FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean area under the curve (AUC) was 17.0 ± 4.86 h x nM and Cmax (maximum concentration) was 15.7 ± 3.72 nM.
Maltese: Iż-żona taħt il-kurva medja (AUC) kienet ta' 17.0 ± 4.86 h x nM u Cmax (konċentrazzjoni massima) kien 15.
English: Mild-moderate tachycardia (50%), hypertension (26%) and hypotension (29%) were very commonly reported in uncontrolled studies of mifamurtide.
Maltese: Takikardja ħafifa-moderata (50%), ipertensjoni (26%) u ipotensjoni (29%) kienu komunement ħafna irrapportati fi studji mhux kontrollati ta' mifamurtide.
English: Figure 1
Maltese: Stampa 1
English: Paediatric population < 2 years
Maltese: Popolazzjoni pedjatrika < 2 snin
English: Concurrent use with high-dose non-steroidal-anti-inflammatory drugs (NSAIDs, cyclooxygenase inhibitors) (see section 4.5).
Maltese: Użu konkurrenti ma' mediċini anti-infjammatorji mhux sterojdi (NSAIDs, inibituri taċ-ċikloossiġenażi) f'doża għolja (ara sezzjoni 4.5).
English: Dysmenorrhoea
Maltese: Diżmenorreja
English: Vertigo, Tinnitus, Hearing loss
Maltese: Vertigo, Tinnitus, Telf tas-smigħ
English: Common side effects (may affect up to 1 in 10 people): - blue colour of tissues such as the skin or gums caused by too little oxygen - perceptible increase in frequency or force of heartbeat - swelling in arms or legs or other swelling - chest discomfort - upset stomach, decreased appetite or weight loss - injection site or catheter site redness, swelling, infection or other local reaction - rash or redness, inflammation of the skin, itching, dry skin, pale or transient red appearance - inflammation of skin, tendons, muscles or similar tissues that support body structure - inflammation of a vein - upper abdominal or chest wall pain; abdominal bloating or pain; indigestion or pain in your liver - other pain, including neck, shoulder, groin, bone or throat pain; pain after an operation - muscle spasms or stiffness - feeling cold - tired feeling, drowsiness or sleepiness - burning, pricking/tingling sensation, diminished sensitivity to sensation or feeling a sensation without stimulus - involuntary shaking movement - dehydration - low concentration of potassium in blood - mucosal inflammation - nose, throat, or sinus congestion or inflammation - infections of the upper respiratory tract (such as a cold) or the urinary tract (such as a bladder infection) - generalised infection - Herpes simplex (virus) infection - productive cough, wheezing or exertional or exacerbated shortness of breath - spitting of blood or nosebleed - fluid in the lung cavity - blood in urine, difficulty or pain in urination or frequent urination - difficulty sleeping, depression, anxiety or confusion - dizziness - ears ringing - blurred vision - hair loss - difficult, painful menstruation - hearing loss - low number of white blood cells with or without fever, low number of platelets
Maltese: indiġestjoni jew uġigħ fil-fwied tiegħek - uġigħ ieħor, inklużi uġigħ tal-għonq, spalla, groin, għadam jew ġerżuma; uġigħ wara operazzjoni - spażmi jew ebusija tal-muskoli - tħossok kiesaħ - sensazzjoni ta' għeja, ħedla jew ħedla tan-ngħas - ħruq, sensazzjoni ta' tingiż/textix, tnaqqis fis-sensittività tas-sensazzjoni jew tħoss sensazzjoni mingħajr stimolu - moviment ta' tregħid involontarju - deidratazzjoni - konċentrazzjoni baxxa ta' potassium fid-demm - infjammazzjoni tal-mukoża - konġestjoni jew infjammazzjoni tal-imnieħer, gerżuma, jew sinus - infezzjonijiet tal-passaġġi respiratorji tan-naħa ta' fuq (bħal ma huwa riħ) jew tal-passaġġi awrinarji (bħal infezzjoni fil-bużieqa tal-awrina) - infezzjoni ġeneralizzata - infezzjoni b'Herpes simplex (virus) - sogħla bil-bili, tħarħir jew qtugħ ta' nifs waqt ix-xogħol jew imħarrax - tobżoq id-demm jew tinfaraġ - fluwidu fil-cavity tal-pulmun - demm fl-awrina, diffikultà jew uġigħ waqt l-għemil tal-awrina jew għemil spiss tal-awrina - diffikultà dfl-irqad, depressjoni, ansjetà jew konfużjoni - sturdament - ċempil fil-widnejn - vista mċajjpra - telf ta' xagħar - mestrwazzjoni diffiċli, bl-uġigħ - telf tas-smiegħ - numru baxx ta' ċelluli bojod tad-demm bid-deni jew mingħajr deni, numru baxx ta' plejtlits
English: • Sodium chloride 9 mg/mL (0.9%) solution for injection, 100 mL bag
Maltese: • Soluzzjoni għall-injezzjoni ta' sodium chloride 9 mg/mL (0.9%), borża ta' 100 mL
English: Figure 3
Maltese: Stampa 3
English: The liposomes were phagocytosed by cells of the reticuloendothelial system.
Maltese: Il-liposomi kienu phagocytosed minn ċelluli tas-sistema retikuloendoteljali.
English: Clinical safety and efficacy
Maltese: Sigurtà u effikaċja klinika
English: Store in a refrigerator (2 C-8 °C).
Maltese: Aħżen fi friġġ (2 C - 8 °C).
English: Respiratory disorders, including dyspnoea (21%), cough (18%) and tachypnoea (13%) were very commonly reported, and 2 patients with pre-existing asthma developed mild to moderate respiratory distress associated with MEPACT treatment in a phase II study.
Maltese: Disturbi respiratorji, inklużi dispnea (21%), sogħla (18%) u takipnea (13%) kienu rrapportati komunement ħafna, u 2 pazjenti b'ażma pre-eżistenti żviluppaw sitwazzjoni perikoluża respiratorja ħafifa għal moderata assoċjata ma' kura MEPACT fi studju fażi
English: What MEPACT contains - The active substance is mifamurtide.
Maltese: X'fih MEPACT - Is-sustanza attiva hija mifamurtide.
English: Store in a refrigerator (2 C-8 C).
Maltese: Aħżen fi friġġ (2 C - 8 C).
English: Concurrent use with ciclosporin or other calcineurin inhibitors (see section 4.5).
Maltese: Użu konkurrenti ma' ciclosporin jew inibituri calcineurin oħrajn (ara sezzjoni 4.5).
English: • MEPACT powder for concentrate for dispersion for infusion (vial)
Maltese: • MEPACT trab għal konċentrat għal dispersjoni għall-infużjoni (kunjett).
English: Figure 4
Maltese: Stampa 4
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).
Maltese: Gruppi ta' frekwenza huma definiti skond il-konvenzjoni segwenti: komuni ħafna (≥ 1/10), komuni ( 1/100 sa < 1/10), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Pharmacotherapeutic group: Immunostimulants, Other immunostimulants, ATC code: L03AX15
Maltese: Immunostimulanti, Immunostimulanti oħrajn, kodiċi ATC:
English: Once reconstituted in sodium chloride 9 mg/mL (0.9%) solution, store at room temperature (approximately 20ºC - 25ºC) and use within 6 hours.
Maltese: La darba rikonstitwita f'soluzzjoni ta' sodium chloride 9 mg/mL (0.9%), aħżen f'temperatura tal-kamra (madwar 20ºC - 25ºC) u uża fi żmien 6 sigħat.
English: Pleural effusion, Exacerbated dyspnoea, Productive cough, Haemoptysis, Wheezing, Epistaxis, Exertional dyspnoea, Sinus congestion, Nasal congestion, Pharyngolaryngeal pain
Maltese: Ħruġ ta' likwidu mill-plewra, dispnea mħarrxa, sogħla produttiva, haemoptysis, tħarħir, epistassi, exertional dyspnoea, konġestjoni fis-sinus, konġestjoni fl-imnieħer, uġigħ faringolarinġejali
English: There was no effect of mild (50 mL/min ≤ creatinine clearance [CLcr] ≤ 80 mL/min) or moderate (30 mL/min ≤ CLcr < 50 mL/min) renal insufficiency on the clearance of total MTP-PE, when compared with that observed in healthy adult subjects with normal renal function (CLcr > 80 mL/min).
Maltese: Ma kien hemm ebda effett ta' insuffiċjenza renali ħafifa (50 mL/min  tneħħija tal-kreatinina [CLcr]  80 mL/min) jew moderata (30 mL/min  CLcr < 50 mL/min) fuq it-tneħħija tal-MTP-PE totali, meta mqabbel ma' dak osservat f'suġġetti adulti b'saħħithom b'funzjoni renali normali (CLcr > 80 mL/min).
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.
