qanastek/EMEA-V3 huggingface dataset:
20 In clinical trials, weight did not change from baseline when vildagliptin 100 mg daily was administered as monotherapy (-0.3 kg and -1.3 kg for vildagliptin and placebo, respectively).
Fil- provi kliniċi, il- piż ma nbidilx mill- linja bażi meta vildagliptin 100 mg kuljum ingħata bħala monoterapija (- 0. 3 kg u - 1. 3 kg għal vildagliptin u plaċebo, rispettivament).
Known adverse reactions for metformin component
20 Tabella 3 Reazzjonijiet magħrufa għall- komponent metformin
21 Pharmacotherapeutic group:
Kategorija farmakoterapewtika:
Zomarist combines two antihyperglycaemic agents with complimentary mechanisms of action to improve glycaemic control in patients with type 2 diabetes: vildagliptin, a member of the islet enhancer class, and metformin hydrochloride, a member of the biguanide class.
21 Zomarist jikkombina żewġ aġenti kontra l- ipergliċemija b’ mekkaniżmu ta ’ azzjoni kumplimentari sabiex jitjieb il- kontroll ta ’ pazjenti bid- dijabete tat- tip 2: vildagliptin, membru tal- klassi li jtejjeb l - islet, u metformin hydrochloride, membru tal- klassi biguanide.
22 In humans, independently of its action on glycaemia, metformin has favourable effects on lipid metabolism.
22 Fil- bniedem, b’ mod indipendenti mill- effett tiegħu fuq il- gliċemija, metformin għandu effetti tajbin fuq il- metaboliżmu tal- lipidi.
Vildagliptin is not metabolised by CYP 450 enzymes to any quantifiable extent, and accordingly the metabolic clearance of vildagliptin is not anticipated to be affected by co-
Studji in vitro
23 medications that are CYP 450 inhibitors and/or inducers.
23 wrew li vildagliptin ma jimpedixxix/ jinduċix l- enzimi CYP 450.
Metformin Absorption After an oral dose of metformin, the maximum plasma concentration (T max) is achieved after about 2.5 h..
Metformin Assorbiment Wara doża metformin li tittieħed mill- ħalq, il- konċentrazzjoni massima fil- plażma (C max) tintlaħaq wara madwar 2. 5 h.
24 Metabolism Metformin is excreted unchanged in the urine.
24 Metaboliżmu Metformin jitneħħa mingħajr ma jiġi mibdul fl- awrina.
Flaking skin, peeling skin, scabs and tail sores with correlating histopathological changes were noted at doses ≥ 20 mg/kg/day (approximately 3 times human AUC
Ġilda li tinqala, ġilda li titqaxxar, qxur u selħiet fid- denb flimkien ma ’ bidliet istopatoloġiċi
25 exposure at the 100 mg dose).
25 korrelatanti kienu nnutati b’ dożi ≥ 20 mg/ kg/ jum (madwar 3 darbiet l- esponiment ta ’ l- AUC fil - bniedem b’ doża ta ’ 100 mg).
MARKETING AUTHORISATION NUMBER(S)
NUMRU( I) TA ’ L- AWTORIZZAZZJONI GĦAT- TQEGĦID FIS- SUQ EU/ 0/ 00/ 000/ 000- 000 EU/ 0/ 00/ 000/ 000- 000
PSURs The PSUR cycle of Zomarist will correspond to the one attributed to the cross-referred product, Eucreas, until otherwise specified.
PSURs Ic- ciklu ta ’ PSUR ta ’ Zomarist ħa jikkorrispondi ghal dak attribwit ghal prodott li ghalih qed issir referenza, Eucreas, sakemm jigi speċifikat mod ieħor.
Zomarist 50 mg/850 mg film-coated tablets vildagliptin/metformin hydrochloride
Zomarist 50 mg/ 850 mg pilloli miksijin b’ rita vildagliptin/ metformin hydrochloride
Zomarist 50 mg/1000 mg film-coated tablets vildagliptin/metformin hydrochloride
Zomarist 50 mg/ 1000 mg pilloli miksijin b’ rita vildagliptin/ metformin hydrochloride
Zomarist 50 mg/850 mg film-coated tablets Zomarist 50 mg/1000 mg film-coated tablets
Zomarist 50 mg/ 850 mg pilloli miksijin b’ rita Zomarist 50 mg/ 1000 mg pilloli miksijin b’ rita
What Zomarist is and what it is used for 2.
X’ inhu Zomarist u għalxiex jintuża 2.
Before you take Zomarist 3.
Qabel ma tieħu Zomarist 3.
How to take Zomarist 4.
Kif għandek tieħu Zomarist 4.
How to store Zomarist 6.
Kif taħżen Zomarist 6.
WHAT ZOMARIST IS AND WHAT IT IS USED FOR
X’ INHU ZOMARIST U GĦALXIEX JINTUŻA
The active substances of Zomarist belong to a group of medicines called “oral antidiabetics”.
Is- sustanzi attivi ta ’ Zomarist jagħmlu parti minn grupp ta ’ mediċini li jissejħu “ antidijabetiċi orali ”.
Zomarist is used to treat patients with type 2 diabetes.
Zomarist jintuża għall- kura ta ’ pazjenti bid- dijabete tat- tip 2.
Zomarist contains two active substances called vildagliptin and metformin.
Zomarist fih żewġ sustanzi attivi li jissejħu vildagliptin u metformin.
BEFORE YOU TAKE ZOMARIST
QABEL MA TIEĦU ZOMARIST
Do not take Zomarist
Tieħux Zomarist
Zomarist (listed in section 6).
oħra ta ’ Zomarist (elenkati f’ sezzjoni 6).
If you think you may be allergic to any of these, talk to your doctor before taking Zomarist.
Jekk taħseb li tista ’ tkun allerġiku/ a għal kwalunkwe wieħed minn dawn, tkellem mat- tabib tiegħek qabel tieħu Zomarist.
Please also see information about this in section “Take special care with Zomarist”.
Jekk jogħġbok ara wkoll l- informazzjoni fuq dan fis- sezzjoni “ Oqgħod attent ħafna b’ Zomarist ”.
Take special care with Zomarist Stop taking this medicine and talk to your doctor if you experience one or more of the following symptoms which may be related to a condition called “lactic acidosis”:
Oqgħod attent ħafna b’ Zomarist Tibqax tieħu din il- mediċina u kellem lit- tabib tiegħek jekk tħoss wieħed jew aktar mis- sintomi li ġejjin li jistgħu jkunu relatati ma ’ kundizzjoni imsejjħa “ aċidożi lattika ”:
If you have previously taken Galvus (vildagliptin) or Zomarist but had to stop taking it because of side effects (liver disease), you should not take Zomarist again.
Jekk xi darba hadt Galvus (vildagliptin) jew Zomarist iżda kellek twaqqfu minħabba l- effetti sekondarji (mard tal- fwied), m’ għandekx terġa tieħu Zomarist mill- ġdid.
You are also advised to pay particular attention to new onset of blisters or ulcers while taking Zomarist.
Int konsiljat ukoll li toqgħod attent b’ mod partikolari għal xi nfatet jew ulċeri li jistgħu joħorġu waqt li tkun qed tieħu Zomarist.
If you have stopped using Zomarist due to surgery (you should stop at least 48 hours before planned surgery with general anesthesia and should not start again until at least 48 hours afterwards) or due to an x-ray involving an injectable dye, talk to your doctor before taking Zomarist again.
Jekk waqaft tuża Zomarist minħabba operazzjoni (għandek twaqqfu mill- anqas 48 siegħa qabel ma tkun ippjanata l- operazzjoni b’ loppju ġenerali u m’ għandekx terġa ’ tibdih sa mill- anqas 48 siegħa wara) jew minħabba raġġi- x li jinvolvu l- injezzjoni ta ’ kimika bil- kulur, tkellem mat- tabib tiegħek qabel terġa tibda tieħu Zomarist.
A test to determine your liver function will be performed before the start of Zomarist treatment, at three-month intervals for the first year and periodically thereafter.
Test sabiex tiġi stabbilita l- funzjoni tal- fwied tiegħek se ssir qabel ma tibda l- kura b’ Zomarist, f’ intervalli ta ’ tlett xhur fl- ewwel sena u darba kulltant minn hemm ’ l quddiem.
Elderly patients (65-74 years) taking Zomarist should have their kidney function monitored regularly.
Pazjenti anjzani (65- 74 sena) li qed jieħdu Zomarist għandu jkollhom il- funzjoni tal- fwied immonitorata b’ mod regolari.
Zomarist is not recommended for patients aged 75 years or older.
Zomarist mhux rakkomandat għal pazjenti li għandhom 75 sena jew aktar.
Taking Zomarist with food and drink Take the tablets either with or just after food.
Meta tieħu Zomarist ma ’ l- ikel u max- xorb Ħu l- pilloli ma ’ l- ikel jew eżatt wara l- ikel.
Avoid alcohol while taking Zomarist since alcohol may increase the risk of lactic acidosis (please see section “Possible side effects”).
Evita l- alkoħol meta tkun qed tieħu Zomarist peress li l- alkoħol jista ’ jżid ir- riskju ta ’ aċidożi lattika (jekk jogħġbok ara “ Effetti Sekondarji li Jista ’ jkollu ”.
Your doctor will discuss with you the potential risk of taking Zomarist during pregnancy.
It- tabib tiegħek ser jiddiskuti miegħek dwar ir- riskju li jista ’ jkun hemm jekk tieħu Zomarist waqt it- tqala.
- Do not use Zomarist if you are breast-feeding.
- Tużax Zomarist jekk qed tredda ’.
Driving and using machines If you feel dizzy while taking Zomarist, do not drive or use any tools or machines.
Sewqan u tħaddim ta ’ magni Jekk tħossok sturdut meta tkun qed tieħu Zomarist, mgħandekx issuq jew tuża l- ebda għodda jew magni.
HOW TO TAKE ZOMARIST
KIF GĦANDEK TIEĦU ZOMARIST
Always take Zomarist exactly as your doctor has told you.
Dejjem għandek tieħu Zomarist skond il- parir tat- tabib.
How much to take The amount of Zomarist that people have to take varies depending on their condition.
Kemm għandek tieħu L- ammont ta ’ Zomarist li n- nies għandhom jieħdu jvarja skond il- kondizzjoni tagħhom.
Your doctor will tell you exactly the dose of Zomarist to take.
It- tabib tiegħek ser jgħidlek eżattament id- doża ta ’ Zomarist li għandek tieħu.
When and how to take Zomarist
Meta u kif għandek tieħu Zomarist
In particular, if you are following a diabetic weight control diet, continue with this while you are taking Zomarist.
B’ mod partikolari, jekk qed issegwi dieta ta ’ kontroll tal- piż għad- dijabete, kompli b’ din waqt li qed tieħu Zomarist.
If you take more Zomarist than you should If you take too many Zomarist tablets, or if someone else takes your tablets, talk to a doctor or pharmacist immediately.
Jekk tieħu Zomarist aktar milli suppost Jekk tieħu wisq pilloli Zomarist, jew jekk xi ħadd ieħor jieħu l- pilloli tiegħek, kellem lit- tabib jew l - ispiżjar tiegħek mill- ewwel.
If you forget to take Zomarist If you forget to take a tablet, take it with your next meal unless you are due to take one then anyway.
Jekk tinsa tieħu Zomarist Jekk tinsa tieħu pillola, ħudha ma ’ l- ikla li jkun imissek sakemm ma tkunx wasalt sabiex tieħu oħra xorta waħda.
If you stop taking Zomarist Do not stop taking Zomarist unless your doctor tells you to.
Jekk tieqaf tieħu Zomarist Tieqafx tieħu Zomarist sakemm it- tabib tiegħek ma jgħidlekx biex tgħamel hekk.
Like all medicines, Zomarist can cause side effects, although not everybody gets them.
Bħal kull mediċina oħra, Zomarist jista ’ jkollu effetti sekondarji, għalkemm ma jidhrux fuq kulħadd.
These side effects may occur with certain frequencies, which are defined as follows:  very common: affects more than 1 patient in 10  common: affects 1 to 10 patients in 100  uncommon: affects 1 to 10 patients in 1,000  rare: affects 1 to 10 patients in 10,000 49  very rare: affects less than 1 patient in 10,000  not known: frequency cannot be estimated from the available data.
49  komuni: jaffettwaw 1 sa 10 pazjenti f’ 100  mhux komuni: jaffettwaw 1 sa 10 pazjenti f’ 1, 000  rari: jaffettwaw 1 sa 10 pazjenti f’ 10, 000  rari ħafna: jaffettwaw anqas minn pazjent 1 f’ 10, 000  mhux magħruf: il- frekwenza ma tistax tittieħed stima mid- data disponibbli.
Some symptoms need immediate medical attention You should stop taking Zomarist and see your doctor immediately if you experience the following side effects:
Xi sintomi jista ’ jkollhom bżonn attenzjoni medika immedjata Għandek tieqaf tieħu Zomarist u tara t- tabib tiegħek mill- ewwel jekk tħoss kwalunkwe minn dawn l- effetti sekondarji:
Other side effects Some patients have experienced the following side effects while taking Zomarist:
Effetti sekondarji oħrajn Xi pazjenti kellhom l- effetti sekondarji li ġejjin meta kienu qed jieħdu Zomarist:
HOW TO STORE ZOMARIST
KIF TAĦŻEN ZOMARIST
- Do not use Zomarist after the expiry date which is stated on the blister and carton.
- Tużax Zomarist wara d- data ta ’ skadenza li tidher fuq il- folja u l- kartuna.
What Zomarist contains 50
X’ fih Zomarist
- Each Zomarist 50 mg/850 mg film-coated tablet contains 50 mg vildagliptin and 850 mg
- Kull pillola miksija b’ rita ta ’ Zomarist fiha 50 mg vildagliptin u 850 mg metformin
metformin hydrochloride (corresponding to 660 mg of metformin).
hydrochloride (jikkorrispondu għal 660 mg metformin).
- Each Zomarist 50 mg/1000 mg film-coated tablet contains 50 mg vildagliptin and 1000 mg
- Kull pillola miksija b’ rita ta ’ Zomarist fiha 50 mg vildagliptin u 1000 mg metformin
What Zomarist looks like and contents of the pack Zomar ist 50 mg/850 mg film-coated tablets are yellow, oval tablets with “NVR” on one side and “SEH” on the other.
