qanastek/EMEA-V3 huggingface dataset:
Epivir should not be given with zalcitabine, high doses of co-trimoxazole, or infusions of ganciclovir or foscarnet.
Epivir m’ għandux jingħata ma 'zalcitabine, dożi għolja ta ’ co- trimoxazole, jew infużjonijiet ta ’ ganciclovir jew foscarnet.
Pregnancy and Breast-feeding If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.
Tqala u Treddigħ Jekk int toħroġ tqila, jew qed tippjana biex toħroġ tqila għandek tikkuntatja lit- tabib tiegħek biex tiddiskuti l- effetti mhux mixtieqa li jistgħu jinqalgħu u l- benefiċċji u r- riskji tat- trattament antiretrovirali tiegħek fuqek u fuq it- tarbija tiegħek.
Epivir is not recommended during the first three months of pregnancy.
Epivir m’ huwiex rakkommandat fl- ewwel tlett xhur tat- tqala.
If you have taken Epivir during your pregnancy, your doctor may request regular visits to monitor the development of your child.
Jekk tkun ħadt Epivir waqt it- tqala, it- tabib jista ’ jirrikjedi viżti regolari biex josserva l- iżvilupp tat - tarbija tiegħek.
Such visits may include blood tests and other diagnostic tests.
F’ dawn il- viżti jistgħu isiru testijiet tad- demm u testijiet dijanjostiċi oħra.
In children whose mothers 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.
Fit- tfal li l- omm tkun ħadet in- nukleosidi u analogi tan- nukleosidi waqt it- tqala, il- benefiċċju ta ’ ċans inqas li jkunu infettati bl- HIV huwa akbar mir- riskju li jsofru minn xi effetti sekondarji.
Since lamivudine and the virus pass into breast milk it is recommended that mothers taking Epivir do not breast-feed their infants.
59 Billi lamivudine u l- virus jgħaddu għal ġol- ħalib tas- sider hu rakkomandat li ommijiet fuq Epivir ma jreddgħux lit- trabi tagħhom.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV.
Hu rakkomandat li, fl- ebda ċirkostanza, nisa nfettati bl- HIV m' għandhom ireddgħu lit- trabi tagħhom biex hekk jevitaw li jgħaddulhom l- HIV.
HOW TO TAKE EPIVIR
KIF GĦANDEK TIEĦU EPIVIR
Always take Epivir exactly as your doctor has told you.
Dejjem ħu Epivir preċiżament kif jgħidlek it- tabib.
Swallow Epivir tablets with water or another drink.
Iblà l- pilloli ta ’ Epivir ma ’ l- ilma jew xarba oħra.
The tablets can be taken with or without food.
Il- pilloli jistgħu jittieħdu ma 'l- ikel jew fuq stonku vojt.
The usual daily dose of Epivir in adults and adolescents over 12 years of age is 300 mg.
Id- doża normali ta 'kuljum ta' Epivir għall- adulti u l- adolexxenti ta ’ 'l fuq minn 12- il sena hi ta' 300 mg.
This can be taken either as 1 x 150 mg tablet twice a day approximately 12 hours apart or 300 mg once a day (2 x 150 mg tablet or 1 x 300 mg tablet).
Din tista 'tittieħed jew bħala pillola waħda ta' 150 mg darbtejn kuljum b' madwar 12- il siegħa bejn waħda u oħra jew 300 mg darba kuljum (żewġ pilloli x150 mg jew pillola waħda tat- 300 mg).
Children (under 12 years of age):
Tfal (taħt it- 12 il sena):
For children weighing at least 30 kg, the recommended oral dose of Epivir is 1 x 150 mg tablet twice a day, approximately 12 hours apart.
Għal tfal li jiżnu mill- anqas 30kg, id- doża orali rakkomandata ta ’ Epivir hija pillola waħda x 150mg darbtejn kuljum, bejn wieħed u ieħor 12 il siegħa minn xulxin.
For children weighing between 21 kg to 30 kg: the recommended oral dose of Epivir (150 mg) is one- half tablet taken in the morning and one whole tablet taken in the evening.
Għal tfal li jiżnu bejn 21kg u 30kg: id- doża orali ta ’ Epivir (150mg) rakkomandata hija ta ’ nofs pillola filgħodu u pillola sħiħa filgħaxija.
Children weighing 14 to 21 kg: the recommended oral dose of Epivir (150 mg) is one half of a scored tablet taken twice daily.
Tfal li jiżnu bejn 14kg u 21kg: id- doża orali ta ’ Epivir (150mg) rakkomandata hija ta ’ nofs pillola mmarkata biex tinqasam minn nofs darbtejn kuljum.
An oral solution is also available for the treatment of children over three months of age and for patients unable to take tablets or who need a lower dose.
Hawn ukoll soluzzjoni orali għall- kura ta 'tfal minn tlett xhur' il fuq jew għal pazjenti li ma jistgħux jieħdu pilloli jew li għandhom bżonn doża iżgħar.
If you have a kidney problem, your dose may be altered.
Jekk għandek xi problema fil- kliewi, jista 'jkun li d- doża tkun trid tinbidel.
Please follow the instructions of your doctor.
Jekk jogħġbok imxi fuq dak li jgħidlek it- tabib.
If you take more Epivir than you should Accidentally taking too much Epivir is unlikely to cause any serious problems.
Jekk tieħu aktar Epivir milli suppost għandek Jekk aċċidentalment tieħu aktar Epivir milli suppost għandek tieħu mhux probabbli li jkollok xi problemi serji.
However, you should tell your doctor or your pharmacist, or contact your nearest hospital emergency department for further advice.
Madankollu, għandek tgħid b' dan lit- tabib jew lill- ispiżjar tiegħek, jew tikkuntattja d - dipartiment ta 'l- emerġenza ta' sptar qrib tiegħek biex tingħata parir.
If you forget to take Epivir If you forget to take a dose of Epivir, take it as soon as you remember and then continue as before.
Jekk tinsa tieħu Epivir Jekk tinsa tieħu xi doża ta 'Epivir, ħudha malli tiftakar imbagħad kompli bħal qabel.
Do not take a double dose to make up for a forgotten dose.
Tieħux doża doppja biex tpatti għal xi dożi li tkun insejt tieħu.
Like all medicines, Epivir can cause side effects, although not everybody gets them.
Bħall- mediċini kollha, Epivir jista 'jikkawża effetti oħra għalkemm mhux kulħadd jista' jkollu.
When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Epivir, by other medicines you are taking at the same time or by the HIV disease.
Meta tkun qed tikkura l- infezzjoni HIV, mhux dejjem ikun possibbli tgħid li xi effetti mhux mixtieqa li jinħassu jkunu kawżati minn Epivir, minn xi mediċini oħra li tkun qed tieħu fl- istess ħin jew mill - marda ta 'l- HIV.
