Zoleum infusion solution is used for the following indications:
Treatment of osteoporosis in postmenopausal women and men at increased risk of fracture, including those with a recent low-traumatic hip fracture; Treatment of osteoporosis associated with long-term systemic glucocorticoid therapy in postmenopausal women and men at increased risk of fracture; Treatment of Paget's disease of bone in adults.
Composition
The active substance is zoledronic acid (100 ml of solution contains zoledronic acid monohydrate equivalent to 5 mg of zoledronic acid).
Excipients: mannitol (E 421), sodium citrate, water for injections.
Contraindication
Hypersensitivity to the active substance or to any component of the drug or hypersensitivity to bisphosphonates. Hypocalcemia. Severe renal impairment with creatinine clearance <35 ml / minute. Pregnancy and breastfeeding.
Method of application
The administration of Zoleum should be carried out under the condition that the patient is adequately hydrated. This is especially important for elderly patients (≥ 65 years) and patients receiving diuretics.
In connection with the use of the drug "Zoleum", adequate intake of calcium and vitamin D is recommended.
Osteoporosis
Treatment of postmenopausal osteoporosis, osteoporosis in men, treatment of osteoporosis associated with long-term systemic glucocorticoid therapy, the recommended dose is one infusion of 5 mg of the drug "Zoleum" per year.
The optimal duration of bisphosphonate treatment for osteoporosis has not been established. The need for continued treatment should be reviewed periodically, assessing the benefits and risks of using Zoleum individually for each patient, especially after 5 or more years of use.
For patients with a recent low-traumatic hip fracture, administration of Zoleum is recommended two or more weeks after hip fracture surgery. For patients with a recent low-traumatic hip fracture, administration of a loading dose of 50,000 to 125,000 IU of vitamin D orally or intramuscularly is recommended prior to the first administration of Zoleum.
Paget's disease
The drug should only be prescribed by doctors with experience in the treatment of Paget's disease of the bone. The recommended dose is a single infusion of 5 mg of Zoleum. In addition, patients with Paget's disease require additional calcium, at least 500 mg of elemental calcium twice daily for at least 10 days after the administration of Zoleum.
Retreatment with Paget's disease drug: After initiation of treatment with Zoleum for Paget's disease, a prolonged period of remission has been observed in patients who respond to treatment. Retreatment involves an additional infusion of 5 mg of Zoleum to patients who relapse, at intervals of 1 year or more after initiation of treatment. Data on retreatment of Paget's disease are limited.
Instructions for use of the drug
"Zoleum" should be administered slowly through a separate infusion system with air removal and taking into account a constant rate of administration. The administration time of the drug should be at least 15 minutes. Any unused residue or waste should be disposed of in accordance with local requirements. Only clear solutions, without visible particles and without discoloration, should be used.
If the solution is refrigerated, it should be allowed to reach room temperature before use. Aseptic technique should be followed when preparing the solution for intravenous infusion.
Use the drug only once.
From a microbiological point of view, the product should be used immediately. Otherwise, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C.
Application features
Children
The drug "Zoleum" is not recommended for use in children and adolescents (under 18 years of age), as there is insufficient data on the safety and effectiveness of the drug in this age group.
Drivers
Adverse reactions, such as dizziness, may affect the ability to drive or operate machinery.
Overdose
Clinical experience of acute overdose is limited. The condition of patients who have received doses exceeding the recommended one requires careful monitoring. In the event of an overdose leading to clinically significant hypocalcemia, compensation for the condition can be achieved by additional oral calcium administration and/or intravenous infusion of calcium gluconate.
Side effects
Metabolism and nutrition disorders: often (≥1/100, <1/10) - hypocalcemia.
From the nervous system: often (≥1/100, <1/10) - headache, dizziness.
On the part of the organs of vision: often (≥1/100, <1/10) - eye hyperemia.
From the cardiovascular system: often (≥1/100, <1/10) - atrial fibrillation.
Gastrointestinal: often (≥1/100, <1/10) - nausea, vomiting, diarrhea.
Musculoskeletal and connective tissue disorders: common (≥1/100, <1/10) - muscle pain, joint pain, bone pain, back pain, pain in extremities.
General disorders and administration site conditions: very common (≥1/10) - fever; common - flu-like symptoms, chills, fatigue, asthenia, pain, malaise, injection site reaction.
Zoleum solution for infusion should not be mixed with solutions containing calcium. Zoleum should not be mixed or administered with other medicinal products.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C, out of the reach of children.
Shelf life - 2 years.
