qanastek/EMEA-V3 huggingface dataset:
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 sections 4.4 and 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 4. 4 u 5. 3).
Women of childbearing potential should be advised to use effective contraception for a period of at least 2 years after treatment.
Nisa li jistgħu joħorġu tqal għandhom jingħataw il- parir li jużaw kontraċettiv effettiv għal perijodu ta 'mill- anqas sentejn wara t- trattament.
Women of child-bearing potential should inform their surgeon of the possibility of pregnancy prior to treatment with Opgenra.
Nisa li jistgħu joħorġu tqal għandhom jagħrfu lill- kirurgu tagħhom dwar il- possibbiltà tat- tqala qabel it- trattament b’ Opgenra.
In animal studies, excretion of IgG class anti-OP-1 antibodies into milk was shown.
Studji fuq bhejjem, urew l- eskrezzjoni ta ’ antikorpi klassi IgG u anti- OP- 1 fil- ħalib.
As human IgG is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during Opgenra therapy (see section 5.3).
Peress li l- IgG joħroġ fil- ħalib uman, u l- potenzjal tal- ħsara għat- tarbija mhux magħruf, in- nisa ma għandhomx ireddgħu matul it- terapija b’ Opgenra (ara sezzjoni 5. 3).
The medicinal product should be used in breast-feeding women only when the attending physician decides that the benefits outweigh the risks.
Il- prodott mediċinali għandu jingħata biss lil nisa li qed ireddgħu meta it- tabib kuranti jiddeċiedi li l- benefiċċji huma akbar mir- riskji.
It is recommended that breast-feeding be discontinued following treatment.
Hu rrakkomandat li t– treddigħ għandu jitwaqqaf wara t- trattament.
No studies on the effects on the ability to drive and use machines have been performed.
Ma sarux studji fuq il- ħila biex issuq u tħaddem magni.
Opgenra has no known pharmacological effect on neuro-motor co-ordination or performance consequently it is unlikely to alter any pre-existing skills used for driving vehicles or operating machines.
Opgenra ma għandu l- ebda effett magħruf farmakoloġiku fuq il- koordinazzjoni newro- motorja jew l- operat u għalhekk probabbilment mhux ser jibdel kwalunkwe ħilijiet li kienu jeżistu qabel biex isuqu vetturi jew iħaddmu magni.
Opgenra is implanted during an invasive surgical procedure performed under general anaesthesia.
4 Opgenra hu mpjantat matul proċedura li tinvolvi operazzjoni invasiva li ssir bl- anestesija ġenerali.
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.
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.
The frequency and severity of post-operative adverse events was similar in both test and control groups.
Il- frekwenza u s- severità ta ’ episodji avversi ta ’ wara l- operazzjoni kienu l- istess fil- gruppi tat- test u tal- kontroll.
The pattern of unrelated post-operative adverse events varied with the extent of surgical trauma, procedural complications and the pre-operative health of the patient.
Il- mod kif seħħu l- avvenimenti avversi ta ’ wara l- operazzjoni li ma kellhomx x’ jaqsmu ma 'xulxin kien ivarja skond il- medda tat- trawma ta' l- operazzjoni, komplikazzjonijiet tal- proċedura u s- saħħa ta 'qabel l- operazzjoni tal- pazjent.
The following undesirable effects were reported as possibly causally related to Opgenra.
L- effetti mhux mixtieqa li jidhru hawn taħt kienu rrapportati li hemm il- possibbiltà li għandhom x’ jaqsmu b’ mod kawżali ma ’ Opgenra.
The frequency of undesirable effects listed in the table below is based on the following convention:
Il- frekwenza ta ’ l- effetti mhux mixtieqa elenkati fit- tabella ta ’ hawn taħt hi bbażata fuq ill- konvenzjoni li ġejja:
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).
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).
In fections and infestations
Infezzjonijiet u infestazzjonijiet
Common: post-operative infection
Infezzjonijiet ta ’ wara l- operazzjoni,
Uncommon: localised swelling, seroma, product migration when mixed with synthetic bone void filler
Nefħa lokalizzata, seroma, migrazzjoni tal- prodott meta mħallta ma filler tal- vojt tal- għadam sintetiċi.
Surgical and medical procedures
Proċeduri kirurġiċi u tal- mediċina
Common: wound dehiscence, secretion, erythema; heterotopic bone formation, pseudarthrosis.
Qsim tal- ġerħa, tnixxija, eritema, formazzjoni tal- għadam eterotopiċi, psewdartrożi.
In the study populations, some patients with common pre-existing co-morbidities (e.g. cardiovascular, respiratory, genitourinary disorders, neoplasms) experienced exacerbations of their prior disease
Fil- popolazzjonijiet tal- istudju, xi pazjenti li għandhom ko- morbiditajiet komuni li kienu jeżistu qabel (p. e. kardjovaskulari, respiratorji, disturbi ġenitorinarji, nejoplażmi) ħassew taħrix tal- marda li diġà kellhom matul il- perjodu ta ’ żmien twil (tlett snin) u ta ’ wara.
Patients with a known history of heart disease or frequent infections should be identified and observed more closely following surgery..
Pazjenti li għandhom passat magħruf ta ’ mard tal- qalb jew infezzjonijiet frekwenti għandhom ikunu identifikati u osservati aktar bir- reqqa wara l- operazzjoni.
Bone morphogenetic proteins, ATC code:
Proteini morfoġenetiċi ta ’ l- għadam, kodiċi ATC:
Opgenra is an osteoinductive and osteoconductive medicinal product.
Opgenra hu prodott mediċinali ostejoinduttiv u ostejokonduttiv.
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.
Eptotermin alfa, is- sustanza attiva, tibda l- formazzjoni ta 'l- għadam permezz ta' l- induzzjoni tad- differenzjazzjoni ċellulari fiċ- ċelluli mesenkimali, li huma reklutati għas- sit ta 'l- impjant mill- mudullum tal - għadam, il- perjosteum u l- muskolu.
Once bound at the cell surface, the active substance induces a cascade of cellular events leading to the formation of chondroblasts and osteoblasts, which play a key role in the bone formation process.
Hekk kif tintrabat fil- wiċċ taċ - ċellula, is- sustanza attiva tinduċi sensiela ta 'episodji ċellulari li twassal għall- formazzjoni ta' kondroblasti u ostejoblasti, li għandhom sehem importanti fil- proċess tal- formazzjoni ta 'l - għadam.
The collagen matrix is insoluble and consists of particles with a size range of 75-425µm.
Il- matrix tal- kollaġen ma jdubx u jikkonsisti fi frak li għandhom firxa ta ’ qies ta '75 - 425µm.
This provides an appropriate bioresorbable scaffold for the anchorage dependent cell proliferation and differentiation processes induced by the active substance.
Dan jipprovdi pjattaforma adekwata bijoresorbabbli indutti mis- sustanza attiva biex ikun hemm proċessi ta ’ proliferazzjoni u differentjazzjoni taċ- ċelluli li jinħtieġu l- ankrar.
The carmellose imparts a putty-like consistency to the medicinal product for ease of molding and placement on each side of the spine.
5 Carmellose jagħti konsistenza li qiesha stokk lill- prodott mediċinali biex ikun jista ’ jingħata b’ mod faċli forma u jkun jista ’ jitpoġġa fuq kull naħa tax- xewka tad- dahar.
The cellular events induced by the active substance take place within the product matrix.
L- episodji ċellulari indutti mis- sustanza attiva jseħħu fi ħdan il- matrix tal- prodott.
The matrix is also osteoconductive and it allows bone in-growth into the defect area from the adjacent healthy bone.
Il- matrix hi wkoll ostejokonduttiva u tħalli l- iżvilupp ġewwa tal- għadam fl- arja tad- difett mill- għadam b’ saħħtu li hemm maġenbhom.
The pivotal study with 295 patients involved un-instrumented postero-lateral lumbar spine fusion in 208 patients treated with Opgenra..
L- istudju pivotali ta ’ 295 pazjent involva fużjoni tax- xewka lombari postero – laterali mhux instrumentali f’ 208 pazjent ikkurati b’ Opgenra.
There are no data on the pharmacokinetics of the active substance in man.
M’ hemm l- ebda tagħrif dwar il- farmakokinetika tas- sustanza attiva fil- bniedem.
However, results from implantation studies in animals demonstrate that the active substance eptotermin alfa is released from the implant site over several weeks and never reaches a level higher than 3% of the total amount implanted in the peripheral blood.
Imma, r - riżultati minn studji ta 'impjantazzjoni f' bhejjem urew li s- sustanza attiva eptotermin alfa tinħareġ mis- sit ta' l- impjant fuq medda ta 'ġimgħat, u qatt ma tilħaq livell ogħla minn 3% ta ’ l- ammont totali impjantat fid- demm periferali.
Single dose and repeat dose studies in a range of animal models (rats and primates) were performed.
Saru studji ta ’ doża waħda u dawk ripetuti fuq firxa ta ’ mudelli ta ’ annimali (firien u primati).
The results of these showed no unanticipated or systemic effects of toxicity during the observation period and after administration.
Ir- riżultati ta ’ dawn urew li ma kien hemm l- ebda effett mhux mistenni minn qabel jew sistemiku tat- tossiċità matul il- perijodu ta ’ l- osservazzjoni u wara l- għoti.
In a 2 year subcutaneous implantation study in rats, heterotopic bone formation was observed, as expected.
Fi studju li dam sentejn ta ’ l- impjantazzjoni taħt il- ġilda fil- firien, kienet osservata il - formazzjoni eterotopika ta 'l- għadam, kif kien mistenni.
Sarcoma was associated with the long-term presence of the heterotopic bone.
Sarkoma kienet assoċjata mal - preżenza fuq żmien twil tal- għadam eterotopiċi.
This effect, termed solid state carcinogenicity, has been frequently observed in rats in which solid materials (plastics or metals) were implanted subcutaneously.
Dan l- effett magħruf bħala karċinoġeniċità fi stat solidu, dehret ta 'spiss fil- firien meta kienu impjantati taħt il- ġilda materjali solidi (plastik u metalli).
Heterotopic ossification commonly occurs in humans following accidental or surgical trauma to the skeleton.
Ossifikazzjoni eterotopika spiss dehret fil- bnedmin wara trawma aċċidentali jew kirugika fl - iskeltru.
It has been observed following use (see section 4.8).
Kien osservat wara l- użu (ara sezzjoni 4. 8).
However, there is no evidence to suggest that heterotopic ossification is linked to sarcoma development in humans.
Imma, ma hemm l- ebda xhieda li tissuġġerixxi li l- ossifikazzjoni eterotopika hi marbuta ma ’ l- iżvilupp tas- sarkoma fil - bnedmin.
The effect of anti-OP-1 antibodies on the bone healing process was studied in dogs with two long bone defects treated with repeat implantations.
L- effett ta ’ antikorpi anti- OP- 1 fuq il- proċess ta ’ fejqan tal- għadam kien studjat fil- klieb fil - każ ta ’ difetti ta ’ żewġ għadmiet twal li kienu kkurati b’ impjantazzjonijiet ripetuti.
The results of radiological and histological examinations in this study showed bone healing following the initial and repeat exposure in the same animal.
Ir- riżultati ta ’ eżamijiet radjoloġiċi u istoloġiċi f’ dan l- istudju wrew xi fejqan tal- għadam wara l - esponiment inizjali u ripetut fl- istess bhima.
Not
Antikorpi għal OP- 1, u kolaġen tip 1 tal- għadam bovin nstabu wara ż- żewġ esponimenti.
5/25 surprisingly, the antibody peak concentration was higher after the second exposure.
Mhux ta ’ b’ xejn li l- ogħla konċentrazzjoni ta 'antikorpi kienet ogħla wara t- tieni esponiment.
The antibody levels declined towards baseline during the follow-up period.
Il- livelli ta ’ l- antikorpi naqsu lejn il- linja bażi matul il- perjodu ta 'wara.
Controlled studies of the effects of exposure to eptotermin alfa on pre and postnatal development were performed in rabbit models.
Studji kkontrollati ta 'l- effetti ta' l- esponiment għal eptotermin alfa fuq l- iżvilupp ta 'qabel u wara t- twelid saru fuq mudelli ta' fniek.
Eptotermin alfa in Freund’s adjuvant was first administered subcutaneously with booster doses given after 14 and 28 days.
Eptotermin alfa f’ adjuvant ta ’ Freund ingħata għall - ewwel darba taħt il- ġilda b’ dożi buster mogħtija wara 14 u 28- il ġurnata.
Blood and milk samples were collected at regular intervals and analysed using a solid phase enzyme-linked immunoassay (ELISA) test.
Kampjuni tad- demm u tal– ħalib inġabru f’ intervalli regolari u kienu analizzati permezz ta ’ l- użu tat- test immunoassay marbut ma ’ enżima fil- fażi solida (ELISA).
Detectable levels of IgG and IgM antibodies to eptotermin alfa had developed and were found in the serum of all exposed adult animals.
Livelli osservati ta 'antikorpi IgG u IgM għal eptotermin alfa kienu żviluppaw u nstabu fis- serum tal- bhejjem kollha adulti esposti.
Antibodies to eptotermin alfa were also found in sera from pooled foetal and umbilical cord blood, at levels that correlated to that of the maternal blood.
Antikorpi għal eptotermin alfa nstabu wkoll fis- sera mid- demm fetali u tal- kurdun ta ’ umbelikali miġbura flimkien, f’ livelli li kienu korrelati mad- demm matern.
Antibodies were detectable in adults and offspring during the gestation and lactation periods.
Antikorpi kienu osservati wkoll f’ adulti u trabi matul il- perijodi tat- tqala u treddigħ.
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).
Titri li huma sinifikament għoljin ta 'antikorpi ta' klassi IgG u anti- OP- 1 kienu osservati fil- ħalib matul l - istudju kollu tal- fażi ta 'wara t- twelid sat- 28 ġurnata tat- treddigħ (ara sezzjoni 4. 6).
A statistically significant increase in foetal malformations (misaligned sternabrae) was seen in litters of the OP-1 immunized group.
6 Żieda statistikament sinifikanti fil- malformazzjonijiet fetali (sternabrae miżalinejata) kienet osservata fil- boton ta ’ grupp immunizzat ta ’ OP- 1.
However the rate of malformations was similar to those from historical controls.
Imma r- rata tal- malformazzjonijiet kienet simili għal dawk mill- kontrolli storiċi.
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.
Fi studju ieħor kienet osservata differenza fiż- żieda fil- piż tal- ġisem fin- nisa adulti immuniżżati bejn il- ġranet 14 sa 21 tat- treddigħ meta kienu mqabbla mal- bhejjem tal- kontroll.
The weight of the offspring in the treated group was noted to be less than that of the control group during the observation period.
Il- piż tat- trabi fil- grupp ikkurat kien osservat li kien inqas minn dak tal- grupp tal- kontroll matul il- perijodu ta 'osservanza.
The clinical implications of these observations for human use of the finished medicinal product remain uncertain (see section 4.6).
L- implikazzjonijiet kliniċi ta ’ dawn l- osservazzjonijet għall- użu uman tal- prodott mediċinali lest għadhom mhumiex ċerti (ara sezzjoni 4. 6).
Bovine collagen Carmellose
Bovine collagen Carmellose.
Potential interaction with Calstrux, a bone void filler has been reported (ssee section 4.5).
Kienet irrapportata interazzjoni potenzjali ma ’ Calstrux, li hu filler tal- vojt tal- għadam (ara sezzjoni 4. 5).
The reconstitued product should be used immediately.
2 snin Il- prodott rikostiwit għandu jintuża minnufih.
Keep the blisters in the outer carton.
Aħżen fil- friġġ (2°C - 8°C) Żomm l- istrixxi fil- kartuna ta ’ barra.
Opgenra is supplied in two Type I glass vials, sealed with a butyl rubber stopper and aluminium crimp cap.
Opgenra jingħata f’ żewġ kunjetti tal- ħġieġ tat- Tip 1 issiġilati b' għatu tal- lastiku butajl u għatu krimp ta 'l- aluminju.
The vials are maintained sterile within individual blisters and packaged together in an outer tray and box.
Il- kunjetti jinżammu sterili f 'l- istrixxi individwali u ppakkjati flimkien fi tray u kaxxa ta' barra.
One vial containing 1g of powder (3.5 mg eptotermin alfa); One vial containing 230 mg carmellose powder.
Kunjett wieħed li fih 1g ta ’ trab (3. 5 mg eptotermin alfa); Kunjett wieħed li fih 230 mg trab carmellose.
6.6 Special precautions for disposal and other handling
6. 6 Prekawzjonijiet speċjali li għandhom jittieħdu meta jintrema u għal immaniġġjar ieħor
6/25 Each unit of Opgenra consists of two vials of powder, which are first combined and then reconstituted with 2.5 ml of sodium chloride 9 mg/ml (0.9%) solution for injection prior to use.
Kull unità ta 'Opgenra fiha żewġ kunjetti ta ’ trab, li l- ewwel ikunu mħallta u mbagħad rikostitwiti ma ’ soluzzjoni ta ’ 2. 5 ml ta ’ sodium chloride 9 mg/ ml (0. 9%) għall- injezzjoni qabel l- użu.
Once Opgenra is prepared it should be used immediately.
Hekk kif l- Opgenra tkun ippreparata din għandha tintuża minnufih.
Using sterile technique, remove the vials from the packaging.
Uża teknika sterili, neħħi l- kunjetti mill- pakkett.
Lift the plastic flip-tops and remove the crimp caps from the vials.
Neħħi t- tapp tal- plastik li tifflippjah u neħħi t- tappijiet tal- krimp mill- kunjetti.
Handle the crimp caps with care.
7 Oqgħod attent kif taqbad it- tappijiet tal- krimp.
The edges of the crimp caps are sharp and may cut or damage gloves.
It- truf tat- tappijiet tal- krimp jaqtgħu u għandhom mnejn jaqtgħu jew jirrovinaw l- ingwanti.
Aligning a thumb with the internal gaps of the stoppers, pry up the edges of the stoppers.
Allinja saba ’ ma ’ l- ispazju ta ’ ġewwa tat- tappijiet, iftaħ bis- saħħa it- truf tat- tappijiet.
Once the vacuums are broken, remove the vial stoppers while holding the vials upright to prevent loss of contents.
Hekk kif jitneħħa l- vakum, neħħi t- tappijiet tal- kunjett waqt li tkun qed iżżomm l - kunjetti dritti biex tevita ħela tal- kontenuti.
Do not insert a needle through the stoppers.
Iddaħħalx labra ġot- tappijiet.
Puncture of the stoppers with a needle may result in particles of stopper material contaminating the medicinal product.
Jekk it- tappijiet jittaqqbu b’ labra, il- frak tal- materjal tat - tapp għandu mnejn jikkontaminaw il- prodott mediċinali.
Place the contents of the eptotermin alfa vial and carmellose vial in a sterile bowl.
Poġġi l- kontenuti tal- kunjett eptotermin alfa u kunjett ta ’ carmellose fi skutella sterili.
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.
Permezz ta ’ labra sterili, żied soluzzjoni sterili ta ’ 2. 5 ml ta ’ sodium chloride ta ’ 9 mg/ ml għall- injezzjoni (0. 9% w/ v) fl- iskutella sterili bil- mod u bir- reqqa.
Gently stir the contents of the bowl with a sterile spatula to aid mixing.
Ħawwad bil- mod il- kontenuti ta ’ l- iskutella bi spatula sterili biex tgħin it- taħlita.
The same procedure should be used to prepare the medicinal product for the contralateral side of the spine.
L- istess proċedura għandha tintuża biex tipprepara il- prodott mediċinali għan- naħa kontralaterali tax- xewka tad- dahar.
Use the product promptly following reconstitution.
Uża l- prodott minnufih wara r- rikostituzzjoni.
Debride and decorticate bone so that the reconstituted medicinal product will directly contact viable tissue.
Naddaf u neħħi r- rita ta’ barra tal- għadam biex il- prodott mediċinali rikonstitwit ikun f' kuntatt dirett mat- tessut vijabbli.
Provide adequate haemostasis to ensure that the material stays at the surgical site.
Ipprovdi emostażi adekwati biex tiżgura li l- materjal jibqa 'fis- sit li ġie operat.
Irrigate the surgical site as necessary prior to the implantation of the medicinal product.
Aħsel is - sit fejn saret l– operazzjoni hekk kif hemm bżonn qabel l- impjantazzjoni tal- prodott mediċinali.
Where practical, surgical manipulations to the site should be completed prior to product implantation.
Il- manipulazzjonijiet kirurġiċi tas- sit għandhom jintemmu qabel l - impjantazzjoni tal- prodott, meta dan ikun prattiku.
Remove the reconstituted product from the sterile bowl with a sterile instrument such as a spatula or curette.
Neħħi l- prodott rikostitwit mill- iskutella sterili b’ istrument sterili bħal ngħidu aħna spatula jew kurette.
The product should have a malleable, coherent putty-like consistency
Il- prodott għandu jkun ta ’ konsistenza malleabbli, koorenti u qisha stokk.
Carefully apply the product to the prepared site on each side of the spine, bridging the dorsal surfaces of the adjacent transverse processes.
Applika bir- reqqa il- prodott fis- sit ippreparat fuq kull naħa tax- xewka, u b’ hekk tgħaqqad l- uċuh dorsali tal- proċessi transversi li huma maġenb xulxin.
Close soft tissues around the site containing the product using suture material of choice.
Agħlaq it- tessuti rotob madwar is- sit li fih il- prodott billi tuża materjal tas- sutura li trid int.
Closure is critical for containment and maintenance of the product in the area of intended fusion.
L- għeluq hu ħaġa kritika għaż- żammu u l- manteniment tal- prodott fl- arja tal- fużjoni ntiża.
Do not place a drain directly in the implant or fusion site.
Tpoġġix drejn direttament fis- sit ta ’ l- impjant jew tal- fużjoni.
Place it subcutaneously if possible.
Jekk tista ’ poġġih taħt il - ġilda.
After closure of the soft tissues around the implant, irrigate the field if necessary to remove any stray particles of the medicinal product which may have been dislodged during soft tissue closure.
Wara l- għeluq tat- tessuti rotob madwar l- impjant, aħsel bl- ilma l- post, jekk hemm bżonn biex tneħħi kwalunkwe frak iżolat tal- prodott mediċinali, li għandu mnejn inqala 'matul l - għeluq tat- tessut artab.
7/25 Tel +353 61 498200 Fax +353 61 498247
8 Limerick, Irlanda Tel +353 61 498200 Fax +353 61 498247
DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L - AWTORIZZAZZJONI
Detailed information on this medicinal product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu/.
Tagħrif dettaljat fuq dan il- prodott mediċinali jista ’ jinkiseb minn fuq il- website ta 'l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
8/25 ANNEX II
Anness II A.
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT B. KUNDIZZJONIJIET TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
B.
9 A.
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL - ĦRUĠ TAL- LOTT
• CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
• KUNDIZZJONIJIET JEW RESTRIZZJOIJIET FUQ IL- FORNIMENT U L - UŻU IMPOSTI FUQ ID- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT - TQEGĦID FIS- SUQ
Summary of Product Characteristics section 4.2).
Sommarju tal - Karatteristiċi tal- Prodott, sezzjoni 4. 2)
The MAH shall agree the details of an education programme for surgeons with the National Competent Authorities and must implement such programme nationally to ensure that:
L- MAH ser taqbel id- dettalji ta 'programm edukattiv għall- kirurgi mal- Awtoritajiet Nazzjonali Kompitenti u trid timplimenta tali programm b’ mod nazzjonali biex tiżgura li:
- a copy of the SPC
- -
• the recommended methods for reconstitution of the product prior to implantation • the preparation of the selected paraspinal site where the intended implantation will occur • the recommended manner of placement of the material together with some comments on the importance of local haemostasis • the methods for soft tissue closure around the implant.
kopja tal- SPC deskrizzjoni dettaljata ta ’: • il- metodi rrakkomandati tar- rikostituzzjoni tal- prodott qabel l- impjantazzjoni • il- preparazzjoni tas- sit paraspinali magħżula fejn ser issir l- impjantazzjoni ntiża • il- mod irrakkomandat tal- ippostjar tal- materjal flimkien ma ’ xi kummenti dwar l- importanza tal- emostażi lokali • il- metodi tal- għeluq tat- tessut artab madwar l- impjant.
- Information about:
-
Hypersensitivity and antibody formation Embryo -foetotoxicity and the need for women with childbearing potential to use effective contraception for 2 years following implant • the risks of ectopic bone formation interaction with bone void fillers that the product should only be used once
Tagħrif dwar: • Sensittività eċċessiva u formazzjoni ta ’ antikorpi • Tossiċità fl- embriju u fil- fetu u l- bżonn għal nisa li jista ’ jkollhom it- tfal biex jużaw kontraċettiv effettiv għal sentejn wara l- impjant • ir- riskji ta ’ formazzjoni tal- għadam ektopiċi • interazzjoni ma ’ fillers tal- vojt tal- għadam • li l- prodott għandu jintuża darba biss
- details of the post marketing surveillance studies including information on how to enroll patients
dettalji ta ’ studji tas- sorveljanza ta ’ wara t- tqegħid fis- suq inkluż tagħrif dwar kif tingaġġa pazjenti
10/25 In addition, prior to use, surgeons intending to use Opgenra should receive a Training DVD contain images recorded during the course of an operation on a live patient and including the following information:
10 Barra minn dan, qabel l- użu il- kirurgi li biħsiebhom jużaw Opgenra għandhom jirċievu DVD ta ’ Taħriġ li fih immaġini rrekordjati matul il- kors ta ’ operazzjoni fuq pazjent ħaj u jinkludi it- tagħrif li ġej:
- Placement in sterile field
- Ippostjar f’ żona sterili
Pharmacovigilance system The MAH must ensure that the system of pharmacovigilance, as described in version 1.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Sistema Farmakoviġilanza L- MAH trid tiżgura li s- sistema tal- farmakoviġilanza, hekk kif inhi deskritta f’ verżjoni 1. 0 ippreżentata f’ Modul 1. 8. 1 tal- Applikazzjoni tal- Awtorizzazzjoni għat- Tqegħid fis- Suq, qed taħdem u tiffunzjona qabel u waqt li l- prodott ikun fuq is- suq.
Risk Management Plan The MAH commits to performing the studies and additional pharmacovigilance activities detailed in the Pharmacovigilance Plan, as agreed in version 1.3 of the Risk Management Plan (RMP) presented in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP agreed by the CHMP.
Pjan tal- Immaniġġjar tar- Riskju L- MAH timpenja ruħha li tagħmel l- istudji u l- attivitajiet l- oħra ta 'farmakoviġilanza dettaljati fil- Pjan tal- Farmakoviġilanza, hekk kif kien miftiehem f' verżjoni 1. 3 tal- Pjan tal- Immaniġġjar tar- Riskju (RMP) ippreżentat f’ Modul 1. 8. 2 tal- Applikazzjoni tal- Awtorizzazzjoni għat - Tqegħid fis- Suq u aġġornamenti sussegwenti tal- RMP miftehma mill- CHMP.
Protocols for a study or studies to investigate the long term safety and efficacy of patients treated with Opgenra and also actual drug utilisation in real life will be submitted by the MAH and agreed with the CHMP before product launch and before the study is started.
Protokolli għall- istudju jew studji biex jinvestigaw is- sigurtà u l- effikaċja fuq tul ta 'żmien twil ta' pazjenti kkurati b' Opgenra u anki l- utilizzazzjoni tal- mediċina attwali fil- ħajja reali ser ikunu sottomessi mill- MAH u miftehma ma ’ CHMP qabel il- varar tal- prodott u qabel ma jibda l- istudju.
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skont il- Linjagwida ta ’ CHMP dwar is- Sistemi tal- Immaniġġjar tar- Riskju għal prodotti mediċinali għall- użu uman, l- RMP aġġornat għandu jkun sottomess fl- istess ħin tar- Rapport Perjodiku u Aġġornat tas- Sigurtà (PSUR) li jmiss.
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn dan, RMP aġġornat għandu jkun sottomess • Meta jasal tagħrif ġdid li għandu mnejn jaffettwa l- Ispeċfikazzjoni kurrenti dwar is - Sigurtà, Pjan dwar il- Farmakoviġilanza jew l- attivitajiet tal- minimizzazzjoni tar - riskju • Fi żmien 60 ġurnata minn meta jintlaħaq stadju importanti (farmakoviġilanza jew minimizzazzjoni tar- riskju) • Meta jkun hemm talba mill- EMEA
11/25 ANNEX III
11 ANNESS III
LABELLING
12 A. TIKKETTA
13/25 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
13 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Opgenra 3.5 mg powders for suspension for implantation eptotermin alfa
Opgenra 3. 5 mg trab għal suspensjoni għall- impjantazzjoni eptotermin alfa
One vial containing 3.5 mg of eptotermin alfa.
Kunjett fih 3. 5 mg ta ’ eptotermin alfa.
After reconsistuation, Opgenra contains 1 mg/ml eptotermin alfa.
Wara r- rikostituzzjoni Opgenra fih 1 mg/ ml eptotermin alfa.
Bovine collagen, carmellose.
Bovine collagen, carmellose
Powders for suspension for implantation.
Trab għal suspensjoni għall- impjantazzjoni.
1 vial containing 1 g of powder (3.5 mg eptotermin alfa).
Kunjett wieħed fih 1 g ta ’ trab (3. 5 mg eptotermin alfa).
1 vial containing 230 mg carmellose.
Kunjett wieħed fih 230 mg carmellose.
Intraosseuous use Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
Store in a refrigerator (2 C – 8 C).
DATA TA ’ META JISKADI
The reconstitued product should be used immediately.
Il- prodott rikostitwit għandu jintuża minnufih.
Keep the blisters in the outer carton.
Żomm l- istrixxi fil- kartuna ta ’ barra.
14/25 Any unused product or waste material should be disposed of in accordance with local requirements
Kull prodott li ma jkunx intuża jew skart għandu jintrema kif jitolbu l- liġijiet lokali.
Raheen Business Park Limerick Ireland
Raheen Business Park Limerick, Irlanda
Justification for not including Braille accepted”
Il- Ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċettata ”
15/25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
15 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
BLISTER FOIL ACTIVE SUBSTANCE POWDER VIAL
FOJL TAL- ISTRIXXI TAS- SUSTANZA ATTIVA F’ KUNJETT - TAT- TRAB
Opgenra 3.5 mg powder for suspension for implantation epotermin alfa Intraosseous use
Opgenra 3. 5 mg trab għal suspensjoni għall- impjantazzjoni, epotermin alfa Użu intraossejojuż.
BATCH NUMBER
NUMRUTAL- LOTT
1g powder (3.5 mg eptotermin alfa)
1g ta ’ trab (3. 5 mg ta ’ eptotermin alfa)
Do not open before use The reconstitued product should be used immediately
Il- prodott rikostitwit għandu jintuża minnufih.
16/25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
16 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL OF ACTIVE SUBSTANCE POWDER
KUNJETT TA ’ TRAB TA ’ SUSTANZA ATTIVA
Opgenra 3.5 mg powder for suspension for implantation Eptotermin alfa Intraosseous use
Eptotermin alfa Użu intraossejojuż
1 g (3.5 mg eptotermin alfa)
1 g (3. 5 mg ta’ eptotermin alfa)
17/25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
17 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
BLISTER FOR THE CARMELLOSE POWDER VIAL
STRIXXA GĦALL- KUNJETT TAT- TRAB CARMELLOSE
Carmellose powder for suspension for implantation for Opgenra Intraosseous use
Użu intraossejojuż.
18/25 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
CARMELLOSE VIAL
KUNJETT TA ’ CARMELLOSE
19/25 MEDICAL OR HEALTHCARE PROFESSIONAL EDUCATIONAL STICKER
19 STIKER EDUKATTIV TAL- PROFESSJONIST MEDIKU JEW TAL- KURA TAS - SAĦĦA
To be attached to the patients medical record.
Li għandu jkun mehmuż mar- rekord mediku tal- pazjenti.
“{Patient Name} was implanted with a medicinal product containing eptotermin alfa on {dd/mm/yyy}.
“ (Isem tal- Pazjent) kien impjantat bil- prodott mediċinali li fih eptotermin alfa f ’ (ġġ/ xx/ ssss).
Repeat use of this bone morphogenetic protein (BMP) is not recommended.”
L- użu ripetut ta ’ dan il- proteina morfoġenetika tal- għadam (BMP) mhux irrakkomandat. ”
21/25 PACKAGE LEAFLET:
21 FULJETT TA ’ TAGĦRIF:
- If any of the side effects gets serious or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li
please tell your doctor.
mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib tiegħek.
What Opgenra is and what it is used for.
X’ inhi Opgenra u għalxiex tintuża.
Before you use Opgenra.
Qabel ma tuża Opgenra.
How to use Opgenra.
Kif għandek tuża Opgenra.
5 How to store Opgenra.
5 Kif taħżen Opgenra.
WHAT OPGENRA IS AND WHAT IT IS USED FOR
X’ INHI OPGENRA U GĦALXIEX TINTUŻA
Opgenra is a type of medicine known as a bone morphogentic protein (BMP).
Opgenra hi tip ta ’ mediċina magħrufa bħala proteina morfoġentika tal- għadam (BMP).
This group of medicines cause new bone to grow at the location where the surgeon has placed (implanted) it.
Dan il- grupp ta ’ mediċini jikkawża it- tkabbir ta ’ għadam ġdid fil- post fejn il- kirurgu poġġiehom (impjantom).
Opgenra is implanted in adult patients with slippage of the spine (spondylolisthesis) in cases where treatment with autograft (transplanted bone from you hip) has failed or should not be used.
Opgenra hu impjantat f’ pazjenti adulti li għandhom żerżiq tax- xewka tad- dahar (spondilolisteżi) f’ każi fejn it- trattament b’ awtograft (għadam trapjantat minn ġenbek) falla jew m’ għandux jintuża.
BEFORE YOU USE OPGENRA
QABEL MA TUŻA OPGENRA
Opgenra must not be used
OPGENRA M’ GĦANDĦIEX TINTUŻA
- if you are allergic (hypersensitive) to eptotermin alfa or to any of the ingredients of Opgenra
- jekk int allerġiku (tbati minn sensittività eċċessiva) għal eptotermin alfa jew għal
(see section 6).
kwalunkwe ingredjent ta ’ Opgenra (ara sezzjoni 6).
- if you have an autoimmune disease (disease arising from or directed against your own tissues),
- jekk għandek xi marda awtoimmuni (marda kaġun minn jew diretta kontra t- tessuti
including Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren’s syndrome and dermatomyositis/ polymyositis.
tiegħek stess), inkluża marda Crohn, artrite rewmatojde, lupus erythematosus sistemiku, skleroderma, sindrome ta ’ Sjögren, u dermatomijositi/ polimijositi.
- if you have an active infection in your spine or have been told that you have an active internal
- jekk għandek infezzjoni attiva fix- xewka tad- dahar tiegħek jew ġejt mgħarraf li
(systemic) infection.
għandek infezzjoni attiva interna (sistemika).
- if you have inadequate skin coverage and inadequate blood supply at the site of surgery (your
- jekk għandek kopertura inadekwata tal- ġilda u provvista inadekwata tad- demm fis- sit
doctor should have told you if this is the case).
ta ’ l- operazzjoni (it- tabib tiegħek messu qallek jekk dan hu l- każ).
- if you require a spinal fusion because of a metabolic bone disease or tumours
- jekk għandek bżonn ta ’ fużjoni tax- xewka tad- dahar minħabba marda metabolika tal -
- have any tumours in the area intended for surgery.
- jekk għandek kwalunkwe tumur fis- sit fejn ser issir l- operazzjoni.
- if you are receiving chemotherapy, radiation treatment or immunosuppression.
- jekk qed tingħata kemoterapija, trattament bir- radjazzjoni jew immunosuppressjoni.
- have had Opgenra, eptotermin alfa or any similar medicine before.
- jekk diġà kellek Opgenra, eptotermin alfa jew mediċina simili qabel.
- if you are a child.
- jekk int tifel/ tifla.
- if you are an adolescent and your skeleton is not yet be fully formed (you are still growing).
- jekk int adolexxent u l- iskeletru tiegħek ikun għadu ma ġiex iffurmat kompletament
Take special care with Opgenra:
(int għadek qed tikber).
The following are precautions for use of Opgenra to be discussed with your doctor.
Oqgħod attent ħafna b’ Opgenra:
Your doctors will monitor you if they suspect this is the case.
Dawn li ġejjin huma prekawzjonijiet għall- użu ta ’ Opgenra li għandhom jiġu diskussi mat - tabib tiegħek.
22/25 • Inform your doctor or surgeon if you have a history of heart problems or are prone to frequent infections so that they can closely monitor you. • Repeated use of Opgenra cannot be recommended.
It- tobba tiegħek ser jimmonitorjawk jekk jissuspettaw li dan hu l- każ. • Għarraf lit- tabib jew il- kirurgu tiegħek jekk għandek passat ta ’ problemi tal- qalb jew sikwit ikollok xi infezzjonijiet biex ikun jistgħu jimmonitorjawk bir- reqqa. • L- użu ripetut ta ’ Opgenra mhux irrakkomandat.
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.
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.
Use of Opgenra does not guarantee fusion; additional surgeries may be required.
L- użu ta ’ Opgenra ma jiggarantix fużjoni; għandhom mnejn ikun hemm bżonn ta ’ operazzjonijiet oħra.
Using other medicines Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib tiegħek jekk int qed tieħu jew ħadt dan l- aħħar mediċini oħra, anki dawk mingħajr riċetta.
Pregnancy and breast-feeding Opgenra should not be used during pregnancy unless the benefits to the mother outweigh the risks to the unborn child.
Tqala u treddigħ Opgenra m’ għandux jintuża matul it- tqala għajr meta l- benefiċċji għal omm huma akbar mir - riskji għat- tarbija li għadha ma twelditx.
Women of child-bearing potential should inform their surgeon of the possibility of pregnancy before undergoing treatment with Opgenra.
Nisa li jistgħu joħorġu tqal għandhom jagħrfu lill - kirurgu tagħhom dwar il- possibbiltà tat- tqala qabel it- trattament b’ Opgenra.
Women of childbearing potential are advised to use effective contraception for a period of 2 years after their treatment.
Nisa li jistgħu joħorġu tqal għandhom jingħataw il- parir li jużaw kontraċettiv effettiv għal perijodu ta 'sentejn wara t- trattament tagħhom.
Do not breast-feed your baby during Opgenra therapy.
Treddax it- tarbija tiegħek matul it- terapija b’ Opgenra.
As the potential for harm to the breast fed infant is unknown, women should not breast-feed during the period immediately following treatment with Opgenra.
Peress li l- potenzjal għal- ħsara għat - tarbija li hi mredda ’ mhux magħruf, in- nisa m’ għandhomx ireddgħu matul il- perijodu immedjatament wara t- trattament b’ Opgenra.
If you are nursing, you should receive Opgenra only if your treating physician or surgeon considers the benefits to you outweigh the risks to your child.
Jekk int qed tredda ’, int għandek tingħata Opgenra biss jekk it- tabib jew il- kirurgu kuranti jemmen li l- benefiċċji huma akbar mir- riskji għat- tifel/ tifla tiegħek.
Driving and using machines Studies on the effects on the ability to drive and use machines have not been performed with Opgenra.
Sewqan u tħaddim ta ’ magni Ma sarux studji dwar Opgenra fuq l- effetti dwar il- ħila tas- sewqan u t- tħaddim tal- magni.
HOW TO USE OPGENRA
KIF TUŻA OPGENRA
Opgenra is only used by an appropirately qualified surgeon during the course of spinal fusion surgery.
Opgenra jintuża biss minn kirurgu kwalifikat b’ mod adegwat matul il– perijodu ta ’ operazzjoni tal- fużjoni tax- xewka tad- dahar.
This is normally done under a full general anasethetic so you will not be awake during the surgery.
Dan normalment isir permezz ta ’ anestesija ġenerali totali biex hekk int ma tkunx imqajjem matul l- operazzjoni.
A small quantity (one unit) of Opgenra is placed directly on each side of the spine at the site requiring fusion.
Kwantità żgħira (unità waħda) ta ’ Opgenra titpoġġa direttament fuq kull naħa tax- xewka tad - dahar fis- sit li għandha bżonn il- fużjoni.
The surrounding muscle tissue is then closed around the implanted medicine as is the skin on top of the muscle.
It- tessut tal- muskolu tal- madwar imbagħad jingħalaq madwar il- mediċina impjantata u tingħalaq ukoll il- ġilda ta 'fuq il- muskolu.
This specialised medicine is used instead of autograft bone (some of a patients own bone taken from the hip) to fuse the spine.
Din il - mediċina speċjalizzata tintuża minflok awtograft bl- għadam (fil- każ ta 'xi wħud mill- pazjenti tkun l- għadma tagħhom stess li tittieħed mill- ġenb) biex ikun hemm fużjoni tax- xewka tad - dahar.
The maximum dose of this medicine should not exceed 2 units (7.0 mg eptotermin alfa) since its effectiveness and safety in higher doses has not been studied.
Id- doża massima ta ’ din il- mediċina m’ għandhiex taqbeż 2 unitajiet (7. 0 mg eptotermin alfa) għax l- effettività u sigurtà tagħha f’ dożi ogħla ma ġietx studjata.
Like all medicines, Opgenra can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Opgenra tista 'jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These side effects may occur with certain frequencies, which are defined as follows: common: affects 1 to 10 users in 100 uncommon: affects 1 to 10 users in 1,000
Dawn l- effetti sekondarji għandhom mnejn jinħassu b’ ċerti frekwenzi, li huma definiti kif ġej: komuni: jolqtu 1 sa 10 utenti f’ 100 mhux komuni: jolqtu 1 sa 10 utenti f’ 1, 000
In clinical studies, the following side effects were reported:
Fi studji kliniċi, ġew irrapportati l- effetti sekondarji li ġejjin:
Common reported side effects included: • erythema (redness of the skin), • tenderness and swelling over the implant site, • heterotopic ossification (bone formation outside of the fusion area), • pseudarthrosis (failure of the spine to fuse), • wound infections.
Effetti sekondarji komuni rrapportati kienu jinkludu: • eritema (ħmura tal- ġilda), • tweġġa ’ malajr u nefħa fuq is- sit ta ’ l- impjant, • ossifikazzjoni eterotopika (formazzjoni tal- għadam barra l- arja tal- fużjoni), • psewdartrożi (ma ssirx fużjoni tax- xewka tad- dahar), • infezzjonijiet tal- ġrieħi.
Uncommon reported side effects included: • localised swelling 23/25 • seroma (a collection of fluid in the tissues) • product migration (this has been observed when the product was mixed with a synthetic product used to fill the bone void)
Effetti sekondarji mhux komuni rrapportati kienu jinkludu: • nefħa lokalizzata • seroma (kwantità ta ’ fluwidu fit- tessuti) • migrazzjoni tal- prodott (dan kien osservat meta l- prodott kien imħallat ma ’ prodott sintetiku wżat biex jimla l- vojt tal- għadam).
Some common undesirable side effects can follow spine surgery itself and these include: • wound infection, • osteomyelitis (infection of the bone), • complications of mechanical support (such as instruments used for stabilisation), • bleeding at the wound site, • failure of the wound to heal, • nausea, • fever and • pain.
Jista ’ jkun hemm xi effetti sekondarji mhux mixtieqa li huma komuni wara l- operazzjoni nnifisha tax- xewka tad- dahar u dawn jinkludu: • infezzjoni tal- ġerħa, • osteomajelite (infezzjoni tal- għadam), • komplikazzjonijiet fis- support mekkaniku (bħal ngħidu aħna strumenti wżati għall - istabilizzazzjoni), • ħruġ ta ’ demm fis- sit tal- ġerħa, • il- ġerħa ma tfiqx, • nawsija, • deni u • wġigħ.
If the side effects gets serious or you notice any side effects not listed in this leaflet, please tell your doctor.
Jekk l- effetti sekondarji jiggravaw jew tinnota xi effetti sekondarji li mhumiex elenkati f' dan il- fuljett, jekk jogħġbok għarraf lit- tabib tiegħek.
HOW TO STORE OPGENRA
KIF TAĦŻEN OPGENRA
Do not use Opgenra after the expiry date which is stated on the carton and blisters.
Tużax Opgenra wara d- data ta ’ skadenza li tidher fuq il- kartuna u strixxi.
Opgenra should be used immediately after reconstitution.
Id- data ta ’ skadenza tirreferi għal aħħar ġurnata tax- xahar. Opgenra għandu jintuża minnufih wara r – rikostituzzjoni.
Store in a refrigerator (2°C - 8˚C).
Aħżen fil- friġġ (2°C - 8˚C).
The hospital pharmacist or surgeon is responsible for the correct storage of the product both before and during its use, as well as for the correct disposal.
L- ispiżjar ta ’ l- isptar jew il- kirurgu hu responsabbli tal- ħażna korretta tal- prodott qabel u matul l- użu, u anki għar- rimi tiegħu kif suppost.
What Opgenra contains
24 X’ fih Opgenra
One vial of Opgenra contains 1 g of powder including 3,5 mg of eptotermin alfa and the excipient bovine collagen.
Is- sustanza attiva hi eptotermin alfa (proteina 1 rikombinata umana Ostejoġenika magħmula f’ linja ta ’ ċelluli ta ’ ovarju rikombinata ta ’ ħamster Ċiniż (CHO). Kunjett ta 'Opgenra fih 1 g ta ’ trab inkluż 3. 5 mg ta ’ eptotermin alfa u s- sustanza mhux attiva bovine collagen.
The other vial contains the excipient carmellose.
Il- kunjett l- ieħor fih sustanza mhux attiva carmellose.
What Opgenra looks like and contents of the pack
Id- dehra ta ’ Opgenra u l- kontenut tal- pakkett
Opgenra powders for suspension for implatation comes as two separate powders.
It- trab Opgenra għal suspensjoni għall- impjantazzjoni jingħata bħala żewġ tipi separati ta ’ trab.
The powder containing the active substance and the excipient bovine collagen has the appearance of a white to off- white granular powder; the carmellose powder is a yellowish white powder.
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.
The powders come in glass vials.
It- trab jingħata f’ kunjetti tal- ħġieġ.
Each vial is secured in a sterile blister.
Kull kunjett hu ssiġillat bi strixxa sterili.
Each outer carton contains one 3.5 mg eptotermin alfa vial containing 1 g of powder and one carmellose powder vial containing 230 mg powder.
Kull kartuna ta ’ barra fiha kunjett wieħed ta ’ 3. 5 mg eptotermin alfa li fih 1 g ta ’ trab u kunjett ta ’ trab carmellose li fih 230 mg ta ’ trab.
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Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http://www.emea.europa.eu/
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA): http: // www. emea. europa. eu /
What is Oprymea?
X' inhu Oprymea?
Oprymea is a medicine containing the active substance pramipexole base.
Oprymea huwa mediċina li fiha s- sustanza attiva bażi pramipexole.
0.088 mg, 0.7 mg and 1.1 mg; oval:
0. 088 mg, 0. 7 mg u 1. 1 mg; ovali:
0.18 mg and 0.35 mg).
0. 18 mg u 0. 35 mg).
Oprymea is a ‘ generic medicine’.
Oprymea huwa ‘ mediċina ġenerika ’.
This means that Oprymea is similar to a ‘ reference medicine’ already authorised in the European Union (EU) called Sifrol (also known as Mirapexin).
Dan ifisser li Oprymea huwa simili għall - ‘ mediċina ta ’ referenza ’ diġà awtorizzata fl- Unjoni Europea (UE) li jisimha Sifrol (magħrufa wkoll bħala Mirapexin).
For more information on generic medicines, see the question-and-answer document here.
Għal aktar informazzjoni dwar il- mediċini ġeneriċi, ara id- dokument mistoqsija- u- tweġiba hawn.
What is Oprymea used for?
Għal x' hiex jintuża Oprymea?
Oprymea is used to treat the symptoms of Parkinson’ s disease, a progressive brain disorder that causes shaking, slow movement and muscle stiffness.
Oprymea jintuża għat- trattament tas- sintomi tal- marda ta 'Parkinson li hija disturb mentali progressiv li jikkawża rogħda, dewmien fil- movimenti u ebusija muskolari.