GENERIC NAME OF THE MEDICINAL PRODUCT:

A. Cerebroprotein hydrolysate for Injection (30mg)
B. Cerebroprotein hydrolysate for Injection (60mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Cerebroprotein hydrolysate for Injection (30mg)
Composition:
Each vial contains:
Cerebroprotein
hydrolysate………1050mg (approx)
Equivalent to Nitrogen……30mg
Excipients………………………q.s.
One Ampoule contains:
Sterile Water for Injection USP…………5ml


B. Cerebroprotein hydrolysate for Injection (60mg)
Composition:
Each vial contains:
Cerebroprotein
hydrolysate………2100mg (approx)
Equivalent to Nitrogen……60mg
Excipients………………………q.s.
One Ampoule contains:
Sterile Water for Injection USP…………10ml

THERAPEUTIC INDICATIONS:

Cerebroprotein Hydrolysate is used in the treatment of stroke, head injury and Alzheimer's disease. Cerebroprotein Hydrolysate is a nerve repairing medicine. It works on the brain by repairing the nerve cells and improves their survival.

DIRECTION OF USE:

Reconstituted solution: From a microbial point of view, the product should be used immediately.
If not use immediately, in the use storage time & conditions prior to use are the responsibility of the user, unless reconstitution has taken place in controlled & validated aseptic conditions.
For method of reconstitution, storage, administration, dosage & indications: Refer to the enclosed package insert.

CAUTION & WARNING:

CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Warning: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution & return for the replacement.
WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Do not freeze.
If not use immediately, the reconstituted solution can be stored at up to 25°C for up to 24 hours.
Keep all medicines out of reach of children.
Dosage: As directed by Physician.
Do not skip any doses and finish the full course of treatment even if you feel better.

Cerebroprotein hydrolysate for Injection 30mg Technical Specification:

Product Name:Cerebroprotein Hydrolysate for Injection 30mg
Brand Name:Ceretaj
Strength:30mg, 60mg
Dosage Form:Lyophilized
Dry Powder Injection (Sterile) *Preservative Free
Packing:1 Vial + 1 Ampule + WFI Tray
Route of Administration:For I.V. infusion only
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Anti-Alzheimer’s
Indication: Cerebroprotein Hydrolysate is used in the treatment of stroke, head injury and Alzheimer’s disease. Cerebroprotein Hydrolysate is a nerve repairing medicine. It works on the brain by repairing the nerve cells and improves their survival.
Storage:Store below 25°C. Do not freeze. If not use immediately, the reconstituted solution can be stored at up to 25°C for up to 24 hours.

GENERIC NAME OF MEDICINAL PRODUCT:

  • Cerebroprotein hydrolysate for Injection (30mg)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Cerebroprotein hydrolysate for Injection (30mg)
    Composition:
    a.Each vial contains:
    Cerebroprotein
    hydrolysate………1050mg (approx)
    Equivalent to Nitrogen……30mg
    Excipients………………………q.s.
    b.One Ampoule contains:
    Sterile Water for Injection USP…………5ml

 THERAPEUTIC INDICATIONS:

Cerebroprotein Hydrolysate is used in the treatment of stroke, head injury and Alzheimer’s disease. Cerebroprotein Hydrolysate is a nerve repairing medicine. It works on the brain by repairing the nerve cells and improves their survival.

DIRECTION OF USE:

Reconstituted solution: From a microbial point of view, the product should be used immediately.

If not use immediately, in the use storage time & conditions prior to use are the responsibility of the user, unless reconstitution has taken place in controlled & validated aseptic conditions.

For method of reconstitution, storage, administration, dosage & indications: Refer to the enclosed package insert.

CAUTION & WARNING:

CAUTION: Do not use the injection if the contents are not clear or contains visible particulate matter after reconstitution.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Warning: If any foreign particle is visible in the vial after dissolving the contents, please do not use the solution & return for the replacement.

WARNING: To be sold by retail on the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Store below 25°C.
Do not freeze.
If not use immediately, the reconstituted solution can be stored at up to 25°C for up to 24 hours.

Keep all medicines out of reach of children.

Dosage: As directed by Physician.
Do not skip any doses and finish the full course of treatment even if you feel better.