Botulinum Toxin Type A 50 Units Technical Specification:

Product Name:Botulinum Toxin Type A
Brand Name:Generic
Strength:50 Units, 100 Units, 200 Units
Dosage Form:Lyophilized
Dry Powder Injection (Sterile) *Preservative Free
Packing:1 Vial
Route of Administration:For Intramuscular & Intradermal use
Pack Insert/Leaflet:PIL (Patient Information Leaflet), SmPC (Summary Product Characteristics)
Regulatory Documents:COA, MOA, COPP, FSC, Stability Studies, GMP, CTD Dossier
Therapeutic use:Neurotoxin, Chronic Migraine, Spastic Disorders, Cervical Dystonia, Analgesic
Indication: Botulinum toxin A is indicated for the prevention of chronic migraines, for the treatment of muscle spasms, cervical dystonia, axillary hyperhidrosis, strabismus, 15, and disorders of the 7th cranial nerve.
Storage:Stored for up to 24 hours in a refrigerator (2°-8°C). Store the unopened vial in a refrigerator (2°-8°C). Store in a fridge (2°-8°C) or store in a freezer (at or below -5°C).

GENERIC NAME OF MEDICINAL PRODUCT:

  • Botulinum Toxin Type A (50 Units)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

  • Botulinum Toxin Type A (50 Units)
    One vial contains:
    Botulinum Toxin Type A Complex
    Ph. Eur ……………………………………………50 Units
    Human Albumin,
    Ph. Eur/USP/JP ………………………………0.25mg
    Sodium Chloride BP/USP/JP ……………0.45mg
    Vacuum-dried powder contains
    no preservative.

THERAPEUTIC INDICATIONS:

Botulinum toxin A is indicated for the prevention of chronic migraines, for the treatment of muscle spasms, cervical dystonia, axillary hyperhidrosis, strabismus, 15, and disorders of the 7th cranial nerve.

DIRECTION OF USE:

Reconstitute with non-preserved saline.
After reconstitution, immediate use of the solution is recommended.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution.

Purified Neurotoxin Complex.

FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE

Disposal precautions: See the package insert.

WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Stored for up to 24 hours in a refrigerator (2°-8°C). Store the unopened vial in a refrigerator (2°-8°C). Store in a fridge (2°-8°C) or store in a freezer (at or below -5°C).

Keep all medicines out of reach of children.

Dosage: As directed by the Physician.

GENERIC NAME OF MEDICINAL PRODUCT:

A. Botulinum Toxin Type A (100 Units)
B. Botulinum Toxin Type A (50 Units)
C. Botulinum Toxin Type A (200 Units)

QUALITATIVE AND QUANTITATIVE COMPOSITION:

A. Botulinum Toxin Type A (100 Units)
One vial contains:
Botulinum Toxin Type A Complex
Ph. Eur ……………………………………………100 units
Human Albumin,
Ph. Eur/USP/JP ………………………………0.5mg
Sodium Chloride BP/USP/JP ……………0.9mg
Vacuum dried powder, contains
no preservative.

B. Botulinum Toxin Type A (50 Units)
One vial contains:
Botulinum Toxin Type A Complex
Ph. Eur ……………………………………………50 units
Human Albumin,
Ph. Eur/USP/JP ………………………………0.25mg
Sodium Chloride BP/USP/JP ……………0.45mg
Vacuum dried powder, contains
no preservative.

C. Botulinum Toxin Type A (200 Units)
One vial contains:
Botulinum Toxin Type A Complex
Ph. Eur ……………………………………………200 units
Human Albumin,
Ph. Eur/USP/JP ………………………………1mg
Sodium Chloride BP/USP/JP ……………1.8mg
Vacuum dried powder, contains
no preservative.

THERAPEUTIC INDICATIONS:

Botulinum toxin A is indicated for the prevention of chronic migraines, for the treatment of muscle spasms, cervical dystonia, axillary hyperhidrosis, strabismus, 15 and disorders of the 7th cranial nerve.

DIRECTION OF USE:

Reconstitute with non-preserved saline.
After reconstitution immediate use of the solution is recommended.

CAUTION & WARNING:

CAUTION: If any foreign particle is visible in the vial after reconstitution, please do not use the solution.
Purified Neurotoxin Complex.
FLIP-OFF SEAL IS PROVIDED FOR TAMPER EVIDENCE
Disposal precautions: See the package insert.
WARNING: Not to be sold by retail without the prescription of a Registered Medical Practitioner only.

STORAGE & DOSAGE:

Storage: Stored up to 24 hours in a refrigerator (2°-8°C). Store unopened vial in a refrigerator (2°-8°C).
Store in a refrigerator (2°-8°C) or store in a freezer (at or below -5°C).
Keep all medicines out of reach of children.
Dosage: As directed by Physician.