Zoltero 4

Zoltero 4 Caution For Usage

zoledronic acid

Manufacturer:

Hetero Labs

Distributor:

Medicell Pharma
Full Prescribing Info
Caution For Usage
Instructions for Use and Handling: Zoledronic acid 4 mg/5 mL concentrate for solution for infusion and Zoledronic acid 4mg/100mL solution for infusion are for intravenous use only.
The 4mg/5mL concentrate from one vial (or the volume of the concentrate withdrawn as required) must be further diluted with 100 mL of calcium-free infusion solution (0.9 % w/v sodium chloride solution or 5 % w/v glucose solution).
The 4 mg/100 mL solution is a "ready-to-use" presentation which must not be further diluted or mixed with other infusion solutions except for patients with renal impairment. For reduced doses of this presentation in patients with mild and moderate renal impairment (see Dosage & Administration).
After aseptic reconstitution and dilution (or for reduced doses of the 'ready-to-use' presentation), it is preferable to use the reconstituted and diluted product immediately. If not used immediately, the reconstituted solution should be stored at 2 to 8°C. The duration and conditions of storage prior to use are under the healthcare provider's responsibility. The total time between reconstitution, dilution, storage in a refrigerator at 2 to 8°C and end of administration must not exceed 24 hours. If refrigerated, the solutions must be allowed to reach room temperature before administration. (See also Dosage & Administration).
Any unused solution should be discarded. Only clear solution free from particles and discoloration should be used.
Incompatibilities: Studies with glass bottles, as well as several types of infusion bags and infusion lines made from polyvinylchloride, polyethylene and polypropylene (prefilled with 0.9% w/v sodium chloride solution or 5% w/v glucose solution), showed no incompatibility with Zoledronic acid.
To avoid potential incompatibilities, Zoledronic acid concentrate is to be diluted with 0.9% w/v sodium chloride solution or 5% w/v glucose solution.
Zoledronic acid concentrate and Zoledronic acid "ready-to-use" solution for infusion must not be mixed or come into contact 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.
Zoledronic acid should not be used after the date marked "EXP" on the pack.
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