FrancophonIA/ELRC3.0 huggingface dataset:
English: The mean AUC0- was increased by 28 %, 302 % and 412 % in subjects with creatinine clearance of 50-79, 30-49 and 10-29 mL/min, respectively.
Maltese: L-AUC0- medja żdiedet bi 28 %, 302 % u 412 % f'suġġetti bi klirjanza tal-kreatinina ta' 50-79, 30-49 u 10-29 mL/min, rispettivament.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1269/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1269/001
English: At enrollment 85 % of the 296 subjects had a composite influenza symptom score <15.
Maltese: Meta rreġistraw 85 % tal-296 suġġett kellhom punteġġ ta' sintomi komposti tal-influwenza ta' <15.
English: Table 4: Key efficacy results from study 0722T0621 (ITTI Population) Peramivir 600 mg n=97
Maltese: Tabella 4: Ir-riżultati ewlenin tal-effikaċja mill-istudju 0722T0621 (Popolazzjoni ITTI) Peramivir 600 mg n=97
English: • blood tests showing increased levels of chloride, potassium, sodium, uric acid, protein total,
Maltese: • testijiet tad-demm li juru livelli ogħla ta' klorur, potassju, sodju, aċidu uriku, proteina totali,
English: Mean (SD) Geometric Mean %CV
Maltese: Medja (SD) Medja Ġeometrika %CV
English: The pharmacokinetics of peramivir following a 600 mg intramuscular (IM) injection was similar in males and females with AUC0-∞ of 76,600 ng•hr/mL and 101,000 ng•hr/mL, respectively, and Cmax of 27,760 ng/mL and 34,710 ng/mL, respectively.
Maltese: Il-farmakokinetiċi ta' peramivir wara injezzjoni ta' 600 mg fil-muskolu (IM) kienet simili fl-irġiel u fin-nisa b'AUC0-∞ ta' 76,600 ng•hr/mL u 101,000 ng•hr/mL, rispettivament, u Cmax ta' 27,760 ng/mL u 34,710 ng/mL, rispettivament.
English: Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000).
Maltese: Il-frekwenzi huma definiti bħala: komuni ħafna (≥1/10), komuni (>1/100 sa <1/10), mhux komuni (>1/1000 sa <1/100), rari (>1/10,000 sa <1/1000), rari ħafna (<1/10,000).
English: Marketing Authorisation Holder BioCryst Ireland Limited Atlantic Avenue
Maltese: BioCryst Ireland Limited Atlantic Avenue
English: Uncomplicated influenza in adults
Maltese: Influwenza mhux ikkumplikata fl-adulti
English: • blood test showing increased levels of alanine aminotransferase, aspartate aminotransferase
Maltese: • test tad-demm juri livelli ogħla ta' aminotransferażi tal-alanina, ta' aminotransferażi tal-aspartat
English: Randomisation was 4:1 for peramivir and oseltamivir.
Maltese: Ir-randomizzazzjoni kienet ta' 4:1 għal peramivir u oseltamivir.
English: • abnormal behaviour, delirium
Maltese: • mġiba anormali, delirju
English: • Visually inspect the peramivir concentrate 10 mg/mL.
Maltese: • Osserva l-konċentrat ta' peramivir 10 mg/mL.
English: Based on a population pharmacokinetic analysis, the central volume of distribution was 12.56 L.
Maltese: Abbażi tal-analiżi tal-popolazzjoni farmakokinetika, il-volum ċentrali tad-distribuzzjoni kien 12.56 L.
English: %CV SD = Standard Deviation; CV = Coefficient of Variation
Maltese: %CV SD = Devjazzjoni Standard; CV = Koeffiċjent ta' Varjazzjoni
English: 2 years - <7 years
Maltese: Sentejn - <7 snin
English: Among the 97 subjects enrolled in the peramivir 600 mg dose group, 99 % were infected with influenza A virus (subtypes H1 and H3; 71 % and 26 %, respectively) and 1 % with influenza B virus.
Maltese: Fost is-97 suġġett irreġistrati fil-grupp tad-doża ta' 600 mg peramivir, 99 % kienu infettati bil-virus tal-influwenza A (subtipi H1 u H3; 71 % u 26 %, rispettivament) u 1 % bil-virus tal-influwenza B.
English: • Adults and adolescents (13 years and older) receive 600 mg (3 Alpivab vials).
Maltese: • L-adulti u l-adolexxenti (13-il sena 'l fuq) jirċievu 600 mg (3 kunjetti ta' Alpivab).
English: Each mL of concentrate contains 0.154 millimole (mmol) sodium, which is 3.54 mg of sodium.
Maltese: Kull mL ta' konċentrat fih 0.154 millimole (mmol) ta' sodju, li huwa 3.54 mg ta' sodju.
English: Table 2: Peramivir dose for adults and adolescents (from 13 years and 50 kg) based on absolute GFR Absolute Glomerular Filtration Rate (GFR)*
Maltese: Tabella 2: Doża ta' peramivir għall-adulti u l-adolexxenti (minn 13-il sena u minn 50 kg 'l fuq) abbażi tal-GFR assolut Rata ta' Filtrazzjoni Glomerulari (GFR)* assoluta
English: The elderly subjects enrolled were aged 65 to 79 years, with a mean age of 70.1 years, with creatinine clearance (Cockcroft-Gault calculation) CrClcg ranging from 82.8 mL/min to 197.9 mL/min.
Maltese: Is-suġġetti anzjani rreġistrati kellhom bejn 65 u 79 sena, b'età medja ta' 70.1 sena, b'eliminazzjoni ta' kreatinina (kalkolu Cockcroft-Gault) CrClcg tvarja minn 82.8 mL/min sa 197.9 mL/min.
English: Time to recovery of normal temperature median (hours) (95 % CI)
Maltese: Ħin sal-irkupru tat-temperatura normali medja (sigħat) (95 % CI)
English: The mean temperature at enrolment was 38.6 °C (axillary).
Maltese: It-temperatura (taħt l-abt) medja firreġistrazzjoni kienet ta' 38.6 °C.
English: What you need to know before you are given Alpivab 3.
Maltese: X'għandek tkun taf qabel ma tingħata Alpivab 3.
English: Skin and subcutaneous tissue disorders dermatitis, drug eruption, eczema, urticaria erythema multiforme dermatitis exfoliative*, Stevens-Johnson syndrome*
Maltese: Disturbi fil-ġilda u fit-tessuti ta' taħt ilġilda dermatite, raxx millmediċina, ekżema, ħakk eritema multiformi dermatite esfoljattiva*, sindrome ta' StevensJohnson*
English: Follow the steps below in the provided order to prepare a diluted solution of Alpivab:
Maltese: Segwi l-passi li ġejjin fl-ordni mogħtija sabiex tħejji soluzzjoni dilwita ta' Alpivab:
English: In a clinical trial in which 245 subjects were infected at baseline with influenza A/H1N1 containing the H275Y mutation, the median baseline IC50 values for peramivir, oseltamivir and zanamivir were 51.0 nM, 487.6 nM and 0.95 nM, respectively.
Maltese: Fi prova klinika li fiha 245 suġġett kienu infettati fil-linja bażi bl-influwenza A/H1N1 li fih ilmutazzjoni tal-H275Y, il-valuri IC50 medjani tal-linja bażi għal peramivir, oseltamivir u zanamivir kienu 51.0 nM, 487.6 nM u 0.95 nM, rispettivament.
English: Dilute the required dose of Alpivab concentrate in sodium chloride 9 mg/mL (0.9 %) or 4.5 mg/mL (0.45 %) solution for infusion, 5 % dextrose or Ringer lactate solution to a volume of 100 mL.
Maltese: Iddilwixxi d-doża meħtieġa ta' konċentrat ta' Alpivab f'9 mg/mL (0.9 %) ta' klorur tas-sodju jew f'4.5 mg/mL (0.45 %) soluzzjoni għal infużjoni, 5 % destrożju jew soluzzjoni Ringer lactate għal volum ta' 100 mL. 6.
English: 2 years - <18 years
Maltese: Sentejn - <18 snin
English: This is equivalent to 10.6 % of the recommended maximum daily dietary intake of sodium for an adult.
Maltese: Dan huwa ekwivalenti għal 10.6 % tad-doża massima ta' sodju rakkomandata kuljum għal adult.
English: Recommended single dose 600 mg
Maltese: Doża waħda rakkomandata 600 mg
English: Musculoskeletal and connective tissue disorders arthralgia, blood creatine phosphokinase increased
Maltese: Disturbi muskoluskeletriċi u tat-tessuti konnettivi artralġja, żieda fil-kreatina fosfokinase fid-demm
English: Among 467 adult subjects with uncomplicated influenza who received a single intravenous dose of peramivir 600 mg in clinical trials, the most commonly observed adverse reactions were neutrophil count decreased (3.2 %) and nausea (2.4 %).
Maltese: Fost 467 suġġett adult b'influwenza mhux ikkumplikata li ngħataw doża waħda ġol-vina ta' peramivir 600 mg fi provi kliniċi, l-aktar reazzjonijiet avversi osservati b'mod komuni kienu tnaqqis fl-għadd ta' newtrofili (3.2 %) u dardir (2.4 %).
English: • blood tests showing decreased levels of albumin, glucose, lactate dehydrogenase
Maltese: • testijiet tad-demm li juru livelli baxxa ta' albumina, glukożju, lattatdeidroġenażi
English: Alpivab is indicated for the treatment of uncomplicated influenza in adults and children from the age of 2 years (see sections 4.4 and 5.1).
Maltese: Alpivab huwa indikat għall-kura tal-influwenza mhux kumplikata fl-adulti u fit-tfal mill-età ta' sentejn (ara s-sezzjonijiet 4.4 u 5.1).
English: In a clinical trial, no statistically significant clinical benefit could be demonstrated for peramivir over placebo in patients infected with the A/H1N1 virus containing the H275Y mutation.
Maltese: Fi studju kliniku, ma seta' jintwera ebda benefiċċju kliniku statistikament sinifikanti għal peramivir meta mqabbel mal-plaċebo f'pazjenti infettati bil-virus A/H1N1 li fih il-mutazzjoni H275Y.
English: In simulations of a single dose of 600 mg, the predicted AUC in Asians (AUC0-24 88,800 ng•h/mL) was slightly higher as compared to Non-Asians (AUC0-24 77,200 ng•h/mL).
Maltese: F'simulazzjonijiet ta' doża waħda ta' 600 mg, l-AUC mbassra fl-Asjatiċi (AUC0-24 88,800 ng•h/mL) kienet xi ftit ogħla meta mqabbla ma' dawk Mhux Asjatiċi (AUC0-24 77,200 ng•h/mL).
English: (3 vials with 20 mL each).
Maltese: 60 mL (3 kunjetti ta' 20 mL kull wieħed).
English: Nervous system disorders hypoaesthesia, paraesthesia
Maltese: Disturbi fis-sistema nervuża ipoestesija, parestesija
English: Other medicines and Alpivab
Maltese: Mediċini oħra u Alpivab
English: The intent to treat influenza population (ITTI) included 296 subjects with influenza confirmed by polymerase chain reaction (PCR).
Maltese: L-intenzjoni tal-kura tal-popolazzjoni bl-influwenza (ITTI) kienet tinkludi 296 suġġett bl-influwenza kkonfermata permezz ta' reazzjoni katina bil-polimerażi (PCR).
English: Gastrointestinal disorders nausea, vomiting abdominal pain upper, abdominal discomfort, gastritis
Maltese: Disturbi gastrointestinali dardir, rimettar uġigħ fin-naħa ta' fuq taladdome, skonfort addominali, gastrite
English: Risk of bacterial infections
Maltese: Riskju ta' infezzjonijiet batteriċi
English: STATEMENT OF ACTIVE SUBSTANCE(S) 1 mL concentrate contains 10 mg peramivir (anhydrous base).
Maltese: ATTIVA(I) 1 mL ta' konċentrat fih 10 mg ta' peramivir (bażi anidruża).
English: Table 3: Adverse reactions in studies investigating peramivir for treatment of uncomplicated influenza in adults
Maltese: Tabella 3: Ir-reazzjonijiet avversi fi studji li investigaw peramivir għall-kura tal-influwenza mhux ikkumplikata fl-adulti
English: 13 years - <18
Maltese: 13-il sena - <18-il sena
English: Each 20 mL vial contains 200 mg peramivir.
Maltese: Kull kunjett ta' 20 mL fih 200 mg peramivir.
English: Mean peak concentrations of peramivir were approximately 10 % higher in elderly subjects following administration of a single dose when compared to young adults (22,647 vs. 20,490 ng/mL, respectively).
Maltese: Il-konċentrazzjonijiet massimi medji ta' peramivir kienu madwar 10 % ogħla fis-suġġetti anzjani wara l-għoti ta' doża waħda meta mqabbla ma' adulti żgħażagħ (22,647 vs. 20,490 ng/mL, rispettivament).
English: A randomised, multicentre, double-blind trial conducted in Japan evaluated a single intravenous administration of peramivir 300 mg or 600 mg, or placebo administered over 30 minutes in subjects 20 to 64 years of age with uncomplicated influenza.
Maltese: Prova aleatorja, double-blind u li saret f'diversi ċentri fil-Ġappun evalwat amministrazzjoni waħda ta' 300 mg jew 600 mg peramivir ġol-vini, jew plaċebo mogħti fuq 30 minuta f'suġġetti ta' bejn l-20 u l64 sena b'influwenza mhux ikkumplikata.
English: Alpivab 200 mg concentrate for solution for infusion peramivir
Maltese: Alpivab 200 mg konċentrat għal soluzzjoni għal infużjoni peramivir
English: Chemical and physical in-use stability has been demonstrated for 72 hours at 5 ºC and 25 ºC.
Maltese: L-istabbiltà kimika u fiżika waqt l-użu ntweriet għal 72 siegħa f'temperatura ta' 5˚C u ta' 25˚C.
English: UNITED KINGDOM
Maltese: Reżistenza
English: System Organ Class (SOC)
Maltese: Sistema talKlassifika talOrgani
English: It is first diluted and then given into a vein by infusion (drip), over 15 to 30 minutes.
Maltese: L-ewwel tiġi dilwita u mbagħad tingħata f'vina permezz ta' infużjoni (dripp), għal 15 sa 30 minuta.
English: Resistance to peramivir
Maltese: Reżistenza għal peramivir
English: Anaphylactic reactions and serious skin reactions (including erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported with peramivir (see section 4.8).
Maltese: Kien hemm rapporti ta' reazzjonijiet anafilattiċi u reazzjonijiet serji tal-ġilda (fosthom eritema multiformi, nekroliżi epidermali tossika u s-sindrome ta' Stevens-Johnson) b'peramivir (ara sezzjoni 4.8).
English: Acute renal failure, renal failure, pre-renal failure, renal disorder, anuria, nephritis, and increased blood creatinine have been reported in patients with influenza who were receiving peramivir.
Maltese: Ġew rappurtati insuffiċjenza tal-kliewi akuta, insuffiċjenza tal-kliewi, insuffiċjenza pre-renali, disturbi fil-kliewi, anurja, nefrite, u żieda fil-kreatinina tad-demm f'pazjenti bl-influwenza li kienu qed jingħataw peramivir.
English: In-vitro binding of peramivir to human plasma proteins is less than 30 %.
Maltese: It-twaħħil in vitro ta' peramivir mal-proteini tal-plażma umana hu inqas minn 30%.
English: Serum creatinine measurements were used to calculate creatinine clearance (Cockcroft-Gault equation).
Maltese: Intuża kejl tal-kreatinina fis-serum sabiex tiġi kkalkulata l-klirjanza tal-kreatinina (ekwazzjoni Cockcroft-Gault).
English: Alpivab contains the active substance peramivir which belongs to a group of medicines called neuraminidase inhibitors.
Maltese: Alpivab fih is-sustanza attiva peramivir li tappartjenti għal grupp ta' mediċini msejħa inibituri tannewroaminidażi.
