qanastek/EMEA-V3 huggingface dataset:
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) 90 • fl- istess ħin tal- ġurnata (preferibbilment fil- għaxija).
84 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 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.
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.
85 If you stop using Rebif
91 Jekk tieqaf tuża Rebif
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 tiegħek 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.
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’ pazjient 1 sa 10 minn 1000 li huma taħt din il- kura.
The occurrence of injection site reactions usually decreases over time.
(ara ‘ ’ Oqgħod attent meta tuża Rebif ’’) Ir- reazzjonijiet fil- post fejn issir l- injezzjoni ġeneralment jonqsu biż- żmien.
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 lu huma taħt din il- kura) jinkludu diarrea, nuqqas ta ’ aptit, vomitu, infjammazzjoni tal- fwied, 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 tal- ġilda u membrani mukosi.
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’ pazjient 1 sa 10 minn kull 1’ 000 li huma taħt din il- kura).
However your doctor may recommend testing as appropriate.
Madankollu t- 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 1 minn 10 li huma taħt din il- kura f’ pazjenti li jbatu mill- isklerożi multipla.
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.
92 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.
Each syringe contains 44 micrograms, corresponding to 12 million International Units (IU) of interferon beta-1a.
Kull siringa fih 44 mikrogrammi li jikkorrispondu għal 12 miljun Unità Internazzjonali (IU) ta ’ interferon beta- 1a.
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.
Via delle Magnolie 15 I-70026 Modugno (Bari) Italy
Via delle Magnolie 15 I- 70026 Modugno (Bari) L- Italja Għal kull tagħrif dwar din il - mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
België/Belgique/Belgien MERCK NV/SA Brusselsesteenweg 288
93 België/ Belgique/ Belgien MERCK NV/ SA Brusselsesteenweg 288 B- 3090 Overijse Tél/ Tel:
France Merck Lipha Santé s.a.s.
94 France Merck Lipha Santé s. a. s.
Reb if 8.8 micrograms solution for injection in pre-filled syringe Rebif 22 micrograms solution for injection in pre-filled syringe Interferon beta-1a Initiation pack
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 Pakkett inizjali
Rebif is used for the treatment of multiple sclerosis.
Rebif jintuża għall- kura ta’ l- i sklerożi 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- progressioni tad- diżabilita ’.
Do not use Rebif
Tiħux Rebif:
Take special care with Rebif
Oqgħod attent ħafna b’ Rebif:
If you experience troubling local reactions, contact your doctor.
• Rebif għandu jintuża biss taħt is- superviżoni tat- tabib tiegħek.
90 • Before treatment with Rebif, advise your doctor if you have an allergy (hypersensitivity) to any other medicines.
Jekk ikollok reazzjonijiet inkwetanti fil- post tat- tilqim, kellem lit- tabib tiegħek. • Qabel tibda l- kura b’ Rebif, avża lit- tabib tiegħek jekk inti allerġiku (għandek sensittività eċċessiva) għal xi mediċini oħra.
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.
Must not be given to premature babies or neonates.
Dan il- prodott mediċinali fih 1. 0 mg ta ’ benzyl alkoħol f’ kull doża ta ’ 0. 2 ml u 2. 5 mg ta ’ benzyl alkoħol f’ kull doża ta ’ 0. 5 ml M’ għandux jingħata lil trabi prematuri jew lil trabi tat- twelid.
Initiating treatment
Il- bidu tal- kura:
When treatment is started, in order to reduce some of the side effects, it is recommended that: • During weeks one and two,, Rebif 8.8 micrograms should be injected three times per week. • During weeks three and four, Rebif 22 micrograms syringe should be injected three times per week.
Meta tinbeda l- kura, sabiex jitnaqqsu ftit minn l- effetti mhux mixtieqa, huwa rrakkomandat illi: • Għal ġimgħat numru wieħed u tnejn, Rebif 8. 8 mikrogrammi għandu jkun injettat tlett darbiet fil- ġimgħa.
From the fifth week onwards, the usual dose is 44 micrograms (12 million IU) given three times per week for adults and adolescents from 16 years of age.
97 • Għal ġimgħat numru tlieta u erbgħa, siringa ta ’ Rebif 22 mikrogrammi għandu jkun injettat tlett darbiet fil- ġimgħa.
A lower dose of 22 micrograms (6 million IU) given three times per week, is recommended for • patients who cannot tolerate the higher dose.
Mil- ħames ġimgħa ’ l quddiem, id- doża normali hija ta ’ 44 mikrogrammi (12 il- miljun IU) mogħtija tliet darbiet fil- ġimgħa, għall- adulti u adolexxenti minn 16- il sena ’ l fuq.
