FrancophonIA/ELRC3.0 huggingface dataset:
English: Each vial contains a total of 6.44 mmol of sodium (approximately 148 mg), equivalent to 7.4% of the WHO recommended maximum daily intake for sodium.
Maltese: Kull kunjett fih total ta' 6.44 mmol ta' sodium (bejn wieħed u ieħor 148 mg), ekwivalenti għal 7.4 % tat-teħid massimu rakkomandat ta' kuljum tal-WHO għas-sodium.
English: Dose recommendations are based on pharmacokinetic modelling Ceftazidime and avibactam are removed by haemodialysis (see sections 4.9 and 5.2).
Maltese: Ir-rakkomandazzjonijiet tad-doża huma bbażati fuq l-immudellar farmakokinetiku Ceftazidime u avibactam jitneħħew bl-emodijaliżi (ara sezzjonijiet 4.9 u 5.2).
English: Antibacterial activity in combination with other antibacterial agents
Maltese: Attività antibatterjali f'kombinament ma' aġenti antibatterjali oħra
English: ZAVICEFTA 2 g/0.5g powder for concentrate for solution for infusion ceftazidime/avibactam
Maltese: Zavicefta 2 g/0.5 g trab għal konċentrat għal soluzzjoni għall-infużjoni ceftazidime/avibactam
English: Ceftazidime is excreted unchanged into the urine by glomerular filtration; approximately 80-90% of the dose is recovered in the urine within 24 h. Avibactam is excreted unchanged into the urine with a renal clearance of approximately 158 mL/min, suggesting active tubular secretion in addition to glomerular filtration.
Maltese: Ceftazidime huwa eliminat mhux mibdul fl-awrina permezz ta' filtrazzjoni glomerulari; bejn wieħed u ieħor 80-90% tad-doża hija rkuprata fl-awrina fi żmien 24 siegħa.
English: No metabolism of avibactam was observed in human liver preparations (microsomes and hepatocytes).
Maltese: Ma ġie osservat ebda metaboliżmu ta' avibactam filpreparazzjonijiet tal-fwied tal-bniedem (mikrosomi u epatoċiti).
English: For avibactam the PK-PD index is the percent time of the free drug concentration above a threshold concentration over the dose interval (% fT >CT).
Maltese: Għal avibactam l-indiċi PK-PD huwa l-ħin perċentwali tal-konċentrazzjoni tal-mediċina ħielsa fuq il-limiti talkonċentrazzjoni fuq l-intervall tad-doża (% fT >CT).
English: No dosage adjustment is required in patients with mild renal impairment (estimated CrCL ≥ 51≤ 80 mL/min) (see section 5.2).
Maltese: L-ebda aġġustament tad-doża ma huwa meħtieġ f'pazjenti b'indeboliment ħafif tal-kliewi (CrCL stmat ≥ 51 - ≤ 80 mL/min) (ara sezzjoni 5.2).
English: Ceftazidime has little or no activity against the majority of Gram-positive organisms and anaerobes (see sections 4.2 and 5.1).
Maltese: Ceftazidime għandu ftit jew l-ebda attività kontra l-maġġoranza ta' organiżmi Gram-pożittivi u anerobi (ara sezzjonijiet 4.2 u 5.1).
English: Ceftazidime and avibactam are eliminated via the kidneys, therefore, the dose should be reduced according to the degree of renal impairment (see section 4.2).
Maltese: Ceftazidime u avibactam huma eliminati permezz tal-kliewi, għaldaqstant, id-doża għandha titnaqqas skont il-grad ta' indeboliment tal-kliewi (ara sezzjoni 4.2).
English: Marketing Authorisation Holder Pfizer Ireland Pharmaceuticals Operations Support Group Ringaskiddy, County Cork Ireland
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Pfizer Ireland Pharmaceuticals Operations Support Group
English: Very common (≥1/10)
Maltese: Komuni (≤1/100 u <1/10)
English: For storage conditions of the reconstituted and diluted medicinal product, see section 6.3.
Maltese: Għall-kundizzjonijiet ta' ħażna tal-prodott mediċinali rikostitwit u dilwit, ara sezzjoni 6.3.
English: Clinical efficacy against specific pathogens
Maltese: Effikaċja klinika kontra patoġeni speċifiċi
English: • Ceftazidime belongs to the group of antibiotics called “cephalosporins”.
Maltese: • Ceftazidime jagħmel parti mill-grupp ta' antibjotiċi li jissejħu "ċefalosporini".
English: Zavicefta is used in adults to treat:
Maltese: Zavicefta jintuża fl-adulti sabiex jikkura:
English: Avibactam does not inhibit class B enzymes (metallo-β-lactamases) and is not able to inhibit many of the class D enzymes (see section
Maltese: Avibactam ma jinibixxix l-enzimi talklassi B (metallo-β-lactamases) u mhuwiex kapaċi jinibixxi ħafna mill-enzimi tal-klassi D (ara sezzjoni 5.1).
English: Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function (see section 4.4).
Maltese: Kura konkomittanti b'dożi għoljin ta' ċefalosporini u prodotti mediċinali nefrotossiċi bħal aminoglycosides jew dijuretiċi qawwija (eż. furosemide) tista' taffettwa l-funzjoni tal-kliewi b'mod avvers (ara sezzjoni 4.4).
English: Very rare: (may affect up to 1 in 10,000 people) • swelling in a part of the kidney that causes a reduction in its normal working function
Maltese: Rari ħafna: (jistgħu jaffettwaw sa persuna 1 minn kull 10,000)
English: The chemical and physical in-use stability has been demonstrated for up to 24 hours at 2 - 8°C, followed by up to 12 hours at not more than 25
Maltese: L-istabilità kimika u fiżika waqt l-użu ntweriet sa 24 siegħa fi 2 - 8°C, segwita minn massimu ta' 12-il siegħa f'mhux aktar minn 25
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of European 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 webportal.
Maltese: Ir-rekwiżiti biex jiġu ppreżentati 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 lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: These include thrush (fungal infections of the mouth or genital area).
Maltese: Dawn jinkludu “thrush” (infezzjonijiet fungali tal-ħalq jew tal-erja ġenitali).
English: CARTON
Maltese: KARTUNA
English: The pharmacokinetics of both ceftazidime and avibactam are approximately linear across the dose range studied (50 mg to 2000 mg) for a single intravenous administration.
Maltese: Il-farmakokinetika kemm ta' ceftazidime kif ukoll ta' avibactam hija bejn wieħed u ieħor lineari filfirxa kollha tad-doża studjata (50 mg sa 2000 mg) għal għotja waħda minn ġol-vina.
English: For instructions on reconstitution and dilution of the medicinal product before administration see section 6.6.
Maltese: Għal istruzzjonijiet dwar ir-rikostituzzjoni u d-dilwizzjoni tal-prodott mediċinali qabel lamministrazzjoni, ara sezzjoni 6.6.
English: Approximately 97% of the avibactam dose is recovered in the urine, 95% within 12 h. Less than 1% of ceftazidime is excreted via the bile and less than 0.25% of avibactam is excreted into faeces.
Maltese: Bejn wieħed u ieħor 97% tad-doża ta' avibactam hija rkuprata fl-awrina, 95% fi żmien 12-il siegħa.
English: Lymphocytosis
Maltese: Limfoċitożi
English: To be used in combination with metronidazole when anaerobic pathogens are known or suspected to be contributing to the infectious process To be used in combination with an antibacterial agent active against Gram-positive pathogens when these are known or suspected to be contributing to the infectious process The total duration shown may include intravenous Zavicefta followed by appropriate oral therapy There is very limited experience with the use of Zavicefta for more than 14 days
Maltese: CrCl stmata permezz tal-formula Cockcroft-Gault Sabiex jintuża f'kombinament ma' metronidazole meta hemm suspett jew għarfien ta' patoġeni anaerobiċi li qegħdin jikkontribwixxu għall-proċess infettiv Sabiex jintuża f'kombinament ma' aġent antibatterjali attiv kontra patoġeni Gram-pożittivi meta jkun hemm suspett jew għarfien li dawn ikunu qegħdin jikkontribwixxu għall-proċess infettiv
English: Hypersensitivity reactions
Maltese: Reazzjonijiet ta' sensittività eċċessiva
English: Minimum Inhibitory Concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) for ceftazidime/avibactam are as follows: Organisms
Maltese: Il-breakpoints tal-Konċentrazzjoni Inibitorja Minima (MIC) stabbiliti mill-Kumitat Ewropew dwar itTestijiet tas-Suxxettibbiltà Antimikrobjali (EUCAST) ta' ceftazidime/avibactam huma kif ġejjin:
English: Susceptibility testing breakpoints
Maltese: Valuri kritiċi tat-testijiet tas-suxxettibbilità
English: It is recommended that Zavicefta should be used to treat infections due to aerobic Gram-negative organisms in adult patients with limited treatment options only after consultation with a physician with appropriate experience in the management of infectious diseases (see section 4.4).
Maltese: Huwa rrakkomandat li Zavicefta jintuża sabiex jikkura infezzjonijiet minħabba organiżmi aerobiċi Gram-negattivi f'pazjenti adulti b'għażliet ta' kura limitati biss wara konsultazzjoni ma' tabib b'esperjenza xierqa fil-ġestjoni ta' mard infettiv (ara sezzjoni 4.4).
English: Clinical data have demonstrated that there is no interaction between ceftazidime and avibactam, and between ceftazidime/avibactam and metronidazole.
Maltese: Id-data klinika uriet li mhemmx interazzjoni bejn ceftazidime u avibactam, u bejn ceftazidime/avibactam u metronidazole.
English: Reduced doses may be achieved by transfer of an appropriate volume of the resultant solution to an infusion bag, based upon ceftazidime and avibactam content of 167.3 mg/mL and 41.8 mg/mL, respectively.
Maltese: Id-dożi mnaqqsa jistgħu jintlaħqu permezz tat-trasferiment tal-volum xieraq tas-soluzzjoni li tirriżulta għal ġo borża tal-infużjoni, abbażi tal-kontenut ta' ceftazidime u avibactam ta' 167.3 mg/mL u 41.8 mg/mL, rispettivament.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with Zavicefta in one or more subsets of the paediatric population in the treatment of intra-abdominal infections, urinary tract infections, pneumonia and Gram-negative bacterial infections (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini ddifferiet għall-obbligu li jigu ppreżentati r-riżultati tal-istudji b'Zavicefta f'subsett wieħed jew aktar tal-popolazzjoni pedjatrika fil-kura tal-infezzjonijiet intraaddominali, l-infezzjonijiet fl-apparat tal-awrina, il-pulmonite u l-infezzjonijiet batterjali Gramnegattivi (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: Renal and urinary disorders
Maltese: Disturbi filkliewi u fissistema urinarja
English: The human protein binding of both ceftazidime and avibactam is approximately 10% and 8%, respectively.
Maltese: It-twaħħil mal-proteina fil-bniedem kemm ta' ceftazidime kif ukoll ta' avibactam huwa baxx, bejn wieħed u ieħor 10% u 8%, rispettivament.
English: Manufacturer
Maltese: Reżistenza
English: • decrease in the number of red blood cells (haemolytic anaemia) - shown in blood tests
Maltese: • tnaqqis fin-numru ta' ċelluli ħomor tad-demm (anemija emolitika) - murija fit-testijiet tad-demm
English: Table 1 Recommended intravenous dose for patients with estimated CrCL ≥ 51 mL/min Type of infection
Maltese: Tabella 1 Kors tad-doża minn ġol-vina għal pazjenti b' CrCL stmat ≥ 51 mL/min Tip ta' infezzjoni
English: Vomiting
Maltese: Tromboċitożi
English: Zavicefta 2 g/0.5 g powder for concentrate for solution for infusion
Maltese: Zavicefta 2 g/0.5 g trab għal konċentrat għal soluzzjoni għall-infużjoni
English: Aseptic technique must be followed in preparing the infusion solution.
Maltese: Għandha tiġi segwita teknika asettika fil-preparazzjoni tas-soluzzjoni għall-infużjoni.
English: Pfizer ΕΛΛΑΣ Α.Ε.
Maltese: Pfizer ΕΛΛΑΣ Α.Ε. (CYPRUS BRANCH)
English: Introduce the syringe needle through the vial closure and inject 10 mL of sterile water for injections.
Maltese: Daħħal il-labra tas-siringa minn ġot-tapp tal-kunjett u injetta 10 mL ta' ilma sterili għallinjezzjonijiet.
English: Blood alkaline phosphatase increased
Maltese: Żieda fl-alkaline phosphatase fiddemm
English: Vivian Corporation Ltd. Tel: +35621 344610
Maltese: Tel: +35621 344610
English: Avibactam penetration of the blood brain barrier has not been studied clinically; however, in rabbits with inflamed meninges, CSF exposures of ceftazidime and avibactam were 43% and 38% of plasma AUC, respectively.
Maltese: Il-penetrazzjoni ta' avibactam fil-barriera bejn id-demm u l-moħħ ma ġietx studjata klinikament; madankollu, fil-fniek bil-meninġi infjammati, esponimenti CSF ta' ceftazidime u avibactam kienu 43% u 38% tal-AUC tal-plażma, rispettivament. Ceftazidime faċilment jgħaddi millplaċenta, u jiġi eliminat fil-ħalib tas-sider tal-bniedem.
English: Dizziness
Maltese: Disgewsja
English: • raised itchy skin rash (“hives”)
Maltese: • raxx imqabbeż tal-ġilda li jqabbad il-ħakk ("urtikarja")
English: Nausea
Maltese: Żieda
English: Studies have shown that Zavicefta solutions for infusion are stable for up to 12 hours at room temperature.
Maltese: L-istudji urew li Zavicefta soluzzjonijiet għall-infużjoni huma stabbli sa 12-il siegħa f'temperatura talkamra.
English: Overall, the safety profile in these 61 children was similar to that observed in the adult population with cIAI.
Maltese: B'kollox, il-profil tassigurtà f'dawn il-61 tifel u tifla kien simili għal dak osservat fil-popolazzjoni adulta b'cIAI.
English: Thrombocytosis
Maltese: Tromboċitopenija
English: This reaction may be life-threatening.
Maltese: Ir-riskju gћat-trabi tat-twelid mhux eskluż.
English: In-vitro data indicate that the following species are not susceptible to ceftazidime/avibactam.
Maltese: Data in-vitro tindika li l-ispeċi li ġejjin mhumiex suxxettibbli għal ceftazidime/avibactam.
English: Animal studies with avibactam do not indicate harmful effects with respect to fertility (see section 5.3).
Maltese: Studji fl-annimali b'avibactam ma jindikawx effetti ta' ħsara fir-rigward tal-fertilità (ara sezzjoni 5.3).
English: Ceftazidime concentrations of 4 to 20 mg/L or more are achieved in the CSF when the meninges are inflamed.
Maltese: Ilkonċentrazzjonijiet ta' Ceftazidime ta' 4 sa 20 mg/L jew aktar huma milħuqa fis-CSF meta l-meninġi huma infjammati.
English: Mild to moderate hepatic impairment had no effect on the pharmacokinetics of ceftazidime in individuals administered 2 g intravenously every 8 hours for 5 days, provided renal function was not impaired.
Maltese: L-indeboliment ħafif sa moderat tal-fwied ma għandux effett fuq il-farmakokinetika ta' ceftazidime mogħti f'2 g minn ġol-vina lil individwi kull 8 sigħat għal 5 ijiem, sakemm il-funzjoni tal-kliewi ma tkunx ġiet indebolita.
English: No data are available on animal studies with ceftazidime.
Maltese: M'hemmx data disponibbli dwar studji fl-annimali b'ceftazidime.
English: Pruritus
Maltese: Remettar
English: Very common
Maltese: Importanti:
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation and any agreed subsequent updates of the RMP.
Maltese: L-MAH għandu jwettaq l-attivitajiet u l-interventi meħtieġa ta' farmakoviġilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Concurrent treatment with high doses of cephalosporins and nephrotoxic medicinal products such as aminoglycosides or potent diuretics (e.g. furosemide) may adversely affect renal function.
Maltese: Kura konkomittanti b'dożi għoljin ta' ċefalosporini u prodotti mediċinali nefrotossiċi bħal aminoglycosides jew dijuretiċi qawwija (eż. furosemide) tista' taffettwa l-funzjoni tal-kliewi b'mod avvers.
English: PC: SN: NN:
Maltese: SN:
English: • itchiness
Maltese: L-Italja
English: How to store Zavicefta
Maltese: Kif taħżen Zavicefta
English: While DAGT seroconversion in patients receiving Zavicefta was very common in clinical studies (the estimated range of seroconversion across Phase 3 studies was 3.2% to 20.8% in patients with a negative Coombs test at baseline and at least one followup test), there was no evidence of haemolysis in patients who developed a positive DAGT on treatment.
Maltese: Filwaqt li s-serokonverżjoni DAGT fil-pazjenti li kienu qed jirċievu Zavicefta kienet frekwenti fi studji kliniċi (il-medda stmata ta' serokonverżjoni matul l-istudji ta' Fażi 3 kienet 3.2% sa 20.
English: Infections due to aerobic Gram-negative organisms in patients with limited treatment options
Maltese: Infezzjonijiet minħabba organiżmi aerobiċi Gramnegattivi f'pazjenti b'għażliet ta' kura limitati
English: IV
Maltese: B.
English: Both ceftazidime and avibactam penetrate into human bronchial epithelial lining fluid (ELF) to the same extent with concentrations around 30% of those in plasma.
Maltese: Kemm ceftazidime kif ukoll avibactam jippenetraw fil-fluwidu li jmiss mal-epitilju tal-bronki tal-bniedem (Epithelial lining fluid -ELF) bl-istess mod b'konċentrazzjonijiet ta' madwar 30% ta' dawk fil-plażma.
English: This test looks for antibodies that fight against your red blood cells.
Maltese: Dan it-test ifittex għal antikorpi li jiġġieldu kontra ċ-ċelluli ħomor tad-demm tiegħek.
English: Nausea and diarrhoea were usually mild or moderate in intensity.
Maltese: Ġeneralment, in-nawsea u d-dardir kienu ħfief jew moderati flintensità.
English: • Avibactam is a “beta-lactamase inhibitor” that helps ceftazidime kill some bacteria that it cannot kill on its own.
Maltese: • Avibactam huwa "inibitur beta-lactamase" li jgħin lil ceftazidime joqtol xi batterji li ma jistax joqtol waħdu.
English: Τηλ.
Maltese: Treddigħ
English: Overdose with ceftazidime/avibactam can lead to neurological sequelae including encephalopathy, convulsions and coma, due to the ceftazidime component.
Maltese: Doża eċċessiva b'ceftazidime/avibactam tista' twassal għal konsegwenzi newroloġiċi inkluż enċefalopatija, aċċessjonijiet u koma, minħabba l-komponent ceftazidime.
English: In the rat, no adverse effects were observed on embryofetal development or fertility.
Maltese: Fil-far, ma ġewx osservati effetti avversi fl-iżvilupp tal-embriju u l-fetu jew il-fertilità.
English: Standard aseptic techniques should be used for solution preparation and administration.
Maltese: Għandhom jintużaw tekniki asettiċi standard għall-preparazzjoni u l-għoti tas-soluzzjoni.
English: What is in this leaflet:
Maltese: Mhux magħruf:
English: How much to use The recommended dose is one vial (2 g of ceftazidime and 0.5 g of avibactam), every 8 hours.
Maltese: Id-doża rakkomandata hija kunjett wieħed (2 g ta' ceftazidime u 0.5 g ta' avibactam) kull 8 sigħat.
English: Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali li jingħata b'riċetta ristretta tat-tabib (ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: This medicine is subject to additional monitoring.
Maltese: Dan il-prodott mediċinali huwa suġġett għal monitoraġġ addizzjonali.
English: Ceftazidime does not interfere with enzymebased tests for glycosuria.
Maltese: Zavicefta jista' jaffettwa wkoll ir-riżultati ta' xi testijiet tal-awrina għaz-zokkor.
English: The contents of Zavicefta vial should be reconstituted with 10 mL of sterile water for injections.
Maltese: Il-kontenut talkunjett ta' Zavicefta għandu jiġi rikostitwit b'10 mL ta' ilma sterili għall-injezzjonijiet.
English: Zavicefta will be given to you by a doctor or a nurse.
Maltese: Zavicefta ser jingħatalek minn tabib jew infermier.
English: Uncommon: (may affect up to 1 in 100 people)
Maltese: Mhux komuni: (jistgħu jaffettwaw sa persuna 1 minn kull 100)
English: A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE
Maltese: Suxxettibbli (≥S) Reżistenti (R>)
English: Reproduction toxicity
Maltese: Effett tossiku fuq is-sistema riproduttiva
English: Elimination of ceftazidime and avibactam is decreased in patients with moderate or severe renal impairment.
Maltese: L-eliminazzjoni ta' ceftazidime u avibactam hija mnaqqsa f'pazjenti b'indeboliment moderat jew sever tal-kliewi.
English: • you have ever had a severe allergic reaction to other antibiotics belonging to the penicillin or carbapenem groups
Maltese: • ġieli kellek reazzjoni allerġika severa għal antibijotiċi li jappartjenu għall-gruppi tal-peniċillini jew karbapenemi
English: Nephrotoxicity
Maltese: Newtropenija
English: • fungal infections, including those of the mouth and vagina
Maltese: • infezzjonijiet fungali, inkluż dawk tal-ħalq jew tal-vaġina
English: Avibactam is a non β-lactam, βlactamase inhibitor that acts by forming a covalent adduct with the enzyme that is stable to hydrolysis.
Maltese: Avibactam huwa inibitur β-lactamase li mhux β-lactam li jaġixxi billi jifforma addott kovalenti mal-enzima li hija stabbli għal idrolisi.
English: If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 - 8ºC, unless reconstitution/dilution has taken place in controlled and validated aseptic conditions.
Maltese: Jekk ma jintużax minnufih, ilħinijiet tal-ħażna waqt l-użu u l-kundizzjonijiet qabel l-użu huma r-responsabbilità tal-utent u normalment ma jkunux aktar minn 24 siegħa f'2 sa 8ºC, sakemm ir-rikostituzzjoni/dilwizzjoni ma tkunx seħħet f'kundizzjonijiet asettiċi vvalidati.
English: Transfer the entire contents (approximately 12.0 mL) of the resultant solution to an infusion bag immediately.
Maltese: Ittrasferixxi l-kontenut kollu (bejn wieħed u ieħor 12.0 mL) tas-soluzzjoni li tirriżulta għal ġo borża tal-infużjoni minnufih.
English: Currently available data are described in section 4.8 but no recommendation on a posology can be made.
Maltese: Data attwalment disponibbli hija deskritta fis-sezzjoni 4.8 iżda ma tista' ssir l-ebda rakkomandazzjoni dwar pożoloġija.
English: In two studies in patients with cIAI, the most common diagnosis (approximately 42%) was appendiceal perforation or peri-appendiceal abscess.
Maltese: F'żewġ studji f'pazjenti b'cIAI, l-aktar dijanjożi komuni (bejn wieħed u ieħor 42%) kienet perforazzjoni appendiċitali jew axxessi peri-appendiċitali.
English: The total inuse stability from reconstitution to administration should not exceed 36 hours (24 hours at 2-8°C plus 12 hours room temperature).
Maltese: L-istabbilità waqt l-użu totali mir-rikostituzzjoni għall-għoti ma għandhiex taqbeż 36 siegħa (24 siegħa f'2-8°C kif ukoll 12il siegħa f'temperatura tal-kamra).
English: The Netherlands (REG NL 10411)
Maltese: L-Olanda (REG NL 10411)
English: Strength / Active substance (INN)
Maltese: Qawwa / Sustanza attiva (INN)
English: The Netherlands (REG NL 8913)
Maltese: L-Olanda (REG NL 8913)
English: Conclusion
Maltese: Konklużjoni
English: Eurovet referred to the originator product from Dopharma, Na-salicylaat 100%, REG NL 8913.
Maltese: Eurovet irreferiet għall-prodott oriġinatur minn Dopharma, Na-salicylaat 100%, REG NL 8913.
English: 2.2 Documentation provided
Maltese: 2.2 Dokumentazzjoni pprovduta
English: Decentralised procedure subject to an Article 33 Referral (CD 17 April 2008)
Maltese: Proċedura deċentralizzata soġġetta għal Riferiment skond l-Artikolu 33 (CD 17 ta' April 2008)
English: Dopharma submitted all requested parts of the dossier (Part I, Part IV and PSURs).
Maltese: Dopharma ppreżentat il-partijiet tad-dossier mitlubin kollha (Parti I, Parti IV u PSURs).
English: Pharmaceutical form
Maltese: Għamla farmaċewtika
English: Introduction and background
Maltese: Introduzzjoni u sfond
English: Solacyl was the subject of an Article 33 Referral, further to the submission of a Decentralised Application.
Maltese: Solacyl kien is-suġġett ta' referenza skond l-Artikolu 33, wara l-preżentazzjoni ta' Applikazzjoni Deċentralizzata.
English: The CVMP concluded that Solacyl 100% powder for oral solution was essentially similar to the reference product, Natrium salicylaat 100%.
Maltese: Is-CVMP ikkonkluda li Solacyl 100% trab għall-soluzzjoni orali kien essenzjalment simili għall-prodott ta' referenza, Natrium salicylaat 100%.