Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
Aztreonam
Bristol-Myers Squibb Pharmaceuticals uc
J01DF; J01DF01
Aztreonam
2 gram(s)
Powder for solution for injection/infusion
Product subject to prescription which may not be renewed (A)
Monobactams; aztreonam
Marketed
1985-03-05
________________________________________________________________________ PACKAGE LEAFLET: INFORMATION FOR THE PATIENT AZACTAM 1G OR 2G POWDER FOR SOLUTION FOR INJECTION OR INFUSION AZTREONAM PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING YOUR MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - PLEASE KEEP THIS LEAFLET. YOU MAY NEED TO READ IT AGAIN. - IF YOU HAVE ANY FURTHER QUESTIONS, ASK YOUR DOCTOR. THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU ONLY. DO NOT PASS IT ON TO OTHERS. IT MAY HARM THEM, EVEN IF THEIR SIGNS OF ILLNESS ARE THE SAME AS YOURS. IF YOU GET ANY SIDE EFFECTS, TALK TO YOUR DOCTOR OR PHARMACIST. THIS INCLUDES ANY POSSIBLE SIDE EFFECTS NOT LISTED IN THIS LEAFLET. WHAT IS IN THIS LEAFLET: 1. What Azactam is and what it is used for 2. What you need to know before you are given your medicine 3. How you will be given your medicine 4. Possible side effects 5. How to store your medicine 6. Contents of the pack and other information 1. WHAT AZACTAM IS AND WHAT IT IS USED FOR The name of this medicine is Azactam. The active ingredient in Azactam is aztreonam. Azactam is available in two strengths and each vial contains either 1g or 2g aztreonam as a powder for solution for injection or infusion. Aztreonam is an antibiotic and a member of the family of medicines called monobactams. Azactam also contains L-arginine. Azactam is for the treatment of serious infections caused by bacteria which require an antibiotic injection. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN YOUR MEDICINE DO NOT TAKE AZACTAM IF: You are allergic to aztreonam or L-arginine or any of the ingredients of this medicine (listed in Section 6) You are pregnant or planning to become pregnant WARNINGS AND PRECAUTIONS Talk to your doctor before taking Azactam. TAKE SPECIAL CARE WITH AZACTAM IF You have ever had an allergic reaction to any antibiotics You have diarrhoea or usually get diarrhoea when you take antibiotics or have ever suffered from problems with your stomach or intestines. If you develop Pročitajte cijeli dokument
Health Products Regulatory Authority 01 December 2022 CRN00D7QD Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Azactam 2 g Powder for Solution for Injection or Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 2g aztreonam. Excipients with known effect For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Powder for solution for injection or infusion A sterile white to off-white, sodium-free powder. 4 CLINICAL PARTICULARS 4.1 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 bacteriuria, including those due to pathogens resistant to the aminoglycosides, cephalosporins or penicillins. Gonorrhoea: Acute uncomplicated urogenital or anorectal infections including infections due to beta-lactamase producing or non-producing strains of _N. gonorrhoeae_. Lower respiratory tract infections: Including pneumonia, bronchitis and lung infections in patients with cystic fibrosis. Bacteraemia / septicaemia. Meningitis caused by _Haemophilus influenzae_ or _Neisseria meningitidis_. Since Azactam provides only Gram negative cover, it should not be given alone as initial blind therapy, but may be used with an antibiotic active against Gram positive organisms until the results of sensitivity tests are known. Bone and joint infections. Skin and soft tissue infections: Including those associated with postoperative wounds, ulcers and burns. Intra-abdominal infections: Peritonitis. Gynaecological infections: Pelvic inflammatory disease, endometritis, and pelvic cellulitis. Azactam is indicated for adjunctive therapy to surgery in the management of infections caused by susceptible organisms, including abscesses, infections complicating hollow viscus perforations, cutaneous infections and infections of serous surfaces. Bacteriological studies to determine the causative organism(s) and their Pročitajte cijeli dokument