Maltese: Voluntier adult b'saħħtu aċċidentalment irċieva doża waħda ta' 6.96 mg mifamurtide u esperjenzja ipotensjoni ortostatika riversibbli marbuta mal-kura.
English: Activation of human macrophages by mifamurtide is associated with production of cytokines, including tumour necrosis factor (TNF-), interleukin-1 (IL-1), IL-6, IL-8, and IL-12 and adhesion molecules, including lymphocyte function-associated antigen-1 (LFA-1) and intercellular adhesion molecule-1 (ICAM-1).
Maltese: L-attivazzjoni ta' makrofaġi umani b'mifamurtide huwa assoċjat mal-produzzjoni ta' ċitokini, inklużi l-fattur nekrożi tat-tumuri (TNF-), interlewkin-1 (IL-1), IL-6, IL-8, u IL-12 u molekoli ta' adeżjoni, inklużi aniġeni-1 assoċjati mal-funzjoni tal-limfoċiti(LFA-1) u adeżjoni interċellulari tal-molekola-1 (ICAM-1). Monoċiti umani trattati in vitro qatlu ċelloli alloġenejċi u awtologwi (inklużi melanoma, ovarji, tal-kolon u karċinoma renali), iżda ma kellhomx tossiċità lejn ċelloli normali.
English: In sensitive species (rabbit and dog) the highest daily dose of liposomal mifamurtide that did not cause adverse effects was 0.1 mg/kg, corresponding to 1.2 and 2 mg/m2, respectively.
Maltese: Fi speċi sensittivi (fenek u kelb) id-doża ta' kuljum l-iktar għolja ta' mifamurtide lipożomali li ma kkaġunatx effetti avversi kienet 0.1 mg/kg, li tikkorrespondi għal 1.2 u 2 mg/m², rispettivament.
English: No dedicated fertility studies have been conducted with mifamurtide (see section 5.3).
Maltese: Ma sarux studji dedikati tal-fertilità b'mifamurtide (ara sezzjoni 5.3).
English: Metabolism and nutritional disorders Anorexia (21%) was very commonly reported in phase I and II studies of mifamurtide
Maltese: Disturbi tal-metaboliżmu u nutrizzjonali Anoressja (21%) kienet rappurtata komunement ħafna fi provi ta' mifamurtide.
English: 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS)
Maltese: 1-Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC) 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS) 6.2 Inkompatibilitajiet
English: Animal studies are insufficient with respect to reproductive toxicity (see section 5.3).
Maltese: Studji tal-annimali mhumiex suffiċjenti b'rispett ta' tossiċità riproduttività (ara sezzjoni 5.3).
English: In 28 osteosarcoma patients aged 6 to 39 years serum total (liposomal and free) mifamurtide concentrations declined rapidly with a mean half-life of 2.04 ± 0.456 hours.
Maltese: F'28 pazjent b'osteosarkoma ta' bejn 6 u 39 sena il-konċentrazzjonijiet ta' mifamurtide totali (liposomali u ħielsa) fis-serum naqsu malajr b'half-life medja ta' 2.04 ± 0.456 siegħat.
English: Pharmacokinetic variability was higher in the moderate hepatic impairment group (co-efficient of variation in systemic exposure [AUCinf] was 50% versus < 30% in the other hepatic function groups).
Maltese: Varjabilità farmakokinetika kienet ogħla fil-grupp b'indeboliment moderat tal-fwied (ko-effiċjenti tal-varjazzjoni fl-esponiment sistemiku [AUCinf] kienet ta' 50% kontra < 30% fil-gruppi l-oħra tal-funzjoni tal-fwied).
English: Powder for concentrate for dispersion for infusion Pack of 1 vial of powder, 1 sterile filter
Maltese: U KONTENUT Trab għal konċentrat għal dispersjoni għall-infużjoni Pakkett ta' kunjett ta' trab, 1 filtru sterili ta'
English: In a randomised phase III study of 678 patients (age range from 1.4 to 30.6 years) with newly-diagnosed resectable high-grade osteosarcoma, the addition of adjuvant mifamurtide to chemotherapy (either doxorubicin cisplatin and methotrexate with or without ifosfamide), significantly increased the 6-year overall survival and resulted in a relative reduction in the risk of death by 28% (p = 0.0313, hazard ratio (HR) = 0.72 [95% confidence interval (CI): 0.53, 0.
