AZACTAM Powder for solution for injection or infusion Ref.[8665] Active ingredients: Aztreonam

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2023  Publisher: Bristol-Myers Squibb Pharmaceuticals Unlimited Company, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, Dublin, D15 T867

Product name and form

Azactam 1 g Powder for Solution for Injection or Infusion.

Azactam 2 g Powder for Solution for Injection or Infusion.

Pharmaceutical Form

Powder for solution for injection or infusion.

Qualitative and quantitative composition

Each vial contains 1 g aztreonam.

Each vial contains 2 g aztreonam.

For the full list of excipients, see section 6.1.

Active Ingredient Description
Aztreonam

Aztreonam exhibits activity in vitro against gram-negative aerobic pathogens, including P. aeruginosa. Aztreonam binds to penicillin-binding proteins of susceptible bacteria, which leads to inhibition of bacterial cell wall synthesis, followed by filamentation and cell lysis.

List of Excipients

L-arginine 780 mg per g of aztreonam
L-arginine 1.54 g per 2 g of aztreonam

Pack sizes and marketing

Type III clear molded glass vials, closed with silicone grey butyl rubber closure, and sealed with aluminium seal with flip off plastic button:

1 g glass vials: pack of 1 × 15 mL

2 g glass vials: pack of 1 × 15 mL

Marketing authorization holder

Bristol-Myers Squibb Pharmaceuticals Unlimited Company, Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, Dublin, D15 T867

Marketing authorization dates and numbers

Azactam 1 g vial: PL 12038/0002
Azactam 2 g vial: PL 12038/0003

15th October 1986 / 22nd November 1991 / 13th August 1998

Drugs

Drug Countries
AZACTAM Austria, Spain, Finland, France, Ireland, Japan, Malta, New Zealand, Singapore, United Kingdom, United States

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