English: Each carton contains 3 vials.
Maltese: Kull kartuna fiha 3 kunjetti.
English: Inspect the Alpivab concentrate.
Maltese: Osserva sew il-konċentrat ta' Alpivab.
English: 1 mL concentrate for solution for infusion contains 10 mg peramivir (anhydrous base).
Maltese: 1 mL konċentrat għal soluzzjoni għal infużjoni fih 10 mg peramivir (bażi anidruża).
English: Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Maltese: Ipersensittività għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkata fissezzjoni 6.1.
English: Serious hypersensitivity reactions
Maltese: Reazzjonijiet ta' ipersensittività serji
English: • increased level of urine ketone body
Maltese: • preżenza ta' urobilina fl-urina
English: The pharmacokinetics of peramivir was evaluated in 20 elderly subjects (>65 years of age) following a single 4 mg/kg IV dose of peramivir.
Maltese: Il-farmakokinetika ta' peramivir kienet evalwata f'20 suġġett anzjan (>65 sena) wara doża waħda ta' 4 mg/kg IV ta'peramivir.
English: Uncomplicated influenza in paediatric subjects aged 2-17 years The safety of peramivir was evaluated in a randomised, active-controlled study of 110 subjects with uncomplicated influenza who received open label treatment with a single dose of peramivir (600 mg for subjects 13 to 17 years of age and 12 mg/kg up to a maximum dose of 600 mg in subjects 2 to 12 years of age) or oral oseltamivir administered twice daily for 5 days.
Maltese: Influwenza mhux ikkumplikata fis-suġġetti pedjatriċi ta' bejn is-sentejn u s-17-il sena Is-sigurtà ta' peramivir kienet evalwata fi studju aleatorju, ikkontrollat b'komparatur, ta' 110 suġġetti b'influwenza mhux ikkumplikata li rċevew kura miftuħa b'doża waħda ta' peramivir (600 mg għassuġġetti ta' bejn it-13 u s-17-il sena u 12 mg/kg sa doża massima ta' 600 mg f'suġġetti bejn is-sentejn u t-12-il sena) jew oseltamivir orali mogħti darbtejn kuljum għal ħamest ijiem.
English: Exposure (AUC0-12) to peramivir following a single dose was approximately 33 % higher in elderly subjects compared to young adults (61,334 vs. 46,200 ng•hr/mL, respectively).
Maltese: L-esponiment (AUC0-12) għal peramivir wara doża waħda kien madwar 33 % ogħla fis-suġġetti anzjani meta mqabbla mal-adulti żgħażagħ (61,334 vs.
English: 6.6 Special precautions for disposal and other handling Aseptic technique should be used during the preparation of Alpivab to prevent inadvertent microbial contamination.
Maltese: .6 Prekawzjonijiet speċjali għar-rimi u għal immaniġġar ieħor Għandha tintuża teknika asettika waqt it-tħejjija ta' Alpivab sabiex tiġi evitata l-kontaminazzjoni involontarja mill-mikrobi.
English: In a study in subjects with various degrees of renal impairment and subjects with normal renal function, a single 2 mg/kg IV dose of peramivir was administered.
Maltese: Fi studju f'suġġetti b'diversi gradi ta' indeboliment tal-kliewi u suġġetti b'funzjoni normali tal-kliewi, ingħatat doża waħda ta' 2 mg/kg IV ta' peramivir.
English: The pharmacokinetic parameters following intravenous (IV) administration of peramivir (0.17 to 2 times the recommended dose) showed a linear relationship between dose and exposure parameters (maximum serum concentration [Cmax] and area under the curve [AUC]).
Maltese: Il-parametri farmakokinetiċi wara l-għoti ta' peramivir (0.17 sa darbtejn id-doża rakkomandata) minn ġol-vina (IV) urew relazzjoni lineari bejn id-doża u l-parametri tal-espożizzjoni (konċentrazzjoni massima fis-serum [Cmax] u l-erja taħt il-kurva
English: Table 5: Pharmacokinetic parameters in paediatric subjects
Maltese: Il-parametri farmakokinetiċi f'suġġetti pedjatriċi
English: In paediatric subjects (age 2 to 17 years) with uncomplicated influenza enrolled in a clinical trial, the safety profile of peramivir was similar to that reported in adults.
