HYDROXO-B12 SOLUTION FOR INJECTION 1MG1ML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Hydroxocobalamin chloride 1.027mg eqv Hydroxocobalamin

Available from:

GOLDPLUS UNIVERSAL PTE LTD

ATC code:

B03BA03

Dosage:

1.000mg

Pharmaceutical form:

INJECTION, SOLUTION

Composition:

Hydroxocobalamin chloride 1.027mg eqv Hydroxocobalamin 1.000mg

Administration route:

INTRAMUSCULAR

Prescription type:

Pharmacy Only

Manufactured by:

Biologici Italia Laboratories S.r.l

Authorization status:

ACTIVE

Authorization date:

2014-09-18

Patient Information leaflet

1 

Product Information 

HYDROXO-B12 

NAME OF MEDICINE 
Hydroxocobalamin (vitamin B 
12
Molecular formula: C
) as chloride.   
62
 H
90
 ClCoN
13
 O
15
Molecular weight is 1,383.   
 P.   
CAS: 58288-50-9.   

DESCRIPTION 
Hydroxocobalamin is a dark red, odourless crystalline
powder or crystals. It 
is soluble in water and alcohol, sparingly soluble in
methyl alcohol and 
practically insoluble in acetone, chloroform and
ether. HYDROXO-B12 also 
contains sodium chloride 9.0
mg and hydrochloric acid for pH adjustment 
and water for injections. The pH of the solution
is approximately 4.6.   

PHARMACOLOGY   
Several chemically related forms of vitamin B 
12
, differing in slight modification of a 
side chain attached to the cobalamin nucleus have been isolated. Two
such variants 
of vitamin B 
12
 are cyanocobalamin and hydroxocobalamin. Vitamin B
12
 is essential 
2 

for normal growth, haemopoiesis, production
of all epithelial cells and maintenance 
of myelin throughout the nervous system. Whenever nucleic acid
synthesis occurs 
and therefore whenever cell reproduction occurs, vitamin B 
12
The amounts of vitamin B 
12
 needed to maintain normal blood forming functions are 
small and low doses are sufficient to correct the
usual symptoms of vitamin B 
12

deficiency. Vitamin B
12
 acts as an enzyme or coenzyme in a number of metabolic 
processes and is transformed in the body to at least two
compounds which possess 
enzymatic properties.   
 is required. 
i) Coenzyme B
12
 is required for conversion of propionate to
succinate, thus involving 
vitamin B
12
 in both fat and carbohydrate metabolism.   
ii) Methylcobalamin acts in a transmethylation process converting
homocysteine to 
methionine, thus involving vitamin B 
12
 in fat and protein metabolism. In some cases 
of vitamin B deficiency, severe

Summary of Product characteristics

1
Product Information
HYDROXO-B12
NAME OF MEDICINE
Hydroxocobalamin (vitamin B
12
Molecular formula: C
) as chloride.
62
H
90
ClCoN
13
O
15
Molecular weight is 1,383.
P.
CAS: 58288-50-9.
DESCRIPTION
Hydroxocobalamin is a dark red, odourless crystalline powder or
crystals. It
is soluble in water and alcohol, sparingly soluble in methyl alcohol
and
practically insoluble in acetone, chloroform and ether. HYDROXO-B12
also
contains sodium chloride 9.0 mg and hydrochloric acid for pH
adjustment
and water for injections. The pH of the solution is approximately 4.6.
PHARMACOLOGY
Several chemically related forms of vitamin B
12
, differing in slight modification of a
side chain attached to the cobalamin nucleus have been isolated. Two
such variants
of vitamin B
12
are cyanocobalamin and hydroxocobalamin. Vitamin B
12
is essential
2
for normal growth, haemopoiesis, production of all epithelial cells
and maintenance
of myelin throughout the nervous system. Whenever nucleic acid
synthesis occurs
and therefore whenever cell reproduction occurs, vitamin B
12
The amounts of vitamin B
12
needed to maintain normal blood forming functions are
small and low doses are sufficient to correct the usual symptoms of
vitamin B
12
deficiency. Vitamin B
12
acts as an enzyme or coenzyme in a number of metabolic
processes and is transformed in the body to at least two compounds
which possess
enzymatic properties.
is required.
i) Coenzyme B
12
is required for conversion of propionate to succinate, thus involving
vitamin B
12
in both fat and carbohydrate metabolism.
ii) Methylcobalamin acts in a transmethylation process converting
homocysteine to
methionine, thus involving vitamin B
12
in fat and protein metabolism. In some cases
of vitamin B deficiency, severe neurological symptoms develop, as
vitamin B
12
is
necessary for the formation of protein structures required for the
integrity of the
nerve cell and myelin sheath.
_PHARMACOKINETICS_
Hydroxocobalamin produces higher and more prolonged serum levels of
vitamin B
12
than cyanocobalamin when