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PAMIDRONATE DISODIUM 9 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): PAMIDRONATE DISODIUM PENTAHYDRATE

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PIL Size 160 x 480 mm

PACKAGE LEAFLET: INFORMATION FOR THE USER

PAMIDRONATE DISODIUM 3 mg/ ml, 6 mg/ ml & 9 mg/ ml
CONCENTRATE FOR SOLUTION FOR INFUSION )

Pamidronate 3/6/9 mg - PIL (all)

(Pamidronate disodium)
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.

Like all medicines, pamidronate can cause side effects, although not everybody gets them.
If any of the following happen, tell the 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.

The most common effects are flu-like symptoms and a mild fever (increase in body temperature) which occurs
at the start of treatment and may last for 48 hours.
Some patients notice an increase in bone pain soon after starting treatment. This usually improves after a few
days. If it does not, tell your doctor.
Other side effects:
Please tell your doctor if any of the following gets serious or lasts longer than a few days:
Very Common (affects more than 1 in 10 people)
Changes in blood test results (including low potassium, low phosphate, low magnesium and
raised serum creatinine levels or, very rarely, raised potassium or sodium levels).
Common (affects less than 1 in 10 people)
pain, redness or swelling at the injection site
joint muscle pain or generalised pain
nausea, vomiting, headache sleeplessness, tiredness
eye irritations
skin rash or unexplained bruising/increased bleeding
loss of appetite, stomach pain, gastritis, constipation or diarrhoea
tingling in hands and feet and muscle spasms (symptoms of low level of calcium)
high blood pressure
low level of white blood cells (leucopenia) or red blood cells (anaemia)

WHAT PAMIDRONATE IS AND WHAT IT IS USED FOR

The name of your medicine is Pamidronate Disodium 3 mg/ ml, 6 mg/ ml or 9 mg/ ml Concentrate For Solution
For Infusion which is to be given as a slow injection via a drip. Throughout the rest of the leaflet it will be
referred to as Pamidronate.
The active ingredient in Pamidronate is called pamidronate disodium. This is one of a group of medicines
called biphosphonates which can help to regulate the amount of calcium in the blood.
High blood calcium levels (hypercalcaemia) occur in a number of conditions, including some types of cancer.
Often, hypercalcaemia is caused by the release of calcium from bones. Pamidronate sticks to bones and helps
to reduce the release of calcium into the blood. If untreated, hypercalcaemia can cause symptoms such as
nausea, tiredness and confusion.

Uncommon (affects less than 1 in 100 people)
muscle cramps or spasms
dizziness, confusion, agitation, seizures
problems with vision, painful red eyes
low blood pressure
itching
indigestion
deterioration of kidney function (e.g. unexpected change in the amount of urine produced
and/or its appearance), abnormal liver function tests or increases in serum urea
problems with teeth or jaw

Pamidronate is used to treat high blood calcium levels caused by some cancers. In some patients with cancer,
it is also used to treat bone disease and to help relieve bone pain.
Pamidronate is also used to treat Paget’s disease.
2.

POSSIBLE SIDE EFFECTS

These are very serious side effects. You may need urgent medical attention. All of these very serious side
effects are rare.

In this leaflet:
1.
What Pamidronate is and what it is used for
2.
Before you use Pamidronate
3.
How to use Pamidronate
4.
Possible side effects
5.
How to store Pamidronate
6.
Further information
1.

4.

BEFORE YOU USE PAMIDRONATE

Do not use Pamidronate
- if you have shown signs of hypersensitivity (severe) allergy to Pamidronate on previous occasions
- if you are pregnant or breastfeeding

Rare (affects less than 1 in 1,000 people)
A change in kidney function known as glomerulosclerosis. Some of the symptoms of this condition may
be, fluid retention, nausea and fatigue. Tell your doctor if you suspect that you might have these
symptoms.
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.

Take special care with Pamidronate
- if you have kidney problems
- if you have heart problems
- if you have thyroid problems
- if you have low levels of blood cells (red blood cells, white blood cells or platelets)
- if you suffer from calcium or vitamin D deficiency
- if you are taking other similar medicines that reduce the levels of calcium
- if you had or have pain, swelling or numbness of the jaw or a “heavy jaw feeling” or loosening of a tooth
It is important to tell the doctor about any of your medical conditions, whether they are included in the above
lists or not. Please tell your doctor if you are taking, or have recently taken, any other medicines, including ones
that are not prescribed for you.
Please tell your doctor if you need to undergo an examination of your bones, as Pamidronate could interfere
with the examination.
If you go into hospital, let the medical staff know you are taking Pamidronate.

Very rare (affects less than 1 in 10,000 people)
cardiac effects which may include a difficulty in breathing and fluid retention
confusion or hallucinations (seeing things or hearing things that are not there)
worsening of an existing kidney problem e.g. blood in urine
flare up of cold sores or shingles
Pamidronate may affect your blood (the number of particular cells and the chemistry of the blood). Your doctor
will monitor for this with blood tests.

Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines
obtained without a prescription, especially, if you are using other drugs known as biphosphonates.

If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please
tell your doctor or pharmacist.

Pregnancy and breast-feeding

Pamidronate Injection (PIL)

Pregnancy
Pamidronate should not be used during pregnancy at any stage, unless you have life-threatening high amount
of calcium in the blood, which cannot be controlled by any other means.

Size: 160 x 479mm

5.

HOW TO STORE PAMIDRONATE

Keep out of the reach and sight of children.
This medicine should not be used after the expiry date which is stated on the vial label and carton after “EXP”.
The expiry date refers to the last day of that month.

If pregnancy occurs during treatment, contact your doctor for genetic counselling.

Your medication should not be stored above 25°C. The vials should be kept in the original package in order to
protect from light.

Women of childbearing potential
Women of child-bearing potential should use effective contraception during treatment and up to 3 months after
treatment.

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.

Breast feeding
Breast feeding must be discontinued before starting treatment with Pamidronate.

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.

Fertility
Men being treated with Pamidronate are advised not to father a child during and up to 3 months after treatment.
Ask your doctor or pharmacist for advice before taking any medicine.

6.

Driving and using machines
Do not drive or use machines:

if you feel drowsy or dizzy

if you experience any effect which may impair your ability to drive or use machines.

FURTHER INFORMATION

What Pamidronate contains
Each ml contains 3 mg or 6 mg or 9 mg of the active ingredient pamidronate disodium anhydrous.
The other ingredients are mannitol, phosphoric acid and water for injections.

Important Information about Pamidronate
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are being treated with
Pamidronate.

The 3mg/ml strength of Pamidronate contains 3.97mg/ml of pamidronate disodium pentahydrate, which is
equivalent to 3mg/ml of pamidronate disodium anhydrous
The 6mg/ml strength of Pamidronate contains 7.93mg/ml of pamidronate disodium pentahydrate, which is
equivalent to 6mg/ml of pamidronate disodium anhydrous

3. HOW PAMIDRONATE IS USED
Your doctor will have decided on the right dose depending on your condition.

The 9mg/ml strength of Pamidronate contains 11.90mg/ml of pamidronate disodium pentahydrate, which is
equivalent to 9mg/ml of pamidronate disodium anhydrous

A doctor or nurse will prepare the injection by diluting this solution with a special infusion fluid. The made-up
solution must be stored in a refrigerator and used within 24 hours.

This leaflet does not contain the complete information on Pamidronate. If you have any questions, or are not
sure about anything, ask your doctor or pharmacist.

Pamidronate is given by very slow injection into a vein (intravenous infusion). The infusion will take from one
to several hours depending on the dose. Your doctor will decide how many infusions you need and how often
they will be given

What Pamidronate looks like and contents of the pack

Dosage guidelines are as follows:

Pamidronate 3 mg/ ml or 6 mg/ ml or 9 mg/ ml is produced in 10 ml vials. They are available in single packs.

Pamidronate 3 mg/ ml or 6 mg/ ml or 9 mg/ ml is a clear colourless solution in glass vials with rubber stoppers
sealed with colour coded aluminium flip-off, tear-off seals.

For hypercalcaemia
15-90 mg given as a single or several infusions.
For bone diseases and bone pain
90 mg every 4 weeks. In some patients the dose may be given every 3 weeks at the same time as chemotherapy.
For Paget’s disease
180 mg given as either 30 mg once a week for 6 weeks, or 60 mg every other week for 6 weeks.

Marketing Authorisation Holder
APTIL Pharma Limited,
9th floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL.
Manufacturer:
APC Pharmaceuticals & Chemicals (Europe) Limited,
9th floor, CP House, 97-107 Uxbridge Road, Ealing, London W5 5TL.

Your doctor may also give you a test dose of 30 mg to see how you respond to the treatment.
What if you have had too much Pamidronate? (Overdose)
If you think you have either been given or have taken too much Pamidronate tell your doctor or nurse straight
away.
If you miss one of your appointments, please let your doctor or nurse know immediately.

XXXXX

What if you miss a dose of Pamidronate?

This leaflet was last amended 05/2012.

XXXXX

Your doctor may also have prescribed treatment with Calcium and Vitamin D at the same time as Pamidronate.

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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.

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