qanastek/EMEA-V3 huggingface dataset:
Based on pooled analysis of placebo-controlled studies, severe anaemia (Hb < 8.0 g/ dl) was reported in 5.2% of patients receiving Zometa 4 mg versus 4.2% on placebo.
Analiżi ta ’ ġabra ta ’ studji kkontrollati bil- plaċebo wriet li anemija severa (Hb < 8. 0 g/ dl) ġiet irrapportata f’ 5. 2% tal- pazjenti li qed jirċievu Zometa, meta mqabbla ma ’ 4. 2% li kienu jieħdu plaċebo.
20 Blood and lymphatic system disorders
20 Disturbi tad- demm u tas- sistema limfatika
In one 3 year, randomised, double-blind controlled trial that evaluated the efficacy and safety of zoledronic acid 5 mg once yearly vs. placebo in the treatment of postmenopausal osteoporosis (PMO), the overall incidence of atrial fibrillation was 2.5% (96 out of 3,862) and 1.9% (75 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Fi prova ta ’ 3 snin, randomised, double- blind kontrollata li evalwat l- effikaċja u s- sigurtà ta ’ zoledronic acid 5 mg darba fis- sena kontra plaċebo fil- kura ta ’ osteoporosi ta ’ wara l- menopawża (PMO), l- inċidenza globali tal- fibrillazzjoni atrijali kienet 2. 5% (96 minn 3, 862) u 1. 9% (75 minn 3, 852) f’ pazjenti li kienu qed jirċievu zoledronic acid 5 mg u plaċebo, rispettivament.
The rate of atrial fibrillation serious 21 adverse events was 1.3% (51 out of 3,862) and 0.6% (22 out of 3,852) in patients receiving zoledronic acid 5 mg and placebo, respectively.
Ir- rata ta ’ 21 każijiet avversi serji ta ’ fibrillazzjoni atrijali kienet 1. 3% (51 minn 3, 862) u 0. 6% (22 minn 3, 852) f’ pazjenti li kienu qed jirċievu zoledronic acid 5 mg u plaċebo, rispettivament.
The imbalance observed in this trial has not been observed in other trials with zoledronic acid, including those with Zometa (zoledronic acid) 4 mg every 3-4 weeks in oncology patients.
L- iżbilanċ li deher f’ din il- prova ma deherx fi provi oħrajn b’ zoledronic acid, inklużi dawk b’ Zometa (zoledronic acid) 4 mg kull 3- 4 ġimgħat f’ pazjenti b’ mard tat- tumur.
Clinical experience with acute overdose of Zometa is limited.
L- esperjenza klinika b’ doża eċċessiva akuta ta’ Zometa hija limitata.
tumour cells, synergistic cytostatic effect with other anti-cancer drugs, anti-adhesion/ invasion activity.
tumur u wkoll effett pro- apoptotiku fuq iċ- ċelloli tat- tumur, jaħdem b’ mod sinerġistiku ma ’ mediċini oħrajn kontra l- kanċer biex jagħmel effett li jfixkel it- tkattir taċ- ċelloli tat- tumur, kif ukoll għandu attività kontra l- adeżjoni/ l- invażjoni.
22 Clinical trial results in the prevention of skeletal related events in patients with advanced malignancies involving bone The first randomised, double-blind, placebo-controlled study compared Zometa to placebo for the prevention of skeletal related events (SREs) in prostate cancer patients.
Riżultati ta ’ provi kliniċi dwar il- prevenzjoni ta ’ problemi skeletrali f’ pazjenti li għandhom kanċer avvanzat li jinvolvi l- għadam L- ewwel studju randomised, double- blind u kkontrollat bi plaċebo qabbel Zometa ma ’ plaċebo fil - prevenzjoni ta ’ effetti skeletrali (SRE) f’ pazjenti b’ kanċer tal- prostata.
23 Table 3:
23 Tabella 3:
24 Table 4:
24 Tabella 4:
26 In clinical trials performed in patients with tumour-induced hypercalcaemia (TIH), the overall safety profile amongst all three treatment groups (zoledronic acid 4 and 8 mg and pamidronate 90 mg) was similar in types and severity.
Fi provi kliniċi fuq pazjenti b’ żieda fil- livell tal- calcium fid- demm minħabba tumuri (TIH), il- profil ta ’ sigurtà fost it- tliet gruppi ttrattati (zoledronic acid 4 mg u zoledronic acid 8 mg u pamidronate) kien ta ’ l- istess mill- lat ta ’ tipi u severità.
5.3 Preclinical safety data
27 5. 3 Tagħrif ta ’ qabel l- użu kliniku dwar is- sigurtà tal- mediċina
27 The most frequent finding in repeat-dose studies consisted of increased primary spongiosa in the metaphyses of long bones in growing animals at nearly all doses, a finding that reflected the compound’ s pharmacological antiresorptive activity.
Studji b’ dożi ripetuti wrew ta ’ spiss li kien hemm żieda fl- ammont ta ’ sponġoża primarja fil- metafiżi ta ’ l- għadam twil f’ annimali li jkunu għadhom qed jiżviluppaw u għal kważi d- dożi kollha, sejba li tirrifletti li din is- sustanza għandha effett farmakoloġiku li timpedixxi r- risorbiment.
To avoid potential incompatibilities, Zometa concentrate is to be diluted with 0.9% w/ v sodium chloride solution or 5% w/ v glucose solution.
Biex wieħed jevita inkompatibilitajiet, il- konċentrat ta ’ Zometa għandu jiġi ddilwit b’ sodium chloride 0. 9% w/ v jew soluzzjoni ta ’ glucose 5% w/ v.
Zometa concentrate must not be mixed with calcium or other divalent cation-containing infusion solutions such as lactated Ringer’ s solution, and should be administered as a single intravenous solution in a separate infusion line.
Il- konċentrat ta ’ Zometa m’ għandux jiġi mħallat ma ’ soluzzjonijiet oħra li jkun fihom calcium jew ma ’ soluzzjonijiet oħra li jingħataw minn ġol- vina bħal soluzzjoni lactated Ringer u għandha tingħata bħala soluzzjoni waħda minn ġol- vina f’ linja ta ’ infużjoni separata..
6.3 Shelf life
28 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
The Zometa solution is stable for 24 hours at 2°C – 8°C after further dilution in 100 ml physiological saline or 5% w/ v glucose solution.
Is- soluzzjoni ta ’ Zometa hija stabbli għal 24 siegħa f’ 2°C – 8°C wara li tkun iddilwita f’ 100 ml ta ’ ilma bil- melħ fiżjoloġiku jew 5% w/ v soluzzjoni ta ’ glucose.
After aseptic dilution, it is preferable to use the diluted product immediately.
Wara li jiġi ddilwit taħt kundizzjonijiet asettiċi, huwa preferibbli li l- prodott iddilwit jintuża minnufih.
If not used immediately, the duration and conditions of storage prior to use are the user’ s responsibility.
Jekk ma tintużax mill- ewwel, iż- żmien li għalih idum maħżun u l- kundizzjonijiet li fihom jinħażen qabel ma jintuża, huma r- risponsabillta ’ ta ’ min ser jużah.
The total time between dilution, storage in a refrigerator at 2°C – 8°C and end of administration must not exceed 24 hours.
Il- ħin totali minn mindu jiġi ddilwit, u jkun maħżun fil- friġġ f’ temperatura ta ’ 2°C – 8°C, sa ma tintemm l- għotja tad- doża m’ għandux ikun aktar minn 24 siegħa.
28 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
Zometa 4 mg/ 5 ml concentrate for solution for infusion is supplied as packs containing 1, 4 or 10 vials.
Il- konċentrat ta ’ Zometa 4 mg/ 5 ml għal soluzzjoni għall- infużjoni jiġi f’ pakketti ta ’ Kunjett 1, 4 jew 10 kunjetti.
5-ml plastic vial made of clear, colourless cycloolefine copolymer with fluoropolymer-coated bromobutyl rubber stopper and aluminium cap with plastic flip-off component.
Kunjett magħmula minn cycloolefine copolymer ċar u bla kulur b’ tapp tal- lasktu ta ’ bromobutyl miksi b’ fluoropolymer, u b’ tapp ta ’ l- aluminium b’ komponent flip- off tal- plastik.
Prior to administration, 5.0 ml concentrate from one vial or the volume of the concentrate withdrawn as required must be further diluted with 100 ml of calcium-free infusion solution (0.9% w/ v sodium chloride solution or 5% w/ v glucose solution).
Qabel ma tiġi mogħtija, 5. 0 ml konċentrat minn kunjett wieħed għandu jiġi ddilwit b’ 100 ml ta ’ soluzzjoni għall- infużjoni mingħajr calcium (0. 9% w/ v soluzzjoni ta ’ sodium chloride jew 5% w/ v soluzzjoni ta ’ glucose).
If refrigerated, the solution must be allowed to reach room temperature before administration.
Jekk titpoġġa fil- friġg, is- soluzzjoni għandha titħalla tilħaq it- temperatura ambjentali qabel tiġi mogħtija.
24.03.2003 Date of first renewal:
24. 03. 2003 Data ta ’ l- ewwel tiġdid:
29 ANNEX II
29 ANNESS II
Name and address of the manufacturer responsible for batch release
Isem u indirizz tal- manifattur responsabbli għall - ħruġ tal- lott
Novartis Pharma GmbH, Roonstrasse 25, D-90420 Nüremberg, Germany.
Novartis Pharma GmbH, Roonstraβe 25, D- 90420 Nuremberg, Il- Ġermanja
Manufacturing authorisation issued on 1 August 1997 by Regierungspräsidium Freiburg, Germany.
Awtorizzazzjoni tal- manifattura maħruġa fl’ 1 August 1997 minn Regierungspräsidium Freiburg, Il - Ġermanja.
FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS UNIT PACK (INCLUDING BLUE BOX) FOLDING BOX FOR 4 VIALS AND 4 AMPOULES AS UNIT PACK (INCLUDING BLUE BOX
KAXXA TINTLEWA GĦAL KUNJETT 1 U AMPULLA 1 BĦALA PAKKETT INDIVIDWALI (KAXXA ĊELESTI INKLUŻA) KAXXA TINTLEWA GĦAL 4 KUNJETTI U 4 AMPULLI BĦALA PAKKETT INDIVIDWALI (KAXXA ĊELESTI INKLUŻA)
Zometa 4 mg Powder and solvent for solution for infusion Zoledronic acid
Zometa 4 mg Trab u solvent għal soluzzjoni għall- infużjoni Zoledronic acid
One vial contains 4 mg of zoledronic acid (anhydrous).
Kunjett wieħed fih 4 mg zoledronic acid (anhydrous).
It also contains mannitol and sodium citrate.
Fih ukoll mannitol u sodium citrate.
The solvent ampoule contains water for injections.
L- ampulla tas- solvent fiha ilma għall- injezzjonijiet.
One vial 4 mg One ampoule of solvent 5 ml Four vials 4 mg Four ampoules of solvent 5 ml
Kunjett wieħed ta ’ 4 mg Ampulla waħda b’ 5 ml solvent Erba ’ kunjetti ta ’ 4 mg Erba ’ ampulli b’ 5 ml solvent
METHOD AND ROUTE(S) OF ADMINISTRATION
MOD TA ’ KIF U MNEJN JINĠĦATA
For intravenous use only.
Użu għal ġol- vini biss.
No special precautions for storage.
M’ hemm l- ebda prekawzjonijiet speċjali għall- ħażna.
The reconstituted solution is stable for 24 hours at 2°C – 8°C.
Wara li jkun rikostitwit, is- soluzzjoni tibqa ’ stabbli għal 24 siegħa f’ temperatura ta ’ bejn 2°C – 8°C.
1 vial and 1 ampoule 4 vials and 4 ampoules
kunjett 1 u ampulla 1 4 kunjetti u 4 ampulli
Please open here
Jekk jogħġbok iftaħ hawn.
FOLDING BOX FOR 1 VIAL AND 1 AMPOULE AS INTERMEDIATE PACK (WITHOUT BLUE BOX)
KAXXA TINTLEWA GĦAL KUNJETT 1 U AMPULLA 1 BĦALA PAKKETT INDIVIDWALI (KAXXA ĊELESTI INKLUŻA)
One vial 4 mg One ampoule of solvent 5 ml Component of a multipack comprising ten packs, each containing one vial and one ampoule
Kunjett wieħed ta ’ 4 mg Ampulla waħda b’ 5 ml solvent Jagħmel parti minn pakkett multiplu li jinkludi 10 pakketti, kull wieħed ikun fih kunjett 1 u ampulla 1.
WRAPPER LABEL ON MULTIPACKS WRAPPED IN NON-TRANSPARENT FOIL (INCLUDING BLUE BOX)
IT- TIKKETTA TA ’ FUQ IL- KISJA TA ’ BARRA FUQ PAKKETTI MULTIPLI MIKSIJIN FIL- FOJL MHUX TRASPARENTI (INKLUŻA L- KAXXA Ċ- ĊELESTI)
Multipack comprising ten packs, each containing one vial and one ampoule of solvent 5 ml.
Jagħmel parti minn pakkett multiplu li jinkludi 10 pakketti, kull wieħed ikun fih kunjett 1 u ampulla 1 b’ solvent 5 ml.
38 The reconstituted solution is stable for 24 hours at 2°C – 8°C.
Wara li jkun rikostitwit, is- soluzzjoni tibqa ’ stabbli għal 24 siegħa f’ temperatura ta ’ bejn 2°C – 8°C.
Zometa 4 mg Powder for solution for infusion Zoledronic acid For intravenous use only
Zometa 4 mg Trab għal soluzzjoni għall- infużjoni Zoledronic acid Użu għal ġol- vini biss
The reconstituted solution is stable for 24 hours at 2°C – 8°C.
Is- soluzzjoni rikostitwita tibqa stabbli għal 24 siegħa f’ temperatura ta ’ bejn 2°C – 8°C.
MAH logo
Logo tal- MAH
Solvent for Zometa Water for injections 5 ml
Solvent għal Zometa Ilma għall- injezzjonijiet 5 ml
Use the entire contents.
Uża l- kontenut kollu.
FOLDING BOX FOR 1 VIAL AS UNIT PACK (INCLUDING BLUE BOX) FOLDING BOX FOR 4 VIALS AS UNIT PACK (INCLUDING BLUE BOX)
KAXXA TINTLEWA GĦAL KUNJETT 1 BĦALA PAKKETT INDIVIDWALI (KAXXA ĊELESTI INKLUŻA) KAXXA TINTLEWA GĦAL 4 KUNJETTI BĦALA PAKKETT INDIVIDWALI (KAXXA ĊELESTI INKLUŻA)
Zometa 4 mg/ 5 ml concentrate for solution for infusion Zoledronic acid
Zometa 4 mg/ 5 ml konċentrat għal soluzzjoni għall- infużjoni Zoledronic acid
It also contains mannitol, sodium citrate and water for injections.
Fiha wkoll mannitol, sodium citrate u ilma għall- injezzjonijiet.
One vial with 5 ml concentrate for solution for infusion Four vials with 5 ml concentrate for solution for infusion
Kunjett wieħed b’ 5 ml ta ’ konċentrat għal soluzzjoni għall- infużjoni Erba ’ kunjetti b’ 5 ml ta ’ konċentrat għal soluzzjoni għall- infużjoni
Stable for 24 hours at 2°C – 8°C after further dilution in 100 ml physiological saline or 5% w/ v glucose solution.
Stabbli għal 24 siegħa f’ temperatura ta ’ bejn 2°C – 8°C, wara li jkun dilwit f’ 100 ml ta ’ ilma bil- melħ fiżjoloġiku jew 5% w/ v soluzzjoni ta ’ glucose.
Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom
Novarits Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB Ir- Renju Unit
1 vial 4 vials
kunjett 1 4 kunjetti
FOLDING BOX FOR 1 VIAL AS INTERMEDIATE PACK (WITHOUT BLUE BOX)
KARTUNA LI FIHA KUNJETT 1 BĦALA PAKKETT INTERMEDJU (MINGĦAJR IL - KAXXA Ċ- ĊELESTI)
One vial with 5 ml concentrate for solution for infusion Component of a multipack comprising ten packs, each containing one vial
Kunjett wieħed b’ 5 ml ta ’ konċentrat għal soluzzjoni għall- infużjoni Jagħmel parti minn pakkett multiplu li jinkludi 10 pakketti, kull wieħed ikun fih kunjett 1.
Stable for 24 hours at 2°C – 8°C after further dilution in 100 ml physiological saline or 5% w/ v glucose solution.
44 Stabbli għal 24 siegħa f’ temperatura ta ’ bejn 2°C – 8°C, wara li jkun dilwit f’ 100 ml ta ’ ilma bil- melħ fiżjoloġiku jew 5% w/ v soluzzjoni ta ’ glucose.
Multipack comprising ten packs, each containing one vial.
Kunjett wieħed b’ 5 ml ta ’ konċentrat għal soluzzjoni għall- infużjoni Pakkett multiplu li jinkludi 10 pakketti, kull wieħed ikun fih kunjett 1
Stable for 24 hours at 2°C – 8°C after further dilution in 100 ml physiological saline or 5% w/ v glucose solution.
46 Stabbli għal 24 siegħa f’ temperatura ta ’ bejn 2°C – 8°C, wara li jkun dilwit f’ 100 ml ta ’ ilma bil- melħ fiżjoloġiku jew 5% w/ v soluzzjoni ta ’ glucose.
Zometa 4 mg/ 5 ml concentrate for solution for infusion Zoledronic acid For intravenous use only
Zometa 4 mg/ 5 ml konċentrat għal soluzzjoni għall- infużjoni Zoledronic acid Użu għal ġol- vini biss
Stable for 24 hours at 2°C – 8°C after further dilution in 100 ml physiological saline or 5% w/ v glucose solution.
Stabbli għal 24 siegħa f’ temperatura ta ’ bejn 2°C – 8°C, wara li jkun ddilwit f’ 100 ml ta ’ ilma bil - melħ fiżjoloġiku jew 5% w/ v soluzzjoni ta ’ glucose.
Zometa 4 mg powder and solvent for solution for infusion Zoledronic acid
Zometa 4 mg trab u solvent għal soluzzjoni għall- infużjoni Zoledronic acid
Read all of this leaflet carefully before you are given Zometa. − Ask your doctor, nurse or pharmacist if you have further questions. − Keep this leaflet.
- Jekk ikollok aktar mistoqsijiet, jekk jogħġbok staqsi lit- tabib, infermier jew spiżjar tiegħek.
You may need to read it again. − If any of the side effects gets serious, or if you notice side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
- Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li m’ humiex
What Zometa is and what it is used for 2.
X’ inhu Zometa u għalxiex jintuża 2.
Before you are given Zometa 3.
Qabel ma tingħata Zometa 3.
How Zometa is used 4.
Kif jintuża Zometa 4.
How to store Zometa 6.
Kif taħżen Zometa 6.
WHAT ZOMETA IS AND WHAT IT IS USED FOR
X’ INHU ZOMETA U GĦALXIEX JINTUŻA
Zometa is given as an infusion into a vein.
Zometa jingħata bħala infużjoni ġo vina.
Zoledronic acid is a member of a group of substances called bisphosphonates.
Zoledronic acid jifforma parti minn grupp ta ’ sustanzi li jissejħu bisphosphonates.
It is used to treat bone metastases (spread of cancer), to prevent bone complications, e. g. fractures, and to lower the amount of calcium in the blood in patients with tumour-induced hypercalcaemia (TIH).
Jingħata għall- kura ta ’ metastasi (firxa tal- kanċer) ta ’ l- għadam, għall- prevenzjoni ta ’ kumplikazzjonijiet fl- għadam, eż. ksur, u biex ibaxxi l- livell ta ’ kalċju fid- demm f’ pazjenti li għandhom żjieda fil- livell tal- kalċju fid - demm kawża ta ’ tumuri (TIH).
Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change.
Zoledronic acid jaħdem billi jeħel ma ’ l- għadam u jnaqqas ir- rata ta ’ tibdil ta ’ l- għadam.
It is used to reduce the amount of calcium in the blood in cases where it is too high due to the presence of a tumour.
Jintuża biex inaqqas il- livelli ta ’ kalċju fid- demm f’ każijiet fejn ikun għoli wisq minħabba l- preżenza ta ’ tumur.
Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increased.
It- tumuri jistgħu jgħollu r- rata ta ’ tibdil ta ’ l- għadam b’ ċertu mod li jiżdied il- kalċju li jinħeles mill- għadam.
This condition is known as tumour-induced hypercalcaemia.
Din il- kundizzjoni hija magħrufa bħala żjieda fil- livell tal - kalċju fid- demm kawża ta ’ tumuri.
BEFORE YOU ARE GIVEN ZOMETA
QABEL MA TINGĦATA ZOMETA
Follow carefully all instructions given to you by your doctor.
Segwi bil- galbu l- istruzzjonijiet kollha li tak it- tabib tiegħek.
You should not be given Zometa: − if you are breast-feeding. − if you are allergic (hypersensitive) to zoledronic acid, another bisphosphonate (the group of substances to which Zometa belongs), or any of the other ingredients of Zometa.
- jekk int allerġiku/ a (sensittività eċċessiva) għal zoledronic acid, xi bisphosphonate (il- grupp ta ’
Before you are given Zometa, tell your doctor: − if you have or have had a liver problem. − if you have or have had a kidney problem. − if you have or have had a heart problem. − if you have or have had pain, swelling or numbness of the jaw or a “ heavy jaw feeling” or loosening of a tooth.
sustanzi li Zometa jagħmel parti minnu) ieħor, jew xi sustanzi oħra f’ Zometa.
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Zometa.
Għid lit- tabib qabel tingħata Zometa:
Your doctor will check your response to treatment at regular intervals.
- jekk kellek jew għandek uġigħ, nefħa jew tnemnim tax- xedaw jew tħoss “ sensazzjoni ta ’ xedaq
He or she must perform blood tests prior to your treatment with Zometa.
Jekk qed tingħata kura għas- snien jew ser tgħamel xi kirurġija fi snienek, għid lid- dentist tiegħek li qed tingħata kura b’ Zometa.
50 Ensure sufficient intake of liquids prior to infusions as directed by your doctor as this will help to prevent dehydration.
50 It- tabib għandu jeżamina r- rispons tiegħek għall- kura minn żmien għall- ieħor b’ mod regolari.
Using other medicines Tell your doctor about any other medicines you are taking or have recently been taking, including any you have bought without a prescription.
Meta tuża mediċini oħra Avża lit- tabib dwar xi mediċini oħrajn li qed tieħu jew li ħadt dan l- aħħar inklużi dawk li ħadt mingħajr ir- riċetta tat- tabib.
It is particularly important that your doctor knows if you are also taking aminoglycosides (a type of medicine used to treat severe infections), since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low.
Huwa importanti ħafna li t- tabib ikun jaf jekk intix ukoll qed tieħu aminoglycosides (tip ta ’ mediċina li tintuża għall- kura ta ’ infezzjonijiet severi), minħabba li meta jingħataw flimkien ma ’ bisphosphonates jistgħu jniżżlu l- livell ta ’ calcium fid- demm għal wieħed baxx wisq.
Tell your doctor if you are taking thalidomide or medicines known to be harmful to your kidneys.
Għid ukoll lit- tabib jekk tkun qed tieħu thalidomide jew xi mediċini oħrajn li huwa magħruf li jagħmlu ħsara fil- kliewi.
Use in the elderly Zometa can be given to elderly people.
Użu fl- anzjani Zometa jista ’ jingħata lill- anzjani.
There is no evidence to suggest that any additional precautions are needed.
M’ hemm l- ebda evidenza li tissuġġerixxi li għandhom jittieħdu xi prekawzjonijiet addizzjonali.
Use in children The use of Zometa in children has not been studied and therefore it is not recommended.
Użu fit- tfal L- użu ta ’ Zometa fit- tfal għadu ma ġiex studjat u minħabba f’ hekk mhux rakkomandat.
Pregnancy and breast-feeding You should not be given Zometa if you are pregnant.
Tqala u Treddigħ M’ għandekx tingħata Zometa jekk ħriġt tqila.
Tell your doctor if you are or think that you may be pregnant.
Avża lit- tabib tiegħek jekk ħriġt tqila, jew taħseb li tista ’ tkun ħriġt tqila.
You must not be given Zometa if you are breast-feeding.
M’ għandekx tingħata Zometa jekk qed tredda.
Ask your doctor for advice before taking any medicine while you are pregnant or breast-feeding.
Itlob il- parir tat- tabib tiegħek qabel tieħu xi mediċina waqt it- tqala jew meta tkun qed tredda.
Driving and using machines The effects of Zometa on driving, using machines and performing other tasks that need your full attention have not been studied.
Sewqan u tħaddim ta ’ magni L- effetti ta ’ Zometa fuq is- sewqan, fuq l- użu tal- magni jew waqt xi xogħol ieħor li jirrekjedi l - attenzjoni sħiħa tiegħek għadhom ma ġewx studjati.
However, there have been very rare cases of drowsiness with the use of Zometa.
Madankollu, kien hemm każijiet rari ħafna ta ’ ngħas bl- użu ta ’ Zometa.
You should therefore be careful when driving, using machinery or performing other tasks that need full attention.
Għalhekk għandek toqgħod attent meta tkun qed issuq, tħaddem magni jew tagħmel xi attivitajiet oħra li jeħtieġu attenzjoni sħieħa.
HOW ZOMETA IS USED
KIF JINTUŻA ZOMETA
Follow carefully all instructions given to you by your doctor, nurse or pharmacist.
Segwi sew l- istruzzjonijiet kollha li jingħatawlek mit- tabib, infermier jew spiżjar.
How much is given The usual dose given is 4 mg.
Kemm jingħata Id- doża tas- soltu hija ta ’ 4 mg.
If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.
Jekk għandek problema tal- kliewi, it- tabib tiegħek ser jagħtik doża aktar baxxa skond il- gravità tal- problema fil- kliewi.
How Zometa is given Zometa is given as an infusion into a vein which should last no less than 15 minutes and should be administered as a single intravenous solution in a separate infusion line.
Kif jingħata Zometa Zometa jingħata bħala infużjoni ġo vina fuq medda ta ’ mhux anqas minn 15- il minuta u għandu jingħata bħala soluzzjoni waħda minn ġol- vina f’ linja ta ’ infużjoni separata.
In addition, patients without hypercalcaemia will also receive supplementary doses of calcium and vitamin D daily.
Dawk il- pazjenti li m’ għandhomx żjieda fil- livell ta ’ calcium fid- demm għandhom jingħataw ukoll dożi supplimentari ta ’ calcium u vitamina D kuljum.
When Zometa is given Your doctor will determine when you will be given Zometa.
Meta jingħata Zometa It- tabib tiegħek jiddeċiedi meta għandek tingħata Zometa.
How long to use Zometa If you are being treated for bone metastases, you will be given one infusion of Zometa every three to four weeks.
Għal kemm żmien għandu jintuża Zometa Jekk qed tiġi kkurat għall- metastasi fl- għadam, tingħata infużjoni ta ’ Zometa darba kull 3– 4 ġimgħat.
Your doctor will decide how often you should receive the infusions.
It- tabib tiegħek jiddeċiedi kemm- il infużjoni jkollok bżonn u kull kemm għandek teħodhom.
If you are being treated for TIH, you will normally only be given one infusion of Zometa.
51 Jekk qed tiġi kkurat għal TIH, normalment tingħata infużjoni waħda biss ta ’ Zometa.
51 If you are given more Zometa than you should be If you have received doses higher than those recommended you must be carefully monitored by your doctor.
Jekk tingħata aktar Zometa milli suppost Jekk ingħatajt dożi aktar għoljin minn dawk rakkomandati għandek tinżamm taħt osservazzjoni b’ attenzjoni mit- tabib tiegħek.
This is because you may develop serum electrolyte abnormalities (e. g. abnormal levels of calcium, phosphorus and magnesium) and/ or changes in kidney function, including severe kidney impairment.
Dan għaliex tista ’ tiżviluppa anormalitajiet ta ’ l- elettroliti fis- serum (eż. livelli anormali ta ’ calcium, phosphorous u magnesium) u/ jew bidliet fil- funzjoni tal- kliewi, inkluża insuffiċjenza severa tal- kliewi.
If your level of calcium falls too low, you may have to be given supplemental calcium by infusion.
Jekk il- livell tal- calcium tiegħek jaqa ’ baxx wisq, jista ’ jkollok bżonn tingħata suppliment tal- calcium permezz ta ’ infużjoni.
Like all medicines, Zometa can cause side effects, although not everybody gets them.
Bħall- kull mediċina oħra Zometa jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
The most common ones are usually mild and will probably disappear after a short time.
Dawk l- effetti l- aktar komuni ta ’ spiss ikunu ħfief u probabli jgħebu wara żmien qasir.
Tell your doctor about any of the following side effects as soon as possible:
Avża lit- tabib dwar xi waħda minn dawn l- effetti l- oħra mill- aktar fis possibli:
Rise in body temperature.
Jekk jitlagħlek id- deni.
One third of the patients on Zometa have reported headache and a flu-like syndrome consisting of fever, fatigue, weakness, drowsiness, chills and bone, joint and/ or muscle ache.
Terz tal- pazjenti kollha fuq Zometa irrapurtaw uġigħ ta ’ ras u sindrome bħal ta ’ l- influwenza b’ deni, għeja, debbulizza, ngħas, tkexkix ta ’ bard u uġigħ fl- għadam, fil- ġogi u/ jew fil- muskoli.
In most cases no specific treatment is required and the symptoms subside after a couple of hours or days.
F’ ħafna każijiet ma jkunx hemm bżonn kura speċifika għal dawn is- sintomi għax jitilqu waħedhom wara ftit siegħat jew ġranet.
Very rare cases of severe bone, joint, and/ or muscle pain, occasionally incapacitating, have been reported.
Każijiet rari ħafna ta ’ uġigħ li kultant inaqqas il- ħila tal - movimenti fl- għadam, ġogi u/ jew muskoli, kienu rrappurtati.
Irregular heart rhythm (atrial fibrillation) has been seen in patients receiving zoledronic acid for postmenopausal osteoporosis.
Ritmu irregolari tal- qalb (fibrillazzjoni atrijali) dehret f’ xi pazjenti li kienu qed jirċievu zoledronic acid għall- osteoporosi ta ’ wara l- menopawża.
It is currently unclear whether zoledronic acid causes this irregular heart rhythm but you should report it to your doctor if you experience such symptoms after you have received zoledronic acid.
Bħalissa mhux ċar jekk zoledronic acid jikkawżax dan ir- ritmu irregolari tal- qalb iżda għandek tirrapportha lit- tabib tiegħek jekk tħoss sintomi bħall dawn wara li tkun ingħatajt zoledronic acid.
Uncommonly, in some patients bone damage in the jaw (osteonecrosis) may occur.
Mhux komuni, f’ xi pazjenti tista ’ sseħħ ħsara ta ’ l- għadam fix- xedaq (osteonekrożi).
Signs of this condition can be pain in the mouth, teeth and/ or jaw, swelling or sores inside the mouth, numbness or a “ heavy jaw feeling”, or loosening of a tooth.
Sinjali ta ’ din il - kundizzjoni jistgħu jkunu uġigħ fil- ħalq, snien u/ jew xedaq, nefħa jew ġrieħi fil- ħalq, tnemnim jew “ sensazzjoni ta ’ sedaq tqil ”, jew sinna tiċċaqlaq.
Tell your oncologist and dentist immediately if you experience such symptoms.
Għid lill- onkoloġista u lid- dentist tiegħek mill- ewwel jekk tħoss dawn it- tip ta ’ sintomi.
Other common side effects are: − Gastrointestinal reactions such as nausea and vomiting as well as loss of appetite. − Conjunctivitis, as reported with other bisphosphonates (the group of substances to which Zometa belongs). − Blood tests indicating changes in kidney function (higher levels of creatinine), including severe kidney impairment; such changes are also known to occur with other medicinal products of this kind.
indeboliment sever tal- kliewi; dawn il- bidliet huma magħrufin li jseħħu wkoll bi prodotti mediċinali oħra ta ’ l- istess tip.
In addition, some cases of kidney disease have been reported.
Barra minn hekk, ġew irrapurtati każijiet ta ’ mard fil- kliewi.
Occasional side effects may also include hypersensitivity reactions, high blood pressure, shortness of breath, dizziness, sleep disturbances, tingling or numbness of the hands or feet or diarrhoea.
Xi effetti sekondarji li kultant jista ’ jkun hemm huma sensittività eċċessiva, pressjoni għolja, qtugħ ta ’ nifs, sturdament, problemi ta ’ l- irqad, tingiż jew mejt fl- idejn u fis- saqajn, u dijarrea.
Cases of low blood pressure have also occasionally been reported; in very rare cases, this resulted in fainting.
Kultant kienu wkoll irrappurtati każijiet ta ’ pressjoni baxxa; f’ każijiet rari ħafna, dan wassal għall- ħass ħażin.
Uncommonly, skin reactions (redness and swelling) at the infusion site may occur and cases of rash, itching and chest pain have been observed.
Effetti sekondarji mhux komuni bħal reazzjonijiet fil- ġilda (ħmura u nefħa) fis- sit ta ’ l- injezzjoni, każijiet ta ’ raxx, ħakk u uġigħ fis- sider, ġew osservati.
Rarely, slow heart beat and confusion occurred.
Rarament, kien hemm każijiet fejn il- qalb ħabbtet bil- mod u xi każijiet ta ’ konfużjoni.
Anaemia, a condition in which the number of red blood cells is decreased, has been reported; low counts of white blood cells and blood platelets have been observed in some cases.
Ġew irrapurtati xi każijiet ta ’ anemija, kundizzjoni li fiha jonqos in- numru taċ- ċelloli ħomor fid - demm; livelli baxxi ta ’ ċelloli bojod u ta ’ plejtlits kienu wkoll osservati f’ ċertu każijiet.
The level of calcium, phosphate, magnesium and potassium in the blood may become too low without symptoms, but your doctor will monitor this and take necessary measures.
Il- livelli ta ’ kalċju, fosfat, manjesju u potassju fid- demm jistgħu wkoll jinżlu wisq, u mingħajr ma jagħtu sintomi, imma t- tabib tiegħek jissorveljak għal dan u jieħu il- passi neċessarji kollha.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.
Jekk xi wieħed mill- effetti sekondarji jiggrava jew jekk tinnota xi effetti sekondarji li mhumiex imsemmijin f’ dan il- fuljett, jekk jogħġbok, għid lit- tabib lill- infermier jew lill- ispiżjar tiegħek.
HOW TO STORE ZOMETA
KIF TAĦŻEN ZOMETA
Your doctor, nurse or pharmacist knows how to store Zometa properly.
It- tabib, l- infermier jew l- ispiżjar tiegħek jafu kif għandhom jaħżnu Zometa kif suppost.
FURTHER INFORMATION
X’ fih Zometa
What Zometa contains − The active substance of Zometa is zoledronic acid. − The other ingredients are: mannitol, sodium citrate.
- Is- sustanzi l- oħra huma: mannitol, sodium citrate.
What Zometa looks like and contents of the pack Zometa is supplied as a powder in a vial.
Id- Dehra ta ’ Zometa u l- kontenuti tal- pakkett Zometa j iġi bħala trab f’ kunjett.
One vial contains 4 mg of zoledronic acid.
Kunjett wieħed fih 4 mg ta ’ zoledronic acid.
Each pack contains the vial with powder, together with an ampoule of 5 ml water for injections, which is used to dissolve the powder.
Kull pakkett fih kunjett bit- trab, flimkien ma ’ ampulla ta’ 5 ml ilma għall- injezzjonijiet, li jintuża biex jinħall it- trab fih.
Zometa is supplied as packs containing 1, 4 or 10 vials and 1, 4 or 10 ampoules, respectively.
Zometa jiġi f’ pakketti ta ’ 1, 4 jew 10 kunjetti u 1, 4 jew 10 ampulli, rispettivament.
Manufacturer Novartis Pharma GmbH Roonstrasse 25 D-90429 Nuremberg Germany
Manifattur Novartis Pharma GmbH Roonstrasse 25 D- 90429 Nuremberg Il- Ġermanja
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
Għal kull tagħrif dwar dan il- prodott mediċinali, jekk jogħġbok għamel kuntatt mar- rappreżentant lokali tas- sid ta ’ l- awtorizzazzjoni għall- kummerċ.
54 INFORMATION FOR THE HEALTHCARE PROFESSIONAL
54 TAGĦRIF GĦALL- PROFESSJONIST FIL- KURA TAS- SAĦĦA
How to prepare and administer Zometa
- Biex tipprepara soluzzjoni għall- infużjoni ta ’ 4 mg ta ’ Zometa, żid 5 ml ta ’ ilma għall -
− To prepare an infusion solution containing 4 mg Zometa, add 5 ml of water for injections from the ampoule supplied in the pack to the vial containing the Zometa powder under aseptic conditions.
injezzjonijiet mill- ampulla fil- pakkett għal ġol- kunjett li fih it- trab ta ’ Zometa, taħt kundizzjonijiet asettiċi.
Shake the vial gently to dissolve the powder.
Ħawwad il- kunjett bil- mod biex tħoll it- trab.
− Further dilute the Zometa reconstituted solution (5 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
- Erġa ’ ddilwixxi s- soluzzjoni rikostitwita ta ’ Zometa (5 ml) ma ’ 100 ml ta ’ soluzzjoni għall -
If a lower dose of Zometa is required, first withdraw the appropriate volume of the reconstituted solution (4 mg/ 5 ml) as indicated below and then dilute it further with 100 ml of infusion solution.
Jekk tkun meħtieġa doża aktar baxxa ta ’ Zometa, l- ewwel iġbed il- volum xieraq tas- soluzzjoni rikostitwita (4 mg/ 5 ml) kif jidher hawn taħt u imbagħad erġa żidilha 100 ml ta ’ soluzzjoni għall- infużjoni.
To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/ v sodium chloride or 5% w/ v glucose solution.
Biex wieħed jevita inkompatibilitajiet, is- soluzzjoni ghall- infużjoni għandha tigi ddilwita b ’ 0. 9% w/ v sodium chloride jew 5% w/ v soluzzjoni ta ’ glucose.
Do not mix Zometa reconstituted solution with calcium-containing or other divalent cation-containing solutions such as lactated Ringer’ s solution.
Tħallatx is- soluzzjoni rikostitwita ta ’ Zometa ma ’ soluzzjonijiet li jkun fihom il- calcium jew soluzzjonijiet li jkun fihom divalent cations oħrajn, bħal ma hi s- soluzzjoni lactated Ringer.
Instructions for preparing reduced doses of Zometa:
Istruzzjonijiet biex tipprepara d- dożi meħtieġa ta ’ Zometa:
Withdraw the appropriate volume of the reconstituted solution (4 mg/ 5 ml), as follows:
Iġbed il- volum meħtieġ tas- soluzzjoni rikostitwita (4 mg/ 5 ml), kif ġej:
4.4 ml for 3.5 mg dose 4.1 ml for 3.3 mg dose 3.8 ml for 3.0 mg dose
4. 4 ml għal doża ta ’ 3. 5 mg 4. 1 ml għal doża ta ’ 3. 3 mg 3. 8 ml għal doża ta ’ 3. 0 mg
− The Zometa infusion solution should preferably be used immediately.
Jekk is -
If the solution is not used immediately, storage prior to use is the responsibility of the care provider and should be in a refrigerator at 2°C – 8°C.
soluzzjoni ma tintużax mill- ewwel, r- responsabbiltà ta ’ kif tinħażen sa ma tintuża tkun ta ’ min qed jipprovdi l- kura, u din il- ħażna għandha ssir ġo friġġ f’ temperatura ta ’ bejn 2°C - 8°C.
Allow the refrigerated solution to reach room temperature before administration.
Qabel ma tingħata, is- soluzzjoni li kienet ġol- friġġ għandha titħalla tilħaq it- temperatura ambjentali.
− The total time between reconstitution, dilution, storage in the refrigerator and end of administration must not exceed 24 hours.
- M’ għandhomx igħaddu aktar minn 24 siegħa minn meta l- mediċina tiġi rikostitwita, ddilwita u
− The solution containing Zometa is given as a single 15-minute intravenous infusion.
- Is- soluzzjoni ta ’ Zometa tingħata ta ’ darba bħala infużjoni ġol- vini fuq medda ta ’ 15- il minuta.
The hydration status of patients must be assessed prior to and following administration of Zometa to assure that they are adequately hydrated.
L- istat ta ’ idratazzjoni tal- pazjenti għandu jiġi assessjat qabel u wara li tingħata Zometa, sabiex wieħed ikun ċert li l- pazjenti jkunu idratati kif jixraq.
− Studies with glass bottles, several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with 0.9% w/ v sodium chloride solution or 5% w/ v glucose solution) showed no incompatibility with Zometa.
infużjoni magħmulin minn polyvinyl chloride, polyethylene u polypropylene (mimlijin minn qabel b’ 0. 9% w/ v soluzzjoni ta ’ sodium chloride jew b’ 5% w/ v soluzzjoni ta ’ glucose) ma deherx li kien hemm xi inkompatibbiltà ma ’ Zometa.
− Since no data are available on the compatibility of Zometa with other intravenously administered substances, Zometa must not be mixed with other medications/ substances and should always be given through a separate infusion line.
- Billi m’ hemmx tagħrif fuq il- kompatibbiltà ta ’ Zometa ma ’ sustanżi oħrajn li jingħataw ġol -
How to store Zometa
Kif taħżen Zometa
− Keep Zometa out of the reach and sight of children. − Do not use Zometa after the expiry date stated on the pack. − The Zometa infusion solution should preferably be used immediately.
Jekk is -
If the solution is not used immediately, storage prior to use is the responsibility of the user and should be in a refrigerator at 2°C – 8°C. − The total time between reconstitution, dilution, storage in the refrigerator and end of administration must not exceed 24 hours.
soluzzjoni ma tintużax mill- ewwel, allura r- responsabbiltà ta ’ kif tinħażen qabel ma tintuża tkun ta ’ min qed jipprovdi l- kura, u din il- ħażna għandha ssir ġo friġġ f’ temperatura ta ’ bejn 2°C - 8°C.
55 PACKAGE LEAFLET:
55
INFORMATION FOR THE USER
56 FULJETT TA ’ TAGĦRIF:
The Zometa concentrate requires further dilution before it is given as an infusion into a vein.
Il- konċentrat ta ’ Zometa għandu jerġa jiġi ddilwit qabel ma jingħata bħala infużjoni ġol- vini.
Before you are given Zometa, tell your doctor: − if you have or have had a liver problem. − if you have or have had a kidney problem. − if you have or have had a heart problem. − if you have or have had pain, swelling or numbness of the jaw or a “ heavy jaw feeling” or loosening of a tooth.
- jekk kellek jew għandek uġigħ, nefħa jew tnemnim tax- xedaw jew tħoss “ sensazzjoni ta ’ xedaq
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with Zometa.
Jekk qed tingħata kura għas- snien jew ser tgħamel xi kirurġija fi snienek, għid lid- dentist tiegħek li qed tingħata kura b’ Zometa.
Your doctor will check your response to treatment at regular intervals.
57 It- tabib għandu jeżamina r- rispons tiegħek għall- kura minn żmien għall- ieħor b’ mod regolari.
He or she must perform blood tests prior to your treatment with Zometa.
It- tabib għandu mnejn ikollu bżonn jieħu xi testijiet tad- demm qabel jibdik fuq kura b’ Zometa.
56 Ensure sufficient intake of liquids prior to infusions as directed by your doctor as this will help to prevent dehydration.
Aċċerta ruħek illi tixrob biżżejjed skond kif jgħidlek it- tabib qabel ma jibdew l- infużjonijiet sabiex tilqa kontra d- deidratazzjoni.
If you are being treated for TIH, you will normally only be given one infusion of Zometa.
58 Jekk qed tiġi kkurat għal TIH, normalment tingħata infużjoni waħda biss ta ’ Zometa.
57 If you are given more Zometa than you should be If you have received doses higher than those recommended, you must be carefully monitored by your doctor.
Jekk tingħata aktar Zometa milli suppost Jekk ingħatajt dożi aktar għoljin minn dawk rakkomandati għandek tinżamm taħt osservazzjoni b’ attenzjoni mit- tabib tiegħek.
Other common side effects are: − Gastrointestinal reactions such as nausea and vomiting, as well as loss of appetite. − Conjunctivitis, as reported with other bisphosphonates (the group of substances to which Zometa belongs). − Blood tests indicating changes in kidney function (higher levels of creatinine), including severe kidney impairment; such changes are also known to occur with other medicinal products of this kind.
indeboliment sever tal- kliewi; dawn il- bidliet huma magħrufin li jseħħu wkoll bi prodotti mediċinali oħra ta ’ l- istess tip.
Anaemia, a condition in which the number of red blood cells is decreased, has been reported; low counts of white blood cells and blood platelets have been observed.
Ġew irrapurtati xi każijiet ta ’ anemija, kundizzjoni li fiha jonqos in- numru taċ- ċelloli ħomor fid - demm; livelli baxxi ta ’ ċelloli bojod u ta ’ plejtlits kienu wkoll osservati f’ ċertu każijiet.
What Zometa contains − The active substance of Zometa is zoledronic acid. − The other ingredients are: mannitol, sodium citrate, water for injections.
- Is- sustanzi l- oħra huma: mannitol, sodium citrate, ilma għall- injezzjonijiet.
What Zometa looks like and contents of the pack Zometa is supplied as a liquid concentrate in a vial.
Id- Dehra ta ’ Zometa u l- kontenuti tal- pakkett Zometa j iġi bħala trab f’ kunjett.
Each pack contains the vial with concentrate.
Kunjett wieħed fih 4 mg ta ’ zoledronic acid.
Zometa is supplied as packs containing 1, 4 or 10 vials.
Zometa jiġi f’ pakketti ta ’ 1, 4 jew 10 kunjetti.
Eesti Novartis Pharma Services Inc.
60 Eesti Österreich Novartis Pharma Services Inc.
60 INFORMATION FOR THE HEALTHCARE PROFESSIONAL
Ħawwad il- kunjett bil- mod biex tħoll it- trab.
How to prepare and administer Zometa
- Biex tipprepara soluzzjoni għall- infużjoni li jkun fiha 4 mg ta ’ Zometa, erġa ’ ddilwixxi l -
− To prepare an infusion solution containing 4 mg Zometa, further dilute the Zometa concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution.
konċentrat ta ’ Zometa (5 ml) ma ’ 100 ml ta ’ soluzzjoni għall- infużjoni ħielsa mill- calcium jew minn soluzzjonijiet li jkun fihom divalent cations oħrajn.
If a lower dose of Zometa is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution.
Jekk tkun meħtieġa doża aktar baxxa ta ’ Zometa, l- ewwel iġbed il- volum xieraq kif jidher hawn taħt u imbagħad erġa żidilha 100 ml ta ’ soluzzjoni għall- infużjoni.
To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/ v sodium chloride or 5% w/ v glucose solution.
Biex wieħed jevita inkompatibilitajiet, is- soluzzjoni ghall - infużjoni għandha tigi ddilwita b ’ 0. 9% w/ v sodium chloride jew 5% w/ v soluzzjoni ta ’ glucose.
Do not mix Zometa concentrate with calcium-containing or other divalent cation- containing solutions such as lactated Ringer’ s solution.
Tħallatx il- koncentrat ta ’ Zometa ma ’ soluzzjonijiet li jkun fihom il- calcium, jew soluzzjonijiet li jkun fihom divalent cations oħrajn bħal ma hi s- soluzzjoni lactated Ringer.
Withdraw the appropriate volume of the liquid concentrate, as follows:
Iġbed il- volum meħtieġ tal- konċentrat likwidu, kif ġej:
− After preparation, Zometa infusion solution should preferably be used immediately.
- Wara l- preparazzjoni, is- soluzzjoni għall- infużjoni ta ’ Zometa għandha preferibbilment tintuża
If the solution is not used immediately, storage prior to use is the responsibility of the care provider and should be in a refrigerator at 2°C – 8°C.
Jekk is- soluzzjoni ma tintużax mill- ewwel, r- responsabbiltà ta ’ kif tinħażen sa ma tintuża tkun ta ’ min qed jipprovdi l- kura, u din il- ħażna għandha ssir ġo friġġ f’ temperatura ta ’ bejn 2°C - 8°C.
Allow the refrigerated solution to reach room temperature before administration.
Qabel ma tingħata, is- soluzzjoni li kienet ġol- friġġ għandha titħalla tilħaq it - temperatura ambjentali.
− The total time between dilution, storage in the refrigerator and end of administration must not exceed 24 hours.
- M’ għandhomx igħaddu aktar minn 24 siegħa minn meta l- mediċina tiġi ddilwita u maħżuna fil -
The hydration status of patients must be assessed prior to and following administration of Zometa to ensure that they are adequately hydrated.
L- istat ta ’ idratazzjoni tal- pazjenti għandu jiġi assessjat qabel u wara li tingħata Zometa, sabiex wieħed ikun ċert li l- pazjenti jkunu idratati kif jixraq.
− Keep Zometa out of the reach and sight of children. − Do not use Zometa after the expiry date stated on the pack. − The readily prepared Zometa infusion solution should preferably be used immediately.
Jekk is- soluzzjoni ma tintużax mill- ewwel, allura r- responsabbiltà ta ’ kif tinħażen qabel ma tintuża tkun ta ’ min qed jipprovdi l- kura, u din il- ħażna għandha ssir ġo friġġ f’ temperatura ta ’ bejn 2°C - 8°C.
If the solution is not used immediately, storage prior to use is the responsibility of the user and should be in a refrigerator at 2°C – 8°C. − The total time between dilution, storage in the refrigerator and end of administration must not exceed 24 hours.
- M’ għandhomx jgħaddu aktar minn 24 siegħa minn meta l- mediċina tiġi ddilwita u maħżuna fil -
What is Zonegran?
X’ inhu Zonegran?
Zonegran is a medicine containing the active substance zonisamide.
Zonegran hu mediċina li fiha s- sustanza attiva zonisamide.
It is available as capsules (25 mg: white; 50 mg: white and grey; 100 mg: white and red).
Jiġi bħala kapsuli (25 mg: bojod; 50 mg: bojod u griżi; 100 mg: bojod u ħomor).
What is Zonegran used for?
Għalxiex jintuża Zonegran?
Zonegran is used as an add-on to existing epilepsy treatment in adult patients who have partial seizures (epileptic fits starting in one specific part of the brain).
Zonegran jintuża bħala żieda ma ’ trattament eżistenti għall- epilessija f’ pazjenti adulti li jkollhom epilessija parzjali (attakki tal- qamar li jibdew minn parti speċifika tal- moħħ).
It can be used in patients with and without secondary generalisation (where the seizure subsequently spreads to the whole brain).
Jista ’ jintuża kemm jekk il- pazjenti jkollhom ġeneralizzazzjoni sekondarja (fejn l- epilessija mbagħad tinfirex għall- moħħ kollu) kif ukoll jekk le.
How is Zonegran used?
Kif jintuża Zonegran?
Zonegran must be added to the patient ’ s existing treatment.
Zonegran irid jiżdied mat- trattament eżistenti tal- pazjent.
The recommended starting dose is 25 mg twice a day with or without food.
Id- doża rakkomandata hi 25 mg darbtejn kuljum ma ’ l- ikel jew fuq stonku vojt.
After one week the dose may be increased to 100 mg daily and then further increased in steps of 100 mg every week, depending on the patient’ s response.
Wara ġimgħa, id- doża tista ’ tiżdied għal 100 mg kuljum u mbagħad tiżdied gradwalment b’ 100 mg kull ġimgħa, skond ir- rispons tal- pazjent.
Zonegran can be given once or twice a day after an appropriate dose is reached.
Zonegran jista ’ jingħata darba jew darbtejn kuljum wara li tkun instabet doża adattata.
Doses of 300 to 500 mg per day have been shown to be effective, but lower doses may be sufficient in some patients.
Intwera li dożi ta ’ bejn 300 u 500 mg kuljum huma effettivi, iżda għal xi pazjenti dożi iżgħar jistgħu jkunu biżżejjed.
The maximum daily dose is 500 mg.
Id- doża massima kuljum hi 500 mg.
Dose increases may need to be made less frequently in patients with liver or kidney problems or those taking certain other medicines.
Fil- każ ta ’ pazjenti bi problemi tal- fwied jew tal- kliewi jew li jkunu qed jieħdu mediċini oħra jista ’ jkun hemm bżonn li ż- żidiet fid- doża jsiru inqas spiss.
Zonegran should be used with caution in elderly patients and those with kidney problems.
F’ pazjenti anzjani u bi problemi fil- kliewi, Zonegran għandu jintuża b’ kawtela.
It is not recommended for use in patients who have severe problems with their liver.
Mhux rakkomandat li jintuża f’ pazjenti li jkollhom problemi severi fil- fwied.
Before stopping Zonegran, the dose should be decreased gradually.
Qabel jitwaqqaf, id- doża ta ’ Zonegran għandha titnaqqas ftit ftit.
How does Zonegran work?
Kif jaħdem Zonegran?
The active substance in Zonegran, zonisamide, is an anti-epileptic.
Is- sustanza attiva f’ Zonegran, zonisamide, hi mediċina anti- epilettika.
Epileptic fits are caused by abnormal electrical activity in the brain.
L- attakki ta ’ epilessija huma kkawżati minn attività elettrika anormali fil- moħħ.
Zonisamide works by blocking specific pores on the surface of nerve cells called sodium channels and calcium channels.
Zonisamide jaħdem billi jimblokka pori speċifiċi fuq is- superfiċje taċ- ċelloli tan- nervituri magħrufa bħala kanali tas- sodju u tal- kalċju.
These channels transmit electrical impulses between nerve cells.
Dawn il- kanali jittrasmettu impulsi elettriċi bejn iċ- ċelloli tan- nervituri.
By blocking these channels, zonisamide prevents the nerve cells from synchronising their activity and prevents abnormal electrical activity spreading through the brain.
Bl- imblukkar ta ’ dawn il- kanali, zonisamide jipprevjeni liċ- ċelloli tan- nervituri milli jissinkronizzaw l- attività u jipprevjeni l- attività elettrika milli tinxtered f’ partijiet oħra tal- moħħ.
This reduces the chances of an epileptic fit.
Dan inaqqas iċ- ċans li jseħħ attakk epilessija.
Zonegran also acts on the neurotransmitter gamma- aminobutyric acid (GABA, a chemical that allows nerve cells to communicate with each other).
Zonegran jaġixxi wkoll fuq in- newrotrażmettitur gamma- aminobutyric acid (GABA, kimika li tippermetti liċ- ċelloli tan - nervituri jikkomunikaw ma ’ xulxin).
This may help to stabilise electrical activity in the brain.
Dan jgħin biex jistabbilixxi l- attività elettrika fil- moħħ.
Reproduction is authorised provided the source is acknowledged.
Reproduction is authorised provided the source is acknowledged Kif ġie studjat Zonegran?
The applicant presented data on experimental models from the scientific literature.
L- applikant ippreżenta d- dejta minn mudelli esperimentali mil- letteratura xjentifika.