Pamisol ™

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Pamidronic acid 7.58 mg/mL equivalent to 9 mg/ml pamidronate disodium

Available from:

Pfizer New Zealand Limited

INN (International Name):

Pamidronic acid 7.58 mg/mL (equivalent to 9 mg/ml pamidronate disodium)

Dosage:

9 mg/mL

Pharmaceutical form:

Concentrate for injection

Composition:

Active: Pamidronic acid 7.58 mg/mL equivalent to 9 mg/ml pamidronate disodium Excipient: Mannitol Phosphoric acid Sodium hydroxide Water for injection

Units in package:

Vial, glass, single dose, Clear,Type1,Rubb clos,Al cap, 10mL vial, 10 mL

Class:

Prescription

Prescription type:

Prescription

Manufactured by:

Hospira Boulder Inc

Therapeutic indications:

Treatment of conditions associated with increased osteoclast activity: · Predominately lytic bone metastases from breast cancer and advanced multiple myeloma · Acute management of tumour induced hypercalcaemia (hypercalcaemia of malignancy) · Treatment of symptomatic Paget's disease of the bone.

Product summary:

Package - Contents - Shelf Life: Vial, glass, single dose, Clear,Type1,Rubb clos,Al cap, 10mL vial - 10 mL - 24 months from date of manufacture stored at or below 25°C 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

Authorization date:

2000-03-17

Summary of Product characteristics

Version hhdpamii10520
Superceded: Version 6.0
Page 1 of 18
NEW ZEALAND DATA SHEET
1. PRODUCT NAME
Pamisol
TM
Concentrate for injection.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pamisol are available in 3 mg/mL, 6 mg/mL and 9 mg/mL strengths.
For the full list of excipients, see section 6.1 List of excipients.
3. PHARMACEUTICAL FORM
Concentrate for injection.
Pamisol is a clear, colourless, sterile solution. The pH of the
solution is approximately 6.5.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of conditions associated with increased osteoclast activity:
•
Predominantly lytic bone metastases from breast cancer and advanced
multiple myeloma
•
Acute management of tumour induced hypercalcaemia (hypercalcaemia of
malignancy)
•
Treatment of symptomatic Paget's disease of bone.
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSE
PREDOMINANTLY LYTIC BONE METASTASES FROM BREAST CANCER AND ADVANCED
MULTIPLE MYELOMA
The
recommended
dose
of
pamidronate
for
the
treatment
of
predominantly
lytic
bone
metastases from breast cancer and advanced multiple myeloma is 90 mg
administered as a
single infusion every 4 weeks.
In patients with bone metastases who receive chemotherapy at 3-weekly
intervals, Pamisol
90 mg may also be given on a 3-weekly schedule.
The infusion rate should not exceed 60 mg/hour (1 mg/min), and the
concentration of
pamidronate in the infusion solution should not exceed 90 mg/250 mL.
In breast cancer patients,
a dose of 90 mg should normally be administered as a 2-hour infusion
in 250 mL infusion
solution. However, in patients with multiple myeloma, it is
recommended not to exceed 90 mg
in 500 mL administered over 4 hours.
TUMOUR INDUCED HYPERCALCAEMIA
Rehydration with sodium chloride 0.9% before or during treatment is
necessary.
Version hhdpamii10520
Superceded: Version 6.0
Page 2 of 18
INITIAL TREATMENT:
The total dose for a treatment course can be given as a single
infusion. It can
also be divided into 2 or 3 consecutive daily doses. The infusion rate
should not exceed
60 mg/hour (1 mg/min