Pamidronate BNM

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pamidronic acid 50.54mg equivalent to 60 mg disodium pamidronate

Available from:

Boucher & Muir (New Zealand) Limited t/a BNM Group

INN (International Name):

Pamidronic acid 50.54 mg (equivalent to 60 mg disodium pamidronate)

Dosage:

60 mg/10mL

Pharmaceutical form:

Solution for infusion

Composition:

Active: Pamidronic acid 50.54mg equivalent to 60 mg disodium pamidronate Excipient: Mannitol Phosphoric acid Sodium hydroxide Water for injection

Units in package:

Vial, single dose, type I glass with Bromobutyl rubber stopper, 1x 10ml, 10 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Orchid Chemicals and Pharmaceuticals Limited

Therapeutic indications:

Treatment of conditions associated with increased osteoclast activity: · Predominantly lytic bone metastases from breast cancer and advanced multiple myeloma

Product summary:

Package - Contents - Shelf Life: Vial, single dose, type I glass with Bromobutyl rubber stopper, 1x 10ml - 10 mL - 24 months from date of manufacture stored at or below 25°C 8 hours diluted stored at or below 25°C. Shelf life includes infusion time

Authorization date:

2011-08-18

Patient Information leaflet

1 

PAMIDRONATE BNM

31052012

New Zealand Consumer Medicine Information 

PAMIDRONATE BNM 

_DISODIUM PAMIDRONATE  _

Solution for infusion 
15 mg/5 mL, 30 mg/10 mL, 60 mg/10 mL and 90 mg/10 mL 

WHAT IS IN THIS LEAFLET 

Please read this leaflet carefully before you
start using Pamidronate BNM. 

This leaflet answers some common questions about Pamidronate
BNM. It does not 
contain all the available information. The
most up-to-date  Consumer Medicine 
Information can be downloaded from www.medsafe.govt.nz. 

Reading this leaflet does not take the place of talking to
your doctor or pharmacist.  

All medicines have risks and
benefits. Your doctor has weighed the risks of you using 
Pamidronate BNM against the benefits this medicine
is expected to have for you.  

IF YOU HAVE  ANY CONCERNS ABOUT USING THIS MEDICINE, ASK
YOUR DOCTOR OR 
PHARMACIST.  

KEEP THIS LEAFLET WITH THE MEDICINE.  
You may want to read it again. 

WHAT PAMIDRONATE BNM IS USED FOR 

Pamidronate
BNM  contains disodium pamidronate, which  belongs to a group of 
medicines called bisphosphonates. It works by  slowing down the
rate of bone change 
and helps restore the amount of calcium in the blood
to normal.   

Pamidronate BNM is used in conditions with increased bone
changes or pain, including 
Paget’s disease, advanced cancer of the bone marrow (called
multiple myeloma) and 
advanced breast cancer where the cancer has spread to the
bone. 

Pamidronate BNM can also be used when the amount of calcium in
the blood becomes 
too high, as may happen in some forms of cancer. Some
cancers can speed up normal 
changes in bone so that the amount of calcium released from the bones into the blood is 
increased.  
Your doctor may have prescribed this medicine
for another reason. 
ASK YOUR DOC

Summary of Product characteristics

1 

PAMIDRONATE BNM

31052012

New Zealand Data Sheet 

PAMIDRONATE BNM

Disodium pamidronate 15 mg/5 mL, 30 mg/10 mL, 60 mg/10 mL
and 90 mg/10 mL  

Solution for infusion 

PRESENTATION(S) 

Pamidronate BNM solution for infusion is a
clear, colourless, sterile solution of disodium 
pamidronate, mannitol, phosphoric acid and sodium hydroxide
in water for injection. 
Phosphoric acid is added to adjust the pH to 6.4-6.8. 

The vials are uncoloured, type I glass vial with
bromobutyl rubber stopper and flip-off cap. 

INDICATIONS 

Treatment of conditions associated with increased
osteoclast activity: 
•  Predominantly lytic bone
metastases from breast cancer and  advanced  multiple 
myeloma 
•  Tumour-induced hypercalcaemia.  Acute
management of tumour-induced 
hypercalcaemia (Hypercalcaemia of malignancy). 

Paget's disease
of bone. Treatment of symptomatic Paget’s disease of bone. 

DOSAGE AND ADMINISTRATION 

Pamidronate BNM must never be given as a bolus injection since
severe local reactions 
and thrombophlebitis may occur as a result of high
local concentrations.  

Pamidronate BNM  should always be diluted and administered
by slow intravenous 
infusion in sodium chloride 0.9% or dextrose 5%.  

Do not co-administer with
other bisphosphonates. If other calcium lowering agents are 
used in conjunction with pamidronate, significant hypocalcaemia
may result.  

Pamidronate BNM should not be
added to intravenous infusion fluids containing calcium. 

In order to minimise local reactions at the infusion site, the
cannula should be inserted 
carefully into a relatively large vein.  

_ _
2 

PAMIDRONATE BNM

31052012

_Dosage regimen _
Due to the risk of clinically significant deterioration in
renal function which may progress to 
renal failure, single doses of