The official letter 6132/QLD-ĐK Guideline on indication, contraindication, dosage of Glucosamin

The official letter 6132/QLD-ĐK Guideline on indication, contraindication, dosage of Glucosamin

Attn:   Applicant, Manufacturers of circulated pharmaceutical product in Vietnam

Based on the result of meeting of Ministry of Health for evaluating and approving on pharmaceutical products dated 26/05/2010 on indication, contraindication and dose regimen of glucosamine,

In order to ensure the safety, efficacy of medicines for user, the Drug Administration has informed as follows:

1. Unify the content of indication, contraindication and dosage of glucosamine as follows:

• Therapeutic indications: Relief the mild to moderate symptoms of gonarthritis.
• Contraindications: Pregnancy, Lactation, Children, adolescent below 18 years of age because there are not the data on treatment safety and effectiveness.
• Dosage:

[sociallocker id=7424]

Adults and children above 18 years: 1250 mg to 1500 mg glucosamine / day (the forms of Glucosamine Salts are exchanged equivalent to glucosamine), in divided to 3 times. Glucosamine sulfat can be used as single or in combination with other medicines as chondroitin 1200 mg/day. Treatment duration depend on individuals, at least 2-3 consecutive months to ensure treatment efficacy.

[/sociallocker]

2. Guideline for implementation:

• For the medicine containing ingredient of glucosamine having the marketing authorization license: During 03 months from the issuance date of this letter, applicants, manufacturers has the responsibility to change, supplement the relevant information of glucosamine recommended in this letter into the package insert, drug information to patients.
• For the registration dossier during evaluation: Drug Administration only consider to grant the visa number after company submit the supplement/variation (on the relevant part of registration dossier) according to the recommendation of this letter and pass the evaluation.

The Drug Administration informs the company to acknowledge and implement.

FOR GENERAL DIRECTOR OF DRUG ADMINISTRATION

(signed and stamped)

Truong Quoc Cuong

The official letter 6132/QLD-ĐK Guideline on indication, contraindication, dosage of Glucosamin

Vietnamese Version Click here