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Applicant: TEVA Pharmaceuticals (Pty) Product name: OXALIPLATIN PC 50 & 100 Dosage form & strength: Oxaliplatin 50 mg & 100 mg (5 mg/ml) (concentrate for solution for infusion)PATIENT INFORMATION
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01
Step 1: Gather all necessary supplies, including the vial of injection powder lyophilized, a sterile syringe, and a vial of sterile diluent.
02
Step 2: Cleanse the rubber stoppers of both the vial of injection powder lyophilized and the vial of sterile diluent with an alcohol swab.
03
Step 3: Draw up the desired amount of sterile diluent into the syringe. The amount will depend on the instructions provided.
04
Step 4: Insert the syringe needle into the rubber stopper of the vial of injection powder lyophilized.
05
Step 5: Slowly inject the sterile diluent into the vial, making sure to direct the flow onto the wall of the vial rather than the powder.
06
Step 6: Gently swirl or rotate the vial to assist in dissolving the powder. Avoid shaking vigorously to prevent foaming.
07
Step 7: Once the powder is completely dissolved, withdraw the desired amount of reconstituted solution back into the syringe.
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Step 8: Remove the syringe from the vial and replace the needle if necessary.
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Step 9: Follow the appropriate administration guidelines for the injection powder lyophilized, such as injecting intramuscularly or intravenously.
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Step 10: Dispose of any unused solution and properly discard all used supplies in accordance with applicable regulations.

Who needs injection powder lyophilized for?

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Injection powder lyophilized is typically needed by healthcare professionals, such as doctors, nurses, or pharmacists, who are responsible for administering medications to patients.
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Additionally, patients receiving certain types of treatments or therapies may require injection powder lyophilized under the guidance and supervision of a healthcare professional.
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It is important to note that the specific indications for the use of injection powder lyophilized may vary depending on the medication it contains, and should always be determined by a healthcare professional.
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Injection powder lyophilized is used for the formulation of injectable medications that require a stable powder form for storage and transport, allowing for rapid reconstitution before administration.
Manufacturers and distributors of lyophilized injection powders are required to file relevant documentation to comply with regulatory standards.
The filing process typically involves completing specific regulatory forms with details about the product, its ingredients, production methods, and safety information.
The purpose is to ensure the quality and safety of injectable medications, provide necessary information to regulators, and facilitate market access.
Information required includes product composition, manufacturing process, labeling details, stability data, and any clinical trial data.
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