qanastek/EMEA-V3 huggingface dataset:
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients including the loss of peripheral and facial subcutaneous fat, increased intra-abdominal and visceral fat, breast hypertrophy and dorsocervical fat accumulation (buffalo hump) (see section 4.4).
It- terapija antiretrovirali kombinata ġiet assoċjata mar- ridistribuzzjoni tax- xaħam fil- ġisem (lipodistrofija) f’ pazjenti bl- HIV fosthom it- telf tax- xaħam ta ’ taħt il- ġilda tal- wiċċ u fil- partijiet periferali tal- ġisem, żieda fix- xaħam intra- addominali u vixxerali, ipertrofija tas- sider u akkumulazzjoni ta ’ xaħam dorsoċervikali (ħotba tal- buflu) (ara sezzjoni 4. 4).
Emtricitabine is phosphorylated by cellular enzymes to form emtricitabine 5'-triphosphate, which competitively inhibits HIV-1 reverse transcriptase, resulting in DNA chain termination.
Emtricitabine huwa fosforilat permezz ta ’ enzimi ċellulari biex jifforma emtricitabine 5 ’ - trifosfat li tinibixxi kompetittivament ir- reverse transcriptase ta ’ l- HIV- 1 li jirriżulta fit- terminazzjoni tal- katina tad- DNA.
19 When tested for activity against laboratory strains of HBV, the 50% inhibitory concentration (IC50) value for emtricitabine was in the range of 0.01 to 0.04 µmol/ l.
Meta ttestajta għall- attività kontra strejns tal- HBV tal- laboratorju, il- valur ta ’ konċentrazzjoni inibitorja ta ’ 50% (IC50) għal emtricitabine kien fil- medda ta ’ 0. 01 sa 0. 04 µmol/ l.
Emtricitabine-resistant viruses were cross-resistant to lamivudine, but retained sensitivity to other nucleoside reverse transcriptase inhibitors (NRTIs) (zidovudine, stavudine, tenofovir, abacavir, didanosine and zalcitabine), all non-nucleoside reverse transcriptase inhibitors (NNRTIs) and all protease inhibitors (PIs).
Il- viri reżistenti għal emtricitabine kienu cross- resistant għal lamivudine, iżda żammew is- sensittività għall- impedituri ta ’ nucleoside reverse transcriptase oħra (NRTI) (zidovudine, stavudine, tenofovir, abacavir, didanosine u zalcitabine), l- impedituri ta ’ non- nucleoside reverse transcriptase kollha (NNRTI) u l- impedituri tal- protease kollha (PIs).
In virologically stable treatment-experienced adults, emtricitabine, in combination with an NRTI (either stavudine or zidovudine) and a protease inhibitor (PI) or an NNRTI was shown to be non-inferior to lamivudine with respect to the proportion of responders (< 400 copies/ ml) through 48 weeks (77% emtricitabine, 82% lamivudine).
F’ adulti esperjenzati bil- kura, viroloġikament stabbli, emtricitabine kkombinata ma ’ NRTI (jew stavudine jew zidovudine) u impeditur tal- protease (PI) jew NNRTI wriet li mhijiex inferjuri għal lamivudine rigward il- proporzjon ta ’ responders (< 400 kopja/ ml) matul 48 ġimgħa (77%
In a pilot study in children and a definitive bioequivalence study in adults, the Emtriva 10 mg/ ml oral solution was shown to have approximately 80% of the bioavailability of the Emtriva 200 mg hard
Fi studju pilota fit- tfal u fi studju definittiv ta ’ bijoekwivalenza fl- adulti, is- soluzzjoni orali Emtriva ta ’ 10 mg/ ml ntwera li għandha bejn wieħed u ieħor 80% tar- rata tal- biodisponibiltà tal- kapsuli iebsin Emtriva ta ’ 200 mg.
Emtricitabine did not inhibit in vitro drug metabolism mediated by the following human CYP450 isoenzymes:
22 Emtricitabine ma impedixxix in vitro l- metaboliżmu tal- mediċina medjat bl- iżoenzimi CYP450 umani li ġejjin:
Linearity/ non-linearity:
Linejarità/ non- linejarità:
In patients with ESRD on haemodialysis, approximately 30% of the emtricitabine dose was recovered in dialysate over a 3 hour dialysis period which had been started within 1.5 hours of emtricitabine
F’ pazjenti bl- ESRD fuq l- dijaliżi tad- demm, madwar 30% tad- doża ta ’ emtricitabine ġiet irkuprata fid- dijalizzat fuq 3 sigħat ta ’ dijaliżi li nbdiet sa siegħa u nofs mid- dożaġġ b’ emtricitabine (rata tat - tnixxija tad- demm ta ’ 400 ml/ min u rata tat- tnixxija ta ’ dijalizzat ta ’ madwar 600 ml/ min).
The mean AUC in 77 infants, children and adolescents receiving 6 mg/ kg emtricitabine once daily as oral solution or 200 mg emtricitabine as hard capsules once daily was similar to the mean AUC of 10.0 µg·h/ ml in 20 adults receiving 200 mg hard capsules once daily.
L- AUC medja f’ 77 tarbija, tfal u adolexxenti li kienu jirċievu 6 mg/ kg ta ’ emtricitabine darba kuljum bħala soluzzjoni orali jew 200 mg ta ’ emtricitabine bħal kapsuli iebsin darba kuljum, kienet tixbah lill- medja ta ’ l- AUC ta ’ 10. 0 µg· h/ ml f’ 20 adult, li kienu jirċievu 200 mg kapsuli iebsin darba kuljum.
Although the mean Cmax and Cmin were approximately 20% higher and mean AUC was 16% higher in females compared to males, this difference was not considered clinically significant.
23 Għalkemm il- medja ta ’ Cmax u ta ’ Cmin kienet ta ’ madwar 20% ogħla u l- medja ta ’ l- AUC kienet ta ’ 16% ogħla fin- nisa meta mqabbla ma ’ l- irġiel, din id- differenza ma kinetx ikkunsidrata li kienet klinikament sinifikanti.
Cotton candy flavouring Disodium edetate Hydrochloric acid Methyl parahydroxybenzoate (E218) Propylene glycol Propyl parahydroxybenzoate (E216) Sodium hydroxide Sodium phosphate monobasic hydrate Sunset yellow (E110) Purified water Xylitol (E967)
Cotton candy flavouring Disodium edetate Hydrochloric acid Methyl parahydroxybenzoate (E218) Propylene glycol Propyl parahydroxybenzoate (E216) Sodium hydroxide Sodium phosphate monobasic hydrate Sunset yellow (E110) Purified water Xylitol (E967)
22 6.3 Shelf life
6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
After first opening:
Wara l- ewwel darba li jinfetaħ:
45 days.
45 jum.
Amber-coloured polyethylene terephthalate (PET) bottle with a child-resistant closure.
