qanastek/EMEA-V3 huggingface dataset:
The proportion of patients with hardware failure (locking screws bent or broken) was significantly lower in the InductOs 1.5 mg/ml group as compared to standard-care group (11% vs.
Il- proporzjon ta ’ pazjenti li kellhom ħsara fit- tagħmir tal- metall (viti locking mgħawġin jew miksurin) kien aktar baxx b’ mod sinifikanti fil - grupp ta ’ InductOs 1. 5 mg/ ml meta mqabbel mal- grupp li ngħata kura standard (11% vs.
22%; P=0.0174).
22%; P=0. 0174).
InductOs is active at the site of implantation.
InductOs hu attiv fis- sit ta ’ l- impjantazzjoni.
In two exploratory studies, pre- and post-surgery serum samples were collected from a few long-bone fracture patients.
F’ żewġ studji esploratorji, li saru qabel u wara l - operazzjoni, inġabru kampjuni tas- serum minn ftit pazjenti li kellhom ksur fl- għadam it- twil.
Dibotermin alfa was not detectable in serum.
Dibotermin alfa ma kienx osservat fis- serum.
In animal studies (rats) using InductOs containing radiolabelled dibotermin alfa, the mean residence time at the site of implantation was 4-8 days.
Fi studji fuq l- annimali (firien) bl- użu ta ’ InductOs li kien fih dibotermin alfa radjutikkettat, il- medja taż- żmien tar- residenza fis- sit ta ’ l- impjantazzjoni kienet ta ’ 4- 8 ijiem.
Peak levels of circulating dibotermin alfa (0.1% of the
Il- livelli massimi ta ’ dibotermin alfa fiċ- ċirkolazzjoni (0. 1% tad- doża impjantata) kienu osservati fi żmien 6 sigħat wara l - impjantazzjoni.
When injected intravenously, the terminal half-life of dibotermin alfa was 16 minutes in rats and 6.7 minutes in cynomolgus monkeys.
Meta injettat minn ġol- vina, il- half- life terminali ta ’ dibotermin alfa kienet ta ’ 16- il minuta fil- firien u 6. 7 minuti fix- xadini cynomolgus.
It is concluded therefore that at the site of implantation dibotermin alfa is slowly released from the matrix and rapidly cleared when taken up into the systemic circulation.
Għalhekk, wieħed jista ’ jikkonkludi li fis- sit ta ’ l - impjantazzjoni, dibotermin alfa jintreħa bil- mod mill- matriċi u jitneħħa malajr meta jidħol fiċ - ċirkolazzjoni sistemika.
Non-clinical data reveal no special hazard for humans on conventional studies of pharmacology, acute and repeat exposure toxicity.
Informazzjoni li mhix klinika, magħmula fuq studji konvenzjonali ta ’ sigurtà farmakoloġika, effett akut u tossiku minn dożi ripetuti, ma turi l- ebda periklu speċjali għall- bnedmin.
In reproductive toxicity studies in rats, where dibotermin alfa was administered intravenously to maximize systemic exposure, increased fetal weight and increased fetal ossification was observed and a treatment related effect could not be ruled out.
Fi studji dwar it- tossiċità riproduttiva fil- firien, fejn dibotermin alfa ngħata minn ġol- vina biex jimmassimizza l- espożizzjoni sistemika, żieda fil- piż tal- fetu u żieda fl- ossifikazzjoni tal- fetu kienet osservata, u effett relatat mal- kura ma setax jiġi eskluż.
The clinical relevance of these effects is unknown.
Ir- rilevanza klinika ta ’ dawn l- effetti mhijiex magħrufa.
Anti-dibotermin antibodies have been investigated in pregnant rabbits following hyper-immunisation with dibotermin alfa to experimentally induce anti-BMP-2 antibodies.
Antikorpi anti- dibotermin kienu investigati fi fniek tqal wara iper- immunizzazzjoni b’ dibotermin alfa biex tikkaġuna antikorpi anti- BMP- 2 b’ mod sperimentali.
In some fetuses with decreased body weights there were decreases in ossification of frontal and parietal bones (4 out of 151 fetuses), which is generally considered to be reversible, and antibody related effects could not be ruled out.
F’ xi feti li kellhom tnaqqis fil- piż tal - ġisem, kien hemm tnaqqis fl- ossifikazzjoni ta ’ l- għadam frontali u parjetali (4 minn 151 fetu), li hu ġeneralment ikkunsidrat li hu riversibbli, u effetti relatati ma ’ l- antikorpi ma setgħux jiġu esklużi.
There were no other alterations in fetal external, visceral, or skeletal morphology.
Ma kien hemm l- ebda tibdil ieħor fil- morfoloġija fetali esterna, vixxerali, jew skeletrika.
Other animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, maternal toxicity, embryolethality, or fetotoxicity.
Studji fuq il - bhejjem ma jurux effetti ħżiena diretti jew indiretti fuq it- tqala, it- tossiċità materna, l- embrijoletalità jew il- fetotossiċità.
InductOs has not been tested for in vivo carcinogenicity.
InductOs ma kienx ittestjat għal karċinoġeneċità in vivo.
Dibotermin alfa has demonstrated variable effects on human tumour cell lines in vitro.
Dibotermin alfa wera effetti varjabbli fuq razez ta ’ ċelluli umani tat- tumur in vitro.
Although the available in vitro data suggest a low potential for promotion of tumour growth, the use of InductOs is contraindicated in patients with an active malignancy or in patients undergoing treatment for a malignancy (see also section 4.3).
Għalkemm l- informazzjoni disponibbli in vitro tissuġġerixxi potenzjal baxx għal promozzjoni ta ’ tkabbir tat- tumur, l- użu ta ’ InductOs hu kontra- indikat f’ pazjenti li għandhom malinn attiv jew f’ pazjenti li jkunu qed jiġu kkurati għal malinn (ara wkoll sezzjoni 4. 3).
InductOs has been studied in a canine spinal implantation model.
12 InductOs kien studjat f’ mudell ta ’ l- impjant fis- sinsla tal- klieb.
InductOs was implanted directly onto the exposed dura following a laminectomy.
InductOs kien impjantat direttament fuq id- dura esposta wara laminektomija.
Although narrowing of the neuroforamen and stenosis was observed, no mineralization of the dura, no spinal cord stenosis, and no neurological deficits subsequent to the application of InductOs were observed.
Għalkemm kien osservat it- tidjiq tan- newroforamen u stenosi, ma kienet osservata l- ebda mineralizzazzjoni tad- dura, l- ebda stenosi tas- sinsla, u l- ebda tnaqqis newroloġiku wara l- għoti ta ’ InductOs.
The significance of these data for humans is not known.
Ir- rilevanza ta ’ din l- informazzjoni għall- bnedmin mhijiex magħrufa.
