qanastek/EMEA-V3 huggingface dataset:
If you have taken Ziagen during your pregnancy, your doctor may request regular visits to monitor the development of your child.
Jekk tkun ħadt Ziagen waqt it- tqala, it- tabib jista ’ jitlob visti regolari biex josserva l- iżvilupp tat- tarbija tiegħek.
In children whose mother took nucleoside and nucleotide analogues during pregnancy, the benefit from the reduced chance of being infected with HIV is greater than the risk of suffering from side effects.
Fi tfal fejn l- omm tkun ħadet nukleosidi u analogi tan- nukleotidi waqt it- tqala, huwa akbar il - benefiċċju minħabba li tnaqqas iċ- ċans ta ’ xi infezzjoni milli huwa r- riskju li ssoffri xi effetti mhux mixtieqa.
The active substance abacavir in this medicine is likely to be found in human breast milk.
Is- sustanza attiva abacavir f`din il- mediċina huwa possibli li tkun qiegħda fil- ħalib tas- sider uman.
There are no safety data available following treatment with Ziagen in babies under three months of age.
M`hemm l- ebda tagħrif ta ’ sigurtà fuq kura b`Ziagen f’ trabi ta ’ anqas minn tlett xhur.
You are therefore recommended not to breast-feed your baby while taking Ziagen.
Għalhekk qiegħed jiġi rakkomandat sabiex ma treddax lit- tarbija tiegħek meta tkun qiegħda tieħu Ziagen.
Additionally, it is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV from mother to child.
Huwa rakkomandat ukoll, li nisa li huma infettati bl- HIV m`għandhom taħt l- ebda ċirkostanza jreddgħu lit - trabi tagħhom sabiex ikun evitat li tinfirex il- marda tal- HIV mill- omm għat- tarbija.
If you are breast-feeding you must inform your doctor.
Jekk qed tredda’ għandek tinforma lit- tabib.
Driving and using machines No studies on the effects of Ziagen on the ability to drive and use machines have been performed.
Ma saru l- ebda studji fuq l- effetti ta ’ Ziagen fuq l- abilita ’ li ssuq jew tħaddem magni.
However, you should take into account the state of your health and the possible side effects of Ziagen before considering driving or using machines.
Madankollu, għandek tqis l- istat ta ’ saħħtek u l- effetti mhux mixtieqa li jista ’ jkun hemm qabel taħsibha biex issuq jew tuża xi magni.
HOW TO TAKE ZIAGEN
KIF JITTIEĦED ZIAGEN
Always take Ziagen exactly as your doctor has told you, and take great care not to miss any doses if at all possible.
Dejjem għandek tieħu Ziagen eżatt skond kif qallek it- tabib, u oqgħod attent ħafna li ma titlifx xi doża minnhom jekk jista jkun.
You should check with your doctor or pharmacist if you are not sure.
Għandek tiċċekkja mat- tabib jew lill- ispiżjar tiegħek jekk m’ intix żgur.
This can be taken either as one 300 mg tablet twice a day approximately 12 hours apart or two 300 mg tablets once a day.
Id- doża normali ta ’ kuljum ta` Ziagen fl- adulti u adolexxenti ‘ l fuq minn 12- il sena hija 600 mg Din tista ’ teħodha jew bħala pillola ta ’ 300mg waħda darbtejn kuljum bejn wieħed u ieħor 12 ’ il siegħa min xulxin jew inkella żewġ pilloli ta ’ 300mg darba kuljum.
In children three months to 12 years of age the dose given depends on the body weight of your child.
Fi tfal ta` tlett xhur sa tnax- il sena d- doża li tingħata tiddependi fuq il- piż tat- tarbija.
Children weighing at least 30 kg should take the adult dose of one tablet twice daily.
Tfal li jiżnu mill- anqas 30kg għandhom jieħdu id- doża ta ’ l- adulti ta ’ pillola darbtejn kuljum.
52 Children weighing more than 21 kg to less than 30 kg: one-half of a Ziagen tablet taken in the morning and one whole tablet taken in the evening.
Tfal li jiżnu aktar minn 21kg sa anqas minn 30kg: nofs pillola Ziagen filgħodu u pillola sħiħa filgħaxija.
Children weighing 14 to 21 kg: one-half of a Ziagen tablet twice daily.
Tfal li jiżnu minn 14 sa 21kg: nofs pillola Ziagen darbtejn kuljum.
Swallow the tablet(s) with water.
Ibla ’ l- pillola( i) ma ’ l- ilma.
An oral solution (20 mg abacavir/ ml) is also available for the treatment of children over three months and weighing less than 14 kg and patients who require a reduction in the usual dose or for patients unable to take tablets.
Soluzzjoni li tittieħed mill- ħalq (20 mg abacavir/ ml) tista tinstab ukoll għall- kura tat- tfal ta ’ aktar minn tlett xhur u li jiżnu anqas minn 14kg u pazjenti li għandhom bżonn tnaqqis fid- doża normali jew għal pazjenti li ma jistgħux jieħdu pilloli.
If you take more Ziagen than you should If you accidentally take too much of your medicine you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Madanakollu, int għandek tgħid lit- tabib jew lill- ispiżjar tiegħek jew irrikorri f’ dipartiment ta ’ emerġenza ta ’ l- eqreb sptar għall- parir.
If you forget to take Ziagen If you forget to take a dose of your medicine, take it as soon as you remember, and then continue as before.
Jekk tinsa tieħu Ziagen Jekk tinsa tieħu doża mill- mediċina tiegħek, ħudha hekk kif tiftakar, imbgħad kompli ħudha bħal qabel.
Do not take a double dose to make up for a forgotten dose.
Tieħux doża doppja biex tagħmel tajjeb għal dik id- doża li ma kontx ħadt.
It is important to take Ziagen regularly because irregular intake may increase the risk of hypersensitivity reactions.
Huwa importanti li tieħu Ziagen b`mod regolari għaliex jekk tieħdu b’ mod irregolari jista jkun hemm zieda fir - reazzjonijiet ta ’ sensittività eċċessiva.
If you stop taking Ziagen If you have stopped taking Ziagen for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting.
Jekk tieqaf tieħu Ziagen Jekk waqaft tieħu Ziagen għal xi raġuni, b`mod speċjali għaliex taħseb li qed ikollok xi effetti oħra jew minħabba xi mard ieħor, huwa importanti li tkellem lit- tabib tiegħek qabel ma terġa tibda teħodha.
In some cases your doctor will ask you to restart Ziagen in a place where you will be able to get ready access to medical care if needed.
F`xi każijiet, it- tabib jgħidlek sabiex terġa tibda tieħu Ziagen f`post fejn tkun tista tingħata kura medika fil - pront f’ każ ta ’ bżonn.
Like all medicines, Ziagen can cause side effects, although not everybody gets them.
