Aclasta 5mg 100ml Infusion

Product Description:

• 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.

Warnings And Precautions:

• Follow all instructions from your doctor, pharmacist or nurse carefully before receiving Aclasta.

You must not receive Aclasta:

• If you are allergic to zoledronic acid, other bisphosphonates or any of the other ingredients of this medicine .


• If you have hypocalcaemia (i.e. Too low calcium level in the blood).


• If you have severe kidney problems.


• If you are pregnant.


• If you are breastfeeding.

Talk to your doctor before using Aclasta:

• If you are being treated with a medicine containing zoledronic acid, which is also the active substance in Aclasta (zoledronic acid is used in adult patients with specific types of cancer to prevent bone complications or to reduce the amount of calcium).


• If you have or have had kidney problems.


• If you are prevented from taking a daily calcium supplement.


• If you have had some or all of the parathyroid glands in your neck surgically removed.


• If you have had parts of your intestines removed.


• In patients receiving Aclasta (zoledronic acid) for osteoporosis , a side effect called osteonecrosis of the jaw (bone damage in the jaw) has been reported after marketing.


• Osteonecrosis of the jaw may also occur after treatment has ended.


• It is important to try to prevent the development of osteonecrosis of the jaw, as it is a painful condition that can be difficult to treat.


• There are some precautions you should take to reduce your risk of developing osteonecrosis of the jaw.

Before you are treated with Aclasta, you must tell your doctor, pharmacist or nurse if:

• You have any problems with your mouth or teeth, such as poor dental health, gum disease or a planned tooth extraction.


• You do not go to the dentist regularly or have not had a dental check-up for a long time.


• You smoke (as this can increase the risk of dental problems).


• You have previously been treated with a bisphosphonate (used to treat or prevent bone disorders).


• You are using medicines called corticosteroids (eg prednisolone or dexamethasone).


• You have cancer.


• Your doctor may ask you to undergo a dental examination before starting treatment with Aclasta.


• While you are being treated with Aclasta, you should maintain good oral hygiene (including brushing your teeth regularly) and have routine dental check-ups. 


• If you use dentures, make sure they are fitted properly.


• If you are undergoing dental treatment or are going to undergo dental surgery (e.g. Tooth extraction).


• tell your doctor about the dental treatment and tell your dentist that you are being treated with Aclasta. 


• Contact your doctor and dentist immediately if you experience problems with your mouth or teeth such as loose teeth, pain or swelling, wounds that do not heal or ooze, as these may be signs of osteonecrosis of the jaw.

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. 

Product Details: