Zoltero

Zoledronic acid INN 5 mg infusion
IV Infusion

What is Zoltero® and what it is used for?
Zoltero® solution for infusion: One bottle with 100 ml solution contains Zoledronic acid INN 5 mg. Zoltero® is indicated for the treatment of osteoporosis in postmenopausal women to reduce the incidence of hip, vertebral and non-vertebral fractures; prevention of clinical fractures after a hip fracture; treatment and prevention of glucocorticoid-induced osteoporosis; treatment of osteoporosis in men and for the treatment of paget′s disease of bone. Treatment should be restricted to three annual doses.

Before you take Zoltero®
The drug is contraindicated if patients have hypersensitivity to the active substance or to any of the excipients or to any bisphosphonates, hypocalcaemia, renal impairment (creatinine clearance <35 ml/min), current or recent uveitis, or a history of bisphosphonate-associated uveitis, pregnancy and lactation. Adverse Effects: The post-dose side-effects are fever, myalgia, flu-like symptoms, arthralgia and headache, the majority of which occur within the first 3 days following Zoltero® administration. The majority of these symptoms were mild to moderate in nature and resolved within 3 days of the event onset. The incidence of these symptoms occurring within the first 3 days after administration of Zoltero®, can be reduced with the administration of Paracetamol or Ibuprofen shortly following Zoltero® administration. Severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking Zoltero®.

How to take Zoltero®
Doctors should check the level of calcium (blood test) in patients prior to administration of ZOLTERO. Doctors should also check the kidney function of patients. It is important that patient drink enough fluid both before and after infusion to prevent dehydration. Must be given in a separate infusion line at a constant infusion rate. The dose of 5mg ZOLTERO must be administered over at least 15 minutes. If refrigerated, it should be allowed to reach the room temperature prior to administration.
Zoltero should be administered with the help of a trained personnel.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

Possible side effects
The post-dose side-effects are fever, myalgia, flu-like symptoms, arthralgia and headache, the majority of which occur within the first 3 days following Zoltero® administration. The majority of these symptoms were mild to moderate in nature and resolved within 3 days of the event onset. The incidence of these symptoms occurring within the first 3 days after administration of Zoltero®, can be reduced with the administration of Paracetamol or Ibuprofen shortly following Zoltero® administration. Severe and occasionally incapacitating bone, joint, and/or muscle pain have been infrequently reported in patients taking Zoltero®.

How to store Zoltero® (Storage condition)
Zoltero® must be kept out of the reach and sight of children. Protect from light.


Zoltero® Prescribing Information