GENERIC NAME OF MEDICINAL PRODUCT:

a) Phentolamine mesylate injection BP 10mg/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

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

Phentolamine mesylate injection BP 10mg/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:Antihypertensive, 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:

  1. Phentolamine mesylate injection BP 10mg/ml
  2. 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