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CENTER FOR DRUG EVALUATION AND RESEARCH Approval Package for: APPLICATION NUMBER: 209363Orig1s000 Trade Name:Solo sec Oral Granules, 2 generic or Proper Name:secnidazoleSponsor:Symbiotic Therapeutics,

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How to fill out solosec oral granules 2

01

Familiarize yourself with the instructions provided with the Solosec oral granules 2.

02

Wash your hands thoroughly before handling the granules.

03

Open the sachet containing the oral granules by tearing along the dotted line.

04

Empty the entire contents of the sachet onto a teaspoon or into a small container.

05

Take the granules by mouth and swallow them without chewing.

06

You may mix the granules with yogurt or applesauce if preferred, but do not mix with water or any other liquids.

07

Follow the recommended dosage as prescribed by your healthcare provider.

08

If you have any questions or concerns about the dosage or administration, consult your healthcare provider or pharmacist.

Who needs solosec oral granules 2?

01

Solosec oral granules 2 are prescribed to individuals who have bacterial vaginosis (BV), a common vaginal infection caused by an imbalance of bacteria in the vagina.

02

It is important to consult with a healthcare provider to determine if Solosec is appropriate for you and to receive proper dosage instructions.

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What is solosec oral granules 2?

Solosec oral granules 2 is a medication used to treat bacterial vaginosis in adult women.

Who is required to file solosec oral granules 2?

Healthcare providers are required to prescribe and administer solosec oral granules 2 to patients.

How to fill out solosec oral granules 2?

Solosec oral granules 2 should be taken orally by mixing the granules with water and drinking the solution.

What is the purpose of solosec oral granules 2?

The purpose of solosec oral granules 2 is to effectively treat bacterial vaginosis and its symptoms.

What information must be reported on solosec oral granules 2?

Information such as patient's name, dosage, frequency of administration, and date of prescription must be reported on solosec oral granules 2.

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