qanastek/EMEA-V3 huggingface dataset:
225 ml oral suspension A 10 ml graduated dosing syringe and adapter are also provided in the pack
225 ml ta ’ sospensjoni orali Siringa ta ’ l- 10 ml immarkata għad- dożaġġ u adapter huma wkoll provduti fil- pakkett
Shake bottle vigorously before use
Ħawwad sew il- flixkun qabel l- użu
Telzir 700 mg film-coated tablets Fosamprenavir
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINNU
Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
Aqra sew dan il- fuljett kollu qabel tibda tieħu din il- mediċina • Żomm dan il- fuljett.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist (chemist). • This medicine has been prescribed for you personally.
Jista ’ jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek.
Do not pass it on to other people - it may harm them even if their symptoms seem to be the same as yours. • If you have serious side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Tista ’ tagħmlilhom il - ħsara, anki jekk ikollom l- istess sintomi bħal tiegħek. • Jekk għandek effetti sekondarji serji jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmija f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
What Telzir is and what it is used for 2.
X’ inhu Telzir u għalxiex jintuża 2.
Before you take Telzir 3.
Qabel ma tieħu Telzir 3.
How to take Telzir 4.
Kif għandek tieħu Telzir 4.
How to store Telzir 6.
Kif taħżen Telzir 6.
WHAT TELZIR IS AND WHAT IT IS USED FOR
X’ INHU TELZIR U GĦALXIEX JINTUŻA
Telzir is used to treat HIV (human immunodeficiency virus) infection.
Telzir jintuża għal kura ta 'infezzjoni b' HIV (vajrus ta ’ l- immunodefiċjenza fil- bniedem).
The active ingredient in Telzir is fosamprenavir.
Is- sustanza attiva f’ Telzir hija fosamprenavir.
Fosamprenavir is a ‘ pro-drug ’ of the medicine amprenavir.
Fosamprenavir huwa ‘ pro- drug ’ tal- mediċina amprenavir.
This means that it is converted into active amprenavir once it is inside the body.
Dan ifisser li tinbidel f’ amprenavir f’ forma attiva la darba tkun ġewwa l- ġisem.
Telzir is a type of medicine known as an anti-retroviral.
Telzir huwa tip ta 'mediċina magħrufa bħala anti- retrovirali.
It is taken with low doses of another drug, ritonavir, which boosts the level of Telzir in the blood.
Jittieħed ma ’ dożi baxxa ta ’ mediċina oħra, ritonavir, li ssaħħaħ il- livelli ta 'Telzir fid- demm.
Telzir belongs to a group of anti-retroviral medicines called protease inhibitors.
Telzir jagħmel parti minn grupp ta 'mediċini anti- retrovirali li jissejħu inibituri tal- protease.
Protease is an enzyme produced by HIV which enables the virus to multiply in white blood cells (CD4 cells) in your blood.
Protease huwa enżima prodott minn HIV li jgħin lil vajrus jimmoltipplika fiċ- ċelluli bojod tad- demm (ċelluli CD4) fid- demm tiegħek.
By stopping protease from working, Telzir stops HIV multiplying and infecting more CD4 cells.
Telzir iżomm HIV milli jimmoltipplika u jinfetta aktar ċelluli CD4 billi jwaqqaf il- protease milli jagħmel effett.
Telzir with low doses of ritonavir is used in combination with other anti-retroviral medicines (‘ combination therapy ’) to treat adults, adolescents and children aged over 6 years infected with HIV-1.
Telzir flimkien ma ’ dożi żgħar ta ’ ritonavir jintuża flimkien ma ’ mediċini anti- retrovirali oħra (‘ terapija kombinata ’) fil- kura ta ’ adulti, adolexxenti u tfal ta ’ 6 snin u aktar, infettati bl’ HIV- 1.
HIV can become resistant to anti-HIV medicines.
HIV jista ’ jsir reżistenti għal mediċini anti_ HIV.
To avoid this happening, and to stop your illness getting worse, it is very important that you keep taking all your medicines exactly as prescribed.
Biex dan ma jiġrix, u biex tevita li l- marda tiegħek tmur għall- agħar huwa mportanti ħafna li tibqa tieħu l- mediċini kollha tiegħek eżatt kif preskritti.
Telzir will not stop you passing on HIV.
Telzir ma jwaqqfekx milli tgħaddi l- HIV lil ħaddieħor.
HIV infection is spread by sexual contact with someone who ’ s got the infection, or by transfer of infected blood (for example by sharing needles).
L- infezzjoni bl- HIV tinxtered b’ kuntatt sesswali ma ’ xi ħadd li għandu l- infezzjoni, jew minn trasferiment ta' demm infettat (per eżempju meta jintużaw il- labar ta ’ xulxin).
BEFORE YOU TAKE TELZIR
QABEL MA TIEĦU TELZIR
Telzir is to be taken in combination with low doses of ritonavir and other antiretroviral medicines.
Telzir għandu jittieħed flimkien ma ’ dożi baxxi ta ’ ritonavir u mediċini antiretrovirali oħra.
It is therefore important that you carefully read the package leaflet provided with these medicines.
Għalhekk hu importanti li taqra sew il- fuljett ta ’ tagħrif li jingħata ma ’ dawn il- mediċini.
If you have any further questions about ritonavir or the other medicines prescribed, please ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar ritonavir jew xi mediċini oħra li nkitbulek, jekk jogħġbok staqsi lit - tabib jew spiżjar tiegħek
Don ’ t take Telzir: • if you are allergic (hypersensitive) to fosamprenavir, amprenavir or any of the other ingredients in Telzir (listed in section 6), or to ritonavir. • if you are taking any of the medicines listed in the section ‘ Don’ t take these medicines with Telzir’.
Tieħux Telzir: • jekk inti allerġiku (tbati minn sensitività eċċessiva) għal fosamprenavir, amprenavir jew kull wieħed mis- sustanzi oħra f ’ Telzir (imsemmija f’ sezzjoni 8) jew għal ritonavir.
You will find this section under ‘ Other medicines and Telzir’. → Tell your doctor if any of these applies to you.
62 • jekk qed tieħu xi mediċini msemmija fis- sezzjoni ‘ Tieħux dawn il- mediċini ma ’ Telzir.
Take special care with Telzir Before you take Telzir your doctor needs to know: • If you have a known allergy to medicines containing sulphonamide.
Oqgħod attent ħafna b’ Telzir →Qabel ma tieħu Telzir it- tabib tiegħek għandu bżonn ikun jaf: • Jekk tafx li għanded allerġija għal mediċini li fihom sulphonamide.
You may also be allergic to Telzir. • If you have liver disease.
Tista ’ tkun allerġiku ukoll għal Telzir. • Jekk tbatix minn xi mard tal- fwied.
Your doctor may lower your dose of Telzir and ritonavir depending on the amount of liver damage.
It- tabib tiegħek jista ’ jbaxxi d- doża tiegħek ta ’ Telzir u ritonavir skond kemm għandek ħsara fil- fwied.
You will be monitored while you are taking Telzir.
Tkun taħt sorveljanza waqt li tkun qed tieħu Telzir.
If your liver disease gets worse, you may need to stop taking Telzir for a while, or permanently.
Jekk il- mard tal- fwied tiegħek imur għall- agħar, jista 'jkollok bżonn tieqaf tieħu Telzir għal xi ftit, jew għal dejjem.
People with hepatitis B or C taking combination therapy are at increased risk of getting severe liver problems. • If you have haemophilia.
Nies li jbatu minn epatite B jew Ċ u li qed jieħdu terapija kombinata għandhom riskju akbar li jkollhom problemi serji fil- fwied. • Jekk għandek l- emofilija.
Increased bleeding may occur while taking protease inhibitors.
Jista ’ jkollok tnixxija ta ’ demm aktar waqt li tkun qed tieħu inibituri tal- protease.
The reason for this is not known.
M' hijiex magħrufa ir- raġuni għal dan.
You may need additional factor VIII to control any bleeding. • If you have diabetes.
Jista 'jkollok bżonn aktar factor VIII biex tikkontrolla xi tnixxija ta ’ demm. • Jekk għanded id- dijabete.
In some patients taking antiretroviral medicines including protease inhibitors, there have been reports of increased sugar in the blood and diabetes getting worse.
Kien hemm rapporti ta ’ livell aktar għoli ta ’ zokkor fid- demm u dijabete li marret għall- agħar f’ xi pazjenti fuq mediċini anti- retrovirali li jinkludu inibituri tal - protease.
Also, some people have become diabetic while taking these medicines. → Tell your doctor if any of these applies to you.
Kien hemm ukoll xi nies li saru dijabetiċi waqt li kienu qed jieħdu dawn il- mediċini. →Għid lit- tabib tiegħek jekk xi wieħed minn dawn japplika għalik.
You will need extra check-ups, including blood tests, while you ’ re taking your medication.
Ikollok bżonn aktar check - ups, li jinkludu testijet tad- demm, waqt li tkun qed tieħu il- mediċina tiegħek.
Look out for important symptoms Some people taking medicines for HIV infection develop other conditions, which can be serious.
Oqgħod attent għal sintomi importanti Xi nies li jkunu fuq mediċini għal infezzjoni b’ HIV jiżviluppaw kundizzjonijiet oħra, li jistgħu ikunu serji.
You need to know about important signs and symptoms to look out for while you ’ re taking Telzir.
Għandek bżonn tkun taf fuq sinjali u sintomi importanti li għandek toqgħod attent għalihom waqt li tkun qed tieħu Telzir.
Please read the information in section 4 of this leaflet.
Jekk jogħġbok aqra l- informazzjoni f’ sezzjoni 4 ta ’ dan il- fuljett.
If you have any questions about this information or the advice given: → Talk to your doctor.
Jekk għandek xi mistoqsijiet fuq din l- informazzjoni jew il- parir li tkun ingħatajt: →Kellem lit- tabib tiegħek.
Other medicines and Telzir Tell your doctor or pharmacist if you ’ re taking any other medicines, if you’ ve taken any recently, or if you start taking new ones – these include herbal medicines or other medicines you bought without a prescription.
Mediċini oħra u Telzir Għid lit- tabib jew lil- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, jew jekk bdejt tieħu xi mediċini ġodda – dawn jinkludu mediċini erbali jew mediċini oħra li tkun xtrajt mingħajr riċetta.
Your doctor will decide if these medicines are suitable for you to take with Telzir and ritonavir.
It- tabib tiegħek jiddeċiedi jekk dawn il- mediċini humiex addatati għalik biex teħodhom ma 'Telzir u ritonavir.
This is very important, as Telzir or ritonavir can strengthen or weaken the effects of other medicines.
Dan huwa importanti ħafna, għax Telzir u ritonavir jistgħu isaħħu jew idagħajfu l- effetti ta 'mediċini oħra.
This can sometimes lead to serious medical conditions.
Dan kultant jista 'jwassal għal kundizzjonijiet mediċi serji.
Don ’ t take these medicines with Telzir: • other medicines containing amprenavir (used to treat HIV) • astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without prescription) • pimozide (used to treat schizophrenia) • cisapride (used to relieve indigestion) • ergot derivatives (used to treat headaches) • rifampicin (used to treat tuberculosis) • amiodarone, quinidine, flecainide and propafenone (heart medicines) • bepridil (used to treat high blood pressure) • products containing St John’ s wort (Hypericum perforatum). • These medicines are not recommended with Telzir/ ritonavir:
Tieħux dawn il- mediċini ma 'Telzir: • mediċini oħra li fihom amprenavir (li jintuża fil- kura ta' HIV) • astemizole jew terfenadine (użati ħafna fil- kura ta ’ sintomi ta ’ allerġiji – dawn il- mediċini jistgħu jinbiegħu bla riċetta tat- tabib) • pimozide (użat fil- kura ta ’ skizofrenja) • cisapride (użat biex tittaffa l- indiġistjoni) • derivattivi ta ’ l- ergot (użat għal kontra l- uġigħ ta ’ ras) • rifampicin (użat fil- kura tat- tuberkulożi) • amiodarone, quinidine, flecainide u propafenone (mediċini tal- qalb) • bepridil (użat fil- kura ta ’ pressjoni għolja) • prodotti li fihom St John’ s wort (Hypericum perforatum)
62 • doses of ketoconazole and itraconazole greater than 200 mg per day (used to treat fungal infections) • doses of rifabutin greater than 150 mg every other day (an antibiotic) • lidocaine given by injection (an anaesthetic) • halofantrine (used to treat malaria) • midazolam and triazolam (used to treat anxiety) • sildenafil and vardenafil (used to treat erectile dysfunction) • lovastatin, simvastatin and doses of atorvastatin greater than 20 mg per day (used to lower cholesterol) • fluticasone propionate and similar medicines used to treat asthma, unless considered essential.
Dawn il- mediċini m’ humiex rakkomandati ma ’ Telzir/ ritonavir: • dożi ta ’ ketoconazole u itraconazole akbar minn 200mg kuljum (użati għal kura ta ’ infezzjonijiet fungali) • dożi ta ’ rifabutin akbar minn 150mg ġurnata iva u ġurnata le (antibijotiku) • lidocaine li jingħata b’ injezzjoni (anestetiku) • halofantrine (użat għal kura tal- malarja) • midazolam u triazolam (użati għal kura ta ’ l- ansjeta ’)
In this case close monitoring is required. • lopinavir/ ritonavir combination (used to treat HIV infection)
F’ dan il- kas hemm bżonn sorveljanza mill- qrib. • Teħid flimkien ta ’ lopinavir/ ritonavir (li jintużaw biex jikkuraw infezzjoni ta ’ HIV)
You will be closely monitored if you are taking these medicines with Telzir/ ritonavir: • atorvastatin up to 20 mg per day (used to lower cholesterol) • carbamazepine, phenobarbital (used to treat epilepsy) • cyclosporin, rapamycin, tacrolimus (used to suppress the immune system) • desipramine, nortriptyline, paroxetine and similar medicines (used to treat depression) • warfarin and other medicines that stop blood clotting.
Ikollok bżonn sorveljanza mill- qrib jekk tkun qed tieħu dawn il- mediċini ma ’ Telzir/ ritonavir: • atorvastatine sa 20mg kuljum (użat biex ibaxxi l- kolesterol) • carbamezapine, phenobarbital (użati għal kura ta 'l- epilessija) • cyclosporin, rapamycin, tacrolimus (użati biex irażżnu is- sistema immunitarja) • desipramine, nortriptyline, paroxetine u mediċini simili (użati għal kura tad- dipressjoni) • warfarin u mediċini oħra li jwaffqu id- demm milli jagħqad.
Hormonal contraception Taking Telzir and ritonavir while taking the contraceptive pill may harm your liver and may stop the contraceptive from working properly. → Use an alternative non-hormonal type of contraception such as a condom.
Kontraċezzjoni ormonali Tista ’ tagħmel ħsara fil- fwied jekk tieħu Telzir u ritonavir mal- pillola kontraċettiva u jistgħu iwaqqfu il- kontraċettiv milli jagħmel effett kif suppost. →Uża tip ta ’ kontraċezzjoni ieħor mhux ormonali bħal kondom.
No studies have been done on the use of Telzir/ ritonavir with other hormonal therapies, such as hormone replacement therapy (HRT).
Ma saru l- ebda studji fuq l- użu ta ’ Telzir/ ritonavir ma ’ terapiji ormonali oħra, bħal hormone replacement therapy (HRT).
Pregnancy and breast feeding If you are pregnant, if you become pregnant, or if you are planning to become pregnant: → Talk to your doctor about the risks and benefits of taking Telzir.
Tqala u Treddigħ Jekk inti tqila, jekk tinqabad tqila, jew jekk qed tippjana li tinqabad tqila: →Kellem lit- tabib tiegħek dwar ir- riskji u l- benefiċċji li tieħu Telzir.
Women who are HIV-positive must not breast feed because HIV infection can be passed on to the baby in breast milk.
Nisa li huma pożittivi għal HIV m’ għandhomx ireddgħu għaliex l- infezzjoni ta ’ l- HIV tista ’ tgħaddi għat- tarbija fil- ħalib tas- sider.
If you ’ re breast feeding, or thinking about breast feeding: → Talk to your doctor.
Jekk qed tredda 'jew qed taħseb biex tredda' →Kellem lit- tabib tiegħek.
However you can still continue to take Telzir.
Jista ’ jkollok raxx fil- ġilda Madankollu xorta tista ’ tkompli tieħu Telzir.
It can be treated with antihistamines.
Tista ’ tkun ittratata bl- anti- istaminiċi.
Rarely, the skin rash can be severe and serious (Stevens Johnson syndrome).
Rarament, ir- raxx fil- ġilda jista ’ jkun qawwi u serju (sindromu Stevens Johnson).
If this happens, Telzir must be stopped immediately and you must never take it again.
Jekk jiġri dan, Telzir għandu jitwaqqaf mill- ewwel u m’ għandek qatt terġa ’ tieħdu.
Driving and using machines Telzir can make you feel dizzy and have other side effects that make you less alert. → Don’ t drive or operate machinery unless you ’ re feeling well.
Sewqan u tħaddim ta ’ magni Telzir jista ’ jagħmillek sturdament jew effetti sekondarji oħra li jagħmluk anqas fuq tiegħek., Issuqx jew tħaddem magni sakemm ma tħossokx f' siktek.
Stay in regular contact with your doctor Telzir helps to control your condition, but it is not a cure for HIV infection.
Ibqa ’ f’ kuntatt regolari mat- tabib tiegħek Telzir jgħin biex jikkontrolla il- kundizzjoni tiegħek, imma m’ huwiex kura għal infezzjoni b’ HIV.
You need to keep taking it every day to stop your illness getting worse.
Għandek bżonn tibqa ’ toħodha kuljum biex il- marda tiegħek ma tmurx għall- agħar.
You may still develop other infections and illnesses linked to HIV infection. → Keep in touch with your doctor, and don’ t stop taking Telzir without your doctor ’ s advice.
Xorta tista ’ tiżviluppa infezzjonijiet u mard ieħor li għandu x’ jaqsam ma ’ infezzjoni b’ HIV. →Ibqa 'f’ kuntatt mat- tabib tiegħek, u tieqafx tieħu Telzir mingħajr il- parir tat- tabib tiegħek.
Protect other people Telzir will not stop you passing HIV infection on to other people, by having sex or by blood transfer.
Ipproteġi nies oħra Telzir ma jżommokx milli tgħaddi l- infezzjoni b’ HIV lil nies oħra, bl- att sesswali jew b’ taħlit ta ’ demm.
To protect other people from becoming infected with HIV: → Use a condom when you have oral or penetrative sex. → Don’ t risk blood transfer – for example, don’ t share needles.
Biex tipproteġi nies oħra milli jiġu infettati b' HIV: →Uża condom meta jkollok sess orali jew penettrattiv →Tirriskjax taħlit ta ’ demm – per eżempju, tużax l- istess labar.
63 3.
64 3.
HOW TO TAKE TELZIR
KIF GĦANDEK TIEĦU TELZIR
Always take Telzir exactly as your doctor has told you.
Dejjem għandek tieħu Telzir eżatt kif ikun qallek it- tabib.
It is very important that you take the full daily dose of Telzir and ritonavir as prescribed by your doctor.
Huwa mportanti ħafna li tieħu d- doża ta ’ Telzir u ritonavir ta 'kuljum kollha kif preskritta mit- tabib tiegħek.
Do not take more than the recommended dose.
Tieħux aktar mid- doża rakkomandata.
Check with your doctor or pharmacist if you are not sure.
Aċċerta ruħek mat- tabib jew spiżjar tiegħek jekk ikollok xi dubju.
Swallow the tablets whole, with some water or another drink.
Ibla l- pilloli sħaħ flimkien ma ’ tazza ilma jew xi xarba oħra.
Telzir tablets can be taken with or without food.
Tista ’ tieħu l- pilloli ta ’ Telzir kemm ma ’ l- ikel kif ukoll waħidhom.
Telzir is also available as a liquid (oral suspension) for people who are unable to swallow tablets.
Telzir issibu wkoll bħala likwidu (sospensjoni orali) għal nies li ma jistgħux jibilgħu pilloli.
(Read the package leaflet of Telzir oral suspension for guidance on whether to take it with or without food.)
(Aqra l- fuljett ta ’ tagħrif tas- sospensjoni orali ta ’ Telzir għal gwida fuq jekk għandekx toħodha ma ’ l- ikel jew waħedha.)
How much to take Adults The recommended dose is one 700 mg Telzir tablet twice daily with 100 mg ritonavir twice daily.
Kemm tieħu Adulti Id- doża rakkomandata hi ta ’ pillola waħda ta ’ 700mg ta ’ Telzir darbtejn kuljum ma ’ 100 mg ritonavir darbtejn kuljum.
Children from 6 years of age and weighing at least 39 kg Children can take the adult tablet dose of one 700 mg Telzir tablet twice daily with ritonavir 100 mg twice daily if they can swallow the tablets whole.
Tfal minn 6 snin u li jiżnu anqas minn 39kg.
Children from 6 years of age and weighing less than 39 kg Use Telzir oral suspension.
Uża s- sospensjoni orali ta ’ Telzir.
Adults with liver disease If you have mild liver disease, the dose is one Telzir tablet (700 mg) twice daily with 100 mg ritonavir only once daily.
Adulti b’ mard tal- fwied Jekk tbati minn mard mhux serju tal- fwied, id- doża hija ta ’ pillola waħda ta ’ Telzir (700mg) darbtejn kuljum b’ 100mg ritonavir darba kuljum biss.
If you have moderate or severe liver disease the dose of Telzir has to be lowered.
Jekk tbati minn mard moderat jew sever tal - fwied id- doża rakkomandata ta ’ Telzir għandha titbaxxa.
This dose adjustment can not be made with Telzir tablets.
Dan l- aġġustament fid- doża ma jistax isir bil- pilloli ta ’ Telzir.
You must take Telzir oral suspension..
Għandek tuża s- suspensjoni orali ta ’ Telzir.
If you take too much Telzir If you have taken more than the prescribed dose of Telzir: → Contact your doctor or pharmacist immediately for advice.
Jekk tieħu Telzir aktar milli suppost Jekk ħadt aktar Telzir minn kemm ordnalek it- tabib: →Ikkuntatja lit- tabib jew lill- ispiżjar tiegħek għal parir minnufih.
If you forget to take Telzir If you forget to take a dose of Telzir, take it as soon as you remember and then continue your treatment as before.
Jekk tinsa tieħu Telzir Jekk tinsa tieħu xi doża ta ’ Telzir, ħudha hekk kif tiftakar u kompli bil- kura tiegħek bħal qabel.
Don’ t take a double dose to make up for a missed dose.
M’ għandekx tieħu doża doppja biex tpatti għal kull doża li tkun insejt tieħu.
Don’ t stop Telzir without advice Take Telzir for as long as your doctor recommends.
Tieqafx tieħu Telzir mingħajr parir.
Don’ t stop unless your doctor advises you to.
Hu Telzir sakemm jirrakomandalek it- tabib tiegħek.
Like all medicines, Telzir can cause side effects, but not everyone gets them.
Bħal kull mediċina oħra, Telzir jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
When treating HIV, it can be hard to tell whether side effects are caused by Telzir, by other medicines taken at the same time or by the HIV disease itself.
Waqt il- kura ta ’ l- infezzjonijiet ta ’ l- HIV mhux dejjem ikun possibbli li wieħed jgħid jekk xi effetti mhux mixtieqa li jinħassu jkunux ġejjin minħabba Telzir jew minħabba xi mediċina oħra li tkun qed tingħata fl- istess waqt jew mill- marda tal- HIV nnifisha.
For this reason, it is very important to talk to your doctor about any changes in your health.
Għalhekk huwa mportanti ħafna li tkellem lit - tabib tiegħek jekk tħoss xi tibdil f’ saħħtek.
Very common side effects These may affect more than 1 in 10 people: • Diarrhoea • Increases in triglycerides (a type of blood fat).
Effetti sekondarji komuni ħafna Dawn jistgħu jaffettwaw aktar minn 1 f’ 10 minn nies; • Dijarea • Żieda fit- triġliċeridi (tip ta ’ xaħam fid- demm)
Common side effects These may affect up to 1 in 10 people: • Feeling sick or being sick (nausea or vomiting), pain in the stomach, loose stools • Skin rashes (red, raised or itchy) – if the skin rash is severe, you may have to stop taking this medicine • Headache, feeling dizzy 64 • Feeling tired • Increases in enzymes produced by the liver called transaminases, increases of an enzyme produced by the pancreas called lipase. • Tingling or numbness around the lips and mouth
65 • Tħossok imqalla jew tkun imqalla (dardir jew remettar), uġigħ fl- istonku, purgar artab • Raxx fil- ġilda (aħmar, imqabbes jew bil- ħakk) – jista ’ jkun li jkollok tieqaf tieħu din il - mediċina jekk ir- raxx fil- ġilda ikun qawwi • Uġigħ ta ’ ras, sturdament • Għeja • Żieda fil- livelli ta ’ enżimi tal- fwied magħrufa bħala transaminases u żieda fil- livelli ta ’ enżima tal- pankreas magħruf bħala lipase. • Tingiż jew tnemnim madwar ix- xufftejn u l- ħalq
Uncommon side effects These may affect up to 1 in 100 people: • Large increases in cholesterol (a type of blood fat). • Swelling of the face, lips and tongue (angioedema)
Effetti sekondarji mhux komuni Dawn jistgħu jaffettwaw sa 1 f’ 100 minn nies • Żidiet kbar fil- kolesterol (tip ta ’ xaħam fid- demm) • Nefħa fil- wiċċ, fix- xuftejn u l- ilsien (angioedema)
Rare side effects These may affect up to 1 in 1000 people: • A severe or life-threatening skin reaction (Stevens Johnson syndrome).
Effetti sekondarji rari Dawn jistgħu jaffettwaw sa 1 f’ 1000 minn nies • Reazzjoni severa jew li tista ’ tkun ta ’ periklu għal ħajja, fil- ġilda (sindromu Stevens- Johnson)
You may experience muscle problems There have been reports of muscle pain, tenderness or weakness, particularly with antiretroviral therapy including protease inhibitors and nucleoside analogues.
Tista ’ tesperjenza problemi fil- muskoli Kien hemm rapporti ta ’ uġigħ fil- muskoli, sensibilita 'jew nuqqas ta ’ saħħa, speċjalment b’ terapija antiretrovirali li tinkludi inibituri tal- protease u analogi tan- nukleosidi.
On rare occasions, these muscle disorders have been serious (rhabdomyolysis).
F’ okkażjonijiet rari, dawn id - disturbi fil- muskoli kienu ta ’ natura serja (rabdomajoliżi).
If you notice any muscle problems: → Tell your doctor.
Jekk tinnota xi problemi fil- muskoli: →Għid lit- tabib tiegħek.
Haemophiliacs may bleed more In patients with haemophilia type A and B, there have been reports of increased bleeding while taking protease inhibitors.
Nies li jbatu minn emofilija jistgħu ikollhom aktar fsada F’ dawk il- pazjenti li jbatu minn emofilja Tip A u B kien hemm rapporti ta ’ żieda fil- fsada waqt l- użu ta ’ l- impedituri protease.
If this happens to you: → Talk to your doctor immediately.
Jekk jiġrilek hekk: →Kellem lit- tabib tiegħek immedjatament.
If you get side effects → Tell your doctor or pharmacist if any of the side effects gets severe or troublesome, or if you notice any side effects not listed in this leaflet.
Jekk ikollok xi effetti sekondarji →Għid lit- tabib jew lill- ispiżjar tiegħek. jekk xi wieħed mill- effetti sekondarji jiggravaw jew ituk il- problemi, jew jekk tinnota xi efetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett.
Other side effects of combination therapy for HIV
Effetti sekondarji oħra ta ’ terapija kombinata għal HIV
Old infections may flare up People with advanced HIV infection (AIDS) have weak immune systems and are more likely to develop serious infections (opportunistic infections).
Infezzjonijiet tal- passat jistgħu jerġgħu jitqanqlu Nies b’ infezzjoni avvanzata ta ’ HIV (AIDS) għandhom sistema ta ’ immunità dgħajfa u għandhom aktar possibilità li jiżviluppaw infezzjonijiet serji (infezzjonijiet opportunistiċi).
When these people start treatment, they may find that old, hidden infections flare up, causing signs and symptoms of inflammation.
Meta dawn in- nies jibdew il- kura, jistgħu isibu li infezzjonijiet antiki moħbija jitqanqlu u jikkawżaw sinjali u sintomi ta ’ infjammazzjoni.
These symptoms are probably caused by the body’ s immune system becoming stronger, so that the body starts to fight these infections.
Dawn is- sintomi probabilment joħorġu minħabba li s- sistema immunitarja tal- ġisem issir aktar b' saħħitha, u għalhekk il- ġisem jibda 'jiġġieled dawn l- infezzjonijiet.
If you get any symptoms of infection or signs of inflammation while you ’ re taking Telzir: → Tell your doctor immediately.
Jekk ikollok xi sintomi ta ’ infezzjoni jew sinjali ta ’ infjammazzjoni waqt li tkun qed tieħu Telzir: →Għid lit- tabib tiegħek immedjatament.
Don’ t take other medicines for the infection without your doctor’ s advice.
Tieħux mediċini oħra għal infezzjoni mingħajr il- parir tat- tabib tiegħek.
Your body shape may change People taking combination therapy may find that their body shape changes, because of changes in fat distribution: • Fat may be lost from the legs, arms or face • Extra fat may build up around the tummy (abdomen) or the breasts or internal organs • Fatty lumps (sometimes called a buffalo hump) may appear on the back of the neck.
Tista ’ tinbidel is- sura ta 'ġismek Nies fuq terapija kombinata jistgħu jsibu li s- sura ta ’ ġisimhom tinbidel, minħabba bdil fit- tqassim tax - xaħam: • Jista ’ jintilef xaħam mir- riġlejn, dirgħajn u l- wiċċ • Jista ’ ikun hemm żieda ta ’ xaħam madwar iż- żaqq (addomenu) jew is- sider jew organi interni • Għoqod ta ’ xaħam (li kultant jissejħu buffalo hump) jistgħu joħorġu fuq wara ta ’ l- għonq.
It is not yet known what causes these changes, or whether they have any long-term effects on your health.
66 Għad mhuwiex magħruf x’ jikkawża dawn il- bidliet, jew jekk għandhomx effetti fit- tul fuq saħħtek.
If you notice changes in your body shape: → Tell your doctor.
Jekk tinnota xi bdil fis- sura ta ’ ġismek: →Għid lit- tabib tiegħek.
You may have problems with your bones Some people taking combination therapy for HIV develop a condition called osteonecrosis.
Jista ’ jkollok problemi b’ għadmek Xi nies fuq terapija kombinata għal HIV jiżviluppaw kondizzjoni li tissejjaħ ostejonekrożi.
With this condition, parts of the bone tissue die because of reduced blood supply to the bone.
F’ din il - kondizzjoni, partijiet mis- sustanza ta ’ l- għadam imutu minħabba nuqqas ta ’ cirkolazzjoni lill- għadam.
65 People may be more likely to get this condition: • if they have been taking combination therapy for a long time • if they are also taking anti-inflammatory medicines called corticosteroids • if they drink alcohol • if their immune systems are very weak • if they are overweight.
In- nies jista ’ jkollhom aktar possibilità li jkollhom din il- kondizzjoni: • jekk ikunu ilhom jieħdu terapija kombinata għal tul ta ’ żmien • jekk ikunu qegħdin jieħdu wkoll mediċini kontra l- infjammazzjoni li jissejħu kortikosterojdi • jekk jixorbu alkoħol • jekk is- sistemi immunitarji tagħhom ikunu dgħajfa • jekk ikollhom piż żejjed
Signs to look out for include: • stiffness in the joints • aches and pains (especially in the hip, knee or shoulder) • difficulty moving.
• egħbusija fil- ġogi • uġigħ (speċjalment fil- ġog tal- koxxa, fl- irkoppa jew fl- ispalla) • diffikultaà biex tiċċaqlaq
If you notice any of these symptoms: → Tell your doctor.
Jekk tinnota xi wieħed minn dawn is- sintomi: →Għid lit- tabib tiegħek
Other effects may show up in tests Combination therapy for HIV can also cause: • increased levels of lactic acid in the blood • increased levels of sugar or fats in the blood • resistance to insulin (so if you’ re diabetic, you may have to change your insulin dose to control your blood sugar).
Effetti oħra jistgħu jidhru f’ testijiet Terapija kombinata għal HIV tista ’ wkoll tikkawża: • żieda fil- livelli ta ’ aċidu laktiku fid- demm • żieda fil- livelli ta ’ zokkor jew xaħmijiet fid- demm • reżistenza għal insulina (jiġifieri jekk inti dijabetiku, jista ’ jkollok bżonn tibdel id- doża ta ’ insulina tiegħek biex tikkontrolla z- zokkor fid- demm tiegħek).
HOW TO STORE TELZIR
KIF TAĦŻEN TELZIR
Keep Telzir out of the sight and reach of children.
Żomm fejn ma jintlaħaqx u ma jidhirx mit- tfal.
Telzir does not require any special storage conditions.
Telzir m’ għandux bżonn ħażna speċjali.
Don’ t use Telzir after the expiry date shown on the bottle and the carton.
M’ għandekx tuża Telzir wara d- data ta ’ skadenza li tidher fuq il- flixkun jew il- kartuna.
If you have any unwanted Telzir tablets, don’ t dispose of them in your waste water or your household waste.
Jekk għandek xi pilloli ta ’ Telzir li ma tridx tarmihomx ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
Take them back to your pharmacist who will dispose of them in a way that won ’ t harm the environment.
Hudhom lura lill- ispiżjar tiegħek u hu jiddisponi minnhom b’ mod li ma jagħmlux ħsara l - ambjent.
What Telzir contains
X’ fih Telzir
• The active substance is fosamprenavir.
• Is- sustanza attiva hi fosamprenavir.
Each tablet contains 700 mg of fosamprenavir as fosamprenavir calcium (equivalent to approximately 600 mg amprenavir).
Kull pillola fiha 700mg ta ’ fosamprenavir bħala fosamprenavir calcium (ekwivalenti għal bejn wieħed u ieħor 600mg ta ’ amprenavir)
• The other ingredients are: microcrystalline cellulose, croscarmellose sodium, povidone K30, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), glycerol triacetate, iron oxide red (E172).
• Is- sustanzi l- oħra huma: microcrystalline cellulose, croscarmellose sodium, povidone K30, magnesium stearate, colloidal anhydrous silica, hypromellose, titanium dioxide (E171), glycerol triacetate, iron oxide red (E172).
What Telzir looks like and contents of the pack
67 Id- dehra ta ’ Telzir u l- kontenuti tal- pakkett
Telzir is supplied in plastic bottles containing 60 film-coated tablets.
Telzir jinbiegħ fi flixken tal- plastik li jkun fihom 60 pillola miksijin b’ rita.
The tablets are capsule shaped, biconvex, pink coloured and marked with GXLL7 on one side.
Il- pilloli qegħdin f’ għamla ta ’ kapsuli, imbuzzati fuq iż- żewġ naħat, ta ’ kulur roża u bil- marka GXLL7 fuq naħa waħda.
Telzir is also available as an oral suspension for those patients unable to swallow the tablets.
Telzir jinbiegħ wkoll bħala sospensjoni orali għal dawk il- pazjenti li ma jistgħux jibilgħu pilloli.
66 Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manufattur
Marketing Authorisation Holder
Detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq
Glaxo Wellcome Operations Priory Street Ware Hertfordshire SG12 0DJ United Kingdom
Glaxo Wellcome Operations Priory Street Ware Hertfordshire SG 12 0DJ Ir- Renju Unit
Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN United Kingdom
Glaxo Group Ltd Greenford Road Greenford Middlesex UB6 0NN Ir- Renju Unit
For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
España GlaxoSmithKline, S. A.
68 Portugal España GlaxoSmithKline - Produtos Farmacêuticos, GlaxoSmithKline, S. A.
INFORMATION FOR THE USER
69 FULJETT TA ’ TAGĦRIF:
Telzir 50 mg/ ml oral suspension Fosamprenavir Read all of this leaflet carefully before you start taking this medicine. • Keep this leaflet.
INFORMAZZJONI GĦAL MIN QED JAGĦMEL UŻU MINN U Sospensjoni orali ta ’ 50 mg/ ml Telzir Fosamprenavir
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist (chemist). • This medicine has been prescribed for you personally.
- Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not pass it on to other people - it may harm them even if their symptoms seem to be the same as yours. • If you have serious side effects, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li
Fosamprenavir is a ‘ pro-drug’ of the medicine amprenavir.
Fosamprenavir huwa ‘ pro- drug ’ tal- mediċina amprenavir.
By stopping protease from working, Telzir stops HIV multiplying and infecting more CD4 cells
Telzir iżomm HIV milli jimmoltipplika u jinfetta aktar ċelluli CD4 billi jwaqqaf il- protease milli jagħmel effett.
Telzir with low doses of ritonavir is used in combination with other anti-retroviral medicines (‘ combination therapy’) to treat adults, adolescents and children aged over 6 years infected with HIV-1.
Telzir flimkien ma ’ dożi żgħar ta ’ ritonavir jintuża flimkien ma ’ mediċini anti- retrovirali oħra (‘ terapija kombinata ’) fil- kura ta ’ adulti, adolexxenti u tfal ta ’ 6 snin u aktar, infettati bl’ HIV- 1.
HIV infection is spread by sexual contact with someone who’ s got the infection, or by transfer of infected blood (for example by sharing needles).
L- infezzjoni bl- HIV tinxtered b’ kuntatt sesswali ma ’ xi ħadd li għandu l- infezzjoni, jew minn trasferiment ta' demm infettat (per eżempju meta jintużaw il- labar ta ’ xulxin).
Telzir is to be taken in combination with low doses of ritonavir and other antiretroviral medicines.
Telzir għandu jittieħed flimkien ma ’ ritonavir u mediċini antiretrovirali oħra.
It is therefore important that you carefully read the package leaflet provided with these medicines.
Għalhekk hu importanti li taqra sew il- fuljett ta ’ tagħrif li jingħata ma ’ din il- mediċina.
If you have any further questions about ritonavir or the other medicines prescribed, please ask your doctor or pharmacist.
Jekk għandek aktar mistoqsijiet dwar ritonavir jew xi mediċini oħra li nkitbulek, jekk jogħġbok staqsi lit- tabib jew spiżjar tiegħek.
Don’ t take Telzir: • if you are allergic (hypersensitive) to fosamprenavir, amprenavir or any of the other ingredients in Telzir (listed in section 6), or to ritonavir.
Tieħux Telzir: • jekk inti allerġiku (tbati minn sensitività eċċessiva) għal fosamprenavir, amprenavir jew kull wieħed mis- sustanzi oħra f ’ Telzir (imsemmija f’ sezzjoni 8) jew għal ritonavir.
• if you are taking any of the medicines listed in the section ‘ Don’ t take these medicines with Telzir’.
70 • jekk qed tieħu xi mediċini msemmija fis- sezzjoni ‘ Tieħux dawn il- mediċini ma ’ Telzir.
You will find this section under ‘ Other medicines and Telzir’.
Din is - sezzjoni issibha taħt ‘ Mediċini oħra u Telzir ’. →Għid lit- tabib tiegħek jekk xi wieħed minn dawn japplika għalik.
Take special care with Telzir → Before you take Telzir your doctor needs to know: • If you have a known allergy to medicines containing sulphonamide.
Oqgħod attent ħafna b’ Telzir →Qabel ma tieħu Telzir it- tabib tiegħek għandu bżonn ikun jaf: • Jekk tafx li għanded allerġija għal mediċini li fihom sulphonamide.
You will need extra check-ups, including blood tests, while you’ re taking your medication.
Ikollok bżonn aktar check - ups, li jinkludu testijet tad- demm, waqt li tkun qed tieħu il- mediċina tiegħek.
You need to know about important signs and symptoms to look out for while you’ re taking Telzir.
Għandek bżonn tkun taf fuq sinjali u sintomi importanti li għandek toqgħod attent għalihom waqt li tkun qed tieħu Telzir.
Other medicines and Telzir Tell your doctor or pharmacist if you’ re taking any other medicines, if you’ ve taken any recently, or if you start taking new ones – these include herbal medicines or other medicines you bought without a prescription.
Mediċini oħra u Telzir Għid lit- tabib jew lil- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, jew jekk bdejt tieħu xi mediċini ġodda – dawn jinkludu mediċini erbali jew mediċini oħra li tkun xtrajt mingħajr riċetta.
Don’ t take these medicines with Telzir: • other medicines containing amprenavir (used to treat HIV) • astemizole or terfenadine (commonly used to treat allergy symptoms – these medicines may be available without prescription) • pimozide (used to treat schizophrenia) • cisapride (used to relieve indigestion) • ergot derivatives (used to treat headaches) • rifampicin (used to treat tuberculosis) • amiodarone, quinidine, flecainide and propafenone (heart medicines)
Tieħux dawn il- mediċini ma 'Telzir: • mediċini oħra li fihom amprenavir (li jintuża fil- kura ta' HIV) • astemizole jew terfenadine (użati ħafna fil- kura ta ’ sintomi ta ’ allerġiji – dawn il- mediċini jistgħu jinbiegħu bla riċetta tat- tabib) • pimozide (użat fil- kura ta ’ skizofrenja) • cisapride (użat biex tittaffa l- indiġistjoni) • derivattivi ta ’ l- ergot (użat għal kontra l- uġigħ ta ’ ras) • rifampicin (użat fil- kura tat- tuberkulożi) • amiodarone, quinidine, flecainide u propafenone (mediċini tal- qalb) • bepridil (użat fil- kura ta ’ pressjoni għolja) • prodotti li fihom St John’ s wort (Hypericum perforatum)
70 • bepridil (used to treat high blood pressure). • products containing St John’ s wort (Hypericum perforatum).
Dawn il- mediċini m’ humiex rakkomandati ma ’ Telzir/ ritonavir: • dożi ta ’ ketoconazole u itraconazole akbar minn 200mg kuljum (użati għal kura ta ’ infezzjonijiet fungali) • dożi ta ’ rifabutin akbar minn 150mg ġurnata iva u ġurnata le (antibijotiku) • lidocaine li jingħata b’ injezzjoni (anestetiku) • halofantrine (użat għal kura tal- malarja) • midazolam u triazolam (użati għal kura ta ’ l- ansjeta ’)
These medicines are not recommended with Telzir/ ritonavir: • doses of ketoconazole and itraconazole greater than 200 mg per day (used to treat fungal infections) • doses of rifabutin greater than 150 mg every other day (an antibiotic) • lidocaine given by injection (an anaesthetic) • halofantrine (used to treat malaria) • midazolam and triazolam (used to treat anxiety) • sildenafil and vardenafil (used to treat erectile dysfunction) • lovastatin, simvastatin and doses of atorvastatin greater than 20 mg per day (used to lower cholesterol) • fluticasone propionate and similar medicines used to treat asthma, unless considered essential.
71 • sildenafil u vardenafil (użati għal kura ta ’ disfunzjoni erettili) • lovastatin, simvastatin u dożi ta ’ atorvastatin akbar minn 20mg kuljum (użati biex ibaxxu l - kolesterol) • fluticasone propionate u mediċini simili użati għal kura ta ’ l- ażma, sakemm mhux ikkonsidrat neċessarju.
In this case close monitoring is required. • lopinavir/ ritonavir combination (used to treat HIV infection)
F’ dan il- kas hemm bżonn sorveljanza mill- qrib. • Teħid flimkien ta ’ lopinavir/ ritonavir (li jintużaw biex jikkuraw infezzjonijiet ta ’ HIV)
Taking Telzir and food Adults should take the Telzir oral suspension without food and on an empty stomach.
Meta tieħu Telzir ma ’ l- ikel u max- xorb L- adulti għandhom jieħdu is- sospensjoni orali ta ’ Telzir mhux ma ’ l- ikel u fuq stonku vojt.
Children and adolescents should take the Telzir oral suspension with food.
Tfal u adolexxenti għandhom jieħdu is- sospensjoni orali ta ’ Telzir ma ’ l- ikel.
If you’ re breast feeding, or thinking about breast feeding: → Talk to your doctor.
Jekk qed tredda 'jew qed taħseb biex tredda' →Kellem lit- tabib tiegħek.
Important information about ingredients of Telzir oral suspension Telzir oral suspension contains propyl and methyl parahydroxybenzoate.
Informazzjoni importanti dwar l- ingredjenti tas- sospensjoni orali ta ’ Telzir Is- sospensjoni orali ta ’ Telzir fiha propyl u methyl parahydroxybenzoate.
These ingredients may cause allergic reactions (sometimes delayed).
Dawn l- ingredjenti jistgħu jikkawżaw reazzjonijiet allerġiċi (li xi kultant jiġu tard).
Driving and using machines Telzir can make you feel dizzy and have other side effects that make you less alert. → Don’ t drive or operate machinery unless you’ re feeling well.
Sewqan u tħaddim ta ’ magni Telzir jista ’ jagħmillek sturdament jew effetti sekondarji oħra li jagħmluk anqas fuq tiegħek., Issuqx jew tħaddem magni sakemm ma tħossokx f' siktek.
71 Stay in regular contact with your doctor Telzir helps to control your condition, but it is not a cure for HIV infection.
Ibqa ’ f’ kuntatt regolari mat- tabib tiegħek Telzir jgħin biex jikkontrolla il- kundizzjoni tiegħek, imma m’ huwiex kura għal infezzjoni b’ HIV.
You may still develop other infections and illnesses linked to HIV infection. → Keep in touch with your doctor, and don’ t stop taking Telzir without your doctor’ s advice.
Xorta tista ’ tiżviluppa infezzjonijiet u mard ieħor li għandu x’ jaqsam ma ’ infezzjoni b’ HIV. →Ibqa 'f’ kuntatt mat- tabib tiegħek, u tieqafx tieħu Telzir mingħajr il- parir tat- tabib tiegħek.
Shake the bottle for 20 seconds before the first use.
Ħawwad il- flixkun għal 20 sekonda qabel ma tużah l- ewwel darba.
Shake the bottle for 5 seconds before subsequent uses.
Ħawwad il- flixkun għal 5 sekondi qabel ma tużah drabi oħra.
A dosing syringe with a 10 ml graduation is supplied with the pack so you can measure your dose accurately.
Siringa għad- dożaġġ bi gradwazzjoni ta ’ 10ml tiġi mal- pakkett għalhekk tista ’ tkejjel id- doża tiegħek eżattament.
Adults Adults should take the Telzir oral suspensions without food and on an empty stomach.
Kemm għandek tieħu Adulti L- adulti għandhom jieħdu s- sospensjoni orali ta ’ Telzir mingħajr ikel u fuq stonku vojt.
The recommended dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir (as capsule or oral solution) twice daily.
Id- doża rakkomandata hi ta ’ 14ml ta ’ suspensjoni orali ta ’ Telzir (700mg fosamprenavir) darbtejn kuljum ma ’ 100 mg ritonavir (bħala kapsula jew soluzzjoni orali) darbtejn kuljum.
Children from 6 years of age and weighing at least 25 kg Children should take the Telzir oral suspension with food.
Tfal mill- eta 'ta' 6 u li jiżnu almenu 25kg It- tfal għandhom jieħdu s- sospensjoni orali ta ’ Telzir ma ’ l- ikel.
Your doctor will work out the right dose based on your weight.
It- tabib tiegħek jikkalkula id- doża adatta skond il- piż tiegħek.
The recommended dose is 0.36 ml/ kg of Telzir oral suspension (18 mg per kg fosamprenavir) twice daily with 3 mg/ kg ritonavir oral solution twice daily.
Id- doża rakkomandata tas- sospensjoni orali ta ’ Telzir hija ta ’ 0. 36ml / kg piż tal- ġisem (18mg/ kg fosamprenavir) darbtejn kuljum bi 3mg għal kull kg ta ’ piż tal- ġisem għas- soluzzjoni orali ta ’ ritonavir darbtejn kuljum.
No dosing recommendations can be made for children weighing less than 25 kg.
Ma hemm l- ebda rakkomandazzjonijiet ta’ doża għal tfal li jiżnu anqas minn 25kg.
Children can take the adult dose of ritonavir capsules (100 mg twice daily) if they weigh at least 33 kg and can swallow the capsules whole.
It- tfal jistgħu jieħdu id- doża adulta ta ’ ritonavir (100mg darbtejn kuljum) jekk jiżnu almenu 33kg u jistgħu jibilgħu il- kapsuli sħaħ.
As an alternative to taking Telzir oral suspension:
Bħala alternattiva għat- teħid tas- sospensjoni orali ta 'Telzir:
Children can take the adult dose of one 700 mg Telzir tablet twice daily (with ritonavir 100 mg twice daily) if they weigh at least 39 kg and can swallow the tablets whole.
It- tfal jistgħu jieħdu id- doża ta ’ l- adulti ta ’ pillola waħda ta ’ 700mg ta ’ Telzir darbtejn kulum (ma ’ ritonavir 100mg darbtejn kuljum) jekk ikunu jiżnu 39kg u jkunu jistgħu jibilgħu il- pilloli sħaħ.
Children less than 6 years of age Telzir is not recommended for children less than 6 years old.
Tfal ta ’ anqas minn 6 snin Telzir mhuwiex rakkomandat għal tfal ta ’ anqas minn 6 snin.
Adults with liver disease If you have mild liver disease, the dose is 14 ml Telzir oral suspension (700 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
Adulti b’ mard tal- fwied Jekk tbati minn mard mhux serju tal- fwied, id- doża hija ta ’ 14ml ta ’ sospensjoni orali ta ’ Telzir (700mg fosamprenavir) darbtejn kuljum b’ 100mg ritonavir darba kuljum biss.
If you have moderate liver disease the dose is 9 ml Telzir oral suspension (450 mg fosamprenavir) twice daily with 100 mg ritonavir only once 72 daily.
Jekk tbati minn mard moderat tal- fwied id- doża rakkomandata ta ’ 9ml ta ’ suspensjoni orali ta ’ Telzir (450mg ta ’ fosamprenavir) darbtejn kuljum ma ’ 100mg ta ’ ritonavir darba kuljum biss.
If you have severe liver disease the dose is 6 ml Telzir oral suspension (300 mg fosamprenavir) twice daily with 100 mg ritonavir only once daily.
Jekk tbati minn mard sever tal- fwied id- doża hija ta ’ 6ml sospensjoni orali ta ’ Telzir (300mg fosamprenavir) darbtejn kuljum ma ’ 100mg ritonavir darba kuljum biss.
Step by step instructions Do not mix Telzir with any other medicines in the bottle or the syringe.
Tħallatx Telzir ma ’ mediċini oħra fil- flixkun jew fis- siringa.
Shake the bottle vigorously before use.
Ħawwad il- flixkun tajjeb qabel l- użu.
3.
Neħħi t- tapp tal- flixkun u żommu fi żgur 3.
Push the plastic adapter into the neck of the bottle, while holding the bottle firmly.
Imbotta l- adapter tal- plastik fl- għonq tal- flixkun, filwaqt li żżomm il- flixkun sew.
Insert the syringe firmly into the adapter.
Daħħal is- siringa sewwa fl- adapter.
Turn the bottle upside down.
Dawwar il- flixkun rasu l- isfel.
Pull out the syringe plunger until the first portion of your full dose is withdrawn.
Oħrog il- planġer tas- siringa sakemm tiġbed l- ewwel porzjon tad- doża kollha tiegħek.
8.
Dawwar il- flixkun il- fuq u neħħi s- siringa mill- adapter 8.
Put the syringe into your mouth, placing the tip of the syringe against the inside of your cheek.
Poġġi s- siringa f’ ħalqek, filwaqt li tagħmel it- tarf tas- siringa man- naħa ta ’ ġewwa tal- warda ta ’ wiċċek.
Slowly push the plunger in, allowing time to swallow.
Imbotta l- planġer il- ġewwa bilmod, filwaqt li tħalli ħin biex tibla ’.
Don’ t push too hard and squirt the liquid into the back of the throat or you may choke.
Timbuttax ħafna li ttajjar il- likwidu fuq in- naħa ta ’ wara ta ’ griżmejk għax inkella tista ’ tixraq.
Repeat steps 4 to 8 in the same way until you have taken the whole dose.
Irrepeti l- istruzzjonijiet minn 4 sa 8 bl- istess mod sakemm tkun ħadt id- doża kollha.
Do not leave the syringe in the bottle.
Tħallix is- siringa fil- flixkun.
Take the syringe and the adapter off and wash them thoroughly in clean water.
Neħħi s- siringa u l- adapter u aħsilhom sew f’ ilma nadif.
Let them dry completely before you use them again.
Ħallihom jinxfu sew qabel terġa ’ tuzahom.
Close the bottle tightly with the cap.
Agħlaq il- flixkun sew bit- tapp.