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Osate 4 mg/5 ml

concentrate for solution for infusion

Zoledronic acid

PACKAGE LEAFLET:

INFORMATION FOR THE PATIENT

Osate 4 mg/5 ml concentrate for solution for infusion

Zoledronic acid

Read all of this leaflet carefully before you are given 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 nurse.

•    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.

What is in this leaflet:

1.    What Osate is and what it is used for

2.    What you need to know before you are given Osate

3.    How to use Osate

4.    Possible side effects

5.    How to store Osate

6.    Contents of the pack and other information

1.    WHAT IS OSATE AND WHAT IS IT USED FOR

The active substance of Osate is zoledronic acid, which belongs to a group of substances called bisphosphonates. Zoledronic acid works by attaching itself to the bone and slowing down the rate of bone change. It is used:

•    To prevent bone complications, e.g. fractures, in adult patients with bone metastases (spread of cancer from primary site to the bone).

•    To reduce the amount of calcium

in the blood in adult patients where it is too high due to the presence of a tumour. Tumours can accelerate normal bone change in such a way that the release of calcium from bone is increa sed. This condition is known as tumour-induced hyper-calcaemia (TIH).

Osate will always be given to you by a doctor or a nurse as an infusion in a vein.

2.    WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN OSATE

Follow carefully all instructions given to you by your doctor.

Your doctor will carry out blood tests before you start treatment with Osate and will check your response to treatment at regular intervals.

You should not be given Osate:

•    if you are allergic to zoledronic acid, another bisphosphonate (the group of substances to which Osate belongs), or any of the other ingredients of this medicine (listed in section 6.1)

•    if you are breast-feeding. Warnings and precautions

Talk to your doctor or nurse before you are given Osate:

•    if you have or have had a kidney problem

•    if you have or have had pain, swelling or numbness of the

jaw, a feeling of heaviness in the jaw or loosening of a tooth

•    if you are having dental treatment or are due to undergo dental surgery, tell your dentist that you are being treated with Osate

•    if you have any pain in your thigh, hip or groin. It is also important that you tell your doctor if you experience this after starting treatment with Osate (see section 4).

Children and adolescents Osate is not recommended for use in children and adolescents below the age of 18 years.

Patients aged 65 years and over Osate can be given to people aged 65 years and over. There is no

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evidence to suggest that any extra precautions are needed.

Other medicines and Osate

Tell your doctor if you are taking or have recently taken any other medicines. It is especially important that you tell your doctor if you are also taking:

•    Aminoglycosides (medicines used to treat severe infections), since the combination of these with bisphosphonates may cause the calcium level in the blood to become too low

•    Thalidomide (a medicine used to treat a certain type of blood cancer involving the bone) or any other medicines which may harm your kidneys

•    Other medicines that also contains zoledronic acid and is used to treat osteoporosis and other non-cancer diseases of the bone, or any other bisphosphonate, since the combined effects of these medicines taken together with Osate are unknown

•    Anti-angiogenic medicines (used to treat cancer), since the combination of these with Osate has been associated with reports of osteonecrosis of the jaw (ONJ).

Pregnancy, breast-feeding and fertility

You should not be given Osate if you are pregnant. Tell your doctor if you are or think that you may be pregnant.

You must not be given Osate if you are breast-feeding.

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Driving and using machines

There have been very rare cases of drowsiness and sleepiness with the use of Osate. You should therefore be careful when driving, using machinery or performing other tasks that need full attention.

Important information about some of the ingredients in Osate

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially sodium-free.

3. HOW OSATE IS GIVEN

•    Osate must only be given by healthcare professionals trained in administering bisphosphonates intravenously, i.e. through a vein

•    Your doctor will recommend that you drink enough water before each treatment to help prevent dehydration

•    Carefully follow all the other instructions given to you by your doctor, nurse or pharmacist.

How much Osate is given

•    The usual single dose given is 4 mg

•    If you have a kidney problem, your doctor will give you a lower dose depending on the severity of your kidney problem.

How often Osate is given

•    If you are being treated for the prevention of bone complications due to bone metastases, you will be given one infusion of Osate every three to four weeks

•    If you are being treated to reduce the amount of calcium in your blood, you will normally only be given one infusion of Osate.

How Osate is given

•    Osate is given as a drip (infusion) into a vein which should take at least 15 minutes and should be administered as a single intravenous solution in a separate infusion line.

Patients whose blood calcium levels are not too high will also be prescribed calcium and vitamin D supplements to be taken each day.    .../...

THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE PROFESSIONALS ONLY:

How to prepare and administer Osate

To prepare an infusion solution containing 4 mg zoledronic acid, further dilute the Osate concentrate (5.0 ml) with 100 ml of calcium-free or other divalent cation-free infusion solution. If a lower dose of Osate is required, first withdraw the appropriate volume as indicated below and then dilute it further with 100 ml of infusion solution. To avoid potential incompatibilities, the infusion solution used for dilution must be either 0.9% w/v sodium chloride or 5% w/v glucose solution.

Do not mix Osate concentrate with calcium-containing or other divalent cation-containing solutions such as lactated Ringer's solution.

Instructions for preparing reduced doses of Osate:

Withdraw the appropriate volume of the liquid concentrate, as follows:

•    4.4 ml for 3.5 mg dose

•    4.1 ml for 3.3 mg dose

•    3.8 ml for 3.0 mg dose

For single use only. Any unused solution should be discarded. Only clear solution free from particles and discolouration should be used. Aseptic techniques must be followed during the preparation of the infusion.

Chemical and physical in-use stability has been demonstrated for 24 hours at 2°C -    8°C;

however from a microbiological point of view, the diluted solution for infusion should be used immediately. If not used immediately, in-use storage times and