qanastek/EMEA-V3 huggingface dataset:
If you are taking a treatment against parasite infection, please tell your doctor.
Jekk inti qed tieħu kura kontra infezzjoni bil- parassiti, jekk jogħoġbok għid lit- tabib tiegħek.
Xolair may reduce the efficacy of your treatment.
Xolair jista ’ jnaqqas l- effikaċja tal- kura tiegħek.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, even those not prescribed.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
Pregnancy and breast-feeding If you are pregnant or plan to become pregnant, tell your doctor before starting treatment with Xolair.
Tqala u treddigħ Jekk int ħriġt tqila jew bi ħsiebek toħroġ tqila, kellem lit- tabib tiegħek qabel tibda l- kura b’ Xolair.
Your doctor will discuss with you the benefits and potential risks of being given this medicine during pregnancy.
It - tabib tiegħek se jiddiskuti miegħek il- benefiċji u r- riskji jekk tieħu din il- mediċina waqt it- tqala.
If you become pregnant while being treated with Xolair, tell your doctor straight away.
Jekk toħroġ tqila waqt li tkun qed tiġi kkurata b’ Xolair, għarraf lit- tabib tiegħek minnufih.
If you are breast-feeding or intend to breast-feed, get advice from your doctor before taking Xolair.
Jekk qed tredda jew bi ħsiebek tredda, ħu parir min għand it- tabib tiegħek qabel tieħu Xolair.
Xolair may be passed in your breast milk to your baby.
Xolair jista ’ joħroġ mal- ħalib tas- sider u tieħdu t- tarbija tiegħek.
Driving and using machines Xolair can make some people feel dizzy, sleepy or faint, although this is uncommon.
Sewqan u tħaddim ta ’ magni Meta jieħdu Xolair, xi ftit nies jistgħu jħossuhom sturduti, bi ngħas jew jintilfu minn sensihom, għalkemm dan mhux komuni.
Take care: make sure you are not affected before you drive or use machines.
Ħu ħsieb: aċċerta ruħek li ma jeffettwakx qabel issuq jew tuża magni.
Important information about some of the ingredients of Xolair If you are a diabetic or have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking Xolair.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Xolair Jekk inti tbati mid- dijabete jew qallek it- tabib li tbati minn- nuqqas ta ’ tolleranza għal xi tipi ta ’ zokkor, kellem lit- tabib tiegħek qabel tieħu Xolair.
Xolair contains sucrose.
Xolair fih sucrose.
HOW TO USE XOLAIR
KIF JINTUŻA XOLAIR
Your doctor or nurse will give you Xolair as an injection just under the skin.
It- tabib jew infermier tiegħek se jtik Xolair bħala injezzjoni eżatt taħt il- ġilda.
Before you start Xolair therapy, your doctor will do a blood test to measure the amount of IgE in your blood.
Qabel ma tibda t- terapija b’ Xolair, it- tabib tiegħek se jgħamillek test tad- demm biex ikun jaf l- ammont ta ’ IgE li għandek fid- demm.
The doctor will work out how much Xolair you need and how often you will be given it.
It- tabib se jikkalkula kemm se jkollok bżonn Xolair u kemm se jkollok bżonn tirċevih ta ’ spiss.
This will depend on your body weight and the amount of IgE measured in your blood.
Dan jiddependi minn fuq il- piż ta ’ ġismek, u l- ammont ta ’ IgE li jkollok fid - demm.
87 Follow your doctor’ s instructions carefully.
Segwi l- istruzzjonijiet tat- tabib tiegħek bir- reqqa.
How much you will be given You will be given 1-3 injections.
Kemm se tingħata Se tingħata bejn 1- 3 injezzjonijiet.
The injections will be given every two weeks, or every four weeks.
L- injezzjonijiet jingħataw kull ġimgħatejn, jew kull erba ’ ġimgħat.
You will need to carry on taking your current asthma medicine during Xolair treatment.
Se jkollok bżonn tibqa ’ tieħu l- mediċini li qed tieħu bħalissa għall- ażżma waqt il- kura b’ Xolair.
Do not stop taking any asthma medications without talking to your doctor.
Twaqqaf l- ebda mediċina għall- ażżma mingħajr ma tkellem lit- tabib tiegħek.
You may not see an immediate improvement in your asthma after beginning Xolair therapy.
Jista ’ jkun li ma tara l- ebda titjib immedjat meta tibda t- terapija b’ Xolair.
It usually takes several weeks to have the full effect.
Normalment iridu jgħaddu bosta ġimgħat qabel ikollok l- effett kollu.
If a dose of Xolair is missed Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Jekk titlef doża ta ’ Xolair Ikkuntattja lit- tabib jew lill- isptar tiegħek mill- aktar fis biex jagħtuk appuntament ieħor.
If you stop treatment with Xolair Interrupting or ending the treatment with Xolair may cause your asthma symptoms to come back.
Jekk tieqaf tieħu Xolair Jekk twaqqaf il- kura b’ Xolair għal xi żmien jew għall- kollox, jistgħu jerġgħu joħorġu s- sintomi ta ’ l - ażżma.
Like all medicines, Xolair can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Xolair jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The side effects caused by Xolair are usually mild to moderate but occasionally can be serious.
L - effetti sekondarji kawżati b’ Xolair ħafna drabi jkunu minn ħfief għal moderati iżda kultant jistgħu jkunu serji.
Serious side effects include: • Sudden severe allergic reactions (rare - likely to affect between 1 and 10 in every 10,000 patients).
Effetti sekondarji serji jinkludu: • Reazzjonijiet allerġiċi serji f’ salt wieħed (rari – x’ aktarx jeffettwa bejn 1 u 10 f’ kull 10, 000 pazjent).
If you notice sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness and light- headedness, shortness of breath, wheezing or trouble breathing, or any other new symptoms, tell your doctor or nurse immediately. • Development of any combination of the following symptoms: pain, numbness, tingling in the arms and legs, lumps or raised patches in the skin, worsening problems with breathing, nasal congestion (signs of so-called “ Churg-Strauss syndrome”). • Low blood platelet count with symptoms such as bleeding or bruising more easily than normal. • Development of any of the following symptoms, especially if in combination: joint pain with or without swelling, rash, fever, swollen lymph nodes, muscle pain (signs of serum sickness).
