qanastek/EMEA-V3 huggingface dataset:
65 If you stop taking VIRAMUNE for more than 7 days your doctor will instruct you to start the 14 day'lead in 'period (described above) once again before returning to the twice daily dose.
Jekk tieqaf tieħu VIRAMUNE għal aktar minn 7 ijiem it- tabib tiegħek għandu jagħtik parir biex tibda bil- perijodu ta '14- il jum' tal- bidu '(mfissra hawn fuq) mill- ġdid qabel tibda bid- doża ta' żewġ pilloli kuljum.
Like all medicines, VIRAMUNE can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra VIRAMUNE jista 'jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
As mentioned in ‘ Take special care with VIRAMUNE ', above, the most important side effects of VIRAMUNE are severe and life threatening skin reactions and serious liver damage.
Kif imsemmi fit- taqsima ‘ Oqgħod attent ħafna meta tieħu VIRAMUNE, hawn fuq, l- effetti sekondarji l- aktar importanti ta ’ VIRAMUNE huma reazzjonijiet tal- ġilda u ħsara fil- fwied li jistgħu jkunu severi u ta ’ periklu għal ħajja.
These reactions occur mainly in the first 18 weeks of treatment with VIRAMUNE.
Dawn ir- reazzjonijiet iseħħu prinċipalment fl - ewwel 18- il ġimgħa ta 'trattament b' VIRAMUNE.
This is therefore an important period which requires close monitoring by your doctor.
Huwa għalhekk perijodu importanti li jinħtieġ monitoraġġ mill- qrib mit- tabib tiegħek.
If you ever observe any rash symptoms please inform your doctor immediately.
Jekk tosserva xi sintomi ta ’ raxx jekk jogħġbok informa lit- tabib tiegħek minnufih.
When rash occurs it is normally mild to moderate.
Meta jiżviluppa r- raxx dan hu normalment minn ħafif sa moderat.
However, in some patients a rash, which appears as a blistering skin reaction, can be severe or life-threatening (Stevens-Johnson syndrome and toxic epidermal necrolysis) and deaths have been recorded.
Madankollu, f' xi pazjenti raxx, li jidher bħala nfafet fuq il- ġilda jista 'jkun serju u ta' periklu għal ħajja (sindromu ta 'Stevens- Johnson u nekroliżi epidermali tossika) u kien hemm anke imwiet ġew irreġistrati.
Most of the cases of both severe rash and mild/ moderate rash occur in the first six weeks of treatment.
Il- biċċa l- kbira tal- każijiet kemm ta 'raxx serju u raxx ħafif/ moderat jseħħu fl- ewwel sitt ġimgħat ta' trattament.
If rash occurs with feeling sick, you must stop treatment and visit your doctor immediately.
Jekk tinnota xi sintomi ta 'raxx meta tħossok ma tiflaħx, għandek twaqqaf it- trattament u tinvista lit - tabib minnufih.
Hypersensitivity (allergic) reactions can occur.
Reazzjonijiet ta 'sensittività eċċessiva (allerġiji) jistgħu jseħħu.
Such reactions may appear in the form of anaphylaxis (characterised by rash, facial swelling, bronchial spasm or shock), or rash accompanied by other side effects such as fever, blistering, mouth sores, eye inflammation, facial swelling, general swelling, shortness of breath, muscle or joint aches, a reduction in white blood cells (granulocytopaenia), general feelings of illness or severe problems with liver or kidneys.
Dawn ir- reazzjonijiet jistgħu jidhru fil- forma ta 'ta' anafilassi (kkaraterizzati b' raxx, infih tal- wiċċ, spażmu bronkjali jew xokk), jew raxx akkumpanjat b' effetti oħrajn bħal deni, nfafet, uġigħ fil- ħalq, infjammazzjoni tal- għajnejn, infiħ tal- wiċċ, infiħ ġenerali, qtugħ ta ’ nifs, uġigħ fl- għadam u fil- ġogi, tnaqqis fl- għadd ta 'ċelluli bojod tad- demm (granuloċitopenija), wieħed iħossu marid b' mod ġenerali jew problemi serji bil- fwied jew kliewi.
If you experience rash and any of the other side effects of a hypersensitivity (allergic) reaction, please be sure to tell your doctor immediately as such reactions can be potentially life-threatening.
Jekk ikollok xi raxx jew xi effett kollaterali ieħor ta 'reazzjoni eċċessiva (allerġija), jekk jogħġbok tkellem it- tabib tiegħek minnufih peress li dawn ir- reazzjonijiet jistgħu jkunu ta' periklu għal ħajja.
Abnormal liver functioning has been reported with the use of VIRAMUNE, including some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis) and liver failure, which have resulted deaths.
Funzjonament anoramli tal- fwied ġie rrapportat bit- teħid ta 'VIRAMUNE, inkluż xi każijiet ta' infjammazzjoni tal- fwied (epatite), li tista ’ tkun f’ daqqa u intensa (epatite fulminanti) u insuffiċjenza tal- fwied li rriżultaw fi mwiet.
If you experience clinical symptoms suggesting an injury of the liver, such as loss of appetite, feeling sick (nausea), vomiting, yellow skin (jaundice), abdominal pain you should inform your doctor.
Jekk tħoss xi sintomi kliniċi li jimputaw xi ferita fil- fwied, bħal tnaqqis fl- aptit, tħossok ma tiflaħx (tqallih), rimettar, ġilda safra (suffejra) uġigħ addominali għandek tinforma minnufih lit- tabib tiegħek.
