Phentolamine mesylate injection BP 5mg/ml Technical Specification:
| Product Name: | Phentolamine mesylate injection BP |
| Brand Name: | Pegitor |
| Strength: | 5mg/ml, 10mg/ml |
| Dosage Form: | Dry Powder Injection (Sterile) |
| Packing: | LYOPHILIZED Powder |
| Route of Administration: | FOR IM OR IV 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: | Antihypertensives, Antidotes, Alpha Blockers |
| Indication: | Phentolamine may also be used to reverse the effects of an anesthetic medicine in soft tissues, such as the lips and tongue. |
| Storage: | Store Protected from moisture at a temperature not exceeding 30°C |
GENERIC NAME OF MEDICINAL PRODUCT:
- Phentolamine mesylate injection BP 10mg/ml
- Phentolamine mesylate injection BP 5mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
1.Phentolamine mesylate injection BP 10mg/ml
Each ml contains:
Phentolamine mesylate BP………………10mg
Benzyl alcohol USP……………………………1%w/v
2.Phentolamine mesylate injection BP 5mg/ml
Each ml contains:
Phentolamine mesylate BP………………5mg
Benzyl alcohol USP……………………………0.5%w/v
THERAPEUTIC INDICATION:
Phentolamine Mesylate for Injection is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine.
CAUTION & Warning:
CAUTION: It is Dangerous to take this preparation Except in accordance with the medical advice.
Warning: Not to be sold by retail without the prescription of registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store Protected from moisture at a temperature not exceeding 30°C
Keep medicine out of reach of children.
The Injection should be discarded if any particles Appear.
Dosage: As directed by Physician
GENERIC NAME OF MEDICINAL PRODUCT:
a) Phentolamine mesylate injection BP 10mg/ml
b) Phentolamine mesylate injection BP 5mg/ml
b) Phentolamine mesylate injection BP 5mg/ml
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Phentolamine mesylate injection BP 10mg/ml
Each ml contains:
Phentolamine mesylate BP………………10mg
Benzyl alcohol USP…………………………...1%w/v
2. Phentolamine mesylate injection BP 5mg/ml
Each ml contains:
Phentolamine mesylate BP………………5mg
Benzyl alcohol USP…………………………...0.5%w/v
Each ml contains:
Phentolamine mesylate BP………………10mg
Benzyl alcohol USP…………………………...1%w/v
2. Phentolamine mesylate injection BP 5mg/ml
Each ml contains:
Phentolamine mesylate BP………………5mg
Benzyl alcohol USP…………………………...0.5%w/v
THERAPEUTIC INDICATION:
Phentolamine Mesylate for Injection is indicated for the prevention or treatment of dermal necrosis and sloughing following intravenous administration or extravasation of norepinephrine.
CAUTION & WARNING:
CAUTION: It is Dangerous to take this preparation Except in accordance with the medical advice.
Warning: Not to be sold by retail without the prescription of registered Medical Practitioner.
Warning: Not to be sold by retail without the prescription of registered Medical Practitioner.
STORAGE & DOSAGE:
Storage: Store Protected from moisture at a temperature not exceeding 30°C
Keep medicine out of reach of children.
The Injection should be discarded if any particles Appear.
Dosage: As directed by Physician
Keep medicine out of reach of children.
The Injection should be discarded if any particles Appear.
Dosage: As directed by Physician
