OSSICA 3 mg. / 3 ml. 1 ampoule
Osika belongs to a group of medicines called bisphosphonates. It contains ibandronic acid. It does not contain hormones.
Osika may reverse bone loss by stopping more loss of bone and increasing bone mass in most women who take it, even though they can not see or feel a difference. Osika can help reduce the risk of broken bones (fractures). Reduction in fractures was shown for the spine but not for the hip.
Osika 3 mg solution for injection in pre-filled syringes is a solution for intravenous injection by a medical specialist. Do not inject Osika alone.
Osika is prescribed to treat postmenopausal osteoporosis because you have an increased risk of fractures is greater.
Osteoporosis is a thinning and weakening of the bones, which is common in women after menopause. In menopause, the ovaries stop producing the female hormone estrogen, which helps to keep the strength of her skeleton.
The earlier a woman reaches the menopause, the greater her risk of fractures in osteoporosis.
Other factors that may increase the risk of fractures include:
not enough calcium and vitamin D in the diet;
smoking, or drinking too much alcohol;
not enough walking or other weight-bearing exercise;
the presence of osteoporosis in the family.
Many people with osteoporosis have no symptoms. If you have no symptoms you may not know that you have this disease. However, osteoporosis makes you more likely to break bones if you fall or hurt yourself. A broken bone after the age of 50 may be a sign of osteoporosis. Osteoporosis can also cause back pain, height loss and a curved back.
Osika prevents loss of bone from osteoporosis, and helps to rebuild lost bone. Therefore, Osika less likely to break bones.
A healthy lifestyle will also help you to get the maximum benefit from your treatment. This includes eating a balanced diet rich in calcium and vitamin D, walking or other weight-bearing exercise, not smoking and not drinking too much alcohol.
2. BEFORE YOU USE OSICCA
Do not use Osika:
if you have or have had in the past low blood calcium. Please consult your doctor;
If you are allergic (hypersensitive) to the active substance or any of the other ingredients of Osika injection.
Take special care with Osika
Some patients need to be especially careful when using Osika. Tell your doctor:
if you have or have ever had kidney problems, kidney failure or have needed dialysis, or if you have any other disease that may affect your kidneys;
if you have any disturbances of mineral metabolism (such as lack of vitamin D);
You should take supplements of calcium and vitamin D, while receiving Osika. If this is not possible, you should tell your doctor;
If you are under dental treatment or will undergo dental surgery, tell your dentist that you are taking Osika.
Children and adolescents
Osika not use in children and adolescents under 18 years of age.
Taking other medicines
Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines. Tell them about everything taking which you bought without a prescription.
Pregnancy and lactation
You should not apply Osika if you are pregnant or likely to become pregnant.
If you are breastfeeding, you will need to stop breastfeeding you are given Osika.
Ask your doctor or pharmacist before taking any medicine.
Driving and using machines
Not studied the effects of Osika on ability to drive or operate machinery.
Important information about some of the ingredients of Osika
This medicinal product contains less than 1 mmol sodium (practically does not contain sodium.
3. HOW TO USE OSICCA
The recommended dose Osika injection for intravenous administration was 3 mg (1 pre-filled syringe) once every 3 months.
The injection should be administered into a vein by a physician or qualified / trained health care professional. Do not inject yourself.
The injection should be administered into a vein only, and not anywhere else in the body.
Keep taking Osicca
To get maximum benefit from the treatment, it is important to continue receiving the injections every 3 months until your doctor prescribes it. Osika can treat osteoporosis only as long as receiving the treatment, even if you can not see or feel a difference.
You should also take and dietary supplements containing calcium and vitamin D, as recommended by your doctor.
If you use more than the amount Osicca
You may develop low levels of calcium, phosphorus or magnesium in the blood. Your doctor may take steps to correct such changes and may give you an injection containing these minerals.
If you forget to use Osicca
You have to arrange an appointment to get the next injection in the shortest possible time. Then continue with the injections every 3 months from the date of the last injection.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Osika can cause side effects, although not everybody gets them.
These side effects may occur with a certain frequency, which is 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.
Speak immediately with a nurse or doctor if you notice any of the following serious side effects - you may need urgent medical treatment:
rash, itching, swelling of the face, lips, tongue and throat, with difficulty breathing. You may have an allergic reaction to the drug;
severe chest pain, severe pain after swallowing food or drink, severe nausea or vomiting;
flu-like symptoms (if any effects become troublesome or last more than a few days);
pain or irritation in the mouth or jaw;
eye pain and inflammation (if sustained).
Other possible side effects
heartburn, stomach pain (eg. "gastroenteritis" or "gastritis"), indigestion, nausea, gas, diarrhea or constipation;
pain or muscle stiffness, joint or back pain;
flu-like symptoms (including fever, shaking and shivering feeling of discomfort, fatigue, bone pain and aching muscles and joints);
a feeling of weakness;
inflammation of a vein and pain or injury at the injection site.
hypersensitivity; swelling of the face, lips and mouth (see allergy);
eye pain or inflammation.
condition involving exposed bone in the mouth called "osteonecrosis of the jaw."
Rarely can occur abnormal femoral fractures, especially in patients on long-term treatment of osteoporosis. Contact your doctor if you experience pain, weakness or discomfort in your thigh, hip or groin as this may be an early indication of a possible fracture of the femur.
If any of the side effects gets serious, or you notice other effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE OSICCA
Keep out of the reach and sight of children.
Store in the original package in order to protect from light. This medicinal product does not require any special storage conditions.
Do not use Osika 3 mg solution for injection in pre-filled syringes after the expiry date stated on the carton after "EXP".
The person giving the injection should throw away any unused solution and put the used syringe and injection needle into an appropriate waste container.
6. FURTHER INFORMATION
What Osika 3 mg solution for injection in pre-filled syringes
The active substance is ibandronic acid (ibanclronic acid). A pre-filled syringe contains 3 mg of ibandronic acid in 3 ml solution (in the form of sodium 3,375 mg ibandronate monohydrate). 1 ml injection solution contains 1 mg of ibandronic acid.
The other ingredients are sodium chloride, acetic acid, sodium acetate trihydrate, water for injections. Sodium hydroxide and hydrochloric acid (for pH adjustment).
INFORMATION FOR MEDICAL PROFESSIONALS
Please refer to the Summary of Product Characteristics for more information.
Application of Osika 3 mg solution for injection in pre-filled syringe:
Osika 3 mg solution for injection in pre-filled syringe should be injected intravenously over 15-30 seconds.
The solution is irritant, therefore strict adherence to the intravenous route of administration is important. If you inadvertently inject into the tissues around the vein, patients may experience local irritation, pain and inflammation at the injection site.
Osika 3 mg solution for injection in pre-filled syringe must not be mixed with calcium-containing solutions (such as Ringer's lactate, calcium heparin) or other medicinal products for intravenous use. When Osika administered via an existing intravenous infusion, the infusion solution should be restricted to either saline or 50 mg / ml (5%) dextrose solution.
If a dose is missed, the injection should be placed as far as possible in advance. Thereafter, injections should be scheduled every 3 months from the date of the last injection.
Based on knowledge of this class of compounds, intravenous overdosage may result in hypocalcaemia, hypophosphataemia, and hypomagnesaemia, which can cause paraesthesia. In severe cases may require intravenous infusion of appropriate doses of calcium gluconate, potassium or sodium phosphate, and magnesium sulfate.
Osika 3 mg solution for injection in pre-filled syringe like other bisphosphonates administered intravenously, may cause a transient decrease in serum calcium levels.
Hypocalcemia and other disturbances of bone and mineral metabolism should be assessed and effectively treated before starting treatment with Osika injection. Adequate intake of calcium and vitamin D is important in all patients. All patients must receive supplemental calcium and vitamin D.
Patients with concomitant diseases, or who use medicinal products with potential adverse effects on the kidney, should be reviewed regularly during treatment in accordance with good medical practice.
Any unused solution for injection, syringe and injection needle should be disposed of in accordance with local requirements.