Evaluation of the side effects is based on the following frequencies:
69 L- evalwazzjoni ta ’ l- effetti sekondarji hi msejsa fuq il- frekwenzi li ġejjin:
Very common: in at least 1 out of 10 patients treated Common: in at least 1 out of 100 and less than 1 out 10 patients treated Uncommon: in at least 1 out of 1000 and less than 1 out 100 patients treated Rare: in at least 1 out of 10,000 and less than 1 out 1000 patients treated
Komuni ħafna: f’ ta ’ lanqas pazjent 1 f’ kull 10 ikkurati Komuni: f’ ta ’ lanqas pazjent 1 f’ kull 100 ittrattati imma inqas minn pazjent 1 f’ kull 10 ikkurati Mhux komuni: f’ ta ’ lanqas pazjent 1 f’ kull 1000 ittrattati imma inqas minn pazjent 1 f’ kull 100 ikkurati Rari: f’ ta ’ lanqas pazjent 1 f’ kull 10, 000 u inqas minn 1 f’ kull 1000 pazjent ikkurat
The side effects described below have been experienced by patients given VIRAMUNE:
L- effetti sekondarji deskritti hawn taħt inħassu minn pazjenti li ngħataw VIRAMUNE:
66 Common:
Komuni:
- reduction in white blood cells (granulocytopenia)
- tnaqqis fl- għadd ta ’ ċelloli bojod (granuloċitopenija)
- allergic reactions (hypersensitivity)
- reazzjonijiet allerġiċi (sensittività eċċessiva)
- feeling sick (nausea)
- tħossok ma tiflaħx (nawsea)
- loose stools (diarrhoea)
- ippurgar artab (dijarea)
- inflammation of the liver (hepatitis)
- infjammazzjoni tal- fwied (epatite)
- muscle aches (myalgia)
- uġigħ fil- muskoli (mijalġja)
- liver function tests abnormal
- testijiet tal- funjonament tal- fwied abnormali
- reduction in red blood cells (anaemia)
- tnaqqis fl- għadd ta ’ ċelloli ħomor tad- demm (anemija)
- yellow skin (jaundice)
- ġilda safranija (suffejra)
- Stevens Johnson Syndrome/ toxic epidermal necrolysis
- is- Sindromu ta ’ Stevens Johnson/ nekrolisi epidermali tossika
- hives (urticaria)
- ħorriqija (urtikarja)
- fluid under the skin (angioneurotic oedema)
- fluwidu taħt il- ġilda (edema anġjonewrotika)
- joint pain (arthralgia)
- uġigħ fil- ġogi (artralġja)
- sudden and intense inflammation of the liver (hepatitis fulminant)
- infjammazzjoni tal- fwied f’ daqqa u intensa (epatite fulminanti)
- drug rash with systemic symptoms (drug rash with eosinophilia and systemic symptoms)
- raxx minħabba l- mediċina b’ sintomi sistemiċi (raxx minħabba l- mediċina b’ eosinofilja u sintomi
- allergic reaction characterised by rash, facial swelling, bronchial spasm or shock (anaphylaxis)
- reazzjoni allerġika kkaraterizzata b’ raxx, tinfiħ tal- wiċċ, spażmu bronkjali jew xokk (anafilassi)
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Terapija antiretrovirali kkombinata tista 'toħloq bidliet fil- forma tal- ġisem minħabba bidliet fid - distribuzzjoni 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 tnaqqis ta 'xaħam mir- riġlejn, driegħ u wiċċ, żjieda fix- xaħam fl- addome (żaqq) u organi interni oħrajn, tkabbir tas- sider u għoqol ta' xaħam fuq in- naħa ta 'wara ta' l- għonq ('il- ħotba tal- buflu').
The cause and long-term health effects of these conditions are not known at this time.
Il- kawża u l- effetti fuq żmien twil fuq is- saħħa ta 'dawn il- kundizzjonijiet għad m' humiex magħrufa.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
Terapija antiretrovirali kombinata tista 'ukoll twassal għal żjieda fl- aċidu lattiku u z- zokkor jogħla, iperlipidemija (żjieda ta' xaħam fid- demm) u reżistenza għal insulina.
The following events have also been reported when VIRAMUNE has been used in combination with other antiretroviral agents:
Il- każijiet li ġejjin ġew rapportati wkoll meta VIRAMUNE ġie użat f' kombinazzjoni ma 'mediċini antiretrovirali oħrajn:
- a reduction in red blood cells or in platelets
- tnaqqis fiċ- ċelloli l- ħomor tad- demm jew fil- plejtlets
- inflammation of pancreas
- infjammazzjoni tal- frixa
- decrease in or abnormal skin sensations.
- tnaqqis jew sensazzjonijiet abnoramli tal- ġilda.
These events are commonly associated with other antiretroviral agents and may be expected to occur when VIRAMUNE is used in combination with other agents; however, it is unlikely that these events are due to a treatment with VIRAMUNE.
Dawn il- każijiet huma komunament assoċjati ma mediċini anti- retrovirali oħrajn u jista 'jkun li jseħħu meta VIRAMUNE jiġi użat flimkien ma' mediċini oħra; madankollu huwa x' aktarx improbabbli li dawn il- każijiet iseħħu minħabba trattament b’ VIRAMUNE.
Use in children:
Użu fi tfal:
A reduction in white blood cells (granulocytopenia) can occur, which is more common in children.
Jista ’ jkun hemm tnaqqis fl- għadd ta ’ ċelloli bojod tad- demm (granuloċitopenija), li hu aktar komuni fit- tfal.
A reduction in red blood cells (anaemia), which may be related to nevirapine therapy, is also more commonly observed in children.
Tnaqqis fl- għadd ta ’ ċelloli ħomor tad- demm (anemija) li jista ’ jkun relatat ma ’ kura ta ’ nevirapine, huwa wkoll osservat aktar komunament fit- tfal.
As with rash symptoms, please inform your doctor of any side effects.
Bħal fil- każ ta ’ sintomi tar- raxx, jekk jogħġbok informa lit- tabib tiegħek minnufih ta ’ xi effetti sekondarji.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- spiżjar tiegħek.
HOW TO STORE VIRAMUNE
KIF TAĦŻEN VIRAMUNE
Do not use VIRAMUNE after the expiry date which is stated on the carton and on the blister after EXP.
Tużax VIRAMUNE wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- folja wara JIS.
What VIRAMUNE contains
X’ fih VIRAMUNE:
- The active substance is nevirapine.
- Is- sustanza attiva hi nevirapine.
Each tablet contains 200 mg nevirapine.
Kull pillola fiha 200 mg nevirapine.
- The other ingredients are microcrystalline cellulose, lactose monohydrate, povidone K25, sodium
- Is- sustanzi l- oħra huma microcrystalline cellulose, lactose monohydrate, povidone K25, sodium
starch glycolate, colloidal silicon dioxide and magnesium stearate.
starch glycolate, colloidal silicon dioxide u magnesium stearate.
What VIRAMUNE looks like and contents of pack
Id- Dehra tal- prodott u d- daqs tal- pakkett:
VIRAMUNE tablets are supplied in blisters, with 14, 60 or 120 tablets per carton.
Il- pilloli VIRAMUNE jiġu f’ folji, b’ 14, 60 jew 120 pillola f’ kull kartuna.
VIRAMUNE is also available as an oral suspension.
VIRAMUNE jiġi wkoll bħala suspensjoni orali.
Manufacturer
71 Manifattur:
KG Binger Strasse 173 55216 Ingelheim am Rhein Germany
KG Binger Strasse 173 55216 Ingelheim am Rhein Il- Ġermanja
5th km Paiania-Markopoulo 194 00 Koropi Greece
5th km Paiania- Markopoulo 194 00 Koropi Il- Greċja
68 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
72 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta 'l- Awtorizzazzjoni għat- tqegħid fis- Suq.
Κύπρος Boehringer Ingelheim Ellas A. E.
73 Κύπρος Boehringer Ingelheim Ellas A. E.
This leaflet was last approved in {MM/ YYYY}
Dan il- fuljett kien approvat l- aħħar f '{data}
70 PACKAGE LEAFLET:
74 FULJETT TA 'TAGĦRIF:
VIRAMUNE 50 mg/ 5 ml oral suspension Nevirapine
VIRAMUNE 50 mg/ 5ml suspensjoni orali Nevirapine
What VIRAMUNE is and what it is used for 2.
X' inhu VIRAMUNE u għalxiex tintuża 2.
WHAT VIRAMUNE IS AND WHAT IT IS USED FOR
X’ INHU VIRAMUNE U GĦALXIEX JINTUŻA
VIRAMUNE belongs to the class of non-nucleoside reverse transcriptase inhibitors (NNRTIs).
VIRAMUNE jappartjeni għal kategorija ta ’ inibituri non- nucleoside reverse transcriptase (NNRTIs).
- if you or your child are allergic (hypersensitive) to nevirapine or any of the other ingredients of
- jekk inti jew it- tifel/ tifla tiegħek għandkom allerġija (sensittività eċċessiva) għal nevirapine jew
VIRAMUNE (see other ingredients)
xi sustanza oħra li tinsab f’ VIRAMUNE (ara sustanzi oħra).
- if you or your child previously experienced inflammation of the liver (hepatitis), severe skin
- jekk inti jew it- tifel/ tifla tiegħek qabel kellek infjammazzjoni tal- fwied (epatite), raxx sever fuq
rash, or liver damage while on VIRAMUNE treatment.
il- ġilda, jew ħsara fil- fwied waqt li kont fuq kura ta 'VIRAMUNE.
Take special care with VIRAMUNE
Oqgħod attent ħafna b’ VIRAMUNE:
During the first 18 weeks of treatment with VIRAMUNE you should watch out for signs of liver or skin reactions as these can become severe and even life threatening.
L- ewwel 18- il ġimgħa ta 'trattatment b' VIRAMUNE huwa importanti li inti toqgħod attent ħafna sabiex jintgħarfu sinjali ta ’ reazzjonijiet tal- fwied jew tal- ġilda peress li dawn jistgħu jagggravaw u jkunu ta ’ periklu għal ħajja.
71 If you experience severe rash or hypersensitivity (allergic reactions that may appear in the form of rash accompanied by other side effects such as
75 Jekk tesperjenza raxx sever jew sensittività eċċessiva (reazzjonijiet allerġiċi li jistgħu jidhru f’ forma ta ’ raxx akkumpanjat minn effetti sekondarji oħra bħal:
YOU SHOULD DISCONTINUE TAKING VIRAMUNE AND YOU MUST CONTACT your doctor IMMEDIATELY as such reactions can be potentially life-threatening or lead to death.
GĦANDEK TIEQAF TIEĦU VIRAMUNE U GĦANDEK TIKKUNTATTJA lit- tabib tiegħek MINNUFIH peress li reazzjonijiet bħal dawn jistgħu jkunu ta ’ periklu għal ħajja jew iwassli għal mewt.
If you ever have only mild rash symptoms without any other reaction please inform your doctor immediately, who will advise you whether you should stop taking VIRAMUNE.
Jekk qatt ikollok xi sintomi ħfief ta ’ raxx mingħajr reazzjoni oħra jekk jogħġbok informa lit- tabib tiegħek minnufih, li ser jagħtik parir jekk għandekx tieqaf tieħu VIRAMUNE.
This is especially important within the first 14 days of treatment (see more information in How to take VIRAMUNE).
(ara aktar informazzjoni f’ Kif għandek tieħu VIRAMUNE).
In some patients with advanced HIV infection (AIDS) and a history of opportunistic infection (AIDS defining illness), signs and symptoms of inflammation from previous infections may occur soon after anti-HIV treatment is started.
F' xi pazjenti li għandhom infezzjoni avvanzata ta 'HIV (AIDS) u storja ta' reazzjonijiet opportunistiċi (mard infisser bħala AIDS), is- sinjali u s- sintomi ta 'infjammazzjoni minn infezzjonijiet li kellhom qabel jistgħu jerġgħu jitfaċċaw wara li jinbeda mill- ġdid it- trattament kontra l- HIV.
Contact your or your child’ s doctor if you notice changes in body fat.
Bidliet fix- xaħam tal- ġisem jistgħu jseħħu f' pazjenti li jkunu fuq terapija antiretrovirali kombinata Ikkuntattja lit- tabib tiegħek jekk tinduna f' xi bidliet fix- xaħam tal- ġisem tiegħek.
Some patients taking combination antiretroviral therapy may experience death of bone tissue (osteonecrosis).
Xi pazjenti li qed jieħdu terapija antiretrovirali kombinata jistgħu jesperjenzaw mewt ta 'tessut tal- ġisem (osteonekrosi).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe weakness of the immune system, higher body mass index may be some of the many risk factors for developing this disease.
It- tul tat- terapija antiretrovirali kombinata, l- użu ta 'kortikosterojdi, il- konsum ta' alkoħol, debolezza tas- sistema immuni severa, indiċi ogħla fil- piż tal - ġisem fost oħrajn, jistgħu jkunu xi wħud mill- ħafna fatturi li jippredisponu l- iżvilupp ta 'din il- marda.
72 VIRAMUNE is not a cure for HIV infection and you or your child may continue to develop infections or other illnesses associated with HIV infection.
VIRAMUNE mhix kura għall- infezzjoni ta ’ HIV u jista ’ jkun li int tkompli tiżviluppa infezzjonijiet jew mard ieħor assoċjat ma ’ l- infezzjoni ta ’ HIV.
VIRAMUNE oral suspension can be taken by children of all age groups.
Użu fi tfal Is- suspensjoni orali VIRAMUNE tista ’ tittieħed minn tfal ta ’ kull età.
Always follow the exact instructions given by your child’ s doctor for the use of VIRAMUNE in your child.
Dejjem għandek issegwi l - istruzzjonijiet eżatti dwar VIRAMUNE li jkun tak it- tabib tat- tifel/ tifla tiegħek.
VIRAMUNE is also available as tablets for children 16 years or older or adolescents under 16 years of age who weigh 50 kg or more or whose body surface area is above 1.25 m2.
VIRAMUNE jiġi wkoll bħala pilloli għat- tfal li għandhom 16- il sena jew aktar jew adoloxxenti taħt is- 16- il sena li jiżnu 50 kg jew aktar jew li l- erja superfiċjali korporali tagħhom hi 'l fuq minn 1. 25 m2.
You should inform your doctor of all other medicines you or your child are taking before you start taking VIRAMUNE because he or she might need to monitor whether the other medicines are still having their desired effects and make necessary dose-adjustments.
Għandek tinforma t- tabib dwar kull mediċina oħra li int jew it- tifel/ tifla tiegħek qed tieħu qabel ma tibda tieħu VIRAMUNE sabiex hu jew hi għandu mnejn ikun irid jissorvelja jekk il- mediċini humiex ikollhom l- effett mixtieq u sabiex jagħmel l- aġġustamenti meħtieġa tad- doża.
You should carefully read the package leaflet of the other HIV medicinal products which you will be taking in combination with VIRAMUNE.
Dejjem għandek taqra sew il- fuljett ta ’ tagħrif ta ’ prodotti mediċinali oħra ta ’ l- HIV li inti ser tieħu flimkien ma ’ VIRAMUNE..
- macrolides (e. g. clarithromycin) (medicine to treat bacterial infections)
- makrolidi (eż. clarithromycin (mediċina li tikkura l- infezzjonijiet batteriċi)
- hormonal contraceptives, e. g. the “ pill”
- kontraċettivi ormonali eż. il - “ pill ”
Taking VIRAMUNE with food and drink
Meta tieħu VIRAMUNE ma 'l- ikel u x- xorb:
There are no restrictions on taking VIRAMUNE with food and drink.
M' hemm l- ebda restrizzjoni fuq it- teħid ta 'pilloli VIRAMUNE ma' l- ikel u x- xorb
You should discontinue breast feeding if you are taking VIRAMUNE.
77 Għandek twaqqaf tredda ’ jekk qed tieħu s- suspensjoni orali VIRAMUNE.
It is in general recommended that you do not breast-feed if you have HIV infection in order to lower the risk of passing the infection
Hija rakkomandazzjoni ġenerali li m’ għandekx tredda ’ jekk int infettata b’ HIV sabiex tnaqqas ir- riskju li tgħaddi l- infezzjoni lit- tarbija tiegħek.
There are no specific studies on the ability to drive vehicles and use machinery.
Sewqan u tħaddim ta 'magni M’ hemm l- ebda studju speċifiku fuq il- ħila biex issuq jew tħaddem magni.
Important information about some of the ingredients of VIRAMUNE
Tagħrif importanti dwar xi sustanzi li jinsabu f’ VIRAMUNE
VIRAMUNE oral suspension contains 150 mg sucrose and 162 mg sorbitol per ml of VIRAMUNE oral suspension.
Is- suspensjoni orali VIRAMUNE fiha 150 mg ta ’ sukrożju u 162 mg ta ’ sorbitol f’ kull ml ta ’ suspensjoni orali ta ’ VIRAMUNE.
This should be taken into account in patients with diabetes mellitus.
Dan għandu jitqies sew f’ pazjenti li jbatu minn diabetes mellitus.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi tipi ta ’ zokkor, ikkuntattja lit- tabib tiegħek qabel ma tieħu dan il- prodott mediċinali
VIRAMUNE oral suspension contains methyl parahydroxybenzoate and propyl parahydroxybenzoate, which may cause allergic reactions (possibly delayed).
Is- suspensjoni orali VIRAMUNE fiha methyl parahydroxybenzoate u propyl parahydroxybenzoate li jistgħu jikkaġunaw reazzjonijiet allerġiċi (possibilment ittardjati).
You should check with your doctor or pharmacist if you are not sure..
Dejjem għandek taċċerta ruħek mat- tabib jew ma ’ l- ispiżjar tiegħek jekk ikollok xi dubju.
VIRAMUNE oral suspension is in a liquid suspension form and should only be taken by mouth.
Is- suspensjoni orali VIRAMUNE hija f' għamla ta 'likwidu b' ħafna partiċelli żgħar u għandha tittieħed biss mill- ħalq.
Shake well before you use.
Ħawwad sew il- flixkun qabel ma tuża.
The usual dose is the same for all adults (20 ml).
Id- doża li ġeneralment tingħata hija ta ’ l- istess bħal fl- adulti kollha (20 ml).
The required dosage for children is calculated according to your child's age and body weight or your child’ s body surface area.
Id- doża meħtieġa għal tfal hija kalkulata skond l- età tat- tfal u l- piż korporali jew l- erja superfiċjali tal- ġisem tat- tarbija tiegħek.
Be sure that your child's doctor clearly informs you what the correct dosage for your child should be.
Kun żgur li t- tabib ta 'uliedek jinfurmak b' mos ċar x' għandha tkun id- doża korretta tat- tfal tiegħek.
The exact dosage should be measured using the supplied measuring syringe and adapter as follows:
Id- doża eżatta għandha tiġi mkejla billi tuża s- siringa fornuta u l- adapter kif ġej:
2.
L- ewwel, ħawwad bil- mod il- flixkun 2.
Open the bottle and fit (by first pressing and then screwing) the plastic adapter onto the open bottle neck.
Iftaħ il- flixkun u qiegħed (billi l- ewwel tagħfas imbagħad tinvita) l- adapter tal- plastik fl - għonq miftuħ tal- flixkun.
Make sure the adapter is tightly fitted.
Kun żgur li l- adapter ikun issikat sew.
Insert the syringe into the adapter.
Daħħal is- siringa fl- adapter.
Make sure the syringe is tightly inserted.
Kun żgur li s- siringa tidħol issikkata.
Turn the bottle upside down and gently withdraw the required amount of VIRAMUNE oral suspension.
Dawwar il- flixkun rasu 'l isfel u iġbed bil- mod l- ammont meħtieġ ta' suspensjoni orali VIRAMUNE.
The maximum volume you can withdraw is 5 ml at a time.
Il- volum massimu li int tista 'tiġbed hu 5 ml kull darba.
If you require a higher dose please repeat steps 3-4 above.
Jekk tinħtieġ doża akbar jekk jogħġbok irrepeti l- istadji 3- 4 hawn fuq.
The bottle can be kept sealed with the lid of the plastic adapter.
Il- flixkun jista 'jinżamm issiġillat bl- għatu ta' l- adapter tal- plastik.
If you are an adult and choose to use another measuring device (e. g. cup or teaspoon) please be sure that the entire dose is taken as some VIRAMUNE can remain in the cup or spoon.
Jekk int adult u tagħżel li tuża tagħmir ta 'kejl ieħor (eż. kikkra jew mgħarfa) jekk jogħġbok kun żgur li d- doża kollha tittieħed billi xi ftit VIRAMUNE jista' jibqa 'fil- kikkra jew mgħarfa.
