qanastek/EMEA-V3 huggingface dataset:
SUSTIVA 600 mg film-coated tablets efavirenz
SUSTIVA 600 mg pilloli miksija b’ rita efavirenz
Each film-coated tablet contains: efavirenz 600 mg.
Kull pillola miksija b’ rita fiha: efavirenz 600 mg
30 x 1 film-coated tablets 90 (3 x30 x 1) film-coated tablets
30 x 1 pillola miksija b’ rita 90 (3 x 30 x 1) pillola miksija b’ rita
136 10.
146 10.
30 x 1 film-coated tablets EU/ 1/ 99/ 110/ 010:
30 x 1 pillola miksija b’ rita EU/ 1/ 99/ 110/ 010:
90 (3 x 30 x 1) film-coated tablets
90 (3 x 30 x 1) pillola miksija b’ rita
137 PARTICULARS TO APPEAR ON THE INTERMEDIATE OUTER PACKAGING
147 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT INTERMEDJU TA ’ BARRA
INTERMEDIATE CARTON TEXT FOR BLISTER PACK (WITHOUT BLUE BOX) 30 x 1 TABLETS
KLIEM FUQ IL- KARTUNA INTERMEDJA GĦALL- PAKKETT BIL- FOLJI (MINGĦAJR IL- KAXXA L- BLU) 30 X 1 PILLOLA
SUSTIVA 600 mg film-coated tablets efavirenz
SUSTIVA 600 mg pilloli miksija b’ rita Efavirenz
Each film-coated tablet contains: efavirenz 600 mg.
Kull pillola miksija b’ rita fiha: efavirenz 600 mg.
It contains: lactose monohydrate.
Fih: lactose monohydrate.
See package leaflet for further information.
Ara l- fuljett ta ’ tagħrif għal aktar tagħrif.
30 x 1 film-coated tablets Component of a multipack comprising 3 boxes each containing 30 x 1 film-coated tablets.
30 x 1 pillola miksija b’ rita Komponent ta ’ pakkett multiplu li fih 3 kaxxi li kull waħda fiha 30 x 1 pillola miksija b’ rita.
Not to be sold separately.
Mhux biex jinbiegħ separatament.
138 10.
148 10.
139 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
149 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ L- ISTRIXXI JEW FUQ IL- FOLJI
SUSTIVA 600 mg film-coated tablet efavirenz
SUSTIVA 600 mg pillola miksija b’ rita efavirenz
140 B.
150 B.
141 PACKAGE LEAFLET:
151 FULJETT TA ’ TAGĦRIF:
SUSTIVA 50 mg hard capsules efavirenz
SUSTIVA 50 mg kapsula iebsa efavirenz
Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina. • Żomm dan il- fuljett.
If you have any further questions, ask your doctor or pharmacist.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek. • Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
What SUSTIVA is and what it is used for 2.
X’ inhu SUSTIVA u għalxiex jintuża 2.
Before you take SUSTIVA 3.
Qabel ma tieħu SUSTIVA 3.
How to take SUSTIVA 4.
Kif għandek tieħu SUSTIVA 4.
How to store SUSTIVA 6.
Kif taħżen SUSTIVA 6.
WHAT SUSTIVA IS AND WHAT IT IS USED FOR
X’ INHU SUSTIVA U GĦALXIEX JINTUŻA
SUSTIVA belongs to a class of antiretroviral medicines called non-nucleoside reverse transcriptase inhibitors (NNRTIs).
SUSTIVA hija parti minn klassi ta ’ drogi antiretrovirali li jissejħu inibituri non- nukleosidi ta ’ reverse transcriptase (NNTRIs).
Your doctor has prescribed SUSTIVA for you because you have HIV infection.
It- tabib tiegħek ordnalek SUSTIVA għax għandek l- infezzjoni ta ’ l- HIV.
SUSTIVA taken in combination with other antiretroviral medicines reduces the amount of the virus in the blood.
Meta SUSTIVA jittieħed flimkien ma ’ mediċini antiretrovirali oħra, inaqqas l- ammont ta ’ virus fid- demm.
BEFORE YOU TAKE SUSTIVA
QABEL MA TIEĦU SUSTIVA
Do not take SUSTIVA if you are allergic (hypersensitive) to efavirenz or any of the other ingredients of SUSTIVA listed at the end of this leaflet.
Tiħux SUSTIVA • jekk int allerġiku (tbati minn sensittività eċċessiva) għal efavirenz jew sustanzi oħra ta ’ SUSTIVA elenkati fi tmiem dan il- fuljett.
Contact your doctor or pharmacist for advice.
Ikkuntattja lit- tabib jew lill- ispiżjar tiegħek għal parir.
if you have severe liver disease.
• jekk għandek mard tal- fwied sever
if you are currently taking any of the following medicines:
• jekk bħalissa qed tieħu xi waħda minn dawn il- mediċini:
astemizole or terfenadine (used to treat allergy symptoms) bepridil (used to treat heart disease) cisapride (used to treat heartburn) ergot alkaloids (for example, ergotamine, dihydroergotamine, ergonovine, and methylergonovine) (used to treat migraine and cluster headaches)
astemizole jew terfenadine (użat biex jikkura sintomi allerġiċi) bepridil (użat biex jikkura ħruq fl- istonku) cisapride (użat biex jikkura ħruq fl- istonku) ergot alkaloids (eżempju, ergotamine, dihydroergotamine, ergonovine, u methylergonovine) (użati biex jikkuraw l- emikranji u uġigħ ta ’ ras regolari)
midazolam or triazolam (used to help you sleep) pimozide (used to treat certain mental conditions) St.
midazolam jew triazolam (użati biex jgħinuk torqod) pimozide (użat biex jikkura ċerti kundizzjonijiet mentali) St.
John's wort (Hypericum perforatum) (a herbal remedy used for depression and anxiety)
John' s wort (Hypericum perforatum) (rimedju erbali użat biex jikkura depressjoni u ansjetà
Taking these medicines with SUSTIVA could create the potential for serious and/ or life-threatening side-effects or stop SUSTIVA from working properly.
Jekk tieħu dawn il - mediċini ma ’ SUSTIVA jista ’ jkollok effetti mhux mixtieqa serji u/ jew ta ’ theddida għall- ħajja jew tista ’ timpedixxi lil SUSTIVA milli jaħdem b’ mod xieraq.
Take special care with SUSTIVA
Oqgħod attent ħafna bi SUSTIVA
142 SUSTIVA must be taken with other medicines that act against the HIV virus.
152 • SUSTIVA irid jittieħed ma ’ mediċini oħra li jaħdmu kontra l- virus ta ’ l- HIV.
If SUSTIVA is started because your current treatment has not prevented the virus from multiplying, another medicine you have not taken before must be started at the same time.
