Disodium Pamidronate 15mg/ml Concentrate for Solution for Infusion, 6ml

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

Pamidronic acid

Available from:

Pinewood Laboratories Ltd,

ATC code:

M05BA; M05BA03

INN (International Name):

Pamidronic acid

Dosage:

15 milligram(s)/millilitre

Pharmaceutical form:

Concentrate for solution for infusion

Therapeutic area:

Bisphosphonates; pamidronic acid

Authorization status:

Not marketed

Authorization date:

2005-08-26

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION FOR THE USER
DISODIUM PAMIDRONATE 15MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
- Keep this leaflet. You may need to read it again.
- If you have further questions, please ask your doctor or nurse.
- This medicine has been prescribed for you only. Do not pass it on to
others. It may harm
them, even if their signs of illness are the same as yours.
- If you get any side effects, talk to your doctor or nurse. This
includes any possible side
effects not listed in this leaflet. See section 4.
The name of your medicine is Disodium Pamidronate 15mg/ml Concentrate
for Solution for
Infusion. In the rest of this leaflet it is called Disodium
Pamidronate.
WHAT IS IN THIS LEAFLET:
1. What Disodium Pamidronate is and what it is used for
2. What you need to know before you are given Disodium Pamidronate
3. How Disodium Pamidronate should be given
4. Possible side effects
5. How to store Disodium Pamidronate
6. Contents of the pack and other information
1. WHAT DISODIUM PAMIDRONATE IS AND WHAT IT IS USED FOR
The active ingredient is called Disodium Pamidronate.
Disodium pamidronate belongs to a group of medicines called
bisphosphonates, which
prevent bones from weakening and breaking.
Disodium Pamidronate is used to treat:
• high blood calcium levels (hypercalcaemia) due to tumours
• holes in the bone and bone pain due to the spread of breast cancer
or bone marrow cancer
(myeloma)
• Paget’s disease of the bone (a chronic bone disorder)
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DISODIUM PAMIDRONATE
YOU SHOULD NOT BE GIVEN DISODIUM PAMIDRONATE:
• if you are allergic to Disodium Pamidronate, any other
bisphosphonate, or any of the other
ingredients of this medicine (listed in section 6.)
• if you are pregnant
• if you are breast feeding
WARNINGS AND PRECAUTIONS
TALK TO YOUR DOCTOR OR NURSE BEFORE BEING GIVEN DISODIUM PAMIDRONATE
IF YOU:
• are receiving dental tr

Summary of Product characteristics

Health Products Regulatory Authority
04 January 2021
CRN009YTH
Page 1 of 11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Disodium Pamidronate 15mg/ml Concentrate for Solution for Infusion,
6ml
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:
Each 6 ml ampoule contains 36 mg 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
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