Jekk tinnota xi sinjali ta ’ allerġija f’ salt wieħed bħal raxx, ħakk jew ħorriqija fuq il- ġilda, nefħa fil- wiċċ, xofftejn, ilsien jew partijiet oħra tal- ġisem, qalb tħabbat bil- għaġġla, sturdament jew rasek ħafifa, qtugħ ta ’ nifs, tħarħir jew tbatija biex tieħu n- nifs jew xi sintomu ieħor ġdid, għid lit- tabib jew infermier tiegħek mill- ewwel. • Żvilupp ta ’ kwalunkwe kumbinazzjoni bejn dawn is- sintomi li ġejjin: uġigħ, tnemnim, tingiż fid- dirgħajn u r- riġlejn, għoqiedi jew dbabar minfuħa fil- ġilda, aggravar ta ’ problemi bin- nifs, imnieħer imblukkat (sinjali ta ’ l- hekk imsejjħa “ Sindrome Churg- Strauss ”). • Għadd baxx tal- plejtlits b’ sintomi bħall fsada jew tbenġil aktar malajr mis- soltu. • Żvilupp ta ’ kwalunkwe mis- sintomi li ġejjin, speċjalment jekk iseħħu flimkien: uġigħ fil- ġogi bin- nefħa jew mingħajrha, raxx, deni, għoqod tal- limfa minfuħin, uġigħ fil- muskoli (sinjali ta ’ mard tas- serum).
If you experience any of these, tell your doctor or nurse straight away.
Jekk tħoss xi ħaga minn dawn, għid lit- tabib jew infermier tiegħek mill- ewwel.
Common side effects – likely to affect up to 10 in every 100 patients • headache • reactions at the injection site including pain, swelling, itching and redness.
Effetti sekondarji komuni - x’ aktarx li jeffettwaw sa 10 f’ kull 100 pazjent • Uġigħ ta ’ ras • Reazzjonijiet fil- post ta ’ l- injezzjoni inklużi uġigħ, nefħa, ħakk u ħmura.
Uncommon side effects – likely to affect up to 1 in every 100 patients • feeling dizzy, sleepy or tired • tingling or numbness of the hands or feet • fainting, low blood pressure while sitting or standing (postural hypotension), flushing • sore throat, coughing, acute breathing problems • feeling sick (nausea), diarrhoea, indigestion • itching, hives, rash, increased sensitivity of the skin to sun • weight increase • flu-like symptoms, joint pain, muscle pain and joint swelling • hair loss
89 • Tħossok sturdut, bi ngħas jew għajjien • Tħoss tingiż jew tnemnim f’ idejk jew saqajk • Tintilef minn sensik, taqalek il- pressjoni tad- demm meta tkun bil- qegħda jew bil- wieqfa (ipotensjoni skond il- qagħda), issir ruxxan • Uġigħ fil- grieżem, sogħla, problemi akuti biex tieħu n- nifs. • Tħossok ħażin (tqallih), diarrea, indiġestjoni • Ħakk, infafet, raxx, il- ġilda ssir aktar sensittiva għax- xemx • Żieda fil- piż • Sintomi li jixbħu l- influwenza, uġigħ fil- ġogi, uġigħ fil- muskoli u nefħa fil- ġogi • Jaqa ’ x- xagħar.
HOW TO STORE XOLAIR
KIF TAĦŻEN XOLAIR
- Store in the original package.
- Aħżen fil- pakkett oriġinali.
- Store in a refrigerator (2°C - 8°C).
- Aħżen fi friġġ (2°C – 8°C).
- Do not use after the expiry date which is stated on the label.
- Tużax Xolair wara d- data ta ’ skadenza li tidher fuq it- tikketta.
What Xolair contains
X’ fih Xolair
- The active substance is omalizumab.
- Is- sustanza attiva hija omalizumab.
- The other ingredients are sucrose, histidine, histidine hydrochloride monohydrate and
- Sustanzi oħra jinkludu sucrose, histidine, histidine hydrochloride monohydrate u
- An ampoule containing 2 ml of water for injections, which is used to dissolve the powder before
- Fil- pakkett issib ukoll ampulla li fiha 2 ml ta ’ ilma għall- injezzjonijiet, li jintuża sabiex jinħall
injection, is also provided in the pack.
it- trab qabel tingħata l- injezzjoni.
What Xolair looks like and contents of the pack Xolair is supplied as an off-white powder in a small glass vial together with an ampoule containing 2 ml of water for injections.
Id- Dehra ta ’ Xolair u l- kontenuti tal- pakkett Xolair huwa fornut bħala trab offwajt f’ kunjett żgħir tal- ħġieġ flimkien m’ ampulla li fiha 2 ml ta ’ ilma għall- injezzjonijiet.
The powder is reconstituted in the water before it is injected by a health professional.
It- trab huwa rikostitwit fl- ilma qabel ma jiġi injettat minn professjonist fil- kura tas- saħħa.
Each vial delivers 75 mg of omalizumab.
Kull kunjett jagħti 75 mg ta ’ omalizumab.
Xolair is available in packs containing one vial of powder for solution for injection and one ampoule of 2 ml water for injections.
Xolair huwa disponibbli f’ pakketti li fihom kunjett wieħed ta ’ trab għal soluzzjoni għall- injezzjoni u ampulla waħda ta ’ 2 ml ilma għall- injezzjonijiet.
Xolair is also available in vials with 150 mg omalizumab.
Xolair huwa disponibbli wkoll f’ kunjetti b’ 150 mg omalizumab.
Manufacturer Novartis Pharma S. A. S.
90 Manifattur Novartis Pharma S. A. S.
Italia Novartis Farma S. p. A.
91 Italia Novartis Farma S. p. A.
91 INFORMATION FOR THE HEALTHCARE PROFESSIONAL
92 TAGĦRIF GĦALL- PROFESSJONIST FIL- QASAM TAS- SAĦĦA
The lyophilised product takes 15-20 minutes to dissolve, although in some cases it may take longer.
Il- prodott lajofilizzat jieħu bejn 15- 20 minuta biex jinħall, għalkemm f’ xi każi jista ’ jieħu aktar.
The fully reconstituted product will appear clear or slightly opaque and may have a few small bubbles or foam around the edge of the vial.
Il- prodott imħallat lest jidher ċar jew ftit opak u jista ’ jkollu ftit bżieżaq ta ’ l- arja jew ragħwa max- xifer tal- kunjett.
Because of the viscosity of the reconstituted product care must be taken to WITHDRAW ALL OF THE PRODUCT from the vial before expelling any air or excess solution from the syringe in order to obtain the 0.6 ml.
Minħabba li t- taħlita tkun daqsxejn magħquda, trid tingħata attenzjoni sabiex IL- PRODOTT KOLLU JINĠIBED mill- kunjett qabel tneħħi xi arja jew soluzzjoni żejda mis- siringa sabiex tikseb 0. 6 ml.
To prepare Xolair 75 mg vials for subcutaneous administration, please adhere to the following instructions:
Sabiex tipprepara kunjetti ta ’ Xolair 75 mg użu għal taħt il- ġilda, jekk jogħġbok żomm ma ’ dawn l - istruzzjonijiet:
Draw 0.9 ml of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
Iġbed 0. 9 ml ta ’ ilma għall- injezzjonijiet mill- ampulla fis- siringa mgħammra b’ labra 18- gejġ b’ kalibru wiesa ’.
With the vial placed upright on a flat surface, insert the needle and transfer the water for injections into the vial containing the lyophilised powder using standard aseptic techniques, directing the water for injections directly onto the powder.
