FrancophonIA/ELRC3.0 huggingface dataset:
English: However, the following side effects are seen in between 1 and 10 patients in 1,000: headache, dizziness, nausea, arthralgia (joint pain), back pain, myalgia (muscle pain), fatigue (tiredness), induration (hardening at the injection site), malaise (feeling unwell), pain at injection site and pyrexia (fever).
Slovenian: Pri 1 do 10 bolnikih izmed 1 000 so bili opaženi naslednji neželeni učinki: glavobol, omotica, slabost, artralgija (bolečine v sklepih), bolečine v hrbtu, mialgija (bolečine v mišicah), utrujenost, induracija (zatrdina na mestu injiciranja), občutek nelagodja (slabo počutje), bolečine na mestu injiciranja in pireksija (povišana telesna temperatura).
English: The Committee for Medicinal Products for Human Use (CHMP) decided that ImmunoGam's benefits are greater than its risks and recommended that it be given marketing authorisation.
Slovenian: Odbor za zdravila za uporabo v humani medicini (CHMP) je sklenil, da so koristi zdravila ImmunoGam večje od z njim povezanih tveganj, zato je priporočil, da se zanj odobri dovoljenje za promet.
English: • people at continuous risk of hepatitis B infection who have not responded to vaccination.
Slovenian: • pri ljudeh, pri katerih obstaja stalno tveganje okužbe s hepatitisom B in ki se niso odzvali na cepljenje.
English: Medicines containing human hepatitis B immunoglobulins have been used in the European Union (EU) for many years.
Slovenian: Zdravila s človeškimi imunoglobulini proti hepatitisu B se v Evropski uniji (EU) uporabljajo že vrsto let.
English: Doctors should also consider other official guidance when choosing a dose and dosing schedule for ImmunoGam
Slovenian: Zdravniki morajo upoštevati tudi druga uradna priporočila glede izbire odmerka in sheme odmerjanja za zdravilo ImmunoGam.
English: • people accidentally exposed to the virus who are not known to have been vaccinated fully;
Slovenian: • pri ljudeh, ki so naključno izpostavljeni virusu in najverjetneje niso prejeli vseh cepljenj;
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 ImmunoGam.
Slovenian: Pojasnjuje, kako je Odbor za zdravila za uporabo v humani medicini (CHMP) ocenil zdravilo, na podlagi česar je oblikoval mnenje za odobritev dovoljenja za promet z zdravilom in priporočila glede pogojev uporabe zdravila ImmunoGam.
English: This means that it supplies the antibodies the body needs to fight the virus rather than stimulating the body to produce its own.
Slovenian: To pomeni, da dovaja protitelesa, ki jih telo potrebuje za boj proti virusu, telesa pa ne spodbuja k tvorbi lastnih protiteles.
English: What benefit has ImmunoGam shown during the studies?
Slovenian: Kakšne koristi je zdravilo ImmunoGam izkazalo med študijami?
English: Haemodialysed patients should received 8 to 12 IU per kilogram body weight up to a maximum of 500 IU, every two months.
Slovenian: Bolniki s hemodializo morajo prejeti 8 do 12 i.e. zdravila na kilogram telesne mase, skupno do 500 i.e., vsaka dva meseca.
English: Finally, people at continuous risk of hepatitis B infection who did not show an immune response after vaccination may be given 500 IU (in adults) or 8 IU/kg (in children) every two months.
Slovenian: Ljudje, pri katerih obstaja stalno tveganje okužbe s hepatitisom B in ki po cepljenju niso imeli imunskega odziva, bodo morda morali prejeti 500 i.e. (odrasli) ali 8 i.e./kg (otroci) vsaka dva meseca.
English: ImmunoGam is given as an injection into a muscle.
Slovenian: Zdravilo ImmunoGam se daje z injiciranjem v mišico.
English: Newborn babies whose mothers are carriers of the hepatitis B virus should receive 30 to 100 IU/kg at birth or as soon as possible after birth.
Slovenian: Novorojenčki, katerih matere so prenašalke virusa hepatitisa B, morajo ob rojstvu ali čimprej po njem prejeti 30 do 100 i.e. zdravila na kilogram telesne mase.
English: ImmunoGam should not be used in people who may be hypersensitive (allergic) to the active substance, to any of the other ingredients or to human immunoglobulins, especially where they have deficiency (very low levels) of immunoglobulin A (IgA) and they have antibodies against IgA.
Slovenian: Zdravila ImmunoGam ne smejo uporabljati osebe, ki utegnejo biti preobčutljive za (alergične na) zdravilno učinkovino, katero koli drugo sestavino zdravila ali človeške imunoglobuline, zlasti v primeru pomanjkanja (zelo nizkih ravni) imunoglobulina A (IgA) in v primeru prisotnosti protiteles proti IgA.
English: Side effects with ImmunoGam are not common.
Slovenian: Neželeni učinki zdravila ImmunoGam niso pogosti.
English: ImmunoGam protects against the hepatitis B virus by keeping the blood levels of human hepatitis B immunoglobulins high enough so that they can attach to the virus and stimulate the immune system to destroy it.
Slovenian: Zdravilo ImmunoGam varuje pred okužbo z virusom hepatitisa B tako, da ohranja dovolj visoke ravni človeških imunoglobulinov proti hepatitisu B v krvi, da se lahko vežejo na virus in spodbujajo imunski sistem k njegovemu uničenju.
English: What is the risk associated with ImmunoGam?
Slovenian: Kakšna tveganja so povezana z zdravilom ImmunoGam?
English: It is highly recommended that all those receiving ImmunoGam should also be given a hepatitis B vaccine.
Slovenian: Zelo priporočljivo je, da vsi bolniki, ki prejemajo zdravilo ImmunoGam, prejmejo tudi cepivo proti hepatitisu B.
English: The results in adults also provided some supportive evidence to show that ImmunoGam protects against hepatitis B virus infection.
Slovenian: Iz rezultatov pri odraslih je razvidnih nekaj podpornih ugotovitev, ki kažejo, da zdravilo ImmunoGam ščiti proti okužbi z virusom hepatitisa B.
English: Of the 178 babies who completed the study, 174 (98%) remained free of hepatitis B infection.
Slovenian: Zdravilo ImmunoGam je bilo učinkovito pri zaščiti proti okužbi z virusom hepatitisa B. Izmed 178 dojenčkov, ki so do konca sodelovali v študiji, se pri 174 (98 %) dojenčkih okužba s hepatitisom B ni razvila.
English: Why has ImmunoGam been approved?
Slovenian: Zakaj je bilo zdravilo ImmunoGam odobreno?
English: ImmunoGam is a solution for injection that contains the active substance human hepatitis B immunoglobulin.
Slovenian: Zdravilo ImmunoGam je raztopina za injiciranje, ki vsebuje zdravilno učinkovino človeški imunoglobulin proti hepatitisu B.
English: What is ImmunoGam used for?
Slovenian: Za kaj se zdravilo ImmunoGam uporablja?
English: ImmunoGam human hepatitis B immunoglobulin
Slovenian: ImmunoGam človeški imunoglobulin proti hepatitisu B
English: How has ImmunoGam been studied?
Slovenian: Kako je bilo zdravilo ImmunoGam raziskano?
English: The full EPAR for ImmunoGam can be found here.
Slovenian: Celotno evropsko javno poročilo o oceni zdravila (EPAR) za zdravilo ImmunoGam je na voljo tukaj.
English: How does ImmunoGam work?
Slovenian: Kako zdravilo ImmunoGam deluje?
English: The active substance in ImmunoGam, human hepatitis B immunoglobulin, is a purified antibody extracted from human blood.
Slovenian: Zdravilna učinkovina zdravila ImmunoGam, človeški imunoglobulin proti hepatitisu B, so prečiščena protitelesa iz človeške krvi.
English: What is ImmunoGam?
Slovenian: Kaj je zdravilo ImmunoGam?
English: ImmunoGam provides ‘passive' protection.
Slovenian: Zdravilo ImmunoGam se uporablja za zaščito proti virusu hepatitisa B, in sicer zagotavlja „pasivno“ zaščito.
English: The main measure of effectiveness was the number of people who remained free of hepatitis B infection.
Slovenian: Vsi, ki so prejeli zdravilo ImmunoGam, so prejeli tudi cepivo proti hepatitisu B. Glavno merilo učinkovitosti je bilo število ljudi, pri katerih se okužba z virusom hepatitisa B ni razvila.
English: The HMPC conclusions on the use of dittany of Crete herb medicines for cough, stomach, gut and skin problems are based on their ‘traditional use' in these conditions.
Slovenian: Zaključki odbora HMPC o uporabi zdravil iz zeli kretske dobre misli za kašelj ter želodčne, črevesne in kožne težave temeljijo na njihovi „tradicionalni uporabi“ pri teh tegobah.
English: Dittany of Crete herb EMA/HMPC/441263/2013
Slovenian: Zel kretske dobre misli EMA/HMPC/441263/2013
English: It also considered published experimental studies and reports which supported the plausibility of the use of dittany of Crete herb in the approved indications.
Slovenian: Prav tako je preučil objavljene poskusne študije in poročila, ki podpirajo verodostojnost uporabe zeli kretske dobre misli pri odobrenih indikacijah.
English: Dittany of Crete herb is the common name for the flowering above-ground (aerial) parts of Origanum dictamnus L. The plant is cultivated or gathered to obtain the above-ground parts for medicinal use.
Slovenian: Zel kretske dobre misli je slovensko ime za cvetoče nadzemne (zračne) dele rastline Origanum dictamnus L. Rastlina se goji ali nabira za pridobivanje nadzemnih delov za medicinsko uporabo.
English: Herbal teas containing dittany of Crete should only be used in adults and should not be used for longer than a week for cough, or for longer than two weeks for stomach and gut problems, without seeking advice from a qualified healthcare practitioner.
Slovenian: Zeliščne čaje, ki vsebujejo zel kretske dobre misli, lahko uporabljajo le odrasli, in sicer največ en teden za kašelj ter največ dva tedna za želodčne in črevesne težave, ne da bi se posvetovali z usposobljenim zdravstvenim delavcem.
English: Further information on the risks associated with dittany of Crete herb medicines, including the appropriate precautions for their safe use, can be found in the monograph under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o tveganjih, povezanih z zdravili, ki vsebujejo zel kretske dobre misli, vključno z ustreznimi previdnostmi ukrepi za njihovo varno uporabo, so na voljo v monografiji na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: The infusion can also be used to soak a dressing and applied to the skin for minor skin inflammations and bruises.
Slovenian: Prelivek lahko uporabimo tudi tako, da vanj namočimo obkladek in ga položimo na kožo ter tako lajšamo blažja kožna vnetja in modrice.
English: Herbal medicines are usually available as comminuted herbal material that is used to make herbal teas or added to water to produce a liquid (infusion) to be applied to the skin.
Slovenian: Zdravila rastlinskega izvora so običajno na voljo v obliki zdrobljenega rastlinskega materiala, ki se uporabi za pripravo zeliščnih čajev oziroma se doda vodi, da bi dobili tekočino (prelivek), ki se nanese na kožo.
English: The HMPC concluded that, on the basis of its long-standing use, dittany of Crete herb can be used as a herbal tea for the relief of cough associated with cold and for mild disorders of the stomach and gut such as a sensation of fullness or digestive problems.
Slovenian: Odbor HMPC je zaključil, da se zel kretske dobre misli glede na njeno dolgotrajno uporabo lahko uporablja kot zeliščni čaj za lajšanje kašlja, povezanega s prehladom, ter za blage želodčne in črevesne motnje, kot so občutek polnosti ali prebavne težave.
English: This summary is not intended to provide practical advice on how to use medicines containing dittany of Crete herb.
Slovenian: Povzetek ni namenjen zagotavljanju praktičnih nasvetov o uporabi zdravil, ki vsebujejo zel kretske dobre misli.
English: In its assessment the HMPC took into account the well documented and longstanding use of dittany of Crete for these conditions.
Slovenian: Pri svoji oceni je odbor HMPC upošteval dobro dokumentirano in dolgotrajno uporabo zeli kretske dobre misli za te indikacije.
English: Detailed instruction on how to use dittany of Crete medicines and who can use them can be found in the package leaflet that comes with the medicine.
Slovenian: Podrobna navodila glede tega, kako se uporabljajo zdravila iz zeli kretske dobre misli in kdo jih lahko uporablja, najdete v navodilu za uporabo, ki je priloženo zdravilu.
English: Any applications for the licensing of medicines containing dittany of Crete herb have to be submitted to the national authorities responsible for medicinal products, which will assess the application for the herbal medicine and take into account the scientific conclusions of the HMPC.
Slovenian: Vlogo za izdajo dovoljenja za promet z zdravili, ki vsebujejo zel kretske dobre misli, je treba predložiti pristojnemu nacionalnemu organu za zdravila, ki bo to vlogo za izdajo dovoljenja za promet z zdravilom rastlinskega izvora ocenil in upošteval znanstvene zaključke odbora HMPC.
English: EMA/HMPC/441263/2013
Slovenian: EMA/HMPC/441263/2013 Odbor za zdravila rastlinskega izvora (HMPC)
English: This is a summary of the scientific conclusions reached by the Committee on Herbal Medicinal Products (HMPC) on the medicinal uses of dittany of Crete herb.
Slovenian: To je povzetek znanstvenih zaključkov Odbora za zdravila rastlinskega izvora (HMPC) v zvezi z medicinsko uporabo zeli kretske dobre misli.
English: The HMPC conclusions are taken into account by EU Member States when evaluating applications for the licensing of herbal medicines containing dittany of Crete.
Slovenian: Ugotovitve odbora HMPC države članice EU upoštevajo pri ocenjevanju vlog za izdajo dovoljenja za promet z zdravili rastlinskega izvora, ki vsebujejo zel kretske dobre misli.
English: Further information on the HMPC assessment of dittany of Crete herb medicines, including details of the Committee's conclusions, can be found under the tab ‘All documents' on the Agency's website: ema.europa.eu/Find medicine/Herbal medicines for human use.
Slovenian: Dodatne informacije o oceni zdravil, ki vsebujejo zel kretske dobre misli, ki jo je opravil odbor HMPC, vključno z njegovimi znanstvenimi zaključki, so na voljo na spletni strani agencije pod zavihkom „Vsi dokumenti“: ema.europa.eu/Find medicine/Herbal medicines for human use.
English: How are dittany of Crete herb medicines approved in the EU?
Slovenian: Kako so zdravila, ki vsebujejo zel kretske dobre misli, odobrena v EU?
English: Information on the use and licensing of dittany of Crete herb medicines in EU Member States should be obtained from the relevant national authorities.
Slovenian: Za informacije o uporabi in dovoljenjih za promet z zdravili, ki vsebujejo zel kretske dobre misli, v državah članicah EU se obrnite na pristojni nacionalni organ.
English: For practical information about using dittany of Crete medicines, patients should read the package leaflet that comes with the medicine or contact their doctor or pharmacist.
Slovenian: Za praktične informacije o njihovi uporabi naj bolniki preberejo navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujejo z zdravnikom ali farmacevtom.
English: Preparations of the herb are obtained by comminuting (reducing into tiny pieces) the harvested material.
Slovenian: Pripravki iz rastline se izdelujejo z drobljenjem pridobljenega materiala.
English: For more information about treatment with dittany of Crete herb medicines, read the package leaflet that comes with the medicine or contact your doctor or pharmacist.
Slovenian: Za več informacij o zdravljenju z zdravili, ki vsebujejo zel kretske dobre misli, preberite navodilo za uporabo, ki je priloženo posameznemu zdravilu, ali se posvetujte z zdravnikom ali farmacevtom.
English: When used for skin problems the infusion may be used in those above the age of 12 years for up to two weeks; if symptoms last longer than this, advice should be sought from a qualified healthcare practitioner.
Slovenian: V primeru kožnih težav se prelivek lahko uporablja pri osebah, starejših od 12 let, in sicer največ dva tedna.
English: What evidence supports the use of dittany of Crete herb medicines?
Slovenian: Kateri dokazi podpirajo uporabo zdravil, ki vsebujejo zel kretske dobre misli?
English: What are the risks associated with dittany of Crete herb medicines?
Slovenian: Kakšna tveganja so povezana z zdravili, ki vsebujejo zel kretske dobre misli?
English: What is dittany of Crete herb?
Slovenian: Kaj je zel kretske dobre misli?
English: Other information about dittany of Crete herb medicines
Slovenian: Druge informacije o zdravilih, ki vsebujejo zel kretske dobre misli
English: Dittany of Crete herb
Slovenian: Zel kretske dobre misli
English: (frequency cannot be estimated from available data)
Slovenian: (pogostnosti ni mogoče oceniti iz razpoložljivih podatkov)
English: 2333 BE Leiden Netherlands
Slovenian: 2333 BE Leiden Nizozemska
English: Currently available data are described in section 4.8, 5.1, 5.2.
Slovenian: Razpoložljivi podatki so navedeni v poglavjih 4.8, 5.1 in 5.2.
English: Date of first authorisation: 25 April 2008 Date of latest renewal: 19 February 2018
Slovenian: Datum prve odobritve: 25. april 2008 Datum zadnjega podaljšanja: 19. februar 2018
English: The powder will dissolve completely.
Slovenian: Prašek se bo popolnoma raztopil.
English: Unopened vial: 3 years.
Slovenian: Neodprta viala: 3 leta.
English: Possible allergic-like symptoms
Slovenian: Možni alergiji podobni simptomi
English: Other Candida spp.
Slovenian: Druge Candida spp.
English: The clinical relevance of this finding is not known.
Slovenian: Klinična pomembnost te ugotovitve ni znana.
English: Standard infusion (added up to 100 ml)
Slovenian: Standardna infuzija (dodano do 100 ml)
English: Your doctor will determine how much Mycamine you will receive each day.
Slovenian: Zdravnik bo odločil, koliko zdravila Mycamine boste dobili vsak dan.
English: These findings showed reversibility over a follow-up period of 18 months.
Slovenian: Te ugotovitve so pokazale reverzibilnost med 18-mesečnim sledenjem.
English: % Difference [95% CI]
Slovenian: % razlike [95 % interval zaupanja]
English: Consideration should be given to official/national guidance on the appropriate use of antifungal agents.
Slovenian: Upoštevane morajo biti uradne/nacionalne smernice za primerno uporabo učinkovin proti glivam.
English: Elimination and excretion
Slovenian: Eliminacija in izločanje
English: The volume of distribution at steady state (Vss) was approximately 18-19 litres.
Slovenian: Volumen porazdelitve v stanju dinamičnega ravnovesja (Vss) je približno 18-19 litrov.
English: The concentrate should be used immediately.
Slovenian: Koncentrat je treba uporabiti takoj.
English: In addition, only a small number of cases involved these species in the clinical trials.
Slovenian: Poleg tega so le pri majhnem številu bolnikov v kliničnih preskušanjih opazili omenjene vrste.
English: Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Slovenian: Pred začetkom uporabe zdravila natančno preberite navodilo, ker za vas vsebuje pomembne podatke!
English: Your doctor may decide to adjust the dose of these medicines.
Slovenian: Vaš zdravnik se lahko odloči za drugačen odmerek teh zdravil.
English: Therapy may be instituted before the results of the cultures and other laboratory studies are known.
Slovenian: Z zdravljenjem se lahko začne še preden so znani rezultati kultur in drugih laboratorijskih preiskav.
English: Mycamine must be prepared and given to you by a doctor or another healthcare professional.
Slovenian: Zdravilo Mycamine mora pripraviti in vam ga dati zdravnik ali drug zdravstveni delavec.
English: The drug is rapidly distributed into tissues.
Slovenian: Zdravilo se hitro porazdeli v tkiva.
English: ¶ Clinical efficacy was also observed (< 5 patients) in the following Candida species: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua and C. dubliniensis.
Slovenian: ¶ Klinično učinkovitost so opazili (< 5 bolnikov) tudi pri naslednjih sevih Candide: C. guilliermondii, C. famata, C. lusitaniae, C. utilis, C. inconspicua in C. dubliniensis.
English: >R (Resistant)
Slovenian: >R (odpornost)
English: Mycamine is indicated for:
Slovenian: Zdravilo Mycamine je indicirano za:
English: Based on clinical trial experience, overall 32.2% of the patients experienced adverse drug reactions.
Slovenian: Na podlagi kliničnih izkušenj je imelo skupno 32,2 % bolnikov neželene učinke.
English: Information from clinical studies
Slovenian: Podatki iz kliničnih študij
English: In case of overdose, general supportive measures and symptomatic treatment should be administered.
Slovenian: Ob prevelikem odmerjanju je treba uvesti splošne podporne ukrepe in simptomatično zdravljenje.
English: Mycamine should not be used during pregnancy unless clearly necessary.
Slovenian: Zdravila Mycamine se ne sme uporabljati med nosečnostjo, razen če je nujno potrebno.
English: The exposure levels at which these effects did not occur (NOAEL) were in the same range as the clinical exposure or lower.
Slovenian: Stopnje izpostavljenosti, pri katerih se ti učinki niso pojavili (NOAEL), so bile v enakem razponu kot stopnje izpostavljenosti v klinični uporabi ali nižje.
English: In systemic circulation, micafungin is highly bound to plasma protein (> 99%), primarily to albumin.
Slovenian: V sistemskem krvnem obtoku se mikafungin v veliki meri veže na plazemske beljakovine (> 99 %), predvsem na albumin.
English: Pack size: packs of 1 vial.
Slovenian: Velikost pakiranja: pakiranja z 1 vialo.
English: ≤S (Susceptible)
Slovenian: ≤S (občutljivost)
English: If you experience an allergic attack, or a severe skin reaction (e.g. blistering and peeling of the skin), you must inform your doctor or nurse immediately
Slovenian: Če se pri vas pojavi alergijski napad ali huda kožna reakcija (npr. pojavljanje mehurjev in luščenje kože), morate takoj obvestiti vašega zdravnika ali medicinsko sestro.
English: Binding to albumin is independent of micafungin concentration (10-100 µg/ml).
Slovenian: Vezava na albumin je neodvisna od koncentracije mikafungina (10-100 µg/ml).
English: Insufficient evidence
Slovenian: nezadostni podatki
English: Mycamine with food and drink
Slovenian: Zdravilo Mycamine skupaj s hrano in pijačo
English: Neutropenia persisted for a median of 13 days.
Slovenian: Mediana trajanja nevtropenije je bila 13 dni.
English: The lower limit of the 95% CI was above the predefined non-inferiority margin of -10%, proving non-inferiority.
Slovenian: Spodnja meja 95-odstotnega IZ je bila nad predhodno opredeljeno mejo enakovrednosti -10 %, kar je dokazalo enakovrednost.
English: If you are pregnant of breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujte z zdravnikom ali farmacevtom, preden vzamete to zdravilo.
English: Few patients (1.1%; 0.4% serious) discontinued treatment due to a hepatic event.
Slovenian: Nekaj bolnikov (1,1 %; 0,4 % resnih) je zdravljenje prekinilo zaradi neželenih učinkov na jetra.
English: In reproductive and developmental toxicity studies, reduced birth weight of the pups was noted.
Slovenian: Pri študijah reproduktivne in razvojne toksičnosti so opazili zmanjšano težo mladičev ob rojstvu.
English: PK/PD relationship
Slovenian: Razmerje FK/FD
English: Non-inferiority was proven for adult patients, and similar findings were demonstrated for the paediatric subpopulations (including neonates and premature infants).
Slovenian: Enakovrednost je bila dokazana pri odraslih bolnikih, podobne ugotovitve pa so pokazali pri podpopulacijah otrok (vključno z novorojenčki in nedonošenčki).
English: If this happens, your doctor may decide to monitor your kidney function more closely.
Slovenian: Če se to zgodi, se bo zdravnik morda odločil, da bo podrobneje spremljal delovanje ledvic.