Fortum 500mg Powder for Solution for Injection

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Summary of Product Characteristics last updated on medicines.ie: 1/7/2016
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GlaxoSmithKline (Ireland) Ltd

GlaxoSmithKline (Ireland) Ltd

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When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 1 July 2016 PIL

Reasons for updating

  • Change to storage instructions
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Change due to harmonisation of PIL
  • Discontinuation of one or more strengths
  • Improved electronic presentation

Updated on 1 July 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 July 2016 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • 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
  • Change to improve clarity and readability
  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company

 Section 2:             editorial changes + addition of sodium excipient – harmonised text

Section 3:              powder description – harmonised text

Section 4.4:           sodium quantity clarification – harmonised text

Section 6.2:           administrative update – harmonised text

Sections 6.3:         Reconstituted storage and shelf life has been added on reconstitution and dilution + microbiological statements

Sections 6.4:         editorial changes update, reference to reconstituted storage conditions added – harmonised text

Section 6.5:           description update – harmonised text

Section 6.6:           instructions for constitution clarified by tables for powder for injection and powder for solution for infusion – harmonised text

Section 9:              editorial changes  update

Updated on 1 July 2016 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 23 June 2016 PIL

Reasons for updating

  • Previous version of PIL reinstated

Updated on 10 December 2015 PIL

Reasons for updating

  • Change to date of revision

Updated on 14 August 2015 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • 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

Section 4.4 – Additions of sub-headings for W&P (QRD)
Section 4.8 - To include Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) as an Adverse Event with frequency “unknown”
Section 7 – Update to MAH Address Change
Section 10 - Update date of revision of text

Updated on 12 August 2015 PIL

Reasons for updating

  • Change to side-effects
  • Change to date of revision
  • Change to MA holder contact details

Updated on 17 July 2015 SmPC

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 to address of the MA Holder

Updated on 17 July 2015 PIL

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 16 February 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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

Section 4.2 – Changes to the method of administration and administrative changes.
Section 4.3 – changes to align with the latest QRD template.
Section 4.8- Addition of reporting details.
Section 5.1- update to bacterial susceptibility.
Section 6.6 Administrative changes.
Section 10- update to the revision of the text date.

Updated on 13 February 2015 PIL

Reasons for updating

  • Change to side-effects
  • Addition of information on reporting a side effect.

Updated on 27 November 2012 PIL

Reasons for updating

  • Change to, or new use for medicine

Updated on 13 August 2009 SmPC

Reasons for updating

  • Change to section 6.2 - Incompatibilities
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition

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

Free text change information supplied by the pharmaceutical company



SUMMARY OF PRODUCT CHARACTERISTICS CHANGES (Marked in red)

 

500mg (PA 1077/7/1)

 

1.       NAME OF THE MEDICINAL PRODUCT

 

Fortum 500mg Powder for Solution for Injection

 

2.       QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each vial contains 500mg of ceftazidime (as pentahydrate).

When reconstituted as directed, the reconstituted solution contains 500mg ceftazidime (as sodium salt).

Excipients: Contains approximately 26mg sodium per vial.

 

            For a full list of excipients, see section 6.1

 

6.2     Incompatibilities

 

Fortum is less stable in Sodium Bicarbonate Injection than in other intravenous fluids.  It is not recommended as a diluent.

 

Ceftazidime and aminoglycosides should not be mixed in the same giving set or syringe.

Precipitation has been reported with vanomycin added to ceftazidime in solution. Therefore, it would be prudent to flush giving sets and intravenous lines between administration of these agents.

 

This medicinal product must not be mixed with other medicinal products except those mentioned in 6.6.

 

Updated on 26 August 2008 SmPC

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

Section 10:
 
Date from "June 2006" to "November 2007"

Updated on 5 December 2007 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • 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 4.8 - Undesirable effects
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.6 - Special precautions for disposal and other handling

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

Free text change information supplied by the pharmaceutical company

1.         NAME OF THE MEDICINAL PRODUCT

 

Fortum for Injection 500mg Powder for Solution for Injection

 

3.         PHARMACEUTICAL FORM

 

            Powder for solution for injection or infusion

            A white to cream powder in a clear glass vial with a rubber closure.

 

4.4       Special Warnings and Special Precautions for Use

 

Cross-resistance and cross-sensitisation may exist between penicillins and cephalosporins.

 

Before beginning treatment establish whether a patient has a history of hypersensitivity reactions to ceftazidime, cephalosporins, penicillins or other drugs.

 

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.  If an allergic reaction occurs discontinue the drug.  Serious hypersensitivity reactions may require epinephrine (adrenaline), hydrocortisone, antihistamine or other emergency measures.

 

Prolonged use of an anti-infective may result in the development of superinfection due to organisms resistant to that anti-infective.

 

As with other extended-spectrum cephalosporins and penicillins, some initially susceptible strains of Enterobacter spp. and Serratia spp. may develop resistance during ceftazidime therapy.  When clinically appropriate during therapy of such infections, periodic susceptibility testing should be considered. 

 

Use of this anti-infective in the presence of renal insufficiency requires careful monitoring of dosage to avoid excessive accumulation in blood. Blood urea nitrogen levels are influenced by diet and by tissue breakdown, therefore renal function is more appropriately gauged by creatinine clearance. The maximum dose should be limited to 2 g in 24 hours in patients with oliguria or creatinine clearance of 50-31 ml/min.  The reason being that blood urea nitrogen levels are influenced by diet and tissue break down, therefore renal function is more appropriately gauged by creatinine clearance.

 

Ceftazidime is eliminated via the kidneys, therefore the dosage should be reduced according to the degree of renal impairment. Neurological sequelae have occasionally been reported when the dose has not been reduced appropriately (see Dosage in Impaired Renal Function).

 

A positive Coombs¡¯ may occur.

 

4.5                   Interactions with other Medicaments Medicinal Products and Other Forms of Interaction

 

Ceftazidime may interfere with tests for glucose using copper reagents, but does not affect enzyme-based tests for glycosuria, nor the alkaline picrate assay for creatinine.

 

Concurrent use at high doses with nephrotoxic drugs including frusemide, and some aminoglycosides may increase the risk of renal toxicity. Kidney function should be monitored carefully.

 

Ceftazidime at high doses may increase the activity of hepatic mixed function oxidases and hence affect the activity of drugs dependent on this metabolic system. No such effects have so far been recorded at therapeutic doses.

 

Chloramphenicol is antagonistic in vitro with ceftazidime and other cephalosporins. The clinical relevance of this finding is unknown, but if concurrent administration of ceftazidime with chloramphenicol is proposed, the possibility of antagonism should be considered.

 

In common with other antibiotics, ceftazidime may affect the gut flora, leading to lower oestrogen reabsorption and reduced efficacy of combined oral contraceptives.

 

4.8       Undesirable Effects

 

            Local:

Repeated intravenous administration may induce thrombophlebitis. Local pain at the site of injection may follow intramuscular administration. As with other cephalosporins, there have been rare reports of toxic epidermal necrolysis.

 

            Hypersensitivity:

Maculopapular or urticarial rash, fever, pruritis, anaphylactic reactions and very rarely angioedema and anaphylaxis including bronchospasm and hypotension may occur.

 

As with other cephalosporins, there  have been rare reports of erythema multiform, Stevens-Johnson syndrome, and toxic epidermal necrolysis. 

 

Gastrointestinal:

Gastrointestinal upset including, diarrhoea; nausea; vomiting; abdominal pain, oral thrush; colitis have been reported. As with other cephalosporins, colitis may be associated with Clostridium difficile and may present as pseudomembranous colitis.

 

Genito-urinary:

Candidiasis and vaginitis have been reported.

 

Hepatobiliary tract and pancreas:

            Very rarely jaundice

 

            CNS:

Headache, dizziness, bad taste and paraesthesia have been reported. There have been reports of neurological sequelae including tremor, myoclonia, convulsions, and encephalopathy in patients with renal impairment in whom the dose of ceftazidime has not been appropriately reduced.

 

            Transient laboratory test changes:

Transient changes noted during ceftazidime therapy include eosinophilia, thrombocytosis and elevations in one or more of the hepatic enzymes, ALT (SGPT), AST (SGOT), LDH, GGT and alkaline phosphatase. As with other cephalosporins, transient elevations of blood urea, blood urea nitrogen and/or serum creatinine have been observed occasionally. Very rarely leucopenia, neutropenia, agranulocytosis, thrombocytopenia and lymphocytosis have been reported.

 

Data from large clinical trials (internal and published) were used to determine the frequency of very common to uncommon undesirable effects.  The frequencies assigned to all other undesirable effects were mainly determined using post-marketing data and refer to a reporting rate rather than a true frequency. 

 

The following convention has been used for the classification of frequency:- 

very common ¡Ý1/10,

common ¡Ý1/100 and <1/10,

uncommon ¡Ý1/1000 and<1/100,

rare ¡Ý1/10,000 and <1/1000,

very rare <1/10,000.

 

Infections and infestations

Uncommon:     Candidiasis (including vaginitis and oral thrush)

 

Blood and lymphatic system disorders

Common:         Eosinophilia and thrombocytosis.

 

Uncommon:     Leucopenia, neutropenia, and thrombocytopenia,

 

Very Rare:       Lymphocytosis, haemolytic anaemia and agranulocytosis.

 

Immune system disorders

Very Rare:       Anaphylaxis (including bronchospasm and/or hypotension).

 

Nervous system disorders

Uncommon:     Headache and dizziness

 

Very Rare:       Paraesthesia

 

There have been reports of neurological sequelae including tremor, myoclonia, convulsions, encephalopathy and coma in patients with renal impairment in whom the dose of ceftazidime has not been appropriately reduced.

 

Vascular disorders

Common:         Thrombophlebitis with IV administration.

 

Gastrointestinal disorders

Common:         Diarrhoea

 

Uncommon:     Nausea, vomiting, abdominal pain, and colitis

 

Very Rare:       Bad taste

 

As with other cephalosporins, colitis may be associated with Clostridium difficile and may present as pseudomembranous colitis.

 

Hepatobiliary disorders

Common:         Transient elevations in one or more of the hepatic enzymes, ALT (SGPT), AST (SOGT), LDH, GGT and alkaline phosphatase.

 

Very Rare:       Jaundice.

 

Skin and subcutaneous tissue disorders

Common:         Maculopapular or urticarial rash

 

Uncommon:     Pruritus

 

Very Rare:       Angioedema, erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis. 

 

General disorders and administration site conditions

Common:         Pain and/or inflammation after IM injection.

 

Uncommon:     Fever

 

Investigations

Uncommon:     As with some other cephalosporins, transient elevations of blood urea, blood urea nitrogen and/or serum creatinine have been observed

 

6.2       Incompatibilities

 

Fortum is less stable in Sodium Bicarbonate Injection than in other intravenous fluids.  It is not recommended as a diluent.

 

Ceftazidime and aminoglycosides should not be mixed in the same giving set or syringe.

Precipitation has been reported with vanomycin added to ceftazidime in solution. Therefore, it would be prudent to flush giving sets and intravenous lines between the administration of these two agents.

Therefore it would be prudent to flush giving sets and i.v. lines between administration of these two agents.

 

6.6       Instructions for Use and Handling Special precautions for disposal of a used medicinal product or waste materials derived from such medicinal product and other handling of the product

 

Fortum is compatible with most commonly used intravenous fluids.

 

Vials of Fortum for Injection do not contain any preservatives and should be used as single-dose preparations.

 

All sizes of vials of Fortum for Injection as supplied are under reduced pressure. As the product dissolves, carbon dioxide is released and a positive pressure develops.  Small bubbles of carbon dioxide in the constituted solution may be ignored.

 

Preparation of Solution

 

 

Vial Size

 

 

Amount of Diluent to be added (ml)

Approximate Concentration (mg/ml)

500 mg

intramuscular

1.5 ml

260

 

intravenous

5 ml

90

1 g

intramuscular

3 ml

260

 

intravenous

10 ml

90

2 g

intravenous bolus

10 ml

170

 

intravenous infusion

50 ml*

40

 

*Addition should be in 2 stages (see text).

 

Fortum is compatible with most commonly used intravenous fluids. However, Sodium Bicarbonate Injection is not recommended as a diluent (see 6.2 Incompatibilities).

 

Solutions range from light yellow to amber depending on concentration, diluent and storage conditions used. Within the stated recommendations, product potency is not adversely affected by such colour variations.

 

Ceftazidime at concentrations between 1 mg/ml and 40 mg/ml is compatible with:

0.9% Sodium Chloride Injection

M/6 Sodium Lactate Injection

Compound Sodium Lactate Injection (Hartmann's Solution).

5% Dextrose Injection

0.225% Sodium Chloride and 5% Dextrose Injection

0.45% Sodium Chloride and 5% Dextrose Injection

0.9% Sodium Chloride and 4% Dextrose Injection

10% Dextrose Injection

Dextran 40 Injection 10% in 0.9% Sodium Chloride Injection

Dextran 40 Injection 10% in 5% Dextrose Injection

Dextran 70 Injection 6% in 0.9% Sodium Chloride Injection

Dextran 70 Injection 6% in 5% Dextrose Injection

 

Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with Intra-peritoneal Dialysis Fluid (Lactate).

 

Ceftazidime may be constituted for intramuscular use with 0.5% or 1% Lignocaine Hydrochloride Injection.

 

Both components retain satisfactory potency when ceftazidime at 4 mg/ml is admixed with:

Hydrocortisone (hydrocortisone sodium phosphate) 1 mg/ml in 0.9% Sodium Chloride Injection or 5% Dextrose Injection.

Cefuroxime (cefuroxime sodium) 3 mg/ml in 0.9% Sodium Chloride Injection.

Cloxacillin (cloxacillin sodium) 4 mg/ml in 0.9% Sodium Chloride Injection.

Heparin 10 IU/ml or 50 IU/ml in 0.9% Sodium Chloride Injection.

Potassium Chloride 10 mEq/I or 40 m Eq/I in 0.9% Sodium Chloride Injection.

 

The contents of a 500 mg vial of Fortum for Injection, reconstituted with 1.5 ml Water for Injections, may be added to metronidazole injection (500 mg in 100 ml) and both retain their activity.

 

Preparation of solutions for IM or IV bolus injection:

1.         Introduce the syringe needle through the vial closure and inject the recommended volume of diluent.

2.       Withdraw the needle and shake the vial to give a clear solution.

3.         Invert the vial. With the syringe piston fully depressed, insert the needle into the solution.  Withdraw the total volume of solution into the syringe ensuring that the needle remains in the solution.  Small bubbles of carbon dioxide may be disregarded.

 

Preparation of solutions for IV infusion:

1.         Introduce the syringe needle through the vial closure and introduce the syringe needle through the vial closure and inject the recommended volume of diluent.

2.         Withdraw the needle and shake the vial to give a clear solution.

3.         Insert a gas relief needle through the vial closure to relieve the internal pressure. With the gas relief in place, add the remainder of the diluent. Remove both gas relief needle and syringe needle; shake the vial and set up for infusion use in the normal way.

 

Note: To preserve product sterility, it is important that a gas relief needle is not inserted through the vial closure before the product has dissolved.

 

Preparation of Solution

Vial Size

Route of administration

Diluent

Amount of Diluent to be added

Approximate Concentration (mg/ml)

500mg

Intramuscular

Water for Injection or 0.5% or 1% Lignocaine Hydrochloride Injection

1.5ml

260

500mg

Intravenous Bolus

Water for Injection

5ml

90

 

Vials of Fortum do not contain any preservatives and should be used as single-dose preparations.

All sizes of vials of Fortum 500mg as supplied are under reduced pressure. As the product dissolves, carbon dioxide is released and a positive pressure develops. Small bubbles of carbon dioxide in the constituted solution may be ignored.

Solutions range from light yellow to amber depending on concentration, diluent and storage conditions used. Within the stated recommendations, product potency is not adversely affected by such colour variations.

The contents of a 500 mg vial of Fortum for Injection, reconstituted with 1.5 ml Water for Injections, may be added to metronidazole injection (500 mg in 100 ml) and both retain their activity.

Fortum may be constituted for intramuscular use with 0.5% or 1% Lignocaine Hydrochloride Injection.

Fortum is compatible with most commonly used intravenous fluids. However, Sodium Bicarbonate Injection is not recommended as a diluent (see 6.2 Incompatibilities).

 

Both components retain satisfactory potency when ceftazidime at 4 mg/ml is admixed with:

Hydrocortisone (hydrocortisone sodium phosphate) 1 mg/ml in 0.9% Sodium Chloride Injection or 5% Dextrose Injection.

Cefuroxime (cefuroxime sodium) 3 mg/ml in 0.9% Sodium Chloride Injection.

Cloxacillin (cloxacillin sodium) 4 mg/ml in 0.9% Sodium Chloride Injection.

Heparin 10 IU/ml or 50 IU/ml in 0.9% Sodium Chloride Injection.

Potassium Chloride 10 mEq/I or 40 m Eq/I in 0.9% Sodium Chloride Injection

 

Ceftazidime at concentrations between 0.05 mg/ml and 0.25 mg/ml is compatible with Intra-peritoneal Dialysis Fluid (Lactate).

 

Preparation of solutions for IM and IV bolus injection:

1.       Introduce the syringe needle through the vial closure and inject the recommended volume of diluent.

2.       Withdraw the needle and shake the vial to give a clear solution.

3.       Invert the vial. With the syringe piston fully depressed, insert the needle into the solution.  Withdraw the total volume of solution into the syringe ensuring that the needle remains in the solution.  Small bubbles of carbon dioxide may be disregarded.

 

 

Updated on 4 December 2007 PIL

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to warnings or special precautions for use

Updated on 9 March 2007 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 25 May 2005 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 22 October 2003 SmPC

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 4.8 - Undesirable effects

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

Updated on 1 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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