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Case Study: CIPLA - TAZACT, Drug reconstitution

Client: CIPLA

Executive Summary of the Project

Drug reconstitution CIPLA

TAZACT (PIPERACILLIN/TAZOBACTAM) - 2.25 grams & 4.5 grams Reconstitution and storage of Anti-infective - Brought to you by Cipla Critical Care

Reconstitution and storage of -

Procedure for Reconstitution Let us reconstitute Tazact 4.5 grams with 20 ml Sterile Water for Injection The pack contains an anti-infective vial of Tazact 4.5 grams, 20 ml sterile water for injection, a sterile syringe, a sterile needle and the instruction manual

Remove the pack stored at room temperature of 15 to 30 degree Celsius. Open the syringe and the needle from the pack. Fix the needle on the syringe. Do not over tighten the needle, as it may be difficult to remove later. Also, do not leave it loose, as it may leak during transfer of fluids. Loosen the needle shield and place the unit on the table

Now take the sterile water and visually examine if there is water trapped in the top of the container. Tap the FFS vial a few times to release any trapped water. Open the FFS vial by twisting of the top. Draw out the water from the FFS vial into the syringe, by tilting the FFS vial. It does not matter if there are air bubbles in the water. Just ensure complete withdrawal of water from the FFS vial.

Alternate - Tap the vial a few times to release any trapped water. Open the vial by twisting of the top. Draw out the water from the vial into the syringe, by tilting the vial. It does not matter if there are air bubbles in the water. Just ensure complete withdrawal of water from the vial.

Pick up the anti-invective vial and snap off the flip top. Pierce the rubber stopper at the center Allow the water to be drawn into the vial. Push the plunger. Ensure that the entire syringe is emptied. (Push the plunger, only if required.)

Disconnect the syringe from the needle to break any residual vacuum to avoid any dissolution of the anti-infective. Disconnect the syringe from the FFS vial.

Alternate - Disconnect the syringe from the vial.

Rotate the vial gently between the palms of your hand till the contents are fully dissolved. Shake the vial till the contents are fully dissolved.

Connect the syringe and readjust the needle depth so that the entire contents of the vial are withdrawn into the syringe. If there is any air bubble, push the contents back into the vial and again withdraw it. Once the entire contents are withdrawn, disconnect the syringe along with the needle from the vial.

Procedure for IV Administration The reconstituted solution should be further diluted with a compatible intravenous solution.

Incompatibilities Storage and Stability

How To Pharmaceutical Drug Medicine Medical

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