FrancophonIA/ELRC3.0 huggingface dataset:
English: It is unlikely that the undesirable systemic side effects associated with oral retinoids will be observed with the use of Panretin gel because the range and frequency of quantifiable 9-cis-retinoic acid plasma levels concentrations after application of the medicinal product were comparable to the range and frequency of quantifiable plasma concentrations of circulating, naturally occurring 9-cis-retinoic acid in untreated individuals.
Maltese: Mhux probabbli li l-effetti sekondarji sistemiċi mhux mixtieqa assoċjati ma' retinojdi li jittieħdu mill-ħalq ser ikunu osservati bl-użu tal-ġell Panretin minħabba li l-medda u l-frekwenza tal-livelli tal-konċentrazzjonijiet li jistgħu jiġu kkwantifikati, ta' 9-cis-retinoic acid fil-plażma wara l-użu tal-prodott mediċinali, kienu kumparabbli mal-medda u l-frekwenza ta' konċentrazzjonijiet li jistgħu jiġu kkwantifikati, ta' 9-cis-retinoic acid, li jiċċirkola u li jseħħ b'mod naturali fil-plażma ta' individwi li ma kinux ikkurati.
English: • OTHER CONDITIONS
Maltese: • KONDIZZJONIJIET OĦRA
English: For cutaneous use.
Maltese: U KWANTITATTIVA
English: Lesions
Maltese: Infezzjoni
English: However, it is not currently certain to what extent topical treatment with Panretin gel would increase 9-cis-retinoic acid plasma concentrations, in women with KS above naturally occurring levels; therefore, Panretin is contraindicated ( see section 4.3) in pregnancy, or in women planning a pregnancy.
Maltese: Madankollu, bħalissa mhuwiex ċert sa liema punt il-kura topika bil-ġell Panretin tista' żżid il-konċentrazzjonijiet ta' 9-cis-retinoic acid fil-plażma, f'nisa b'KS f'livelli ogħla minn dawk li jseħħu b'mod naturali; għalhekk, Panretin hu kontra-indikat (ara sezzjoni 4.3) fit-tqala, jew f'nisa li qed jippjanaw tqala.
English: Increased redness, possible oedema
Maltese: Żieda fil-ħmura, edima possibbli
English: Local dermal toxicity associated with Panretin gel therapy generally resolved with treatment adjustment or discontinuation (see section 4.2).
Maltese: It-tossiċità lokali fil-ġilda assoċjata mal-kura bil-ġell Panretin ġeneralment tneħħiet bl-aġġustament jew bit-twaqqif tal-kura (ara sezzjoni 4.2).
English: Common (can occur in less than 1 in 10 but in more than 1 in 100 patients treated): Flaking, peeling, dry skin
Maltese: Komuni (jistgħu jseħħu f'anqas minn 1 minn kull 10 pazjenti, iżda f'aktar minn 1 minn kull 100 pazjent ikkurat):
English: Number of Responding
Maltese: Numru ta' dawk li Rrispondew
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2)
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Orally administered retinoids have been associated with congenital abnormalities.
Maltese: Disturbi ġenerali u kondizzjonijiet ta' mnejn jingħata
English: Apply Panretin to your KS lesions using a clean finger.
Maltese: Panretin hu ġell isfar trasparenti.
English: OUTER CARTON TEXT AND TUBE LABEL TEXT
Maltese: KLIEM FUQ IL-KARTUNA TA' BARRA U FUQ IT-TIKKETTA TAL-ISTOĊĊ
English: The patient response rate was evaluated using the AIDS Clinical Trials Group (ACTG) criteria for lesion response in KS. Study 1 included an open-label phase, in which patients themselves elected to enroll.
Maltese: Studju 1 inkluda fażi open-label, li fiha l-pazjenti nfushom għażlu li jirreġistraw.
English: How to store Panretin
Maltese: Kif tapplika Panretin:
English: While no data are available, it is possible that co-administration of medicinal products which induce CYP isozymes may reduce circulating levels of alitretinoin, with a possible negative effect on the efficacy of Panretin gel.
Maltese: Filwaqt li m'hemmx tagħrif disponibbli, hu possibbli li l-għoti flimkien ta' prodotti mediċinali li jinduċu l-isozimi CYP, jista' jnaqqas il-livelli ta' alitretinoin li jiċċirkola fil-ġisem, u dan jista' jkollu effett negattiv fuq l-effikaċja tal-ġell Panretin.
English: However, because of the potential for undesirable effects from Panretin gel in infants being breast-fed, mothers must discontinue breast-feeding prior to using the medicinal product and not initiate breast-feeding while using the medicinal product.
Maltese: Il-ġell Panretin hu mistenni li jkollu effetti terapewtiċi lokali biss u m'għandu l-ebda sehem fil-prevenzjoni jew fil-kura ta' KS vixxerali.
English: The projected time for lesions that were in partial response (PR) to later attain clinical complete response (CCR) was 168 days.
Maltese: Il-ħin ikkalkulat għal-leżjonijiet li kellhom rispons parzjali (PR) biex aktar tard jiksbu rispons kliniku sħiħ (CCR) kien ta' 168 jum.
English: Observed effects at the application site included erythema, epidermal thickening, scaling and loosening of the stratum corneum.
Maltese: L-effetti osservati fis-sit tal-applikazzjoni kienu jinkludu eritema, ġilda li ħxienet, qxur li jitfarfar u llaxkar tal-istratum corneum.
English: Although the molecular action of alitretinoin is thought to be mediated through interaction with the retinoid receptors, the exact mechanism of action of this medicinal product in the topical treatment of cutaneous lesions of AIDS-related KS is unknown.
Maltese: Għalkemm hu maħsub li l-azzjoni molekulari ta' alitretinoin tkun medjata permezz ta' interazzjoni mar-riċetturi retinojdi, il-mekkaniżmu preċiż tal-azzjoni ta' dan il-prodott mediċinali fil-kura topika ta' leżjonijiet tal-ġilda ta' KS marbuta mal-AIDS mhuwiex magħruf.
English: B. PACKAGE LEAFLET
Maltese: C OBBLIGAZZJONIJIET SPEĊIFIĊI
English: Uncommon
Maltese: Irġiel
English: Pale skin
Maltese: Irġiel anzjani
English: However, the incidence of other equally common drug-related adverse events such as pruritus, oedema, exfoliative dermatitis and dry skin did not appear to increase as a function of the frequency of application.
Maltese: Madankollu, l-inċidenza ta' avvenimenti avversi oħrajn marbuta mal-mediċina, li huma komuni bl-istess mod, bħal ħakk, edima, dermatite bil-qxur u ġilda xotta, ma jidhirx li jiżdiedu minħabba l-frekwenza tal-applikazzjoni tal-ġell.
English: Based on the plasma concentrations observed in patients, milk concentrations of 9-cis-retinoic acid probably pose a low risk for the infant.
Maltese: Ibbażat fuq konċentrazzjonijiet fil-plażma osservati fil-pazjenti, konċentrazzjonijiet fil-ħalib ta' 9-cis-retinoic acid probabbilment għandhom riskju baxx għat-tarbija.
English: Pregnancy
Maltese: AĠĠUSTAMENTI
English: • Treatment of KS lesions in close proximity to other skin disorders.
Maltese: • Kura ta' leżjonijiet ta' KS li huma qrib ħafna ta' disturbi oħrajn fil-ġilda.
English: Animal toxicology studies showed increased DEET toxicity when DEET was included as part of the formulation.
Maltese: Studji tossikoloġiċi li saru fuq l-annimali wrew żieda fit-tossiċità tad-DEET meta d-DEET kien inkluż bħala parti mill-formulazzjoni.
English: It is supplied in a multi-use 60 g epoxy-lined aluminium tube.
Maltese: Is-sarkoma ta' Kaposi marbuta mal-AIDS mhijiex frekwenti f'din il-popolazzjoni.
English: - Avoid prolonged exposure of the treated area to sunlight or other ultraviolet (UV) light (such as tanning lamps).
Maltese: - Evita espożizzjoni fit-tul tal-parti kkurata għad-dawl tax-xemx jew għal xi dawl ultravjola (UV) ieħor (bħal-lampi li jintużaw biex wieħed jismar).
English: Skin ulcer
Maltese: Ulċera fil-ġilda
English: Very common
Maltese: Ġell.
English: Frequency of application
Maltese: It-tul tal-applikazzjoni
English: Two controlled, multicentre, randomised, double blind parallel group, Phase III studies provided the data for Panretin gel in the treatment of index cutaneous lesions of KS (Table 4).
Maltese: III, ipprovdew it-tagħrif għall-ġell Panretin fil-kura ta' leżjonijiet indiċi fil-ġilda ta' KS (Tabella 4).
English: Percentages calculated as number of patients with responding lesions divided by total number of patients in the initial blinded phase.
Maltese: Il-perċentwali kkalkulati bħala n-numru ta' pazjenti b'leżjonijiet li rrispondew, diviż bin-numru totali ta' pazjenti fil-fażi blinded inizjali.
English: Alitretinoin was shown to have a weak potential to be a photo-irritant based on histidine and photoprotein binding.
Maltese: Intwera li alitretinoin għandu potenzjal dgħajjef li jkun foto-irritant ibbażat fuq it-twaħħil ma' histidine u fotoproteini.
English: No gross malformations were observed following oral administration to rabbits of doses 12 times the human topical dose (which resulted in plasma concentrations 60 times the highest observed plasma concentration in patients with KS following topical application of the gel).
Maltese: Stoċċijiet miftuħin tal-ġell Panretin m'għandhomx jinħażnu f'temperatura 'l fuq minn 25 °C, u għandhom ikunu protetti mill-espożizzjoni għal dawl qawwi u sħana (eż., xemx diretta).
English: In this latter group, the range and frequency of detection of quantifiable 9-cis-retinoic acid plasma concentrations in patients with KS after application of the medicinal product were comparable to the range and frequency of detection of quantifiable plasma concentrations of circulating, naturally-occurring 9-cis-retinoic acid in untreated individuals.
Maltese: F'dan il-grupp tal-aħħar, il-medda u l-frekwenza tal-osservazzjoni ta' konċentrazzjonijiet li jistgħu jiġu kkwantifikati, ta' 9-cis-retinoic acid fil-plażma f'pazjenti li qed ibatu minn KS wara li wżaw il-prodott mediċinali, kienu kumparabbli mal-medda u l-frekwenza tal-osservazzjoni ta' konċentrazzjonijiet li jistgħu jiġu kkwantifikati, ta' 9-cis-retinoic acid li jiċċirkola u li jseħħ b'mod naturali fil-plażma ta' individwi li ma kinux ikkurati.
English: Further information on Isemid can be found on the Agency's website: ema.europa.eu/ medicines/veterinary/EPAR/isemid.
Maltese: ema.europa.eu/ medicines/veterinary/EPAR/isemid.
English: Isemid received a marketing authorisation valid throughout the EU on 09/01/2019.
Maltese: Isemid ingħata awtorizzazzjoni għat-tqegħid fis-suq valida fl-UE kollha fi 09/01/2019.
English: Torasemide is a diuretic medicine.
Maltese: Torasemide hija mediċina dijuretika.
English: Isemid contains the active substance torasemide.
Maltese: Isemid fih issustanza attiva torasemide.
English: The usual dose is 0.13 to 0.25 mg torasemide per kg bodyweight once daily.
Maltese: Id-doża normali hija 0.13 sa 0.25 mg torasemide għal kull kg tal-piż tal-ġisem darba kuljum.