Sucrose Glycine Glutamic acid Sodium chloride Polysorbate 80 Sodium hydroxide
Sucrose Glycine Glutamic acid Sodium chloride Polysorbate 80 Sodium hydroxide
Matrix:
Matriċi:
Bovine Type I collagen
Kollaġen tal- baqar ta ’ Tip I
12 This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Dan il- prodott mediċinali m’ għandux jitħallat ma ’ prodotti mediċinali oħrajn ħlief dawk imsemmija f’ sezzjoni 6. 6.
6. 3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Each kit of InductOs is provided with:
Kull kitt ta ’ InductOs ikun fih:
12 mg of sterile dibotermin alfa powder in a 20 ml vial (Type I glass) stoppered with a bromobutyl rubber closure sealed with an aluminum flip-off seal and plastic cap.
12 mg ta ’ trab sterili ta ’ dibotermin alfa f’ kunjett ta ’ 20 ml (ħġieġ ta ’ Tip I) magħluq b’ tapp tal- lastku tal- bromobutyl, issiġillat b’ siġill flip- off ta ’ l- aluminju u għatu tal- plastik.
Solvent for reconstitution in a 10 ml vial (Type I glass) stoppered with a bromobutyl rubber closure sealed with an aluminum flip-off seal and plastic cap.
Solvent għar- rikostituzzjoni f’ kunjett ta ’ 10 ml (ħġieġ ta ’ Tip I) magħluq b’ tapp tal- lastku tal - bromobutyl, issiġillat b’ siġill flip- off ta ’ l- aluminju u għatu tal- plastik.
One sterile matrix in a polyvinyl chloride (PVC) blister package sealed with a Tyvek lid.
Matriċi sterili waħda f’ pakkett bil- folji tal- polyvinyl chloride (PVC) issiġilat b’ għatu Tyvek.
Two sterile 10 ml disposable polypropylene syringes.
Żewġ siringi sterili tal- polypropylene ta ’ 10 ml li jintremew wara li jintużaw.
Two sterile needles (stainless steel).
Żewġ labar sterili (ta ’ azzar li ma jsaddadx).
Any unused product or waste material should be disposed of in accordance with local requirements.
13 Kull fdal tal- prodott li ma jkunx intuża jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Dibotermin alfa must be used only with the accompanying solvent and matrix provided in the InductOs kit.
Dibotermin alfa għandu jintuża biss mas- solvent u mal- matriċi li jakkompanjawh, li huma pprovduti fil- kitt ta ’ InductOs.
See section 4.2.
Ara sezzjoni 4. 2.
8 MARKETING AUTHORISATION NUMBER(S)
8 NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
9 DATA TA ’ L- EWWEL AWTORIZZAZZJONI/ TIĠDID TA ’ L- AWTORIZZAZZJONI
Date of first authorisation:
Date ta ’ l- ewwel awtorizzazzjoni:
9 September 2002 Date of latest renewal:
9 ta ’ Settembru 2002 Data ta ’ l- aħħar tiġdid:
9 September 2007
9 ta ’ Settembru 2007
10 DATE OF REVISION OF THE TEXT
10 DATA TA ’ META ĠIET RIVEDUTA L- KITBA
13 Detailed information on this product is available on the website of the European Medicines Agency (EMEA) http://www.emea.europa.eu
Informazzjoni dettaljata dwar dan il- prodott tinsab fuq il- website ta ’ l- Aġenzija Ewropea dwar il - Mediċini (EMEA) http: // www. emea. europa. eu.
14 ANNEX II
14 ANNESS II
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
MANUFACTURER(S) OF THE BIOLOGICAL ACTIVE SUBSTANCE(S) AND MANUFACTURING AUTHORISATION HOLDER(S) RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR( I) TAS- SUSTANZA( I) BIJOLOĠIKA ATTIVA U DETENTUR( I) TA ’ L- AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL- ĦRUĠ TAL- LOTT
Wyeth BioPharma One Burtt Road Andover Massachusetts 01810 USA
Wyeth BioPharma One Burtt Road Andover Massachusetts 01810 Stati Uniti ta ’ l- Amerika
Wyeth Pharmaceuticals New Lane Havant Hants PO9 2NG United Kingdom
Wyeth Pharmaceuticals New Lane Havant Hants PO9 2NG Ir- Renju Unit
CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON THE MARKETING AUTHORISATION HOLDER
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET 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 - Prodot, sezzjoni 4. 2)
CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI
The Marketing Authorisation Holder will continue to submit yearly PSURs.
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq ser ikompli jissottometti l- PSURs fuq bażi annwali.
KIT OUTER CARTON
KARTUNA TA ’ BARRA TAL- KITT
InductOs 12 mg kit for implant dibotermin alfa
InductOs 12 mg kitt għall- impjant dibotermin alfa
Each kit contains 12 mg dibotermin alfa.
Kull kitt fih 12 mg ta ’ dibotermin alfa.
When reconstituted, InductOs contains 1.5 mg/ml dibotermin alfa.
Meta rikostitwit, InductOs ikun fih 1. 5 mg/ ml ta ’ dibotermin alfa.
Powder: sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80 Solvent: water for injections Matrix:
Trab: sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide u polysorbate 80 Solvent: ilma għall- injezzjonijiet Matriċi:
Type I bovine collagen
Kollaġen tal- baqar ta ’ Tip I
Kit for implant contains:
Il- kitt għall- impjant fih:
1 vial of dibotermin alfa 12 mg powder for solution 1 vial of solvent for dibotermin alfa (10 ml water for injections) 1 sterile 7.5 x 10 cm matrix 2 sterile 10 ml syringes 2 sterile 20 gauge needles.
Kunjett 1 ta ’ dibotermin alfa 12 mg trab għal soluzzjoni Kunjett 1 ta ’ solvent għal dibotermin alfa (10 ml ilma għall- injezzjonijiet) Matriċi 1 sterili ta ’ 7. 5 x 10 ċm 2 siringi sterili ta ’ 10 ml 2 labar sterili - 20 gauge.
Kit for implant and single use only.
Kitt għall- impjant u biex jintuża darba biss.
For instructions for use, see section 4.2 of the enclosed Summary of Product Characteristics.
Għall- istruzzjonijiet għall- użu, ara sezzjoni 4. 2 tas - Sommarju tal- Karatteristiċi tal- Prodott li hawn inkluż.
19 EXP:
JIS:
20 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
20 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
TRAY TOP LID LABEL
TIKKETTA TA ’ L- GĦATU TA ’ FUQ TAT- TRAY
When reconstituted, contains 1.5 mg/ml dibotermin alfa.
Meta rikostitwit, ikun fih 1. 5 mg/ ml ta ’ dibotermin alfa.
Store in original package.
Aħżen fil- pakkett oriġinali.
