qanastek/EMEA-V3 huggingface dataset:
Since plasma concentrations following topical ocular dosing of olopatadine are 50-to 200-fold lower than after well-tolerated oral doses, dose adjustment is not expected to be necessary in the elderly or in the renally impaired population.
Billi l- livelli ta 'olopatadine fil- plażma huma minn 50 - sa 200 - darba aktar baxxi meta jingħata b' mezz topiku fl- għajnejn milli meta jingħata mill - ħalq, mhux mistenni li għandu jkun hemm bżonn ta ’ tibdil fid- doża meta jingħata lill- anzjani jew pazjenti morda bil- kliewi.
Liver metabolism is a minor route of elimination.
Parti żgħira ħafna minnu jitneħħa mill- fwied.
Dose adjustment is not expected to be necessary with hepatic impairment.
Mhux mistenni li jkun hemm bżonn tibdil fid- doża għall- pazjenti li jsofru minn indeboliment tal- fwied.
5 5.3 Preclinical safety data
5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurta ’ tal- mediċina
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction.
Informazzjoni li mhiex klinika, magħmula fuq studji konvenzjonali ta ’ sigurta, farmakoloġiija, effett tossiku minn dożi ripetuti, ġenotrossiċità, riskju ta ’ kanċer, u effett tossiku fuq is- sistema riproduttiva ma ’ juri l- ebda periklu speċjali għall- bnedmin.
Benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate (E339), hydrochloric acid (E507) and/ or sodium hydroxide (E524) (to adjust pH), purified water.
Benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate (E339), hydochloric acid (E507) u/ jew sodium hydroxide( E524) (biex jikontrollaw il- pH), ilma pur.
6.3 Shelf-life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinal
Discard four weeks after first opening.
Armi dak li jibqa erba 'ġimgħat wara li tiftħu l- ewwel darba
5 ml opaque low density polyethylene bottles with polypropylene screw caps (DROP-TAINER).
Flixken tal- plastik opaki ta ’ 5 ml magħmula minn polyethylene ta 'densita' baxxa, u b’ tapp tal- kamin magħmul minn polypropylene (BIL- QATTARA).
Cartons containing 1 or 3 bottles.
Kaxxa ta ’ 1 jew 3 tiflixken.
MARKETING AUTHORISATION NUMBERS
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦALL- KUMMERĊ
17th May 2002 22nd May 2007
22 ta ’ Mejju 2007.
7 ANNEX II
7 ANNESS II
Names and addresses of the manufacturer(s) responsible for batch release
Isem u indirizz tal- manifattur( i) responsabbli għall- ħruġ tal- lott.
or
Jew
The printed package leaflet of the medicinal product must state the name and address of the manufacturer responsible for the release of the concerned batch.
Fuq il- fuljett ta 'tagħrif tal- prodott mediċinali għandu jkun hemm l- isem u l- indirizz tal - manifattur responsabbli mill- ħruġ tal- lott konċernat
11 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
11 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA JEW, FIN- NUQQAS TA DAN, FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
OPATANOL 1 mg/ ml eye drops, solution Olopatadine
OPATANOL 1 mg/ ml qtar għall- għajnejn, soluzzjoni.
1 ml of solution contains 1 mg olopatadine (as hydrochloride).
1 ml fih 1 mg olopatadine (bħala hydrochloride).
Benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate, hydrochloric acid/ sodium hydroxide (to adjust pH) and purified water.
Benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate, hydrochloric acid/ sodium hydroxide (biex jikontrollaw il- pH), ilma pur.
Eye drops, solution; 1 x 5 ml 3 x 5 ml
Qtar għall- għajnejn, soluzzjoni 1 x 5 ml 3 x 5 ml
Ocular use.
Għall- użu fl- għajnejn.
Read the package leaflet before use.
Aqra il- fuljett ta ’ tagħrif qabel ma ’ tużah.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA ’ JIDHIRX MIT- TFAL
Opened:
JIS {XX/ SSSS} Għarmi erba ’ ġimgħat wara li tiftaħ.
Opened (1):
Miftuħ (1):
Opened (2):
Miftuħ (2):
Opened (3):
Miftuħ (3):
Pentagon Park Boundary Way Hemel Hempstead Herts., HP2 7UD United Kingdom
Boundary Way Pentagon Park Hemel Hempstead Herts., HP2 7UD Ir- Renju Unit
MARKETING AUTHORISATION NUMBERS
NUMRU( I) TA ’ L - AWTORIZZAZZJONI GĦALL- KUMMERĊ
Lot: xxxxx
Lott Numru: xxxxx
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGHATA
13 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
13 TAGHRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
TIKETTA TAL- FLIXKUN
OPATANOL 1 mg/ ml eye drops.
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN JINGĦATA
Olopatadine.
OPATANOL 1 mg/ ml qtar għall- għajnejn Olopatadine.
Ocular use.
Għal l- użu fl- għajnejn.
Exp: xx/ xxxx Discard four weeks after first opening.
JIS {XX/ SSSS} Għarmi erba ’ ġimgħat wara li tiftaħ.
Lot:
Lott: xxxxx
OPATANOL 1 mg/ ml eye drops, solution.
OPATANOL 1 mg/ ml qtar għall- għajnejn, soluzzjoni.
This medicine has been prescribed for you.
Din il- mediċina ġiet mogħtija għall- użu personali tiegħek.
It may harm them even if their symptoms are the same as yours.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollom l- istess sintomi bħal tiegħek.
WHAT OPATANOL DOES
X’ INHU OPATANOL U GĦALXIEX JINTUŻA
OPATANOL is used for the treatment of signs and symptoms of seasonal allergic conjunctivitis.
OPATANOL huwa użat għal kura ta ’ sinjali u sintomi ta 'allerġija ta' l- istaġun fil- konġuntiva ta 'l- għajnejn
Allergic conjunctivitis.
Allergija ta 'l- istaġun fl- għajnejn:
Some materials (allergens) like pollens, house dust or animal fur may cause allergic reactions resulting in itching, redness as well as swelling of the surface of your eye.
Xi sustanzi (allerġeni) bħal polline, trab tad- dar jew suf tal - bhejjem jistgħu jikkawżaw allerġijji li jidhru f' forma ta 'ħakk, ħmura kif ukoll nefħa f' wiċċ l- għajnejn.
