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Azactam 1g and 2g Powder for Solution for Injection or Infusion

*
Pharmacy Only: Prescription

  • Company:

    Bristol-Myers Squibb Pharmaceuticals uc

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Aztreonam

    *Additional information is available within the SPC or upon request to the company

Updated on 14 December 2022

File name

20221028-ie-azactam-spc-non-annotated.pdf

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 6.1 is updated to reflect the actual quantity of active ingredient. The minor adjustment of the quantitative composition of the finished product with respect to excipients


Updated on 14 December 2022

File name

20221028-ie-azactam-pil-non-annotated.pdf

Reasons for updating

  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 11 April 2022

File name

Approved-ie-azactam-pil-non annotated.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Free text change information supplied by the pharmaceutical company

Change in legal entity name from Swords Laboratories to Swords Laboratories Unlimited Company.

Updated on 18 May 2020

File name

Approved-pack-insert.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 07 January 2019

File name

Approved-pack-insert.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - driving and using machines
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 04 January 2019

File name

Approved Azactam IE SmPC.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text
  • Change to section 4 - Clinical particulars

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 07 August 2018

File name

2018 04 ie-spc-clean-1-2g-azactam.pdf

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 December 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 06 December 2017

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Change of name and address of MAH (Previous details: BMS Pharmaceuticals Ltd, Swords, Dublin).

Updated on 05 December 2017

File name

PIL_14572_419.pdf

Reasons for updating

  • New PIL for new product

Updated on 05 December 2017

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 08 September 2017

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Nature of the container updated to change the type of closure of the vial from aluminum crimp capsule to flip-off aluminum seal.

Updated on 07 September 2017

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision

Updated on 25 June 2015

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company


4.8       Undesirable effects

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via:

HPRA Pharmacovigilance

Earlsfort Terrace

IRL-Dublin 2

Tel: +353 1 6764971

Fax: +353 1 6762517

Website: www.hpra.ie

e-mail: medsafety@hpra.ie

10.       DATE OF REVISION OF THE TEXT

 

June 2015

Updated on 24 June 2015

Reasons for updating

  • Change to further information section
  • Addition of information on reporting a side effect.

Updated on 30 March 2015

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

4.2       Posology and method of administration - the below text have been added

Hepatic impairment:

 

A dose reduction of 20-25% is recommended for long-term treatment of patients with chronic liver disease with cirrhosis, especially in cases of alcoholic cirrhosis and when renal function is also impaired.

 



10.       DATE OF REVISION OF THE TEXT - the below text have been updated

March 2015

Updated on 25 March 2015

Reasons for updating

  • Change to date of revision

Updated on 07 January 2014

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

This Type IB application proposes to align the summary of product characteristics (SmPC) and the patient information leaflet to the current QRD template. In addition, minor typographical errors have been corrected and approved text moved to elsewhere in the document.

Updated on 23 December 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about driving or using machinery
  • Change to date of revision

Updated on 19 December 2013

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC uploaded in error (additional questions received from IMB for incorrect SPC uploaded). Therefore, previous version dated June 2011 re-uploaded.

Updated on 11 December 2013

Reasons for updating

  • Change to date of revision

Updated on 26 November 2013

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

 

 
This Type IB application proposes to align the summary of product characteristics (SmPC) and the patient information leaflet (PIL) to the current QRD template. In addition, minor typographical errors have been corrected and approved text moved to elsewhere in the document.

Updated on 21 November 2013

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to further information section
  • Change to date of revision

Updated on 25 April 2012

Reasons for updating

  • Addition of legal category
  • Change to improve clarity and readability

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Addition of legal category and formatting changes.

Updated on 19 April 2012

Reasons for updating

  • Change to improve clarity and readability

Updated on 05 September 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

SPC Sections 4.2, 4.4, 4.5, 4.6, 4.7, 4.8 and 4.9 of the SPC are updated in line with agreed Core Safety Profile (CSP) following the EU PSUR WS-Final Assessment Report

4.2 Posology and method of admnistration

Dosage Guide - simplified and following added

Moderately severe systemic infections

1 g or 2 g

8 or 12

IM or IV

 

Elderly:  Following text added:

Renal status is a major determinant of dosage in the elderly; these patients in particular may have diminished renal function.  Serum creatinine may not be an accurate determinant of renal status. Therefore, as with all antibiotics eliminated by the kidneys, estimates of creatinine clearance should be obtained, and appropriate dosage modifications made if necessary.

 

Renal Impairment:   Table replaced by the following text:

Prolonged serum levels of aztreonam may occur in patients with transient or persistent renal insufficiency. Therefore, after an initial usual dose, the dosage of aztreonam should be halved in patients with estimated creatinine clearances between 10 and 30 mL/min/1.73 m2.