Id- Dehra ta ’ Zomarist u l- kontenuti tal- pakkett Zomarist 50 mg/ 850 mg pilloli miksijin b’ rita huma pilloli sofor, ovali b ’ “ NVR ” fuq naħa waħda u “ SEH ” fuq l- oħra.
Zomarist 50 mg/1000 mg film-coated tablets are dark yellow, oval tablets with “NVR” on one side and “FLO” on the other.
Zomarist 50 mg/ 1000 mg pilloli miksijin b’ rita huma pilloli sofor skuri, ovali b ’ “ NVR ” fuq naħa waħda u “ FLO ” fuq l- oħra.
Zomarist is available in packs containing 10, 30, 60, 120, 180 or 360 film-coated tablets and in multi- packs containing 120 (2x60), 180 (3x60) or 360 (6x60) film-coated tablets.
Zomarist jiġi f’ pakketti li jkun fihom 10, 30, 60, 120, 180 jew 360 pillola miksija b’ rita u f’ pakketti b’ ħafna li jkun fihom 120 (2x60), 180 (3x60) jew 360 (6x60) pillola miksija b’ rita.
EPAR summary for the public
ZOMETA Sommarju ta ’ l- EPAR għall- pubbliku
What is Zometa?
X’ inhi Zometa?
Zometa is a medicine containing the active substance zoledronic acid.
Zometa hija mediċina li fiha s- sustanza attiva zoledronic acid.
It is available as a powder and solvent, and as a concentrate, which are made up into a solution for infusion (drip into a vein).
Hija tiġi bħala trab u solvent, u bħala konċentrat, li jitħalltu f’ soluzzjoni għal infużjoni (drip ġol- vina).
What is Zometa used for?
Għalxiex tintuża Zometa?
Zometa can be used to prevent bone complications in patients with advanced cancer that is affecting the bone.
Zometa tista ’ tintuża biex timpedixxi kumplikazzjonijiet ta ’ l- għadam f’ pazjenti b’ kanċer avvanzat li jkun qiegħed jaffettwa l- għadam.
This includes fractures, spinal compression, bone disorders needing radiotherapy or surgery, and hypercalcaemia (high levels of calcium in the blood).
Dawn jinkludu ksur, kompressjoni ta ’ l- ispina, disturbi ta ’ l- għadam li jkunu jeħtieġu radjuterapija jew kirurġija, u iperkalċimja (livelli għoljin ta ’ kalċju fid- demm).
Zometa can also be used to treat the hypercalcaemia caused by tumours.
Zometa tista ’ tintuża biex tikkura iperkalċimja kkawżata minn tumuri.
How is Zometa used?
Kif tintuża Zometa?
Zometa must only be used by a doctor who has experience in the use of this type of intravenous medicine.
Zometa jeħtieġ li tintuża biss minn tabib li jkollu esperjenza fl- użu ta ’ din it- tip ta ’ mediċina intravenuża.
The usual dose of Zometa is one infusion of 4 mg over at least 15 minutes.
Id- doża normali ta ’ Zometa hija infużjoni ta ’ 4 mg fuq ta ’ l- anqas 15- il minuta.
When used to prevent bone complications, the infusion can be repeated every three to four weeks, and patients should also take supplements of calcium and vitamin D.
L- infużjoni tista ’ tiġi ripetuta kull tlieta sa erba ’ ġimgħat meta wżata biex timpedixxi kumplikazzjonijiet ta ’ l- għadam, u l - pazjenti għandhom jieħdu wkoll supplimenti ta ’ kalċju u vitamina D.
A lower dose is recommended for patients with bone metastases (cancer that has spread to the bone) if they have mild to moderate problems with their kidneys.
Hija rrakkomandata doża aktar baxxa għal pazjenti b’ metastasi fl- għadam (kanċer li jkun infirex għall- għadam) jekk ikollhom problemi ħfief għal moderati bil- kliewi tagħhom.
It is not recommended for patients with severe kidney problems.
Mhijiex irrakkomandata għal pazjenti bi problemi serji fil- kliewi tagħhom.
How does Zometa work?
Kif taħdem Zometa?
The active substance in Zometa, zoledronic acid, is a bisphosphonate.
Is- sustanza attiva f’ Zometa, zoledronic acid, hija bifosfonat.
It stops the action of the osteoclasts, the cells in the body that are involved in breaking down the bone tissue.
Hija twaqqaf l- azzjoni ta ’ l- osteoklasti, iċ- ċelloli fil- ġisem li huma nvoluti fit- tkissir tat- tessut ta ’ l- għadam.
The reduction of bone loss helps to make bones less likely to break, and this is useful in preventing fractures in cancer patients with bone metastases.
It- tnaqqis ta ’ telf ta ’ l- għadam jgħin biex jagħmel l- għadam inqas suxxettibbli li jinkiser, u dan huwa bżonnjuż għall- prevenzjoni ta ’ ksur f’ pazjenti b’ metastasi fl- għadam.
Patients with tumours can have high level of calcium in their blood, released from the bones.
Pazjenti b’ tumuri jista ’ jkollhom livelli għoljin ta ’ kalċju fid- demm tagħhom, li jiġi rilaxxat mill- għadam.
By preventing the breakdown of bones, zoledronic acid helps to reduce the levels of calcium released in the blood.
Zoledronic acid jgħin biex inaqqas il- livelli ta ’ kalċju rilaxxat fid- demm billi jimpedixxi t- tkissir ta ’ l- għadam.
How has Zometa been studied?
Kif ġiet studjata Zometa?
Zometa has been studied in over 3,000 patients with bone metastases to look at its effectiveness in the prevention of bone damage.
Zometa ġiet studjata fuq aktar minn 3, 000 pazjent b’ metastasi ta ’ l- għadam, biex ikun magħruf l - effettività tagħha fil- prevenzjoni ta ’ ħsara fl- għadam.
Zometa was compared with placebo (a dummy treatment) in two studies, and with pamidronate (another bisphosphonate) in the third study.
Zometa tqabblet ma ’ plaċebo (kura finta) f’ żewġ studji, u ma ’ pamidronate (bifosfonat ieħor) fit- tielet studju.
The main measure of effectiveness 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Il- miżura ewlenija ta ’ l- effettività kienet 7 Westferry Circus, Canary Wharf, London E14 4HB, UK Tel.
Reproduction is authorised provided the source is acknowledged. was the proportion of patients who developed at least one new ‘ skeletal event ’ over 13 months.
Reproduction is authorised provided the source is acknowledged. il- proporzjon ta ’ pazjenti li żviluppaw għallinqas ‘ episodju skeletali ’ ġdid fuq 13- il xahar.
This included any bone complication needing to be treated either with radiotherapy or surgery, any fractures or any occurrence of spinal compression.
Dan inkluda kwalunkwe kumplikazzjoni ta ’ l- għadam li kienet teħtieġ li tiġi kkurata jew b’ radjuterapija jew b’ kirurġija, kwalunkwe ksur jew kwalunkwe okkorrenza ta ’ kompressjoni ta ’ l- ispina.
The effectiveness of Zometa in patients with hypercalcaemia caused by tumours has been studied in two main studies involving a total of 287 patients.
L- effettività ta ’ Zometa f’ pazjenti b’ iperkalċimja kkaġunata minn tumuri ġiet studjata f’ żewġ studji ewlenin li nvolvew total ta ’ 287 pazjent.
Zometa was compared with pamidronate.
Zometa tqabblet ma ’ pamidronate.
The main measure of effectiveness was the proportion of patients whose calcium levels had returned to normal within 10 days after treatment.
Il- miżura ewlenija ta ’ l - effettività kienet il- proporzjon ta ’ pazjenti li l- livelli ta ’ kalċju tagħhom irritornaw għan- normal fi żmien 10 ijiem wara l- kura.
What benefit has Zometa shown during the studies?
Liema benefiċċju wriet Zometa waqt l- istudji mwettqa?
In patients with bone metastases, the proportion of patients who developed a new skeletal event was lower with Zometa (33 to 38%) than with placebo (44%).
F’ pazjenti b’ metastasi fl- għadam, il- proporzjon ta ’ pazjenti li żviluppaw episodju skeletali ġdida kien aktar baxx b’ Zometa (33 sa 38%) milli bi plaċebo (44%).
Zometa was also as effective as pamidronate: the proportion of patients with one event was 44% with Zometa and 46% with pamidronate.
Zometa kienet ukoll effettiva daqs pamidronate: il- proporzjon ta ’ pazjenti b’ episodju kien 44% b’ Zometa u 46% b’ pamidronate.
In patients with hypercalcaemia, Zometa was more effective than pamidronate.
F’ pazjenti b ’ iperkalċimja, Zometa kienet aktar effettiva milli pamidronate.
Looking at the results of the two studies together, the proportion of patients whose calcium levels were normal within 10 days after treatment was 88% with Zometa compared with 70% for pamidronate.
Jekk wieħed iħares lejn ir - riżultati taż- żewġ studji flimkien, il- proporzjon ta ’ pazjenti li l- livelli ta ’ kalċju tagħhom kien normali fi żmien 10 ijiem mill- kura kien 88% b’ Zometa meta mqabbel ma ’ 70% għal pamidronate.
What is the risk associated with Zometa?
X’ inhu r- riskju assoċjat ma ’ Zometa?
The most common side effect with Zometa (seen in more than 1 patient in 10) is hypophosphataemia (low blood phosphate levels).
L- aktar effett sekondarju komuni b’ Zometa (jidher f’ aktar minn pazjent 1 minn kull 10) huwa ipofosfatimja (livelli baxxi ta ’ fosfati fid- demm).
For the full list of all side effects reported with Zometa, see the Package Leaflet.
Għal- lista sħiħa ta ’ effetti sekondarji rrapportati b’ Zometa, ara l- Fuljett ta ’ Tagħrif.
Zometa should not be used in people who may be hypersensitive (allergic) to zoledronic acid, to other bisphosphonates or to any of the other ingredients.
Zometa m’ għandhiex tintuża f’ nies li jistgħu jkunu ipersensittivi (allerġiċi) għal zoledronic acid, għal bifosfonati oħrajn jew għal kwalunkwe mis- sustanzi l- oħrajn.
Zometa should not be used in pregnant or breast- feeding women.
Zometa m’ għandhiex tintuża f’ nisa tqal jew f’ nisa li jkunu qegħdin irreddgħu.
As with all bisphosphonates, patients taking Zometa may be at risk of osteonecrosis (death of bone tissue) in the jaw.
Bħalma jista ’ jiġri bil- bifosfonati kollha, pazjenti li jkunu qegħdin jieħdu Zometa jistgħu jkunu f’ riskju ta ’ osteonekrożi (mewt tat- tessut ta ’ l- għadam) fix - xedaq.
Why has Zometa been approved?
Għaliex ġiet approvata Zometa?
The Committee for Medicinal Products for Human Use (CHMP) decided that Zometa’ s benefits are greater than its risks for the prevention of skeletal related events (pathological fractures, spinal compression, radiation or surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone, and for the treatment of tumour-induced hypercalcaemia.
Il- Kumitat għal Prodotti Mediċinali għal Użu tal- Bniedem (CHMP) iddeċieda li l- benefiċċji ta ’ Zometa huma akbar mir- riskji tagħha għall- prevenzjoni ta ’ episodji relatati ma ’ l- iskelettru (ksur patoloġiku, kompressjoni ta ’ l- ispina, radjazzjoni jew kirurġija fl- għadam, jew iperkalċimja mqanqla minn tumur) f’ pazjenti b’ malinni avvanzati li jinvolvu l- għadam, u għall- kura ta ’ iperkalċimja imqanqla minn tumur.
The Committee recommended that Zometa be given marketing authorisation.
Il- Kumitat irrakkomanda li Zometa tingħata awtorizzazzjoni għat- tqegħid fis - suq.
Other information about Zometa:
Informazzjoni oħra dwar Zometa:
The European Commission granted a marketing authorisation valid throughout the European Union to Novartis Europharm Limited for Zometa on 20 March 2001.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fuq is- suq valida madwar l- Unjoni Ewropea, għal Zometa lil Novartis Europharm Limited fl- 20 ta ’ Marzu 2001.
The marketing authorisation was renewed on 20 March 2006.
L- awtorizzazzjoni għat - tqegħid fis- suq ġiet imġedda fl- 20 ta ’ Marzu 2006.
The full EPAR for Zometa is available here.
L- EPAR sħiħ għal Zometa jista ’ jiġi konsultat hawnhekk.
This summary was last updated in 04-2008.
Dan is- sommarju kien l- aħħar aġġornat fi 04- 2008.
EU Number
Numru ta ’ l- EMEA
Powder and solvent for solution for infusion
Trab u solvent ghal tahlita likwida ghall- infużjoni
powder: vial (glass); solvent: ampoule (glass)
trab: kunjett (ħġieġ); solvent: ampulla (ħġieġ)
1 vial + 1 ampoule
1 kunjett + 1 ampulli
4 vials + 4 ampoules
4 kunjetti + 4 ampulli
Concentrate for solution for infusion
Konċentrat ghal soluzzjoni ghall- infużjoni
vial (plastic)
kunjett (plastik)
Zometa 4 mg powder and solvent for solution for infusion
Zometa 4 mg trab u solvent għal soluzzjoni għall- infużjoni
One vial contains 4 mg zoledronic acid (anhydrous), corresponding to 4.264 mg zoledronic acid monohydrate.
Kunjett wieħed fih 4 mg zoledronic acid (anhydrous), ekwivalenti għal 4. 264 mg zoledronic acid monohydrate.
Powder and solvent for solution for infusion
Trab u solvent għal soluzzjoni għall- infużjoni
- Prevention of skeletal related events (pathological fractures, spinal compression, radiation or
- Prevenzjoni ta ’ problemi skeletrali (ksur patoloġiku, kompressjoni tas- sinsla, radjazzjoni jew
surgery to bone, or tumour-induced hypercalcaemia) in patients with advanced malignancies involving bone.
kirurġija fl- għadam, jew żieda fil- livell ta ’ calcium fid- demm kawżat minn tumur) f’ pazjenti b’ kanċer avvanzat li jinvolvi l- għadam.
