qanastek/EMEA-V3 huggingface dataset:
Store the cartridge in the original package in order to protect from light.
Aħżen l- iskartoċċ fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
The RebiSmart autoinjector device containing a pre-filled cartridge of Rebif must be stored in the device storage box in a refrigerator (2°C – 8°C).
L- apparat awtoinjettatur RebiSmart li fih skartoċċ mimli għal- lest ta ’ Rebif għandu jinħażen fil- kaxxa tal- ħżin tal- apparat fi friġġ (2°C – 8°C).
Cartridges (type 1 glass) with a plunger stopper (rubber) and crimp cap (aluminium and halobutyl rubber) containing 1.5 ml solution for injection.
Skrataċ (ħġieġ ta ’ tip I), b’ tapp bi planġer (lastku) u b’ għatu li jissiġilla (aluminju u lastku halobutyl) li fihom soluzzjoni għall- injezzjoni ta ’ 1. 5 ml.
Pack size of 4 cartridges.
Daqs tal- pakkett ta ’ 4 skrataċ.
The solution for injection in a pre-filled cartridge is ready for use with the RebiSmart autoinjector device.
Is- soluzzjoni għall- injezzjoni fi skartoċċ mimli għal- lest hija lesta għall- użu bl- apparat awtoinjettatur RebiSmart.
For storage of the autoinjector device with the cartridge, see section 6.4.
Għall- ħżin tal- apparat awtoinjettatur bl- iskartoċċ, ara sezzjoni 6. 4.
For multidose use.
Għall- użu multiplu.
Rebif 44 micrograms/ 0.5ml solution for injection in cartridge
Rebif 44 mikrogrammi/ 0. 5 ml soluzzjoni għall- injezzjoni fi skartoċċ
Each pre-filled cartridge contains132 micrograms (36 MIU*) of interferon beta-1a** in 1.5 ml solution, corresponding to 88 micrograms/ ml.
Kull skartoċċ mimli għal- lest fih 132 mikrogrammi( 36 MIU *) ta ’ interferon beta- 1a ** f’ soluzzjoni ta ’ 1. 5 ml, li jikkorrispondu għal 88 mikrogrammi/ ml.
7.5 mg benzyl alcohol For a full list of excipients, see section 6.1.
7. 5 mg benzyl alkohol Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
Clear to opalescent solution, with pH3.7 to 4.1 and osmolarity 250 to 450 mOsm/ l.
Soluzzjoni ċara għal opalexxenti b’ pH ta ’ 3. 7 sa 4. 1 u osmolarità ta ’ 250 sa 450 mOsm/ l.
Method of administration Rebif solution for injection in cartridge is intended for multidose use and should only be used with the RebiSmart autoinjector device following adequate training of the patient and/ or carer.
Kif Jingħata Rebif soluzzjoni għall- injezzjoni fi skartoċċ b’ ħafna dożi hija intenzjonata għall- użu biss mal- apparat awtoinjettatur ta ’ RebiSmart wara taħriġ adegwat tal- pazjent u/ jew min ikun jieħu ħsiebu.
For administration, the instructions provided in the package leaflet and in the instruction manual provided with the RebiSmart autoinjector device should be followed.
Għall- għoti, segwi l- istruzzjonijiet li hemm fil- fuljett ta ’ tagħrif u fil- manwal ta ’ istruzzjonijiet li jiġi pprovdut mal- apparat awtoinjettatur ta ’ RebiSmart għandhom jiġu segwiti.
Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with Rebif administration.
38 Qabel l- injezzjoni u għal 24- il siegħa wara kull injezzjoni, huwa rakkomandat li jingħata analġesiku li huwa ukoll kontra d- deni sabiex jitnaqqsu is- sintomi li jixbħu l- influenza li huma assoċjati ma ’ l - amministrazzjoni ta ’ Rebif.
35 At the present time, it is not known for how long patients should be treated.
S’ issa għadu mhux magħruf għal kemm tul ta ’ żmien il- pazjenti għandhom ikunu ikkurati.
If the patient experiences any break in the skin, which may be associated with swelling or drainage of fluid from the injection site, the patient should be advised to consult with their physician before continuing injections with Rebif.
39 Jekk fil- pazjent jidher xi qsim fil- ġilda, li jista ’ jkun assoċjat ma ’ nefħa jew telf ta ’ likwidu mis- sit ta ’ l- injezzjoni, il- pazjent għandu jkun mgħarraf sabiex jikkonsulta mat- tabib qabel ikompli l - injezzjonijiet b’ Rebif.
36 In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
Fi provi kliniċi b’ Rebif, elevazzjonijiet mingħajr sintomi ta ’ transminases epatika (b’ mod partikolari ALT) kienu komuni u bejn 1 u 3% tal- pazjenti żviluppaw elevazzjoni ta ’ transminases epatika aktar minn 5 darbiet l- għola limitu normali (ULN- upper limit of normal).
Rebif has not yet been investigated in patients with primary progressive multiple sclerosis and should not be used in such patients
Rebif għadu ma kienx investigat f’ pazjenti bi sklerosi multipla progressiva primarja u m’ għandux jintuża f’ dawn il- pazjenti.
No interaction studies have been performed with Iinterferon beta-1a in humans.
Ma sarux studji dwar l- effett ta ’ mediċini jew ta ’ affarijiet oħra fuq l- effett farmaċewtiku ta ’ interferon beta- 1a fil- bnedmin.
37 medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e. g. antiepileptics and some classes of antidepressants.
Għandha ssir attenzjoni meta jingħata Rebif flimkien ma ’ prodotti mediċinali oħra li għandhom indiċi terapewtiku qasir u li jiddependu ħafna fuq is- sistema hepatic cytochrome P450 sabiex jitnaddfu eż: anti- epilettiċi u xi tipi ta ’ antidipressivi.
The adverse reactions reported below are classified according to frequency of occurrence as follows:
L- effetti mhux mixtieqa li jissemmew hawn taħt huma klassifikati skond il- frekwenza ta ’ kif jidhru kif ġej:
≥ 1/ 10 ≥ 1/ 100 to < 1/ 10 ≥ 1/ 1,000 to < 1/ 100 ≥ 1/ 10,000 to < 1/ 1,000 < 1/ 10,000
≥ 1/ 10 ≥1/ 100 sa < 1/ 10 ≥1/ 1, 000 sa < 1/ 100 ≥1/ 10, 000 sa < 1/ 1, 000 < 1/ 10, 000
Cannot be estimated from the available data
Ma tistax tittieħed stima mid - dejta disponibbli
38 The data presented is obtained from pooled clinical studies in multiple sclerosis (placebo=824 patients; Rebif 22 micrograms three times per week (TIW)=398 patients; Rebif 44 micrograms TIW=727 patients) and shows the frequency of adverse reactions observed at six months (excess over placebo).
L- informazzjoni ppreżentata hi miksuba minn studji kliniċi fi sklerożi multipla (plaċebo=824 pazjienti; Rebif 22 mikrogrammi TIW=398 pazjienti; Rebif 44 mikrogrammi tlitt darbiet fil- ġimgħa (TIW) =727 pazjienti) u turi l- frekwenza ta ’ l- effetti mhux mixtieqa f’ sitt xhur (żieda fuq plaċebo).
General disorders and administration site conditions
42 Sistema tal- klassifika tal- organi
Injection site inflammation, injection site reaction, influenza-like symptoms
Komuni ħafna
Injection site pain, fatigue, rigors, fever
Komuni
Respiratory, thoracic and mediastinal disorders
Infjammazjoni fis - sit ta ’ injezzjoni, reazzjoni fis- sit ta ’ injezzjoni, sintomi b] al ta ’ l- influenza
Not known* Hepatitis with or without icterus
Qtugħ ta ’ nifs Reazzjonijiet anafilattiċi Eventi tromboemboliċi Epatite b’ ikterus jew migħajr
40 Rebif has not yet been investigated in patients with primary progressive multiple sclerosis, and should not be used in such patients.
Rebif s’ issa ma kienx studjat f’ pazjenti li jbatu minn sklerożi multipla progressiva primarja, u m’ g] andux jintuża fuq dawn il- pazjenti.
After first injection use within 28 days.
Wara l- ewwel injezzjoni uża fi żmien 28 jum
41 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
For storage of the RebiSmart autoinjector device with the cartridge, see section 6.4.
Għall- ħżin tal- apparat awtoinjettatur bl- iskartoċċ, ara sezzjoni 6. 4.
For multidose use.
Għal użu multiplu biss.
Rebif 8.8 micrograms/ 0.1 ml solution for injection in cartridge Rebif 22 micrograms/ 0.25 ml solution for injection in cartridge
Rebif 8. 8 mikrogrammi/ 0. 1 ml – soluzzjoni għall- injezzjoni fi skartoċċ Rebif 22 mikrogrammi/ 0. 25 ml – soluzzjoni għall- injezzjoni fi skartoċċ
Each pre-filled cartridge contains 132 micrograms (36 MIU*) of interferon beta-1a** in 1.5 ml solution, corresponding to 88 micrograms/ ml.
Kull skartoċċ mimli għal- lest fih 132 mikrogrammi (36 MIU *) ta ’ interferon beta- 1a ** f’ soluzzjoni ta ’ 1. 5 ml, li jikkorrispondu għal 88 mikrogrammi/ ml.
* Million International Units measured by cytopathic effect (CPE) bioassay against the in-house IFN beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531). ** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology.
* Miljun Unità Internazzjonali meqjus permezz ta ’ test tal- effett kitopatiku (EKP) mqabbel ma ’ l - istandard IFN beta- 1a li jsir fil- fabbrika li jinstab wara li jitqabbel ma ’ l- istandard kurrenti internazzjonali NIH (GB- 23- 902- 531). ** magħmulin fiċ- Ċelluli ta ’ l- ovarji tal- hamster Ċiniz (CHO- K1) li għandhom materjal ġenetiku mibdul.
7.5 mg benzyl alcohol For a full list of excipients, see section 6.1.
Għal- lista kompleta ta ’ sustanzi mhux attivi, ara sezzjoni 6. 1.
When first starting treatment with Rebif, in order to allow tachyphylaxis to develop thus reducing adverse reactions, it is recommended that 8.8 micrograms be administered by subcutaneous injection three times per week during the initial 2 weeks of therapy.
Għal pazjenti li jkunu qegħdin jibdew il- kura b’ Rebif, id- doża għandha tiżdied gradwalment sabiex tkun tista ’ tiżviluppa takifilassi u b’ hekk jitnaqqsu r- reazzjonijiet avversi, huwa rakkomandat li 8. 8mg jingħataw b’ injezzjoni taħt il- ġilda tlett darbiet fil- ġingħa waqt l- ewwel ġimgħatejn ta ’ terapija.
Thereafter, 22 micrograms be administered by subcutaneous injection three times per week in weeks 3 and 4, and the total of the 44 micrograms strength be administered from the fifth week onwards.
Wara, 22 mikrogrammi jingħataw b’ injezzjoni taħt il- ġilda tlett darbiet fil- ġimgħa f’ ġimgħat 3 u 4 u t - total ta ’ 44 mikrogrammi doża sħiħa jingħata mill- 5 ġimgħa ‘ l quddiem.
Prior to injection and for an additional 24 hours after each injection, an antipyretic analgesic is advised to decrease flu-like symptoms associated with Rebif administration.
47 Qabel l- injezzjoni u għal 24- il siegħa wara kull injezzjoni, huwa rakkomandat li jingħata analġesiku li huwa ukoll kontra d- deni sabiex jitnaqqsu is- sintomi li jixbħu l- influenza li huma assoċjati ma ’ l - amministrazzjoni ta ’ Rebif.
43 At the present time, it is not known for how long patients should be treated.
S’ issa għadu mhux magħruf għal kemm tul ta ’ żmien il- pazjenti għandhom ikunu ikkurati.
44 In clinical trials with Rebif, asymptomatic elevations of hepatic transaminases (particularly alanine aminotransferase (ALT)) were common and 1-3% of patients developed elevations of hepatic transaminases above 5 times the upper limit of normal (ULN).
Fi provi kliniċi b’ Rebif, elevazzjonijiet mingħajr sintomi ta ’ transminases epatika (b’ mod partikolari ALT) kienu komuni u bejn 1 u 3% tal- pazjenti żviluppaw elevazzjoni ta ’ transminases epatika aktar minn 5 darbiet l- għola limitu normali (ULN- upper limit of normal).
This medicinal product contains 0.5 mg benzyl alcohol per dose of 0.1 ml and 1.25 mg benzyl alcohol per dose of 0.25 ml.
Dan il- prodott mediċinali fih 0. 5 mg ta ’ benzyl alkohol f’ kull doża ta ’ 0. 1 ml u 1. 25 mg ta ’ benzyl alkohol f’ kull doża ta ’ 0. 25 ml.
4.5 Interaction with other medicinal products and other forms of interaction
49 4. 5 Prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott u affarjiet oħra li jistgħu jibdlu l- effett farmaċewtiku tal- prodott
45 medicinal products that have a narrow therapeutic index and are largely dependent on the hepatic cytochrome P450 system for clearance, e. g. antiepileptics and some classes of antidepressants.
Għandha ssir attenzjoni meta jingħata Rebif flimkien ma ’ prodotti mediċinali oħra li għandhom indiċi terapewtiku qasir u li jiddependu ħafna fuq is- sistema hepatic cytochrome P450 sabiex jitnaddfu eż: anti- epilettiċi u xi tipi ta ’ antidipressivi.
46 The data presented is obtained from pooled clinical studies in multiple sclerosis (placebo=824 patients; Rebif 22 micrograms three times per week (TIW)=398 patients; Rebif 44 micrograms TIW=727 patients) and shows the frequency of adverse reactions observed at six months (excess over placebo).
L- informazzjoni ppreżentata hi miksuba minn studji kliniċi fi sklerożi multipla (plaċebo=824 pazjienti; Rebif 22 mikrogrammi tlitt darbiet fil- ġimgħa (TIW) =398 pazjienti; Rebif 44 mikrogrammi TIW=727 pazjienti) u turi l- frekwenza ta ’ l- effetti mhux mixtieqa f’ sitt xhur (żieda fuq plaċebo).
General disorders and administration site conditions
51 Sistema tal- klassifika tal- organi
Immune system disorders
Uġigħ fis- sit ta ’ injezzjoni, għeja, tertir, deni
47 System Organ Class Vascular disorders
Nekrozi fis- sit ta ’ injezzjoni, massa fis- sit ta ’ injezzjoni
Very common
Investigazzjonijiet Disturbi respiratorji, toraċiċi u medjastinali Disturbi fis- sistema immuni Disturbi vaskulari Disturbi fil- fwied u fil - marrara
Pharmacotherapeutic group: Immunostimulants, Interferons, ATC code:
Immunostimulanti, Interferons, Kodiċi ATC:
At licensed posology, Rebif 22 micrograms has been demonstrated to decrease the incidence (approximately 30% over 2 years) and severity of clinical relapses in patients with at least 2 exacerbations in the previous 2 years and with an EDSS of 0-5.0 at entry.
F’ posoloġija liċenzjata, Rebif 22 mikrogramma instab li jnaqqas l - inċidenza (bejn wieħed u ieħor bi 30% fi żmien sentejn) u s- severità ta ’ attakki ripetuti f’ pazjienti bi
49 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
Pack size of 2 cartridges.
Daqs tal- pakkett ta ’ 2 skrataċ.
For multidose use.
Għall- użu multiplu biss.
50 ANNEX II
55 ANNESS II
MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
MANIFATTUR TAS- SUSTANZA BIJOLOĠIKA ATTIVA U DETENTUR TA ’ L - AWTORIZZAZZJONI TAL- MANIFATTURA RESPONSABBLI GĦALL - ĦRUĠ TAL - LOTT
CH-1804 Corsier-sur-Vevey Switzerland
CH- 1804 Corsier- sur- Vevey Switzerland
Via delle Magnolie 15 I-70026 Modugno (Bari) Italy
Via delle Magnolie 15 I- 70026 Modugno (Bari) L- Italja
Medicinal product subject to restricted medical prescription (See Annex I:
Prodott mediċinali jingħata b' riċetta ristretta tat- tabib (ara Anness I:
The MAH must ensure that the system of pharmacovigilance, as described in version 4.0 presented in Module 1.8.1. of the Marketing Authorisation Application, is in place and functioning before and whilst the product is on the market.
Id- detentur ta ’ l- awtorizazzjoni għat- tqegħid fis- suq jrid jiżgura li s- sistema ta ’ farmakoviġilanza, kif deskritta f’ verżjoni 4. 0, ippreżentata fil- modulu 1. 8. 1. tal- Applikazzjoni ta ’ l- Awtorizazzjoni għat - tqegħid fis- suq, tkun implimentata u taħdem qabel u waqt li l- prodott ikun fuq s- suq.
The MAH will submit PSURs on an annual basis until otherwise specified.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq (MAH) ser jagħti PSURs fuq basi annwali, sakemm jkun speċifikat mod ieħor.
52 ANNEX III
57 ANNESS III
54 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 3 AND 12 SYRINGES
59 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ 1, 3 U 12 SIRINGI
Rebif 22 micrograms solution for injection in pre-filled syringe Interferon beta-1a
Rebif 22 mikrogrammi soluzzjoni għall- injezzjoni b’ siringa mimlija għal- lest Interferon beta- 1a
Composition:
Komposizzjoni:
Each pre-filled syringe (0.5 ml) contains 22 micrograms (6 MIU) of interferon beta-1a.
Kull siringa mimlija lesta għal użu (0. 5ml) fiha 22 mikrogrammi (6 MIU) ta ’ interferon beta- 1a.
Mannitol, poloxamer 188, L-methionine, benzyl alcohol, sodium acetate, acetic acid and sodium hydroxide for pH adjustment and water for injections.
Mannitol, poloxamer 188, L- methionine, benzyl alkohol, sodium acetate, acetic acid u sodium hydroxide għal aġġustament tal- pH u ilma għall- injezzjoni.
1 pre-filled syringe.
Siringa waħda mimlija lesta għal użu.
3 pre-filled syringes.
3 siringi mimlijin lesti għal użu.
12 pre-filled syringes.
12- il siringa mimlijin lesti għal użu.
For single dose only.
Għal doża waħda biss.
New Formulation
Formulazzjoni ġdida
Store the syringe in the original package in order to protect from light.
Aħżen s- siringa fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
EU/ 1/ 98/ 063/ 001 1 pre-filled syringe.
EU/ 1/ 98/ 063/ 001 siringa mimlija lesta.
EU/ 1/ 98/ 063/ 002 3 pre-filled syringes.
EU/ 1/ 98/ 063/ 002 3 siringi mimlijin lesti.
EU/ 1/ 98/ 063/ 003 12 pre-filled syringes.
EU/ 1/ 98/ 063/ 003 12- il siringa mimlijin lesti.
56 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
61 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SIRINGA MIMLIJA LESTA
Rebif 22 micrograms solution for injection Interferon beta-1a SC use
Rebif 22 mikrogrammi soluzzjoni għall- injezzjoni Interferon beta- 1a SC (Użu għal taħt il- ġilda)
22 micrograms (6 million IU)/ 0.5 ml
22 mikrogrammi (6 miljuni IU) / 0. 5 ml
57 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 1, 3 AND 12 SYRINGES
62 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ 1, 3 u 12 SIRINGI
Rebif 44 micrograms solution for injection in pre-filled syringe Interferon beta-1a
Rebif 44 mikrogrammi soluzzjoni għall- injezzjoni b’ siringa mimlija għal- lest Interferon beta- 1a
Eachpre-filled syringe (0.5 ml) contains 44 micrograms (12 MIU) of interferon beta-1a.
Kull siringa mimlija lesta għal użu (0. 5ml) fiha 44 mikrogrammi (12 MIU) ta ’ interferon beta- 1a.
See the package leaflet for further information.
Ara l- fuljett ta ’ tagħrif għal aktar informazzjoni
New Formulation
Formulazzjoni ġdida.
EU/ 1/ 98/ 063/ 004 1 pre-filled syringe EU/ 1/ 98/ 063/ 005 3 pre-filled syringes EU/ 1/ 98/ 063/ 006 12 pre-filled syringes
EU/ 1/ 98/ 063/ 006 12- il siringa mimlijin lesti.
59 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
64 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SIRINGA MIMLIJA LESTA
Rebif 44 micrograms solution for injection Interferon beta-1a SC use
Rebif 44 mikrogrammi soluzzjoni għall- injezzjoni Interferon beta- 1a SC (Użu għal taħt il- ġilda)
44 micrograms (12 million IU)/ 0.5 ml
44 mikrogrammi( 12 miljuni IU) / 0. 5 ml
60 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 6 X 8.8 MICROGRAMS SYRINGES + 6 X 22 MICROGRAMS SYRINGES
65 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA 6 X 8. 8 MIKROGRAMMI SIRINGI + 6 X 22 MIKROGRAMMI SIRINGI,
Rebif 8.8 micrograms solution for injection in pre-filled syringe Rebif 22 micrograms solution for injection in pre-filled syringe Interferon beta-1a
Rebif 8. 8 mikrogrammi soluzzjoni għall- injezzjoni b’ siringa mimlija għal- lest Rebif 22 mikrogrammi soluzzjoni għall- injezzjoni b’ siringa mimlija għal- lest Interferon beta- 1a
Each Rebif 8.8 micrograms pre-filled syringe (0.2 ml) contains 8.8 micrograms (2.4 Million IU) of interferon beta-1a.
Kull Rebif 8. 8 mikrogrammi siringa mimlija lesta għal użu (0. 2 ml) fiha 8. 8 mikrogrammi (2. 4 MIU) ta ’ interferon beta- 1a.
Each Rebif 22 micrograms pre-filled syringe (0.5 ml) contains 22 micrograms (6 Million IU) of interferon beta-1a.
Kull Rebif 22 mikrogrammi siringa mimlija lesta għal użu (0. 5 ml) fiha 22 mikrogrammi (6 MIU) ta ’ interferon beta- 1a.
See the package leaflet for further information.
Ara il- fuljett ta ’ tagħrif għal aktar informazzjoni.
Initiation pack.
Pakkett għall- ewwel fażi tal- kura.
6 pre-filled syringes of Rebif 8.8 micrograms and 6 pre-filled syringes of Rebif 22 micrograms.
6 siringi mimlijien lesti għal użu ta ’ Rebif 8. 8 mikrogrammi u 6 siringi mimlijien lesti għal użu ta ’ Rebif 22 mikrogrammi.
62 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
67 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SIRINGA MIMLIJA LESTA
Rebif 8.8 micrograms solution for injection Interferon beta-1a SC use
Rebif 8. 8 mikrogrammi soluzzjoni għall- injezzjoni Interferon beta- 1a SC (Użu għal taħt il- ġilda)
8.8 micrograms (2.4 million IU)/ 0.2 ml
8. 8 mikrogrammi (2. 4 miljuni IU) / 0. 2 ml
63 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS PRE-FILLED SYRINGE
68 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SIRINGA MIMLIJA LESTA
64 PARTICULARS TO APPEAR ON THE LAYERS SEPARATORS FOR THE STARTER PACK
69 TAGĦRIF LI GĦANDU JIDHER FUQ IL- KARTI LI JINTUŻAW BĦALA SEPARAŻŻJONI FIL- PAKETT INIŻJALI TAL- KURA
(UPPER FLAP) Rebif 8.8 micrograms solution for injection Interferon beta-1a Subcutaneous use BRAILLE: rebif 8.8
(KARTA TA ’ FUQ) Rebif 8. 8 mikrogrammi soluzzjoni g] all- injezzjoni Interferon beta- 1a Għall- użu taħt il- ġilda BRAILLE: rebif 8. 8
(LOWER FLAP) Rebif 22 micrograms solution for injection Interferon beta-1a Subcutaneous use BRAILLE: rebif 22
(KARTA TA ’ TAĦT) Rebif 22 mikrogrammi soluzzjoni għall- injezzjoni Interferon beta- 1a Għall- użu taħt il- ġilda BRAILLE: rebif 22
65 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 4 CARTRIDGES
70 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ 4 SKRATAĊ
Rebif 22 micrograms/ 0.5 ml solution for injection in cartridge Interferon beta-1a
Rebif 22 mikrogrammi/ 0. 5 ml soluzzjoni għall- injezzjoni fi skartoċċ Interferon beta- 1a
Each cartridge contains 66 micrograms (18 MIU) of interferon beta-1a in 1.5 ml solution.
Kull skartoċċ fih 66 mikrogrammi (18 MIU) ta ’ interferon beta- 1a f’ soluzzjoni ta ’ 1. 5 ml.
For multidose use.
Għal doża multipla.
EXP After first injection use within 28 days.
JIS Wara l- ewwel injezzjoni, uża fi żmien 28 jum.
The RebiSmart autoinjector device containing a cartridge of Rebif must be stored in the device storage box in a refrigerator (2°C – 8°C).
L- apparat awtoinjettatur RebiSmart li fih skartoċċ ta ’ Rebif għandu jinħażen fil- kaxxa tal- ħżin tal - apparat fi friġġ (2°C – 8°C).
rebif 22/ 0.5
rebif 22/ 0. 5
67 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARTRIDGE
72 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SKARTOĊĊ
Rebif 22 micrograms/ 0.5 ml solution for injection Interferon beta-1a SC use
Rebif 22 mikrogrammi/ 0. 5 ml soluzzjoni għall- injezzjoni Interferon beta- 1a SC (Użu għal taħt il- ġilda)
66 micrograms (18 million IU)/ 1.5 ml
66 mikrogrammi (18- il miljun IU) / 1. 5 ml
68 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 4 CARTRIDGES
73 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ 4 SKRATAĊ
Rebif 44 micrograms/ 0.5 ml solution for injection in cartridge Interferon beta-1a
Rebif 44 mikrogrammi/ 0. 5 ml soluzzjoni għall- injezzjoni fi skartoċċ Interferon beta- 1a
Each cartridge contains 132 micrograms (36 MIU) of interferon beta-1a in 1.5 ml solution.
Kull skartoċċ fih 132 mikrogrammi (36 MIU) ta ’ interferon beta- 1a f’ soluzzjoni ta ’ 1. 5 ml.
For multidose use.
Għal użu multiplu.
EXP After first injection use within 28 days.
JIS Wara l- ewwel injezzjoni uża fi żmien 28 jum
69 Store the cartridge in the original package in order to protect from light.
Aħżen l- iskartoċċ fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
rebif 44/ 0.5
rebif 44/ 0. 5
70 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARTRIDGES
75 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SKRATAĊ
Rebif 44 micrograms/ 0.5 ml solution for injection Interferon beta-1a SC use
Rebif 44 mikrogrammi/ 0. 5 ml soluzzjoni għall- injezzjoni Interferon beta- 1a SC (Użu għal taħt il- ġilda)
132 micrograms (36 million IU)/ 1.5 ml
132 mikrogrammi (36 miljun IU) / 1. 5 ml
71 PARTICULARS TO APPEAR ON THE OUTER PACKAGING BOX OF 2 CARTRIDGES
76 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA KAXXA TA ’ 2 SKRATAĊ,
Rebif 8.8 micrograms/ 0.1 ml solution for injection in cartridge Rebif 22 micrograms/ 0.25 ml solution for injection in cartridge Interferon beta-1a
Rebif 8. 8 mikrogrammi/ 0. 1 ml – soluzzjoni għall- injezzjoni fi skartoċċ Rebif 22 mikrogrammi/ 0. 25 ml – soluzzjoni għall- injezzjoni fi skartoċċ Interferon beta- 1a
Each cartridge contains 132 micrograms (36 MIU) of interferon beta-1a in 1.5 ml solution.
Kull skartoċċ fih 132 mikrogrammi (36 Miljun IU) ta ’ interferon beta- 1a f’ soluzzjoni ta ’ 1. 5 ml.
2 cartridges
2 skrataċ.
rebif 8.8/ 0.1 / 22/ 0.25
rebif 8. 8/ 0. 1 / 22/ 0. 25
73 MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS CARTRIDGE
78 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETTI Ż- ŻGĦAR EWLENIN SKARTOĊĊ
Rebif 8.8 micrograms/ 0.1 ml Rebif 22 micrograms/ 0.25 ml Solution for injection Interferon beta-1a SC use
Rebif 8. 8 mikrogrammi/ 0. 1 ml Rebif 22 mikrogrammi/ 0. 25 ml Soluzzjoni għall- injezzjoni Interferon beta- 1a SC (Użu għal taħt il- ġilda)
74 B.
79 80 B.
75 PACKAGE LEAFLET:
81 FULJETT TA ’ TAGĦRIF:
Rebif22 micrograms solution for injection in pre-filled syringe Interferon beta-1a
Rebif 22 mikrogrammi soluzzjoni għall- injezzjoni b’ siringa mimlija għal- lest Interferon beta- 1a
What Rebif is and what it is used for 2.
X’ inhu Rebif u għalxiex jintuża 2.
Before you use Rebif 3.
Qabel ma tuża Rebif 3.
How to use Rebif 4.
Kif għandek tuża Rebif 4.
How to store Rebif 6.
Kif taħżen Rebif 6.
WHAT REBIF IS AND WHAT IT IS USED FOR
X’ INHU X U GĦALXIEX JINTUŻA
Rebif belongs to a class of medicines known as interferons.
Rebif jifforma parti mill- klassi tal- mediċini magħrufa bħala interferons.
These are natural substances that transmit messages between cells.
Dawn huma sustanzi naturali li jibgħati messaġġi bejn iċ- ċelluli.
Interferons are produced by the body and play an essential role in the immune system.
L- interferons huma prodotti mill- ġisem u għandhom parti importanti fis- sistema immunitarja.
Through mechanisms that are not totally understood, interferons help to limit the damage of the central nervous system associated with multiple sclerosis.
Permezz ta ’ mekkaniżmi li mhumiex magħrufa sew, l- interferons jgħinu jillimitaw il- ħsara lis- sistema nervuża assoċjata ma ’ l- isklerożi multipla.
Rebif is a highly purified soluble protein that is similar to the natural interferon beta that is produced in the human body.
Rebif hi proteina pura ħafna u li tinħall sew u hi simili għall- interferon beta naturali li jagħmel il - ġisem tal- bniedem.
Rebif is used for the treatment of multiple sclerosis.
Rebif jintuża għall- kura ta ’ l- isklerożi multipla.
It has been shown to reduce the number and the severity of relapses and to slow the progression of disability.
Deher li naqqas in- numru u s- severita ’ ta ’ l- attakki ripetuti u li jnaqqas il- progressjoni tad- diżabilita ’.
BEFORE YOU USE REBIF
QABEL MA TUŻA REBIF
Do not use Rebif
Tiħux Rebif
• if you are allergic (hypersensitive) to natural or recombinant interferon beta or any of the other ingredients of Rebif, • if you are pregnant (see Pregnancy and breast-feeding), • if you are severely depressed at present.
• jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal interferon naturali jew artifiċjali jew sustanzi oħra ta ’ Rebif, • jekk inti tqila (ara Tqala u treddigħ) • jekk inti dipress b’ mod gravi.
Take special care with Rebif
Oqgħod attent ħafna b ’ Rebif
Before using Rebif, you should tell your doctor if any of the following applies to you:
Qabel tuża Rebif, għandek tgħid lit- tabib tiegħek jekk kwalunkwe minn dawn li ġejjin japplikaw għalik:
• Rebif should only be used under the supervision of your doctor. • Before treatment with Rebif, read carefully and follow the advice given under “ How to use Rebif” in order to minimise the risk of injection site necrosis (skin breakdown and tissue destruction) that has been reported in patients treated with Rebif.
Sabiex tnaqqas ir- riskju aqra sew u segwi l- istruzzjonijiet mogħtija taħt ‘ ’ Kif tuża Rebif ’’.
If you experience troubling local reactions, contact your doctor. • Before treatment with Rebif, advise your doctor if you have an allergy (hypersensitivity) to any other medicines.
82 • Qabel tibda l- kura b’ Rebif, avża lit- tabib tiegħek jekk inti allerġiku (għandek sensittività eċċessiva) għal xi mediċini oħra.
76 Inform your doctor if you have a disease of • the bone marrow, • kidney, • liver, • heart, • thyroid, • or if you have experienced depression, • or if you have any history of epileptic seizures, so that he/ she can closely monitor your treatment and any worsening of these conditions.
Informa lit- tabib tiegħek jekk tbati minn mard tal - • mudullun, • kliewi, • fwied, • qalb, • tirojde • jew jekk kellek dipressjoni • jew jekk għandek storja ta ’ attakki ta ’ epilessija sabiex hu/ hi jkun jista ’ jsegwi mill- qrib il- kura tiegħek u jekk jiħżienux dawn il- kundizzjonijiet.
Please tell your doctor or pharmacist if you are using or have recently used any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib tiegħek jekk qiegħed tuża jew użajt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
In particular you should tell your doctor if you are using antiepileptics or antidepressants.
B’ mod partikulari għandek tgħid lit- tabib tiegħek jekk qed tuża mediċini kontra l- epillesija u kontra d - dipressjoni.
You must not start treatment with Rebif if you are pregnant.
M’ għandekx tuża Rebif jekk inti tqila.
While taking Rebif, you must use effective methods of contraception if you are a woman of child-bearing potential.
Jekk inti mara fertili, trid tuża metodu effettiv ta ’ kontraċezzjoni waqt li qed tieħu Rebif.
If you become pregnant or plan to become pregnant while using Rebif ask your doctor for advice.
Għandek tinforma immedjatament lit- tabib tiegħek jekk tinqabad tqila jew jekk tixtieq tinqabad tqila waqt li tkun qiegħda tieħu Rebif.
Prior to taking the medicine, please inform your doctor if you are breast-feeding.
Qabel tieħu l- mediċina, jekk jogħġbok informa lit- tabib tiegħek jekk qiegħda tredda ’.
The use of Rebif is not recommended if you are breast-feeding.
L- użu ta ’ Rebif mhuwiex rakkomandat jekk qed tredda ’.
Effects of the disease itself or of its treatment might influence your ability to drive or to operate machines.
Effetti tal- marda innifisha jew tal- kura tagħha jistgħu jinfluwenzaw l- abilità ta ’ sewqan jew ta ’ użu ta ’ magni tiegħek.
You should discuss this with your doctor if you are concerned.
Għandek titkellem mat- tabib tiegħek jekk dan jgħodd għalik.
Important information about some of the ingredients of Rebif
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Rebif
This medicinal product contains 2.5 mg benzyl alcohol per dose.
Dan il- prodott mediċinali fih 2. 5 mg ta ’ benzyl alkoħol f’ kull doża.
May cause toxic reactions and allergic reactions in infants and children up to 3 years old.
Jista ’ jikkawża reazzjonijiet tossiċi u reazzjonijiet allerġiċi fit- trabi u fi tfal sa l- età ta ’ 3 snin.
HOW TO USE REBIF
KIF GĦANDEK TUŻA REBIF
Always use Rebif exactly as your doctor has told you.
Dejjem għandek tuża Rebif skond il- parir eżatt tat- tabib.
Dose The usual dose is 44 micrograms (12 million IU) given three times per week for adults and adolescents from 16 years of age.
Doża Id- doża normali hi 44 mikrogrammi (12 miljun IU) mogħtija tlett darbiet fil- ġimgħa għall- adulti u pazjenti minn 16- il sena ’ l fuq.
A lower dose of 22 micrograms (6 million IU) given three times per week, is recommended for • patients who cannot tolerate the higher dose. • adolescents from the age of 12 years.
Doża iktar baxxa ta ’ 22 mikrogrammi (6 miljun IU) mogħtija tlett darbiet fil- ġimgħa, hi rakkomandata għal: • pazjenti li ma jittolerawx l- għola doża. • Addolexxenti mill- eta ’ ta ’ 12- il sena.
Rebif should be administered, if possible: • three times per week • on the same three days (at least 48 hours apart) • at the same time (preferably in the evening).
Rebif għandu jingħata, kemm jista ’ jkun: • tliet darbiet fil- ġimgħa • fl- istess tlett ijiem (għall- inqas 48 siegħa bejniethom)
77 Method of administration Rebif is intended for subcutaneous (under the skin) injection.
Kif jingħata Rebif hu maħsub għal injezzjoni subkutaneja (taħt il- ġilda).
The first injection(s) must be performed under the supervision of an appropriately qualified healthcare professional., After receiving adequate training you, a family member, friend or a carer can use Rebif syringes to administer the medicine at home.
Wara taħriġ adegwat, inti, membru tal- familja, ħabib jew persuna oħra li tieħu ħsieb il- pazjent tistgħu tużaw s- siringi Rebif biex tagħtu l- mediċina d- dar.
It may also be administered with a suitable auto-injector.
Jista ’ jingħata wkoll permezz ta ’ awtoinjettatur xieraq.
For administration of Rebif, please read the following instructions carefully:
Għat- teħid ta ’ Rebif, jekk jogħġbok aqra sew dawn l- istruzzjonijiet segwenti:
This medicinal product is for single use.
Dan il- prodott mediċinali huwa għall- użu singolari biss.
Only clear to opalescent solution without particles should be used and without visible signs of deterioration.
Trid tintuża biss soluzzjoni li hija ċara għal opalexxenti mingħajr frak u mingħajr sinjali visibbli ta ’ deterjorament.
How to inject Rebif • Choose an injection site.
Kif għandek tinjetta Rebif • Agħżel sit għall- injezzjoni.
Your doctor will advise you on the possible injection sites (good sites include the upper thighs and the lower abdomen).
It- tabib tiegħek għandu jtik parir dwar postijiet tajba għall- injezzjoni (postijiet tajba jinkludu n- naħa ta ’ fuq tal- koxxa u n- naħa t’ isfel taż- żaqq).
Hold the syringe like a pencil or dart.
Żomm is- siringa bħal lapes jew dart.
It is recommended that you keep track of and rotate your injection sites, so that one area is not injected too frequently in order to minimise the risk of injection site necrosis.
Nagħtuk parir li tiftakar il- postijiet fejn tkun għamilt l- injezzjoni u tbiddilhom, biex b’ hekk l- ebda post ma jsirulu ħafna injezzjonijiet wara xulxin sabiex jitnaqqas ir- riskju ta ’ nekrożi tas- sit tal- injezzjoni.
NOTE: do not use any areas in which you feel lumps, firm knots, or pain; talk to your doctor or healthcare professional about anything you find. • Wash your hands thoroughly with soap and water. • Remove the Rebif syringe from the blister pack by peeling back the plastic covering. • Before the injection use an alcohol wipe to clean the skin at the injection site.
NOTA: tużax postijiet fejn tħoss balal, għoqod jew uġigħ: tkellem mat- tabib jew professur tiegħek dwar dak li ssib. • Aħsel idejk sewwa bl- ilma u s- sapun. • Neħħi Rebif mill- pakkett billi tiġbed lura l- plastik li jiksiha. • Qabel l- injezzjonijiet, uża tajjara bl- alkoħol sabiex tnaddaf il- ġilda fejn se ssir l- injezzjoni.
Let the skin dry.
Agħti ċans lill- ġilda sabiex tinxef.
If a bit of alcohol is left on the skin, you may get a stinging sensation.
Jekk jibqa ’ ftit alkoħol fuq il- ġilda, dan jista ’ jniggżek.
Gently pinch the skin together around the site (to lift it up a bit).
Oqros bil- mod il- ġilda madwar il- post (sabiex tgħolliha ftit).
Resting your wrist on the skin near the site, stick the needle at a right angle straight into the skin with a quick, firm motion.
Serraħ il- polz fuq il- ġilda madwar il- post, daħħal il- labra f’ angolu ta ’ 90 grad direttament fil- ġilda b’ moviment sod u ta ’ malajr.
Inject the medicine by using a slow, steady push (push the plunger all the way in until the syringe is empty).
Injetta l- mediċina billi timbotta bil- mod u mingħajr tregħid (agħfas il- plunger kollu ‘ l isfel sakemm is- siringa tkun vojta).
Hold a swab on the injection site.
Żomm tajjara fil- post fejn tkun saret l- injezzjoni.
Remove the needle from the skin.
Neħħi l- labra minn ġol- ġilda.
• Gently massage the injection site with a dry cotton ball or gauze. • Dispose of all used items: once you have finished your injection, immediately discard the syringe in an appropriate disposal unit.
• Immassaġġja bil- mod il- post fejn tkun sarett l- injezzjoni b’ tajjara jew garża. • Eħles mill- affarijiet kollha wżati: malli tispiċċa l- injezzjoni tiegħek, armi s- siringa tiegħek f’ post xieraq.
If you use more Rebif than you should
Jekk tuża aktar Rebif milli suppost
In case of overdose, contact your doctor immediately.
F’ każ ta ’ doża żejda, informa lit- tabib tiegħek immedjatament.
If you forget to use Rebif
Jekk tinsa tuża Rebif
If you miss a dose, continue to inject from the day of the next scheduled dose.
Jekk taqbeż doża, kompli hu l- injezzjoni mill- jum tad- doża li jkun imissek.
Do not take a double dose to make up for a forgotten dose.
Tiħux doża doppja sabiex tirkupra d- dożi individwali li tkun insejt.
78 If you stop using Rebif
84 Jekk tieqaf tuża Rebif
The effects of Rebif may not be noticed immediately.
L- effetti ta ’ Rebif jistgħug ma jiġux innutati immedjatament.
Therefore you should not stop using Rebif but continue to use it regularly to achieve the desired result.
Għalhekk m’ għandekx tieqaf tuża Rebif iżda kompli użah regolarment biex tikseb ir- riżultat mixtieq.
If you are uncertain about the benefits, please consult your doctor.
Jekk ma tkunx ċert/ a dwar il- benefiċċji, jekk jogħġbok kellem lit- tabib tiegħek.
You should not discontinue the treatment without first contacting your doctor.
M’ għandekx twaqqaf il- kura mingħajr ma tinforma lit- tabib tiegħek l- ewwel.
Like all medicines, Rebif can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Rebif jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Interferon beta may cause flu-like symptoms such as headache, fever, chills, muscle and joint pains, fatigue and nausea.
Interferon beta jista ’ joħloq sintomi li jixbhu lill- influwenza bħal uġigħ ta ’ ras, deni, bard, uġigħ fil - muskoli u l- ġogi, għejja u nawżea.
To help reduce these symptoms your doctor may advise you to take a fever-reducing painkiller before a dose of Rebif and then for 24 hours after each injection.
Dawn il- problemi jistgħu jaffetaw iżjed minn persuna 1 minn 10 taħt din il- kura u huma ġeneralment mhux qawwija, huma komuni malli tinbeda l- kura u jonqsu meta titkompla. Biex tgħin li jitnaqqsu dawn is- sintomi t- tabib tig] ek jista javżak li tieħu mediċina kontra l - uġigħ li jbaxxi d- deni, qabel doża ta ’ Rebif u imbagħad għal 24- il siegħa wara kull injezzjoni.
Injection site reactions including redness, swelling, discolouration, inflammation, pain and skin breakdown may affect between 1 and 10 patients out of 100 treated.
Reazzjonijiet fil- post fejn issir l- injezzjoni li jinkludu ħmura, nuqqas ta ’ kulur, infjammazzjoni, uġigħ u qsim fil- ġilda u jistgħu jaffetaw bejn 1 sa 10 persuni minn kull 100 taħt din il- kura.
Tissue destruction (necrosis), and non-specific reactions may occur in 1 to 10 patients out of 1’000 patients treated (see “Take special care with Rebif ”).
Qerda tat- tessuti (nekrożi), u reazzjonijiet oħra mhux speċifiċi jistgħu jidhru f’ 1 sa 10 persuni minn 1000 taħt il- kura ta ’ din il- mediċina( ara ‘ ’ Oqgħod attent meta tuża Rebif ’’).
The occurrence of injection site reactions usually decreases over time.
Ir- reazzjonijiet fil- post fejn issir l- injezzjoni ġeneralment jonqsu biż- żmien.
You should not stop or alter the medication without your doctor’s advice.
M’ għandekx twaqqaf jew tbiddel il- medikament mingħajr il- parir tat - tabib.
Occasionally, the injection site can become infected; the skin may become swollen, tender and hard and the whole area could be very painful.
Xi drabi, is- sit ta ’ l- injezzjoni jista ’ jiġi infettat; il- ġilda tista ’ tintefaħ, tuġaħ meta tmissaħ u iebsa, u dik il- parti kollha tista ’ tweġġahlek.
If you experience any of these symptoms, contact your doctor for advice.
Jekk tbati minn xi wieħed ta ’ dawn is- sintomi, għamel kuntatt mat- tabib tiegħek għal parir tiegħu.
Other less common adverse events (between 1 and 10 patients out of 100 treated) reported in association with interferon beta include diarrhoea, loss of appetite, vomiting, sleeping difficulty, dizziness, nervousness, itching, rash, nettle-rash, hair loss, dilatation of the blood vessels and palpitation, irregularities and/or changes in menstrual flow and serious reactions of the skin and mucous membranes.
Sintomi oħra relatati ma ’ l- interferon beta u li huma anqas komuni (bejn 1 u 10 minn 100 taħt din il - kura) jinkludu diarrea, nuqqas ta ’ aptit, vomitu, diffikultà fl- irqad, sturdament, ħakk, raxx, urtikarja, telf tax- xagħar, twessigħ ta ’ l- arterji u taħbit qawwi tal- qalb, irregolarijiet u/ jew bidliet fil - menstruazzjoni u reazzjonijiet serji fil- ġilda u l- membrani mukosi.
Very rarely (less than 1 patient in 10’000 treated) serious allergic reactions occur.
Rarement ħafna (inqas minn pazjient wieħed minn 10’ 000 taħt din il- kura) jista jkun hemm reazzjonijiet allerġiċi ta livell serju ħafna.
If, immediately following Rebif administration you experience a sudden difficulty breathing, which may appear in association with nettle rash, and a feeling of weakness or faintness, seek medical attention immediately.
Jekk immedjatament wara li tieħu Rebif tħoss diffikulta sabiex tieħu n- nifs, li jista jkun assoċtjat ma ’ raxx, u sensazzjoni ta debulizza jew ħass ħazin, fittex attenzjoni medika immedjatament.
Inflammation of the liver has also been reported.
Infjammazjoni tal- fwied ġie wkoll irrapurtat.
Certain laboratory tests may change: the number of white blood cells or platelets may decrease and liver function tests may be disturbed.
Ċerti testijiet tal- laboratorju jistgħu jinbidlu: in- numru ta ’ ċelluli tad- demm bojod jew platelets jista ’ jonqos u t- testijiet tal- funzjoni tal- fwied jistgħu jkunu affettwati.
These changes are generally not noticed by the patient (no symptoms), are usually reversible and mild, and most often do not require particular treatment.
Dawn il- bidliet is- soltu ma jinħassux mill- pazjent (ma jkunx hemm sintomi), huma ġeneralment riversibbli u mhux qawwija, u ħafna drabi ma jirrikjedux kura partikolari.
However, if you experience symptoms suggesting a liver disorder, such as loss of appetite accompanied by other symptoms such as nausea, vomiting or jaundice, please contact your doctor immediately.
Madankollu, jekk tħoss sintomi li jindikaw problemi fil- fwied bħal nuqqas ta ’ aptit flimkien ma ’ sintomi oħra bħal nawżea, vomitu jew suffejra, jekk jogħġbok ikkuntattja lit- tabib tiegħek immedjatament.
Interferons may cause your thyroid gland to function either excessively, or insufficiently in 1 to 10 patients out of 1’000 treated.
L- interferons jistgħu jikkawżaw lill- glandola tat- tirojde sabiex taħdem iżżejjed, jew mhux biżżejjed f’ 1 sa 10 minn 1’ 000 li huma taħt din il- kura.
These changes in the thyroid activity are almost always not felt by the patient as symptoms.
Dawn il- bidliet fil- ħidma tat- tirojde kważi qatt jinħassu mill- pazjent bħala sintomi.
However your doctor may recommend testing as appropriate.
Madankollu, it- tabib tiegħek jista ’ jagħtik parir li tagħmel it- testijiet meħtieġa.
Depression may occur in 1 patient out of 10 treated for multiple sclerosis.
Dipressjoni tista ’ tinstab f’ pazjient wieħed minn 10 li huma taħt din il- kura li jbatu mill- isklerożi multipla.
If you feel depressed, please contact your doctor immediately.
Jekk tħossok dipress, jekk jogħġbok ikkuntattja lit- tabib tiegħek immedjatament.
If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or pharmacist.
85 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.
HOW TO STORE REBIF
KIF TAĦŻEN REBIF
(To prevent accidental freezing, avoid placing near the freezer compartment).
(Sabiex tevita ffiriżar aċċidentali, tħallix qrib il- freezer).
Do not use Rebif after the expiry date which is stated on the label after EXP.
Tużax Rebif wara d- data ta ’ skadenza li tidher fuq it- tikketta wara JIS.
Do not use Rebif if you notice any visible signs of deterioration such as if the solution is no longer clear or if it contains particles.
Tużax Rebif jekk tinnota sinjali ta ’ deterjorament bħal meta s- soluzzjoni ma tkunx għadha ċara jew jekk ikun fiha l- frak.
The se measures will help to protect the environment.
Dawn il- miżuri jgħinu għal protezzjoni ta ’ l- ambjent
What Rebif contains
X’ fih Rebif
The active substance is interferon beta-1a.
Is- sustanza attiva hi interferon beta- 1a.
Each syringe contains 22 micrograms, corresponding to 6 million International Units (IU) of interferon beta-1a.
Kull siringa fih 22 mikrogrammi li jikkorrispondu għal 6- il miljun Unità Internazzjonali (IU) ta ’ interferon beta- 1a.
The other ingredients are mannitol, poloxamer 188, L-methionine, benzyl alcohol, sodium acetate, acetic acid, sodium hydroxide and water for injections.
Is- sustanzi l- oħra huma mannitol, poloxamer 188, L- methionine, benzyl alkohol, sodium acetate, acetic acid, sodium hydroxide u ilma għall- injezzjoni.
What Rebif looks like and contents of the pack
Id- dehra ta ’ Rebif u lkontenuti tal- pakkett
Rebif is available as a solution for injection in a pre-filled syringe with a fixed needle for self- administration.
Rebif huwa disponibbli bħala soluzzjoni għall- injezzjoni f’ siringa mimlija lesta għall- użu b’ labra mwaħħla għall- amministrazzjoni mill- pazjient stess.
Rebif solution is clear to opalescent.
Is- soluzzjoni ta ’ Rebif hija ċara għal opalexxenti.
The pre-filled syringe is ready for use and contains 0.5 ml of solution.
Is- siringa mimlija hija lesta għall- użu u fiha 0. 5ml ta ’ soluzzjoni.
Rebif is available in packs of 1, 3 and 12 pre-filled syringes.
Rebif huwa disbonibbli f’ paketti ta ’ 1, 3 u 12 siringi mimlijien lesti għall- użu.
Not all pack sizes may be marketed.
Mhux il- paketti kollha jistaw jkunu għal skop kummerċjali.
Marketing Authorization Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
86 Għal kull tagħrif dwar din il - mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Κηfιsίaς 41-45, Κtήριο Β GR-151 23 Μαρούσι Αθήνα Tηλ: +30-210-61 65 100
Jerozolimskie 178 Κηfιsίaς 41- 45, Κtήριο Β 02- 486 Warszawa GR- 151 23 Μαρούσι Polska Αθήνα Tηλ: +30- 210- 61 65 100
Rebif 44 micrograms solution for injection in pre -filled syringe Interferon beta-1a
Rebif 44 mikrogrammi soluzzjoni għall- injezzjoni b’ siringa mimlija għal- lest Interferon beta- 1a
• Rebif should only be used under the supervision of your doctor. • Before treatment with Rebif, read carefully and follow the advice given under “How to use Rebif” in order to minimise the risk of injection site necrosis (skin breakdown and tissue destruction) that has been reported in patients treated with Rebif.
Sabiex tnaqqas ir- riskju aqra sew u segwi l- istruzzjonijiet mogħtija taħt ‘ ’ Kif tużaRebif ’’.
If you experience troubling local reactions, contact your doctor. • Before treatment with Rebif, advise your doctor if you have an allergy (hypersensitivity) to any other medicines.
89 • Qabel tibda l- kura b’ Rebif, avża lit- tabib tiegħek jekk inti allerġiku (għandek sensittività eċċessiva) għal xi mediċini oħra.
83 Inform your doctor if you have a disease of • the bone marrow, • kidney, • liver, • heart, • thyroid, • or if you have experienced depression, • or if you have any history of epileptic seizures, so that he/she can closely monitor your treatment and any worsening of these conditions.
Informa lit- tabib tiegħek jekk tbati minn mard tal - • mudullun, • kliewi, • fwied, • qalb, • tirojde, • jew jekk kellek dipressjoni • jew jekk għandek storja ta ’ attakki ta ’ epilessija sabiex hu/ hi jkun jista ’ jsegwi mill- qrib il- kura tiegħek u jekk jiħżienux dawn il- kundizzjonijiet.
The use of Rebif is not recommended if you are breast-feeding.
L- użu ta ’ Rebif mhux rakkomandat jekk qed tredda ’.
Effects of the disease itself or of its treatment might influence your ability to drive or to use machines.
Effetti tal- marda innifisha jew tal- kura tagħha jistgħu jinfluwenzaw l- abilità ta ’ sewqan jew ta ’ użu ta ’ magni tiegħek.
Dose The usual dose is 44 micrograms (12 million IU) given three times per week for adults and adolescents from 16 years of age.
Doża Id- doża normali hi 44 mikrogrammi (12- il miljun IU) mogħtija tlett darbiet fil- ġimgħa għall- adulti u pazjenti minn 16- il sena ’ l fuq.
A lower dose of 22 micrograms (6 million IU) given three times per week is recommended for: • patients who cannot tolerate the higher dose. • adolescents from the age of 12 years
Doża iktar baxxa ta ’ 22 mikrogrammi (6 miljun IU) mogħtija tlett darbiet fil- ġimgħa hi rakkomandata għal: • pazjenti li ma jittolerawx l- għola doża. • Addolexxenti mill- eta ’ ta ’ 12- il sena.