Serebal™

SEREBAL 500 mcg tablet

SEREBAL 500 mcg/ml Injection

SEREBAL is a mecobalamin preparation used as a treatment for peripheral neuropathies, SEREBAL contains Mecoba­lamin, a vitamin B12-coenzyme that occurs in the blood and the cerebrospinal fluid; it is taken up by nerve tissues more actively and extensively than other homologues of vitamin B12.

Biochemically, SEREBAL promotes the metabolic pathways of nucleic acids, proteins and lipids through its involvement in trans-methylation reac­tion; thus, it exerts a repairing effect on injured nerve tissues. Clinically, SEREBAL is the pharmaceutical Product that has been shown, by double-blind clinical trials, to be effective and useful for the treatment of numbness, pain and paralysis due to peripheral neuropathies such as diabetic neuropathy and polyneuritis.

Composition and Strengths

SEREBAL Tablets are white, sugar-coated tablets.

Each tablet contains 500 mcg of mecobalamin

SEREBAL injection 500 mcg/ml is a clear red liquid contained in brown ampoules

Indication

Peripheral neuropathies

Megaloblastic anemia

 
Pharmacology

1. Mecobalamin is well transported to nerve cell organelles, and promotes nucleic acid and protein synthesis.

Mecobalamin is better transported to nerve cell organelles than cyanoco­balamin (in rats). It plays the role of a co enzyme in the synthesis of methionine from homocysteine. It has shown best results in experiments in which cells of brain and spinal nerve cells to be concerned in the synthesis of thymidine from deoxyuridine in nucleic acids and protein synth­esis.

2. Mecobalamin promotes axonal transport of skeletal protein and axonal regeneration.

Mecobalamin normalizes axonal transport of skeletal protein in sciatic nerve cells in rats with streptomycin-induced diabetes mellitus. It exhibits neuro physiological and electro physiological inhibitory effects on nerve degen­eration in neuropathies induced by drugs, such as adriamycist, acrylamide, and vincristine (in rats and rabbits), models of axonal degeneration in mice and neuropathies in rats with spontaneous diabetes mellitus.

3. Mecobalamin promotes myelination (phospholipid synthesis).

Mecobalamin promotes the synthesis of lecithin, the main constituent of medullary sheath lipid, by increasing methionine synthetase activity, thus promotes myelination.

4. Mecobalamin restores delayed synaptic transmission and diminished neurotransmitters toward normal.

Mecobalamin restores end-plate potential induction early by increasing nerve fiber excitability in the embedded sciatic nerve (rats). ln addition, mecobalamin normalizes diminished brain tissue levels of acetylecholine in cats fed a choline-deficient diet.
 

Precautions

1. General precautions

SEREBAL should not be used for more than one month unless it is effective.

2. Adverse Reactions (rarely : <0.1%, infrequently: 0.1 % - <5%, no specific designation:  > 5% or frequency unknown).

(1) Gastrointestinal

Symptoms such as anorexia, nausea or diarrhea may infrequently occur

  (2) Hypersensitivity

Rash may occur rarely.

3. Others

Prolonged use of larger doses of SEREBAL is not recommended for patients whose occupation requires handling mercury or its compounds.

Storage and Handling

1.- SEREBAL Tablet/Injection should be stored at room temperature.

2.- SEREBAL; Tablet/Injection should be protected from moisture and light, after unsealing. (Light decomposes the active ingredient)

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