OPATANOL is a medicine for treatment of allergic conditions of the eye.
OPATANOL huwa mediċina għall - kura ta ’ kundizjonijiet allerġiċi tal- għajnejn.
It works by reducing the intensity of the allergic reaction.
Jaħdem billi jnaqqas il- qawwa tar- reazzjoni allerġika.
BEFORE YOU USE OPATANOL
Tużax OPATANOL...
Do not use OPATANOL • If you are allergic (hypersensitive) to olopatadine or any of the other ingredients of OPATANOL.
• jekk inti allerġiku (tbati minn sensittività eċċessiva) għal olopatadine jew xi wieħed mill - ingredjenti ta ’ OPATANOL
Take special care with OPATANOL... • Do not use OPATANOL in children under the age of 3 years.
• OPATANOL m’ għandux jintuża fit- tfal taħt l- eta ’ ta 3 snin.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qed tieħu jew ħadt dan l- aħħar xi mediċini oħra anki dawk mingħajr riċetta.
If you are using other eye drops at the same time as OPATANOL, follow the advice at the end of section 3.
Jekk qed tuża xi qtar oħra ta ’ l- għajnejn fl- istess żmien li qed tuża OPATANOL, aqra it- tagħrif li jidher fl- aħħar ta ’ sezzjoni 3.
Pregnant women If you are pregnant, or might get pregnant, talk to your doctor before you use OPATANOL.
Jekk inti tqila, jew qed taħseb biex issir tqila, kellem lit- tabib tiegħek għall- parir qabel ma ’ tuża OPATANOL.
Breast feeding women If you are breast feeding.
16 Jekk qed tredda ’.
Do not use OPATANOL, it may get into your milk.
Tużax OPATANOL, jista joħroġ fil- ħalib tas- sider.
Ask your doctor for advice before taking any medicine
Staqsi lit- tabib tiegħek għal parir qabel ma tieħu xi mediċini.
Driving and using machines You may find that your vision is blurred for a time just after you use OPATANOL.
Jista ’ jkun li għal ftit ħin wara li tuża OPATANOL, il- vista tiegħek tiċċajpar xi ftit.
Do not drive or use machines until this has worn off.
Issuqx jew tużax magni sakemm il- vista tiegħek terġa ’ lura għan- normal
16 Important information about some of the ingredients of OPATANOL If you wear soft contact lenses.
Jekk tuża l- lentijiet tal- kuntatt.
Do not use the drops while your contact lenses are in your eyes.
Tużax il- qtar waqt li għandek il- lentijiet tal- kuntatt f’ għajnejk.
Wait 10-15 minutes after using the eye drops before putting your lenses back into your eyes.
Wara li tqatar, stenna 10- 15 – il minuta qabel ma tilbes l- lentijiet tal- kuntatt.
A preservative in OPATANOL (benzalkonium chloride) can affect soft lenses.
Preservativ li jinstab ġewwa OPATANOL (benzalkonium chloride) jista ’ jeffetwa il- lentijiet tal- kuntatt rotob.
HOW TO USE OPATANOL
KIF JINTUŻA OPATANOL
Always use OPATANOL exactly as your doctor has told you.
Dejjem għandek tuża OPATANOL skond il- parir tat- tabib tiegħek.
The usual dose is …
Id- doża li ssoltu tingħata hija...
one drop in the eye or eyes, twice a day – morning and evening.
Qatra waħda fl- għajn, jew fl- għajnejn darbtejn kuljum – filgħodu u filgħaxija.
Use this much unless your doctor tells you to do differently.
Uża din il- kwantita ’ sakemm ma jigħdlekx mod ieħor it- tabib tiegħek.
Only use OPATANOL in both eyes if your doctor told you to.
Għandek tuża OPATANOL f’ għajnejk it- tnejn jekk jgħidlek it- tabib biss.
Use it for as long as your doctor told you to.
Uża għaż- żmien li qallek it- tabib.
Only use OPATANOL as an eye drop.
Uża OPATANOL biex tqattar f’ għajnejk biss.
TURN THE PAGE FOR MORE ADVICE
AQLEB IL- PAĠNA GĦAL AKTAR TAGĦRIF.
Now turn over >
Aqleb issa >
HOW TO USE OPATANOL (continued)
KIF JINTUŻA OPATANOL (ikompli)
• Get the OPATANOL bottle and a mirror. • Wash your hands. • Take the bottle and twist off the cap. • Hold the bottle, pointing down, between your thumb and middle finger. • Tilt your head back.
• Aqbad il- flixkun ta ’ OPATANOL u mera. • Aħsel idejk. • Aqbad il- flixkun u neħħilu t- tapp. • Żomm il- flixkun wiċċu ‘ l isfel bejn subgħajk il- kbir u subgħajk tan- nofs. • Itfa rasek naqra lura.
Pull down your eyelid with a clean finger, until there is a ‘ pocket ’ between the eyelid and your eye.
B’ seba ’ nadif, niżżel il- parti t’ isfel tat- tebqa ta ’ għajnejk sakemm jiformma speċi ta ’ but bejn it- tebqa t’ għajnejk u l- għajn.
The drop will go in here (picture 1). • Bring the bottle tip close to the eye.
Il- qatra ser tidħol hawn ġew (stampa 1) • Ġib il- flixkun viċin tal- għajn.
Use the mirror if it helps. • Don’ t touch your eye or eyelid, surrounding areas or other surfaces with the dropper.
Dan jista jniġġes il- qtar li jkun fadal fil- flixkun. • Imbotta bil- ġentilezza il- qih tal- flixkun biex tqattar OPATANOL taqtira taqtira. • M' għandekx tagħfas il- flixkun.
It could infect the drops left in the bottle. • Gently press on the base of the bottle to release one drop of OPATANOL at a time. • Don ’ t squeeze the bottle, it is designed so that just a gentle press on the bottom is needed (picture 2). • If you use drops in both eyes, repeat the steps for your other eye. • Put the bottle cap back on firmly immediately after use. • Use up one bottle before opening the next bottle.
