qanastek/EMEA-V3 huggingface dataset:
After reconstitution 1 ml contains 250 microgram (8 million IU)Interferon beta-1b*
Wara r- rikostituzzjoni 1ml fih 250 mikrogramma (8 miljun IU) / ml ta ’ Interferon beta- 1b *
For subcutaneous injection after reconstitution with 1.2 ml of solvent Single use.
Għall- injezzjoni minn taħt il- ġilda wara rikostituzzjoni b’ 1. 2 ml ta ’ solvent.
EXP {MM/ YYYY}
EXP {XX/ SSSS})
Do not freeze
Taħżinx f’ temperatura ’ l fuq minn 25°C Tagħmlux fil- friża
43 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF MULTIPACKS (5x1 SINGLE PACK) (INCLUDING BLUE BOX)
43 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ MULTIPAKK (5 PAKKETTI SINOGLI x 1) (INKLUŻ KAXXA BLU)
Ecipients:
Sustanzi mhux attivi:
Multipack comprising 5 single packs, each containing:
Multipakk li jikkonsisti minn 5 pakketti singoli, li kull wieħed fih:
1 pre-filled syringe with solvent for reconstitution contains 1.2 ml sodium chloride solution 5.4 mg/ ml.
Siringa waħda mimlija għal- lest b’ solvent għar- rikostituzzjoni fiha 1. 2 ml ta ’ soluzzjoni ta ’ sodium chloride ta ’ 5. 4 mg/ ml.
EXPIRY DATE
44 Wara r- rikostituzzjoni huwa rrakkomandat użu mmedjat.
CARTON OF 45 (3x 15) SINGLE PACKS (INCLUDING BLUE BOX)
KARTUNA TA ’ 45 (3 x 15) PAKKETT SINGOLU (INKLUŻ KAXXA BLU)
3-month pack comprising 45 (3x15) single packs, each containing:
Pakkett għal 3 xhur li fih 45 (3x15) pakkett singolu, li kull wieħed fih:
EXPIRY DATE
46 Wara r- rikostituzzjoni huwa rrakkomandat użu mmedjat.
Do not freeze.
Tagħmlux fil- friża.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDIĊINALI, JEKK HEMM BŻONN
NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER
ISEM U INDIRIZZ TAD- DETENTUR TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
Bayer Schering Pharma AG D-13342 Berlin Germany
Bayer Schering Pharma AG D- 13342 Berlin Il- Ġermanja
MARKETING AUTHORISATION NUMBER
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ
BATCH NUMBER
NUMRU TAL- LOTT
GENERAL CLASSIFICATION FOR SUPPLY
KLASSIFIKAZZJONI ĠENERALI TA ’ KIF JINGĦATA
Medicinal product subject to medical prescription.
Prodott mediċinali jingħata bir- riċetta tat- tabib.
INSTRUCTIONS ON USE
ISTRUZZJONIJIET DWAR L- UŻU
INFORMATION IN BRAILLE
INFORMAZZJONI BIL- BRAILLE
47 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
47 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON OF 42 (3x 14) SINGLE PACKS (INCLUDING BLUE BOX)
KARTUNA TA ’ 42 (3 x 14) PAKKETT SINGOLU (INKLUŻ KAXXA BLU)
NAME OF THE MEDICINAL PRODUCT
ISEM TAL- PRODOTT MEDIĊINALI
Betaferon 250 microgram/ ml powder and solvent for solution for injection Interferon beta-1b
Betaferon 250 mikrogramma/ ml trab u solvent għal soluzzjoni għall- injezzjoni Interferon beta- 1b
STATEMENT OF ACTIVE SUBSTANCE(S)
DIKJARAZZJONI TAS- SUSTANZA( I) ATTIVA
1 ml contains 250 microgram (8 million IU) Interferon beta-1b when reconstituted.
1 ml fih 250 mikrogramma (8 miljun IU) Interferon beta- 1b meta rikostitwit.
LIST OF EXCIPIENTS
LISTA TA ’ SUSTANZI MHUX ATTIVI
Excipients:
Sustanzi mhux attivi:
Human albumin, mannitol
Albumina umana, mannitol
3-month pack comprising 42 (3x14) single packs, each containing:
Pakkett għal 3 xhur li fih 42 (3x14) pakkett singolu, li kull wieħed fih:
1 vial with powder for solution for injection contains 300 microgram (9.6 million IU).
Kunjett wieħed bi trab għal soluzzjoni għall- injezzjoni fih 300 mikrogramma (9. 6 miljun IU).
After reconstitution 1 ml contains 250 microgram (8 million IU) Interferon beta-1b*.
Wara r- rikostituzzjoni 1 ml fih 250 mikrogramma (8 miljun IU) ta ’ Interferon beta- 1b *.
1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ ml.
Siringa waħda mimlija għal- lest b’ 1. 2 ml ta ’ solvent għar- rikostituzzjoni fiha soluzzjoni ta ’ sodium chloride ta ’ 5. 4mg/ ml.
1 vial adapter with needle + 2 alcohol wipes
Adattatur tal- kunjett wieħed b’ labra + 2 imsielaħ ta ’ l- alkoħol
*Betaferon is formulated to contain a calculated overfill of 20%.
* Betaferon huwa magħmul biex ikun fih ammont ikkalkulat żejjed ta ’ 20%.
METHOD AND ROUTE OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINGĦATA
For subcutaneous injection after reconstitution with 1.2 ml of solvent.
Għall- injezzjoni minn taħt il- ġilda wara rikostituzzjoni b’ 1. 2 ml ta ’ solvent.
Single use.
Użu ta ’ darba.
Read the package leaflet before use.
Aqra l- fuljett ta ’ tagħrif qabel l- użu.
SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF THE REACH AND SIGHT OF CHILDREN
TWISSIJA SPEĊJALI LI L- PRODOTT MEDIĊINALI GĦANDU JINŻAMM FEJN MA JINTLAĦAQX U MA JIDHIRX MIT- TFAL
Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA/ IET SPEĊJALI OĦRA, JEKK MEĦTIEĠA
EXPIRY DATE
48 Wara r- rikostituzzjoni huwa rrakkomandat użu mmedjat.
In-use stability demonstrated for 3 hours at 2- 8 °C.
Stabbiltà waqt l- użu kienet dimostrata għal 3 sigħat f’ temperatura ta ’ 2- 8 °C.
SPECIAL STORAGE CONDITIONS
KUNDIZZJONIJIET SPEĊJALI TA ’ KIF JINĦAŻEN
Do not store above 25°C.
Taħżinx f’ temperatura ’ l fuq minn 25°C.
49 PARTICULARS TO APPEAR ON THE OUTER PACKAKING CARTON WITH 15 SINGLE PACKS, PART OF A CARTON WITH 45 (3 x 15) SINGLE PACKS (INCLUDING BLUE BOX)
49 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA BI 15- IL PAKKETT SINGOLU, PARTI MINN KARTUNA B’ 45 (3 X 15) PAKKETT SINGOLU (INKLUŻ KAXXA BLU)
Pack comprising 15 single packs, part of a 3-month pack containing 45 (3 x 15) single packs.
Pakkett li fih 15- il pakkett singolu, parti minn pakkett għal 3 xhur li fih 45 (3 x 15) pakketti singoli.
No individual sale of single packs.
M’ għandux jinbigħ waħdu.
