ACLASTA. 5 mg. 100 ml. 1 flacon
ACLASTA. 5 mg. 100 ml. 1 flacon
WHAT ACLASTA AND WHAT IT IS USED
Aclasta contains the active substance zoledronic acid. It belongs to the group of medicines called bisphosphonates and is used for treatment of post-menopausal women and men with osteoporosis, or osteoporosis caused by corticosteroids and for the treatment of a disease of Paget.
Osteoporosis is a disease that involves the thinning and weakening of the bones and is common in women after menopause, but can occur in men . During menopause, the ovaries stop producing the female hormone estrogen, which helps keep bones healthy. After menopause bone loss , bones become weaker and break more easily. Osteoporosis can also occur in both men and women as a result of prolonged use of corticosteroids, which may affect the strength of the bone. Many patients with osteoporosis have no symptoms , however, they are still at risk of breaking bones because osteoporosis has weakened their strength . The reduction of the levels of circulating sex hormones , preferably oestrogens conversion of androgens , is important for a gradual loss of bone that occurs in men. Both men and women Aclasta strengthens bones and thus reduces the likelihood of breakage. Aclasta is also used in patients who have recently had a fracture of the femoral neck low-trauma such as a fall, and are therefore exposed to the risk of further fractures.
Normal that old bone is removed and replaced with new bone . This process is called remodeling. When disease Paget, bone remodeling is too fast and the new bone is misaligned and less than normal. If the disease is not treated, bones may become deformed and painful , and may break . Aclasta works by restoring the normal bone remodeling process , and provides the formation of normal bone, thus restoring the bone strength .
2 . BEFORE YOU ARE GIVEN ACLASTA
Follow all instructions of your doctor before you are given Aclasta.
You should not be given Aclasta:
if you are allergic (hypersensitive) to zoledronic acid, other bisphosphonates or any of the other ingredients of Aclasta;
if you have hypocalcaemia (this means that the levels of calcium in your blood is too low ) ;
if you have severe kidney problems ;
if you are pregnant ;
if you are breastfeeding .
Take special care with Aclasta
Tell your doctor before you are given Aclasta:
if you are being treated with Zometa, which contains the same active substance as Aclasta;
if you have kidney problems or have had ;
if you can not take daily calcium supplements;
if surgically removed some or all of the parathyroid glands in your neck ;
if removed parts of your intestine .
Before you are given Aclasta tell your doctor if you have ( or have had ) pain , swelling or numbness of the gums , jaw , or both, if your jaw feels heavy or you have lost a tooth. Before carrying out dental treatment or dental surgery, tell your dentist that you are being treated with Aclasta.
Use in children
Aclasta is not recommended for patients under the age of 18 years . The use of Aclasta in children and adolescents has not been studied.
Taking other medicines
Please tell your doctor , pharmacist or nurse if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Especially important for your doctor to be informed about all the medicines you take, especially if you are taking medicines known that can damage your kidneys ( eg, aminoglycosides ) or diuretics ( water pills ) , which can cause dehydration.
Use of Aclasta with food and drink
Make sure you drink enough fluids (at least one or two glasses) before and after treatment with Aclasta, as directed by your doctor. This will help prevent dehydration. You can eat normally on the day of treatment with Aclasta. This is particularly important in patients who are taking diuretics ( water pills ) and in the elderly .
Pregnancy and lactation
Lack of sufficient information on the use of Aclasta in pregnant women. Studies in animals have shown reproductive toxicity effects. Furthermore, no information concerning the use of Aclasta in nursing . You should not be given Aclasta, if you are pregnant or planning a pregnancy .
You should not be given Aclasta, if you are breastfeeding .
Ask your doctor, pharmacist or nurse before taking any medicine .
Driving and using machines
If you feel dizzy while taking Aclasta, do not drive or operate machinery until you feel better.
3 . HOW TO USE ACLASTA
Follow carefully the instructions of your doctor or nurse. If you are not sure , ask your doctor or nurse.
Before administration of Aclasta Your doctor should do blood tests to check your kidney function ( serum creatinine) . It is important to drink at least one or two glasses of fluid (eg water) within a few hours prior to administration of Aclasta, as instructed by your doctor or nurse.
The usual dose is 5 mg, administered by your doctor or nurse as an infusion into a vein once a year. The infusion will take at least 15 minutes.
If you have recently suffered a fracture of the femur is recommended Aclasta administration to make two or more weeks after hip fracture repair .
It is important to take calcium and vitamin D supplements (eg tablets) as directed by your doctor.
For osteoporosis, Aclasta works for one year. Your doctor will tell you when to come back to get the next dose.
The usual dose is 5 mg, given by your doctor or nurse as an initial infusion into a vein. The infusion lasts for at least 15 minutes. Aclasta may work for a period longer than one year and your doctor will tell you if you need to perform a new treatment .
Your doctor may advise you to take calcium and vitamin D supplements (eg tablets) for a period of at least ten days after you have been given Aclasta. It is important to carefully follow this advice so that calcium levels in your blood will not become too low in the period after the infusion . Your doctor will inform you regarding the symptoms associated with hypocalcemia .