- Treatment of tumour-induced hypercalcaemia (TIH).
- Kura ta ’ żieda fil- livell ta ’ calcium fid- demm kawża ta ’ tumuri (TIH).
Zometa must only be used by clinicians experienced in the administration of intravenous bisphosphonates.
Zometa għandu jintuża biss minn tobba li għandhom esperjenza fl- għoti ta ’ bisphosphonates ġol- vini.
Zometa reconstituted solution 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.
Is- soluzzjoni rikostitwita ta ’ Zometa m’ għandiex titħallat ma ’ soluzzjonijiet ta ’ l- infużjoni li jkun fihom calcium jew xi divalent cations oħrajn bħal soluzzjoni ta ’ lactated Ringer, u għandhom jingħataw bħala soluzzjoni waħda minn ġol- vina f’ linja ta ’ infużjoni separata.
Prevention of skeletal related events in patients with advanced malignancies involving bone Adults and elderly The recommended dose in the prevention of skeletal related events in patients with advanced malignancies involving bone is 4 mg reconstituted and further diluted Zometa solution for infusion (diluted with 100 ml 0.9% w/ v sodium chloride or 5% w/ v glucose solution), given in no less than a 15-minute intravenous infusion every 3 to 4 weeks.
Prevenzjoni ta ’ problemi skeletrali f’ pazjenti b’ kanċer avvanzat li qed jinvolvi l- għadam Adulti u anzjani Id- doża rakkomandata għall- prevenzjoni ta ’ problemi skeletrali f’ pazjenti b’ kanċer avvanzat li jinvolvi l- għadam hija ta ’ 4 mg soluzzjoni għall- infużjoni ta ’ Zometa rikostitwita u terġa tiġi ddilwita (ddilwita b’ 100 ml ta ’ 0. 9% w/ v sodium chloride jew 5% w/ v soluzzjoni ta ’ glucose) u mogħtija bħala infużjoni ġol- vini fuq medda ta ’ mhux inqas minn 15- il minuta kull 3 jew 4 gimgħat.
Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily.
Il- pazjenti għandhom jingħataw ukoll suppliment mill- ħalq ta ’ 500 mg calcium u 400 IU vitamina D kuljum.
Treatment of TIH Adults and elderly The recommended dose in hypercalcaemia (albumin-corrected serum calcium ≥ 12.0 mg/ dl or 3.0 mmol/ l) is 4 mg reconstituted and further diluted Zometa solution for infusion (diluted with 100 ml sterile 0.9% w/ v sodium chloride or 5% w/ v glucose solution), given as a single intravenous infusion in no less than 15 minutes.
Kura ta ’ TIH Adulti u anzjani Id- doża rakkomandata għall- kura ta ’ żieda fil- livell ta ’ calcium fid- demm (livell ta ’ calcium fis- serum korrett għall- albumina ≥12. 0 mg/ dl jew 3. 0 mmol/ l) hija ta ’ 4 mg soluzzjoni għall- infużjoni ta ’ Zometa rikostitwita u terġa tiġi ddilwita (ddilwita b’ 100 ml 0. 9% w/ v ta ’ sodium chloride sterili jew 5% w/ v soluzzjoni ta ’ glucose) u mogħtija bħala infużjoni ġol- vini ta ’ darba fuq medda ta ’ 15- il minuta.
Patients must be maintained well hydrated prior to and following administration of Zometa.
Il- pazjent għandu jinżamm idratat sew kemm qabel kif ukoll wara l- għoti ta ’ Zometa.
2 Renal impairment TIH:
2 Indeboliment tal- kliewi TIH:
Zometa treatment in TIH patients who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment.
Il- kura b’ Zometa f’ pazjenti TIH li għandhom ukoll indeboliment sever tal- kliewi għandha titqies biss wara li jiġu evalwati ir- riskji u l- benefiċċji tal- kura.
In the clinical studies, patients with serum creatinine > 400 µmol/ l or > 4.5 mg/ dl were excluded.
Fl- istudji kliniċi, pazjenti li kellhom krejatinina fis- serum ta ’ > 400 µmol/ l jew > 4. 5 mg/ dl kienu esklużi.
No dose adjustment is necessary in TIH patients with serum creatinine < 400 µmol/ l or < 4.5 mg/ dl (see section 4.4).
M’ hemmx bżonn tibdil fid- doża f’ pazjenti b’ TIH li għandhom krejatinina fis- serum < 400 µmol/ l jew < 4. 5 mg/ dl (ara sezzjoni 4. 4).
Prevention of skeletal related events in patients with advanced malignancies involving bone:
Prevenzjoni ta ’ problemi skeletrali f’ pazjenti b’ kanċer avvanzat li jinvolvi l- għadam:
When initiating treatment with Zometa in patients with multiple myeloma or metastatic bone lesions from solid tumours, serum creatinine and creatinine clearance (CrCl) should be determined.
Meta tkun ser tibda l- kura b’ Zometa f’ pazjenti b’ majeloma multipla jew ġrieħi ta ’ metastasi fl- għadam minn tumuri solidi, il- krejatinina fis- serum u t- tneħħija tal- krejatinina (CrCl) għandhom jiġu determinati.
CrCl is calculated from serum creatinine using the Cockcroft-Gault formula.
CrCl tiġi kkalkulata mill- krejatinina fis- serum bil- formula Cockcroft- Gault.
Zometa is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as CrCl < 30 ml/ min.
Zometa mhux rakkomandat għall- pazjenti li jkollhom indeboliment sever tal- kliewi qabel tibda t- terapija, li għal din il- popolazzjoni hi meqjusa bħala CrCl < 30 ml/ min.
In clinical trials with Zometa, patients with serum creatinine > 265 µmol/ l or > 3.0 mg/ dl were excluded.
Fi provi kliniċi b’ Zometa, pazjenti b’ krejatinina fis- serum ta ’ > 265µmol/ l jew > 3. 0 mg/ dl kienu esklużi.
In patients with bone metastases presenting with mild to moderate renal impairment prior to initiation of therapy, which is defined for this population as CrCl 30– 60 ml/ min, the following Zometa dose is recommended (see also section 4.4):
F’ pazjenti b’ metastasi ta ’ l- għadam li jkollhom indeboliment tal- kliewi ħafif għal moderat qabel tibda t- terapija, li għal din il- popolazzjoni titqies bħala CrCl 30- 60 ml/ min, id- doża ta ’ Zometa li Gejja hi rakkomandata (ara wkoll sezzjoni 4. 4):
Clearance (ml/ min) > 60
Tneħħija tal- krejatinina mal- linja bażi (ml/ min)
Zometa Recommended Dose* 4.0 mg
Doża ta ’ Zometa Rakkomandata *
50– 60 40– 49 30– 39
> 60 50– 60 40– 49 30– 39
3.5 mg* 3.3 mg* 3.0 mg*
4. 0 mg 3. 5 mg * 3. 3 mg * 3. 0 mg *
*Doses have been calculated assuming target AUC of 0.66 (mg• hr/ l) (CrCl=75 ml/ min).
