qanastek/EMEA-V3 huggingface dataset:
Starlix 60 mg tablets Nateglinide
Starlix 60 mg pilloli Nateglinide
Starlix 120 mg film-coated tablets Nateglinide
Starlix 120 mg pilloli miksijin b’ rita Nateglinide
1 film-coated tablet contains 120 mg nateglinide.
Pillola 1 miksija b’ rita fiha 120 mg nateglinide.
12 film-coated tablets 24 film-coated tablets 30 film-coated tablets 60 film-coated tablets 84 film-coated tablets 120 film-coated tablets 360 film-coated tablets
12 pillola miksija b’ rita 24 pillola miksija b’ rita 30 pillola miksija b’ rita 60 pillola miksija b’ rita 84 pillola miksija b’ rita 120 pillola miksija b’ rita 360 pillola miksija b’ rita
Starlix 120 mg tablets Nateglinide
Starlix 120 mg pilloli Nateglinide
Starlix 180 mg film-coated tablets Nateglinide
Starlix 180 mg pilloli miksijin b’ rita Nateglinide
1 film-coated tablet contains 180 mg nateglinide.
Pillola 1 miksija b’ rita fiha 180 mg nateglinide.
Starlix 180 mg tablets Nateglinide
Starlix 180 mg pilloli Nateglinide
Starlix 60 mg film-coated tablets Starlix 120 mg film-coated tablets Starlix 180 mg film-coated tablets Nateglinide
Starlix 60 mg pilloli miksija b’ rita Starlix 120 mg pilloli miksija b’ rita Starlix 180 mg pilloli miksija b’ rita Nateglimide
What Starlix is and what it is used for 2.
X’ inhu Starlix u għalxiex jintuża 2.
Before you take Starlix 3.
Qabel ma tieħu Starlix 3.
How to take Starlix 4.
Kif għandek tieħu Starlix 4.
How to store Starlix 6.
Kif taħżen Starlix 6.
WHAT STARLIX IS AND WHAT IT IS USED FOR
X’ INHU STARLIX U GĦALXIEX JINTUŻA
Starlix is a medicine to lower blood sugar (glucose), which is taken by mouth (these medicines are also known as oral anti-diabetics).
Starlix hija mediċina biex tbaxxi z- zokkor fid- demm (glucose), li tittieħed mill- ħalq (dawn il- mediċini huma magħrufin ukoll bħala anti- dijabetiċi li jittieħdu mill- ħalq).
It is used by people with type 2 diabetes.
Tintuża minn nies b’ dijabete tip 2.
(This kind of diabetes is also called non-insulin-dependent diabetes mellitus.)
(Din it- tip ta ’ dijabete hija msejjħa ukoll dijabete mellitus li ma tiddependix mill- insulina).
Insulin is a substance produced by a body organ called the pancreas.
L- insulina hija sustanza mgħamula minn organu tal- ġisem li jissejjaħ il- frixa.
It helps to decrease blood sugar levels, especially after meals.
Tgħin biex tnaqqas il - livell ta ’ zokkor fid- demm, speċjalment wara l- ikel.
In patients with type 2 diabetes, the body may not start producing insulin quickly enough after meals.
F’ pazjenti b’ dijabete tip 2, il- ġisem jista ’ ma jibdix jagħmel insulina malajr biżżejjed wara l- ikel.
Starlix works by stimulating the pancreas to produce insulin more quickly.
Starlix jaħdem billi jistimula l- frixa biex tibda tgħamel l- insulina iżjed malajr.
This helps to keep the blood sugar controlled after meals.
Dan jgħin biex tikkontrolla z- zokkor fid- demm wara l- ikel.
Your doctor will prescribe Starlix together with another oral anti-diabetic containing metformin.
It- tabib tiegħek ser jordnalek Starlix flimkien ma ’ mediċina anti- dijabetika oħra li tittieħed mill- ħalq, li fiha metformin.
Starlix tablets start to act quickly after you take them and are eliminated from the body rapidly.
Il- pilloli Starlix jibdew jaħdmu malajr wara li tieħodhom u huma mneħħija mill- ġisem fi żmien qasir.
BEFORE YOU TAKE STARLIX
QABEL MA TIEĦU STARLIX
Follow all instructions given to you by your doctor and pharmacist carefully, even if they are different from what is in this leaflet.
Segwi l- parir tat- tabib jew ta ’ l- ispiżjar tiegħek b’ kawtela, anke jekk ikunu differenti minn dak li hemm fil- fuljett ta ’ tagħrif.
Do not take Starlix
Tieħux Starlix
- if you are allergic (hypersensitive) to nateglinide or any of the other ingredients of Starlix.
- jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal nateglinide jew sustanzi oħra ta ’
- if you have type 1 diabetes (i. e. your body does not produce any insulin).
- jekk għandek dijabete tip 1 (i. e. il- ġisem tiegħek ma jagħmel l- ebda insulina).
- if you know that you have a severe liver problem.
- jekk taf li għandek problema severa tal- fwied.
- if you are pregnant or planning to become pregnant.
- jekk ħriġt tqila jew qed tippjana li toħroġ tqila.
Talk to your doctor if you have any further questions or you think that any of these may apply to you.
40 Itlob għall- parir tat- tabib tiegħek jekk għandek iżjed mistoqsijiet jew taħseb li kwalunkwe minn dawn japplikaw għalik.
37 Take special care with Starlix People with diabetes sometimes get symptoms of low blood sugar (also called hypoglycaemia).
Oqgħod attent ħafna bi Starlix Nies bid- dijabete xi kultant ikollhom sintomi ta` livell baxx ta ’ zokkor fid- demm (imsejjħa anke ipogliċemija).
Medicines, including Starlix, may also produce symptoms of low blood sugar.
Mediċini, inkluż Starlix, jistgħu anke jikkawżaw sintomi ta ’ livell baxx ta ’ zokkor fid - demm.
If you get any of these symptoms – feeling dizzy, light-headed, hungry, shaky or any of the other signs in section 4, “ Possible side effects” – eat or drink something containing sugar.
Jekk ikollok kwalunkwe minn dawn is- sintomi - tħossok sturdut, rasek ħafifa, bil- ġuħ, titriegħed jew kwalunkwe mis- sinjali l- oħra f’ sezzjoni 4, “ Effetti sekondarji li jista ’ jkollu ” - kul jew ixrob xi ħaġa li fiha z- zokkor.
Some people are more likely to get symptoms of low blood sugar than others.
Ftit nies huma iżjed suxxettibbli li jkollom sintomi minn oħrajn.
Take care
Ħu ħsieb
- if you are over 65 years of age.
- jekk għandek iżjed minn 65 sena
- if you are undernourished.