Each single pack contains:
Kull pakkett singolu fih:
1 pre-filled syringe with 1.2 ml solvent for reconstitution contains sodium chloride solution 5.4 mg/ ml.
Siringa waħda mimlija għal- lest b’ 1. 2 ml ta ’ solvent għar- rikostituzzjoni fiha soluzzjoni ta ’ sodium chloride ta ’ 5. 4 mg/ ml.
*Betaferon is formulated to contain a calculated overfill of 20%.
Adattatur tal- kunjett wieħed b’ labra + 2 imsielaħ ta ’ l- alkoħol * Betaferon huwa magħmul biex ikun fih ammont ikkalkulat żejjed ta ’ 20%.
OTHER SPECIAL WARNING(S), IF NECESSARY
TWISSIJA( IET) SPEĊJALI OĦRA, JEKK MEĦTIEĠA
EXPIRY DATE
DATA TA ’ META JISKADI
EXP {MM/ YYYY}
EXP {XX/ SSSS}
After reconstitution an immediate use is recommended.
Wara r- rikostituzzjoni huwa rrakkomandat użu mmedjat.
51 PARTICULARS TO APPEAR ON THE OUTER PACKAKING CARTON WITH 14 SINGLE PACKS, PART OF A CARTON WITH 42 (3 x 14) SINGLE PACKS (INCLUDING BLUE BOX)
51 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA B’ 14- IL PAKKETT SINGOLU, PARTI MINN KARTUNA B’ 42 (3 X 14) PAKKETT SINGOLU (INKLUŻ KAXXA BLU)
Pack comprising 14 single packs, part of a 3-month pack containing 42 (3 x 14) single packs.
Pakkett li fih 14- il pakkett singolu, parti minn pakkett għal 3 xhur li fih 42 (3 x 14) pakkett singolu.
53 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 1 SINGLE PACK (1VIAL/ 1PFS), PART OF A CARTON WITH 15 SINGLE PACKS IN A CARTON OF 3x15 SINGLE PACKS
53 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ PAKKETT SINGOLU WIEĦED (KUNJETT WIEĦED/ SIRINGI MIMLIJA GĦAL- LEST WAĦDA), PARTI MINN KARTUNA BI 15- IL PAKKETT SINGOLU F’ KARTUNA TA ’ 3X15 PAKKETTI SINGOLI
Part of a pack containing 15 single packs in a 3-month pack of 3x15 single packs.
Parti minn pakkett li fih 15- il pakkett singolu f’ pakkett għal 3 xhur ta ’ 3x15 pakketti singoli.
1 vial with powder:
Kunjett wieħed bi trab:
300 microgram (9.6 mio IU) per vial.
300 mikrogramma (9. 6 mio IU) f’ kull kunjett.
When reconstituted 250 microgram/ ml (8 mio IU/ ml) Interferon beta-1b.
Meta rikostitwit fih 250 mikrogramma/ ml (8 mio IU/ ml) Interferon beta- 1b.
1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ ml, 1 vial adapter with needle + 2 alcohol wipes
Siringa waħda mimlija għal- lest b’ 1. 2 ml ta ’ solvent: soluzzjoni ta ’ sodium chloride ta ’ 5. 4 mg/ ml, adattatur tal- kunjett wieħed b’ labra + 2 imsielaħ ta ’ l- alkoħol
For subcutaneous injection after reconstitution with solvent.
Għall- injezzjoni minn taħt il- ġilda wara rikostituzzjoni bis- solvent.
54 9.
54 Wara r- rikostituzzjoni huwa rrakkomandat użu mmedjat.
55 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 1 SINGLE PACK (1VIAL/ 1PFS), PART OF A CARTON WITH 14 SINGLE PACKS IN A CARTON OF 3x14 SINGLE PACKS
55 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KARTUNA TA ’ PAKKETT SINGOLU WIEĦED (KUNJETT WIEĦED/ SIRINGI MIMLIJA GĦAL- LEST WAĦDA), PARTI MINN KARTUNA B’ 14- IL PAKKETT SINGOLU F’ KARTUNA TA ’ 3X14 PAKKETTI SINGOLI
Part of a pack containing 14 single packs in a 3-month pack of 3x14 single packs.
Parti minn pakkett li fih 14- il pakkett singolu f’ pakkett għal 3 xhur ta ’ 3x14 pakketti singoli.
56 9.
56 Wara r- rikostituzzjoni huwa rrakkomandat użu mmedjat.
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING (TITRATION PACK WITH 4x1 TRIPLE PACK (3 VIALS/ 3 PRE-FILLED SYRINGES)), FOR FIRST 12 INJECTIONS/ TREATMENT DAYS
57 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA (PAKKETT TA ’ TITRAZZJONI B’ 4x1 PAKKETTI TRIPLI (3 KUNJETTI/ 3 SIRINGI MIMLIJA GĦAL- LEST)), GĦALL- EWWEL 12- IL INJEZZJONI/ ĠRANET TA ’ KURA
Titration pack comprising 4 triple packs, each containing:
Pakkett ta ’ titrazzjoni fih 4 pakketti tripli, u kull wieħed fih:
3 Vials with powder for solution for injection, each containing 300 microgram (9.6 million IU).
3 kunjetti bi trab għal soluzzjoni għall- injezzjoni, kull wieħed fih 300 mikrogramma (9. 6 miljun IU).
After reconstitution 1 ml contains 250 microgram (8 million IU) Interferon beta-1b*.
Wara r- rikostituzzjoni 1 ml fih 250 mikrogramma (8 miljun IU) Interferon beta- 1b *.
3 Pre-filled syringes with solvent for reconstitution, each containing 1.2 ml sodium chloride solution, 5.4 mg/ ml.
3 siringi mimlija għal- lest b’ solvent għar- rikostituzzjoni, kull waħda fiha 1. 2 ml ta ’ soluzzjoni ta ’ sodium chloride, 5. 4 mg/ ml.
3 Vial adapters with needles + 6 alcohol wipes
3 adattaturi tal- kunjett b’ labar + 6 imsielaħ ta ’ l- alkoħol
Keep out of the reach and sight of children
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Medicinal product subject to medical prescription
Prodott mediċinali jingħata bir- riċetta tat- tabib.
Use yellow triple pack No.
Uża l- pakkett triplu No.
1 for treatment days 1, 3 and 5 Use red triple pack No.
1 ta ’ lewn isfar għall- ġranet ta ’ kura 1, 3 u 5 Uża l- pakkett triplu No.
2 for treatment days 7, 9 and 11 Use green triple pack No.
2 ta ’ lewn aħmar għall- ġranet ta ’ kura 7, 9 u 11 Uża l- pakkett triplu No.
3 for treatment days 13, 15 and 17 Use blue triple pack No.
3 ta ’ lewn aħdar għall- ġranet ta ’ kura 13, 15 u 17 Uża l- pakkett triplu No.
4 for treatment days 19, 21 and 23
4 ta ’ lewn blu għall- ġranet ta ’ kura 19, 21 u 23
59 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 1 SINGLE PACK (1VIAL/ 1PFS) AS AN INTERMEDIATE PACK OF A MULTIPACK OF 15 PACKS (WITHOUT BLUE BOX)
KARTUNA TA ’ PAKKETT SINGOLU (KUNJETT WIEĦED/ SIRINGI MIMLIJA GĦAL - LEST WAĦDA) BĦALA PAKKETT INTERMEDJU TA ’ MULTIPAKK TA ’ 15- IL PAKKETT (MINGĦAJR KAXXA BLU)
Betaferon 250 microgram/ ml, Powder and solvent for solution for injection Interferon beta-1b
Betaferon 250 mikrogramma/ ml, Trab u solvent għal soluzzjoni għall- injezzjoni Interferon beta- 1b
1 ml contains 250 microgram (8 million IU) Interferon beta-1b when reconstituted.
