FrancophonIA/ELRC3.0 huggingface dataset:
English: If your problems increase, you should contact your doctor, as these may have been caused by MEPACT when used with chemotherapy.
Slovenian: Če se težave slabšajo, se posvetujte z zdravnikom, saj bi lahko bile posledica uporabe zdravila MEPACT v kombinaciji s kemoterapijo.
English: No dedicated fertility studies have been conducted with mifamurtide (see section 5.3).
Slovenian: Posebnih študij o vplivu mifamurtida na plodnost niso izvedli (glejte poglavje 5.3).
English: Some very common and common side effects of MEPACT treatment (such as dizziness, vertigo, fatigue and blurred vision) may affect your ability to drive and use machines.
Slovenian: Vpliv na sposobnost upravljanja vozil in strojev Nekateri zelo pogosti in pogosti neželeni učinki zdravljenja z zdravilom MEPACT (kot so omotica, vrtoglavica, utrujenost in zamegljen vid) lahko vplivajo na sposobnost vožnje in upravljanja s stroji.
English: MEPACT is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection.
Slovenian: Zdravilo MEPACT je indicirano za zdravljenje operabilnega nerazsejanega osteosarkoma visoke stopnje pri otrocih, mladostnikih in mladih odraslih po popolni makroskopski kirurški odstranitvi.
English: Taking into account the PRAC Assessment Report on the PSUR(s) for mifamurtide, the scientific conclusions of the CHMP are as follows:
Slovenian: Upoštevajoč poročilo Odbora za oceno tveganja na področju farmakovigilance (PRAC) o oceni rednih posodobljenih poročil o varnosti zdravila (PSUR) za mifamurtid je Odbor za zdravila za uporabo v humani medicini (CHMP) sprejel naslednje znanstvene zaključke:
English: • 2 medium (18) gauge sterile injection needles
Slovenian: • 2 sterilni injekcijski igli srednje dimenzije (18)
English: Unopened vial of powder
Slovenian: Zaprta viala s praškom
English: For intravenous use after reconstitution, filtering using the filter provided and further dilution.
Slovenian: Za intravensko uporabo po rekonstituciji, filtriranju s priloženim filtrom in nadaljnjem redčenju.
English: Oedema, chest discomfort, local infusion or catheter site reactions and ‘feeling cold' were less frequently reported in these patients, mostly with late stage malignant disease.
Slovenian: Pri teh bolnikih so redkeje poročali o edemu, nelagodju v prsnem košu, lokalnih reakcijah na mestu aplikacije ali katetra ter “občutku mraza”, večinoma pri bolnikih z maligno boleznijo v poznem stadiju.
English: if you have stomach problems such as nausea, vomiting and lack of appetite.
Slovenian: - če imate prebavne težave, kot so siljenje na bruhanje, bruhanje in izguba apetita.
English: If you have worsening symptoms, you should contact your doctor, as these may have been caused by MEPACT.
Slovenian: V primeru simptomov, ki se slabšajo, se posvetujte z zdravnikom, saj bi le-ti lahko bili posledica zdravila MEPACT.
English: Each vial contains 4 mg of mifamurtide.
Slovenian: Ena viala vsebuje 4 mg mifamurtida.
English: Other generalised symptoms that were typically mild to moderate and very common included hypothermia (23%), malaise (13%), pain (15%), asthenia (13%) and chest pain (11%).
Slovenian: Ostali generalizirani simptomi, ki so bili tipično blagi do zmerni in zelo pogosti, so hipotermija (23%), splošno slabo počutje (13%), bolečina (15%), astenija (13%) in bolečina v prsih (11%).
English: 50 mL type I glass vial with a grey butyl rubber stopper, aluminium seal and plastic flip-off cap, containing 4 mg of mifamurtide.
Slovenian: 50-mililitrska viala iz stekla tipa I, zaprta z zamaškom iz sive butilne gume, aluminijastim obročkom in dvižno plastično zaporko, ki vsebuje 4 mg mifamurtida.
English: Mean half-lives of total and free MTP-PE in mild hepatic impairment were 2.02 hours and 1.99 hours, respectively, and were comparable to those in subjects with normal hepatic function (2.15 hours and 2.26 hours, respectively).
Slovenian: Pri blagi okvari jeter je bil srednji razpolovni čas skupnega MTP-PE 2,02 ure, prostega MTP-PE pa 1,99 ure, kar je primerljivo z vrednostmi pri osebah z normalnim delovanjem jeter (2,15 ure oziroma 2,26 ure).
English: Continued monitoring of the kidney and liver function is recommended if mifamurtide is used beyond completion of chemotherapy until all therapy is completed.
Slovenian: Če se mifamurtid uporablja po zaključku kemoterapije, se priporoča neprekinjeno spremljanje ledvične in jetrne funkcije, dokler ni celotno zdravljenje zaključeno.
English: The volume of reconstituted suspension corresponding to the calculated dose is extracted through the filter provided and further diluted with additional 50 mL sodium chloride 9 mg/mL (0.9%) solution for injection according to the detailed instructions shown below.
Slovenian: Volumen rekonstituirane suspenzije, ki ustreza izračunanemu odmerku, se izvleče skozi priloženi filter in nato razredči z dodatnimi 50 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje v skladu s podrobnimi navodili, ki so navedena spodaj.
English: Consistent with other generalised symptoms, the very common nervous system disorders were headache (50%) and dizziness (17%).
Slovenian: V skladu z ostalimi generaliziranimi simptomi sta bili zelo pogosti bolezni živčevja glavobol (50%) in omotica (17%).
English: Vertigo, Tinnitus, Hearing loss
Slovenian: Vrtoglavica, Tinitus, Izguba sluha
English: Anaemia has very commonly been reported when mifamurtide is used in conjunction with chemotherapeutic agents.
Slovenian: O anemiji so zelo pogosto poročali pri uporabi mifamurtida skupaj s kemoterapevtskimi zdravili.
English: Administration of mifamurtide was commonly associated with transient neutropenia, usually when used in conjunction with chemotherapy.
Slovenian: Uporaba mifamurtida je bila pogosto povezana s prehodno nevtropenijo, ponavadi ko se je zdravilo uporabljalo v kombinaciji s kemoterapijo.
English: Additionally, the geometric mean plasma AUCinf of free (non-liposome associated) MTP-PE in mild and moderate hepatic impairment were 47% higher than the corresponding values in the matched normal hepatic function groups.
Slovenian: Razen tega pa je bila pri blagi in zmerni okvari jeter geometrijska srednja vrednost AUCinf prostega (nevezanega na liposome) MTP-PE v plazmi za 47% večja od ustreznih vrednosti pri primerljivih skupinah z normalnim delovanjem jeter.
English: There are no clinically meaningful effects of mild to moderate renal (creatinine clearance (CrCL) ≥ 30 mL/min) or hepatic impairment (Child-Pugh class A or B) on the pharmacokinetics of mifamurtide; therefore, dose adjustments are not necessary for these patients.
Slovenian: Blaga do zmerna okvara ledvic (kreatininski očistek (CrCL) ≥ 30 ml/min) ali jeter (Child-Pugh razred A ali B) nimata klinično pomembnih učinkov na farmakokinetiko mifamurtida, zato pri teh bolnikih odmerka ni treba prilagajati.
English: Musculoskeletal and connective tissue disorders Low grade pain was very common in patients receiving mifamurtide, including myalgia (31%), back pain (15%), extremity pain (12%) and arthralgia (10%).
Slovenian: Bolezni mišično-skeletnega sistema in vezivnega tkiva Pri bolnikih, ki so prejemali mifamurtid, je bila zelo pogosta blaga bolečina, vključno z mialgijo (31%), bolečino v hrbtu (15%), bolečino v okončinah (12%) in artralgijo (10%).
English: Concurrent use with high-dose non-steroidal-anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors) (see section 4.5).
Slovenian: Sočasna uporaba z visokim odmerkom nesteroidnih protivnetnih zdravil (NSAIDs, zaviralci ciklooksigenaze) (glejte poglavje 4.5).
English: Sepsis, Cellulitis, Nasopharyngitis, Catheter site infection, Upper respiratory tract infection, Urinary tract infection, Pharyngitis, Herpes simplex infection
Slovenian: Sepsa, Celulitis, Nazofaringitis, Okužba na mestu vstavljenega katetra, Okužba zgornjih dihal, Okužba sečil, Faringitis, Okužba s Herpes simplex
English: Patients with a history of venous thrombosis, vasculitis or unstable cardiovascular disorders should be closely monitored during mifamurtide administration.