If a dose is missed Aclasta
Contact your doctor or hospital as soon as possible and note new time to visit.
Before stopping treatment with Aclasta
If you are considering stopping treatment with Aclasta, please go to your next appointment and discuss this with your doctor. Your doctor will advise you and decide how long you should be treated with Aclasta.
If you have any further questions on the use of this medicine, ask your doctor, pharmacist or nurse.
4 . POSSIBLE SIDE EFFECTS
Like all medicines , Aclasta can cause side effects, although not everybody gets them . In most cases, no specific treatment is required .
Side effects may occur with certain frequencies, which are defined as follows:
Very common: affects more than 1 user in 10;
Common: affects 1 to 10 users in 100 ;
Uncommon: affects 1 to 10 users in 1000 ;
Rare: affects 1 to 10 users in 10,000 ;
Very rare: affects less than 1 user in 10 000 ;
Not known from the available data can not be estimated frequency .
Adverse reactions associated with the first infusion are very common ( occurring in more than 30% of patients) , but are less common after subsequent infusions. The majority of adverse reactions such as fever , chills , pain in muscles or joints, and headache occur in the first three days after administration of Aclasta. Symptoms are usually mild to moderate and resolved within three days. Your doctor may recommend a mild pain reliever such as ibuprofen or paracetamol to these side effects may be limited. The chance of experiencing these side effects decreases with subsequent doses Aclasta.
Very common side effects:
Common side effects:
Headache, dizziness, nausea , vomiting, diarrhea , muscle pain, bone pain and / or joint pain, back , arms or legs , flu-like symptoms (eg, fatigue , chills , joint and muscle pain), chills , feeling fatigue and loss of interest , weakness , pain , malaise, skin reactions such as redness, swelling and / or pain at the infusion site .
In patients with disease Paget: symptoms due to low levels of calcium in the blood, such as numbness or tingling, especially in the area around the mouth.
Irregular heart rhythm (atrial fibrillation) has been reported in patients receiving Aclasta for the treatment of postmenopausal osteoporosis . It is currently unclear whether Aclasta causes this irregular heart rhythm but you should inform your doctor if you experience these symptoms after you have been given Aclasta.
Uncommon side effects:
Influenza infections of the upper respiratory tract , reduce the number of red blood cells , loss of appetite , insomnia , drowsiness, which may include a reduced attention, and decreased level of consciousness, sensation of tingling or numbness , extreme fatigue , tremor, loss of temporary consciousness , eye infection or irritation or inflammation with pain and redness, eye sensitivity to light, sensation of dizziness, increased blood pressure, flushing , cough , shortness of breath , upset stomach , abdominal pain, constipation, dry mouth, heartburn , skin rash, excessive sweating , itching, redness of the skin , neck pain , stiffness in muscles, bones and / or joints , joint swelling , muscle spasms , pain in the shoulders, chest pain and chest muscles , sore joints , muscle weakness , abnormal test results for the evaluation of renal function, urinating more often than usual , swelling of the hands, ankles and legs , thirst, toothache , taste disturbance .
Additional adverse reactions reported (frequency not known ):
Severe allergic reactions including dizziness and difficulty breathing, swelling mainly of the face and throat, low blood pressure, pain in the mouth, teeth and jaw , swelling or sores in the mouth, numbness or a feeling of heaviness in the jaw or loosening of a tooth , renal dysfunction (eg, decreased urine output ) , dehydration secondary to post- dose symptoms such as fever , vomiting or diarrhea.
May occur rarely atypical fracture of the femur , especially in patients on prolonged treatment. Contact your doctor if you experience pain, weakness or discomfort in the thigh , hip or groin as this may be an early indication of a possible fracture of the femur .
If you notice any of these side effects, tell your doctor.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet , please tell your doctor, pharmacist or nurse.
5 . HOW TO STORE ACLASTA
Your doctor , pharmacist or nurse knows how to store Aclasta properly.
Keep out of reach of children.
Do not use Aclasta after the expiry date stated on the carton and bottle after " EXP" .
The unopened bottle does not require any special storage conditions .
After opening the bottle, the product should be used immediately to avoid microbial contamination . If not used immediately, storage in use and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 ° C - 8 ° C. Allow the solution cooled to room temperature prior to administration.
6 . ADDITIONAL INFORMATION
What Aclasta contains
The active agent is zoledronic acid . Each bottle with 100 ml of a solution containing 5 mg of anhydrous zoledronic acid (as monohydrate ) .
One milliliter of solution contains 0,05 mg zoledronic acid ( as monohydrate).
The other ingredients are mannitol , sodium citrate and water for injection.
Aclasta looks like and contents of the pack
Aclasta is a clear and colorless solution. Available in plastic bottles of 100 ml as a ready to use solution for infusion . Supplied in packs containing one bottle as a single package or in multi-packs containing 5 packs , each with 1 bottle.
Not all pack sizes may be marketed.