Pamidronate disodium 90mg/6ml solution for infusion ampoules

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Pamidronate disodium

Available from:

Wockhardt UK Ltd

ATC code:

M05BA03

INN (International Name):

Pamidronate disodium

Dosage:

15mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 06060200; GTIN: 5012727904511

Patient Information leaflet

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Wockhardt UK Limited
DISODIUM PAMIDRONATE CONCENTRATE FOR SOLUTION FOR INFUSION
104228/5
See uploaded pdf
210 x 420mm
MPI
4
19/12/2017
914495
n/a
5pt (Main Body) / 6pt (Variables)
UK
English
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Disodium pamidronate 15mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSTION
1ml of concentrate contains 15mg disodium pamidronate.
One ampoule of 1ml contains 15mg disodium pamidronate.
One ampoule of 2ml contains 30mg disodium pamidronate.
One ampoule of 4ml contains 60mg disodium pamidronate.
One ampoule of 6ml contains 90mg disodium pamidronate.
Excipient: Sodium.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Colourless solution, free from particles.
4.
CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Treatment of conditions associated with increased osteoclast activity:
•
Tumour-induced hypercalcaemia
•
Osteolytic lesions and bone pain in patients with bone metastases
associated with
breast cancer or multiple myeloma
•
Paget’s disease of bone.
4.2. POSOLOGY AND METHOD OF ADMINISTRATION
Disodium pamidronate concentrate must never be given as a bolus
injection (see
“Warnings”). The concentrate of disodium pamidronate concentrate
in ampoules should be
diluted in a calcium-free infusion solution (0.9 % Sodium Chloride
Intravenous Infusion B.P. is
recommended) and i

Summary of Product characteristics

OBJECT 1
DISODIUM PAMIDRONATE 15MG/ML CONCENTRATE FOR
SOLUTION FOR INFUSION (90MG STRENGTH)
Summary of Product Characteristics Updated 23-Jan-2018 | Wockhardt UK
Ltd
1. Name of the medicinal product
Disodium Pamidronate 15mg/ml Concentrate for Solution for Infusion
2. Qualitative and quantitative composition
1ml of concentrate contains 15mg disodium pamidronate. One ampoule of
6ml contains 90mg of
disodium pamidronate.
Excipient with known effect
Sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion
Colourless solution, free from particles.
4. Clinical particulars
4.1 Therapeutic indications
Treatment of conditions associated with increased osteoclast activity:
• Tumour-induced hypercalcaemia
• Osteolytic lesions and bone pain in patients with bone metastases
associated with breast cancer or
multiple myeloma
• Paget's disease of bone.
4.2 Posology and method of administration
Disodium pamidronate concentrate must never be given as a bolus
injection (see "Warnings"). The
concentrate of disodium pamidronate concentrate in ampoules should be
diluted in a calcium-free
infusion solution (0.9 % Sodium Chloride Intravenous Infusion B.P. is
recommended) and infused
slowly.
The infusion rate should never exceed 60mg/hour (1mg/min), and the
concentration of disodium
pamidronate concentrate in the infusion solution should not exceed
90mg /250ml. A dose of 90mg should
normally be administered as a 2-hour infusion in 250mL infusion
solution. However, in patients with
multiple myeloma and in patients with tumour-induced hypercalcaemia,
it is recommended not to exceed
90mg in 500mL over 4 hours.
In patients with established or suspected renal impairment (e.g. those
with tumour-induced
hypercalcaemia or multiple myeloma) it is recommended that the
infusion rate does not exceed 20mg/h
(see also "Renal Impairment"). In order to minimise local reactions at
the infusion site, the cannula should
be inserted carefully into a relatively large vein.
Until further exp