Maltese: Fis-suġġetti pedjatriċi (ta' bejn is-sentejn u s-17-il sena) b'influwenza mhux ikkumplikata rreġistrati fi prova klinika, il-profil tas-sigurtà ta' peramivir kien simili għal dak irrappurtat fl-adulti.
English: Children aged from 2 years and <50 kg
Maltese: Tfal minn sentejn 'il fuq u <50 kg
English: However, in an embryo-foetal development study in rats, in which dams received continuous infusions of peramivir from day 6-17 of gestation at doses of 50, 400 or 1000 mg/kg/day, dose related increases in the incidences of reduction of the renal papillae and dilatation of the ureters were observed.
Maltese: Madankollu, fl-istudji dwar l-iżvilupp tal-embriju-fetu fil-firien, li fihom il-firien nisa ngħataw infużjonijiet kontinwi ta' peramivir mill-jum 6-17 tal-ġestazzjoni f'dożi ta' 50, 400 jew 1000 mg/kg/kuljum, ġew osservati żidiet fl-inċidenzi ta' tnaqqis tal-papilli tal-kliewi u dilatazzjoni talureteri relatati mad-doża.
English: Elderly No dose adjustment is required based on age (see sections 4.4 and 5.2).
Maltese: L-ebda aġġustament tad-doża mhuwa meħtieġ abbażi tal-età (ara sezzjonijiet 4.4 u 5.2).
English: Neuraminidase inhibition occurred at very low peramivir concentrations in-vitro, with median inhibitory concentration 50% (IC50) values of 0.13 nanomolar (nM) to 0.99 nM against influenza A and B strains.
Maltese: L-inibizzjoni tan-newroaminidażi seħħet f'konċentrazzjonijiet baxxi ħafna ta' peramivir in-vitro, b'valuri ta' konċentrazzjoni inibitorja medjana ta' 50% (IC50) ta' 0.13 nanomolar (nM) għal 0.99 nM kontra r-razez tal-influwenza A u B.
English: Immune system disorders anaphylactic reaction*, anaphylactic shock*
Maltese: Disturbi fis-sistema immuni reazzjoni anafilattika*, xokk anafilattiku*
English: Peramivir was not mutagenic or clastogenic in a battery of in-vitro and in-vivo assays.
Maltese: Peramivir ma kienx mutaġeniku jew klastoġeniku f'sensiela ta' assaġġi in-vitro u in-vivo.
English: Among the 93 subjects enrolled in the peramivir dose group, 43% were infected with influenza A virus (subtypes H1 and H3; 54 % and 46 %, respectively) and 27% with influenza B virus.
Maltese: Il-popolazzjoni ITTI kienet tinkludi 84 suġġett bl-influwenza kkonfermata permezz ta' PCR. Fost it-93 suġġett irreġistrati fil-grupp tad-doża ta' peramivir, 43% kienu infettati bil-virus tal-influwenza A (subtipi H1 u H3; 54 % u 46 %, rispettivament) u 27% bil-virus tal-influwenza B.
English: • Children aged from 2 years weighing 50 kg or more receive 600 mg (3 Alpivab vials).
Maltese: • It-tfal ta' bejn is-sentejn li jiżnu 50 kg jew aktar jirċievu 600 mg (3 kunjetti ta' Alpivab).
English: Alpivab is administered via intravenous infusion for 15 to 30 minutes.
Maltese: Alpivab jingħata permezz ta' infużjoni ġol-vini għal 15 sa 30 minuta.
English: Time to alleviation of symptoms median (hours) (95 % CI)
Maltese: Ħin sakemm ittaffew is-sintomi medjan (sigħat) (95 % CI)
English: Psychiatric disorders insomnia abnormal behaviour*, delirium*
Maltese: Disturbi psikjatriċi insomnija mġiba anormali*, delirju*
English: Pharmacokinetics of peramivir in subjects 2 to 17 years of age (administered 12 mg/kg or 600 mg according to age and body weight) and in healthy adults (administered 600 mg) was similar (Table 5).