Slovenian: Bolnike z vensko trombozo, vaskulitisom ali nestabilnimi srčno-žilnimi boleznimi v anamnezi je treba med uporabo mifamurtida skrbno nadzirati.
English: if you have a history of asthma or other breathing disorders.
Slovenian: - če imate ali ste kdaj imeli astmo ali druga obolenja dihal.
English: What MEPACT contains - The active substance is mifamurtide.
Slovenian: Kaj vsebuje zdravilo MEPACT - Zdravilna učinkovina je mifamurtid.
English: Rash, Pruritis, Erythema, Alopecia, Dry skin
Slovenian: Izpuščaj, Srbenje, Rdečina, Alopecija, Suha koža
English: In addition, pericardial effusion is a listed ADR for another immunostimulant, i.e. aldesleukin.
Slovenian: Poleg tega je perikardialni izliv naveden kot neželeni učinek tudi pri drugem imunostimulantu, tj. aldeslevkin.
English: The bag injection site should be wiped with an alcohol pad and the suspension in the syringe should be injected into the original bag containing the remaining 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection (figure 4).
Slovenian: Mesto, kjer boste prebodli vrečko, morate obrisati z alkoholno blazinico, suspenzijo v brizgi pa injicirajte v originalno vrečko, ki vsebuje preostalih 50 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje (slika 4).
English: Additionally, the systemic exposures AUC from zero to infinity (AUCinf of free (non-liposome associated) MTP-PE in mild or moderate renal insufficiency were similar to those observed in healthy adult subjects with normal renal function.
Slovenian: Tudi sistemska izpostavljenost za AUC od nič do neskončnosti (AUCinf) prostemu (nevezanemu na liposome) MTP-PE je bila pri odraslih prostovoljcih z blago ali zmerno ledvično insuficienco podobna kot pri zdravih odraslih osebah z normalnim delovanjem ledvic.
English: The spike should then be inserted into the vial septum firmly until seated.
Slovenian: Konico nato trdno potisnite v septum viale, dokler ni nameščena.
English: You do not need to be hospitalised to receive MEPACT.
Slovenian: Za uporabo zdravila MEPACT ni potrebna hospitalizacija.
English: You must not use MEPACT with high doses of NSAIDs.
Slovenian: Zdravila MEPACT ne smete uporabljati, če jemljete velike odmerke nesteroidnih protivnetnih zdravil.
English: These are typically mild to moderate and transient and can usually be treated by your doctor, e.g. with paracetamol for fever.
Slovenian: Ti neželeni učinki so običajno blagi do zmerni in prehodni, zdravnik pa jih običajno lahko uspešno zdravi, npr. paracetamol za zvišano telesno temperaturo.
English: In vivo administration of mifamurtide resulted in the inhibition of tumour growth in mouse and rat models of lung metastasis, skin and liver cancer, and fibrosarcoma.
Slovenian: In vivo je uporaba mifamurtida zavrla rast tumorja pri miših in podganah s pljučnimi metastazami, kožnim rakom in rakom jeter ter fibrosarkomom.
English: The patient experienced shaking, chills, fever, nausea, vomiting, uncontrollable coughing, shortness of breath, cyanotic lips, dizziness, weakness, hypotension, tachycardia, hypertension and hypothermia leading to study discontinuation.
Slovenian: Pri bolniku so poročali o tresenju, mrzlici, zvišani telesni temperaturi, navzei, bruhanju, nenadzorovanem kašlju, težkem dihanju, cianozi ustnic, omotici, oslabelosti, hipotenziji, tahikardiji, hipertenziji in hipotermiji.
English: Dysmenorrhoea
Slovenian: Dismenoreja
English: You should take your temperature as you may have a fever.
Slovenian: Izmerite si telesno temperaturo, saj bi le-ta lahko bila povišana.
English: The no-adverse-effect level for mifamurtide in animals corresponds roughly to the 2 mg/m2 recommend dose for humans.
Slovenian: Koncentracija mifamurtida, ki pri živalih ne povzroči neželenih učinkov, ustreza približno priporočenemu odmerku za človeka (2 mg/m2).
English: MEPACT contains sodium
Slovenian: Zdravilo MEPACT vsebuje natrij
English: The freeze-dried powder has to be reconstituted into a liquid suspension, filtered using the filter provided and further diluted before use.