* Id- dożi ġew kalkulati billi kienet assumata mira ta ’ AUC ta ’ 0. 66 (mg• hr/ l) (CrCl=75 ml/ min).
The reduced doses for patients with renal impairment are expected to achieve the same AUC as that seen in patients with creatinine clearance of 75 ml/ min.
Id - dożi mnaqqsa għall- pazjenti b’ indeboliment tal- kliewi huma mistennija li jiksbu l- istess AUC bħall dawk li jidhru f’ pazjenti bi tneħħija tal- krejatinina ta ’ 75 ml/ min.
Following initiation of therapy, serum creatinine should be measured prior to each dose of Zometa and treatment should be withheld if renal function has deteriorated.
Wara li tibda t- terapija, il- krejatinina fis- serum għandha titkejjel qabel kull doża ta ’ Zometa u l- kura għandha titwaqqaf jekk il- funzjoni renali tkun marret għall- agħar.
In the clinical trials, renal deterioration was defined as follows:
Fil- provi kliniċi d- deterjorazzjoni tal- funzjoni tal- kliewi ġiet definita hekk:
- For patients with normal baseline serum creatinine (< 1.4 mg/ dl or < 124 µmol/ l), an increase of
- Għall- pazjenti b’ linja bażi normali ta ’ krejatinina fis- serum (< 1. 4 mg/ dl jew < 124 µmol/ l),
0.5 mg/ dl or 44 µmol/ l;
żieda ta ’ 0. 5 mg/ dl jew 44 µmol/ l;
- For patients with an abnormal baseline creatinine (> 1.4 mg/ dl or > 124 µmol/ l), an increase of
- Għall- pazjenti b’ linja bażi anormali ta ’ krejatinina (> 1. 4 mg/ dl jew > 124 µmol/ l), żieda ta ’
1.0 mg/ dl or 88 µmol/ l.
1. 0 mg/ dl jew 88 µmol/ l.
In the clinical studies, Zometa treatment was resumed only when the creatinine level returned to within 10% of the baseline value (see section 4.4).
Fi studji kliniċi, il- kura b’ Zometa reġgħet inbdiet biss meta l- livell ta ’ krejatinina kien reġa ġie lura għal 10% tal- valur tal- linja bażi (ara sezzjoni 4. 4).
Zometa treatment should be resumed at the same dose as that prior to treatment interruption.
Il- kura b’ żometa għandha terġa tibda bl- istess doża li kienet qed tingħata qabel ma twaqqfet il- kura.
Instructions for preparing reduced doses of Zometa Withdraw an appropriate volume of the reconstituted solution (4 mg/ 5 ml) as needed:
Istruzzjonijiet biex tipprepara dożi imnaqqsa ta ’ Zometa Iġbed volum xieraq tas- soluzzjoni rikostitwita (4 mg/ 5 ml) kif meħtieġ:
- 4.4 ml for 3.5 mg dose
- 4. 4 ml għal doża ta ’ 3. 5 mg
- 4.1 ml for 3.3 mg dose
- 4. 1 ml għal doża ta ’ 3. 3 mg
- 3.8 ml for 3.0 mg dose
- 3. 8 ml għal doża ta ’ 3. 0 mg
For information on the reconstitution and dilution of Zometa, see section 6.6.
Għal tagħrif dwar ir- rikostituzzjoni u d- dilwazzjoni ta ’ Zometa ara sezzjoni 6. 6.
The withdrawn amount of reconstituted solution must be diluted in 100 ml of sterile 0.9% w/ v sodium chloride solution or 5% w/ v glucose solution.
L- ammont miġbud tas- soluzzjoni rikostitwita għandu jiġi dilwit f’ 100 ml ta ’ soluzzjoni sterili ta ’ 0. 9% w/ v sodium chloride jew 5% w/ v soluzzjoni ta ’ glucose.
The dose must be given as a single intravenous infusion over no less than 15 minutes.
Id- doża għandha tingħata bħala infużjoni waħda ġol vina fuq mhux anqas minn 15- il minuta.
The use of Zometa in paediatric patients has not been studied.
L- użu ta ’ Zometa f’ pazjenti pedjatriċi ma ġiex studjat.
Zometa should not be used in that patient population until further data becomes available.
Zometa m’ għandux jintuża f’ din il - popolazzjoni ta ’ pazjenti sakemm ma jkunx hemm aktar tagħrif.
Zometa powder for solution for infusion is contraindicated in breast-feeding women and in patients with clinically significant hypersensitivity to zoledronic acid, other bisphosphonates or any of the excipients in the formulation of Zometa.
It- trab ta ’ Zometa għal soluzzjoni għall- infużjoni m’ għandux jintuża f’ nisa li qed ireddgħu u f’ pazjenti b’ sensitività eċċessiva klinikament sinifikanti għal zoledronic acid, bisphosphonates oħrajn jew sustanżi oħrajn mhux attivi li hemm fil- formulazzjoni ta ’ Zometa.
General Patients must be assessed prior to administration of Zometa to ensure that they are adequately hydrated.
Ġenerali Il- pazjenti għandhom jiġu eżaminati qabel ma jingħatalhom Zometa biex ikun aċċertat li jkunu idratati b’ mod xieraq.
Overhydration should be avoided in patients at risk of cardiac failure.
Għandha tiġi evitata l- idratazzjoni eċċessiva f’ pazjenti li għandhom riskju ta ’ insuffiċjenza kardijaka.
Standard hypercalcaemia-related metabolic parameters, such as serum levels of calcium, phosphate and magnesium, should be carefully monitored after initiating Zometa therapy.
Wara li tinbeda l- kura b’ Zometa, il- parametri metaboliċi stàndard li għandhom x’ jaqsmu ma ’ żieda fil - livell ta ’ calcium fid- demm, per eżempju, livelli fis- serum ta ’ calcium, phosphate u magnesium għandhom jinżammu taħt osservazzjoni bir- reqqa.
If hypocalcaemia, hypophosphataemia, or hypomagnesaemia occurs, short-term supplemental therapy may be necessary.
Jekk il- livelli ta ’ calcium, phosphate, jew magnesium fid- demm jinżlu, għandu mnejn ikun hemm bżonn li tingħata terapija b’ supplementi għal żmien qasir.
Untreated hypercalcaemia patients generally have some degree of renal function impairment, therefore careful renal function monitoring should be considered.
Pazjenti li jkollhom livelli għoljin fid- demm li ma jkunux ikkurati ġeneralment ikollhom xi grad ta ’ indeboliment tal- funzjoni renali, għaldaqstant monitoraġġ b’ attenzjoni tal- funzjoni renali għandu jitqies.
The safety and efficacy of Zometa in paediatric patients have not been established.
Is- sigurtà u l- effikaċja ta’ Zometa f’ pazjenti tfal ma ġewx stabbiliti.
Renal insufficiency Patients with TIH with evidence of deterioration in renal function should be appropriately evaluated with consideration given as to whether the potential benefit of treatment with Zometa outweighs the possible risk.
Insuffiċjenza renali Pazjenti b’ TIH li jkollhom deterjorazzjoni fil- funzjoni tal- kliewi għandhom jiġu eżminati b’ mod xieraq sabiex jitqies jekk il- benefiċċju li titkompla l- kura b’ Zometa jgħelibx ir- riskju li jista ’ jkun hemm.
The decision to treat patients with bone metastases for the prevention of skeletal related events should consider that the onset of treatment effect is 2– 3 months.
Id- deċiżjoni li jiġu kkurati pazjenti b’ metastasi fl- għadam biex tilqgħalhom kontra problemi skeletrali għandha wkoll tikkunsidra l- fatt li l- kura tieħu minn 2– 3 xhur sabiex tibda tagħmel effett.
As with other bisphosphonates, Zometa has been associated with reports of renal dysfunction.
Bħal fil- każ ta ’ bisphosphonates oħrajn, Zometa ġieli ġie assoċjat ma ’ rapporti ta ’ disfunzjoni renali.
Factors that may increase the potential for deterioration in renal function include dehydration, pre-existing renal impairment, multiple cycles of Zometa and other bisphosphonates as well as use of other nephrotoxic drugs.
Fatturi li jistgħu jżidu l- potenzjal li l- funzjoni tal- kliewi tmur għall- agħar jinkludu deidratazzjoni, indeboliment tal- kliewi li jkun hemm minn qabel, ħafna ċikli ta ’ Zometa u bisphosphonates oħrajn kif ukoll l- użu ta ’ mediċini oħra li jkunu nefrotossiċi.
While the risk is reduced with a dose of Zometa 4 mg administered over 15 minutes, deterioration in renal function may still occur.
Filwaqt li jitnaqqas ir- riskju b’ doża ta ’ 4 mg Zometa li tingħata fuq medda ta ’ 15- il minuta, xorta waħda l- funzjoni tal- kliewi tista ’ tmur għall - agħar.
Renal deterioration, progression to renal failure and dialysis have been reported in patients after the initial dose or a single dose of Zometa.
Kienu rappurtati każijiet fejn il- kliewi marru għall- agħar, avvanz għal insuffiċjenza renali u dijaliżi kienu rrappurtati f’ pazjenti wara l- ewwel doża jew doża waħda ta ’ Zometa.
Increases in serum creatinine also occur in some patients with chronic administration of Zometa at recommended doses for prevention of skeletal related events, although less frequently.
Żiediet tal - krejatinina fis- serum iseħħu wkoll f’ xi pazjenti li jingħataw Zometa fit- tul f ’ dozi li huma rakkomandati għall- prevenzjoni ta ’ problemi skeletrali, għalkemm b’ mod anqas frekwenti.
Patients should have their serum creatinine levels assessed prior to each dose of Zometa.
Il- pazjenti jrid ikollhom il- livelli ta ’ krejatinina fis- serum evalwati qabel kull doża ta ’ Zometa.
Upon initiation of treatment in patients with bone metastases with mild to moderate renal impairment, lower doses of Zometa are recommended.
Malli tinbeda l- kura f’ pazjenti b’ metastasi ta ’ l- għadam li jkollhom indeboliment tal- kliewi ħafif għal moderat, dożi aktar baxxi ta ’ Zometa huma rakkomandati.
In patients who show evidence of renal deterioration during treatment, Zometa should be withheld.
F’ pazjenti li jkollhom sinjali li juru li l - kliewi sejrin għall- agħar waqt il- kura, Zometa għandu jitwaqqaf.
Zometa should only be resumed when serum creatinine returns to within 10% of baseline (see section 4.2).
Zometa jista ’ jerġa jingħata meta l - krejatinina fis- serum terġa lura għal 10% tal- linja bażi (ara sezzjoni 4. 2).
In view of the potential impact of bisphosphonates, including Zometa, on renal function, the lack of clinical safety data in patients with severe renal impairment (in clinical trials defined as serum creatinine ≥ 400 µmol/ l or ≥ 4.5 mg/ dl for patients with TIH and ≥ 265 µmol/ l or ≥ 3.0 mg/ dl for patients with cancer and bone metastases, respectively) at baseline and only limited pharmacokinetic data in patients with severe renal impairment at baseline (creatinine clearance < 30 ml/ min), the use of Zometa is not recommended in patients with severe renal impairment.
Minħabba l- impatt potenzjali tal- bisphosphonates, inkluż Zometa, fuq il- funzjoni tal- kliewi, u minħabba nuqqas ta ’ tagħrif kliniku dwar is- sigurtà f’ pazjenti b’ indeboliment sever tal- kliewi (definit fi provi kliniċi bħala livell ta ’ krejatinina fis- serum ta ’ ≥400 µmol/ l jew ≥4. 5 mg/ dl għal pazjenti b ’ TIH u ≥265 µmol/ l jew ≥3. 0 mg/ dl għal pazjenti b ’ kanċer u metastasi fl- għadam, rispettivament) fil - linja bażi u minħabba t- tagħrif farmakokinetiku limitat f’ pazjenti li fil- linja bażi għandhom indeboliment sever fil- funzjoni tal- kliewi (tneħħija tal- krejatinina < 30 ml/ min), l- użu ta ’ Zometa f’ pazjenti b’ indeboliment sever fil- funzjoni tal- kliewi mhux rakkomandat.
Hepatic insufficiency As only limited clinical data are available in patients with severe hepatic insufficiency, no specific recommendations can be given for this patient population.
4 Insuffiċjenza epatika Billi hemm tagħrif kliniku limitat dwar pazjenti b’ insuffiċjenza severa tal- fwied, ma jistgħux jingħataw rakkomandazzjonijiet speċifiċi f’ dan il- grupp ta ’ pazjenti.
4 Osteonecrosis of the jaw Osteonecrosis of the jaw has been reported in patients, predominantly those with cancer, receiving treatment with bisphosphonates, including Zometa.
Osteonekrożi tax- xedaq Osteonekrożi tax- xedaq kienet rappurtat f’ pazjenti, l- aktar dawk b’ kanċer li jkunu qed jirċievu kuri bi bisphosphonates, inkluż Zometa.
The majority of reported cases have been associated with dental procedures such as tooth extraction.
Il- maġġoranza tal- każijiet rappurtati kienu assoċjati ma ’ proċeduri fis- snien bħal qlugħ ta ’ sinna.
Many had signs of local infection including osteomyelitis.
Ħafna kellhom sinjali ta ’ infezzjoni lokali inkluż ostejomajlajtis.
A dental examination with appropriate preventive dentistry should be considered prior to treatment with bisphosphonates in patients with concomitant risk factors (e. g. cancer, chemotherapy, corticosteroids, poor oral hygiene).
Għandhom jiġu eżaminati s- snien u proċeduri xierqa jiġu kkonsidrati qabel ma tibda l- kura b’ bisphosphonates f’ pazjenti li jkollhom ukoll fatturi ta ’ riskju (eż kanċer, kimoterapija, kortikosterojdi, nuqqas ta ’ iġene fil- ħalq).
While on treatment, these patients should avoid invasive dental procedures if possible.
Meta jkunu qed jingħataw il- kura, dawn il- pazjenti għandhom jevitaw proċeduri invażivi tas- snien.
For patients who develop osteonecrosis of the jaw while on bisphosphonate therapy, dental surgery may exacerbate the condition.
Għall- pazjenti li jiżviluppaw osteonekrożi tax- xedaq waqt terapija b’ bisphosphonates, proċeduri ta ’ kirurġija fis- snien jistgħu jaggravaw il- kundizzjoni.
For patients requiring dental procedures, there are no data available to suggest whether discontinuation of bisphosphonate treatment reduces the risk of osteonecrosis of the jaw.
Għall- pazjenti li jkollhom bżonn proċeduri fis - snien, m’ hemmx tagħrif li jindika jekk il- waqfien tal- kura b’ bisphosphonate jnaqqasx ir- riskju ta ’ osteonekrożi tax- xedaq.
Clinical judgement of the treating physician should guide the management plan of each patient based on individual benefit/ risk assessment.
Il- ġudizzju kliniku tat- tabib li jkun qed jikkura għandu jservi ta ’ gwida għal pjan ta ’ manniġjar ta ’ kull pazjent bażat fuq l- evalwazzjoni tal- benefiċċju/ riskju individwali.
Musculoskeletal pain In post-marketing experience, severe and occasionally incapacitating bone, joint, and/ or muscle pain have been reported in patients taking bisphosphonates.
Uġigħ muskoluskeletali Mill- esperjenza ta ’ wara t- tqegħid fis- suq, uġigħ sever u kultant li jnaqqas il- ħila tal- movimenti fl - għadam, ġogi u/ jew muskoli kienu rappurtati f’ pazjenti li jkunu qed jieħdu bisphosphonates.
However, such reports have been infrequent.
Madankollu dawn ir- rapporti ma kienux frekwenti.
This category of drugs includes Zometa (zoledronic acid).
Din il- kategorija ta ’ mediċini tinkludi Zometa (zoledronic acid).
The time to onset of symptoms varied from one day to several months after starting treatment.
Iż- żmien li ħadu s- sintomi biex jidhru kien ivarja bejn jum wieħed għal ħafna xhur wara li tkun bdiet il- kura.
Most patients had relief of symptoms after stopping treatment.
Il- parti l- kbira tal- pazjenti straħu mis- sintomi wara li waqqfu l- kura.
A subset had recurrence of symptoms when rechallenged with the same drug or another bisphosphonate.
Parti minnhom reġgħu ħarġulhom is- sintomi meta reġgħu ingħataw l- istess mediċina jew bisphosphonate ieħor.
In clinical studies, Zometa has been administered concomitantly with commonly used anticancer agents, diuretics, antibiotics and analgesics without clinically apparent interactions occurring.
Fi studji kliniċi, Zometa ngħata flimkien ma ’ mediċini li jintużaw ta ’ spiss kontra l- kanċer, dijuretiċi, antibijotiċi u analġeżiċi, mingħajr ma kien hemm interazzjonijiet li kienu klinikament evidenti.
Zoledronic acid shows no appreciable binding to plasma proteins and does not inhibit human P450 enzymes in vitro (see section 5.2), but no formal clinical interaction studies have been performed.
Ma jidhirx li zoledronic acid jeħel b’ xi mod apprezzabli mal- proteini fil- plażma u mhuwiex impeditur ta ’ l- enzima umana P450 in vitro (ara sezzjoni 5. 2), biss qatt ma saru studji kliniċi formali dwar l - interazzjonijiet.
Caution is advised when bisphosphonates are administered with aminoglycosides, since both agents may have an additive effect, resulting in a lower serum calcium level for longer periods than required.
Wieħed għandu joqgħod attent meta jagħti bisphosphonates ma ’ aminoglycosides, minħabba li t- tnejn flimkien jista ’ jkollhom effett addittiv, li jirriżulta f’ livell baxx ta ’ calcium fis - serum għal perijodi itwal milli jkun hemm bżonn.
Caution is indicated when Zometa is used with other potentially nephrotoxic drugs.
Wieħed għandu joqgħod attent meta Zometa jintuża flimkien ma ’ mediċini oħra li jistgħu jikkawżaw tossiċità tal- kliewi.
Attention should also be paid to the possibility of hypomagnesaemia developing during treatment.
Wieħed għandu joqgħod attent ukoll għall- possibiltà li l- livelli ta ’ magnesium fid- demm jaqgħu matul il- kura.
In multiple myeloma patients, the risk of renal dysfunction may be increased when intravenous bisphosphonates are used in combination with thalidomide.
F’ pazjenti b’ majeloma multipla r- riskju ta ’ disfunzjoni tal- kliewi jista ’ jiżdied jekk wieħed jagħti bisphosphonates ġol- vini flimkien ma ’ thalidomide.
Animal reproduction studies with zoledronic acid have shown reproductive toxicity (see section 5.3).
Studji fl- annimali fuq is - sistema riproduttiva b’ zoledronic acid wrew ħsara fuq is- sistema riproduttiva (ara sezzjoni 5. 3).
The potential risk for humans is unknown.
Ir - riskju li jista jkun hemm fuq in- nies, mhux magħruf.
Zometa should not be used during pregnancy.
Zometa m’ għandux jintuża waqt it- tqala.
It is not known whether zoledronic acid is excreted into human milk.
Mhux magħruf jekk zolendronic acid joħroġx mal- ħalib tas- sider tal- mara.
Zometa is contraindicated in breast-feeding women (see section 4.3).
Zometa huwa kontra - indikat f’ nisa li qed ireddgħu (ara sezzjoni 4. 3).
4.7 Effects on ability to drive and use machines
5 4. 7 Effetti fuq il- ħila biex issuq jew tħaddem magni
Frequencies of adverse reactions for Zometa 4 mg are mainly based on data collection from chronic treatment.
Il- frekwenza ta ’ reazzjonijiet avversi għal Zometa 4 mg huma bbażati l- aktar fuq tagħrif miġbur minn fuq pazjenti fuq kura kronika.
Intravenous administration has been most
Ir- reazzjonijiet avversi għal Zometa jixbħu lil dawk irrapportati għal bisphosphonates oħra u huma mistennija li jidhru f’ bejn wieħed u ieħor terż tal- pazjenti.
5 commonly associated with a flu-like syndrome in about 9% of patients, including bone pain (9.1%), fever (7.2%), fatigue (4.1%) and rigors (2.9%).
L- għoti ġol - vini ġie assoċjat l- aktar ma ’ sintomi bħal ta ’ l- influwenza f’ 9% tal- pazjenti, u jinkludu uġigħ fl - għadam (9. 1%), deni (7. 2%), għejja (4. 1%) u tertir (2. 9%).
Occasionally cases of arthralgia and myalgia in approximately 3% have been reported.
Kultant ġew irrapportati każijiet ta ’ uġigħ fil- ġogi u fil- muskoli f’ bejn wieħed u ieħor 3%.
No information is available on the reversibility of these adverse effects.
M’ hemm l- ebda informazzjoni dwar ir- riversibiltà ta ’ dawn l- effetti.
Frequently, the reduction in renal calcium excretion is accompanied by a fall in serum phosphate levels (in approximately 20% of patients), which is asymptomatic not requiring treatment.
Ta ’ spiss, it- tnaqqis fl- eskrezzjoni ta ’ calcium mill- kliewi tkun assoċjata ma ’ inżul fil- livell ta ’ phosphate fis- serum (f’ madwar 20% tal- pazjenti) fejn ma jidhrux sintomi u allura m’ għandux għalfejn jiġi kkurat.