Maltese: Il-farmakokinetiċi ta' peramivir f'suġġetti ta' bejn sentejn u 17-il sena (mgħotija 12 mg/kg jew 600 mg skont l-età u l-piż tal-ġisem) u f'adulti b'saħħithom (mogħtija 600 mg) kienu simili (Tabella 5).
English: Hydrochloric acid (for pH adjustment)
Maltese: Aċidu idrokloriku (għall-aġġustament tal-pH)
English: Table 1: Peramivir dose based on age and body weight Age and body weight
Maltese: Tabella 1: Id-doża ta' peramivir skont l-età u l-piż tal-ġisem Età u piż tal-ġisem
English: Live attenuated influenza vaccines are not recommended to be used until 48 hours following Alpivab administration due to a theoretical risk that peramivir could reduce the immunogenicity of the vaccine.
Maltese: Mhux irrakkomandat li jintużaw vaċċini ħajjin tal-influwenza sa 48 siegħa wara li jingħata Alpivab minħabba riskju teoretiku li peramivir jista' jnaqqas l-immunoġeniċità tal-vaċċin.
English: Common adverse reactions not reported in adults were injection site rash, pyrexia, tympanic membrane hyperaemia, psychomotor hyperactivity, and pruritus.
Maltese: Reazzjonijiet avversi komuni mhux irrappurtati fl-adulti kienu raxx fis-sit tal-injezzjoni, deni, iperimija talmembrana timpanika, iperattività psikomotorja, u ħakk.
English: *Absolute GFR not adjusted for body surface area
Maltese: *GFR assolut mhux aġġustat għall-erja tas-superfiċje tal-ġisem
English: Haemodialysis initiated at 2 hours after dosing reduced systemic exposure of peramivir by 73 to 81 %.
Maltese: Id-dijalisi tad-demm mibdija sagħtejn wara l-għoti tad-doża naqqset l-esponiment sistemiku ta' peramivir bi 73 sa 81 %.
English: In the case of a 300 mg peramivir dose, 30 mL (1½ vials) of Alpivab concentrate is needed and for a 200 mg dose, only 20 mL (1 vial).
Maltese: F'każ ta' doża ta' 300 mg peramivir, jenħtieġu 30 mL (kunjett u nofs) konċentrat ta' Alpivab u għal doża ta' 200 mg, jenħtieġu biss 20 mL (kunjett wieħed).
English: Most of the cases occurred in elderly patients with comorbidities and multiple concomitant medicinal products.
Maltese: Ħafna mill-każijiet seħħew f'pazjenti anzjani b'komorboditajiet u diversi prodotti mediċinali konkomitanti.
English: Alpivab contains sodium
Maltese: Kif jidher Alpivab u l-kontenut tal-pakkett
English: Subjects were eligible if they had fever greater than 38 °C and a positive rapid antigen test for influenza virus, accompanied by at least two of the following symptoms: cough, nasal symptoms, sore throat, myalgia, chills/sweats, malaise, fatigue or headache.
Maltese: Is-suġġetti kienu eliġibbli jekk kellhom deni ta' aktar minn 38 °C u test tal-antiġenu rapidu pożittiv għall-virus tal-influwenza, akkumpanjat minn mill-inqas tnejn minn dawn is-sintomi: sogħla, sintomi tal-imnieħer, uġigħ fil-griżmejn, mijalġija, tkexkix/għaraq, telqa, għeja jew uġigħ ta' ras.
English: The H275Y substitution is associated with reduced susceptibility to peramivir and oseltamivir.
Maltese: Is-sostituzzjoni tal-H275Y hija assoċjata ma' suxxettibbiltà mnaqqsa għal peramivir u għal oseltamivir.
English: Pharmacotherapeutic group: Antivirals for systemic use, neuraminidase inhibitors ATC code: J05AH03
Maltese: Antivirali għal użu sistemiku, inibituri tal-newroaminidażi Kodiċi ATC: