Aclasta 5 mg/100 mL zoledronic acid intravenous infusion

Aclasta contains the active substance zoledronic acid.

• • Aclasta belongs to a group of medicines called bisphosphonates and is used in the treatment of post-menopausal women and adult men with osteoporosis , or osteoporosis caused by treatment with corticosteroids used to treat inflammation, and Paget’s bone disease in adults

Osteoporosis:

• • Osteoporosis is a disease which means that the bone tissue becomes thinner and weaker.

• • It is common in women after menopause, but can also occur in men.

• • At menopause, the woman’s ovaries stop producing the female hormone oestrogen, which helps to maintain healthy bone tissue.

• • After menopause, bone mass decreases, and the bone tissue becomes weaker and is more prone to fractures.

• • Osteoporosis can also occur in men and women as a result of long-term use of steroids, which can affect bone strength.

• • Many patients with osteoporosis have no symptoms, but still have a risk of bone fracture because of the osteoporosishas made the bone tissue weaker.

• • Reduced levels of circulating sex hormones in the body, mainly estrogen formed from androgens, also play a role in the gradual loss of bone tissue observed in men.

• • Aclasta strengthens the bone tissue in both women and men and therefore makes it less prone to fractures.

• • Aclasta is also used in patients who have recently broken their hip in an accident, e.g. A fall, and who therefore has a risk of later breaking a bone .

Pagets bensykdom:

• • It is normal for old bone tissue to be removed and replaced by new bone substance.

• • The process is called remodeling. In Paget’s bone disease , remodeling is too rapid and new bone is formed in a disorganized manner, making it weaker than normal.

• • If the disease is not treated, deformities and pain in the skeleton can occur, and bone fractures can occur.

• • Aclasta works by normalizing the remodeling process, ensuring that normal bone is formed, thereby restoring bone strength.

How To Use:

• • Carefully follow all instructions given to you by your doctor or nurse.

• • Contact a doctor or nurse if you are unsure.

Osteoporosis:

• • The usual dose is 5 mg given by your doctor or nurse as a single annual infusion into a vein (vein). The infusion takes a minimum of 15 minutes.

• • If you have recently had a hip fracture, it is recommended that Aclasta be given two or more weeks after hip surgery.

• • It is important that you take supplements of calcium and vitamin D (e.g. Tablets) as recommended by your doctor.

• • In osteoporosis , Aclasta works for 1 year. Your doctor will tell you when to return for your next dose.

Pagets bensykdom:

• • When treating Paget’s bone disease , Aclasta should only be prescribed by doctors with experience in treating Paget’s bone disease .

• • The usual dose is 5 mg, given by your doctor or a nurse, as an initial infusion into a vein (vein). The infusion takes a minimum of 15 minutes.

• • Aclasta can work for more than a year and your doctor will tell you if you need more treatments.

• • The doctor may recommend that you take calcium and vitamin D supplements (e.g. Tablets) for at least the first ten days after receiving Aclasta.

• • It is important that you follow this advice carefully so that the level of calcium in the blood does not become too low ( hypocalcemia ) in the time after the infusion.

• • The doctor will inform about symptoms associated with hypocalcaemia .

Taking Aclasta with food and drink:

• • Make sure you drink enough fluids (minimum one or two glasses) before and after treatment with Aclasta, as your doctor tells you.

• • This will help you prevent dehydration.

• • You can eat normally on the days you receive Aclasta.

• • This is particularly important for patients who use diuretics (“diuretics”) and in elderly patients (65 years or older).

If you have forgotten a dose of Aclasta:

• • Contact a doctor or the hospital as soon as possible to arrange a new appointment.

Before stopping Aclasta treatment:

• • If you are considering stopping treatment with Aclasta, you must attend your next appointment and discuss this with your doctor.

• • Your doctor will advise you and decide how long you should be treated with Aclasta.

• • Ask your doctor, pharmacist or nurse if you have any questions about the use of this medicine.

Investigations:

• • Your doctor should do a blood test to check your kidney function (creatinine level) before each dose of Aclasta.

• • It is important that you drink at least two glasses of liquid (eg water) within a few hours before receiving Aclasta, as you have been told by your healthcare

Children and youth:

• • Aclasta is not recommended for anyone under the age of 18.

Pregnancy And Breastfeeding:

• • You should not receive Aclasta if you are pregnant or breast-feeding, think you may be pregnant or plan to become pregnant.

• • Talk to your doctor, pharmacist or nurse before taking this medicine.

Driving and using machines:

• • If you feel dizzy while using Aclasta, you should not drive or use machines.

• • Wait until you feel better.

Ingredients:

• • The active ingredient is zoledronic acid.

• • Each bottle of 100 ml solution contains 5 mg zoledronic acid (as monohydrate).
    1 ml of solution contains 0.05 mg zoledronic acid (as monohydrate).

What Aclasta looks like and contents of the pack:

• • Aclasta is a clear and colorless solution.

• It is supplied in 100 ml plastic bottles as a ready-to-use infusion solution.