Nội dung toàn văn Official Dispatch No. 4396/QLD-DK on Guiding the methods for writing indications
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THE
MINISTRY OF HEALTH |
THE
SOCIALIST REPUBLIC OF VIETNAM |
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No. 4396/QLD-DK |
Hanoi, April 03, 2012 |
To: Companies involving in registration, production and import of medicines circulated in Vietnam (hereinafter reffered to as Company)
After synthensizing the verification and appoval results of medicines registration dossiers, Vietnam Drug Administration realizes that there are incompatibilities among indications stated in registration dossiers of medicines containing arginine and a large number of indications are unable to provide adequate clinical materials and scientific evidence for proof.
Pursuant to publicized scientific materials on medicine information;
Pursuant to conclusion of Medicine Review Council – Ministry of Health, on writing indications of medicines containing Arginine;
For the purpose of sound, safe and efficient use of medicines, Vietnam Drug Administration guides the unification in writing indications, dosage and use of medicines containing arginine, as follows:
I. Unification in writing the specific indications, dosage and use
1. Through venoclysis
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Indications |
Dosage and use |
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Assist diagnosis of a number of diseases e.g Hypopituitarism, growth retardation due to pituitary gland, chromopobe cell tumors, Craniopharyngeal duct tumor, removal of the pituitary gland, pituitary injury, acromegaly, giantism (overgrowth) and issues related to body and stature growth. |
Adults: 30g (300ml of 10% solution) by venoclysis for 30 min. Children: 0.5g/kg (5ml of 10%/kg solution) by venoclysis for 30 min. Total dosage shall not exceed 30g. |
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Treatment of acute blood ammonia elevation for patients with carbamoyl phosphate synthetase deficiency, ornithine carbamyl transferase deficiency.
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By venoclysis: Newborn: 200mg/kg for 90min for the first dose; then 8mg/kg/h 1-18 month babies: 200mg/kg for 90min for the first dose; then 8mg/kg/h. |
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Treatment of acute blood ammonia elevation for patients elevated blood citrulline and urinary argininosuccinic. |
By venoclysis: Newborn: 600mg/kg for 90min for the first dose; then 25mg/kg/h 1-18 month babies: 600mg/kg for 90min for the first dose; then 25mg/kg/h |
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Treatment of Metaboiic alkalosis
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Under the following formula: Dosage of Arginine hydrochloride by venoclysis = the bicarbonate concentration in blood plasma (mEq/L) x {body weight (kg) / 9.6} |
2. Via oral route
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Indications |
Dosage and use |
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Treatment of keeping blood ammonia levels increased for patients with carbamoyl phosphate synthetase deficiency, ornithine carbamyl transferase deficiency. |
Via oral route: Newborn: 100mg/kg per day total, given in 3-4 equally divided doses 1-18 month babies: 100mg/kg per day total, given in 3-4 equally divided doses. |
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Treatment of keeping blood ammonia levels increased for patients suffered from blood citrulline, urinary argininosuccinate. |
Via oral route: Newborn: 100-175mg/kg/time; 3-4 times per day with meals; adjust according to responses. 1-18 month babies: 100-175mg/kg/time; 3-4 times per day with meals; adjust according to responses. |
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Assist treatment of dyspeptic disorders |
Adults: 3-6g per day via oral route |
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Assist treatment of improving excersise capacity for patients with stable cardiovascular disease |
Adults: 6-21g per day via oral route; not exceeding 8g each time |
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Supplement of nutrition for those having Urea Cycle Disorders e.g elevated blood ammonia level type I and II, elevated blood citrulline, urinary argininosuccinate and N - Acetyl Glutamate Synthetase Deficiency. |
Adults: take 3-20g per day via oral route depending on seriousness of the disease. |
Note: All the above-mentioned recommended dosages are for arginine hydrochloride.
II. Guiding the implementation regarding medicines containing merely Arginine.
1. Regarding medicine that have been granted permit for circulation in the market: within 03 months as from the signing date of this Official Dispatch, the registing companies and manufacturers are responsible for actively amending the contents of indications, dosage and use in the instruction and description leaflets in according to recommendation prescribed in this Offial Dispatch.
2. Regarding medicine registration dossiers pending for approval, the Vietnam Drug Administration shall only consider and grant registration number after receiving from the company documents amending/ supplementing indications, dosage and use (into corresponding parts in the dossier) in according to recommendation prescribed in this Offial Dispatch and those documents are verified to be qualified.
3. In addition to the above-mentioned indications, dosage and use, the Vietnam Drug Administration shall only accept other indications, dosage and use regarding medicines when registering establishments provide adequate reliable scientific foundations for demonstration.
The Vietnam Drug Administration informs agencies for acknowledgment and implementation.
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FOR
THE DIRECTOR GENERAL |
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