For adults
Għal adulti
The normal dosage for adults is 20 ml (200 mg) once a day for the first 14 days (this'lead in 'period has been shown to lower the incidence of skin rash) followed by 20 ml (200 mg) twice daily.
Id- doża normali għall- adulti hi ta '20 ml (200 mg) darba kuljum għall- ewwel 14- il jum (dan il- perijodu tal- bidu ntwera li naqqas l- inċidenza ta' raxx tal- ġilda) segwit b '20 ml (200 mg) darbtejn kuljum.
It should be noted that VIRAMUNE is also available as 200 mg tablets for adults (16 years and older).
Għandu jiġi mgħarraf li VIRAMUNE huwa wkoll disponibbli f' pilloli ta '200 mg għall- adulti (16- il sena jew aktar).
For children
78 Għat- tfal
For all children the dosage during the first two weeks is 4 mg/ kg body weight or 150 mg/ m2 body surface area once a day.
Id- doża fl- ewwel ġimagħtejn hi ta '4 mg/ kg ta ’ piż korporali jew 150 mg/ m2 ta ’ erja superfiċjali tal - ġisem darba kuljum għat- tfal kollha.
Thereafter your child will be switched to a twice daily dosing schedule and your doctor will decide the right dose based either on the child’ s weight or body surface area.
Minn hemm 'il quddiem it- tfal tiegħek se jitpoġġew fuq doża skedata ta' kuljum u t- tabib tiegħek se jiddeċiedi dwar l- aħjar doża jew skond il- piż tal- ġisem tiegħek jew l- erja superfiċjali tal- ġisem.
VIRAMUNE is also available as 200 mg tablets for older children, particularly adolescents, weighing
VIRAMUNE huwa disponibbli wkoll bħala pilloli ta '200 mg għal tfal akbar, b' mod partikolari adoloxxenti, li jiżnu 50 kg jew aktar jew għandhom erja superfiċjali tal- ġisem ta' aktar minn 1. 25 m2.
Your child's doctor will inform you exactly of the correct dose for your child, and will continually check your child’ s weight or body surface area to ensure the correct dose.
It- tabib tat- tfal tiegħek għandu jinfurmak eżattament dwar x' inhi d- doża korretta għal uliedek, u għandu kontinwament jibqa 'jiċċekkja l- piż tat- tfal tiegħek jew l- erja superfiċjali sabiex jiżgura li tingħata d- doża eżatta.
If you are uncertain please be sure to ask your child’ s doctor or pharmacist.
Jekk inti m' intiex żgur, aċċerta ruħek billi ssaqsi it- tabib jew spiżjar tat- tfal tiegħek.
VIRAMUNE will always be taken in combination with other HIV antiretrovirals, for which you should follow the instructions within the supplied package leaflet.
VIRAMUNE għandu dejjem jittieħed flimkien ma 'antiretrovirali ta' HIV oħrajn, li għalihom int għandek isegwi l- istruzzjonijiet li jinsabu fil- fuljett tal- pakkett.
It is essential to follow strictly the once a day dosage during the 14-day ‘ lead in’ period before rising to the twice daily dosage.
Huwa essenzjali li ssegwi b' mod strett id- doża ta 'pillola darba kuljum matul l- ewwel 14- il jum' tal - bidu 'qabel ma żżid id- doża għal darbtejn kuljum.
If you have any rash within this period see your doctor before increasing the dose.
Jekk ikollok xi raxx matul dan il- perijodu ara t- tabib tiegħek qabel ma żżid id- doża
You or your child should continue to take VIRAMUNE for as long as instructed by you or your child's doctor.
Int jew it- tfal tiegħek għandkom tibqgħu tieħdu s- suspensjoni orali VIRAMUNE sakemm ikun qallek biex tibqa 'tagħmel dan it- tabib tiegħek jew tat- tfal tiegħek.
As explained in'Take special care with VIRAMUNE ', above, your doctor will monitor you or your child with liver tests or for undesirable effects such as rash.
Kif hemm spjegat fit- taqsima, ‘ Oqgħod attent ħafna meta tieħu VIRAMUNE ’, hawn fuq, it- tabib għandu jissorvelja t- testijiet tal- fwied tiegħek jew tat- tfal tiegħek u jara jekk hemmx xi effetti mhux mixtieqa bħal raxx.
Depending on the outcome he or she may decide to interrupt or stop VIRAMUNE treatment.
Skond ir- riżultati hu jew hi jista 'jiddeċiedi jekk għandux iwaqqaf it- trattament tiegħek b’ VIRAMUNE.
He or she might then decide to restart you or your child on a lower dose.
Hu jew hi jistgħu mbagħad jiddeċiedu jekk it- tfal għandhomx jibdew mill - ġdid fuq doża aktar baxxa.
If you take more VIRAMUNE than you should Do not exceed the dose prescribed by your doctor and described in this leaflet.
M' għandekx taqbeż id- doża li t- tabib tiegħek ikun kitiblek u mfissra f' dan il- fuljett.
There is at present little information on the effects of VIRAMUNE overdose.
Attwalment, hemm biss ftit tagħrif fuq l- effetti ta 'doża eċċessiva ta' VIRAMUNE.
Consult your doctor if you or your child have taken an overdose.
Ikkonsulta t- tabib tiegħek jekk int jew it- tfal tiegħek tkunu ħadtu xi doża eċċessiva.
If you forget to take VIRAMUNE Try not to miss a dose.
Jekk tinsa tieħu VIRAMUNE Ipprova titlifx milli tieħu doża.
If you notice later take the next regular dose at the scheduled time.
Jekk tinduna wara dan iż- żmien hu d- doża regolari li jmiss tiegħek fil- ħin skedat..
If you stop taking VIRAMUNE Taking all doses at the appropriate times greatly increase the effectiveness of your medicinal product combination regimen and reduce the development of viral resistance.
Intwera li jekk tieħu d- dożi kollha fil- ħinijiet xierqa tiżdied l- effettività tal- kors kkombinat tal- prodott mediċinali tiegħek u tnaqqas l- iżvilupp ta 'reżistenza virali.
Therefore, unless your doctor or your child’ s doctor, instructs you or your child to stop treatment, it is important to keep taking VIRAMUNE correctly, as described above.
Għalhekk, sakemm it- tabib tiegħek, jew tat- tfal tiegħek ma jgħidlekx sabiex twaqqaf it- trattament, huwa importanti li tibqa 'tieħu s- suspensjoni orali VIRAMUNE b' mod korrett, kif imfisser hawn fuq.
If you or your child stop taking VIRAMUNE for more than 7 days your doctor will instruct you to start the 14 day'lead in 'period (described above) once again before returning to the twice daily dose.
