qanastek/EMEA-V3 huggingface dataset:
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 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 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,
Xi wħud mill- ħafna fatturi ta ’ riskju li
193 corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
207 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- massa tal- ġisem fost oħrajn.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ ostjonekrożi huma għebusija tal- ġogi, għuġihat (speċjalment tal- ġenb, l- irkoppa u l- ispalla) u diffikultà fil- moviment.
If you notice any of these symptoms please inform your doctor.
Jekk tinnota xi sintomu minn dawn jekk jogħġbok informa lit- tabib tiegħek..
Use in children STOCRIN 50 mg hard capsules can be taken by children 3 years of age and older who are able to swallow the capsules (see How to take STOCRIN).
Użu fit- tfal Kapsuli ibsin STOCRIN ta ’ 50 mg jista ’ jittieħed minn tfal ta ’ 3 snin u ikbar li jistgħu jibilgħu il - kapsuli ibsin (ara Kif tieħu STOCRIN.)
Taking other medicines You must not take STOCRIN with certain medicines.
Ma għandekx tieħu STOCRIN ma ’ ċerti mediċini.
These are listed under Do not take STOCRIN, at the start of Section 2.
Dawn huma elenkati taħt Tiħux STOCRIN, fil - bidu ta ’ Sezzjoni 2.
They include some common medicines and a herbal remedy (St.
Jinkludu mediċini komuni u rimedju erbali (St.
John’ s wort) which can cause serious interactions.
John’ s wort) li jistgħu jikkawżaw interazzjonijiet serji.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal remedies.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta u rimedji erbali.
STOCRIN may interact with other medicines.
STOCRIN jista ’ jinteraġġixxi ma ’ mediċini oħrajn.
As a result, the amounts of STOCRIN or other medicines in your blood may be affected.
B’ konsegwenza ta ’ hekk, l- ammonti ta ’ STOCRIN jew mediċini oħrajn fid- demm tiegħek jistgħu jiġu affettwati..
This may stop the medicines from working properly, or may make any side effects worse.
Dan jista ’ jwaqqaf lill- mediċini milli jaħdmu kif suppost, jew jista ’ jiggrava kwalunkwe effett sekondarju.
In some cases, your doctor may need to adjust your dose or check your blood levels.
F’ xi każijiet, it- tabib tiegħek jista ’ jkollu bżonn jaġġusta d- doża tiegħek jew jiċċekkja l- livelli tad- demm tiegħek.
It is important to tell your doctor if you are taking any of the following:
Huwa importanti li tgħid lit- tabib tiegħek jekk tkun qed tieħu xi ħaġa minn dawn:
Other medicines used for HIV infection:
Mediċini oħrajn użati għal infezzjoni tal- HIV:
-
- inibituri tal- protease: darunavir, indinavir, lopinavir/ ritonavir, ritonavir, atazanavir, saquinavir
protease inhibitors: darunavir, indinavir, lopinavir/ ritonavir, ritonavir, ritonavir boosted atazanavir, saquinavir or fosamprenavir/ saquinavir.
jew fosamprenavir/ saquinavir imsaħħin b’ ritonavir.
Your doctor may consider giving you an alternative medicine or changing the dose of the protease inhibitors.
It- tabib tiegħek jista ’ jikkunsidra li jagħtik mediċina alternattiva jew li jibdel id- doża tal- inibituri tal- protease.
maraviroc a combination medicine which contains efavirenz, emtricitabine and tenofovir, which is currently known as ATRIPLA.
- mediċina ta ’ kombinazzjoni li fiha efavirenz, emtricitabine u tenofovir li fil- preżent hija
STOCRIN should not be taken with ATRIPLA since it contains efavirenz, the active ingredient of STOCRIN.
STOCRIN ma għandux jittieħed ma ’ ATRIPLA minħabba li din fiha efavirenz, is- sustanza attiva ta ’ STOCRIN.
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.
Your doctor may consider changing your dose or giving you an alternative antibiotic.
It- tabib tiegħek jista ’ jikkunsidra li jibdel id- doża tiegħek jew li jagħtik antibijotiku alternattiv.
In addition, your doctor may prescribe a higher dose of STOCRIN.
Barra minn hekk, it- tabib tiegħek jista ’ jagħtik b’ riċetta doża għolja ta ’ STOCRIN.
Medicines used to treat fungal infections (antifungals):
Mediċini użati biex jikkuraw infezzjonijiet fungali (antifungali):
voriconazole.
- voriconazole.
STOCRIN may reduce the amount of voriconazole in your blood and voriconazole may increase the amount of STOCRIN in your blood.
voriconazole jista ’ jżid l- ammont ta ’ STOCRIN 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.
You must check with your doctor first.
Għandek tara dan mat- tabib tiegħek l- ewwel.
itraconazole.
- itraconazole.
STOCRIN may reduce the amount of itraconazole in your blood. posaconazole.
STOCRIN jista ’ jnaqqas l- ammont ta ’ itraconazole fid- demm tiegħek.
STOCRIN may reduce the amount of posaconazole in your blood.
STOCRIN jista ’ jnaqqas l- ammont ta ’ posaconazole fid- demm tiegħek.
Medicines used to treat convulsions/ seizures (anticonvulsants): carbamazepine, phenytoin, phenobarbital.
Mediċini użati biex jikkuraw konvulżjonijiet/ attakki (antikonvulżjonijiet): carbamazepine, phenytoin, phenobarbital.
