qanastek/EMEA-V3 huggingface dataset:
Because APTIVUS is specifically used for the treatment of HIV which is resistant to most other antiretrovirals, your doctor will take blood samples before starting treatment to test that the HIV in your blood is resistant and that APTIVUS treatment is appropriate.
Minħabba li APTIVUS jintuża speċifikament għat- tratatment ta 'HIV li hu reżistenti għal biċċa l- kbira ta' antiretrovirali oħrajn, it- tabib tiegħek ser jieħu diversi kampjuni tad- demm qabel ma jibda t- trattament sabiex jiċċekkja jekk l- HIV fid- demm tiegħek hux reżistenti u li t- trattament b' APTIVUS huwa adattat.
APTIVUS treatment should not be used if you have never received antiretroviral therapy (treatment-naïve).
It- trattament b’ APTIVUS m’ għandux jintuża jekk inti qatt ma rċevejt terapija antiretrovirali (inkonsapevoli tat- tratatment).
BEFORE YOU TAKE APTIVUS
QABEL MA TIEĦU APTIVUS
Aptivus is to be taken in combination with low dose ritonavir and other antiretroviral medicines.
Aptivus għandu jittieħed flimkien ma 'doża baxxa ta' ritonavir u mediċini antiretrovirali oħrajn.
It is therefore important that you carefully read the Package Leaflet that is provided with these medicines.
Għalhekk huwa importanti ħafna li taqra sew l- istruzzjonijiet fil- Fuljett tat- Tagħrif li jiġi mogħti 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 mediċini oħra preskritti, staqsi lit- tabib jew lill- ispiżjar tiegħek.
Do not take APTIVUS
Tieħux APTIVUS:
- if you are allergic (hypersensitive) to tipranavir or any of the other ingredients of APTIVUS
- jekk inti allerġiku (għandek sensittività eċċessiva) għal tipranavir jew sustanzi oħra ta ’
- if you are currently taking rifampicin (used to treat tuberculosis) as this may stop APTIVUS
- jekk int attwalment qed tieħu rifampicin (użat sabiex jikkura t- tuberkolosi) billi dan jista ’
from working properly
jimpedixxi l- APTIVUS milli jiffunzjona kif suppost
- if you have moderate to severe liver problems.
- jekk int għandek problemi moderati sa serji tal- fwied.
In addition your doctor, based upon blood tests
Barra minn hekk it- tabib tiegħek, skond
used to monitor your liver function, may decide to delay the start, or to stop APTIVUS therapy
ir- riżultati tat- testijiet tad- demm użati biex jimmonitorjaw il- fwied, jista ’ jiddeċiedi li jdewwem il- bidu, jew li jwaqqaf it- terapija b' APTIVUS
- if you are currently taking products containing cisapride (used to treat stomach problems),
- jekk int attwalment qed tieħu prodotti li fihom cisapride (użat biex jikkura problemi ta ’
pimozide or sertindole (used to treat schizophrenia), triazolam or oral (taken by mouth) midazolam (used to treat anxiety or sleep disorders), ergot derivatives (used to treat headaches), astemizole or terfenadine (used to treat allergies or hay fever), the statins simvastatin or lovastatin (used to lower blood cholesterol) or amioradone, bepridil, flecainide, propafenone or quinidine (used to treat heart disorders), and metoprolol (used to treat heart failure).
l- istonku), pimozide jew sertindole (użat biex jikkura l- iskożofrenja), triazolam jew midazolam orali (meħud mill- ħalq) (użat biex jikkura l- ansjetà jew disturbi ta ’ l- irqad), derivati ta ’ ergot (użati biex jikkuraw l- uġigħ ta ’ ras), astemizole jew terfenadine (użati għat- trattament ta ’ l- allerġiji jew hay fever), l- istatins simvastatin jew lovastatin (użati biex ibaxxu l- kolesterol fid- demm) jew amioradone, bepridil, flecainide, propafenone jew quinidine (użati għat- trattament ta’ disturbi tal- qalb), u metoprolol (użat biex jittratta falliment kardijaku).
- Patients taking APTIVUS must not take products containing St John’ s wort (Hypericum
- Il- pazjenti li qegħdin fuq APTIVUS m’ għandhomx jieħdu prodotti li fihom St John’ s wort
perforatum) as this may stop APTIVUS from working properly.
(Hypericum perforatum) billi dan jista ’ jimpedixxi lil APTIVUS milli jiffunzjona kif suppost.
Take special care with APTIVUS
Oqgħod attent ħafna b' APTIVUS
These
- APTIVUS jista ’ jirreaġixxi ma ’ mediċini oħrajn, li jista ’ jwassal biex ikun hemm effetti
include erectile dysfunction agents (eg sildenafil, vardenafil, tadalafil), agents to treat alcohol dependence (disulfiram), anti-asthma agents (fluticasone), lipid lowering agents (atorvastatin) and agents to treat infections (metronidazole).
Dawn jinkludi mediċini ta ’ disfunzjoni erettili (eż. sildenafil, vardenafil, tadalafil), mediċini wżati biex jikkuraw id- dipendenza fuq l- alkoħol (disulfiram), mediċini ta ’ kontra l- ażma (fluticasone), mediċini li jnaqqsu x- xaħam (atorvastatin) u mediċini użati biex jikkuraw l- infezzjonijiet (metronidazole).
You must tell your doctor about all medicines which you are taking, or planning to take, including those medicines you can buy without a prescription.
Għandek tgħarraf lit- tabib tiegħek dwar il- mediċini kollha li qed tieħu, jew qed tippjana li tieħu, inkluż dawk il- mediċini li tista ’ tixtri mingħajr riċetta tat- tabib.
- APTIVUS may also interact with other types of medicines, which may lead to a loss of
- APTIVUS jista ’ jirreaġixxi ma tipi ta ’ mediċini oħrajn, li jista ’ jwassal biex l- effettività ta ’
effectiveness of these medicines.
dawn il- mediċini, tonqos.
These include the morphine-substitute methadone and oral contraceptives.
Dawn jinkludu il- mediċina li tiġi użata biex tissostitwixxi l- morfina, il- methadone, u xi kontraċettivi orali.
If you are using oral contraceptives to prevent pregnancy you should use an additional or different type of contraception.
Jekk inti qed tuża l- kontraċettivi orali sabiex tevita tqala, għandek tuża metodi ta 'kontraċezzjoni addizzjonali jew ta ’ tip differenti.
- if you have liver disease or hepatitis.
- jekk għandek il- mard tal- fwied jew l- epatite.
Patients with higher liver function tests and patients with
Pazjenti li t- testijiet tagħhom ta ’ kif qed jaħdem
hepatitis B or C infection are at increased risk for severe and potentially fatal liver damage while taking antiretroviral therapy in general, including APTIVUS.
il- fwied huma ogħla aktar milli suppost u pazjenti li għandhom l- epatite B jew Ċ, b’ mod ġenerali, jinsabu f’ riskju akbar li jiġrilhom ħsara serja u li anke tista 'tkun fatali bit- teħid ta ’ terapija antiretrovirali b' mod ġenerali inkluż b' APTIVUS.
Your doctor will monitor the function of your liver by blood tests before and during APTIVUS treatment.
It- tabib tiegħek għandu josserva l- funzjoni tal- fwied tiegħek permezz ta ’ testijiet tad- demm, qabel u waqt il- kura b’ APTIVUS.
If you have liver disease or hepatitis your doctor will decide if you need additional testing.
Jekk għandek il- mard tal- fwied jew l- epatite, it- tabib tiegħek se jiddeċiedi jekk għandekx bżonn ta ’ aktar testijiet.
If you notice the signs or symptoms of hepatitis (fever, malaise, nausea, vomiting, abdominal pain, fatigue, jaundice) you should inform your doctor as soon as possible.
Jekk tinduna b' xi sinjali jew sintomi ta 'epatite (deni, tħossok ma tiflaħx, nawsea, remettar, uġigħ addominali, għejja, suffejra) għandek tinforma lit- tabib tiegħek minnufih.
- if you have type A or B haemophilia
- jekk għandek emofelija tat- tip A jew B
- if you have diabetes
- jekk għandek id- dijabete
- mild to moderate rash, including flat or raised rashes or sensitivity to the sun, have been
- raxx ħafif sa moderat, li jinkludi raxx ċatt jew elevat jew sensitività għax- xemx ġew rapportati
reported in approximately 10% of subjects receiving APTIVUS.
f' madwar 10% ta 'suġġetti li jirċievu APTIVUS.
Some patients who developed rash also had joint pain or stiffness, throat tightness, or generalized itching.
Xi pazjenti li żviluppaw raxx kellhom ukoll uġigħ fil- ġogi jew ebusija, griżmejn issikkati, jew ħakk ġeneralizzat.
- always take APTIVUS together with ritonavir, as failure to take ritonavir will prevent
- Dejjem għandek tieħu APTIVUS flimkien ma 'ritonavir, billi jekk ma tagħmilx hekk APTIVUS
APTIVUS from working properly.
ma jkunx jista 'jaħdem tajjeb.
APTIVUS is not a cure for HIV infection and you should know that you may continue to develop infections and other illnesses associated with HIV disease.
APTIVUS mhuwiex kura għal infezzjoni b' HIV u għandek tkun taf li tista 'tibqa' tiżviluppa infezzjonijiet u mard ieħor assoċjat mal- mard ta 'l- HIV.
You should therefore remain in regular contact with your doctor.
Għalhekk int għandek tibqa 'f' kuntatt regolari mat- tabib tiegħek.
In addition, APTIVUS does not prevent the risk of transmission of HIV to others through blood or sexual contact.
Barra minn hekk, APTIVUS ma jimpedixxiex ir- riskju li HIV jgħaddi lil oħrajn permezz ta 'kuntatt bid- demm jew kuntatt sesswali.
You should therefore continue to use appropriate precautions to prevent this.
Għalhekk għandek tibqa 'tieħu prekawzjonijiet xierqa sabiex tevita dan.
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
F' pazjenti li qed jirċievu terapija antiretrovirali kombinata jista 'jkun hemm ridistribuzzjoni, akkumulazzjoni jew telf ta' xaħam tal- ġisem.
Contact your doctor if you notice changes in body fat.
Ikkuntattja lit- tabib tiegħek jekk tinduna b' xi bidliet fix- xaħam korporali.
Your doctor may decide to monitor the levels of blood lipids (fats) both before and during APTIVUS treatment.
It- tabib tiegħek għandu mnejn jiddeċiedi li jimmonitorja l- livelli ta 'lipidi fid- demm (xaħam) kemm qabel u waqt it- trattament b' APTIVUS.
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection, signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
F' xi pazjenti li għandhom infezzjoni ta 'HIV avvanzata (AIDS) u bi storja ta' infezzjonijiet opportunistiċi, sinjali u sintomi ta 'infjammazzjoni minn infezzjonijiet preċedenti jistgħu jseħħu wara li jkun beda t- trattament ta ’ kontra l- HIV.
It is believed that these symptoms are due to an improvement in the body’ s immune response, enabling the body to fight infections that may have been present with no obvious symptoms.
Huwa maħsub li dawn is- sintomi huma dovuti għal titjib fir- rispons immunitarju tal- ġisem, li jippermetti l- ġisem jiġġieled infezzjonijiet li setgħu kienu preżenti
If you notice any symptoms of infection, please inform your doctor immediately.
Jekk tinduna b' xi sintomi ta 'infezzjoni, jekk jogħġbok informa lit- tabib tiegħek minnufih.
Bone problems:
Problemi ta 'l- 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 qed jieħdu t- terapija antiretrovirali kombinata jistgħu jiżviluppaw marda ta 'l- għadam li tissejjaħ osteonekrosi (mewt tat- tessut ta' l- għadam minħabba li l- għadam ma jkunx fornut bid- demm).
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 'corticosteroids, il- konsum ta' alkoħol, immunosoppressjoni qawwija u indiċi korporali ogħla, fost oħrajn, jistgħu jkunu ftit mill- ħafna fatturi ta 'riskju għall- iżvilupp tal- marda.
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
Sinjali ta 'osteonekrosi huma ebusija tal- ġog, uġigħ (speċjalment il- ġenbejn, l- irkoppa u l- ispalla) u diffikultà fil- moviment.
If you notice any of these symptoms please inform your doctor.
Jekk tinduna b' xi sintomi minn dawn għarraf lit- tabib tiegħek.
APTIVUS should not be used by patients under 18 years of age.
APTIVUS m' għandux jintuża minn pazjenti li huma taħt it- 18- il sena.
36 Taking other medicines Before starting treatment with APTIVUS, please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Meta tieħu mediċini oħra Qabel tibda t- trattament tiegħek b’ APTIVUS, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
This is very important, as taking some types of medicines at the same time with APTIVUS and ritonavir can strengthen or weaken the effect of the medicines.
Dan importanti ħafna, peress li t- teħid ta ’ ċertu tip ta ’ mediċini fl- istess ħin tat- teħid ta ’ APTIVUS u ritonavir jista ’ jqawwi jew idgħajjef l- effett tal- mediċini.
This can sometimes lead to serious medical conditions.
Dan xi kultant jista ’ jwassal għal kundizzjonijiet serji fuq is - saħħa.
APTIVUS, taken together with ritonavir, may interact with other medicines.
APTIVUS, meħud flimkien ma 'ritonavir, jista' jirreaġixxi ma 'mediċini oħra.
Your doctor may have to increase or decrease the dose of other medicines which you take together with APTIVUS.
It- tabib tiegħek jista 'jżid jew inaqqas id- doża tal- mediċini l- oħra li int tieħu flimkien ma' APTIVUS.
Examples include the cholesterol-reducing agent atorvastatin, the antibiotics rifabutin and clarithromycin, the asthma treatment theophylline, the antidepressants desipramine, trazodone and bupropion (also used for smoking cessation), the anticonvulsants carbamazepine, phenobarbital and phenytoin, the proton pump inhibitors omeprazole and esomeprazole and sedative agents (e. g. midazolam administered by injection).
Eżempji jinkludu l- mediċina li tnaqqas l- ammont ta 'kolesterol, atorvastatin, l- antibijotiċi rifabutin u clarithromycin, it- trattament għall- ażma theophylline, l- mediċini li jaħdmu kontra d- dipressjoni desipramine, trazodone u bupropion (li jintuża wkoll sabiex jitwaqqaf it- tipjip), l- antikonvulsanti carbamazepine, phenobarbital u phenytoin, l- impedituri tal- proton pump omeprazole u esomeprazole u aġenti sedattivi (eż. midazolam mogħti b’ injezzjoni).
In addition, medicines containing rifampicin (antibiotic) and St.
Barra minn hekk, mediċini li fihom rifampicin (antibijotiku) u St.
John’ s wort are likely to prevent APTIVUS from working properly and should not be taken together with APTIVUS (see 2.
John’ s wort x' aktarx jimpedixxu lil APTIVUS milli jaħdem sew u m' għandhomx jittieħdu flimkien ma 'APTIVUS (ara 2.
BEFORE YOU TAKE APTIVUS).
QABEL MA TIEĦU APTIVUS).
Tell your doctor if you receive medication such as antiplatelet agents and anticoagulants, or if you are taking vitamin E.
Għarraf lit- tabib tiegħek jekk qed tieħu xi mediċini bħal sustanzi kontra l- plejtlets u kontra t- tgħaqqid tad- demm, jew jekk qed tieħu vitamina E.
Your doctor may wish to consider certain precautionary measures in such circumstances.
It- tabib tiegħek għandu mnejn ikun irid jikkonsidra jieħu xi miżuri prekawzjonarji f’ ċirkostanzi bħal dawn.
If you are taking didanosine enteric coated tablets, it should be separated by at least two hours from APTIVUS.
Jekk qed tieħu pilloli didanosine b' kisja enterika, dawn għandhom jittieħdu f’ mill- anqas sagħtejn differenza mat- teħid ta ’ APTIVUS.
Your doctor will only prescribe you abacavir and zidovudine if you are unable to take other nucleoside reverse transcriptase inhibitors.
It- tabib tiegħek jippreskrivilek abacavir u zidovudine biss jekk inti ma tistax tieħu impedituri oħra ta 'nucleoside reverse transcriptase.
Otherwise, APTIVUS, taken together with ritonavir, can be taken together with the HIV reverse transcriptase inhibitors stavudine, lamivudine, or tenofovir.
Inkella, APTIVUS, meħud flimkien ma 'ritonavir, jista' jittieħed flimkien ma 'l- impedituri ta ’ HIV reverse transcriptase, stavudine, lamivudine, jew tenofovir.
APTIVUS, taken together with ritonavir, strongly decreases the blood levels of the HIV protease inhibitors amprenavir, atazanavir, lopinavir and saquinavir.
APTIVUS, li jittieħed flimkien ma 'ritonavir, inaqqas b' mod qawwi l- livelli tad- demm ta ’ l- impedituri ta ’ l- enżimi protease ta' l- HIV amprenavir, atazanavir, lopinavir u saquinavir.
The blood levels of tipranavir and ritonavir are markedly increased when APTIVUS, taken together with ritonavir, is associated with atazanavir.
Il- livelli ta 'tipranavir u ritonavir fid- demm huma notevolment miżjuda meta APTIVUS, li jittieħed flimkien ma' ritonavir, huwa assoċjat ma 'atazanavir.
Your doctor will carefully consider whether to treat you with combinations of APTIVUS and these protease inhibitors.
It- tabib tiegħek ser jikkonsidra b' kawtela jekk għandux jittrattak b' kombinazzjonijiet ta 'APTIVUS u dawn l- impedituri ta ’ l- enżimi protease.
APTIVUS, taken together with ritonavir, can affect oral contraceptives and therefore you should employ an alternative contraceptive method such as barrier contraception (eg condoms) if you are taking APTIVUS.
APTIVUS, meħud flimkien ma 'ritonavir, jista' jaffettwa l- kontraċettivi orali u għalhekk għandek tuża metodi alternattivi ta 'kontraċezzjoni bħal kontraċezzjoni ta' barriera (eż. kondoms) jekk qed tieħu APTIVUS.
Generally, it is not recommended to take APTIVUS, with ritonavir, together with oral contraceptives or hormone replacement therapy (HRT).
Ġeneralment, mhux rakkomandat li APTIVUS, flimkien ma 'ritonavir, jittieħed ma' kontraċettivi orali jew terapija ta 'sostituzzjoni ormonali (HRT).
You should check with your doctor if you do wish to continue taking oral contraceptives or HRT.
Għandek tiċċekkja mat- tabib tiegħek jekk għandekx tibqa 'tieħu kontraċettivi orali jew HRT.
If you use oral contraceptives or HRT you have an increased chance of developing a skin rash while taking APTIVUS.
Jekk qed tuża kontraċettivi orali jew HRT għandek aktar ċans li tiżviluppa raxx tal- ġilda meta qed tieħu APTIVUS.
If a rash occurs, it is usually mild to moderate, but you should talk to your doctor as you may need to temporarily stop taking either APTIVUS or the other medicine that contains oestrogen or female hormones.
38 jkollok tieqaf b' mod temporanju milli tieħu jew l- APTIVUS jew xi mediċina oħra li fiha oestrogen jew ormoni feminili.
Taking APTIVUS with food and drink APTIVUS should be taken with food.
Meta tieħu APTIVUS ma ’ l- ikel u max- xorb APTIVUS għandu jittieħed ma ’ l- ikel.
Pregnancy Tell your doctor if you are pregnant or planning to become pregnant.
Tqala Għid lit- tabib tiegħek jekk inti tqila jew qed tippjana li tinqabad tqila.
If you are pregnant APTIVUS should only be taken after careful discussion with your doctor.
Jekk inti tqila APTIVUS għandu jittieħed biss wara diskussjoni kawta mat- tabib tiegħek.
The safe use of APTIVUS in pregnancy has not been established.
L- użu sikur ta 'APTIVUS fit- tqala għadu ma ġiex stabbilit.
APTIVUS contains very small amounts of alcohol (see Important information about some of the ingredients of APTIVUS).
APTIVUS fih ammonti żgħar ħafna ta 'alkoħol (ara Tagħrif importanti dwar xi sustanzi ta' APTIVUS).
Tell your doctor immediately if you become pregnant.
Għid lit- tabib tiegħek minnufih jekk tinqabad tqila.
37 Ask your doctor or pharmacist for advice before taking any medicine.
Itlob għall- parir tat- tabib jew ta ’ l- ispiżjar tiegħek qabel tieħu xi mediċina.
APTIVUS can affect oral contraceptives (see 2.
APTIVUS jista 'jaffettwa l- kontraċettivi orali (ara 2.
Taking other medicines).
Konsum ta 'mediċini oħra).
Therefore, you should employ an alternative, effective and safe contraceptive method if you are taking APTIVUS.
Għalhekk, għandek tuża kontraċettiv alternattiv ieħor li hu effettiv u sikur jekk qed tieħu APTIVUS.
Breast-feeding Make sure you tell your doctor if you are breast-feeding.
Treddigħ Jekk jogħġbok għarraf lit- tabib tiegħek jekk inti qed tredda '.
It is anyway recommended that HIV-infected women must not breast-feed babies because it is possible that the baby can become HIV-infected through the breast milk.
Madankollu, huwa rakkomandat li nisa infettati bl- HIV m' għandhomx ireddgħu lit- trabi minħabba li hu possibbli li t- tarbija tista 'tiġi infettata bl- HIV bil- ħalib tas- sider.
Driving and using machines APTIVUS has not been tested for its effect on your ability to drive a car or operate machinery.
Sewqan u tħaddim ta 'magni APTIVUS għadu ma ġiex ittestajat għall- effett tiegħu fuq min isuq jew iħaddem il- magni.
Important information about some of the ingredients of APTIVUS APTIVUS contains 7% ethanol (alcohol), i. e. up to 400 mg per daily dose, equivalent to 8 ml of beer, or less than 4 ml of wine.
Tagħrif importanti dwar xi wħud mis- sustanzi ta 'APTIVUS APTIVUS fih 7% ethanol (alkoħol), ie sa doża ta ’ 400 mg kuljum, ekwivalenti għal 84 ml ta' birra jew inqas minn 4 ml ta 'inbid.
Harmful for those suffering from alcoholism.
Jista ’ jkun ta ’ ħsara għal dawk li jbatu mill- alkoħoliżmu.
To be taken into account in pregnant or breast-feeding women, children and high-risk groups such as patients with liver disease, or epilepsy.
Dan għandu jitqies ukoll min- nisa tqal jew li jreddgħu, tfal u gruppi li jinsabu f’ riskju għoli bħal pazjenti bil- mard tal- fwied, jew epilessija.
APTIVUS also contains macrogolglycerol ricinoleate which may cause stomach upset and diarrhoea.
APTIVUS fih ukoll macrogolglycerol ricinoleate li jista 'jikkaġuna tqalligħ fl- istonku u dijarrea.
This medicine contains small amounts of sorbitol.
Din il- mediċina fiha ammonti żgħar ta 'sorbitol.
HOW TO TAKE APTIVUS
KIF GĦANDEK TIEĦU APTIVUS
Always take APTIVUS exactly as your doctor has told you.
Dejjem għandek tieħu APTIVUS skond il- parirtat- tabib.
It is essential that you take APTIVUS together with ritonavir.
Huwa essenzjali li tieħu APTIVUS flimkien ma 'ritonavir.
The usual dose is 500 mg (two 250 mg capsules) APTIVUS, together with 200 mg (two 100 mg capsules) ritonavir, twice per day with food.
Id- doża normali hi ta ’ 500 mg (żewġ kapsuli ta ’ 250 mg) APTIVUS, flimkien ma ’ 200 mg (żewġ kapsuli ta ’ 100 mg) ritonavir, darbtejn kuljum ma l- ikel.
The capsules should always be taken by mouth, and swallowed whole and not chewed.
Il- kapsuli għandhom dejjem jittieħdu mill - ħalq, u għandhom jinbelgħu sħaħ mingħajr ma tomgħodhom.
APTIVUS will also always be taken in combination with other antiretroviral medicines, for which you should follow the instructions within the supplied Package Leaflet.
APTIVUS għandu dejjem jittieħed flimkien ma ’ mediċini antiretrovirali oħra, li għalihom inti għandek issegwi l- istruzzjonijiet li jiġu mogħtija fil- Fuljett tat- Tagħrif.
You should continue to take APTIVUS for as long as instructed by your doctor.
39 Inti għandek tkompli tieħu APTIVUS skond l- istruzzjonijiet li jagħtik it- tabib tiegħek.
If you take more APTIVUS than you should Inform your doctor as soon as possible if you take more than the prescribed dose of tipranavir.
Jekk tieħu APTIVUS aktar milli suppost Għarraf lit- tabib tiegħek kemm jista ’ ikun malajr jekk int ħadt aktar mid- doża preskritta ta ’ tipranavir.
If you forget to take APTIVUS Take the next dose of APTIVUS, together with ritonavir, as soon as possible.
Jekk tinsa tieħu APTIVUS Ħu d- doża ta ’ APTIVUS, flimkien ma ’ ritonavir, kemm jista ’ jkun malajr.
If you stop taking APTIVUS It has been shown that taking all doses at the appropriate times may greatly increase the effectiveness of your combination antiretroviral medicines and reduce the chances of development of antiretroviral resistance.
Jekk tieqaf tieħu APTIVUS Intwera li meta jittieħdu d- dożi kollha u fil- ħinijiet kif suppost jista ’ ikun hemm titjib fl- effettività tal- mediċina kkombinata antiretrovirali u titnaqqas il- possibbiltà li tiżviluppa reżistenza antiretrovirali.
Therefore, unless your doctor instructs you to stop treatment, it is important to keep taking APTIVUS correctly, as described above.
Għalhekk, sakemm it- tabib tiegħek jgħidlek biex ma twaqqafx il- kura, huwa importanti li tibqa ’ tieħu APTIVUS b’ mod korrett, kif deskritt hawn fuq.
