Pamidronate disodium 90mg/10ml solution for infusion vials

Valsts: Lielbritānija

Valoda: angļu

Klimata pārmaiņas: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktīvā sastāvdaļa:

Pamidronate disodium

Pieejams no:

Pfizer Ltd

ATĶ kods:

M05BA03

SNN (starptautisko nepatentēto nosaukumu):

Pamidronate disodium

Deva:

9mg/1ml

Zāļu forma:

Solution for infusion

Ievadīšanas:

Intravenous

Klase:

No Controlled Drug Status

Receptes veids:

Valid as a prescribable product

Produktu pārskats:

BNF: 06060200; GTIN: 5015997494713

Lietošanas instrukcija

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PACKAGE LEAFLET: INFORMATION FOR THE USER
PAMIDRONATE DISODIUM 3 MG/ML, 6 MG/ML AND 9 MG/ML STERILE CONCENTRATE
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 any further questions, ask your doctor or pharmacist.
•
If you get any side effects, talk to your doctor or pharmacist. This
includes any
possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
:
1.
What pamidronate disodium is and what it is used for
2.
What you need to know before you use pamidronate disodium
3.
How to use pamidronate disodium
4.
Possible side effects
5.
How to store pamidronate disodium
6.
Contents of the pack and other information
1.
WHAT PAMIDRONATE DISODIUM IS AND WHAT IT IS USED FOR
Pamidronate disodium is member of the group of medicines called
bisphosphonates. It
is useful in medicine because pamidronate disodium binds to bone and
reduces bone
loss.
This medicinal product may be used in the treatment of a number of
disorders
associated with bone disease. For example, it is used to help reduce
the amount of
calcium in the blood and/or reduce bone loss which may occur in
certain types of
cancer.
Pamidronate disodium is used to treat patients with specific tumours
such as bone
metastases (secondaries) associated with breast cancer or multiple
myeloma which is
a type of bone marrow cancer. It can also be used in the prevention of
skeletal-related
events with a history of bone metastases which can lead to bone pain,
radiation or
surgery
to
the
bone,
spinal
cord
compression,
pathological
fractures
and
hypercalcaemia (high level of calcium in the blood). In addition, it
can also be used
to treat a bone disorder called ‘Paget's disease of bone’.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE PAMIDRONATE
DISODIUM
DO NOT USE PAMIDRONATE DISODIUM:
•
If you are allergic to pamidronate disodium, medicines of the same
group
(bisphosphonates) or any of the o

Produkta apraksts

OBJECT 1
PAMIDRONATE DISODIUM 9 MG/ML STERILE
CONCENTRATE
Summary of Product Characteristics Updated 21-Jun-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Pamidronate Disodium 9 mg/ml Sterile Concentrate
2. Qualitative and quantitative composition
Each ml of concentrate for solution for infusion contains 9 mg
pamidronate disodium.
1 vial of 10 ml of sterile concentrate contains 90 mg of pamidronate
disodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion.
4. Clinical particulars
4.1 Therapeutic indications
The treatment of tumour-induced hypercalcaemia
The prevention of skeletal related events (pathological fractures,
spinal compression, radiation or surgery
to bone, hypercalcaemia and bone pain) in patients with breast cancer
with bone metastases, or multiple
myeloma with bone lesions, in addition to specific treatment of the
tumour
Paget's disease of bone
4.2 Posology and method of administration
Patients treated with pamidronate disodium should be given the package
leaflet and the patient reminder
card.
For intravenous use as infusion only.
Pamidronate disodium must never be given as a bolus injection (see
“Warnings”). The solution must be
diluted before use (see below) and must be infused slowly.
For information concerning compatibility with infusion solutions, see
section 6.2.
The infusion rate should never exceed 60 mg/hour (1 mg/min), and the
concentration of pamidronate
disodium in the infusion solution should not exceed 90 mg/250 ml. 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 22 mg/hour (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. A single dose of 90 mg should normally be administered as
a 2 hour infusion in 250 ml of
infusion solution. However in patients with established