English: The most common side effects with Isemid (which may affect more than 1 in 10 animals) are poor function of the kidneys, alterations in blood tests measuring kidney function, haemoconcentration (increase in the concentration of red blood cells circulating in the blood), and changes in electrolyte (salt) levels (chloride, sodium, potassium, phosphorus, magnesium and calcium).
Maltese: L-effetti sekondarji l-aktar komuni b'Isemid (li jistgħu jaffettwaw aktar minn 1 minn kull 10 annimali) huma funzjoni dgħajfa tal-kliewi, alterazzjonijiet fit-testijiet tad-demm li jkejlu l-funzjoni tal-kliewi, emokonċentrazzjoni (żieda fil-konċentrazzjoni ta' ċelloli ħomor tad-demm li jiċċirkolaw fid-demm), u bidliet fil-livelli tal-elettrolit (melħ) (klorur, sodju, potassju, fosforu, manjeżju u kalċju).
English: Other information about Isemid
Maltese: Informazzjoni oħra dwar Isemid
English: What are the risks associated with Isemid?
Maltese: X'inhuma r-riskji assoċjati ma' Isemid?
English: This medicine may also cause hypersensitivity (allergic) reactions.
Maltese: Din il-mediċina tista' tikkawża wkoll reazzjonijiet ta' ipersensittività (reazzjonijiet allerġiċi).
English: In a field study involving 321 dogs with congestive heart failure, treatment with Isemid was compared with another established diuretic medicine, furosemide.
Maltese: Fi studju prattiku li involva 321 kelb b'insuffiċjenza kardijaka konġestiva, il-kura b'Isemid tqabblet ma' mediċina dijuretika stabbilita oħra, furosemide.
English: Isemid is a veterinary medicine used to treat signs related to congestive heart failure in dogs.
Maltese: Isemid huwa mediċina veterinarja użata għall-kura ta' sinjali relatati ma' insuffiċjenza kardijaka konġestiva fil-klieb.
English: This may be increased for up to 5 days to a maximum of 0.4 mg per kg bodyweight once daily in dogs with moderate to severe fluid retention in the lungs.
Maltese: Din tista' tiżdied sa massimu ta' 5 ijiem b'massimu ta' 0.4 mg għal kull kg tal-piż talġisem darba kuljum fil-klieb b'żamma tal-fluwidu moderata sa severa fil-pulmun.
English: Why is Isemid authorised in the EU?
Maltese: Għaliex Isemid huwa awtorizzat fl-UE?
English: How is Isemid used?
Maltese: Isemid?
English: Isemid to be as least as effective as furosemide for the treatment of signs related to congestive heart failure with 74% of dogs in each group being successfully treated.
Maltese: L-istudju wera li Isemid huwa effettiv minn tal-inqas daqs furosemide għall-kura tas-sinjali relatati mal-insuffiċjenza kardijaka konġestiva b'74 % tal-klieb f'kull grupp li jiġu kkurati b'suċċess.
English: For the full list of side effects and restrictions of Isemid, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet ta' Isemid, ara l-fuljett ta' tagħrif.
English: This can lead to exercise intolerance (inability to carry out physical activity), difficulty breathing and fluid retention.
Maltese: Dan jista' jwassal għal intolleranza għall-eżerċizzju (inabbiltà li titwettaq attività fiżika), problemi fit-teħid tan-nifs u żamma tal-fluwidu.
English: Isemid may increase urination, and lead to thirst, gut disturbances, low blood pressure and dehydration if ingested.
Maltese: Isemid jista' jżid l-awrina, u jwassal għal għatx, disturbi fl-imsaren, pressjoni tad-demm baxxa u deidratazzjoni jekk jinbela'.
English: What benefits of Isemid have been shown in studies?
Maltese: X'inhuma l-benefiċċji ta' Isemid li ħarġu mill-istudji?
English: The main measure of effectiveness was a reduction in scores for lung fluid and cough (both are signs of congestive heart failure) after 14 days of treatment and no worsening of difficulty in breathing or exercise intolerance scores.
Maltese: Il-kejl ewlieni tal-effikaċja kien tnaqqis fil-punteġġi għall-fluwidu fil-pulmun u għas-sogħla (it-tnejn huma sinjali ta' insuffiċjenza kardijaka konġestiva) wara 14-il ġurnata ta' kura u l-ebda deterjorament fil-punteġġi tad-diffikultà fit-teħid tan-nifs u tal
English: The European Medicines Agency decided that Isemid's benefits are greater than its risks and it can be authorised for use in the EU.
Maltese: L-Aġenzija Ewropea għall-Mediċini ddeċidiet li l-benefiċċji ta' Isemid huma akbar mir-riskji tiegħu u li jista' jiġi awtorizzat għall-użu fl-UE.
English: In vitro activity
Maltese: Attività in vitro
English: Q3 2025
Maltese: Q3 tal-2025
English: • the in vitro activity of zanamivir;
Maltese: • l-attività in vitro ta' zanamivir;
English: Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Harmire Road
Maltese: Glaxo Operations UK Ltd (li topera bħala Glaxo Wellcome Operations) Harmire Road
English: AUC(0-) (g.h/mL)
Maltese: AUC(0-∞) (µg.h/mL)
English: 15 to <30
Maltese: 15 sa <30
English: 50 to <80
Maltese: 50 sa <80
English: GM %CV GM %CV GM Range
Maltese: (h) GM %CV GM %CV GM Medda GM %CV
English: T1/2 (h)
Maltese: T1/2
English: The median patient age was 57 years and 35% (218/615) of patients were ≥65 years, of which 17% (n=103) were 65 to <75; 14% (n=84) were 75 to <85, and 5% (n=31) were ≥85 years of age.
Maltese: L-età medjana tal-pazjenti kienet ta' 57 sena u 35% (218/615) tal-pazjenti kellhom ≥65 sena, li 17% minnhom (n=103) kellhom bejn 65 u <75; 14% (n=84) kellhom bejn 75 u <85, u 5% (n=31) kellhom ≥85 sena.
English: 30 to <50
Maltese: 30 sa <50
English: Age Group
Maltese: Grupp ta' Età
English: Pack size: 1 vial.
Maltese: Kull pakkett fih kunjett 1.
English: CLcr or CLCRRT (mL/min/1.73 m
Maltese: CLcr jew CLCRRT (mL/min/1.73 m2)
English: Resistance in immunocompromised patients
Maltese: Reżistenza f'pazjenti immunokompromessi
English: Gastrointestinal disorders diarrhoea common
Maltese: Disturbi gastro-intestinali dijarea komuni
English: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 43056 San Polo di Torrile, Parma Italy
Maltese: GlaxoSmithKline Manufacturing S.P.A Strada Provinciale Asolana No. 90 43056 San Polo di Torrile, Parma L-Italja
English: Adverse reactions are listed by MedDRA system organ class.
Maltese: Ir-reazzjonijiet avversi huma elenkati skont is-sistema tal-klassifika tal-organi MedDRA.
English: The most commonly reported adverse reactions considered possibly or probably related to Dectova are alanine aminotransferase increased (2%), aspartate aminotransferase increased (1%), hepatocellular injury (1%), diarrhoea (1%) and rash (1%).
Maltese: L-aktar reazzjonijiet avversi rrapportati b'mod komuni meqjusa bħala possibbilment jew probabbilment relatati ma' Dectova huma żieda fl-alanina aminotransferażi (2%), żieda fl-aspartata aminotransferażi (1%), ħsara epatoċellulari (1%), dijarea (1%) u raxx (1%).
English: In adults with normal renal function, the elimination half-life is approximately 2-3 hours.
Maltese: F'adulti b'funzjoni talkliewi normali, in-nofs ħajja tal-eliminazzjoni hija ta' madwar 2-3 sigħat.
English: Table 7: Pharmacokinetic parameters in paediatric and adult subjects
Maltese: Parametri farmakokinetiċi f'suġġetti pedjatriċi u adulti
English: Dectova is used to treat severe flu (influenza virus infection).
Maltese: Dectova jintuża għall-kura ta' influwenza severa (infezzjoni bil-virus tal-influwenza).
English: dk-info@gsk.com
Maltese: gskcyprus@gsk.com
English: The frequency of adverse reactions is defined using the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000) and not known (cannot be estimated from available data).
Maltese: Il-frekwenza tar-reazzjonijiet avversi hija definita billi tintuża l-konvenzjoni li ġejja: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); rari ħafna (<1/10,000) u mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: In vitro studies indicate that zanamivir is not an inhibitor or substrate of Breast Cancer Resistant Protein (BCRP), P-glycoprotein, Multidrug And Toxin Extrusion protein (MATE)1, MATE2-K, Organic Anion Transporter (OAT)1, OAT3, Organic Anion Transporting Polypeptide (OATP)1B1, OATP1B3 and Organic Cation Transporter (OCT)2 transporters, nor is it an inhibitor of cytochrome P450 (CYP) enzymes CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 and 3A4.
Maltese: MATE2-K, tat-Trasportatur tal-Anjoni Organiċi (OAT)1, OAT3, tal-Polipeptid Trasportatur tal-Anjon Organiku (OATP)1B1, OATP1B3 u tat-Trasportatur tal-Katjon Organiku (OCT)2, u lanqas ma huwa inibitur tal-enzimi taċ-ċitokromju P450 (CYP) CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6 u 3A4.
English: • serum zanamivir levels from patients with complicated influenza (see section 5.1).
Maltese: • il-livelli ta' zanamivir fis-serum minn pazjenti b'influwenza kkomplikata (ara sezzjoni 5.1).
English: • Use aseptic techniques throughout preparation of the dose.
Maltese: • Uża tekniki asettiċi matul il-preparazzjoni tad-doża.
English: Each vial contains 3.08 mmol (70.8 mg) sodium.
Maltese: Kull kunjett fih 3.08 mmol (70.
English: There is no evidence that zanamivir is metabolised.
Maltese: Ma hemm l-ebda evidenza li zanamivir jiġi metabolizzat.
English: Preparation of Dectova
Maltese: Preparazzjoni ta' Dectova
English: • The patient's influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/or
Maltese: • Il-virus tal-influwenza tal-pazjent huwa magħruf jew huwa suspettat li huwa reżistenti għal prodotti mediċinali kontra l-influwenza minbarra zanamivir, u/jew
English: The serum pharmacokinetics of zanamivir administered intravenously have been studied in healthy volunteers receiving single escalating doses from 1 to 1200 mg and repeated doses of 600 mg twice daily for 5 days.
Maltese: Il-farmakokinetika fis-serum ta' zanamivir mogħti fil-vini ġiet studjata fuq voluntiera b'saħħithom li ngħataw dożi uniċi eskalenti bejn 1 u 1200 mg u dożi ripetuti ta' 600 mg darbtejn kuljum għal 5 ijiem.
English: A double-blind, randomised study to examine the prophylactic antiviral activity and efficacy of repeat dose zanamivir 600 mg every 12 hours intravenously compared to placebo in healthy male volunteers against infection from inoculation with influenza A/Texas/91 (H1N1) virus was conducted.
Maltese: Sar studju randomizzat bi blindaġġ doppju biex tiġi eżaminata l-attività antivirali profilattika u l-effikaċja ta' dożi ripetuti ta' zanamivir 600 mg kull 12-il siegħa fil-vini meta mqabbel ma' plaċebo f'voluntiera rġiel b'saħħithom kontra l-infezzjoni minn inokulazzjoni bil-virus tal-influwenza A/Texas/91 (H1N1).