Like all medicines, APTIVUS can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, APTIVUS jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
It may be difficult to tell between side effects caused by APTIVUS, by the other medicines you are also taking, or by the complications of HIV infection.
Jista ’ ikun diffiċli li wieħed jagħraf jekk l- effetti mhux mixtieqa humiex ikkawżati minn APTIVUS, jew minn xi mediċina oħra li qed tieħu, jew minħabba kumplikazzjonijiet ta ’ l- infezzjoni ta ’ l- HIV.
For this reason it is very important that you tell your doctor about any changes in your health.
Għal din ir- raġuni huwa importanti li tgħarraf lit- tabib tiegħek dwar bidliet fis- saħħa tiegħek li tinduna bihom.
Very common side effects (which can occur in more than one in 10 patients treated) are diarrhoea and nausea.
Effetti mhux mixtieqa komuni ħafna (li jseħħu f' aktar minn 1 minn kull 10 pazjenti trattati) huma dijarrea u nawsea.
Common side effects (which can occur in less than one in ten but in more than one in a hundred patients treated) are vomiting, abdominal pain, flatulence, tiredness, headache and rash.
Effetti mhux mixtieqa komuni (li jistgħu jseħħu f' inqas minn wieħed minn kull għaxra imma aktar minn wieħed minn kull mitt pazjent trattat) huma remettar, uġigħ addominali, gass, għejja, uġigħ ta 'ras u raxx.
The most commonly reported changes in blood chemistry are increases in blood lipid (fat) levels (very common) and increases in liver enzyme activity (common).
L- aktar bidliet komuni rapportati fil- kimika tad- demm huma żidiet fil- livelli tal- lipidi tad- demm (xaħam) (komuni ħafna) u żidiet fl- attività enżimatika tal- fwied (komuni).
Uncommon side effects (which can occur in less than one in a hundred but more than one in a thousand patients treated) are reduction in red and white blood cells, reduction in blood platelets, allergic reactions, decreased appetite, diabetes, increased blood levels of the pancreas enzymes amylase and lipase, increased cholesterol blood levels, sleeplessness and other sleep disorders (including sleepiness), dizziness, numbness and/ or tingling and/ or pain in the feet or hands, breathing difficulties, heartburn, inflammation of the pancreas, skin inflammation, loss or gain of body fat and other changes in fat distribution (see below), muscle cramp, muscle pain, kidney malfunction, flu like symptoms, general feelings of illness, fever and weight loss.
Effetti mhux mixtieqa mhux komuni (li jistgħu jseħħu f' inqas minn wieħed minn kull mija imma aktar minn f' pazjent wieħed minn kull elf trattati) huma tnaqqis fl- għadd sħiħ ta 'ċelluli ħomor u bojod, tnaqqis fl- għadd ta' plejtlets, reazzjonijiet allerġiċi, tnaqqis fl- aptit, dijabete, livelli ogħla fid- demm ta ’ l- enżimi amylase u lipase li jinsabu fil- frixa, livelli ogħla ta 'kolesterol fid- demm, nuqqas ta' irqad u disturbi ta 'l- irqad (li jinkludu ngħas), sturdamenti, tnemnin u/ jew tinġiż u/ jew uġigħ fis- saqajn u fl- idejn, diffikultajiet biex tieħu n- nifs, ħruq ta ’ stonku, infjammazzjoni tal- frixa, infjammazzjoni tal- ġilda, telf jew żjieda fl- ammont ta' xaħam tal- ġisem u bidliet oħra fit- tqassim tax- xaħam (ara isfel), bugħawwieġ, uġigħ fil- muskolu, problemi fil- kliewi, sintomi bħal ta 'l- influwenza, tħossok ma tiflaħx, deni, telf ta' piż.
Rare side effects (which can occur in less than one in a thousand patients treated) are dehydration, thinning of the face and increased blood sugar.
Effetti mhux mixtieqa rari (li jistgħu jseħħu f' inqas minn pazjent wieħed minn kull elf trattati) huma diżidrazzjoni, irquqija tal- wiċċ u żjieda fil- livell ta 'zokkor fid- demm.
Abnormal liver function has been reported with the use of APTIVUS.
Funzjonament abnormali tal- fwied ġie rapportat bl- użu ta 'APTIVUS.
This has included uncommon reports of hepatitis and fatty liver (which can occur in less than one in a hundred patients treated) and rare reports of liver failure (which can occur in less than one in a thousand patients treated), including fatal outcome.
Dan kien jinkludi rapporti mhux komuni ta 'epatite u fwied mxaħħam (li jista' jseħħ f' inqas minn wieħed minn kull mitt pazjent trattat) u rapporti rari ta 'indeboliment epatiku (li jista' jseħħ f' inqas minn wieħed minn kull 'elf pazjent ittrattat), li jista' jinkludi anke mewt.
Furthermore, increased blood levels of bilirubin (a breakdown product of haemoglobin) have been reported.
Barra minn hekk, ġew irrapportati livelli ogħla ta 'bilirubina fid- demm (prodott ta' meta l- emaglobulina titkisser).
If you experience clinical symptoms suggesting an injury of the liver, such as loss of appetite, nausea, vomiting and/ or jaundice, you should inform your doctor.
Jekk tħoss xi sintomi kliniċi li jistgħu jissuġerixxu ħsara fil- fwied, bħal telf fl- aptit, nawsea, remettar u/ jew suffejra, għandek tinforma lit- tabib tiegħek.
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
40 It- terapija kombinata antiretrovirali tista ’ tikkaġuna bidliet fis- sura tal- ġisem minħabba bidliet li jseħħu fit- tqassim tax- xaħam.
These may include loss of fat from legs, arms and face, increased fat in the abdomen (belly) and other internal organs, breast enlargement and fatty lumps on the back of the neck (‘ buffalo hump’).
Dawn jistgħu jinkludu telf ta ’ xaħam mir- riġlejn, mid- driegħ u mill- wiċċ u żjieda fl- addome (żaqq) u organi interni oħrajn, tkabbir tas- sider u boċċi tax- xaħam fuq in- naħa ta ’ wara ta ’ l- għonq (‘ ħotob il- buflu ’).
The cause and long-term health effects of these conditions are not known at this time.
Il- kawża u l- effetti fit- tul ta ’ dawn il- kundizzjonijiet m’ humiex magħrufa s’ issa.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipidaemia (increased fats in the blood) and resistance to insulin.
It- terapija kombinata antiretrovirali tista ’ ukoll tgħolli l- aċidu lattiku u z- zokkor fid- demm, tikkaġuna iperlipidemija (żjieda tax- xaħam fid- demm) u toħloq reżistenza għall- insulina.
In patients with haemophilia type A and B, there have been reports of increased bleeding while taking this treatment or another protease inhibitor.
F’ pazjenti b’ emofilja ta ’ tip A u B, kien hemm rapporti ta ’ żjieda fil- fsada waqt it- teħid ta ’ dan it- trattament jew waqt it- teħid ta ’ impeditur ta ’ protease ieħor.
Should this happen to you, seek immediate advice from your doctor.
Jekk dan iseħħ lilek, fittex minnufih lit- tabib għal parir.
Bleeding in the brain, which can lead to permanent disability or death, has occurred in some patients treated with APTIVUS in clinical trials.
Fsada fil- moħħ, li tista 'twassal għal diżabilità permanenti jew il- mewt ġrat f' xi pazjenti trattati b' APTIVUS fil- provi kliniċi.
A majority of the patients experiencing intracranial haemorrhage (ICH) in the APTIVUS clinical development programme had other medical conditions or were receiving concomitant medicine that may have caused or contributed to these events.
Maġġoranza ta 'pazjenti li kellhom emorraġija intrakranjali (ICH) fil- programm ta' żvilupp kliniku b' APTIVUS kellhom kundizzjonijiet mediċi oħra jew kienu qed jirċievu mediċini oħra fl- istess ħin li setgħu kkaġunaw jew taw kontribut għal dawn il- każijiet.
There have been reports of muscle pain, tenderness or weakness, particularly in combination antiretroviral therapy including protease inhibitors and nucleoside analogues.
Kien hemm rapporti ta ’ uġigħ fil- muskoli, sensittività għolja jew indeboliment, b’ mod partikolari f’ terapija kombinata antiretrovirali li tinkludi impedituri tal- protease u analogi ta ’ nukleosidi.
On rare occasions these muscle disorders have been serious (rhabdomyolysis).
F’ każijiet rari dawn id- disturbi muskolari kienu serji (rabdomajlosi).
HOW TO STORE APTIVUS
KIF TAĦŻEN APTIVUS
Do not use APTIVUS after the expiry date which is stated on the bottle after EXP.
Tużax APTIVUS wara d- data ta 'skadenza li tidher fuq il- flixkun wara JIS.
Store in a refrigerator (2°C to 8°C).
Aħżen fi friġġ (f’ temperatura ta ’ bejn 2°C sa 8°C).
Once the bottle is opened the contents must be used within 60 days (stored below 25°C).
La darba l- flixkun ikun infetaħ, il- kontenut irid jittieħed fi żmien 60 jum (żomm f' temperatura taħt 25°C).
You should write the date of opening the bottle on the label and/ or outer carton.
Inti għandek tikteb id- data ta ’ meta ftaħt il- flixkun fuq it- tikketta u / jew fuq il- kartuna ta ’ barra.
Ask you pharmacist how to dispose of medicines no longer required.
Staqsi lill - ispiżjar dwar kif għandek tarmi mediċini li m’ għandekz bżonn.
What APTIVUS contains
X’ fih APTIVUS
- The active substance is tipranavir.
- Is- sustanza attiva hi tipranavir.
Each capsule contains 250 mg tipranavir.
Kull kapsula ratba fiha 250 mg ta 'tipranavir.
- The other ingredients are macrogolglycerol ricinoleate, ethanol (alcohol), mono/ diglycerides of
- Is- sustanzi l- oħra huma macrogolglycerol ricinoleate, ethanol (alkoħol), mono/ diglycerides ta '
caprylic/ capric acid, propylene glycol, purified water, trometamol and propyl gallate.
caprylic/ capric acid, propylene glycol, ilma purifikat, trometamol u propyl gallate.
The capsule shell contains gelatin, red iron oxide, propylene glycol, purified water, ‘ sorbitol special- glycerin blend’ (d-sorbitol, 1,4 sorbitan, mannitol and glycerin) and titanium dioxide.
Il- qoxra tal- kapsula fiha ġelatina, red iron oxide, propylene glycol, ilma purifikat, ‘ sorbitol special - glycerin blend ’ (d- sorbitol, 1, 4 sorbitan, mannitol u glycerin) u titanium dioxide.
The black printing ink contains propylene glycol, black iron oxide, polyvinyl acetate phthalate, macrogol and ammonium hydroxide.
Il- linka ta ’ l- istampar sewda tikkonsisti minn propylene glycol, black iron oxide, polyvinyl acetate phthalate, macrogol u ammonium hydroxide.
What APTIVUS looks like and contents of the pack APTIVUS soft capsules are pink coloured, with a black print imprint of TPV 250.
Il- kapsuli rotob ta ’ APTIVUS huma ta ’ lewn roża u fuqha hemm stampat bl- iswed “ TPV 250 ”.
Each APTIVUS capsule contains 250 mg of the active substance tipranavir.
Kull kapsula APTIVUS fiha 250 mg tas- sustanza attiva tipranavir.
APTIVUS is supplied in bottles containing 120 capsules.
APTAVUS jiġi fi fliexken li fihom 120 kapsula.
Marketing Authorisation Holder and Manufacturer
41 Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
The Manufacturer is:
Il- Manifattur tal- Prodott hu:
KG Binger Strasse 173 D-55216 Ingelheim am Rhein Germany
Boehringer Ingelheim Pharma GmbH & Co. KG Binger Strasse 173 D- 55216 Ingelheim am Rhein Il- Ġermanja
40 For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
42 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 '{XX/ SSSS}
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 Ewropea dwar il- Mediċini (EMEA) http: // www. emea. europa. eu /.
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropea (EPAR). Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqin, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
What is Aranesp?
X’ inhu Aranesp?
Aranesp is a solution for injection in a vial, a pre-filled syringe or a pre-filled pen.
Aranesp huwa soluzzjoni għall- injezzjoni f’ kunjett, siringa mimlija għal- lest jew pinna mimlija għal - lest.
It contains the active substance darbepoetin alfa.
Huwa fih is- sustanza attiva darbepoetin alfa.
Aranesp exists in various strengths, from 10 to 500 micrograms per millilitre.
Aranesp jeżisti f’ diversi qawwiet, minn 10 sa 500 mikrogramma kull millilitru.
See the Package Leaflet for full details.
Ara l- Fuljett tal- Pakkett għad- dettalji sħaħ.
What is Aranesp used for?
Għal xiex jintuża Aranesp?
Aranesp is used to treat anaemia (fewer red blood cells in the blood than normal) in two groups of patients: • adults and children over one year of age with anaemia caused by long-term kidney failure, when the body does not produce enough of the natural hormone erythropoietin, • adult patients with certain types of cancer who are receiving chemotherapy (the medicines used to treat cancer), when the chemotherapy stops the bone marrow producing enough blood cells.
Aranesp jintuża biex jikkura anemija (inqas ċelloli tad- demm ħomor fid- demm min- normal) f’ żewġ gruppi ta ’ pazjenti: • Adulti u tfal ta ’ aktar minn sena b’ anemija ikkaġunata minn indeboliment tal- kliewi fuq tul ta ’ żmien, meta l- ġisem ma jipproduċix biżżejjed mill- ormon naturali erythropoietin. • Pazjenti adulti b’ ċerti tipi ta ’ kanċer li qed jirċievu kemoterapija (il- mediċini użati biex jikkuraw il- kanċer), meta l- kemoterapija twaqqaf lill- mudullun milli jipproduċi biżżejjed ċelloli tad- demm.
The types of cancer where Aranesp can be used are ‘ non-myeloid’ (do not affect the bone marrow).
It- tipi ta ’ kanċer fejn jista ’ jintuża Aranesp huma ‘ non- myeloid ’ (ma jaffettwawx il- mudullun).
How is Aranesp used?
Kif jintuża Aranesp?
Aranesp treatment should be initiated by a doctor who has experience in treating either of the two types of anaemia mentioned above.
Il- kura b’ Aranesp għandha tinbeda minn tabib li għandu esperjenza fil- kura ta ’ kemm waħda u kemm l- oħra miż- żewġ tipi ta ’ anemiji msemmija hawn fuq.
Aranesp is injected intravenously (into a vein) or subcutaneously (under the skin).
Aranesp huwa injettat fil- vina jew taħt il- ġilda.
Lower doses may be necessary for children with kidney failure aged 10 years or below.
Id- doża użata tiddependi fuq għalfejn ħa jintuża Aranesp, tvarja minn 0. 45 mikrogrammi kull kilogramm tal- piż tal- ġisem kull ġimgħa (jew 0. 75 mikrogrammi/ kg kull ġimgħa iva u ġimgħa le) fl - adulti u tfal ta ’ etajiet ta ’ 11- il sena jew akbar b’ indeboliment tal- kliewi, għal 6. 75 mikrogrammi/ kg kull tlett ġimgħat f’ pazjenti bil- kanċer.
In all cases the doses are adjusted to obtain haemoglobin levels that remain within the recommended range.
Fil- każijiet kollha d- dożi huma aġġustati biex jinkisbu livelli ta ’ emoglobina li jibqgħu fi ħdan il- medda irrikmandata.
Haemoglobin is the protein in red blood cells that carries oxygen around the body.
L- emoglobina hija l- proteina fiċ- ċelloli ħomor tad- demm li ġġorr l- ossiġnu madwar il- ġisem.
Doses and dose frequency (how often Aranesp is given) are adjusted depending on the response.
Dożi u frekwenzi tad- doża (kemm Aranesp jingħata ta ’ spiss) huma aġġustati skond ir- reazzjoni.
Aranesp is supplied ready for use in a pre-filled syringe or pre-filled pen, which can be used by the patient or their carer.
Aranesp huwa fornut lest għall- użu f’ siringa mimlija għal- lest jew f’ pinna mimlija għal- lest, li tista ’ tintuża mill- pazjent jew minn min jieħu ħsiebu.
How does Aranesp work?
Kif jaħdem Aranesp?
Darbepoetin alfa is 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Darbepoetin alfa, is- sustanza attiva f’ Aranesp, taħdem eżattament bħal erythropoietin naturali magħmul mill- ġisem, iżda hija xi ftit differenti fl- istruttura tagħha, u dan ifisser li darbepoetin alfa 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes the cell able to produce darbepoetin alfa.
Darbepoetin alfa hija magħmula permezz ta ’ metodu magħruf bħala ‘ teknoloġija rekombinanti tad - DNA ’, li tagħmel liċ- ċellola kapaċi tipproduċi darbepoetin alfa.
A lack of natural erythropoietin is also one of the causes of anaemia in patients receiving chemotherapy.
Nuqqas ta ’ erythropoietin naturali huwa ukoll wieħed mill- kaġuni ta ’ anemija f’ pazjenti li jkunu qed jirċievu l- kemoterapija.
Aranesp works by stimulating the production of red blood cells in the same way as natural erythropoietin.
Aranesp jaħdem billi jistimola l- produzzjoni ta ’ ċelloli ħomor tad- demm bl - istess mod bħal erythropoietin naturali.
How has Aranesp been studied?
Kif ġie studjat Aranesp?
The effectiveness of Aranesp has been studied in patients with long-term kidney disease, where it was compared with recombinant human erythropoietin in four studies involving over 1,200 patients, and in patients receiving chemotherapy for cancer such as lung cancer, myeloma or lymphoma, where it was compared with placebo (a dummy treatment) in two studies involving 669 patients.
L- effettività ta’ Aranesp ġiet studjata f’ pazjenti b’ mard tal- kliewi fit- tul, fejn ġie mqabbel ma ’ erythropoietin rekombinanti tal- bniedem f’ erba ’ studji li jinvolvu aktar minn 1, 200 pazjent, u f’ pazjenti li qed jirċievu kemoterapija għal kanċer bħal ma ’ huwa kanċer tal- pulmun, majeloma jew limfoma, fejn tqabbel ma ’ plaċebo (trattament finta) f’ żewġ studji li jinvolvu 669 pazjent.
In patients receiving chemotherapy, the main measure of effectiveness was the reduction in number of patients who needed a blood transfusion.
F’ pazjenti li qed jirċievu kemoterapija, il- miżura ewlenija ta ’ l- effettività kienet it- tnaqqis fin- numru ta ’ pazjenti li kienu jeħtieġu trasfużjoni tad- demm.
Aranesp has also been studied in 124 children with long-term kidney disease to check that it is absorbed in the same way as in adults.
Aranesp ġie studjat ukoll f’ 124 tifel u tifla b’ mard tal- kliewi fit- tul biex jiċċekkjaw li huwa assorbit bl - istess mod bħal fl- adulti.
What benefit has Aranesp shown during the studies?
X’ benefiċċu wera Aranesp waqt l- istudji?
Aranesp was as effective as human recombinant erythropoietin at increasing the haemoglobin levels in patients with kidney disease, and at keeping these levels maintained after they had been improved, whether given as an intravenous or subcutaneous injection.
Aranesp kien effettiv daqs erythropoietin rekombinanti tal- bniedem fiż- żieda ta ’ livelli ta ’ emoglobina f’ pazjenti b’ mard tal- kliewi, u biex iżomm dawn il- livelli mantenuti wara li jkunu ttejjbu, kemm jekk jingħata bħala injezzjoni fil- vina kif ukoll taħt il- ġilda.
In cancer patients receiving chemotherapy, fewer patients treated with Aranesp needed a blood transfusion compared with those given placebo.
F’ pazjenti bil- kanċer li qed jirċievu kemoterapija, inqas pazjenti ikkurati b’ Aranesp kellhom bżonn trasfużjoni tad- demm meta mqabbla ma ’ dawk li ngħataw plaċebo.
What is the risk associated with Aranesp?
X’ inhu r- riskju assoċjat ma ’ Aranesp?
The most common side effects with Aranesp (seen in between 1 and 10 patients in 100) are headache, hypertension (high blood pressure), thrombosis (blood clots), injection site pain, arthralgia (joint pain) and peripheral oedema (fluid retention).
L- aktar effetti sekondarji komuni b’ Aranesp (dehru f’ madwar 1 u 10 pazjenti minn kull 100) huma uġigħ ta ’ ras, pressjoni għolja, trombożi (ċapep tad- demm), uġigħ fis- sit ta ’ l- injezzjoni, artralġja (uġigħ fil- ġogi) u edema periferali (żamma ta ’ fluwidu).
For the full list of all side effects reported with Aranesp, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha b’ Aranesp, ara l- Fuljett ta ’ Tagħrif.
Aranesp should not be used in people who may be hypersensitive (allergic) to darbepoetin alfa or any of the other ingredients, or in patients who have poorly controlled high blood pressure.
Aranesp m’ għandux jintuża f’ nies li huma sensittivi żżejjed (allerġiċi) għal darbepoetin alfa jew għal xi sustanza oħra tiegħu, jew f’ pazjenti li għandhom pressjoni għolja mhux ikkontrollata sew.
Why has Aranesp been approved?
Għalfejn ġie approvat Aranesp?
The Committee for Medicinal Products for Human Use (CHMP) decided that Aranesp’ s benefits are greater than its risks for the treatment of anaemia associated with chronic renal failure in adults and paediatric patients, and of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Aranesp huma akbar mir- riskji tiegħu għall- kura ta ’ anemija assoċjata ma ’ falliment renali kroniku fl - adulti u f’ pazjenti pedjatriċi, u ta ’ anemija sintomatika f’ pazjenti adulti bil- kanċer b’ malinni ‘ non- myeloid ’ li qed jirċievu kemoterapija.
The Committee recommended that Aranesp be given marketing authorisation.
Il- Kumitat irrikmanda li Aranesp jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Aranesp:
Tagħrif ieħor dwar Aranesp:
The European Commission granted a marketing authorisation valid throughout the European Union for Aranesp to Amgen Europe B. V. on 8 June 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Aranesp lil Amgen Europe B. V. fit- 8 ta ’ Ġunju 2001.
The marketing authorisation was renewed on 8 June 2006.
L- awtorizzazzjoni għat- tqegħid fis - suq ġiet imġedda fit- 8 ta ’ Ġunju 2006.
The full EPAR for Aranesp is available here.
L- EPAR sħiħ għal Aranesp huwa disponibbli minn hawnhekk.
1 pre-filled syringe
Siringa waħda mimlija għal- lest
EU/ 1/ 01/ 185/ 011
1/ 7 EU/ 1/ 01/ 185/ 011
4 pre-filled syringe
4 siringi mimlija għal- lest
EU/ 1/ 01/ 185/ 022
2/ 7 EU/ 1/ 01/ 185/ 022
1 pre-filled syringe (non- blister)
Siringa waħda mimlija għal- lest (mhux ġo folja)
EU/ 1/ 01/ 185/ 041
3/ 7 EU/ 1/ 01/ 185/ 041
1 pre-filled pen
Pinna waħda mimlija għal- lest
EU/ 1/ 01/ 185/ 052
4/ 7 EU/ 1/ 01/ 185/ 052
4 pre-filled pens
4 Pinen mimlija għal- lest
EU/ 1/ 01/ 185/ 063
5/ 7 EU/ 1/ 01/ 185/ 063
Aranesp 10 micrograms solution for injection in a pre-filled syringe.
Aranesp 10 mikrogrammi soluzzjoni għall- injezzjoni ġo siringa mimlija għal- lest.
Solution for injection (injection) in a pre-filled syringe.
Soluzzjoni għall- injezzjoni (injezzjoni) ġo siringa mimlija għal- lest.
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.
Kura ta ’ l- anemija sintomatika assoċjata ma ’ insuffiċjenza renali kronika (CRF) f ’ pazjenti adulti u tfal.
Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.
Kura ta ’ l- anemija sintomatika f ’ pazjenti adulti b’ kanċer li għandhom tumuri malinni mhux majelojdi li qed jirċievu kura b’ kimoterapija.
Aranesp treatment should be initiated by physicians experienced in the above mentioned indications.
Il- kura b’ Aranesp għandha tinbeda minn tobba li għandhom esperjenza fil- kura ta ’ l- indikazzjonijiet imsemmija hawn fuq.
Aranesp is supplied ready for use in a pre-filled syringe.
Aranesp jiġi lest għall- użu ġo siringa mimlija għal- lest.
The instructions for use, handling and disposal are given in section 6.6.
L- istruzzjonijiet għall- użu, l- immaniġġjar u r - rimi huma mniżżla f’ sezzjoni 6. 6.
Treatment of symptomatic anaemia in adult and paediatric chronic renal failure patients
Kura ta ’ l- anemija sintomatika f ’ pazjenti adulti u f 'pazjenti tfal li għandhom insuffiċjenza renali kronika
Anaemia symptoms and sequelae may vary with age, gender, and overall burden of disease; a physician’ s evaluation of the individual patient’ s clinical course and condition is necessary.
Sintomi u problemi ta ’ anemija jistgħu jvarjaw skond l- età, is- sess, u l- piż ta ’ mard fuq kollox; evalwazzjoni minn tabib ta ’ l- istat kliniku u l- kundizzjoni tal- pazjent huma neċessarji.
Aranesp should be administered either subcutaneously or intravenously in order to increase haemoglobin to not greater than 12 g/ dl (7.5 mmol/ l).
Aranesp għandu jingħata bħala injezzjoni taħt il- ġilda jew ġol- vina sabiex tiżdied il- konċentrazzjoni ta ’ l - emoglobina għal mhux aktar minn 12 g/ dl (7. 5 mmol/ l).
Subcutaneous use is preferable in patients who are not receiving haemodialysis to avoid the puncture of peripheral veins.
L- użu taħt il- ġilda huwa aħjar f’ pazjenti li mhux qegħdin fuq dijalisi tad- demm sabiex jevitaw titqib tal- vini periferali.