Botulinum Toxin Type A 200 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 (200 Units)
QUALITATIVE AND QUANTITATIVE COMPOSITION:
- 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 for up to 24 hours in a refrigerator (2°-8°C). Store the 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 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)
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.
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.
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.
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.
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.