- jekk int nieqes mill- ikel
- if you have another medical condition that may cause low blood sugar (e. g. an under-active
- jekk qiegħed taħt kundizzjoni medika li tista ’ tikkawża livell baxx ta ’ zokkor fid- demm (ez.
pituitary or adrenal gland).
glandola pitwitarja għajjiena jew glandoli adrenali għajjenin).
If any of these apply to you, monitor your blood sugar levels more carefully.
Jekk kwalinkwe minn dawn jgħoddu għalik, ħares il- livelli taz- zokkor fid- demm tiegħek b’ aktar kawtela.
Talk to your doctor
Kellem lit- tabib tiegħek
- if you know that you have a liver problem.
- jekk taf li għandek xi problema fil- fwied
- if you have a severe kidney problem.
- jekk għandek problema severa fil- kliewi
- if you have problems of drug metabolism.
- jekk għandek problemi tal- metaboliżmu tal- mediċini
- if you are due to have an operation.
- jekk daqt ser ikollok operazzjoni
- if you have suffered a fever, an accident or an infection.
- jekk kellek id- deni, xi inċident jew infezzjoni.
Your treatment may need to be adjusted.
Il- kura tiegħek għandha mnejn ikollha bżonn tinbidel.
The amount of Starlix that you need may change if you take other medicines as these may cause your blood sugar levels to go up or down.
L- ammont ta ’ Starlix li jkollok bżonn jista ’ jinbidel jekk qed tieħu mediċini oħra għaliex dawn jistgħu jgħollu jew ibaxxu l- livelli ta ’ zokkor fid- demm.
It is especially important that you tell your doctor or pharmacist if you are taking:
Huwa ta ’ importanza speċjali li tgħarraf lit- tabib jew spiżjar tiegħek jekk qed tieħu:
- Beta blockers or angiotensin-converting enzyme inhibitors (used, for example, to treat high
- imblokkaturi beta jew impedituri ta ’ l- enżimi li jikkonvertu l’ angiotensin (użati, per eżempju,
blood pressure and certain heart conditions).
għal kura ta ’ pressjoni għolja u ċerti kundizzjonijiet tal- qalb).
- Diuretics (used in the treatment of high blood pressure).
- Dijuretiċi (użati fil- kura ta ’ pressjoni għolja).
- Corticosteroids such as prednisone and cortisone (used to treat inflammatory disorders).
- Kortikosterojdi bħal prednisone u cortisone (użati biex jikkuraw problemi nfjammatorji).
- Inhibitors of drug metabolism such as fluconazole (used to treat fungal infection), gemfibrozil
- Impedituri tal- metaboliżmu tal- mediċini bħal fluconazole (użati biex jikkuraw infezzjonijiet tal -
(used to treat dyslipidaemia) or sulfinpyrazone (used to treat chronic gout).
moffa), gemfibrizol (użat fil- kura ta ’ diżlipidemija) jew sulfinpyrazone (użat fil- kura tal- gotta kronika).
Your doctor may adjust the dose of these medicines.
It- tabib tiegħek jista ’ jibdillek id- doża ta ’ dawn il- mediċini.
Food, drink and exercise Take Starlix before meals (see section 3, “ How to take Starlix”).
Ikel, xorb u eżerċizzju Ħu Starlix qabel l- ikel (ara sezzjoni 3 “ Kif għandek tieħu Starlix ”).
Its effect may be delayed if it is taken during or after meals.
L- effett tiegħu jista ’ jittardja jekk jittieħed waqt jew wara l- ikel.
Even though you are taking medicines for your diabetes, it is important to keep following the diet and/ or exercise your doctor has recommended for you.
Allavolja qed tieħu mediċini għad- dijabete huwa importanti li tkompli ssegwi d- dieta u/ jew l - eżerċizzju li rrikkmandalek it- tabib.
Watch carefully for signs of low blood sugar, especially
Ħares b’ kawtela għal sinjali ta ’ livell baxx ta ’ zokkor fid- demm, speċjalment
- if you have exercised more strenuously than usual.
- jekk eżerċitajt ruħek iżjed mis- soltu
- if you have drunk alcohol.
- jekk xrobt l- alkoħol
Alcohol may upset the control of your blood sugar so you are advised to talk to your doctor about drinking alcohol while taking Starlix.
41 L- Alkoħol jista ’ jiżbilanċja l- kontroll taz- zokkor fid- demm għalhekk qed tiġi imwissi tkellem lit- tabib tiegħek fuq ix- xorb ta ’ l- alkoħol waqt li qed tieħu Starlix.
If you do get symptoms of low blood sugar, eat or drink something containing sugar and talk to your doctor.
Jekk ma jkollokx sintomi ta ’ livell ta ’ zokkor baxx fid- demm, kull jew ixrob xi ħaġa li fiha z- zokkor u kellem lit- tabib tiegħek.
Starlix and older people Starlix can be used by people over 65 years of age.
Starlix u l- Anzjani Starllix jista ’ jintuża f ’ nies li għandhom iżjed minn 65 sena.
Take special care to avoid low blood sugar.
Oqgħod attent b’ mod speċjali sabiex tevita li jaqa ’ l- livell ta ’ zokkor fid- demm.
38 Starlix and children and adolescents Starlix is not recommended for children and adolescents (under 18 years of age) because its effects in this age group have not been studied.
Starlix u tfal u adolexxenti Starlix mhuwiex rakkomandat għal tfal u adolexxenti (taħt it- 18- il sena) minħabba li l- effetti fuq dan il- grupp ta ’ din l- età ma ġiex studjat.
Pregnancy and breast-feeding Do not take Starlix if you are pregnant or planning to become pregnant.
Tqala u treddigħ Starlix m’ għandux jintuża jekk int ħriġt tqila jew qed tippjana li toħroġ tqila.
See your doctor as soon as possible if you become pregnant during treatment.
Ara lit- tabib tiegħek mill- aktar fis possibli jekk tinqabad tqila waqt il- kura.
Do not breast-feed during treatment with Starlix.
Treddax waqt il- kura bi Starlix
Ask your doctor or pharmacist for advice before taking any medicine while you are pregnant or breast- feeding.
Itlob għall- parir tat- tabib jew spiżjar tiegħek qabel tieħu xi mediċina waqt it- tqala jew treddigħ.
Driving and using machines You are advised to take precautions to avoid hypoglycaemia whilst driving.
Sewqan u tħaddim ta ’ magni Qed tiġi avvżat biex tieħu l- prekawzjonijiet biex tevita ipogliċemija waqt li qed issuq jew tħaddem magni.
This is particularly important if you have reduced or absent awareness of the warning signs of hypoglycaemia or if you have frequent episodes of hypoglycaemia.
Dan huwa importanti b’ mod partikolari jekk ma tantx tħoss jew ma tħoss xejn is- sinjali ta ’ twissija ta ’ ipogliċemija jew għandek episodji frekwenti ta ’ ipogliċemija.
The advisability of driving should be considered in these circumstances.
F’ dawn iċ- ċirkustanzi wiehed għandu jara jekk jaqbillux isuq jew le.
Important information about some of the ingredients of Starlix Starlix tablets contain lactose monohydrate.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Starlix Il- pilloli Starlix fihom lactose monohydrate.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li ma tistax tieħu ċerti tipi ta ’ zokkor, għamel kuntatt mat- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
HOW TO TAKE STARLIX
KIF GĦANDEK TUŻA STARLIX
Always take Starlix exactly as your doctor has told you.
Dejjem għandek tieħu Starlix skond il- parir tat- tabib.
When to take Starlix Take Starlix before the three main meals, usually:
Meta għandek tieħu Starlix Ħu Starlix qabel it- tlett ikliet prinċipali, ġeneralment:
- 1 dose before breakfast
- doża 1 qabel il- kolazzjon
- 1 dose before lunch
- doża 1 qabel l- ikla ta ’ wara nofsinhar
- 1 dose before dinner
- doża 1 qabel l- ikla ta ’ filgħaxija
It is best to take it right before a main meal but you can take it up to 30 minutes before.
L- aħjar li tieħu Starlix qabel- ikla prinċipali iżda tista ’ tieħu d- doża sa 30 minuta qabel.
Do not take it if you are not going to eat a main meal.
Toħodix jekk mintiex sa tiekol ikla prinċipali.
If you miss a meal, skip that dose of Starlix and wait until your next meal.
Jekk titlef ikla, aqbeż id- doża ta ’ Starlix u stenna sa l - ikla li jkun imissek.
How much to take Take Starlix as your doctor told you to.
Kemm għandek tieħu Ħu Starlix kif qallek it- tabib tiegħek.
Your doctor will determine the dosage you require.
It- tabib tiegħek jiddeċiedi d- dożaġġ li għandek bżonn.
The usual dose of Starlix to start with is 60 mg before the three main meals.
Id- doża ta ’ Starlix li ssoltu tingħata biex tibda hija ta ’ 60 mg qabel it- tlett ikliet prinċipali.
In some cases your doctor may prescribe higher doses.
Kultant it - tabib tiegħek jista ’ jordnalek dożi aktar għoljin.
The recommended maximum daily dose is 180 mg three times daily to be taken before the three main meals.
L- ogħla doża rakkomandata kuljum hija 180 mg tlett darbiet kuljum li għandhom jittieħdu mat- tlett ikliet prinċipali.
Swallow the tablets whole with a glass of water before the meal.
Ibla l- pilloli sħaħ ma ’ tazza ilma qabel l- ikla.
How long to take Starlix Take Starlix daily until your doctor tells you to stop.
42 Ħu Starlix kuljum sakemm jgħidlek tieqaf it- tabib tiegħek.
If you take more Starlix than you should If you have accidentally taken too many tablets, talk to a doctor straight away.
Jekk tieħu Starlix aktar milli suppost Jekk bi żball ħadt wisq pilloli, kellem lit- tabib tiegħek minnufih.
If you experience symptoms of low blood sugar – if you feel dizzy, light-headed, hungry, shaky, or any of the other signs in section 4, “ Possible side effects” – eat or drink something containing sugar.
Jekk ikollok sintomi ta ’ livelli ta ’ zokkor baxx fid- demm - jekk tħossok sturdut, rasek tiħfief, bil- ġuħ, titriegħed jew tħoss kwalunkwe sinjal ieħor imniżżel f’ sezzjoni 4, “ Effetti sekondarji li jista ’ jkollu ” - kull jew ixrob xi ħaġa li fiha z - zokkor.
39 If you feel as if you are about to have a severe hypoglycaemic attack (which may lead to loss of consciousness or seizure), call for urgent medical help – or make sure that someone else does this for you.
Jekk tħoss li ser ikollok attakk sever ta ’ ipogliċemija (li jtelfek minn sensik jew aċċessjoni) sejjaħ għal għajnujna medika b’ mod urġenti – jew kun żgur li ħaddieħor jagħmel dan għalik.
If you forget to take Starlix If you forget to take a tablet simply take the next one before your next meal.
Jekk tinsa tieħu Starlix Jekk tinsa tieħu pillola ħu dik li jmiss qabel l- ikla li jmissek.
Do not take a double dose of Starlix to make up for the one that you missed.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Like all medicines, Starlix can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Starlix jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The side effects caused by Starlix are usually mild to moderate.
L - effetti sekondarji ikkawżati minn Starlix huma ġeneralment ħfief għal moderati.
The most common side effects are symptoms of low blood sugar (hypoglycaemia), which are usually mild.
L- aktar effetti sekondarji komuni huma sintomi ta ’ livell ta ’ zokkor baxx fid- demm (ipogliċemija), li huma ġeneralment ħfief.
- sweating,
- għaraq
- dizziness,
- sturdament
- shaking,
- rogħda
- weakness,
- debbulizza
- hunger,
- ġuħ
- feeling your heart beating fast,
- tħoss qalbek tħabbat malajr
- tiredness,
- għeja
- feeling sick (nausea).
- tħossok ma tiflaħx (tqallih)
They can also be caused by lack of food or too high a dose of any anti-diabetic medicine you are taking.
Jistgħu jkunu kkawżati minn nuqqas ta ’ ikel jew doża għolja wisq ta ’ medicini anti- dijabetiċi li qed tieħu.
If you do get symptoms of low blood sugar, eat or drink something containing sugar.
Jekk ikollok sintomi ta ’ livell ta ’ zokkor baxx fid- demm, kull u ixrob xi ħaġa li fiha z- zokkor.
Abdominal pain, indigestion, diarrhoea, nausea and vomiting have been reported.
Kienu rrappurtati uġigħ addominali, indiġestjoni, tqallih u rimettar.
Rare effects are mild abnormalities in liver function tests and allergic (hypersensitivity) reactions such as rash and itching.
Effetti rari huma anormalitajiet fit- testijiet tal- funzjoni tal- fwied u reazzjonijiet allergiċi (sensittivita ’ eċċessiva) bħal raxx u ħakk.
A very rare effect is skin rash with blisters affecting the lips, eyes, mouth, sometimes with headache, fever and/ or diarrhoea.
Effett rari ħafna huwa raxx tal- ġilda bi bżieżaq li jieħdu x- xofftejn, l- għajnejn, il- ħalq, kultant b’ uġigħ ta ’ ras, deni u/ jew dijarea.
HOW TO STORE STARLIX
KIF TAĦŻEN STARLIX
Do not use Starlix after the expiry date stated on the carton after EXP.
M’ għandekx tuża Starlix wara d- data ta ’ skadenza li tidher fuq il- kartuna wara JIS.
Do not use any Starlix pack that is damaged or shows signs of tampering.
M’ għandekx tuża l- pakkett ta ’ Starlix jekk tara li huwa danneġġat jew jidher li ġie imbagħbas.
Medicines should not be disposed of via wastewater or household waste.
43 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Starlix contains
X’ Fih Starlix
- The active substance is nateglinide.
- Is- sustanza attiva hija nateglinide.
- The other ingredients are lactose monohydrate; cellulose, microcrystalline; povidone;
- Is- sustanzi l- oħra huma lactose monohydrate; cellulose, microcrystalline; povidone;
croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous.
croscarmellose sodium; magnesium stearate and silica, colloidal anhydrous.
- The tablet coating contains hypromellose; titanium dioxide (E171); talc; macrogol and red (60
- Il- pillola fiha hypromellose; titanium dioxide (E171); talc; macrogol and red (60 and 180 mg
and 180 mg tablets) or yellow (120 mg tablets) iron oxide (E172).
tablets) or yellow (120 mg tablets) iron oxide (E172).
What Starlix looks like and contents of the pack Starlix 60 mg film-coated tablets are pink, round tablets with “ STARLIX” marked on one side and “ 60” on the other.
Id- Dehra ta ’ Starlix u l- kontenuti tal- pakkett Starlix 60 mg pilloli miksijin b’ rita huma roża, tondi b ’ “ Starlix ” immarkata fuq naħa u “ 60 ” fuq l - oħra.
Starlix 120 mg film-coated tablets are yellow, ovaloid tablets with “ STARLIX” marked on one side and “ 120” on the other.
Starlix 120 mg pilloli miksijin b’ rita huma sofor, b’ għamla ovali b ’ “ Starlix ” immarkata fuq naħa u “ 120 ” fuq l- oħra.
Starlix 180 mg film-coated tablets are red, ovaloid tablets with “ STARLIX” marked on one side and “ 180” on the other.
Starlix 180 mg pilloli miksijin b’ rita huma ħomor, b’ għamla ovali b ’ “ Starlix ” immarkata fuq naħa u “ 180 ” fuq l- oħra.
Each blister pack contains 12, 24, 30, 60, 84, 120 or 360 tablets.
Kull pakkett ta ’ folji fih 12, 24, 30, 60, 84, 120 jew 360 pillola.
Not all pack sizes or tablet strengths may be available in your country.
Jista ’ jkun li mhux il- pakketti kollha jkunu għal skop kummerċjali.
Marketing Authorisation Holder Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Id- Detentur ta ’ L- Awtorizzazzjoni għat- Tqegħid fis- Suq Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
Danmark Novartis Healthcare A/ S Tlf: +45 39 16 84 00
Danmark Novartis Healthcare A/ S
1 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT TO BE IMPLEMENTED BY THE MEMBER STATES
1 KUNDIZZJONIJIET JEW RESTRIZZJONIJIET FIR- RIGWARD TA ’ L- UŻU MINGĦAJR PERIKLU U EFFETTIV TAL- PRODOTT MEDIĊINALI LI GĦANDHOM JIĠU IMPLIMENTATI MILL- ISTATI MEMBRI
The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented.
L- Istati Membri għandhom jiżguraw li l- kundizzjonijiet jew restrizzjonijiet kollha fir- regward ta ’ l- użu mingħajr periklu u effettiv tal- prodott mediċinali deskritti hawn taħt jiġu implimentati.
The Marketing authorisation Holder (MAH) shall ensure that, at launch, all healthcare professionals who are experienced to prescribe/ use Stelara are provided with educational materials containing the following:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq għandu jiżgura li, meta l- prodott ikun fis- suq, il- professjonisti tas- saħħa li għandhom esperjenza jippreskrivu/ jużaw Stelara jingħataw materjal edukattiv li fih dawn li ġejjin:
The objectives of this Health Care Professional educational program will be focused on: • Local Guidance for TB screening (see draft materials in RMP Appendix 1). • The potential risks will be the focus of this EM
Gwida lokali għall- monitoraġġ ta ’ TB (ara l- abbozz tal- materjali fl- RMP appendiċi 1).
- Serious infections including salmonella, TB, and non-tuberculous mycobacterial infections-
Ir- riskji potenzjali jkunu l- fokus ta ’ dan il- materjal edukattiv Infezzjonijiet serji li jinkludu salmonella, TB, u infezzjonijiet ta ’ mycobacterium li mhumiex tuberkulużi
- Malignancies
Tumuri malinni
Patient education initiatives will be focused on: • Potential risks/ side effects as described in the Patient Information Sheet.
Il- pakkett ta ’ informazzjoni għall- pazjenti jkun iffukat fuq:
- Serious infections, including salmonella infections, TB, and non-tuberculous mycobacterial
Riskji/ effetti mhux mixtieqa potenzjali kif deskritt fil- fuljett ta ’ tagħrif Infezzjonijiet serji li jinkudu salmonella, TB, u infezzjonijiet ta ’ mycobacterium li mhumiex tuberkulużi
• Appropriate techniques for administration of ustekinumab.
Metodu xieraq ta ’ kif għandu jingħata ustekinumab.
What is Stelara?
X’ inhi Stelara?
Stelara is a solution for injection that contains the active substance ustekinumab.
Stelara hija soluzzjoni għall- injezzjoni li fiha s- sustanza attiva ustekinumab.
What is Stelara used for?
Għalxiex tintuża Stelara?
Stelara is used to treat adults with moderate to severe plaque psoriasis (a disease causing red, scaly patches on the skin).
Stelara tintuża biex tikkura adulti li għandhom psorijażi bil- qoxra moderata sa severa (marda li tikkawża rqajja ’ ħomor u bil- qxur fuq il- ġilda).
It is used in patients who failed to respond to or cannot use other systemic (whole-body) treatments for psoriasis, including ciclosporin, methotrexate and PUVA (psoralen ultraviolet-A).
Din tintuża fuq pazjenti li naqsu milli jirrispondu għal jew ma jistgħux jużaw trattamenti sistemiċi (fuq il- ġisem kollu) oħrajn għall- psorijażi, inkluż ciclosporin, methotrexate u PUVA (psoralen ultraviolet- A).
PUVA is a type of treatment where the patient receives a medicine containing a compound called a ‘ psoralen ’ before being exposed to ultraviolet light.
PUVA huwa tip ta ’ trattament fejn il - pazjent jirċievi mediċina li fiha taħlita msejħa ‘ psoralen ’ qabel ma jiġi espost għal dawl ultravjola.
The medicine can only be obtained with a prescription.
Il- mediċina tista ’ tinkiseb b’ riċetta ta ’ tabib.
How is Stelara used?
Kif tintuża Stelara?
Stelara is given under the supervision of a doctor who has experience in diagnosing and treating psoriasis.
Stelara tingħata taħt superviżjoni ta ’ tabib li jkollu esperjenza fid- dijanjostikar u t- trattament tal - psorijażi.
It is given as an injection under the skin at a dose of 45 mg.
Din tingħata bħala injezzjoni taħt il- ġilda f’ doża ta ’ 45 mg.
This is followed by a further injection four weeks later, and then an injection every three months (12 weeks).
Din hija segwita b’ injezzjoni oħra erba ’ ġimgħat wara, u imbagħad b’ injezzjoni kull tliet xhur (12- il ġimgħa).
The doctor should consider stopping treatment if there is no response after 28 weeks.
It- tabib għandu jikkunsidra li jwaqqaf it- trattament jekk ma jkunx hemm rispons wara 28 ġimgħa.
Patients weighing over 100 kg should be given Stelara in 90-mg doses.
Pazjenti li jiżnu aktar minn 100 kg għandhom jingħataw Stelara f’ dożi ta ’ 90 mg.
Patients may inject themselves once they have been trained, if their doctor thinks that this is appropriate.
Il- pazjenti jistgħu jinjettaw lilhom infushom ladarba jkunu ġew imħarrġa, jekk it- tabib tagħhom jaħseb li dan ikun xieraq.
How does Stelara work?
Kif taħdem Stelara?
The active substance in Stelara, ustekinumab, is a monoclonal antibody.
Is- sustanza attiva fi Stelara, ustekinumab, hija anti- korp monoklonali.
A monoclonal antibody is an antibody (a type of protein) that has been designed to recognise and bind to a specific structure (called an antigen) in the body.
Antikorp monoklonali huwa antikorp (tip ta ’ proteina) li ġie mfassal biex jagħraf u jingħaqad ma ’ struttura speċifika (msejħa antiġen) fil- ġisem.
Ustekinumab has been designed to bind to a protein called ‘ IL-12/ 23p40’.
Ustekinumab ġiet imfassla biex tingħaqad ma ’ proteina msejħa ‘ IL- 12/ 23p40 ’.
This protein forms part of two of the messenger molecules (cytokines) in the immune system, interleukin-12 and interleukin-23.
Din il- proteina tifforma parti minn tnejn mill- molekuli messaġġiera (cytokines) fis- sistema immunitarja, interleukin- 12 u interleukin- 23.
These interleukins are involved in causing the inflammation and other processes that cause psoriasis.
Dawn l- interleukins huma involuti fil- kawża tal- infjammazzjoni u l - proċessi l- oħrajn li jikkawżaw psorijażi.
By blocking their activity, ustekinumab reduces the activity of the immune system and the symptoms of the disease.
Billi timblokka l- attività tagħhom, ustekinumab tnaqqas l - attività tas- sistema immunitarja u s- sintomi tal- marda.
Stelara has been compared with placebo (a dummy treatment) in two main studies involving a total of 1,996 adults with moderate to severe plaque psoriasis.
L- effetti ta ’ Stelara għall- ewwel ġew ittestjati fuq mudelli sperimentali qabel ma ġew studjati fuq il - bniedem.
Over half of the patients had failed one or more other treatments for psoriasis or could not receive them.
Stelara l- ewwel tqabblet ma ’ plaċebo (trattament finta) f’ żewġ studji ewlenin li involvew total ta ’ 1, 996 adult bi psorijażi bil- qoxra moderata sa severa.
Both studies looked at two doses of Stelara (45 and 90 mg).
Iż- żewġ studji ħarsu lejn żewġ dożi ta ’ Stelara (45 u 90 mg).
The main measure of effectiveness was the number of patients who ‘ responded ’ to treatment after 12 weeks, meaning that symptom scores improved by 75% or more.
Il- kejl ewlieni tal- effikaċja kien in- numru ta ’ pazjenti li ‘ irrispondew ’ għat- trattament wara 12- il ġimgħa, li fisser li l- iskor tas- sintomi tjieb b’ 75% jew aktar.
The studies were still ongoing at the time of the medicine’ s assessment and are scheduled to last for up to five years.
L- istudji kienu għadhom għaddejjin fil- ħin tal- valutazzjoni tal- mediċina u huma skedati li jibqgħu għaddejjin għal massimu ta ’ ħames snin.
The company provided some of the longer-term results of one of the studies (after 18 months of treatment), and the early results of an ongoing study comparing Stelara with etanercept (another medicine for psoriasis).
Il- kumpanija pprovdiet uħud mir- riżultati fit- tul ta ’ wieħed mill- istudji (wara 18- il xahar ta ’ trattamenti), u r- riżultati bikrija ta ’ studju li għadu għaddej li jqabbel Stelara ma ’ etanercept (mediċina oħra għall- psorijażi).
What benefit has Stelara shown during the studies?
Liema benefiċċju wriet Stelara waqt l- istudji?
Stelara was more effective than placebo at improving the symptoms of psoriasis.
Stelara kienet aktar effettiva mill- plaċebo fit- titjib tas- sintomi tal- psorijażi.
Looking at the results of the two main studies taken together, around 69% of the patients receiving Stelara responded to treatment after 12 weeks, compared with around 3% of the patients receiving placebo.
Meta wieħed iħares lejn ir - riżultati taż- żewġ studji ewlenin flimkien, madwar 69% tal- pazjenti li kienu qed jirċievu Stelara irrispondew għat- trattament wara 12- il ġimgħa, meta mqabbel ma ’ madwar 3% tal- pazjenti li kienu qed jirċievu l- plaċebo.
There was no difference in response rates between the two doses of Stelara in patients weighing below 100 kg.
Ma kien hemm l- ebda differenza fir- rati ta ’ rispons bejn iż- żewġ dożi ta ’ Stelara f’ pazjenti li jiżnu inqas minn 100 kg.
Patients weighing over 100 kg had a better response to the 90-mg dose.
Pazjenti li jiżnu aktar minn 100 kg kellhom rispons aħjar għad- doża ta ’ 90 mg.
The longer-term results showed that with continuous treatment, the response to Stelara is maintained for at least 18 months.
Ir- riżultati b’ terminu twil urew li bi trattament kontinwu, ir- rispons għal Stelara jinżamm għallinqas għal 18- il xahar.
The ongoing comparative study has shown that Stelara is more effective than etanercept after 12 weeks of treatment.
L- istudju komparattiv li għadu għaddej wera li Stelara hija aktar effettiva minn etanercept wara 12- il ġimgħa ta ’ trattament.
What is the risk associated with Stelara?
X’ inhu r- riskju assoċjat ma ’ Stelara?
The most common side effects with Stelara (seen in more than 1 patient in 10) are upper respiratory tract infection (colds) and nasopharyngitis (inflammation of the nose and throat).
L- aktar effetti sekondarji komuni bi Stelara (li deheru f’ aktar minn pazjent 1 minn 10) huma infezzjoni fil- parti ta ’ fuq tal- apparat tan- nifs (irjiħat) u r- rinofarinġite (infjammazzjoni tal- imnieħer u l - gerżuma).
For the full list of all side effects reported with Stelara, see the Package Leaflet.
Għal- lista sħiħa tal- effetti sekondarji kollha rrapportati bi Stelara, ara l- Fuljett ta 'Tagħrif.
Stelara should not be used in people who may be hypersensitive (allergic) to ustekinumab or any of the other ingredients.
Stelara m’ għandhiex tintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għal ustekinumab jew għal xi sustanza oħra tiegħu.
It must not be used in patients who have an active infection that the doctor considers important.
M’ għandhiex tintuża fuq pazjenti li għandhom infezzjoni attiva li t- tabib iqis importanti.
The doctor may interrupt treatment in patients who develop a serious infection.
It- tabib jista ’ jwaqqaf il- kura f’ pazjenti li jiżviluppaw infezzjoni serja.
Why has Stelara been approved?
Għaliex ġiet approvata Stelara?
The Committee for Medicinal Products for Human Use (CHMP) noted that Stelara has a new mode of action, blocking the activity of two messenger molecules (interleukin-12 and interleukin-23) rather than only one.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li Stelara għandha mod ġdid ta ’ azzjoni, li timblokka l- attività ta ’ żewġ molekuli messaġġiera (interleukin- 12 u interleukin- 23) aktar milli waħda biss.
The Committee also noted that unexpected increases in problems affecting the heart and blood vessels and psychiatric problems such as depression were seen in some studies and that these might be related to Stelara.
Il- Kumitat innota wkoll li f’ xi studji ġew innotati żidiet mhux mistennija ta ’ problemi li jaffettwaw il- qalb u l- vini u ta ’ problemi psikjatriċi bħad- depressjoni u li dawn jistgħu jkunu relatati ma ’ Stelara.
Therefore, based on the information currently available, the CHMP decided to restrict the use of the medicine to patients in whom other treatments had failed or who could not receive them.
Għalhekk, skont l- informazzjoni disponibbli bħalissa, is - CHMP iddeċieda li jillimita l- użu tal- mediċina għal pazjenti li fuqhom ma jkunux irnexxew trattamenti oħrajn jew li ma setgħux jirċevuhom.
The Committee decided that Stelara’ s benefits are greater that its risks for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA.
Il- Kumitat iddeċieda li l- benefiċċji ta ’ Stelara huma akbar mir- riskji tagħha għall- kura ta ’ psorijażi bil - qoxra moderata sa severa f’ adulti li naqsu milli jirrispondu għal, jew li għandhom kontraindikazzjoni għal, jew li huma intolleranti għal terapiji sistemiċi oħrajn inkluż ciclosporin, methotrexate u PUVA.
The Committee recommended that Stelara be given marketing authorisation.
Il- Kumitat irrakkomanda li Stelara jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Stelara?
Liema miżuri qed jittieħdu sabiex jiġi assigurat l- użu sigur ta ’ Stelara?
The company that makes Stelara will provide educational programmes for healthcare providers and patients.
Il- kumpanija li tipproduċi Stelara se tipprovdi programmi edukattivi għall- persuni involuti fil- kura tas - saħħa u għall- pazjenti.
These will focus on the safety of Stelara, particularly the risks of developing tuberculosis, other infections and cancers.
Dawn se jiffokaw fuq is- sigurtà ta ’ Stelara, b’ mod partikolari fuq ir- riskji ta ’ żvilupp tat- tuberkulożi, infezzjonijiet oħrajn u kanċer.
The patient programme will also include details of how Stelara should be injected.
Il- programm għall- pazjent se jinkludi wkoll dettalji ta ’ kif għandha tiġi injettata Stelara.
Other information about Stelara:
Informazzjoni oħra dwar Stelara:
The European Commission granted a marketing authorisation valid throughout the European Union for Stelara to Janssen-Cilag International NV on 16 January 2009.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea, għal Stelara lil Janssen- Cilag International NV fis- 16 ta ’ Jannar 2009.
The full EPAR for Stelara can be found here.
L- EPAR sħiħ għal Stelara jista ’ jinstab hawnhekk.
This summary was last updated in 12-2008.
2/ 3 Dan is- sommarju ġie aġġornat l- aħħar f’ 12- 2008.
Packaging
Il- Kontenut
Package size
Kunjett wieħed
Solution for injection Solution for injection
Soluzzjoni għall- injezzjoni
Subcutaneous use Subcutaneous use
Użu taħt il- ġilda
1 vial 1 vial
Kunjett wieħed
STELARA 45 mg solution for injection
STELARA 45 mg soluzzjoni għall- injezzjoni
Each vial contains 45 mg ustekinumab in 0.5 ml.
Kull fjala fih 45 mg ustekinumab f’ 0. 5 ml.
Ustekinumab is a fully human IgG1κ monoclonal antibody to interleukin (IL)-12/ 23 produced in a murine myeloma cell line using recombinant DNA technology.
Ustekinumab huwa antikorp monoklonali IgG1κ kollu kemm hu uman għal interleukin (IL) - 12/ 23 magħmul f’ linja ta ’ ċelloli ta ’ mijeloma murine bl- użu tat- teknoloġija rikombinanti tad- DNA.
The solution is clear to slightly opalescent, colourless to light yellow.
Is- soluzzjoni hija minn trasparenti sa tkanġi ftit, minn bla kulur sa safra ċara.
STELARA is indicated for the treatment of moderate to severe plaque psoriasis in adults who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapies including ciclosporin, methotrexate and PUVA (see section 5.1).
STELARA huwa indikat għall- kura ta ’ psorijasi bil- plakka moderata sa qawwija fl- adulti li ma kellhomx rispons għal, jew li għandhom kontraindikazzjoni għal, jew li ma jittollerawx terapiji sistemiċi oħra, li jinkludu ciclosporin, methotrexate u PUVA (ara sezzjoni 5. 1).
STELARA is intended for use under the guidance and supervision of a physician experienced in the diagnosis and treatment of psoriasis.
L- iskop ta ’ STELARA huwa li jintuża taħt il- gwida u s- superviżjoni ta ’ tabib b’ esperjenza fid - dijanjosi u l- kura tal- psorijasi.
Posology The recommended posology of STELARA is an initial dose of 45 mg administered subcutaneously at week 0, followed by a 45 mg dose at week 4, then every 12 weeks thereafter.
Pożoloġija Il- pożoloġija rrakkomandata ta ’ STELARA hija doża tal- bidu ta ’ 45 mg mogħtija taħt il- ġilda fil - ġimgħa 0, segwita b’ doża ta ’ 45 mg fir- raba ’ ġimgħa,, imbagħad tkompli kull 12- il ġimgħa..
Consideration should be given to discontinuing treatment in patients who have shown no response up to 28 weeks of treatment.
Għandu jiġi kkunsidrat it- twaqqif tal- kura f’ pazjenti li ma wrew l- ebda rispons sat- 28 ġimgħa ta ’ kura.
Patients with body weight > 100 kg For patients with a body weight > 100 kg the dose is 90 mg administered subcutaneously at week 0, followed by a 90 mg dose at week 4, then every 12 weeks thereafter (see section 5.1).
Pazjenti li jiżnu > 100 kg Għall- pazjenti li jiżnu > 100 kg id- doża hija ta ’ 90 mg mogħtija taħt il- ġilda fl- ewwel ġimgħa, segwita b’ doża ta ’ 90 mg fil- ġimgħa 4, imbagħad kull 12- il ġimgħa minn hemm ’ il quddiem (ara sezzjoni 5. 1).
In patients weighing > 100 kg, 45 mg was also shown to be efficacious.
F’ pazjenti li jiżnu > 100 kg, doża ta ’ 45 mg ukoll intweriet li kienet effettiva.
However, 90 mg resulted in greater efficacy in these patients.
Madankollu, doża ta ’ 90 mg kienet aktar effettiva f’ dawn il- pazjenti.
Elderly patients (≥ 65 years) No dose adjustment is needed for elderly patients.
Pazjenti anzjani (≥ 65 sena) Ma huwa meħtieġ l- ebda aġġustament tad- doża għal pazjenti anzjani.
Children and adolescents (< 18 years) STELARA is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
Tfal u adoloxxenti (< 18- il sena) STELARA mhux irrakkommandat għall- użu fi tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
2 Renal and hepatic impairment STELARA has not been studied in these patient populations.
Indebolimet tal- kliewi u tal- fwied STELARA ma ġiex studjat f’ dawn il- popolazzjonijiet ta ’ pazjenti.
No dose recommendations can be made.
L- ebda rakkomandazzjoni tad- doża ma tista ’ ssir.
Method of administration STELARA is for subcutaneous injection.
2 Kif jingħata STELARA għandu jingħata b’ injezzjoni taħt il- ġilda.
If possible, areas of the skin that show psoriasis should be avoided as injection sites.
Jekk huwa possibbli, għandhom jiġu evitati bħala siti ta ’ injezzjoni żoni tal- ġilda li jkollhom il- psorijasi.
After proper training in subcutaneous injection technique, patients may self-inject STELARA if a physician determines that it is appropriate.
Wara taħriġ tajjeb fit- teknika tal- injezzjoni taħt il- ġilda, il- pazjenti jistgħu jinjettaw STELARA lilhom infushom jekk it- tabib jiddeċiedi li dan huwa xieraq.
However, the physician should ensure appropriate follow- up of patients.
Madanakollu, it- tabib għandu jaċċerta ruħu li l - pazzjenti jiġu segwiti.
Comprehensive instructions for administration are given in the package leaflet.
Il- pazjenti għandhom jiġu mgħallma jinjettaw l- ammont sħiħ ta ’ STELARA skont l- istruzzjonijiet komprensivi provduti fil- fuljett ta ’ tagħrif.
For further instructions on preparation and special precautions for handling, see section 6.6.
Għal aktar informazzjoni dwar il- preparazzjoni u prekawzjonijiet speċjali li għandhom jittieħdu għall - immaniġġar, ara sezzjoni 6. 6.
Clinically important, active infection.
Infezzjoni attiva klinikament sinifikanti.
Infections Ustekinumab may have the potential to increase the risk of infections and reactivate latent infections.
Infezzjonijiet Ustekinumab jista ’ jkollu l- effett li jżid ir- riskju ta ’ infezzjonijiet u jattiva mill- ġdid infezzjonijiet rieqda.
In clinial studies, serious bacterial, fungal, and viral infections have been observed in patients receiving STELARA (see section 4.8).
Fi studji kliniċi, infezzjonijiet serji batterjali, fungali, u virali kienu osservati f’ pazjenti li kienu qed jingħataw STELARA (ara sezzjoni 4. 8).
Caution should be exercised when considering the use of STELARA in patients with a chronic infection or a history of recurrent infection (see section 4.3).
Wieħed għandu joqgħod attent meta jiġi kkunsidrat l- użu ta ’ STELARA f’ pazjenti b’ infezzjoni kronika jew storja ta ’ infezzjoni li terġa ’ titfaċċa (ara sezzjoni 4. 3).
Prior to initiating treatment with STELARA, patients should be evaluated for tuberculosis infection.
Qabel ma tinbeda kura bi STELARA, il- pazjenti għandhom jiġu evalwati għal infezzjoni bit - tuberkulosi.
STELARA must not be given to patients with active tuberculosis (see section 4.3).
STELARA m’ għandux jingħata lill- pazjenti b’ tuberkulosi attiva (ara sezzjoni 4. 3).
Treatment of latent tuberculosis infection should be initiated prior to administering STELARA.
Kura tal- infezzjoni tat- tuberkulosi rieqda għandha tinbeda qabel ma jingħata STELARA.
Anti-tuberculosis therapy should also be considered prior to initiation of STELARA in patients with a history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.
L- użu ta ’ kura għal kontra t- tuberkulosi għandu jiġi kkunsidrat ukoll qabel ma tinbeda l- kura bi STELARA f’ każ ta ’ pazjenti li għandhom storja ta ’ tuberkulosi attiva jew rieqda, u li fil- każ tagħhom ma jistgħax jiġi kkonfermat jekk huma ħadux kura adegwata għaliha jew le.
Patients receiving STELARA should be monitored closely for signs and symptoms of active tuberculosis during and after treatment.
Pazjenti li qed jirċievu STELARA għandhom jiġu mmonitorjati mill- qrib għal sinjali u sintomi ta ’ tuberkulosi attiva waqt u wara l- kura.
Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur.
Il- pazjenti għandhom ikunu mwissija biex jitolbu parir mediku jekk ifeġġu sinjali jew sintomi li jindikaw xi infezzjoni.
If a patient develops a serious infection, the patient should be closely monitored and STELARA should not be administered until the infection resolves.
Jekk pazjent jiżviluppa infezzjoni serja, il- pazjent għandu jiġi mmonitorjat mill- qrib u STELARA m’ għandux jingħata sakemm l- infezzjoni tfieq.
Malignancies Immunosuppressants like ustekinumab have the potential to increase the risk of malignancy.
Tumuri malinni Immunosoppressanti bħal ustekinumab jistgħu iżidu r- riskju ta ’ tumuri malinni.
Some patients who received STELARA in clinical studies developed cutaneous and non-cutaneous malignancies (see section 4.8).
Fi studji kliniċi, xi pazjenti li ngħataw STELARA żviluppaw tumuri malinni tal- ġilda u oħrajn mhux tal- ġilda (ara sezzjoni 4. 8).
No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving STELARA.
L- ebda studji ma saru li jikludu pazjenti bi storja ta ’ tumur malinn jew f’ pazjenti li komplew il- kura wara li żviluppaw tumur malinn waqt li kienu qed jirċievu kura bi STELARA.
Thus, caution should be exercised when considering the use of STELARA in these patients.
Għalhekk, wieħed għandu joqgħod attent meta jiġi kkunsidrat l- użu ta ’ STELARA f’ dawn il- pazjenti.
Hypersensitivity reactions If an anaphylactic or other serious allergic reaction occurs, administration of STELARA should be discontinued immediately and appropriate therapy instituted (see section 4.8).
Reazzjonijiet ta ’ sensittività eċċessiva Jekk ikun hemm reazzjoni anafilattika jew xi reazzjoni allerġika serja oħra, l- għoti ta ’ STELARA għandu jitwaqqaf immedjatament u għandha tinbeda kura adattata (ara sezzjoni 4. 8).
3 Vaccinations It is recommended that live viral or live bacterial vaccines (such as Bacillus of Calmette and Guérin (BCG)) should not be given concurrently with STELARA.
3 rċievew tilqim virali ħaj jew batterjali ħaj.
Before live viral or live bacterial vaccination, treatment with STELARA should be withheld for at least 15 weeks after the last dose and can be resumed at least 2 weeks after vaccination.
STELARA m’ għandux jingħata għal mill- anqas 15- il ġimgħa qabel l- ewwel doża ta ’ tilqim virali jew batterjali ħaj, u jista ’ jerġa ’ jingħata mhux inqas minn ġimagħtejn wara t- tilqim.
Prescribers should consult the Summary of Product Characteristics for the specific vaccine for additional information and guidance on concomitant use of immunosuppressive agents post-vaccination.
Għal aktar informazzjoni u gwida dwar l- użu konkomitanti ta ’ sustanzi immunosoppressivi wara t- tilqim, it- tobba għandhom jikkonsultaw Is- Sommarju tal- Karatteristiċi tal - Prodott tat- tilqima speċifika.
Patients receiving STELARA may receive concurrent inactivated or non-live vaccinations.
Pazjenti li qed jirċievu STELARA jistgħu jirċievu flimkien miegħu tilqim inattivat jew mhux ħaj.
Concomitant immunosuppressive therapy The safety and efficacy of STELARA in combination with other immunosuppressants, including biologics, or phototherapy have not been evaluated.
Kura immunosoppressiva konkomitanti Is- sigurtà u l- effikaċja ta ’ STELARA flimkien ma ’ immunosoppressanti oħra, inklużi prodotti bijoloġiċi jew fototerapija, ma ġewx evalwati.
Caution should be exercised when considering concomitant use of other immunosuppressants and STELARA or when transitioning from other immunosuppressive biologics (see section 4.5).
Għandha tingħata attenzjoni meta jiġi kkunsidrat l- użu ta ’ immunosoppressanti oħra flimkien ma ’ STELARA jew meta jkun hemm tibdil minn prodotti immunosoppressivi bijoloġiċi oħra (ara sezzjoni 4. 5).
Special populations Children and adolescents (< 18 years) STELARA is not recommended for use in children below age 18 due to a lack of data on safety and efficacy.
Popolazzjonijiet speċjali Tfal u adoloxxenti (< 18- il sena) STELARA mhux irrakkommandat għall- użu fi tfal ta ’ taħt it- 18- il sena peress li m’ hemmx biżżejjed informazzjoni dwar is- sigurtà u l- effikaċja.
Elderly patients (≥ 65 years) No overall differences in efficacy or safety in patients age 65 and older who received STELARA were observed compared to younger patients.
Pazjenti anzjani (≥ 65 snin) Ebda differenzi ġenerali fl- effikaċja jew fis- sigurtà ma ġew osservati f’ pazjenti ta ’ 65 sena jew iktar li ngħataw STELARA meta mqabbel ma ’ pazjenti iżgħar.
Because there is a higher incidence of infections in the elderly population in general, caution should be used in treating the elderly.
Minħabba li hemm inċidenza ogħla ta ’ infezzjonijiet fil- popolazzjoni anzjana inġenerali, għandha tingħata attenzjoni meta jiġu ttrattati l - anzjani.
Hepatic and renal impairment Specific studies have not been conducted in patients with hepatic and renal impairment (see section 4.2).
Indeboliment tal- fwied u tal- kliewi Ma sarux studji speċifiċi f’ pazjenti b’ indeboliment tal- fwied u tal- kliewi (ara sezzjoni 4. 2).
No interaction studies have been performed.
Ma saru l- ebda studji dwar prodotti mediċinali oħra li ma jaqblux ma ’ dan il- prodott.
In the population pharmacokinetic analysis of the phase III studies, the effect of the most frequently used concomitant medicinal products in patients with psoriasis (including paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) on pharmacokinetics of ustekinumab was explored.
Fl- analiżi tal - farmakokinetika ta ’ popolazzjoni fl- istudji tal- fażi III, kien studjat l- effett ta ’ prodotti mediċinali konkomitanti użati l- aktar frekwenti f’ pazjenti bil- psorijasi (inkluż paracetamol, ibuprofen, acetylsalicylic acid, metformin, atorvastatin, levothyroxine) fuq il- farmakokinetika ta ’ ustekinumab.
There were no indications of an interaction with these concomitantly administered medicinal products.
Ma kienx hemm indikazzjonijiet li dawn il- prodotti mediċinali konkomitanti ma jaqblux mal- prodott mediċinali.
The basis for this analysis was that at least 100 patients (> 5% of the studied population) were treated concomitantly with these medicinal products for at least 90% of the study period.
Il- bażi ta ’ din l- analiżi kienet li mill- anqas 100 pazjent (> 5% tal- popolazzjoni studjata) kienu kkurati fl- istess waqt b’ dawn il- prodotti mediċinali għal mill- anqas 90% tal- perijodu ta ’ l - istudju.
Live vaccines should not be given concurrently with STELARA (see section 4.4).
Tilqimiet ħajjin m’ għandhomx jingħataw fl- istess ħin ma ’ STELARA (ara sezzjoni 4. 4).