Slovenian: Liofiliziran prašek je treba pred uporabo pripraviti v obliko tekoče suspenzije, filtrirati s priloženim filtrom in nato še nadalje razredčiti.
English: General disorders and administration site conditions The majority of patients experience chills (89%), fever (85%) and fatigue (53%).
Slovenian: Pri večini bolnikov se je pojavila mrzlica (89%), zvišana telesna temperatura (85%) in utrujenost (53%).
English: White to off-white homogeneous cake or powder.
Slovenian: Bel ali skoraj bel homogen zbit ali prost prašek.
English: Mean half-lives of total and free MTP-PE in moderate hepatic impairment were 3.21 hours and 3.15 hours, respectively.
Slovenian: Pri zmerni okvari jeter je srednji razpolovni čas skupnega MTP-PE znašal 3,21 ure, prostega MTP-PE pa 3,15 ure.
English: Powder for concentrate for dispersion for infusion Pack of 1 vial of powder, 1 sterile filter
Slovenian: FARMACEVTSKA OBLIKA IN VSEBINA Prašek za koncentrat za disperzijo za infundiranje Škatla z 1 vialo s praškom in 1 sterilnim filtrom
English: The bag should be gently swirled to mix the solution.
Slovenian: Vrečko nežno zavrtite, da se raztopina premeša.
English: Cancer pain
Slovenian: Bolečina zaradi raka
English: The filter should be removed from the blister pack, and the cap removed from the filter spike.
Slovenian: Vzemite filter iz pretisnega omota in odstranite zamašek s filtrske konice.
English: It is recommended to separate the times of administration of MEPACT and doxorubicin or other medicines if used in the same chemotherapy treatment regimen.
Slovenian: Zdravilo MEPACT in doksorubicin ali druga zdravila, ki se uporabljajo v istem režimu zdravljenja s kemoterapijo, je priporočljivo uporabljati ob različnih časih.
English: MEPACT must be reconstituted, filtered using the filter provided and further diluted using aseptic technique, prior to administration.
Slovenian: Pred uporabo je zdravilo MEPACT treba rekonstituirati, filtrirati z uporabo priloženega filtra in nato dodatno razredčiti z aseptično tehniko.
English: You may experience more severe side effects, including fever, chills, fatigue, nausea, vomiting, headache and high blood pressure or low blood pressure.
Slovenian: Če ste uporabili večji odmerek zdravila MEPACT, kot bi smeli Pojavijo se lahko hujši neželeni učinki, vključno z zvišanjem telesne temperature, mrzlico, utrujenostjo, slabostjo, bruhanjem, glavobolom in visokim krvnim tlakom ali nizkim krvnim tlakom.
English: The pharmacokinetics of a single 4 mg dose of mifamurtide following a 1 hour intravenous infusion were evaluated in adult volunteers with mild (n = 9) or moderate (n = 8) renal impairment and in age-, sex-, and weight-matched healthy adults with normal renal function (n = 16).
Slovenian: Farmakokinetiko enkratnega 4 mg odmerka mifamurtida po 1 urnem intravenskem infundiranju so vrednotili pri odraslih prostovoljcih z blago (n = 9) ali zmerno (n = 8) okvaro ledvic in pri po starosti, spolu in telesni masi primerljivih zdravih odraslih osebah z normalnim delovanjem ledvic (n = 16).
English: The sodium chloride 9 mg/mL (0.9%) solution for injection is added to the vial by slow, firm depression of the syringe plunger.
Slovenian: Raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje dodajte v vialo, tako da počasi in trdno pritiskate bat brizge.
English: The pharmacokinetics of a single 4 mg dose of mifamurtide following a 1 hour intravenous infusion were evaluated in adult volunteers with mild (Child-Pugh class A; n = 9) or moderate (Child-Pugh class B; n = 8) hepatic impairment and in age, sex-, and weight-matched healthy adults with normal hepatic function (n = 19).
Slovenian: Farmakokinetiko enkratnega 4 mg odmerka mifamurtida po 1 urnem intravenskem infundiranju so vrednotili pri odraslih prostovoljcih z blago (Child-Pugh razred A, n = 9) ali zmerno (Child-Pugh razred B, n = 8) okvaro jeter in pri po starosti, spolu in telesni masi primerljivih zdravih odraslih osebah z normalnim delovanjem jeter (n = 19).
English: Treatment with MEPACT can often cause stomach problems such as nausea, vomiting and loss of appetite when used with chemotherapy.