Bil- kunjett wieqaf fuq superfiċje ċatta, daħħal il- labra u ixħet l- ilma għall- injezzjonijiet fil- kunjett li fih it- trab lajofilizzat billi tħares it- teknika asettika standard, immira l- ilma għall- injezzjonijet direttament fuq it- trab.
Keeping the vial in an upright position, vigorously swirl it (do not shake) for approximately 1 minute to evenly wet the powder.
Bil- kunjett wieqaf, dawwar bil- qawwi (imma tħawwadx) għal madwar minuta sabiex it- trab jixxarrab kollu b’ mod indaqs.
To aid in dissolution after completing step 3, gently swirl the vial for 5-10 seconds approximately every 5 minutes in order to dissolve any remaining solids.
Jekk jiġri hekk, erġa irrepeti punt 4 sakemm ma jibqgħux jidhru biċċiet qishom ġell fis- soluzzjoni.
If this is the case, repeat step 4 until there are no visible gel-like particles in the solution.
Meta l- prodott jinħall għal kollox m’ għandux ikollu biċċiet qieshom ġell jidhru fis- soluzzjoni.
When the product is fully dissolved, there should be no visible gel-like particles in the solution.
Ħafna drabi jkun hemm bżieżaq żgħar jew rawgħa max- xifer tal- kunjett.
The reconstituted product will appear clear or slightly opaque.
Il- prodott imħallat lest ikun jidher ċar jew ftit opak.
Do not use if solid particles are present.
Tuzahx jekk ikun hemm xi biċċiet solidi fih.
Invert the vial for at least 15 seconds in order to allow the solution to drain towards the stopper.
Aqleb il- kunjett għal mill- anqas 15- il sekonda sabiex tħalli s- soluzzjoni tinżel l- isfel lejn it- tapp.
Using a new 3-ml syringe equipped with a large-bore, 18-gauge needle, insert the needle into the inverted vial.
B’ siringa ġdida ta ’ 3 ml mgħammra b’ labra ta ’ kalibru wiesa ’, 18- gejġ, daħħal il- labra fil- kunjett maqlub.
Keeping the vial inverted position the needle tip at the very bottom of the solution in the vial when drawing the solution into the syringe.
Bil- kunjett rasu l- isfel, poġġi l- ponta tal- labra fil- qiegħ nett tas- soluzzjoni fil- kunjett waqt li tiġbed is- soluzzjoni fis- siringa.
Before removing the needle from the vial, pull the plunger all the way back to the end of the syringe barrel in order to remove all of the solution from the inverted vial.
Qabel toħroġ il- labra mill- kunjett, iġbed il- planġer lura għal kollox sat- tarf tal- bettija tas- siringa sabiex tneħħi s- soluzzjoni kollha mill- kunjett maqlub rasu l- isfel.
Expel air, large bubbles, and any excess solution in order to obtain the required 0.6 ml dose.
Imbotta l- arja, bżieżaq kbar, u s- soluzzjoni żejda sabiex tikseb id- doża ta ’ 0. 6 ml li hemm bżonn.
Do not use Xolair to prevent or treat other allergy-type conditions, such as:
94 Tużax Xolair biex tevita jew tikkura kundizzjonijiet oħra tat- tip allerġiku, bħal:
93 Xolair will not harm you but you may need other medicines to treat these conditions.
Xolair mhux ser jgħamillek ħsara iżda jkollok bżonn mediċini oħrajn biex tikkura dawn il - kundizzjonijiet.
Important information about some of the ingredients of Xolair If you are a diabetic or have been told by your doctor that you have an intolerance to some sugars, talk to your doctor before taking Xolair.
95 Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Xolair Jekk inti tbati mid- dijabete jew qallek it- tabib li tbati minn- nuqqas ta ’ tolleranza għal xi tipi ta ’ zokkor, kellem lit- tabib tiegħek qabel tieħu Xolair.
94 Follow your doctor’ s instructions carefully.
Segwi l- istruzzjonijiet tat- tabib tiegħek bir- reqqa.
Other side effects include:
96 Effetti sekondarji oħra jinkludu:
Uncommon side effects – likely to affect up to 1 in every 100 patients • feeling dizzy, sleepy or tired • tingling or numbness of the hands or feet • fainting, low blood pressure while sitting or standing (postural hypotension), flushing • sore throat, coughing, acute breathing problems • feeling sick (nausea), diarrhoea, indigestion • itching, hives, rash, increased sensitivity of the skin to sun • weight increase • flu-like symptoms, joint pain, muscle pain and joint swelling • hair loss
Effetti sekondarji mhux komuni - x’ aktarx li jeffettwaw sa 1 f’ kull 100 pazjent • Tħossok sturdut, bi ngħas jew għajjien • Tħoss tingiż jew tnemnim f’ idejk jew saqajk • Tintilef minn sensik, taqalek il- pressjoni tad- demm meta tkun bil- qegħda jew bil- wieqfa (ipotensjoni skond il- qagħda), issir ruxxan • Uġigħ fil- grieżem, sogħla, problemi akuti biex tieħu n- nifs. • Tħossok ħażin (tqallih), diarrea, indiġestjoni • Ħakk, infafet, raxx, il- ġilda ssir aktar sensittiva għax- xemx • Żieda fil- piż • Sintomi li jixbħu l- influwenza, uġigħ fil- ġogi, uġigħ fil- muskoli u nefħa fil- ġogi • Jaqa ’ x- xagħar.
Each vial delivers 150 mg of omalizumab.
Kull kunjett jagħti 150 mg ta ’ omalizumab.
Xolair is available in packs containing one, four or ten vials of powder for solution for injection and one, four or ten ampoules of 2 ml water for injections.
Xolair huwa disponibbli f’ pakketti li fihom kunjett wieħed, erba ’ kunjetti jew għaxar kunjetti ta ’ trab għal soluzzjoni għall- injezzjoni u ampulla waħda, erba ’ ampulli jew għaxar ampulli ta ’ 2 ml ilma għall- injezzjonijiet.
Xolair is also available in vials with 75 mg omalizumab.
Xolair huwa disponibbli wkoll f’ kunjetti b’ 75 mg omalizumab.
Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
97 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
Ireland Novartis Ireland Limited Tel: +353 1 260 12 55
98 Ireland Novartis Ireland Limited Tel: +353 1 260 12 55
98 INFORMATION FOR THE HEALTHCARE PROFESSIONAL
99 TAGĦRIF GĦALL- PROFESSJONIST FIL- QASAM TAS- SAĦĦA
The fully reconstituted product will appear clear or slightly opaque and may have a few small bubbles or foam around the edge of the vial.
Il- prodott imħallat lest jidher ċar jew ftit opak u jista ’ jkollu ftit bżieżaq ta ’ l- arja jew ragħwa max- xifer tal - kunjett.
Because of the viscosity of the reconstituted product care must be taken to WITHDRAW ALL OF THE PRODUCT from the vial before expelling any air or excess solution from the syringe in order to obtain the 1.2 ml.