91 • adolescents from the age of 12.
Doża iktar baxxa ta ’ 22 mikrogrammi (6 miljuni IU) 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 jittieħed, kemm jista ’ jkun: • tliet darbiet fil- ġimgħa • fl- istess tlett ijiem (għall- inqas 48 siegħa bejniethom) • fl- istess ħin tal- ġurnata (preferibbilment fil- għaxija).
Method of administration Rebif is intended for subcutaneous (under the skin) injection.
Kif jingħata Rebif hu maħsub għal injezzjoni subkutaneja (taħt il- ġilda).
This medicinal product is for single use.
Dan il- prodott mediċinali huwa għal użu multiplu.
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 22 mikrogramma 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.
• 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.
98 • 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.
In case of overdose, contact your doctor immediately.
F’ każ ta ’ doża żejda, informa lit- tabib tiegħek immedjatament
92 If you forget to use Rebif
Jekk tinsa tuża Rebif
If you stop using Rebif
Jekk tieqaf tuża Rebif
These problems may affect more than 1 patient out of 10 treated and are usually mild, are more common at the start of the treatment and decrease with continued use.
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.
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.
Biex tgħin li jitnaqqsu dawn is- sintomi t- tabib tiegħek jista javżak li tieħu mediċina kontra l- uġigħ li jbaxxi d- deni, qabel doża ta ’ Rebif w 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, qsim fil- ġilda u jistgħu jaffetaw bejn 1 sa 10 persuni minn kull 100 taħt din il- kura.
The occurrence of injection site reactions usually decreases over time.
Qerda tat- tessuti (nekrożi), u reazzjonijiet oħra mhux speċifiċi jistgħu jidhru f’ pazjient 1 sa 10 minn 1’ 000 li huma taħt din il- kura (ara ‘ ’ Oqgħod attent meta tuża Rebif ’) Ir- reazzjonijiet fil- post fejn issir l- injezzjoni ġeneralment jonqsu biż- żmien.
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 lu huma taħt din il- kura) jinkludu diarrea, nuqqas ta ’ aptit, vomitu, infjammazzjoni tal- fwied, 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 reazzjonijet serji tal- ġilda u tal- membrani mukosi.
Certain laboratory tests may change: the number of white blood cells or platelets may decrease and liver function tests may be disturbed.
Dawn il- bidliet is- soltu ma jinħassux
These changes are generally not noticed by the patient (no symptoms), are usually reversible and mild, and most often do not require particular treatment.
99 mill- pazjent (ma jkunx hemm sintomi), huma ġeneralment riversibbli u mhux qawwija, u ħafna drabi ma jirrikjedux kura partikolari.
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’ pazjient 1 sa 10 minn kull 1’ 000 li huma taħt din il- kura.
93 Depression may occur in 1 patient out of 10 treated for multiple sclerosis.
Dipressjoni tista ’ tinstab f’ pazjient 1 minn 10 li huma taħt din il- kura li jbatu mill- isklerożi multipla.
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.
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.
The active substance is interferon beta-1a. • Each 8.8 micrograms syringe contains 8.8 micrograms of interferon beta-1a (2.4 million IU). • Each 22 micrograms syringe contains 22 micrograms of interferon beta-1a (6 million IU).
Is- sustanza attiva hi interferon beta- 1a. • Kull 8. 8 mikrogrami siringa fiha 8. 8 mikrogrammi ta ’ interferon- beta- 1a (2, 4 milljuni IU). • Kull 22 mikrogrammi siringa fiha 22 mikrogrammi ta ’ interferon- beta- 1a (6 milljuni IU).
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 alkoħol, sodium acetate, acetic acid, sodium hydroxide u ilma għall- injezzjoni.
Rebif 8.8 micrograms is a solution for injection in a pre-filled syringe with a fixed needle for self-administration.
Rebif 8. 8 mikrogrammi huwa soluzzjoni għall- injezzjoni f’ siringa mimlija lesta għall- użu b’ labra mwaħħla għall- amministrazzjoni mill- pazjient stess.
The pre-filled syringe is ready for use and contains 0.2 ml of solution.
Is- siringa mimlija hija lesta għall- użu u fiha 0. 2ml ta ’ soluzzjoni
Rebif 22 micrograms is a solution for injection in a pre-filled syringe with a fixed needle for self-administration.
Rebif 22 mikrogrammi huwa soluzzjoni għall- injezzjoni f’ siringa mimlija lesta għall- użu b’ labra mwaħħla għall- amministrazzjoni mill- pazjient stess.
Rebif solution is clear to opalescent.