Jekk int jew it- tifel/ tifla tiegħek tieqfu tieħdu VIRAMUNE għal aktar minn 7 ijiem it- tabib tiegħek jew tat- tifel/ tifla għandu jagħtik parir biex tibda bil- perijodu ta '14- il jum' tal- bidu '(mfissra hawn fuq) mill- ġdid qabel tibda bid- doża ta' żewġ pilloli kuljum.
Like all medicines, VIRAMUNE can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, VIRAMUNE jista 'jkollha effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
As mentioned in'Take special care with VIRAMUNE ', above, the most important side effects of VIRAMUNE are severe and life threatening skin reactions and serious liver damage.
Kif imsemmi fit- taqsima ‘ Oqgħod attent ħafna meta tieħu VIRAMUNE ', hawn fuq, l- effetti sekondarji l- aktar importanti ta ’ VIRAMUNE huma reazzjonijiet tal- ġilda u ħsara fil- fwied li jistgħu jkunu severi u ta ’ periklu għal ħajja.
However, in some patients a rash, which appears as a blistering skin reaction, can be severe or life-threatening (Stevens-Johnson syndrome and toxic
Madankollu, f' xi pazjenti raxx, li jidher bħala nfafet fuq il- ġilda jista 'jkun serju u ta' periklu għal ħajja (sindrome ta 'Stevens- Johnson u nekroliżi epidermali tossika) u kien hemm anke imwiet ġew irreġistrati.
If rash occurs with feeling sick, you must stop treatment and visit your doctor immediately.
Jekk tinnota xi sintomi ta 'raxx meta tħossok ma tiflaħx għandek twaqqaf it- trattament u tinvista lit - tabib tiegħek minnufih.
Please pay special attention to any rashes which your child develops.
Agħti attenzjoni speċjali jekk it- tfal tiegħek jiżviluppaw xi raxx.
Although these may appear normal (for example nappy rash), they may in fact be rashes due to VIRAMUNE.
Għalkemm jistgħu jidhru normali (per eżempju raxx tal- ħarqa), jista 'fil- fatt ikun raxx minħabba VIRAMUNE.
If in doubt ask your child's doctor.
Jekk ikollok xi dubju staqsi lit- tabib tal- wild tiegħek.
Such reactions may appear in the form of anaphylaxis (characterised by rash, facial swelling, bronchial spasm or shock), or rash accompanied by other side effects such as fever, blistering, mouth sores, eye inflammation, facial swelling, general swelling, shortness of breath, muscle or joint aches, a reduction in white blood cells (granulocytopaenia), general feelings of illness or severe problems with liver or kidneys.
Dawn ir- reazzjonijiet jistgħu jidhru fil - forma ta 'ta' anafilassi (karaterizzati b' raxx, infih tal- wiċċ, spażmu bronkjali jew xokk), jew raxx akkumpanjat b' effetti oħrajn bħal deni, nuffat, uġigħ fil- ħalq, infjammazzjoni tal- għajnejn, infiħ tal - wiċċ, infiħ ġenerali, qtugħ ta ’ nifs, uġigħ fl- għadam u fil- ġogi, tnaqqis fl- għadd ta 'ċelluli bojod tad - demm (granuloċitopenija), wieħed iħossu marid b' mod ġenerali jew problemi serji bil- fwied jew kliewi.
If you or your child experience rash and any of the other side effects of a hypersensitivity (allergic) reaction, please be sure to tell your or your child’ s doctor immediately as such reactions can be potentially life-threatening.
Jekk int jew t- tfal tiegħek ikollok xi raxx jew xi effett kollaterali ieħor ta 'sensittività eċċessiva (allerġija), kun żgur li tkellem it- tabib tiegħek jew tat- tfal minnufih, billi dawn ir- reazzjonijiet jistgħu jkunu ta' periklu għal ħajja.
Abnormal liver functioning has been reported with the use of VIRAMUNE, including some cases of inflammation of the liver (hepatitis), which can be sudden and intense (fulminant hepatitis) and liver failure, which have resulted in recorded deaths.
Funzjonament abnoramli tal- fwied ġie rrapportat bit- teħid ta 'VIRAMUNE, inkluż xi każijiet ta' infjammazzjoni tal- fwied (epatite), li tista ’ tkun f’ daqqa jew intensa (epatite fulminanti) u insuffiċjenza tal- fwied li rriżultaw fi mwiet.
If you or your child experience clinical symptoms suggesting an injury of the liver, such as loss of appetite, feeling sick (nausea), vomiting, yellow skin (jaundice), abdominal pain you should inform your or your child’ s doctor.
Jekk inti jew it- tfal tiegħek iħossu xi sintomi kliniċi li jimputaw xi ferita fil- fwied, bħal tnaqqis fl- aptit, tħossok ma tiflaħx (tqallih), rimettar, jew ġilda safra (suffejra), uġigħ addominali għandek tinforma minnufih lit- tabib tiegħek.
Evaluation of the side effects is based on the following frequencies:
L- evalwazzjoni ta ’ l- effetti sekondarji hi msejsa fuq il- frekwenzi li ġejjin:
Very common: in at least 1 out of 10 patients treated Common: in at least 1 out of 100 and less than 1 out 10 patients treated Uncommon: in at least 1 out of 1000 and less than 1 out 100 patients treated Rare: in at least 1 out of 10,000 and less than 1 out 1000 patients treated
Komuni ħafna: f’ ta ’ lanqas pazjent 1 f’ kull 10 ikkurati Komuni: f’ ta ’ lanqas pazjent 1 f’ kull 100 ittrattati imma inqas minn pazjent 1 f’ kull 10 ikkurati Mhux komuni: f’ ta ’ lanqas pazjent 1 f’ kull 1000 ittrattati imma inqas minn pazjent 1 f’ kull 100 ikkuratiRari: f’ ta ’ lanqas pazjent 1 f’ kull 10, 000 u inqas minn 1 f’ kull 1000 pazjent ikkurati
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Terapija antiretrovirali kombinata tista 'toħloq bidliet fil- forma tal- ġisem minħabba bidliet fid - distribuzzjoni tax- xaħam.
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
Terapija antiretrovirali kombinata tista 'ukoll tikkaġuna żjieda fl- aċidu lattiku u z- zokkor jogħla, iperlipidemija (żjieda ta' xaħam fid- demm) u reżistenza għall- insulina.
The following events have also been reported when VIRAMUNE has been used in combination with other antiretroviral agents:
Il- każijiet li ġejjin ġew rapportati wkoll meta l- pilloli VIRAMUNE ġew użati f' kombinazzjoni ma 'mediċini antiretrovirali oħrajn:
- a reduction in red blood cells or in platelets
- tnaqqis fiċ- ċelloli l- ħomor tad- demm jew fil- plejtlets,
These events are commonly associated with other antiretroviral agents and may be expected to occur when VIRAMUNE is used in combination with other agents; however, it is unlikely that these events are due to a treatment with VIRAMUNE.
jseħħu meta VIRAMUNE suspensjoni orali jiġi użat flimkien ma 'mediċini oħra; madankollu huwa x' aktarx improbabbli li dawn il- każijiet iseħħu minħabba trattament b’ VIRAMUNE.
As with rash symptoms, please inform your doctor of any side effects.
Bħal fil- każ ta ’ sintomi tar- raxx, jekk jogħġbok informa lit- tabib tiegħek minnufih Ta ’ xi effetti sekondarji.
Do not use VIRAMUNE after the expiry date which is stated on the carton and on the bottle after EXP.
Tużax VIRAMUNE wara d- data ta ’ skadenza li tidher fuq il- kartuna u fuq il- flixkun wara JIS.
VIRAMUNE should be used within 6 months of opening the bottle.
VIRAMUNE għandha tintuża fi żmien 6 xhur minn wara li jinfetaħ il- flixkun.
This medicinal product does not require any special storage conditions.
Dan il- prodott mediċinali m' għandhux bżonn ħażna speċjali.
Each ml contains 10 mg of the active substance nevirapine
Kull ml ta 'VIRAMUNE suspensjoni orali fiha 10 mg tas -
(as nevirapine hemihydrate).
sustanza attiva nevirapine (bħala nevirapine hemihydrate).
- The other ingredients are carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate,
- Is- sustanzi l- oħra huma carbomer, methyl parahydroxybenzoate, propyl parahydroxybenzoate,
sorbitol, sucrose, polysorbate 80, sodium hydroxide and water.
sorbitol, sukrożju, polysorbate 80, sodium hydroxide u ilma.
VIRAMUNE oral suspension is supplied in plastic bottles of suspension for oral use, with 240 ml suspension per bottle.
Is- suspensjoni orali VIRAMUNE tiġi fi fliexken tal- plastik għal suspensjoni għal użu orali, li tesa ’ 240 ml suspensjoni kull flixkun.
For measuring the correct dose a plastic measuring syringe is included.
Sabiex tkejjel id- doża korretta hemm inkluża siringa tal- kejl tal - plastik.
VIRAMUNE is also supplied as 200 mg tablets for older children and adults.
VIRAMUNE jiġi wkoll f’ pilloli ta ’ 200 mg għal tfal akbar u adulti
Boehringer Ingelheim Pharma GmbH & Co.
Manifattur Boehringer Ingelheim Pharma GmbH & Co.
78 For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
82 Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad - Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq.
România Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucuresti Tel: +4 021 330 99 63
România Boehringer Ingelheim RCV GmbH & Co KG Viena - Sucursala Bucuresti Reprezentanţa din România Tel: +4 021 330 99 63
What is Viread?
X’ inhi Viread?
Viread is a medicine containing the active substance tenofovir disoproxil, available as light blue almond-shaped tablets.
Viread hija mediċina li fiha s- sustanza attiva tenofovir disoproxil li tiġi bħala pilloli forma ta ’ lewża kulur ċelesti.
What is Viread used for?
Għal x’ hiex tintuża Viread?
Viread is an antiviral medicine.
Viread hija mediċina antivirali.
It is used in combination with other antiviral medicines to treat adults infected with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
Tintuża flimkien ma ’ mediċini antivirali oħra fit- trattament ta ’ adulti u tfal infettati bil- vajrus ta ’ l- immunodefiċjenza umana tat- tip 1 (HIV- 1), virus li jikkawża s- sindromu ta ’ l- immunodefiċjenza akkwiżita (AIDS).
For patients who have taken medicines to treat HIV infection before, doctors should only prescribe Viread once they have looked at the antiviral medicines the patient has taken before or the likelihood of the virus ’ s response to antiviral medicines.
Għal pazjenti li jkunu ħadu mediċini għat- trattament ta ’ infezzjoni bl- HIV u ma jkunux irrispondew għal dak it- trattament, it- tobba għandhom jippreskrivu Viread wara li jkunu raw x’ mediċini antivirali jkun diġà ħa l- pazjent jew wara li jkunu raw x’ inhi l- probabilità li l- virus jirrispondi għal mediċini antivirali.
How is Viread used?
Kif tintuża Viread?
Treatment with Viread should be initiated by a doctor who has experience in the treatment of HIV infection.
It- trattament b’ Viread għandu jinbeda minn tabib li jkollu esperjenza fit- trattament ta ’ l- infezzjoni ta ’ l- HIV.
The recommended dose of Viread is one tablet taken once a day with food.
Id- doża rakkomandata ta ’ Viread hi pillola waħda darba kuljum li tittieħed ma ’ l- ikel.
In exceptional cases, patients who have particular difficulty swallowing can crush the tablet in at least 100 ml of water, orange juice or grape juice, and drink the resulting suspension.
F’ każijiet eċċezzjonali, pazjenti li għandhom diffikultà partikolari biex jibilgħu jistgħu jfarrku l- pillola f’ għallinqas 100 ml ilma, meraq tal- larinġ jew ta ’ l- għeneb u jixorbu s- suspensjoni li tirriżulta.
The dose may need to be adjusted in patients who have problems with their kidneys.
Għal pazjenti li jbatu minn problemi fil- kliewi, jista ’ jkun hemm bżonn li d- doża tiġi aġġustata.
How does Viread work?
Kif taħdem Viread?
The active substance in Viread, tenofovir disoproxil, is a ‘ prodrug ’ that is converted into tenofovir in the body.
Is- sustanza attiva f’ Viread, tenofovir disoproxil, hi ‘ prodrug ’ li fil- ġisem tinbidel f’ tenofovir.
Tenofovir is a nucleotide reverse transcriptase inhibitor (NRTI) that blocks the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
Tenofovir huwa nucleotide reverse transcriptase inhibitor (NRTI) li jimblokka l- attività tar- reverse transcriptase, enzim prodott mill- HIV li jħallih jinfetta ċ- ċelloli u jimmultiplika.
Viread, taken in combination with other antiviral medicines, reduces the amount of HIV in the blood and keeps it at a low level.
Meta tittieħed ma ’ mediċini antivirali oħra, Viread tnaqqas l- ammont ta ’ HIV fid- demm u żżommu f’ livell baxx.
Viread does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Viread ma tfejjaqx infezzjoni ta ’ l- HIV jew ta ’ l- AIDS, iżda tista ’ ttawwal iż- żmien qabel ma tibda ssir ħsara lis- sistema immunitarja u qabel l- iżvilupp ta ’ infezzjonijiet u mardiet relatati ma ’ l- AIDS.
How has Viread been studied?
Kif ġiet studjata Viread?
Viread has been studied in three main studies involving 1,343 HIV-infected adults.
Viread ġiet studjata fi tliet studji ewlenin li fihom ħadu sehem 1, 343 adult infettati bl- HIV.
They had been taking HIV treatments for at least 4 years, but were not
L- ewwel żewġ studji qabblu l- effetti taż- żieda ta ’ Viread ma ’ dawk taż- żieda ta ’ plaċebo (trattament finta) f’ 741 pazjent.
7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Kienu ilhom jieħdu trattamenti kontra l- HIV għal mill- inqas 4 snin, madankollu 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 responding to them.
(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 ma kinux qed iwieġbu għalihom.
The main measure of effectiveness was the change in the level of HIV in the blood (viral load), after 4 or 24 weeks of treatment.
Il- kejl prinċipali ta ’ l- effettività kien il- bidla fil- livell ta ’ HIV fid - demm (tagħbija virali), għal 4 jew 24 ġimgħa ta ’ trattament.
The effects of Viread were also assessed in a study of 602 treatment-naïve patients (who had not taken HIV treatment before).
L- effetti ta ’ Viread ġew ivvalutati wkoll fi studju li sar fuq 602 pazjenti ġodda għat- trattament (ma ħadux trattament kontra l- HIV qabel).
The study compared the effects of either Viread with those of stavudine (another antiviral medicine) when they were taken together with lamivudine and efavirenz (other antiviral medicines).
L- istudju qabbel l- effetti ta ’ Viread ma ’ dawk ta ’ stavudine (mediċina antivirali oħra) meta ttieħdu flimkien ma ’ lamivudine u efavirenz (mediċini antivirali oħra).
The main measure of effectiveness was the number of patients with viral loads below 400 copies/ ml after 48 weeks.
Il- kejl ewlieni ta ’ l- effettività kien in- numru ta ’ pazjenti b’ tagħbija virali inqas minn 400 kopja/ ml wara 48 ġimgħa.
What benefit has Viread shown during the studies?
X’ inhuma l- benefiċċji ta ’ Viread li ntwerew f’ dawn l- istudji?
Viread, taken in combination with other antiviral medicines, caused a reduction in viral load.
Viread, meta meħuda ma ’ mediċini antivirali oħra, ikkawżat tnaqqis fil- tagħbija virali.
In the first study of treatment-experienced patients, those adding Viread to their existing treatment had a fall in viral load of 76% after 4 weeks, compared to a rise of 4% in the placebo group.
Fl- ewwel studju ta ’ pazjenti li kienu diġà ħadu trattament, dawk li kellhom Viread miżjuda mat- trattament eżistenti tagħhom kellhom tnaqqis fil- tagħbija virali ta ’ 76% wara 4 ġimgħat, meta mqabbel ma ’ żieda ta ’ 4% fil- grupp tal- plaċebo.
Similar results were seen after 24 weeks.
Riżultati simili dehru wkoll wara 24 ġimgħa.
The second study showed the same effect, with a 75% fall in the Viread group, compared to a fall 7% in those adding placebo, after 24 weeks.
It- tieni studju wera l- istess effett, bi tnaqqis ta ’ 75% fil- grupp ta ’ Viread, meta mqabbel ma ’ tnaqqis ta ’ 7% f’ dawk li kellhom plaċebo miżjud, wara 24 ġimgħa.
In treatment-naïve patients, Viread was as effective as stavudine, with similar numbers of patients in the Viread and stavudine groups having viral loads below 400 copies/ ml after 48 weeks.
F’ pazjenti li ma ħadux trattament qabel, Viread kienet effettiva daqs stavudine, b’ numru simili ta ’ pazjenti fil- gruppi ta ’ Viread u ta ’ stavudine b’ tagħbijiet virali inqas minn 400 kopja/ ml wara 48 ġimgħa.
What is the risk associated with Viread?
X’ riskji huma assoċjati ma ’ Viread?
The most common side effects when taking Viread (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, diarrhoea, dizziness, and hypophosphataemia (low levels of phosphate in the blood).
L- iktar effetti sekondarji komuni meta wieħed jieħu Viread (li dehru f’ iktar minn pazjent wieħed minn kull 10) huma dardir, dijarea, stordament u hypophosphataemia (livelli baxxi ta ’ phosphate fid- demm).
For the full list of side effects reported with Viread, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rappurtati ma ’ Viread, ara l- Fuljett ta ’ Tagħrif.
Viread should not be used in people who may be hypersensitive (allergic) to tenofovir, to tenofovir disoproxil fumarate, or to any of the other ingredients.
Viread m’ għandhiex tintuża minn persuni sensittivi żżejjed (allerġiċi) għal tenofovir, għal tenofovir disoproxil fumarate jew għal kwalunkwe sustanza oħra minn tiegħu.
As with other anti-HIV medicines, patients taking Viread may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal fil- każ ta ’ mediċini oħra ta ’ kontra l- HIV, il- pazjenti li jkunu qed jieħdu Viread jista ’ jkollhom riskju ta ’ lipodistrofija (tibdil fid- distribuzzjoni tax- xaħam tal- ġisem), ostjonekrożi (mewt tat- tessut tal- għadam) jew sindromu tar- riattivazzjoni immuni (sintomi ta ’ infezzjoni kkawżata mill- irkupru tas - sistema immunitarja).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Viread.
Pazjenti li jkollhom problemi bil- fwied (inklużi infezzjonijiet ta ’ l- epatite B jew C) jista ’ jkollhom riskju ikbar ta ’ ħsara fil- fwied meta jieħdu Viread.
As with all other NRTIs, Viread may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Viread during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Bħal fil- każ ta ’ l- NRTIs kollha l - oħra, Viread tista ’ tikkawża wkoll aċidożi lattika (żieda fil- livell ta ’ aċidu lattiku fil- ġisem) u, fit- trabi ta ’ ommijiet li jkunu qed jieħdu Viread waqt it- tqala, disfunzjoni mitokondrijali (ħsara fil- komponenti li jipproduċi l- enerġija fiċ- ċelloli li tista ’ tikkawża problemi fid- demm).
Why has Viread been approved?
Għaliex ġiet approvata Viread?
The Committee for Medicinal products for Human Use (CHMP) decided that Viread’ s benefits are greater than its risks in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected patients over 18 years of age.
Il- Kumitat għall- Prodotti Mediċinali għal Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Viread huma ikbar mir- riskji tagħha meta tittieħed flimkien ma ’ prodotti mediċinali antiretrovirali oħra għat- trattament ta ’ pazjenti infettati bl- HIV- 1 li għandhom iktar minn 18- il sena.