 

In patients with severe renal failure (creatinine clearance less than 10 mL/min/1.73 m2), such as those supported by hemodialysis, the usual dose should be given initially. The maintenance dose should be one-fourth of the usual initial dose given at the usual fixed interval of 6, 8 or 12 hours. For serious or life-threatening infections, in addition to the maintenance doses, one-eighth of the initial dose should be given after each hemodialysis session.

 

Paediatrics: Following sentence added:

 

The maximum daily paediatric dose should not exceed the maximum recommended dose for adults.


4.4. Special warnings and precautions of use

 

Allergic reactions:  Following sentence added:

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 reactions occurs, discontinue the drug and institute supportive treatments as approprite.  Serious hypersensitivity reactions may require epinephrine and other emergency measures.

 

 

Following sections added:

 

Serious blood/skin disorders

Serious blood disorders (incl. pancytopenia) and skin disorders (incl. toxic epidermal necrolysis) have been reported with the use of aztreonam. In case of serious hemogram and skin changes, it is recommended to stop aztreonam.

 

Convulsions

Convulsions have rarely been reported during treatment with beta-lactams, including aztreonam (see section 4.8).


Clostridium difficile associated diarrhoea: Following sentence added:

 

Medication that inhibits intestinal peristalsis should not be given.

 

Overgrowth of non-susceptible organisms:  Updated as below:

 

Therapy with Azactam may result in overgrowth of non-susceptible organisms, including gram-positive organisms and fungi. Should superinfection occur during therapy, appropriate measures should be taken. 

 

Following sections added:

 

Prolongation of prothrombin time / increased activity of oral anticoagulants

Prolongation of prothrombin time has been reported rarely in patients receiving aztreonam. Additionally, numerous cases of increased activity of oral anticoagulants have been reported in patients receiving antibiotics, including beta-lactams. Severe infection or inflammation, and the age and general condition of the patient appear to be risk factors.  Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see section 4.5 and 4.8).

 

Concomitant use with aminoglycosides

If an aminoglycoside is used concurrently with aztreonam, especially if high dosages of the former are used or if therapy is prolonged, renal function should be monitored because of the potential nephrotoxicity and ototoxicity of aminoglycoside antibiotics.

 

Paediatric population

Data on safety and effectiveness in neonates younger than one week are limited; use in this population needs to be carefully assessed.

 

Arginine

Aztreonam for injection contains arginine.  Studies in low birth weight infants have demonstrated that arginine administered in the aztreonam formulation may result in increases in serum arginine, insulin, and indirect bilirubin. The consequences of exposure to this amino acid during treatment of neonates have not been fully ascertained.

 

Interference with serological testing

A positive direct or indirect Coombs test may develop during treatment with aztreonam.

 

 

4.5        Interaction with other medicinal products and other forms of interactions: 

 

Following added

 

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 (eg, cefoxitin, imipenem) have been found to cause antagonism with many beta-lactams, including aztreonam, for certain gram-negative aerobes, such as Enterobacter species and Pseudomonas species.

 

Appropriate monitoring should be undertaken when anticoagulants are prescribed concomitantly. Adjustments in the dose of oral anticoagulants may be necessary to maintain the desired level of anticoagulation (see section 4.4 and 4.8).

 

4.6        Use during pregnancy and lactation

 

Following added:

 

Aztreonam crosses the placenta and enters the foetal circulation.

There are no adequate and well-controlled studies in pregnant women.  Studies in pregnant rats and rabbits, with daily doses up to 15 and 5 times the maximum recommended human dose respectively, revealed no evidence of embryo- or fetotoxicity or teratogenicity. Because animal reproduction studies are not always predictive of human response, aztreonam should be used during pregnancy only if clearly needed.

 

4.7        Effects on ability to drive and use machines

 

Updated as follows:

 

No studies on the effects on the ability to drive and use machines have been performed.

 

4.8        Undesirable effects

 

A Table of list of undesirable effects presented by system organ class, MedDRA preferred term, and frequency replaces the text.

 

 

4.9        Overdose symptoms, emergency procedures, antidotes

 

Following added:

 

Aztreonam has been shown to be cleared from the serum by continuous arteriovenous hemofiltration.

 

 

 

Updated on 05 September 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to dosage and administration

Updated on 27 October 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 26 October 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.4 and 4.8: Revised to include information with regards to Clostridium difficile associated diarrhoea (CDAD).

Updated on 05 October 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Following sections revised following renewal

Section 2 - revised as per QRD template

Section 4.2 - reconstitution information moved to Section 6.6

Section 6.2 - revised as a result of Section 6.6

Section 6.6. - see 4.2. above

Sections 9 & 10 - renewal date and SPC revision date

Updated on 05 October 2010

Reasons for updating

  • Change to storage instructions
  • Change to further information section
  • Change to date of revision

Updated on 29 March 2010

Reasons for updating

  • Correction of spelling/typing errors
  • Improved electronic presentation

Updated on 04 February 2010

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 1, 2, 6.5 and 8 - Removal of 500mg strength

Updated on 03 February 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 15 August 2005

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 15 October 2004

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 20 August 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 22 May 2003

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)