FrancophonIA/ELRC3.0 huggingface dataset:
English: The expected in vivo peak increase in factor X level expressed as IU/dL (or % of normal) can be estimated using the following formulae:
Maltese: Iż-żieda massima mistennija in vivo fil-livell ta' fattur X espressa bħala IU/dL (jew % tan-normal) tista' tiġi stmata permezz tal-formuli li ġejjin:
English: Routine prophylaxis was used by two subjects.
Maltese: Intużat profilassi ta' rutina minn żewġ individwi.
English: Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.6 OR Increase in factor X level (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 1.7
Maltese: Żieda fil-livell ta' fattur X (IU/dL jew % tan-normal) [doża totali (IU)/piż tal-ġisem (kg)] x 1.7
English: Systemic exposure to FX:C at the Repeat PK visit (at least 6 months later) was equivalent to that at baseline, since repeat/baseline ratios for all PK parameters were within the range of 90% to 110%.
Maltese: PK ripetuta (mill-inqas 6 xhur wara) kienet ekwivalenti għal dak fil-linja bażi, peress li proporzjonijiet tar-ripetizzjoni/tal-linja bażi għall-parametri kollha tal-PK kienu fil-medda ta' 90% sa 110%.
English: How much is given regularly for long-term prevention of bleeds?
Maltese: Kemm jingħata regolarment għall-prevenzjoni fit-tul tal-fsada?
English: Other medicines and Coagadex
Maltese: Mediċini oħra u Coagadex
English: Bio Products Laboratory Ltd Tel: +44 (0) 20 8957 2255 e-mail: medinfo@bpl.co.uk
Maltese: Bio Products Laboratory Ltd Teл.: + 44 (0) 20 8957 2255 e-mail: medinfo@bpl.co.uk
English: powder and solvent for solution for injection human coagulation factor X This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: • Immediately invert the vial of solution, which will be drawn into the syringe.
Maltese: • Immedjatament aqleb il-kunjett tas-soluzzjoni ta' taħt fuq, li se tinġibed ġos-siringa.
English: Careful control of replacement therapy is especially important in cases of major surgery or life-threatening bleeding episodes.
Maltese: Kontroll b'attenzjoni ta' terapija ta' sostituzzjoni hu importanti b'mod speċjali f'każijiet ta' operazzjoni maġġuri jew episodji ta' fsada ta' theddida għall-ħajja.
English: Quantity of Coagadex
Maltese: Kwantità ta' Coagadex
English: There is a potential for thromboembolism with overdose.
Maltese: Hemm il-potenzjal għal tromboemboliżmu b'doża eċċessiva.
English: Some patients may achieve desired FX trough levels on once weekly prophylactic therapy (see section 5.1).
Maltese: Xi pazjenti jistgħu jilħqu l livelli minimi ta' FX mixtieqa fuq terapija profilattika ta' darba f'ġimgħa (ara sezzjoni 5.1).
English: Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed rarely with treatment of other haemophilias and may in some cases have progressed to severe anaphylaxis (including shock).
Maltese: Sensittività eċċessiva jew reazzjonijiet allerġiċi (li jistgħu jinkludu anġjodema, ħruq u tingiż fil-post tal-infużjoni, tertir, fwawar, urtikarja ġeneralizzata, uġigħ ta' ras, ħorriqija, pressjoni baxxa, letarġija, dardir, irrekwitezza, takikardja, tagħfis fis-sider, tnemnim, remettar, tħarħir) ġew osservati b'mod rari bil-kura ta' emofilja oħra u jistgħu f'xi każijiet avvanzaw għal anafilassi severa (li tinkludi xokk).
English: Four subjects were aged 0 to 5 years and five were aged 6 to 11 years inclusive.
Maltese: Erba' pazjenti kellhom bejn 0 u 5 snin, u ħamsa kienu bejn 6 u 11-il sena inklużi.
English: The efficacy of Coagadex in treating bleeding episodes was assessed by the subject and/or investigator for each new bleeding episode, using a pre-determined bleed-specific ordinal rating scale of excellent, good, poor and unassessable.
Maltese: L-effikaċja ta' Coagadex fil-kura ta' episodji ta' fsada kienet evalwata mill-individwu u/jew investigatur għal kull episodju ġdid ta' fsada , bl-użu ta' skala ta' klassifika ordinali pre-determinata speċifika għall-fsada ta' eċċellenti, tajba, dgħajfa u ma tistax tiġi valutata.
English: Surgical haemostasis
Maltese: Emostasi kirurġika
English: Presentations
Maltese: Inibituri
English: Four bleeding episodes in two subjects were considered treatment failures.
Maltese: Erba' episodji ta' fsada f'żewġ individwi tqiesu bħala fallimenti tal-kura.
English: The safety and efficacy of Coagadex for perioperative management was evaluated in five subjects aged 14 to 59 years with mild (n=2), moderate (n=1), and severe (n=2) disease, who underwent a total of seven surgical procedures.
Maltese: Is-sigurtà u l-effikaċja ta' Coagadex għall-immaniġġjar perioperattiv kienu evalwati f'ħames individwi li kellhom bejn 14 sa 59 sena b'mard ħafif (n = 2), moderat (n = 1), u sever (n = 2) , li għaddew minn total ta' seba' proċeduri kirurġiċi.
English: A dose of 2000 IU Coagadex administered to a 70 kg patient should be expected to result in a peak post-infusion factor X increase of 2000 x {[2 IU/dL]/[IU/kg]}/[70 kg] = 57 IU/dL (i.e. 57% of normal)
Maltese: {[2 IU/dL]/[IU/kg]}/[70 kg] = 57 IU/dL (i.e. 57% tan-normal) Livell massimu ta' fattur X ta' 90% tan-normal hu meħtieġ f'pazjent ta' 70 kg.
English: The formation of neutralising antibodies (inhibitors) to factor X is a possible complication in the management of individuals with factor X deficiency.
Maltese: Il-formazzjoni ta' antikorpi (inibituri) li jinnewtralizzaw għal fattur X hi kumplikazzjoni possibbli fl-immaniġġjar ta' individwi b'defiċjenza ta' fattur X.
English: Dose (IU) = body weight (kg) x desired factor X rise (IU/dL or % of normal) x 0.5 OR Increase in factor X level (IU/dL or % of normal) = [total dose (IU)/body weight (kg)] x 2
Maltese: Doża (IU) = piż tal-ġisem (kg) x żieda mixtieqa ta' fattur X (IU/dL jew % tan-normal) x 0.5
English: No investigations on genotoxicity, carcinogenicity and reproductive or developmental toxitcity have been conducted since human plasma coagulation factor X (as contained in Coagadex) is an endogenous protein.
Maltese: Ma twettqet l-ebda investigazzjoni dwar il-ġenotossiċità, il-karċinoġeniċità u t-tossiċità riproduttiva u tal-iżvilupp minħabba li l-fattur X tal-koagulazzjoni tal-plażma umana (kif jinsabu f'Coagadex) hu proteina endoġena.
English: Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses.
Maltese: Miżuri standard sabiex jiġu evitati infezzjonijiet li jirriżultaw mill-użu ta' prodotti mediċinali ppreparati minn demm jew plażma umana jinkludu l-għażla tad-donaturi, skrinjar ta' donazzjonijiet individwali u ġabriet tal-plażma għal markaturi speċifiċi ta' infezzjoni u l-inklużjoni ta' passi effettivi ta' manifattura għall-inattivazzjoni/tneħħija ta' virusijiet.
English: BATCH NUMBER>
Maltese: NUMRU TAL-LOTT
English: The other two subjects used doses up to 30 IU/kg and 33 IU/kg.
Maltese: Iż-żewġ individwi l-oħrajn użaw dożi ta' 30 IU/kg u 33 IU/kg
English: Coagadex to raise plasma factor X levels to 70-90 IU/dL.
Maltese: Id-doża użata ta' Coagadex għandha tkun biżżejjed biex iżżid il-livell ta' fattur X fid-demm tiegħek għal bejn 70 u 90 unità/dL.
English: In adults and adolescents at least 12 years of age, the expected in vivo peak increase in factor X level expressed as IU/dL (or % of normal) can be estimated using the following formulae:
Maltese: F'adulti u adolexxenti li għandhom tal-anqas 12-il sena, iż-żieda massima mistennija in vivo fil-livell ta' fattur X espressa bħala IU/dL (jew % tan-normal) tista' tiġi stmata permezz tal-formuli li ġejjin:
English: Your doctor may recommend that you consider vaccination against hepatitis A and B if you regularly or repeatedly receive human plasma-derived factor X products.
Maltese: Jista' jkun hemm bżonn ta' tilqim kontra l-epatite A u B f'pazjenti li regolarment jew ripetutament jirċievu prodotti tal-Fattur X derivati mill-plażma tal-bniedem.
English: After reconstitution, the product should be administered by the intravenous route at a suggested rate of 10 mL/min, but no more than 20 mL/min.
Maltese: Wara r-rikostituzzjoni, il-prodott għandu jingħata fil-vina b'rata ssuġġerita ta' 10 mL/min, iżda mhux aktar minn 20 mL/min.
English: In general, all patients treated with Coagadex should be carefully monitored for the development of inhibitors by appropriate clinical observations and laboratory tests.
Maltese: B'mod ġenerali, il-pazjenti kollha kkurati b'Coagadex, għandhom jiġu mmonitorjati bir-reqqa għall-iżvilupp ta' inibituri permezz ta' osservazzjonijiet kliniċi u testijiet tal-laboratorju adattati.
English: or
Maltese: Tqala
English: Coagadex is indicated for the treatment and prophylaxis of bleeding episodes and for perioperative management in patients with hereditary factor X deficiency.
Maltese: Coagadex hu indikat għall-kura u l-profilassi ta' episodji ta' fsada u għall-immaniġġjar perioperattiv f'pazjenti b'defiċjenza ereditarja ta' fattur X.
English: How to store Coagadex
Maltese: Meta tinjetta Coagadex
English: In a clinical study of Coagadex in subjects with severe or moderate factor X deficiency (basal FX:C <5 IU/dL), the pharmacokinetics of Coagadex were assessed in 16 subjects after administration of a nominal dose of 25 IU/kg.
Maltese: Id-doża u t-tul tat-terapija jiddependu fuq is-severità tad-defiċjenza ta' fattur X (i.e. il-livell ta' fattur X fil-linja bażi tal-pazjent), fuq il-post u l-ammont ta' fsada, u fuq il-kundizzjoni klinika tal-pazjent.
English: Ninety eight (53%) were major bleeding episodes, and 88 (47%) were minor bleeds (one bleed was not assessed).
Maltese: Tmienja u disgħin (53%) kienu episodji ta' fsada maġġuri, u 88 (47%) kienu fsada żgħira (episodju wieħed ta' fsada ma ġiex ivvalutat).
English: Powder vial: 250 IU or 500 IU of human coagulation factor X in a type I glass vial stoppered with a halobutyl rubber stopper, oversealed with a snap-off polypropylene cap and aluminium lacquered skirt.
Maltese: IU ta' fattur X tal-koagulazzjoni umana f'kunjett tal-ħġieġ ta' tip I, b'tapp tal-gomma halobutyl, u overseal b'għatu tal-polypropylene tat-tip snap-off u b'aluminium lacquered skirt.
English: The recommended dose of 25 IU/kg Coagadex to treat a bleed was maintained during the study for 14 of the 16 subjects.
Maltese: Id-doża rakkomandata ta' 25 IU/kg Coagadex biex tikkura episodju ta' fsada kienet miżmuma waqt l-istudju ta' 14 mis-16-il individwu.
English: One subject, aged 58 years, used 28 IU/kg once weekly for 8 weeks and, later, 25 IU/kg every 2 weeks for more than 5 months.
Maltese: Individwu wieħed, ta' 58 sena, uża 28 IU/kg darba fil-ġimgħa għal 8 ġimgħat u, wara, 25 IU/kg kull ġimagħtejn għal iktar minn 5 xhur.
English: Solvent vial: 2.5 mL or 5 mL solution in a type I glass vial sealed with a halobutyl rubber stopper and an overseal.
Maltese: 2.5 mL jew 5 mL ta' soluzzjoni f'kunjett tal-ħġieġ ta' tip I, issiġilatti b'tapp tal-gomma halobutyl, u overseal.
English: The study in young children (see section 5.1) measured incremental recovery at 30 min (IR30min) after the first dose and after the last dose in the study (approximately 6 months later) (see section 5.1) Combining IR30min values for FX:C at the baseline visit (n=9) and the Repeat PK assessment (n=9) gave an overall geometric mean IR of 1.74 (range 1.3-2.2) IU/dL per IU/kg administered (n=9).
Maltese: Il-kombinazzjoni ta' valuri ta' IR30min għal FX:C fil-viżta fil-linja bażi (n=9) u l-eżami PK ripetut (n=9) ta medja ġeometrika globali tal-IR ta' 1.74
English: For secondary prophylaxis against re-bleeding or short-term prophylaxis prior to anticipated physical activity or dental appointments: 30 IU/kg Coagadex should be injected and repeated as required.
Maltese: Għal profilassi sekondarja kontra fsada mill-ġdid, jew profilassi għal żmien qasir qabel attività fiżika antiċipata jew appuntamenti dentali: 30 IU/kg ta' Coagadex għandhom jiġu injettati, u rrepeti skont il-ħtieġa.
English: For i.v.
Maltese: IL-PROVVISTA U L
English: Your doctor will check regularly for the development of these antibodies, and especially before an operation.
Maltese: It-tabib tiegħek ser jiċċekkja regolarment għalliżvilupp ta' dawn l-antikorpi, u speċjalment qabel operazzjoni.
English: For secondary prophylaxis against re-bleeding or short-term prophylaxis prior to anticipated physical activity or dental appointments: 25 IU/kg Coagadex should be injected and repeated as required.
Maltese: Għal profilassi sekondarja kontra fsada mill-ġdid, jew profilassi għal żmien qasir qabel attività fiżika antiċipata jew appuntamenti dentali: 25 IU/kg ta' Coagadex, għandhom jiġu injettati, u rrepeti skont il-ħtieġa.
English: Pharmacotherapeutic group: Anti-haemorrhagics, vitamin K and other haemostatics, coagulation factor X, ATC code: B02BD13.
Maltese: It-tabib tiegħek ser jagħtik parir jekk dan l-użu huwiex adattat għalik u, jekk iva, dwar id-doża xierqa.
English: For major surgery, a median of 13 infusions (range 2 to 15 infusions) and a median cumulative dose of 181 IU/kg (range 45 to 210 IU/kg) were required to maintain haemostasis.
Maltese: Għal kirurġija maġġuri, medja ta' 13-il infużjoni (medda ta' 2 sa 15-il infużjoni) u doża kumulattiva medja ta' 181 IU/kg (medda ta' 45
English: Solvent vial containing clear colourless liquid.
Maltese: Solvent: ilma għall-injezzjonijiet.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, single and repeat-dose toxicity, thrombogenicity and local tolerability.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn doża waħda u minn dożi ripetuti, tromboġeniċità u tollerabilità lokali, ma juri l-ebda periklu speċjali għall-bnedmin.
English: Coagadex 500 IU powder and solvent for solution for injection human coagulation factor X
Maltese: trab u solvent għal soluzzjoni għall-injezzjoni fattur X tal-koagulazzjoni umana
English: 25 IU/kg twice weekly is the proposed starting dose for prophylaxis in patients >12 years of age with dose levels and dosing intervals to be adjusted as clinically indicated.
Maltese: Id doża tal-bidu proposta hija 25 IU/kg darbtejn fil-ġimgħa għal profilassi f'pazjenti li għandhom >12-il sena b'aġġustamenti fil-livelli tad-doża u intervalli tad-dożaġġ skont kif indikat klinikament.
English: • tiredness
Maltese: Treddigħ
English: Coagadex is supplied with the amount of solvent as shown in the table.
Maltese: Coagadex jiġi fornut bl-ammont ta' solvent kif muri fit-tabella.
English: Coagadex 500 IU
Maltese: IU Coagadex 500
English: Do not use this medicine after the expiry date which is stated on the containers after “EXP”.
Maltese: Tużax din il-mediċina wara d-data ta' meta tiskadi li tidher fuq il-kontenituri wara “JIS”.
English: Common (may affect up to 1 in 10 people):
Maltese: Komuni (jistgħu jaffetwaw sa persuna 1 minn kull 10):
English: Method of administration Intravenous use.
Maltese: Mhux applikabbli.
English: Note: If you have more than one vial to make up your dose, repeat steps 1 through 6 withdrawing the solution in the vial into the same syringe.
Maltese: Nota: Jekk ikollok aktar minn kunjett wieħed biex tifforma d-doża tiegħek, irrepeti passi 1 sa 6 biex tiġbed is-soluzzjoni fil-kunjett ġol-istess siringa.
English: • Repeat this step with the vial of solvent.
Maltese: • Irrepeti dan il-pass bil-kunjett tas-solvent.
English: For routine prophylaxis of bleeding episodes in children aged less than 12 years: 40 IU/kg twice weekly.
Maltese: Kontroll ta' Episodji ta' Fsada Għall-kura ta' episodji ta' fsada f'adulti u adolexxenti li għandhom 12-il sena jew aktar: 25 IU/kg ta'
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti tar-rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad
English: There are no known effects of this medicine on the ability to drive or operate machinery.
Maltese: Kemm tingħata mediċina qabel, waqt u wara operazjoni maġġuri?
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Maltese: Ma ġew irrappurtati l-ebda avvenimenti avversi relatati ma' dan id-doża eċċessiva.
English: It is used to treat and prevent bleeding in patients with hereditary factor X deficiency, including during surgery.
Maltese: Dan jintuża sabiex jikkura u jipprevjeni l-fsada f'pazjenti b'defiċjenza ereditarja ta' fattur X inkluż waqt operazzjoni.
English: • Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus)
Maltese: • Streptococcus anginosus group (inklużi S. anginosus, S. intermedius, u S. constellatus)
English: (agranulocytosis).
Maltese: (agranulokijtożi).
English: ≥ 15 to ≤ 30
Maltese: ≥ 15 sa ≤ 30
English: See sections 4.4 and 5.1.
Maltese: Ara sezzjonijiet 4.4 u 5.1.
English: Staphylococcus aureus Streptococcus pneumoniae Streptococcus Groups A, B, C, G
Maltese: Staphylococcus aureus Streptococcus pneumoniae Streptococcus Gruppi A, B, C, G
English: Date of first authorisation: 23 August 2012 Date of the latest renewal: 24 April 2017
Maltese: Data tal-ewwel awtorizzazzjoni: 23 ta' Awwissu 2012 Data tal-aħħar tiġdid: 24 ta' April 2017
English: Infusion time (minutes)/Frequency
Maltese: Ħin tal-infużjoni (minuti)/Frekwenza
English: > 30 to ≤ 50
Maltese: > 30 sa ≤ 50
English: ≥ 15 to ≤ 30 300 mg ESRD, including haemodialysis
Maltese: ≥ 15 sa ≤ 30 300 mg ESRD, inkluż emodijaliżi
English: • Anaemia
Maltese: • Anemija
English: Lab Test
Maltese: Test tal-Laboratorju
English: Ceftaroline is neither a substrate, nor an inhibitor of renal uptake transporters (OCT2, OAT1, and OAT3) in vitro.
Maltese: Ceftaroline la huwa substrat, u lanqas inibitur tat-trasportaturi tar-riassorbiment renali (OCT2, OAT1, u OAT3) in vitro.
English: Store below 30 °C.
Maltese: Aħżen f'temperatura taħt 30°C.
English: Approximate ceftaroline concentration (mg/mL)
Maltese: Konċentrazzjoni approssimattiva ta' ceftaroline (mg/mL)
English: ESRD, including haemodialysis
Maltese: ESRD, inkluż emodijaliżi
English: Renal cortical cysts were oberved in all groups, including controls, on PND50.
Maltese: Ċesti kortikali renali ġew osservati fil-gruppi kollha, inkluż kontrolli, fuq PND50.
English: Posology (mg/infusion)
Maltese: Pożoloġija (mg/infużjoni)
English: Calculated using the Cockcroft-Gault formula for adults.
Maltese: Ikkalkulata permezz tal-formula ta' Cockcroft-Gault għall-adulti.
English: • Staphylococcus aureus (including methicillin-resistant strains)
Maltese: • Staphylococcus aureus (inklużi razez reżistenti għal methicillin)
English: Agranulocytosis, eosinophilia
Maltese: Agranulokjitoż i, eoisinofilja
English: Frequency categories are derived according to the following conventions: 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), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji tal-frekwenza huma derivati skont il-konvenzjonijiet li ġejjin: 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), mhux magħrufa (ma tistax tiġi stmata mid-data disponibbli).
English: Infer susceptibility from susceptibility to benzylpenicillin.
Maltese: Iddeduċi s-suxxettibilità mis-suxxettibilità għal benzylpenicillin.
English: Each vial contains ceftaroline fosamil acetic acid solvate monohydrate equivalent to 600 mg ceftaroline fosamil.
Maltese: Kull kunjett fih ceftaroline fosamil acetic acid solvate monohydrate ekwivalenti għal 600 mg ceftaroline fosamil.
English: In vitro studies have not demonstrated any antagonism between ceftaroline in combination with other commonly used antibacterial agents (e.g. amikacin, azithromycin, aztreonam, daptomycin, levofloxacin, linezolid, meropenem, tigecycline, and vancomycin).
Maltese: Studji in vitro ma wrew l-ebda antagoniżmu bejn ceftaroline flimkien ma' sustanzi antibatteriċi oħra li jintużaw ta' spiss (eż. amikacin, azithromycin, aztreonam, daptomycin, levofloxacin, linezolid, meropenem, tigecycline u vancomycin).
English: Ceftaroline is a cephalosporin antibacterial with in vitro activity against Gram-positive and -negative bacteria.
Maltese: Ceftaroline huwa antibatterjali ta' cephalosporin b'attività in vitro kontra batterji Gram-pożittivi u -negattivi.
English: Reproductive toxicology
Maltese: Tossikoloġija tas-sistema riproduttiva
English: MIC breakpoints (mg/L) Susceptible (≤ S)
Maltese: Breakpoints tal-MIC (mg/L) Suxxettibbli (≤ S) Reżistenti (R>)
English: > 50 mL/min*
Maltese: (CrCL) > 50 mL/min*
English: Anaemia, leucopenia, neutropenia, thrombocytopenia, prothrombin time (PT) prolonged, activated partial thromboplastin time (aPTT) prolonged, international normalized ratio (INR) increased
Maltese: Anemija, lewkopenija, newtropenija, tromboċitopenja, ħin talprotrombin imtawwal (PT), titwil fil-ħin ta' tromboplastin parzjali attivat (aPTT), Żieda filproporzjon internazzjonali normalizzat (INR)
English: Zinforo is an antibiotic medicine that contains the active substance ceftaroline fosamil.
Maltese: Zinforo huwa mediċina antibijotika li fiha s-sustanza attiva ceftaroline fosamil.
English: Ceftaroline is not active against strains of Enterobacterales producing extended-spectrum betalactamases (ESBLs) from the TEM, SHV or CTX-M families, serine carbapenemases (such as KPC), class B metallo-beta-lactamases or class C (AmpC) cephalosporinases.
Maltese: Ceftaroline mhux attiv kontra razez ta' Enterobacterales li jipproduċu beta-lactamases ta' spettru wiesa' (ESBLs) mill-familji TEM, SHV jew CTX-M, serine carbapenemases (bħal KPC), metallo beta-lactamases ta' klassi B jew klassi Ċ (AmpC) cephalosporinases.
English: Rash, pruritus Anaphylaxis, hypersensitivity (e.g. urticaria, lip and face swelling) (see sections 4.3 and 4.4)
Maltese: Anafilassi, sensittività eċċessiva (eż. urtikarja, nefħa fix-xofftejn u filwiċċ) (ara sezzjonijiet 4.3 u 4.4)
English: The chemical and physical in-use stability has been demonstrated for up to 24 hours at 2-8 °C.
Maltese: L-istabilità kimika u fiżika waqt l-użu ntweriet li tibqa' għal 24 siegħa f'temperatura bejn 2-8°C.
English: * Calculated using the Schwartz formula (in mL/min/1.73 m2) for paediatric patients.
Maltese: * Ikkalkulat permezz tal-formula ta' Schwartz (f'mL/min/1.73 m2) għal pazjenti pedjatriċi.
English: Table 1 Dosage in adults with normal renal function, creatinine clearance (CrCL) > 50 mL/min Indications
Maltese: Tabella 1 Dożaġġ fl-adulti b'funzjoni renali normali, tneħħija tal-kreatinina (CrCL) > 50 mL/min
English: Hypersensitivity to the cephalosporin class of antibacterials.
Maltese: Sensittività eċċessiva għall-klassi ta' antibijotiċi cephalosporins.
English: The recommended durations of treatment are 5-14 days for cSSTI and 5-7 days for CAP.
Maltese: Pożoloġija It-tul ta' trattament irrakkomandat huwa 5-14-il jum għal cSSTI u 5-7 ijiem għal CAP.
English: Dosage strength (mg)
Maltese: Qawwa tad-doża (mg)
English: 10 mg/kg 120/every 8 hours
Maltese: 10 mg/kg 120/kull 8 sigħat
English: Treatment of overdose should follow standard medical practice;
Maltese: It-trattament ta' doża eċċessiva għandu jsegwi prattika medika standard;
English: • Pain and irritation of the veins
Maltese: • Uġigħ u irritazzjoni fil-vini
English: Anaerobic micro-organisms Gram-positive micro-organisms
Maltese: Mikro-organiżmi anerobiċi Mikro-organiżmi Gram-pożittivi
English: • Staphylococcus aureus (methicillin-susceptible strains only)
Maltese: • Staphylococcus aureus (razez suxxettibbli għal methicillin biss)
English: > 30 to ≤ 50 400 mg c/every 12 hours
Maltese: > 30 sa ≤ 50 400 mg c/kull 12il siegħa