FrancophonIA/ELRC3.0 huggingface dataset:
English: Acute tibia fracture surgery
Maltese: • Infezzjoni attiva fis-sit kirurġiku
English: Dimensions of wetted matrix
Maltese: Dimensjonijiet tal-matriċi mxarrba
English: A post-hoc meta-analysis of 6 controlled clinical trials with data from patients treated with InductOs or autogenous bone graft administered using CE-marked interbody fusion devices or allograft bone spacers and various surgical approaches showed that, at 24 months post-surgery, InductOs was associated with a higher fusion success rate (95%, 241 out of 255 patients) compared with autogenous bone graft (85 %, 177 out of 209 patients), with an odds ratio of 3.26 (95% CI: 1.172, 9.075; P = 0.024).
Maltese: Analiżi post-hoc ta' 6 provi kliniċi b'kontrolli b'dejta minn pazjenti kkurati b'InductOs jew trapjant tal-għadam awtoġenu li ngħata b'tagħmir ta' fużjoni interkorporali mmarkata KE jew spacers tattrapjant tal-għadam u approċċi kirurġiċi differenti wrew li, sa 24 xahar wara l-kirurġija, InductOs kien assoċjat ma' rata ta' suċċess tal-fużjoni ogħla (95%, 241 minn 255 pazjent) meta mqabbla ma' trapjant tal-għadam awtoġenu (85%, 177 minn 209 pazzjent), b'rata ta' possibbiltà ta' 3.26 (95% CI:
English: • adequate haemostasis (i.e., providing a relatively dry implantation site)
Maltese: • emostasi adegwata (jiġifieri, li tipprovdi sit ta' l-impjantazzjoni relattivament xott)
English: 12 mg pack:
Maltese: Pakkett ta' 12 mg:
English: METHOD OF ADMINISTRATION Implantation.
Maltese: METODU TA' KIF GĦANDU JINGĦATA Impjantazzjoni.
English: 7.5 cm x 10 cm 8 cm3
Maltese: 7.5 ċm x 10 ċm 8 ċm3
English: SPECIAL STORAGE CONDITIONS Do not store above 30°C.
Maltese: Taħżinx f'temperatura 'l fuq minn 30°C.
English: NAME OF THE MEDICINAL PRODUCT Matrix for InductOs 1.5 mg/ml Bovine Type I collagen
Maltese: Matriċi għal InductOs 1.5 mg/ml Kollaġen tal-baqar ta' Tip I
English: • Risk Management Plan (RMP)
Maltese: • Pjan tal-immaniġġar tar-riskju (RMP)
English: 5 cm x 10 cm 5.3 cm3
Maltese: 5 ċm x 10 ċm 5.3 ċm3
English: 2.5 cm x 10 cm 2.7 cm3
Maltese: 2.5 ċm x 10 ċm 2.7 ċm3
English: Dispense onto matrix and wait 15 min.
Maltese: Poġġi fuq il-matriċi u stenna 15-il minuta
English: Frequencies are defined as very common (≥1/10) or common (≥1/100 to <1/10).
Maltese: Il-frekwenzi huma definiti bħala komuni ħafna (≥1/10) jew komuni (≥1/100 sa <1/10).
English: Powder:
Maltese: Trab:
English: InductOs is active at the site of implantation.
Maltese: InductOs hu attiv fis-sit ta' l-impjantazzjoni.
English: 1 vial with12 mg dibotermin alfa 1 vial with 10 ml water for injections 1 sterile matrix (7.5 x 10 cm) 2 syringes (10 ml)
Maltese: Kunjett b'12 mg dibotermin alfa Kunjett b'10 ml ilma għall-injezzjonijiet Matriċi sterili ta' (7.5 x 10 ċm) 2 siringi (10 ml)
English: Dibotermin alfa was not detectable in serum.
Maltese: Dibotermin alfa ma kienx osservat fis-serum.
English: The number of secondary and subsequent interventions was significantly reduced for the InductOs patients, particularly with regard to more invasive interventions, such as bone graft and exchange nailing (P = 0.0326).
Maltese: In-numru ta' interventi sekondarji u sussegwenti kien imnaqqas b'mod sinifikanti għal pazjenti li ngħataw InductOs, partikularment firrigward ta' interventi aktar invażivi, bħal trapjant tal-għadam u exchange nailing (P=0.0326).
English: 1 vial with 4 mg dibotermin alfa 1 vial with 10 ml water for injections 2 sterile matrices (2.5 x 5 cm) 2 syringes (5 ml)
Maltese: Kunjett b'4 mg dibotermin alfa Kunjett b'10 ml ilma għall-injezzjonijiet 2 matriċijiet sterili ta' (2.5 x 5 ċm) 2 siringi (5 ml)
English: Pharmacodynamic information specific to lumbar interbody fusion studies
Maltese: Informazzjoni farmakodinamika speċifika għal studji dwar il-fużjoni intrakorporali tas-sinsla taddahar lumbari
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, acute and repeated exposure toxicity and genotoxicity.
Maltese: Informazzjoni li mhix klinika ma tiżvela ebda periklu speċjali għal bniedem, fuq bażi ta' studji konvenzjonali ta' sigurtà farmakoloġika, effett akut u tossiku minn dożi ripetutiu ġenotossiċità.
English: Powder, solvent and matrix for implantation matrix contain:
Maltese: Trab, solvent u matriċi għall-matriċi ta' impjant fihom:
English: 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains 4 mg (4 mg pack) or 12 mg (12 mg pack) dibotermin alfa.
Maltese: Kunjett wieħed fih 4 mg (pakkett ta' 4 mg) jew 12 mg (pakkett ta' 12 mg) ta' dibotermin alfa.
English: Due to the unknown risks to the foetus associated with the potential development of neutralising antibodies to dibotermin alfa, InductOs is not recommended during pregnancy and in women of childbearing potential not using contraception (see section 4.4).
Maltese: Minħabba r-riskji mhux magħrufa għall-fetu marbuta ma' l-iżvilupp potenzjali ta' antikorpi li jinnewtralizzaw għal dibotermin alfa, InductOs mhxu rakkomandat waqt it-tqala u f'nisa li jista' jkollhom it-tfal li ma jkunux qed jużaw kontraċezzjoni (ara sezzjoni 4.4).
English: • You should inform your doctor if you have an autoimmune disease, such as rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome or dermatomyositis/polymyositis.
Maltese: • Għandek tinforma it-tabib tiegħek jekk għandek xi marda awtoimmuni bħal artrite rewmatojde, lupus erythematosus sistemiku, skleroderma, is-sindrome ta' Sjögren jew dermatomijosite/polymijosite.
English: InductOs 12 mg pack contains:
Maltese: Pakkett ta' 12 mg ta' InductOs jinkludi:
English: In some foetuses with decreased body weights, there were decreases in ossification of frontal and parietal bones (4 out of 151 foetuses), which is generally considered to be reversible, and antibody related effects could not be ruled out.
Maltese: F'xi feti li kellhom tnaqqis fil-piż tal-ġisem, kien hemm tnaqqis fl-ossifikazzjoni ta' l-għadam frontali u parjetali (4 minn 151 fetu), li hu ġeneralment ikkunsidrat li hu riversibbli, u effetti relatati ma' l-antikorpi ma setgħux jiġu esklużi.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 12 mg dibotermin alfa.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett fih 12 mg ta' dibotermin alfa.
English: In the acute tibia fracture pivotal trial, InductOs increased the probability of fracture healing; patients treated with InductOs 1.5 mg/ml had a 44% reduced risk for treatment failure (secondary intervention to promote fracture healing) compared with patients in the standard-care group (RR = 0.56; 95% CI = 0.40 to 0.78).
Maltese: Fi prova importanti dwar ksur akut fil-qasba tas-sieq, InductOs żied il-probabbiltà tal-fejqan tal-ksur; pazjenti kkurati b'InductOs 1.5 mg/ml kellhom riskju mnaqqas ta' 44% li l-kura ma tirnexxix (intervent sekondarju biex jippromwovi l-fejqan mill-ksur) meta mqabbla ma' pazjenti fil-grupp tal-kura standard (RR = 0.56; 95% CI = 0.40 sa 0.78).
English: InductOs must not be used in concentrations higher than 1.5 mg/ml (see section 4.9).
Maltese: InductOs m'għandux jintuża f'konċentrazzjonijiet ogħla minn 1.5 mg/ml (ara sezzjoni 4.9).
English: After reconstitution, InductOs contains 1.5 mg/ml dibotermin alfa.
Maltese: Trab għal InductOs 1.5 mg/ml dibotermin alfa
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, Bone Morphogenetic Proteins, ATC code: M05BC01
Maltese: Mediċini għall-kura ta' mard fl-għadam, Proteini Morfoġenetiċi ta' Għadam; Kodiċi ATC:
English: In lumbar interbody fusion studies, over 600 patients received InductOs.
Maltese: Fi studji dwar il-fużjoni interkorporali lumbari, aktar minn 600 pazjent irċivew InductOs.
English: The Marketing Authorisation Holder (MAH) must agree the content and format of the educational programme, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq (MAH) għandu jaqbel mal-kontenut u l-formatt tal-programm edukattiv, inluż mal-media ta' komunikazzjoni, malmodalitajiet ta' distribuzzjoni u kwalunkwe aspett ieħor tal-programm, mal-Awtorità Nazzjonali Kompetenti.
English: Patients received (in a 1:1:1 ratio) standard care (control group) consisting of intramedullary (IM) nail fixation and routine soft-tissue management, standard care plus InductOs 0.75 mg/ml, or standard care plus InductOs 1.5 mg/ml.
Maltese: Il-pazjenti rċivew (fi proporzjon ta' 1:1:1) kura standard (il-grupp tal-kontroll) li kienet tikkonsisti fi twaħħil bl-imsiemer fiż-żona intramedullari (IM) u mmaniġġjar ta' rutina tat-tessut artab, kura standard flimkien ma' InductOs 0.75 mg/ml, jew kura standard flimkien ma' InductOs 1.5 mg/ml.
English: Pre-Implantation
Maltese: L-impjantazzjoni
English: The maximum dosage is limited to 8 mg (5.3 cm3 of wetted matrix) of InductOs in the intervertebral disc space.
Maltese: Id-dożaġġ massimu hu limitat għal 8 mg (5.3 ċm3 tal-matriċi mxarrba) ta' InductOS) fl-ispazju tad-diska intervertebrali.
English: All patients who were tested for neutralizing antibodies to bone morphogenetic protein-2 were negative.
Maltese: Il-pazjenti kollha li kienu ttestjati għall-antikorpi newtralizzanti għall-proteina-2 morfoġenetika tal-għadam kienu negattivi.
English: This medicine contains less than 1 mmol (23 mg) sodium per maximum dose (two 12 mg packs), i.e. it is essentially ‘sodium-free'.
Maltese: Dan il-prodott mediċinali fih inqas minn 1 mmol (23 mg) sodium f'kull doża massima (2 paketti ta' 12 mg), jiġifieri huwa essenzjalment ‘mingħajr sodium'.
English: InductOs 4 mg pack contains:
Maltese: Pakkett ta' 4 mg ta' InductOs fih:
English: This radiographic finding may be asymptomatic or symptomatic.
Maltese: Din is-sejba radjografika tista' tkun asintomatika jew sintomatika.
English: InductOs 1.5 mg/ml powder, solvent and matrix for implantation matrix Dibotermin alfa
Maltese: InductOs 1.5 mg/ml trab, solvent u matriċi għall-matriċi ta' impjant dibotermin alfa
English: Dosing table for InductOs 4 mg pack InductOs wetted matrices (4 mg pack)
Maltese: InductOs (pakkett ta' 4 mg)
English: In long-bone fracture studies, 6.3% of patients receiving dibotermin alfa with bovine Type I collagen matrix developed antibodies to dibotermin alfa versus 1.3% in the control group.
Maltese: Fi studji kliniċi li saru fuq il-ksur akut tal-għadma ttwila, 6.3% tal-pazjenti li kienu qed jirċievu dibotermin alfa b'matriċi tal-kollaġen tal-baqar ta' Tip I, żviluppaw antikorpi meta mqabbla ma' 1.3% fil-grupp tal-kontroll.
English: STATEMENT OF ACTIVE SUBSTANCE(S) One vial contains 4 mg dibotermin alfa.
Maltese: DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I) Kunjett fih 4 mg ta' dibotermin alfa.
English: The medical staff will prepare InductOs in the operating room.
Maltese: L-istaff mediku ser jipprepara InductOs fis-sala operatorja.
English: Device dislocation
Maltese: Impjantazzjoni
English: 4 mg pack:
Maltese: Pakkett ta' 4 mg:
English: In an in vitro study, dibotermin alfa was shown to bind to fibrin-based haemostatic agents or sealants.
Maltese: Fi studju in vitro, intwera li dibotermin alfa jingħaqad ma' aġenti jew siġġilaturi emostatiċi b'bażi ta' fibrin.
English: 3 PHARMACEUTICAL FORM
Maltese: 3 GĦAMLA FARMAĊEWTIKA
English: Radiculopathic events1, 4
Maltese: Avvenimenti radjukulopatiċi 1 4
English: In a pooled safety data analysis of 8 clinical trials at 24 months post-surgery, the frequency of patients with pseudarthrosis was approximately 2-fold lower following treatment with InductOs (4.8%, 22 out of 456 patients) compared with autogenous bone graft (12.7%, 31 out of 244 patients).
Maltese: F'analiżi ta' dejta miġbura dwar is-sigurtà ta' 8 provi kliniċi 24 xahar wara l-kirurġija, il-frekwenza tal-pazjenti b'psewdoartrożi li kienu ta' madwar darbtejn anqas wara l-kura b' InductOs (4.8%, 22 minn 456 pazjent) meta mqabbel mat-trapjant tal-għadam awtoġenu (12.7%, 31 minn 244 pazjent).
English: MARKETING AUTHORISATION NUMBER(S) EU/1/02/226/001
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/02/226/002
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' farmakovigilanza dettaljati flRMP maqbul ippreżentat fil-Modulu 1.8.2 tal-Awtorizzazzjoni għat-Tqegħid fis-Suq u kwalunkwe aġġornament sussegwenti maqbul tal-RMP.
English: In a clinical study in which the intramedullary canal was reamed to cortical chatter, an increased rate of infection was observed in the InductOs-treated group versus the standard of care control group (see section 4.8).
Maltese: Fi studju kliniku li fih il-kanal intramedullari kien reamed malcortical chatter, kienet osservata żieda fir-rata ta' l-infezzjoni fil-grupp li kien ikkurat b'InductOs meta mqabbel mal-grupp tal-kontroll tal-kura (ara sezzjoni 4.8).
English: Detailed information on this medicine is available on the European Medicines Agency web site http://www.ema.europa.eu
Maltese: Informazzjoni dettaljata dwar din il-mediċina tinsab fuq is-sit elettroniku tal-Aġenzija Ewropea għallMediċini http://www.ema.europa.eu.
English: BATCH NUMBER LOT: see reverse
Maltese: NUMRU TAL-LOTT LOTT: ara n-naħa ta' wara
English: Special consideration of risks and benefits should be given for patients who have previously received injectable collagen (see section 4.3).
Maltese: Għandha tingħata konsiderazzjoni speċjali dwar ir-riskji u l-benefiċċji għal pazjenti li fil-passat kienu rċivew kollaġen li jista' jiġi injettat (ara sezzjoni 4.3).
English: Histological evidence from animal studies of lumbar interbody fusion using anterior or posterior surgical approaches showed dibotermin alfa administered with titanium, PEEK or allograft interbody devices was biocompatible and produced consistently high rates of fusion independent of surgical approach or device material with less fibrous tissue evident compared with autograft.
Maltese: Fi studji dwar it-tossiċità riproduttiva fil-firien, fejn dibotermin alfa ngħata minn ġol-vina biex jimmassimizza l-espożizzjoni sistemika, żieda fil-piż tal-fetu u żieda fl-ossifikazzjoni tal-fetu kienet osservata, u effett relatat mal-kura ma setax jiġi eskluż.
English: For use with unreamed nails, estimated rates of infection were similar between treatment and control groups in a study (21% versus 23%, respectively).
Maltese: Għall-użu ma' dwiefer mhux imwessa', ir-rati stmati ta' infezjoni kienu simili bejn il-kura u l-gruppi ta' kontroll fi studju (21% kontra 23%, rispettivament).
English: In long-bone fracture studies, 13.0% of patients receiving dibotermin alfa with bovine Type I collagen matrix developed antibodies to bovine Type I collagen versus 5.3% of control patients.
Maltese: Fi studji dwar ksur tal-għadma t-twila, 13.0% tal-pazjenti li kienu qed jirċievu dibotermin alfa b'matriċi tal-kollaġen tal-baqar ta' Tip I, żviluppaw antikorpi għall-kollaġen tal-baqar ta' Tip I, meta mqabbla ma' 5.3% tal-pazjenti fil-grupp tal-kontroll.
English: The safety and efficacy of InductOs in children below 18 years of age have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' InductOs fi tfal b'età inqas minn 18-il sena ma ġewx determinati s'issa.
English: In animal studies (rats) using InductOs containing radiolabelled dibotermin alfa, the mean residence time at the site of implantation was 4-8 days.
Maltese: Fi studji fuq l-annimali (firien) bl-użu ta' InductOs li kien fih dibotermin alfa radjutikkettat, il-medja taż-żmien tar-residenza fis-sit ta' l-impjantazzjoni kienet ta' 4-8 ijiem.
English: Anti-dibotermin alfa antibodies: In spine fusion studies, 1.3% of patients receiving InductOs developed antibodies to dibotermin alfa versus 0.8% of patients receiving autogenous bone graft.
Maltese: Fi studji dwar il-fużjoni tas-sinsla tad-dahar, 1.3% tal-pazjenti li kienu qed jirċievu InductOs żviluppaw antikorpi għal dibotermin alfa meta mqabbla ma' 0.8% tal-pazjenti li kienu qed jirċievu trapjant tal-għadam awtoġenu.
English: The matrix is in 1 piece of 7.5 cm x 10 cm.
Maltese: Il-matriċi hi f'biċċa 1 ta' 7.5 ċm x 10 ċm.
English: Dosing table for InductOs 12 mg pack Portion of InductOs wetted matrix (12 mg pack)
Maltese: Tabella tad-dożaġġ għall-pakkett ta' 12 mg ta' InductOs Prozjon ta' matriċi mxarrba InductOs
English: Volume of wetted matrix
Maltese: Volum tal-matriċi mxarrba
English: InductOs is implanted after the completion of standard fracture and wound management (i.e. at the time of soft-tissue closure).
Maltese: InductOs jiġi impjantat wara t-tlestija tal-immaniġġjar tal-ksur standard u tal-ferita, i.e. fil-ħin talgħeluq tat-tessut artab.
English: Bovine Type I collagen
Maltese: Kollaġen tal-baqar ta' Tip I
English: 1 Observed during use in lumbar interbody fusion 2 Fluid collection includes localised oedema, pseudocyst and implant site effusion.
Maltese: 1 Osservati waqt l-użu f'fużjoni interkorporali lumbari 2 Akkumulazzjoni ta' fluwidu jinkludi edima lokalizzata, psewdoċesta u effużjoni fis-sit tal-impjant 3 Ossifikazzjoni eterotopika tinkludi ekostożi, ossifikazzjoni ekstraskeletali, kalċifikazzjoni eterotopika wara l-operazzjoni, żjieda fil-formazzjoni tal-għadam u kalaċifikazzjoni fis-sit talimpjantazzjoni.
English: 2.5 cm x 5 cm 1.3 cm3
Maltese: 2.5 ċm x 5 ċm 1.3 ċm3
English: The proportion of patients with healed soft-tissue wounds was significantly higher at the 6-week post-treatment visit in the InductOs 1.5 mg/ml group compared with the standard-care group (83% versus 65%; P= 0.0010).
Maltese: Il-proporzjon ta' pazjenti li kellhom fejqan ta' feriti fit-tessut artab, kien ogħla b'mod sinifikanti filviżta ta' wara l-kura wara 6 ġimgħat fil-grupp ta' InductOs 1.5 mg/ml, meta mqabbel mal-grupp li kien qed jirċievi kura standard (83% kontra 65%; P=0.0010).
English: In the absence of any experience, the repeat use of InductOs is not recommended.
Maltese: Fl-assenza ta' kull tip ta' esperjenza, l-użu ripetut ta' InductOs mhux rakkomandat.
English: Solvent: Water for injections
Maltese: Solvent: ilma għall-injezzjonijiet
English: InductOs contains bovine collagen, a protein obtained from cattle Some patients may develop antibodies (made by your body to fight a foreign protein) against the collagen in the medicine.
Maltese: InductOs fih kollaġen tal-baqar, proteina miksuba mill-baqar Xi pazjenti jistgħu jiżviluppaw antikorpi (magħmulin minn ġismek biex jiġġieldu proteina barranija) kontra l-kollaġen fil-mediċina.
English: Using sterile technique, place one syringe, one needle and the matrix inner package in the sterile field.
Maltese: Bl-użu tat-teknika sterili, poġġi siringa waħda, labra waħda u l-pakkett ta' ġewwa tal-matriċi fil-kamp sterili.
English: The maximum dosage is limited to 24 mg (2 entire 12 mg pack matrices).
Maltese: Id-dożaġġ massimu hu limitat għal 24 mg (2 matriċi sħaħ ta' pakkett ta' 12 mg).
English: Severity of fractures: Treatment with InductOs 1.5 mg/ml was significantly effective in all fracture classes, including severe Gustilo IIIB fractures (52% reduced risk of secondary interventions as compared to standard-care patients).
Maltese: Il-kura b'InductOs 1.5 mg/ml kienet effettiva b'mod sinifikanti fil-klassijiet kollha tal-ksur, li jinkludu ksur sever tat-tip Gustilo IIIB (riskju mnaqqas bi 52% ta' interventi sekondarji meta mqabbla ma' pazjenti li kienu qed jirċievu kura standard).
English: Powder, solvent and matrix for implantation matrix.
Maltese: Trab, solvent u matriċi għall-matriċi ta' impjant.
English: The available in vivo data on human tumour cell lines do not suggest a potential for promotion of tumour growth or metastasis.
Maltese: L-informazzjoni disponibbli in vivo ma tissuġġerixxix potenzjal għal promozzjoni ta' tkabbir tat-tumur jew metastażi.
English: There were no other alterations in foetal external, visceral, or skeletal morphology.
Maltese: Ma kien hemm l-ebda tibdil ieħor fil-morfoloġija fetali esterna, vixxerali, jew skeletrika.
English: Morphogenetic Protein-2), 4 mg (4 mg pack) or 12 mg (12 mg pack).
Maltese: X'fih InductOs - Is-sustanza attiva f'InductOs hi dibotermin alfa (magħruf ukoll bħala Proteina-2 Morfoġenika ta' l-Għadam umana rikombinanti), 4 mg (pakkett ta' 4 mg) jew 12 mg (pakkett ta' 12 mg).
English: As dibotermin alfa is a protein and has not been identified in the general circulation, it is an unlikely candidate for pharmacokinetic drug-drug interactions.
Maltese: Minħabba li dibotermin alfa hu proteina u ma kienx identifikat fiċ-ċirkolazzjoni ġenerali, x'aktarx li mhux ser jikkawża interazzjonijiet farmakokinetiċi bejn mediċina u oħra.
English: • Powder in a vial (20 ml; Type I glass) with a stopper (bromobutyl rubber).
Maltese: • Trab f'kunjett (20 ml; ħġieġ tat-Tip I) b'tapp (lastku tal-bromobutyl,)
English: Generally, one 12 mg pack is used; however, a maximum of two 12 mg packs may be used.
Maltese: Ġeneralment, jintuża pakkett wieħed ta' 12 mg: madankollu, jistgħu jintużaw sa massimu ta' żewġ pakketti ta' 12 mg.
English: It is a copy of a protein called bone morphogenetic protein 2 (BMP-2), which is produced naturally by the body and helps with the formation of new bone tissue.
Maltese: Huwa kopja ta' proteina msejħa Proteina-2 Morfoġenika tal-Għadam (BMP 2), li hija magħmula b'mod naturali mill-ġisem u tgħin filformazzjoni ta' tessut ġdid tal-għadam.
English: Reporting of suspected adverse reactions
Maltese: Rappurtaġġ ta' reazzjonijiet avversi suspettati
English: The powder is white.
Maltese: Ġabra ta' fluwidu
English: For pain and disability (Oswestry score), the success rate was 72.9% in the group using InductOs versus 72.5% in the group using autogenous bone graft (95% two-sided CI of the difference: -11.2, 12.0).
Maltese: Għall-uġigħ u diżabilità (punteġġ Oswestry), ir-rata ta' suċċess kienet ta' 72.9% fil-grupp li uża InductOs kontra 72.5% fil-grupp li uża trapjant tal-għadam awtoġenu (95% two-sided CI tad-differenza:
English: The most common adverse reactions for InductOs in lumbar interbody fusion surgery were radiculopathic events, and in acute tibia fracture surgery it was localised infection.
Maltese: L-aktar reazzjonijiet avversi komuni għal InductOs f'operazzjoni tas-sinsla tad-dahar lumbari interkorporali kienu avvenimenti radjokulopatiċi, u f'kirurġija ta' ksur fil-qasba tas-sieq kienet infezzjoni lokalizzata.
English: • Common (may affect up to 1 in 10 people):
Maltese: Komuni (jistgħu jaffettwaw sa persuna waħda minn kull 10):
English: • Powder in a vial (10 ml; Type I glass) with a stopper (bromobutyl rubber).
Maltese: • Trab f'kunjett (10 ml; ħġieġ ta' Tip I) b'tapp (lastku tal-bromobutyl).
English: Serious side effects
Maltese: Effetti sekondarji serji
English: Anti-bovine Type I collagen antibodies: In spine fusion studies, 13.5% of patients receiving InductOs developed antibodies to bovine Type I collagen versus 14.3% of patients receiving autogenous bone graft.
Maltese: Antikorpi ta' kontra l-kollaġen tal-baqar ta' Tip I: Fi studji li saru dwar il-fużjoni tas-sinsla taddahar, 13.5% tal-pazjenti li kienu qed jirċievu InductOs żviluppaw antikorpi kontra l-kollaġen talbaqar ta' Tip I, meta mqabbla ma' 14.3% tal-pazjenti li kienu qed jirċievu trapjant tal-għadam awtoġenu.
English: Reporting of side effects
Maltese: Rappurtar ta' effetti sekondarji oħra
English: • Additional risk minimisation measures
Maltese: Miżuri addizzjonali għall-minimizzazzjoni tar-riskji
English: The use of these products in close proximity to InductOs is not recommended as this may lead to bone formation at the site of implant of the fibrin-based haemostatic agent or sealant (see section 4.2).
Maltese: L-impjant jista' jitpoġġa biss fis-sit fejn ikun hemm il-ksur sit, meta l-kirurgu jkun jista' jara s-sit b'mod adegwat u bl-akbar attenzjoni (ara sezzjoni 4.2).
English: The incidence of adverse reactions with InductOs was not affected by gender, age or race.
Maltese: L-inċidenza ta' reazzjonijiet avversi b'InductOs ma kienetx affettwata minn sess, età jew razza.
English: • Solvent in a vial (10 ml; Type I glass) with a stopper (bromobutyl rubber).
Maltese: • Solvent f'kunjett (10 ml; ħġieġ ta' Tip I) b'tapp (lastku tal-bromobutyl).
English: CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 1 sterile matrix (7.5 x 10 cm)
Maltese: Matriċi 1 sterili (7.5 x 10 ċm)