Minħabba li t- taħlita tkun daqsxejn magħquda, trid tingħata attenzjoni sabiex IL- PRODOTT KOLLU JINĠIBED mill- kunjett qabel tneħħi xi arja jew soluzzjoni żejda mis- siringa sabiex tikseb 1. 2 ml.
To prepare Xolair 150 mg vials for subcutaneous administration, please adhere to the following instructions:
Sabiex tipprepara kunjetti ta ’ Xolair 150 mg użu għal taħt il- ġilda, jekk jogħġbok żomm ma ’ dawn l - istruzzjonijiet:
Draw 1.4 ml of water for injections from the ampoule into a syringe equipped with a large-bore 18-gauge needle.
Iġbed 1. 4 ml ta ’ ilma għall- injezzjonijiet mill- ampulla fis- siringa mgħammra b’ labra 18- gejġ b’ kalibru wiesa ’.
99 PACKAGE LEAFLET:
100 FULJETT TA ’ TAGĦRIF:
Xolair 75 mg solution for injection Xolair 150 mg solution for injection Omalizumab
Xolair 75 mg soluzzjoni għall- injezzjoni Xolair 150 mg soluzzjoni għall- injezzjoni Omalizumab
Before you are given Xolair 3.
Qabel ma tingħata Xolair 3.
How Xolair is given 4.
Kif għandu jingħata Xolair 4.
WHAT XOLAIR IS AND WHAT IT IS USED FOR
X’ INHU XOLAIR U GĦALXIEX JINTUŻA 1.
Xolair is used to prevent asthma from getting worse by controlling symptoms of severe allergic asthma in adults or adolescents (12 years of age and older) who are already receiving asthma medication, but whose asthma symptoms are not well controlled by medicines such as high-dose steroid inhalers or beta-agonist inhalers.
Xolair jintuża biex jevita milli taggrava l- ażma billi jikkontrolla s- sintomi ta ’ ażma allerġika qawwija fl- adulti jew l- adolexxenti (minn 12- il sena ’ l fuq) li jkunu diġà qed jieħdu mediċini għall- ażma iżda li l- ażma tagħhom ma tkunux ikkontrollata tajjeb b’ mediċini bħal dożi għoljin ta ’ sterojdi li jittieħdu man- nifs jew b’ agonisti- beta li jittieħdu man- nifs.
Xolair works by blocking a substance called immunoglobulin E (IgE), which is produced by the body.
Xolair jaħdem billi jimblokka sustanza msejħa immunoglobulina E (IgE), li tiġi magħmula mill- ġisem.
IgE plays a key role in causing allergic asthma.
IgE għandu rwol important ħafna bħala fattur li jikkawża l- ażma allerġika.
BEFORE YOU ARE GIVEN XOLAIR
QABEL MA TINGĦATA XOLAIR
You should not be given Xolair
M’ għandekx tingħata Xolair
ingredients are listed in section 6 of this leaflet.
Is- sustanzi qegħdin imniżżla f’ sezzjoni 6 ta ’ dan il- fuljett.
If you think you may be allergic, tell your doctor since you should not be given Xolair.
Jekk inti taħseb li inti allerġiku/ a, għid lit- tabib tiegħek minħabba li m’ għandekx tingħata Xolair
Take special care with Xolair Tell your doctor before you are given Xolair:
Oqogħod attent b’ Xolair Għid lit- tabib tiegħek qabel tingħata Xolair:
- If you have kidney or liver problems.
- Jekk inti għandek problemi fil- kliewi jew fil- fwied.
- If you have a disorder where your own immune system attacks parts of your own body
- Jekk inti għandek disturb fejn is- sistema immuni tiegħek stess tattakka partijiet mill- ġisem
(autoimmune disease).
tiegħek stess (marda awtoimmuni).
- If you live in a region where infections caused by parasites are common or if you are travelling
- Jekk inti toqogħod f’ reġjun fejn infezzjonijiet minn parassiti huma komuni jew jekk inti se tmur
to such a region as Xolair may weaken your resistance to such infections.
f’ reġjun bħal dan minħabba li Xolair jista ’ jdgħajjef ir- reżistenza tiegħek għal infezzjonijiet bħal dawn.
Signs include rash, difficulty in breathing, swelling or feeling faint.
Sinjali ta ’ dan jinkludu raxx, tbatija biex tieħu n- nifs, nefħa jew tħossok tintilef minn sensik.
Xolair does not treat acute asthma symptoms, such as a sudden asthma attack.
Xolair ma jikkurax sintomi akuti tal- ażma, bħal attakk tal- ażma għal għarrieda.
Xolair is not meant to prevent or treat other allergy-type conditions, such as sudden allergic reactions, hyperimmunoglobulin E syndrome (an inherited immune disorder), aspergillosis (a fungus-related lung disease), food allergy, allergic skin rash or hay fever.
Xolair mhuwiex intenzjonat li jilqa ’ kontra jew jikkura kundizzjonijiet oħra tat- tip allerġiċi, bħal reazzjonijiet allerġiċi għall- għarrieda, sindrome ta ’ iperimmunoglobulina E (disturb immuni li jintiret), asperġillożi (marda tal- pulmun li għandha x’ taqsam ma ’ fungu), allerġija għall- ikel, raxx allerġiku fil - ġilda jew riħ tal- ħuxlief.
100 Children (under 12 years of age) Do not give Xolair to children under 12 years of age.
101 Tfal (ta ’ età taħt it- 12- il sena) M’ għandekx tagħti Xolair lil tfal taħt it- 12- il sena.
There are not enough data in this age group.
M’ hemmx tagħrif biżżejjed fil- grupp ta’ din l- età.
Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicine, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċina oħra, anki dawk mingħajr riċetta.
This is especially important if you are taking:
Dan huwa importanti b’ mod speċjali jekk inti qed tieħu:
- medicines to treat an infection caused by a parasite, as Xolair may reduce the effect of your
- mediċini biex tikkura infezzjoni kkawżata minn parassit, minħabba li Xolair jista ’ jnaqqas l -
medicines,
effett tal- mediċini tiegħek,
- inhaled corticosteroids and other medicines for allergic asthma.
- kortikosterojdi li jittieħdu man- nifs u mediċini oħra għal ażma allerġika.
Pregnancy and breast-feeding You should not take Xolair when you are pregnant.
Tqala u treddigħ Inti m’ għandekx tieħu Xolair waqt li inti tqila.
If you plan to become pregnant, tell your doctor before starting treatment with Xolair.
Jekk qed tippjana biex toħoġ tqila, għid lit- tabib tiegħek qabel tibda l- kura b’ Xolair.
Your doctor will discuss with you the benefits and potential risks of being given this medicine during pregnancy.
It- tabib tiegħek se jiddiskuti miegħek il- benefiċji u r- riskji jekk tieħu din il- mediċina waqt it- tqala.
If you become pregnant while being treated with Xolair, tell your doctor immediately.
Jekk toħroġ tqila waqt li tkun qed tiġi kkurata b’ Xolair, għid lit- tabib tiegħek minnufih.
You should not take Xolair when you are breast feeding.
Inti m’ għandekx tieħu Xolair waqt li tkun qed tredda ’.
Driving and using machines Xolair may make you feel dizzy, sleepy or faint.
Sewqan u tħaddim ta ’ magni Xolair jista ’ jġagħlek tħossok stordut/ a, bi ngħas jew tħoss li se jagħtik ħass ħażin.
If this happens to you, do not drive or use machines.
Jekk dan jiġrilek, issuqx u tħaddimx magni.
HOW XOLAIR IS GIVEN
KIF GĦANDU JINGĦATA XOLAIR
Xolair is given to you by a doctor or nurse as an injection just under the skin.
Xolair jingħatalek minn tabib jew infermier bħala injezzjoni eżatt taħt il- ġilda.
Your doctor will work out how much Xolair you need, and how often you will be given it.
It- tabib tiegħek se jaħdem kemm għandek bżonn Xolair, u kemm- il darba se tieħdu.
This depends on your body weight and the results of a blood test carried out before the start of the treatment to measure the amount of IgE in your blood.
Dan jiddependi mill - piż tal- ġisem tiegħek u mir- riżultat ta ’ test tad- demm li jsir qabel il- bidu tal- kura biex ikejjel l - ammont ta ’ IgE fid- demm tiegħek.
Follow carefully all instructions given by your doctor or nurse.
Segwi sewwa l- istruzzjonijiet kollha li tak it- tabib jew l- infermier tiegħek.
How much you will be given You will be given 1 to 3 injections at a time, either every two weeks, or every four weeks.
Kemm se tingħata Inti se tingħata minn injezzjoni waħda sa 3 injezzjonijiet kull darba, jew kull ġimagħtejn, jew kull erba ’ ġimgħat.
Carry on taking your current asthma medicine during Xolair treatment.
Ibqa ’ ħu l- mediċina tiegħek tal- ażma li qed tieħu bħalissa waqt li tieħu l- kura b’ Xolair.
Do not stop taking any asthma medicines without talking to your doctor.
Tieqafx tieħu xi mediċina tal- ażma mingħajr ma tkellem lit- tabib tiegħek.
If a dose of Xolair is missed Contact your doctor or hospital as soon as possible to re-schedule your appointment.
Jekk titlef doża ta ’ Xolair Ikkuntattja lit- tabib jew lill- isptar tiegħek kemm jista ’ jkun malajr biex terġa ’ tagħmel appuntament ieħor.
If you stop treatment with Xolair Interrupting or stopping the treatment with Xolair may cause your asthma symptoms to come back.
102 Jekk tieqaf mill- kura b ’ Xolair Jekk twaqqaf il- kura b’ Xolair għal xi żmien jew għall- kollox, jistgħu jerġgħu joħorġu s- sintomi tal - ażma.
The side effects caused by Xolair are usually mild to moderate but can occasionally be serious:
L- effetti sekondarji kkawżati b’ Xolair ħafna drabi jkunu minn ħfief għal moderati iżda kultant jistgħu jkunu serji:
Common side effects (affects 1 to 10 users in 100) Uncommon side effects (affects 1 to 10 users in 1,000) 101 Rare side effects (affects 1 to 10 users in 10,000) Not known (frequency cannot be estimated from the available data)
Effetti sekondarji komuni (jaffettwaw minn persuna 1 sa 10 persuni minn kull 100 li jużawh) Effetti sekondarji mhux komuni (jaffettwaw minn persuna 1 sa 10 persuni minn kull 1, 000 li jużawh) Effetti sekondarji rari (jaffettwaw minn persuna 1 sa 10 persuni minn kull 10, 000 li jużawh) Mhux magħrufa (ma tistax tittieħed stima mid- data disponibbli)
Serious side effects include:
Effetti sekondarji serji jinkludu:
Rare side effects • Sudden severe allergic reactions.
Effetti sekondarji rari • Reazzjonijiet allerġiċi qawwijin f’ daqqa waħda.
If you notice any serious sudden sign of allergy or combination of signs such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, fast heart beat, dizziness and light-headedness, shortness of breath, wheezing or trouble breathing, or any other new symptoms, tell your doctor or nurse immediately.
Jekk tinnota xi sinjal serju u f’ daqqa waħda ta ’ allerġija bħal raxx, ħakk jew ħorriqija fuq il- ġilda, nefħa fil- wiċċ, xofftejn, ilsien jew partijiet oħra tal- ġisem, qalb tħabbat bil- għaġġla, sturdament jew rasek ħafifa, qtugħ ta ’ nifs, tħarħir jew tbatija biex tieħu n- nifs jew xi sintomu ieħor ġdid, għid lit- tabib jew infermier tiegħek mill - ewwel.
Not known • Development of any combination of the following symptoms: pain, numbness, tingling in the arms and legs, lumps or raised patches in the skin, worsening problems with breathing, nasal congestion (signs of so-called “ Churg-Strauss syndrome”). • Low blood platelet count with symptoms such as bleeding or bruising more easily than normal. • Development of any of the following symptoms, especially if in combination: joint pain with or without swelling, rash, fever, swollen lymph nodes, muscle pain, (signs of serum sickness).
Mhux magħruf • Żvilupp ta ’ kwalunkwe taħlita tas- sintomi li ġejjin: uġigħ, tnemnim, tingiż fid- dirgħajn u r - riġlejn, għoqiedi jew dbabar minfuħa fil- ġilda, problemi bin- nifs li jmorru għall- agħar, konġestjoni fl- imnieħer (sinjali tal- hekk imsejjħa “ Sindrome Churg- Strauss ”). • Għadd baxx tal- plejtlits b’ sintomi bħal fsada jew tbenġil aktar malajr mis- soltu. • Żvilupp ta ’ kwalunkwe minn dawn is- sintomi li ġejjin, speċjalment jekk iseħħu flimkien: uġigħ fil- ġogi bin- nefħa jew mingħajrha, raxx, deni, għoqod tal- limfa minfuħin, uġigħ fil- muskoli (sinjali ta ’ marda tas- serum).
If you experience any of these, tell a doctor or nurse straight away.
Jekk tħoss xi ħaga minn dawn, għid lit- tabib jew infermier tiegħek mill- ewwel.
Common side effects • headache • reactions at the injection site including pain, swelling, itching and redness.
Effetti sekondarji komuni • uġigħ ta ’ ras • reazzjonijiet fil- post tal- injezzjoni inklużi uġigħ, nefħa, ħakk u ħmura.
