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PHARMACY COVERAGE GUIDELINES SECTION: DRUGSORIGINAL EFFECTIVE DATE: LAST REVIEW DATE: LAST CRITERIA REVISION DATE: ARCHIVE DATE:3/19/15 2/21/19 2/21/19KUVAN (hydrochloride) oral pack and soluble tablet

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How to fill out dihydrochloride oral pack and

01

Open the dihydrochloride oral pack by tearing along the designated perforation.

02

Take out one tablet or capsule from the pack.

03

If it is a tablet, place it on your tongue and swallow it with water. If it is a capsule, swallow it whole with water.

04

Repeat steps 2 and 3 for the remaining tablets or capsules as prescribed by your healthcare provider.

05

After completing the dose, dispose of the empty pack according to local regulations for medical waste.

Who needs dihydrochloride oral pack and?

01

Individuals who have been prescribed dihydrochloride by their healthcare provider.

02

Patients who require dihydrochloride to treat a specific medical condition.

03

People who have been diagnosed with a condition that dihydrochloride can help manage or alleviate symptoms.

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What is dihydrochloride oral pack?

Dihydrochloride oral pack is a collection of documents and forms required for the filing and reporting of specific pharmaceutical products that contain dihydrochloride as an active ingredient in an oral dosage form.

Who is required to file dihydrochloride oral pack?

Manufacturers, distributors, and authorized representatives involved in the production and sale of dihydrochloride products are required to file the dihydrochloride oral pack.

How to fill out dihydrochloride oral pack?

To fill out the dihydrochloride oral pack, entities must provide detailed information such as product formulation, manufacturing processes, quality control measures, and any testing results relevant to the dihydrochloride product.

What is the purpose of dihydrochloride oral pack?

The purpose of the dihydrochloride oral pack is to ensure compliance with regulatory standards, facilitate proper monitoring of pharmaceutical products, and ensure the safety and efficacy of dihydrochloride-containing medications.

What information must be reported on dihydrochloride oral pack?

Required information includes product name, active ingredient concentration, manufacturing details, labeling information, batch records, and any adverse event reports associated with the product.

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