SYRENEV PLUS Capsule Ref.[115622] Active ingredients: Pregabalin Vitamin B12

Source: Registered Drug Product Database (NG)  Publisher: SUNRISE REMEDIES PVT. LTD., At: Block No. 2244, At & Post-Santej, Tal-Kalol. Dist-Gandhinagar

Product name and form

1.1 (Invented) Name of the medicinal product

SYRENEV PLUS (PREGABALIN AND METHYLCOBALAMIN CAPSULES (75MG/750MCG)).

1.2 Strength

Each hard gelatin capsule contains:

Pregabalin BP 75 mg

Methylcobalamin 750 mcg

Excipients Q.S.

Approved colour used in empty capsule shell.

1.3 Pharmaceutical Form

Hard Gelatin Capsule.

Pharmaceutical Form

Maroon/Yellow colored hard gelatin capsule containing with white colored powder ("2" size) capsule.

Qualitative and quantitative composition

Batch Size: 1,00,000 Capsules.

Sr.
No.
Name of IngredientQuantity/
Capsule
(mg)
Quantity/
Batch
(Kg)
%Functions
Mixing
1.Pregabalin BP75.0007.50030.000%Anti-epileptics
2.Colloidal anhydrous silica BP2.0000.2000.800%Disintegrant
3.Base Granules of Starch/DCP IHS165.06016.50666.024%Diluent
4.Croscarmellose sodium BP5.0000.5002.000%Disintegrant
5.Magnesium Stearate BP2.0000.2000.800%Lubricant
6.Methylcobalamin IHS0.9400.0940.376%Anti-anemic
agent
Total Weight of Filled Powder250.000 mg25.000 Kg100% 
7.Capsule Maroon/yellow size "2"
IHS
Q.S.1,00,000
Nos.
---Capsule
Shell
Active Ingredient

Pregabalin binds to an auxiliary subunit (α2-δ protein) of voltage-gated calcium channels in the central nervous system.

Hydroxocobalamin is used in the treatment and prevention of Vitamin B12 deficiency. For adults, the daily requirement of Vitamin B12 is probably about 1 to 2 micrograms and this amount is present in most normal diets. However, Vitamin B12 only occurs in animal products, not in vegetables, and therefore strict vegetarian or vegan diets that exclude dairy products may provide an inadequate amount, although a deficiency may not be apparent for many years.

List of Excipients
ExcipientsSpecification
Colloidal anhydrous silicaBP
Base Granules of Starch/DCPIHS
Croscarmellose sodiumBP
Magnesium StearateBP

Pack sizes and marketing

3 x 10 Capsules Alu-Alu Blisters packed in printed carton along with package insert.

Marketing authorization holder

SUNRISE REMEDIES PVT. LTD., At: Block No. 2244, At & Post-Santej, Tal-Kalol. Dist-Gandhinagar

Marketing authorization dates and numbers

SUNRISE REMEDIES PVT. LTD., At: Block No. 2244, At & Post-Santej, Tal-Kalol. Dist-Gandhinagar

Drugs

Drug Countries
SYRENEV PLUS Nigeria

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