FrancophonIA/ELRC3.0 huggingface dataset:
English: Ophthalmic (eye) formulations of mercaptamine are made up locally and used for the management of eye symptoms.
Maltese: Il-formulazzjonijiet oftalmiċi (tal-għajnejn) ta' mercaptamine huma magħmulin lokalment u użati għall-immaniġġjar tas-sintomi tal-għajnejn.
English: Because mercaptamine has been used for many years to treat cystinosis and its use is well established, the applicant presented data from the medical literature to support its application for Dropcys.
Maltese: Is-CHMP ikkunsidra li l-istudji mil-letteratura medika ppreżentata sabiex tappoġġja l-applikazzjoni ma kinux biżżejjed.
English: Therefore, the CHMP was of the opinion that the benefits of Dropcys did not outweigh its risks and recommended that it be refused marketing authorisation.
Maltese: Għaldaqstant, is-CHMP kien tal-opinjoni li l-benefiċċji ta' Dropcys ma għelbux ir-riskji tiegħu u għaldaqstant irrakkomanda li l-awtorizzazzjoni għat-tqegħid fis-suq tiegħu tiġi rrifjutata.
English: The company informed the CHMP that there are no ongoing clinical trials or compassionate use programmes with Dropcys.
Maltese: Għaldaqstant, is-CHMP afferma mill-ġdid ir-rakkomandazzjoni tiegħu ta' qabel, li lawtorizzazzjoni għat-tqegħid fis-suq tiegħu tiġi rrifjutata.
English: Dropcys was expected to be used to prevent and treat cystinosis affecting the cornea.
Maltese: Dropcys kien mistenni li jintuża għall-prevenzjoni u l-kura taċ-ċistinożi li taffettwa l-kornea.
English: Cystinosis is a rare inherited disease caused by the accumulation of a substance called cystine, which forms crystals inside cells, particularly cells in the cornea and kidneys.
Maltese: Iċ-ċistinożi hija marda rari li tintiret ikkawżata mill-akkumulazzjoni ta' sustanza li tissejjaħ cystine, li tifforma lkristalli ġoċ-ċelluli, b'mod partikolari ċ-ċelluli fil-kornea u l-kliewi.
English: The build-up of cystine crystals inside corneal cells can damage the eyes and cause serious vision problems.
Maltese: L-akkumulazzjoni ta' kristalli ta' cystine ġewwa ċ-ċelluli tal-kornea tista' tagħmel ħsara fl-għajnejn u tikkawża problemi serji fil-viżta.
English: MA (EU) number (Invented) name Strength
Maltese: Numru tal-MA (EU) Isem (ivvintat) Qawwa
English: • The CHMP considered the procedure under Article 31 of Directive 2001/83/EC for metformin containing medicinal products.
Maltese: • Is-CHMP ikkunsidra l-proċedura skont l-Artikolu 31 tad-Direttiva 2001/83/KE għall-prodotti mediċinali li fihom metformin.
English: Grounds for CHMP opinion
Maltese: Raġunijiet għal opinjoni tas-CHMP Billi
English: • The CHMP considered that there is evidence from clinical and epidemiological studies indicating the benefits of the use of metformin containing medicinal products in patients with moderate renal impairment (GFR 30-59 ml/min).
Maltese: • Is-CHMP ikkunsidra li hemm evidenza minn studji kliniċi u epidemjoloġiċi li tindika l-benefiċċji tal-użu ta' prodotti mediċinali li fihom metformin f'pazjenti b'indeboliment tal-kliewi moderat (GFR 30-59 ml/min).
English: • The CHMP reviewed the totality of the data submitted by the MAHs on the safety and efficacy of metformin containing medicinal products for the treatment of Type 2 diabetes mellitus in subjects with moderate renal impairment (GFR 30-59 ml/min) with a focus on the risk of lactic acidosis.
Maltese: • Is-CHMP irreveda t-totalità tad-dejta ppreżentata mill-MAHs dwar is-sigurtà u l-effikaċja ta' prodotti mediċinali li fihom metformin għall-kura ta' dijabete milletus tat-Tip 2 f'individwi b'indeboliment tal-kliewi moderat (GFR 30-59 ml/min) b'enfasi fuq ir-riskju ta' aċidożi lattika.
English: The most common side-effects observed in association with metformin use in diabetic individuals are mild to moderate gastrointestinal events including diarrhea, nausea, vomiting, abdominal pain, and decreased appetite.
Maltese: L-aktar effetti sekondarji komuni osservati f'assoċjazzjoni mal-użu ta' metformin f'individwi dijabetiċi huma episodji gastrointestinali minn ħfief sa moderati li jinkludu dijarea, dardir, rimettar, uġigħ addominali, u tnaqqis fl-aptit.
English: On 25 January 2016 the Netherlands therefore triggered a referral under Article 31 of Directive 2001/83/EC, and requested the CHMP to assess the impact of the above concerns on the benefit-risk balance of metformin containing products and to issue an opinion on whether the relevant marketing authorisations should be maintained, varied, suspended or revoked.
Maltese: Fil-25 ta' Jannar 2016, in-Netherlands għalhekk tat bidu għal riferiment skont l-Artikolu 31 tadDirettiva 2001/83/KE, u talbet lis-CHMP biex jivvaluta l-impatt fuq it-tħassib imsemmi hawn fuq dwar ilbilanċ bejn il-benefiċċju u r-riskju ta' prodotti li fihom metformin u biex tinħareġ opinjoni dwar jekk lawtorizzazzjonijiet għat-tqegħid fis-suq rilevanti għandhomx jinżammu, jiġu varjati, jiġu sospiżi jew jiġu revokati.
English: The benefits of metformin in the treatment of T2DM in patients with moderate renal impairment have been demonstrated in terms of the reduction of cardiovascular risk and all-cause mortality.
Maltese: Il-benefiċċji ta' metformin fil-kura ta' T2DM f'pazjenti b'indeboliment tal-kliewi moderat intwerew f'termini ta' tnaqqis ta' riskju kardjovaskulari u mortalità minn kull kawża.
English: As there is a clear relationship between renal function and metformin exposure, a recommendation for a daily dose of 2000 mg/day and 1000 mg/day dose in patients with moderate renal impairment stages 3a and 3b, respectively, can be concluded from the data provided.
Maltese: Peress li hemm relazzjoni ċara bejn il-funzjoni tal-kliewi u l-esponiment għal metfromin, mid-dejta pprovduta tista' tiġi konkluża rakkomandazzjoni għal doża ta' kuljum ta' 2000 mg/kuljum u doża ta' 1000 mg/kuljum f'pazjenti b'indeboliment tal-kliewi moderat ta' stadji 3a u 3b, rispettivament.
English: Apart from lactic acidosis, the overall safety profile of metformin in patients with moderate renal impairment is similar to the safety profile in patients with normal renal function.
Maltese: Minbarra l-aċidożi lattika, il-profil ta' sigurtà globali ta' metformin f'pazjenti b'indeboliment tal-kliewi moderat huwa simili għall-profil ta' sigurtà f'pazjenti b'funzjoni talkliewi normali.
English: Recent scientific data have concluded that the main causes of lactic acidosis are cardiogenic or hypovolemic shock, severe heart failure, severe trauma, and sepsis; therefore lactic acidosis is not primarily caused by metformin treatment.
Maltese: Id-data xjentifika riċenti kkonkludiet li l-kawżi ewlenin ta' aċidożi lattika huma xokk kardjoġeniku jew ipovolemiku, insuffiċjenza tal-qalb severa, trawma severa, u sepsis; għalhekk l-aċidożi lattika mhijiex primarjament ikkawżata minn kura b'metformin.
English: In conclusion, the possible elevated risk of lactic acidosis could be sufficiently minimised in patients with moderate renal impairment (GFR greater than 30 ml/min) with a clear dosing recommendation, additional monitoring of GFR levels before and during treatment, and updated warnings and precautions in the SmPC and package leaflet.
Maltese: Bħala konklużjoni, ir-riskju possibbli elevat ta' aċidożi lattika jista' jiġi minimizzat biżżejjed f'pazjenti b'indeboliment tal-kliewi moderat (GFR akbar minn 30 ml/min) b'rakkomandazzjoni ta' dożaġġ ċara, monitoraġġ addizzjonali tal-livelli GFR qabel u waqt il-kura, u twissijiiet u prekawzjonijiet aġġornati flSmPC u fil-fuljett ta' tagħrif.
English: Metformin, alone or in combination with other medicines, is considered the first choice in the treatment for Type 2 diabetes mellitus (T2DM) and it is widely used in the EU.
Maltese: Metformin, waħdu jew flimkien ma' mediċini oħra, huwa meqjus l-ewwel għażla fil-kura tad-dijabete mellitus tat-Tip 2 (T2DM) u jintuża m'mod komuni fl-UE.
English: • The CHMP considered that publications in the medical literature have shown that metformin at reduced dose may be safely used in patients with moderate renal impairment.
Maltese: • Is-CHMP ikkunsidra li l-publikazzjonijiet fil-letteratura medika wrew li metformin f'dożi mnaqqsa jista' jintuża b'mod sigur f'pazjenti b'indeboliment tal-kliewi moderat.
English: • The CHMP was of the view that the risk of lactic acidosis can be minimised in patients with moderate renal impairment with clear dosing recommendations, additional monitoring of GFR levels before and during treatment and updated warnings and precautions in the Summary of Product Characteristics (SmPC) and Package Leaflet (PL).
Maltese: • Is-CHMP kien tal-fehma li r-riskju ta' aċidożi lattika jista' jitnaqqas f'pazjenti b'indeboliment talkliewi moderat b'rakkomandazzjonijiet ta' dożaġġ ċari, monitoraġġ addizzjonali tal-livelli ta' GFR qabel u waqt il-kura u twissijiet u prekawzjonijiet aġġornati fis-Sommarju tal-Karatteristiċi tal-Prodott (SmPC) u l-Fuljett ta' Tagħrif (PL).
English: Moreover, recent clinical guidelines in the treatment of T2DM recommend the use of metformin in moderate renal impairment.
Maltese: Barra minn hekk, il-linji gwida kliniċi riċenti fil-kura ta' T2DM irrakkomandaw l-użu ta' metformin f'indeboliment tal-kliewi moderat.
English: Moreover, metformin treatment slows the further deterioration of renal function and provides additional significant micro-and macrovascular benefits in this patient population.
Maltese: Barra minn hekk, il-kura ta' metformin tnaqqas id-deterjorament ulterjuri tal-funzjoni tal-kliewi u tipprovdi benefiċċji mikro u makrovaskulari sinifikanti addizzjonali f'din il-popolazzjoni ta' pazjenti.
English: In addition, routine risk minimisation will be extended to include cumulative review of lactic acidosis in the PSURs and a targeted questionnaire.
Maltese: Barra minn hekk, se jiġi estiż tnaqqis ta' riskju ta' rutina biex tiġi inkluża reviżjoni kumulattiva ta' aċidożi lattika fil-PSURs kif ukoll kwestjonarju mmirat.
English: In addition, routine pharmacovigilance activities will be extended to include a cumulative review and a targeted follow up questionnaire on lactic acidosis cases to be submitted in subsequent PSURs.
Maltese: Barra minn hekk, l-attivitajiet tar-rutina ta' farmakoviġilanza se jiġu estiżi biex tiġi inkluża reviżjoni kumulattiva u kwestjonarju ta' segwitu mmirat dwar każijiet ta' aċidożi lattika li għandhom jiġu ppreżentati fil-PSURs sussegwenti.
English: • The CHMP considered the evidence from epidemiological studies, which have shown that lactic acidosis is a very rare condition that occurs most often in patients with acute renal or cardiorespiratory illness or sepsis.
Maltese: • Is-CHMP ikkunsidra l-evidenza minn studji epidemjoloġiċi, li wriet li l-aċidożi lattika hija kundizzjoni rari ħafna li sseħħ l-aktar spiss f'pazjenti b'mard jew sepsis akuti tal-kliewi jew kardjorespiratorji.
English: Overall, metformin has been used safely in patients with moderate renal impairment at reduced doses without causing significant metformin or lactate plasma elevations.
Maltese: B'mod ġenerali, metformin intuża b'mod sigur f'pazjenti b'indeboliment tal-kliewi moderat f'dożi mnaqqsa mingħajr ma kkawża żidiet sinifikanti fil-plażma ta' metformin jew tal-lactate.
English: Overall summary of the scientific evaluation
Maltese: Sommarju ġenerali tal-evalwazzjoni xjentifika
English: Currently the use of metformin in patients with renal failure is not harmonised across the EU, being contraindicated in patients with different stages of moderate renal failure depending on the member state and product.
Maltese: Bħalissa, l-użu ta' metfromin f'pazjenti b'insuffiċjenza tal-kliewi mhuwiex armonizzat madwar l-UE, peress li qed jiġi kontraindikat f'pazjenti bi stadji differenti ta' insuffiċjenza tal-kliewi moderata skont l-Istat Membru u l-prodott.
English: In addition, published epidemiological studies indicate that metformin is often used in clinical practice in patients with moderate renal impairment as reflected in current clinical guidelines without a marked increase in risk of lactic acidosis or other serious side effects.
Maltese: Barra minn hekk, studji epidemjoloġiċi ppubblikati jindikaw li metformin huwa spiss użat fil-prattika klinka f'pazjenti b'indeboliment tal-kliewi moderat kif rifless fil-linji gwida kliniċi attwali mingħajr żieda kbira fir-riskju ta' aċidożi lattika jew effetti sekondarji serji oħrajn.
English: Failure to follow the method of administration of InductOs may compromise its safety and efficacy.
Maltese: Failure to follow the product preparation instructions for InductOs may compromise its safety and effectiveness.
English: 6422 PJ Heerlen The Netherlands tel +31 (0) 45 566 8000 fax +31 (0) 45 566 8012
Maltese: 6422 PJ Heerlen L-Olanda telefon +31 (0) 45 566 8000 fax +31 (0) 45 566 8012
English: • Skeletal immaturity
Maltese: • Immaturità skeletrika
English: System organ class
Maltese: Sistema talklassifika talorgani
English: Localised infection5*
Maltese: Infezzjoni lokalizzata5*
English: REVERSE {number} {YYYY MM}
Maltese: NAĦA TA' WARA {numru} {SSSS XX}
English: 3.2 ml solvent
Maltese: 3.2 ml ta' solvent
English: 1.5 mg/cm3
Maltese: 1.5 mg/ċm3
English: Date of latest renewal: 20 July 2012
Maltese: Data tal-aħħar tiġdid: 20 Lulju, 2012
English: 9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 9 September 2002
Maltese: 9 DATA TAL-EWWEL AWTORIZZAZZJONI/TIĠDID TAL-AWTORIZZAZZJONI Date tal-ewwel awtorizzazzjoni: 9 ta' Settembru 2002
English: Glutamic acid Sodium chloride Polysorbate 80 Sodium hydroxide
Maltese: Glutamic acid Sodium chloride Polysorbate 80
English: Localised infection
Maltese: Infezzjoni lokalizzata
English: 6422 PJ Heerlen The Netherlands
Maltese: 6422 PJ Heerlen L-Olanda
English: 1 matrix
Maltese: 1 matriċi
English: When injected intravenously, the terminal half-life of dibotermin alfa was 16 minutes in rats and 6.7 minutes in cynomolgus monkeys.
Maltese: Meta injettat minn ġol-vina, il-half-life terminali ta' dibotermin alfa kienet ta' 16-il minuta fil-firien u 6.7 minuti fix-xadini cynomolgus.
English: InductOs contains the active substance, dibotermin alfa.
Maltese: InductOs fih is-sustanza attiva, dibotermin alfa.
English: No reactions are observed with the frequency uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) or very rare (<1/10,000).
Maltese: Ma kienux osservati reazzjonijiet bi frekwenza mhux komuni (≥1/1,000 sa <1/100), rari (≥1/10,000 sa <1/1,000) jew rari ħafna (<1/10,000).
English: Heterotopic ossification
Maltese: Ossifikazzjoni eterotopika
English: InductOs was implanted directly onto the exposed dura following a laminectomy.
Maltese: InductOs kien impjantat direttament fuq id-dura esposta wara laminektomija.
English: Dibotermin alfa (recombinant human Bone Morphogenetic Protein-2; rhBMP-2) is a human protein derived from a recombinant Chinese Hamster Ovary (CHO) cell line.
Maltese: Dibotermin alfa (Proteina-2 Morfoġenika ta' l-Għadam umana rikombinanti; rhBMP-2) hi proteina umana derivata minn razza ta' ċelluli rikombinanti ta' l-Ovarju tal-Ħamster Ċiniż (Chinese Hamster Ovary - CHO).
English: • Two syringes (5 ml; polypropylene).
Maltese: • Żewġ siringi (5 ml; polypropylene).
English: 2 matrices
Maltese: 2 matriċijiet
English: 2 x (2.5 cm x 5 cm)
Maltese: 2 x (2.5 ċm x 5 ċm)
English: The estimated absolute difference in fusion success rate between InductOs and autogenous bone graft was 11.7% (95% CI: 0.8%, 22.5%; P = 0.035).
Maltese: Id-differenza assoluta stmata fir-rata ta' suċċess tal-fużjoni bejn InductOs u t-trapjant tal-għadam awtoġenu kienet ta' 11.7% (95% CI: 0.8%, 22.5%; P = 0.035).
English: 2.7 cm3
Maltese: 2.7 ċm3
English: InductOs contains sodium
Maltese: InductOs fih sodium
English: Other medicines and InductOs
Maltese: Mediċini oħra u InductOs
English: Heterotopic ossification1, 3*
Maltese: Ossifikazzjoni eterotopika)1 3
English: Dibotermin alfa has demonstrated variable effects on human tumour cell lines in vitro.
Maltese: Dibotermin alfa wera effetti varjabbli fuq razez ta' ċelluli umani tat-tumur in vitro.
English: Immune response
Maltese: Rispons immuni
English: Wait a MINIMUM of 15 minutes before using the prepared InductOs product.
Maltese: Stenna MINIMU ta' 15-il minuta qabel ma tuża l-prodott ippreparat ta' InductOs.
English: OTHER Medtronic BioPharma B.V.
Maltese: OĦRAJN Medtronic BioPharma B.V.
English: Over 1700 patients have received InductOs in clinical studies.
Maltese: Aktar minn 1700 pazjent irċevew InductOs fi studji kliniċi.
English: • Two syringes (10 ml; polypropylene).
Maltese: • Żewġ siringi (10 ml; polypropylene)
English: Typically, 4 mg (2.7 cm3 of wetted matrix) of InductOs is used in the intervertebral disc space.
Maltese: Tipikament, 4 mg (2.7 ċm3 tal-matriċi mxarrba) ta' InductOs jintuża fl-ispazju tad-diska intervertebrali.
English: Anti-dibotermin antibodies have been investigated in pregnant rabbits following hyper-immunisation with dibotermin alfa to experimentally induce anti-dibotermin alfa antibodies.
Maltese: Antikorpi anti-dibotermin kienu investigati fi fniek tqal wara iper-immunizzazzjoni b'dibotermin alfa biex tikkaġuna antikorpi anti-dibotermin alfa b'mod sperimentali.
English: Compatibility has been demonstrated with titanium, polyetheretherketone (PEEK), and allograft bone.
Maltese: Il-kompatibilità ġiet murija mat-titanju, mal polyetheretherketone (PEEK), u mal-għadma trapjantata.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
Maltese: • Sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe wieћed mill-eċċipjenti elenkati fis-sezzjoni 6.1.
English: 1/6 of the matrix
Maltese: 1/6 tal-matriċi
English: BATCH NUMBER Lot
Maltese: NUMRU TAL-LOTT Lott
English: The efficacy of InductOs was demonstrated in a multinational, randomized, controlled, single-blind study of 450 patients (age range 18 to 87 years; 81% male) with open tibial shaft fractures requiring surgical management.
Maltese: L-effikaċja ta' InductOs intweriet fi studju multinazzjonali, randomized, ikkontrollat, single-blind ta' 450 pazjent (medda ta' età minn 18 sa 87 sena; 81% irġiel) li kellhom ksur miftuħ tax-xaft tal-qasba tas-sieq li kien jeħtieġ immaniġġjar kirurġiku.
English: Powder: sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80 Solvent: water for injections
Maltese: Trab: sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide u polysorbate 80
English: Dibotermin alfa
Maltese: Doża ta' dibotermin alfa
English: These autoimmune diseases include rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis.
Maltese: Dan il-mard awtoimmuni jinkludi artrite rewmatojde, lupus erythematosus sistemiku, skleroderma, is-sindrome ta' Sjögren jew dermatomijosite/polimijosite.
English: PHARMACEUTICAL FORM AND CONTENTS
Maltese: FARMAĊEWTIKA U KONTENUT
English: The efficacy and safety of InductOs were demonstrated in a randomised, controlled, multicenter, non-inferiority study of 279 patients aged 19-78 years undergoing an open anterior lumbar interbody fusion procedure.
Maltese: L-effikaċja u s-sigurtà ta' InductOs intwerew fi studju randomised, ikkontrollat, multiċetriku, noninferiority fuq 279 pazjent li kellhom bejn 19-78 sena, li kien qed ikollhom proċedura ta' fużjoni interbody lumbari anterjuri.
English: Clinical intervention (aspiration and/or surgical removal) may be required if symptoms persist (see section 4.8).
Maltese: Intervent kliniku (aspirazzjoni u/jew tneħħija kirurġika) jista' jkun meħtieġ jekk is-sintomi jippersistu (ara sezzjoni 4.8).
English: • Two matrices (2.5 cm x 5 cm) in a blister package (polyvinyl chloride - PVC).
Maltese: • Żewġ matriċijiet (2.5 ċm x 5 m) f'pakkett bil-folji (polyvinyl chloride - PVC).
English: No clinical data are available; potential risk for human is unknown.
Maltese: M'hemmx dejta klinika disponibbli, irriskju potenzjali għall-bniedem mhux magħruf.
English: • adequate neurovascular status (e.g. absence of compartment syndrome, low risk of amputation)
Maltese: • stat newrovaskulari adegwat (eż. l-assenza tas-sindrome tal-kompartiment, riskju baxx ta'
English: EXPIRY DATE
Maltese: DATA META JISKADI
English: 1/3 of the matrix
Maltese: 1/3 tal-matriċi
English: 2/3 of the matrix
Maltese: 2/3 tal-matriċi
English: One vial contains 4 mg dibotermin alfa.
Maltese: INDIVIDWALI 4 mg dibotermin alfa
English: It allows continued monitoring of the benefit/risk balance of the medicinal product.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ riskju/benefiċċju tal-prodott mediċinali.
English: • Persistent compartment syndrome or neurovascular residua of compartment syndrome
Maltese: • Is-sindrome tal-kompartiment persistenti jew fdal newrovaskulari tas-sindrome tal kompartiment
English: 4 Radiculopathic events includes radiculitis, lumbar radiculopathy, radicular pain, radiculitis lumbosacral, radiculopathy and sciatica.
Maltese: Każijiet radjukulopatiċi jinkludu radikulite, radjukulopatija lumbari, uġigħ radikulari, radikulite lumbosakrali, radikulopatija u xatka.5
English: Localised fluid build-up
Maltese: Akkumulazzjoni ta' fluwidu lokalizzat
English: Additional educational materials for healthcare professionals are available on the following URL: [URL to be included] <and the <Member State> website>.
Maltese: Materjal edukattiv addizzjonali għall-professjonisti tal-kura tas-saħħa huwa disponibbli fuq il-URL li ġej: [il-URL irid jiġi inkluż] <u l-websajt tal-<Istat Membru>>.
English: At 24 months post-operation, InductOs was demonstrated to be statistically non-inferior to autogenous bone graft with a success rate for radiologically determined fusion of 94.4% for InductOs versus 88.9% for autogenous bone graft (95% two-sided CI of the difference: -1.53, 12.46).
Maltese: Wara 24 xahar mill-operazzjoni, intwera li InductOs kien statistikament mhux inferjuri għat-trapjant tal-għadam awtoġenu b'rata ta' suċċess għall-fużjoni stabbilita permezz tar-radjoloġija kienet ta' 94.4% għal InductOs kontra 88.9% għat-trapjant tal-għadam awtoġenu (95% two-sided CI taddifferenza: -1.53, 12.46).
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: 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) tadDirettiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikati fuq il-portal elettroniku Ewropew tal-mediċini.
English: Disinfect the stoppers of the dibotermin alfa and solvent vials.
Maltese: Iddiżinfetta t-tappijiet ta' dibotermin alfa u tal-kunjetti tas-solvent.
English: Marketing Authorisation Holder and Manufacturer Medtronic BioPharma B.V.
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u l-Manifattur Medtronic BioPharma B.V.
English: Peak levels of circulating dibotermin alfa (0.1% of the implanted dose) were observed within 6 hours following implantation.
Maltese: Il-livelli massimi ta' dibotermin alfa fiċ-ċirkolazzjoni (0.1% tad-doża impjantata) kienu osservati fi żmien 6 sigħat wara limpjantazzjoni.
English: - The other ingredients are sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80, water for injections, and bovine Type I collagen.
Maltese: - Is-sustanzi l-oħra huma sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide u polysorbate 80, ilma għal injezzjonijiet, u kollaġen tal-baqar ta' Tip I.
English: In the sterile field
Maltese: Fil-kamp sterili
English: An increased rate of infection was observed in the InductOs-treated group versus the standard of care control group (19% versus 9%, respectively; see section 4.4).
Maltese: Rata akbar ta' infezzjoni kienet osservata fil-grupp ikkurat b'InductOs kotnra l-grupp b'kura ta' kontroll standard (19% kontra 9% rispettivament; ara sezzjoni 4.4).
English: Animal studies have shown reproductive toxicity (see section 5.3).
Maltese: Studji fuq il-bhejjem urew tossiċità riproduttiva (ara sezzjoni 5.3).
English: • One matrix (7.5 cm x 10 cm) in a blister package (polyvinyl chloride - PVC).
Maltese: • Matriċi waħda (7.5 ċm x 10 ċm) f'pakkett bil-folji (polyvinyl chloride PVC)