Flixkun ta ’ kulur safrani tal- polyethylene terephthalate (PET) b’ għatu li ma jinfetaħx mit- tfal.
The pack also contains a 30 ml polypropylene measuring cup with 1.0 ml graduations.
Il - pakkett fih ukoll tazza tal- kejl ta ’ 30 ml bi gradazzjonijiet ta ’ 1. 0 ml.
The bottle contains 170 ml of solution.
Il- flixkun fih 170 ml ta ’ soluzzjoni orali.
Patients should be instructed that any solution left in the bottle 45 days after opening should be discarded according to local requirements or returned to the pharmacy.
Il- pazjenti għandhom ikunu jingħataw parir li kull soluzzjoni li jibqa ’ fil- flixkun 45 jum wara li jinfetaħ għandha tintrema kif jitolbu l- liġijiet lokali jew tintradd lura lill- ispiżerija.
Gilead Science Limited Unit 13 Stillorgan Industrial Park Blackrock County Dublin Ireland
Gilead Science Limited Unit 13 Stillorgan Industrial Park Blackrock County Dublin L- Irlanda
Cork Ireland
Cork L- Irlanda
The holder of this marketing authorisation must inform the European Commission about the marketing plans for the medicinal product authorised by this decision.
Sid ta ’ din l- awtorizzazzjoni għall- kummerċ għandu jagħti tagħrif lill- Kummissjoni Ewropeja dwar il - pjanijiet kummerċjali tal- prodott mediċinali awtorizzat b’ din id- deċiżjoni.
Risk Management Plan
Pjan ta ’ Maniġġar tar- Riskji
As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, the updated RMP should be submitted at the same time as the next Periodic Safety Update Report (PSUR).
Skond il- Linja gwida tal- CHMP dwar is- Sistemi ta ’ Maniġġar tar- Riskji għal prodotti mediċinali għall- użu mill- bniedem, l- Pjan ta ’ Maniġġar tar- Riskji (RMP) aġġornat għandu jiġi ppreżentat fl- istess ħin tar- Rapport ta ’ Aġġornament tas- Sigurtà Perjodika li jmiss (PSUR).
In addition, an updated RMP should be submitted • When new information is received that may impact on the current Safety Specification, Pharmacovigilance Plan or risk minimisation activities • Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being reached • At the request of the EMEA
Barra minn hekk, għandu jiġi ppreżentat RMP aġġornat • Meta tiġi rċevuta informazzjoni ġdida li jista ’ jkollha impatt fuq l- Ispeċifikazzjoni tas- Sigurtà attwali, il- Pjan ta ’ Farmakoviġilanza jew l- attivitajiet ta ’ tnaqqis tar- riskji • Fi żmien 60 jum minn meta tintlaħaq mira importanti (farmakoviġilanza jew tnaqqis tar- riskji) • Fuq talba ta ’ l- EMEA
PSURs:
PSURs
The Marketing Authorisation Holder will submit PSUR’ s on an annual basis.
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- suq ser jibgħat il- PSURs fuq bażi annwali.
27 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
29 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
BOTTLE AND CARTON LABELLING
TIKKETTA TAL- FLIXKUN U TAL- KARTUNA
Emtriva 200 mg hard capsules Emtricitabine
Emtriva 200 mg kapsuli iebsin Emtricitabine
Each hard capsule contains 200 mg emtricitabine.
Kull kapsula iebsa fiha 200 mg emtricitabine.
Gilead Sciences Intl Ltd Cambridge CB21 6GT United Kingdom
Gilead Sciences Intl Ltd Cambridge CB21 6GT Ir- Renju Unit
Emtriva [outer packaging only]
Emtriva [pakkett ta ’ barra biss]
29 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
31 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
BLISTER CARTON LABELLING
TIKKETTA TAL- KARTUNA BIL- FOLJA
31 MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS
33 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- FOLJI JEW FUQ L- ISTRIXXI
BLISTER
TIKKETTA TAL- FOLJA JEW TA ’ L- ISTRIXXA
Gilead Sciences Intl Ltd
Gliead Sciences Intl Ltd
32 PARTICULARS TO APPEAR ON THE OUTER PACKAGING AND THE IMMEDIATE PACKAGING
34 TAGĦRIF LI GĦANDU JIDHER FUQ IL- PAKKETT TA ’ BARRA U L- PAKKETT LI JMISS MAL- PRODOTT
Emtriva 10 mg/ ml oral solution Emtricitabine
Emtriva 10 mg/ ml soluzzjoni orali Emtricitabine
Each ml contains 10 mg emtricitabine.
Kull ml fih 10 mg ta ’ emtricitabine.
Contains E110, E216, E218, and sodium.
Fiha E110, E216, E218 u sodium.
170 ml oral solution.
170 ml soluzzjoni orali.
After opening: the solution should be used within 45 days.
Is- soluzzjoni għandha tintuża fi żmien 45 jum.
It is advised to write the date of removal from the refrigerator on the package.
Ikun xieraq li d- data ta ’ meta jinħareġ mill- friġġ tinkiteb fuq il- pakkett.
After opening: do not store above 25ºC.
Taħżinx f’ temperatura ’ l fuq minn 25°C.
35 PACKAGE LEAFLET:
37 FULJETT TA ’ TAGĦRIF:
- If any of the side effects get serious, or if you notice any side effects not listed in this leaflet,
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li
What Emtriva is and what it is used for 2.
X’ inhi Emtriva u għalxiex tintuża 2.
Before you take Emtriva 3.
Qabel ma tieħu Emtriva 3.
How to take Emtriva 4.
Kif għandek tieħu Emtriva 4.
How to store Emtriva 6.
Kif taħżen Emtriva 6.
WHAT EMTRIVA IS AND WHAT IT IS USED FOR
X’ INHI EMTRIVA U GĦALXIEX TINTUŻA
Emtriva is a treatment for Human Immunodeficiency Virus (HIV) infection in adults, children and infants above 4 months of age.
Emtriva hi trattament għall- infezzjoni mill- Virus ta ’ l- Immunodefiċjenza Umana (HIV) fl - adulti, fit- tfal u trabi ta ’ ’ l fuq minn l- età ta’ 4 xhur.
Emtriva 200 mg hard capsules are only suitable for patients who weigh at least 33 kg.
Il- kapsuli iebsin ta ’ Emtriva 200 mg huma tajbin biss għall- pazjenti li jiżnu mill- inqas 33 kg.
Emtriva oral solution is available for people who have difficulty in swallowing Emtriva hard capsules.
Emtriva soluzzjoni orali hi disponibbli għal nies li jkollhom diffikultà biex jibilgħu il- kapsuli iebsin ta ’ Emtriva.
Emtriva contains the active substance emtricitabine.
Emtriva fiha s- sustanza attiva, emtricitabine.
This active substance is an antiretroviral medicine which is used to treat HIV infection.
Din is- sustanza attiva hi mediċina antiretrovirali li tintuża biex tittratta l- infezzjoni ta ’ l- HIV.
Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) which works by interfering with the normal working of an enzyme (reverse transcriptase) that is essential for the HIV virus to reproduce itself.
Emtricitabine hu impeditur tan- nucleoside reverse transcriptase (NRTI) u jaħdem billi jinterferixxi mal- ħidma normali ta ’ enzima (reverse transcriptase) li hi essenzjali biex il- virus ta ’ l- HIV jirriproduċi lilu nnifsu.
Emtriva may lower the amount of HIV in the blood (viral load).
Emtriva tista ’ tnaqqas l - ammont ta ’ HIV fid- demm (ammont ta ’ viri).
It may also help to increase the number of T cells called CD4 cells.
Tista ’ wkoll tgħin biex iżżid in- numru ta ’ ċelluli T li jissejħu ċelluli CD4.
Emtriva should always be combined with other medicines to treat HIV infection.
Emtriva għandha dejjem tintuża ma ’ mediċini oħrajn biex tittratta infezzjoni bl - HIV.
You can still pass on HIV to others while you’ re taking this drug, so it is important to take precautions to avoid infecting other people.
Tista ’ tibqa ’ tgħaddi l- HIV lill- oħrajn waqt li qed tieħu din il- mediċina, u għalhekk hu importanti li tieħu prekawzjonijiet biex ma tinfettax nies oħrajn.
This medicine is not a cure for HIV infection.
Din il- mediċina ma tfejjaqx l- infezzjoni ta ’ HIV.
While taking Emtriva you may still develop infections or other illnesses associated with HIV infection.
Waqt li tkun qed tieħu Emtriva inti xorta waħda tista ’ tiżviluppa infezzjonijiet u mard ieħor marbut ma ’ l- infezzjoni ta ’ l- HIV.
BEFORE YOU TAKE EMTRIVA
QABEL MA TIEĦU EMTRIVA
Do not take Emtriva
Tieħux Emtriva
• If you are allergic (hypersensitive) to emtricitabine or any of the other ingredients of Emtriva 200 mg hard capsules listed at the end of this leaflet.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal emtricitabine jew sustanzi oħra tal- kapsuli iebsin ta ’ Emtriva ta ’ 200 mg elenkati fl- aħħar ta ’ dan il- fuljett.
If this applies to you, tell your doctor immediately.
Jekk dan japplika għalik, għid lit- tabib tiegħek immedjatament.
Take special care with Emtriva
38 Oqgħod attent ħafna b’ Emtriva
• Tell your doctor if you have had kidney disease, or if tests have shown problems with your kidneys.
• Għid lit- tabib tiegħek jekk inti kellek mard tal- kliewi, jew jekk it- testijiet urew li hemm problemi bil- kliewi tiegħek.
Before starting treatment, your doctor may order blood tests to assess kidney function 36 and may advise you to take the capsules less often or prescribe Emtriva oral solution.
Qabel tibda t- trattament, it- tabib tiegħek jista ’ jordna testijiet tad - demm biex jevalwa l- funzjoni tal- kliewi u jista ’ jagħtik parir biex tieħu l- kapsuli inqas ta ’ spiss jew jagħtik riċetta għal Emtriva soluzzjoni orali.
Your doctor may also order blood tests during treatment to monitor your kidneys.
It- tabib tiegħek jista ’ jordna wkoll testijiet tad - demm matul it- trattament biex jimmonitorja l- kliewi tiegħek.
• Talk to your doctor if you are over 65.
• Kellem lit- tabib tiegħek jekk għandek iktar minn 65 sena.
Emtriva has not been studied in patients over 65 years of age.
Emtriva ma ġietx studjata f’ pazjenti li għandhom iktar minn 65 sena.
If you are older than this and are prescribed Emtriva, your doctor will monitor you carefully.
Jekk għandek iktar minn 65 sena u tingħata riċetta għal Emtriva, it- tabib tiegħek ser jimmonitorjak b’ attenzjoni.
• Do not give Emtriva to infants under 4 months of age.
• Tagħtix Emtriva lil trabi li jkollhom inqas minn 4 xhur.
• Talk to your doctor if you have a history of liver disease, including hepatitis.
• Kellem lit- tabib tiegħek jekk inti għandek passat mediku ta ’ mard tal- fwied, li jinkludi l - epatite.
Patients with liver disease including chronic hepatitis B or C, who are treated with antiretrovirals, have a higher risk of severe and potentially fatal liver complications.
Pazjenti b’ mard fil- fwied li jinkludu epatite kronika B jew Ċ, li huma ttrattati bl - antitretrovirali, għandhom riskju ogħla ta ’ kumplikazzjonijiet serji tal- fwied li potenzjalment jistgħu ikunu fatali.
If you have hepatitis B infection, your doctor will carefully consider the best treatment regimen for you.
Jekk għandek infezzjoni ta ’ l- epatite B, it- tabib tiegħek ser jikkunsidra b’ attenzjoni l- aħjar kors ta ’ trattament għalik.
If you have a history of liver disease or chronic hepatitis B infection your doctor may conduct blood tests in order to carefully monitor liver function.
Jekk għandek passat mediku ta ’ mard tal- fwied jew infezzjoni kronika bl- epatite B, it- tabib tiegħek jista ’ jagħmillek testijiet tad- demm biex jimmonitorja b’ attenzjoni il- funzjoni tal- fwied tiegħek.
• If you are diabetic, overweight or have high cholesterol, talk to your doctor.
• Jekk inti dijabetiku/ a, għandek piż żejjed jew kolesterol għoli, kellem lit- tabib tiegħek.
Combination antiretroviral therapies may raise blood sugar, increase blood fats (hyperlipaemia), cause changes to body fat, and resistance to insulin (see section 4, Possible side effects).
Terapiji antiretrovirali kombinati jistgħu jgħollu l- livell taz- zokkor fid- demm, ix- xaħmijiet fid - demm (iperlipimja), jikkawżaw tibdil fix- xaħam tal- ġisem, u reżistenza għall- insulina (ara sezzjoni 4, Effetti sekondarji li jista ’ jkollu).
• Once you start taking Emtriva, look out for possible signs of lactic acidosis.
• Ġaladarba tibda tieħu Emtriva, oqgħod attent/ a għal sinjali possibbli ta ’ aċidożi lattika.
Medicines containing nucleoside analogues, including Emtriva, can cause lactic acidosis (excess of lactic acid in your blood), together with an enlarged liver.
Mediċini li fihom analogi tan- nukleosidi, li jinkludu Emtriva, jistgħu jikkawżaw l- aċidożi lattika (ammont żejjed ta ’ aċidu lattiku fid- demm tiegħek), kif ukoll tkabbir tal- fwied.
This is a rare but serious side effect; it has occasionally been fatal.
Dan hu effett sekondarju rari iżda serju; xi drabi wassal għall- mewt.
Lactic acidosis occurs more often in women, particularly if they are very overweight.
L- aċidożi lattika sseħħ iżjed spiss fin- nisa partikularment jekk ikunu ta ’ piż żejjed ħafna.
If you have liver disease you may also be more at risk of getting this condition.
Jekk tbati minn mard tal- fwied, jista ’ jkun li hemm riskju akbar li tibda tbati minn din il- kundizzjoni.
While you are being treated with Emtriva, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
Waqt li tkun qed tieħu Emtriva, it- tabib tiegħek ser jeżaminak mill- qrib għal xi sinjali li jindikaw li tkun qed tiżviluppa l- aċidożi lattika.
Signs are:
Is- sinjali huma:
Deep, rapid breathing Drowsiness Nausea (feeling sick), vomiting and stomach pain notice any of these symptoms, tell your doctor immediately.
Jekk tinnota xi sintomu minn dawn, għid lit- tabib tiegħek minnufih.
• Look out for infections.
• Oqgħod attent/ a għall- infezzjonijiet.
If you have advanced HIV disease (AIDS) and another infection, you may develop inflammation or worsening of the symptoms of infection when you start treatment with Emtriva.
Jekk għandek mard avvanzat ta ’ l- HIV (AIDS) u infezzjoni oħra, inti tista ’ tiżviluppa infjammazzjoni jew is- sintomi ta ’ infezzjoni jistgħu imorru għall- agħar meta tibda t- trattament b’ Emtriva.
These may be signs that your body’ s improved immune system is fighting infection.
Dawn jistgħu jkunu sinjali li s- sistema immuni mtejba ta ’ ġismek qed tiġġieled lill- infezzjoni.
If you notice signs of inflammation or infection soon after you start taking Emtriva, tell your doctor at once.
Jekk tinnota sinjali ta ’ infjammazzjoni jew infezzjoni dritt wara li tibda tieħu Emtriva, għid lit- tabib tiegħek minnufih.
• 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).
Xi pazjenti li jkunu qed jieħdu terapija antiretrovirali kombinata jistgħu jiżviluppaw marda ta ’ l- għadam imsejħa osteonekrożi (il- mewt tat- tessut ta ’ l- għadam ikkawżata minn telf tal- provvista tad- demm lill- 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.
It- tul tat- terapija antiretrovirali kombinata, l- użu ta ’ kortikosterojdi, konsum ta ’ l- alkoħol, immunosoppressjoni severa, indiċi ogħla tal- piż tal- ġisem, fost l- oħrajn, jistgħu jkunu xi wħud mill- ħafna fatturi ta ’ riskju li wieħed jista ’ jiżviluppa din il- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta ’ osteonekrożi huma: ebusija u uġigħ fil- ġogi (speċjalment fl- għadam tal- ġenbejn, l- irkopptejn u l- ispallejn) u diffikultà fiċ- ċaqliq.
If you notice any of these symptoms please inform your doctor.
Jekk tinnota xi sintomu minn dawn, jekk jogħġbok informa t- tabib tiegħek.
Taking other medicines
39 Meta tieħu mediċini oħra
You should not take Emtriva if you are already taking other medicines that contain emtricitabine, lamivudine or zalcitabine, which are also used to treat HIV infection, unless otherwise directed by your doctor.
M’ għandekx tieħu Emtriva jekk diġà qed tieħu mediċini oħra li fihom emtricitabine, lamivudine jew zalcitabine, li jintużaw ukoll fit- trattament ta ’ l- HIV, ħlief jekk dan ma jkunx ordnat mit- tabib tiegħek.
They will advise if Emtriva can be taken with your other medicines.
Huma ser jgħidulek jekk Emtriva tistax tittieħed flimkien mal- mediċini l- oħra tieghek.
37 Do not stop your treatment without contacting your doctor.
Twaqqafx it- trattament tiegħek mingħajr ma tikkuntattja lit- tabib tiegħek.
• You must not take Emtriva during pregnancy unless specifically directed by your doctor.
• M’ għandekx tieħu Emtriva matul it- tqala ħlief jekk it- tabib tiegħek ma jkunx qallek tagħmel hekk speċifikament.
There are no clinical data on the use of Emtriva in pregnant women and it is not usually used unless absolutely necessary.
M’ hemmx informazzjoni klinika dwar l- użu ta ’ Emtriva f’ nisa tqal u din normalment ma tintużax jekk mhux assolutament meħtieġ.
• If you could get pregnant during treatment with Emtriva, you must use an effective method of contraception to stop you getting pregnant.
• Jekk tista ’ toħroġ tqila matul it- trattament b’ Emtriva, għandek tuża metodu effettiv ta ’ kontraċezzjoni li ma jħallikx toħroġ tqila.
• If you become pregnant, or plan to become pregnant, ask your doctor about the potential benefits and risks of your antiretroviral therapy to you and your child.
• Jekk toħroġ tqila jew qed tippjana biex toħroġ tqila, staqsi lit- tabib tiegħek dwar il - benefiċċji u r- riskji potenzjali tat- terapija antiretrovirali għalik u għat- tarbija tiegħek.
If you have taken Emtriva during your pregnancy, your doctor may request regular blood tests and other diagnostic tests to monitor the development of your child.
Jekk ħadt Emtriva waqt it- tqala, it- tabib jista ’ jagħmillek testijiet regolari tad- demm u testijiet dijanjostiċi oħra biex jimmonitorja l- iżvilupp tat- tarbija tiegħek.
In children whose mothers took NRTIs during pregnancy, the benefit from the protection against HIV outweighed the risk of side effects.
Fi tfal li ommhom ħadet NRTIs waqt it- tqala, il- benefiċċju mill- protezzjoni kontra l- HIV kien ikbar mir- riskju ta ’ l- effetti sekondarji.
• Do not breast-feed if you are taking Emtriva.
• M’ għandekx tredda ’ jekk qed tieħu Emtriva.
It is not yet known whether the active substance in this medicine passes into human breast milk.
Għadu mhux magħruf jekk is- sustanza attiva f’ din il- mediċina tgħaddix ġol- ħalib tas- sider uman.
It is known that the virus can be passed to the baby in breast milk.
Hu magħruf li l- virus jista ’ jgħaddi lit - tarbija fil- ħalib tas- sider.
Emtriva may cause dizziness.
Emtriva tista ’ tikkawża sturdament.
If you experience dizziness while taking Emtriva, do not drive and do not use any tools or machines.
Jekk tħoss l- isturdament waqt li tkun qed tieħu Emtriva, issuqx u m’ għandekx tagħmel użu minn għodda jew tħaddem magni.
HOW TO TAKE EMTRIVA
KIF GĦANDEK TIEĦU EMTRIVA
• Always take Emtriva exactly as your doctor has told you.
• Dejjem għandek tieħu Emtriva skond il- parir eżatt tat- tabib.
The usual dose:
Id- doża li ssoltu tingħata:
• Adults: one 200 mg hard capsule each day with or without food.
• Adulti: kapsula iebsa waħda ta ’ 200 mg kuljum ma ’ l- ikel jew mingħajr ikel.
Swallow the hard capsule with a glass of water. • Children and adolescents up to 18 years of age who weigh at least 33 kg and who are able to swallow hard capsules: one 200 mg hard capsule, each day with or without food.
Ibla ’ l - kapsula iebsa ma ’ tazza ilma. • Tfal u adolexxenti sa 18- il sena li jiżnu mill- inqas 33 kg u li jistgħu jibilgħu kapsuli iebsin: kapsula iebsa waħda ta ’ 200 mg kuljum ma ’ l- ikel jew mingħajr ikel.
For infants from 4 months, children, and patients who are unable to swallow hard capsules and patients with kidney problems, Emtriva is available as a liquid (an oral solution).
Għat- trabi ta ’ ’ l fuq minn 4 xhur, tfal u pazjenti li ma jistgħux jibilgħu kapsuli iebsin u pazjenti b’ mard tal- kliewi, Emtriva hija disponibbli ukoll bħala likwidu (soluzzjoni orali).
If you have difficulty in swallowing the capsules, tell your doctor.
Jekk issib diffikultà biex tibla ’ l- kapsuli, għid lit- tabib tiegħek.
• Always take the dose recommended by your doctor.
40 • Dejjem ħu d- doża rakkomandata mit- tabib tiegħek.
This is to make sure that your medicine is fully effective, and to reduce the risk of developing resistance to the treatment.
Dan biex taċċerta ruħek li l- mediċina tkun effettiva kompletament, u biex tnaqqas ir- riskju li tiżviluppa reżistenza għat- trattament.
Do not change the dose unless your doctor tells you to.
Tibdilx id- doża jekk ma jgħidlekx it- tabib tiegħek biex tagħmel hekk.
• If you have problems with your kidneys, your doctor may advise you to take Emtriva less frequently.
• Jekk għandek problemi bil- kliewi, it- tabib tiegħek jista ’ jagħtik parir biex tieħu Emtriva inqas ta ’ sikwit.
38 • Your doctor will prescribe Emtriva with other antiretroviral medicines.
• It- tabib tiegħek ser jagħtik riċetta għal Emtriva flimkien ma ’ mediċini antiretrovirali oħra.
Please refer to the patient information leaflets of the other antiretrovirals for guidance on how to take those medicines.
Jekk jogħġbok irreferi għall- fuljetti ta ’ tagħrif ta ’ l- antitretrovirali l- oħra għall- gwida dwar kif tieħu dawk il- mediċini.
If you take more Emtriva than you should
Jekk tieħu Emtriva aktar milli suppost
If you accidentally take too many Emtriva hard capsules, contact your doctor or nearest emergency department for advice.
Jekk aċċidentalment tieħu kapsuli iebsin ta ’ Emtriva żejda, ikkuntattja lit- tabib tiegħek jew l- eqreb dipartiment ta ’ l- emerġenza għal parir.
Keep the carton with you so that you can easily describe what you have taken.
Żomm il- kartuna miegħek ħalli tkun tista ’ faċilment tiddeskrivi dak li tkun ħadt.
If you forget to take Emtriva
Jekk tinsa tieħu Emtriva
It is important not to miss a dose of Emtriva.
Huwa importanti li ma tinsa tieħu ebda doża ta ’ Emtriva.
If you do miss a dose of Emtriva, take it as soon as you can, and then take your next dose at its regular time.
Jekk tinsa tieħu doża ta ’ Emtriva, ħudha malli tkun tista ’, imbagħad ħu d- doża li jmiss fil- ħin regolari tagħha.
If it is almost time for your next dose anyway, forget about the missed dose.
Jekk ikun kważi wasal il- ħin għad- doża li jmiss, tiħux id- doża li tkun qbiżt.
Wait and take the next dose at the regular time.
Stenna u ħu d- doża li jmiss fil- ħin regolari tagħha.
Do not take a double dose to make up for a forgotten hard capsule.
M’ għandekx tieħu doża doppja biex tpatti għal kull kapsula iebsa li tkun insejt tieħu.
If you are sick (vomit) If it’ s less than an hour since you took Emtriva, take another capsule.
Jekk tirrimetti Jekk tkun għaddiet inqas minn siegħa minn x’ ħin ħadt Emtriva, ħu kapsula oħra.
You do not need to take another capsule if you were sick more than an hour after taking Emtriva.
M’ hemmx bżonn li tieħu kapsula oħra, jekk tirremetti iktar minn siegħa wara li tkun ħadt Emtriva.
If you stop taking Emtriva
Jekk tieqaf tieħu Emtriva
• Don’ t stop taking Emtriva without talking to your doctor.
• Tiqafx tieħu Emtriva mingħajr ma tkellem lit- tabib tiegħek.
Stopping treatment with Emtriva may reduce the effectiveness of the anti-HIV therapy recommended by your doctor.
It- twaqqif tat- trattament b’ Emtriva jista ’ jwassal għal tnaqqis fl- effett tat- terapija ta ’ kontra l- HIV rakkomandata mit - tabib tiegħek.
Speak with your doctor before you stop, particularly if you are experiencing any side effects or you have another illness.
Kellem lit- tabib tiegħek qabel ma tieqaf, partikularment jekk tkun qed iġarrab xi effetti sekondarji jew jekk ikollok xi marda oħra.
Contact your doctor again before you restart taking Emtriva capsules.
Ikkuntattja lit- tabib tiegħek mill- ġdid qabel ma terġa ’ tibda tieħu l- kapsuli Emtriva.
• If you have both HIV infection and hepatitis B, it is especially important not to stop your Emtriva treatment without talking to your doctor first.
• Jekk għandek kemm infezzjoni ta ’ l- HIV kif ukoll epatite B, hu partikularment importanti li ma twaqqafx it- trattament tiegħek b’ Emtriva mingħajr ma tkellem lit- tabib tiegħek qabel.
Some patients have had blood tests or symptoms indicating that their hepatitis has got worse after stopping Emtriva.
Xi pazjenti kellhom testijiet tad- demm jew sintomi li indikaw li l- epatite tagħhom marret għall - agħar wara li waqfu jieħdu Emtriva.
You may require blood tests for several months after stopping treatment.
Jista ’ jkun hemm bżonn li jsirulek testijiet tad- demm għal diversi xhur wara li twaqqaf it- trattament.
Tell your doctor immediately about new or unusual symptoms after you stop treatment, particularly symptoms you associate with hepatitis B infection.
Għid lit- tabib tiegħek immedjatament dwar sintomi ġodda jew mhux tas- soltu wara li twaqqaf it- trattament, b’ mod partikulari dawk is- sintomi li normalment inti tassoċja ma ’ l- epatite B.
Like all medicines, Emtriva can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Emtriva jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
Tell your doctor about any of the following side effects:
41 Għid lit- tabib tiegħek dwar kwalunkwe wieħed minn dawn l- effetti sekondarji:
Very common side effects (These can affect more than 1 user in 10)
Effetti sekondarji komuni ħafna (Dawn jistgħu jaffettwaw iktar minn 1 minn kull 10 li jużawha)
• headache, diarrhoea, feeling sick (nausea)
• uġigħ ta ’ ras, dijarrea, tqalligħ (nawseja)
• muscle pain and weakness (if creatine kinase levels in the blood are increased)
• uġigħ u dgħjufija fil- muskoli (jekk il- livelli tal- creatine kinase fid- demm jiżdiedu)
39 Common side effects (These can affect 1 to 10 users in 100)
Effetti sekondarji komuni (Dawn jistgħu jaffettwaw minn 1 sa 10 minn kull 100 li jużawha)
• dizziness, weakness, difficulty sleeping, abnormal dreams
• sturdament, dgħufija, diffikultà biex torqod, ħolm anormali
• being sick (vomiting), problems with digestion resulting in discomfort after meals, stomach pain
• rimettar, problemi bid- diġestjoni li jwasslu għal skonfort wara l- ikel, uġigħ fl- addome
• rashes (including red spots or blotches sometimes with blistering and swelling of the skin), which may be allergic reactions, itching, changes in skin colour including darkening of the skin in patches
• raxx (fosthom tikek ħomor jew dabriet xi kultant bl- infafet u nefħa tal- ġilda), li jistgħu jkunu reazzjonijiet allerġiċi, ħakk, tibdil fil- kulur tal- ġilda li jinkludi l- iskurament fi dbabar tal- ġilda
• pain
• uġigħ
Tests may also show:
It- testijiet jistgħu juru wkoll:
• low white blood cell count (a reduced white blood cell count can make you more prone to infection)
• għadd baxx ta ’ ċelluli tad- demm bojod (tnaqqis fl- għadd taċ- ċelluli tad- demm bojod jista ’ jagħmlek iktar suxxettibbli għall- infezzjoni)
• increased triglycerides (fatty acids), bile or sugar in the blood
• żieda ta ’ trigliċeridi (fatty acids), bile jew zokkor fid- demm
• liver and pancreas problems
• problemi fil- fwied u fil- frixa
Uncommon side effects (These can affect 1 to 10 users in 1,000)
Effetti sekondarji mhux komuni (Dawn jistgħu jaffettwaw minn 1 sa 10 minn kull 1, 000 li jużawha)
• anaemia (low red blood cell count)
• anemija (għadd baxx ta ’ ċelluli tad- demm ħomor)
Other possible effects
Effetti oħra li jistgħu jinħassu
Children given emtricitabine experienced changes in skin colour including darkening of the skin in patches (very common) and anaemia (common).
It- tfal li ngħataw emtricitabine, kellhom tibdil fil- kulur tal- ġilda li kien jinkludi l- iskurament tal - ġilda fi dbabar (komuni ħafna) u l- anemija (komuni).
Anaemia means the production of red blood cells is reduced, and a child may have symptoms of tiredness or breathlessness.
Anemija tfisser li l- produzzjoni ta ’ ċelluli tad - demm ħomor titnaqqas u li t- tfal jista ’ jkollhom sintomi ta ’ għeja jew qtugħ ta ’ nifs.
Medicines like Emtriva can cause lactic acidosis (excess lactic acid in the blood).
Mediċini bħal Emtriva jistgħu jikkawżaw l- aċidożi lattika (ammont żejjed ta ’ aċidu lattiku fid- demm).
The following may be signs of lactic acidosis: • Deep, rapid breathing • Drowsiness • Nausea (feeling sick), vomiting and stomach pain If you notice any of these symptoms, tell your doctor immediately.
Dawn li ġejjin jistgħu jkunu sinjali ta ’ aċidożi lattika: • Nifs qawwi u mgħaġġel • Telqa • Nawseja (tqalligħ), rimettar u uġigħ ta ’ l- addome Jekk tinnota xi sintomu minn dawn, għid lit- tabib tiegħek minnufih.
Combination antiretroviral therapy (including Emtriva) may change your body shape, by changing the way body fat is distributed.
It- terapija antiretrovirali kombinata (li tinkludi Emtriva) tista ’ twassal għal bidliet fil- forma ta ’ ġismek dovuti għall- bidliet fit- tqassim tax- xaħam.
You may lose fat from your legs, arms and face; gain fat around the abdomen (tummy) and internal organs; get larger breasts or fatty lumps on the back of the neck (‘ buffalo hump’).
Tista ’ titlef xaħam mir- riġlejn, mid- dirgħajn u mill - wiċċ; tista ’ żżid ix- xaħam fl- addome (żaqq) u f’ organi interni oħra; tkabbir fis- sider u għoqod ta ’ xaħam fuq wara ta ’ l- għonq (’ ħotba tal- buflu ’).
The cause and the long-term effects of these changes are not yet known.
Il- kawża u l- effetti fit- tul ta ’ dawn il- kundizzjonijiet m’ humiex magħrufa bħalissa.
Combination antiretroviral therapy may also cause hyperlipaemia (increased fats in the blood) and resistance to insulin.
42 It- terapija antiretrovirali kombinata tista ’ wkoll tikkawża l- iperlipimja (żieda tax- xaħmijiet fid - demm) u reżistenza għall- insulina.
Your doctor will test for these changes.
It- tabib tiegħek ser jittestjak għal dawn it- tibdiliet.
If you get any of the side effects listed, or if you notice any side effects not listed in this leaflet, tell your doctor.
Jekk ikollok xi wieħed mill- effetti sekondarji li huma msemmijin, jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib tiegħek.
HOW TO STORE EMTRIVA
KIF TAĦŻEN EMTRIVA
40 Do not use Emtriva after the expiry date which is stated on the bottle, blister pack and outer carton after {EXP}.
Tużax Emtriva wara d- data ta ’ skadenza li tidher fuq il- flixkun, il- folja fil- pakkett u l- kartuna ta ’ barra wara {JIS}.
This medicine does not require any special storage conditions.
Din il- mediċina m’ għandhiex bżonn ħażna speċjali.
What Emtriva contains
X’ fih Emtriva
• The active substance is emtricitabine.
• Is- sustanza attiva hi emtricitabine.
Capsule contents: microcrystalline cellulose (E460), crospovidone, magnesium stearate (E572), povidone (E1201)
Kontenut tal- kapsula: microcrystalline cellulose (E460), crospovidone, magnesium stearate (E572), povidone (E1201)
Capsule shell: gelatin, indigotine (E132), titanium dioxide (E171)
Qoxra tal- kapsula: gelatin, indigotine (E132), titanium dioxide (E171)
Printing ink containing: black iron oxide (E172), shellac (E904)
Linka ta ’ l- istampar fiha: black iron oxide (E172), shellac (E904)
What Emtriva looks like and contents of the pack
Id- Dehra ta’ Emtriva u l- kontenuti tal- pakkett
Emtriva hard capsules have a white opaque body with a light blue opaque cap.
Il- kapsuli iebsin ta ’ Emtriva huma bojod opaki b’ għatu ċelesti opak ċar.
Each capsule is printed with “ 200 mg” on the cap and “ GILEAD” and [Gilead logo] on the body in black ink.
Kull kapsula fiha “ 200 mg ” stampata fuq l- għatu u “ GILEAD ” u [logo ta ’ Gilead] fuq il- parti l- oħra b’ linka sewda.
Emtriva comes in bottles or blister packs containing 30 capsules.
Emtriva tiġi fi fliexken jew f’ pakketti ta ’ folji li fihom 30 kapsula.
Emtriva is also available as an oral solution for use in children and infants older than 4 months, patients who have difficulty in swallowing and patients with kidney problems.
Emtriva hija disponibbli wkoll bħala soluzzjoni orali għall- użu fi tfal u trabi ta ’ aktar minn 4 xhur, pazjenti li jkollhom diffikultà biex jibilgħu, u pazjenti b’ mard tal- kliewi.
There is a separate Package Leaflet for Emtriva 10 mg/ ml oral solution.
Hemm Fuljett ta ’ Tagħrif separat għas- soluzzjoni orali ta ’ Emtriva ta ’ 10 mg/ ml.
Manufacturer:
43 Manifattur:
Gilead Sciences Limited Unit 13, Stillorgan Industrial Park Blackrock County Dublin Ireland
Gilead Sciences Limited Unit 13, Stillorgan Industrial Park Blackrock County Dublin L- Irlanda
Cork Ireland
Gilead Sciences Limited IDA Business & Technology Park Carrigtohill County Cork L- Irlanda
41 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:
This leaflet was last approved in MM/ YYYY.
Dan il- fuljett kien approvat l- aħħar f ’ MM/ YYYY.
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu/.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il - Mediċini (EMEA) http: // www. emea. europa. eu /.
Emtriva is a treatment for Human Immunodeficiency Virus (HIV) infection in adults, children and infants above 4 months of age.
Emtriva hi trattament għall- infezzjoni mill- Virus ta ’ l- Immunodefiċjenza Umana (HIV) fl - adulti, fit- tfal u trabi ta ’ ’ l fuq minn l- eta ’ ta ’ 4 xhur.
Emtriva oral solution is particularly suitable for people who have difficulty in swallowing Emtriva hard capsules.
Emtriva soluzzjoni orali hi adattata partikularment għal nies li jkollhom diffikultà biex jibilgħu il- kapsuli iebsin ta ’ Emtriva.
• If you are allergic (hypersensitive) to emtricitabine or any of the other ingredients of Emtriva 10 mg/ ml oral solution listed at the end of this leaflet.
• Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal emtricitabine jew sustanzi oħra ta ’ Emtriva 10 mg/ ml soluzzjoni orali elenkati fl- aħħar ta ’ dan il- fuljett.
Take special care with Emtriva
Oqgħod attent ħafna b’ Emtriva
Before starting treatment, your doctor may order blood tests to assess kidney function
• Għid lit- tabib tiegħek jekk inti kellek mard tal- kliewi, jew jekk it- testijiet urew li hemm problemi bil- kliewi tiegħek.
44 and may advise you to take a reduced dose of the oral solution or prescribe Emtriva hard capsules.
Qabel tibda t- trattament, it- tabib tiegħek jista ’ jordna testijiet tad - 46 demm biex jevalwa l- funzjoni tal- kliewi u jista ’ jagħtik parir biex tieħu doża mnaqqsa ta ’ soluzzjoni orali jew jagħtik riċetta ta ’ Emtriva kapsuli iebsin.
Your doctor may also order blood tests during treatment to monitor your kidneys.
It- tabib tiegħek jista ’ jordna wkoll testijiet tad- demm matul it- trattament biex jimmonitorja l- kliewi tiegħek.
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
47 Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
45 Do not stop your treatment without contacting your doctor.
Twaqqafx it- trattament tiegħek mingħajr ma tikkuntattja lit- tabib tiegħek.
Important information about some of the ingredients of Emtriva oral solution
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Emtriva soluzzjoni orali
Sunset yellow (E110) may cause allergic reactions.
Sunset yellow (E110) jista ’ jikkawża reazzjonijiet allerġiċi.
The methyl parahydroxybenzoate (E218) and propyl parahydroxybenzoate (E216) may cause allergic reactions (possibly delayed).
Methyl parahydroxybenzoate (E218) u propyl parahydroxybenzoate (E216) jistgħu jikkawżaw reazzjonijiet allerġiċi (li jistgħu jittardjaw).
This medicine contains 254 mg of sodium per dose which should be taken into consideration by patients on a controlled sodium diet.
Din il- mediċina fiha 254 mg ta ’ sodium f’ kull doża u allura għandu jitqies f’ pazjenti li jikkontrollaw l- ammont ta ’ sodium li jieħdu fid- dieta.
Your doctor will advise the correct amount of Emtriva oral solution to be taken.
It- tabib tiegħek ser jgħidlek l- ammont korrett ta ’ Emtriva soluzzjoni orali li għandu jittieħed.
Emtriva oral solution can be taken with or without food.
Emtriva soluzzjoni orali tista ’ tittieħed ma ’ l- ikel jew mingħajr ikel.
• Infants, children and adolescents weighing 40 kg or less: the dose of Emtriva 10 mg/ ml oral solution is calculated according to your body weight.
• Trabi, tfal u adolexxenti li jiżnu 40 kg jew inqas: id- doża ta ’ Emtriva 10 mg/ ml soluzzjoni orali hija kkalkulata skond il- piż tal- ġisem tiegħek.
Examples of body weight and the corresponding doses and volumes of the oral solution to be taken each day are given in the table below:
48 volumi ta ’ soluzzjoni orali li jikkorrispondu li għandhom jittieħdu kuljum huma elenkati fil - qosor fit- tabella ta ’ hawn taħt.
46 Per day Body weight (kg)
Kuljum Piż tal- ġisem (kg)
Emtricitabine dose (mg)
emtricitabine (mg)
How much 10 mg/ ml (ml)
Kemm għandek tieħu soluzzjoni ta ’ 10 mg/ ml (ml)
Make sure that you understand how to measure and give the right amount of oral solution according to the weight of the person being treated.
Kun ċert/ a li tifhem kif tkejjel u kif tagħti l- ammont korrett ta ’ soluzzjoni orali skond il- piż tal - persuna li tkun qed tieħu t- trattament.
Use the measuring cup provided in the carton to measure the correct dose.
Uża t- tazza tal- kejl ipprovduta fil- kartuna biex tkejjel id- doża korretta.
The cup has lines to indicate each ml of solution.
It- tazza fiha sinjali biex jindikaw kull ml ta ’ soluzzjoni orali.
If you are unsure how much Emtriva you should take ask your doctor or pharmacist.
Jekk m’ intix ċert/ a kemm għandek tieħu Emtriva, għandek issaqsi lit- tabib jew lill- ispiżjar tiegħek.
• Always take the dose recommended by your doctor.
• Dejjem ħu d- doża rakkomandata mit- tabib tiegħek.
• Your doctor will prescribe Emtriva with other antiretroviral medicines.
• It- tabib tiegħek ser jagħtik riċetta għal Emtriva flimkien ma ’ mediċini antiretrovirali oħra.
Emtriva is also available as hard capsules.
Emtriva hija disponibbli wkoll bħala kapsuli iebsin.
These are only suitable for patients who weigh at least 33 kg and can swallow hard capsules.
Dawn huma adatatti biss għal pazjenti li jiżnu mill- inqas 33 kg u li jistgħu jibilgħu kapsuli iebsin.
The blood levels obtained after taking one Emtriva 200 mg hard capsule are similar to those obtained after taking 24 ml of the oral solution.
Il- livelli fid- demm li jintlaħqu wara li tittieħed kapsula iebsa ta ’ Emtriva 200 mg jixbħu lil dawk li jintlaħqu wara li jittieħdu 24 ml ta ’ soluzzjoni orali.
If you would like to switch from taking Emtriva oral solution to Emtriva hard capsules, please talk to your doctor.
Jekk trid taqleb minn Emtriva soluzzjoni orali għal Emtriva kapsuli iebsin, jekk jogħġbok kellem lit- tabib tiegħek.
If you accidentally take too much Emtriva oral solution, contact your doctor or nearest emergency department for advice.
Jekk aċċidentalment tieħu Emtriva soluzzjoni orali żejda, ikkuntattja lit- tabib tiegħek jew l- eqreb dipartiment ta ’ l- emerġenza għal parir.
Keep the oral solution bottle with you so that you can easily describe what you have taken.
Żomm il- flixkun tas- soluzzjoni orali miegħek ħalli tkun tista ’ faċilment tiddeskrivi dak li tkun ħadd.
If you do miss a dose of Emtriva, take it as soon as you can, and then take your next dose at its regular time.
49 Jekk tinsa tieħu doża ta ’ Emtriva, ħudha malli tkun tista ’, imbagħad ħu d- doża li jmiss fil- ħin regolari tagħha.
47 If you are sick (vomit) If it’ s less than an hour since you took Emtriva, take another dose.
Jekk tirremetti Jekk tkun għaddiet inqas minn siegħa minn x’ ħin ħadt Emtriva, ħu doża oħra.
You do not need to take another dose if you were sick more than an hour after taking Emtriva.
M’ hemmx bżonn li tieħu doża oħra, jekk tirremetti iktar minn siegħa wara li tkun ħadt Emtriva.
Contact your doctor again before you restart taking Emtriva oral solution.
Ikkuntattja lit- tabib tiegħek mill- ġdid qabel ma terġa ’ tibda tieħu Emtriva soluzzjoni orali.
Tell your doctor about any of the following side effects:
Għid lit- tabib tiegħek dwar kwalunkwe wieħed minn dawn l- effetti sekondarji:
Common side effects (These can affect 1 to 10 users in 100)
Effetti sekondarji komuni (Dawn jistgħu jaffettwaw minn 1 sa 10 minn kull 100 li jużawha)
Tests may also show:
50 It- testijiet jistgħu juru wkoll:
48 • liver and pancreas problems
• problemi fil- fwied u fil- frixa
Combination antiretroviral therapy may also cause hyperlipaemia (increased fats in the blood) and resistance to insulin.
It- terapija antiretrovirali kombinata tista ’ wkoll tikkawża l- iperlipimja (żieda tax- xaħmijiet fid - demm) u reżistenza għall- insulina.
Do not use Emtriva after the expiry date which is stated on the bottle and outer carton after {EXP}.
Tużax Emtriva wara d- data ta ’ skadenza li tidher fuq il- flixkun u l- kartuna ta ’ barra wara {JIS}.
The expiry date refers to the last day of that month.
Id - data ta ’ skadenza tirreferi għal l- aħħar ġurnata ta ’ dak ix- xahar.
Store in a refrigerator (2°C – 8°C) until opened.
Aħżen fi friġġ (2°C – 8°C) sakemm jinfetaħ.
After opening the bottle, do not store above 25ºC.
Wara li tiftaħ il- flixkun, taħżinx f’ temperatura ’ l fuq minn 25°C.
The content of the bottle should be used up within 45 days of opening.
Il- kontenut tal- flixkun għandu jintuża fi żmien 45 jum wara li jinfetaħ.
If there is any solution left in the bottle after 45 days, this should be discarded according to local requirements or returned to the pharmacy.
51 Jekk jibqa ’ xi soluzzjoni fil- flixkun wara 45 jum, din għandha tintrema ’ kif jitolbu l- liġijiet lokali jew tintradd lura lill- ispiżerija.
One ml of Emtriva oral solution contains 10 mg emtricitabine (10 mg/ ml).
F’ ml wieħed ta ’ Emtriva soluzzjoni orali hemm 10 mg ta ’ emtricitabine (10 mg/ ml).
• The other ingredients are: cotton candy flavouring, disodium edetate, hydrochloric acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sodium phosphate monobasic hydrate, sunset yellow (E110), purified water, xylitol (E967).
• Is- sustanzi l- oħra huma: cotton candy flavouring, disodium edetate, hydrochloric acid, methyl parahydroxybenzoate (E218), propylene glycol, propyl parahydroxybenzoate (E216), sodium hydroxide, sodium phosphate monobasic hydrate, sunset yellow (E110), purified water, xylitol (E967).
Emtriva oral solution is a clear, orange to dark orange solution that comes in bottles containing 170 ml with a measuring cup.
Emtriva soluzzjoni orali hija soluzzjoni trasparenti ta ’ kulur oranġjo tagħti fl- oranġjo skur li tiġi pprovduta fi fliexken ta ’ 170 ml b’ tazza tal- kejl.
These are only suitable for patients who weigh at least 33 kg and can swallow hard capsules.
Dawn huma adattati biss għal pazjenti li jiżnu mill- inqas 33 kg u li jistgħu jibilgħu kapsuli iebsin.
There is a separate Package Leaflet for Emtriva 200 mg hard capsules.
Hemm Fuljett ta ’ Tagħrif separat ta ’ Emtriva 200 mg kapsuli iebsin.
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: