qanastek/EMEA-V3 huggingface dataset:
KIOVIG may be stored at room temperature (not more than 25°C) for up to 9 months.
KIOVIG jista 'jinħażen f' temperatura tal- kamra (mhux aktar minn 25°C) għal mhux aktar minn 9 xhur.
Record date of transfer to room temperature and end of 9-month period on the carton.
Ikteb id- data tat- trasferiment għal temperatura ambjentali u t- tmiem tal- perijodu ta '9 xhur fuq il- kartuna.
After a maximum storage period of 9 months at room temperature, the product must be used or discarded.
Wara perijodu massimu ta 'ħażna ta' 9 xhur f' temperatura tal- kamra, il- prodott għandu jintuża jew jintrema.
EU/1/05/329/001 1 g / 10 ml EU/1/05/329/002 2.5 g / 25 ml EU/1/05/329/003 5 g / 50 ml EU/1/05/329/004 10 g / 100 ml EU/1/05/329/005 20 g / 200 ml
EU/ 1/ 05/ 329/ 001 1 g / 10 ml EU/ 1/ 05/ 329/ 002 2. 5 g / 25 ml EU/ 1/ 05/ 329/ 003 5 g / 50 ml EU/ 1/ 05/ 329/ 004 10 g / 100 ml EU/ 1/ 05/ 329/ 005 20 g / 200 ml
18 PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING
18 TAGĦRIF MINIMU LI GĦANDU JIDHER FUQ IL- PAKKETT LI JMISS MAL- PRODOTT
VIAL LABEL (5G, 10G AND 20G)
TIKKETTA TAL- KUNJETT (5G, 10G U 20G)
Solution for infusion (10%) 5 g in 50 ml 10 g in 100 ml 20 g in 200 ml
Soluzzjoni għall- infużjoni (10%) 5 g f’ 50 ml 10 g f’ 100 ml 20 g f’ 200 ml
KIOVIG may be stored at room temperature (not more than 25°C) for up to 9 months.
19 KIOVIG jista 'jinħażen f' temperatura tal- kamra (mhux aktar minn 25°C) għal mhux aktar minn 9 xhur.
SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF APPROPRIATE
PREKAWZJONIJIET SPEĊJALI GĦAR- RIMI TA ’ PRODOTTI MEDIĊINALI MHUX UŻATI JEW SKART MINN DAWN IL- PRODOTTI MEDICINALI, JEKK
VIAL LABEL (1G)
TIKKETTA TAL- KUNJETT (1G)
KIOVIG 100 mg/ml solution for infusion Human Normal Immunoglobulin Intravenous use.
KIOVIG 100 mg/ ml soluzzjoni għall- infużjoni Immunoglobulina normali umana Użu għal ġol- vini.
1 g in 10 ml
1 g f’ 10 ml
VIAL LABEL (2.5G)
TIKKETTA TAL- KUNJETT (2. 5G)
2.5 g in 25 ml
2. 5 g f’ 25 ml
Do not freeze.
Tużax wara d- data ta 'skadenza stampata fuq il- kaxxa.
Keep the container in the outer carton in order to protect from light.
Tagħmlux fil- friża.
KIOVIG may be stored at room temperature (not more than 25°C) for up to 9 months.
Żomm ir- reċipjent fil- kaxxa tal- kartun sabiex tilqa ’ mid- dawl. KIOVIG jista 'jinħażen f' temperatura tal - kamra (mhux aktar minn 25°C) għal mhux aktar minn 9 xhur.
Record date of transfer to room temperature and end of 9-month period on the carton.
Ikteb id- data tat- trasferiment għal temperatura tal- kamra u t- tmiem tal- perijodu ta '9 xhur fuq il- kartuna.
KIOVIG 100 mg/ml solution for infusion Human normal immunoglobulin
KIOVIG 100 mg/ ml soluzzjoni għal infużjoni Immunoglobulina normali umana
Read all of this leaflet carefully before you start using this medicine • Keep this leaflet.
Aqra dan il- fuljett kollu qabel tibda tuża din il- mediċina • Żomm dan il- fuljett.
You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you.
Jista 'jkollok bżonn terġa ’ taqrah. • Jekk ikollok aktar mistoqsijiet, staqsi lit- tabib jew lill- ispiżjar tiegħek. • Din il- mediċina ġiet mogħtija lilek.
What KIOVIG is and what it is used for 2.
X’ inhu KIOVIG u għalxiex jintuża 2.
Before you use KIOVIG 3.
Qabel ma tuża KIOVIG 3.
How to use KIOVIG 4.
Kif għandek tuża KIOVIG 4.
How to store KIOVIG 6.
Kif taħżen KIOVIG 6.
WHAT KIOVIG IS AND WHAT IT IS USED FOR
X’ INHU KIOVIG U GĦALXIEX JINTUŻA
KIOVIG belongs to a class of medications called immunoglobulins.
KIOVIG jagħmel parti minn kategorija ta 'mediċini msejħa immunoglobulini.
Antibodies help your body to fight infections.
Dawn il- mediċini fihom antikorpi umani, li huma preżenti wkoll fid- demm tiegħek. L- antikorpi jgħinu lil ġismek jiġġieled l- infezzjonijiet.
They can also be used in patients who need additional antibodies for the cure of certain inflammatory disorders (autoimmune diseases).
Mediċini bħal KIOVIG jintużaw f' pazjenti li m’ għandhomx biżżejjed antikorpi fid- demm tagħhom u b' hekk għandhom it- tendenza li jieħdu infezzjonijiet ta 'spiss. Jistgħu jintużaw ukoll f' pazjenti li jeħtieġu antikorpi addizzjonali għall- fejqan ta' ċertu mard infjammatorju (mard awtoimmuni).
KIOVIG is used for
KIOVIG huwa użat għal
Treatment of patients who do not have sufficient antibodies (replacement therapy).
Trattament ta 'pazjenti li m’ għandhomx biżżejjed antikorpi (terapija ta' sostituzzjoni).
There are three groups:
Jeżistu tliet gruppi:
Patients with inborn lack of antibodies (primary immunodeficiency syndromes (PID)) such as:
Pazjenti li twieldu b' nuqqas ta 'antikorpi (sindromi ta' immunodefiċjenza primarja (PID)) bħal:
congenital agammaglobulinemia or hypogammaglobulinemia, common variable immunodeficiency, severe combined immunodeficiencies, Wiskott Aldrich syndrome.
agammaglobulinimja jew ipogammaglobulinimja konġenitali immunodefiċjenza varjabbli komuni immunodefiċjenzi kombinati serji is- sindromu ta 'Wiskott Aldrich
3.
Pazjenti b’ mard tad- demm li jwassal għal nuqqas ta ’ produzzjoni ta ’ antikorpi u infezzjonijiet rikorrenti (majeloma jew lewkimja limfatika kronika b' ipogammaglobulinimja sekondarja serja) 3.
Children who suffer from inborn AIDS and get frequent infections.
Tfal li twieldu bl- AIDS u spiss jieħdu infezzjonijiet.
Treatment of patients with certain inflammatory disorders (immunomodulation).
Trattament ta ’ pazjenti b’ ċertu disturbi infjammatorji (immunomodulazzjoni).
2.
Pazjenti li m’ għandhomx biżżejjed plejtlits tad- demm (purpura tromboċitopenika idjopatika, ITP), u li għandhom riskju għoli ta ’ fsada jew li se jgħaddu minn kirurġija fil- futur qarib 2.
3.
Pazjenti b’ marda li hija assoċjata ma ’ infjammazzjonijiet multipli tan- nervituri tal- ġisem kollu (is- sindromu ta ’ Guillain Barré) 3.
Patients with a disease which results in multiple inflammations of several organs of the body (Kawasaki disease).
Pazjenti b’ marda li tirriżulta f’ infjammazzjonijiet multipli ta ’ bosta organi tal- ġisem (il- marda ta ’ Kawasaki)
24 Treatment or prevention of infections after a bone marrow transplantation (allogeneic bone marrow transplantation).
24 It- trattament jew il- prevenzjoni ta ’ infezzjonijiet wara trapjant tal- mudullun (trapjant tal- mudullun alloġeniku)
BEFORE YOU USE KIOVIG
QABEL MA TUŻA KIOVIG
KIOVIG must not be used
Tużax KIOVIG
If you are allergic (hypersensitive) to immunoglobulins or to any other ingredient of KIOVIG.
Jekk inti allerġiku/ a (tbati minn sensittività eċċessiva) għal immunoglobulini jew għal sustanzi oħra ta 'KIOVIG.
Since KIOVIG contains trace amounts of immunoglobulin A (less than 0.14 mg/ml), you might get an allergic reaction.
Eżempju, jekk għandek defiċjenza ta ’ l- immunoglobulina A, jista 'jkollok antikorpi kontra immunoglobulin A fid- demm tiegħek. Minħabba li KIOVIG fih traċċi ta ’ immunoglobulina A (inqas minn 0. 14 mg/ ml), tista ’ taqbdek reazzjoni allerġika.
Take special care with KIOVIG
Oqgħod attent ħafna b’ KIOVIG
How long monitoring is required during the infusion • You will be carefully observed during the infusion period with KIOVIG to make sure that you do not suffer a reaction.
Kemm għandu jdum il- monitoraġġ matul l- infużjoni • Inti se tiġi osservat/ a b’ attenzjoni matul il- perijodu ta ’ infużjoni b’ KIOVIG sabiex jiġi aċċertat li inti ma ssofrix reazzjoni.
Your doctor will make sure that the rate at which KIOVIG is infused is suitable for you. • If KIOVIG is administered at a high rate, if you suffer from a condition with low antibody levels in your blood (hypo- or agammaglobulinemia), if you have not received this medicine before or if there has been a long interval (e.g. several weeks) since you last received it, there may be a higher risk of side effects.
It- tabib tiegħek ser jaċċerta ruħu li r- rata ta ’ infużjoni ta ’ KIOVIG tkun addattata għalik. • Jekk KIOVIG jingħata b’ rata għolja, jekk inti tbati minn kundizzjoni b’ livelli baxxi ta ’ antikorpi fid- demm tiegħek (ipo - jew agammaglobulinimja), jekk inti ma rċevejtx din il- mediċina qabel jew jekk kien hemm intervall twil (eż. bosta ġimgħat) minn meta inti rċevejtu l- aħħar, jista ’ jkun hemm riskju akbar ta ’ effetti sekondarji.
In such cases, you will be closely monitored during your infusion and for an hour after your infusion has stopped. • If you have already received KIOVIG previously and received the last treatment recently, then you will only be observed during the infusion and for at least 20 minutes after your infusion.
F’ każijiet bħal dawn, inti se tiġi mmonitorjat/ a mill - qrib matul l- infużjoni tiegħek u għal siegħa wara li l- infużjoni tiegħek tkun intemmet. • Jekk inti diġà rċevejt KIOVIG qabel u rċevejt l- aħħar trattament dan l- aħħar, inti ser tiġi osservat/ a biss matul l- infużjoni u għal mill- inqas 20 minuta wara l- infużjoni tiegħek.
When slowing or stopping the infusion may be required In rare cases your body may have previously reacted to specific antibodies and therefore will be sensitive to medicines containing antibodies.
Meta jkun meħtieġ li tnaqqas jew li twaqqaf l- infużjoni F’ każijiet rari, il- ġisem tiegħek seta ’ għamel reazzjoni għal antikorpi speċifiċi u għalhekk ikun sensittiv għal mediċini li fihom l- antikorpi.
This may happen particularly if you suffer from immunoglobulin A deficiency.
Dan jista ’ jseħħ b’ mod partikolari jekk inti tbati minn defiċjenza ta ’ l- immunoglobulina A.
In these rare cases, you may get allergic reactions such as a sudden fall in blood pressure or shock even if you have already received treatment with medicines containing antibodies in the past.
F’ dawn il- każijiet rari, tista ’ tesperjenza reazzjonijiet allerġiċi bħal waqgħa f’ daqqa fil- pressjoni tad- demm jew xokk anke jekk fil- passat tkun diġà rċevejt it - trattament b’ mediċini li fihom antikorpi.
Depending on your doctor’s decision the rate of infusion can be slowed or the infusion can be stopped altogether.
Jekk tesperjenza reazzjoni matul l- infużjoni ta ’ KIOVIG, avża lit- tabib tiegħek minnufih. skond id - deċiżjoni tat- tabib tiegħek, ir- rata ta ’ infużjoni tista ’ titnaqqas jew l- infużjoni tista ’ titwaqqaf għal kollox.
Special patient groups • Your doctor will take special care if you are overweight, elderly, diabetic, or if you suffer from high blood pressure, low blood volume (hypovolaemia), or problems with your blood vessels (vascular diseases).
Gruppi ta ’ pazjenti speċjali • It- tabib tiegħek se jagħti attenzjoni speċjali jekk inti għandek piż żejjed, inti anzjan/ a, dijabetiku/ a, jew jekk tbati minn pressjoni għolja, volum baxx tad- demm (ipovolimja), jew tbati minn problemi fil- vini u fl- arterji (mard vaskulari).
Tell your doctor if you are diabetic.
F’ dawn il- kundizzjonijiet, immunoglobulini jistgħu jżidu r- riskju ta ’ infart kardijaku, puplesija, emboliżmu pulmonari jew trombożi venuża profonda, għalkemm f’ każijiet rari ħafna biss.
Your doctor will choose the appropriate intravenous immunoglobulin for you.
Avża lit- tabib tiegħek jekk inti dijabetiku/ a. Għalkemm KIOVIG ma fihx zokkor, jista ’ jiġi dilwit b’ soluzzjoni speċjali biz- zokkor (5% glucose), li tista ’ taffettwa l- livell taz- zokkor fid - demm tiegħek. • It- tabib tiegħek se jagħti attenzjoni speċjali fil- każ li inti għandek jew kellek problemi fil- kliewi tiegħek, jew jekk tirċievi prodotti mediċinali li jistgħu jagħmlu ħsara lill- kliewi tiegħek (prodotti mediċinali nefrotossiċi), minħabba li hemm ċans rari ħafna ta ’ insuffiċjenza renali akuta.
Information on the source material of KIOVIG KIOVIG is made from human plasma (the liquid part of blood).
Jekk jogħġbok avża lit- tabib tiegħek jekk tbati minn xi disturbi fil- kliewi.
Manufacturers of these products also include steps in the processing of the blood or
It- tabib tiegħek jagħżel l- immunoglobulina li tingħata minn ġol vina, adegwata għalik.
25 plasma that can inactivate or remove viruses.
25 Tagħrif fuq il- materjal li hu magħmul minnu KIOVIG KIOVIG huwa magħmul minn plażma umana (il- parti likwida tad- demm).
Despite these measures, when medicines prepared from human blood or plasma are administered, the possibility of passing on infection cannot be totally excluded.
Minkejja dawn il- miżuri, meta jingħataw prodotti mediċinali ppreparati minn demm uman jew plażma umana, il- possibbiltà li tiġi trasmessa infezzjoni ma tistax tiġi eskluża għal kollox.
This also applies to any unknown or emerging viruses or other types of infections.
Dan japplika wkoll għal kwalunkwe vajrus mhux magħruf jew ġdidjew għal tipi oħra ta 'infezzjonijiet.
The measures taken for the manufacture of KIOVIG are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus and hepatitis C virus, and for the non- enveloped hepatitis A virus and parvovirus B19.
Il- miżuri meħudin għall- manifattura ta ’ KIOVIG huma meqjusin effettivi għal viri enveloped bħal vajrus ta ’ l- immunodefiċjenza umana (HIV), vajrus ta ’ l- epatite B u vajrus ta ’ l- epatite Ċ, u għall - vajrus ta ’ l- epatite A mhux enveloped u parvovirus B19.
KIOVIG also contains certain antibodies that can prevent an infection with hepatitis A virus and parvovirus B19.
KIOVIG fih ukoll ċerti antikorpi li jistgħu jimpedixxu infezzjoni b’ vajrus ta ’ l- epatite A u parvovirus B19.
• Please inform your doctor if you are taking, or have recently taken any other medicines, including medicines obtained without a prescription, or if you have received a vaccination during the last six weeks. • Infusion of immunoglobulins like KIOVIG may impair the effect of some live virus vaccines such as measles, rubella, mumps and chicken pox.
• Jekk jogħġbok għid lit- tabib tiegħek jekk qed tieħu, jekk qiegħed tieħu jew ħadt dan l- aħħar xi mediċini oħra, anki dawk mingħajr riċetta, jew jekk ħadt xi vaċċin matul dawn l- aħħar sitt ġimgħat. • Infużjoni ta ’ immunoglobulini bħal KIOVIG tista ’ timpedixxi l- effett ta ’ xi vaċċini ta ’ viri ħajjin bħall- ħosba, rubella, gattone u ġidri r- riħ.
You may have to wait for up to 1 year after receiving immunoglobulins before you receive your measles vaccine.
Għalhekk, wara li tirċievi dawn il- mediċini għandek tistenna sa 3 xhur qabel tirċievi il- vaċċin ħaj attenwat tiegħek. Għandeu mnejn ikollok tistenna sa sena wara li tirċievi immunoglobulini qabel tirċievi l- vaċċin kontra l- ħosba.
KIOVIG contains a wide variety of different antibodies, some of which can affect blood tests.
KIOVIG fih firxa sħiħa ta ’ antikorpi differenti, li wħud minnhom jistgħu jaffettwaw it- testijiet tad- demm.
If you have a blood test after receiving KIOVIG, please inform the person taking your blood or your doctor that you have received the medication.
Jekk tagħmel test tad- demm wara li tirċievi KIOVIG, jekk jogħġbok avża lit- tabib jew lill - persuna li tkun qegħda teħodlok id- demm li inti rċevejt il- medikazzjoni.
However, medicines that contain antibodies have been used in pregnant or breast-feeding women for years, and it has been shown that there are no harmful effects on the course of pregnancy or the baby to be expected. • If you are breast-feeding and receive KIOVIG, the antibodies of the medicine can also be found in the breast milk.
• Jekk jogħġbok, avża lit- tabib tiegħek jekk inti tqila jew jekk qegħda tredda ’. It- tabib tiegħek jiddeċiedi jekk KIOVIG ikunx jista ’ jintuża matul it- tqala jew it- treddigħ. • Ma saru ebda provi kliniċi b’ KIOVIG f’ nisa tqal jew li jkunu qegħdin ireddgħu. Madankollu, mediċini li fihom l- antikorpi, ilhom jintużaw f’ nisa tqal jew li qegħdin ireddgħu għal snin sħaħ, u ntwera li m’ huma mistennija ebda effetti ta ’ ħsara fuq il- kors tat- tqala jew fuq it- tarbija. • Jekk inti qiegħda tredda ’ u qiegħda tirċievi KIOVIG, l- antikorpi tal- mediċina jistgħu jinstabu wkoll fil- ħalib tas- sider.
Therefore, your baby may be protected from certain infections.
Għalhekk, it- tarbija tiegħek tista 'tkun protetta minn ċerti infezzjonijiet.
KIOVIG has no influence on your ability to drive or use machines.
KIOVIG m’ għandu l- ebda effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
HOW TO USE KIOVIG
KIF GĦANDEK TUŻA KIOVIG
KIOVIG is intended for intravenous administration (infusion into a vein).
KIOVIG huwa ntenzjonat biex jingħata fil- vini (infużjoni f’ vina).
It is given to you by your doctor or nurse.
Jingħatalek mit- tabib jew mill- infermier tiegħek.
Dosage will vary depending on your condition and your body weight.
Id- doża tvarja skond il- kundizzjoni u l- piż tal- ġisem tiegħek.
At the beginning of your infusion you will receive KIOVIG at a slow rate.
Fil- bidu ta ’ l- infużjoni tiegħek, tirċievi KIOVIG b’ rata bil- mod.
Dependent on how comfortable you are, your doctor may then gradually increase the infusion rate.
Jiddependi fuq kemm tħossok komdu/ a, it- tabib tiegħek jista ’ jżid gradwalment ir- rata ta ’ infużjoni.
If you use more KIOVIG than you should
26 Jekk tieħu KIOVIG aktar milli suppost
If you get more KIOVIG than you should, your blood may become too thick (hyperviscous).
Jekk tieħu KIOVIG aktar milli suppost, id- demm tiegħek jista ’ jsir oħxon wisq (iperviskuż).
This could particularly happen when you are a patient at risk, e.g. an elderly patient or a patient having problems with your kidneys.
B’ mod partikolari dan jista ’ jseħħ meta inti pazjent b’ riskju, eż. pazjent anzjan jew pazjent bi problemi fil- kliewi.
Like all medicines, KIOVIG can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, KIOVIG jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
However, possible side effects may be reduced by slowing the infusion rate.
Madankollu, l- effetti sekondarji possibbli jistgħu jitnaqqsu billi titnaqqas ir- rata ta ’ infużjoni.
• General reactions such as chills, headaches, fever, vomiting, allergic reactions, nausea, joint pain, low blood pressure and moderate lower back pain have been experienced occasionally.Rarely, cases of a sudden fall in blood pressure were observed, and in isolated cases allergic reactions (anaphylactic shock), even in patients who have shown no reactions to previous infusions. • Cases of temporary meningitis (reversible aseptic meningitis), isolated cases of temporary decrease of red blood cells (reversible haemolytic anaemia/haemolysis), transient increases in liver function values (liver transaminases) and rare cases of eczema-like symptoms (transient cutaneous reactions) have been observed with immunoglobulin products. • An increase in blood creatinine content and kidney failure has also been observed. • Very rarely, cases of blood clot formation in the veins (thromboembolic reactions) resulting in cardiac infarction, stroke, lung defects (pulmonary embolism), and deep vein thrombosis have been reported which may be related to the infusion of immunoglobulins.
Bi prodotti ta ’ immunoglobulina ġew osservati każijiet ta ’ meninġite temporanja (meninġite asettika riversibbli), każijiet iżolati ta ’ tnaqqis temporanju fl- għadd taċ- ċelloli tad- demm ħomor (anemija emolitika riversibbli/ emolisi), żidiet mhux permanenti fil- valuri tal- funzjoni tal- fwied (transaminases tal- fwied) u każijiet rari ta 'sintomi simili għal dawk ta ’ l- ekżema (reazzjonijiet kutaneji lu jgħaddu). • Ġew osservati wkoll żieda fil- kontenut ta ’ kreatinina tad- demm u indeboliment fil- kliewi. • Rari ħafna, ġew irrapportati każijiet ta ’ formazzjoni ta ’ demm magħqud fil- vini (reazzjonijiet tromboemboliċi) li wasslu għal infart kardijaku, puplesija, difetti pulmonarji (emboliżmu pulmonari) u trombożi venuża profonda, li jistgħu jkunu relatati ma ’ l- infużjoni ta ’ immunoglobulini.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex imsemmija f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib jew lill- ispiżjar tiegħek.
HOW TO STORE KIOVIG
KIF TAĦŻEN KIOVIG
• Keep out of the reach and sight of children.
• Żommu fejn ma jintlaħaqx u ma jidhirx mit- tfal.
• Do not use KIOVIG after the expiry date which is printed on the label and carton after EXP.
• Tużax KIOVIG wara d- data ta ’ skadenza li tidher fuq it- tikketta u l- kaxxa wara JIS.
• Store in a refrigerator (2°C – 8°C).
• Aħżen fi friġġ (2°C – 8°C).
• Do not store above 25°C.
• Taħżnux f' temperatura ’ l fuq minn minn 25°C.
• Do not freeze.
• Tagħmlux fil- friża.
• Keep the container in the outer carton in order to protect from light.
• Żomm ir- reċipjent fil- kaxxa tal- kartun sabiex tilqa ’ mid- dawl.
• KIOVIG may be stored at room temperature (not more than 25°C) for up to 9 months.
• KIOVIG jista 'jinħażen f' temperatura tal- kamra (mhux aktar minn 25°C) għal mhux aktar minn 9 xhur.
Record date of transfer to room temperature and the end of the 9-month period on the outer carton.
Ikteb id- data ta 'trasferiment għal temperatura tal- kamra u tat- tmiem tal- perijodu ta' 9 xhur fuq il- kartuna ta 'barra.
Once stored at room temperature KIOVIG must not be returned to the refrigerator and must be discarded, if not used by the end of the 9-month period.
Ladarba l- prodott ikun maħżun f' temperatura tal- kamra, KIOVIG m’ għandux jitpoġġa lura fil- friġġ u għandu jintrema, jekk ma jintużax sa tmiem il- perijodu ta '9 xhur.
What KIOVIG contains
X' fih KIOVIG
– The active substance of KIOVIG is hum an normal immunoglobulin.
– Is- sustanza attiva ta ’ KIOVIG hija immunoglobulina normali umana.
KIOVIG contains 10% (100 mg/ml) of human protein of which at least 98% is immunoglobulin G (IgG). – The other ingredients are glycine and water for injections.
KIOVIG fih 10% (100 mg/ ml) ta ’ proteina umana li mill- inqas 98% tagħha huwa immunoglobulina G (IgG). – Is- sustanzi l- oħra huma glycine u ilma għall- injezzjonijiet.
27 What KIOVIG looks like and contents of the pack
Id- dehra tal- prodott u d- daqs tal- pakkett
KIOVIG is a solution for infusion in a vial (1 g/10 ml or 2.5 g/25 ml or 5 g/50 ml or 10 g/100 ml or 20 g/200 ml – pack size of 1 vial).
KIOVIG huwa soluzzjoni għall - infużjoni f' kunjett (1 g/ 10 ml jew 2. 5 g/ 25 ml jew 5 g/ 50 ml jew 10 g/ 100 ml jew 20 g/ 200 ml – pakkett b ’ kunjett wieħed).
The solution is clear or slightly opalescent and colourless or pale- yellow.
Is- soluzzjoni hija ċara jew kemmxejn opalexxenti u bla kulur jew safra ċara.
Marketing Authorisation Holder Baxter AG Industriestrasse 67 A-1221 Vienna Austria
Id- Detentur ta ’ l- Awtorizzazzjoni għat- Tqegħid fis - Suq Baxter AG Industriestrasse 67 A- 1221 Vienna L- Awstrija
Manufacturer Baxter S.A.
Manifattur Baxter S. A.
Boulevard René Branquart, 80 B-7860 Lessines Belgium
Boulevard René Branquart, 80 B- 7860 Lessines Il- Belġju
For any further information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok ikkuntattja lir- rappreżentant lokali
Luxembourg Baxter Belgium SPRL Bd. de la Plaine 5 B-1050 Bruxelles, Belgique Tél/ Tel: + 32 2 650 1711
Luxembourg/ Luxemburg Baxter Belgium SPRL Bd. de la Plaine B- 1050 BruxellesBelgique Tél/ Tel: + 32 2 650 1711
Kobaltweg 49 NL-3542 CE Utrecht Tel: + 31 30 2488911
Kobaltweg 49 NL- 3542 CE Utrecht Tel.: + 31 30 2488911
2 8 Deutschland Baxter Deutschland GmbH Im Breitspiel 13 D-69126 Heidelberg Tel: + 49 6221 397 0
Deutschland Baxter Deutschland GmbH Im Breitspiel 13 D- 69126 Heidelberg Tel.: + 49 6221 397 0
Ελλάδα Baxter Hellas EPE Εθνάρχου Μακαρίου 34 Ηλιούπολη GR – 163 41 Αθήνα Τηλ: + 30 210 99 87 000
Ελλάδα Baxter Hellas EPE Εθνάρχου Μακαρίου 34 Ηλιούπολη GR – 163 41 Αθήνα, Ελλάδα Τηλ: + 30- 210- 99 87 000
Portugal Baxter Médico Farmacêutica Lda Sintra Business Park Zona Industrial da Abrunheira, Edifício 10 P-2710-089 Sintra Tel: + 351 21 9252500
Portugal Baxter Médico Farmacêutica Lda Sintra Business Park Zona Industrial da Abrunheira, Edifício 10 P- 2710- 089 Sintra Tel.: + 351 21 9252500
Pouet de Camilo, 2E-46394 Ribarroja del Turia (Valencia) Tel: + 34 96 2722800
Pouet de Camilo, 2 E- 46394 Ribarroja del Turia (Valencia) Tel.: + 34 96 2722800
France Baxter Avenue Louis Pasteur BP 56 F-78311 Maurepas Cedex Tél: + 33 1 3461 5050
France Baxter Avenue Louis Pasteur BP 56 F- 78311 Maurepas Cedex Tel.: + 33 1 3461 5050
Ireland Baxter Healthcare Ltd Unit 7 Deansgrange Industrial Estate IRL – Blackrock, Dublin Tel: + 353 1 2065500
Ireland Baxter Healthcare Ltd Unit 7 Deansgrange Industrial Estate IRL – Blackrock, Dublin Tel.: + 353 1 2065500
Dúbravská cesta 2 SK-841 04 Bratislava Tel: + 421 2 59418455
Dúbravská cesta 2 SK- 841 04 Bratislava Tel.: + 421 2 59418455
Suomi/Finland Baxter Oy PL 270 Valimotie 15 A FIN-00381 Helsinki Puh/Tel: + 358 9 8621111
Suomi/ Finland Baxter Oy PL 270 Valimotie 15 A FIN- 00381 Helsinki Tél/ Tel: + 358 9 8621111
Italia Baxter S.p.A.
29 Italia Baxter S. A.
Viale Tiziano, 25 I-00196 Roma Tel: + 39 06 324911
Viale Tiziano, 25 I- 00196 Roma Tel.: + 39 06 324911
Sverige Baxter Medical AB Torshamnsgatan 35 S-164 40 Kista Tel: + 46 8 6326400
Sverige Baxter Medical AB Torshamnsgatan 35 S- 164 40 Kista Tel.: + 46 8 6326400
United Kingdom Baxter Healthcare Ltd Wallingford Road Compton Berkshire RG20 7QW Tel: + 44 1635 206345
United Kingdom Baxter Healthcare Ltd Wallingford Road Compton Berkshire RG20 7QW - UK Tel.: + 44 1635 206345
This leaflet was last approved in
Dan il- fuljett kien approvat fi
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 - mMediċini (EMEA) http: // www. emea. europa. eu /.
The following information is intended for medical or healthcare professionals only:
IT- TAGĦRIF LI JMISS QED JINGĦATA BISS GĦALL- PROFESSJONISTI FIL- QASAM MEDIKU
• KIOVIG must only be administered intravenously.
• KIOVIG jista 'jingħata biss minn ġol- vini.
Other routes of administration have not been evaluated. • KIOVIG should be infused intravenously at an initial rate of 0.5 ml/kg bodyweight/hour for 30 minutes.
Postijiet oħra mnejn jingħata għadhom ma ġewx evalwati. • KIOVIG għandu jingħata b' infużjoni ġol- vini b' rata inizjali ta '0. 5 ml/ kg piż tal- ġisem/ siegħa għal 30 minuta.
If well tolerated, the rate of administration may gradually be increased to a maximum of 6 ml/kg bodyweight/hour.
Jekk din tiġi ttollerata sewwa, ir- rata ta 'l- għoti tista', bil- mod il- mod tiżdied għal massimu ta '6 ml/ kg piż tal- ġisem/ siegħa.
Clinical data obtained from a limited number of patients also indicate that adult PID patients may tolerate an infusion rate of up to 8 ml/kg BW/hr. • If dilution to lower concentrations is required prior to infusion, KIOVIG may be diluted with 5% glucose solution to a final concentration of 50 mg/ml (5% immunoglobulin).
Informazzjoni klinika miksuba minn numru limitat ta 'pazjenti tindika wkoll li pazjenti adulti b' PID jista ’ jkun li jittolleraw rata ta' infużjoni ta 'mhux aktar minn 8 ml/ kg BW/ siegħa. • Jekk ikun hemm bżonn ta' dilwizzjoni għal konċentrazzjonijiet iktar baxxi qabel l- infużjoni, KIOVIG jista 'jiġi dilwit b' soluzzjoni ta ’ 5% glucose għal konċentrazzjoni finali ta' 50 mg/ ml (5% immunoglobulina).
• Any infusion-related adverse events should be treated by lowering the infusion rate or by stopping the infusion. • It is recommended that every time KIOVIG is administered, the name and batch number of the product is recorded.
• Kull każ avvers relatat ma 'l- infużjoni għandu jiġi ttrattat billi titbaxxa r- rati ta' infużjoni jew billi l- infużjoni titwaqqaf għal kollox. • Huwa rrakkomandat li kull darba li jingħata KIOVIG, l- isem u n- numru tal- lott tal- prodott jiġu reġistrati.
• After dilution to lower concentrations, immediate use is recommended.
• Wara dilwizzjoni għal konċentrazzjonijiet iktar baxxi, huwa rrakkomandat li jintuża minnufih.
The in-use stability of KIOVIG after dilution with a 5% glucose solution to a final concentration of 50 mg/ml (5% immunoglobulin) has been demonstrated for 21 days at 2°C to 8°C as well as at 28°C to 30°C; however, these studies did not include the microbial contamination and safety aspects.
L- istabbilità waqt l- użu ta 'KIOVIG wara dilwizzjoni b' soluzzjoni ta' glucose ta '5% għal konċentrazzjoni finali ta' 50 mg/ ml (5% immunoglobulina) ntweriet għal 21 jum f' temperatura
Instructions for handling and disposal
30 ta ’ 2°C sa 8°C kif ukoll f’ temperatura ta ’ 28°C sa 30°C; madankollu, dawn l- istudji ma nkludewx il- kontaminazzjoni mikrobika u l- aspetti tas- sigurtà.
• The product must be brought to room or body temperature before use.
Struzzjonijiet għall- maniġġar u għar- rimi
30 • KIOVIG should be inspected visually for particulate matter and discoloration prior to administration.
• Il- prodott għandu jilħaq it- temperatura tal- kamra jew tal- ġisem qabel jintuża. • KIOVIG għandu jiġi spezzjonat viżwalment għal frak u tifi fil- kulur tiegħu qabel jingħata.
Do not use if particulate matter or discolouration is observed. • If dilution is required, 5% glucose solution is recommended.
Tużahx jekk tosserva frak jew tifi fil- kulur tiegħu. • Jekk ikun hemm bżonn ta 'dilwizzjoni, hija rrakkomandata soluzzjoni ta' 5% ta 'glucose.
It is recommended that during dilution the risk of microbial contamination is minimised. • Any unused product or waste material should be disposed of in accordance with local requirements.
Huwa rrakkomandat li matul id - dilwizzjoni, ir- riskju ta 'kontaminazzjoni mikrobika jiġi minimizzat. • Kull fdal tal- prodott li ma jiġix użat jew skart li jibqa ’ wara l- użu tal- prodott għandu jintrema kif jitolbu l- liġijiet lokali.
Dosage recommendations
31 Rakkomandazzjonijiet dwar id- doża
Frequency of infusions
Frekwenza ta 'l- infużjonijiet
Replacement therapy in:
Terapija ta 'sostituzzjoni fi:
Primary immunodeficiency
Immunodefiċjenza primarja
0.4 – 0.8 g/kg
0. 4 – 0. 8 g/ kg BW
BW - thereafter:
- minn hemm 'il quddiem:
0.2 – 0.8 g/kg BW
0. 2 – 0. 8 g/ kg BW
every 2 – 4 weeks to obtain IgG minimum (trough) level of at least 4 – 6 g/l
kull 2 – 4 ġimgħat biex jinkiseb livell minimu ta 'IgG ta' mill - inqas 4 – 6 g/ l
Secondary immunodeficiency
Immunodefiċjenza sekondarja
0.2 – 0.4 g/ kg
0. 2 – 0. 4 g/ kg BW
every 3 – 4 weeks to obtain IgG trough level of at least 4 – 6 g/l
kull 3 – 4 ġimgħat biex jinkiseb livell minimu ta ’ IgG mill- inqas 4- 6g/ l /
BW
0. 2 – 0. 4 g/ kg BW
every 3 – 4 weeks
kull 3 - 4 ġimgħat
0.2 – 0.4 g/kg BW Immunomodulation:
Immunomodulazzjoni:
0.8 – 1 g/kg BW or
0. 8 – 1 g/ kg BW jew
on day 1, possibly repeated once within 3 days
f’ Jum 1, possibilment tiġi ripetuta darba fi 3 ijiem
0.4 g/kg BW/d
0. 4 g/ kg BW/ J
for 3 – 7 days
għal 3 – 7 ijiem 0. 4 g/ kg BW/ J Is- sindrome ta 'Guillain Barré −
in several doses for 2 – 5 days in association with acetylsalicylic acid
f' bosta dożi għal 2 - 5 ijiem 1. 6 – 2 g/ kg BW Il- marda ta 'Kawasaki − flimkien ma' acetylsalicylic acid jew
2 g/kg BW
f' doża waħda flimkien ma '2 g/ kg BW acetylsalicylic acid Trapjant tal- mudullun ta' l- għadam alloġeniku:
in one dose in association with acetylsalicylic acid
−
− Treatment of infections and prophylaxis of graft versus host disease
Trattament ta 'infezzjonijiet u profilassi tal- marda "graft versus host ”
every week from 7 days before up to 3 months after transplantation
kull ġimgħa minn 7 ijiem qabelsa 3 xhur wara t- trapjant
Persistent lack of antibody production
Nuqqas persistenti ta 'produzzjoni ta'
every month until antibody levels return to normal
kull xahar sakemm il- livelli ta 'l -
BW = bodyweight D = day
BW =
What is Kivexa?
X’ inhi Kivexa?
Kivexa is a medicine that contains two active substances, abacavir (600 mg) and lamivudine (300 mg).
Kivexa hija mediċina li fiha żewġ sustanzi attivi, abacavir (600 mg) u lamivudine (300 mg).
It is available as orange capsule-shaped tablets.
Hija tiġi bħala pilloli oranġjo forma ta ’ kapsuli.
What is Kivexa used for?
Għalxiex tintuża Kivexa?
Kivexa is an antiviral medicine.
Kivexa hija mediċina antivirali.
It is used in combination with at least one other antiviral medicine to treat adults and adolescents over 12 years old who are infected with HIV (human immunodeficiency virus), the virus that causes acquired immune deficiency syndrome (AIDS).
Hija tintuża f’ kumbinazzjoni ma ’ ta ’ l- inqas mediċina antivirali oħra biex tikkura adulti u adolexxenti ta ’ aktar minn 12- il sena li huma infettati b’ HIV (vajrus ta ’ immunodefiċjenza tal- bniedem), il- vajrus li jikkaġuna sindromu ta ’ defiċjenza immunitarja akkwistata (AIDS).
How is Kivexa used?
Kif tintuża Kivexa?
Kivexa should be prescribed by a doctor who has experience in the management of HIV infection.
Kivexa għandha tingħata b’ riċetta ta ’ tabib li għandu esperjenza fil- ġestjoni ta ’ infezzjoni bl- HIV.
Kivexa is taken as one tablet once a day, with or without food.
Kivexa tittieħed bħala pillola waħda darba kuljum, ma ’ l- ikel jew fuq stonku vojt.
The medicine should only be given to patients who weigh over 40 kg.
Il- mediċina għandha tingħata lil pazjenti li jiżnu aktar minn 40 kg.
Patients requiring dose adjustments of abacavir or lamivudine should take the medicines separately.
Pazjenti li jeħtieġu aġġustamenti fid- doża ta ’ abacavir jew lamivudine għandhom jieħdu l- mediċini separatament.
Kivexa should not be given to patients who have severe problems with their liver and is not recommended for patients who have severe problems with their kidneys.
Kivexa m’ għandhiex tingħata lil pazjenti li għandhom problemi serji bil- fwied tagħhom u mhix irrikmandata għal pazjenti li għandhom problemi serji bil- kliewi tagħhom.
Patients with mild or moderate problems with their liver should be monitored closely by their doctor.
Pazjenti bi problemi bil- fwied tagħhom ħfief jew moderati għandhom ikunu sorveljati bir- reqqa mit- tabib tagħhom.
Kivexa should be used with caution in patients over 65 years of age.
Kivexa għandha tintuża bil- kawtela f’ pazjenti ta ’ aktar minn 65 sena.
Patients who take Kivexa must be given the special alert card that summarises the key safety information about the medicine.
Pazjenti li jieħdu Kivexa għandhom jingħataw kard ta 'twissija speċjali li tiġbor fil- qosor it- tagħrif ta' sigurtà ewlieni dwar il- mediċina.
How does Kivexa work?
Kif taħdem Kivexa?
Both active substances in Kivexa, abacavir and lamivudine, are nucleoside reverse transcriptase inhibitors (NRTIs).
Iż- żewġ sustanzi attivi f’ Kivexa, abacavir u lamivudine, huma impedituri nucleoside reverse transcriptase (NRTIs).
They both work in similar ways by blocking the activity of reverse transcriptase, an enzyme produced by HIV that allows it to infect cells and make more viruses.
It- tnejn jaħdmu b’ modi simili billi jimblokkaw l- attività ta ’ reverse transcriptase, enzima magħmula minn HIV li tħallih jinfetta ċ- ċelloli u jagħmel aktar vajrusijiet.
Kivexa, taken in combination with at least one other antiviral medicine, reduces the amount of HIV in the blood and keeps it at a low level.
Kivexa, meħuda f’ kumbinazzjoni ma ’ ta ’ l- anqas mediċina antivirali oħra, tnaqqas l- ammont ta ’ HIV fid- demm u żżommu f’ livell baxx.
Kivexa does not cure HIV infection or AIDS, but it may delay the damage to the immune system and the development of infections and diseases associated with AIDS.
Kivexa ma tikkurax infezzjoni bl- HIV jew AIDS, iżda tista ’ tittardja l- ħsara fis- sistema immunitarja u l- iżvilupp ta ’ infezzjonijiet u mard assoċjat ma ’ AIDS.
Both active substances have been available in the European Union (EU) since the late 1990s: abacavir was granted marketing approval as Ziagen in 1999, and lamivudine was granted marketing authorisation as Epivir in 1996.
Iż- żewġ sustanzi attivi ilhom disponibbli fl- Unjoni Ewropea (UE) sa mis- snin disgħin: abacavir ingħata approvazzjoni għat- tqegħid fis- suq bħala Ziagen fl- 1999, u lamivudine ingħata approvazzjoni għat- tqegħid fis- suq bħala Epivir fl- 1996.
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged How has Kivexa been studied?
(44- 20) 74 18 84 00 Fax (44- 20) 74 18 84 16 E- mail: mail@ emea. europa. eu http: // www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged Kif ġiet studjata Kivexa?
Kivexa has been studied in three main studies involving 1,230 patients.
Kivexa ġiet studjata fi tliet studji ewlenin li involvew 1, 230 pazjent.
At the time of Kivexa’ s approval, abacavir was authorised at a dose of 300 mg twice a day.
Fiż- żmien ta ’ l- approvazzoni ta ’ Kivexa, abacavir kien awtorizzat f’ doża ta ’ 300 mg darbtejn kuljum.
Therefore, the studies compared abacavir taken at 600 mg once a day and at 300 mg twice a day, in combination with lamivudine and one or two other antiviral medicines.
Għaldaqstant, l- istudji qabblu abacavir meħud b’ doża ta ’ 600 mg darba kuljum u 300 mg darbtejn kuljum, f’ kombinazzjoni ma ’ lamivudine u waħda jew żewġ mediċini antivirali kuljum.
Two studies used the active substances taken as separate medicines, while the third used a combination tablet for the once-daily dose.
Żewġ studji wżaw is- sustanzi attivi meħuda bħala mediċini separati, waqt li t- tielet uża pillola ta ’ kombinazzjoni għad- doża ta ’ darba kuljum.
The main measure of effectiveness was the change in the level of HIV in the blood (viral load) after 24 or 48 weeks of treatment.
Il - miżura ewlenija ta ’ l- effikaċja kienet il- bidla fil- livell ta ’ HIV fid- demm (tagħbija virali) wara 24 jew 48 ġimgħa ta ’ kura.
What benefit has Kivexa shown during the study?
X’ benefiċċju wriet Kivexa waqt l- istudju?
Both doses of abacavir, taken in combination with lamivudine and other antiviral medicines, were equally effective in reducing viral loads.
Iż- żewġ dożi ta ’ abacavir, meħudin f’ kumbinazzjoni ma ’ lamivudine u mediċini antivirali oħra, kienu ugwalment effettivi fit- tnaqqis ta ’ tagħbijiet virali.
In the first study, 253 (66%) of the 384 patients taking abacavir once a day had viral loads below 50 copies/ ml after 48 weeks, compared to 261 (68%) of the 386 taking it twice a day.
Fl- ewwel studju, 253 (66%) tat- 384 pazjent li kienu qed jieħdu abacavir darba kuljum kellhom tagħbijiet virali taħt 50 kopji/ ml wara 48 ġimgħa, meta mqabbla ma ’ 261 (68%) tat- 386 li qed jieħduh darbtejn kuljum.
The combination tablet taken once a day was also as effective as the medicines taken separately twice a day in reducing viral loads over 24 weeks of treatment.
Il- pillola ta ’ kumbinazzjoni meħuda darba kuljum kienet ukoll effettiva fit- tnaqqis ta ’ tagħbijiet virali fuq 24- il ġimgħa ta ’ kura daqs il - mediċini meħudin separatament darbtejn kuljum.
What is the risk associated with Kivexa?
X’ inhu r- riskju assoċjat ma ’ Kivexa?
The most common side effects when taking Kivexa (seen in between 1 and 10 patients in 100) are hypersensitivity (allergic reactions), rash, nausea (feeling sick), vomiting, diarrhoea, abdominal (tummy) pain, headache, arthralgia (joint pain), muscle disorders, cough, nasal symptoms, fever, lethargy, fatigue (tiredness), insomnia (difficulty sleeping), malaise (feeling unwell), anorexia (loss of appetite) and alopecia (hair loss).
L- aktar effetti sekondarji komuni waqt it- teħid ta ’ Kivexa (li dehru f’ madwar pazjent 1 u 10 minn kull 100) huma sensittività eċċessiva (reazzjoniet allerġiċi), raxx, nawżja (dardir), remettar, dijarea, uġigħ addominali (ta ’ zaqq), uġigħ ta ’ ras, artralġja (uġigħ fil- ġogi), disturbi fil- muskoli, sogħla, sintomi nażali, deni, letarġija, għeja kbira, insomnja (diffikultà fl- irqad), tħossok ma tiflaħx, anoressja (telf ta ’ aptit) u alopijxja (telf ta ’ xagħar).
For the full list of all side effects reported with Kivexa, see the Package Leaflet.
Għal- lista sħiħa ta ’ l- effetti sekondarji kollha irrapportati b’ Kivexa, ara l- Fuljett ta ’ Tagħrif.
Hypersensitivity reactions (allergic reactions) occur in about 5% of patients taking Kivexa, usually within the first six weeks of treatment.
Reazzjonijiet ta ’ sensittività eċċessiva (reazzjonijiet allerġiċi) jseħħu f’ madwar 5% ta ’ pazjenti li qed jieħdu Kivexa, ġeneralment fi żmien l- ewwel sitt ġimgħat ta ’ kura.
Some of these cases can be fatal.
Xi wħud minn dawn il- każijiet jistgħu jkunu fatali.
Symptoms almost always include fever or rash, but also very commonly include nausea, vomiting, diarrhoea, abdominal pain, dyspnoea (difficulty breathing), cough, lethargy, malaise, headache, signs of liver damage in the blood and myalgia (muscle pain).
Is- sintomi kważi dejjem jinkludu deni jew raxx, iżda huma wkoll komuni ħafna nawżja, remettar, dijarea, uġigħ addominali, dispneja (diffikultà fit- teħid tan- nifs), sogħla, letarġija, tħossok ma tiflaħx, uġigħ ta ’ ras, sinjali ta ’ ħsara fil- fwied fid- demm u majalġja (uġigħ fil- muskoli).
Patients treated with Kivexa receive a card detailing these symptoms so that they are aware of them, and must contact their doctor immediately if they develop a reaction.
Pazjenti ikkurati b’ Kivexa jirċievu kard li tiddeskrivi fid- dettall dawn is- sintomi sabiex huma jkunu konxji tagħhom, u jkunu jistgħu jikkuntattjaw lit- tabib tagħhom minnufih jekk jiżviluppaw reazzjoni.
Kivexa should not be used in patients with severe liver disease or in patients who may be hypersensitive (allergic) to lamivudine, abacavir or any of the other ingredients.
Kivexa m’ għandhiex tintuża f’ pazjenti b’ mard serju tal- fwied jew f’ pazjenti li jistgħu jkunu sensittivi żżejjed (allerġiċi) għal lamivudine, abacavir jew għal xi sustanza oħra tiegħu.
As with other anti-HIV medicines, patients taking Kivexa may be at risk of lipodystrophy (changes in the distribution of body fat), osteonecrosis (death of bone tissue) or immune reactivation syndrome (symptoms of infection caused by the recovering immune system).
Bħal b’ mediċini oħra kontra l- HIV, pazjenti li qed jieħdu Kivexa jistgħu jkunu f’ riskju ta ’ lipodistrofija (bidliet fid- distribuzzjoni tax- xaħam fil- ġisem), osteonekrożi (mewt tat- tessut ta ’ l - għadam) jew sindromu ta ’ attivazzjoni immunitarja mill- ġdid (sintomi ta ’ infezzjoni ikkaġunati mis - sistema immunitarja li tkun qed tirkupra).
Patients who have problems with their liver (including hepatitis B or C infection) may be at an elevated risk of liver damage when taking Kivexa.
Pazjenti li għandhom problemi bil- fwied tagħhom (inklużi infezzjoni b’ epatite B jew Ċ) jistgħu jkunu f’ riskju għola ta ’ ħsara fil- fwied meta jkunu qed jieħdu Kivexa.
As with all other NRTIs, Kivexa may also cause lactic acidosis (a build-up of lactic acid in the body) and, in the babies of mothers taking Kivexa during pregnancy, mitochondrial dysfunction (damage to the energy-producing components within cells that can cause problems in the blood).
Bħal bl- NRTI’ s l- oħra kollha, Kivexa tista ’ tikkaġuna ukoll aċidożi lattika (akkumulazzjoni ta ’ aċidu lattiku fil- ġisem) u, fi trabi ta ’ ommijiet li qed jieħdu Kivexa waqt it- tqala, funzjoni ħażina mitokondrijali (ħsara lill- komponenti li jipproduċu l- enerġija ġewwa ċ- ċelloli li jistgħu jikkaġunaw problemi fid- demm).
Why has Kivexa been approved?
Għaliex ġiet approvata Kivexa?
The Committee for Medicinal products for Human Use (CHMP) concluded that Kivexa’ s benefits are greater than its risks in antiretroviral combination therapy for the treatment of HIV infected adults and adolescents from 12 years of age.
Il- Kumitat għal Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) ikkonkluda li l- benefiċċji ta ’ Kivexa huma akbar mir- riskji tagħha f’ terapija ta ’ kumbinazzjoni antiretrovirali għall- kura ta ’ adulti u adolexxenti minn 12- il sena infettati bl- HIV.
The Committee noted that the demonstration of Kivexa’ s benefit was mainly based on one study in adults, most of whom had not received previous treatment for HIV infection and had no symptoms of HIV infection.
Il- Kumitat innota li l- wiri tal- benefiċċji ta ’ Kivexa kien prinċipalment ibbażat fuq studju wieħed fl- adulti, bosta minn liema ma kinux irċievew kura qabel għal infezzjoni bl- HIV u ma kellhomx sintomi ta ’ infezzjoni bl- HIV.
The Committee recommended that Kivexa be given marketing authorisation.
Il- Kumitat irrikmanda li Kivexa tingħata awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Kivexa:
Tagħrif ieħor dwar Kivexa:
The European Commission granted a marketing authorisation valid throughout the EU for Kivexa to Glaxo Group Ltd on 17 December 2004.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq għal Kivexa valida fl- Unjoni Ewropea kollha lil Glaxo Group Ltd fis- 17 ta ’ Diċembru 2004.
The full EPAR for Kivexa is available here.
L- EPAR sħiħ għal Kivexa huwa disponibbli minn hawn.
bottle (HDPE)
flixkun (HDPE)
Film-coated tablet Film-coated tablet
Pillola miksija b’ rita
Oral use Oral use
Użu orali
30 tablets 3 x 30 tablets
3 x 30 pillola
1 600 mg abacavir (as sulfate) 300 mg lamivudine
1 600 mg abacavir (bħala sulfate) 300 mg lamivudine
Kivexa 600 mg/ 300 mg film-coated tablets
Kivexa 600 mg/ 300mg pilloli miksijin b’ rita
Each film-coated tablet contains 600 mg of abacavir (as sulfate) and 300 mg lamivudine.
Kull pillola miksija b' rita fiha 600 mg ta` abacavir (bħala sulphate) u 300 mg ta` lamivudine.
Sunset yellow (E110) 1.7 mg per tablet
Sunset Yellow (E110) 1. 7mg f’ kull pillola.
Film-coated tablet.
Pillola miksija b' rita
Orange, film-coated, modified capsule shaped tablets, debossed with GS FC2 on one side.
Pilloli oranġjo, miksijin b’ rita, modifikati forma ta ’ kapsula, u fuq naħa minnhom għandhom imnaqqax GS FC2
Kivexa is a fixed-dose combination of two nucleoside analogues (abacavir and lamivudine).
Kivexa hi kombinazzjoni ta ’ żewġ analogi tan- nukleosidi b’ doża fissa( abacavir u lamivudine).
It is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age.
Hija indikata għal terapija antiretrovirali kombinata għall- kura ta ’ l- infezzjoni bil - virus ta ’ Immunodefiċjenza Umana (HIV) f’ adulti u adolexxenti minn 12- il sena ’ l fuq.
The demonstration of the benefit of the combination abacavir/ lamivudine as a once daily regimen in antiretroviral therapy, is mainly based on results of one study performed in primarily asymptomatic treatment-naïve adult patients (see sections 4.4 and 5.1).
Il- wiri ta ’ benefiċċju tal- kombinazzjoni ta ’ abacavir/ lamivudine bħala kors ta ’ pillola kuljum fit - terapija antiretrovirali, hi prinċipalment ibbażata fuq riżultati ta ’ studju wieħed li sar fuq pazjenti adulti primarjament asintomatiċi u li qatt ma kienu ħadu din it- terapija qabel (ara taqsimiet 4. 4 u 5. 1).
Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin.
Qabel ma tinbeda kura b’ abacavir, għanda ssir investigazzjoni għall- ġarr ta ’ l- allel HLA- B* 5701 f’ kull pazjent infettat bl- HIV, irrispettavament mir- razza.
Abacavir should not be used in patients known to carry the HLA-B*5701 allele, unless no other therapeutic option is available in these patients, based on the treatment history and resistance testing (see section 4.4 and 4.8).
Abacavir m’ għandux jintuża f’ pazjenti magħrufa li jġorru l- allel HLA- B* 5701, sakemm ma jkunx hemm l- ebda għażla oħra terapewtika f’ dawn il- pazjenti, fuq bażi ta ’ trattamenti ta ’ qabel u testijiet ta ’ reżistenza (ara sezzjoni 4. 4 u 4. 8)
Therapy should be prescribed by a physician experienced in the management of HIV infection.
It- terapija għandha tiġi preskritta minn tabib ta 'esperjenza fl- immaniġġar ta' l- infezzjoni HIV.
The recommended dose of Kivexa in adults and adolescents is one tablet once daily.
Id- doża rakkomandata ta 'Kivexa fl- adulti u fl- adolexxenti hi ta ’ pillola waħda kuljum.
Kivexa should not be administered to adults or adolescents who weigh less than 40 kg because it is a fixed-dose tablet that cannot be dose reduced.
Kivexa m’ għandhiex tingħata lill- adulti u adolexxenti li għandhom piż ta ’ inqas minn 40 kg għax hi pillola ta ’ doża fissa u d- doża tagħha ma tistax titnaqqas.
Kivexa can be taken with or without food.
Kivexa tista ’ tittieħed ma ’ l- ikel jew fuq stonku vojt.
Kivexa is a fixed-dose tablet and should not be prescribed for patients requiring dosage adjustments.
Kivexa hi pillola b’ doża fissa u m’ għandhiex tingħata lil pazjenti li jkollhom bżonn aġġustamenti fid - doża.