Justification for not including Braille accepted
Il- ġustifikazzjoni biex ma jkunx inkluż il- Braille hija aċċetta
22 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
22 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
TRAY UNDERSIDE OF LID STICKER
IT- TREJ FUQ IN- NAĦA TA ’ TAĦT TA ’ L- ISTIKER TA ’ L- GĦATU
Dispense onto sponge and wait 15 min.
Poġġi fuq l- isponża u stenna 15- il minuta.
23 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS
23 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN
VIAL PROTEIN LABEL
TIKKETTA TAL- KUNJETT BIL- PROTEINA
Powder for InductOs 12 mg kit for implant, dibotermin alfa
Trab għal InductOs 12 mg kitt għall- impjant, dibotermin alfa
For instructions for use, see section 4.2 of the enclosed Summary of Product Characteristics
Għall- istruzzjonijiet għall- użu, ara sezzjoni 4. 2 tas- Sommarju tal- Karatteristiċi tal- Prodott li hawn inkluż.
12mg dibotermin alfa; when reconstituted, contains 1.5 mg/ml.
12 mg dibotermin alfa; meta rikostitwit, ikun fih 1. 5 mg/ ml.
VIAL SOLVENT LABEL
TIKKETTA TAL- KUNJETT BIS- SOLVENT
Solvent for InductOs 12 mg kit for implant Water for injections
Solvent għal InductOs 12 mg kitt għall- impjant Ilma għall- injezzjonijiet
10 ml water for injections
10 ml ta ’ ilma għall- injezzjonijiet
MATRIX LABEL
TIKKETTA TAL- MATRIĊI
Matrix for InductOs 12 mg kit for implant Type I bovine collagen
Matriċi għal InductOs 12 mg kitt għall- impjant Kollaġen tal- baqar ta ’ Tip I
EXP: see reverse
JIS: ara n- naħa ta ’ wara
LOT: see reverse
LOTT: ara n- naħa ta ’ wara
1 sterile matrix (7.5 x 10 cm)
Matriċi 1 sterili (7. 5 x 10 ċm)
REVERSE
NAĦA TA ’ WARA
{YYYY MM}
{SSSS XX}
27 PACKAGE LEAFLET:
27 FULJETT TA ’ TAGĦRIF:
Read all of this leaflet carefully before you are given this medicine. − Keep this leaflet.
Aqra dan il- fuljett kollu qabel ma tingħata din il- mediċina. − Żomm dan il- fuljett.
You may need to read it again. − If you have any further questions, ask your doctor. − If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor.
Jista ’ jkollok bżonn terġa ’ taqrah. − Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib tiegħek. − Jekk xi wieħed mill- effetti sekondarji jiggrava, jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib tiegħek.
What InductOs is and what it is used for 2.
X’ inhu InductOs u għalxiex jintuża 2.
Before you receive InductOs 3.
Qabel ma tirċievi InductOs 3.
How InductOs is given 4.
Kif jingħata InductOs 4.
How to store InductOs 6.
Kif taħżen InductOs 6.
WHAT INDUCTOS IS AND WHAT IT IS USED FOR
X’ INHU INDUCTOS U GĦALXIEX JINTUŻA
InductOs contains the active substance, dibotermin alfa.
InductOs fih is- sustanza attiva, dibotermin alfa.
This is a protein that helps bone to grow, and is very similar to a protein that is already found in your body.
Din hi proteina li tgħin lill- għadam biex jikber, u hi simili ħafna għall- proteina li diġà tinsab f’ ġismek.
InductOs may be used either in lower back spine fusion surgery or to repair fractures of the shin bone.
InductOs jista ’ jintuża jew f’ operazzjoni tal- fużjoni fil- parti t’ isfel tas- sinsla tad- dahar, jew biex ifejjaq ksur fil- qasba tas- sieq.
Lower back spine fusion surgery If you have a lot of pain from a damaged disc in your lower back and other treatments have not proved effective, you may be considered for lower back spine fusion surgery.
Operazzjoni tal- fużjoni fil- parti t’ isfel tas- sinsla tad- dahar Jekk għandek ħafna wġigħ minħabba ħsara f’ disk fin- naħa t’ isfel ta ’ dahrek, u l- ebda kuri oħrajn ma kienu effettivi, inti tista tkun ikkunsidrat/ a għal operazzjoni tal- fużjoni fil- parti t’ isfel tas- sinsla tad - dahar.
InductOs is used instead of taking a bone graft from your hip; this avoids the problems and pain that can be caused by an operation to collect the bone graft.
InductOs jintuża minflok ma jittieħed trapjant ta ’ l- għadam minn ġenbejk; dan jevita problemi u wġigħ li jistgħu jiġu kkawżati minn operazzjoni biex jinkiseb it- trapjant ta ’ l- għadam.
When used in lower back fusion surgery InductOs is used in combination with a metal cage which corrects the position of your spine.
Meta jintuża f’ operazzjoni tal- fużjoni fil- parti t’ isfel tas- sinsla tad- dahar, InductOs jintuża flimkien ma ’ gaġġa tal- metall li tikkoreġi l- pożizzjoni tas- sinsla ta ’ dahrek.
If you have any question about the cage, please ask your doctor.
Jekk ikollok xi mistoqsijiet dwar din il- gaġġa, jekk jogħġbok staqsi lit- tabib tiegħek.
Fractures of the shin bone If you have broken your shin bone, InductOs is used to increase the chance that your broken bone will heal, to help your fracture heal faster, and to reduce the need for additional surgeries to help your fracture heal.
Ksur fil- qasba tas- sieq Jekk għandek ksur fil- qasba tas- sieq, InductOs jintuża biex iżid iċ- ċans li l- għadma miksura tiegħek tfieq, biex jgħin lill- ksur ifieq aktar malajr, u biex inaqqas il- ħtieġa għal operazzjonijiet addizzjonali biex jgħinu lill- ksur tiegħek ifieq.
InductOs is used in addition to standard treatment and care of shin bone fractures.
InductOs jintuża flimkien mal- kura standard u l- kura ta ’ ksur fil - qasba tas- sieq.
BEFORE YOU RECEIVE INDUCTOS
QABEL MA TIRĊIEVI INDUCTOS
You should not receive InductOs • if you are allergic (hypersensitive) to dibotermin alfa or bovine collagen or any of the other ingredients of InductOs. • if you are still growing (skeletally immature). • if you have an active infection at the surgery site. • if the doctor treating you decides that you have inadequate blood supply at the fracture site. • for treating a fracture that is disease-related (eg. fractures due to Paget’s disease or cancer). • if you have been diagnosed with or are being treated for cancer.
M’ għandek tirċievi InductOs • jekk inti allerġiku/ a (għandek sensittività eċċessiva) għal dibotermin alfa jew kollaġen tal - baqar jew xi sustanzi oħra ta ’ InductOs. • jekk għadek qed tikber (ma mmaturajtx b’ mod skeletriku) • jekk għandek infezzjoni attiva fis- sit ta ’ l- operazzjoni. • jekk it- tabib li qiegħed jikkurak jiddeċiedi li għandek provvista tad- demm inadegwata fis- sit fejn għandek il- ksur.
28
28 • biex tikkura ksur li hu relatat mal- marda (eż. ksur minħabba l- marda ta ’ Paget marda jew kanċer). • jekk kont dijanjostikat/ a b’ kanċer, jew qed tieħu kura għal kanċer.
You should inform your doctor if you have an autoimmune disease such as rheumatoid arthritis, sytemic lupus erythematosus, scleroderma, Sjögren's syndrome or dermatomyositis/ polymyositis.
Dawn li ġejjin huma l- prekawzjonijiet għall- użu ta ’ InductOs li jridu jkunu diskussi mat- tabib tiegħek • Għandek tinforma it- tabib tiegħek jekk għandek xi marda awtoimmuni bħal artrite rewmatojde, lupus erythematosus sistemiku, skleroderma, is- sindrome ta ’ Sjögren jew dermatomijosite/ polymijosite. • Għandek tinforma lit- tabib tiegħek jekk għandek xi marda ta ’ l- għadam. • Il- prodott m’ għandux jitpoġġa f’ kuntatt dirett ma ’ ċerti tipi ta ’ għadam.
Use of InductOs may cause bone formation (heterotopic ossification) in the surrounding tissues, which can result in complications.
Il- kirurgu tiegħek ser ikun jaf liema tipi ta ’ għadam għandu jevita. • L- użu ta ’ InductOs jista ’ jikkawża l- formazzjoni ta ’ għadam (ossifikazzjoni eterotopika) fit- tessut tal- madwar, li jista ’ jirriżulta f’ kumplikazzjonijiet. • Xi pazjenti jistgħu jiżviluppaw antikorpi (magħmulin minn ġismek biex jiġġieldu proteina barranija) għal InductOs.
Localised swelling, in some cases resulting in breathing difficulties, has been reported in patients when InductOs has been used in surgery of the upper (neck) region of the spine.
Filwaqt li ma kienu osservati l- ebda effetti li jagħmlu ħsara, l - effetti fit- tul mhumiex magħrufa. • Għandek tinforma it- tabib tiegħek jekk għandek mard tal- kliewi jew tal- fwied. • Xi pazjenti jistgħu jiżviluppaw uġigħ fin- nervaturi minħabba l- ġbir ta ’ fluwidu lokalizzat li jkun jeħtieġ li jitneħħa, jew proċedura kirurġika biex jitneħħa l- fluwidu. • Nefħa lokalizzata, li f’ xi każijiet li tirriżulta f’ diffikultajiet biex tieħu n- nifs, kienet irrappurtata f’ pazjenti meta InductOs intuża f’ operazzjoni fin- naħa ta ’ fuq tas- sinsla tad - dahar (fl- għonq).
The safety and effectiveness of InductOs in cervical spine surgery have not been established and InductOs should not be used in this situation.
Is- sigurtà u l- effettività ta ’ InductOs f’ operazzjonijiet tas- sinsla tad - dahar ċervikali ma kinitx stabbilita, u InductOs m’ għandux jintuża f’ din is- sitwazzjoni.
Using InductOs with other medicines Some shin bone clinical trials have shown that if you are treated with InductOs and take pain medication such as aspirin or non-steroidal anti-inflammatory drugs (NSAIDs), like ibuprofen, for a longer period of time (e.g. for more than 14 days) more fluid may discharge from your wound.
Meta tuża InductOs ma ’ mediċini oħra Xi provi kliniċi dwar il- qasba tas- sieq urew li jekk tiġi kkurati b’ InductOs u tieħu mediċina kontra l - uġigħ, bħall- aspirina jew mediċini mhux sterojdi kontra l- infjammazzjoni (NSAIDs), bħal ibuprofen, għal tul ta ’ żmien itwal (eż. għal aktar minn 14- il jum), aktar fluwidu jista ’ joħroġ mill- ferita tiegħek.
This additional fluid discharge has not been associated with problems in fracture or wound healing.
Din it- tnixxija addizzjonali ta ’ fluwidu ma kinitx assoċjata ma ’ problemi fil- fejqan tal- ksur jew tal - ferita.
Please inform your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Pregnancy and breast-feeding The effects of InductOs on pregnancy are not known.
Tqala u treddigħ L- effetti ta ’ InductOs fuq it- tqala mhumiex magħrufa.
The use of the product in pregnant women is not advised.
L- użu tal- prodott f’ nisa tqal mhuwiex rakkomandat.
Ask your doctor for advice if you become pregnant or intend to become pregnant.
Staqsi lit- tabib tiegħek għal parir toħroġ tqila jew jekk qed tippjana li toħroġ tqila.
Your doctor should advise you about using contraception for one year after having been treated with InductOs.
It - tabib tiegħek għandu jagħtik parir dwar l- użu tal- kontraċezzjoni għal sena wara li tkun ġejt ikkurata b’ InductOs.
It is not known if InductOs passes into breast milk.
Mhux magħruf jekk InductOs jitneħħiex fil- ħalib tas- sider.
Treatment with InductOs is not recommended in mothers who are breastfeeding an infant.
Il- kura b’ InductOs mhix rakkomandata f’ ommijiet li jkunu qed ireddgħu tarbija.
Ask your doctor for advice before breast-feeding your baby.
Staqsi it- tabib tiegħek għal parir qabel ma tredda ’ lit- tarbija tiegħek.
Driving and using machines InductOs will not affect your ability to drive or operate machinery.
Sewqan u tħaddim ta ’ magni InductOs mhux ser jaffettwa l- ħila tiegħek li ssuq jew tħaddem il- magni.
Important information about some of the ingredients of InductOs Some patients may develop antibodies (made by your body to fight a foreign protein) against dibotermin alfa or against the collagen in the sponge.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ InductOs Xi pazjenti jistgħu jiżviluppaw antikorpi (magħmulin minn ġismek biex jiġġieldu proteina barranija) kontra dibotermin alfa jew kontra l- kollaġen fl- isponża.
In clinical studies, the presence of antibodies was not associated with side effects, e.g. allergies, nor was it shown to decrease the effectiveness of InductOs.
Fi studji kliniċi, il- preżenza ta ’ antikorpi ma kinitx assoċjata ma ’ effetti sekondarji, eż. allerġiji, u lanqas ma ntwera li dan inaqqas l- effettività ta ’ InductOs.
HOW INDUCTOS IS GIVEN
KIF JINGĦATA INDUCTOS
The doctor treating you will administer InductOs during surgery.
It- tabib li jkun qed jikkurak ser jagħtik InductOs matul l- operazzjoni.
The medical staff will prepare InductOs in the operating room.
L- istaff mediku ser jipprepara InductOs fis- sala operatorja.
The metal cages
Jekk tkun qed tirċievi InductOs għal fużjoni fil- parti t’ isfel tas- sinsla tad- dahar, il- kirurgu tiegħek ser ineħħi d- disk li tkun bil- ħsara li tkun qed tikkawża l- uġigħ, u jibdilha b’ żewġ gaġeġ tal- metall mimlijin b’ InductOs.
29 correct the position of your spine, and InductOs encourages the bone to grow between the two vertebrae to join them permanently in the correct position.
Il- gaġeġ tal- metall jikkoregu l- pożizzjoni tas- sinsla tad- dahar tiegħek, u InductOs jinkoraġġixxi l- għadam biex jikber bejn iż- żewġ vertebri, biex jgħaqqadhom b’ mod permanenti fil- pożizzjoni korretta.
If you are receiving InductOs for a broken shin bone, your doctor will then place InductOs around your broken bone when your fracture is treated.
Jekk qed tirċievi InductOs għal ksur fil- qasba tas- sieq, it- tabib tiegħek imbagħad ser ipoġġi InductOs madwar l- għadma miksura tiegħek meta jikkura l- ksur.
The doctor will determine how many kits of InductOs you will receive, depending on the size and number of fractures.
It- tabib ser jiddeċiedi kemm kitts ta ’ InductOs inti ser tirċievi, skond id- daqs u n- numru ta ’ ksur.
Generally, one kit is used.
Ġeneralment, jintuża kitt wieħed.
However, a maximum of 2 kits may be used.
Madankollu, jistgħu jintużaw sa massimu ta ’ 2 kitts.
Side effects specific to shin bone fracture surgery Like all medicines, InductOs can cause side effects, although not everybody gets them.
Effetti sekondarji li huma speċifiċi għal operazzjoni minħabba ksur fil- qasba tas- sieq Bħal kull mediċina oħra, InductOs jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most frequent (likely to occur in more than 1 in 10 patients) events reported in clinical studies were similar to those due to the traumatic injuries sustained by the patients or to the surgery itself.
L- aktar avvenimenti frekwenti (li x’ aktarx li ser iseħħu f’ aktar minn 1 minn kull 10 pazjenti) irrappurtati fi studji kliniċi kienu simili għal dawk li jseħħu minħabba korrimenti trawmatiċi li jkollhom il- pazjenti, jew minħabba l- operazzjoni nnifisha.
These effects were pain, swelling, wound infection, and fever.
Dawn l- effetti kienu wġigħ, nefħa, infezzjoni tal- ferita, u deni.
These were observed slightly more frequently in patients treated with InductOs for shin bone studies than in patients who did not receive the product.
Effetti sekondarji komuni (li x’ aktarx li jseħħu f’ inqas minn 1 minn kull 10 pazjenti) kienu l- uġigħ ta ’ ras, sinjali li jindikaw funzjonament ħażin tal- frixa (amilasemija), tnaqqis fil- livelli ta ’ magnesium fid - demm, u żieda temporanja fir- rata ta ’ taħbit tal- qalb Dawn kienu osservati ftit aktar b’ mod frekwenti f’ pazjenti kkurati b’ InductOs għal studji dwar il- ksur fil- qasba tas- sieq, milli f’ pazjenti li ma rċivewx il- prodott.
Side effects specific to lower back fusion surgery The most common (more that 1 in 10 patients) side effects observed in spinal fusion studies were: accidental injury, nerve pain, back pain and disorders of the bone such as delayed healing.
Effetti sekondarji li huma speċifiċi għal operazzjoni tal- fużjoni fil- parti t’ isfel tas- sinsla tad - dahar L- aktar effetti sekondarji komuni (f’ aktar minn 1 minn kull 10 pazjenti) osservati fi studji dwar il - fużjoni tas- sinsla tad- dahar kienu: korriment aċċidentali, uġigħ fin- nervaturi, uġigħ fid- dahar u disturbi fl- għadam, bħal fejqan li jdum ma jseħħ.
There have been reports of nerve pain due to localised fluid collection which would require drainage or a surgical procedure to remove the fluid.
Kien hemm xi rapporti ta ’ wġigħ fin- nervaturi minħabba l - ġbir ta ’ fluwidu lokalizzat li jkun jeħtieġ li jitneħħa, jew proċedura kirurġika biex jitneħħa l- fluwidu.
Localised swelling, in some cases resulting in breathing difficulties, has been reported in patients when InductOs has been used in surgery of the upper (neck) region of the spine.If any of the side effects get serious or if you notice any side effects not listed in this leaflet, please tell your doctor.
Nefħa lokalizzata, li f’ xi każijiet li tirriżulta f’ diffikultajiet biex tieħu n- nifs, kienet irrappurtata f’ pazjenti meta InductOs intuża f’ operazzjoni fin- naħa ta ’ fuq tas- sinsla tad- dahar (fl- għonq).
HOW TO STORE INDUCTOS
KIF TAĦŻEN INDUCTOS
Keep out of the reach and sight of children You will not be required to store this product.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal
What InductOs contains The active substance in InductOs is dibotermin alfa (recombinant human Bone Morphogenetic Protein-2), 12 mg.
X’ fih InductOs Is- sustanza attiva f’ InductOs hi dibotermin alfa (Proteina- 2 Morfoġenika ta ’ l- Għadam umana rikombinanti), 12 mg.
The other ingredients are sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide and polysorbate 80, water for injections, and bovine Type I collagen.
Is- sustanzi l- oħra huma sucrose, glycine, glutamic acid, sodium chloride, sodium hydroxide u polysorbate 80, ilma għal injezzjonijiet, u kollaġen tal- baqar ta ’ Tip I.
What InductOs looks like and contents of the pack InductOs is supplied to your doctor as a kit for implanting during surgery.
Id- dehra ta ’ InductOs u d- daqs tal- pakkett InductOs hu fornut lit- tabib tiegħek bħala kitt għall- impjant matul l- operazzjoni.
The kit contains 12 mg of dibotermin alfa powder, a solvent (water) and a sponge, which is made from a protein called collagen obtained from cattle (otherwise known as bovine Type I collagen).
Il- kitt fih 12 mg ta ’ trab dibotermin alfa, solvent (ilma) u sponża, li hi magħmula minn proteina msejħa kollaġen li tinkiseb mill- baqar (magħrufa wkoll bħala kollaġen tal- baqar ta ’ Tip I).
Dibotermin alfa is supplied in the kit as a white powder.
Dibotermin alfa hu fornut f’ kitt bħala trab abjad.
30 For use during surgery, it must be dissolved in the water provided to form a solution, which is used to soak the sponge.
Għall- użu matul l- operazzjoni, irid jinħall fl- ilma pprovdut biex jifforma soluzzjoni, li tintuża biex ixxarrab l- isponża.
The soaked sponge may then be placed where bone growth is desired.
L- isponża mxarrba mbagħad tkun tista ’ titpoġġa fejn it- tkabbir ta ’ l- għadam ikun mixtieq.
The sponge and dibotermin alfa solution will gradually disappear as bone is formed.
L- isponża u s- soluzzjoni ta ’ dibotermin alfa gradwalment ser jgħibu hekk kif jifforma l - għadam.
Marketing Authorisation Holder Wyeth Europa Ltd.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Wyeth Europa Ltd.
Manufacturer Wyeth Pharmaceuticals New Lane Havant Hants, PO9 2NG United Kingdom
Manifattur Wyeth Pharmaceuticals New Lane Havant Hants, PO9 2NG Ir- Renju Unit
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
Tel :+35621 344610 Fax:+35621 341087
Tel: +35621 344610 Fax: +356 21 341087
Ελλάδα Wyeth Hellas A.E.B.E.
31 Ελλάδα Wyeth Hellas A. E. B. E.
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 Ewropea dwar il - Mediċini (EMEA): http: // www. emea. europa. eu.
What is Infanrix Hexa?
X’ inhu Infanrix Hexa?
Infanrix Hexa is a vaccine, which is available as a powder and suspension to be made up into a suspension for injection.
Infanrix Hexa huwa vaċċin li jinsab disponibbli bħala trab u bħala sospensjoni għall- injezzjoni.
It contains the following active substances: toxoids (chemically weakened toxins) from diphtheria and tetanus, parts of Bordetella pertussis (a bacterium that causes whooping cough), parts of the hepatitis B virus, inactivated (killed) polioviruses and polysaccharides (sugars) from the bacterium Haemophilus influenzae type b (‘ Hib’, a bacterium that causes meningitis).
Din il - mediċina fiha dawn iż- żewġ sustanzi attivi: tossojdi (tossojdi mdgħajfa kimikament) tad- difterite u t - tetnu, partijiet minn Bordetella pertussis (batterju li jikkawża sogħla konvulsiva), partijiet mill- vajrus tal- epatite B, poljovajrus mhux attivat u polisakkaridi (zokkor) ġejjin mill- batterju Haemophilus influenzae tat- tip B (Hib, batterju li jikkawża l- meninġite).
What is Infanrix Hexa used for?
Għalxiex jintuża Infanrix Hexa?
Infanrix Hexa is used to vaccinate infants under three years of age against diphtheria, tetanus, pertussis (whooping cough), hepatitis B, poliomyelitis (polio) and diseases caused by Hib (such as bacterial meningitis).
Infanrix Hexa jintuża għat- tilqim ta ’ trabi u tfal żgħar taħt l- età ta ’ tliet snin kontra d- difterite, t- tetnu, il- pertussi (sogħla konvulsiva), l- epatite B, il- poljomjelite (poljo) u l- mard ikkawżat minn Hib (bħal meninġite batterika).
It is also used as a booster vaccination.
Jista ’ wkoll jintuża bħala tilqima ‘ booster ’.
How is Infanrix Hexa used?
Kif jintuża Infanrix Hexa?
The recommended vaccination schedule for Infanrix Hexa is two or three doses, given at least one month apart, usually within the first six months of life.
Il- programm tat- tilqim rakkomandat għal Infanrix Hexa huwa ta ’ żewġ jew tliet dożi, mogħtija minn tal- inqas xahar il- bogħod minn xulxin normalment matul l- ewwel sitt xhur tal- ħajja.
Infanrix Hexa is given by deep injection into a muscle.
Infanrix Hexa jingħata permezz ta ’ injezzjoni fonda fil- muskolu.
The site of injection should be alternated for subsequent injections.
Il- punt tal- injezzjoni għandu jinbidel għall - injezzjonijiet suċċessivi.
A booster dose of Infanrix Hexa or a similar vaccine must be given at least six months after the last dose of the initial course.
Għandha tingħata doża ‘ booster ’ ta ’ Infanrix Hexa jew ta ’ vaċċin simili minn tal- inqas sitt xhur wara l- aħħar doża tal- kors inizjali.
The choice of which vaccine to use depends on official recommendations.
L- għażla dwar liema vaċċin għandu jintuża tiddependi fuq ir - rakkomandazzjonijiet uffiċjali.
Infanrix Hexa can be given to infants who received a hepatitis B vaccine at birth.
Infanrix Hexa jista ’ jingħata lit- trabi jew tfal żgħar li jkunu rċevew il- vaċċin għall- epatite B fit- twelid.
How does Infanrix Hexa work?
Kif jaħdem Infanrix Hexa?
Infanrix Hexa is a vaccine.
Infanrix Hexa huwa vaċċin.
Vaccines work by ‘ teaching’ the immune system (the body’ s natural defences) how to defend itself against diseases.
Il- vaċċini jaħdmu billi 'jgħallmu' lis- sistema immunitarja (id- difiżi naturali tal- ġisem) kif tiddefendi lilha nnifisha kontra l- mard.
Infanrix Hexa contains small amounts of: • toxoids from the bacteria that cause diphtheria and tetanus; • toxoids and other proteins purified from B. pertussis; • surface antigen (proteins from the surface) of the hepatitis B virus; • inactivated polioviruses (types 1, 2 and 3); • polysaccharides extracted from the ‘ capsules’ that surround the Hib bacteria.
Infanrix Hexa fih ammonti żgħar ta: • tossojdi mill- batterji li jikkawżaw difterite u tetnu; • tossojdi u proteini oħra ppurifikati minn B pertussis; • antiġenu tas- superfiċje (proteina mis- superfiċje) tal- vajrus tal- epatite B; • poljovajrusis mhux attivati (tat- tipi 1, 2 u 3);
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged. • polisakkaridi estratti mill - ‘ kapsuli ’ li jinsabu madwar il- batterji Hib.
When an infant is given the vaccine, the immune system recognises the parts of the bacteria and viruses as ‘ foreign’ and makes antibodies against them.
Meta t- trabi jew it- tfal ta ’ età żgħira jingħataw il- vaċċin, is- sistema immunitarja tagħraf il- partijiet tal - batterji u l- vajrusis bħala 'barranin' u tipproduċi antikorpi kontrihom.
The immune system will then be able to produce antibodies more quickly when the person is naturally exposed to the bacteria or viruses.
Is- sistema immunitarja mbagħad tkun tista 'tipproduċi antikorpi iktar malajr meta tkun esposta mill- ġdid għall- batterji jew il- vajrusis.
This helps to protect against the diseases that these bacteria and viruses cause.
Dan jgħin fil- protezzjoni kontra l- mard li dawn il- batterji u l- vajrusis jikkawżaw.
The vaccine is ‘ adsorbed’.
Il- vaċċin huwa ‘ assorbit ’.
This means that the active substances are fixed onto aluminium compounds, to stimulate a better response.
Dan ifisser li s- sustanzi attivi jeħlu fuq komposti ta ’ aluminju sabiex jistimolaw rispons aħjar.
The surface antigens of the hepatitis B virus are produced by a method known as ‘ recombinant DNA technology’: they are made by a yeast that has received a gene (DNA), which makes it able to produce the proteins.
L- antiġeni tas- superfiċje tal- vajrus tal- epatite B huma prodotti minn metodu magħruf bħala ‘ teknoloġija rikombinanti tad- DNA ’: magħmula minn ħmira li tkun irċiviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- proteini.
Infanrix Hexa is a combination of components that have been available in the European Union (EU) in other vaccines: diphtheria, tetanus, pertussis and hepatitis B were available in Infanrix HepB from 1997 until 2005, and diphtheria, tetanus, pertussis, polioviruses and the Hib component are available in other vaccines.
Infanrix Hexa huwa kumbinazzjoni ta ’ komponenti li ilhom disponibbli fl- Unjoni Ewopea (UE) f’ vaċċini oħra:. difterite, tetnu, pertussi u epatite B kienu disponibbli f’ Infanrix HepB mill- 1997 sal - 2005, u d- difterite, it- tetnu, il- pertussi, il- poljovajrusis u l- komponenti Hib jinsabu disponibbli f’ vaċċini oħra.
How has Infanrix Hexa been studied?
Kif ġie studjat Infanrix Hexa?
Infanrix Hexa has been studied in nine studies, involving a total of almost 5,000 infants who were at least six weeks of age.
Infanrix Hexa ġie studjat f’ disa ’ studji, li kienu jinvolvu total ta ’ madwar 5, 000 tarbija li kellhom mill - inqas sitt ġimgħat.
Over 3,000 of the infants received the first course of vaccination with Infanrix Hexa.
Iktar minn 3, 000 tarbija rċevew l- ewwel kors tal- vaċċin b’ Infanrix Hexa.
The effects of Infanrix Hexa were compared with those of separate vaccines containing the same active substances.
L- effetti ta ’ Infanrix Hexa tqabblu ma ’ dawk ta ’ vaċċini separati li fihom l- istess sustanzi attivi.
The main measure of effectiveness was the production of protective antibodies in the infants.
L- effikaċja tal - vaċċin ġiet tkejlet prinċipalment permezz tal- produzzjoni ta ’ antikorpi protettivi fit- trabi.
An additional five studies looked at the effects of a booster vaccination with Infanrix Hexa.
Ħames studji eżaminaw l- effetti ta ’ vaċċin ‘ booster ’ b’ Infanrix Hexa.
What benefit has Infanrix Hexa shown during the studies?
X’ benefiċċji wera Infanrix Hexa waqt l- istudji mwettqa?
The nine studies showed that the first course of injections with Infanrix Hexa was as effective at producing protective levels of antibodies as separate vaccines containing the same active substances.
Id- disa ’ studji wrew li l- ewwel kors ta ’ tilqim b’ Infanrix Hexa kien effikaċi fil- produzzjoni talivelli protettivi ta ’ antikorpi daqs vaċċini separati li fihom l- istess sustanzi attivi.
Overall, between 95 and 100% of infants had antibodies to diphtheria, tetanus, pertussis, hepatitis B virus, polioviruses, and Hib, one month after the first vaccination course.
Kien hemm bejn 95 u 100% tat- trabi li kellhom antikorpi għad- difterite, it- tetnu, il- pertussi, il- vajrus tal- epatite B, il - poljovajrus, u l- Hib, xahar wara l- ewwel kors tal- vaċċin.
The additional studies showed that booster vaccinations with Infanrix Hexa were as effective as separate vaccines containing the same active substances one month after the booster vaccination.
L- istudji addizzjonali wrew li l- vaċċini ‘ booster ’ b’ Infanrix Hexa kienu effikaċi daqs il- vaċċini separati li kien fihom l- istess sustanzi attivi xahar wara l- vaċċin ‘ booster ’.
What is the risk associated with Infanrix Hexa?
X’ inhu r- riskju assoċjat ma ’ Infanrix Hexa?
The most common side effects with Infanrix Hexa (seen in more than 1 in 10 doses of the vaccine) are loss of appetite, fever of 38ºC or more, local swelling, pain and redness at the injection site, fatigue (tiredness), abnormal crying, irritability and restlessness.
L- iktar effetti sekondarji komuni b’ Infanrix Hexa (li dehru f’ iktar minn doża waħda minn kull 10 tal - vaċċin) huma t- telf ta ’ aptit, deni bi 38ºC jew iktar, nefħa, uġigħ u ħmura fil- post fejn tingħata t- tilqima, għeja, biki mhux normali, irritabilità u aġitazzjoni.
For the full list of all side effects reported with Infanrix Hexa, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrappurtata b’ Infanrix Hexa, ara l- Fuljett ta ’ Tagħrif.
Infanrix Hexa should not be used in infants who may be hypersensitive (allergic) to any of the active substances, to any of the other ingredients of the vaccine, or to neomycin and polymyxin (antibiotics), or if the infant has had an allergic reaction after a previous vaccine containing diphtheria, tetanus, pertussis, hepatitis B, polio or Hib.
Infanrix Hexa m’ għandhux jintuża fi trabi jew tfal żgħar li jistgħu jkunu ipersensittivi (allerġiċi) għal kwalunkwe mis- sustanzi attivi, kwalunkwe mill- ingredjenti l- oħra tal- vaċċin, jew għal neomiċina u polimissina (antibijotiċi), jew jekk it- tarbija kellha reazzjoni allerġika wara vaċċin li jkun fih difterite, tetnu, pertussi, epatite B, poljo jew Hib.
Infanrix Hexa should not be given if the infant has had encephalopathy (brain disease) of unknown cause within seven days of a previous vaccination with a vaccine containing pertussis components.
Infanrix Hexa m’ għandux jingħata lil trabi li kellhom enċefalopatija (marda fil- moħħ) li tagħha l- kawża ma tkunx magħrufa fi żmien sebat ijiem ta ’ vaċċin preċedenti b’ vaċċin li fih komponenti ta ’ pertussi.
Infanrix Hexa should be postponed in infants with a severe sudden fever.
Infanrix Hexa għandu jiġi pospost fi trabi li jkollhom deni qawwi f’ daqqa.
As for all vaccines, if Infanrix Hexa is used in very premature babies, there is a risk of the babies experiencing apnoea (brief pauses in breathing).
Bħal ma hu l- każ għall- vaċċini kollha jekk Infanrix Hexa jintuża fi trabi tassew prematuri, ikun hemm ir- riskju li t- trabi jesperjenzaw apnea (pawżi qosra fit- teħid tan- nifs).
Their breathing should be monitored for up to three days after vaccination.
In- nifs tagħhom għandu jiġi ssorveljat sa tliet ijiem wara l- vaċċin.
Why has Infanrix Hexa been approved?
Għaliex ġie approvat Infanrix Hexa?
The Committee for Medicinal Products for Human Use (CHMP) decided that Infanrix Hexa’ s benefits are greater than its risks for primary and booster vaccination of infants against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and disease caused by Hib.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Infanrix Hexa huma ikbar mir- riskji tiegħu fil- vaċċin primarju u l - ‘ booster ’ fi trabi u tfal żgħar għal kontra d- difterite, t- tetnu, il- pertussi, l- epatite B, il- poljomjelite u l- mard ikkawżata minn Hib.
The Committee recommended that Infanrix Hexa be given marketing authorisation.
Il - Kumitat irrakkomanda li Infanrix Hexa jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Infanrix Hexa:
Informazzjoni oħra dwar Infanrix Hexa:
The European Commission granted a marketing authorisation valid throughout the EU for Infanrix Hexa to GlaxoSmithKline Biologicals s. a. on 23 October 2000.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha, għal GlaxoSmithKline Biologicals s. a. fit- 23 ta ’ Ottubru 2000.
The marketing authorisation was renewed on 23 October 2005.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fit- 23 ta ’ Ottubru 2005.
The full EPAR for Infanrix Hexa can be found here.
2/ 3 L- EPAR sħiħ Infanrix Hexa jista ’ jiġi kkonsultat hawn.
This summary was last updated in 11-2008.
Dan is- sommarju kien aġġornat l- aħħar fi:
EU Number
Isem inventat
Invented name Strength
Għamla farmaċewtika
Pharmaceutical Form
Mnejn jingħata
Route of administration Packaging
Il- pakkett
Powder and suspension for suspension for injection
Trab u suspensjoni għal
Intramuscular use Powder: vial (glass) Suspension: pre-filled syringe (glass)
Trab: fjala (ħġieġ)
suspension:
suspensjoni:
1 vial + 1 pre-filled syringe
siringa 1 mimlija
Powder and suspension for suspension for injection
Trab u suspensjoni għal suspensjoni għall -
Intramuscular use Powder: vial (glass) Suspension: pre-filled syringe (glass)
Trab: fjala (ħġieġ) Suspensjoni: siringa
10 vials + 10 pre-filled syringes
10 fjali + 10 siringi mimlijin
20 vials + 20 pre-filled syringes
20 siringa mimlija
50 vials + 50 pre-filled syringes
50 fjala + 50 siringa mimlija
Powder and suspension for suspension for injection
Użu fil- muskolu
1 vial + 1 pre-filled syringe + 2 needles
siringa 1 mimlija
10 vials + 10 pre- filled syringes + 20 needles
mimlijin lesti + 20
20 vials + 20 pre- filled syringes + 40 needles
20 fjala + 20 siringa mimlija lesta + 40
50 vials + 50 pre- filled syringes + 100 needles
50 fjala + 50 siringa mimlija lesta + 100
1 vial with Bioset cap + 1 pre-filled syringe
Fjala 1 b’ tapp Bioset + siringa 1 mimlija
10 vials with Bioset cap + 10 pre-filled syringes
+ 10 siringi mimlijin
20 vials with Bioset cap + 20 pre-filled syringes
+ 20 siringa mimlija
EU/ 1/ 00/ 152/ 012
1/ 2 _ 1 _ EU/ 1/ 00/ 152/ 012
1/ 2
Użu fil- muskolu
50 vials with Bioset cap + 50 pre-filled syringes
50 fjala b’ tapp Bioset
EU Number
suspensjoni għall -
Invented name Strength
Suspensjoni: siringa
Pharmaceutical Form
0. 5 ml
Route of administration Packaging
+ 50 siringa mimlija
Content
injezzjoni
Package size
mimlija lesta (ħġieġ)
1 vial with Bioset cap + 1 pre-filled syringe + 1 needle
Fjala 1 b’ tapp Bioset + siringa 1 mimlija
10 vials with Bioset cap + 10 pre-filled syringes + 10 needles
10 fjali b’ tapp Bioset + 10 siringi mimlijin
20 vials with Bioset cap + 20 pre-filled syringes + 20 needles
20 fjala b’ tapp Bioset + 20 siringa mimlija
50 vials with Bioset cap + 50 pre-filled syringes + 50 needles
50 fjala b’ tapp Bioset + 50 siringa mimlija
1 vial with Bioset cap + 1 pre-filled syringe + 2 needles
Fjala 1 b’ tapp Bioset + siringa 1 mimlija
10 vials with Bioset cap + 10 pre-filled syringes + 20 needles
+ 10 siringi mimlijin
Diphtheria toxoid, adsorbed Tetanus toxoid, adsorbed Pertussis toxoid, adsorbed Filamentous haemagglutinin, adsorbed Pertactin, adsorbed Recombinant Hepatitis B surface
Toxoid tat- tetnu, adsorbit Toxoid tal- pertussis, adsorbit Filamentous haemagglutinin, adsorbit Pertactin, adsorbit Antiġen tas- superfiċje ta ’ l- epatite B (proteina S)
≥ 30IU ≥ 40IU 25 micrograms 25 micrograms 8 micrograms
≥40 IU 25 mikrogrammi 25 mikrogrammi 8 mikrogrammi
Antigen (S protein), adsorbed Inactivated type 1 Poliovirus Inactivated type 2 Poliovirus Inactivated type 3 Poliovirus Conjugate of Haemophilus influenzae
manifatturat b’ teknoloġija rekombinanti, adsorbit Poliovirus inattivat tip 1 Poliovirus inattivat tip 2 Poliovirus inattivat tip 3 Haemophilus influenzae tip b
10 micrograms 40 DU 8 DU 32 DU
10 mikrogrammi 40 DU 8 DU 32 DU
type b capsular polysaccharide (PRP) and Tetanus toxoid (T), adsorbed
capsular polysaccharide (PRP) konjugat ma ’ toxoid tat- Tetnu (T), adsorbit
Infanrix hexa, Powder and suspension for suspension for injection.
Infanrix hexa, trab u suspensjoni għall- injezzjoni.
Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus type b (Hib) conjugate vaccine (adsorbed).
Vaċċin (adsorbit) konjugat tad- difterite (D), tetnu (T), sogħla konvulsiva (komponent aċellulari), epatite B (rDNA) (HBV), poljomelite (inattivat) (IPV), u Haemophilus ta ’ tip B (Hib).
After reconstitution, 1 dose (0.5 ml) contains:
Wara r- rikostituzjoni, doża 1 (0. 5 ml) ikun fiha:
Diphtheria toxoid1 Tetanus toxoid1 Bordetella pertussis antigens
Toxoid tad- Difterite1 Toxoid tat- tetnu1 Antiġeni tal- Bordatella pertussis
less than 30 IU less than 40 IU
mhux anqas minn 30 IU mhux anqas minn 40 IU