Zometa 4 mg/5 mL zoledronic acid powder for concentrate – single vial

The active substance in Zometa is zoledronic acid which belongs to a group of medicines called bisphosphonates.

• • Zoledronic acid works by attaching to bone and slowing the rate of bone turnover. It is used:

To prevent skeletal complications:

• • Like Fractures in adult patients with skeletal metastases (spread of cancer from the place where the cancer originally arose to the skeleton).

To reduce the amount of calcium:

• • In the blood in adult patients when it is too high due to a tumor.

• • Tumors can affect normal bone formation in such a way that larger amounts of calcium are released from bones.

• • This condition is called tumor-induced hypercalcemia (TIH).

How To Use:

• • Zometa should only be given by healthcare personnel trained in the administration of intravenous bisphosphonates, e.g. Via a blood vessel (vein).

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

• • Carefully follow any other instructions given by your doctor, pharmacist or nurse.

How much Zometa is given:

• • The usual single dose is 4 mg.

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

How often will you get Zometa:

• • If you are receiving preventive treatment against skeletal complications due to skeletal metastases, you will receive one infusion of Zometa every three to four weeks.

• • If you are being treated to reduce the amount of calcium in your blood you will usually only have one infusion of Zometa.

How Zometa is given:

• • Zometa is given as a drip (infusion) into a blood vessel (vein), and the infusion will last at least 15 minutes.

• • Zometa should be administered alone in a separate infusion line.

• • Patients who do not have too high a calcium content in their blood will be prescribed a daily supplement of calcium and vitamin D.

If you have received more Zometa than you should have:

• • If you have received doses that are higher than what is recommended, you must be closely monitored by your doctor.

• • This is because you may have abnormal levels of salts in your blood (eg abnormal levels of calcium, phosphate and magnesium) and/or changes in kidney function, including severe impairment of kidney function.

• • If your calcium level drops and becomes too low, you may need to receive calcium by infusion.

Ingredients:

• • The active ingredient is zoledronic acid.

• • One bottle contains 4 mg zoledronic acid, corresponding to 4.264 mg zoledronic acid monohydrate.

What Zometa looks like and contents of the pack:

• • Zometa is supplied as a solution in a clear, colorless plastic bottle.

• One bottle contains 100 ml of solution.