STOCRIN can reduce or increase the amount of anticonvulsant in your blood.
STOCRIN jista ’ jnaqqas l- ammont ta ’ antikonvulżant fid- demm tiegħek.
Carbamazepine may make STOCRIN less likely to work.
Carbamazepine jista ’ jnaqqas il- probabbiltà li STOCRIN jaħdem.
Your doctor may need to consider giving you a different anticonvulsant.
It- tabib tiegħek jista ’ jkollu bżonn jikkunsidra li jagħtik antikonvulżant differenti.
Medicines used to lower blood fats (also called statins): atorvastatin, pravastatin, simvastatin.
Mediċini użati biex ibaxxu l- ammont ta ’ xaħam fid- demm (magħrufin ukoll bħala statini): atorvastatin, pravastatin, simvastatin.
STOCRIN can reduce the amount of statins in your blood.
STOCRIN jista ’ jnaqqas l- ammont ta ’ statini fid- demm tiegħek.
Your doctor will check your cholesterol levels and will consider changing the dose of your statin, if needed.
It- tabib tiegħek jara l- livelli ta ’ kolesterol tiegħek u jikkunsidra jibdilx id- doża tal - istatin tiegħek, jekk ikun hemm bżonn.
Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your dose of methadone.
Methadone, mediċina użata biex tikkura l- vizzju ta ’ opjati, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ methadone tiegħek.
194 Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
208 Sertraline, mediċina użata biex tikkura d- depressjoni, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ sertraline tiegħek.
Diltiazem or similar medicines (called calcium channel blockers): when you start taking STOCRIN, 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 STOCRIN, 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 STOCRIN, 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 STOCRIN, it- tabib tiegħek jimmonitorja l- livelli tal- immunosuppressant fil- plasma tiegħek mill- qrib u jista ’ jkollu bżonn jaġġusta d- doża tiegħu.
Taking STOCRIN with food and drink Taking STOCRIN on an empty stomach may reduce the undesirable effects.
Meta tieħu STOCRIN ma ’ l- ikel u max- xorb Jekk tieħu STOCRIN fuq stonku vojt tista ’ ttaffi l- effetti mhux mixtieqa.
Pregnancy and breast-feeding Women should not get pregnant during treatment with STOCRIN and for 12 weeks thereafter.
Tqala u Treddigħ In- nisa m’ għandhomx jinqabdu tqal waqt kura bi STOCRIN 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 STOCRIN.
It- tabib tiegħek jista ’ jitolbok tagħmel test tat- tqala biex ikun ċert li m’ intix tqila qabel tibda l- kura bi STOCRIN.
If you could get pregnant while receiving STOCRIN, 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 STOCRIN, 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).
Efavirenz may remain in your blood for a time after therapy is stopped.
Efavirenz jista ’ jibqa ’ fid- demm tiegħek għal xi żmien wara li titwaqqaf it- terapija.
Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking STOCRIN.
Għalhekk, inti għandek tkompli tuża miżuri ta ’ kontraċezzjoni, bħal fuq, għal 12- il ġimgħa wara li tieqaf tieħu STOCRIN.
Tell your doctor immediately if you are pregnant or intend to become pregnant.
Għid lit- tabib tiegħek jekk int tqila jew jekk beħsiebek toħroġ tqila.
If you are pregnant, you should take STOCRIN only if you and your doctor decide it is clearly needed.
Jekk int tqila, għandek tieħu STOCRIN biss jekk int u t- tabib tiegħek tiddeċiedu li hija ċara li hemm bżonn tieħdu.
Ask your doctor or pharmacist for advice before taking any medicine.
Itlob parir mingħand it- tabib jew l- ispiżjar tiegħek qabel tieħu xi mediċina.
Serious birth defects have been seen in unborn animals and in the babies of women treated with efavirenz during pregnancy.
Ġew osservati difetti serji tat- twelid f’ annimali mhux imwielda u fit- trabi ta ’ nisa kkurati b’ efavirenz waqt it- tqala.
If you have taken STOCRIN during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Jekk ħadt STOCRIN waqt it- tqala, it- tabib tiegħek jista ’ jitolbok tagħmel testijiet regolari tad- demm u testijiet dijanjostiċi oħra biex jimmonitorja l- iżvilupp tat- tarbija tiegħek.
You should not breast feed your baby if you are taking STOCRIN.
M’ għandekx tredda ’ lit- tarbija tiegħek jekk qed tieħu STOCRIN.
Driving and using machines STOCRIN may cause dizziness, impaired concentration, and drowsiness.
Sewqan u tħaddim ta ’ magni STOCRIN jista ’ jikkawża sturdament, tnaqqis fil- konċentrazzjoni u ngħas.
If you are affected, do not drive and do not use any tools or machines.
Jekk inti affettwat, issuqx u tużax għodod jew makkinarju.
Important information about some of the ingredients of STOCRIN This medicinal product contains 342 mg of lactose in each 600-mg daily dose.
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ STOCRIN Dan il- prodott mediċinali fih 342 mg ta ’ lactose f’ kull doża ta ’ kuljum ta ’ 600 mg.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel tieħu dan il- prodott mediċinali.
Individuals with these conditions may take STOCRIN oral solution, which is free from lactose.
Individwi b’ dawn il- kondizzjonijiet jistgħu jużaw STOCRIN soluzzjoni orali, li ma fihiex lactose.
HOW TO TAKE STOCRIN
KIF GĦANDEK TIEĦU STOCRIN
Always take STOCRIN exactly as your doctor has told you.
Dejjem għandek tieħu STOCRIN skond il- parir tat- tabib.
• STOCRIN is for oral use.
209 • STOCRIN huwa għal użu orali.
STOCRIN is recommended to be taken on an empty stomach preferably at bedtime.
Huwa rakkomandat li STOCRIN jittieħed fuq stonku vojt preferibbilment qabel l- irqad.
This may make some side effects (for example, dizziness, drowsiness) less troublesome.
Dan jista ’ jagħmel xi effetti sekondarji (eżempju, sturdament, ħedla) inqas ta ’ fastidju.
An empty stomach is commonly defined as 1 hour before or 2 hours after a meal. • The dose for adults, and children weighing 40 kg or more, is 600 mg once daily.
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:
Body Weight kg 13 to < 15 15 to < 20 20 to < 25 25 to < 32.5 32.5 to < 40
Piż tal- Ġisem Kg 13 sa < 15 15 sa < 20 20 sa < 25 25 sa < 32. 5 32. 5 sa < 40
STOCRIN Dose (mg) 200 250 300 350 400
STOCRIN Doża (mg) 200 250 300 350 400
• The dose for STOCRIN may need to be increased or decreased if you are also taking certain medicines (see Taking other medicines).
• Id- doża ta ’ STOCRIN jista ’ jkollha bżonn tiżdied jew titnaqqas jekk tkun qed tieħu ċerti mediċini (ara Meta tieħu mediċini oħra).
Your doctor will give you instructions for proper dosage.
It- tabib tiegħek jagħtik l- istruzzjonijiet xierqa ta ’ kif teħodhom.
• STOCRIN must be taken every day. • STOCRIN should never be used alone to treat HIV.
• STOCRIN irid jittieħed kuljum. • STOCRIN qatt m’ għandu jintuża waħdu biex jikkura l- HIV.
STOCRIN must always be taken in combination with other anti-HIV medicines.
STOCRIN dejjem għandu jittieħed flimkien ta ’ mediċini oħra anti- HIV.
If you take more STOCRIN than you should If you take too much STOCRIN contact your doctor or nearest emergency department for advice.
Jekk tieħu STOCRIN aktar milli suppost Jekk tieħu wisq STOCRIN ikkuntattja lit- tabib jew l- eqreb dipartiment tal- emerġenza għal parir.
Keep the medicine container with you so that you can easily describe what you have taken.
Żomm il- pakkett tal- mediċina miegħek sabiex tkun tista ’ tiddeskrivi faċilment dak li tkun ħadt.
If you forget to take STOCRIN Try not to miss a dose.
Jekk tinsa tieħu STOCRIN Ipprova taqbiżx doża.
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.
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 STOCRIN When your STOCRIN supply starts to run low, get more from your doctor or pharmacist.
Jekk tieqaf tieħu STOCRIN Meta l- ħażna tiegħek ta ’ STOCRIN tibda tonqos, ġib iktar mit- tabib jew spiżjar tiegħek.
This is very important because the amount of virus may start to increase if the medicine is stopped for even a short time.
Dan importanti ħafna billi l- ammont ta ’ virus jista ’ jibda jikber jekk il- mediċina titwaqqaf anke għal żmien qasir.
The virus may then become harder to treat.
Imbagħad il- virus jista ’ jsir iktar iebes biex tikkurah.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar l- użu ta ’ dan il- prodott, saqsi lit- tabib jew l- ispiżjar tiegħek.
Like all medicines, STOCRIN can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, STOCRIN 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 STOCRIN 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 STOCRIN jew minn mediċini oħrajn li tkun qed tieħu fl- istess ħin, jew mill- marda tal- HIV infisha.
The most notable unwanted effects reported with STOCRIN in combination with other anti-HIV medicines are skin rash and nervous system symptoms.
L- iktar reazzjonijiet mhux mixtieqa notabbli marbuta ma ’ STOCRIN meta jingħata flimkien ma ’ mediċini oħra ta ’ kontra l- HIV u li ġew irrapurati jinkludu raxx u sintomi marbuta mas- sistema nervuża.
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 STOCRIN.
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 STOCRIN.
Rash was more common in children than in adults treated with STOCRIN.
Ir- raxx kienet iktar komuni fit- tfal milli f’ adulti kkurati bi STOCRIN.
The nervous system symptoms tend to occur when treatment is first started, but generally decrease in the first few weeks.
210 Is- sintomi tas- sistema nervuża aktarx li joħorġu meta tibda l- kura, imma ġeneralment jonqsu fl- ewwel ftit ġranet.
If you are affected your doctor may suggest that you take STOCRIN at bedtime and on an empty stomach.
Jekk tkun affettwat it- tabib tiegħek jista ’ jissuġġerilek li tieħu STOCRIN f’ ħin l- irqad u fuq stonku vojt.
Some patients have more serious symptoms that may affect mood or the ability to think clearly.
Xi pazjenti jkollhom sintomi iktar serji li jistgħu jaffettwaw il- burdata u l- ħila li taħseb b’ mod ċar.
Some patients have actually committed suicide.
Xi pazjenti waslu biex jikkommettu suwiċidju.
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.
Always notify your doctor immediately if you have these symptoms or any side effects while taking STOCRIN.
Dejjem għarraf lit- tabib tiegħek mal- ewwel jekk għandek xi wieħed linn dawn is- sintomi jew fi effetti mhux mixtieqa waqt li qed tieħu STOCRIN.
196 The frequency of the side effects listed below is defined using the following conventions:
Il- frekwenza tal- effetti sekondarji elenkati taħt hija definita permezz tal- konvenzjonijiet li ġejjin:
affects more than 1 user in 10 affects 1 to 10 users in 100 affects 1 to 10 users in 1,000
taffettwa aktar minn utent 1 minn kull 10 taffettwa utent 1 sa 10 minn kull 100 taffettwa utent 1 sa 10 minn kull 1, 000
Tell your doctor if you notice any of the following side effects:
Għid lit- tabib tiegħek jekk
- abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness
- ħolm mhux normali, diffikultà fil- konċentrazzjoni, sturdament, uġigħ ta ’ ras, diffikultà fl -
- stomach pain, diarrhoea, feeling sick (nausea), vomiting
- uġigħ ta ’ stonku, dijarea, tħossok ma tiflaħx (nawsja), rimettar
- feeling worried, feeling depressed
- tħossok inkwetat/ a, tħossok imdejjaq/ imdejjqa
- nervousness, forgetfulness, problems with coordination, confusion, fitting (seizures), abnormal
- nervożiżmu, tinsa l- affarijiet, problemi bil- koordinazzjoni, konfużjoni, attakki (kollassi),
thoughts
ħsibijiet mhux normali
- blurred vision
- viżta mċajpra
- a feeling of spinning or tilting (vertigo)
- sensazzjoni ta ’ tidwir jew għelib (vertiġni)
- pain in the abdomen (stomach) caused by inflammation of the pancreas
- uġigħ fl- istonku ikkawżat minn infjammazzjoni tal- frixa
- allergic reaction (hypersensitivity) that may cause severe skin reactions (erythema multiforme,
- reazzjoni allerġika (sensittività eċċessiva) li tista ’ tikkawża reazzjonijiet severi tal- ġilda (ertema
Stevens-Johnson syndrome)
multiforme, is- sindromu ta ’ Stevens- Johnson)
- yellow skin or eyes, itching, or pain in the abdomen (stomach) caused by inflammation of the
- ġilda jew għajnejn sofor, ħakk, jew uġigħ fl- istonku ikkawżat minn infjammazzjoni tal- fwied
- breast enlargement in males
- tkabbir tas- sider fl- irġiel
- angry behaviour, mood being affected, seeing or hearing things that are not really there
- imġiba ta ’ rabja, tibdil tal- burdati, tara u tisma ’ affarijiet li mhumiex veru hemm
(hallucinations), mania (mental condition characterised by episodes of overactivity, elation or irritability), paranoia, suicidal thoughts
(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 body fat 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).
The cause and long-term health effects of these conditions are not yet known.
Bħalissa l- kawża u l- effetti fit- tul fuq is- saħħa ta ’ dawn il- kondizzjonijiet għadhom mhumiex magħrufa.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, increased fat levels in the blood (hyperlipaemia) and resistance to insulin.
It- terapija antiretrovirali kombinata tista ’ tikkawża wkoll livelli ogħla ta ’ lactic acid u zokkor fil- demm, żieda fl- ammont ta ’ xaħam fid- demm (iperlipemija) u reżistenza għall- insulina.
Your doctor will test for these changes.
It- tabib tiegħek sejjer jittestja dawn il- bidliet.
If any of the side effects get serious, or 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 STOCRIN
KIF TAĦŻEN STOCRIN
Keep out of the reach and sight of children.
211 Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Do not use STOCRIN after the expiry date which is stated on the bottle and on the carton after EXP.
Tużax STOCRIN wara d- data ta ’ l- iskadenza li tinstab fuq il- flixkun u l- kartuna wara JIS.
The expiry date refers to the last day of that month.
Id- data ta ’ l- iskadenza tirreferi għall- aħħar ġurnata ta ’ dak ix- xahar.
What STOCRIN contains
X’ fih STOCRIN
• Each STOCRIN hard capsule contains 50 mg of the active substance efavirenz. • The other ingredients of the powder contained in the hard capsule are: sodium laurilsulfate, lactose monohydrate, magnesium stearate and sodium starch glycolate. • The capsule shell contains: gelatine, sodium laurilsulfate, yellow iron oxide (E172), titanium dioxide (E171) and silicon dioxide (E551). • The capsules are printed with inks containing cochineal carminic acid (E120), indigo carmine (E132), and titanium dioxide (E171).
• Kull kapsula STOCRIN 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 STOCRIN looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett
STOCRIN 50 mg hard capsules are supplied in bottles of 30 capsules.
Il- kapsuli ibsin STOCRIN tal- 50 mg jiġu fi fliexken ta ’ 30 kapsula.
Waarderweg 39 Postbus 581 2003 PC Haarlem The Netherlands
Waarderweg 39 Postbus 581 2003 PC Haarlem L- Olanda
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar din il- mediċina, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq.
198 Eesti Österreich Merck Sharp & Dohme OÜ Tel.: +372 6139 750 msdeesti@merck. com
Österreich Eesti Merck Sharp & Dohme GmbH.
Suomi/ Finland MSD Finland Oy Puh/ Tel: +358 (0) 9 804650 info@msd. fi
Suomi/ Finland Suomen MSD Oy Puh/ Tel: +358 (0) 9 804650 info@ msd. fi
199 This leaflet was last approved in
213 Dan il- fuljett kien approvat l- aħħar f ’
200 PACKAGE LEAFLET:
214 FULJETT TA ’ TAGĦRIF:
Before you take STOCRIN 3.
Qabel ma tieħu STOCRIN Kif għandek tieħu STOCRIN 3.
201 Take special care with STOCRIN • STOCRIN must be taken with other medicines that act against the HIV virus.
215 • STOCRIN irid jittieħed ma ’ mediċini oħra li jaħdmu kontra l- virus ta ’ l- HIV.
The length of combination antiretroviral therapy,
Xi wħud mill- ħafna fatturi ta ’ riskju li jistgħu jwasslu għal din il- marda jinkludu t- tul tat- terapija antiretrovirali kombinata,
202 corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
216 użu ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa u indiċi ogħla tal- massa tal- ġisem fost oħrajn.
Use in children STOCRIN 100 mg hard capsules can be taken by children 3 years of age and older who are able to swallow the capsules (see How to take STOCRIN).
Użu fit- tfal Kapsuli ibsin STOCRIN ta ’ 50 mg jista ’ jittieħed minn tfal ta ’ 3 snin u ikbar li jistgħu jibilgħu il - kapsuli ibsin (ara Kif tieħu STOCRIN.)
Taking other medicines You must not take STOCRIN with certain medicines.
Meta tieħu mediċini oħra Ma għandekx tieħu STOCRIN ma ’ ċerti mediċini.
This may stop the medicines from working properly, or may make any side effects worse.
B’ konsegwenza ta ’ hekk, l- ammonti ta ’ STOCRIN jew mediċini oħrajn fid- demm tiegħek jistgħu jiġu affettwati Dan jista ’ jwaqqaf lill- mediċini milli jaħdmu kif suppost, jew jista ’ jiggrava kwalunkwe effett sekondarju.
203 Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
217 Sertraline, mediċina użata biex tikkura d- depressjoni, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ sertraline tiegħek.
Your doctor may require you to take a pregnancy test to ensure you are not pregnant before starting treatment with STOCRIN.
It- tabib tiegħek jista ’ jitolbok tagħmel test tat- tqala biex ikun ċert li m’ intix tqila qabel tibda l- kura bi STOCRIN
Therefore, you should continue to use contraceptive measures, as above, for 12 weeks after you stop taking STOCRIN.
Għalhekk, inti għandek tkompli tuża miżuri ta ’ kontraċezzjoni, bħal fuq, għal 12- il ġimgħa wara li tieqaf tieħu STOCRIN
• STOCRIN is for oral use.
218 • STOCRIN huwa għal użu orali.
The most notable unwanted effects reported with STOCRIN 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.
The nervous system symptoms tend to occur when treatment is first started, but generally decrease in the first few weeks.
219 Is- sintomi tas- sistema nervuża aktarx li joħorġu meta tibda l- kura, imma ġeneralment jonqsu fl- ewwel ftit ġranet.
If you are affected your doctor may suggest that you take STOCRIN at bedtime and on an empty stomach.
Jekk tkun affettwat it- tabib tiegħek jista ’ jissuġġerilek li tieħu STOCRIN f’ ħin l- irqad. u fuq stonku vojt.
Some patients have more serious symptoms that may affect mood or the ability to think clearly.
Xi pazjenti jkollhom sintomi iktar serji li jistgħu jaffettwaw il- burdata u l- ħila li taħseb b’ mod ċar (ara Disturbi psikjatriċi hawn taħt).
These problems tend to occur
Dawn il - problemi aktarx li jseħħu iktar fost dawk li għandhom storja medika ta ’ mard mentali.
The frequency of the side effects listed below is defined using the following conventions:
Il- frekwenza tal- effetti sekondarji elenkati taħt hija definita permezz tal- konvenzjonijiet li ġejjin:
- stomach pain, diarrhoea, feeling sick (nausea), vomiting
irqad, ħedla uġigħ ta ’ stonku, dijarea, tħossok ma tiflaħx (nawsja), rimettar
Combination antiretroviral therapy may change your body shape by changing the way body fat is distributed.
It- terapija antiretrovirali kombinata tista ’ tibdel il- forma ta ’ ġismek billi tibdel il- mod kif ix- xaħam f’ ġismek jiġi distribwit.
The cause and long-term health effects of these conditions are not yet known.
Bħalissa l- kawża u l- effetti fit- tul fuq is- saħħa ta ’ dawn il- kondizzjonijiet mhux magħrufa.
If any of the side effects get serious, or you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
220 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.
206 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What STOCRIN contains
X’ fih STOCRIN:
• Each STOCRIN hard capsule contains 100 mg of the active substance efavirenz. • The other ingredients of the powder contained in the hard capsule are: sodium laurilsulfate, lactose monohydrate, magnesium stearate and sodium starch glycolate. • The capsule shell contains: gelatine, sodium laurilsulfate, titanium dioxide (E171) and silicon dioxide (E551). • The capsules are printed with inks containing cochineal carminic acid (E120), indigo carmine (E132), and titanium dioxide (E171).
• Kull kapsula STOCRIN 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), 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 STOCRIN looks like and contents of the pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU United Kingdom
Il- Manifattur Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq Merck Sharp & Dohme Limited Hertford Road, Hoddesdon Hertfordshire EN11 9BU Ir- Renju Unit
Tel.: +420 233 010 111 msd_cr@merck. com
Česká republika Merck Sharp & Dohme IDEA, Inc., org. sl Tel.: +420 233 010 111
Tel: +356 2397 6000 medinfo_mt@merck. com
Tel: +356 2397 6000
208 Lietuva UAB “ Merck Sharp & Dohme” Tel.: +370 5 278 02 47 msd_lietuva@merck. com
222 Lietuva UAB “ Merck Sharp & Dohme ” Tel.: +370 5 278 02 47 msd_ lietuva@ merck. com
209 PACKAGE LEAFLET:
223 FULJETT TA ’ TAGĦRIF:
210 Take special care with STOCRIN • STOCRIN must be taken with other medicines that act against the HIV virus.
224 • STOCRIN irid jittieħed ma ’ mediċini oħra li jaħdmu kontra l- virus ta ’ l- HIV.
211 corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
225 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- massa tal- ġisem fost oħrajn.
Use in children STOCRIN 200 mg hard capsules can be taken by children 3 years of age and older who are able to swallow the capsules (see How to take STOCRIN).
Użu fit- tfal Kapsuli ibsin STOCRIN ta ’ 50 mg jista ’ jittieħed minn tfal ta ’ 3 snin u ikbar li jistgħu jibilgħu il - kapsuli ibsin (ara Kif tieħu STOCRIN.)
As a result, the amounts of STOCRIN or other medicines in your blood may be affected.
B’ konsegwenza ta ’ hekk, l- ammonti ta ’ STOCRIN jew mediċini oħrajn fid- demm tiegħek jistgħu jiġu affettwati.
Methadone, a medicine used to treat opiate addiction, as your doctor may need to change your dose of methadone.
226 Methadone, mediċina użata biex tikkura l- vizzju ta ’ opjati, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ methadone tiegħek.
212 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.
• STOCRIN is for oral use.
• STOCRIN huwa għal użu orali.
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 STOCRIN.
228 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 STOCRIN.
The nervous system symptoms tend to occur when treatment is first started, but generally decrease in the first few weeks.
Is- sintomi tas- sistema nervuża aktarx li joħorġu meta tibda l- kura, imma ġeneralment jonqsu fl- ewwel ftit ġranet.
These problems tend to occur
Dawn il- problemi aktarx li jseħħu iktar fost dawk li għandhom storja medika ta ’ mard mentali.
- abnormal dreams, difficulty concentrating, dizziness, headache, difficulty sleeping, drowsiness
Effetti sekondarji komuni ħolm mhux normali, diffikultà fil- konċentrazzjoni, sturdament, uġigħ ta ’ ras, diffikultà fl -
Do not use STOCRIN after the expiry date which is stated on the bottle or blister and on the carton after EXP.
Tużax STOCRIN wara d- data ta ’ l- iskadenza li tinstab fuq il- flixkun u l- kartuna wara JIS.
215 Medicines should not be disposed of via wastewater or household waste.
Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
• Each STOCRIN hard capsule contains 200 mg of the active substance efavirenz. • The other ingredients of the powder contained in the hard capsule are: sodium laurilsulfate, lactose monohydrate, magnesium stearate and sodium starch glycolate. • The capsule shell contains: gelatine, sodium laurilsulfate, yellow iron oxide (E172) and silicon dioxide (E551). • The capsules are printed with inks containing cochineal carminic acid (E120), indigo carmine (E132), and titanium dioxide (E171).
• Kull kapsula STOCRIN 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), 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).
STOCRIN 200 mg capsules are supplied in bottles of 90 capsules and in packs containing 42 x 1 capsules in aluminium perforated unit dose blisters.
Id- Dehra tal- prodott u d- daqs tal- pakkett Il- Kapsuli STOCRIN tal- 200mg jiġu fi fliexken ta ’ 90 Kapsula u f’ pakketti li fihom 42 x 1 Kapsula f’ folji ta ’ l- aluminju mtaqqab għal dożi waħedhom.
България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3740 info-msdbg@merck. com
230 България Мерк Шарп и Доум България ЕООД Тел.: +359 2 819 3740 info- msdbg@ merck. com
Österreich Merck Sharp & Dohme GmbH.
Eesti Österreich Merck Sharp & Dohme GmbH.
Κύπρος Merck Sharp & Dohme (Middle East) Limited.
231 Sverige Κύπρος Merck Sharp & Dohme (Sweden) AB Merck Sharp & Dohme (Middle East) Limited.
Sverige Merck Sharp & Dohme (Sweden) AB Tel: +46 (0) 8 626 1400 medicinskinfo@merck. com
United Kingdom Latvija Bristol- Myers Squibb Pharmaceuticals Ltd.
Latvija SIA “ Merck Sharp & Dohme Latvija” Tel: +371 7364 224 msd_lv@merck. com
SIA “ Merck Sharp & Dohme Latvija ”.
218 PACKAGE LEAFLET:
232 FULJETT TA ’ TAGĦRIF:
219 Take special care with STOCRIN • STOCRIN must be taken with other medicines that act against the HIV virus.
233 • STOCRIN irid jittieħed ma ’ mediċini oħra li jaħdmu kontra l- virus ta ’ l- HIV.
220 corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
234 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- massa tal- ġisem fost oħrajn.
Use in children STOCRIN oral solution can be taken by children 3 years of age and older (see How to take STOCRIN).
