AFT-Pamidronate
Country: New Zealand
Language: English
Source: Medsafe (Medicines Safety Authority)
Summary of Product characteristics
(SPC)
13-12-2007
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Active ingredient:
Pamidronic acid 26mg equivalent to 30.9 mg pamidronic acid disodium
Available from:
AFT Pharmaceuticals Ltd
INN (International Name):
Pamidronic acid 26 mg (equivalent to 30.9 mg pamidronic acid disodium)
Dosage:
30 mg
Pharmaceutical form:
Powder for injection
Composition:
Active: Pamidronic acid 26mg equivalent to 30.9 mg pamidronic acid disodium Excipient: Mannitol Phosphoric acid Sodium hydroxide
Units in package:
Vial, glass, Type I clear 15 mL vial, bromobutyl stopper/Al seal/plastic cover, 1 dose unit
Class:
Prescription
Prescription type:
Prescription
Manufactured by:
Ofichem BV
Product summary:
Package - Contents - Shelf Life: Vial, glass, Type I clear 15 mL vial, bromobutyl stopper/Al seal/plastic cover - 1 dose units - 24 months from date of manufacture stored at or below 25°C
Authorization date:
2005-04-08
Summary of Product characteristics
AFT-PAMIDRONATE
_PAMIDRONATE DISODIUM POWDER FOR INTRAVENOUS INFUSION 30MG, 60MG AND 90MG _
PRESENTATION
AFT-Pamidronate 30 mg is a white to practically white lyophilised powder which
when reconstituted with 10mL water for injection results in a clear, colourless solution
containing 3 mg/mL Pamidronate disodium.
AFT-Pamidronate 60 mg is a white to practically white lyophilised powder which
when reconstituted with 10mL water for injection results in a clear, colourless solution
containing 6 mg/mL Pamidronate disodium.
AFT-Pamidronate 90 mg is a white to practically white lyophilised powder which
when reconstituted with 10mL water for injection results in a clear, colourless solution
containing 9 mg/mL Pamidronate disodium.
USES
_ACTIONS _
Pamidronate disodium, the active substance of AFT-Pamidronate, is a potent
inhibitor of osteoclastic bone resorption. It binds strongly to hydroxyapatite crystals
and inhibits the formation and dissolution of these crystals _in vitro_. Inhibition of
osteoclastic bone resorption _in vivo _may be at least partly due to binding of the drug
to the bone mineral.
Pamidronate suppresses the accession of osteoclast precursors onto the bone and
their subsequent transformation into the mature, resorbing osteoclasts. However, the
local and direct antiresorptive effect of bone-bound bisphosphonate appears to be
the predominant mode of action _in vitro_ and _in vivo_.
Experimental studies have demonstrated that pamidronate inhibits tumour-induced
osteolysis when given prior to or at the time of inoculation or transplantation with
tumour cells. Biochemical changes reflecting the inhibitory effect of AFT-Pamidronate
on tumour-induced hypercalcaemia, are characterised by a decrease in serum
calcium and phosphate and s
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