1ml fih 250 mikrogramma (8 miljun IU) Interferon beta- 1b meta rikostitwit.
Part of a multipack containing 15 single packs.
Parti minn multipakk li fih 15- il pakkett singolu.
No individual sale of single packs.
M’ għandux jinbigħ waħdu
300 mcg (9.6 mio IU) per vial.
300mcg (9. 6 miljun IU) kull kunjett.
When reconstituted 250 mcg/ ml (8 mio IU/ ml) Interferon beta-1b.
Meta rikostitwit fih 250mcg/ ml (8 mio IU/ ml) Interferon beta- 1b.
1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ ml, 1 vial adapter with needle + 2 alcohol wipes
Siringa waħda mimlija għal- lest b’ 1. 2ml ta ’ solvent: soluzzjoni ta ’ sodium chloride ta ’ 5. 4mg/ ml, adattatur tal- kunjett wieħed b’ labra + 2 imsielaħ ta ’ l- alkoħol
For subcutaneous injection after reconst. with solvent.
Għall- injezzjoni minn taħt il- ġilda wara rikostituzzjoni bis- solvent.
60 9.
60 Wara r- rikostituzzjoni huwa rrakkomandat użu mmedjat.
61 PARTICULARS TO APPEAR ON THE OUTER PACKAGING CARTON OF 1 SINGLE PACK (1VIAL/ 1PFS) AS AN INTERMEDIATE PACK OF A MULTIPACK OF 14 PACKS (WITHOUT BLUE BOX)
KARTUNA TA ’ PAKKETT SINGOLU (KUNJETT WIEĦED/ SIRINGI MIMLIJA GĦAL - LEST WAĦDA) BĦALA PAKKETT INTERMEDJU TA ’ MULTIPAKK TA ’ 14- IL PAKKETT (MINGĦAJR KAXXA BLU)
Part of a multipack containing 14 single packs.
Parti minn multipakk li fih 14- il pakkett singolu.
62 9.
62 Wara r- rikostituzzjoni huwa rrakkomandat użu mmedjat.
63 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
63 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
Betaferon 250 microgram/ ml, Powder and solvent for solution for injection Interferon beta-1b
Betaferon 250 mikrogramma, Trab u solvent għal soluzzjoni għall- injezzjoni Interferon beta- 1b
1 ml contains 250 microgram (8 million IU) Interferon beta-1b per ml when reconstituted.
1ml fih 250 mikrogramma (8 miljun IU) Interferon beta- 1b kull ml meta rikostitwit.
Part of a multipack containing 5 single packs.
Parti minn multipakk li fih 5 pakketti singoli.
300 mcg (9.6 mio IU) per vial.
300mcg (9. 6 mio IU) kull kunjett.
When reconstituted 250 mcg/ ml (8 mio IU/ ml) Interferon beta-1b.
Meta rikostitwit 250mcg/ ml (8 mio IU/ ml) Interferon beta- 1b.
1 pre-filled syringe with 1.2 ml solvent: sodium chloride solution 5.4 mg/ ml, 1 vial adapter with needle + 2 alcohol wipes
Siringa waħda mimlija bil- lest b’ 1. 2ml ta ’ solvent: soluzzjoni ta ’ sodium chloride ta ’ 5. 4mg/ ml, adattatur tal- kunjett wieħed b’ labra + 2 imsielaħ ta ’ l- alkoħol
After reconst. immediate use recommended.
Wara r- rikostituzzjoni huwa rrakkomandat użu mmedjat.
In-use stability demonstrated for 3 hours at 2-8 °C.
Stabbiltà waqt l- użu kienet dimostrata għal 3 sigħat f’ temperatura ta ’ 2- 8 °C.
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON OF 1 TRIPLE PACK (3 VIALS/ 3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS – TREATMENT DAYS 1, 3, 5
KARTUNA TA ’ PAKKETT TRIPLU (3 KUNJETTI/ 3 SIRINGI MIMLIJA GĦAL- LEST) BĦALA PAKKETT INTERMEDJU TA ’ PAKKETT TA ’ TITRAZZJONI TA ’ 4 PAKKETTI TRIPLI – ĠRANET TA ’ KURA 1, 3, 5
Triple pack 1 1st dosage step (0.25 ml) for treatment days 1, 3, 5
1 L- ewwel pass tad- dożaġġ (0. 25 ml) għall- ġranet ta ’ kura 1, 3, 5
Part of a titration pack.
Parti minn pakkett ta ’ titrazzjoni.
No individual sale.
M’ għandux jinbigħ waħdu.
3 Vials with powder:
3 Kunjetti bi trab:
300 microgram (9.6 mio IU) per vial.
300 mikrogramma (9. 6 mio IU) kull kunjett.
When reconstituted 250 microgram/ ml (8 mio IU/ ml) Interferon beta-1b.
Meta rikostitwit 250 mikrogramma/ ml (8 mio IU/ ml) Interferon beta- 1b.
3 Pre-filled syringes with 1.2 ml solvent: sodium chloride solution, 5.4 mg/ ml, 3 Vial adapters with needles + 6 alcohol wipes
3 Siringi mimlija għal- lest b’ 1. 2 ml ta ’ solvent: soluzzjoni ta ’ sodium chloride, 5. 4 mg/ ml, 3 Adattaturi tal- kunjett b’ labar + 6 imsielaħ ta ’ l- alkoħol
For subcutaneous injection after reconstitution with solvent.
Għall- injezzjoni minn taħt il- ġilda wara rikostituzzjoni b’ solvent.
After reconstitution immediate use recommended.
Wara r- rikostituzzjoni huwa rrakkomandat użu mmedjat.
Bayer Schering Pharma AG D-13342 Berlin Germany 12.
Bayer Schering Pharma AG D- 13342 Berlin Il- Ġermanja
INSTRUCTIONS ON USE (text for inside the lid)
ISTRUZZJONIJIET DWAR L- UŻU (ktiba n- naħa ta ’ ġewwa ta ’ l- għatu)
Dear patient,
Għażiż pazjent, Il- pakkett triplu no.
Triple pack 1 is designed to help you prepare the first 3 injections (days 1, 3 and 5).
1 huwa maħsub biex jgħinek tipprepara l- ewwel 3 injezzjonijiet (ġranet 1, 3 u 5).
Use all the solvent in the syringe to dissolve the Betaferon powder in the vial.
Uża s- solvent kollu fis- siringa biex iddewweb it- trab ta ’ Betaferon fil- kunjett.
Then draw up solution as far as the mark on the syringe:
Wara iġbed soluzzjoni sal- marka fuq is- siringa:
0.25 ml for first three injections (at day 1, 3 and 5 of therapy).
0. 25 ml għall- ewwel tliet injezzjonijiet (fi ġranet 1, 3 u 5 ta ’ terapija).
Discard the vial with the remaining solution.
Armi l- kunjett bis- soluzzjoni li jifdal.
16.
67 16.
67 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
68 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON OF 1 TRIPLE PACK (3 VIALS/ 3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS – TREATMENT DAYS 7, 9, 11
KARTUNA TA ’ PAKKETT TRIPLU (3 KUNJETTI/ 3 SIRINGI MIMLIJA GĦAL- LEST) BĦALA PAKKETT INTERMEDJU TA ’ PAKKETT TA ’ TITRAZZJONI TA ’ 4 PAKKETTI TRIPLI – ĠRANET TA ’ KURA 7, 9, 11
Triple pack 2 2nd dosage step (0.5 ml) for treatment days 7, 9, 11
2 It- tieni pass tad- dożaġġ (0. 5 ml) għall- ġranet ta ’ kura 7, 9, 11
Triple pack 2 is designed to help you prepare the next 3 injections (days 7, 9 and 11).
2 huwa maħsub biex jgħinek tipprepara it- 3 injezzjonijiet li jmiss (ġranet 7, 9 u 11).
0.5 ml for the injections at day 7, 9 and 11 of therapy.
0. 5 ml għall- injezzjonijiet fi ġranet 7, 9 u 11 ta ’ terapija).
CARTON OF 1 TRIPLE PACK (3 VIALS/ 3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS – TREATMENT DAYS 13, 15, 17
KARTUNA TA ’ PAKKETT TRIPLU (3 KUNJETTI/ 3 SIRINGI MIMLIJA GĦAL- LEST) BĦALA PAKKETT INTERMEDJU TA ’ PAKKETT TA ’ TITRAZZJONI TA ’ 4 PAKKETTI TRIPLI – ĠRANET TA ’ KURA 13, 15, 17
Triple pack 3 3rd dosage step (0.75 ml) for treatment days 13, 15, 17
3 It- tielet pass tad- dożaġġ (0. 75 ml) għall- ġranet ta ’ kura 13, 15, 17
INSTRUCTIONS ON USE (text for inside the lid) Dear patient,
ISTRUZZJONIJIET DWAR L- UŻU (ktiba n- naħa ta ’ ġewwa ta ’ l- għatu)
Triple pack 3 is designed to help you prepare the next 3 injections (days 13, 15 and 17).
3 huwa maħsub biex jgħinek tipprepara t- 3 injezzjonijiet li jmiss (ġranet 13, 15 u 17).
0.75 ml for the injections at day 13, 15 and 17 of therapy.
0. 75 ml għall- injezzjonijiet fi ġranet 13, 15 u 17 ta ’ terapija.
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING
74 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA
CARTON OF 1 TRIPLE PACK (3 VIALS/ 3 PFS) AS AN INTERMEDIATE PACK OF A TITRATION PACK OF 4 TRIPLE PACKS – TREATMENT DAYS 19, 21, 23
KARTUNA TA ’ PAKKETT TRIPLU (3 KUNJETTI/ 3 SIRINGI MIMLIJA GĦAL- LEST) BĦALA PAKKETT INTERMEDJU TA ’ PAKKETT TA ’ TITRAZZJONI TA ’ 4 PAKKETTI TRIPLI – ĠRANET TA ’ KURA 19, 21, 23
Triple pack 4 4th dosage step (1.0 ml) for treatment days 19, 21, 23
4 Ir- raba ’ pass tad- dożaġġ (1. 0 ml) għall- ġranet ta ’ kura 19, 21, 23
72 8.
75 8.
Triple pack 4 is designed to help you prepare the next 3 injections (days 19, 21 and 23).
4 huwa maħsub biex jgħinek tipprepara t- 3 injezzjonijiet li jmiss (ġranet 19, 21 u 23).
Then draw up solution as far as the 1.0 ml mark on the syringe:
Wara iġbed soluzzjoni sal- marka 1. 0 ml fuq is- siringa:
1.0 ml for the injections at day 19, 21 and 23 of therapy.
1. 0 ml għall- injezzjonijiet fi ġranet 19, 21 u 23 ta ’ terapija).
73 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS (SOLVENT / BLISTER OF PRE-FILLED SYRINGE)
77 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI (SOLVENT / FOLJA TAS- SIRINGA MIMLIJA GĦAL- LEST)
Solvent for reconstitution of Betaferon 1.2 ml sodium chloride solution 5.4 mg/ ml
Solvent għar- rikostituzzjoni ta ’ Betaferon 1. 2 ml ta ’ soluzzjoni ta ’ sodium chloride ta ’ 5. 4mg/ ml
EXPIRY DATE
OĦRAJN
OTHER
1. 2 ml
Read the package leaflet before use.
OĦRAJN
74 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (SOLVENT / PREFILLED SYRINGE)
79 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN (KUNJETTI TA ’ BETAFERON (KUNJETTI / PFS))
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
ISEM TAL- PRODOTT MEDIĊINALI U MNEJN GĦANDU JINGĦATA
Solvent for reconstitution of Betaferon 1.2 ml sodium chloride solution 5.4 mg/ ml
Betaferon 250 mikrogramma/ ml, Trab għal soluzzjoni għall- injezzjoni Interferon beta- 1b Użu minn taħt il- ġilda
METHOD OF ADMINISTRATION
METODU TA ’ KIF GĦANDU JINGĦATA
1.2 ml
250 mcg (8 MIO IU) kull ml wara r- rikostituzzjoni
6.
80 B.
OTHER
FULJETT TA ’ TAGĦRIF
75 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS (VIALs BETAFERON (VIALs / PFS))
81 FULJETT TA ’ TAGĦRIF:
NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU
Betaferon 250 microgram/ ml, Powder for solution for injection Interferon beta-1b Subcutaneous use
Betaferon 250 mikrogramma/ ml, Trab u solvent għal soluzzjoni għall- injezzjoni Interferon beta- 1b
METHOD OF ADMINISTRATION
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina.
EXPIRY DATE
- Żomm dan il- fuljett.
EXP {MM/ YYYY}
Tista ’ tagħmlilhom
After reconst. immediate use recommended.
X’ inhu Betaferon u għalxiex jintuża 2.
In-use stability demonstrated for 3 hours at 2-8 °C.
Qabel ma tuża Betaferon 3.
BATCH NUMBER
Kif għandek tuża Betaferon 4.
CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT
Effetti sekondarji li jista ’ jkollu 5.
250 mcg (8 MIO IU) per ml after reconstitution
Aktar tagħrif Anness – proċedura ta ’ kif tinjetta lilek innifsek
PACKAGE LEAFLET
X’ inhu Betaferon u għalxiex jintuża
77 PACKAGE LEAFLET:
X’ inhu Betaferon
Betaferon 250 microgram/ ml, Powder and solvent for solution for injection Interferon beta-1b
Betaferon huwa tip ta ’ mediċina magħrufa bħala interferon użata għal- kura ta ’ sklerożi multipla.
Read all of this leaflet carefully before you start using this medicine.
Kif jaħdem Betaferon
- Keep this leaflet.
Dan huwa msejjaħ demyelination.
You may need to read it again.
Il- kawża eżatta ta ’ MS mhux magħrufa.
- If you have any further questions, ask your doctor or pharmacist.
Il- ħsara lis- CNS tista ’ sseħħ f’ attakk tal- MS (rikaduta).
- This medicine has been prescribed for you.
Tista ’ tikkawża diżabilità temporanja bħal diffikultà fil- mixi.
