Skip to Content

PAMIDRONATE DISODIUM 3MG/ML STERILE CONCENTRATE

Active substance(s): PAMIDRONIC ACID

View full screen / Print PDF » Download PDF ⇩
Transcript
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.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even if their symptoms are the same
as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor or
pharmacist
In this leaflet:
1. What pamidronate disodium is and what it is used for
2. Before you use pamidronate disodium
3. How to use pamidronate disodium
4. Possible side effects
5. How to store pamidronate disodium
6. Further 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. BEFORE YOU USE PAMIDRONATE DISODIUM
Do not use pamidronate disodium if:
• you have shown signs of hypersensitivity (severe allergy) to pamidronate
disodium, medicines of the same group (bisphosphonates) or any of the
other ingredients of this medicine (see section 6) in the past.
Tell your doctor if the above applies to you before this medicine is used.

Take special care with pamidronate disodium and speak to your
doctor first if:






you have kidney problems
you have heart problems
you have liver problems
you have had thyroid surgery
you have been told you have, or think you may have, low levels of red
blood cells (anaemia), white blood cells or platelets. Your doctor may do
tests to check for these problems
• you have dental problems or are planning to have dental surgery
If you are under dental treatment or will undergo dental surgery, tell your
doctor before starting pamidronate disodium treatment. Remedial dental
work should be carried out before starting this treatment.
Before this medicine is given to you, tell your doctor if any of the above
applies to you or if you are unsure.
The use of pamidronate disodium in children is not recommended.

Going for a scan?
If you are asked to have a bone scan, tell the doctor doing the scan that you
are being treated with pamidronate disodium.

Taking/using other medicines
Special care is needed if you are taking/using other medicines as some
could interact with pamidronate disodium, particularly those medicines that
contain a bisphosphonate (the group of substances pamidronate disodium
belongs to).
This medicine should not be used with other bisphosphonate medicines,
e.g. zoledronic acid (used to treat osteoporosis and Paget’s disease),
tiludronic acid (used to treat Paget’s disease), or disodium etidronate
(used to treat bone metastases associated with breast cancer or multiple
myeloma).
Please tell your doctor if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or
breast-feeding. If you are pregnant, your doctor will only use this
medicine if your life is in danger and no alternative treatment is available.
Breast-feeding is not recommended if you are receiving treatment with
pamidronate disodium.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
Do not drive or use machines if you have blurred or poor vision, or if you
experience any other side effect (e.g. drowsiness, dizziness, confusion)
which may lessen your ability to do so. If you have pamidronate as an
outpatient at a hospital/clinic you should not drive yourself home.

Important information about one of the ingredients of pamidronate
disodium
Pamidronate disodium contains less than 1 mmol sodium (23 mg) per
maximum dose (90 mg), i.e. it is essentially “sodium-free”.

3. HOW TO USE PAMIDRONATE DISODIUM
This medicine is diluted and then given by infusion (drip) into a vein. The
infusion will last from one to several hours depending on the dose.

Dose
Your doctor will work out the correct dose of pamidronate disodium for you
and how often it must be given.
The usual dose for each infusion is between 15 and 90 mg.
During treatment you will have blood tests and may be asked to provide
urine samples.

If you are given too much or too little pamidronate disodium
This medicine will be given to you by a doctor or nurse. It is unlikely that you
will be given too much or too little, however, tell your doctor or nurse if you
have any concerns.

4. POSSIBLE SIDE EFFECTS
Like all medicines, pamidronate disodium can cause side effects, although
not everybody gets them.

If the following very rare but serious reaction happens, tell your
doctor immediately:
• severe allergic reaction - you may experience a sudden itchy rash
(hives), swelling of the hands, feet, ankles, face, lips, mouth or throat
(which may cause difficulty in swallowing or breathing), and you may feel
you are going to faint
You may need urgent medical attention or hospitalisation.
Tell your doctor immediately if you notice or are worried by any of the known
side effects listed below. These unwanted side effects occur at the following
frequencies:

Pamidronate Disodium
3 mg/ml, 6 mg/ml and 9 mg/ml
Sterile Concentrate
The following information is intended for medical or healthcare
professionals only
Further to the information included in section 3, practical information on the
preparation/handling of the medicinal product is provided here.

Incompatibilities
Pamidronate will form complexes with divalent cations and should not be added
to calcium-containing intravenous solutions such as Ringer’s solution.

Instructions for use and handling
Must be diluted prior to administration.
H03612
434736

Very common side effects (occur in more than 1 person in 10)
The most common effects are flu-like symptoms and a mild fever (increase
in body temperature which may last for 48 hours) which occur at the start of
treatment.
Decrease in the levels of calcium and phosphate in the blood.

Common side effects (occur in less than 1 person in 10)

























pain, redness or swelling at the injection site
tender or painful veins
joint or muscle pain, or generalised pain
temporary increase in bone pain
conjunctivitis
feeling or being sick
headache
decreased number of white blood cells (lymphocytopenia)
anaemia
reduced number of platelets in the blood (thrombocytopenia)
reduced level of potassium and magnesium in the blood
tingling sensation in hands and feet
numbness
sleeplessness
high blood pressure
diarrhoea
constipation
skin rash
increase in blood test values used to measure kidney function
muscle spasms
loss of appetite
stomach pain
drowsiness
generalised pain

Uncommon side effects (occur in less than 1 person in 100)















allergic reactions
oedema (excess retention of fluid in the body)
seizures (fits)
inflammation of the eye (uveitis, iritis)
itching
muscle cramps, indigestion
dizziness, agitation
tiredness
low blood pressure (symptoms may include light-headedness, fainting or
general weakness)
death of bone tissue (osteonecrosis)
renal failure
pain or inflammation of the jaw
difficulty in breathing and cough
changes in liver function which show up in blood tests

Rare side effects (occur in less than 1 person in 1,000)
• kidney problems

Unusual fracture of the thigh bone, particularly in patients on long-term
treatment for osteoporosis, may occur rarely. Contact your doctor if you
experience pain, weakness or discomfort in your thigh, hip or groin as this
may be an early indication of a possible fracture of the thigh bone.

Very rare side effects (occur in less than 1 person in 10,000)












flare up of cold sores or shingles (reactivation of Herpes virus)
decreased number of white blood cells (leukopenia)
increase in levels of potassium and sodium in the blood
confusion
hallucinations (seeing things or hearing things that are not there)
problems with vision/eye pain (scleritis)
heart failure
respiratory problems
lung disease
kidney problems (usually in patients with previous kidney problems)
talk to your doctor if you have ear pain, discharge from the ear, and/or an
ear infection. These could be signs of bone damage in the ear

Side effects of unknown frequency
• redness around the eye area
• irregular heart rhythm (atrial fibrillation) has been seen in patients
receiving pamidronate. It is currently unclear whether pamidronate
causes this irregular heart rhythm. You should report to your doctor if you
experience irregular heart rhythm during treatment with pamidronate.
As pamidronate disodium may affect your blood (the number of particular
cells and the chemistry of the blood), your doctor will monitor for these side
effects with blood tests.
If any of the side effects gets serious, or if you notice any side effects
not listed in this leaflet, please tell your doctor.

5. HOW TO STORE PAMIDRONATE DISODIUM
Keep out of the reach and sight of children.

Expiry
This medicine must not be used after the expiry date which is stated on
the vial and carton after ‘EXP’. Where only a month and year is stated, the
expiry date refers to the last day of that month.

Storage
The vials should be kept in the outer carton, in order to protect from light,
and stored at, or below, 25°C.
Unused portions of opened vials must not be stored for later use.
Prepared injections or infusions should be used immediately, however, if this
is not possible they can be stored for up to 24 hours at 2-8°C before use.

Visible signs of deterioration
The solutions should only be used if they are free from visible particles.

Disposal
Medicines should not be disposed of via wastewater or household waste.
Ask your pharmacist how to dispose of medicines no longer required. These
measures will help to protect the environment.

6. FURTHER INFORMATION
What pamidronate disodium contains
The active substance is pamidronate disodium. Each millilitre (ml) of
solution contains either 3, 6 or 9 milligrams (mg) of pamidronate disodium.
The other ingredients are mannitol, phosphoric acid, sodium hydroxide and
Water for Injections.

What pamidronate disodium looks like and contents of the pack
Pamidronate disodium is a clear, colourless concentrate for solution for
infusion which comes in glass containers called vials.
It may be supplied in packs containing:
• 5 x 15 mg/5 ml vials
• 1 x 30 mg/10 ml vial
• 1 x 60 mg/10 ml vial
• 1 x 90 mg/10 ml vial
Not all packs may be marketed.

Marketing authorisation holder and manufacturer responsible for
batch release in Europe
Hospira UK Limited, Horizon, Honey lane, Hurley, Maidenhead, SL6 6RJ, UK

Manufacturer
Hospira Australia Pty Ltd,
1-5, 7-23 and 25-39 Lexia Place,
MULGRAVE VIC 3170,
Australia
This leaflet was last revised in November 2015.

The concentration of pamidronate disodium in the infusion solution should not
exceed 90 mg/250 ml.
Do not use solution if particles are present.
Any portion of the contents remaining after use should be discarded.

In use storage precautions
Following dilution in 0.9% sodium chloride and 5% glucose infusion solutions,
chemical and physical in-use stability has been demonstrated for 24 hours at
temperatures not exceeding 25°C.
From a microbiological point of view, the product should be used immediately.
If not used immediately, in-use storage times and conditions prior to use are
the responsibility of the user and would normally not be longer than 24 hours
at 2-8°C, unless dilution has taken place in controlled and validated aseptic
conditions.

H03612
434736

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide