qanastek/EMEA-V3 huggingface dataset:
Do not use STELARA • If you are allergic (hypersensitive) to ustekinumab or to any of the other ingredients of STELARA (listed in section 6 ‘ What STELARA contains’). • If you have an active infection which your doctor considers important (see also below ‘ Take special care with STELARA’).
Tużax STELARA • Jekk inti allerġiku/ a (għandek sensittività eċċessiva) għal ustekinumab jew għal xi wieħed mis - sustanzi l- oħra ta ’ STELARA (elenkati f’ sezzjoni 6 hawn taħt ‘ X’ fih STELARA ’). • Jekk inti għandek infezzjoni attiva li t- tabib tiegħek jikkunsidraha importanti (ara wkoll hawn taħt ‘ Oqgħod attent ħafna bi STELARA ’).
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using STELARA.
Jekk inti m’ intix ċert/ a, jekk xi waħda minn dawn t’ hawn fuq tapplikax għalik, kellem lit- tabib jew lill- ispiżjar tiegħek qabel ma tuża STELARA..
34 Take special care with STELARA Your doctor will assess your health before treatment.
34 Oqgħod attent ħafna bi STELARA It- tabib tiegħek se jara l- istat ta ’ saħħtek qabel il- kura.
Make sure you tell your doctor about any illness you have.
Kun żgur li tgħid lit- tabib tiegħek dwar kwalunkwe mard li għandek.
Check with your doctor before using STELARA if you have: • Infections o You must tell your doctor if you have any kind of infection STELARA may make you less able to fight infections.
Xi infezzjonijiet jistgħu wkoll isiru serji.
Some infections could also become serious. o Tell your doctor if you have any signs of infection, even if it is very minor.
Għid lit- tabib tiegħek jekk inti għandek xi sinjali ta ’ infezzjoni, anke jekk din hija ħafifa o ħafna.
Signs may include fever, feeling tired, cough, flu-like symptoms, diarrhoea, dental problems and burning when urinating.
Sinjali jistgħu jinkludu deni, tħossok għajjien/ a, sogħla, sintomi bħal tal - influwenza, dijarea, problemi bis- snien, u ħruq meta tgħaddi l- awrina.
If you are not sure, talk to your doctor straight away o It is particularly important to tell your doctor if you have an infection that will not go away or keeps coming back o Tell your doctor if you have any open cuts or sores – they might get infected.
Jekk m’ intix ċert/ a kellem lit- tabib tiegħek mill- ewwel Huwa speċjalment importanti li tgħid lit- tabib tiegħek jekk għandek infezzjoni li ma o tfieqx jew li tibqa ’ terġa ’ taqbdek Għid lit- tabib tiegħek jekk għandek xi qsim tal- ġilda jew feriti miftuħin – huma jistgħu o jiġu infettati.
o Tuberculosis (TB) Tell your doctor if you have had tuberculosis.
Tuberkulosi (TB) o Għid lit- tabib tiegħek jekk qatt kellek it- tuberkulosi.
Also tell him or her if you have recently been near anyone who might have tuberculosis Your doctor will examine you for tuberculosis and perform a test to see if you have tuberculosis, before you are given STELARA If your doctor thinks that you are at risk of tuberculosis, you may be given medicines for tuberculosis.
Għidlu wkoll jekk dan l- aħħar kontx ħdejn xi ħadd li jista ’ jkun li għandu t- tuberkulosi It- tabib tiegħek jeżaminak għat- tuberkulosi u jgħammillek test biex jara jekk għandekx it - tuberkulosi, qabel ma jingħatalek STELARA Jekk it- tabib tiegħek jaħseb li inti qiegħed/ a f’ riskju li tieħu t- tuberkulosi, inti tista ’ tingħata mediċini għat- tuberkulosi.
This will be before you begin treatment with STELARA, and during treatment with STELARA.
Dan ikun qabel ma inti tibda l- kura bi STELARA, u waqt il- kura bi STELARA.
• Cancer.
• Kanċer.
Immunosuppressants like STELARA decrease the activity of the immune system.
Immunosoppressanti bħal STELARA jnaqqsu l- attività tas- sistema immuni.
This may increase the risk of cancer.
Dan jista ’ jżid ir- riskju tal- kanċer.
Tell your doctor if you have ever had any type of cancer.
Għid lit- tabib tiegħek jekk inti qatt kellek kwalunkwe tip ta ’ kanċer.
• Vaccinations.
• Tilqim.
Tell your doctor if you have recently had or are going to have a vaccine.
Għid lit- tabib tiegħek jekk inti dan l- aħħar ħadt jew se tieħu xi tilqima.
• Other therapies for psoriasis.
• Kuri oħrajn għall- psorijasi.
Tell your doctor if you are receiving any other immunosuppressant or phototherapy (when your body is treated with specific ultraviolet (UV) light) while using STELARA, which may also decrease the activity of your immune system.
Għid lit- tabib tiegħek jekk inti qed tingħata kwalunkwe immunosoppressant ieħor jew fototerapija (kurat b’ dawl speċifiku ultravjola (UV)) waqt li tkun qed tuża STELARA, li jista ’ wkoll inaqqas l- attività tas- sistema immuni tiegħek.
The combination of these therapies has not been investigated and it may increase the risk of diseases related to a weakened immune system.
Dawn it- tipi ta ’ kura flimkien għadhom ma ġewx investigati u jistgħu jżidu r- riskju ta ’ mard li għandu x’ jaqsam ma ’ sistema immuni dgħajfa.
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist before using STELARA.
Jekk m’ intix ċert/ a jekk xi waħda minn dawn t’ hawn fuq tapplikax għalik, kellem lit- tabib jew lill - ispiżjar tiegħek qabel tuża STELARA.
Using other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tuża mediċini oħra Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, inkluż mediċini li ksibt mingħajr riċetta.
You should not be given certain types of vaccines while on treatment with STELARA.
Inti m’ għandekx tingħata ċerti tipi ta ’ tilqim meta tkun qed tieħu kura bi STELARA.
Pregnancy and breast-feeding Talk to your doctor before using STELARA: • If you are pregnant or are planning to become pregnant while using STELARA.
Tqala u treddigħ Itlob il- parir tat- tabib tiegħek qabel tuża STELARA: • Jekk inti tqila jew qed tippjana li tinqabad tqila waqt li tkun qed tuża STELARA.
The effects of this medicine in pregnant women are not known.
L- effetti ta ’ din il- mediċina fuq in- nisa tqal m’ humiex magħrufa.
Your doctor will decide whether you should use this medicine.
Jekk inti mara li jista ’ jkollok it- tfal, inti għandek tevita li tinqabad tqila u li tuża kontraċezzjoni xierqa waqt li tkun qed tuża STELARA u għal mill- anqas 15- il ġimgħa wara l- aħħar kura bi STELARA. • Jekk inti qed tredda ’ jew jekk qed tippjana li tredda ’ waqt li tkun qed tuża STELARA, it- tabib tiegħek se jiddeċiedi jekk inti għandekx tuża din il- mediċina.
Driving and using machines It is not known if STELARA can affect the ability to drive or use machines.
Sewqan u tħaddim ta ’ magni M’ huwiex magħruf jekk STELARA jistax jaffettwa l- ħila biex issuq u tħaddem magni.
HOW TO USE STELARA
KIF GĦANDEK TUŻA STELARA
Always use STELARA exactly as your doctor has told you.
Dejjem uża STELARA eżatt kif qallek it- tabib.
You should check with your doctor if you are not sure.
Inti għandek tiċċekkja mat- tabib tiegħek jekk m’ intix ċert/ a.
Make sure you discuss with your doctor when you will have your injections and your follow-up appointments.
Kun żgur/ a li tiddiskuti mat- tabib tiegħek meta se tieħu l- injezzjonijiet u meta għandek l - appuntamenti ta ’ sorveljanza.
How much STELARA is given • Your doctor will decide how much STELARA you need and for how long • This may depend on your weight • The usual starting dose is 45 mg ustekinumab.
Kemm jingħata STELARA • It- tabib tiegħek jiddeċiedi kemm għandek bżonn STELARA u għal kemm tul ta ’ żmien • Dan jista ’ jiddependi mill- piż tiegħek • Id- doża li ssoltu tibda biha hija ta ’ 45 mg ustekinumab.
After the starting dose, you will receive the next dose 4 weeks later, and then every 12 weeks • Patients who weigh more than 100 kg may be given 90 mg instead of 45 mg.
Wara d- doża tal- bidu, inti se tirċievi d - doża li jkun imiss 4 ġimgħat wara, imbagħad kull 12- il ġimgħa. • Il- pazjenti li jiżnu aktar minn 100 kg jistgħu jingħataw 90 mg minflok 45 mg.
Children and adolescents (under 18 years) STELARA is not recommended for children and adolescents (under 18 years old) because it has not been studied in this age group.
Tfal u adoloxxenti (taħt it- 18- il sena) STELARA m’ huwiex irrakkommandat għat- tfal u adoloxxenti (taħt it- 18- il sena) minħabba li ma ġiex studjat f’ din l- età.
How STELARA is given • STELARA is given by injection under your skin (subcutaneously) • At the start, medical or nursing staff may inject STELARA.
Kif jingħata STELARA • STELARA jingħata permezz ta ’ injezzjoni taħt il- ġilda • Fil- bidu, staff mediku jew infermiera jistgħu jinjettaw STELARA.
However, you and your doctor may decide that you may inject STELARA yourself.
Madankollu, inti u t- tabib tiegħek tistgħu tiddeċiedu li inti stess tista ’ tinjetta STELARA.
In this case you will get training on how to inject STELARA yourself.
F’ dan il- każ inti tingħata taħriġ dwar kif inti stess tinjetta STELARA.
Talk to your doctor if you have any questions about giving yourself an injection.
Kellem lit- tabib tiegħek jekk għandek xi mistoqsijiet dwar kif tagħti injezzjoni lilek innifsek.
See below in section ‘ Instructions for administration ’ for further information about how to inject STELARA.
Ara hawn taħt fis- sezzjoni ‘ Istruzzjonijiet dwar kif jingħata ’ għal aktar informazzjoni dwar kif tinjetta STELARA.
If you use more STELARA than you should If you have used or been given too much STELARA, talk to a doctor or pharmacist straight away.
Jekk tuża STELARA aktar milli suppost Jekk inti wżajt jew ingħatajt wisq STELARA, kellem lit- tabib jew lill- ispiżjar tiegħek mill- ewwel.
Always have the outer carton of the medicine with you, even if it is empty.
Dejjem qis li jkollok miegħek il- kartuna ta ’ barra tal- mediċina, anke jekk din tkun vojta.
If you forget to use STELARA If you forget a dose, contact your doctor or pharmacist.
Jekk tinsa tuża STELARA Jekk tinsa doża, ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you stop using STELARA It is not dangerous to stop using STELARA.
Jekk tieqaf tuża STELARA M’ huwiex perikoluż li tieqaf tuża STELARA.
However, the symptoms for which STELARA was prescribed may come back.
Madankollu, is- sintomi li għalihom kien preskritt STELARA jistgħu jerġgħu jitfaċċaw.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ din- il- mediċina, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Like all medicines, STELARA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, STELARA jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Most side effects are mild to moderate.
Il- biċċa l- kbira ta ’ l- effetti sekondarji huma minn ħfief sa moderati.
However, some patients may experience serious side effects and may require treatment.
Madankollu, xi pazjenti jista ’ jkollhom effetti sekondarji serji u jista ’ jkollhom bżonn kura.
Tell your doctor straight away if you notice any of the following serious side effects – you may need urgent medical treatment:
Għid lit- tabib tiegħek mill- ewwel jekk tinnota xi wieħed mill- effetti sekondarji serji li ġejjin – inti jista ’ jkollok bżonn kura medika urġenti:
• Signs of an allergic reaction such as swelling of the face, lips, mouth or throat which may make it difficult to swallow or breathe; skin rash; hives; swelling of the hands, feet or ankles • Signs of infection (including tuberculosis) such as fever, feeling tired or short of breath, cough which will not go away, flu-like symptoms, night sweats, diarrhoea, wounds, dental problems and burning when urinating.
36 • Sinjali ta ’ infezzjoni (inkluż tuberkulosi) bħal deni, tħossok għajjien/ a jew ikollok qtugħ ta ’ nifs, sogħla li ma tfieqx, sintomi bħal tal- influwenza, għaraq bil- lejl, dijarea, feriti, problemi fis - snien u ħruq meta tgħaddi l- awrina.
Side effects may occur with certain frequencies, which are defined as follows: • very common: affects more than 1 user in 10 36 • common: affects 1 to 10 users in 100 • uncommon: affects 1 to 10 users in 1,000 • rare: affects 1 to 10 users in 10,000 • very rare: affects less than 1 user in 10,000 • not known: frequency cannot be estimated from the available data.
Effetti sekondarji jistgħu jiġru spiss jew rari, jiġifieri: • komuni ħafna: jaffettwaw aktar minn persuna 1 minn kull 10 li jużawh • komuni: jaffettwaw minn persuna waħda sa 10 persuni minn kull 100 li jużawh • mhux komuni: jaffettwaw minn persuna waħda sa 10 persuni minn kull 1, 000 li jużawh • rari: jaffettwaw minn persuna waħda sa 10 persuni minn kull 10, 000 li jużawh • rari ħafna: jaffettwaw anqas minn persuna waħda minn kull 10, 000 li jużawh • mhux magħuf: ma tistax tittieħed stima tal- frekwenza mid- data disponibbli.
The following side effects have been observed with STELARA:
L- effetti sekondarji li ġejjin kienu osservati bi STELARA:
Very common: • Infection of the throat or airways.
Komuni ħafna: • Infezzjoni fil- gerżuma jew fil- pajp tan- nifs.
Common: • Depression • Feeling dizzy • Headache • Sore throat • Blocked or stuffy nose • Diarrhoea • Itching • Back or muscle pain • Feeling tired • Redness of the injection site • Inflammation of tissue under the skin.
Komuni: • Depressjoni • Tħossok stordut/ a • Uġigħ ta ’ ras • Uġiġħ fil- gerżuma • Imnieħer misdud • Dijarea • Ħakk • Uġigħ fid- dahar jew fil- muskoli • Tħossok għajjien/ a • Ħmura fis- sit ta ’ l- injezzjoni • Infjammazzjoni fit- tessut ta ’ taħt il- ġilda.
The signs include warmth, swelling, redness and pain.
Is- sinjali jinkludu sħana, nefħa, ħmura u wġigħ
Uncommon: • Pain, swelling, itching, hardness, bleeding, bruising and irritation where the injection is given.
Mhux komuni: • Uġigħ, nefħa, ħakk, ebusija, fsada, tbenġil u irritazzjoni fejn tkun ingħatat l- injezzjoni.
HOW TO STORE STELARA
KIF TAĦŻEN STELARA
Store in a refrigerator (2°C– 8°C).
Aħżen fi friġġ (2°C– 8°C).
Keep the vial in the outer carton in order to protect from light.
Żomm il- fjala fil- kartuna ta ’ barra sabiex tipproteġi mid- dawl.
Do not shake STELARA vials.
Tħawwadx il- fjali ta ’ STELARA.
Prolonged vigorous shaking may damage the medicine.
Jekk tħawwad bil- qawwa għal- tul ta ’ ħin, il- mediċina tista ’ ssirilha l- ħsara.
Do not use STELARA • After the expiry date which is stated on the label and the carton after “ EXP”.
Tużax STELARA • Wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna wara “ JIS ”.
The expiry date refers to the last day of that month • If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see further section 6 ‘ What STELARA looks like and contents of the pack ’) • If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated) • If the product has been shaken vigorously • If the seal is broken.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar • Jekk il- likwidu tilef il- kulur, ikun imdardar jew jekk tara frak jgħum fih (ara aktar informazzjoni f’ sezzjoni 6 ‘ Id- dehra ta ’ STELARA u l- kontenut tal- pakkett ’) • Jekk taf jew taħseb li huwa seta ’ ġie espost għal temperaturi estremi (bħal per eżempju ġie ffriżat jew imsaħħan aċċidentalment) • Jekk il- prodott ġie mħawwad bil- qawwa
STELARA is for single use only.
37 • Jekk is- sigill ikun imkisser.
Any unused product remaining in the vial and the syringe should be disposed of.
Kull fdal tal- prodott li ma jkunx intuża u li jibqa ’ fil- fjala u fis- siringa għandu jintrema.
What STELARA contains • The active substance is ustekinumab.
X’ fih STELARA
Each vial contains 45 mg ustekinumab (45 mg in 0.5 ml). • The other ingredients are sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 and water for injections.
Kull fjala fih 45 mg ustekinumab (45 mg f’ 0. 5 ml).. • Is- sustanzi l- oħra huma sucrose, L- histidine, L- histidine monohydrochloride monohydrate, polysorbate 80 u ilma għall- injezzjonijiet.
What STELARA looks like and contents of the pack STELARA is a clear to slightly opalescent, colourless to light yellow solution for injection.
Id- dehra ta ’ STELARA u l- kontenuti tal- pakkett STELARA hija soluzzjoni għall- injezzjonijiet trasparenti sa tkanġi ftit, bla kulur sa safra ċara.
The solution may contain a few small translucent or white particles of protein.
Is - soluzzjoni jista ’ jkun fiha xi ftit frak żgħir tal- proteina transluċidu jew abjad.
It is supplied as a carton pack containing 1 single-dose, glass 2 ml vial.
Huwa fornut f’ pakkett tal- kartun li fih fjala tal- ħġieġ ta ’ 2 ml b’ doża waħda.
Each vial contains 45 mg ustekinumab in 0.5 ml of solution for injection.
Kull fjala fih 45 mg ustekinumab f’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni.
Marketing Authorisation Holder Janssen-Cilag International NV Turnhoutseweg 30 2340 Beerse Belgium
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq Janssen- Cilag International NV Turnhoutseweg 30 2340 Beerse Il- Belġju
Manufacturer Centocor B. V.
Il- Manifattur Centocor B. V.
Бизнес Парк София, Младост 4, сграда 4, етаж 3 София 1715 Тел.: +359 2 489 94 00
Бизнес Парк София, Младост 4, сграда 4, етаж 3 София 1715 Тел.: +359 2 489 94 00 (05)
Č eská republika JANSSEN-CILAG s. r. o.
38 Česká republika JANSSEN- CILAG s. r. o.
Eesti Janssen-Cilag Polska Sp. z o. o.
Eesti Janssen- Cilag Polska Sp.
Eesti filiaal Lõõtsa 2 EE-11415 Tallinn Tel: +372 617 7410
Z. o. o Eesti filiaal Lõõtsa 2 EE- 11415 Tallinn Tel: +372 617 7410
Λεωφόρος Ειρήνης 56 GR-151 21 Πεύκη Αθήνα Tηλ: +30 210 61 40 061
Ελλάδα JANSSEN- CILAG Φαρµακευτική Λεωφόρος Ειρήνης 56 GR- 151 21 Πεύκη Αθήνα Tηλ: +30 210 61 40 061
Ísland JANSSEN-CILAG c/ o Vistor hf.
39 Ísland JANSSEN- CILAG c/ o Vistor hf.
Latvija Janssen-Cilag Polska Sp. z o. o. filā le Latvijā Matrož u iela 15 LV-1048, Rī ga Tel: +371 678 93561
Latvija Janssen- Cilag Polska Sp. z o. o. filāle Latvijā
< -------------------------------------------------------------------------------------------------------------------------- ---
< -------------------------------------------------------------------------------------------------------------------------- - ISTRUZZJONIJIET DWAR KIF JINGĦATA
At the start of treatment, medical or nursing staff assists you with your first injection.
Fil- bidu tal- kura, staff mediku jew infermiera jgħinuk għall- ewwel injezzjoni tiegħek.
However, you and your doctor may decide that you may inject STELARA yourself.
Madankollu, int u t- tabib tiegħek tistgħu tiddeċiedu li inti tista ’ tinjetta STELARA lilek innifsek.
If this happens, you will get training on how to inject STELARA.
Jekk dan iseħħ, inti tieħu taħriġ dwar kif tinjetta STELARA.
Talk to your doctor if you have any questions about giving yourself an injection. • Do not mix STELARA with other liquids for injection • Do not shake STELARA vials.
Kellem lit- tabib tiegħek jekk għandek xi mistoqsijiet dwar kif tagħti l- injezzjoni lilek innifsek. • Tħallatx STELARA ma ’ likwidi oħra għall- injezzjoni • Tħawwadx il- fjali ta ’ STELARA.
This is because strong shaking may damage the medicine.
Dan għaliex jekk il- mediċina tiġi mħawwda bil- qawwa tista ’ ssirilha ħsara.
Do not use the medicine if it has been shaken strongly.
Tużax il- mediċina jekk tkun ġiet imħawda bil- qawwa.
Check the number of vials and prepare the materials:
Iċċekkja n- numru ta ’ fjali u pprepara l- oġġetti li għandek bżonn:
Take the vial(s) out of the refrigerator and check the vial(s) to make sure • the number of vials and strength is correct o If your dose is 45 mg you will get one 45 mg vial of STELARA o If your dose is 90 mg you will get two 45 mg vials of STELARA and you will need to give yourself two injections.
Agħżel żewġ siti differenti għal
Use a new needle and syringe for each injection. • it is the right medicine • it has not passed its expiry date • the vial is not damaged and the seal is not broken • the solution is not discoloured, cloudy or contains any foreign particles • the solution is not frozen.
40 dawn l- injezzjonijiet (eż. injezzjoni waħda ġol- koxxa tal- lemin u l- injezzjoni l- oħra ġol - koxxa tax- xellug), u agħti dawn l- injezzjonijiet waħda eżatt wara l- oħra.
This will let the liquid come to a comfortable temperature for injection. • Wash your hands very well with soap and warm water • Get everything together that you need and lay out on a clean surface.
Uża labra ġdida u siringa ġdida għal kull injezzjoni. • li hija l- mediċina t- tajba • li għadha ma qabżitx id- data ta ’ meta tiskadi • li l- fjala m’ għandux ħsara u li s- siġill mhux imkisser • li s- soluzzjoni ma tilfitx il- kulur, mhux imdardra jew li ma fihiex frak • li s- soluzzjoni mhix iffriżata • Ħalli l- fjala joqgħod għal madwar nofs siegħa, biex il- likwidu jilħaq temperatura komda għall - injezzjoni • Aħsel idejk tajjeb ħafna bl- ilma fietel u bis- sapun • Iġbor flimkien dak kollu li għandek bżonn u ifrixhom fuq superfiċje nadif.
This includes a syringe, needle and antiseptic swabs.
Dan jinkludi siringa, labra u garża antisettiċi.
Choose and prepare the injection site:
Agħżel u pprepara s- sit tal- injezzjoni:
Choose an injection site • STELARA is given by injection under your skin (subcutaneously) • Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm away from the navel (belly button) • If possible, do not use areas of skin that show signs of psoriasis • If someone will assist in giving you the injection, then he or she may also choose the upper arms or buttocks as an injection site.
Agħżel is- sit tal- injezzjoni • STELARA jingħata b’ injezzjoni taħt il- ġilda • Partijiet tal- ġisem tajbin għall- injezzjoni huma il- parti tan- naħa ta ’ fuq tal- koxxa jew madwar iż- żaqq (addome) għallinqas 5 ċm ’ l bogħod miż- żokra • Jekk inhu possibbli, tużax partijiet tal- ġilda li għandhom sinjali ta ’ psorijasi • Jekk xi ħadd se jgħinek fl- għoti tal- injezzjoni, f’ dak il- każ, huwa jew hija jistgħu jagħżlu wkoll il- parti tan- naħa ta ’ fuq tad- dirgħajn jew il- warrani bħala sit tal- injezzjoni.
41 Prepare the injection site • Wipe the injection site on the skin with an alcohol swab • Do not touch this area again before giving the injection.
Ipprepara s- sit ta ’ l- injezzjoni • Imsaħ is- sit tal- injezzjoni fuq il- ġilda b’ garża imxarrba bl- alkoħol • Terġax tmiss din il- parti qabel ma tagħti l- injezzjoni.
Prepare the dose: • Take the cap off the top of the vial
Ipprepara d- doża: • Neħħi l- biċċa ta ’ fuq it- tapp
• Do not remove the stopper • Clean the stopper with an antiseptic swab • Put the vial on a flat surface.
41 • Tneħħix it- tapp • Naddaf it- tapp b’ garża antisettika • Poġġi l- fjala fuq superfiċje ċatt.
Remove the needle cover • Do not touch the needle or let the needle touch anything • Push the needle through the rubber stopper • Turn the vial and the syringe upside down • Pull on the syringe plunger to fill the syringe with the amount of liquid in the vial • It is important that the needle is always in the liquid.
Neħħi l- għata tal- labra • Tmissx il- labra jew tħalli l- labra tmiss ma ’ xi ħaġa • Imbotta l- labra minn ġot- tapp tal- lastku • Aqleb il- fjala u s- siringa rashom l- isfel • Iġbed il- planġer tas- siringa biex timla s- siringa bl- ammont ta ’ likwidu li hemm fil- fjala • Huwa importanti li l- labra tkun dejjem ġol- likwidu.
This stops air bubbles forming in the syringe
Dan ma jħallix il- bżieżaq ta ’ l- arja jiffurmaw fis- siringa
• Remove the needle from the vial • Hold the syringe with the needle pointing up to see if it has any air bubbles inside • If there are air bubbles, tap the side gently until the air bubbles go to the top of the syringe
• Neħħi l- labra mill- fjala • Żomm is- siringa bil- labra tipponta l- fuq biex tara jekk għandhiex xi bżieżaq ta ’ l- arja ġewwa • Jekk hemm il- bżieżaq ta ’ l- arja, taptap ħelu ħelu mal- ġenb sakemm il- bżieżaq ta ’ l- arja jmorru fuq nett tas- siringa
• Then press the plunger until all of the air (but none of the liquid) has been removed • Do not lay the syringe down or allow the needle to touch anything.
• Imbagħad agħfas il- planġer sakemm l- arja kollha (iżda mhux il- likwidu) titneħħa • Titlaqx s- siringa xi mkien u tħalli l- labra tmiss ma xejn
Inject the dose: • Gently pinch the cleaned skin between your thumb and index finger.
42 • Oqros bil- ħlewwa l- ġilda li ġiet mnaddfa, bejn is- saba ’ l- kbir u l- werrej.
Do not squeeze it tightly • Push the needle into the pinched skin • Push the plunger with your thumb as far as it will go to inject all of the liquid.
Tagħfasx ħafna • Imbotta l- labra ġol- ġilda maqrusa • Agħfas il- planġer bis- saba ’ l- kbir l- isfel kemm jista ’ jkun biex tinjetta l- likwidu kollu.
Push it slowly and evenly, keeping the skin gently pinched • When the plunger is pushed as far as it will go, take out the needle and let go of the skin • Press an antiseptic swab over the injection site for a few seconds after the injection.
Agħfsu bil- mod u dejjem l- istess, filwaqt li żżomm il- ġilda maqrusa bil- ħlewwa • Meta l- planġer jingħafas l- isfel kemm jista ’ jkun, iġbed il- labra l- barra u ħalli l- ġilda • Agħfas garża antisettika fuq is- sit ta ’ l- injezzjoni għal ftit sekondi wara l- injezzjoni
Disposal: • Used syringes and needles should be placed in a puncture-resistant container, like a sharps container.
Rimi: • Siringi u labar użati għandhom jitpoġġew f’ kontenitur li ma jittaqqabx, bħal kontenitur apposta għal oġġetti li għandhom xifer jew ponta.
Dispose of your sharps container according to your local regulations • Empty vials, antiseptic wipes, and other supplies can be disposed in your garbage.
Armi l- kontenitur apposta għal oġġetti li għandhom xifer jew ponta skont il- liġijiet lokali • Fjali vojta, gareż antisettiċi u provvisti oħra jistgħu jintremew mal- iskart.
STELARA 90 mg solution for injection Ustekinumab
STELARA 90 mg soluzzjoni għall- injezzjoni Ustekinumab
1.
F’ dan il- fuljett:
Possible side effects 7.
7.
How to store STELARA 8.
X’ inhu STELARA u għalxiex jintuża 8.
Further information
Qabel ma tuża STELARA 9.
WHAT STELARA IS AND WHAT IT IS USED FOR
Kif għandek tuża STELARA 10.
STELARA belongs to a group of medicines called immunosuppressants (medicines that inhibit your immune system).
Effetti sekondarji li jista ’ jkollu 11.
STELARA contains the active substance ustekinumab, a monoclonal antibody.
Kif taħżen STELARA 12.
This disease causes inflammation of skin and nails.
Aktar tagħrif
Do not use STELARA • If you are allergic (hypersensitive) to ustekinumab or to any of the other ingredients of STELARA (listed in section 6 ‘ What STELARA contains’). • If you have an active infection which your doctor considers important (see also below ‘ Take special care with STELARA’).
Tużax STELARA • Jekk inti allerġiku/ a (għandek sensittività eċċessiva) għal ustekinumab jew għal xi wieħed mis - sustanzi l- oħra ta ’ STELARA (elenkati f’ sezzjoni 6 hawn ‘ X’ fih STELARA ’). • Jekk inti għandek infezzjoni attiva li t- tabib tiegħek jikkunsidraha importanti (ara wkoll hawn taħt ‘ Oqgħod attent ħafna bi STELARA ’).
44 Take special care with STELARA Your doctor will assess your health before treatment.
44 Oqgħod attent ħafna bi STELARA It- tabib tiegħek se jara fhiex inhi saħħtek qabel il- kura.
Make sure you tell your doctor about any illness you have.
Żgura li tgħid lit- tabib tiegħek dwar kwalunkwe mard li għandek.
If you are not sure, talk to your doctor straight away o It is particularly important to tell your doctor if you have an infection that will not go away or keeps coming back o Tell your doctor if you have any open cuts or sores – they might get infected.
Jekk m’ intix ċert/ a kellem lit- tabib tiegħek mill- ewwel Huwa speċjalment importanti li tgħid lit- tabib tiegħek jekk għandek infezzjoni li ma o tfieqx jew li tibqa ’ terġa ’ taqbdek Għid lit- tabib tiegħek jekk għandek xi qtugħ jew feriti miftuħin – huma jistgħu jiġu o infettati.
Tell your doctor if you are receiving any other immunosuppressant or phototherapy (when your body is treated with specific ultraviolet (UV) light) while using STELARA, which may also decrease the activity of your immune system.
Għid lit- tabib tiegħek jekk inti qed tirċievi kwalunkwe immunosoppressant ieħor jew fototerapija (meta ġismek jiġi kkurat b’ dawl speċifiku ultravjola (UV)) waqt li tkun qed tuża STELARA, li jista jkollu wkoll inaqqas l- attività tas- sistema immuni tiegħek.
The combination of these therapies has not been investigated and it may increase the risk of diseases related to a weakened immune system.
Dawn il- kuri flimkien għadhom ma ġewx investigati u jistgħu jżidu r- riskju ta ’ mard li għandu x’ jaqsam ma ’ sistema immuni mdgħajfa.
If you are a woman of childbearing potential, you are advised to avoid becoming pregnant and must use adequate contraception while using STELARA and for at least 15 weeks after the last STELARA treatment. • If you are breast-feeding or if you plan to breast-feed while using STELARA.
Jekk inti mara li jista ’ jkollok it- tfal, inti rrikkmandata li tevita li tinqabad tqila u li tuża kontraċezzjoni xierqa waqt li tkun qed tuża STELARA u għal mill- anqas 15- il ġimgħa wara l- aħħar kura bi STELARA. • Jekk inti qed tredda ’ jew jekk qed tippjana li tredda ’ waqt li tkun qed tuża STELARA.
Your doctor will decide whether you should use this medicine.
It- tabib tiegħek se jiddeċiedi jekk inti għandekx tuża din il- mediċina.
45 3.
45 5.
After the starting dose, you will receive the next dose 4 weeks later, and then every 12 weeks • Patients who weigh more than 100 kg may be given 90 mg instead of 45 mg.
Wara d- doża tal- bidu, inti se tirċievi d - doża li jkun imiss 4 ġimgħat wara mbagħad kull 12- il ġimgħa. • Il- pazjenti li jiżnu aktar minn 100 kg jistgħu jingħataw 90 mg minflok 45 mg.
Children and adolescents (under 18 years) STELARA is not recommended for children and adolescents (under 18 years old) because it has not been studied in this age group.
Tfal u adoloxxenti (taħt it- 18- il sena) STELARA m’ huwiex rakkommandat għat- tfal u adoloxxenti (taħt it- 18- il sena) minħabba li ma ġiex studjat f’ din l- età.
How STELARA is given • STELARA is given by injection under your skin (subcutaneously) • At the start, medical or nursing staff may inject STELARA.
Kif jingħata STELARA • STELARA jingħata permezz ta ’ injezzjoni taħt il- ġilda tiegħek • Fil- bidu, staff mediku jew infermiera jistgħu jinjettaw STELARA.
See below in section ‘ Instructions for administration’ for further information about how to inject STELARA.
Ara hawn taħt fis- sezzjoni ‘ Istruzzjonijiet dwar kif jingħata ’ għal aktar informazzjoni dwar kif tinjetta STELARA.
If you forget to use STELARA If you forget a dose, contact your doctor or pharmacist.
Jekk tinsa tuża STELARA Jekk tinsa doża, ikkuntatja lit- tabib jew lill- ispiżjar tiegħek.
However, some patients may experience serious side effects and may require treatment.
Madankollu, xi pazjenti jistgħu jesperjenzaw effetti sekondarji serji u jista ’ jkollhom bżonn kura.
• Signs of an allergic reaction such as swelling of the face, lips, mouth or throat which may make it difficult to swallow or breathe; skin rash; hives; swelling of the hands, feet or ankles • Signs of infection (including tuberculosis) such as fever, feeling tired or short of breath, cough which will not go away, flu-like symptoms, night sweats, diarrhoea, wounds, dental problems and burning when urinating.
46 • Sinjali ta ’ infezzjoni (inkluż tuberkulosi) bħal deni, tħossok għajjien/ a jew ikollok qtugħ ta ’ nifs, sogħla li ma tfieqx, sintomi bħal tal- influwenza, għaraq bil- lejl, dijarea, feriti, problemi fis - snien u ħruq meta tgħaddi l- awrina.
Side effects may occur with certain frequencies, which are defined as follows: • very common: affects more than 1 user in 10 46 • common: affects 1 to 10 users in 100 • uncommon: affects 1 to 10 users in 1,000 • rare: affects 1 to 10 users in 10,000 • very rare: affects less than 1 user in 10,000 • not known: frequency cannot be estimated from the available data.
Effetti sekondarji jistgħu jiġru b’ ċertu frekwenzi, li huma ddefiniti kif ġej: • komuni ħafna: jaffettwaw aktar minn persuna 1 minn kull 10 li jużawh • komuni: jaffettwaw minn persuna waħda sa 10 persuni minn kull 100 li jużawh • mhux komuni: jaffettwaw minn persuna waħda sa 10 persuni minn kull 1, 000 li jużawh • rari: jaffettwaw minn persuna waħda sa 10 persuni minn kull 10, 000 li jużawh • rari ħafna: jaffettwaw anqas minn persuna waħda minn kull 10, 000 li jużawh • mhux magħuf: ma tistax tittieħed stima tal- frekwenza mid- data disponibbli.
Prolonged vigorous shaking may damage the medicine.
Jekk ġiet imħawwda bil- qawwa għal- tul ta ’ ħin il- mediċina tista ’ ssirilha l- ħsara.
Do not use STELARA • After the expiry date which is stated on the label and the carton after “ EXP”.
Tużax STELARA • Wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kartuna wara “ EXP ”.
The expiry date refers to the last day of that month • If the liquid is discoloured, cloudy or you can see other foreign particles floating in it (see further section 6 ‘ What STELARA looks like and contents of the pack’) • If you know, or think that it may have been exposed to extreme temperatures (such as accidentally frozen or heated) • If the product has been shaken vigorously • If the seal is broken.
Id- data ta ’ skadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar • Jekk il- likwidu tilef il- kulur, imdardar jew jekk tara frak jgħum fih (ara aktar informazzjoni f’ sezzjoni 6 ‘ Id- dehra ta ’ STELARA u l- kontenut tal- pakkett ’) • Jekk taf, jew taħseb li huwa seta ’ ġie espost għal temperaturi estermi (bħal per eżempju ġie ffriżat jew imsaħħan aċċidentalment) • Jekk il- prodott ġie mħawwad bil- qawwa
STELARA is for single use only.
47 • Jekk is- sigill ikun imkisser.
Each vial contains 90 mg ustekinumab (90 mg in 1 ml). • The other ingredients are sucrose, L-histidine, L-histidine monohydrochloride monohydrate, polysorbate 80 and water for injections.
Kull fjala fih 90 mg ustekinumab (90 mg f’ 1 ml).. • Is- sustanzi l- oħra huma sucrose, L- histidine, L- histidine monohydrochloride monohydrate, polysorbate 80 u ilma għall- injezzjonijiet.
What STELARA looks like and contents of the pack STELARA is a clear to slightly opalescent, colourless to light yellow solution for injection.
Id- Dehra ta ’ STELARA u l- kontenuti tal- pakkett STELARA hija soluzzjoni għall- injezzjonijiet trasparenti sa tkanġi ftit, bla kulur sa safra ċara.
Each vial contains 90 mg ustekinumab in 1 ml of solution for injection.
Kull fjala fih 45 mg ustekinumab f’ 0. 5 ml ta ’ soluzzjoni għall- injezzjoni.
Č eská republika JANSSEN-CILAG s. r. o.
48 Česká republika JANSSEN- CILAG s. r. o.
Ísland JANSSEN-CILAG c/ o Vistor hf.
49 Ísland JANSSEN- CILAG c/ o Vistor hf.
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50 INSTRUCTIONS FOR ADMINISTRATION
50 ISTRUZZJONIJIET DWAR KIF JINGĦATA
However, you and your doctor may decide that you may inject STELARA yourself.
Madankollu, int u t- tabib tiegħek tistaw tiddeċiedu li inti tista ’ tinjetta STELARA lilek innifsek.
Do not use the medicine if it has been shaken strongly.
Tużax il- mediċina jekk tkun ġiet imħawwda bil- qawwa.
Take the vial(s) out of the refrigerator and check the vial(s) to make sure • the number of vials and strength is correct o If your dose is 90 mg you will get one 90 mg vial of STELARA. • it is the right medicine • it has not passed its expiry date • the vial is not damaged and the seal is not broken • the solution is not discoloured, cloudy or contains any foreign particles • the solution is not frozen.
Oħroġ il- fjala( i) minn ġol- friġġ u ċċekkja l- fjala( i) biex tiżgura • li n- numru ta ’ fjali huwa tajjeb u li l- qawwa tad- doża hija tajba o Jekk id- doża tiegħek hija ta ’ 90 mg inti se jkollok fjala wieħed ta ’ 90 mg STELARA • li hija l- mediċina t- tajba • li għadha ma qabżitx id- data ta ’ meta jiskadi • li l- fjala m’ għandux ħsara u li s- siġill mhux imkisser • li s- soluzzjoni ma tilifx il- kulur, mhux imdardra jew li ma fihiex frak • li s- soluzzjoni mhijiex iffriżata • Ħalli l- fjala joqgħod għal madwar nofs siegħa.
This will let the liquid come to a comfortable temperature for injection. • Wash your hands very well with soap and warm water • Get everything together that you need and lay out on a clean surface.
Dan se jwassal biex il- likwidu jilħaq temperatura komda għall- injezzjoni • Aħsel idejk tajjeb ħafna bl- ilma fietel u bis- sapun • Iġbor flimkien dak kollu li għandek bżonn u ifrixhom fuq superfiċje nadif.
This includes a syringe, needle and antiseptic swabs.
Dan jinkludi siringa, labra u gareż antisettiċi.
Choose an injection site • STELARA is given by injection under your skin (subcutaneously) • Good places for the injection are the upper thigh or around the belly (abdomen) at least 5 cm away from the navel (belly button) • If possible, do not use areas of skin that show signs of psoriasis • If someone will assist in giving you the injection, then he or she may also choose the upper arms or buttocks as an injection site.
Agħżel is- sit tal- injezzjoni • STELARA jingħata b’ injezzjoni taħt il- ġilda • Partijiet tal- ġisem tajbin għall- injezzjoni huma il- parti tan- naħa ta ’ fuq tal- koxxa jew madwar iż- żaqq (addome) ta ’ lanqas 5 ċm ’ l bogħod miż- żokra • Jekk inhu possibbli, tużax partijiet tal- ġilda li għandhom sinjali ta ’ psorijasi • Jekk xi ħadd se jgħinek fl- għoti tal- injezzjoni, f’ dak il- każ, huwa jew hija jistgħu jagħżlu wkoll il- parti tan- naħa ta ’ fuq tad- dirgħajn jew il- warrani bħala sit tal- injezzjoni.
Prepare the injection site • Wipe the injection site on the skin with an alcohol swab • Do not touch this area again before giving the injection.
Ipprepara s- sit ta ’ l- injezzjoni • Imsaħ is- sit tal- injezzjoni fuq il- ġilda b’ garża imxarrba bl- alkoħol • Terġax tmiss din il- parti qabel ma tagħti l- injezzjoni.
Prepare the dose: • Take the cap off the top of the vial
Ipprepara d- doża: • Take the cap off the top of the vial
• Do not remove the stopper • Clean the stopper with an antiseptic swab • Put the vial on a flat surface.
• Tneħħix it- tapp • Naddaf it- tapp b’ garża antisettika • Poġġi l- fjala fuq superfiċje ċatt.
• Remove the needle from the vial • Hold the syringe with the needle pointing up to see if it has any air bubbles inside • If there are air bubbles, tap the side gently until the air bubbles go to the top of the syringe
• Neħħi l- labra mill- fjala • Żomm is- siringa bil- labra tipponta l- fuq biex tara jekk għandiex xi bżieżaq ta ’ l- arja ġewwa • Jekk hemm il- bżieżaq ta ’ l- arja, taptap ħelu ħelu mal- ġenb sakemm il- bżieżaq ta ’ l- arja jmorru fuq nett tas- siringa
Inject the dose: • Gently pinch the cleaned skin between your thumb and index finger.
Injetta d- doża: • Oqros bil- ħlewwa l- ġilda li ġiet mnaddfa, bejn is- saba ’ l- kbir u l- werrej.
Do not squeeze it tightly • Push the needle into the pinched skin • Push the plunger with your thumb as far as it will go to inject all of the liquid.
Tgħafasx ħafna • Imbotta l- labra ġol- ġilda maqrusa • Agħfas il- planġer bis- saba ’ l- kbir l- isfel kemm jista ’ jkun biex tinjetta l- likwidu kollu.
What is Stocrin?
X’ inhu Stocrin?
Stocrin is a medicine that contains the active substance efavirenz.
Stocrin huwa mediċina li fiha s- sustanza attiva efavirenz.
It is available as capsules (yellow and white:
Huwa disponibbli f’ kapsuli (sofor u bojod:
50 mg; white:
50 mg; bojod:
100 mg; yellow:
100 mg; sofor:
200 mg), as yellow, capsule-shaped tablets (600 mg), as round, yellow tablets (50 and 200 mg), and as an oral solution (30 mg/ ml).
200 mg), f’ pilloli f’ forma ta ’ kapsuli sofor (600 mg), f’ pilloli tondi ta ’ lewn isfar (50 u 200 mg) u f’ soluzzjoni orali (30 mg/ ml).
What is Stocrin used for?
Għal xiex jintuża Stocrin?
Stocrin is an antiviral medicine.
Stocrin huwa mediċina antivirali.
It is used together with other antiviral medicines to treat adults and children aged three years or older infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Jintuża flimkien ma ’ mediċini antivirali oħra fit- trattament ta ’ adulti u tfal ta ’ tal- anqas tliet snin infettati mill- vajrus tal- immunodefiċjenza umana tat- tip 1 (HIV- 1), vajrus li jikkawża s- sindromu minn immunodefiċjenza akkwiżita (AIDS).
How is Stocrin used?
Kif jintuża Stocrin?
Treatment with Stocrin should be started by a doctor who has experience in the management of HIV infection.
It- terapija bi Stocrin għandha tinbeda minn tabib li jkollu esperjenza fit- trattament tal- infezzjoni mill - HIV.
Stocrin must be given in combination with other antiviral medicines.
Stocrin għandu jintuża f’ kombinazzjoni ma ’ mediċini antivirali oħra.
It is recommended that Stocrin be taken on an empty stomach and without food, preferably at bedtime.
Huwa rakkomandat li Stocrin jittieħed fuq stonku vojt u mingħajr ikel, preferibbilment qabel il- ħin tal- irqad.
The recommended dose of Stocrin for adults is 600 mg once a day.
Id- doża rakkomandata ta ’ Stocrin għall- adulti hija 600 mg darba kuljum.
In patients aged three to 17 years, the dose depends on body weight.
Fil- pazjenti ta ’ età minn tliet snin sa 17- il sena, id- doża tiddependi mill- piż tal- ġisem.
For patients who are unable to swallow the capsules or tablets, Stocrin can be given using the oral solution.
Il- pazjenti li ma jistgħux jibilgħu l- kapsuli jew il- pilloli, jistgħu jieħdu Stocrin f’ soluzzjoni orali.
The dose of Stocrin needs to be reduced in patients taking voriconazole (used to treat fungal infections).
F’ pazjenti ttrattati b’ voriconazole (użat għat - trattament ta ’ infezzjonijiet fungali), jeħtieġ li titnaqqas id- doża ta ’ Stocrin.
Patients taking rifampicin (an antibiotic) may need to take a higher dose of Stocrin.
Il- pazjenti ttrattati b’ rifampiċina (rifampicin, antibijotiku) aktarx ikunu jeħtieġu doża aktar qawwija ta ’ Stocrin.
How does Stocrin work?
Kif jaħdem Stocrin?
The active substance in Stocrin, efavirenz, is a non-nucleoside reverse transcriptase inhibitor (NNRTI).
Is- sustanza attiva fi Stocrin, efavirenz, hija inibitur mhux nukleosidiku tat- transkrittażi inversa (non - nucleoside reverse transcriptase inhibitor, NNRTI).
It blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells in the body and make more viruses.
Hija timblokka l- attività tat- transkrittażi inversa, enzima prodotta mill- HIV li tħallih jinfetta ċ- ċelloli fil- ġisem u jirriproduċi ruħu.
By blocking this enzyme, Stocrin, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Billi jimblokka din l - enzima, Stocrin, meħud flimkien ma ’ mediċini antivirali oħra, inaqqas l- ammont ta ’ HIV fid- demm u jżommu f’ livell baxx.
Stocrin does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Stocrin ma jfejjaqx infezzjoni mill- HIV jew tal- AIDS, iżda jista ’ jittardja l- ħsara prodotta lis- sistema immunitarja u l- iżvilupp ta ’ infezzjonijiet u mard assoċjat mal- AIDS.
Stocrin has been studied in three main studies involving over 1,100 adults:  in the first study, Stocrin in combination with lamivudine and zidovudine or with indinavir (other antiviral medicines) was compared with the combination of indinavir, lamivudine and zidovudine;  the second study compared Stocrin in combination with nelfinavir and two other antiviral medicines with the same combination without Stocrin;  the third study compared adding Stocrin or placebo (a dummy treatment) to a combination of antiviral medicines that included indinavir and two other antiviral medicines, in patients who had already been receiving treatment for HIV infection.
Reproduction is authorised provided the source is acknowledged.  fl- ewwel studju, Stocrin f’ kombinazzjoni mal- lamivudina (lamivudine) u z- zidovudina (zidovudine) jew ma ’ indinavir (mediċini antivirali oħra), tqabbel ma ’ kombinazzjoni ta ’ indinavir, lamivudina u zidovudina;  fit- tieni studju qabbel Stocrin f’ kombinazzjoni ma ’ nelfinavir u żewġ mediċini antivirali oħra mal - istess kombinazzjoni mingħajr Stocrin.  fit- tielet studju qabbel iż- żieda ta ’ Stocrin jew plaċebo (trattament finta) ma ’ kombinazzjoni ta ’ mediċini antivirali li kienu jinkludu indinavir u żewġ mediċini antivirali oħra, f’ pazjenti li diġà kienu qed jingħataw trattament għall- infezzjoni mill- HIV.
Stocrin has also been studied in 57 children aged between three and 16 years, in combination with nelfinavir and other antiviral medicines.
Stocrin ġie studjat ukoll f’ 57 tifel u tifla ta ’ etajiet bejn tliet snin u 16- il sena, f’ kombinazzjoni ma ’ nelfinavir u mediċini antivirali oħra.
In all of the studies, the main measure of effectiveness was the number of patients who had undetectable levels of HIV-1 in their blood (viral loads) after 24 or 48 weeks of treatment.
Fl- istudji kollha li saru, il- kejl ewlieni tal- effikaċja kien l- għadd ta ’ pazjenti b’ livelli ta ’ HIV- 1 li ma jistgħux jiġu osservati fid- demm (tagħbija virali [viral load]) wara t- trattament ta ’ 24 jew 48 ġimgħa.
What benefit has Stocrin shown during the studies?
X’ inhuma l- benefiċċji li wera Stocrin f’ dawn l- istudji?
70% and 30% of the patients, respectively, had viral loads below 500 copies/ ml after 48 weeks;  the third study showed that more patients receiving Stocrin had viral loads below 400 copies/ ml than those taking placebo after 24 weeks.
L- istudji kollha wrew li l- kombinazzjonijiet li kienu jinkludu Stocrin kienu tal- anqas effikaċi daqs il - mediċini ta ’ tqabbil:  fl- ewwel studju wera li f’ 67% tal- adulti ttrattati bi Stocrin f’ kombinazzjoni ma ’ zidovudina u lamivudina ġiet osservata tagħbija virali taħt l- 400 kopja/ ml wara 48 ġimgħa, meta mqabbla ma ’ 54% ta ’ dawk ittrattati bi Stocrin u indinavir, u 45% ta ’ dawk ittrattati b’ indinavir, lamivudina u zidovudina;  fit- tieni studju, Stocrin f’ kombinazzjoni ma ’ nelfinavir kien superjuri għall- kombinazzjoni mingħajr Stocrin: f’ 70% u f’ 30% tal- pazjenti, rispettivament, ġiet osservata tagħbija virali taħt il - 500 kopja/ ml wara 48 ġimgħa;  fit- tielet studju wera li f’ aktar pazjenti ttrattati bi Stocrin ġiet osservata tagħbija virali taħt l - 400 kopja/ ml minn f’ dawk ittrattati bi plaċebo wara 24 ġimgħa.
Similar results were seen in the study in children.
Riżultati simili ġew osservati fl- istudju fit- tfal.
What is the risk associated with Stocrin?
X’ inhu r- riskju assoċjat ma ’ Stocrin?
The most common side effect with Stocrin (seen in more than 1 patient in 10) is rash.
L- effett sekondarju l- aktar komuni bi Stocrin (li deher f’ aktar minn pazjent 1 minn 10) hu raxx.
Stocrin is also associated with nervous system symptoms, such as dizziness, insomnia (difficulty sleeping), somnolence (sleepiness), impaired concentration and abnormal dreaming, and with psychiatric disorders, including severe depression, suicidal thoughts, suicide attempts and aggressive behaviour, especially in patients with a history of mental illness.
Stocrin huwa assoċjat ukoll ma ’ sintomi marbuta mas- sistema nervuża bħal sturdament, insonnja (diffikultà fl- irqad), ħedla tan- ngħas, diffikultà ta ’ konċentrazzjoni u ħolm mhux normali, u disturbi psikjatriċi fosthom depressjoni gravi, ħsibijiet ta ’ suwiċidju, tentattivi ta ’ suwiċidju u mġiba aggressiva, speċjalment f’ pazjenti bi storja ta ’ mard mentali.
Taking Stocrin with food may lead to an increase in the frequency of side effects.
It- teħid ta ’ Stocrin mal- ikel jista ’ jwassal għal żieda fil- frekwenza ta ’ effetti sekondarji.
For a more complete list of side effects reported with Stocrin, see the Package Leaflet.
Għal lista aktar sħiħa tal- effetti sekondarji rrapportati bi Stocrin, ara l- Fuljett ta ’ Tagħrif.
Stocrin should not be used in patients who may be hypersensitive (allergic) to efavirenz or any of the other ingredients.
Stocrin ma għandux jintuża f’ pazjenti li jistgħu jkunu ipersensittivi (allerġiċi) għal efavirenz jew għal kwanlunkwe mill- ingredjenti l- oħra.