The most commonly reported (greater than 1 in every 100 patients treated) side effects are nausea, vomiting, stomach pain, diarrhoea, headache, joint pain, muscle disorders, cough, nasal symptoms (irritation, runny nose), fever, tiredness, general feeling of being unwell, skin rash, hair loss and difficulty in sleeping.
L- aktar effetti oħra li jiġu rappurtati (aktar minn 1 minn kull mitt pazjent fuq din il- kura) huma dardir, remettar, uġigħ fl- istonku, dijarrea, uġigħ ta 'ras, uġigħ fil- ġogi, problemi fil- muskoli, sogħla, sintomi fl- imnieħer (irritazzjoni, imnieħer inixxi), deni, għeja, ma tħossokx f' siktek, raxx fil- ġilda, xagħar jaqa' u nuqqas ta 'rqad.
The following side effects are uncommon (between 1 in 1,000 and 1 in 100 patients treated); anaemia (low red blood cell count), neutropenia (low white blood cell count), and reductions in platelets (blood cells important for blood clotting).
60 L- effetti oħra li ġejjin mhumiex komuni (bejn 1 minn kull 1, 000 jew 1 minn kull 100 pazjent li jkunu qed jieħdu l- mediċina); anemija (għadd baxx taċ- ċelluli ħomor tad- demm), newtropenja (għadd baxx taċ- ċelluli bojod tad- demm), u tnaqqis fil- plejtlits (ċelluli tad- demm importanti għat- tagħqid tad- demm).
If the number of red blood cells is reduced you may have symptoms of tiredness or breathlessness.
Jekk in- numru taċ- ċelluli ħomor tad- demm jonqos jista 'jkollok sintomi ta' għeja jew qtugħ ta 'nifs.
A reduction in your white blood cell count can make you more prone to infection.
Tnaqqis fl- għadd taċ- ċelluli bojod tad- demm jista 'jagħmlek f’ tendza akbar għall- infezzjoni.
58 Increases in some liver enzymes have also been noted in blood samples from patients being treated with Epivir.
Żjidiet f' xi enżimi tal- fwied ġew ukoll innutati f' kampjuni tad- demm ta 'pazjenti li kienu qed jieħdu Epivir.
There are rare reports (between 1 in 10,000 to 1 in 1,000 patients treated) of inflammation of the liver (hepatitis), inflammation of the pancreas (pancreatitis), breakdown of muscle tissue.
Hemm rapporti rari (bejn 1 f' 10, 000 sa 1 f' 1, 000 pazjent li jkunu qed jieħdu l- mediċina) ta 'infjammazzjoni tal- fwied (epatite), infjammazzjoni tal- frixa (pankreatite), kollass tat- tessuti muskolari.
There are very rare reports (less than 1 in 10,000 patients treated) of numbness, tingling sensation or sensation of weakness in the limbs, and severe anaemia and neutropenia.
Hemm rapporti rari ħafna (inqas minn 1 f' 10, 000 pazjenti li qed jieħdu l- mediċina) ta 'tirżiħ, sensazzjoni ta' tnemnim jew sensazzjoni ta 'dgħjufija fir- riġlejn u d- dirgħajn, u anemija u newtropenja qawwija.
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 Epivir for use for more information).
Każijiet ta 'kundizzjoni msejħa aċidożi lattika, li hi akkumulazzjoni ta' aċidu lattiku fil- ġisem, li tista 'tikkawża t- tneħħija ta' ilma mill- ġisem u koma ġew rappurtati f' każi rari ta 'pazjenti li kienu fuq il- kura ta' xi NRTI (ara Oqgħod attent ħafna b’ Epivir għal aktar tagħrif).
Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
It- terapija antiretrovirali kombinata tista ’ tikkawża bidliet fil- forma tal- ġisem minħabba t- tibdil 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 fis- saqajn, fid- dirgħajn u fil- wiċċ, żjieda ta' xaħam fl- addome (fiż- żaqq) u organi interni oħra, tkabbir tas- sider u għoqod tax- xaħam wara 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 fit- tul ta 'dawn il- kundizzjonijiet s' issa għad mhumiex 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.
It- terapija antiretrovirali kombinata tista 'wkoll tikkawża żjieda ta' l- aċidu lattiku u zokkor fid- demm, iperlipemja (Żjieda ta 'xaħam fid- demm) u reżistenza għall- insulina.
HOW TO STORE EPIVIR
KIF TAĦŻEN EPIVIR
Keep out of the reach and sight of children
Tħallihx fejn jistgħu jilħquh jew jarawh it- tfal
Do not use Epivir after the expiry date which is stated on the container.
Tużax Epivir wara d- data ta 'l- iskadenza tiegħu li tidher fuq il- kontenitur.
What Epivir contains The active substance in Epivir is called lamivudine.
Is- sustanza attiva ta ’ Epivir tissejjaħ lamivudine.
Each Epivir film-coated tablet contains 150 mg of lamivudine.
Kull pillola ta 'Epivir miksija b' rita fiha 150 mg lamivudine.
The tablets also contain the following other ingredients:
Il- pilloli fihom ukoll dawn is- sustanzi:
Tablet core: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate Film-coat: hypromellose, titanium dioxide, macrogol, polysorbate 80
Il- qalba tal- pillola: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate Ir- rita: hypromellose, titanium dioxide, macrogol, polysorbate 80
What Epivir looks like and the contents of the pack Epivir 150 mg film-coated tablets are supplied in white polyethylene bottles or blister packs containing 60 tablets.
Il- pilloli tal- 150 mg Epivir miksijin b' rita jiġu fi fliexken bojod tal- polyethylene jew f' folji li jkun fihom 60 pillola.
They are white, diamond shaped, scored, film-coated tablets, marked with the code ‘ GXCJ7’ on both sides.
Huma pilloli bojod, miksijin b' rita u għandhom forma ta 'djamant, immarkati bil - kodiċi' GXCJ7 'fuq iż- żewġ naħat.
59 Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
60 For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
62 Għal aktar tagħrif dwar dan il- prodott mediċinali jekk jogħġbok kellem lir- rappreżentant lokali ta 'Sid l- Awtorizzazzjoni għall- Kummerċ.
This leaflet was approved in
Dan il- fuljett ġie approvat fil -
Detailed information on this medicine is available on the European Medicines Agency (EMEA) web site: http: / /www. emea. europa. eu.
Informazzjoni dettaljata dwar din il- mediċina tinsab fuq il- website ta ’ l- Aġenzija Ewropeja dwar il- Mediċini (EMEA) http: // www. emea. europa. eu
62 PACKAGE LEAFLET:
64 FULJETT TA 'TAGĦRIF:
Epivir 10 mg/ ml oral solution Lamivudine
Soluzzjoni ta '10 mg/ ml Epivir Lamivudine
It may harm them,
M’ għandekx tgħaddiha lil persuni oħra.
even if their symptoms are the same as yours.
- Tista 'tagħmlilhom il- ħsara, anki jekk ikollhom l- istess sintomi bħal tiegħek.
2.
X' inhu l- Epivir u għalxiex jintuża 2.
- if you are allergic (hypersensitive) to lamivudine or any of the other ingredients found in
- jekk tbati minn allerġija (sensittivita 'eċċessiva) għal lamivudine jew għal xi wieħed mis -
Epivir oral solution.
sustanzi l- oħra li jinsabu fit- soluzzjoni Epivir li tittieħed mill- ħalq.
If you are a diabetic, please note that each dose (150 mg = 15 ml) contains 3 g sugar.
Jekk int dijabetiku, jekk jogħġbok żomm f' rasek li kull doża (150 mg = 15 ml) fiha 3 g zokkor
The class of medicines to which Epivir belongs (NRTIs) can cause a condition called lactic acidosis (build up of lactic acid in the body), together with an enlarged liver.
Il- klassi ta 'mediċini li Epivir jifforma parti minnha (NRTI) jistgħu jikkawżaw kundizzjoni li tissejjaħ aċidożi lattika (akkumulazzjoni ta ’ aċidu laktiku fil- ġisem), barra minn tkabbir tal- fwied.
Deep rapid breathing, drowsiness, and non specific symptoms such as nausea, vomiting and stomach pain, might indicate the development of lactic acidosis.
Nifs mgħaġġel u qawwi, telqa, u sintomi mhux speċifiċi bħal dardir, remettar, u uġigħ fl- istonku, jistgħu jindikaw li qed 65 tiżviluppa l- aċidożi lattika.
While you
Jekk tbati minn xi mard tal- fwied tista 'wkoll tkun f' riskju akbar li tiżviluppalek din il- kundizzjoni.
63 are being treated with Epivir, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
Meta tkun qed tieħu Epivir, it- tabib tiegħek jeżaminak sew għal xi sinjali li jistgħu juru l- iżvilupp ta 'l - aċidożi lattika.
Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
Distribuzzjoni mill- ġdid, akkumulazzjoni jew tnaqqis ta 'xaħam tal- ġisem jistgħu iseħħu f' pazjenti li jkunu fuq terapija antiretrovirali kombinata.
You may continue to develop other infections and other illnesses associated with HIV disease.
Jista 'jkompl u jaqbduk infezzjonijiet u mard ieħor assoċjat mal - marda HIV.
Pregnancy If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.
Tqala Jekk toħroġ tqila, jew qed tippjana biex toħroġ tqila fi żmien qasir, għandek tikkuntatja lit- tabib tiegħek biex tiddiskuti l- effetti mhux mixtieqa li jistgħu jinqalgħu u l- benefiċċji u r- riskji tat- trattament antiretrovirali tiegħek fuqek u fuq it- tarbija tiegħek.
In children whose mothers 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.
66 Fit- tfal li l- omm tkun ħadet in- nukleosidi u analogi tan- nukleosidi waqt it- tqala, il- benefiċċju ta ’ ċans inqas li jkunu infettati bl- HIV huwa akbar mir- riskju li jsofru minn xi effetti sekondarji.
64 Breast-feeding Since lamivudine and the virus pass into breast milk it is recommended that mothers taking Epivir do not breast-feed their infants.
Treddigħ Billi lamivudine u l- virus jgħaddu għal ġol- ħalib tas- sider hu rakkomandat li ommijiet fuq Epivir ma jreddgħux lit- trabi tagħhom.
It is recommended that HIV infected women do not breast-feed their infants under any circumstances in order to avoid transmission of HIV
Hu rakkomandat li, fl- ebda ċirkostanza, nisa nfettati bl- HIV m' għandhom ireddgħu lit- trabi tagħhom biex hekk jevitaw li jgħaddulhom l- HIV.
Epivir contains sucrose.
Epivir fih sucrose.
If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking Epivir.
Jekk it- tabib tiegħek qallek li għandek intolleranza għal xi zokkrijiet, ikkuntatja it - tabib tiegħek qabel ma tieħu Epivir.
Epivir also contains preservatives (parahydroxybenzoates) which may cause allergic reactions (possible delayed).
Epivir fih ukoll priservattivi (parahydroxybenzoates) li jistgħu jikkawżaw reazzjonijiet allerġiċi (possibiliment ittardjati)
You should check with your doctor or pharmacist if you are not sure.
Kellem lit- tabib jew lill ispiżjar tiegħek meta ma tkunx ċert.
The usual daily dose of Epivir in adults and adolescents over 12 years of age is 300 mg (30 ml).
Id- doża normali ta 'kuljum ta' Epivir għall- adulti u l- adolexxenti ta ’ 'l fuq minn 12- il sena hi ta' 300 mg.
This can be taken either as 150 mg (15 ml) twice a day or 300 mg (30 ml) once a day.
Din tista 'tittieħed jew 150 mg (15 ml) darbtejn kuljum jew 300 mg (30 ml) darba kuljum.
In children three months to 12 years of age the recommended dose is 4 mg/ kg twice daily up to a maximum of 300 mg daily.
Għal tfal ta 'minn tlett xhur sa 12- il sena id- doża rakkomandata hi ta' 4 mg/ ml darbtejn kuljum sa massimu ta '300 mg kuljum.
Each dose of Epivir should be taken approximately 12 hours apart.
Kull doża ta 'Epivir għandha tittieħed b' intervall ta' 12- il siegħa bejn waħda u oħra.
Epivir can be taken with or without food.
L- Epivir jista 'jittieħed ma' l- ikel jew mhux ma 'l- ikel.
Use the oral dosing syringe supplied with the pack to measure your dose accurately.
Uża s- siringa għal dożaġġ li jittieħed mill- ħalq li jkun hemm fil- kartuna biex tkejjel sew id- doża tiegħek.
2.
Neħħi t- tapp tal- flixkun 2.
Push the plastic adapter into the neck of the bottle, while holding the bottle firmly.
Imbotta l- adapter tal- plastik f' għonq il- flixkun, waqt li żżomm il- flixkun sew.
Insert the syringe firmly into the adapter.
Daħħal sew is- siringa fl- adapter.
Invert bottle.
Aqleb il- flixkun wiċċu 'l isfel.
Pull out syringe plunger until the correct amount is withdrawn.
Iġbed il- plunger tas- siringa 'l barra sakemm tkun ġbidt l- ammont eżatt.
Turn the bottle the correct way up and remove the syringe from the adapter.
Erġa 'dawwar il- flixkun f' postu u neħħi s- siringa mill- adapter.
Replace and tighten the bottle cap.
Poġġi t- tapp f' postu u għalqu sew.
Administer the dose into the mouth by placing the tip of the syringe against the inside of the cheek.
Qiegħed id- doża fil- ħalq billi tipponta s- siringa lejn il- ġewwieni tal- wiċċ.
Slowly depress the plunger, allowing time to swallow.
Agħfas il- plunger bil - mod biex tkun tista 'tinbela' t- taħlita.
Forceful squirting to the back of the throat may cause choking.
Jekk titfa 't- taħlita bis- saħħa fuq wara l- ġerżuma tista tifga.
After use, the syringe must not be left in the bottle and should be washed thoroughly in clean water.
Meta tispiċċa, tħallix is- siringa fil- flixkun u aħsilha sew f' ilma nadif.
Like all medicines, Epivir can cause side effects, although not everybody gets them.
Bħall- mediċini kollha, Epivir jista 'jkollu effetti oħra, għalkemm mhux kulħadd jista ’ jkollu.
The following side effects are uncommon (between 1 in 1,000 and 1 in 100 patients treated); anaemia (low red blood cell count), neutropenia (low white blood cell count), and reductions in platelets (blood cells important for blood clotting).
L- effetti oħra li ġejjin mhumiex komuni (bejn 1 minn kull 1, 000 jew 1 minn kull 100 pazjent li jkunu qed jieħdu l- mediċina); anemija (għadd baxx taċ- ċelluli ħomor tad- demm), newtropenja (għadd baxx taċ- ċelluli bojod tad- demm), u tnaqqis fil- plejtlits (ċelluli tad- demm importanti għat- tagħqid tad- demm).
Increases in some liver enzymes have also been noted in blood samples from patients being treated with Epivir.
Żjidiet f' xi enżimi tal- fwied ġew ukoll innutati f' kampjuni tad- demm ta 'pazjenti li kienu qed jieħdu Epivir.
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 Epivir for more information).
Każijiet ta 'kundizzjoni msejħa aċidożi lattika, li hi akkumulazzjoni ta' aċidu lattiku fil- ġisem, li tista 'tikkawża t- tneħħija ta' ilma mill- ġisem u koma ġew rappurtati f' każi rari ta 'pazjenti li kienu fuq il- kura ta' xi NRTI (ara Oqgħod attent ħafna b’ Epivir għal aktar tagħrif).
Combination antiretroviral therapy may also cause raised lactic acid and sugar in the blood, hyperlipaemia (increased fats in the blood) and resistance to insulin.
It- terapija antiretrovirali kombinata tista 'wkoll tikkawża Żjieda ta' l- aċidu lattiku u zokkor fid- demm, iperlipemja (Żjieda ta 'xaħam fid- demm) u reżistenza għall- insulina.
Discard one month after first opening.
Armih wara xahar li jkun infetaħ l- ewwel darba.
Do not store above 25oC.
Taħżnux f' temperatura ‘ l fuq minn 25°C.
Medicines should not be disposed of via wastewater or household waste.
68 Il- mediċini m’ għandhomx jintremew ma ’ l- ilma tad- dranaġġ jew ma ’ l- iskart domestiku.
What Epivir contains The active substance in Epivir is called lamivudine.
X’ fih Epivir Is- sustanza attiva fl- Epivir tissejjaħ lamivudine.
Epivir oral solution contains 10 mg of lamivudine in each ml of solution.
It- soluzzjoni li tittieħed mill- ħalq fiha 10 mg ta 'lamivudine f' kull ml tat- taħlita.
The oral solution also contains the following other ingredients: sugar (sucrose 3 g/ 15 ml), methyl parahydroxybenzoate, propyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, propylene glycol, water, artificial strawberry and banana flavourings.
It- taħlita li tittieħed mill- ħalq fiha wkoll dawn is- sustanzi: zokkor (sucrose 3 g/ 15 ml), methyl parahydroxybenzoate, propyl parahydroxybenzoate, anhydrous citric acid, sodium citrate, propylene glycol, ilma, togħmiet artifiċjali ta 'frawli u banana.
What Epivir looks like and the contents of the pack Epivir oral solution is supplied in a white polyethylene bottle containing 240 ml of solution.
Is- soluzzjoni ta ’ Epivir li tittieħed mill- ħalq tiġi fi fliexken bojod tal- polyethylene li jkun fihom 240 ml ta 'soluzzjoni.
An oral dosing syringe and a plastic adapter for the bottle is included in the pack.
Siringa għal dożaġġ li jittieħed mill- ħalq u adapter tal- plastik ikunu fil- kaxxa.
Marketing Authorisation Holder and Manufacturer Marketing Authorisation Holder:
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Glaxo Group Ltd, Greenford Road, Greenford, Middlesex UB6 0NN, United Kingdom
Glaxo Group Ltd, Greenford Road, Greenford, Middlesex UB6 0NN, Renju Unit.
KG, Industriestrasse 32-36, 23843 Bad Oldesloe, Germany
KG, Industriestrasse 32- 36, 23843 Bad Oldesloe, Ġermanja
67 For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
69 Għal aktar tagħrif dwar dan il- prodott mediċinali jekk jogħġbok kellem lir- rappreżentant lokali ta 'Sid l- Awtorizzazzjoni għall- Kummerċ.
69 PACKAGE LEAFLET:
71 FULJETT TA 'TAGĦRIF:
Epivir 300 mg film-coated tablets Lamivudine
Epivir 300 mg pilloli miksijin b' rita Lamivudine
Do not pass it on to others.
M' għandekx tgħaddiha lil persuni oħra.
if their symptoms are the same as yours.
il- ħsara, anki jekk ikollhom l- istess sintomi bħal- tiegħek.
Epivir is used in antiretroviral combination therapy for the treatment of HIV infection in adults and children.
Epivir jintuża fit- terapija kombinata antiretrovirali għall- kura ta 'l- infezzjoni fl- adulti u fit- tfal.
Do not take Epivir:
Tieħux Epivir:
While you are being treated with Epivir, your doctor will monitor you closely for any signs that you may be developing lactic acidosis.
Meta tkun qed tieħu Epivir, it- tabib tiegħek jeżaminak sew għal xi sinjali li jistgħu juru l- iżvilupp ta 'l- aċidożi lattika.
70 Redistribution, accumulation or loss of body fat may occur in patients receiving combination antiretroviral therapy.
72 Distribuzzjoni mill- ġdid, akkumulazzjoni jew tnaqqis ta 'xaħam tal- ġisem jistgħu iseħħu f' pazjenti li jkunu fuq terapija antiretrovirali kombinata.
Pregnancy If you become pregnant, or are planning to become pregnant, you must contact your doctor to discuss the potential adverse effects and the benefits and risks of your antiretroviral therapy to you and your child.
Tqala Jekk toħroġ tqila, jew qed tippjana biex toħroġ tqila għandek tikkuntatja lit- tabib tiegħek biex tiddiskuti l- effetti mhux mixtieqa li jistgħu jinqalgħu u l- benefiċċji u r- riskji tat- trattament antiretrovirali tiegħek fuqek u fuq it- tarbija tiegħek.
In children whose mothers 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.
73 Fit- tfal li l- omm tkun ħadet in- nukleosidi u analogi tan- nukleosidi waqt it- tqala, il- benefiċċju ta ’ ċans inqas li jkunu infettati bl- HIV huwa akbar mir- riskju li jsofru minn xi effetti sekondarji.
Breast-feeding Since lamivudine and the virus pass into breast milk it is recommended that mothers taking Epivir do not breast-feed their infants.
Treddigħ Billi lamivudine u l- virus jgħaddu għal ġol- ħalib tas- sider hu rakkomandat li ommijiet fuq Epivir ma jreddgħux lit- trabi tagħhom.
Swallow Epivir tablets with water or another drink.
Ibla 'l- pilloli Epivir ma' l- ilma jew ma 'xi xarba oħra.
Like all medicines, Epivir can cause side effects, although not everybody gets them.
Bħall- mediċini kollha, Epivir jista 'jkollu effetti oħra għalkemm mhux kulħadd jista ’ jkollu.
When treating HIV infection, it is not always possible to tell whether some of the undesirable effects that occur are caused by Epivir, by other medicines you are taking at the same time or by the HIV disease.
Meta tkun qed tikkura l- infezzjoni HIV, mhux dejjem ikun possibbli tgħid li xi effetti mhux mixtieqa li jinħassu jkunu kawżati minn Epivir, minn xi mediċini oħra li tkun qed tieħu fl- istess ħin jew mill- marda ta 'l - HIV.
If you have a low platelet count you may notice that you bruise more easily.
Jekk ikollok għadd baxx ta 'plejtlits aktarx tintebaħ li
72 Combination antiretroviral therapy may cause changes in body shape due to changes in fat distribution.
It- terapija antiretrovirali kombinata tista ’ tikkawża bidliet fil- forma tal- ġisem minħabba t- tibdil fid - distribuzzjoni tax- xaħam.
Do not use Epivir after the expiry date which is stated on the container.
Tużahx wara d- data ta 'l- iskadenza tiegħu li tidher fuq il- kontenitur.
Do not store above 30oC.
Taħżnux f' temperatura ‘ l fuq minn 30˚C.
What Epivir contains The active substance in Epivir is called lamivudine.
X’ fih Epivir Is- sustanza attiva ta ’ Epivir tissejjaħ lamivudine.
Each Epivir film-coated tablet contains 300 mg of lamivudine.
Kull pillola ta 'Epivir miksija b' rita fiha 300 mg lamivudine.
Tablet core: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate Film-coat: hypromellose, titanium dioxide, black iron oxide (E172), macrogol, polysorbate 80
Il- qalba tal- pillola: microcrystalline cellulose, sodium starch glycollate (gluten free), magnesium stearate Ir- rita: hypromellose, titanium dioxide, macrogol, polysorbate 80
What Epivir looks like and the contents of the pack Epivir 300 mg film-coated tablets are supplied in white polyethylene bottles or blister packs containing 30 tablets.
Il- pilloli tat- 300 mg Epivir miksijin b' rita jiġu fi fliexken bojod tal- polyethylene jew f' folji li jkun fihom 30 pillola.
They are grey, diamond shaped film-coated tablets, marked with the code ‘ GXEJ7’ on one side.
Huma pilloli griżi, miksijin b' rita u għandhom forma ta 'djamant, immarkati bil - kodiċi' GXEJ7 'fuq naħa waħda.
Marketing Authorisation Holder and Manufacturer
Id- Detentur ta ’ l- Awtorizzazzjoni għat- tqegħid fis- Suq u l- Manifattur:
Grunwaldzka 189
Grunwaldzka 189 60- 322 Poznan Poland
For any information about this medicinal product please contact the local representative of the Marketing Authorisation Holder.
76 Għal aktar tagħrif dwar dan il- prodott mediċinali jekk jogħġbok kellem lir- rappreżentant lokali ta 'Sid l- Awtorizzazzjoni għall- Kummerċ.
This leaflet was approved in
Dan il- fuljett gie approvat il -
The Member States shall ensure that prior to launch the MAH provides health care professionals in dialysis centres and retail pharmacies with:
l- Istati Membri għandhom jiżguraw li qabel il- prodott jitpoġġa fuq is- suq u, l- MAH għandu jipprovdi lill- professjonisti fiċ- ċentri tad- dijalisi u spiżeriji kummerċjali dawn li ġejjin:
The educational leaflet shall contain the following key elements: • That the use of epoetin alfa products can cause immunogenicity which in rare cases may lead to Pure Red Cell Aplasia (PRCA) • That with other epoetin products, the risk of immunogenicity in Chronic Kidney Disease (CKD) is increased with the subcutaneous (sc) route. • There is insufficient data on Epoetin alfa HEXAL to know the size of any increased immunogenicity risk with sc use • Therefore, the sc route is not recommended for patients with CKD • The loss of efficacy or other symptoms of the development of immunogenicity should be investigated • Any suspected case of Pure Red Cell Aplasia or development of immunogenicity should be reported to the MAH
Il- fuljett edukattiv għandu jkun fih l- elementi importanti li ġejjin: • Li l- użu tal- prodotti li fihom epoetin alfa jista ’ jikkawża immunoġeniċità li f’ każijiet rari tista ’ twassal għal Aplasija taċ- Ċelluli l- Ħomor Pura (PRCA) • Li ma ’ prodotti oħrajn ta ’ epoetin, ir- riskju ta ’ immunoġeniċità f’ Mard Kroniku tal- Kliewi (CKD) jiżdied meta jingħata minn taħt il- ġilda (sc). • Hemm informazzjoni insuffiċjenti fuq Epoetin alfa HEXAL biex ikun magħruf il- kobor ta ’ xi żieda fir- riskju ta ’ immunoġeniċità bl- użu minn taħt il- ġilda • Għalhekk, ir- rotta ta ’ taħt il- ġilda mhix rakkomandata għal pazjenti li għandhom CKD • It- telf ta ’ effikaċja jew sintomi oħrajn ta ’ l- iżvilupp ta ’ immunoġeniċità għandhom ikunu investigati • Kwalunkwe każ issuspettat ta ’ Aplasija taċ- Ċelluli l- Ħomor Pura jew l- iżvilupp ta ’ immunoġeniċità għandhom ikunu rrappurtati lill- MAH
It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
Huwa jispjega kif il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ivvaluta l- istudji mwettqa, biex jissodisfa r- rakkomandazzjonijiet tiegħu dwar kif tintuża l- mediċina.
What is Epoetin Alfa Hexal?
X' inhu Epoetin Alfa Hexal?
Epoetin Alfa Hexal is a solution for injection.
Epoetin Alfa Hexal huwa soluzzjoni għal injezzjoni.
It is available in pre-filled syringes containing between 1,000 and 10,000 international units (IU) of the active substance, epoetin alfa.
Jiġi f' siringi mimlijin minn qabel li fihom bejn 1, 000 u 10, 000 unità internazzjonali (IU) tas- sustanza attiva, epoetin alfa.
Epoetin Alfa Hexal is a ‘ biosimilar’ medicine.
Epoetin Alfa Hexal huwa mediċina ‘ bijosimili ’.
This means that Epoetin Alfa Hexal is similar to a biological medicine that is already authorised in the European Union (EU) and contains the same active substance (also known as the ‘ reference medicine’).
Dan ifisser li Epoetin Alfa Hexal huwa simili għal mediċina bijoloġika li diġà hija awtorizzata fl- Unjoni Ewropea (UE) u fih l- istess sustanza attiva (magħrufa ukoll bħala ‘ mediċina ta 'referenza ’).
The reference medicine for Epoetin Alfa Hexal is Eprex/ Erypo.
Il- mediċina ta 'referenza għal Epoetin Alfa Hexal hija Eprex/ Erypo.
What is Epoetin Alfa Hexal used for?
Għal xiex jintuża Epoetin Alfa Hexal?
Epoetin Alfa Hexal is used in the following situations: • to treat anaemia (low red blood cell counts) that is causing symptoms in patients with ‘ chronic renal failure’ (long-term, progressive decrease in the ability of the kidneys to work properly) or other kidney problems; • to treat anaemia in adults receiving chemotherapy for certain types of cancer and to reduce the need for blood transfusions; • to increase the amount of blood that can be taken in adult patients with moderate anaemia who are going to have an operation and donate their own blood before surgery (autologous blood transfusion); • to reduce the need for blood transfusions in adults with mild anaemia who are about to undergo major orthopaedic (bone) surgery, such as hip surgery.
Epoetin Alfa Hexal jintuża fis- sitwazzjonijiet li ġejjin: • biex jitratta anemija (għadd baxx ta 'ċelloli tad- demm ħomor) li tikkawża sintomi f’ pazjenti b’ insuffiċjenza kronika tal- kliewi (tnaqqis progressiv, fit- tul fil- kapaċità li l- kliewi jaħdmu tajjeb) jew problemi oħra tal- kliewi; • biex jittratta anemija f' adulti li qed jirċievu kimoterapija għal ċerti tipi ta' kanċer u biex inaqqas il - ħtieġa ta 'trasfużjonijiet tad- demm; • biex jiżdied l- ammont ta ’ demm li jista ’ jiġi meħud minn pazjenti adulti b’ anemija moderata li jkun ser ikollhom operazzjoni u jagħtu demmhom stess qabel intervent kirurġiku (trasfużjoni tad - demm awtologa), • biex inaqqas il- ħtieġa ta' trasfużjonijiet tad- demm fl- adulti b' anemija ħafifa li jkunu se jagħmlu intervent kirurġiku ortopediku (tal- għadam) ta ’ natura serja, bħal intervent kirurġiku fuq il - ġenbejn.
It is used in patients with normal blood iron levels who could experience complications if they were to receive a blood transfusion, if they do not have the opportunity to donate their own blood before surgery and are expected to lose 900 to 1,800 ml of blood.
Jintuża f' pazjenti b' livelli normali ta 'ħadid fid- demm li jistgħu jesperjenzaw kumplikazzjonijiet li kieku kellhom jirċievu trasfużjoni tad- demm, jekk ma jkollhomx l - opportunità li jagħtu d- demm tagħhom stess qabel intervent kirurġiku u huma mistennija li jitilfu 900 sa 1, 800 ml demm.
How is Epoetin Alfa Hexal used?
Kif jintuża Epoetin Alfa Hexal?
Treatment with Epoetin Alfa Hexal must be started under the supervision of a doctor who has experience in the management of patients with the conditions that the medicine is used for.
It- trattament b' Epoetin Alfa Hexal għandu jinbeda taħt is- sorveljanza ta 'tabib li għandu esperjenza fil - ġestjoni ta' pazjenti bil- kundizzjonijiet li l- mediċina hija użata għalihom.
Epoetin Alfa Hexal can be injected under the skin by the patient or their carer if they have been trained appropriately.
Għal pazjenti bi problemi tal- kliewi u pazjenti li ser jagħtu demmhom stess, Epoetin Alfa Hexal għandu jiġi injettat ġol- vini.
The dose, the frequency of injection and how long it is used for depend on why Epoetin Alfa Hexal is being used, and are adjusted according to the patient’ s response.
Epoetin Alfa Hexal jista ’ jiġi injettat taħt il- ġilda mill- pazjent jew minn min jieħu ħsiebu jekk dawn ikunu imħarrġa kif suppost.
For patients with chronic renal failure or receiving chemotherapy, haemoglobin levels should remain within the recommended range (between 10 and 12 grams per decilitre in adults and between 9.5 and 11 g/ dl in children).
Għal pazjenti b’ insuffiċjenza kronika tal- kliewi jew li jirċievu kimoterapija, il- livelli tal- emoglobina għandhom jibqgħu bejn il- livelli rakkomandati (bejn 10 u 12 – il gramma għal kull deċilitru fl- adulti u bejn 9. 5 u 11 g/ dl fit- tfal).
Haemoglobin is the protein in red blood cells that carries oxygen around the body.
L - emoglobina hija l- proteina fiċ- ċelloli ħomor tad- demm li jġorru l- ossiġenu madwar il- ġisem.
For these patients, the lowest does that provides adequate control of symptoms should be used.
Għal dawn il- pazjenti, għandha tintuża l- aktar doża baxxa li tipprovdi kontroll xieraq tas- sintomi.
The iron levels of all patients should be checked before treatment to make sure that they are not too low, and iron supplements should be used throughout treatment.
Il- livelli tal- ħadid tal- pazjenti kollha għandhom jiġu kkontrollati qabel it- trattament sabiex ikun żgurat li ma jkunux baxxi wisq, u għandhom jintużaw supplimenti tal- ħadid tul it- trattament kollu.
How does Epoetin Alfa Hexal work?
Kif jaħdem Epoetin Alfa Hexal?
Erythropoietin is also used before surgery to increase the number of red blood cells and help minimise the consequences of blood loss.
Erythropoietin jintuża wkoll qabel intervent kirurġiku biex iżid in- numru ta 'ċelloli tad- demm ħomor u jgħin inaqqas kemm jista' jkun il- konsegwenzi ta 'telf ta' demm.
The active substance in Epoetin Alfa Hexal, epoetin alfa, is a copy of human erythropoietin and works in exactly the same way as the natural hormone to stimulate red blood cell production.
Is- sustanza attiva f' Epoetin Alfa Hexal, epoetin alfa, hija kopja ta 'erythropoietin umana u taħdem bl - istess mod eżatt tal- ormon naturali biex tistimula l- produzzjoni ta' ċelloli tad- demm ħomor.
The epoetin alfa in Epoetin Alfa Hexal is produced by a method known as ‘ recombinant DNA technology’: it is made by a cell that has received a gene (DNA), which makes it able to produce epoetin alfa.
Epoetin alfa f' Epoetin Alfa Hexal hija prodotta b' metodu magħruf bħala ‘ teknoloġija tad- DNA rikombinanti ’: hija magħmula minn ċellola li tkun irċieviet ġene (DNA) li jagħmilha possibbli li jipproduċi l- epoetin alfa.
How has Epoetin Alfa Hexal been studied?
Kif ġie studjat Epoetin Alfa Hexal?
Epoetin Alfa Hexal was studied to show that it is comparable with the reference medicine, Eprex/ Erypo, in experimental models and in humans.
Epoetin Alfa Hexal ġie studjat biex juri li huwa komparabbli mal- mediċina ta 'referenza, Eprex/ Erypo, f' mudelli sperimentali u fuq il- bniedem.
Epoetin Alfa Hexal, injected into a vein, was compared with the reference medicine in one main study involving 479 patients with anaemia caused by kidney problems.
Epoetin Alfa Hexal, injettat ġol- vina, tqabbel mal- mediċina ta 'referenza fi studju prinċipali wieħed li kien jinvolvi 479 pazjent b' anemija kkawżata minn problemi kroniċi tal- kliewi.
All of the patients had been taking Eprex/ Erypo injected into a vein for at least eight weeks before they were either switched to Epoetin Alfa Hexal or remained on Eprex/ Erypo.
Il- pazjenti kollha kienu qed jieħdu Eprex/ Erypo, injettat ġol- vini, għal mill- inqas tmien ġimgħat qabel ma nqalbu jew għal Epoetin Alfa Hexal jew baqgħu fuq Eprex/ Erypo.
The main measure of effectiveness was the change in the levels of haemoglobin between the start of the study and the evaluation period, between weeks 25 and 29.
Il- kejl ewlieni tal- effikaċja kien il- bidla fil - livelli ta 'emoglobina bejn il- bidu tal- istudju u l- perjodu ta' evalwazzjoni, bejn il- ġimgħat 25 u 29.
The company also presented the results of a study comparing the effects of Epoetin Alfa Hexal injected under the skin with those of Eprex/ Erypo in 114 cancer patients who were receiving chemotherapy.
Il- kumpanija ppreżentat ukoll studju li jqabbel l- effetti ta 'Epoetin Alfa Hexal injettat taħt il- ġilda ma' dawk ta 'Eprex/ Erypo f' 114- il pazjent b' kanċer li kienu qed jirċievu kimoterapija.
What benefit has Epoetin Alfa Hexal shown during the studies?
X' benefiċċji wera Epoetin Alfa Hexal matul l- istudji?
Epoetin Alfa Hexal was as effective as Eprex/ Erypo in increasing and maintaining red blood cell counts.
Epoetin Alfa Hexal kien effikaċi daqs Eprex/ Erypo fiż- żieda u fiż- żamma tal- għadd ta 'ċelloli tad - demm ħomor.
In the study of patients with anaemia caused by kidney problems, patients switching to Epoetin Alfa Hexal maintained haemoglobin levels to the same extent as those continuing to take Eprex/ Erypo.
Fl- istudju ta 'pazjenti b' anemija kkawżata minn problemi tal- kliewi, il- pazjenti li qalbu għal fuq Epoetin Alfa Hexal żammew livelli ta' emoglobina daqs dawk li baqgħu jieħdu Eprex/ Erypo.
On average, the levels of the patients taking Epoetin Alfa Hexal increased by 0.147 g/ dl from a starting value of 11.7 g/ dl.
Bħala medja, il- livelli tal- pazjenti li kienu qegħdin jieħdu Epoetin Alfa Hexal żdiedu bi 0. 147 g/ dl minn valur tal- bidu ta '11. 7 g/ dl.
In comparison, those continuing to take Eprex/ Erypo had an increase of 0.063 g/ dl from a starting value of 12.0 g/ dl.
Meta mqabbla dawk li baqgħu jieħdu Eprex/ Erypo kellhom żieda ta '0. 063 g/ dl minn valur tal- bidu ta' 12. 0 g/ dl.
The study in patients receiving chemotherapy showed that Epoetin Alfa Hexal was also as effective as Eprex/ Erypo when it was injected under the skin.
L- istudju f' pazjenti li kienu qed jirċievu kimoterapija wera li Epoetin Alfa Hexal kien effikaċi daqs Eprex/ Erypo meta ġie injettat taħt il- ġilda.
What is the risk associated with Epoetin Alfa Hexal?
X' inhu r- riskju assoċjat ma 'Epoetin Alfa Hexal?
The most common side effect with Epoetin Alfa Hexal is an increase in blood pressure, which can sometimes lead to symptoms of encephalopathy (brain problems) such as sudden, stabbing migraine- like headache and confusion.
L- aktar effett sekondarju komuni b' Epoetin Alfa Hexal kien żieda fil- pressjoni tad- demm, li xi kultant tista 'twassal għal sintomi ta' enċefalopatija (problemi fil- moħħ) bħal uġigħ ta 'ras simili għal emikranja (simili għal daqqiet ta' sikkina għall- għarrieda) u konfużjoni.
Epoetin Alfa Hexal can also lead to skin rash and flu-like symptoms.
Epoetin Alfa Hexal jista '2/ 3 jwassal ukoll għal raxx tal- ġilda u għal sintomi simili għal dawk tal- influwenza.
For the full list of all side effects reported with Epoetin Alfa Hexal, see the Package Leaflet.
Għal- lista sħiħa tal - effetti sekondarji rrappurtati ma 'Epoetin Alfa Hexal, ara l- Fuljett ta' Tagħrif.
It must not be used in the following groups:
Epoetin Alfa Hexal m' għandux jintuża minn persuni li jistgħu jkunu ipersensittivi (allerġiċi) għal epoetin alfa jew għal xi sustanza oħra tiegħu.
2/ 3 • patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin; • patients with high blood pressure that is not controlled; • patients who are going to donate their own blood who have had a heart attack of stroke within the last month, who have angina pectoris (a severe type of chest pain) or who are at risk of deep venous thrombosis (DVT: formation of blood clots in the deep veins of the body, usually in the leg); • patients who cannot receive medicines for the prevention of blood clots; • patients about to undergo major orthopaedic surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke.
Ma għandux jintuża wkoll fil- gruppi li ġejjin: • pazjenti li żviluppaw aplasija pura ta 'ċelloli ħomor (produzzjoni mnaqqsa jew imwaqqfa ta' ċelloli tad- demm ħomor) wara trattament bi kwalunkwe erythropoietin; • pazjenti bi pressjoni tad- demm għolja li m' hijiex ikkontrollata; • pazjenti li ser jagħtu d- demm tagħhom stess li kellhom attakk tal- qalb jew puplesija matul l- aħħar xahar, li għandhom angina pectoris (uġigħ qawwi fis- sider) jew li huma f’ riskju ta ’ trombożi fil - vini fil- fond (DVT: formazzjoni ta ’ emboli fil- vini fondi tal- ġisem, normalment fir- riġel); • pazjenti li ma jistgħux jirċievu mediċini għall- prevenzjoni ta 'emboli tad- demm; • pazjenti li ser ssirilhom intervent kirurġiku ortopediku ta ’ natura serja, li jbatu minn problemi kardjovaskulari (vini u arterji tad- demm jew tal- qalb) serji inkluż attakk tal- qalb jew puplesija reċenti.
Epoetin Alfa Hexal is not recommended for injection under the skin in the treatment of kidney problems because further studies are needed to make sure that this does not cause allergic reactions.
Epoetin Alfa Hexal m' huwiex irrakkomandat għal injezzjoni taħt il- ġilda fit- trattament ta 'problemi tal - kliewi minħabba li hemm bżonn li jsiru aktar studji sabiex ikun żgurat li dan ma jikkawżax reazzjonjiet allerġiċi.
Why has Epoetin Alfa Hexal been approved?
Għaliex ġie approvat Epoetin Alfa Hexal?
The Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Epoetin Alfa Hexal has been shown to have a comparable quality, safety and efficacy profile to Eprex/ Erypo.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li, skont ir - rekwiżiti tal- UE, Epoetin Alfa Hexal intwera li għandu profil ta 'kwalità, sigurtà u effikaċja komparabbli għal Eprex/ Erypo.
Therefore, the CHMP’ s view was that, as for Eprex/ Erypo, the benefit outweighs the identified risks.
Għalhekk, l- opinjoni tas- CHMP kienet li, bħal Eprex/ Erypo, il - benefiċċju huwa akbar mir- riskji identifikati.
The Committee recommended that Epoetin Alfa Hexal be given marketing authorisation.
Il- Kumitat irrakkomanda li Epoetin Alfa Hexal jingħata awtorizzazzjoni għat- tqegħid fis- suq.
Which measures are being taken to ensure the safe use of Epoetin Alfa Hexal?
X’ miżuri qegħdin jittieħdu biex ikun żgurat l- użu sigur ta ’ Epoetin Alfa Hexal?
The company that makes Epoetin Alfa Hexal will provide information packs for healthcare workers in all Member States, including information on the safety of the medicine.
Il- kumpanija li tipproduċi Epoetin Alfa Hexal sejra tipprovdi pakketti ta 'informazzjoni għall - ħaddiema fil- qasam tal- kura tas- saħħa fl- Istati Membri kollha, inkluż informazzjoni dwar is- sigurtà tal- mediċina.
The company will also provide cool boxes for patients, which will include illustrations showing how the medicine should be used.
Il- kumpanija sejra tipprovdi ukoll kessieħa (cool boxes) għall- pazjenti, li jinkludu stampi li juru kif għandha tintuża l- mediċina.
Other information about Epoetin Alfa Hexal:
Tagħrif ieħor dwar Epoetin Alfa Hexal:
The European Commission granted a marketing authorisation valid throughout the EU for Epoetin Alfa Hexal to Hexal AG on 28 August 2007.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Epoetin Alfa Hexal valida fl - Unjoni Ewropea kollha lil Hexal AG fit- 28 ta 'Awwissu 2007.
The full EPAR for Epoetin Alfa Hexal can be found here.
L- EPAR sħiħ għal Epoetin Alfa Hexal jista ’ jiġi kkonsultat hawn.
EU/ 1/ 07/ 411/ 001
Numru ta ’ l- EU EU/ 1/ 07/ 411/ 001
Epoetin alfa Hexal
Isem ivvintat Epoetin alfa Hexal
1000 IU/ 0.5 ml
Qawwa 1000 IU / 0. 5 ml
Solution for injection in a pre-filled syringe
Għamla farmaċewtika Soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Subcutaneous or intravenous use
Mnejn jingħata Użu għal taħt il - ġilda jew għal ġol - vini
pre-filled syringe (glass)
Il- pakkett siringa mimlija għal- lest (ħġieġ)
0.5 ml (2000 IU/ ml)
Kontenut 0. 5 ml (2000 IU/ ml)
1 pre-filled syringe
Daqs tal- pakkett Siringa 1 mimlija għal- lest
1000 IU/ 0.5 ml
1000 IU / 0. 5 ml
2000 IU/ 1.0 ml
2000 IU / 1. 0 ml
3000 IU/ 0.3 ml
3000 IU / 0. 3 ml
4000 IU/ 0.4 ml
4000 IU / 0. 4 ml
5000 IU/ 0.5 ml
5000 IU / 0. 5 ml
6000 IU/ 0.6 ml
6000 IU / 0. 6 ml
8000 IU/ 0.8 ml
8000 IU / 0. 8 ml
10000 IU/ 1.0 ml
10000 IU / 1. 0 ml
7000 IU/ 0.7 ml
7000 IU / 0. 7 ml
9000 IU/ 0.9 ml
9000 IU / 0. 9 ml
Epoetin alfa HEXAL 1000 IU/ 0.5 ml solution for injection in a pre-filled syringe
Epoetin alfa HEXAL 1000 IU/ 0. 5 ml soluzzjoni għall- injezzjoni f’ siringa mimlija għal- lest
Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients:
Kura ta ’ anemija sintomatika assoċjata ma ’ insuffiċjenza renali kronika( CRF) f’ pazjenti adulti u pedjatriċi:
Epoetin alfa HEXAL can be used to increase the yield of autologous blood from patients in a predonation programme.
Epoetin alfa HEXAL jista ’ jintuża biex iżid l- ammont ta ’ demm awtologu minn pazjenti fi programm ta ’ predonazzjoni.
Its use in this indication must be balanced against the reported risk of thromboembolic events.
L- użu tiegħu f’ din l- indikazzjoni trid tkun ibbilanċjata kontra r- riskju rrappurtat ta ’ avvenimenti tromboemboliċi.