Slovenian: Pri uporabi zdravila MEPACT skupaj s kemoterapijo se pogosto lahko pojavijo prebavne težave, kot so siljenje na bruhanje, bruhanje in izguba apetita.
English: You should use effective contraception if you are being treated with MEPACT.
Slovenian: Če se zdravite z zdravilom MEPACT, morate uporabljati učinkovito kontracepcijo.
English: A healthy adult volunteer accidentally received a single dose of 6.96 mg mifamurtide and experienced a reversible treatment-related event of orthostatic hypotension.
Slovenian: Zdrav odrasel prostovoljec je pomotoma prejel mifamurtid v enkratnem odmerku 6,96 mg.
English: Significant enhancement of disease-free survival was also demonstrated in the treatment of dog osteosarcoma and hemangiosarcoma with mifamurtide as adjuvant therapy.
Slovenian: Dokazano je bilo tudi, da je adjuvantno zdravljenje z mifamurtidom bistveno izboljšalo preživetje brez ponovitve bolezni pri zdravljenju osteosarkoma in hemangiosarkoma pri psih.
English: The filter luer connector cap should not be removed at this time.
Slovenian: Pokrovčka s filtrskega luer nastavka še ne smete odstraniti.
English: Each mL reconstituted suspension contains 0.08 mg mifamurtide.
Slovenian: En ml rekonstituirane suspenzije vsebuje 0,08 mg mifamurtida.
English: The lyophilised powder should be allowed to reach a temperature between approximately 20 C-25 °C prior to reconstitution, filtering using the filter provided and dilution.
Slovenian: Liofiliziran prašek mora pred rekonstitucijo, filtriranjem s priloženim filtrom in razredčitvijo doseči temperaturo okoli 20 C - 25 °C.
English: As no pharmacokinetic data of mifamurtide is available in patients with severe renal or hepatic impairment, caution when administering mifamurtide to these patients is recommended.
Slovenian: Pri bolnikih s hudo okvaro ledvic ali jeter podatki o farmakokinetiki mifamurtida niso na voljo, zato je pri teh bolnikih treba mifamurtid uporabljati previdno.
English: Volume to withdraw = [12.5 x calculated dose (mg)] mL
Slovenian: Volumen suspenzije, ki ga morate izvleči za določen odmerek, se izračuna na naslednji način: Volumen, ki ga je treba izvleči = [12,5 x izračunani odmerek (mg)] ml V pomoč vam bo naslednja preglednica skladnosti: Odmerek
English: A higher percentage of objective and subjective hearing loss was observed overall in patients who received MEPACT and chemotherapy (12% and 4%, respectively) in the phase III study (see section 5.1 for a description of the study) compared to those patients that received only chemotherapy (7% and 1%).
Slovenian: V študiji III. faze (za opis študije glejte poglavje 5.1) so pri bolnikih, ki so se zdravili z zdravilom MEPACT in s kemoterapijo zabeležili višji odstotek objektivne in subjektivne izgube sluha (12% oz. 4%) kot pri bolnikih, ki so se zdravili samo s kemoterapijo (7% oz. 1%).
English: Adverse reactions
Slovenian: Vnetni odziv
English: It should be used with caution in patients with a history of autoimmune, inflammatory or other collagen diseases.
Slovenian: Pri bolnikih, ki so imeli avtoimunske, vnetne ali druge kolagenske bolezni, ga je treba uporabljati previdno.
English: MEPACT 4 mg powder for concentrate for dispersion for infusion mifamurtide
Slovenian: MEPACT 4 mg prašek za koncentrat za disperzijo za infundiranje mifamurtid
English: Each vial should be reconstituted with 50 mL of sodium chloride 9 mg/mL (0.9%) solution for injection.
Slovenian: Eno vialo je treba rekonstituirati s 50 ml raztopine natrijevega klorida 9 mg/ml (0,9%) za injiciranje.
English: The site of the sodium chloride 9 mg/mL (0.9%) solution for injection bag where the needle is going to be inserted should be swabbed with an alcohol pad.
Slovenian: Mesto, kjer boste vrečko z raztopino natrijevega klorida 9 mg/ml (0,9%) za injiciranje prebodli z iglo, morate obrisati z alkoholno blazinico.
English: Mild-moderate tachycardia (50%), hypertension (26%) and hypotension (29%) were very commonly reported in uncontrolled studies of mifamurtide.
Slovenian: V nenadzorovanih študijah mifamurtida so zelo pogosto poročali o blagi do zmerni tahikardiji (50%), hipertenziji (26%) in hipotenziji (29%).
English: In a phase I study, there was one report of severe allergic reaction occurring after the first infusion of mifamurtide at 6 mg/m dose level.
Slovenian: Bolezni imunskega sistema V študiji I. faze so po prvem infundiranju mifamurtida v odmerku 6 mg/m2 poročali o enem primeru hude alergijske reakcije.
English: Excipients: Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC), 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS)
Slovenian: Pomožni snovi: 1-palmitoil-2-oleoil-sn-glicero-3-fosfoholin (POPC), 1,2-dioleoil-sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS)
English: It is recommended to separate the administration times of mifamurtide and doxorubicin or other lipophilic medicinal products if used in the same chemotherapy regimen.
Slovenian: Če se mifamurtid in doksorubicin ali druga lipofilna zdravila uporabljajo v istem režimu kemoterapije, je priporočljivo, da se jih aplicira ob različnih časih.
English: - The other ingredients are 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) and 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS).
Slovenian: - Pomožni snovi sta 1-palmitoil-2-oleoil-sn-glicero-3-fosfoholin (POPC) in 1,2-dioleoil-sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS).
English: Skin and subcutaneous disorders Hyperhidrosis (11%) was very common in patients receiving mifamurtide in uncontrolled studies.
Slovenian: Bolezni kože in podkožja Pri bolnikih, ki so prejemali mifamurtid v nenadzorovanih študijah, je bila zelo pogosta hiperhidroza
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Slovenian: B. POGOJI ALI OMEJITVE GLEDE OSKRBE IN UPORABE Predpisovanje in izdaja zdravila je le s posebnim režimom (glejte Prilogo I: Povzetek glavnih značilnosti zdravila, poglavje 4.2).
English: The syringe should then be removed from the filter and a new needle placed on the suspension-filled syringe.
Slovenian: Brizgo s suspenzijo morate nato odstraniti iz filtra in nanjo namestiti novo iglo.
English: 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS)
Slovenian: 1-palmitoil-2-oleoil-sn-glicero-3-fosfoholin (POPC) 1,2-dioleoil-sn-glicero-3-fosfo-L-serin mononatrijeva sol (OOPS) 6.2 Inkompatibilnosti
English: Pleural effusion, Exacerbated dyspnoea, Productive cough, Haemoptysis, Wheezing, Epistaxis, Exertional dyspnoea, Sinus congestion, Nasal congestion, Pharyngolaryngeal pain
Slovenian: Plevralni izliv, Poslabšanje dispneje, Produktivni kašelj, Hemoptiza, piskajoče dihanje, Krvavitev iz nosu, Dispneja med naporom, Sinusna kongestija, Nazalna kongestija, Bolečina v žrelu in grlu
English: Peripheral oedema, Oedema, Mucosal inflammation, Infusion site erythema, Infusion site reaction, Catheter site pain, Chest discomfort, Feeling cold
Slovenian: Periferni edem, Edem, Vnetje sluznice, Rdečina na mestu aplikacije, Reakcija na mestu aplikacije, Bolečina na mestu vstavljenega katetra, Nelagodje v prsnem košu, Občutek mraza
English: Muscle spasms, Neck pain, Groin pain, Bone pain, Shoulder pain, Chest wall pain, Musculoskeletal stiffness
Slovenian: Mišični krči, Bolečina v vratu, Bolečina v dimljah, Bolečina v kosteh, Bolečina v ramenih, Bolečina v prsni steni, Mišično-skeletna okorelost
English: Phlebitis, Flushing, Pallor
Slovenian: Flebitis, pordevanje, Bledica
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Slovenian: Podatkov o uporabi mifamurtida pri nosečnicah ni. Ni dovolj študij na živalih o vplivu zdravila na sposobnost razmnoževanja (glejte poglavje 5.3).
English: MEPACT 4 mg powder for concentrate for dispersion for infusion
Slovenian: IME ZDRAVILA MEPACT 4 mg prašek za koncentrat za disperzijo za infundiranje
English: Dyspnoea, Tachypnoea, Cough
Slovenian: Zelo pogosti Dispneja, Tahipneja, Kašelj Pogosti