Uncommon side effects • feeling dizzy, sleepy or tired • tingling or numbness of the hands or feet • fainting, low blood pressure while sitting or standing (postural hypotension), flushing • sore throat, coughing, acute breathing problems • feeling sick (nausea), diarrhoea, indigestion • itching, hives, rash, increased sensitivity of the skin to sun • weight increase • flu-like symptoms, joint pain, muscle pain and joint swelling • hair loss
Effetti sekondarji mhux komuni • tħossok sturdut, bi ngħas jew għajjien • tħoss tingiż jew tnemnim f’ idejk jew saqajk • tintilef minn sensik, taqalek il- pressjoni tad- demm meta tkun bil- qegħda jew bil- wieqfa (ipotensjoni skont il- qagħda), issir ruxxan • uġigħ fil- grieżem, sogħla, problemi akuti biex tieħu n- nifs. • tħossok ħażin (tqallih), diarrea, indiġestjoni • ħakk, infafet, raxx, il- ġilda ssir aktar sensittiva għax- xemx • żieda fil- piż • sintomi li jixbħu l- influwenza, uġigħ fil- ġogi, uġigħ fil- muskoli u nefħa fil- ġogi • jaqa ’ x- xagħar.
Rare side effects • parasitic infection
Effetti sekondarji rari • infezzjoni ta ’ parassiti
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
103 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.
- Do not use after the expiry date which is stated on the label.
- Tużahx wara d- data ta ’ skadenza li tidher fuq it- tikketta.
- Store in the original package in order to protect from light.
- Żommu fil- pakkett oriġinali sabiex tilqa ’ mid- dawl.
- Do not use any pack that is damaged or shows signs of tampering.
- Tużax kwalunkwe pakkett li jkun danneġġat jew ikollu sinjali ta ’ tbagħbis.
- The active substance is omalizumab.
- Is- sustanza attiva hi omalizumab.
One syringe of 0.5 ml solution contains 75 mg
Siringa waħda b’ 0. 5 ml ta ’ soluzzjoni fiha 75 mg
One syringe of 1 ml solution contains 150 mg omalizumab.
Siringa waħda b’ 1 ml ta ’ soluzzjoni fiha 150 mg omalizumab.
- The other ingredients are L-arginine hydrochloride, L-histidine hydrochloride, L-histidine,
- Is- sustanzi l- oħra huma L- arginine hydrochloride, L- histidine hydrochloride, L- histidine,
Polysorbate 20 and water for injections.
Polysorbate 20 u ilma għall- injezzjonijiet.
What Xolair looks like and contents of the pack Xolair solution for injection is supplied as a clear to opalescent, slightly yellow to brown solution in a pre-filled syringe, and is available as 75 mg and 150 mg solution for injection.
Id- Dehra ta ’ Xolair u l- kontenuti tal- pakkett Xolair soluzzjoni għall- injezzjoni huwa fornut bħala soluzzjoni minn trasparenti sa tkanġi, minn safra sa kemmxejn kannella f’ siringa mimlija għal- lest, u huwa disponibbli bħala soluzzjoni ta ’ 75 mg u 150 mg għall- injezzjoni.
Xolair 75 mg solution for injection is available in packs containing 1 pre-filled syringe and in multipacks comprising 4 or 10 intermediate packs, each containing 1 pre-filled syringe.
Xolair 75 mg soluzzjoni għall- injezzjoni huwa disponibbli f’ pakketti li fihom siringa waħda mimlija għal- lest u f’ pakketti b’ ħafna li fihom 4 jew 10 pakketti iżgħar, li kull wieħed minnhom fih siringa waħda mimlija għal- lest.
Xolair 150 mg solution for injection is available in packs containing 1 pre-filled syringe and in multipacks comprising 4 or 10 intermediate packs, each containing 1 pre-filled syringe.
Xolair 150 mg soluzzjoni għall- injezzjoni huwa disponibbli f’ pakketti li fihom siringa waħda mimlija għal- lest u f’ pakketti b’ ħafna li fihom 4 jew 10 pakketti iżgħar, li kull wieħed minnhom fih siringa waħda mimlija għal- lest.
Not all pack sizes may be marketed in your country.
Jista ’ jkun li mhux il- pakketti tad- daqsijiet kollha jkunu għall- skop kummerċjali f’ pajjiżek.
Manufacturer Novartis Pharma S. A. S.
Il- Manifattur Novartis Pharma S. A. S.
België/ Belgique/ Belgien Novartis Pharma N. V.
104 België/ Belgique/ Belgien Novartis Pharma N. V.
Latvija Novartis Pharma Services Inc.
105 Latvija Novartis Pharma Services Inc.
104 INFORMATION FOR THE HEALTHCARE PROFESSIONAL
106 TAGĦRIF GĦALL- PROFESSJONIST FIL- QASAM TAS- SAĦĦA
Before using the syringe, please read the following information carefully.
Qabel tuża s- siringa, jekk jogħġbok aqra sewwa l- informazzjoni li ġejja.
Each Xolair pack contains a pre-filled syringe individually sealed in a plastic wrapper.
Kull pakkett ta ’ Xolair fih siringa mimlija għall- lest issiġillata għaliha waħedha f’ tgeżwira tal- plastik.
Parts of the pre-filled syringe Needle cap
Partijiet tas- siringa mimlija għal- lest Protezzjoni Għata tal -
Needle guard Viewing window
għal- labra
Finger flange
Flanġ għas -
Activation clips
Klipps għall -
Plunger rod
labra
Label and expiration date
saba ’
Fill line
planġer
Xolair syringes are intended to be used by a healthcare professional only.
Linja sa fejn timtela Is- siringi Xolair huma maħsuba biex jintużaw biss minn professjonisti tas- saħħa.
Preparing the syringe for use Warning:
Il- preparazzjoni tas- siringa għall- użu Twissija:
Prior to completion of the injection, avoid contact with the device activation clips (see first illustration) to keep from prematurely covering the needle with the needle guard.
Qabel ma titlesta l- injezzjoni, evita l- kuntatt mal- klipps ta ’ attivazzjoni (ara l- ewwel stampa) biex tevita li tgħatti il- labra bil- protezzjoni tal- labra qabel il- waqt.
Take the box containing the syringe out of the refrigerator and leave it unopened for about 20 minutes so that it reaches room temperature.
Neħħi l- kaxxa li fiha s- siringa minn ġol- friġġ u ħalliha magħluqa għal madwar 20 minuta biex tilħaq it- temperatura tal- kamra.
When you are ready to use the syringe, wash your hands thoroughly with soap and water.
Meta inti lest/ a biex tuża s- siringa, aħsel idejk tajjeb ħafna bis- sapun u l- ilma.
Clean the injection site.
Naddaf is- sit tal- injezzjoni.
Remove the plastic tray from the box, peel back the paper cover, and remove the syringe.
Neħħi t- trej tal- plastik minn ġol- kaxxa, qaxxar l- għatu tal- karti u neħħi s- siringa.
Inspect the syringe.
Ifli s- siringa.
DO NOT USE if it is broken or if the liquid looks cloudy or contains particles.
TUŻAHIEX jekk hija mkissra jew jekk il- likwidu jidher imdardar jew fih il- frak.
In all these cases, return the entire pack to the pharmacy.
F’ dawn il- każijiet kollha, reġġa ’ l- pakkett kollu lura l- ispiżerija.
Holding the syringe horizontally (as shown below), look into the viewing window to check the dose (75 mg or 150 mg) of medicine and the expiry date printed on the label.
Filwaqt li żżomm is- siringa orizzontali (kif muri hawn taħt), ħares fit- tieqa minn fejn tara biex tiċċekkja d- doża (75 mg jew 150 mg) tal- mediċina u d- data ta ’ meta tiskadi stampata fuq it - tikketta.
Rotate the inner part of the syringe assembly as shown below so that the label can be read in the viewing window.
Dawwar l- immuntar tal- parti ta ’ ġewwa tas- siringa kif muri hawn taħt biex it - tikketta tista ’ tinqara mit- tieqa minn fejn tara.
DO NOT USE if the product has expired or if the dose is incorrect.
Tieqa minn fejn tara TUŻAĦIEX jekk il- prodott skada jew jekk id - doża hija żbaljata.
In both these cases, return the entire pack to the pharmacy.
Fiż- żewġ każijiet reġġa ’ l - pakkett kollu lura l- ispiżerija.
105 7.
107 7.
Hold the syringe vertically with the plunger uppermost and tap the side of the syringe against your finger to allow the air bubble to rise.
Żomm is- siringa vertikali bil- planġer fuq nett u tektek il- ġenb tas- siringa ma ’ subgħajk biex ġġiegħel il- bużżieqa tal- arja titla ’ ’ l fuq.
Having an air bubble is acceptable.
Il- fatt li jkollok bużżieqa tal- arja huwa aċċettabbli.
You do not have to expel any air before use.
Inti m’ għandekx għalfejn tneħħi xi arja qabel l- użu.
Check to see if the liquid level is at or above the minimum fill line.
Iċċekkja biex tara jekk il- livell tal- likwidu huwiex mal- linja sa fejn għandha mill- anqas tkun mimlija s- siringa jew aktar ’ il fuq.
If the liquid is below the fill line, return the entire pack to the pharmacy.
Jekk il- livell tal- likwidu huwa taħt il- linja sa fejn għandha mill- anqas tkun mimlija s- siringa reġġa ’ l- pakkett kollu lura l- ispiżerija.
Using the syringe
L- użu tas- siringa
Carefully pull off the needle cap from the syringe and discard it.
B’ attenzjoni neħħi l- għatu tal- labra minn mas - siringa u armih.
Keeping the plunger fully depressed, carefully lift the needle straight out from the injection site.
Filwaqt li żżomm il- planġer magħfus s’ isfel nett, b’ attenzjoni oħroġ il- labra kollha minn ġos- sit tal - injezzjoni.
106 Slowly release the plunger and allow the needle guard to automatically cover the exposed needle.
108 Bil- mod erħi l- planġer u ħalli l- protezzjoni tal - labra tgħatti l- labra mikxufa b’ mod awtomatiku.
Hold gauze on the injection site for approximately 30 seconds.
Żomm il- garża fuq is- sit tal- injezzjoni għal madwar 30 sekonda.
Disposal instructions Dispose of the used syringe immediately in a sharps container.
Istruzzjonijiet għar- rimi Armi siringi wżati immedjatament f’ kontenitur apposta għal oġġetti bix- xifer jew bil- ponta
What is Xyrem?
X’ inhu Xyrem?
Xyrem is an oral solution, which contains the active substance sodium oxybate (500 mg/ ml).
Xyrem hu soluzzjoni orali, li fiha s- sustanza attiva sodium oxybate (500 mg/ ml).
What is Xyrem used for?
Għalxiex jintuża Xyrem?
Xyrem is used to treat adults who have narcolepsy with cataplexy.
Xyrem jintuża għat- trattament ta ’ adulti li jbatu bin- narkolessija bil- kataplessja.
Narcolepsy is a sleep disorder that causes excessive daytime sleepiness.
In- narkolessija hija marda ta ’ l- irqad li twassal għal bżonn kbir ta ’ l- irqad matul il- jum.
Cataplexy is a symptom of narcolepsy involving sudden muscle weakness in response to an emotional reaction such as anger, fear, joy, laughter or surprise.
Il- kataplessja hi sintomu tan - narkolessija li tikkonsisti minn dgħufija instantanja tal- muskoli b’ rispons ta ’ reazzjoni emozzjonali bħal rabja, biża ’, ferħ, daħk jew sorpriża.
Cataplexy can sometimes cause a patient to collapse.
Xi drabi l- pazjenti jsofru minn kollass minħabba l - kataplessja.
Because the number of patients with narcolepsy is low, the disease is considered ‘ rare’, and Xyrem was designated an ‘ orphan medicine ’ (a medicine used in rare diseases) on 3 February 2003.
Minħabba l- fatt li n- numru ta ’ pazjenti bin- narkolessija huwa baxx, il- marda hija kkunsidrata bħala waħda ‘ rari ’, u fit- 3 ta ’ Frar 2003, Xyrem ġie mogħti l- isem ta ’ ‘ mediċina orfni ’ (mediċina li tintuża f' mard rari).
The medicine can only be obtained with a special prescription.
Il- mediċina tista ’ biss tinkiseb b’ riċetta speċjali.
How is Xyrem used?
Kif jintuża Xyrem?
Xyrem treatment should be initiated and given under the guidance of a doctor who has experience in the treatment of sleep disorders.
It- trattament b’ Xyrem għandu jiġi sorveljat minn tabib li jkollu esperjenza fit- trattament ta ’ mard ta ’ l - irqad.
Because sodium oxybate can be abused, doctors should check for a history of drug abuse.
Billi hawn min jabbuża minn sodium oxybate, it- tobba għandhom jindagaw jekk il- pazjent ikollux storja ta ’ abbuż mid- droga.
Xyrem is given at a dose of 4.5 to 9 g per day in two equally divided doses.
Xyrem jingħata f’ doża ta ’ 4. 5 sa 9 g kuljum maqsuma f’ żewġ dożi ndaqs.
The maximum daily dose is 9 g.
Id- doża massima hi 9 g kuljum.
Patients should usually start with two doses of 2.25 g (4.5 ml) per day.
Ġeneralment il- pazjenti għandhom jibdew b’ żewġ dożi ta ’ 2. 25 g (4. 5 ml) kuljum.
The dose is then adjusted at one- to two-week intervals depending on the patient’ s response.
Id- doża mbagħad tiġi aġġustata kull ġimgħa jew kull ġimagħtejn skond ir- rispons tal- pazjent.
The starting dose should be halved in patients who have problems with their liver.
Id- doża tal- bidu għandha titnaqqas bin- nofs għal pazjenti li għandhom problemi bil- fwied.
Patients who have problems with their kidneys should consider a low sodium diet.
Pazjenti li jkollhom problemi bil- kliewi għandhom jikkonsidraw li jnaqqsu s- sodju mid- dieta tagħhom.
Patients taking Xyrem should avoid alcohol, as it can increase Xyrem’ s effects.
Il- pazjenti li jieħdu Xyrem għandhom jevitaw l- alkoħol, għax dan jista ’ jżid l- effetti ta ’ Xyrem.
Xyrem is supplied with a measuring device and a cup.
Xyrem jitqassam b’ aċċessorju għall- kejl u tazza.
Before taking the medicine, the patient should dissolve the dose in water to make up a drink.
Qabel ma jieħu l- mediċina, il- pazjent għandu jdewweb id- doża fl- ilma biex joħloq xarba.
The first dose of the day is taken at bedtime, at least 2 to 3 hours after food.
L- ewwel doża tal- jum għandha tittieħed fil- ħin ta ’ l- irqad, ta ’ l- inqas bejn sagħtejn u 3 sigħat wara l- ikel.
The second dose is taken 2.5 to 4 hours later.
It- tieni doża tittieħed bejn sagħtejn u nofs u 4 sigħat wara.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Dan iwassal għal tibdil fl- attività tal- moħħ u b’ hekk iwassal għal mewġ 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
The active substance in Xyrem, sodium oxybate, is a central nervous system depressant.
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged tal- moħħ tat- tip ‘ delta ’ (b’ veloċità baxxa) u rqad ta ’ matul il- lejl.
When taken at bedtime, Xyrem increases deep sleep and increases the amount of time spent asleep at night, whilst reducing the number of sleeping periods during the day.
Meta jittieħed f’ ħin l- irqad, Xyrem iżid l- irqad fil- fond u jgħin lill- pazjent jorqod iktar fit- tul bil- lejl, waqt li jnaqqas l- irqad ta ’ matul il - jum.
This improves the symptoms of narcolepsy.
Dan itejjeb is- sintomi tan- narkolessija.
How has Xyrem been studied?
Kif ġie studjat Xyrem?
The effects of Xyrem in narcolepsy and cataplexy have been studied in 707 patients in four studies.
L- effetti ta ’ Xyrem fin- narkolessija u l- katalessja ġew studjati f’ 707 pazjenti f’ erba ’ studji.
In all studies, Xyrem was given at a daily dose between 3 and 9 g, and it was compared with placebo (a dummy treatment).
B’ kollox, Xyrem ingħata b’ doża ta ’ bejn 3 u 9 g kuljum, u tqabbel ma ’ plaċebo (trattament finta).
The first study (136 patients) examined the effects of Xyrem on the number of cataplexy attacks over 4 weeks of treatment.
L- ewwel studju (136 pazjent) eżamina l- effetti ta ’ Xyrem fuq numru ta ’ attakki ta ’ katalessja matul 4 ġimgħat ta ’ trattament.
The second study, including 56 patients who had taken Xyrem for at least 6 months, compared the effects of continuing to take Xyrem at the same dose as before, with switching to placebo.
It- tieni studju, li kien jikkonsisti minn 56 pazjent li kienu ħadu Xyrem għal ta ’ l- inqas 6 xhur, qabbel l- effetti tat- tkomplija tat- trattament b’ Xyrem mal- bdil għat- trattament plaċebo.
The study measured the number of cataplexy attacks over 2 weeks.
L- istudju kejjel in- numru ta ’ attakki ta ’ katalessja f’ ġimagħtejn.
The other two studies (516 patients) examined the effects of Xyrem on excessive daytime sleepiness and other symptoms of narcolepsy, either taken alone or as an add-on to the patient ’ s existing dose of modafinil (a stimulant medicine used to treat narcolepsy).
Iż- żewġ studji l- oħra (b’ 516- il pazjent) eżaminaw l- effetti ta ’ Xyrem fuq il- bżonn eċċessiv ta ’ l- irqad matul il- jum u sintomi oħra tan - narkoplessija, sew jekk meħud waħdu u sew jekk miżjud mad- doża ta ’ modafinil (mediċina stimulanti li tintuża għat- trattament tan- narkolessija) li l- pazjent ikun qed jieħu diġà.
The main measure of effectiveness was the change in daytime sleepiness.
It- tibdil fil- bżonn ta ’ l- irqad ta ’ matul il- jum intuża bħala l- kejl ewlieni ta ’ kemm hu effettiv.
What benefit has Xyrem shown during the studies?
X’ benefiċċju wera Xyrem matul l- istudji?
Xyrem was more effective than placebo in reducing symptoms.
Xyrem kien iżjed effettiv mill- plaċebo fit- tnaqqis tas- sintomi.
In the first study, a daily dose of 9 g reduced the number of cataplexy attacks by 16.1 (from 23.5 to 8.7) per week, compared to a fall of 4.3 per week in the patients taking placebo.
Fl- ewwel studju, doża ta ’ 9 g kuljum naqqset in- numru ta ’ attakki tal- katalessja b’ 16. 1 (minn 23. 5 sa 8. 7) kull ġimgħa, waqt li fil- pazjenti li kienu qed jieħdu l- plaċebo kien hemm tnaqqis ta ’ 4. 3 kull ġimgħa.
The second study showed that Xyrem continued to prevent cataplexy attacks after long-term treatment: there was no change over 2 weeks in the number of attacks in the patients continuing to take Xyrem, compared to an increase of 21.0 in those switching to placebo.
It- tieni studju wera li Xyrem kompla jipprevjeni l- attakki tal- kataplessja wara trattament fit- tul: f’ pazjenti li komplew jieħdu Xyrem ma kien hemm l- ebda tibdil fin- numru ta ’ attakki f’ ġimagħtejn waqt li kien hemm żieda ta ’ 21. 0 f’ dawk li qalbu għall- plaċebo.
Xyrem also reduced excessive daytime sleepiness, in patients who continued to take modafinil, as well as in those who took Xyrem alone.
Xyrem naqqas ukoll il- ħtieġa eċċessiva għall- irqad ta ’ matul il- jum, f’ pazjenti li komplew jieħdu modafinil, kif ukoll f’ dawk li ħadu Xyrem biss.
What is the risk associated with Xyrem?
X’ inhu r- riskju assoċjat ma ’ Xyrem?
The most common side effects when taking Xyrem (seen in more than 1 patient in 10) are dizziness, headache and nausea (feeling sick).
L- iktar effetti sekondarji komuni ta ’ meta wieħed jieħu Xyrem (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma d- dardir, l- uġigħ ta ’ ras u l- isturdament.
Nausea is more common in women than in men.
L- isturdament hu iktar komuni fin- nisa milli fl- irġiel.
Xyrem can also cause respiratory depression (inhibition of breathing).
Xyrem jista ’ jwassal ukoll għal dipressjoni respiratorja (ma jħallix pazjent jieħu n- nifs).
For the full list of all side effects reported with Xyrem, see the Package Leaflet.
Ara l- Fuljett ta ’ Tagħrif għal- lista sħiħa ta ’ effetti sekondarji rrappurtati bi Xyrem.