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THE
MINISTRY OF HEALTH
DRUG ADMINISTRATION OF VIETNAM
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THE
SOCIALIST REPUBLIC OF VIETNAM
Independence– Freedom – Happiness
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No. 4396/QLD-DK
Ref.: Guiding the methods for writing
indications, dosage and use of medicines containing Arginine
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Hanoi, April 03, 2012
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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
Indications
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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.
Treatment of acute blood
ammonia elevation for patients with carbamoyl phosphate synthetase
deficiency, ornithine carbamyl transferase deficiency.
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.
Treatment of acute blood
ammonia elevation for patients elevated blood citrulline and urinary
argininosuccinic.
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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
Treatment of Metaboiic
alkalosis
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
Indications
Dosage and use
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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.
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.
Assist treatment of dyspeptic
disorders
Adults: 3-6g per day via oral
route
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Adults: 6-21g per day via oral
route; not exceeding 8g each time
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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Mọi chi tiết xin liên hệ:
ĐT: (028) 3930 3279 DĐ: 0906 22 99 66
FOR
THE DIRECTOR GENERAL
DEPUTY DIRECTOR GENERAL
Nguyen Viet Hung