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CENTER FOR DRUG EVALUATION AND RESEARCHAPPLICATION NUMBER:21822MICROBIOLOGY REVIEW(S)DIVISION OF ANTIVIRAL DRUG PRODUCTS (HFD530) MICROBIOLOGY DRAFT REVIEW NDA: 21814 and 21822 SN: 000 DATE REVIEWED:

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How to fill out division of antiviral drug

01

To fill out division of antiviral drug, follow these steps:

02

Begin by collecting all necessary information on the antiviral drug being divided, including dosage strength and quantity.

03

Ensure you have the appropriate tools and equipment. This may include a tablet cutter, if applicable.

04

Verify the medication's safety for division. Some antiviral drugs are not suitable for splitting or dividing, so it's important to refer to the prescribing information or consult a healthcare professional.

05

Wash your hands thoroughly before handling any medication.

06

Carefully measure or count the total number of antiviral drug tablets or capsules.

07

If a tablet cutter is necessary, place the tablet in the appropriate slot and press down firmly to evenly split it into two halves.

08

If the antiviral drug is in capsule form, carefully open the capsule and divide its contents equally, making sure to avoid spillage or contamination.

09

Use a pill dispenser or other appropriate container to separate and store the divided antiviral drug.

10

Label the container clearly with the name of the medication, dosage strength, and expiration date, if applicable.

11

Dispose of any unused or expired portions of the antiviral drug properly, following local regulations and guidelines.

12

Please note that these steps are general guidelines and it's crucial to always refer to the specific instructions provided by the healthcare professional or pharmacist.

Who needs division of antiviral drug?

01

Division of antiviral drugs may be necessary for certain individuals, such as:

02

- Patients requiring a lower dosage due to their specific medical condition or tolerance.

03

- Individuals who are unable to swallow whole tablets or capsules and require a divided form for administration.

04

- Cases where a specific dosage strength is not available, and dividing a higher strength medication is necessary.

05

- Patients who need to gradually taper off their medication by reducing the dosage over time.

06

It's important to consult a healthcare professional or pharmacist to determine if division of an antiviral drug is appropriate for a particular individual.

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