Zometa 4mg Vial\5ml

Product Description:

• 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.

Warnings And Precautions:

Talk to your doctor before receiving Zometa:

• Follow all instructions from your doctor carefully.
• Your doctor will take blood tests before you start treatment with Zometa and will regularly check your response to treatment.
• If you have or have had kidney problems.
• If you have or have had pain, swelling or numbness in your jaw, a feeling of heavy jaw, or if a tooth has become loose. 
• Your doctor may recommend that you undergo a dental examination before starting treatment with Zometa.
• If you are having dental treatment or are going to undergo dental surgery, tell your dentist that you are being treated with Zometa and inform your doctor about your dental treatment.

You should not receive Zometa:

• If you are breastfeeding.
• If you are allergic to zoledronic acid, other bisphosphonates (the group of medicines to which Zometa belongs) or any of the other ingredients in this medicine.
• While you are being treated with Zometa, you should maintain good oral hygiene (including brushing your teeth regularly) and have routine dental check-ups.
• Contact your doctor and dentist immediately if you experience problems with your mouth or teeth such as loose teeth, pain or swelling, sores that do not heal or discharge pus (fluids), as these may be signs of a condition called osteonecrosis of the jaw .
• Patients who are undergoing chemotherapy and/or radiation therapy, who are taking steroids, who are undergoing dental surgery, who are not receiving routine dental care, who have gum disease, who are smokers, or who were previously treated with a bisphosphonate (used to treat or prevent skeletal disorder) may have a higher risk of developing osteonecrosis of the jaw.
• Low levels of calcium in the blood ( hypocalcemia ), sometimes leading to muscle cramps , dry skin, burning sensation, have been reported in patients treated with Zometa.
• Irregular heartbeat ( cardiac arrhythmia ), seizures , spasms and twitching (tetany) have been reported as a consequence of severe hypocalcemia
• In some cases, the hypocalcemia can be life-threatening.
• Inform your doctor immediately if any of these apply to you. 
• If you already have hypocalcemia , it must be corrected before you take the first dose of Zometa. 
• You will be given adequate:calcium and vitamin D supplements.

Patients 65 years and older:

• Zometa can be given to elderly people aged 65 and over. 
• There is nothing to suggest that extra precautions should be taken.

Children and youth:

• Use of Zometa is not recommended in adolescents and children under 18 years of age.
• Pregnancy and breastfeeding:
• You should not use Zometa if you are pregnant. 

Tell your doctor if you are, or think you are, pregnant:

You must not use Zometa if you are breast-feeding:

• Talk to your doctor or pharmacist before taking any kind of medicine when you are pregnant or breastfeeding.

Driving and using machines:

• There have been rare cases of drowsiness and sleepiness with the use of Zometa.
• You should therefore be careful when driving, using machines or performing other tasks that require a lot of attention.

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.