Jekk SUSTIVA jinbeda għax il- kura preżenti ma waqqfitx il- virus milli joktor, trid tibda fl- istess ħin mediċina oħra li ma kontx qed tieħu qabel.
You can still pass on HIV when taking this medicine, so it is important to take precautions to avoid infecting other people through sexual contact or blood transfer.
• Xorta tista ’ tgħaddi l- HIV lil ħaddieħor meta tkun qed tieħu din il- mediċina, għalhekk huwa importanti li tieħu prekawzjonijiet sabiex tevita milli tinfetta lil ħaddieħor permezz ta ’ kuntatt sesswali jew trasferiment ta ’ demm.
You must remain under the care of your doctor while taking SUSTIVA.
• Waqt li qed tieħu SUSTIVA trid tibqa ’ taħt il- kura tat- tabib tiegħek.
Tell your doctor:
• Għid lit- tabib tiegħek:
- if you have a history of mental illness, including depression, or of substance or alcohol
- Jekk għandek storja ta ’ mard mentali, inkluż depressjoni, jew ta ’ abbuż minn sustanzi
abuse.
jew alkoħol.
- if you have a history of convulsions (fits or seizures) or if you are being treated with
- jekk għandek storja ta ’ konvulżjonijiet (attakki jew kollassi) jew jekk tkun qed tiġi
anticonvulsant therapy such as carbamazepine, phenobarbital and phenytoin.
kkurat/ a b’ terapija antikonvulsanti bħal carbamazepine, phenobarbital u phenytoin.
If you are taking any of these medicines, your doctor may need to check the level of anticonvulsant medicine in your blood to ensure that it is not affected while taking SUSTIVA.
Jekk qed tieħu xi mediċina minn dawn, it- tabib tiegħek jista ’ jkollu bżonn li jara l- livell ta ’ mediċina antikonvulsanti fid- demm tiegħek sabiex jiżgura li dan ma jkunx affettwat waqt li tkun qed tieħu SUSTIVA.
- if you have a history of liver disease, including active chronic hepatitis.
- jekk għandek storja medika ta ’ mard fil- fwied inkluż epatite kronika attiva.
Patients with
Pazjenti
chronic hepatitis B or C and treated with combination antiretroviral agents have a higher risk for severe and potentially life-threatening liver problems.
b’ epatite B jew C kronika u li huma kkurati b’ aġenti antiretrovirali ta ’ kombinazzjoni għandhom riskju ikbar li jiżviluppaw problemi tal- fwied serji jew li saħansitra jistgħu jkunu ta ’ theddid għall- ħajja.
If you have severe liver disease, do not take SUSTIVA (see section 2, Do not take SUSTIVA).
Jekk ikollok mard fil- fwied serju, tiħux SUSTIVA (ara Sezzjoni 2, Tiħux SUSTIVA).
Once you start taking SUSTIVA, look out for:
• Ladarba tibda tieħu SUSTIVA oqgħod attent/ a għal:
- signs of dizziness, difficulty sleeping, drowsiness, difficulty concentrating or
- sinjali ta ’ sturdament, diffikultà fl- irqad, ħedla, diffikultà fil- konċentrazzjoni jew
abnormal dreaming.
ħolm mhux normali.
- any signs of skin rash.
- kwalunkwe sinjal ta ’ raxx tal- ġilda.
If you see any signs of a severe rash with blistering or fever, stop
Jekk tara xi sinjal ta ’ raxx tal- ġilda b’ infafet jew
taking SUSTIVA and tell your doctor at once.
deni, waqqaf SUSTIVA u għid lit- tabib tiegħek minnufih.
If you had a rash while taking another NNRTI, you may be at a higher risk of getting a rash with SUSTIVA.
Jekk kellek raxx meta kont qed tieħu NNRTI ieħor, tista ’ tkun f’ riskju akbar li jkollok raxx bi SUSTIVA.
- any signs of inflammation or infection.
- kwalunkwe sinjal ta ’ infjammazzjoni jew infezzjoni.
In some patients with advanced HIV infection
F’ xi pazjenti li jkollhom
(AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
infezzjoni avvanzata ta ’ l- HIV (AIDS) u storja ta ’ infezzjoni opportunistika, jista ’ jkun li ftit wara li tibda l- kura kontra l- HIV, iseħħu sinjali u sintomi ta ’ infjammazzjoni minn infezzjonijiet li ġew qabel.
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Huwa maħsub li dan jiġri minħabba li r- rispons immunitarju tal- ġisem jitjieb, u għalhekk il- ġisem jibda jikkumbatti l- infezzjonijiet li setgħu kienu hemm mingħajr sintomi ovvji.
If you notice any symptoms of infection, please tell your doctor immediately.
Jekk tinnota xi sintomi ta ’ infezzjoni, għid mal- ewwel lit - tabib tiegħek.
- changes in body fat.
- tibdil fix- xaħam tal- ġisem.
Redistribution, accumulation or loss of body fat may occur in
Jista ’ jkun hemm ridistribuzzjoni, akkumulu jew telf tax -
patients receiving combination antiretroviral therapy.
xaħam tal- ġisem f’ pazjenti li qed jingħataw terapija antiretrovirali kombinata.
Tell your doctor if you notice changes in your body fat.
Għid lit - tabib tiegħek jekk tara bidliet fix- xaħam tal- ġisem tiegħek.
- bone problems.
- problemi fl- għadam.
Some patients taking combination antiretroviral therapy may develop a
Xi pazjenti li jieħdu terapija antiretrovirali kombinata jistgħu
bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
jiżviluppaw marda fl- għadam li tissejjaħ astjonekrożi (mewt tat- tessut ta ’ l- għadam minħabba n- nuqqas ta ’ demm lejn l- għadam).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Xi wħud mill- ħafna fatturi ta ’ riskju li jistgħu jwasslu għal din il- marda jinkludu t- tul tat- terapija antiretrovirali kombinata, użu
If you notice any of these symptoms please inform your doctor.
Jekk tinnota xi sintomu minn dawn jekk jogħġbok informa lit- tabib tiegħek.
143 Use in children SUSTIVA 50 mg hard capsules can be taken by children and adolescents 3 years of age and older and weighing at least 13 kg who are able to swallow the capsules.
Użu fit- tfal Il- kapsuli iebsin ta ’ SUSTIVA 50 mg jistgħu jittieħdu minn tfal u adoloxxenti ta ’ 3 snin u ikbar u li jiżnu aktar minn 13 kg li jistgħu jibilgħu il- kapsuli ibsin.
Opening the capsule and taking the contents with a small amount of food may be considered for children who cannot swallow the hard capsule and cannot tolerate the oral solution (see How to take SUSTIVA).
Il- ftuħ tal- kapsula u t- teħid tal- kontenut ma ’ ammont żgħir ta ’ ikel jista ’ jiġi kkunsidrat għal tfal li ma jistgħux jibilgħu l- kapsula iebsa u li ma jistgħux jittolleraw is- soluzzjoni orali (ara Kif tieħu SUSTIVA.)
Taking other medicines You must not take SUSTIVA with certain medicines.
Meta tieħu mediċini oħra Ma għandekx tieħu SUSTIVA ma ’ ċerti mediċini.
These are listed under Do not take SUSTIVA, at the start of Section 2.
Dawn huma elenkati taħt Tiħux SUSTIVA, fil - bidu ta ’ Sezzjoni 2.
SUSTIVA may interact with other medicines.
SUSTIVA jista ’ jinteraġġixxi ma ’ mediċini oħrajn.
As a result, the amounts of SUSTIVA or other medicines in your blood may be affected.
B’ konsegwenza ta ’ hekk, l- ammonti ta ’ SUSTIVA jew mediċini oħrajn fid- demm tiegħek jistgħu jiġu affettwati.
Other medicines used for HIV infection:
• Mediċini oħrajn użati għal infezzjoni tal- HIV:
protease inhibitors: darunavir, indinavir, lopinavir/ ritonavir, ritonavir, ritonavir boosted atazanavir, saquinavir or fosamprenavir/ saquinavir.
inibituri tal- protease: darunavir, indinavir, lopinavir/ ritonavir, ritonavir, atazanavir, saquinavir jew fosamprenavir/ saquinavir imsaħħin b’ ritonavir.
maraviroc a combination medicine containing efavirenz, emtricitabine and tenofovir, which is currently known as ATRIPLA.
Maraviroc mediċina ta ’ kombinazzjoni li fiha efavirenz, emtricitabine u tenofovir li fil- preżent hija magħrufa bħala ATRIPLA.
SUSTIVA should not be taken with ATRIPLA since it contains efavirenz, the active ingredient of SUSTIVA.
SUSTIVA ma għandux jittieħed ma ’ ATRIPLA minħabba li din fiha efavirenz, is- sustanza attiva ta ’ SUSTIVA.
Medicines used to treat bacterial infections, including tuberculosis and AIDS-related mycobacterium avium complex: clarithromycin, rifabutin, rifampicin.
• Mediċini użati biex jikkuraw infezzjonijiet batterjali, inkluż tuberkolożi u kumpless ta ’ avju mijobatterjum: clarithromycin, rifabutin, rifampicin.
In addition, your doctor may prescribe a higher dose of SUSTIVA.
Barra minn hekk, it- tabib tiegħek jista ’ jagħtik b’ riċetta doża għolja ta ’ SUSTIVA.
Medicines used to treat fungal infections (antifungals):
• Mediċini użati biex jikkuraw infezzjonijiet fungali (antifungali):
SUSTIVA may reduce the amount of voriconazole in your blood and voriconazole may increase the amount of SUSTIVA in your blood.
SUSTIVA jista ’ jnaqqas l- ammont ta ’ voriconazole fid- demm tiegħek u voriconazole jista ’ jżid l- ammont ta ’ SUSTIVA fid- demm tiegħek.
If you take these two medicines together, the dose of voriconazole must be increased and the dose of efavirenz must be reduced.
Jekk tieħu dawn iż - żewġ mediċini flimkien, id- doża ta ’ voriconazole għandha tiżdied u d- doża ta ’ efavirenz għandha titnaqqas.
SUSTIVA may reduce the amount of itraconazole in your blood. posaconazole.
SUSTIVA jista ’ jnaqqas l- ammont ta ’ itraconazole fid- demm tiegħek. posaconazole.
SUSTIVA may reduce the amount of posaconazole in your blood.
SUSTIVA jista ’ jnaqqas l- ammont ta ’ posaconazole fid- demm tiegħek.
SUSTIVA can reduce or increase the amount of anticonvulsant in your blood.
SUSTIVA jista ’ jnaqqas l- ammont ta ’ antikonvulżant fid- demm tiegħek.
Carbamazepine may make SUSTIVA less likely to work.
Carbamazepine jista ’ jnaqqas il- probabbiltà li SUSTIVA jaħdem.
SUSTIVA can reduce the amount of statins in your blood.
SUSTIVA jista ’ jnaqqas l- ammont ta ’ statini fid- demm tiegħek.
Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your dose of methadone.
154 Methadone, mediċina użata biex tikkura l- vizzju ta ’ opjati, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ methadone tiegħek.
Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
Sertraline, mediċina użata biex tikkura d- depressjoni, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ sertraline tiegħek.
144 Diltiazem or similar medicines (called calcium channel blockers): when you start taking SUSTIVA, your doctor may need to adjust your dose of the calcium channel blocker.
Diltiazem jew mediċini simili (magħrufin bħala imblokkaturi tal- kanal tal- kalċju): meta tibda tieħu SUSTIVA, it- tabib tiegħek jista ’ jkollu bżonn jaġġusta d- doża tiegħek tal - imblokkatur tal- kanal tal- kalċju.
Immunosuppressants such as cyclosporine, sirolimus, or tacrolimus (medicines used to prevent organ transplant rejection): when you start or stop taking SUSTIVA, your doctor will closely monitor your plasma levels of the immunosuppressant and may need to adjust its dose.
Immunosuppressanti bħal cyclosporine, sirolimus, jew tacrolimus (mediċini użati biex jimpedixxu rifjut ta ’ trapjant ta ’ organu): meta tibda jew tieqaf tieħu SUSTIVA, it- tabib tiegħek jimmonitorja l- livelli tal- immunosuppressant fil- plasma tiegħek mill- qrib u jista ’ jkollu bżonn jaġġusta d- doża tiegħu.
Taking SUSTIVA with food and drink Taking SUSTIVA on an empty stomach may reduce the undesirable effects.
Meta tieħu SUSTIVA ma ’ l- ikel u max- xorb Jekk tieħu SUSTIVA fuq stonku vojt tista ’ ttaffi l- effetti mhux mixtieqa.
Pregnancy and breast-feeding Women should not get pregnant during treatment with SUSTIVA, and for 12 weeks thereafter.
Tqala u Treddigħ In- nisa m’ għandhomx jinqabdu tqal waqt kura bi SUSTIVA u għal 12- il ġimgħa wara.
Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with SUSTIVA.
It- tabib tiegħek jista ’ jitolbok tagħmel test tat- tqala biex ikun ċert li m’ intix tqila qabel tibda l- kura bi SUSTIVA.
If you could get pregnant while receiving SUSTIVA, you need to use a reliable form of barrier contraception (for example, a condom) with other methods of contraception including oral (pill) or other hormonal contraceptives (for example, implants, injection).
Jekk tista ’ tinqabad tqila waqt li tkun qed tieħu SUSTIVA, inti trid tuża forma affidabbli ta ’ kontraċezzjoni barriera (per eżempju, kondom) ma ’ metodi oħra ta ’ kontraċezzjoni fosthom kontraċettivi orali (pillola) jew kontraċettivi oħra ormonali, (per eżempju impjanti, injezzjoni).
Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking SUSTIVA.
Għalhekk, inti għandek tkompli tuża miżuri ta ’ kontraċezzjoni, bħal fuq, għal 12- il ġimgħa wara li tieqaf tieħu SUSTIVA.
If you are pregnant, you should take SUSTIVA only if you and your doctor decide it is clearly needed.
Jekk int tqila, għandek tieħu SUSTIVA biss jekk int u t- tabib tiegħek tiddeċiedu li hija ċara li hemm bżonn tieħdu.
If you have taken SUSTIVA during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Jekk ħadt SUSTIVA waqt it- tqala, it- tabib tiegħek jista ’ jitolbok tagħmel testijiet regolari tad- demm u testijiet dijanjostiċi oħra biex jimmonitorja l- iżvilupp tat- tarbija tiegħek. SUSTIVASUSTIVASUSTIVA
You should not breast feed your baby if you are taking SUSTIVA.
M’ għandekx tredda ’ lit- tarbija tiegħek jekk qed tieħu SUSTIVA.
Driving and using machines SUSTIVA may cause dizziness, impaired concentration, and drowsiness.
Sewqan u tħaddim ta ’ magni SUSTIVA jista ’ jikkawża sturdament, tnaqqis fil- konċentrazzjoni u ngħas.
Important information about some of the ingredients of SUSTIVA This medicinal product contains 342 mg of lactose in each 600-mg daily dose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ SUSTIVA Dan il- prodott mediċinali fih 342 mg ta ’ lactose f’ kull doża ta ’ kuljum ta ’ 600 mg.
Individuals with these conditions may take SUSTIVA oral solution, which is free from lactose.
Individwi b’ dawn il- kondizzjonijiet jistgħu jużaw SUSTIVA soluzzjoni orali, li ma fihiex lactose.
HOW TO TAKE SUSTIVA
KIF GĦANDEK TIEĦU SUSTIVA
Always take SUSTIVA exactly as your doctor has told you.
Dejjem għandek tieħu SUSTIVA skond il- parir tat- tabib.
SUSTIVA is for oral use.
155 • SUSTIVA huwa għal użu orali.
SUSTIVA is recommended to be taken on an empty stomach preferably at bedtime.
Huwa rakkomandat li SUSTIVA jittieħed fuq stonku vojt preferibbilment qabel l- irqad.
The dose for children weighing less than 40 kg is calculated by body weight and is taken once daily as shown below:
Stonku vojt huwa definit bħala siegħa qabel jew sagħtejn wara ikla. • Id- doża għall- adulti, u t- tfal li jiżnu 40 kg u iżjed, hija ta ’ 600 mg kuljum. • Id- doża għal tfal li jiżnu inqas minn 40 kg tiġi kkalkulata skond il- piż tal- ġisem u tittieħed darba kuljum skond it- tabella ta ’ hawn taħt:
SUSTIVA Dose (mg) 200 250 300 350 400
SUSTIVA Doża (mg) 200 250 300 350 400
SUSTIVA oral solution is preferred for children who are not able to swallow the capsules.
Għal tfal li mhumiex kapaċi jibilgħu l- kapsuli, is- soluzzjoni orali SUSTIVA hija ppreferuta.
However, if a child does not tolerate the oral solution, the doctor may recommend opening the hard capsule and mixing the contents with a small amount (1-2 teaspoons) of food (e. g., applesauce, grape jelly, yogurt or infant formula).
Madankollu, jekk it- tifel/ tifla ma jittollerax is- soluzzjoni orali, it- tabib jista ’ jirrakkomanda li tinfetaħ il- kapsula iebsa u l- kontenut jitħallat ma ’ ammont żgħir (1- 2 kuċċarini) ta ’ ikel (eż. meraq tat- tuffieħ, jelly ta ’ l- għeneb, jogurt, jew ħalib tat- trabi).
In a taste preference study, efavirenz mixed with grape jelly received the highest rating.
Fi studju tal- preferenza tat- togħma, efavirenz imħallat ma ’ jelly ta ’ l- għeneb irċieva l- ogħla punteġġ.
The capsules must be opened carefully so that the contents do not spill or escape into the air.
Il- kapsuli għandhom jinfetħu b’ attenzjoni sabiex il - kontenut ma jinxteridx jew jaħrab mar- riħ fl- arja.
Hold the capsule vertically with the cap facing up and pull the cap away from the body of the capsule.
Żomm il- kapsula f’ pożizzjoni wieqfa bil- kappa tħares ’ il fuq u iġbed il- kappa ’ l bogħod mill- bqija tal- kapsula.
Use a small container for mixing.
Uża reċipjent żgħir għat- taħlit.
Give the mixture to the child as soon as possible, but no more than 30 minutes after mixing.
Agħti t - taħlita lit- tifel/ tifla kemm jista ’ jkun malajr, iżda mhux aktar tard minn 30 minuta wara li ssir it- taħlita.
Make sure the child eats the full amount of the mixture of food and capsule contents.
Agħmel ċert li t- tifel/ tifla jieħu l- ammont sħiħ tat- taħlita ta ’ l- ikel u tal- kontenut tal- kapsula.
Add another small amount (approximately 2 teaspoons) of the food to the empty mixing container, stirring to make sure there is no drug residue remaining in the container, and have the child eat the full amount again.
Żid ammont żgħir addizzjonali (madwar 2 kuċċarini) ta ’ l- ikel f’ reċipjent tat- taħlit vojt, u ħawwad sabiex tagħmel ċert li ma jibqa ’ ebda residwu tal- mediċina fir- reċipjent, u qis li t- tifel/ tifla jieħu l- ammont sħiħ mill- ġdid.
The child should not be given any additional food for 2 hours.
It- tifel/ tifla ma għandu jingħata ebda ikel addizzjonali għal sagħtejn.
The doctor may also recommend this method of taking SUSTIVA for adults who cannot swallow capsules and do not tolerate the oral solution.
It- tabib jista ’ jirrakkomanda wkoll dan il- metodu ta ’ teħid ta ’ SUSTIVA għal adulti li ma jistgħux jibilgħu kapsuli u li ma jittollerawx is- soluzzjoni orali.
The dose for SUSTIVA may need to be increased or decreased if you are also taking certain medicines (see Taking other medicines).
• Id- doża ta ’ SUSTIVA jista ’ jkollha bżonn tiżdied jew titnaqqas jekk tkun qed tieħu ċerti mediċini (ara Meta tieħu mediċini oħra).
SUSTIVA should never be used alone to treat HIV.
• SUSTIVA irid jittieħed kuljum. • SUSTIVA qatt m’ għandu jintuża waħdu biex jikkura l- HIV.
SUSTIVA must always be taken in combination with other anti-HIV medicines.
SUSTIVA dejjem għandu jittieħed flimkien ta ’ mediċini oħra anti- HIV.
If you take more SUSTIVA than you should If you take too much SUSTIVA contact your doctor or nearest emergency department for advice.
Jekk tieħu SUSTIVA aktar milli suppost Jekk tieħu wisq SUSTIVA ikkuntattja lit- tabib jew l- eqreb dipartiment tal- emerġenza għal parir.
If you forget to take SUSTIVA Try not to miss a dose.
Jekk tinsa tieħu SUSTIVA Ipprova taqbiżx doża.
If you stop taking SUSTIVA When your SUSTIVA supply starts to run low, get more from your doctor or pharmacist.
Jekk tieqaf tieħu SUSTIVA Meta l- ħażna tiegħek ta ’ SUSTIVA tibda tonqos, ġib iktar mit- tabib jew spiżjar tiegħek.
Like all medicines, SUSTIVA can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, SUSTIVA jista ’ jikkawża effetti oħra, għalkemm mhux kulħadd ikollu dawn l- effetti.
When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by SUSTIVA or by other medicines that you are taking at the same time, or by the HIV disease itself.
Meta tkun qiegħda tiġi kkurata infezzjoni tal- HIV, mhux dejjem ikun possibbli li jingħad jekk xi wħud mill- effetti mhux mixtieqa humiex ikkawżati minn SUSTIVA jew minn mediċini oħrajn li tkun qed tieħu fl- istess ħin, jew mill- marda tal- HIV infisha.
The most notable unwanted effects reported with SUSTIVA in combination with other anti-HIV medicines are skin rash and nervous system symptoms.
L- iktar reazzjonijiet mhux mixtieqa notabbli marbuta ma ’ SUSTIVA meta jingħata flimkien ma ’ mediċini oħra ta ’ kontra l- HIV u li ġew irrapurati jinkludu raxx u sintomi marbuta mas- sistema nervuża.
146 You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with SUSTIVA.
Għandek tikkonsulta lit- tabib jekk għandek raxx, billi xi wħud jistgħu ikunu serji; madankollu, il- biċċa l- kbira mill- każijiet ta ’ raxx jgħibu mingħajr bidla fil- kura bi SUSTIVA.
Rash was more common in children than in adults treated with SUSTIVA.
Ir- raxx kienet iktar komuni fit- tfal milli f’ adulti kkurati bi SUSTIVA.
If you are affected your doctor may suggest that you take SUSTIVA at bedtime and on an empty stomach.
Jekk tkun affettwat it- tabib tiegħek jista ’ jissuġġerilek li tieħu SUSTIVA f’ ħin l- irqad u fuq stonku vojt.
Always notify your doctor immediately if you have these symptoms or any side effects while taking SUSTIVA.
Dejjem għarraf lit- tabib tiegħek mal- ewwel jekk għandek xi wieħed linn dawn is- sintomi jew fi effetti mhux mixtieqa waqt li qed tieħu SUSTIVA.
Tell your doctor if you notice any of the following side effects:
Għid lit- tabib tiegħek jekk tosserva xi wieħed minn dawn l- effetti sekondarji li ġejjin:
Very common side effects
Effetti sekondarji komuni ħafna • raxx tal- ġilda
- nervousness, forgetfulness, problems with coordination, confusion, fitting (seizures), abnormal
Effetti sekondarji komuni • ħolm mhux normali, diffikultà fil- konċentrazzjoni, sturdament, uġigħ ta ’ ras, diffikultà fl- irqad, ħedla • uġigħ ta ’ stonku, dijarea, tħossok ma tiflaħx (nawsja), rimettar • ħakk • għeja • tħossok inkwetat/ a, tħossok imdejjaq/ imdejjqa
(hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts
Effetti sekondarji mhux komuni • nervożiżmu, tinsa l- affarijiet, problemi bil- koordinazzjoni, konfużjoni, attakki (kollassi), ħsibijiet mhux normali • viżta mċajpra • sensazzjoni ta ’ tidwir jew għelib (vertiġni) • uġigħ fl- istonku ikkawżat minn infjammazzjoni tal- frixa • reazzjoni allerġika (sensittività eċċessiva) li tista ’ tikkawża reazzjonijiet severi tal- ġilda (ertema multiforme, is- sindromu ta ’ Stevens- Johnson) • ġilda jew għajnejn sofor, ħakk, jew uġigħ fl- istonku ikkawżat minn infjammazzjoni tal- fwied • tkabbir tas- sider fl- irġiel • imġiba ta ’ rabja, tibdil tal- burdati, tara u tisma ’ affarijiet li mhumiex veru hemm (alluċinazzjonijiet), manija (kundizzjoni mentali kkaratterizzata minn episodji ta ’ attività eċċessiva, ferħ kbir jew irritabbiltà), paranoja, ħsibijiet ta ’ suwiċidju.
Combination antiretroviral therapy may change your body shape, by changing the way bodyfat is distributed.
157 It- terapija antiretrovirali kombinata tista ’ tibdel il- forma ta ’ ġismek billi tibdel il- mod kif ix- xaħam f’ ġismek jiġi distribwit.
You may lose fat from your legs, arms and face, gain fat in the abdomen (tummy) and other internal organs, get larger breasts or fatty lumps on the back of the neck ('buffalo hump ').
Tista ’ titlef xaħam mis- saqajn, dirgħajn u l- wiċċ tiegħek u żżid xaħam fiż - żaqq u f’ organi interni oħra, tkabbar is- sider jew boċċi mxaħħmin fuq wara ta ’ l- għonq (ħotba ta ’ buflu).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi effetti sekondarji jsiru serji, jew jekk tinduna b’ xi effetti oħrajn li mhux imniżżlin f’ dan il - fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE SUSTIVA
KIF TAĦŻEN SUSTIVA
Do not use SUSTIVA after the expiry date which is stated on the bottle and on the carton after EXP.
Tużax wara d- data ta ’ l- iskadenza li tinstab fuq il- flixkun u l- kartuna wara JIS.
These measures will help to protect the environment.
Dawn il- miżuri jgħinu għall protezzjoni ta ’ l- ambjent
What SUSTIVA contains
X’ fih SUSTIVA:
The capsules are printed with inks containing cochineal carminic acid (E120), indigo carmine (E132), and titanium dioxide (E171).
• Kull kapsula SUSTIVA fiha 50 mg tas- sostanza attiva efavirenz. • L- ingredjenti l- oħra tat- trab fil- kapsula iebsa huma: sodium laurilsulfate, lactose monohydrate, magnesium stearate u sodium starch glycolate. • Il- qoxra tal- kapsula fiha: gelatine, sodium laurilsulfate, yellow iron oxide (E172), titanium dioxide (E171) u silicon dioxide (E551). • Il- kapsuli huma stampati b’ linka li fiha cochineal carminic acid (E120), indigo carmine (E132), u titanium dioxide (E171).
What SUSTIVA looks like and contents of the pack SUSTIVA 50 mg hard capsules are supplied in bottles of 30 capsules.
Il- kapsuli ibsin SUSTIVA tal- 50 mg jiġu fi fliexken ta ’ 30 kapsula.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH United Kingdom
Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Bristol- Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Ir- Renju Unit
Manufacturer Bristol-Myers Squibb Champ "Lachaud", La Goualle F- 19250 Meymac France
Manifattur Bristol- Myers Squibb Champ "Lachaud", La Goualle F - 19250 Meymac Franza
Bristol-Myers Squibb S. r. l.
158 Bristol- Myers Squibb S. r. l.
150 PACKAGE LEAFLET:
160 FULJETT TA ’ TAGĦRIF:
Contact your doctor or pharmacist for advice.
Tiħux SUSTIVA • jekk int allerġiku (tbati minn sensittività eċċessiva) għal efavirenz jew sustanzi oħra ta ’ SUSTIVA elenkati fi tmiem dan il- fuljett.
if you are currently taking any of the following medicines:
Ikkuntattja lit- tabib jew lill- ispiżjar tiegħek għal parir. • jekk għandek mard tal- fwied sever • jekk bħalissa qed tieħu xi waħda minn dawn il- mediċini:
Taking these medicines with SUSTIVA could create the potential for serious and/or life-threatening side-effects or stop SUSTIVA from working properly.
Jekk tieħu dawn il - mediċini ma ’ SUSTIVA jista ’ jkollok effetti mhux mixtieqa serji u/ jew ta ’ theddida għall- ħajja jew tista ’ timpedixxi lil SUSTIVA milli jaħdem b’ mod xieraq.
151 SUSTIVA must be taken with other medicines that act against the HIV virus.
161 • SUSTIVA irid jittieħed ma ’ mediċini oħra li jaħdmu kontra l- virus ta ’ l- HIV.
It is believed that these symptoms are due to an improvement in the body’s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Huwa maħsub li dan jiġri minħabba li r- rispons immunitarju tal- ġisem jitjieb, u għalhekk il- ġisem jibda jikkumbatti l- infezzjonijiet li setgħu kienu hemm mingħajr sintomi ovvji.
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Xi wħud mill- ħafna fatturi ta ’ riskju li jistgħu jwasslu għal din il- marda jinkludu t- tul tat- terapija antiretrovirali kombinata, użu ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa u indiċi ogħla tal -
152 Use in children SUSTIVA 100 mg hard capsules can be taken by children and adolescents 3 years of age and older and weighing at least 13 kg who are able to swallow the capsules.
Użu fit- tfal Il- kapsuli iebsin ta ’ SUSTIVA 100 mg jistgħu jittieħdu minn tfal u adoloxxenti ta ’ 3 snin u ikbar u li jiżnu aktar minn 13 kg li jistgħu jibilgħu il- kapsuli ibsin.
protease inhibitors: darunavir, indinavir, lopinavir/ritonavir, ritonavir, ritonavir boosted atazanavir, saquinavir or fosamprenavir/saquinavir.
inibituri tal- protease: darunavir, indinavir, lopinavir/ ritonavir, ritonavir, atazanavir, saquinavir jew fosamprenavir/ saquinavir imsaħħin b’ ritonavir.
Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your dose of methadone.
163 Methadone, mediċina użata biex tikkura l- vizzju ta ’ opjati, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ methadone tiegħek.
153 Diltiazem or similar medicines (called calcium channel blockers): when you start taking SUSTIVA, your doctor may need to adjust your dose of the calcium channel blocker.
Diltiazem jew mediċini simili (magħrufin bħala imblokkaturi tal- kanal tal- kalċju): meta tibda tieħu SUSTIVA, it- tabib tiegħek jista ’ jkollu bżonn jaġġusta d- doża tiegħek tal - imblokkatur tal- kanal tal- kalċju.
Driving and using machines SUSTIVA may cause dizziness, impaired concentration, and drowsiness.
SUSTIVA jista ’ jikkawża sturdament, tnaqqis fil- konċentrazzjoni u ngħas.
SUSTIVA is for oral use.
164 • SUSTIVA huwa għal użu orali.
SUSTIVA oral solution is preferred for children who are not able to swallow the capsules.
Għal tfal li mhumiex kapaċi jibilgħu il- kapsuli, is- soluzzjoni orali SUSTIVA hija ppreferuta.
However, if a child does not tolerate the oral solution, the doctor may recommend opening the hard capsule and mixing the contents with a small amount (1-2 teaspoons) of food (e.g., applesauce, grape jelly, yogurt or infant formula).
Madankollu, jekk it- tifel/ tifla ma jittollerax is- soluzzjoni orali, it- tabib jista ’ jirrakkomanda li tinfetaħ il- kapsula iebsa u l- kontenut jitħallat ma ’ ammont żgħir (1- 2 kuċċarini) ta ’ ikel (eż. meraq tat- tuffieħ, jelly ta ’ l- għeneb, jogurt, jew ħalib tat- trabi).
Hold the capsule vertically with the cap facing up and pull the cap away from the body of the capsule.
Żomm il- kapsula f’ pożizzjoni wieqfa bil- kappa tħares ’ il fuq u iġbed il- kappa ’ il bogħod mill- bqija tal- kapsula.
Give the mixture to the child as soon as possible, but no more than 30 minutes after mixing.
Agħti t- taħlita lit- tifel/ tifla kemm jista ’ jkun malajr, iżda mhux aktar tard minn 30 minuta wara li ssir it - taħlita.
Add another small amount (approximately 2 teaspoons) of the food to the empty mixing container, stirring to make sure there is no drug residue remaining in the container, and have the child eat the full amount again.
Żid ammont żgħir addizzjonali (madwar 2 kuċċarini) ta ’ l- ikel f’ reċipjent tat- taħlit vojt, u ħawwad sabiex tagħmel ċert li ma jibqa ’ ebda residwu tal- mediċina fir- reċipjent, u qis li t- tifel/ tifla jieħu l - ammont sħiħ mill- ġdid.
If you do miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for a forgotten dose.
Jekk taqbeż doża, ħu d- doża li jmiss kemm jista ’ jkun malajr, imma tiħux doża doppja biex tpatti għad- doża li nsejt tieħu..
When treating HIV infection, it is not always possible to tell whether some of the unwanted effects are caused by SUSTIVA or by other medicines that you are taking at the same time, or by the HIV disease itself.
Meta tkun qiegħda tiġi kkurata infezzjoni tal - HIV, mhux dejjem ikun possibbli li jingħad jekk xi wħud mill- effetti mhux mixtieqa humiex ikkawżati minn SUSTIVA jew minn mediċini oħrajn li tkun qed tieħu fl- istess ħin, jew mill- marda tal- HIV infisha.
The most notable unwanted effects reported with SUSTIVA in combination with other anti-HIV medicines are skin rash and nervous system symptoms.
L- effetti mhux mixtieqa li l- iktar li jidhru huma raxx tal- ġilda u sintomi tas- sistema nervuża li jinkludu sturdament, nuqqas ta ’ rqad (ngħas), tnaqqis fil- konċentrazzjoni u ħolm anormali.
155 You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with SUSTIVA.
Għandek tikkonsulta lit- tabib jekk għandek raxx, billi xi wħud jistgħu ikunu serji; madankollu, il- biċċa l- kbira mill- każijiet ta ’ raxx jgħibu mingħajr bidla fil- kura bi SUSTIVA.
If you are affected your doctor may suggest that you take SUSTIVA at bedtime and on an empty stomach.
Jekk tkun affettwat it- tabib tiegħek jista ’ jissuġġerilek li tieħu SUSTIVA f’ ħin l- irqad. u fuq stonku vojt.
These problems tend to occur more often in those who have a history of mental illness.
Dawn il - problemi aktarx li jseħħu iktar fost dawk li għandhom storja medika ta ’ mard mentali.
- nervousness, forgetfulness, problems with coordination, confusion, fitting (seizures), abnormal
Effetti sekondarji komuni • ħolm mhux normali, diffikultà fil- konċentrazzjoni, sturdament, uġigħ ta ’ ras, diffikultà fl - irqad, ħedla • uġigħ ta ’ stonku, dijarea, tħossok ma tiflaħx (nawsja), rimettar • ħakk • għeja • tħossok inkwetat/ a, tħossok imdejjaq/ imdejjqa
- allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme,
Effetti sekondarji mhux komuni • nervożiżmu, tinsa l- affarijiet, problemi bil- koordinazzjoni, konfużjoni, attakki (kollassi), ħsibijiet mhux normali • viżta mċajpra • sensazzjoni ta ’ tidwir jew għelib (vertiġni) • uġigħ fl- istonku ikkawżat minn infjammazzjoni tal- frixa • reazzjoni allerġika (sensittività eċċessiva) li tista ’ tikkawża reazzjonijiet severi tal- ġilda (ertema multiforme, is- sindromu ta ’ Stevens- Johnson)
(hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts
166 • ġilda jew għajnejn sofor, ħakk, jew uġigħ fl- istonku ikkawżat minn infjammazzjoni tal- fwied • tkabbir tas- sider fl- irġiel • imġiba ta ’ rabja, tibdil tal- burdati, tara u tisma ’ affarijiet li mhumiex veru hemm (alluċinazzjonijiet), manija (kundizzjoni mentali kkaratterizzata minn episodji ta ’ attività eċċessiva, ferħ kbir jew irritabbiltà), paranoja, ħsibijiet ta ’ suwiċidju.
Combination antiretroviral therapy may change your body shape, by changing the way bodyfat is distributed.
It- terapija antiretrovirali kombinata tista ’ tibdel il- forma ta ’ ġismek billi tibdel il- mod kif ix- xaħam f’ ġismek jiġi distribwit.
You may lose fat from your legs, arms and face, gain fat in the abdomen (tummy) and other internal organs, get larger breasts or fatty lumps on the back of the neck ('buffalo hump').
Tista ’ titlef xaħam mis- saqajn, dirgħajn u l- wiċċ tiegħek u żżid xaħam fiż - żaqq u f’ organi interni oħra, tkabbar is- sider jew boċċi mxaħħmin fuq wara ta ’ l- għonq (ħotba ta ’ buflu).
If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi effetti sekondarji jsiru serji, jew jekk tinduna b ’ xi effetti oħrajn li mhux imniżżlin f’ dan il - fuljett, jekk jogħġbok għarraf lit- tabib jew lill- ispiżjar tiegħek.
Do not use SUSTIVA after the expiry date which is stated on the bottle and on the carton after EXP.
Tużax SUSTIVA wara d- data ta ’ l- iskadenza li tinstab fuq il- flixkun u l- kartuna wara JIS.
The capsules are printed with inks containing cochineal carminic acid (E120), indigo carmine (E132), and titanium dioxide (E171).
• Kull kapsula SUSTIVA fiha 100 mg tas- sostanza attiva efavirenz. • L- ingredjenti l- oħra tat- trab fil- kapsula iebsa huma: sodium laurilsulfate, lactose monohydrate, magnesium stearate u sodium starch glycolate. • Il- qoxra tal- kapsula fiha: gelatine, sodium laurilsulfate, titanium dioxide (E171) u silicon dioxide. • Il- kapsuli huma stampati b’ linka li fiha cochineal carminic acid (E120), indigo carmine (E132) u titanium dioxide (E171).
What SUSTIVA looks like and contents of the pack SUSTIVA 100 mg hard capsules are supplied in bottles of 30 capsules.
Il- kapsuli ibsin SUSTIVA tal- 100 mg jiġu fi fliexken ta ’ 30 kapsula.
Manufacturer Bristol-Myers Squibb Champ "Lachaud", La Goualle F- 19250 Meymac France
167 Manifattur Bristol- Myers Squibb Champ "Lachaud", La Goualle F - 19250 Meymac Franza
159 PACKAGE LEAFLET:
169 FULJETT TA ’ TAGĦRIF:
160 SUSTIVA must be taken with other medicines that act against the HIV virus.
170 • SUSTIVA irid jittieħed ma ’ mediċini oħra li jaħdmu kontra l- virus ta ’ l- HIV.
Once you start taking SUSTIVA, look out for:
• Ladarba tibda tieħu SUSTIVA oqgħod attent/ a għal: •
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
171 ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa u indiċi ogħla tal - massa tal- ġisem fost oħrajn.
161 Use in children SUSTIVA 200 mg hard capsules can be taken by children and adolescents 3 years of age and older and weighing at least 13 kg who are able to swallow the capsules.
Użu fit- tfal Il- kapsuli iebsin ta ’ SUSTIVA 200 mg jistgħu jittieħdu minn tfal u adoloxxenti ta ’ 3 snin u ikbar u li jiżnu aktar minn 13 kg li jistgħu jibilgħu il- kapsuli ibsin.
Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your dose of methadone.
172 Methadone, mediċina użata biex tikkura l- vizzju ta ’ opjati, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ methadone tiegħek.
162 Diltiazem or similar medicines (called calcium channel blockers): when you start taking SUSTIVA, your doctor may need to adjust your dose of the calcium channel blocker.
Diltiazem jew mediċini simili (magħrufin bħala imblokkaturi tal- kanal tal- kalċju): meta tibda tieħu SUSTIVA, it- tabib tiegħek jista ’ jkollu bżonn jaġġusta d- doża tiegħek tal - imblokkatur tal- kanal tal- kalċju.
If you have taken SUSTIVA during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Jekk ħadt SUSTIVA waqt it- tqala, it- tabib tiegħek jista ’ jitolbok tagħmel testijiet regolari tad- demm u testijiet dijanjostiċi oħra biex jimmonitorja l- iżvilupp tat- tarbija tiegħek. SUSTIVA
Driving and using machines SUSTIVA may cause dizziness, impaired concentration, and drowsiness.
Waqt il- kura bi SUSTIVA ġew irrapurtati sturdament, tnaqqis fil- konċentrazzjoni u ngħas.
If you are affected, do not drive and do not use any tools or machines.
Jekk ikollok dawn is- sintomi għandek tevita xogħol li jista ’ jkun ta ’ periklu bħas- sewqan u t- tħaddim tal - makkinarju.
SUSTIVA is for oral use.
• SUSTIVA huwa għal użu orali.
If you do miss a dose, take the next dose as soon as possible, but do not take a double dose to make up for a forgotten dose.
Jekk taqbeż doża, ħu d- doża li jmiss kemm jista ’ jkun malajr tiħux doża doppja biex tpatti għad- doża li nsejt tieħu.
If you need help in planning the best times to take your medicine, ask your doctor or pharmacist.
Jekk għandek bżonn l- għajnuna biex tippjana l- aħjar ħin għall - mediċina tiegħek, saqsi lit- tabib jew lill- ispiżjar tiegħek.
If you stop taking SUSTIVA When your SUSTIVA supply starts to run low, get more from your doctor or pharmacist.
174 Jekk tieqaf tieħu SUSTIVA Meta l- ħażna tiegħek ta ’ SUSTIVA tibda tonqos ġib iktar mit- tabib jew spiżjar tiegħek.
164 You should consult your doctor if you have a rash, since some rashes may be serious; however, most cases of rash disappear without any change to your treatment with SUSTIVA.
Għandek tikkonsulta lit- tabib jekk għandek raxx, billi xi wħud jistgħu ikunu serji; madankollu, il- biċċa l- kbira mill- każijiet ta ’ raxx jgħibu mingħajr bidla fil- kura bi SUSTIVA.
(hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts
Effetti sekondarji mhux komuni • nervożiżmu, tinsa l- affarijiet, problemi bil- koordinazzjoni, konfużjoni, attakki (kollassi), ħsibijiet mhux normali • viżta mċajpra 175 • sensazzjoni ta ’ tidwir jew għelib (vertiġni) • uġigħ fl- istonku ikkawżat minn infjammazzjoni tal- frixa • reazzjoni allerġika (sensittività eċċessiva) li tista ’ tikkawża reazzjonijiet severi tal- ġilda (ertema multiforme, is- sindromu ta ’ Stevens- Johnson) • ġilda jew għajnejn sofor, ħakk, jew uġigħ fl- istonku ikkawżat minn infjammazzjoni tal- fwied • tkabbir tas- sider fl- irġiel • imġiba ta ’ rabja, tibdil tal- burdati, tara u tisma ’ affarijiet li mhumiex veru hemm (alluċinazzjonijiet), manija (kundizzjoni mentali kkaratterizzata minn episodji ta ’ attività eċċessiva, ferħ kbir jew irritabbiltà), paranoja, ħsibijiet ta ’ suwiċidju.
Do not use SUSTIVA after the expiry date which is stated on the bottle or blister and on the carton after EXP.
Tużax SUSTIVA wara d- data ta ’ l- iskadenza li tinstab fuq il- flixkun u l- kartuna wara JIS.
The capsules are printed with inks containing cochineal carminic acid (E120), indigo carmine (E132), and titanium dioxide (E171).
• Kull kapsula SUSTIVA fiha 200 mg tas- sostanza attiva efavirenz. • L- ingredjenti l- oħra tat- trab fil- kapsula iebsa huma: sodium laurilsulfate, lactose monohydrate, magnesium stearate u sodium starch glycolate. • Il- qoxra tal- kapsula fiha: gelatine, sodium laurilsulfate, yellow iron oxide (E172) u silicon dioxide. • Il- kapsuli huma stampati b’ linka li fiha cochineal carminic acid (E120), indigo carmine (E132), u titanium dioxide (E171).
What SUSTIVA looks like and contents of the pack SUSTIVA 200 mg hard capsules are supplied in bottles of 90 capsules and in packs containing 42 x 1 capsules in aluminium/PVC perforated unit dose blisters.
Il- Kapsuli SUSTIVA tal- 200mg jiġu fi fliexken ta ’ 90 Kapsula u f’ pakketti li fihom 42 x 1 Kapsula f’ folji ta ’ l- aluminju/ PVC mtaqqab għal dożi waħedhom.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road Uxbridge UB8 1DH United Kingdom
176 Id- Detentur ta 'l- Awtorizzazzjoni għat- Tqegħid fis- Suq u l- Manifattur Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq Bristol- Myers Squibb Pharma EEIG Uxbridge Business Park Sanderson Road Uxbridge UB8 1DH Ir- Renju Unit
España Bristol-Myers Squibb, S.A.
177 España Bristol- Myers Squibb, S. A.
168 PACKAGE LEAFLET:
178 FULJETT TA ’ TAGĦRIF:
SUSTIVA 30 mg/ml oral solution efavirenz
SUSTIVA 30 mg/ ml soluzzjoni orali efavirenz
169 SUSTIVA must be taken with other medicines that act against the HIV virus.
179 • SUSTIVA irid jittieħed ma ’ mediċini oħra li jaħdmu kontra l- virus ta ’ l- HIV.
(AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti -HIV treatment is started.
infezzjoni avvanzata ta ’ l- HIV (AIDS) u storja ta ’ infezzjoni opportunistika, jista ’ jkun li ftit wara li tibda l- kura kontra l- HIV, iseħħu sinjali u sintomi ta ’ infjammazzjoni minn infezzjonijiet li ġew qabel.
Signs of osteonecrosis are joint
Xi wħud mill- ħafna fatturi ta ’ riskju li jistgħu jwasslu għal din il- marda jinkludu t- tul tat- terapija antiretrovirali kombinata, użu
170 stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
180 ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa u indiċi ogħla tal - massa tal- ġisem fost oħrajn.
Use in children SUSTIVA oral solution can be taken by children 3 years of age and older (see How to take SUSTIVA).
Użu fit- tfal SUSTIVA soluzzjoni orali jista ’ jittieħed minn tfal ta ’ 3 snin u ikbar (ara Kif tieħu SUSTIVA).
Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
181 Sertraline, mediċina użata biex tikkura d- depressjoni, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ sertraline tiegħek.