Użu fit- tfal STOCRIN soluzzjoni orali jista ’ jittieħed minn tfal ta ’ 3 snin u ikbar (ara Kif tieħu STOCRIN).
protease inhibitors: darunavir, indinavir, lopinavir/ ritonavir, ritonavir, ritonavir-boosted atazanavir, saquinavir or fosamprenavir/ saquinavir.
jew fosamprenavir/ saquinavir imsaħħin b’ ritonavir.
221 Sertraline, a medicine used to treat depression, as your doctor may need to change your dose of sertraline.
235 Sertraline, mediċina użata biex tikkura d- depressjoni, minħabba li t- tabib tiegħek jista ’ jkollu bżonn jibdel id- doża ta ’ sertraline tiegħek.
• STOCRIN oral solution may be taken with or without food. • The dose for adults, and children weighing 40 kg or more, is 24 ml once daily. • The dose for children weighing less than 40 kg is calculated by body weight and is taken once daily as shown below:
• Is- soluzzjoni orali ta ’ STOCRIN jistgħu jittieħu ma ’ l- ikel jew mingħajr ikel. • Id- doża għall- adulti, u t- tfal li jiżnu 40 kg u iżjed, hija ta ’ 24 ml 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:
Body Weight kg
Piż tal- Ġisem Kg
Children
Tfal 3
3 - < 5 years
- < 5 snin
Adults and children aged 5 years or more
Adulti u tfal 5 snin jew iktar
13 to < 15 15 to < 20 20 to < 25
13 sa < 15 15 sa < 20
12 13 15
15
9 10 12
12
The dose of STOCRIN oral solution in mg is not the same as for STOCRIN hard capsules or film- coated tablets.
Id- doża ta ’ STOCRIN soluzzjoni orali f’ mg mhix l- istess bħal STOCRIN kapsuli ibsin jew pilloli miksijin b’ rita.
The dose of STOCRIN oral solution must be measured using the oral syringe supplied in the carton.
Id- doża ta ’ STOCRIN soluzzjoni orali trid tiġi ppreparata b’ siringa orali li tigi fil- kartuna.
On first use, the bottle adapter must be fitted into the neck of the
Meta jintuża l- ewwel darba, l- adapter tal- flixkien irid jitpoġġa fl -
bottle.
għonq tal- flixkun.
14 12 10 8 6 4 2
Biex tagħmel hekk, neħħi l- għatu li ma jinfetaħx 14 12 10 8 6 4 2
The bottle adapter, which is already fixed to the nozzle of the syringe, 0
L- adapter tal- flixkun, li diġa` huma mwaħħal 0
can then be fitted into the neck of the bottle and pressed firmly down.
mal- bokka tas- siringa, jista ’ jiddaħħal fl- għonq tal- flixkun u magħfus sew ‘ l isfel.
• Separate the syringe from the adapter.
• Issepara s- siringa mill- adapter.
The adapter should now f it closely to the neck so that the cap can be replaced without removing 8 6 4
L- adapter għandu jkun marbut sewe ma ’ l- għonq biex l- għatu jista ’ jitneħħa mingħajr ma dan jinqala ’.
• With the bottle upright, fit the tip of the syringe into the bottle adapter.
• Bil- flixkun wieqaf, poġġu tarf is- siringa fl- adapter tal- flixkun.
223 • Turn the bottle upside down with the syringe still in place.
• Dawwar il- flixkun rasu ‘ l isfel bis- siringa għadha f’ postha.
Hold the bottle and the syringe firmly in one hand and with the other hand pull back the plunger slightly beyond the mark for the dose required.
Żomm il - flixkun u s- siringa sodi b’ id waħda u blid l- oħra iġbed lura l- planġer ftit lil hinn mill- marka tad- doża li hemm bżonn.
If air bubbles appear in the syringe, keep the bottle upside down and slowly
Jekk fis- siringa jidhru l- bżieżaq ta ’ l- arja, żomm il- flixkun rasu ‘ l isfel u mbotta bil- mod il -
push in the plunger and pull it back again.
planger u erġa` iġbdu lura.
Repeat until there are no
Irrepeti sakemm ma jkunx hemm bżieżaq
bubbles in the syringe.
ta ’ l- arja fis- siringa.
• To measure the dose accurately, keep the bottle upside down and push the plunger in slowly until the top of the black ring (the edge nearest the syringe tip) lines up with the dose.
237 • Biex tkejjel id- doża bir- reqqa, żomm il- flixkun rasu ‘ l isfel u mbotta l - planġer ‘ il ġewwa bil- mod sakemm il- parti ta ’ fuq taċ- ċirku l- iswed (it- tarf l- eqreb lejn il- ponta tas- siringa) tasal sad- doża.
Turn the bottle the right way
Dawwar il -
up and remove the syringe.
flixkun sew u neħħi s- siringa.
Wipe the adapter and replace the cap
Imsaħ l- adapter u agħlaq sew bit- tapp.
18 19
11 12 mL 13 15 14 16 17 mL 18 20 19
• Before giving the dose of the oral solution make sure that the patient is sitting or standing upright.
• Qabel ma tagħti d- doża tas- soluzzjoni orali kun ċert/ a li l- pazjenti qiegħed bil- qiegħda dritt jew bil- wieqfa.
Put the tip of the syringe just inside the mouth, pointing it towards the cheek.
Daħħal it- traf tas- siringa kemm kemm ġol- ħalq u ppronta lejn il- ħadd.
Press the plunger slowly to allow time for the medicine to be swallowed.
Agħfas il- planġer bil - mod biex dak li jkun ikollu ċans jibla ’ l- mediċina.
Rapid squirting into the
Tagħfis bil- għaġla
ml 18 20 mouth may cause choking.
ml 18 20 jista ’ jwassal biex dak li jkun jifga ’.
After use, soak the syringe in warm soapy water for at least a minute.
Wara l- użu, ħalli s- siringa fl- ilma fietel bis- sapun għal mill- inqas minuta.
Draw the warm soapy water into the syringe until full and then empty completely.
Iġbed l- ilma fietel bis- sapun fis- siringa sakemm tkun mimlija u żvojtaha għal kollox.
Repeat at least three times.
Irrepeti mill- inqas tliet darbiet.
Remove the plunger rod from the barrel and thoroughly rinse both parts with warm running water.
Neħħi l- virga tal- planġer mill- kanna u laħlaħ sew iż- żewg partijiet fl- ilma fietel tal- vit.
If parts of the syringe are not clean, repeat the cleaning instructions.
Jekk xi partijiet mis- siringa mhumiex nodfa, irrepeti dawn l- istruzzjonijiet għat- tindif.
Allow the parts to dry completely prior to reassembly.
Ħalli l- partijiet jinxfu għal kollox qabel ma terġa ’ tintrema ’ s- siringa.
Do not put the syringe in a dishwasher.
Tpoġġix is- siringa fil- magni tal- ħasil tal- platti.
If you stop taking STOCRIN When your STOCRIN supply starts to run low, get more from your doctor or pharmacist.
Jekk tieqaf tieħu STOCRIN Meta l- ħażna tieghek ta ’ STOCRIN tibda tonqos, ġib iktar mit- tabib jew spiżjar tiegħek.
The nervous system symptoms tend to occur when treatment is first started, but generally decrease in the first few weeks.
238 Is- sintomi tas- sistema nervuża aktarx li joħorġu meta tibda l- kura, imma ġeneralment jonqsu fl- ewwel ftit ġranet.
If you are affected your doctor may suggest that you take STOCRIN at bedtime.
Jekk tkun affettwat it- tabib tiegħek jista ’ jissuġġerilek li tieħu STOCRIN f’ ħin l- irqad u fuq stonku vojt.
Diarrhoea occurred in children who took STOCRIN oral solution and nelfinavir in combination with other antiretroviral medicines.
It- tfal li ħadu STOCRIN soluzzjoni orali u nelfinavir flimkien ma ’ mediċini oħra antiretrovirali kellhom dijarrea.
Stevens -Johnson syndrome)
multiforme, is- sindromu ta ’ Stevens- Johnson)
225 Combination antiretroviral therapy may change your body shape by changing the way body fat 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).
Your doctor will test for these changes.
It- tabib tiegħek sejjer jittestja dawn il- bidliet..
If any of the side effects get serious, or 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 STOCRIN after the expiry date which is stated on the bottle and on the carton. after EXP.
Tużax STOCRIN wara d- data ta ’ l- iskadenza li tinstab fuq il- flixkun u l- kartuna wara JIS.
The bottle of STOCRIN oral solution should be used within one month after first opening.
Il- flixkun ta ’ STOCRIN soluzzjoni orali għandu jintuża fi żmien xahar minn meta jinfetaħ l- ewwel darba.
• Each ml of STOCRIN oral solution contains 30 mg of the active substance efavirenz. • The other ingredients are: medium chain triglycerides, benzoic acid (E210) and strawberry/mint flavour.
• Kull ml ta ’ STOCRIN soluzzjoni orali fig 30 mg tas- sustanza attiva efavirenz. • L- ingredjenti l- oħra huma medium chain triglycerides, benzoic acid (E210) u togħma ta ’ frawli/ menta.
STOCRIN 30 mg/ml oral solution is supplied in bottles of 180 ml.
STOCRIN 30 mg/ ml soluzzjoni orali tiġi fi fliexken ta ’ 180 ml.
Nederland Merck Sharp & Dohme B.V.
240 Nederland Danmark Merck Sharp & Dohme B. V.
Suomi/Finland MSD Finland Oy Puh/Tel: +358 (0) 9 804650 info@msd.fi
Suomi/ Finland Suomen MSD Oy Puh/ Tel: +358 (0) 9 804650 info@ msd. fi
United Kingdom Bristol-Myers Squibb Pharmaceuticals Ltd.
241 United Kingdom Latvija Bristol- Myers Squibb Pharmaceuticals Ltd.
228 PACKAGE LEAFLET:
242 FULJETT TA ’ TAGĦRIF:
Do not not pass it on to others.
M’ għandekx tgħaddiha lil persuni oħra.
Taking these medicines with STOCRIN could create the potential for serious and/or life-threatening side-effects or stop STOCRIN from working properly.
Jekk tieħu dawn il - mediċini ma ’ STOCRIN jista ’ jkollok effetti mhux mixtieqa serji u/ jew ta ’ theddida għall- ħajja jew tista ’ timpedixxi lil STOCRIN milli jaħdem b’ mod xieraq.
229 Take special care with STOCRIN • STOCRIN must be taken with other medicines that act against the HIV virus.
243 • STOCRIN 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.
-
Jista ’ jkun hemm ridistribuzzjoni, akkumulu jew telf tax -
-
Xi pazjenti li jieħdu terapija antiretrovirali kombinata jistgħu