Zometa Concentrate for Solution for Infusion 4 mg5 ml

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Zoledronic acid anhydrous

Available from:

SCIGEN PTE. LTD.

ATC code:

M05BA08

Dosage:

4 mg

Pharmaceutical form:

INJECTION, SOLUTION, CONCENTRATE

Composition:

Zoledronic acid anhydrous 4.0mg/5ml

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Novartis Pharma Stein AG

Authorization status:

ACTIVE

Authorization date:

2005-02-18

Patient Information leaflet

ZOMETA


4 mg/5 mL concentrate for solution for infusion 
4 mg/100ml solution for infusion 
Bisphosphonate 
DESCRIPTION AND COMPOSITION  
PHARMACEUTICAL FORMS 
Concentrate for solution for infusion. 
Solution for infusion. 
The solution is sterile, clear and colorless. 
ACTIVE SUBSTANCE 
One vial with 5 mL concentrate contains 4 mg zoledronic acid (anhydrous), corresponding to 
4.264 mg zoledronic acid monohydrate. 
One bottle with 100 ml solution contains 4 mg zoledronic acid (anhydrous), corresponding to 
4.264 mg zoledronic acid monohydrate. 
ACTIVE MOIETY 
Zoledronic acid (anhydrous) 
EXCIPIENTS 
Mannitol, sodium citrate, water for injection 
Pharmaceutical formulations may vary between countries.

INDICATIONS


  Treatment  of  osteolytic,  osteoblastic,  and  mixed  bone  metastases  of  solid  tumours  and 
osteolytic  lesions  of  multiple  myeloma,  in  conjunction  with  standard  antineoplastic 
therapy. 

  Treatment of hypercalcaemia of malignancy (HCM). 
DOSAGE AND ADMINISTRATION 
THE  ZOMETA  4  MG/5  ML  CONCENTRATE  should  be  further  diluted  with  100  mL  0.9%  w/v 
sodium  chloride  or  5%  w/v  glucose  solution  before  infusion  (see  section  INSTRUCTIONS 
FOR USE AND HANDLING). The final Zometa solution for infusion, should be given as an 
intravenous infusion of no less than 15 minutes. 
THE ZOMETA 4 MG/100  ML SOLUTION FOR INFUSION is a “ready to use” presentation and must 
not  be  further  diluted  or  mixed  with  other  infusion  solutions  except  for  patients  with  renal 

impairment. It should be administered as a single intravenous solution in a separate infusion 
line in no less than 15 minutes. 
TREATMENT OF BONE METASTASES AND TREATMENT OF
OSTEOLYTIC LESIONS, IN 
CONJUNCTION WITH STANDA

Summary of Product characteristics

1 of 2
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Production Site:
Switzerland, PharmOps Steriles, Stein
WO:
1896384
ACC:
Khan, Mohammed Haroon
Comp. Description:
Leaflet ZOMETA LIVI SG
Printing Colours:
Black
Comp. No. New:
2229383 SG
Comp. No. Old:
N/A
Format/Dimension:
880 x 297 mm
Tech. Drawing No.:
80349193_4
Technical Colours:
Cutting
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Min. Font Size Text:
10 pt
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Proof No.:
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22 May 2020
J.N.: 550312
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ZOMETA
®
4 mg/5 mL concentrate for solution for infusion
4 mg/100ml solution for infusion
Bisphosphonate
DESCRIPTION AND COMPOSITION
PHARMACEUTICAL FORMS
Concentrate for solution for infusion.
Solution for infusion.
The solution is sterile, clear and colorless.
ACTIVE SUBSTANCE
Zoledronic acid (anhydrous)
CONCENTRATE FOR SOLUTION FOR INFUSION: One vial with 5 mL concentrate
contains 4 mg zoledronic acid (anhydrous), corresponding to 4.264 mg
zoledronic
acid monohydrate.
SOLUTION FOR INFUSION: One bottle with 100 ml solution contains 4 mg
zoledronic
acid (anhydrous), corresponding to 4.264 mg zoledronic acid
monohydrate.
EXCIPIENTS
Mannitol, sodium citrate, water for injection
Pharmaceutical formulations may vary between countries.
INDICATIONS
•
Treatment of osteolytic, osteoblastic, and mixed bone metastases of
solid
tumours and osteolytic lesions of multiple myeloma, in conjunction
with
standard antineoplastic therapy.
•
Treatment of hypercalcemia of malignancy (HCM).
DOSAGE REGIMEN AND ADMINISTRATION
THE ZOMETA 4 MG/5 ML CONCENTRATE FOR SOLUTION FOR INFUSION should be
further diluted with 100 mL 0.9% w/v sodium chloride or 5% w/v glucose
solution
before infusion (see section INSTRUCTIONS FOR USE AND HANDLING). The
final
Zometa solution for infusion, should be given as an intravenous
infusion of no less
than 15 minutes.
THE ZOMETA 4 MG/100 ML SOLUTION FOR INFUSION is a “ready to use”
presentation
and must not be further diluted or mixed with other infusion solutions
except for
patients with renal impa