Bħal kul mediċina oħra, Ziagen jista jagħmel xi effetti mhux mixtieqa, għalkemm ma jidhrux fuq kulħadd.
When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Ziagen, by other medicines you are taking at the same time or by the HIV disease.
Meta tkun qiegħed tingħata kura għall- infezzjonijiet kontra l- HIV, mhux dejjem huwa possibli li tgħid jekk xi wħud mill- effetti mhux mixtieqa li jidhru humiex kawżati b ’ Ziagen,
For this reason it is very important that you inform your doctor about any changes in your health.
Għal din ir- raġuni huwa importanti ħafna li tgħid lit- tabib jekk tħoss xi tibdiliet f’ saħħtek.
A hypersensitivity reaction (serious allergic reaction) has been reported in about 5 in every 100 patients who have been treated with Ziagen.
Reazzjoni ta` sensittività eċċessiva (reazzjoni ta ’ allerġija serja) deheret f`5 każijiet minn kull 100 pazjent li ngħataw il- kura b`Ziagen.
This is described under “ Take special care with Ziagen ” in section 2 of this leaflet.
Id- dettalji jidhru taħt “ Oqgħod attent ħafna b’ Ziagen f`sezzjoni 2 ta` dan il- fuljett.
It is important that you read and understand the information about this serious reaction.
Huwa importanti li taqra u tifhem l- informazzjoni fuq is- serjetà ta` dawn ir- reazzjonijiet.
Common side effects (reported in 1 to 10 out of 100 patients):
Effetti mhux mixtieqa komuni (rrappurtati f’ 1 sa 10 minn 100 pazjent):
- skin rash (without any other illness)
- raxx fil- ġilda (mingħajr sinjal ta ’ mard ieħor)
-nausea, vomiting, diarrhoea, -headache, -high temperature, -lethargy, fatigue, loss of appetite
- letarġija, għejja, nuqqas ta ’ aptit.
Rare side effects (reported in less than 1 in 1000 patients): -inflammation of the pancreas (pancreatitis).
Effetti mhux mixtieqa rari (rrappurtati f’ anqas min 1 sa 1000 pazjent)
Very rare side effects (reported in less than 1 in 10,000 patients): -serious skin reactions
Effetti mhux mixtieqa rari ħafna (rrappurtati f’ anqas min 1 sa 10, 000 pazjent)
53 Cases of a condition called lactic acidosis, which is a build up of lactic acid in the body, that can cause dehydration and coma have been reported on rare occasions in patients taking NRTIs (see ” Take special care with Ziagen ” under section 2 for more information).
Każijiet ta` kundizzjoni imsejjħa aċidożi lattika, li hija akkumulazzjoni ta ’ aċidu lattiku fil- ġisem, li tista tikkawża diżidratazzjoni u koma ġew rappurtati f`każijiet rari f`pazjenti li qegħdin jieħdu NRTIs (Għal aktar informazzjoni ara “ Oqgħod attent ħafna b’ Ziagen ” f’ sezzjoni 2).
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
Terapija antiretrovirali kombinata tista tikkawża xi bidliet fil- forma tal- ġisem minħabba ridistribuzzjoni 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 mis- saqajn, dirgħajn u wiċċ, żieda ta` xaħam fl- addome (żaqq) u organi interni oħra, tkabbir tas- sider u għoqda tax- xaħam fuq il - wara ta` l- għonq ('buffalo hump').
The cause and long-term health effects of these conditions are not known at this time.
Il- kawża u l- effetti fuq is- saħħa li jkun hemm fuq perijodu twil ta ’ żmien għadhom mhux mgħarufin s`issa.
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 kombinata b’ antiretrovirali tista tikkawża wkoll żieda ta` aċidu lattiku u zokkor fid- demm, iperlajpimja (xaħam għoli fid- demm) u reżistenza għall- insulina.
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 min dawn l- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE ZIAGEN
KIF TAĦŻEN ZIAGEN
Keep out of the reach and sight of children.
Żomm fejn ma jintlaħaqx u ma jintlemaħx mit- tfal.
Do not use Ziagen after the expiry date which is stated on the package.
Tużax Ziagen wara d- data ta ’ skadenza li tidher fuq il- kaxxa.
Do not store above 30°C.
Taħżinx f`temperatura `l fuq minn 30°C.
Medicines should not be disposed of via wastewater or household waste.
il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Ziagen contains
X’ fih Ziagen
Each Ziagen film-coated tablet contains 300 mg of the active ingredient abacavir (as sulfate).
Kull pillola miksija b’ rita ta ’ Ziagen fiha 300 mg tas- sustanza attiva abacavir (bħala sulfate).
The tablet core contains microcrystalline cellulose, sodium starch glycollate, magnesium stearate and colloidal anhydrous silica.
Il- qalba tal- pillola fiha microcrystalline cellulose, sodium starch glycollate, magnesium stearate u colloidal anhydrous silica.
The tablet coating contains triacetin, methylhydroxypropylcellulose, titanium dioxide, polysorbate 80 and iron oxide yellow.
Ir- rita tal- pillola fiha triacetin, methylhydroxypropylcellulose, titanium dioxide, polysorbate 80 u iron oxide yellow.
What Ziagen looks like and contents of the pack
Id- dehra tal- prodott u l- kontenuti tal- pakkett
The film-coated, scored capsule shaped tablets are yellow and engraved with ‘ GX 623 ’ on both sides.
Il- pillola mnaqqxa biex tkun tista ’ taqsamha miksija b’ rita, għandha forma ta ’ kapsola, għandha kulur isfar u għandha marka ‘ GX 623 ’ imnaqqxa fuq żewġ naħat waħda.
They are provided in blister packs containing 60 tablets.
Il- pilloli ssibhom f’ folja li jkun fiha 60 pillola.
54 Marketing Authorisation Holder and Manufacturer (s)
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur
Manufacturer
Manufattur
Marketing authorisation holder
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis- Suq
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) Priory Street Ware Herts SG12 0DJ United Kingdom
Glaxo Wellcome Operations Priory Street Ware Herts SG12 0DJ Ir- Renju Unit
Danmark GlaxoSmithKline Pharma A/ S Tlf: + 45 36 35 91 00 info@glaxosmithkline. dk
Nederland Danmark GlaxoSmithKline BV GlaxoSmithKline Pharma A/ S Tel: + 31 (0) 306938100 Tlf: + 45 36 35 91 00 nlinfo@ gsk. com info@ glaxosmithkline. dk
Deutschland GlaxoSmithKline GmbH & Co.
57 Norge Deutschland GlaxoSmithKline GlaxoSmithKline GmbH & Co.
Ελλάδα GlaxoSmithKline A. E. B. E.
Tel.:
Τηλ: + 30 210 68 82 100
48 (0) 22 576 9000 Τηλ: + 30 210 68 82 100
Polska GSK Commercial Sp. z o. o.
Glaxo Wellcome Farmacêutica, Lda.
55 España GlaxoSmithKline, S. A.
España Tel: + 351 21 412 95 00 GlaxoSmithKline, S. A.
Tel: + 34 902 202 700 es-ci@gsk. com
FI. PT@ gsk. com Tel: + 34 902 202 700 es- ci@ gsk. com
Tel: + 4021 3028 208
România France GlaxoSmithKline (GSK) S. R. L.
Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000
Laboratoire GlaxoSmithKline Tel: + 3028 208 Tél.: + 33 (0) 1 39 17 84 44 www. gsk. ro diam@ gsk. com
Tel: + 386 (0)1 280 25 00 medical. x. si@gsk. com
GlaxoSmithKline (Ireland) Limited Tel: + 44 (0) 1 280 25 00 Tel: + 353 (0) 1 4955000 medical. x. si@ gsk. com
This leaflet was last approved in {MM/ YYYY}
58 Dan il- fuljett kien approvat l- aħħar f ’
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
Informazzjoni ddettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- mediċini (EMEA) http: // www. emea. europa. eu /
Ziagen 20 mg/ ml Oral Solution abacavir
ZIAGEN 20 mg/ ml SOLUZZJONI LI TITTIEĦED MILL- ĦALQ abacavir
if their symptoms are the same as yours.
anki jekk ikollom l- istess sintomi bħall- tiegħek.
It is essential you read the information on this reaction under “ Take special care with Ziagen” in section 2 of this leaflet.
Huwa essenzjali li taqra l- informazzjoni fuq din ir- reazzjoni fis- sezzjoni “ Oqgħod attent ħafna b’ Ziagen "f’ sezzjoni 2 f’ dan il- fuljett.
There is also an Alert Card included in the Ziagen pack, to remind you and medical staff about Ziagen hypersensitivity.
Hemm ukoll Alert Card inkluża fil- pakkett ta ’ Ziagen, biex ifakkar lilek u lill- istaff mediku dwar dan l- effett ta ’ sensittività eċċessiva ta` Ziagen.
Ziagen belongs to a group of antiviral medicines, also known as antiretrovirals, called nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Ziagen jifforma parti minn grupp ta ’ mediċini antivirali, mgħarufin ukoll bħala antiretrovirali, msemmija nucleoside analogue reverse transcriptase inhibitors (NRTIs).
Ziagen is used in combination with other antiretroviral medicines for the treatment of HIV infection.
Ziagen jintuża flimikien ma ’ mediċini antiretrovirali oħra għal- kura ta ’ l- infezzjoni tal- HIV.
CD4 cells are a type of white blood cell that play an important role in maintaining a healthy immune system to help fight infection.
Ċelloli CD4 huma tip ta ’ ċelloli bojod li għandhom rwol importanti sabiex iżommu fi stat tajjeb, is- sistema
Response to treatment with Ziagen varies between patients.
60 immunitarja sabiex din tiġġieled l- infezzjoni.
Your doctor will be monitoring the effectiveness of your treatment.
Ir- rispons għal- kura b’ Ziagen ivarja minn pazjent għal ieħor.
BEFORE YOU TAKE ZIAGEN
2 QABEL MA ’ TIEĦU ZIAGEN
- if you are allergic (hypersensitive) to the active substance abacavir, which is also included in
- Jekk inti allerġiku (għandek sensittività eċċessiva) għas- sustanza attiva abacavir li ssibha wkoll
- if you are allergic to any of the other ingredients in Ziagen
- Jekk inti allerġiku għall xi ingredjent oħra ta ’ Ziagen
- if you have severe liver disease
- Jekk inti għandek xi mard tal- fwied gravi.
Other frequently observed signs or symptoms include nausea, vomiting, diarrhoea, abdominal pain and severe tiredness.
Sintomi komuni oħra huma dardir, remettar, dijarrea, uġigħ addominali, għejja qawwija.
-shortness of breath, sore throat or cough -nausea or vomiting or diarrhoea or abdominal pain -severe tiredness or achiness or generally feeling ill
ikollok raxx fuq il- ġilda JEW ikollok wieħed jew aktar sintomi ta ’ mill- anqas TNEJN minn dawn il- gruppi li ġejjin: - deni - qtugħ ta`nifs, uġigħ fil- griżmejn jew sogħla - nawżeja jew rimettar jew dijarrea jew uġigħ addominali - għejja severa jew ituk weġat jew jekk ma tħossokx tiflaħ.
If you have discontinued Ziagen due to a hypersensitivity reaction, YOU MUST NEVER TAKE Ziagen or any other medicine containing abacavir (i. e.
Jekk kont waqaft tieħu Ziagen minħabba din ir- reazzjoni, QATT M`GHANDEK TERĠA TIEĦU Ziagen jew xi mediċina li fiha abacavir (i. e.
Kivexa, Trizivir) again, as within hours you may experience a life-threatening lowering of your blood pressure or death.
Kivexa, Trizivir), minħabba li fi ftit sigħat tista titbaxxilek il- pressjoni f’ daqqa u tkun ta` periklu għall- ħajjtek, jew tmut.
If you have stopped taking Ziagen for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting.
Jekk waqaft tieħu Ziagen għal xi raġuni, l- aktar għax taħseb illi għandek xi effetti oħra, jew għax għandek xi mard ieħor, huwa importanti li tieħu l- parir tat- tabib tiegħek qabel ma terġa tibda l- kura.
Your doctor will check whether any symptoms you had may be related to this hypersensitivity reaction.
61 relatati ma ’ din ir- reazzjoni ta ’ sensittività eċċessiva.
Occasionally life-threatening hypersensitivity reactions have occurred when Ziagen was restarted in patients who reported only one of the symptoms on the Alert Card before stopping.
Xi drabi, reazzjonijiet ta ’ sensittività eċċessiva ta ’ periklu għall- ħajja seħħew f’ pazjenti li reġgħu ħadu Ziagen wara li kienu waqfuh minħabba li kellhom wieħed biss mis- sintomi li jidhru fuq l- Alert Card qabel ma waqfuh.
58 On very rare occasions hypersensitivity has been reported when Ziagen was restarted in patients who had no symptoms of hypersensitivity before stopping.
F’ każijiet rari ħafna, reazzjonijiet ta ’ sensittività eċċessiva dehru f’ pazjenti li reġgħu ħadu Ziagen mingħajr ma kellhom l- ebda sintomu ta ’ sensittività eċċessiva waqt il- kura meta ħaduh l- ewwel darba.
Liver disease/ hepatitis: please tell your doctor if you have a history of liver disease.
Mard tal- fwied: jekk joħoġbok kellem lit- tabib hekk ġieli bgħatejt minn mard tal- fwied.
Patients with chronic hepatitis B or C and treated with antiretroviral agents are at increased risk of severe and potentially fatal liver adverse events and may require blood tests for monitoring of liver function.
Pazjenti b’ epatite B jew C kronika u li qegħdin jingħataw kura b' mediċini antiretrovirali huma f`riskju akbar ta ’ effetti mhux mixtieqa fuq il- fwied, u dawn jistgħu ikunu severi u ta ’ periklu għall- ħajja, u jista jkun hemm il- bżonn ta` testijiet tad- demm għall- osservazzjoni fuq il- funzjoni tal- fwied.
Pancreatitis: inflammation of the pancreas (pancreatitis) has been reported in some patients taking Ziagen.
(pancreatite).
Some patients taking combination antiretroviral therapy may develop a bone disease called osteonecrosis (death of bone tissue caused by loss of blood supply to the bone).
Xi pazjenti li jkunu fuq terapija antiretrovirali kombinata jistgħu jiżvi# luppaw marda fl- għadam imsejħa osteonekrożi (mewt tat- tessuti ta ’ l- għadam kawżata min nuqqas ta ’ demm fl- għadam).
The length of combination antiretroviral therapy, corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index, among others, may be some of the many risk factors for developing this disease.
Sinjali ta ’ osteonekrożi huma ebusija fil -
Signs of osteonecrosis are joint stiffness, aches and pains (especially of the hip, knee and shoulder) and difficulty in movement.
62 ġogi, uġigħ (speċjalment fl- għadam tal- ġenbejn, fl- irkobbtejn u fl- ispalel) u diffikulta` fil- moviment.
Ziagen helps to control your condition but is not a cure for HIV infection.
Ziagen jgħin sabiex jikkontrolla l- kundizzjoni iżda ma jfejjaqx l- infezzjoni ta`l- HIV.
Treatment with Ziagen has not been shown to reduce the risk of passing HIV infection on to others by sexual contact or by blood transfer.
Il- kura b`Ziagen għadha m’ urietx li tista tnaqqas ir- riskju tat- tixrid ta` l- infezzjoni tal- HIV lill - ħaddieħor minn kuntatti sesswali jew mid- demm.
59 Taking other medicines Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Jekk jogħġbok għid lit- tabib jew lill- ispiżjar tiegħek jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta.
If you are taking oral vitamin A related medicines, e. g. isotretinoin, you should inform your doctor, since these may also increase the amount of abacavir in your blood.
Jekk qiegħed tieħu mediċini relatati mall- Vitamina A, eż isotreninoin, għandek tinforma lit- tabib tiegħek, billi dan jista ’ jżid l- ammont ta ’ abacavir fid - demm.
If you are breast-feeding you must inform your doctor.
Jekk qed tredda ’ għandek tinforma lit- tabib.
Important information about some of the other ingredients of Ziagen oral solution
Tagħrif importanti dwar xi wħud mis- sustanzi ta ’ Ziagen
This medicine contains the sweetener sorbitol (approximately 5 g in each 15 ml dose), which may have a mild laxative effect.
Din il- mediċina fiha ħlewwa ta`sorbitol (ta` madwar 5g f`kull doża ta`15 ml), li jista ’ jkollu effett lassattiv ħafif.
Medicines containing sorbitol should not be taken if you have hereditary fructose intolerance.
Mediċini li fihom sorbitol m`għandhomx jittieħdu jekk għandek intolleranza għal fructose ereditarja.
The calorific value of sorbitol is 2.6 kcal/ g.
Il- valur kalorifiku ta ’ Sorbitol hu 2. 6kcal/ g.
Ziagen oral solution also contains methyl parahydroxybenzoate and propyl parahydroxybenzoate which may cause allergic reactions (possibly delayed).
Is- soluzzjoni ta ’ Ziagen li tittieħed mill- ħalq fiha wkoll methyl parahydroxybenzoate u propyl parahydroxybenzoate li jistgħu jagħmlu reazzjonijiet allerġiċi (forsi aktar tard)
You should check with your doctor or pharmacist if you are not sure.
Għandek tistaqsi lit- tabib jew lill- ispiżjar tiegħek jekk ma tkunx ċert.
The usual daily dose of Ziagen in adults and adolescents over 12 years of age is 600 mg (30 ml).
Id- doża normali ta kuljum ta` Ziagen fl- adulti u adolexxenti l fuq mill- eta ta` 12- il sena hija 600mg (30ml).
This can be taken either as 300 mg (15 ml) twice a day approximately 12 hours apart or 600 mg (30 ml) once a day.
Din tista ’ tittieħed jew 300 mg (15ml) darbtejn kuljum bejn wieħed u ieħor 12’ il siegħa min xulxin jew 600mg (30ml) darba kuljum.
Ziagen does not have to be taken with food.
M’ għandekx għalfejn tieħu Ziagen ma ’ l- ikel.
60 In children three months to 12 years of age the dose given depends on the body weight of your child.
Fi tfal ta` tlett xhur sa tnax- il sena d- doża li tingħata tiddependi fuq il- piż tat- tarbija.
The recommended dose is 8 mg/ kg twice a day up to a maximum of 600 mg daily.
Id- doża rakkomandata hija 8 mg/ kg darbtejn kuljum sa massimu ta ’ 600 mg kuljum.
Use the oral dosing syringe supplied with the pack to measure your dose accurately.
Uża s- siringa li tinstab fil- pakkett biex tkejjel id- doża eżatta li tittieħed mill- ħalq.
Remove the bottle cap.
Neħħi l- għatu.
Push the plastic adapter into the neck of the bottle, while holding the bottle firmly.
Imbotta l- adapter tal- plastik fl- għonq tal- flixkun, filwaqt li żomm il- flixkun sewwa.
Turn bottle upside down.
Aqleb il- flixkun rasu l- isfel.
Pull out syringe plunger until the correct amount is withdrawn.
Iġbed il- planġer tas- siringa sakemm jiġi mkejjel l- ammont eżatt.
Turn the bottle the correct way up and remove the syringe from the adapter.
Dawwar il- flixkun b`rasu l- fuq kif suppost u neħħi s- siringa mill- adapter.
Replace and tighten the bottle cap.
Erġa poġġi l- għatu fuq il- flixkun u ssikkaħ sew.
Administer the dose into the mouth by placing the tip of the syringe against the inside of the cheek.
Poġġi d- doża fil- ħalq billi tpoġġi il- ponta tas- siringa ma ġewwa tal- ħadd tal- wiċċ.
Slowly depress the plunger, allowing time to swallow.
Bil- mod għafas il- planġer, u ħalli żmien sabiew id doża tinbela.
Forceful squirting to the back of the throat may cause choking.
Jekk tagħfas bil- qawwa għal fuq wara tal- griżmejn tista tifga.
After use the syringe must not be left in the bottle and should be washed thoroughly in clean water.
Wara l- użu s- siringa m`għandix titħalla fil- flixkun u għandha tinħasel sewwa f`ilma nadif.
If you take more Ziagen than you should If you accidentally take too much of your medicine you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Jekk tieħu Ziagen aktar milli suppost Jekk aċċidentalment tieħu ammont ta ’ mediċina aktar milli suppost, għandek tgħid lit- tabib jew lill - ispiżjar tiegħek jew irrikorri f’ dipartiment ta ’ emerġenza ta ’ l- eqreb sptar għall- parir.
Do not take a double dose to make up for forgotten individual doses.
Tieħux doża doppja biex tagħmel tajjeb għal dawk id- dożi waħdiet li ma kontx ħadt.
It is important to take Ziagen regularly because irregular intake may increase the risk of hypersensitivity reactions.
Huwa importanti li tieħu Ziagen b`mod regolari għaliex jekk tieħdu b’ mod irregolari jista jkun hemm zieda fir- reazzjonijiet ta ’ sensittività eċċessiva.
If you stop taking Ziagen If you have stopped taking Ziagen for any reason, particularly because you think you are having side effects or for other illness, it is important that you contact your doctor before restarting.
F`xi
In some cases your doctor will ask you to restart Ziagen in a place where you will be able to get ready access to medical care if needed.
64 każijiet, it- tabib jgħidlek sabiex terġa tibda tieħu Ziagen f`post fejn tkun tista tingħata kura medika fil - pront f’ każ ta ’ bżonn.
Like all medicines, Ziagen can cause side effects although not everybody gets them.
Bħal kull mediċina oħra, Ziagen jista jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Ziagen, by other medicines you are taking at the same time or by the HIV disease.
Meta tkun qiegħed tingħata kura għall- infezzjonijiet kontra l- HIV, mhux dejjem huwa possibli li tgħid jekk xi wħud mill- effetti mhux mixtieqa li jidhru humiex kawżati b ’ Ziagen, b`mediċini oħra li qed tieħu fl- istess ħin jew bil- marda tal- HIV.
This is described under “ Take special care with Ziagen” in section 2 of this leaflet.
Id- dettalji jidhru f`sezzjoni “ Oqgħod attent ħafna b’ Ziagen ” f’ sezzjoni 2 ta` dan il- fuljett.
It is important that you read and understand the information about this serious reaction.
Huwa importanti li taqra u tifhem l- informazzjoni fuq is - serjetà ta` dawn ir- reazzjonijiet.
61 Cases of a condition called lactic acidosis, which is a build up of lactic acid in the body, that can cause dehydration and coma have been reported on rare occasions in patients taking NRTIs (see “ Take special care with Ziagen” in section 2 for more information).
Każijiet ta` kundizzjoni imsejjħa aċidożi lattika, li hija akkumulazzjoni ta ’ aċidu lattiku fil- ġisem, li tista tikkawża diżidratazzjoni u koma ġew rappurtati f`każijiet rari f`pazjenti li qegħdin jieħdu NRTIs (Għal aktar informazzjoni ara “ Oqgħod attent ħafna b’ Ziagen ” f’ sezzjoni 2).
Keep out of the reach and sight of children.
KIF TAĦŻEN ZIAGEN Żomm fejn ma jintlaħaqx u ma jintlemaħx mit- tfal.
Do not store above 30°C.
Taħżinx f`temperatura `l- fuq minn 30°C.
Discard oral solution two months after first opening.
Armi s- soluzzjoni li tittieħed mill- ħalq wara xaharejn minn meta tkun ftaħt il- flixkun.
Medicines should not be disposed of via wastewater or household waste.
65 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Ziagen contains
AKTAR TAGĦRIF
Ziagen oral solution contains 20 mg of the active ingredient abacavir (as sulfate) in each ml of the solution.
Is- soluzzjoni li tittieħed mill- ħalq ta ’ Ziagen fiha 20mg ta ’ abacavir bħala sustanza attiva (bħala sulphate) f’ kull ml ta ’ likwidu.
Sorbitol 70% (E420), saccharin sodium, sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol (E1520), maltodextrin, lactic acid, glyceryl triacetate, natural and artificial strawberry and banana flavour, purified water.
Sorbitol 70%, saccharin sodium, sodium citrate, citric acid anhydrous, methyl parahydroxybenzoate (E218), propyl parahydroxybenzoate (E216), propylene glycol, maltodextrin, lactic acid, glyceryl triacetate, ħwawar naturali u artifiċjali tal- frawli u tal- banana, ilma purifikat.
What Ziagen looks like and contents of the pack
Id- dehra tal- prodott u l- kontenut tal- pakkett
Ziagen oral solution is clear to yellowish in colour with strawberry/ banana flavouring.
Is- soluzzjoni ta` Ziagen hija ta`kulur bejn dik ċara u safranija b`togħma tal- frawli/ banana.
It is supplied in cartons containing a white polyethylene bottle, with a child resistant cap.
Din tinxtara f`kaxxi li fihom fliexken bojod ta` polyethylene, b`tap li ma jistax jinfetaħ mit- tfal.
The bottle contains 240 ml (20 mg abacavir/ ml) of solution.
Il- flixkun fih 240 ml li għandu soluzzjoni ta` (20 mg ta ’ abacavir/ ml).
A 10 ml oral dosing syringe and a plastic adapter for the bottle is included in the pack.
Siringa ta` 10 ml biex tkejjel id- doża li tittieħed mill- ħalq u adapter tal- plastik għall- flixkun jinstabu fil- pakkett.
62 Marketing Authorisation Holder and Manufacturer
Id- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq u l- Manifattur:
Marketing authorisation holder
Id- detentur ta ’ l- Awtorizzazzjoni għat - Tqegħid fis- Suq
Glaxo Wellcome GmbH & Co.
Glaxo Wellcome GMBH & Co.
KG Industriestrasse 32-36 23843 Bad Oldesloe Germany
KG Industriestrasse 32- 36 23843 Bad Oldesloe Il- Ġermanja
For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Għall kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali tad- detentur ta ’ l- awtorizzazzjoni għat- tqegħid fis- suq:
Deutschland GlaxoSmithKline GmbH & Co.
66 Deutschland GlaxoSmithKline GmbH & Co.
Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00 firmapost@gsk. no
Norge GlaxoSmithKline Tlf: + 47 22 70 20 00 firmapost@ gsk. no
Tel: + 386 (0)1 280 25 00 medical. x. si@gsk. com
Tel: + 44 386 (0) 1 280 25 00 medical. x. si@ gsk. com
This leaflet was last approved in {MM/ YYYY}
67 Dan il- fuljett kien approvat l- aħħar f ’
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu
dwar il- mediċini (EMEA) http: // www. emea. europa. eu /
EUROPEAN PUBLIC ASSESSMENT REPORT (EPAR)
at RAPPORT TA ’ VALUTAZZJONI PUBBLIKA EWROPEW (EPAR)
or ZIMULTI
izz ZIMULTI
This document is a summary of the European Public Assessment Report (EPAR).
tor Dan id- dokument huwa sommarju tar- Rapport ta ’ Valutazzjoni Pubblika Ewropew (EPAR).
It explains how the
Huwa
ra Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
aw jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, biex jissodisfa ir- rakkomandazzjonijiet tagħhom dwar kif tintuża l- mediċina.
If you need more information about your medical condition or your treatment, read the Package Leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Jekk inti teħtieġ aktar informazzjoni dwar il- kondizzjoni medika tiegħek jew it- trattament tiegħek, aqra l - Fuljett ta ’ Tagħrif (huwa parti wkoll mill- EPAR) jew ikkuntattja lit- tabib jew lill- ispiżjar tiegħek.
If you want more information on the basis
Jekk trid
ge of the CHMP recommendations, read the Scientific Discussion (also part of the EPAR).
ux aktar informazzjoni abbażi tar- rakkomandazzjonijiet ta ’ CHMP, aqra d- Diskussjoni Xjentifika (ukoll parti mill- EPAR). ad X’ inhi ZIMULTI? għ ZIMULTI hija mediċina li fiha s- sustanza attiva rimonbant.
It is available as white, teardrop- shaped tablets.
Tiġi bħala pilloli bojod, f’ forma ovali.
What is ZIMULTI used for? no
Għalxiex tintuża ZIMULTI? m ’
ZIMULTI is used together with diet and exercise to treat adult patients: • who are obese (very overweight) with a body mass index (BMI) greater than or equal to 30 kg/ m², • who are overweight (with a BMI greater than or equal to 27 kg/ m²) and also have other risk factors, such as type 2 diabetes or dyslipidaemia (abnormal levels of fat in their blood).
ZIMULTI tintuża flimkien ma ’ dieta u eżerċizzju biex tikkura pazjenti adulti: • Li għandhom piż eċċessiv (ħafna piż żejjed) b’ indiċi tal- massa korporja (BMI) akbar minn jew daqs 30kg/ m², li li
The medicine can only be obtained with a prescription. ct
• Li għandhom piż żejjed (b’ BMI akbar minn jew daqs 27kg / m²) u li għandhom ukoll fatturi ta ’ riskju oħra, bħal ma huma d- dijabete tat- tip 2 u dislipidimija (livelli mhux normali ta ’ xaħmijiet fid- demm tagħhom) / a
How is ZIMULTI used? du
Il- mediċina tista ’ tinkiseb biss b’ riċetta tat- tabib. iċin
ZIMULTI is taken as one tablet once a day, before breakfast.
ZIMUTI tittieħed bħala pillola darba kuljum, qabel il- kollazzjoni.
The medicine should not be used in patients who have severe problems with their liver or their kidneys. ro
li għandhom problemi severi bil- fwied jew bil- kliewi.
How does ZIMULTI work?
Kif taħdem ZIMULTI? tt m
It acts by blocking a lp
Is- sustanza attiva f’ ZIMULTI rimonabant, hija antagonist tar- riċettur kannabinojde.
specific type of receptors, the cannabinoid type 1 (CB1) receptors.
Hija taħdem billi timblokka tip speċifiku ta ’ riċettur, ir- riċetturi kannabinojde (CBP) tip 1.
These receptors are found in the nervous system, and they are part of the system the body uses to control food intake.
Dawn ir- riċetturi jinsabu fis - sistema nervuża, u huma parti mis- sistema li l- ġisem juża biex jikkontrolla t- teħid ta ’ l- ikel.
The receptors are also found in adipocytes (fat tissue). ina
Ir- riċetturi jinsabu ukoll fl- adipoċiti (tessut tax- xaħam). do
How has ZIMULTI been studied?
Kif ġiet studjata ZIMULTI?
The effects of ZIMULTI were first tested in experimental models before being studied in humans.
L- effetti ta ’ ZIMULTI għall- ewwel ġew ittestjati f’ mudelli sperimentali qabel ma ’ ġew studjati fil - Pro
One study looked more dic
Saru erba ’ studji ta ’ ZIMULTI f’ pazjenti b’ piż żejjed u piż eċċessiv, li involvew kważi 7, 000 pazjent, li l - piż tagħhom fil- bidu ta ’ l- istudji kien medja ta ’ 94 sa 104kg.
The studies compared the effect of ZIMULTI with that of a placebo (a dummy treatment) on weight loss over one to two years.
Studju wieħed ħares b’ mod partikolari aktar lejn pazjenti b’ livelli mhux normali ta ’ xaħmijiet fid- demm, u wieħed lejn pazjenti b’ dijabete ta ’ tip 2.
Me
L -
©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged.
©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged. istudji qabblu l- effett ta ’ ZIMULTI ma ’ dak ta ’ plaċebo (kura finta) fuq telf ta ’ piż fuq sena sa sentejn.
Four studies of ZIMULTI as a help to stop smoking were also carried out in over 7,000 patients,
Studju wieħed ħares kif dan it- telf jista ’ jkun miżmum waqt it- tieni sena.
d comparing it with placebo, and measuring the effect of the medicine given for 10 weeks (one year in one
Saru ukoll erba ’ studji ta ’ ZIMULTI bħala għajnuna biex jieqaf it- tipjip f’ aktar minn 7, 000 pazjent, u qabbluha ma ’ plaċebo, u kejlu l- effett tal- mediċina mogħtija għal 10 ġimgħat (sena f’ wieħed mill- istudji) fuq it- twaqqif tat- tipjip, u fuq rikaduti fis- sena segwenti.
What benefit has ZIMULTI shown during the studies?
at Liema benefiċċju wriet ZIMULTI waqt l- istudji li ġew mwettqa?
or they lost on average 4.9 kg more than placebo, except in the study in diabetic patients, where the difference in the weight loss was 3.9 kg.
izz Wara sena, il- pazjenti kollha li rċievew ZIMULTI tilfu aktar piż milli dawk li rċievew plaċebo: tilfu medja ta ’ 4. 9kg aktar minn plaċebo, ħlief fl- istudju f’ pazjenti dijabetiċi, fejn id- differenza fit- telf tal- piż kienet 3. 9kg.
uth was difficult to estimate.
tor L- istudji tat- twaqqif mit- tipjip ma wrewx riżultati konsistenti, u l- effett ta ’ ZIMULTI f’ dan il- qasam kien diffiċli biex tistmah.
Therefore, ZIMULTI is not recommended as an aid for smoking cessation
Għaldaqstant, ZIMULTI mhix irrakkmandata bħala għajnuna għat- twaqqif tat- tipjip.
What is the risk associated with ZIMULTI?
aw X’ inhu r- riskju assoċjat ma ’ ZIMULTI?
ra During the studies, the most common side effects with ZIMULTI (seen in more than 1 patient in 10) were nausea (feeling sick) and infections of the upper respiratory tract.
Waqt l- istudji, l- aktar effetti sekondarji komuni b’ ZIMULTI (dehru f’ aktar minn pazjent 1 minn kull 10) kienu nawżja (dardir) u infezzjonijiet tal- passaġġ respiratorju tan- naħa ta ’ fuq.
For the full list of all side effects reported with ZIMULTI, see the Package Leaflet.
Għal- lista sħiħa ta 'l- effetti
ge other ingredients, or in women who are breast feeding.
ZIMULTI m ’ għandux jintuża min- nies li jista ’ jkollhom sensittività eċċessiva (allerġiċi) għal rimonabant ad jew għal xi sustanzi oħra tiegħu, jew li huma tqal jew qed ireddgħu.
It must also not be used in patients with ongoing major depression or who are being treated with antidepressants, since it can increase the risk of depression, including thoughts about suicide in a small minority of patients.
Ma tistax tintuża f’ pazjenti b’ depressjoni maġġura li għada fuqhom jew li jkunu qed jiġu ikkurati b ’ antidepressanti, peress li tista ’ żżid ir- riskju ta ’ depressjoni, inklużi ħsibijiet dwar suwiċidju f’ minoranza żgħira ta ’ pazjenti.
Patients who experience symptoms of depression should speak to their doctor and may need to stop treatment.
Pazjenti li għ jesperjenzaw sintomi ta ’ depressjoni għandhom ikellmu lit- tabib tagħhom u jistgħu jeħtieġu li jwaqqfu l - kura.
Caution should be lon used when taking ZIMULTI with some medicines, such as ketoconazole or itraconazole (anti-fungal medicines), ritonavir (used in HIV infection), or telithromycin or clarithromycin (antibiotics).
Meta ŻIMULTI tittieħed ma ’ xi mediċini, bħalma huma, ketoconazole jew itraconazole (mediċini anti- fungali), ritonavir (użat f’ infezzjoni HIV), jew telithromycin jew clarithromycin (antibijotiċi), m ’
Why has ZIMULTI been approved?
għandha tintuża l- kawtela.
The Committee for Medicinal products for Human Use (CHMP) concluded that ZIMULTI had shown its no
Għaliex ġiet approvata ZIMULTI? li li
effectiveness in weight reduction in obese or overweight patients with associated risk factors.
Il- Kumitat iddeċieda li l- benefiċċji ta ’ ZIMULTI huma akbar mir- riskji tagħha meta wżata, flimkien ma ’ a
The Committee decided that ZIMULTI’ s benefits are greater than its risks when used, in addition to diet and exercise, to treat obese patients and overweight patients with risk factors such as type 2 diabetes or dyslipidaemia.
dieta u eżerċizzju, biex tikkura f’ pazjenti b’ piż eċċessiv jew b’ piż żejjed b ’ fatturi ta ’ riskju bħalma huma dijabete tip 2 jew dislipidimja.
The Committee recommended that ZIMULTI be given marketing authorisation. ct
Il- Kumitat irrakkomanda li ZIMULTI tingħata awtorizzazzjoni għat - iċin
Which measures are being taken to ensure the safe use of ZIMULTI? du
X’ miżuri qed jittieħdu biex ikun żgurat l- użu sigur ta ’ ZIMULTI?
The company that makes ZIMULTI will put in place a programme to ensure that the medicine is used in patients who need it for health, rather than for cosmetic reasons, by providing educational packs for patients and doctors, and to monitor how the medicine is used.
għandhom bżonnha għas- saħħa, aktar milli għal raġunijiet kożmetiċi, billi tipprovdi pakketti edukattivi għall- pazjenti u għat- tobba, u tissorvelja kif tintuża l- mediċina.
The company will use specific databases to monitor the side effects, especially those linked to the nervous system. ro
Il- kumpanija se tuża databases speċifiċi tt m
The European Commission granted a marketing authorisation valid throughout the European Union for lp
biex tissorvelja l- effetti sekondarji ta ’ ZIMULTI, speċjalment dawk marbuta mas- sistema nervuża.
ZIMULTI to sanofi-aventis on 19 June 2006.
Il- Kummissjoni Ewropea tat awtorizzazzjoni valida madwar l- Unjoni Ewropea kollha għal ZIMULTI lil sanofi aventis fid- 19 ta ’ Ġunju 2006. do
The full EPAR for ZIMULTI can be found here. ina
Pro
This summary was last updated in 10-2007. dic Me
Dan is- sommarju ġie aġġornat l- aħħar fl- 10- 2007.
e d EU number
t za riz Numru ta ’ l- EU
r is Package size
o farma ewtika
o administration EU/ 1/ 06/ 345/ 001
t EU/ 1/ 06/ 345/ 001
Film-coated tablet
Pillola miksija b’ rita U u ora
14 tablets
14 pillola
t
E
h
w E
EU/ 1/ 06/ 345/ 002 EU/ 1/ 06/ 345/ 003
U/ 1/ 06/ 345/ 003
28 tablets 56 tablets
56 pillola
u EU/ 1/ 06/ 345/ 004
a EU/ 1/ 06/ 345/ 004
Film-coated tablet
Pillola miksija b’ rita U u orali
70x1 tablets
70x1 pillola
a EU/ 1/ 06/ 345/ 005 EU/ 1/ 06/ 345/ 006
U/ 1/ 06/ 345/ 006
84 tablets 98 tablets
98 pillola
r EU/ 1/ 06/ 345/ 007
U/ 1/ 06/ 345/ 007
28 tablets
28 pillola
e EU/ 1/ 06/ 345/ 008 EU/ 1/ 06/ 345/ 009
U/ 1/ 06/ 345/ 009
Bottle (HDPE) Bottle (HDPE)
Flixkun (HDPE)
98 tablets 500 tablets
500 pillola
g EU/ 1/ 06/ 345/ 010
U/ 1/ 06/ 345/ 010
n EU/ 1/ 06/ 345/ 011
U/ 1/ 06/ 345/ 011
90 tablets
g ’ m i il l na ċi i ed m t ot d ro
SUMMARY OF PRODUCT CHARACTERISTICS ol tn uc d ro lp ina dic Me
at izz tor aw ux ad ANNESS I għ SOMMARJU TAL- KARATTERISTIĊI TAL- PRODOTT m ’ li li a iċin ed tt m do Pro
ZIMULTI 20 mg film-coated tablets
ZIMULTI 20 mg pilloli miksija b’ rita
Excipients:
at Kull pillola fiha 20 mg ta ’ rimonabant.
The tablets contain approx.
Sustanzi mhux attivi:
d Film-coated tablet
GĦAMLA FARMAĊEWTIKA
ise Biconvex, teardrop-shaped, white tablets debossed with “ 20” on one side.
aw Pillola miksija b’ rita Pilloli bojod, bikonvessi, taħt għamla ta ’ qatra dmugħ, bin- numru “ 20 ” imnaqqax fuq faċċata waħda.
or uth 4.
ux 4.
ra As an adjunct to diet and exercise for the treatment of obese patients (BMI ≥ 30 kg/ m2), or overweight ge patients (BMI > 27 kg/ m2) with associated risk factor(s), such as type 2 diabetes or dyslipidaemia (see section 5.1). on
4. 1 Indikazzjonijiet terapewtiċi ad Bħala żieda mad- dieta u l- eżerċizzju fil- kura tal- obeżità f ’ pazjenti ħoxnin (BMI ≥ 30 kg/ m2), jew għ pazjenti qawwija (BMI > 27 kg/ m2) li għandhom ukoll fattur( i) miżjud( a) ta ’ riskju, bhad- dijabete tat - tip 2 jew livelli abnormali ta ’ xaħam fid- demm (ara sezzjoni 5. 1). m ’
4.2 Posology and method of administration ol tn
4. 2 Pożoloġija u metodu ta ’ kif għandu jingħata
In adults, the recommended dosage is one 20 mg tablet daily to be taken in the morning before breakfast. uc
Fl- adulti, id- doża irrakkomandata hija ta ’ pillola waħda ta ’ 20 mg kuljum li għandha tittieħed li li
The treatment should be introduced with a mildly reduced calorie diet. d ro
Il- kura għandha tinbeda waqt dieta li għandha valur kalorifiku ftit imnaqqas. a
The safety and efficacy of rimonabant have not been evaluated beyond 2 years. lp
Is- sigurtà u l- effikaċja ta ’ rimonabant ma ġewx evalwati għal aktar minn sentejn. iċin
• Special Populations ina
• Gruppi speċjali ed
ZIMULTI should be used with caution dic
M’ hemmx bżonn ta ’ aggustamenti fid- doża fl- anzjani (ara sezzjoni 5. 2).
Me
ZIMULTI għandu jintuża b’ kawtela f’ pazjenti ta ’ ’ l fuq minn 75 sena (ara sezzjoni 4. 4). tt m
Patients with hepatic insufficiency:
Pazjenti b’ insuffiċjenza tal- fwied:
ZIMULTI should be used with caution in patients with moderate hepatic impairment.
ZIMULTI għandu jintuża b’ kawtela f’ pazjenti li għandhom indeboliment moderat fil - do
ZIMULTI should not be used in patients with severe hepatic impairment (see section 4.4 and 5.2).
Pro
ZIMULTI should not be used in patients with severe renal impairment (see section 4.4 and 5.2).
2 Tfal:
ZIMULTI is not recommended for use in children below age 18 due to a lack of data on efficacy and safety.
ZIMULTI mhux irrakkomandat għall- użu fit- tfal ta ’ taħt it- 18 il- sena peress li m’ hemmx biżżejjed informazzjoni dwar l- effikaċja u s- sigurtà.
Hypersensitivity to the active substance or to any of the excipients Lactation.
Sensittività eċċessiva għas- sustanza attiva jew għal xi sustanzi mhux attivi..
4.4 Special warnings and precautions for use
izz 4. 4 Twissijiet speċjali u prekawzjonijiet għall- użu
• Depressive disorders Depressive disorders or mood alterations with depressive symptoms have been reported in up to 10%, and suicidal ideation in up to 1%, of patients receiving rimonabant (see section 4.8).
Rimonabant
In patients with current suicidal ideations and/ or with a history of suicidal ideation and depressive disorder rimonabant should not be used unless the benefits of treatment are considered to outweigh these risks in an individual patient.
aw m’ għandux juntuża f’ pazjenti b’ formazzjoni ta ’ idejat suwiċidali kurrenti u/ jew b’ passat mediku ta’ formazzjoni ta’ idejat suwiċidali u mard depressiv sakemm il- benefiċċji tal- kura huma akbar mir - riskji f’ pazjent individwali.
(See section 4.3 and 4.8). Obesity is a condition that can be associated with depressive disorders.
(Ara sezzjoni 4. 3 u 4. 8).
Depressive disorders can be associated with an increased risk of suicidal
L- obesità hija kundizzjoni li tistà tkun assoċjata ma ’ disturbi depressivi.
ise The prescriber should carefully investigate if the patient has had a depressive disorder in the past in
Disturbi depressivi jistgħu jkunu assoċjati ma ’ riskju akbar ta ’ ħsibijiet
or order to evaluate the potential risks with rimonabant treatment.
ux suwiċidali, li l- persuna tagħmel ħsara lilha innifisha u suwiċidju.
uth Depressive reactions may occur in patients who have no obvious risk factors, apart from obesity itself.
Min jippreskrivi għandu jistħarreġ bir- reqqa jekk il- pazjent kellhux disturbi depressivi fil- passat biex ad ikun jista ’ jevalwa r- riskju potenzjali ta ’ kura b’ rimonbant. għ Reazzjonijiet dipressivi jistgħu jseħħu f’ pazjenti li m’ għandhom ebda fatturi evidenti ta ’ riskju ħlief għall- obesità nnifisha.
In postmarketing experience, more than half of the patients who develop such reactions appear to do
Minn esperjenza wara li l- prodott tqiegħed fis- suq jidher li iżjed minn nofs il - pazjenti li jiżviluppaw dawn ir- reazzjonijiet jagħmlu hekk fi żmien xahar li tinbeda l- kura, fi żmien 3 m ’
ra so within 1 month of starting treatment, approximately 80% appear to do so within 3 months.
xhur jidher li jagħmlu hekk madwar 80%.
Patients should be actively monitored for signs and symptoms of psychiatric disorders, particularly ge depression following the start of treatment.
Wara li tinbeda l- kura, il- pazjenti, għandhom ikunu segwiti b’ mod attiv għal sinjali u sintomi ta ’ disturbi psikjatriċi speċjalment id- dipressjoni.
If depression is diagnosed during rimonabant therapy, rimonabant treatment must be stopped.
Jekk waqt il- kura b’ rimonabant tiġi ddijanjostikata d- dipressjoni, il- kura b’ rimonabant għandha titwaqqaf.
The patient should be monitored and treated appropriately. on
Il- pazjent li li
Patients, especially those with a history of depressive disorders/ mood alterations, (and relatives or ol
għandu jkun segwit u ttrattatat b’ mod xieraq. a
other relevant persons) should be alerted about the need to monitor for the emergence of such tn
Pazjenti, speċjalment dawk b’ passat mediku ta ’ disturbi depressivi/ bidla fil- burdata, (u qraba jew persuni relevanti oħra) għandhom ikunu mwissija dwar il- bżonn ta ’ ħarsien bir- reqqa għat- tfaċċar ta ’ iċin
symptoms and to seek medical advice immediately if these occur. uc
sintomi bħal dawn u biex ifittxu mmedjatament parir mediku jekk dawn jiġru.