FrancophonIA/ELRC3.0 huggingface dataset:
English: The performance parameters from in vitro aerosol characterisation studies are identical for the two controllers and are shown in section 5.1, Table 2.
Maltese: Il-parametri ta' eżekuzzjoni minn studji in vitro dwar karatterizzazzjoni tal-aerosol huma identiċi għaż-żewġ kontrolluri u huma murija f'sezzjoni 5.1, Tabella 2.
English: However, seven of 13 patients (54%) in the placebo-controlled trials who acquired isolates with MICs of 128 µg/ml while using TOBI had improvement in pulmonary function.
Maltese: Madankollu, seba' minn 13-il pazjent (54%) fil-provi kkontrollati bil-plaċebo li kisbu iżolati b'MICs ta' 128 µg/ ml waqt li kienu qed jużaw TOBI kellhom titjib fil-funzjoni pulmonari.
English: It belongs to a class of antibiotic medicines called aminoglycosides.
Maltese: Jagħmel parti minn klassi ta' mediċini antibijotiċi msejħa aminoglycosides.
English: Vantobra is taken in alternating cycles of 28 days.
Maltese: Vantobra jittieħed f'ċikli li jalternaw ta' 28 ġurnata.
English: Adverse drug reactions reported for tobramycin nebuliser solution are listed in Table 1.
Maltese: Ir-reazzjonijiet avversi tal-medicina rrappurtati għas-soluzzjoni ta' tobramycin għan-nebulizzatur huma elenkati f'Tabella 1.
English: Do not use Vantobra:
Maltese: Tużax Vantobra:
English: ON Vantobra
Maltese: TIEĦU Vantobra
English: Rare (may affect up to 1 in 1,000 people)
Maltese: Rari (≥ 1/10,000 sa < 1/1,000);
English: As tobramycin is not metabolised, an effect of hepatic impairment on the exposure to tobramycin is not expected.
Maltese: Peress li tobramycin ma jiġix metabolizzat, mhux mistenni effett ta' indeboliment tal-fwied fuq l-esponiment għal tobramycin.
English: Nephrotoxicity has been associated with parenteral aminoglycoside therapy.
Maltese: terapija ta' aminoglycoside nebulizzat).
English: Concurrent use of Vantobra with diuretic compounds (such as ethacrynic acid, furosemide, urea or mannitol) is not recommended.
Maltese: Mhux irrakkomandat l-użu ta' Vantobra flimkien ma' sustanzi dijuretiċi (bħal ethacrynic acid, furosemide, urea jew mannitol).
English: If an allergic response is suspected, Vantobra should be discontinued.
Maltese: Jekk ikun hemm suspett ta' rispons allerġiku, Vantobra għandu jitwaqqaf.
English: • The other ingredient(s) (excipient(s)) are: sodium chloride, calcium chloride, magnesium sulphate, water for injections, sulphuric acid and sodium hydroxide for pH adjustment.
Maltese: - Is-sustanza(i) l-oħra (eċċipjent(i)) hi (huma): sodium chloride, calcium chloride, magnesium sulphate,
English: In clinical studies patients using inhaled tobramycin continued to take dornase alfa, bronchodilators, inhaled corticosteroids and macrolides.
Maltese: Fi studji kliniċi pazjenti li jużaw tobramycin meħud man-nifs komplew jieħdu dornase alfa, bronkodilataturi, kortikosterojdi meħuda man-nifs u macrolides.
English: Table 2: Comparative performance data for the clinical test and reference batches: Vantobra /Tolero nebuliser handset
Maltese: Karatteristiċi tal-aerosol Tabella 2: Dejta komparattiva ta' eżekuzzjoni għal-lottijiet tat-test kliniku u ta' referenza:
English: • After you have used your medicine for 28 days, you then have a 28-day break, during which you do not inhale any Vantobra.
Maltese: • Wara li tkun użajt il-mediċina tiegħek għal 28 ġurnata, għandek twaqqaf għal 28 ġurnata, li matulu ma tiħux Vantobra man-nifs.
English: • One box with the medicinal product: 56 ampoules with nebuliser solution in 7 sachets.
Maltese: • Kaxxa waħda bil-prodott mediċinali: 56 ampulla b'soluzzjoni għan-nebulizzatur f'7 boroż.
English: A cycle of 28 days of active therapy (on-treatment period) and 28 days of rest from treatment (off-treatment period) should be maintained.
Maltese: Għandu jinżamm ċiklu ta' 28 ġurnata ta' terapija attiva (perijodu fuq il-kura) u 28 ġurnata ta' waqfien mill-kura (perijodu mingħajr kura).
English: PHARMACEUTICAL FORM AND CONTENTS Package contains 56 ampoules with nebuliser solution in 7 sachets.
Maltese: U KONTENUT Pakkett fih 56 ampulla b'soluzzjoni għan-nebulizzatur f'7 iqratas.
English: Ampoules are packed in sachets, one sachet contains 8 ampoules which correspond with 4 days of treatment.
Maltese: L-ampulli huma ppakkjati fi qratas, qartas wieħed fih 8 ampulli li jikkorrispondu għal 4 ijiem ta' kura.
English: • Risk Management Plan (RMP) 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 fl-RMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: Bronchodilator therapy, such as salbutamol 2.
Maltese: Terapija ta' bronkodilatatur, bħal salbutamol Fiżjoterapija tas-sider
English: Urea and creatinine levels should be reassessed after every 6 complete cycles of Vantobra therapy (180 days of nebulised aminoglycoside therapy).
Maltese: Il-livelli tal-urea u tal-krejatinina għandhom jiġu evalwati mill-ġdid wara kull 6 ċikli kompluti ta' terapija ta' Vantobra (180 ġurnata ta'
English: Aerosol characteristics
Maltese: Emoptisi Epistassi
English: Vestibular toxicity may be manifested by vertigo, ataxia or dizziness.
Maltese: Tossiċità vestibulari tista' tidher bħala vertigo, atassja jew sturdament.
English: Total Drug Delivered [mg±SD] Fine Particle Mass < 5 µm [mg±SD] Drug Delivery Rate [mg/min] Mass Median Aerodynamic Diameter [µm ± SD]
Maltese: [mg±SD] Doża respirabbli <5 µm [mg±SD]
English: STATEMENT OF ACTIVE SUBSTANCE(S) Each ampoule of 1.7 ml contains 170 mg tobramycin.
Maltese: Kull ampulla ta' 1.7 ml fiha 170 mg tobramycin.
English: PHARMACEUTICAL FORM AND CONTENTS Package contains
Maltese: GĦAMLA FARMAĊEWTIKA U KONTENUT
English: Subcutaneous administration at doses of 100 mg/kg/day in rats and the maximum tolerated dose of 20 mg/kg/day in rabbits during organogenesis was not teratogenic.
Maltese: Għoti taħt il-ġilda ta' dożi ta' 100 mg/kg/kuljum fil-firien u d-doża massima ttollerata ta' 20 mg/kg/kuljum fil-fniek waqt l-organoġenesi ma kinux teratoġeniċi.
English: In controlled clinical trials with Vantobra the most frequent adverse reactions in cystic fibrosis patients with P. aeruginosa infection were cough and dysphonia.
Maltese: Fi provi kliniċi kkontrollati b'Vantobra l-aktar reazzjonijiet avversi frekwenti f'pazjenti b'fibrożi ċistika b'infezzjoni kkawżata minn P. aeruginosa kienu sogħla u disfonija.
English: Vantobra solution is a sterile, aqueous preparation for single use only.
Maltese: Is-soluzzjoni ta' Vantobra hija sterili, preparazzjoni milwiema għall-użu ta' darba biss.
English: • swelling of lymph glands
Maltese: • nefħa tal-glandoli tal-limfa
English: UNIQUE IDENTIFIER _ HUMAN READABLE DATA
Maltese: IDENTIFIKATUR UNIKU - DATA LI TINQARA MILL-BNIEDEM
English: Such compounds can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue (see section 4.4).
Maltese: Sustanzi bħal dawn jistgħu iżidu t-tossiċità ta' aminoglycoside billi jbiddlu l konċentrazzjonijiet tal-antibijotiku fis-serum u fit-tessut (ara sezzjoni 4.4).
English: In the event of accidental ingestion of Vantobra, toxicity is unlikely as tobramycin is poorly absorbed from an intact gastrointestinal tract.
Maltese: F'każ ta' inġestjoni aċċidentali ta' Vantobra, mhix probabbli tossiċità peress li l-assorbiment ta' tobramycin mill-apparat gastro-intestinali intatt huwa baxx.
English: • hearing problems (including noises in your ears and dizziness);
Maltese: • problemi ta' smigħ (inklużi ħsejjes f'widnejk u sturdament);
English: • One box with 56 ampoules with nebuliser solution in 7 sachets.
Maltese: • Kaxxa waħda b': 56 ampulla b'soluzzjoni għan-nebulizzatur f'7 iqratas.
English: Malaise
Maltese: SUQ
English: In patients with a predisposing risk due to previous prolonged systemic aminoglycoside therapy it may be necessary to consider audiological assessment before initiating Vantobra therapy.
Maltese: F'pazjenti b'riskju li jippredisponihom minħabba terapija sistemika preċedenti fit-tul b'aminoglycoside jista' jkun meħtieġ li tiġi kkunsidrata valutazzjoni awdjoloġika qabel tinbeda terapija b'Vantobra.
English: There was no evidence of nephrotoxicity during clinical trials with inhaled tobramycin and Vantobra.
Maltese: Ma kienx hemm evidenza ta' nefrotossiċità waqt provi kliniċi b'tobramycin u Vantobra meħuda man-nifs.
English: NAME OF THE MEDICINAL PRODUCT Vantobra 170 mg nebuliser solution
Maltese: Vantobra 170 mg soluzzjoni għan-nebulizzatur
English: • One box with a Tolero nebuliser handset.
Maltese: • Kaxxa waħda b'handset ta' nebulizzatur Tolero.
English: Vantobra is administered by inhalation using the Tolero nebuliser handset provided in the pack.
Maltese: Vantobra huwa disponibbli flimkien ma' handset ta' nebulizzatur Tolero.
English: Ototoxicity
Maltese: Emoptisi
English: Dizziness Aphonia Headache
Maltese: Sturdament Afonja
English: Epistaxis
Maltese: Ototossiċità
English: Systemic exposure following inhalation of Vantobra is very low (see section 5.2).
Maltese: L-esponiment sistemiku wara teħid man-nifs ta' Vantobra huwa baxx ħafna (ara sezzjoni 5.2).
English: INNER BOX CONTAINING THE MEDICINE
Maltese: Pazjenti wara trapjant ta' organu
English: Limited data from one controlled clinical study over one treatment cycle indicate that the improvement in lung function was maintained above baseline during the 28-day off-treatment period.
Maltese: Dejta limitata minn studju wieħed kliniku kkontrollat fuq ċiklu wieħed ta' kura tindika li t-titjib fil-funzjoni tal-pulmun inżamm 'il fuq mil-linja bażi matul il-perijodu ta' 28 ġurnata mingħajr kura.
English: B. PACKAGE LEAFLET
Maltese: Pakkett fih
English: Children The medicine is not intended for use in children under 6 years of age.
Maltese: Il-mediċina mhux maħsuba għall-użu fi tfal b'età inqas minn 6 snin.
English: If Vantobra is swallowed, it is unlikely to cause severe problems as tobramycin is poorly absorbed from the stomach, but you should still tell your doctor as soon as possible.
Maltese: Jekk Vantobra jinbela', huwa improbabbli li jikkawża problemi severi peress li tobramycin ftit li xejn jiġi assorbit mill-istonku, iżda xorta għandek tgħid lit-tabib tiegħek malajr kemm jista' jkun.
English: For detailed instructions on use see section 6.6.
Maltese: Għal struzzjonijiet dettaljati dwar l-użu ara sezzjoni 6.6.
English: Vantobra is used in patients with cystic fibrosis aged 6 years and older to treat lung infections caused by bacteria named Pseudomonas aeruginosa.
Maltese: Vantobra jintuża f'pazjenti b'fibrożi ċistika b'età minn 6 snin 'il fuq biex jikkura infezzjonijiet fil-pulmun ikkawżati minn batterja msejjħa Pseudomonas aeruginosa.
English: CFU reduction as an indicator for suppression of P. aeruginosa was comparable for Vantobra and the reference product.
Maltese: Tnaqqis f'CFU bħala indikatur ta' soppressjoni ta' P. aeruginosa kien komparabbli għal Vantobra u għall-prodott ta' referenza.
English: Bronchospasm can occur with inhalation of medicinal products and has been reported with the use of nebulised tobramycin.
Maltese: Bronkospażmu jista' jseħħ permezz ta' teħid man-nifs ta' prodotti mediċinali u kien irrappurtat bl-użu ta' tobramycin nebulizzat.
English: Method of administration
Maltese: Żvilupp ta' reżistenza
English: • It is best to have an interval as close as possible to 12 hours between doses, but this interval must be at least 6 hours.
Maltese: • Ikun l-aħjar li jkollok intervall viċin kemm jista' jkun għal 12-il siegħa bejn id-dożi, iżda dan l intervall irid ikun mill-inqas 6 sigħat.
English: Each additional 6 months of treatment resulted in incremental increases similar in magnitude to that observed in the 6 months of controlled studies.
Maltese: 6 xhur addizzjonali ta' kura wassal għal żidiet inkrementali simili fil-kobor għal dawk osservati fis-6 xhur ta'
English: Treatment with the 28-days on and 28-days off dose regimen in clinical studies showed a small but clear increase in tobramycin, amikacin and gentamicin MICs for P. aeruginosa isolates tested.
Maltese: Kura b'kors ta' 28 ġurnata fuq il-mediċina u 28 ġurnata mingħajr il-mediċina fl-istudji kliniċi wriet żieda żgħira iżda ċara fl-MICs ta' tobramycin, amikacin u gentamicin għall-iżolati ta' P. aeruginosa ttestjati.
English: Patients receiving concomitant parenteral aminoglycoside therapy (or any medicine affecting renal excretion, such as diuretics) should be monitored as clinically appropriate taking into account the risk of cumulative toxicity.
Maltese: Pazjenti li jkunu qed jirċievu terapija ta' aminoglycoside parenterali (jew xi mediċina li taffettwa it-tneħħija mill-kliewi, bħal dijuretiċi) fl-istess waqt għandhom jiġu mmonitorjati kif klinikament xieraq b'konsiderazzjoni ta' riskju ta' tossiċità kumulattiva.
English: Inhaling medicines can cause chest tightness due to narrowing of the airways, and this can happen with Vantobra.
Maltese: Jekk qed tieħu waħda jew aktar mill-mediċini ta' hawn fuq, kellem lit-tabib tiegħek qabel ma tuża Vantobra.
English: Very rare (may affect up to 1 in 10,000 people)
Maltese: Rari ħafna (jistgħu jaffettwaw sa persuna waħda minn kull 10,000)
English: • ringing in the ears (normally transient), hearing loss, dizziness
Maltese: • żarżir fil-widnejn (normalment temporanju), telf tas-smigħ, sturdament
English: Based upon in-vitro data and/or clinical trial experience, the organisms associated with pulmonary infections in CF may be expected to respond to Vantobra therapy as follows:
Maltese: Ibbażat fuq dejta in-vitro u/jew esperjenza minn provi kliniċi, l-organiżmi assoċjati ma' infezzjonijiet pulmonari f'CF jistgħu jkunu mistennija li jirrispondu għal terapija b'Vantobra kif ġej:
English: Non-clinical data reveal that the main hazard for humans, based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction and development, consists of renal toxicity and ototoxicity.
Maltese: Tagħrif mhux kliniku ibbażat fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer u effett tossiku fuq is-sistema riproduttiva u l-iżvilupp, juri li l-periklu ewlieni għall-bnedmin, jikkonsisti minn tossiċità fil-kliewi u ototossiċità.
English: • Use Vantobra only with the Tolero nebuliser handset shown in the picture below to make sure you inhale the correct dose.
Maltese: • Uża Vantobra biss mal-handset ta' nebulizzatur Tolero muri fl-istampa taħt biex tiżgura li tieħu man nifs id-doża korretta.
English: Uncommon (may affect up to 1 in 100 people)
Maltese: Mhux komuni (≥ 1/1,000 sa < 1/100);
English: This necessitates sputum concentrations following treatment with aerosolised tobramycin to be ten to twentyfive-fold above the Minimum Inhibitory Concentration (MIC) for both P. aeruginosa growth suppression and control of bactericidal activity.
Maltese: Minima (MIC - Minimum Inhibitory Concentration) kemm għas-soppressjoni tat-tkabbir ta' P. aeruginosa kif ukoll għall-kontroll tal-attività batteriċida.
English: In repeated dose toxicity studies it has been shown that target organs of toxicity are the kidneys and vestibular/cochlear functions.
Maltese: Fi studji dwar l-effett tossiku minn dożi ripetuti intwera li l-organi fil-mira ta' tossiċità huma l-kliewi u l-funzjonijiet vestibulari/kokleari.
English: This includes monitoring of serum concentrations of tobramycin.
Maltese: Dan jinkludi monitoraġġ tal-konċentrazzjonijiet fis serum ta' tobramycin.
English: • ear pain, ear problems
Maltese: • ħorriqija, ħakk
English: Adverse drug reactions are listed according to system organ classes in MedDRA.
Maltese: Ir-reazzjonijiet avversi tal-mediċina huma elenkati skont il-klassi tas-sistemi u tal-organi f'MedDRA.
English: Symptoms of aerosol overdose may include severe hoarseness.
Maltese: Sintomi ta' doża eċċessiva ta' aerosol jistgħu jinkludu ħanqa severa.
English: The drug delivery rate of Vantobra with the Tolero nebuliser is independent of the breathing pattern applied i.e. adult or child in contrast to the PARI LC PLUS nebuliser.
Maltese: Biex terġa' tibda l-kura, għafas u żomm il-buttuna On/Off mill-ġdid għal sekonda sħiħa biex tkompli l-kura.
English: Please also refer to nephrotoxicity information in section 4.4 and excretion information in section
Maltese: Jekk jogħġbok irreferi wkoll għall-informazzjoni dwar nefrotossiċità f'sezzjoni 4.4 u għallinformazzjoni dwar it-tneħħija f'sezzjoni 5
English: Asthenia Pyrexia Pain
Maltese: IL-PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
English: Lung disorder Chest discomfort Productive cough Rhinitis
Maltese: Disturb fil-pulmun Skonfort fis-sider
English: Established susceptibility breakpoints for parenteral administration of tobramycin are inappropriate in the aerosolised administration of the medicinal product.
Maltese: Breakpoints stabbiliti tas-suxxettibilità għall-għoti parenterali ta' tobramycin mhux siewja għall-għoti aerosolizzat tal-prodott mediċinali.
English: The dose of Vantobra is the same for all patients within the approved age range, regardless of age or weight.
Maltese: Id-doża ta' Vantobra hija l-istess għall-pazjenti kollha fil-firxa ta' età approvata, irrispettivament mill-età jew il-piż.
English: • Inhale by mouth the full content of one ampoule in the morning, and one ampoule in the evening using the Tolero nebuliser handset.
Maltese: • Ħu man-nifs mill-ħalq il-kontenut sħiħ ta' ampulla waħda filgħodu, u ampulla waħda filgħaxija bl-użu tal-handset ta' nebulizzatur Tolero.
English: The most prevalent aminoglycoside resistance mechanism seen in P. aeruginosa isolated from chronically infected CF patients is impermeability, defined by a general lack of susceptibility to all aminoglycosides.
Maltese: aeruginosa iżolata minn pazjenti b'CF infettati b'mod kroniku kien impermeabilità, definita bħala nuqqas ġenerali ta' suxxettibilità għall-aminoglycosides kollha. P. aeruginosa iżolata minn pazjenti b'CF intweriet ukoll li turi reżistenza għal aminoglycoside li tadatta li hija kkaratterizzata suxxettibilità mill-ġdid meta l antibijotiku jitneħħa.
English: Lymphadenopathy
Maltese: IL-ĠERMANJA
English: Vantobra should be used with great caution in patients with neuromuscular disorders such as Parkinsonism or other conditions characterized by myasthenia, including myasthenia gravis, as aminoglycosides may aggravate muscle weakness due to a potential curare-like effect on neuromuscular function.
Maltese: Prodotti mediċinali oħra li kienu rrappurtati li jżidu t-tossiċità potenzjali ta' aminoglycosides mogħtija b'mod parenterali jinkludu: - anticholinesterases, tossina ta' botulinum (effetti newromuskolari).
English: Other side effects may include:
Maltese: Kellem lit-tabib tiegħek jekk qatt kellek xi waħda mill-kondizzjonijiet li ġejjin:
English: When they are given by injection, tobramycin and other aminoglycoside antibiotics can cause harm to an unborn child, such as deafness and kidney problems.
Maltese: Meta jingħataw permezz ta' injezzjoni, tobramycin u antibijotiċi aminoglycoside oħra jistgħu jikkawżaw ħsara littarbija fil-ġuf, bħal truxija u problemi fil-kliewi.
English: In general, toxicity is seen at higher systemic tobramycin levels than are achievable by inhalation of the recommended clinical dose.
Maltese: B'mod ġenerali, tossiċità hija osservata b'livelli sistemiċi ogħla ta' tobramycin milli jistgħu jinkisbu permezz ta' teħid man-nifs tad-doża klinika rrakkomandata.
English: In clinical studies with TOBI, most patients with P. aeruginosa isolates with tobramycin MICs < 128 µg/ml at baseline showed improved lung function following treatment with TOBI.
Maltese: It-tobba għandhom jikkunsidraw il-potenzjal li aminoglycosides jikkawżaw tossiċità vestibulari u kokleari u għandhom iwettqu valutazzjonijiet xierqa tal-funzjoni awditorja waqt terapija b'Vantobra.
English: These medicines may harm the kidneys; o platinum compounds such as carboplatin and cisplatin (used to treat some forms of cancer).
Maltese: Dawn il-mediċini jistgħu jagħmlu ħsara lill-kliewi; o sustanzi tal-platinu bħal carboplatin u cisplatin (użati biex jikkuraw xi tipi ta' kanċer).
English: Tisseel / Tissucol and associated names
Maltese: Tisseel / Tissucol u ismijiet assoċjati
English: • restriction to open wound subcutaneous surgery only
Maltese: • restrizzjoni għall-użu f'kirurġija fuq ferita miftuħa biss
English: • for laparoscopic surgery restriction to only use if the minimum spray distance of 2cm
Maltese: • għal kirurġija laparoskopika restrizzjoni biex jintużaw biss jekk id-distanza minima ta' 2cm tal-isprej (firxa rakkomandata ta' 2-5cm) tista' tiġi ġġudikata preċiżament u b'CO2 biss
English: The MAH should ensure within two years, that the product is used in accordance with the SmPC, with a pressure regulator device that delivers a maximum pressure of no more than 1.5 bar (22 psi) in minimally invasive/laparoscopic procedures.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura fi żmien sentejn, li l-prodott jintuża skont l-SmPC, b'regolatur tal-pressjoni li jwassal pressjoni massima ta' mhux aktar minn 1.5 bar (22 psi) fi proċeduri minimament invażivi/laparoskopiċi.
English: The Marketing Authorisation Holder (MAH) shall submit to the national competent authority, within one month of the European Commission decision on this procedure (EMEA/H/A-31/1337), an EU risk management plan for the products according to the EU Good Vigilance Practices which includes the safety concern of gas embolism.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jissottometti lill-awtorità nazzjonali kompetenti, fi żmien xahar mid-deċiżjoni tal-Kummissjoni Ewropea dwar din ilproċedura (EMEA/H/A-31/1337), pjan għall-ġestjoni tar-riskju tal-UE għall-prodotti skont il-Prattiki ta' Viġilanza Tajba tal-UE li jinkludi t-tħassib dwar is-sigurtà ta' emboliżmu tal-gass.
English: The Marketing Authorisation Holder (MAH) shall submit to the national competent authority, within one month of the European Commission decision on this procedure (EMEA/H/A-31/1337), an EU risk management plan for the product according to the EU Good Vigilance Practices which includes the safety concern of gas embolism.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq (MAH) għandu jissottometti lill-awtorità nazzjonali kompetenti, fi żmien xahar mid-deċiżjoni tal-Kummissjoni Ewropea dwar din ilproċedura (EMEA/H/A-31/1337), pjan għall-ġestjoni tar-riskju tal-UE għall-prodott skont il-Prattiki ta' Viġilanza Tajba tal-UE li jinkludi t-tħassib dwar is-sigurtà ta' emboliżmu tal-gass.
English: The MAH should ensure within two years, that the product is used in accordance with the SmPC, with a pressure regulator device that delivers a maximum pressure of no more than 2.0 bar (28.5 psi) in open wound surgery.
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura fi żmien sentejn, li l-prodott jintuża skont l-SmPC, b'regolatur tal-pressjoni li jwassal pressjoni massima ta' mhux aktar minn 2.0 bar (28.5 psi) f'kirurġija fuq ferita miftuħa.
English: Annex IV Conditions to the marketing authorisation
Maltese: Anness IV Kundizzjonijiet għall-awtorizzazzjoni għat-tqegħid fis-suq
English: The MAH should ensure within two years, that the product is used in accordance with the SmPC, with a pressure regulator device that delivers a maximum pressure of no more than 2.0 bar (28.5 psi).
Maltese: Id-Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq għandu jiżgura fi żmien sentejn, li l-prodott jintuża skont l-SmPC, b'regolatur tal-pressjoni li jwassal pressjoni massima ta' mhux aktar minn 2.0 bar (28.5 psi).
English: Artiss and associated names
Maltese: Artiss u ismijiet assoċjati
English: • which regulator(s) should be used, in line with manufacturer recommendations and the SmPC
Maltese: • liema regolatur(i) għandu(hom) jintuża(w), skont ir-rakkomandazzjonijiet tal-manifattur u listruzzjonijiet tal-SmPC għall-użu
English: Tuberculosis tests
Maltese: Testijiet tat-tuberkulożi
English: (See sections 4.2 Elderly, 4.5, 4.8, and 4.9).
Maltese: (Ara sezzjonijiet 4.2 Anzjani, 4.5, 4.8 u 4.9).
English: ClR [ml/min] 13 t1/2 [h]
Maltese: ClR [ml/minuta] 13 t1/2 [sigħat]