100 Is- soluzzjoni ta ’ Rebif hija ċara għal opalexxenti.
Rebif 8.8 micrograms and Rebif 22 micrograms are supplied in an initiation pack, that is intended for use during the initial 4 weeks of treatment, during which a gradual increase in Rebif dose is recommended.
Rebif 8. 8 mikrogrammi u Rebif 22 mikrogrammi huma xxupliti f’ pakett inizjali, li huwa għall- użu għal l- ewwel 4 ġimgħat tal- kura, meta żieda gradwali tad- doża huwa rakomandat.
One-month treatment pack contains six Rebif 8.8 micrograms pre-filled syringes and six Rebif 22 micrograms pre-filled syringes.
Pakett g] al kura g] al xar fih 6 Rebif 8. 8 mikrogrammi siringi mimlijien lesti u 6 Rebif 22 mikrogrammi siringi mimlijien lesti.
94 Marketing Authorization Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Eesti Merck Serono Esindaja C/o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kaunas, Leedu Tel: +370 37320603
101 Eesti Österreich Merck Serono Esindaja C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kaunas, Leedu Tel: +370 37320603
Ireland Merck Serono Ltd.
Íreland Merck Serono Ltd.
Latvija Merck Serono Pārstāvniecība C/o Ares Trading SA Baltic States Zamenhofo 11 -3, LT-44287 Kauņa, Lietuva Tel: +370 37320603
102 Latvija Merck Serono Pārstāvniecība C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kauņa, Lietuva Tel: +370 37320603
97 PACKAGE LEAFLET:
103 FULJETT TA ’ TAGĦRIF:
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
• 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.
104 • Qabel tibda l- kura b’ Rebif, avża lit- tabib tiegħek jekk inti allerġiku (għandek sensittività eċċessiva) għal xi mediċini oħra.
98 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.
Using other medicines
Meta tuża mediċini oħra:
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.
This medicinal product is for multidose use
Dan il- prodott mediċinali huwa għall- użu b’ ħafna dożi.
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 of day (preferably in the evening).
105 • fl- istess tlett ijiem (għall- inqas 48 siegħa bejniethom) • fl- istess ħin tal- ġurnata (preferibbilment fil- għaxija).
99 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.
L- ewwel injezzjoni( jiet) trid issir taħt is- supervizjoni ta ’ persuna kwalifikata fil- kura tas- saħħa.
After receiving adequate training, you, a family member, friend or carer can use Rebif cartridges with the RebiSmart autoinjector device to administer the medicine at home.
Wara taħriġ adegwat, inti, membru tal- familja, ħabib jew persuna oħra li tieħu ħsieb il- pazjent tistgħu tużaw l- iskartoċċi Rebif b’ apparat tal- awtoinjettatur RebiSmart biex tagħtu l- mediċina d- dar.
This medicinal product is for multidose use.
Dan il- prodott mediċinali huwa għall- użu b’ ħafna dożi.
The manufacturer’s instructions for using the device must be followed carefully for loading the cartridge, attaching the injection needle and administering Rebif 22 micrograms/0.5 ml.
L- istruzzjonijiet tal- manifattur biex tuża dan l- apparat iridu jiġu segwiti bl- attenzjoni biex timla l - iskartoċċ, biex twaħħal il- labra tal- injezzjoni u biex tagħti Rebif 22 microgrammi/ 0. 5 ml.
How to load the Rebif cartridge • Wash your hands thoroughly with soap and water. • Remove the Rebif cartridge from the blister pack by peeling back the plastic covering. • Check (just after removing from the refrigerator) that the cartridge is not accidentally frozen in the pack or inside the RebiSmart device. • To place the cartridge in the device and perform the injection follow the instruction manual provided with the RebiSmart autoinjector device.
Kif twaħħal skartoċċ ta ’ Rebif • Aħsel idejk sewwa bl- ilma u bis- sapun. • Neħħi l- iskartoċċ ta ’ Rebif mill- pakkett bil- folji billi tqaxxar lura il- kisja tal- plastik. • Iċċekkja (dritt wara li tneħħih mill- friġġ) li l- iskartoċċ ma jkunx iffriżat aċċidentalment fil - pakkett jew fl- apparat RebiSmart. • Biex tpoġġi l- iskartoċċ fl- apparat u tagħti l- injezzjoni, segwi l- manwal tal- istruzzjonijiet ipprovdut mal- apparat tal- awtoinjettatur RebiSmart.
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. • The instruction manual provided with the RebiSmart autoinjector device and your doctor will tell you how to choose the correct dose of 22 micrograms.
NOTA: tużax postijiet fejn tħoss balal, għoqod jew uġigħ: tkellem mat- tabib jew professur tiegħek dwar dak li ssib. • Il- manwal tal- istruzzjonijiet ipprovdut mal- apparat awtoinjettatur RebiSmart u t- tabib tiegħek jgħidulek kif għandek tagħżel id- doża t- tajba ta ’ 22 mikrogramma.
Please ensure that the dose displayed on the screen of the device corresponds to the prescribed dose of 22 micrograms before the injection. • Before the injections use an alcohol wipe to clean the skin at the injection site.
Jekk jogħġbok kun żgur li d - doża murija fuq l- iskrin tal- apparat tikkorrespondi mad- doża preskritta ta ’ 22 mikrogramma qabel l- injezzjoni. • Qabel l- injezzjonijiet, uża tajjara bl- alkoħol sabiex tnaddaf il- ġilda fejn se ssir l- injezzjoni.
If a bit of alcohol is left on the skin, you may get a stinging sensation. • Place the RebiSmart autoinjector device at a right angle (90°) against the skin. • Press the injection button. • Wait for the injection to be completed. • Remove the RebiSmart from the injection site. • Remove and discard the needle according to the RebiSmart instruction manual. • Gently massage the injection site with a dry cotton ball or gauze.
Jekk jibqa ’ ftit alkoħol fuq il- ġilda, dan jista ’ jniggżek. • Poġġi l- apparat awtoinjettatur RebiSmart f’ angolu ta ’ 90° mal- ġilda. • Agħfas il- buttuna tal- injezzjoni. • Stenna sakemm tingħata l- injezzjoni. • Neħħi r- RebiSmart mis- sit tal- injezzjoni. • Neħħi u armi l- labra skont il- manwal tal- istruzzjonijiet ta ’ RebiSmart • Immassaġġja bil- mod il- post fejn tkun sarett l- injezzjoni b’ tajjara jew garża niexfa.
Full comprehensive instructions are provided in the instruction manual that is provided with the RebiSmart autoinjector device.
Istruzzjonijiet komprensivi sħaħ huma pprovduti fil- manwal tal- istruzzjonijiet ipprovdut mal- apparat tal- awtoinjettatur RebiSmart.
If you miss a dose, continue to inject from the day of the next scheduled dose.
106 Jekk taqbeż doża, kompli hu l- injezzjoni mill- jum tad- doża li jkun imissek.
100 If you stop using Rebif
Jekk tieqaf tuża Rebif
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 ’’).
These changes in 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.
Depression may occur in 1 patient out of 10 treated for multiple sclerosis.
107 Dipressjoni tista ’ tinstab f’ pazjient wieħed minn 10 li huma taħt din il- kura li jbatu mill- isklerożi multipla.
After first injection use within 28 days.
Wara l- ewwel injezzjoni, uża fi żmien 28 jum.
Do not use Rebif if you notice any visible signs of deterioration such as if the solution in the cartridge is no longer clear and colourless or if it contains particles.
Tużax Rebif jekk tinnota sinjali ta ’ deterjorament bħal meta s- soluzzjoni fl- iskartoċċ ma tkunx għadha ċara u bla kulur jew jekk ikun fiha l- frak.
Each cartridge contains 66 micrograms corresponding to 18 million International Units (IU) of interferon beta-1a.
Kull skartoċċ fih 6622 mikrogrammi li jikkorrispondu għal 18 - il miljun Unità Internazzjonali (IU) ta ’ interferon beta- 1a.
Pre-filled cartridge (type 1 glass) with a plunger stopper (rubber) and a crimp cap (aluminium and halobutyl rubber), containing 1.5 ml solution for injection.
Skartoċċ mimli għal- lest (ħġieġ ta ’ tip 1) b’ tapp bi planġer (lastku) u b’ għatu li jissiġilla (aluminju u lastku halobutyl), li fih soluzzjoni ta ’ 1. 5 ml.
Pack size of 4 catridges.
Daqs tal- pakkett ta ’ 4 skrataċ.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il - mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Κηφισίας 41-45, Κτήριο Β GR-151 23 Μαρούσι Αθήνα Tηλ: +3 0-210-61 65 100
Jerozolimskie 178 Κηfιsίaς 41- 45, Κtήριο Β 02- 486 Warszawa GR- 151 23 Μαρούσι Polska Αθήνα Tηλ: +30- 210- 61 65 100
España Merck Farma y Química, S.L.
109 España Merck Farma y Química, S. L.
This leaflet was last approved in
110 Dan il- fuljett kien approvat l- aħħar f ’
104 PACKAGE LEAFLET:
111 FULJETT TA ’ TAGĦRIF:
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
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.
