviti temeljit nevrološki pregled, vključno s preiskavami cerebrospinalne tekočine, da se izključijo drugi vzroki meningitisa.
English: The dose and dose regimen is dependent on the indication.
Slovenian: Odmerek in režim odmerjanja sta odvisna od indikacije.
English: A significant increase in median platelet levels was achieved in a clinical trial in chronic ITP patients (64,000/µl) although it did not reach normal levels.
Slovenian: Znatno zvišanje srednje ravni trombocitov so dosegli v kliničnem preskušanju pri bolnikih s kronično ITP (64,000/µl), čeprav niso dosegli normalnih ravni.
English: - If you have fructose intolerance, a quite rare genetic condition where the enzyme for breaking down fructose is not produced.
Slovenian: - Če imate intoleranco za fruktozo, redko dedno bolezen, pri kateri ne nastaja encim za razgradnjo fruktoze.
English: Overdose may lead to fluid overload and hyperviscosity, particularly in patients at risk, including elderly patients or patients with cardiac or renal impairment (see section 4.4).
Slovenian: Preveliko odmerjanje lahko vodi do prevelike količine tekočine in hiperviskoznosti, še posebej pri bolnikih s povečanim tveganjem, vključno s starejšimi bolniki in bolniki s srčnimi ali ledvičnimi okvarami (glejte poglavje 4.4).
English: Replacement therapy should be initiated and monitored under the supervision of a physician experienced in the treatment of immunodeficiency.
Slovenian: Nadomestno zdravljenje mora začeti in nadzorovati zdravnik, ki ima ustrezne izkušnje pri zdravljenju imunske pomanjkljivosti.
English: These include:
Slovenian: Med slednjimi so:
English: • reversible haemolytic reactions; especially in those patients with blood groups A, B, and AB and (rarely) haemolytic anaemia requiring transfusion
Slovenian: • reverzibilne hemolitične reakcije, še posebej pri bolnikih s krvnimi skupinami A, B in AB, ter (redko) hemolitično anemijo, zaradi katere je potrebna transfuzija,
English: 6.6 Special precautions for disposal and other handling The product should be brought to room or body temperature before use.
Slovenian: 6.6 Posebni varnostni ukrepi za odstranjevanje Zdravilo pred uporabo segrejte na sobno ali telesno temperaturo.
English: Hypersensitivity to the active substance (human immunoglobulins) or to any of the excipients (see sections 4.4 and 6.1).
Slovenian: Preobčutljivost na učinkovino (humane imunoglobuline) ali katero koli pomožno snov (glejte poglavji 4.4 in 6.1).
English: Flebogamma DIF does not contain sucrose, maltose or glucose.
Slovenian: Zdravilo Flebogamma DIF ne vsebuje saharoze, maltoze ali glukoze.
English: The syndrome usually begins within several hours to 2 days following IVIg treatment.
Slovenian: Sindrom ponavadi nastopi v več urah do 2 dneh po zdravljenju z zdravili z i.v.
English: Dose should be adjusted as necessary to achieve optimal protection against infections, an increase may be necessary in patients with persisting infection; a dose decrease can be considered when the patient remains infection free.
Slovenian: Odmerek je treba ustrezno prilagoditi za doseganje optimalne zaščite prek okužbami; pri bolnikih s trdovratno okužbo bo morda treba odmerek povečati, pri bolnikih, ki nimajo okužb, pa je mogoče razmisliti o zmanjšanju odmerka.
English: It may be self-administered if you have been fully trained by hospital staff.
Slovenian: Infundiranje lahko opravite tudi sami, če so vas zdravstveni delavci v celoti podučili o uporabi.
English: ● tachycardia (acceleration of the heart activity)
Slovenian: ● tahikardija (pospešeno delovanje srca),
English: • Kawasaki disease (in this case in conjunction with acetylsalicylic acid therapy), an illness in children where the blood vessels (arteries) in the body become enlarged.
Slovenian: • Kawasakijev sindrom (v tem primeru se uporablja v kombinaciji z zdravljenjem z acetilsalicilno kislino), otroška bolezen, pri kateri se v telesu povečajo krvne žile (arterije).
English: ● tremor (to tremble)
Slovenian: ● tremor (tresenje),
English: 4.5 Interaction with other medicinal products and other forms of interaction
Slovenian: 4.5 Medsebojno delovanje z drugimi zdravili in druge oblike interakcij Živa oslabljena virusna cepiva
English: Kawasaki disease
Slovenian: Kawasakijev sindrom
English: ● meningitis aseptic (non-infective meningitis)
Slovenian: ● aseptični meningitis (neinfekcijski meningitis),
English: • Effects on vaccines: Flebogamma DIF may reduce the effectiveness of certain types of vaccines (live attenuated virus vaccines).
Slovenian: • Učinki na cepiva: zdravilo Flebogamma DIF lahko zmanjša učinkovitost določenih vrst cepiv
English: No negative effects on the breastfed newborns/infants are anticipated.
Slovenian: Učinkov na dojene novorojence/dojenčke se ne pričakuje.
English: • in case of high rate of infusion.
Slovenian: • v primeru velike hitrosti infundiranja.
English: Patients who experience adverse reactions during treatment should wait for these to resolve before driving or operating machines.
Slovenian: Bolniki, ki imajo med zdravljenjem neželene učinke, naj počakajo, da minejo, preden spet vozijo ali upravljajo stroje.
English: • Cases of transient cutaneous reactions (side effects on your skin).
Slovenian: • Primeri prehodnih kožnih reakcij (neželeni učinki na vaši koži).
English: Immunoglobulins are excreted into human milk.
Slovenian: Imunoglobulini se izločajo v materino mleko.
English: The following dosage regimens are given as a guideline.
Slovenian: Naslednji režimi odmerjanja so dani kot smernice.
English: No differences of the pharmacokinetic properties are expected in the paediatric population.
Slovenian: Pri pediatrični populaciji ni pričakovati razlik v farmakokinetičnih lastnostih.