Maltese: III ta' 678 pazjent (ta' bejn 1.4 xhur u 30.6 sena) grad għoli u risettibbli ta' osetosarkoma li għadu kemm jiġi dijanjostikat, iż-żjieda ta' l-aġġuvant b'mifamurtide mal-kimoterapija (jew doxorubicin ċisplatin u methotrexate flimkien ma' jew mingħajr ifosfamide), naqqas b'mod sinifikanti s-sopravivenza globali ta' 6 snin u rriżulta fi tnaqqis relattiv tar-riskju tal-mewt b'28% (p = 0.
English: Each carton contains 1 vial and 1 single-use, non-pyrogenic, sterile filter for MEPACT supplied in a PVC-grade blister.
Maltese: Kull kartuna fiha 1 kunjett u 1 filtru sterili ta' użu ta' darba, non-piroġeniku għal MEPACT mogħti f'folja tal-PVC-grade.
English: Safety and efficacy have been assessed in studies of patients 2 to 30 years of age at initial diagnosis (see section 5.1).
Maltese: Is-sigurtà u l-effikaċja ġew evalwati fi studji ta' pazjenti ta' età bejn sentejn u 30 sena f'dijanjożi inizzjali (ara sezzjoni 5.1).
English: Excipients: Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC), 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodium salt (OOPS)
Maltese: Palmitoyl-2-oleoyl-sn-glycero-3-phosphocholine (POPC), 1,2-Dioleoyl-sn-glycero-3-phospho-L-serine monosodju melħ (OOPS)
English: MTP-PE is a potent activator of monocytes and macrophages.
Maltese: MTP-PE huwa attivatur qawwi ta' monoċiti u makrofaġi.
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull unità tad-dożaġġ.
English: The pharmacokinetics of mifamurtide have been characterised in healthy adult subjects following a 4 mg intravenous infusion and in paediatric and adult patients with osteosarcoma following a 2 mg/m intravenous infusion.
Maltese: Il-farmakokinetika ta' mifamurtide ġew karatterizzati f'individwi adulti u b'saħħithom wara infużjoni fil-vini ta' 4 mg u f'pazjenti pedjatriċi u adulti b'osteosarkoma wara infużjoni fil-vini ta' 2 mg/m2.
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%).
Maltese: Sintomi ġenerilizzati oħrajn li huma tipikament ħfief għal moderati u komuni ħafna inkludew ipotermja (23%), malaise (13%), uġigħ (15%), astenja (13%) u uġigħ fis-sider(11%).
English: Infections and infestations
Maltese: Infezzjonijiet u infestazzjonjiet
English: Gastrointestinal disorders were frequently associated with mifamurtide administration, including nausea (57%) and vomiting (44%) in about half of patients, constipation (17%), diarrhoea (13%) and abdominal pain (see section 4.4).
Maltese: Disturbi gastroitestinali kienu assoċjati frekwentement ma' għoti ta' mifamurtide, inklużi dardir (57%) u rimettar (44%) f'madwar nofs il-pazjenti, stitikezza (17%), dijarea (13%) u uġigħ addominali (ara sezzjoni 4.4).
English: Rash, Pruritis, Erythema, Alopecia, Dry skin
Maltese: Raxx, prurite, eritema, alopixja, ġilda xotta
English: Volume to withdraw = [12.5 x calculated dose (mg)] mL
Maltese: Volum lit rid tiġbed = [12.5 x doża kkalkulata (mg)] mL Għal konvenjenza, it-tabella ta' konkordanza segwenti hija pprovduta:
English: Chemical and physical stability has been demonstrated for 6 hours up to 25 ºC.
Maltese: Stabbilità kimika u fiżika ġiet murija għal 6 sigħat sa 25 ºC.
English: Phlebitis, Flushing, Pallor
Maltese: Flebite, fwawar, bjuda
English: Each mL reconstituted suspension contains 0.08 mg mifamurtide.
Maltese: Kull mL ta' suspensjoni rikonstitwita fiha 0.08 mg mifamurtide.
English: NN:
Maltese: Manifattur:
English: • 1 single use 60 or 100 mL sterile syringe with luer lock
Maltese: • Użu wieħed 60 jew 100 mL siringa sterili b'għeluq luer
English: Other medicines and MEPACT
Maltese: Mediċini oħra u MEPACT
English: MEPACT is used to treat osteosarcoma (bone cancer) in children, adolescents and young adults (between 2 and 30 years).
Maltese: MEPACT huwa użat biex jittratta ostjosarkoma (kanċer ta' l-għadam) fi tfal, adoloxxenti u adulti żgħażagħ (bejn 2 u 30 sena).
English: Skin and subcutaneous disorders Hyperhidrosis (11%) was very common in patients receiving mifamurtide in uncontrolled studies.
Maltese: Hiperidrosis (11%) kienet komuni ħafna f'pazjenti li rċevew mifamurtide fi studji mhux kontrollati.
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%).
Maltese: Disturbi muskoloskelettriċi u tat-tessuti konnettivi Uġigħ ta' grad baxx kien komuni ħafna f'pazjenti li qed jirċievu mifamurtide, inkluża mijalġja (31%), uġigħ addominali (15%), uġigħ fl-estremità (12%) u artralġja (10%).
English: Leukopenia, Thrombocytopenia, Granulocytopenia, Febrile neutropenia
Maltese: Lewkopenija, tromboċitopenija, granuloċitopenija, newtropenija bid-deni
English: The recommended dose of MEPACT is 2 mg mifamurtide/m body surface area.
Maltese: Id-doża rakkomandata ta' MEPACT hija ta' 2 mg mifamurtide/m2 erja tas-superfiċje korporali.
English: Each vial contains 4 mg mifamurtide*.
Maltese: Kull kunjett fih 4 mg ta' mifamurtide.
English: Chemical and physical in-use stability has been demonstrated for 6 hours at room temperature (between approximately 20 C-25 °C).
Maltese: Stabbilità ta'użu kimika u fiżika ġiet murija għal 6 sigħat f'temperatura ambjentali (bejn madwar 20 C - 25 °C). 15.
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.
Maltese: MEPACT huwa indikat għat-tfal, adoloxxenti u adulti żgħazagħ għat-trattament ta' osteosarkoma mhux metastatika ta' grad għoli u risettibbli wara risezzjoni kirurġika li tkun sħiħa u makroskopika.
English: • 2 medium (18) gauge sterile injection needles
Maltese: • 2 labriet tal-injezzjoni sterili gejġ (18) ta' daqs medju
English: Consistent with other generalised symptoms, the very common nervous system disorders were headache (50%) and dizziness (17%).
Maltese: Konsistenti ma' sintomi ġenerilizzati oħrajn, disturbi tas-sistema nervuża komuni ħafna kienu uġigħ ta' ras (50%) u sturdament (17%).
English: Paraesthesia, Hypoaesthesia, Tremor, Somnolence, Lethargy
Maltese: Paraesthesia, hypoaesthesia, rogħda, ħedla tan-ngħas, letarġija
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).
Maltese: Il-medja tal-half-lives tal-MTP-PE totali u ħieles fl-indeboliment tal-fwied ħafif kienu 2.02 sigħat u 1.99 sigħat, rispettivament, u kienu komparabbli ma' dawk f'suġġetti b'funzjoni epatika normali (2.15 sigħat u 2.26 sigħat, rispettivament).
English: BSA-normalised clearance and half-life were similar across the age range and consistent with that determined in healthy adult subjects, supporting the recommended dose of 2 mg/m
Maltese: It-tneħħija ta' BSA-normalizzati u l-half-life kienu simili madwar l-firxa tal-età u konsistenti ma' dak determinat f''individwi adulti u b'saħħithom, tappoġġja d-doża rakkomandata ta' 2 mg/m2.
English: The safety of liposomal mifamurtide has been assessed in more than 700 patients with various kinds and stages of cancer and in 21 healthy adult subjects (see section 4.8).
Maltese: Is-sigurtà ta' mifamurtide lipożomali ġiet assessjata f'iktar minn 700 pazjenti b'tipi u stadji diversi ta' kanċer u f'21 individwi adulti f'saħħithom (ara sezzjoni 4.8).
English: In vitro interaction studies showed that liposomal and non-liposomal mifamurtide do not inhibit the metabolic activity of cytochrome P450 in pooled human liver microsomes.
Maltese: Studji ta' interazzjoni in vitro urew li mifamurtide lipożomali u mhux-lipożomali ma jimpedixxux l-attività metabolika ta' ċitokroma P450 f'mikrosomi tal-fwied uman ippuljati.
English: One patient in the phase III study experienced 2 episodes of grade 4 seizure while on study therapy with chemotherapy and mifamurtide.
Maltese: III esperjenzaw żewġ episodji ta' aċċessjoni ta' grad 4 waqt terapija ta' studju b'kimoterapija u mifamurtide.
English: Muscle spasms, Neck pain, Groin pain, Bone pain, Shoulder pain, Chest wall pain, Musculoskeletal stiffness
Maltese: Spażmi tal-muskolu, uġigħ fl-għonq, groin pain, uġigħ fl-għadam, uġigħ fl-ispalla, uġigħ fil-ħajt tas-sider, egħbusija muskoloskelettrika
English: MEPACT contains the active substance mifamurtide, similar to a component of the cell wall of certain bacteria.
Maltese: MEPACT fih is-sustanza attiva mifamurtide, simili għall-komponent tal-ħajt taċ-ċellula ta' ċerti batterji.
English: MEPACT 4 mg powder for concentrate for dispersion for infusion mifamurtide
Maltese: MEPACT 4 mg trab għal konċentrat għal dispersjoni għall-infużjoni mifamurtide
English: Haematuria, Dysuria, Pollakiuria
Maltese: Deidratazzjoni, ipokalemija, tnaqqis fl-aptit
English: In a randomised controlled study, the incidence of myeloid malignancy (acute myeloid leukaemia/myelodysplastic syndrome) was the same in patients receiving MEPACT plus chemotherapy as in patients receiving only chemotherapy (2.1%).
Maltese: Fi studju randomised ikkontrollat, l-inċidenza ta' malinnità majelojde (lewkemija majelojde akuta/sindrome majelodisplastiku) kien l-istess f'pazjenti li qed jirċievu MEPACT flimkien ma' kimoterapija bħal f'pazjenti li qed jirċievu kimoterapija biss ( 2.1%).
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.
Maltese: Kunjett ta' 50 mL ta' ħġieġ ta' tip I b'tapp griż tal-lasktu butyl, siġill tal-aluminju u tapp flip-off, li fih 4 mg ta' mifamurtide.
English: Surgical and medical procedures
Maltese: Proċeduri kirurġiċi u mediċi Komuni
English: Powder for concentrate for dispersion for infusion 4 mg mifamurtide
Maltese: U KONTENUT Trab għal konċentrat għal dispersjoni għall-infużjoni 4 mg mifamurtide
English: There was no effect of mild hepatic impairment on the systemic exposure (AUCinf) of total MTP-PE.
Maltese: Ma kien hemm ebda effett ta' indeboliment tal-fwied ħafif fuq l-espożizzjoni sistemika (AUCinf) tal-MTP-PE totali.
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).
Maltese: Il-farmakokinetika ta' doża waħda ta' 4 mifamurtide wara infużjoni ta' siegħa ġol-vina ġew evalwati f'voluntiera adulti b'indeboliment ħafif (n = 9) jew moderat (n = 8) tal-kliewi u f'adulti b'saħħithom b'funzjoni renali normali (n = 16) mqabbla f'età, is-sess, u piż.
English: General disorders and administration site conditions The majority of patients experience chills (89%), fever (85%) and fatigue (53%).
Maltese: Disturbi ġenerali u kundizzonijiet ta' mnejn jingħata Il-maġġoranza ta' pazjenti esperjenzaw tertir ta' bard (89%), deni (85%) u għeja kbira (53%).
English: This medicine contains less than 1 mmol sodium (23 mg) per dosage unit, that is to say essentially ‘sodium-free'.
Maltese: Din il-mediċina fiha anqas minn 1 mmol sodium (23 mg) f'kull unità tad-dożaġġ, jiġifieri essenzjalment ‘ħieles mis-sodium'.
English: Sepsis, Cellulitis, Nasopharyngitis, Catheter site infection, Upper respiratory tract infection, Urinary tract infection, Pharyngitis, Herpes simplex infection
Maltese: Sepsis, ċellulite, nażofarinġite, infezzjoni fissit tal-kateter, infezzjoni fil-passaġġ repiratorju tan-naħa ta' fuq, infezzjoni talpassaġġi tal-awrina, farinġite, infezzjoni b' Herpes simplex
English: Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.
Maltese: Informazzjoni ddettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għall-Mediċini: http://www.ema.europa.eu.
English: MEPACT will be administered only under the supervision of a specialist physician.
Maltese: MEPACT se jingħata biss taħt is-superviżjoni ta' tabib speċjalista.
English: MTP-PE is a specific ligand of NOD2, a receptor found primarily on monocytes, dendritic cells and macrophages.
Maltese: MTP-PE huwa lingant speċifiku ta' NOD2, riċettur misjub primarjament f'monoċiti, ċelloli dentritiċi u makrofaġi.
English: Not known (cannot be estimated from the available data): - abnormal accumulation of fluid around the heart (pericardial effusion)
Maltese: Mhux magħruf (ma tistax tittieħed stima mid-data disponibbli): - żieda mhux normali ta' fluwidu madwar il-qalb (effużjoni perikardjali)