English: 12 mg/kg twice daily up to a maximum dose of 600 mg twice daily
Maltese: 12 mg/kg darbtejn kuljum sa doża massima ta' 600 mg darbtejn kuljum
English: Bronchoalveolar lavage study
Maltese: Studju ta' ħasil bronkoalveolari
English: 6 months to < 6 years
Maltese: 6 xhur sa < 6 snin
English: The pharmacokinetics in elderly subjects was similar to young adult subjects.
Maltese: Il-farmakokinetika f'suġġetti anzjani kienet simili għal dik f'suġġetti adulti iżgħar fl-età.
English: Table 6: Statistical comparisons of TTCR between the 600 mg zanamivir group and each other group (IPP)
Maltese: Tabella 6: Tqabbil statistiku tat-TTCR bejn il-grupp ta' zanamivir 600 mg u kull grupp ieħor (IPP) Zanamivir soluzzjoni għallinfużjoni
English: What Dectova contains The active substance is zanamivir.
Maltese: Is-sustanza attiva hi zanamivir.
English: 26 mL clear vial (type I glass) with a stopper (coated chlorobutyl rubber), an over-seal (aluminium) and a plastic flip-off cap.
Maltese: Kunjett ċar (ħġieġ tat-tip I) ta' 26 mL b'tapp (tal-lasktu tal-klorobutil miksi), siġill addizzjonali (talaluminju) u għatu tal-plastik tat-tip flip-off.
English: The pharmacokinetics of zanamivir in subjects 6 months to <18 years of age (administered standard dose of 12 mg/kg, 14 mg/kg or 600 mg according to age and body weight) and in adult subjects (administered standard dose of 600 mg) was similar (Table 7).
Maltese: bejn is-6 xhur sa <18-il sena (li ngħataw doża standard ta' 12 mg/kg, 14 mg/kg jew 600 mg skont l-età u l piż tal-ġisem) u f'suġġetti adulti (li ngħataw doża standard ta' 600 mg) kienet simili (Tabella 7).
English: Anaphylactic reactions and serious skin reactions (including erythema multiforme, toxic epidermal necrolysis and Stevens-Johnson syndrome) have been reported with zanamivir (see section 4.8).
Maltese: nekroliżi epidermali tossika u s-sindrome ta' Stevens-Johnson) b'zanamivir (ara sezzjoni 4.8).
English: Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when:
Maltese: Dectova huwa indikat għall-kura ta' infezzjoni kkomplikata u potenzjalment ta' periklu għall-ħajja bil-virus tal-influwenza A jew B f'pazjenti adulti u pedjatriċi (età ≥6 xhur) meta:
English: Table 1: Weight-based dose regimen by age for infants, children and adolescents with normal renal function
Maltese: Tabella 1: Reġim tad-dożaġġ ibbażat fuq il-piż skont l-età għal trabi, tfal u adolexxenti b'funzjoni tal kliewi normali Medda ta' età
English: Other medicines and Dectova
Maltese: Mediċini oħra u Dectova
English: Following twice daily administration of 600 mg zanamivir solution for infusion, median trough zanamivir epithelial lining fluid concentrations ranged from 419 ng/mL to 584 ng/mL and were 47-66% of those in the initial bronchoalveolar sample following orally zanamivir inhalation powder 10 mg twice daily.
Maltese: Wara l-għoti ta' 600 mg ta' zanamivir soluzzjoni għallinfużjoni darbtejn kuljum, il-konċentrazzjonijiet medjani l-aktar baxxi ta' zanamivir fil-fluwidu tal-kisja epiteljali kienu jvarjaw bejn 419 ng/mL u 584 ng/mL u kienu ta' bejn 47-66% ta' dawk fil-kampjun inizjali tal-ħasil bronkoalveolari wara l-għoti ta' 10 mg ta' trab ta' zanamivir inalat mill-ħalq darbtejn kuljum.