Công văn 11393/QLD-DK

The medicine named “An cung ngưu hoàng” that is sold in Vietnam has many origins such as China, South Korea, North Korea, etc. and is imported into Vietnam through non-trade channels or official channels. There has been 04 medicines granted registration numbers by the Ministry of Health. They are oriental herbal medicines that must be prescribed by oriental physicians.

In order to ensure the safety and effectiveness of the medicine, according to conclusion of the Advisory Council – the Ministry of Health, Drug Administration of Vietnam hereby provides instructions on the use of “An cung ngưu hoàng” medicine as follows:

I. Formula and use of “An cung ngưu hoàng” medicine:

1. Formula:

Formulae of “An cung ngưu hoàng” according to China’s pharmacopoeia:

A 3-g pill consists of:

- Sufficient refined honey.

2. Instructions:

2.1. Effects: treats inflammation, relieves toxicity, treat convulsion, open orifices.

2.2. Indication: used to clear heat, treat high fever, convulsion, unconsciousness, delirium, unconsciousness because of encephalitis, meningitis, brain haemorrhage, etc. with high fever, hypertension, etc.)

2.3. Administration route and dosage:

- The medicine is administered orally according to prescription, indications. The use of this medicine must be supervised by an oriental or traditional physician.

- Adults: 1 pill/day

- Children under 3: ¼ pill/day;

- Children aged 4 – 6: ½ pill/day;

Dosage: 03 – 05 consecutive days. The pill should be chewed or taken part by part.

If the patient is unconscious due to high fever, the medicine may be administered with a nasogastric tube.

2.4. Contraindications: cerebrovascular accident, encephalitis with complications; complications of cerebrovascular accident, people in the absence of excess heat, pregnant women, people suffering from kidney or liver decline.

2.5. Precautions and warnings: caution is advised when the patient is allergic to any ingredient of the medicine.

2.6. Interactions: Avoid taking too close to modern medicines to avoid interactions. A sensible diet is advised. Avoid using sour, hot, or fat foods because they may generate internal heat and phlegm.

2.7. Overdose and treatment: Stop use immediately when seeing signs of overdose; take the patient to the nearest medical facility and administer emergency treatment.

II. Update of instructions:

1. With regards to the medicines granted registration number

Within 03 months from the day on which this Dispatch is signed, registrants and manufacturers shall review and reach an agreement on the instructions prescribed in Point 2 Section I of this Dispatch in relevant documents according to Appendix II of Circular No. 22/2009/TT-BYT dated November 24, 2009 of the Ministry of Health on drug registration.

2. With regard to the applications pending consideration at Drug Administration of Vietnam:

Drug Administration of Vietnam shall consider granting a registration number after relevant documents are revised and updated as agreed according to Point 2 Section I of this Dispatch.