FrancophonIA/ELRC3.0 huggingface dataset:
English: In pregnant women treated with lamivudine, more than 1000 outcomes from first trimester and more than 1000 outcomes from second and third trimester exposure indicate no malformative and foeto/neonatal effect.
Slovenian: Pri nosečnicah, ki so prejemale lamivudin, podatki iz več kot 1000 izidov po izpostavljenosti v prvem trimesečju in več kot
English: Separate preparations of abacavir or lamivudine are available in cases where discontinuation or dose adjustment of one of the active substances is indicated.
Slovenian: V primeru indikacije za ukinitev ali prilagoditev ene izmed zdravilnih učinkovin so na voljo zdravila z abakavirjem ali lamivudinom.
English: For general Kivexa information enquiries, contact [local company name and telephone number inserted here]
Slovenian: Če imate o zdravilu Kivexa kakršno koli vprašanje, se lahko obrnete na [vnešeno bo ime in telefonska številka lokalnega predstavništva]
English: >1 log reduction in HIV RNA or <50 cp/mL
Slovenian: Zmanjšanje HIV RNA za > 1 log ali < 50 kopij/ml Vsi bolniki
English: In a crossover study in 27 HIV-infected patients, intracellular carbovir-TP exposures were higher for the abacavir 600 mg once daily regimen (AUC24,ss + 32%, Cmax24,ss + 99% and Ctrough + 18%) compared to the 300 mg twice daily regimen.
Slovenian: V navzkrižni študiji pri 27 bolnikih, okuženih z virusom HIV, je bila znotrajcelična izpostavljenost karbovir-TP-ju večja pri režimu odmerjanja abakavirja 600 mg enkrat na dan (AUC24,ss
English: In the small sample size for genotypic analysis, there was a trend toward a higher rate of NRTI-associated mutations in the once daily versus the twice daily abacavir regimens.
Slovenian: povezanih z NRTI večja pri režimu odmerjanju abakavirja enkrat dnevno kot pa pri režimu odmerjanja dvakrat dnevno.
English: Phenotypic susceptibility analyses of clinical isolates from antiretroviral-naïve patients with HIV-1 Group M non-B subtypes in three studies have each reported that all viruses were fully susceptible to both abacavir and lamivudine; one study of 104 isolates that included subtypes A and A1 (n=26), C (n=1), D (n=66), and the circulating recombinant forms (CRFs) AD (n=9), CD (n=1), and a complex inter-subtype recombinant_cpx (n=1), a second study of 18 isolates including subtype G (n=14) and CRF_AG (n=4) from Nigeria, and a third study of six isolates (n=4 CRF_AG, n=1 A and n=1 undetermined) from Abidjan (Côte d'Ivoire).
Slovenian: izolatov, vključno s podtipom G (n = 14) in CRF_AG (n = 4) iz Nigerije, tretja pa šest izolatov (n = 4 CRF_AG, n = 1 A in n = 1 nedoločen) iz Abidjana (Slonokoščena obala).
English: Retinoid compounds (e.g. isotretinoin)/Lamivudine No drug interaction studies
Slovenian: retinoidne sestavine (npr. izotretinoin)/lamivudin
English: The clinical relevance of this is unknown.
Slovenian: Klinični pomen tega podatka ni znan.
English: • diarrhoea
Slovenian: • bruhanje;
English: • numbness, tingly feelings in the skin (pins and needles)
Slovenian: • odrevenelost, občutek mravljinčenja v koži;
English: Response by Baseline HIV-1 RNA <100,000 c/mL
Slovenian: HIV-1 RNA < 100.000 kopij/ml
English: Common: Arthralgia, muscle disorders
Slovenian: Pogosti: artralgija, mišične motnje Redki: rabdomioliza
English: Abacavir hypersensitivity
Slovenian: Preobčutljivost na abakavir
English: Baseline RNA category <100,000 copies/mL
Slovenian: RNA ≥ 100.000 kopij/ml
English: • nausea (feeling sick), vomiting (being sick), diarrhoea, abdominal (stomach) pain, severe tiredness.
Slovenian: • slabost, bruhanje, driska, bolečine v trebuhu, huda utrujenost.
English: ABC QD +3TC+EFV (n=384)
Slovenian: ABC 1-krat/dan +3TC+EFV (n = 384)
English: A similar virologic response was observed for both regimens (point estimate for treatment difference at week 48: 0.39%, 95% CI: -6.63, 7.40).
Slovenian: teden: 0,39 ; 95 % IZ: -6,63; 7,40).
English: Common: fatigue, malaise, fever.
Slovenian: Pogosti: utrujenost, splošen občutek slabosti, povišana telesna temperatura
English: Nucleoside and nucleotide analogues may impact mitochondrial function to a variable degree, which is most pronounced with stavudine, didanosine and zidovudine .There have been reports of mitochondrial dysfunction in HIV-negative infants exposed in utero and/or post-natally to nucleoside analogues: these have predominantly concerned treatment with regimens containing zidovudine.The main adverse reactions reported are haematological disorders (anaemia, neutropenia) and metabolic disorders (hyperlactatemia, hyperlipasemia).
Slovenian: Obstajajo poročila o mitohondrijski disfunkciji pri HIV-negativnih dojenčkih, ki so bili in utero in/ali postnatalno izpostavljeni nukleozidnim analogom; ta so pretežno zadevala zdravljenje z režimi, ki vsebujejo zidovudin.
English: Delay in stopping treatment with Kivexa after the onset of hypersensitivity may result in a life-threatening reaction.
Slovenian: Kivexa, ko se pojavi preobčutljivost, lahko povzroči življenjsko nevarne reakcije.
English: • being sick (vomiting)
Slovenian: • slabost (navzea);
English: These symptoms usually resolve upon discontinuation of abacavir.
Slovenian: Po prenehanju jemanja abakavirja ti simptomi navadno izginejo.
English: The clinical relevance of this finding has not been determined.
Slovenian: Klinična pomembnost tega podatka ni bila ugotovljena.
English: Baseline CD4 category 50-100 21/40 (53%)
Slovenian: >=100.000 kopij/ml Izhodiščna kategorija CD4 < 50 3/6 (50 %)
English: Talk to your doctor if any of these apply to you before using Kivexa.
Slovenian: Pred začetkom jemanja zdravila Kivexa se posvetujte zm zdravnikom, če kaj od tega velja za vas.
English: No definitive recommendation on dose reduction is possible in patients with mild hepatic impairment due to substantial variability of abacavir exposure.
Slovenian: Ker je pri bolnikih z blago jetrno okvaro izpostavljenost abakavirju precej variabilna, pri tej populaciji bolnikov ne moremo podati dokončnih priporočil glede zmanjšanja odmerka.
English: Reproductive toxicology
Slovenian: CITOTOKSIČNA ZDRAVILA
English: In the fasted state there was no significant difference in the extent of absorption, as measured by the area under the plasma concentration-time curve (AUC) and maximal peak concentration (Cmax), of each component.
Slovenian: (AUC) in največje koncentracije (Cmax) je bilo ugotovljeno, da na tešče ni pomembne razlike v obsegu absorpcije vsake izmed učinkovin.
English: 2) you get one or more symptoms from at least TWO of the following groups - fever - shortness of breath, sore throat or cough - nausea or vomiting or diarrhoea or abdominal pain - severe tiredness or achiness or generally feeling ill
Slovenian: - zasoplost, boleče žrelo ali kašelj, - siljenje na bruhanje ali bruhanje ali driska ali bolečine v trebuhu, - huda utrujenost ali bolečine ali splošno slabo počutje.
English: ABC BID +3TC+EFV (n=386)
Slovenian: ABC 2-krat na dan + 3TC + EFV (n = 386)
English: • skin rash
Slovenian: Populacija ZNZ-I
English: Virologic Response Based on Plasma HIV-1 RNA < 50 copies/ml ITT-Exposed Population M=F switch included
Slovenian: Virusni odziv glede na HIV-1 RNA v plazmi < 50 kopij/ml
English: Placental transfer of abacavir and lamivudine has been shown to occur in humans.
Slovenian: Ugotovljeno je, da abakavir in lamivudin pri človeku prehajata skozi placento.
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each film-coated tablet contains 600 mg abacavir (as sulfate) and 300 mg lamivudine
Slovenian: Vsaka filmsko obložena tableta vsebuje 600 mg abakavirja (v obliki sulfata) in 300 mg lamivudina.
English: Screening is also recommended prior to re-initiation of abacavir in patients of unknown HLA-B*5701 status who have previously tolerated abacavir.
Slovenian: Tudi pri bolnikih, ki nimajo znanega statusa HLA-B*5701 in so v preteklosti prenašali abakavir, je priporočljivo izvesti presejanje pred ponovno uvedbo zdravljenja z abakavirjem.
English: • irritated or runny nose
Slovenian: • kašelj; • draženje in izcedek iz nosu;
English: Musculoskeletal
Slovenian: trombocitopenija
English: Diagnosis of Abacavir Hypersensitivity Reaction
Slovenian: zmanjšanje tveganja preobčutljivostnimi reakcijami na ABC
English: Abacavir should not be used in patients known to carry the HLA-B*5701 allele.
Slovenian: Pri bolnikih z alelom HLA-B*5701 se abakavir ne sme uporabljati.
English: Regardless of HLA-B*5701 status, patients who are diagnosed with a hypersensitivity reaction must discontinue abacavir immediately.
Slovenian: Obvladovanje preobčutljivostnih reakcij na ABC Ne glede na status HLA-B*5701 morajo bolniki, pri katerih je ugotovljena preobčutljivostna reakcija,
English: • muscle pain and discomfort
Slovenian: • bolečine v mišicah in nelagodje; • bolečine v sklepih;
English: The pharmacokinetics of abacavir have been studied in patients with mild hepatic impairment (Child-Pugh score 5-6) receiving a single 600 mg dose; the median (range) AUC value was 24.1 (10.4 to 54.8) ug.h/ml.The results showed that there was a mean (90%CI) increase of 1.89 fold [1.32; 2.70] in the abacavir AUC, and 1.58 [1.22; 2.04] fold in the elimination half-life.
Slovenian: Rezultati so pokazali, da je bila AUC abakavirja povečana v povprečju za 1,89-krat [1,32; 2,70]; 90 % interval zaupanja, eliminacijski razpolovni čas pa v povprečju za 1,58-krat [1,22; 2,04]; 90 % interval zaupanja.
English: Following discontinuation of abacavir, the symptoms of the reaction should be treated according to local standard of care Rechallenge can result in a more rapid and severe reaction, which can be fatal, therefore rechallenge is contraindicated.
Slovenian: Po prekinitvi zdravljenja z abakavirjem, je treba simptome reakcije obravnavati v skladu z lokalnimi standardi oskrbe.
English: ABC BID +3TC QD (n=88)
Slovenian: ABC 2krat/dan +3TC 1krat/dan (n = 88)
English: Doctor:.......................…………………… Tel:...................………… If your doctor is not available, you must urgently seek alternative medical advice (e.g. the emergency unit of the nearest hospital).
Slovenian: Če vaš zdravnik ni dosegljiv, morate nujno poiskati zdravniško pomoč drugje (npr. na urgentnem oddelku najbližje bolnišnice).
English: Lamivudine has not shown any genotoxic activity in the in vivo studies at doses that gave plasma concentrations up to 40-50 times higher than clinical plasma concentrations.
Slovenian: Pri odmerkih, ki so dali od 40- do 50-krat večje plazemske koncentracije od terapevtskih, lamivudin in vivo ni pokazal nobenega genotoksičnega delovanja.
English: Hepatic impairment:
Slovenian: Pediatrična populacija:
English: Zidovudine/Abacavir
Slovenian: zidovudin/abakavir
English: EPZ104057 (HEAT study) was a randomised, double-blind, placebo-matched, 96 week, multi-centre study with the primary objective of evaluating the relative efficacy of abacavir/lamivudine (ABC/3TC, 600mg/300mg) and tenofovir /emtricitabine (TDF/FTC, 300mg/200mg), each given once-daily in combination with lopinavir/ritonavir (LPV/r, 800mg/200mg) in HIV-infected, therapy-naive adults.
Slovenian: Njen primarni cilj je bila ocena relativne učinkovitosti zdravljenja z abakavirjem/lamivudinom (ABC/3TC, 600 mg/300 mg) ter tenofovirjem/emtricitabinom (TDF/FTC, 300 mg/200 mg).
English: The M184V or M184I variants arise in HIV-1 infected patients treated with lamivudine-containing antiretroviral therapy.
Slovenian: Protivirusno zdravljenje glede na genotipsko/fenotipsko odpornost Odpornost in vivo (bolniki, ki še niso bili zdravljeni) Pri z virusom HIV-1 okuženih bolnikih, ki so se zdravili s protiretrovirusnim zdravljenjem, ki je vsebovalo lamivudin, sta se pojavili varianti M184V ali M184I.
English: Elderly:
Slovenian: Starostniki:
English: Rare side effects that may show up in blood tests are: • increase in an enzyme called amylase.
Slovenian: Redek neželeni učinek, ki se lahko pokaže v preiskavah krvi, je:
English: • presence of skin rash; OR
Slovenian: • izpuščaj na koži;
English: ABC/3TC FDC QD (n=94)
Slovenian: ABC/3TC + EFV (n =192)
English: The metabolites and unchanged abacavir account for about 83% of the administered abacavir dose in the urine.
Slovenian: Približno 83 % prejetega odmerka abakavirja se izloči v obliki presnovkov ali v nespremenjeni obliki z urinom, ostanek se izloči z blatom.
English: Abacavir-resistant isolates of HIV-1 have been selected in-vitro in wild-type strain HIV-1 (HXB2) and are associated with specific genotypic changes in the RT codon region (codons M184V, K65R, L74V and Y115).
Slovenian: Povezani so bili s specifičnimi genotipskimi spremembami kodonskega področja (kodoni M184V, K65R, L74V and Y115) RT. Selekcija za mutacijo M184V se je pojavila prva in je povzročila 2-kratno povečanje IC50.
English: • development of 1 or more symptom from at least 2 of the following groups: - Fever - Shortness of breath, sore throat or cough - Nausea or vomiting or diarrhoea or abdominal pain - Extreme tiredness or achiness or general ill feeling
Slovenian: povišana telesna temperatura težko dihanje, vnetje žrela ali kašelj navzea ali bruhanje ali driska ali bolečine v trebuhu izredna utrujenost ali bolečnost ali splošno slabo počutje
English: Overall response (stratified by baseline HIV-1 RNA) Response by Baseline HIV-1 RNA <100,000 c/ml Response by Baseline HIV-1 RNA ≥100,000 c/ml
Slovenian: RNA < 100.000 kopij/ml Odziv po izhodiščni HIV-1
English: Uncommon: Neutropenia and anaemia (both occasionally severe), thrombocytopenia Very rare: Pure red cell aplasia
Slovenian: Občasni: nevtropenija in anemija (občasno obe hudi),
English: Therapy-naïve patients
Slovenian: Predhodno še nezdravljeni bolniki
English: For patients receiving lamivudine 300 mg once daily, the terminal intracellular half-life of lamivudine-TP was prolonged to 16-19 hours, compared to the plasma lamivudine half-life of 5-7 hours.
Slovenian: + 32%, Cmax24,ss + 99% in Ctrough + 18%) kot pri režimu odmerjanja 300 mg dvakrat na dan.Pri bolnikih, ki so prejemali lamivudin v odmerku 300 mg enkrat dnevno, je bil terminalni znotrajcelični razpolovni čas lamivudin-TP 16-19 ur, razpolovni čas lamivudina v plazmi pa 5-7 ur.
English: Common side effects These may affect up to 1 in 10 people:
Slovenian: Pojavijo se lahko pri največ 1 od 10 bolnikov:
English: The proportion of treatment-experienced patients in the CAL30001 study with HIVRNA <50 copies/mL at Week 48 by genotypic sensitivity score in optimized background therapy (OBT) are tabulated The impact of major IAS-USA defined mutations to abacavir or lamivudine and multi-NRTI resistance associated mutations to the number of baseline mutations on response was also evaluated.
Slovenian: V preglednici so za študijo CAL30001 prikazani deleži že zdravljenih bolnikov, ki so imeli 48. teden HIV-RNA < 50 kopij/ml, po genotipski občutljivosti pri optimiziranem osnovnem zdravljenju.
English: ANTICONVULSANTS Phenobarbital/Abacavir
Slovenian: ANTIEPILEPTIKI fenobarbital/abakavir
English: • headache
Slovenian: • driska;
English: You should immediately contact your doctor if you think you are having a hypersensitivity reaction to Kivexa.
Slovenian: Če mislite, da imate preobčutljivostno reakcijo na zdravilo Kivexa, se morate nemudoma posvetovati s svojim zdravnikom.
English: Write your doctor's details below:
Slovenian: Nemudoma se posvetujte z zdravnikom:
English: • stiffness in the joints
Slovenian: • togost sklepov;
English: infection
Slovenian: Bolezni živčevja
English: At week 48, a lower rate of virologic response was observed for ABC/3TC compared to TDF/FTC (point estimate for the treatment difference: 11.6%, 95% CI: 2.2, 21.1).
Slovenian: Po 48 tednih so s shemo ABC/3TC ugotovili manjši delež virološkega odziva kot s TDF/FTC
English: • cough
Slovenian: Ziagen).
English: Contact your doctor immediately: 1 if you get a skin rash, OR 2 if you get symptoms from at least 2 of the following groups: fever shortness of breath, sore throat or cough nausea or vomiting, diarrhoea or abdominal pain severe tiredness or achiness, or generally feeling ill.
Slovenian: 1 če se vam pojavi izpuščaj na koži ALI 2 če se vam pojavijo simptomi iz vsaj 2 od naslednjih skupin:
English: Elderly
Slovenian: diareja
English: This should take approximately 30 minutes.
Slovenian: To traja približno 30 minut.
English: This is done by your doctor or a nurse, who will also monitor you during that time.
Slovenian: To stori zdravnik ali medicinska sestra, ki vas med tem tudi nadzoruje.
English: The majority of these events were reported as either mild or moderate.
Slovenian: O teh dogodkih so večinoma poročali kot o blagih ali zmernih.
English: Adults > 30 years
Slovenian: Odrasli > 30 let
English: Clinical safety and efficacy
Slovenian: Klinična varnost in učinkovitost
English: It is especially important to tell your doctor if you are taking medicines containing any of the following active substances:
Slovenian: Še posebej pomembno je, da zdravnika obvestite, če jemljete zdravila, ki vsebujejo katero od naslednjih zdravilnih učinkovin:
English: It has similar immunostimulatory effects as natural MDP.
Slovenian: Ima podobne imunostimulativne učinke kot naravni MDP.
English: This includes medicines that may be obtained without a prescription.
Slovenian: To velja tudi za zdravila, ki jih lahko dobite brez recepta.
English: Supportive measures should be based on institutional guidelines and the clinical symptoms observed.
Slovenian: Podporni ukrepi morajo temeljiti na institucionalnih smernicah in opaženih kliničnih simptomih.
English: Date of first authorisation: 6 March 2009 Date of latest renewal: 20 February 2019
Slovenian: DATUM PRIDOBITVE/PODALJŠANJA DOVOLJENJA ZA PROMET Z ZDRAVILOM Datum prve odobritve: 6. marec 2009 Datum zadnjega podaljšanja: 20. februar 2019
English: Do not use this medicine if you notice any visible signs of deterioration.
Slovenian: Tega zdravila ne uporabljajte, če opazite kakršne koli vidne znake kvarjenja.
English: The safety and efficacy of mifamurtide in children aged 0 to 2 years have not been established.
Slovenian: Varnost in učinkovitost mifamurtida pri otrocih, starih od 0 do 2 let, nista bili dokazani.
English: Therefore, there are not sufficient data to recommend the use of MEPACT in patients > 30 years of age.
Slovenian: Zato ne obstajajo zadostni podatki, da bi lahko priporočili uporabo zdravila MEPACT pri bolnikih, starejših od 30 let.
English: Dose and duration of treatment
Slovenian: Odmerjanje in trajanje zdravljenja
English: Specific studies addressing reproductive function, perinatal toxicity and carcinogenic potential have not been performed.
Slovenian: Posebne študije glede reproduktivne funkcije, perinatalne toksičnosti in karcinogenega potenciala niso bile izvedene.
English: Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis (see section 5.1).
Slovenian: Varnost in učinkovitost sta bili ocenjeni v študijah pri bolnikih, starih od 2 do 30 let ob prvotni diagnozi (glejte poglavje 5.1).
English: In the event of such an overdose, contact your doctor or nearest hospital.
Slovenian: V primeru prevelikega odmerka se obrnite na zdravnika ali najbližjo bolnišnico.
English: In the event of an overdose, it is recommended that appropriate supportive treatment be initiated.
Slovenian: V primeru prevelikega odmerka se priporoča uvedba ustreznega podpornega zdravljenja.
English: Do not use MEPACT: - if you are allergic to mifamurtide or any of the other ingredients of this medicine (listed in section 6).
Slovenian: Ne uporabljajte zdravila MEPACT: - če ste alergični na mifamurtid ali katero koli sestavino tega zdravila (navedeno v poglavju 6).
English: Volume
Slovenian: Volumen
English: It is not recommended to give this medicine to children below the age of 2 years because information on how safe and how well this medicine works is not available for this age group.
Slovenian: Tega zdravila ni priporočljivo uporabljati pri otrocih, mlajših od 2 let, saj podatki o varnosti in učinkovitosti tega zdravila pri tej starostni skupini niso na voljo.
English: The second episode involved multiple grand mal seizures over the course of days.
Slovenian: Druga epizoda je vključevala več grand mal napadov čez cel dan.
English: If you are pregnant or breast-feeding, think you may be pregnant or planning to have a baby, ask your doctor for advice before taking this medicine.
Slovenian: Če ste noseči ali dojite, menite, da bi lahko bili noseči ali načrtujete zanositev, se posvetujete s svojim zdravnikom, preden vzamete to zdravilo.
English: Frequency groupings are defined according to the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), not known (cannot be estimated from the available data).
Slovenian: Skupine pogostnosti so opredeljene skladno z naslednjim dogovorom: zelo pogosti ( 1/10), pogosti ( 1/100 do < 1/10), neznana pogostnost (ni mogoče oceniti iz razpoložljivih podatkov).
English: During this time the liposomes are formed spontaneously (figure 2).
Slovenian: V tem času samodejno nastajajo liposomi (slika 2).
English: None of the patients treated in the osteosarcoma studies were 65 years or older and in the phase III randomised study, only patients up to the age of 30 years were included.
Slovenian: Nobeden od bolnikov, ki so se zdravili v okviru študij o osteosarkomu, ni bil star 65 let ali več, v randomizirano študijo III. faze pa so bili vključeni le bolniki, mlajši od 30 let.
English: There were no results from general toxicity studies that suggested harmful effects on male or female reproductive organs.
Slovenian: Študije splošne toksičnosti niso dale nobenih rezultatov, ki bi kazali na škodljive učinke na moške ali ženske reproduktivne organe.
English: The excretion of mifamurtide in milk has not been studied in animals.
Slovenian: Izločanje mifamurtida v mleko ni bilo raziskano pri živalih.
English: Adverse reactions are classified according to system organ class and frequency.
Slovenian: Neželeni učinki so razvrščeni glede na organski sistem in pogostnost.
English: The liposomes were phagocytosed by cells of the reticuloendothelial system.
Slovenian: Liposome so fagocitirale celice retikuloendotelijskega sistema.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 6 hours at room temperature.
Slovenian: Če ni uporabljeno takoj, je za čas shranjevanja in pogoje pred uporabo odgovoren uporabnik, ta čas pa običajno ne sme preseči 6 ur pri sobni temperaturi.
English: Mifamurtide was not mutagenic and did not cause teratogenic effects in rats and rabbits.
Slovenian: Mifamurtid ni bil mutagen in ni povzročil teratogenih učinkov pri podganah in kuncih.
English: Do not use this medicine after the expiry date which is stated on the vial label and the carton after “EXP”.
Slovenian: Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na nalepki na viali in škatli poleg oznake »EXP«.
English: Materials provided in each package
Slovenian: Materiali, priloženi v vsakem pakiranju
English: In 2 of 4 patients with lung metastases, radioactivity was associated with lung metastases.
Slovenian: Pri 2 od 4 bolnikov s pljučnimi metastazami je bila radioaktivnost povezana s pljučnimi metastazami.
English: MEPACT has a moderate influence on the ability to drive and use machines.
Slovenian: Zdravilo MEPACT ima zmeren vpliv na sposobnost vožnje in upravljanja strojev.
English: Pharmacotherapeutic group: Immunostimulants, Other immunostimulants, ATC code: L03AX15
Slovenian: Farmakoterapevtska skupina: Zdravila za spodbujanje imunske odzivnosti, Drugi imunostimulanti, oznaka ATC: L03AX15
English: Detailed information on warnings and precautions relating to side effects that could occur while you are taking the medicine is presented in section 4.
Slovenian: Podrobne informacije o opozorilih in previdnostnih ukrepih, povezanih z neželenimi učinki, ki se lahko pojavijo med zdravljenjem s tem zdravilom, so navedene v poglavju 4.
English: What MEPACT is and what it is used for
Slovenian: Kaj je zdravilo MEPACT in za kaj ga uporabljamo
English: MEPACT has not been tested in pregnant women.
Slovenian: Zdravilo MEPACT ni bilo preizkušeno pri nosečnicah.