Do not pass it on to others.
Is- sintomi jistgħu jgħaddu għal kollox jew parzjalment.
It may harm them, even
Interferon beta- 1b intwera li jimmodifika r- rispons tas- sistema immuni u jgħin inaqqas l- attività tal - marda.
if their symptoms are the same as yours.
Kif Betaferon jgħin jiġġieled il- marda tiegħek:
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet,
Avveniment kliniku wieħed li jindika riskju għoli ta ’ żvilupp ta ’ sklerożi multipla:
please tell your doctor or pharmacist.
Intwera li Betaferon jittardja l- progressjoni għal sklerożi multipla definita.
In this leaflet:
Sklerożi multipla li tirkadi u tbatti:
What Betaferon is and what it is used for 2.
82 Sklerożi multipla progressiva sekondarja:
How to use Betaferon 4.
F’ xi każijiet, persuni b’ MS li tirkadi u tbatti jsibu li s - sintomi tagħhom jiżdiedu u javvanzaw għal forma oħra ta ’ MS imsejħa MS progressiva sekondarja.
How to store Betaferon 6.
B’ din, il- persuni jsibu ruħhom li qegħdin isiru dejjem iktar indeboliti, kemm jekk ikollhom rikaduti kif ukoll jekk le.
Further information Annex – self injection procedure
Betaferon jista ’ jnaqqas in- numru u s- severità ta ’ l- attakki, u jittardja l- progressjoni tad - diżabilità.
What Betaferon is and what it is used for
Għalxiex jintuża Betaferon:
What Betaferon is
Betaferon huwa għall- użu f’ pazjenti
Betaferon is a type of medicine known as interferon used to treat multiple sclerosis.
► li għall- ewwel darba kellhom sintomi li jindikaw riskju għoli ta ’ żvilupp ta ’ sklerożi multipla.
Interferons are proteins produced by the body that help it fight against attacks on the immune system such as viral infections.
It- tabib tiegħek se jelimina kull raġuni oħra li tista ’ tispjega dawk is- sintomi qabel ma tiġi kkurat/ a.
How Betaferon works
► li jbatu minn sklerożi multipla li tirkadi u tbatti, li kellhom ta ’ l- inqas żewġ rikaduti fl - aħħar sentejn.
Mutiple sclerosis (MS) is a long-term condition that affects the central nervous system (CNS), particularly the functioning of the brain and spinal cord.
► li jbatu minn sklerożi multipla progressiva sekondarja, bil- marda attiva li tintwera permezz tar- rikaduti.
Symptoms may disappear completely or partly.
Qabel ma tuża Betaferon
How Betaferon helps fight your disease:
Tużax Betaferon:
Betaferon has been shown to delay progression to definite multiple sclerosis.
M’ għandekx tibda kura b’ Betaferon (ara ‘ Tqala ’).
People with relapsing-remitting MS have occasional attacks or relapses during which symptoms become noticeably worse.
jekk int allerġiku/ a (tbati minn sensittività eċċessiva) għal interferon beta naturali jew
Betaferon has been shown to cut down the number of attacks and make them less severe.
rikombinanti, għall- albumina umana jew xi sustanzi oħra ta ’ Betaferon.
It reduces the number of hospital stays due to the disease and prolongs the time without relapses.
- jekk attwalment tbati minn depressjoni severa u/ jew ħsibijiet ta ’ suwiċidju (ara ‘ Oqgħod
78 Secondary progressive multiple sclerosis:
attent ’ u 4. ‘ Effetti sekondarji li jista ’ jkollu ’).
In some cases people with relapsing-remitting MS find that their symptoms increase and they progress to another form of MS called secondary progressive MS.
- jekk għandek marda severa tal- fwied (ara ‘ Oqgħod attent ’, ‘ Meta tuża mediċini oħra ’ u 4.
With this, people find themselves becoming increasingly impaired, whether or not they have relapses.
‘ Effetti sekondarji li jista ’ jkollu ’).
Betaferon can reduce the number and severity of the attacks, and slow the progression of disability.
Għid lit- tabib tiegħek jekk xi wieħed mill- kundizzjonijiet elenkati fuq japplika għalik.
What Betaferon is used for:
Oqgħod attent ħafna b’ Betaferon:
Betaferon is for use in patients
It- tabib tiegħek jeħtieġ li jkun jaf ukoll dan li ġej qabel tingħata Betaferon:
► who have experienced symptoms for the first time which indicate a high risk of developing multiple sclerosis.
Jekk għandek gammopatija monoklonali.
Your doctor will rule out any other reasons which could explain these symptoms before you are treated.
Din hija disturb tas- sistema immuni fejn ikun
► who suffer from relapsing-remitting multiple sclerosis, with at least two relapses within the last two years.
Dan jista ’ jwassal għal xokk (kollass) u jista ’ anki jkun fatali.
► who suffer from secondary progressive multiple sclerosis with active disease shown by relapses.
It- tabib
Do not use Betaferon:
tiegħek se jissorveljak mill- qrib matul il- kura tiegħek.
- if you are pregnant.
- Jekk qatt kellek aċċessjonijiet jew jekk qed tieħu mediċini għall- kura ta ’ l- epilessija (anti -
You should not start treatment with Betaferon (see ‘ Pregnancy’).
epilettiċi) (ara wkoll ‘ Meta tuża mediċini oħra ’ u 4. ‘ Effetti sekondarji li jista ’ jkollu ’), it- tabib tiegħek se jissorvelja l- kura tiegħek b’ attenzjoni.
- if you are allergic (hypersensitive) to natural or recombinant interferon beta, human albumin or
- Jekk għandek problemi severi tal- kliewi t- tabib tiegħek jista ’ jissorvelja l- funzjoni tal- kliewi
any of the other ingredients of Betaferon.
tiegħek matul il- kura.
- if you currently suffer from severe depression and/ or suicidal thoughts (see ‘ Take special
► Għid lit- tabib tiegħek jekk xi wieħed minn dawn japplika għalik.
care ’ and 4. ‘ Possible side effects’).
83 It- tabib tiegħek jeħtieġ li jkun jaf ukoll dan li ġej waqt li tkun qed tuża Betaferon:
- if you have a severe liver diesease (see ‘ Take special care’, ‘ Using other medicines’ and
- Jekk ikollok sintomi bħal ħakk ma ’ ġismek kollu, nefħa fil- wiċċ u/ jew fl- ilsien jew qtugħ
4. ‘ Possible side effects’).
ta ’ nifs f’ daqqa.
►
- Jekk tħossok ferm aktar imdejjaq/ imdejqa jew bla ħeġġa minn qabel ma bdejt il- kura
Tell your doctor if any of the above applies to you.
b’ Betaferon, jew jekk tiżviluppa ħsibijiet ta ’ suwiċidju.
Take special care with Betaferon:
Jista ’ jkun ukoll li t- tabib jiddeċiedi li jwaqqaf il- kura tiegħek.
Your doctor also needs to know the following before you are given Betaferon:
- Jekk tinnota xi tbenġil mhux normali, ħruġ ta ’ demm eċċessiv wara korriment jew jekk
− If you have monoclonal gammopathy.
tara li qed tieħu ħafna infezzjonijiet.
This is a disorder of the immune system where an abnormal protein is found in the blood.