Il- flixkun huwa magħmul biex meta tinbotta il- qih tniżżel taqtira waħda (stampa 2). • Jekk qed tuża l- qtar f’ għajnejk it- tnejn, erġa rrepetti il- proċeduri hawn fuq imsemijja għall - għajnejk l- oħra. • Għalaq il- flixkun sewwa kif tieqaf tqattar. • Uża flixkun wieħed qabel ma ’ tiftaħ ieħor
If a drop misses your eye, try again.
Jekk qatra ma ’ tidħolx f’ għajnejk, erġa pprova.
If you use more OPATANOL than you should rinse it all out with warm water.
Jekk tuża OPATANOL aktar milli suppost, laħalħu kollu l- barra b’ ilma sħun.
Don ’ t put in any more drops until it ’ s time for your next regular dose.
Terġax tqattar sakemm jasallek il- ħin tad- doża li jmiss.
If you forget to use OPATANOL, use a single drop as soon as you remember, and then go back to your regular routine.
Jekk tinsa tagħmel OPATANOL, għamel qatra waħda malli tiftakkar, imbagħad erġa ’ lura għal kif kont qed tqattar fil- bidu.
Do not use a double dose to make up for the one missed.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
If you are using other eye drops, wait at least five to ten minutes between putting in OPATANOL and the other drops.
Jekk qed tuża xi qtar tal- għajnejn oħra, stenna mil- lanqas 10 minuti bejn l- użu ta ’ OPATANOL u l- qtar l- ieħor.
If you have any further questions on the use of this product, ask your doctor or pharmacist
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tieghek.
Like all medicines, OPATANOL can cause side effects, although not everybody gets them.
Bhal kull mediċina oħra, OPATANOL jista ’ jkollu effetti sekondarji, ghalkemm ma jidhrux fuq kullħadd.
Common side effects These may affect up to 10 in every 100 people
18 Effetti sekondarji komuni Dawn jistgħu jaffetwaw sa 10 min kull 100 persuna
Effects in the eye: eye pain or swelling, eye irritation, dry eye, abnormal eye sensation
Effetti fl- għajn: uġigħ fl- għajn jew nefħa, irritazzjoni fl- għajn, għajn xotta, sensazzjoni mhux normali fl- għajn.
Effects in the body: headache, fatigue, dry nose, bad taste
Effetti fil- ġisem: uġigħ ta ’ ras, għeja, nixfa fl- imnieħer, togħma ħażina.
Uncommon side effects These may affect up to 1 in every 100 people
Effettti sekondarji mhux komuni Dawn jistgħu jaffetwaw sa 1 min kull 100 persuna
18 Effects in the eye: blurred, reduced, or abnormal vision, corneal disorder, inflammation or infection of the conjunctiva, eye discharge, eye allergy, sensitivity to light, increased tear production, itchy eye, redness of the eye, eyelid abnormality, itching, redness, swelling, or crusting of the eyelid.
Effetti fl- għajn: vista mċajpra, mnaqqsa jew mhux normali, disturbi fil- korneja, infjammazzjoni jew infezzjoni tal- konġuntiva, tnixxija ta ’ l- għajn, allerġija ta ’ l- għajn, sensittività għad- dawl, żieda fid - dmugħ, ħakk fl- għajn, hmura fl- għajn, il- kappell tal- għajn mhux normali; ħakk, ħmura, nefħa, jew qxur fuq il- kappell tal- għajn.
Effects in the body: abnormal or decreased sensation, dizziness, runny nose, dry skin, skin inflammation, redness, and itching.
Effetti fil- ġisem: sensazzjoni mnaqqsa jew mhux normali, sturdament, tnixxija mill- imnieħer, ġilda xotta, infjammazzjoni tal- ġilda, ħmura u ħakk.
Additional side effects that have been reported include:
Effetti sekondarji oħra li ġew irrapurtati jinkludu:
Effects in the eye: change in pupil size
Effetti fl- għajn: tibdil fid- daqs tal- ħabba ta ’ l- għajn.
Effects in the body: shortness of breath, increased allergic symptoms, facial swelling, drowsiness, generalized weakness, nausea, vomiting, sinus infection
Effetti fil- ġisem: qtugħ ta ’ nifs, żieda fis- sintomi ta ’ l- allerġija, nefħa tal- wiċċ, ħedla, dgħjufija ġenerali, tqalligħ, rimettar, infezzjoni tas- sinus
You can usually carry on taking the drops, unless the effects are serious.
Ġeneralment tista tkompli tuża l- qtar sakemm l- effetti mhumiex ta ’ natura serja.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk wieħed mill- effetti sekondarji isir serju jew jekk tinduna b’ xi effetti oħrajn li mhumiex imniżżlin f’ dan il- fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE OPATANOL
KIF TAĦŻEN OPATANOL
Keep out of the reach and sight of children.
Żommu fejn ma ’ jintlaħqax u ma jidhirx mit- tfal.
Do not use OPATANOL after the expiry date which is stated on the bottle and the boxafter ‘ Exp’.
Tużax OPATANOL wara d- data ta ’ skadenza li tidher fuq il- flixkun u fuq il- kaxxa wara ‘ Exp ’.
The expiry date refers to the last day of the month.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata tax- xahar.
This medicine does not require any special storage conditions.
Din il- mediċina m’ għandhiex bżonn ta ’ ħażna speċjali.
You must throw away the bottle four weeks after you first opened it, to prevent infections, and use a new bottle.
Għandek tarmi l- flixkun erba ’ ġimgħat wara li tkun ftaħtu l- ewwel darba, biex b’ hekk tilqa mill - infezzjonijiet, u tuża flixkun ġdid.
Write down the date you opened it in the space on each bottle label and box
Ikteb id- data ta ’ meta ftaħt il- flixkun fl- ispazju pprovdut lilek fuq it - tikketta ta ’ kull flixkun u kaxxa.
Ask your pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għandekx bzonn.
This will help protect the environment.
Dawn il- miżuri jgħinu għall - protezzjoni ta ’ l- ambjent.
What OPATANOL CONTAINS
X’ fih OPATANOL
The active substance is olopatadine 1 mg/ ml (as hydrochloride).
Is- sustanza attiva hi olopatadine 1 mg/ ml (bħala hydrochloride)
The other ingredients are: benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate (E339), and purified water.
Sustanzi oħra jinkludu: benzalkonium chloride, sodium chloride, disodium phosphate dodecahydrate (E339), u ilma purifikat.
Tiny amounts of hydrochloric acid (E507) and/ or sodium hydroxide (E524) are sometimes added to keep acidity levels (pH levels) normal.
Ammonti żgħar ta ’ hydrochloric acid (E507) u/ jew sodium hydroxide (E524) huma xi drabi miżjuda biex iżżommu l- livelli ta ’ l- acidita ’ (livelli tal- pH) normali.
What OPATANOL looks like and the contents of the pack OPATANOL is a clear liquid (a solution) supplied in a pack containing either one 5 ml plastic bottle or three 5 ml bottles with screw caps.
OPATANOL huwa likwidu ċar (soluzzjoni) li jiġi f’ pakkett li fiħ flixkun wieħed tal- plastik ta '5 ml jew pakett li fiħ tlett flixken, kollha b’ tapp tal- kamin.
19 The marketing authorisation holder Alcon Laboratories (UK) Ltd Pentagon Park Boundary Way Hemel Hempstead Herts HP2 7UD United Kingdom
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Alcon Laboratories (UK) Ltd., Pentagon Park Boundary Way, Hemel Hempstead, Herts., HP2 7UD, Ir- Renju Unit
Manufacturer S. A.
A.
Rijksweg 14 B-2870 Puurs Belgium
Alcon- Couvreur N. V Rijskweg 14, B- 2870 Puurs Il- Belġju
Camil Fabra 58 08320 El Masnou Spain
Manifattur Alcon Cusi, S. A., Camil Fabra 58, 08320 El Masnou Spanja
20 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
20 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Danmark Alcon Danmark A/ S + 45 3636 3434
Norge Danmark Alcon Danmark A/ S + 45 3636 3434
This leaflet was last approved on XXXXX
Dan il- fuljett ġie approvat l- aħħar fis XXXX
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHA TIĠI IMPLIMENTATA MILL- ISTATI MEMBRI
1/ 2 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1/ 2 KONDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHA TIĠI IMPLIMENTATA MILL- ISTATI MEMBRI
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
L- Istati Membri għandhom jassiguraw li l- kundizzjonijiet jew restrizzjonijiet kollha dwar l - użu mingħajr periklu u effettiv tal- prodott mediċinali deskritt hawn taħt ikunu implimentati.
The National Competent Authorities shall agree the details of an education programme for surgeons with the MAH, who must implement such programme nationally to ensure that:
L- Awtoritajiet Kompetenti Nazzjonali ser jaqblu d- dettalji ta ’ programm edukattiv għall - kirurgi ma ’ MAH, li jridu jimplimentaw tali programm b’ mod nazzjonali biex jiżguraw li:
Prior to use of the product, surgeons should be provided with educational material containing:
Qabel l- użu tal- prodott, il- kirurgi għandhom jingħataw materjal edukattiv li fih:
- a copy of the SPC
- kopja tal- SPC
- a detailed description of:
- deskrizzjoni dettaljata ta ’:
 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.
 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.
These descriptive texts are included in the product information.
Dawn it- testi deskrittivi huma nklużi fit- tagħrif dwar il- prodott
- Information about:
- Tagħrif dwar:
 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
 Sensittività eċċessiva u formazzjoni ta ’ antikorpi  Tossiċità tal- fetu u l- embriju 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
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:
Barra minn dan, qabel l- użu il- kirurgi li biħsiebhom jużaw Opgenra għandhom jirċievu DVD ta ’ Taħriġ li fih immaġini irrekordjati matul il- kors ta ’ operazzjoni fuq pazjent ħaj u jinkludi it- tagħrif li ġej:
- Product description
- Deskrizzjoni tal- prodott
- Placement in sterile field
- Ippostjar fiż- żona sterili
- Wound opening (soft and hard tissues)
- Ftuħ tal- ferita (tessuti rotob u ibsin)
- Reconstitution of product
- Rikostituzzjoni tal- prodott
- Implant field preparation (haemostasis)
- Preparazzjoni taż- żona impjantata (emostażi)
- Administration (implantation)
- Għoti (impjantazzjoni)
- Containment of implanted materials (soft tissues)
- Trażżin tal- materjal impjantat (tessuti rotob)
- Instrumentation
- Instrumentazzjoni
- Wound closure (drainage)
- Għeluq tal- ferita (dranaġġ)
- Follow-up measures
- Miżuri ta ’ wara.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kundizzjoni medika tiegħek jew it- trattament tiegħek, aqra l- Fuljett ta ’ Tagħrif (ukoll parti mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
What is Opgenra?
X’ inhu Opgenra?
Opgenra is a medicine that contains the active substance eptotermin alfa.
Opgenra huwa mediċina li fiha s- sustanza attiva eptotermina alfa.
It is supplied as two vials, one containing eptotermin alfa and another containing a substance called carmellose.
Jiġi bħala żewġ kunjetti, wieħed li fih eptotermina alfa u ieħor li fih sustanza msejħa karmelloża (carmellose).
The two powders are made up into a ‘ suspension’ (a liquid with solid particles in it) with a putty-like consistency, which is implanted in the body.
Iż- żewġ trabijiet jitħalltu f ’ ‘ sospensjoni ’ (likwidu li fih partikuli solidi ġewwa fih) b’ konsistenza qisha tajn, li tiġi impjantata fil - ġisem.
What is Opgenra used for?
Għalxiex jintuża Opgenra?
Opgenra is used in adults with spondylolisthesis.
Opgenra jintuża fl- adulti bl- ispondilolisteżi.
This is a condition where one lumbar vertebra (one of the bones in the lower part of the spine) has slipped forward so that it is not in line with the vertebra below it.
Din hija kundizzjoni fejn vertebra lumbari (waħda mill - għadmiet fil- parti t’ isfel tas- sinsla) waħda tkun żelqet ’ il quddiem u għalhekk ma tkunx f’ linja mal - vertebra ta ’ taħtha.
This can cause pain, instability, and problems due to pressure on the nerves, including tingling, numbness, weakness and difficulty controlling certain muscles.
Dan jista ’ jikkaġuna wġigħ, instabilità, u problemi minħabba tagħfis fuq in - nervituri, inkluż tnemnim, tirżiħ, djugħfija u diffikultà fil- kontroll ta ’ ċerti muskoli.
Spondylolisthesis can be treated using surgery to fuse (join) the vertebrae above and below the site where the slip occurred.
L- ispondilolisteżi tista ’ tiġi ttrattata bl- użu tal- kirurġija biex iġġonġi (tgħaqqad) il- vertebri ta ’ fuq u ta ’ taħt is- sit fejn tkun seħħet iż- żelqa.
Opgenra is used only in patients who have previously had surgery using an autograft (a bone graft taken from their own body, usually the hip) that has failed or when an autograft must not be carried out.
Opgenra jintuża biss f’ pazjenti li diġà kellhom kirurġija permezz ta ’ awtograft (graft tal- għadma meħuda minn ġisimhom stess, ġeneralment il- ġenbejn) li ma jkunx irnexxa jew meta ma jkunx jista ’ jsir awtograft.
How is Opgenra used?
Kif jintuża Opgenra?
Opgenra is only used by a surgeon who is appropriately qualified.
Opgenra jintuża biss minn kirurgu li huwa kkwalifikat kif xieraq.
During an operation, the surgeon applies Opgenra directly along each side of the two vertebrae to help new bone develop and to make the vertebrae fuse together.
Waqt operazzjoni, il- kirurgu japplika Opgenra direttament ma ’ kull ġenb taż- żewġ vertebrae biex jgħin fl- iżvilupp ta ’ għadam ġdid u biex iġiegħel lill- vertebrae jeħlu ma ’ xulxin.
How does Opgenra work?
Kif jaħdem Opgenra?
The active substance in Opgenra, eptotermin alfa, acts on the bone.
Is- sustanza attiva f’ Opgenra, eptotermina alfa, taġixxi fuq l- għadam.
It is a copy of a protein called osteogenic protein 1, also known as bone morphogenic protein 7 (BMP-7), which is produced naturally by the body and helps the formation of new bone tissue.
Hija kopja ta ’ proteina msejħa proteina osteoġenika 1, magħrufa wkoll bħala proteina morfoġenika tal- għadam 7 (BMP- 7), li hija magħmula b’ mod naturali mill- ġisem u tgħin fil- formazzjoni ta ’ tessut ġdid tal- għadam.
When implanted, eptotermin alfa stimulates the formation of new bone.
Meta tkun impjantata, eptotermina alfa tistimula l- formazzjoni ta ’ għadam ġdid.
This helps to fuse the two vertebrae in patients having surgery for spondylolisthesis.
Dan jgħin biex iż- żewġ vertebri f’ pazjenti li se issirilhom kirurġija għall- ispondilolisteżi, jeħlu flimkien.
Eptotermin alfa is produced by a method known as ‘ recombinant DNA technology’: it is made by cells that have received a gene (DNA), which makes them able to produce eptotermin alfa.
Eptotermina alfa tiġi prodotta b’ metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: hija magħmula minn ċelluli li jkunu rċievew ġene (DNA), li jagħmilhom kapaċi jipproduċu eptotermina alfa.
The replacement eptotermin alfa acts in the same way as naturally produced BMP-7.
L- eptotermina alfa sostituta taġixxi bl- istess mod bħal BMP- 7 magħmul b’ mod naturali.
Eptotermin alfa has been authorised in the European Union (EU) since May 2001 in Osigraft.
Eptotermina alfa ġiet awtorizzata fl- Unjoni Ewropea (UE) minn Mejju 2001 f’ Osigraft.
Osigraft is used to repair fractures (breaks) of the tibia (shin bone).
Osigraft jintuża biex isewwi fratturi (ksur) tat- tibja (l- għadma tal- qasba tas- sieq).
How has Opgenra been studied?
Kif ġie studjat Opgenra?
The effects of Opgenra were first tested in experimental models before being studied in humans.
L- effetti ta ’ Opgenra għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
The company also used some of the data used to support the authorisation of Osigraft.
Il- kumpanija użat ukoll xi wħud mid- dejta użati biex jappoġġjaw l- awtorizzazzjoni ta ’ Osigraft.
Opgenra has been studied in one main study involving 336 patients who needed spinal fusion surgery for spondylolisthesis.
Opgenra ġiet studjata fi studju ewlieni li involva 336 pazjent li kellhom bżonn kirurġija ta ’ fużjoni tas - sinsla għall- ispondilolisteżi.
All of the patients were eligible for an autograft.
Il- pazjenti kollha kienu eliġibbli għall- awtograft.
The study compared surgery using Opgenra and surgery using bone autografts.
L- istudju qabbel kirurġija bl- użu ta ’ Opgenra u kirurġija bl- użu ta ’ awtografts tal- għadam.
The main measure of effectiveness was the number of patients whose treatment was successful after two years.
Il- kejl ewlieni tal- effikaċja kien in- numru ta ’ pazjenti li l- kirurġija tagħhom kienet ta ’ suċċess wara sentejn.
Treatment was defined as ‘ successful’ when bone could be seen between the affected vertebrae on X-rays, and the patient had shown improvement in disability, with no need for further treatment of the spine, no serious side effects and no worsening of the symptoms caused by pressure on the nerves.
It- trattament ġie definit bħala ‘ ta ’ suċċess ’ meta seta ’ jidher l- għadam bejn il- vertebri effettwati fuq ir- raġġi- X, u l - pazjent wera titjib fid- diżabilità, mingħajr ħtieġa ta ’ iktar trattament tas- sinsla, l- ebda effetti sekondarji serji u l- ebda aggravar tas- sintomi kkaġunati mit- tagħfis fuq in- nervituri.
The company also presented evidence from the published scientific literature on patients treated in the United States of America (USA), where the medicine has been approved as a medical device for spine fusion since 2004.
Il- kumpanija ppreżentat ukoll evidenza mil- letteratura xjentifika ppubblikata fuq pazjenti kkurati fl - Istati Uniti tal- Amerika (USA), fejn il- mediċina ġiet approvata bħala apparat mediku għall- fużjoni tas - sinsla mill- 2004.
What benefit has Opgenra shown during the studies?
Liema benefiċċju wera Opgenra waqt l- istudji mwettqa?
In the main study, Opgenra was not as effective as autograft in patients who were eligible for an autograft.
Fl- istudju ewlieni, Opgenra ma kienx effettiv daqs awtograft f’ pazjenti li kienu eliġibbli għall - awtograft.
After two years, treatment with Opgenra was successful in 39% of the patients, compared with 49% with autograft.
Wara sentejn, il- kura b’ Opgenra kienet ta ’ suċċess f’ 39% tal- pazjenti, meta mqabbla ma ’ 49% b’ awtograft.
Despite the lower effectiveness, there was sufficient evidence from the study and from the published literature to support the use of Opgenra in patients in whom autograft has failed or who must not undergo the procedure.
Minkejja l- effikaċja iktar baxxa, kien hemm biżżejjed evidenza mill- istudju u mil- letteratura ppubblikata li tappoġġja l- użu ta ’ Opgenra f’ pazjenti li fuqhom, awtograft ma jkunx irnexxa jew li ma jkollhomx għalfejn jgħaddu mill- proċedura.
In addition, Opgenra had advantages over autograft, including shorter operations, less blood loss and less pain.
Barra minn hekk, Opgenra għandu vantaġġi fuq awtograft, inklużi, operazzjonijiet iqsar, inqas telf ta ’ demm u inqas uġigħ.
What is the risk associated with Opgenra?
X’ inhu r- riskju assoċjat ma ’ Opgenra?
The most common side effects with Opgenra (seen in between 1 and 10 patients in 100) are heterotopic bone formation (bone formation outside the fusion area) and pseudoarthrosis (failure of the spine to fuse).
L- iktar effetti sekondarji komuni b’ Opgenra (li dehru f’ bejn pazjent 1 u 10 minn kull 100) huma formazzjoni ta ’ għadam eterotopiku (formazzjoni ta ’ għadam barra ż- żona ta ’ fużjoni) u psewdoartrożi (nuqqas ta ’ fużjoni tal- ispina).
In addition, some side effects are seen in between 1 and 10 patients in 100 following spine surgery itself, including infection after the operation, wound dehiscence (opening of the wound), secretion (seepage) and erythema (redness of the skin).
Barra minn hekk, xi effetti sekondarji jidhru f’ bejn pazjent 1 u 10 minn kull 100 wara kirurġija fuq l- ispina nfisha, inklużi infezzjoni wara l- operazzjoni, deixxenza (ftuħ) tal - ferita, tnixxija u eritema (ħmura tal- ġilda).
For the full list of all side effects reported with Opgenra, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji kollha rrappurtati b’ Opgenra ara l- Fuljett ta ’ Tagħrif.
Opgenra should not be used in people who may be hypersensitive to eptotermin alfa or any of the other ingredients.
Opgenra m’ għandux jintuża f’ nies li huma ipersensittivi (allerġiċi) għal eptotermina alfa jew għal xi sustanza oħra tiegħu.
It must not be used in the following groups:  patients with an auto-immune disease (a disease caused by the body’ s own defence system attacking normal tissue);  patients who have an active infection at the operation site or have had repeated infections;  patients who do not have adequate skin covering or blood supply at the operation site;  patients who have received a medicine containing BMP in the past;  patients with cancer or being treated for cancer;  patients whose bones are still growing such as children and adolescents.
Ma għandux jintuża fil- gruppi li ġejjin:  pazjenti b’ mard awtoimmuni (mard ikkaġunat mis- sistema difensiva tal- ġisem innifsu li tattakka t - tessut normali);  pazjenti li għandhom infezzjoni attiva fis- sit tal- operazzjoni jew li kellhom infezzjonijiet ripetuti;  pazjenti li m’ għandhomx kisja ta ’ ġilda jew forniment tad- demm adegwati fis- sit tal- operazzjoni;  pazjenti li fil- passat kienu rċievew mediċina li fiha BMP;  pazjenti bil- kanċer jew li qed jiġu kkurati għall- kanċer;  pazjenti li l- għadam tagħhom għadu qed jikber bħal tfal u adolexxenti.
Why has Opgenra been approved?
Għaliex ġie approvat Opgenra?
The Committee for Medicinal Products for Human Use (CHMP) decided that Opgenra’ s benefits are greater than its risks for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Opgenra huma ikbar mir- riskji tiegħu għall- fużjoni spinali lumbari posterolaterali f’ pazjenti adulti bl - ispondilolisteżi fejn awtograft ma kienx irnexxa jew huwa kontraindikat.
The Committee recommended that Opgenra be given marketing authorisation.
Il- Kumitat irrakkomanda li Opgenra jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Opgenra?
Liema miżuri qed jittieħdu sabiex jiġi assigurat użu sigur għal Opgenra?
The company that makes Opgenra will provide educational packs and training DVDs for surgeons in each Member State.
Il- kumpanija li tagħmel Opgenra se jipprovdi pakketti edukattivi u DVDs ta ’ taħriġ għall- kirurgi f’ kull Stat Membru.
These will include information on Opgenra’ s safety and remind them of how to prepare and use the medicine in an operation.
Dawn jinkludu informazzjoni dwar is- sigurtà ta ’ Opgenra u tfakkarhom fuq kif jippreparaw u jużaw il- mediċina f’ operazzjoni.
The company will also submit plans for long-term studies to the CHMP.
Il- kumpanija se tissottometti wkoll pjanijiet għal studji fit- tul lis- CHMP.
These studies will look at the medicine ’ s safety and effectiveness, and how it is used in real life.
Dawn l- istudji se jħarsu lejn is- sigurtà u l- effikaċja tal- mediċina, u kif tintuża fil - ħajja ta ’ vera.
2/ 3 Other information about Opgenra:
2/ 3 Informazzjoni oħra dwar Opgenra:
The European Commission granted a marketing authorisation valid throughout the EU for Opgenra to Howmedica International S. de R.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq madwar l- Unjoni Ewropea, għal Opgenra lil Howmedica International S. de R.
L. on 19 February 2009.
L. fi 19 ta ’ Frar 2009.
The full EPAR for Opgenra can be found here.
L- EPAR sħiħ għal Opgenra jista ’ jiġi kkonsultat hawn.
EU number
Numru tal - Proċedura ta ’ l- EU
Invented name
Isem ivvintaQawwa
Opgenra
Opgenra 3. 5 mg
Powders for suspension for implantation
Trab għal - suspensjoni għall - impjantazzjoni
Implantation
Impjantazzjoni
Powder (eptotermin alfa): vial (glass/ alu)
Trab (eptotermin alfa): kunjett (ħġieġ/ alu) Trab (carboxymethylcellulose): kunjett (ħġieġ/ alu)
3.5 mg / 2.5 ml after reconstitution
3. 5 mg / 2. 5 ml wara r - rikostituzzjoni
1 vial with carboxymethylcellulose
Kunjett 1 b ’ eptotermin alfa Kunjett b ’ carboxymethylcellulose
Opgenra 3.5 mg powders for suspension for implantation
Opgenra 3. 5 mg, trab għal suspensjoni għall- impjantazzjoni
One vial contains 1g powder with 3.5 mg of eptotermin alfa*.
Kunjett fih 1g trab ma ’ 3. 5 mg ta ’ eptotermin alfa *.
After reconstitution, Opgenra contains 1 mg/ ml eptotermin alfa.
Wara r- rikostituzzjoni, Opgenra fih 1mg/ ml eptotermin alfa.
*Eptotermin alfa is human recombinant Osteogenic protein 1 (OP-1) produced in Chinese hamster ovary (CHO) cell line.
* Eptotermin alfa hu proteina 1 (OP- 1) Osteoġenika rikombinanta umana li hi pproduċuta mill- linja ċellulari ta 'l- ovarja tal- ħamster Ċiniż (CHO).
Powder for suspension for implantation.
Trab għal suspensjoni għall- impjantazzjoni.
The powder containing the active substance is granular and white to off-white.
It- trab li fih is- sustanza attiva hu granulari bejn abjad u offwajt.
The powder containing the excipient carmellose (carboxymethylcellulose) is yellowish white.
It- trab li fih is- sustanza mhux attiva carmellose (carboxymethycellulose) hu abjad li jagħti fl - isfar.
Opgenra is indicated for posterolateral lumbar spinal fusion in adult patients with spondylolisthesis where autograft has failed or is contra-indicated.
. Opgenra hu indikat għal fużjoni spinali lombari posterolaterali f’ pazjenti adulti li għandhom spondilolisteżi meta l- awtograft falla jew hu kontra- indikat.
This medicinal product should be used by an appropriately qualified surgeon.
Dan il- prodott mediċinali għandu jintuża minn kirurgu kwalifikat fl- użu adekwat tiegħu.
Opgenra is intended only for single use in each patient.
Opgenra hu intiż biss għall- użu ta ’ darba waħda f’ kull pazjent.
Treatment requires a single surgery.
It- trattament jinħtieġ operazzjoni waħda.
To fuse a single level of the lumbar region of the spine, one unit of medicinal product is used on each side of the spine.
Biex tgħaqqad livell wieħed tar- reġġjun lombari tax- xewka tad- dahar, unità waħda tal- prodott mediċinali jintuża fuq kull naħa tax- xewka tad- dahar.
The maximum human dose should not exceed 2 units since efficacy and safety for spinal fusion requiring higher doses has not been established.
Id- doża massima umana m’ għandhiex taqbeż 2 unitajiet għax l- effikaċja u s- sigurtà għall- fuzjoni spinali li għandha bżonn dożi ogħla ma ġietx stabbilita.
Method of administration:
Kif għandu jingħata:
The reconstituted product is administered by direct surgical placement into the lumber region of the spine following surgical preparation of the site.
Il- prodott rikonstitwit jingħata permezz ta ’ l- ippostjar kirurġiku dirett fir- reġġjun lombari tax - xewka tad- dahar wara l- preparazzjoni kirurġika tas- sit.
The surrounding soft tissues are then closed around the implanted material.
It- tessuti rotob tal- madwar imbagħad jingħalqu madwar il- materjal impjantat.
For detailed recommendations on the reconstitution and administration of the medicinal product see section 6.6.
Għal rakkomandazzjonijiet dettaljati dwar ir- rikostituzzjoni u l- għoti tal- prodotti mediċinali ara sezzjoni 6. 6.
Opgenra is contraindicated in children, adolescents and the skeletally immature (see section 4.3).
Opgenra hu kontraindikat fi tfal, adoloxxenti u dawk skeltralment immaturi (ara sezzjoni 4. 3).
Renal/ hepatic impairment:
2 Indeboliment renali/ epatiku:
Care should be used when Opgenra is used in patients with renal or hepatic impairment (see section 4.4).
Wieħed għandu joqgħod attent meta Opgenra jkun użat f’ pazjenti li jbatu minn indeboliment renali jew epatiku (ara sezzjoni 4. 4).
2/ 25 Opgenra must not be used in patients who:
Opgenra m’ għandux jintuża f’ pazjenti li:
have a hypersensitivity to the active subst ance or to any of the excipients;
għandhom sensittività eċċessiva għas- sustanza attiva jew għal kwalunkwe sustanza mhux attiva,:
have an autoimmune disease, including Crohn’s disease, rheumatoid arthritis, systemic lupus erythematosus, scleroderma, Sjögren’s syndrome and dermatomyositis/polymyositis;
għandhom xi marda awtoimmuni, inkluż il- marda Crohn, artrite rewmatojde, lupus erythematosus sistemiku, sklerodermija, sindrome ta 'Sjögren, u dermatomijositi/ polimijositi;
have an active infection at the site of spinal fusion or history of recurring infections;
għandhom infezzjoni attiva fis- sit tal- fużjoni spinali jew passat ta ’ infezzjonijiet rikorrenti;
have inadequate skin coverage and vascularity at the site of spinal fusion;
m’ għandhomx kopertura biżżejjed tal- ġilda u vaskularità fis- sit tal- fużjoni spinali;
have prior history of exposure to any bone morphogenetic protein (BMP) product;
diġà għandhom passat ta ’ esponiment għal kwalunkwe prodott ta ’ proteina morfoġenetika tal- għadam (BMP);
have an active malignancy or are undergoing treatment for a malignancy.
għandhom tumur attiv malinn jew qed jingħataw trattament għal tumur malinn.
Opgenra is contraindicated in children, adolescents and the skeletally immature.
Opgenra hu kontraindikat fi tfal, adolexxenti u dawk skeltralment immaturi.
Use of the Opgenra does not guarantee fusion; additional surgeries may be required.
L- użu ta ’ Opgenra ma jiggarantix fużjoni; għandu mnejn ikun hemm bżonn ta ’ operazzjonijiet oħra.
Any material dislodged from the fusion site can cause ectopic ossification in the surrounding tissues with potential complications.
Kwalunkwe materjal li jinqala ’ mis- sit tal- fużjoni jista ’ jikkaġuna ossifikazzjoni ektopika fit - tessuti tal- madwar b’ komplikazzjonijiet potenzjali.
The refore, Opgenra may only be administered to the fusion site under adequate vision and with utmost care.
Mela, l- Opgenra għandha mnejn tingħata biss lis- sit tal- fużjoni taħt kontroll visiv adegwat u bl- akbar kura.
Special care must be taken to prevent any leakage of Opgenra due to irrigation, defective closure of surrounding tissue or inadequate haemostasis.
Wieħed għandu joqgħod aktar u aktar attent biex jara li ma jkunx hemm tqattir ta 'Opgenra minħabba l - irrigazzjoni, għeluq difettuż tat- tessut tal- madwar jew emostasi mhux adekwata.
CT examination has suggested that significant medial displacement of Opgenra can occur post-operatively and this can result in bone forming medially.
L- eżami CT issuġġerixxa li jista ’ jkun hemm spostar sinifikanti medjali ta ’ Opgenra wara l- operazzjoni u dan jista ’ jwassal għall- formazzjoni tal- għadam b' mod medjali.
This should be considered in follow-up of patients with CT or X-ray.
Dan għandu jitqies fl- eżami ta ’ wara ta ’ pazjenti b’ CT jew X- ray.
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).
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 bl- għadam (grupp ta ’ kontroll).
Within the test group, 26% of patients produced antibodies with neutralizing capacity versus 1% in the control group.
Fi ħdan il- grupp tat- test, 26% tal- pazjenti ipproduċew antikorpi b' ħila newtralizzanti a paragun ta '1% fil- grupp ta' kontroll.
The peak antibody response was seen 3 months following treatment.
L- ogħla rispons ta ’ antikorp deher 3 xhur wara t- trattament.
There were no patients with neutralizing antibodies 2 years following treatment.
Ma kien hemm l- ebda pazjenti b’ antikorpi newtralizzanti sentejn wara t- trattament.
The clinical significance of these antibodies is not known.
Is- sinifikat kliniku ta ’ dawn l- antikorpi mhux magħruf.
The clinical study results suggest that there does not appear to be any association between neutralizing antibodies and the development of adverse events related to the immune system.
Ir- riżultati ta ’ l- istudju kliniku jissuġerixxu li ma jidhirx li hemm kwalunkwe rabta bejn l- antikorpi newtralizzanti u l- iżvilupp ta ’ episodji avversi li għandhom x' jaqsmu mas- sistema immuni.
However, an immune response to eptotermin alfa should be considered and appropriate validated tests for the presence of antibodies in serum should be performed in cases where an immune-mediated undesirable effect is suspected, including cases where the medicinal product is ineffective.
Wieħed għandu jżomm quddiem għajnejh li jista 'jkun hemm rispons immuni għal eptotermin alfa u għandhom isiru testijiet validati adekwati għal preżenza ta' antikorpi fis- serum f' każijiet meta jkun hemm suspett ta ’ effett mhux mixtieq ikkawżat mis - sistema immuni, inklużi każi fejn l- prodott mediċinali ma jkunx effettiv.
Repeated use of the medicinal product cannot be recommended.
3 Opgenra hu intiż biss għall- użu ta ’ darba waħda f’ kull pazjent. Użu ripetut tal- prodott mediċinali ma jistax ikun irrakkomandat.
Studies with anti-OP-1 antibodies demonstrated some cross-reactivity with closely related bone morphogenetic proteins BMP-5 and BMP-6.
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.
Anti-OP-1 antibodies have the ability to neutralise the in vitro biological activity of at least BMP-6.
Anti- korpi Anti- OP- 1 jistgħu jinnewtralizzaw l- attività bijoloġika in vitro ta ’ l- anqas ta ’ BMP- 6.
Therefore, upon re-administration of Opgenra, a risk of developing autoimmunity towards the endogenous BMP proteins may exist.
Mela, hekk kif jerġa ’ jingħata l- Opgenra, għandu mnejn ikun hemm riskju tal - iżvilupp ta ’ awtoimmunità għal proteini BMP endoġenużi.
There is limited experience on the use of the medicinal product in patients with renal or hepatic impairment therefore caution with its use in such patients is advised.
Hemm esperjenza limitata dwar l- użu tal- prodott mediċinali f’ pazjenti li għandhom indeboliment renali jew epatiku u għalhekk hemm bżonn li wieħed joqgħod attent meta jużah fil- każ ta ’ dan it- tip ta ’ pazjenti.
Clinical studies to investigate the efficacy and safety of this medicinal product in cervical spine surgery have not been performed; consequently its use outside the region of the lumbar spine cannot be recommended.
Studji kliniċi biex jinvestigaw l- effikaċja u s- sigurtà ta ’ dan il- prodott mediċinali fl - operazzjoni tax- xewka ċervikali ma sarux, u għalhekk l- użu tiegħu barra ir- reġġjun lombari tax- xewka tad- dahar ma jistax ikun irrakkomandat.
The concomitant use of Opgenra with a synthetic bone void filler is not recommended (see section 4.5).
L- użu konkomitanti ta ’ Opgenra bil- filler tal- vojt ta ’ l- għadam sintetiċi mhux irrakkomandat (ara sezzjoni4. 5).
3/25 4.5 Interaction with other medicinal products and other forms of interaction
4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarijiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
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).
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).
Animal studies that have been conducted cannot rule out possible effects of anti-OP-1 antibodies on embryofoetal development (see section 5.3).
Studji fuq bhejjem li saru ma jistgħux jeskludi l- effetti possibbi ta ’ antikorpi anti- OP- 1 fuq l - iżvilupp embrijofetali (ara sezzjoni 5. 3).