AZACTAM Powder for solution for injection or infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Azactam 1 g Powder for Solution for Injection or Infusion. Azactam 2 g 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.
Pharmaceutical form
Powder for solution for injection or infusion.
Therapeutic indications
The treatment of the following infections caused by susceptible aerobic Gram-negative micro-organisms: Urinary tract infections: including pyelonephritis and cystitis (initial and recurrent) and asymptomatic ...
Posology and method of administration
Posology Intramuscular or intravenous injection, or intravenous infusion. Azactam is given by deep injection into a large muscle mass, such as the upper quadrant of the gluteus maximus or the lateral part ...
Contraindications
Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1. Aztreonam is contraindicated in pregnancy. Aztreonam crosses the placenta and enters the foetal circulation. ...
Special warnings and precautions for use
Allergic reactions Antibiotics, like other drugs, should be given with caution to any patients with a history of allergic reaction to structurally related compounds. If an allergic reaction occurs, discontinue ...
Interaction with other medicinal products and other forms of interaction
Concomitant administration of probenecid or furosemide and aztreonam cause clinically insignificant increases in the serum levels of aztreonam. Due to the induction of beta-lactamases, certain antibiotics ...
Pregnancy and lactation
Pregnancy Aztreonam is contraindicated in pregnancy. Aztreonam crosses the placenta and enters the foetal circulation. There are no adequate and well-controlled studies in pregnant women. Studies in pregnant ...
Effects on ability to drive and use machines
This medicine can have an important impact on the ability to drive and use of machines should encephalopathy occur (see 4.4 Special warnings and special precautions for use and 4.9 Overdose).
Undesirable effects
The list of undesirable effects shown below is presented by system organ class, MedDRA preferred term, and frequency. Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1000 to <1/100); rare (≥1/10,000 ...
Overdose
Use of beta-lactam containing therapies, including aztreonam, can cause encephalopathy (e.g. confusion, impairment of consciousness, epilepsy, movement disorders); particularly in patients with renal impairment ...
Pharmacodynamic properties
Pharmacotherapeutic group: Anti-infectives for systemic use ATC code: J01DF01 Aztreonam is a monocyclic beta-lactam antibiotic with potent bactericidal activity against a wide spectrum of Gram-negative ...
Pharmacokinetic properties
Single 30-minute i.v. infusions of 0.5 g, 1.0 g and 2.0 g in healthy volunteers produced peak serum levels of 54, 90 and 204 mg/L, and single 3-minute i.v. injections of the same doses produced peak levels ...
Preclinical safety data
Aztreonam was well tolerated in a comprehensive series of preclinical toxicity and safety studies.
List of excipients
L-arginine (780 mg per g of aztreonam)
Incompatibilities
Azactam should not be physically mixed with any other drug, antibiotic or diluent, except those listed in the Posology and Method of Administration section under Reconstitution for Intravenous infusion. ...
Shelf life
Shelf life Product unopened: 3 years. Reconstituted product: 24 hours (2-8°C).
Special precautions for storage
Product unopened: Storage before reconstitution: Do not store above 25°C. Reconstituted product: Stability after reconstitution: Store at 2-8°C for not more than 24 hours. Discard any unused solution. ...
Nature and contents of container
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 ...
Special precautions for disposal and other handling
Reconstitution Azactam for Injection 1 g or 2 g Vial are supplied in 15 mL vials. Upon the addition of the diluent the contents should be shaken immediately and vigorously. Vials of reconstituted Azactam ...
Marketing authorization holder
Bristol-Myers Squibb Pharmaceuticals Limited, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex, UB8 1DH
Marketing authorization number(s)
Azactam 1 g vial: PL 11184/0134 Azactam 2 g vial: PL 11184/0135
Date of first authorization / renewal of the authorization
15<sup>th</sup> October 1986 / 22<sup>nd</sup> November 1991 / 13<sup>th</sup> August 1998
Date of revision of the text
18 January 2019
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