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1. Pamidronate Disodium 3mg/Ml Sterile Concentrate
2. Pamidronate Disodium 3mg/Ml Sterile Concentrate

PACKAGE LEAFLET: INFORMATION FOR THE USER

Pamidronate Disodium

3 mg/ml, 6 mg/ml and 9 mg/ml Sterile Concentrate

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.

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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.

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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.

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