Dawn jistgħu jkunu sintomi ta ’ tnaqqis fl- għadd ta ’ ċelluli tad- demm jew fin- numru ta ’ plejtlits fid- demm tiegħek (ċelluli li jgħinu lid- demm jagħqad).
Problems with your small blood vessels (capillaries) may develop when using medicines like Betaferon (systemic capillary leak syndrome).
Jista ’ jkollok bżonn ta ’ sorveljanza addizzjonali mit- tabib tiegħek.
This can lead to shock (collapse) and even be fatal.
- Jekk ikollok nuqqas t’ aptit, għeja, tħossok ma tiflaħx (dardir), rimettar ripetut, b’ mod
− If you have had depression or are depressed or previously had thoughts of suicide.
speċjali jekk ikollok ħakk ma ’ ġismek kollu, jekk il- ġilda tiegħek tisfar, jew jekk l- abjad t’ għajnejk jisfar jew jekk titbenġel malajr.
Your doctor will closely monitor you during treatment.
Dawn is- sintomi jistgħu jissuġġerixxu problemi bil- fwied tiegħek.
If you r depression and/or suicidal thoughts are severe, you will not be prescribed Betaferon (see also ‘Do not use Betaferon’).
Seħħ tibdil fir- riżultati tal- funzjoni tal- fwied f’ pazjenti kkurati b’ Betaferon waqt studji kliniċi.
− If you have ever had seizures or if you are taking medicines to treat epilepsy (anti- epileptics) (see also ‘Using other medicines’ and 4. ‘Possible side effects’) your doctor will monitor your treatment carefully.
L- aktar każijiet serji kienu rrapportati f’ pazjenti li kienu qegħdin jieħdu mediċini oħra jew li kienu qegħdin isofru minn mard li jista ’ jaffettwa l- fwied (e. ż. abbuż bl- alkoħol, infezzjoni qawwija).
− If you have severe kidney problems your doctor may monitor your kidney function during treatment.
- Jekk ikollok sintomi bħal taħbit tal- qalb mhux regolari, nefħa bħal fl- għekiesi jew fir -
► Tell your doctor if any of these applies to you.
riġlejn, jew qtugħ ta ’ nifs.
79 Your doctor also needs to know the following whilst you are using Betaferon:
- Jekk tinnota uġigħ f’ żaqqek li jinfirex għal dahrek, u/ jew tħossok ma tiflaħx jew ikollok id -
− If you experience symptoms such as itching all over your body, swelling of your face and/or your tongue or sudden shortness of breath.
Dan jista ’ jissuġġerixxi li għandek infjammazzjoni tal- frixa (pankreatite), li kienet irrapportata bl- użu ta ’ Betaferon.
These may be symptoms of a serious allergic reaction (hypersensitivity), which may become life threatening.
Ta ’ spiss, din hija assoċjata ma żjieda f’ ċertu xaħmijiet fid - demm (trigliċeridi).
− If you feel noticeably more sad or hopeless than before the treatment with Betaferon, or if you develop thoughts of suicide.
► Waqqaf l- użu ta ’ Betaferon u għid lit- tabib tiegħek minnufih jekk ikollok xi wieħed minn dawn is- sintomi.
If you suffer from severe depression and/or suicidal thoughts, you will not be treated with Betaferon (see also ‘Do not use Betaferon’).
Affarijiet oħra li għandek tqis meta tuża Betaferon:
− If you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections.
- Se jkollok bżonn ta ’ testijiet tad- demm biex jiġu mkejla n- numru ta ’ ċelluli tad- demm tiegħek,
These symptoms may suggest problems with your liver.
il- kimika tad- demm u l- enzimi tal- fwied tiegħek.
Changes to the liver function values occurred in patients treated with Betaferon during clinical studies.
Dan se jseħħ qabel ma tibda tuża Betaferon, regolarment wara li tkun bdiet il- kura b’ Betaferon u perjodikament waqt li tkun qed tieħu din il- mediċina, anki jekk ma jkollok l- ebda sintomi partikolari.
As for other beta interferons, severe liver damage, including cases of liver failure, have been reported rarely in patients taking Betaferon.
Dawn it- testijiet tad- demm isiru flimkien ma ’ testijiet li normalment isiru biex jissorveljaw l- MS tiegħek.
− If you experience symptoms like irregular heart beat, swelling such as of the ankles or legs, or shortness of breath.
- Jekk għandek marda tal- qalb, is- sintomi simili għal dawk ta ’ l- influwenza, li spiss iseħħu
− If you notice pain in your belly which is radiating to your back, and/or you feel sick or have a fever.
fil- bidu tal- kura, jistgħu jkunu ta ’ stress għalik.
This may suggest an inflammation of the pancreas (pancreatit is), which has been reported with Betaferon use.
Betaferon għandu jintuża b’ attenzjoni u t - tabib tiegħek se jissorveljak biex jara jekk il- kundizzjoni ta ’ qalbek hux qed tiggrava, b’ mod partikolari matul il- bidu tal- kura.
This is often associated with an increase of certain blood fats (triglycerides).
Betaferon innifsu ma jaffettwax il- qalb direttament.
► Stop using Betaferon and tell your doctor immediately if any of these happens to you.
- Se jkollok tittestja l- funzjoni tal- glandola tat- tirojde tiegħek, b’ mod regolari jew kull meta t -
Other things to consider when using Betaferon:
tabib tiegħek jaħseb li jkun hemm bżonn għal raġunijiet oħra.
− You will need blood tests to measure the number of your blood cells, blood chemistry and your liver enzymes.
84
Betaferon itself does not affect the heart directly.
- Betaferon fih albumina umana u għalhekk għandu riskju potenzjali għal trasmissjoni ta ’
− You will have a check of the function of your thyroid gland, regularly or whenever thought necessary by your doctor for other reasons.
Ir- riskju ta ’ trasmissjoni tal- marda Creutzfeld- Jacob (CJD) ma jistax jiġi eliminat.
− Betaferon contains human albumin and therefore carries a potential risk for transmission of viral diseases.
- Matul il- kura b’ Betaferon, ġismek jista ’ jipproduċi sustanzi msejħa antikorpi
80 − During treatment with Betaferon your body may produce substances which are called neutralising antibodies, which may react with Betaferon (neutralising activity).
newtralizzanti, li jistgħu jagħmlu reazzjoni ma ’ Betaferon (attività newtralizzanti).
It is not yet clear whether these neutralising antibodies reduce the effectiveness of the treatment.
Għadu mhux ċar jekk dawn l- antikorpi newtralizzanti jnaqqsux l- effettività tal- kura.
Neutralising antibodies are not produced in all patients.
Antikorpi newtralizzanti mhumiex prodotti fil- pazjenti kollha.
Currently it is not possible to predict which patients belong to this group.
Fil- preżent mhux possibbli li wieħed ibassar liema pazjenti jappartjenu għal dan il- grupp.
Injection site reactions:
Reazzjonijiet fil- lok ta ’ l- injezzjoni:
During Betaferon treatment you are likely to experience injection site reactions.
Matul il- kura b’ Betaferon, x’ aktarx li se jkollok reazzjonijiet fil- lok ta ’ l- injezzjoni.
Symptoms include redness, swelling, change in the skin color, inflammation, pain, and hypersensitivity.
Is- sintomi jinkludu ħmura, nefħa, bidla fil- kulur tal- ġilda, infjammazzjoni, uġigħ u sensittività eċċessiva.
Dead skin and tissue around the injection site (necrosis) are reported less frequently.
Ġilda u tessut mejjet madwar il- lok ta ’ l- injezzjoni (nekrożi) huma rrapportati b’ mod inqas frekwenti.
Injection site reactions usually become less frequent over time.
Maż - żmien, ir- reazzjonijiet fil- lok ta ’ l- injezzjoni normalment isiru inqas frekwenti.
Injection site skin and tissue breakdown can result in scars forming.
Ħsara fil- ġilda mnejn tingħata l- injezzjoni u therrija tat- tessuti jistgħu jwasslu għall- formazzjoni ta ’ ċikatriċi.
If this is severe a doctor may have to remove foreign matter and dead tissue (debridement) and, less often, skin grafting is required and healing may take up to 6 months.
Jekk din tkun severa, jista ’ jkun hemm bżonn li tabib ineħħi t- tessut mejjet (debridement), u f’ każijiet inqas komuni, jista ’ jkun meħtieġ li jsir trapjant ta ’ ġilda ġdida, u f’ dan il- każ, il- fejqan jista ’ jieħu sa ’ 6 xhur.
To reduce the risk of getting injection site reaction you must: − use a sterile (aseptic) injection technique, − rotate the injection sites with each injection (see Annex ‘Self- Injection procedure’).
Biex tnaqqas ir- riskju ta ’ reazzjoni fil- lok ta ’ l- injezzjoni, inti għandek: – tuża teknika ta ’ injezzjoni sterili (asettika) – tuża postijiet ta ’ injezzjoni differenti għal kull injezzjoni (ara Anness ‘ Proċedura ta ’ kif Tinjetta Lilek Innifsek ’)
Injection site reactions may occur less frequently, if you use an auto-injector device.
Ir- reazzjonijiet fil- lok ta ’ l- injezzjoni jistgħu jseħħu inqas ta ’ spiss, jekk tuża awto- injettatur.
Your doctor can tell you more about this.
It- tabib tiegħek jista ’ jgħidlek aktar dwar dan.
If you experience any break in the skin, which may be associated with swelling or fluid leaking out from the injection site:
Jekk ikollok xi qsim fil- ġilda, li jista ’ jkun assoċjat ma ’ nefħa jew ma ’ tnixxija ta ’ fluwidu mil- lok ta ’ l- injezzjoni:
► Stop injections with Betaferon and talk to your doctor.
► Waqqaf l- injezzjonijiet b’ Betaferon u kellem lit- tabib tiegħek.
► If you have only one sore injection site (lesion) and the tissue damage (necrosis) is not too extensive you may continue using Betaferon.
► Jekk għandek post ta ’ l- injezzjoni wieħed biss li huwa sensibbli (leżjoni) u l- ħsara fit - tessut (nekrożi) m’ hijiex mifruxa żżejjed, tista ’ tkompli tuża Betaferon.
► If you have more than one sore injection site (multiple lesions) you must stop using Betaferon until your skin has healed.
► Jekk għandek aktar minn post wieħed ta ’ l- injezzjoni li huwa sensibbli (leżjonijiet multipli) għandek tieqaf tuża Betaferon sakemm il- ġilda tiegħek tkun fieqet.
Your doctor will regularly check the way you inject yourself, particularly if you have experienced injection site reactions.
It- tabib tiegħek se jiċċekkja regolarment il- mod kif inti tinjetta lilek innifsek, b’ mod partikolari jekk inti kellek reazzjonijiet fil- lok ta ’ l- injezzjoni.
Using other medicines:
Meta tuża mediċini oħra:
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 qiegħed tieħu jew jekk dan l- aħħar ħadt xi mediċini oħra, anki dawk mingħajr riċetta.
No formal interaction studies have been carried out to find out whether Betaferon affects other medicines or is affected by them.
Ma sar l- ebda studju formali dwar l- interazzjonijiet sabiex wieħed isir jaf jekk Betaferon jaffettwax mediċini oħra jew jekk jiġix affettwat minnhom.
Using Betaferon with other medicines that modify the immune system response is not recommended, except anti-inflammatory medicines called corticosteroids or the adrenocorticotropic hormone (ACTH).
L- użu ta ’ Betaferon ma ’ mediċini oħra li jimmodifikaw ir- rispons tas- sistema immuni mhux irrakkomandat għajr fil- każ ta ’ mediċini anti- infjammatorji msejħa kortikosterojdi jew l- ormon adrenokortikotropiku (ACTH).
Betaferon should be used with caution with:
Betaferon għandu jintuża b’ kawtela ma ’:
- medicines which need a certain liver enzyme system (known as cytochrome P450 system) for
- mediċini li jeħtieġu ċertu sistema ta ’ enzimi tal- fwied (magħrufa bħala s- sistema taċ -
their removal from the body, for example drugs used to treat epilepsy (like phenytoin).
ċitokromju P450) għat- tneħħija tagħhom mill- ġisem, eżempju, mediċini wżati fil- kura ta ’ l - epilessija (bħal phenytoin)
- medicines which affect the production of blood cells.
- mediċini li jaffettwaw il- produzzjoni taċ- ċelluli tad- demm.
81 Using Betaferon with food and drink:
Meta tuża Betaferon ma ’ l- ikel u max- xorb:
Betaferon is injected under the skin so any food or drink you consume is not thought to have any effect on Betaferon.
Betaferon jingħata bħala injezzjoni minn taħt il- ġilda, għalhekk ikel jew xorb li tieħu mhux maħsub li jkollu xi effett fuq Betaferon.
Children and adolescents:
Tfal u adoloxxenti:
There have been no formal clinical trials undertaken in children or adolescents.
Ma saru l- ebda provi kliniċi formali fit- tfal jew fl- adoloxxenti.
However, there is some data available in children and adolescents from 12 to 16 years.
Madankollu, hemm disponibbli xi tagħrif fi tfal u adoloxxenti minn 12 sa 16- il sena.
This data suggests that the safety profile from this age is the same as in adults for use of Betaferon 8 million IU under the skin (subcutaneously) every other day.
Dan it- tagħrif jissuġġerixxi li l- profil ta ’ sigurtà minn din l- età hu l- istess bħala dak fl- adulti għall- użu ta ’ Betaferon 8 miljun IU minn taħt il- ġilda kull jumejn.
Betaferon should not be used in children under 12 years of age as there is no information on this use.
Betaferon m’ għandux jintuża fi tfal taħt 12- il sena għax m’ hemm l- ebda informazzjoni dwar dan l- użu.
Pregnancy:
Tqala:
If you could get pregnant, use contraception while you are on Betaferon.
Jekk tista ’ toħroġ tqila, uża miżuri ta ’ kontraċezzjoni xierqa waqt li tkun qed tieħu Betaferon.
►
Terapija b’ Betaferon m’ għandhiex tinbeda jekk inti tqila (ara wkoll ‘ Tużax Betaferon ’).
Betaferon therapy should not be started if you are pregnant (see also ‘Do not use Betaferon’).
► Jekk tixtieq toħroġ tqila, iddiskuti dan mat- tabib tiegħek l- ewwel.
►
It- tabib tiegħek ser jiddeċiedi flimkien miegħek, jekk il - kura ta ’ Betaferon għandhiex tissokta jew le.
If you wish to become pregnant, discuss this with your doctor first.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
►
Treddigħ:
If you become pregnant while using Betaferon, stop your treatment and contact your doctor immediately.
Mhux magħruf jekk Interferon beta- 1b jiġix jgħaddix fil- ħalib tas- sider uman.
Your doctor will decide together with you, if your Betaferon treatment will be continued or not.
Madankollu, huwa teoretikament possibbli li trabi mredda ’ mis- sider jista ’ jkollhom effetti sekondarji serji għal Betaferon. ► L- ewwel iddiskuti dan mat- tabib tiegħek biex tieħu deċiżjoni dwar jekk għandekx twaqqaf it- treddigħ jew għandekx twaqqaf Betaferon.
Ask your doctor or pharmacist for advice before taking any medicine.
Itlob il- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
Breast-feeding:
Sewqan u tħaddim ta ’ magni
It is not known whether Interferon beta-1b passes into human breast milk.
Betaferon jista ’ jikkawża effetti sekondarji fis- sistema nervuża ċentrali (ara sezzjoni 4.
However, it is theoretically possible that a breast-fed baby could experience serious side effects to Betaferon. ► Discuss it with your doctor first to decide whether to stop breast-feeding or to stop using Betaferon.
Jekk inti sensittiv/ a żżejjed, dan jista ’ jaffettwa l- ħila tiegħek li ssuq jew tħaddem magni.
Ask your doctor or pharmacist for advice before taking any medicine.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Betaferon
Driving or using machines:
Kif għandek tuża Betaferon
Betaferon may cause side effects in the central-nervous system (see section 4. ‘Possible side effects’).
Il- kura b’ Betaferon għandha tinbeda taħt is- superviżjoni ta ’ tabib li għandu esperjenza fil- kura ta ’ l - isklerożi multipla.
If you are especially sensitive, this might influence your ability to drive or use machines.
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
Important information about some of the ingredients of Betaferon:
Id- doża li ssoltu tingħata hija:
The inactive ingredients of Betaferon include small amounts of mannitol, a naturally occurring sugar and human albumin, a protein.
Ġurnata iva u ġurnata le (darba kull jumejn), 1. 0 ml ta ’ soluzzjoni ppreparata ta ’ Betaferon (ara Anness) injettata minn taħt il- ġilda.
If you know that you are allergic (hypersensitive) to any of the ingredients or if you become so, you must not use Betaferon.
Id- dożi tiegħek imbagħad ser jiżdiedu gradwalment sad- doża sħiħa ta ’ 1. 0 ml (250 mikrogramma).
How to use Betaferon
Preparazzjoni ta ’ l- injezzjoni:
Treatment with Betaferon should be started under the supervision of a doctor who is experienced in the treatment of multiple sclerosis.
Dan għandu jsir mit - tabib jew mill- assistent/ a tiegħu jew minnek wara li tkun ġejt imħarreġ biżżejjed.
Always use Betaferon exactly as your doctor has instructed you.
Dawn l- istruzzjonijiet ifehmuk ukoll kif tipprepara s- soluzzjoni għall- injezzjoni ta ’ Betaferon.
You should check with your doctor or pharmacist if you are unsure.
Il- post fil- ġisem fejn tingħata l- injezzjoni għandu jinbidel b’ mod regolari.
82 Dose:
It- tul tal- kura għandu jiġi deċiż mit- tabib tiegħek flimkien miegħek.
The usual dose is:
Jekk tieħu Betaferon aktar milli suppost:
Every other day (once every two days), 1.0 ml of the prepared Betaferon solution (see Annex) injected under the skin (subcutaneously).
Meta ngħatat doża ħafna ikbar mid- doża ta ’ Betaferon irrakkomandata għall- kura ta ’ sklerożi multipla, ma kienx hemm sitwazzjonijiet fejn il- ħajja tpoġġiet fil- periklu.
This equals 250 microgram (8 million IU) Interferon beta-1b.
► Kellem lit- tabib tiegħek f’ każ li tinjetta wisq Betaferon jew jekk tinjetta ta ’ spiss wisq.
In general, treatment should be started at a low dose of 0.25 ml (62.5 micrograms).
M’ għandekx tinjetta doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Your doses will then be increased gradually to the full dose of 1.0 ml (250 micrograms).
Jekk tieqaf jew tixtieq twaqqaf il- kura, għandek tiddiskuti dan mat- tabib tiegħek.
The dose should be increased at every fourth injection in four steps (0.25 ml, 0.5 ml, 0.75 ml, 1.0 ml).
Il- waqfien ta ’ Betaferon mhux magħruf li jikkawża sintomi akuti ta ’ rtirar meta tieqaf tieħdu.
Your doctor may decide together with you to change the time intervals for dose increase depending on side effects you may experience at the start of treatment.
87 ► Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Preparing the injection:
Effetti sekondarji li jista ’ jkollu
Before injection, the Betaferon solution has to be prepared from a vial of Betaferon powder and 1.2 ml of liquid from the pre-filled solvent syringe.
Bħal kull mediċina oħra, Betaferon jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
This will either be done by your doctor or his/her assistant or by yourself after you have been carefully trained.
Fil- bidu tal- kura, l- effetti sekondarji huma komuni iżdaa ġeneralment dawn ibattu matul il- kura.
Detailed instructions for self-injection of Betaferon under the skin are provided in the Annex at the back of this leaflet.
► Sintomi li jixbħu lil dawk ta ’ l- influwenza bħal deni, tkexkix ta ’ bard, uġigħ fil- ġogi, telqa, għaraq, uġigħ ta ’ ras jew uġigħ fil- muskoli.
The se instructions also tell you how to prepare the Betaferon solution for injection.
Dawn is- sintomi jistgħu jitnaqqsu billi tieħu paracetamol jew mediċini anti- infjammatorji mhux sterojdi bħal ibuprofen.
The injection site must be changed regularly.
► Reazzjonijiet fil- lok ta ’ l- injezzjoni.
See ’Take special care with Betaferon’ and follow the instructions under ’Rotating injection sites’ in the Annex at the back of this leaflet.
Ara ‘ Oqgħod attent ħafna ’ f’ sezzjoni 2 għal aktar informazzjoni u x’ għandek tagħmel, jekk ikollok reazzjoni fil- lok ta ’ l- injezzjoni.
At present it is not known how long treatment with Betaferon should last.
Dawn jistgħu jitnaqqsu bl- użu ta ’ awto- injettatur.
The length of treatment will be decided by your doctor together with you.
Jekk jogħġbok kellem lit- tabib tiegħek għal aktar tagħrif.
If you use more Betaferon than you should:
Biex tnaqqas l- effetti sekondarji fil- bidu tal- kura, it- tabib tiegħek għandu jibdik fuq doża baxxa ta ’ Betaferon u għandu jżidha gradwalment (ara sezzjoni 3. ‘ Kif għandek tuża Betaferon ’).
Giving many times the dose of Betaferon recommended for the treatment of multiple sclerosis has not led to life-threatening situations.
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 jew lill- ispiżjar tiegħek.
Talk to your doctor if you inject too much Betaferon or injected too often.
Għid lit- tabib tiegħek minnufih u waqqaf l- użu ta ’ Betaferon:
If you forget to use Betaferon:
− jekk ikollok sintomi bħal ħakk ma ġismek kollu, nefħa fil- wiċċ u/ jew fl- ilsien jew qtugħ ta ’ nifs f’ daqqa.