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Zometa 4mg / 100ml solution

Ferron Par Pharmaceuticals

Ingredients in every 100 ml

Zoledronic acid 4 mg

Each package contains

1 bottle of 100 ml

Dosage form

solution

Dosage formSolution for infusion

Flavour

None

W.H.O. classification

M05B
M05B

A.T.C. Level 1

Anatomical Main group

M - Musculo-skeletal system
M05B

A.T.C. Level 2

Therapeutic subgroup

M05 - Drugs for Treatment of Bone Diseases
M05B

A.T.C. Level 3

Pharmacological subgroup

M05B - Drugs Affecting Bone Structure and Mineralization

Available in

Indonesia

Warnings

Alcohol

CONSULT YOUR DOCTORSafety of this item for use with alcohol has not been established. Please consult your doctor.

Machinery

CAUTIONThis item may not be safe for use while operating heavy machinery. Use with caution and after consultation with your doctor.

Pregnancy

NOT RECOMMENDEDThis item is not safe for use during pregnancy.

Lactation

NOT RECOMMENDEDThis item is not safe for use during lactation.

Indication

Skeletal-related events
Prevention of skeletal-related events (pathological fractures, spinal compression, radiation or surgery to the bone, or tumor-induced hypercalcemia) in patients with advanced maglinancies involving bone.
Hypercalcemia of malignancy (HCM)

Dosage

18 YEARS OLD AND ABOVE
— Prevention of skeletal related events in patients with advanced malignancies involving bone:
The recommended dose is 4 mg infusion given every 3 to 4 weeks. Patients should also be administered an oral calcium supplement of 500 mg and 400 IU vitamin D daily

— Treatment of hypercalcemia of malignancy:
The recommended dose in hypercalcemia (albumin-corrected serum calcium ≥12.0 mg/dl or 3.0 mmol/l) is a single dose of 4 mg zoledronic acid. Patients must be maintained well hydrated prior to and following administration of zoledronic acid.

Zometa must only be administered to patients by healthcare professionals experienced in the administration of intravenous bisphosphonates. Zometa must not be mixed with calcium or other divalent cation containing infusion solutions, such as Lactated Ringer’s solution, and should be administered as a single intravenous solution in a line separate from all other drugs in no less than 15 minutes. Patients must be maintained in a well hydrated state prior to and following administration of Zometa.

PATIENTS WITH IMPAIRED RENAL FUNCTION
— Hypercalcemia of malignancy (HCM):
Zoledronic acid treatment in adult patients with HCM who also have severe renal impairment should be considered only after evaluating the risks and benefits of treatment. No dose adjustment is necessary in HCM patients with serum creatinine <400 µmol/l or <4.5 mg/dl

— Prevention of skeletal related events in patients with advanced malignancies involving bone:
When initiating treatment with zoledronic acid in patients with multiple myeloma or metastatic bone lesions from solid tumors, serum creatinine levels and creatinine clearance (Clcr) should be determined. Zoledronic acid is not recommended for patients presenting with severe renal impairment prior to initiation of therapy, which is defined for this population as Clcr <30 ml/min.

The following zoledronic acid dose is recommended:
CrCl >60 : recommended dose of zoledronic acid is 4.0 mg
CrCl 50-60 : recommended dose of zoledronic acid is 3.5* mg
CrCl 40-49 : recommended dose of zoledronic acid is 3.3* mg
CrCl 30-39 : recommended dose of zoledronic acid is 3.0* mg
*Doses have been calculated assuming target AUC of 0.66 (mg.hr/l) (Clcr= 75 ml/min).