FrancophonIA/ELRC3.0 huggingface dataset:
English: Step 1 - Choose and prepare injection site
Maltese: Pass 1 - Agħżel u pprepara sit tal-injezzjoni
English: Mylan Healthcare B.V. Tel: +31 (0)20 426 3300
Maltese: Mylan Healthcare Sp. z o.o. Tel: + 48 22 546 64 00
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1319/004 1 pack
Maltese: TAL-AWTORIZZAZZJONI GĦAT-TQEGĦID FIS-SUQ EU/1/18/1319/001 1 pakkett
English: Psoriasis Study IV compared efficacy and safety of adalimumab versus placebo in 217 adult patients with moderate to severe nail psoriasis.
Maltese: L-Istudju tal-Psorijasi IV ikkumpara l-effikaċja u s-sigurtà ta' adalimumab kontra l-plaċebo f'217 pazjent adult bi psorjasi tad-dwiefer minn moderata sa severa.
English: Table 13: Paediatric Plaque Psoriasis Efficacy Results at 16 weeks
Maltese: Tabella 13: Riżultati tal-Effikaċja tal-Psorijasi tal-Plakka Pedjatrika f'Ġimgħa 16
English: No malignancies were observed in 60 paediatric patients with an exposure of 58.4 patient years during an adalimumab trial in paediatric patients with uveitis.
Maltese: Ma ġewx osservati l-ebda tumuri malinni f'60 pazjent pedjatriku b'espożizzjoni ta' 58.4 sena ta' pazjenti waqt prova b'adalimumab f'pazjenti pedjatriċi b'uveite.
English: For storage information, see the package leaflet.
Maltese: Jista' jkun li mhux il-pakketti tad-daqsijiet kollha jkunu fis-suq.
English: Children and adolescents from 6 to 17 years of age weighing 40 kg or more:
Maltese: Tfal u adolexxenti minn 6 sa 17-il sena li jiżnu 40 kg jew aktar:
English: Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adult subjects with rheumatoid arthritis who were treated with adalimumab or placebo.
Maltese: Fi studju li sar fuq 226 individwu adult li jbatu minn artrite rewmatika u li kienu kkurati b'adalimumab jew bi plaċebo, ġew osservati risponsi simili ta'antikorpi għat-tilqima b'vaċċin standard 23-valent ta' pnewmokokkali u t-tilqima tal-virus trivalenti tal-influwenza.
English: Haematologic reactions
Maltese: Reazzjoni Allerġika
English: All subjects received open-label induction therapy at a dose based on their Baseline body weight: 160 mg at week 0 and 80 mg at week 2 for subjects ≥ 40 kg, and 80 mg and 40 mg, respectively, for subjects < 40 kg.
Maltese: L-individwi kollha ngħataw terapija tal-bidu open-label b'doża bbażata fuq il-linja bażi tal-piż talġisem tagħhom: 160 mg f'ġimgħa 0 u 80 mg f'ġimgħa 2 għal individwi ≥40 kg, u 80 mg u 40 mg, rispettivament, għal individwi <40 kg.
English: • mild allergic reactions (including seasonal allergy);
Maltese: • reazzjonijiet allerġiċi ħfief (li jinkludu allerġija assoċjata mal-istaġuni);
English: Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab.
Maltese: Tuberkulosi, inkluż attivazzjoni mill-ġdid u bidu ġdid ta' tuberkulożi, kienet irrappurtata f'pazenti li jirċievu adalimumab.
English: In patients with Crohn's disease, the loading dose of 80 mg adalimumab on week 0 followed by 40 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 5.5 μg/ml during the induction period.
Maltese: F'pazjenti li jbatu mill-marda ta' Crohn (Crohn's disease), id-doża kbira tal-bidu ta' 80 mg adalimumab f'ġimgħa 0 segwita b'40 mg adalimumab f'ġimgħa 2 tilħaq konċentrazzjonijiet fil-livell minimu ta' adalimumab fis-serum ta' madwar 5.5 µg/mL matul il-perjodu tal-bidu.
English: The recommended Hulio induction dose regimen for adult patients with moderately to severely active Crohn's disease is 80 mg at week 0 followed by 40 mg at week 2.
Maltese: Il-kors tad-doża tal-bidu ta' Hulio rrakkomandat għal pazjenti adulti li jbatu mill-marda ta' Crohn attiva li hi minn moderata sa severa huwa ta' 80 mg f'ġimgħa 0 segwita b'40 mg f'ġimgħa 2.
English: Peel the clear plastic just far enough to expose the white plunger rod, but DO NOT take the syringe out of the package.
Maltese: Qaxxar u iftaħ il-plastik trasparenti sakemm tikxef il-parti safra, imma TOĦROĠX illabra mill-pakkett.
English: In RA studies I-IV, adalimumab-treated patients achieved statistically significant ACR 20 and 50 responses compared to placebo as early as one to two weeks after initiation of treatment.
Maltese: Fi Studi RA minn I-IV, pazjenti kkurati b'adalimumab laħqu risponsi statistikament sinifikanti għallACR 20 u 50 sa minn ġimgħa jew tnejn wara li nbdiet il-kura, meta pparagunati mal-plaċebo.
English: 1 sharps disposal container (not included in Hulio pack) 1 gauze pad or cotton ball (not included in Hulio pack)
Maltese: • kontenitur 1 għar-rimi ta' oġġetti li jaqtgħu u bil-ponta (mhux inkluż fil-pakkett ta' Hulio)
English: Study nr-axSpA II was a treatment withdrawal study in nr-axSpA patients who achieved remission during open-label treatment with adalimumab.
Maltese: Dan jippermetti monitoraġġ kontinwu tal-bilanċ bejn il-benefiċċju u r-riskju tal-prodott mediċinali.
English: PsA Study II
Maltese: Studju PsA II
English: A loading dose of 160 mg adalimumab on week 0 followed by 80 mg adalimumab on week 2 achieves serum adalimumab trough concentrations of approximately 12 μg/ml during the induction period.
Maltese: Doża kbira tal-bidu ta' 160 mg adalimumab f'ġimgħa 0 segwita b'80 mg adalimumab f'ġimgħa 2 tilħaq konċentrazzjonijiet fil-livell minimu ta' adalimumab fis-serum ta' madwar 12 µg/mL matul il-perjodu tal-bidu.
English: Cerebrovascular accident 1), tremor, neuropathy
Maltese: Aċċident ċerebrovaskulari1), rogħda, newropatija
English: Children and adolescents from 4 to 17 years of age weighing 30 kg or more:
Maltese: Tfal u adolexxenti minn 4 sa 17-il sena li jiżnu 30 kg jew aktar:
English: • 2 pre-filled syringes (with 2 alcohol pads)
Maltese: • 2 siringi mimlija għal-lest (b'2 tajjariet bl-alkoħol)
English: Clinical remission
Maltese: Rispons Kliniku
English: 10 mg eow
Maltese: 10 mg ġimgħa iva u ġimgħa le
English: Psoriatic arthritis and axial spondyloarthritis including ankylosing spondylitis There is no relevant use of adalimumab in the paediatric population for the indications of ankylosing spondylitis and psoriatic arthritis.
Maltese: Artrite idjopatika poliartikulari taż-żgħażagħ u artrite relatata mal-entesite huma mard infjammatorju tal-ġogi li s-soltu jidhru l-ewwel fit-tfulija.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING OUTER CARTON - PRE-FILLED PEN
Maltese: Tumuri malinni u disturbi fit-tkattir taċ-ċelluli fil-limfa
English: Slovenija Mylan Healthcare d.o.o.
Maltese: Nederland Mylan Healthcare B.V.
English: Patients in clinical response (decrease in CDAI ≥ 70) at week 4 were stratified and analysed separately from those not in clinical response at week 4.
Maltese: Pazjenti li kellhom rispons kliniku (tnaqqis f'CDAI ≥70) f'ġimgħa 4 ġew isseparati minn mal-oħrajn u ġew analizzati separatament minn dawk li ma kellhomx rispons kliniku f'ġimgħa 4.
English: If your child's doctor has told you that your child has an intolerance to some sugars or if your child has been diagnosed with hereditary fructose intolerance (HFI), a rare genetic disorder in which a person cannot break down fructose, talk to your child's doctor before you give your child this medicine.
Maltese: Jekk it-tabib qallek li għandek intolleranza għal ċerti tipi ta' zokkor jew jekk kellek dijanjosi ta' problemi ereditarji ta' intolleranza għall-fructose (HFI, hereditary fructose intolerance), disturb ġenetiku rari li biha persuna ma tkunx tista' timmetabolizza l-fructose, ikkuntattja lit-tabib tiegħek qabel tieħu dan ilprodott mediċinali.
English: EU/1/01/179/001
Maltese: FIS-SUQ EU/1/01/179/001
English: Repeat Use
Maltese: Użu ripetut
English: Date of first authorisation: 18.05.2001 Date of latest renewal: 18.05.2011
Maltese: Data ta' l-aħħar tiġdid: 18.05.2011
English: Post procedural tenderness (Tenderness)
Maltese: Tenerezza post-proċedurali (Tenerezza)
English: 3,3 mg
Maltese: INDIVIDWALI 3.3 mg
English: White to off-white granular powder.
Maltese: Trab granulari abjad għal off-white.
English: Store in a refrigerator (2C - 8C).
Maltese: Aħżen fil-friġġ (2C - 8C)
English: have known autoimmune disease, including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis; have active infection at the site of non-union or active systemic infection; have inadequate skin coverage and vascularity of the non-union site; have vertebral fractures; have a non-union resulting from pathological fractures, metabolic bone disease or tumours; have any tumour in the vicinity of the non-union site; are receiving chemotherapy, radiation treatment or immunosuppression;
Maltese: Osigraft m'għandux jintuża f'pazjenti li: għandhom sensittività eċċessiva magħrufa għas-sustanza attiva jew il-kollaġen: għandhom immaturità skletrali; għandhom xi marda magħrufa tas-sistema ta' awtoimmun, inkluż artrite rematojdi, lupus eritematosuż sistemiku, sklerodermija, sindrom ta' Sjögren, u dermatomijosite/polimijositi; għandhom infezzjoni attiva fis-sit ta' infezzjoni sistematika non-unjoni jew attiva: m'għandhomx biżżejjed kopertura tal-ġilda u vaskularità tas-sit non-unjoni. għandhomfratturi vertebrali; għandhom non-unjoni minħabba fratturi patoloġikali, mard jew tumuri metaboliċi ta' l-għadam; għandhom tumur ħdejn is-sit non-unjoni;
English: Musculoskeletal and connective tissue disorders Bone formation increased (Heterotopic ossification / Myositis ossificans)
Maltese: Żieda fil-formazzjoni tal-għadam (Ossifikazzjoni eterotopika / Myositis ossificans)
English: Osigraft is an osteoinductive and osteoconductive medicinal product.
Maltese: Osigraft hu prodott mediċinali ostejoinduktiv u ostejokonduktiv.
English: Antibodies to OP-1 protein were detected in 66% of patients in the tibial non-union study following the administration of eptotermin alfa.
Maltese: Antikorpi għal proteini OP-1 ġew osservati f'66% tal-pazjenti fl-istudji non-unjoni tibjali wara l-għoti ta' eptotermin alfa.
English: Antibody test positive (Antibody formation)
Maltese: Pożittiv għat-test ta' antikorpi (Formazzjoni ta' antikorpi)
English: The following categories are used to rank the adverse reactions by frequency of occurrence: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); and very rare (<1/10,000), not known (cannot be estimated from the available data).
Maltese: Il-kategoriji li ġejjin huma użati biex jiggradaw ir-reazzjonijiet avversi skont il-frekwenza li seħħew: komuni ħafna (≥1/10); komuni (≥1/100 sa <1/10); mhux komuni (≥1/1,000 sa <1/100); rari (≥1/10,000 sa <1/1,000); u rari ħafna (<1/10,000), mhux magħruf (ma tistax tittieħed stima mid-data disponibbli).
English: Each vial contains 3.3 mg eptotermin alfa*.
Maltese: Kull kunjett fih 3.3 mg eptotermin alfa*.
English: Fertility There is no evidence to suggest that eptotermin alfa alters fertility.
Maltese: Fertilità M'hemmx evidenza li tissuġerixxi li eptotermin alfa tbiddel il-fertilità.
English: Osigraft is a type of medicine known as a bone morphogenetic protein (BMP).
Maltese: Osigraft huwa tip ta' mediċina li tissejjaħ proteina morfoġeniku tal-għadam (BMP).
English: Detectable levels of IgG and IgM antibodies to eptotermin alfa developed and were found in the serum of all exposed adult animals.
Maltese: Kienu osservati li żviluppaw livelli ta' anti-korpi IgG u IgM għall-eptotermin alfa u nstabu fis-serum ta' l-annimali kollha adulti li kienu esposti.
English: Experience from controlled clinical trials is limited to stabilisation of tibial non-union site using concomitant intramedullary nailing.
Maltese: L-esperjenza minn esperimenti klinikali kkontrollati huma limitati għall-istabilizazzjoni tas-sit non-unjoni tibjali permezz ta' l-użu ta' tismir intramedullari konkomitanti.
English: Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related BMP proteins BMP-5 and BMP-6.
Maltese: Studji bl-anti-korpi anti-OP-1 urew xi krossreattività ma' proteini BMP relattati mill-qrib BMP-5 u BMP-6.
English: In another study a difference in body weight gain was seen in the immunized adult females between lactation days 14 to 21 when compared to the control animals.
Maltese: Fi studju ieħor kien osservat differenza fil-piż tal-ġisem f'dawk tas-sess femminili li kienu adulti u immunizzati bejn il-ġranet 14 u 21 tat-treddigħ meta kienu pparagunati ma' l-annimali tal-kontroll.
English: The new bone formed is mechanically and radiographically comparable to normal bone.
Maltese: L-għadma ġdida li tifforma hi mekkanikalment u radjografikalment komparabbli mal-għadma normali.
English: Powder for suspension for implantation.
Maltese: Trab għal suspensjoni għall-impjantazzjoni.
English: The cellular events induced by the active substance take place within the collagen matrix.
Maltese: L-episodji ċellulari indutti mis-sustanza attiva jseħħu fi ħdan il-matrix tal-kollaġen.
English: A statistically significant increase in foetal malformations (misaligned sternabrae) was seen in litters of the OP-1 immunized group.
Maltese: Kienet osservat żjieda sinifikanti statistikali fil-malformazzjonijiet fetali (sternabrae mhux allinjati sewwa) f'boton tal-grupp OP-1 immunizzat.
English: Laboratory studies have shown that antibodies to the eptotermin alfa component of this medicine could react with similar antibodies that the body makes naturally.
Maltese: Studji fil-laboratorju wrew li antikorpi għallkomponent ta' eptotermin alfa f'din il-mediċina jistgħu jirreaġixxu ma' antikorpi simili li l-ġisem jagħmel b'mod naturali.
English: Powder in a glass vial (Type 1, borosilicate) sealed with a stopper (butyl rubber) and a crimp cap (aluminium).
Maltese: Trab f'kunjett tal-ħġieġ (Tip 1, borosilicate) , magħluq b'għatu (tal-lastiku butil) u għatu krimp (aluminju).
English: Pharmacotherapeutic group: Drugs for treatment of bone diseases, bone morphogenetic proteins, ATC code: M05BC02
Maltese: Mediċini għat-trattament ta' mard tal-għadam, proteini morfoġenetiċi tal-għadam,kodiċi ATC:
English: Anti-OP-1 antibodies have the ability to neutralise the in vitro biological activity of at least BMP-6.
Maltese: Anti-korpi Anti-OP-1 għandhom ilħila li jinnewtralizzaw l-attività bijoloġika in vitro ta' l-anqas ta' BMP-6.
English: Each vial contains 3.3 mg of eptotermin alfa* *Produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology For a full list of excipients, see section 6.1.
Maltese: Kull kunjett fih 3.3 mg ta' eptotermin alfa* *Magħmul miċ-ċelluli tal-ovarju tal-ħamster Ċiniż (CHO) bit-teknoloġija rikombinanti tad-DNA Għall-lista kompleta ta' sustanzi mhux attivi, ara sezzjoni 6.1.
English: Osigraft 3.3 mg powder for suspension for implantation eptotermin alfa
Maltese: Osigraft 3.3 mg, trab għal suspensjoni għall-impjantazzjoni eptotermin alfa
English: Each vial of Osigraft is reconstituted with 2 to 3 ml of sterile 9 mg/ml sodium chloride solution (0.9% w/v) prior to use.
Maltese: Kull kunjett ta' Osigraft qabel ma jintuża hu rikonstiwit minn 2 sa 3 ml ta' soluzzjoni sterili ta' klorid tas-sodju ta' konċentrazzjoni ta' 9 mg/ml (0.9% w/v) . Soluzzjoni sterili ta' sodium chloride għall-injezzjoni u l-kontenuti tal-kunjett Osigraft huma ttrasferiti għall-skutella sterili u mħallta bi spatula jew kurett sterili.
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 il-website ta' l-Aġenzija Ewropeja dwar il-mediċini http://www.ema.europa.eu
English: Osigraft 3.3 mg powder for suspension for implantation
Maltese: Osigraft 3.3 mg trab għal suspensjoni għall-impjantazzjoni
English: - if you are receiving chemotherapy, radiation treatment or immunosuppression
Maltese: qed jirċievu kemoterapija, trattament bir-radjazzjoni jew immunosuppressjoni.
English: Blood and milk samples were collected at regular intervals and analysed using a solid phase enzyme-linked immunoassay (ELISA) test.
Maltese: Inġabru kampjuni tad-demm u l-ħalib f'intervalli regulari u kienu analizzati permezz ta' l-użu tat-test immunoassay marbut ma' l-enzima f'fażi solida (ELISA).
English: 3.3 mg of eptotermin alfa
Maltese: 3.3 mg ta' eptotermin alfa.
English: The radiographic healing results of the Osigraft treatment group were slightly inferior compared to the autograft control group (68% and 79% respectively).
Maltese: Ir-riżultati tal-fejqan radjografiku tal-grupp tat-trattament ta' l-Osigraft kienu kemm kemm aktar inferjuri a paragun tal-grupp tal-kontroll ta' l-awtotrapjant (68% u 79% rispettivament).
English: Repeated use of Osigraft is not recommended because clinical trials of multiple surgical treatments at different times have not been undertaken in patients.
Maltese: L-użu ripetut ta' Osigraft mhux rakkomandat minħabba li provi kliniċi ta' trattamenti kirurġiċi multipli f'ħinijiet differenti ma sarux f'pazjenti.
English: Osigraft is contraindicated in children and adolescents (less than 18 years old) and the skeletally immature (see section 4.3).
Maltese: Osigraft hu kontraindikat fit-tfal u adolexxenti (li għadhom m'għalqux 18-il sena) u dawk li għandhom skeletru immatur (ara sezzjoni 4.3).
English: What Osigraft looks like and contents of the pack Osigraft is supplied as white to off-white powder packaged in an amber coloured glass vial (pack size of 1) within a blister pack, comprised of a plastic tray and lid, in a carton.
Maltese: Osigraft jingħata bħala trab bejn abjad u off-white ippakkjat f'kunjett tal-ħġieġ tal-kulur ambra (daqs ta' pakkett 1) fil-pakkett ta' l-istrixxa, li jikkonsisti fi trej tal-plastik u għatu, f'kartuna.
English: Therefore, upon readministration of eptotermin alfa, a risk of developing autoimmunity towards the endogenous BMP proteins may exist.
Maltese: Mela, hekk kif jerġa' jingħata eptotermin alfa, għandu mnejn ikun hemm riskju li tiżviluppa awtoimmunità lejn il-proteini BMP endoġenużi
English: • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation as the result of an important (pharmacovigilance or risk minimisation) milestone being reached
Maltese: • Meta tasal informazzjoni ġdida li jista' jkollha impatt fuq l-Ispeċifikazzjonijiet tas-Sigurta', fuq is-Sistema ta' Farmakoviġilanza jew fuq l-attivitajiet ta' minimizzazzjoni tar-riskju;
English: Antibodies to OP-1 and bovine bone collagen type 1 were found after both exposures; the antibody peak concentration was higher after the second implantation.
Maltese: Anti-korpi għall-OP-1 u l-kollaġen tip 1 tal-għadma bovin instabu wara ż-żewġ esponimenti; l-ogħla konċentrazzjoni ta' anti-korpi kienet ogħla wara t-tieni impjant.
English: Marketing Authorisation Holder Olympus Biotech International Limited 40 Upper Mount Street Dublin 2
Maltese: Id-Detentur ta' l-Awtorizzazzjoni għat-Tqegħid fis-Suq Olympus Biotech International Limited 40 Upper Mount Street
English: A similar pattern of adverse reactions has been recorded from spontaneous reporting with an incidence significantly less than that seen in the clinical trials.
Maltese: Skema simili ta' reazzjonijiet avversi ġiet reġistrata minn raportaġġ spontaneju b'inċidenza sinifikanti inqas minn dik li ntweriet fil-provi kliniċi.
English: The maximum recommended dose for this medicine is 2 vials (2g) since its effectiveness at higher doses has not been established.
Maltese: Id-doża massima rakkomandata għal din il-mediċina hi ta' 2 kunjetti (2 g) peress li l-effettività tagħha f'dożi ogħla ma ġietx stabbilita.
English: Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product Characteristics, section 4.2).
Maltese: Prodott mediċinali jingħata b'riċetta ristretta tat-tabib (Ara Anness I: Sommarju tal-Karatteristiċi tal-Prodott, sezzjoni 4.2).
English: Eptotermin alfa, the active substance, initiates bone formation through the induction of cellular differentiation in mesenchymal cells, which are recruited to the implant site from bone marrow, periosteum and muscle.
Maltese: Dan jipprovdi pjattaforma adekwata bijoresorbabbli indutti mis-sustanza attiva biex ikun hemm proliferazzjoni u differentjazzjoni taċ-ċelluli li jinħtieġu l-ankrar.
English: Eptotermin alfa in Freund's adjuvant was first administered subcutaneously with booster doses given after 14 and 28 days.
Maltese: Eptotermin alfa fl-adjuvant ta' Freund ngħata l-ewwel taħt il-ġilda b'dożi booster li ngħataw wara 14 u 28-il ġurnata.
English: Analysis of these antibodies showed that 9% had neutralizing capacity.
Maltese: L-analiżi ta' dawn l-antikorpi juru li 9% kellhom kapaċità li tinnewtralizza.
English: However, results from Osigraft implantation studies in animals demonstrate that the active substance eptotermin alfa is largely unavailable systemically.
Maltese: Imma, r-riżultati mill-istudji ta' l-impjantazzjoni ta' Osigraft f'annimali juru lis-sustanza attiva eptotermin alfa mhix normalment disponibbli mil-lat sistemikaliku.
English: In animal studies, excretion of IgG class anti-OP-1 antibodies into milk has been shown.
Maltese: Fi studji fuq bhejjem, intwera li kien hemm it-tkeċċija ta' antikorpi antiOP-1 tal-klassi ta' IgG filħalib.
English: The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.0 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation and any subsequent updates of the RMP agreed by the CHMP.
Maltese: Id-detentur tal-awtorizzazzjoni għat-tqegħid fis-suq jimpenja ruħu li jwettaq l-istudji u l-attivitajiet addizzjonali ta' farmakovigilanza kif inhu deskritt fil-Pjan ta' Farmakoviġilanza, kif inhu deciż flverżjoni 1.0 tas-Sistema ta' l-Immaniġġar tar-Riskju inkluz f' Modulu 1.8.2 tal-Applikazzjoni għall-awtorizzazzjoni għat-Tqegħid fis-Suq u aġġornamenti sussegwenti tas-Sistema tal-Immaniġġar tar-Riskju kif deċiż mill-Kumitat ghall-Prodotti Mediċinali għall-Użu Uman tal-Aġenzija Ewropea dwar il-Mediċini (CHMP).
English: Heterotopic ossification may also occur following use (see section 4.8).
Maltese: Ossifikazzjoni eterotopika għandha mnejn tiġri wara l-użu (ara sezzjoni 4.8).
English: Post procedural swelling (Swelling)
Maltese: Nefħa post-proċedurali (Nefħa)
English: This effect, termed solid state carcinogenicity, frequently has been observed in rats where solid materials (plastics or metals) were implanted subcutaneously.
Maltese: Dan l-effett, magħruf bħala karkinoġeniċità fi stat solidu, dehret ta' spiss fil-firien meta kienu impjantati materjali solidi (plastik u metalli) taħt il-ġilda.
English: 5 How to store Osigraft
Maltese: X'fih Osigraft
English: Bovine collagen (vacuum dried).
Maltese: Bovine collagen (imnixxef fil-vakjum)
English: very common (affects more than 1 user in 10)
Maltese: • komuni (jaffettwa minn 1 sa 10 utenti f'100)
English: including rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome
Maltese: - jekk għandek xi marda awtoimmua (marda kaġun minn jew diretta kontra t-tessuti tiegħek stess), inkluża artrite rewmatojdika, lupus eritematosuż sistemiku, skleroderma, sindrom ta'
English: Breast-feeding
Maltese: L-Manifattur
English: Osigraft is contraindicated in children and adolescents (less than 18 years old) and the skeletally immature (see section 4.2).
Maltese: Ossigraft huwa kontraindikat fi tfal u adolexxenti (li għadhom m'għalqux 18-il sena) u dawk li għandhom skeletru immatur (ara sezzjoni4.2).
English: Pack size of 1 vial.
Maltese: Il-pakkett fih kunjett wieħed.
English: Adverse reactions
Maltese: Reazzjonijiet avversi Komuni
English: Clinical outcomes of pain and weight-bearing were comparable to the autograft (81% success in the Osigraft group, 77% success in the autograft group).
Maltese: Ir-riżultati kliniċi ta' l-uġigħ u jekk dak li jkun jiflaħx il-piż kienu komparabbli ma' l-awtotrapjant (suċċess ta' 81% fil-grupp Osigraft, suċċess ta' 77% fil-grupp awtotrapjant).
English: Implanted material dislodged from the non-union site can cause ectopic ossification in the surrounding tissues with potential complications.
Maltese: Materjal impjantat li jinqala' mis-sit non-unjoni jista' jikkaġuna ossifikazzjoni ektopika fit-tessuti tal-madwar b'komplikazzjonijiet potenzjali.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING
Maltese: Id-dehra ta' Osigraft u d-daqs tal-pakkett