FrancophonIA/ELRC3.0 huggingface dataset:
English: It is expected to work by blocking an enzyme called cyclo-oxygenase, which produces prostaglandins, substances that are involved in the inflammation process.
Maltese: Huwa mistenni li jaħdem billi jimblokka enzim imsejjaħ cyclo-oxygenase, li jipproduċi prostaglandins, sustanzi li huma involuti fil-proċess ta' infjammazzjoni.
English: The application was at day 181 when the company withdrew.
Maltese: L-applikazzjoni kienet f'jum 181 meta l-kumpanija rtiratha.
English: How is Diractin expected to work?
Maltese: Għal x'hiex kien mistenni li jintuża Diractin?
English: The effectiveness of Diractin was studied in one main study involving 866 patients with osteoarthritis of the knee.
Maltese: L-effikaċja ta' Diractin ġiet studjata fi studju wieħed prinċipali li jinvolvi 866 pazjent b'osteoartrite tal-irkoppa.
English: In Diractin gel, the ketoprofen is contained in special, small, fatty particles (called ‘Transfersomes') that are expected to carry the ketoprofen through the skin and release it deep below the skin, where the inflammation in osteoarthritis occurs.
Maltese: F'ġell Diracten, il-ketoprofen jinsab f'partikoli speċjali, żgħar u mxaħħmin (imsejħin ‘Transfersomes') li huma mistennija li jġorru l-ketoprofen mill-ġilda u jirrilaxxawh 'l ġewwa taħt ilġilda, fejn isseħħ l-infjammazzjoni fl-osteoartrite.
English: Diractin was expected to be used to treat the symptoms of inflammation and pain associated with osteoarthritis (a condition that causes swelling and pain in the joints).
Maltese: Diractin kien mistenni li jintuża sabiex jikkura s-sintomi tal-infjammazzjoni u l-uġigħ assoċjati malosteoartrite (kundizzjoni li tikkawża nefħa u uġigħ fil-ġogi).
English: On 23 July 2008, IDEA AG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Diractin, for the treatment of the symptoms of inflammation and pain associated with osteoarthritis.
Maltese: Fit-23 ta' Lulju 2008, IDEA AG għarrfet uffiċjalment lill-Kumitat għall-Prodotti Mediċinali għall-Użu mill-Bniedem (CHMP) bl-intenzjoni li tirtira l-applikazzjoni għall-awtorizzazzjoni għat-tqegħid fissuq għal Diractin, għall-kura tas-sintomi ta' infjammazzjoni u uġigħ assoċjati ma' osteoartrite.
English: No compassionate use programmes with Diractin are being conducted.
Maltese: Ma sar ebda programm ta' użu b'kumpassjoni b'Diractin.
English: The CHMP was concerned that the effectiveness of Diractin had not been sufficiently demonstrated in the single main study: compared with placebo, Diractin did not reduce pain levels to an extent that would be relevant for patients.
Maltese: Is-CHMP kien imħasseb li l-effikaċja ta' Diractin ma ntwerietx b'mod suffiċjenti fl-istudju prinċipali waħdieni: meta mqabbel mal-plaċebo, Diractin ma naqqasx il-livelli ta' uġigħ sal-punt li jkun relevanti għall-pazjenti.
English: After the CHMP had assessed the responses from the company to a list of questions, there were still some unresolved issues outstanding.
Maltese: Wara li s-CHMP ivvaluta t-tweġibiet millkumpanija għal lista ta' mistoqsijiet, kien għad hemm xi kwistjonijiet pendenti mhux riżolti.
English: The effects of Diractin were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Diractin ġew ittestjati għall-ewwel darba f'mudelli sperimentali qabel ma ġew studjati fuq il-bniedem.
English: December 2018
Maltese: Diċembru 2018
English: EU/1/08/489/001 EU/1/08/489/002
Maltese: EU/1/08/489/002
English: For intraosseous use.
Maltese: Użu intraossejojuż.
English: 4 vials:
Maltese: 4 kunjetti:
English: 230 mg
Maltese: INDIVIDWALI 230 mg
English: 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); very rare (≤1/10,000), not known (cannot be estimated from the available data).
Maltese: 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); rari ħafna (<1/10,000), mhux magħrufa (ma jistgħux ikunu stmati mid-dejta disponibbli).
English: Musculoskeletal and connective tissue disorders
Maltese: Disturbi muskuloskeletali u tattessuti konnettivi
English: Excipients : Bovine collagen
Maltese: Bovine collagen
English: • hypersensitivity and antibody formation
Maltese: • sensittività eċċessiva u formazzjoni ta' antikorpi
English: • have an autoimmune disease, including Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren's syndrome and dermatomyositis/polymyositis;
Maltese: • għandhom xi marda awtoimmuni, inkluż il-marda Crohn, artrite rewmatojde, lupus erythematosus sistemiku, sklerodermija, sindrome ta' Sjögren, u dermatomijositi/polimijositi;
English: - Uncommon (may affect up to 1 in 100 people):
Maltese: - Mhux komuni (jistgħu jolqtu sa 1 minn kull 100 persuna):
English: HEALTHCARE PROFESSIONAL EDUCATIONAL STICKER
Maltese: STIKER EDUKATTIV TAL-PROFESSJONIST
English: Fax +353-61-585151 medicalinfo@olympusbiotech.com
Maltese: Fax +353-61-585151 medicalinfo@olympusbiotech.com l-Manifattur
English: In a clinical study of the medicinal product, antibodies to the protein eptotermin alfa were detected in 194 out of 207 (94%) patients treated with it and 18 out of 86 (21%) treated with autograft bone (control group).
Maltese: Fi studju kliniku tal-prodott mediċinali, l-antikorpi għall-alfa eptotermina tal-proteina instabu fil-każ ta' 194 minn 207 (94%) tal-pazjenti li kienu kkurati bih u f'18 minn 86 (21%) ikkurati b'awtograft blgħadam (grupp ta' kontroll).
English: Date of first authorisation: 19 February 2009 Date of renewal: 19 February 2014
Maltese: Data ta' l-aħħar tiġdid: 19 ta' Frar 2014
English: Using a sterile syringe, add 2.5 ml of sterile 9 mg/ml sodium chloride solution for injection (0.9% w/v) to the sterile bowl slowly and carefully.
Maltese: Permezz ta' labra sterili, żied soluzzjoni sterili ta' 2.5 ml ta' sodium chloride ta' 9 mg/ml għallinjezzjoni (0.9% w/v) fl-iskutella sterili bil-mod u bir-reqqa.
English: Renal/hepatic impairment
Maltese: Impediment renali/epatiku
English: *Eptotermin alfa is human recombinant osteogenic protein 1 (OP-1) produced in Chinese hamster ovary (CHO) cell line.
Maltese: *Eptotermin alfa hu proteina 1 (OP-1) osteoġenika rikombinanta umana li hi pproduċuta mill-linja ċellulari ta' l-ovarja tal-ħamster Ċiniż (CHO).
English: Opgenra contains the active substance eptotermin alfa.
Maltese: Opgenra fih is-sustanza attiva eptotermin alfa.
English: Opgenra is contraindicated in children aged 0 to 12 years old, adolescents aged 12 to 18 years and the skeletally immature.
Maltese: Opgenra hu kontraindikat fi tfal minn 0 sa 12-il sena, adolexxenti minn 12 sa 18-il sena u dawk skeltralment immaturi.
English: Opgenra is contraindicated in children (<12 years old), adolescents (12-18 years old) and the skeletally immature (see section 4.3).
Maltese: Opgenra hu kontra-indikat fit-tfal (<12-il sena), fl-adoloxxenti (12-18-il sena) u f'dawk li huma skelettrikament immaturi (ara sezzjoni 4.3).
English: The collagen matrix is insoluble and consists of particles with a size range of 75-425µm.
Maltese: Il-matrix tal-kollaġen ma jdubx u jikkonsisti fi frak li għandhom firxa ta' qies ta' 75-425µm.
English: A statistically significant increase in foetal malformations (misaligned sternabrae) was seen in litters of the OP-1 immunized group.
Maltese: Żieda statistikament sinifikanti fil-malformazzjonijiet fetali (sternabrae miżalinejata) kienet osservata fil-boton ta' grupp immunizzat ta' OP-1.
English: Containment
Maltese: Konteniment
English: 1 g (3.3 mg eptotermin alfa)
Maltese: INDIVIDWALI 1 g (3.3 mg eptotermin alfa)
English: For the full list of excipients, see section 6.1.
Maltese: Għall-lista kompluta ta' eċċipjenti, ara sezzjoni 6.1
English: Opgenra is an osteoinductive and osteoconductive medicinal product.
Maltese: Opgenra hu prodott mediċinali ostejoinduttiv u ostejokonduttiv.
English: 1 vial containing 230 mg carmellose.
Maltese: Kunjett wieħed fih 230 mg carmellose.
English: Store in a refrigerator (2°C - 8˚C).
Maltese: Aħżen fil-friġġ (2°C - 8˚C).
English: - if you are receiving chemotherapy, radiation treatment or immunosuppression.
Maltese: - jekk qed tingħata kemoterapija, trattament bir-radjazzjoni jew immunosuppressjoni.
English: The frequency and severity of post-operative adverse events was similar in both test and control groups.
Maltese: Il-frekwenza u s-severità ta' episodji avversi ta' wara l-operazzjoni kienu listess fil-gruppi tat-test u tal-kontroll.
English: Excipients : Bovine collagen, carmellose.
Maltese: TA' EĊĊIPJENTI Sustanzi mhux attivi: Bovine collagen, carmellose
English: It has been observed following use (see section 4.8).
Maltese: Kien osservat wara l-użu (ara sezzjoni 4.8).
English: The active substance is eptotermin alfa (a recombinant human osteogenic protein 1 produced in a Chinese hamster ovary (CHO) cell line).
Maltese: Is-sustanza attiva hi eptotermin alfa (proteina 1 rikombinata umana ostejoġenika magħmula f'linja ta' ċelluli ta' ovarju ta' ħamster Ċiniż (CHO).
English: Adverse events recorded during the clinical studies following such surgery and not specifically causally related to the implanted materials included superficial wound infection, wound dehiscence, osteomyelitis, complications of mechanical support, haematoma formation, nausea, vomiting, fever and pain.
Maltese: Episodji avversi li kienu rrekordjati matul l-istudji kliniċi wara tali operazzjoni u li mhumiex relatati speċifikament b'mod kawżali mal-materjali impjantati jinkludi infezzjoni tal-gerħa superfiċjali, qsim tal-ġerħa, osteomajelite, komplikazzjonijet tas-support mekkaniku, formazzjoni ematomika, tqalligħ, rimettar, deni u wġigħ.
English: • have a hypersensitivity to the active substance or to any of the excipients listed in section 6.1;
Maltese: • għandhom sensittività eċċessiva għas-sustanza attiva jew għal kwalunkwe sustanza mhux attiva elenkati f'sezzjoni 6.1;
English: Opgenra 3.3 mg
Maltese: U MNEJN GĦANDU JINGĦATA Opgenra 3.3 mg
English: Laboratory studies have demonstrated that there is a theoretical risk of developing autoimmunity towards the natural (endogenous) BMP proteins in your body following repeat exposure to this medicine.
Maltese: Studji fil-laboratorji urew li hemm riskju tejoretiku ta' l-iżvilupp ta' awtoimmunità lejn il-proteini naturali (endoġenużi) BMP f'ġismek wara esponiment ripetut għal din il-mediċina.
English: Powder for implantation suspension.
Maltese: Trab għal suspensjoni tall-impjantazzjoni.
English: Within the test group, 26% of patients produced antibodies with neutralizing capacity versus 1% in the control group.
Maltese: Fi ħdan il-grupp tat-test, 26% tal-pazjenti ipproduċew antikorpi b'ħila newtralizzanti a paragun ta' 1% fil-grupp ta' kontroll.
English: Place the contents of the eptotermin alfa vial and carmellose vial in a sterile bowl.
Maltese: Poġġi l-kontenuti tal-kunjett eptotermin alfa u kunjett ta' carmellose fi skutella sterili.
English: After reconstitution, Opgenra contains 1 mg/ml eptotermin alfa.
Maltese: Wara r-rikostituzzjoni, Opgenra fih 1mg/ml eptotermin alfa.
English: Not known: implant site complications (e.g. abscess, implant site induration, pain, oedema, pyrexia)
Maltese: • problemi fil-post tal-impjantazzjoni (pereżempju axxess, twebbis, uġigħ, nefħa, jew deni)
English: The pivotal study with 295 patients involved un-instrumented postero-lateral lumbar spine fusion in 208 patients treated with Opgenra.
Maltese: L-istudju pivotali ta' 295 pazjent involva fużjoni tax-xewka lombari postero -laterali mhux instrumentali f'208 pazjent ikkurati b'Opgenra.
English: 2 x 1 vial containing 230 mg carmellose.
Maltese: 2 x 1 kunjett li fih230 mg carmellose
English: How to store Opgenra
Maltese: X'fih Opgenra
English: Pharmacotherapeutic group: Drugs for the treatment of bone diseases, bone morphogenetic proteins, ATC code: M05BC02
Maltese: Mediċina għall-kura tal-mard tal-għadam , proteini morfoġenetiċi ta' l-għadam, kodiċi ATC:
English: • the risks of ectopic bone formation
Maltese: • ir-riskji ta' formazzjoni tal-għadam ektopiċi
English: Opgenra 3.3 mg powder for implantation suspension eptotermin alfa
Maltese: Opgenra 3.3 mg trab għal suspensjoni tal-impjantazzjoni eptotermin alfa
English: However the rate of malformations was similar to those from historical controls.
Maltese: Imma r-rata tal-malformazzjonijiet kienet simili għal dawk mill-kontrolli storiċi.
English: Other medicines and Opgenra
Maltese: Mediċini oħra u Opgenra
English: For storage conditions after reconstitution, see section 6.3.
Maltese: Għall-kondizzjonijiet ta' ħażna wara r-rikostituzzjoni, ara sezzjoni 6.3. 6.5
English: Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related bone morphogenetic proteins BMP-5 and BMP-6.
Maltese: Studji b'anti-korpi anti-OP-1 urew xi cross-reactivity bil-proteini morfoġenetiċi BMP-5 u BMP-6 ta' l-għadam li huma konnessi mill-viċin .
English: 2 x 1 vial containing 1 g of powder (3.3 mg eptotermin alfa).
Maltese: 2 x 1 kunjett li fih 1 g ta' trab (3.3 mg eptotermin alfa).
English: Opgenra is a type of medicine known as a bone morphogenetic protein (BMP).
Maltese: Opgenra hi tip ta' mediċina magħrufa bħala proteina morfoġenetika tal-għadam (BMP).
English: The maximum dose of this medicine should not exceed 2 units (6.6 mg eptotermin alfa) since its effectiveness and safety in higher doses has not been studied.
Maltese: Id-doża massima ta' din il-mediċina m'għandhiex taqbeż 2 unitajiet (6,6 mg eptotermin alfa) għax leffettività u sigurtà tagħha f'dożi ogħla ma ġietx studjata.
English: Significantly high titers of IgG class anti-OP-1 antibodies were detected in milk throughout the whole post-natal phase study until the lactation day 28 (see section 4.6).
Maltese: Titri li huma sinifikament għoljin ta' antikorpi ta' klassi IgG u anti-OP-1 kienu osservati fil-ħalib matul listudju kollu tal-fażi ta' wara t-twelid sat-28 ġurnata tat-treddigħ (ara sezzjoni 4.6).
English: One vial of this medicine contains 1 g of powder including 3.3 mg of eptotermin alfa and the excipient bovine collagen.
Maltese: Kunjett ta' din il-mediċina fih 1 g ta' trab inkluż 3.3 mg ta' eptotermin alfa u s-sustanza mhux attiva bovine collagen.
English: • collection of fluid in the tissues (seroma),
Maltese: • kwantità ta' fluwidu fit-tessuti (seroma)
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 proċessi ta' proliferazzjoni u differentjazzjoni taċ-ċelluli li jinħtieġu l-ankrar.
English: • have inadequate skin coverage and vascularity at the site of spinal fusion;
Maltese: • m'għandhomx kopertura biżżejjed tal-ġilda u vaskularità fis-sit tal-fużjoni spinali;
English: • failure of the spine to fuse (pseudarthrosis),
Maltese: • ma ssirx fużjoni tax-xewka tad-dahar (psewdartrożi),
English: One vial containing 1g of powder (3.3 mg eptotermin alfa); one vial containing 230 mg carmellose powder.
Maltese: Kunjett wieħed li fih 1g ta' trab (3.3 mg eptotermin alfa); kunjett wieħed li fih 230 mg trab carmellose.
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 jistgħu jinnewtralizzaw l-attività bijoloġika in vitro ta' l-anqas ta' BMP-6.
English: For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Maltese: Għal struzzjonijiet dwar rikostituzzjoni tal-prodott mediċinali qabel ma jingħata ara sezzjoni 6.6.
English: Carmellose (Opgenra)
Maltese: U MNEJN GĦANDU JINGĦATA Carmellose (Opgenra)
English: • have prior history of exposure to any bone morphogenetic protein (BMP) product;
Maltese: • diġà għandhom passat ta' esponiment għal kwalunkwe prodott ta' proteina morfoġenetika tal għadam (BMP);
English: See end of section 4 for how to report side effects.
Maltese: Ara t-tmiem ta' sezzjoni 4 biex tara kif għandek tirrapporta effetti sekondarji.
English: One unit of Opgenra powder for implantation suspension comes as two separate powders.
Maltese: Unità waħda ta' trab Opgenra għal suspensjoni tal-impjantazzjoni jingħata bħala żewġ tipi separati ta' trab.
English: Using sterile technique, remove the vials from the packaging.
Maltese: Uża teknika sterili, neħħi l-kunjetti mill-pakkett.
English: The cellular events induced by the active substance take place within the product matrix.
Maltese: L-episodji ċellulari indutti mis-sustanza attiva jseħħu fi ħdan il-matrix tal-prodott.
English: Carmellose powder for implantation suspension for Opgenra Intraosseous use
Maltese: Trab carmellose għal suspensjoni tal -impjantazzjoni għal Opgenra.
English: Antibodies to OP-1 and bovine bone collagen type 1 were found after both exposures.
Maltese: Antikorpi għal OP-1, u kolaġen tip 1 tal-għadam bovin nstabu wara ż-żewġ esponimenti.
English: • resorption of bone (osteolysis).
Maltese: • risorbiment tal-għadam (osteoliżi)
English: The powder containing the excipient carmellose (carboxymethylcellulose) is yellowish white.
Maltese: It-trab li fih is-sustanza mhux attiva carmellose (carboxymethycellulose) hu abjad li jagħti fl-isfar.
English: This medicinal product should be used by an appropriately qualified surgeon.
Maltese: Dan il-prodott mediċinali għandu jintuża minn kirurgu kwalifikat fl-użu adekwat tiegħu.
English: Administration (implantation)
Maltese: MANIFATTUR(I)
English: In animal studies, excretion of IgG class anti-OP-1 antibodies into milk was shown.
Maltese: Studji fuq bhejjem, urew l-eskrezzjoni ta' antikorpi klassi IgG u anti-OP-1 fil-ħalib.
English: - a pack of two units with 2 x 1 vial containing 1g of powder (3.3 mg eptotermin alfa) and 2 x 1 vial containing 230 mg carmellose powder.
Maltese: - pakkett ta' żewġ unitajiet b'2 x 1 kunjett li fih 1 g ta' trab (3.3 mg eptotermin alfa) u 2 x 1 kunjett li fih 230 mg trab ta' carmellose
English: Post-marketing surveillance data includes reports that the use of the medicinal product in combination with a synthetic bone void filler, may lead to an increase in local inflammation, infection and occasionally migration of the implanted materials (see section 4.4).
Maltese: Dejta ta' sorveljanza wara t-tqegħid fis-suq jinkludi rapporti li l-użu tal-prodott mediċinali flimkien ma' filler tal-vojt tal-għadam sintetiċi, għandu mnejn iwassal għal żieda fl-infjamazzjoni lokali, infezzjoni lokali u xi kultant migrazzjoni tal-materjali impjantati (ara sezzjoni 4.4).
English: Therefore, upon re-administration of Opgenra, a risk of developing autoimmunity towards the endogenous BMP proteins may exist.
Maltese: Mela, hekk kif jerġa' jingħata l-Opgenra, għandu mnejn ikun hemm riskju tal-iżvilupp ta' awtoimmunità għal proteini BMP endoġenużi.
English: (systemic) infection.
Maltese: Infezzjonijiet ta' wara l-operazzjoni,
English: It is possible they may impair the effectiveness of this medicine or cause an immune system response.
Maltese: Huwa possibbli li dawn jistgħu jindebolixxu l-effettività ta' din il-mediċina jew jikkawżaw rispons immunitarju.
English: • Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.
Maltese: • Kull meta s-sistema tal-ġestjoni tar-riskju tiġi modifikata speċjalment minħabba li tasal informazzjoni ġdida li tista' twassal għal bidla sinifikanti fil-profil bejn il-benefiċċjuu r riskju jew minħabba li jintlaħaq għan importanti (farmakoviġilanza jew minimizzazzjoni tar-riskji).
English: Talk to your doctor if you have any of the following: - Common (may affect up to 1 in 10 people):
Maltese: - Komuni (jistgħu jolqtu sa 1 minn 10 persuni):
English: Blood and milk samples were collected at regular intervals and analysed using a solid phase enzyme-linked immunoassay (ELISA) test. Detectable levels of IgG and IgM antibodies to eptotermin alfa had developed and were found in the serum of all exposed adult animals.
Maltese: Livelli osservati ta' antikorpi IgG u IgM għal eptotermin alfa kienu żviluppaw u nstabu fis-serum tal-bhejjem kollha adulti esposti.
English: The powder containing the active substance and the excipient bovine collagen has the appearance of a white to offwhite granular powder; the carmellose powder is a yellowish white powder.
Maltese: It-trab li fih sustanza attiva u s-sustanza mhux attiva bovine collagen għandu d-dehra ta' trab granulari bejn abjad u offwajt, it-trab carmellose hu trab safrani abjad.
English: The frequency of adverse reactions listed in the table below is based on the following convention:
Maltese: Ilfrekwenza tar-reazzjonijiet avversi elenkati fit-tabella ta' hawn taħt hi bbażata fuq ill-konvenzjoni li ġejja:
English: Due to the unknown risks to the foetus associated with the potential development of neutralizing antibodies to OP-1 protein, the medicinal product should not be used during pregnancy unless the potential benefit justifies the potential risks to the foetus (see section 5.3).
Maltese: Studji fuq bhejjem li saru ma jistgħux jeskludi l-effetti possibbi ta' antikorpi anti-OP-1 fuq l-iżvilupp embrijofetali (ara sezzjoni 5.3). Minħabba r-riskji mhux magħrufa għall-fetu marbutin ma' l-iżvilupp potenzjali ta' l-antikorpi newtralizzanti għal proteina OP-1, il-prodott mediċinali m'għandux jintuża matul it-tqala għajr meta l-benefiċċju potenzjali jiġġustifika r-riskji potenzjali għall-fetu (ara sezzjonijiet 5.3).
English: • There is a possibility that new antibodies can form in your body when this medicine is used.
Maltese: • Hemm il-possibbiltà li antikorpi ġodda jistgħu jifformaw f'ġismek meta tintuża din il-mediċina.
English: There have been reports of swelling and infection following the use of this medicine with synthetic bone substitutes.
Maltese: Kien hemm rapporti ta' nefħa u infezzjoni wara l-użu ta' din il-mediċina ma' sostituti tal-għadam sintetiċi.
English: The clinical significance of these antibodies is not known.
Maltese: Issinifikat kliniku ta' dawn l-antikorpi mhux magħruf.
English: Eptotermin alfa in Freund's adjuvant was first administered subcutaneously with booster doses given after 14 and 28 days.
Maltese: Eptotermin alfa f'adjuvant ta' Freund ingħata għall-ewwel darba taħt il-ġilda b'dożi buster mogħtija wara 14 u 28-il ġurnata.
English: Contents of the pack and other information What Opgenra contains
Maltese: Kontenut tal-pakkett u informazzjoni oħra
English: One vial contains 1g powder with 3.3 mg of eptotermin alfa*.
Maltese: U KWANTITATTIVA Kunjett fih 1g trab ma' 3.3 mg ta' eptotermin alfa*.
English: 1 vial containing 1 g of powder (3.3 mg eptotermin alfa).
Maltese: Kunjett wieħed fih 1 g ta' trab (3.3 mg eptotermin alfa).
English: Pack sizes: - a single unit pack with 1 vial containing 1g of powder (3.3 mg eptotermin alfa) and 1 vial containing 230 mg carmellose powder
Maltese: Daqsijiet tal-pakkett: - pakkett ta' unità waħda b'kunjett 1 fih 1g ta' trab (3.3 mg eptotermin alfa) u kunjett 1 li fih 230
English: Indeed, there has been a limited exposure due to a recent and limited marketing of the product (launched in the EU only in August 2011 and marketed in only few Member States).
Maltese: Tabilħaqq, kien hemm espożizzjoni limitata minħabba kummerċjalizzazzjoni reċenti u limitata tal-prodott (imniedi biss fl-UE f'Awwissu 2011 u kkummerċjalizzat biss fi ftit Stati Membri).
English: The carmellose imparts a putty-like consistency to the medicinal product for ease of molding and placement on each side of the spine.
Maltese: Carmellose jagħti konsistenza li qiesha stokk lillprodott mediċinali biex ikun jista' jingħata b'mod faċli forma u jkun jista' jitpoġġa fuq kull naħa taxxewka tad-dahar.
English: • wound problems including infection, discharge and rupture.
Maltese: • problemi bil-ġrieħi inkluż infezzjoni, tnixxija u qsim.
English: The other ingredients are bovine collagen and carmellose.
Maltese: Is-sustanzi l-oħra huma bovine collagen u carmellose.