112 • Qabel tibda l- kura b’ Rebif, avża lit- tabib tiegħek jekk inti allerġiku (għandek sensittività eċċessiva) għal xi mediċini oħra.
105 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.
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 of day (preferably in the evening).
113 • tliet darbiet fil- ġimgħa • fl- istess tlett ijiem (għall- inqas 48 siegħa bejniethom) • fl- istess ħin tal- ġurnata (preferibbilment fil- għaxija).
106 Method of administration Rebif is intended for subcutaneous (under the skin) injection.
Kif jingħata Rebif hu maħsub għal injezzjoni subkutaneja (taħt il- ġilda).
If possible, the first injection(s) must be performed under the supervision of an appropriately qualified healthcare professional.
L- ewwel injezzjoni( jiet) trid issir taħt is- supervizjoni ta ’ persuna kwalifikata fil- kura tas- saħħa.
After receiving adequate training, you, a family member, friend or carer can use Rebif cartridges with the RebiSmart autoinjector device to administer the medicine at home
Wara taħriġ adegwat, inti, membru tal- familja, ħabib jew persuna oħra li tieħu ħsieb il- pazjent tistgħu tużaw l- iskartoċċi Rebif b’ apparat tal- awtoinjettatur RebiSmart biex tagħtu l- mediċina d- dar.
This medicinal product is for multidose use.
Dan il- prodott mediċinali huwa għall- użu multiplu.
The manufacturer’s instructions for using the device must be followed carefully for loading the cartridge, attaching the injection needle and administering Rebif 44 micrograms/0.5 ml.
L- istruzzjonijiet tal- manifattur biex tuża dan l- apparat iridu jiġu segwiti bl- attenzjoni biex timla l - iskartoċċ, biex twaħħal il- labra tal- injezzjoni u biex tagħti Rebif 44 microgrammi/ 0. 5 ml.
How to load the Rebif cartridge • Wash your hands thoroughly with soap and water. • Remove the Rebif cartridge from the blister pack by peeling back the plastic covering. • Check (just after removing from the refrigerator) that the cartridge is not accidentally frozen in the pack or inside the RebiSmart device. • To place the cartridge in the device and perform the injection follow the instructions in the instruction manual provided with the RebiSmart autoinjector device.
Kif twaħħal skartoċċ ta ’ Rebif • Aħsel idejk sewwa bl- ilma u bis- sapun. • Neħħi l- iskartoċċ ta ’ Rebif mill- pakkett bil- folji billi tqaxxar lura il- kisja tal- plastik. • Iċċekkja (dritt wara li tneħħih mill- friġġ) li l- iskartoċċ ma jkunx iffriżat aċċidentalment fil - pakkett jew fl- apparat RebiSmart. • Biex tpoġġi l- iskartoċċ fl- apparat u tagħti l- injezzjoni, segwi l- manwal tal- istruzzjonijiet ipprovdut mal- apparat tal- awtoinjettatur RebiSmart.
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. • The instruction manual provided with the RebiSmart autoinjector device and your doctor will tell you how to choose the correct dose of 44 micrograms.
NOTA: tużax postijiet fejn tħoss balal, għoqod jew uġigħ: tkellem mat- tabib jew professur tiegħek dwar dak li ssib. • Il- manwal tal- istruzzjonijiet ipprovdut mal- apparat awtoinjettatur RebiSmart u t- tabib tiegħek jgħidulek kif għandek tagħżel id- doża t- tajba ta ’ 44 mikrogramma.
Please ensure that the dose displayed on the screen of the device corresponds to the prescribed dose of 44 micrograms before the injection. • Before the injections use an alcohol wipe to clean the skin at the injection site.
Jekk jogħġbok kun żgur li d - doża murija fuq l- iskrin tal- apparat tikkorrespondi mad- doża preskritta ta ’ 44 mikrogramma qabel l- injezzjoni. • Qabel l- injezzjonijiet, uża tajjara bl- alkoħol sabiex tnaddaf il- ġilda fejn se ssir l- injezzjoni.
If you miss a dose, continue to inject from the day of the next scheduled dose.
114 Jekk taqbeż doża, kompli hu l- injezzjoni mill- jum tad- doża li jkun imissek.
107 If you stop using Rebif
Jekk tieqaf tuża Rebif
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’ pazjient 1 sa 10 minn 1000 li huma taħt din il- kura.
Depression may occur in 1 patient out of 10 treated for multiple sclerosis.
115 Dipressjoni tista ’ tinstab f’ pazjient 1 minn 10 li huma taħt din il- kura f’ pazjenti li jbatu mill- isklerożi multipla.
Each cartridge contains 132 micrograms corresponding to 36 million International Units (IU) of interferon beta-1a.
Kull skartoċċ fih 132 mikrogrammi li jikkorrispondu għal 36 miljun Unità Internazzjonali (IU) ta ’ interferon beta- 1a.
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
116 Għal kull tagħrif dwar din il - mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Κηφισίας 41-45, Κτήριο 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
France Merck Lipha Santé s.a.s.
117 France Merck Lipha Santé s. a. s.
111 PACKAGE LEAFLET:
118 FULJETT TA ’ TAGĦRIF:
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
Interferon beta-1a Initiation pack
Interferon beta- 1a Pakkett inizjali
112 • Before treatment with Rebif, advise your doctor if you have an allergy (hypersensitivity) to any other medicines.
Jekk ikollok reazzjonijiet inkwetanti fil- post tat- tilqim, kellem lit- tabib tiegħek. • Qabel tibda l- kura b’ Rebif, avża lit- tabib tiegħek jekk inti allerġiku (għandek sensittività eċċessiva) għal xi mediċini oħra.
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.
Must not be given to premature babies or neonates.
Dan il- prodott mediċinali fih 0. 5 mg ta ’ benzyl alkoħol f’ kull doża ta ’ 0. 1 ml u 1. 25 mg ta ’ benzyl alkoħol f’ kull doża ta ’ 0. 25 ml M’ għandux jingħata lil trabi prematuri jew lil trabi tat- twelid.
Initiating treatment
Il- bidu tal- kura
Treatment is initiated by a gradual increase of the dose in order to reduce some of the side effects.
It- trattament huwa intenzjonat għaż- żieda gradwali tad- doża biex b’ hekk jiġu mnaqqsa l- effetti kollaterali.
The initiation pack contains two identical cartridges of Rebif and you may initiate treatment with either cartridge.
120 Il- pakkett inizjali fih żewġ skrataċ identiċi ta ’ Rebif u tista ’ tibda ’ t- trattament b’ liema trid mill - iskrataċ.
The RebiSmart device is programmed to guide you through the entire initiation process and automatically increases the dose during the initiation period.
L- apparat tar- RebiSmart hu pprogrammat sabiex jieħdok tul il- proċess inizjali kollu u awtomatikament iżid id- doża tul il- perjodu inizjali.
It will also instruct you when you need to change the cartridge.
Jurik ukoll meta jkollok bżonn tbiddel l- iskartoċċ.
113 The device will ensure that: • During weeks one and two, Rebif 8.8 micrograms are injected three times per week. • During weeks three and four, Rebif 22 micrograms are injected three times per week.
L- apparatt jagħmel mezz illi: • Għal ġimgħa numru wieħed u tnejn, Rebif 8. 8 mikrogrammi għandu jkun injettat tlett darbiet fil- ġimgħa. • Għal ġimgħa numru tlieta u erbgħa, siringa ta ’ Rebif 22 mikrogrammi għandu jkun injettat tlett darbiet fil- ġimgħa.
From the fifth week onwards, after you have completed your initiation period, the RebiSmart autoinjector device will automatically switch to the standard dose regimen.
Mil- ħames ġimgħa ’ l quddiem, wara illi tkun ikkompletajt il- perjodu tal- bidu tad- doża tiegħek, l - apparat awtoinjettatur RebiSmart awtomatikament jaqleb għad- doża standard.
The usual dose is 44 micrograms (12 million IU) given three times per week for adults and adolescents from 16 years of age.
Id- doża normali hija ta ’ 44 mikrogrammi (12 il- miljun IU) mogħtija tliet darbiet fil- ġimgħa, għall - adulti u adolexxenti 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 miljuni IU) tlett darbiet fil- ġimgħa hi rakkomandata għal • pazjenti li ma jittolerawx l- għola doża. • Addolexxenti mill- eta ’ ta ’ 12- il sena.
You will need to select the dose prescribed by your doctor via the RebiSmart menu to ensure the correct recording of your dose.
Ikollok bżonn tagħżel il- doża preskritta mit- tabib tiegħek permezz tal- menu RebiSmart biex tiżgura li tiftakar d- doża tiegħek.
Rebif should be administered, if possible: • three times per week • on the same three days (at least 48 hours apart) • at the same time of day (preferably in the evening).
Rebif għandu jittieħed, kemm jista ’ jkun: • tliet darbiet fil- ġimgħa • fl- istess tlett ijiem (għall- inqas 48 siegħa bejniethom) • fl- istess ħin tal- ġurnata (preferibbilment fil- għaxija).
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 carer can use Rebif cartridges with the Rebismart autoinjector device to administer the medicine at home..
Wara taħriġ adegwat, inti, membru tal- familja, ħabib jew persuna oħra li tieħu ħsieb il- pazjent tistgħu tużaw l- iskartoċċi Rebif b’ apparat tal- awtoinjettatur RebiSmart biex tagħtu l- mediċina d- dar.
For the 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 multidose use.
Dan il- prodott mediċinali huwa għal użu multiplu.
The manufacturer’s instructions for using the device must be followed carefully for loading the cartridge, attaching the injection needle and administering Rebif.
L- istruzzjonijiet tal- manifattur biex tuża dan l- apparat iridu jiġu segwiti bl- attenzjoni biex timla l - iskartoċċ, biex twaħħal il- labra tal- injezzjoni u biex tagħti Rebif.
Your doctor will advise you on the possible injection sites (good sites include the upper thighs and the lower abdomen).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. • The Rebismart autoinjector device also includes an “initiation/titration” menu that may be activated by first selecting 44 micrograms, then selecting ‘titration’, press ‘change’, select ‘on’, press ‘ok’ and confirm ‘titration on’ by pressing ‘ok’. • Before the injections use an alcohol wipe to clean the skin at the injection site.
121 NOTA: tużax postijiet fejn tħoss balal, għoqod jew uġigħ: tkellem mat- tabib jew professur tiegħek dwar dak li ssib. • L- apparat awtoinjettatur RebiSmart jinkludi wkoll menu ta ’ “ inizjazzjoni/ titrazzjoni ” li jista ’ jiġi attivat billi l- ewwel tagħżel 44 mikrogramma, imbagħad tagħżel ‘ titrazzjoni ’, agħfas ‘ ibdel ’, agħżel ‘ mixgħul ’, agħfas ‘ ok ’ u kkonferma ‘ titrazzjoni mixgħula ’ billi tagħfas ‘ ok ’. • Qabel l- injezzjonijiet, uża tajjara bl- alkoħol sabiex tnaddaf il- ġilda fejn se ssir l- injezzjoni.
114 • Press the injection button. • Wait for the injection to be completed. • Remove the RebiSmart from the injection site. • Remove and discard the needle according to the RebiSmart instruction manual. • Gently massage the injection site with a dry cotton ball or gauze.
Jekk jibqa ’ ftit alkoħol fuq il- ġilda, dan jista ’ jniggżek. • Poġġi l- apparat awtoinjettatur RebiSmart f’ angolu ta ’ 90° mal- ġilda. • Agħfas il- buttuna tal- injezzjoni. • Stenna sakemm tingħata l- injezzjoni. • Neħħi r- RebiSmart mis- sit tal- injezzjoni. • Neħħi u armi l- labra skont il- manwal tal- istruzzjonijiet ta ’ RebiSmart • Immassaġġja bil- mod il- post fejn tkun sarett l- injezzjoni b’ tajjara jew garża niexfa.
If you forget to use Rebif
Jekk tinsa tuża Rebif:
If you stop using Rebif
Jekk tieqaf tuża Rebif:
The refore 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.
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.
122 Sintomi oħra relatati ma ’ l- interferon beta u li huma anqas komuni (bejn 1 u 10 minn 100 lu huma taħt din il- kura) jinkludu diarrea, nuqqas ta ’ aptit, vomitu, infjammazzjoni tal- fwied, 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 reazzjonijet serji tal- ġilda u tal- membrani mukosi.
If, immediately following Rebif administration you experience a sudden difficulty breathing, which may appear in
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.
Depression may occur in 1 patient out of 10 treated for multiple sclerosis.
Dipressjoni tista ’ tinstab f’ pazjient 1 minn 10 li huma taħt din il- kura li jbatu mill- isklerożi multipla.
Do not use Rebif after the expiry date that is stated on the label after EXP.
Tużax Rebif wara d- data ta ’ skadenza li tidher fuq it- tikketta wara JIS.
Each cartridge contains 132 micrograms corresponding to 36 million International Units (IU) of interferon beta-1a.
Kull skartoċċ fih 132 mikrogrammi li jikkorrispondu għal 36
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 alkoħol, sodium acetate, acetic acid, sodium hydroxide u ilma għall - injezzjoni.
Pack size of 2 catridges.
Daqs tal- pakkett ta ’ 2 skrataċ.
116 Marketing Authorisation Holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq
Eesti Österreich Merck Serono Esindaja C/o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kaunas, Leedu Tel: +370 37320603
124 Eesti Österreich Merck Serono Esindaja C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kaunas, Leedu Tel: +370 37320603
Latvija Merck Serono Pārstāvniecība C/o Ares Trading SA Baltic States Zamenhofo 11-3, LT-44287 Kauņa, Lietuva Tel: +370 37320603
125 Latvija Merck Serono Pārstāvniecība C/ o Ares Trading SA Baltic States Zamenhofo 11- 3, LT- 44287 Kauņa, Lietuva Tel: +370 37320603
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What is ReFacto AF?
X’ inhu ReFacto AF?
ReFacto AF is a powder and solvent that are mixed together to make up a solution for injection.
ReFacto AF huwa trab u solvent li jitħalltu flimkien biex jagħmlu soluzzjoni għall- injezzjoni.
ReFacto AF contains the active substance moroctocog alfa.
ReFacto AF fih is- sustanza attiva moroctocog alfa.
What is ReFacto AF used for?
Għal xiex jintuża ReFacto AF?
ReFacto AF is used for the treatment and prevention of bleeding in patients with haemophilia A (an inherited bleeding disorder).
ReFacto AF jintuża fit- trattament u fil- prevenzjoni ta ’ fsada f’ pazjenti li jbatu mill- emofilija A (marda li tintiret ta ’ fsada).
ReFacto AF can be used in patients of all ages, including newborns.
ReFacto AF jista ’ jintuża f’ pazjenti ta ’ kull età, inkluż trabi tat- twelid.
How is ReFacto AF used?
Kif jintuża ReFacto AF?
ReFacto AF should be started by a doctor who has experience in the treatment of haemophilia A.
ReFacto AF għandu jinbeda minn tabib li jkollu esperjenza fil- kura tal- emofilija A.
ReFacto AF is given by injection into a vein lasting several minutes.
ReFacto AF jingħata permezz ta ’ injezzjoni ġo vina li ddum għal bosta minuti.
The dose and the frequency of injection depend on whether ReFacto AF is used to treat or prevent bleeding, or to reduce bleeding during surgery.
Id- dożaġġ u l- frekwenza tal - injezzjoni jiddependu fuq jekk ReFacto AF jintużax biex jittratta jew jipprevjeni fsada, jew biex inaqqas il- fsada waqt intervent kirurġiku.
The dose is adjusted depending on the severity and location of the bleeding, or the type of surgery.
Id- dożaġġ jiġi adegwat skont il- kwantità u l- post tal- fsada jew it- tip ta ’ intervent kirurġiku.
Full details on how to calculate the dose are included in the Package Leaflet.
Dettalji sħaħ dwar kif tikkalkula d- doża huma inklużi fil- Fuljett ta ’ Tagħrif.
Patients or their carers can give injections of ReFacto AF, provided that they have been trained appropriately.
Il- pazjenti jew min ikun qed jieħu ħsiebhom jistgħu jagħtu l- injezzjoni ta ’ ReFacto AF ladarba dawn jiġu mħarrġa b’ mod xieraq.
How does ReFacto AF work?
Kif jaħdem ReFacto AF?
The active substance in ReFacto AF, moroctocog alfa, is a blood coagulation factor protein (a substance that helps the blood to clot).
Is- sustanza attiva f’ ReFacto AF, moroctocog alfa, hija proteina fattur li jgħaqqad id- demm (sustanza li tgħin lid- demm jagħqad).
Patients with haemophilia A lack a protein called factor VIII, which is involved in blood clotting.
Il- pazjenti li jkollhom emofilija A m’ għandhomx proteina li tissejjaħ fattur VIII, li hija involuta fl- għaqid tad- demm.
The lack of factor VIII causes blood clotting problems, such as bleeding in the joints, muscles and internal organs.
In- nuqqas tal- fattur VIII jikkawża problemi ta ’ għaqid tad- demm, bħalma hija fsada fil- ġogi, fil- muskoli u fl- organi interni.
ReFacto AF is used to replace the missing factor VIII.
ReFacto AF jintuża biex jissostitwixxi l- fattur VIII nieqes.
It corrects the factor VIII deficiency and gives temporary control of the bleeding disorder.
Dan jikkoreġi n- nuqqas tal- fattur VIII u jagħti kontroll temporanju fuq id- disturb bil- fsada.
Moroctocog alfa is not extracted from human blood but is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce human coagulation factor VIII.
Moroctocog alfa ma tittieħidx mid- demm uman iżda tiġi prodotta permezz ta ’ metodu magħruf bħala ‘ teknoloġija tad- DNA rikombinanti ’: hija magħmula minn ċellola li tkun irċeviet ġene (DNA), li jagħmilha kapaċi tipproduċi l- fattur VIII li jgħaqqad id- demm uman.
1 Previously known as ReFacto.
1 Preċedentement magħruf bħala ReFacto.
How has ReFacto AF been studied?
Kif ġie studjat ReFacto AF?