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Zinacef 1.5g Powder for Solution for Injection or Infusion

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Updated on 1 February 2019 PIL

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 1 February 2019 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • 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 'Special warnings and precautions for use' - addition of intracameral use and ocular toxicity data and addition of sodium excipient warning statements.

Updated on 16 July 2015 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 16 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

Section 7 - change to Ireland MAH address

Updated on 15 July 2015 PIL

Reasons for updating

  • New PIL for new product

Updated on 15 July 2015 PIL

Reasons for updating

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

Updated on 21 April 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.1 - Pharmacodynamic properties
  • 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 – Clarification of method for intramuscular administration

Section 4.8 – Updated HPRA reporting details

Section 5.1 – Updated microbiological susceptibility tables

Updated on 20 April 2015 PIL

Reasons for updating

  • Change to dosage and administration
  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 22 July 2014 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4 - Clinical particulars
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5 - Pharmacological properties
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

Section 2 to 5.3 and section 6.5 – all text changed in line with the harmonised annexes

Updated on 18 July 2014 PIL

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to instructions about overdose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about drinking alcohol
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change of special precautions for disposal
  • Change due to harmonisation of PIL

Updated on 17 November 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 18 March 2010 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • 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 6.6 - 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

2.         Qualitative and Quantitative Composition

 

Each vial contains 1.5g of cefuroxime as cefuroxime sodium.

For a full list of excipients, see section 6.1

 

3.         Pharmaceutical Form

 
Powder for solution for intravenous injection or infusion.

A white to cream powder.

 

4.2       Posology and Method of Administration

 

Zinacef is administered by intravenous injection or infusion.

 

Zinacef is a white to cream powder to which appropriate amounts of water are added to prepare a yellowish solution for intravenous administration.

 

Adults: The total daily dosage is in the range of 1500 to 6000mg in divided doses, the usual dose is 750 mg thrice daily.

 

……etc

 

6.2       Incompatibilities

 

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

 

Zinacef should not be mixed in the syringe with aminoglycoside antibiotics.

 

The pH of 2.74% w/v Sodium Bicarbonate Injection BP considerably affects the colour of the solution and therefore this solution is not recommended for the dilution of Zinacef.

 

However, if required, for patients receiving Sodium Bicarbonate Injection by infusion the Zinacef may be introduced into the tube of the giving set.

 

6.3       Shelf Life

 

Powder

2 Years 24 months.  

 

Reconstituted Solution

Chemical and physical in-use stability has been demonstrated for 5 hours at 25°C.  From a microbiological point of view, the product should be used immediately.  If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless reconstitution/dilution (etc) has taken place in controlled and validated aseptic conditions.

 

Single use only. Discard any remaining contents after use.

 

6.4       Special Precautions for Storage

 

Do not store above 25°C.  Keep vial in the outer carton to protect from light.

For storage conditions following reconstitution, please refer to section 6.3.

 

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

 

Intravenous:

Dissolve Zinacef in Water for Injections using at least 15 ml for 1.5g cefuroxime to produce a yellowish solution.

 

Intravenous infusion:

Dissolve 1.5g of cefuroxime sodium in 15 ml of Water for Injections. Dissolve Zinacef in Water for Injections using at least 15 ml for 1.5g cefuroxime to produce a yellowish solution. Add the reconstituted solution of cefuroxime sodium to 50 or 100 ml of a compatible infusion fluid (see information on Compatibility below).

 

….etc

Updated on 17 September 2007 SmPC

Reasons for updating

  • Correction of spelling/typing errors

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

Updated on 10 August 2007 SmPC

Reasons for updating

  • 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)

Free text change information supplied by the pharmaceutical company

Special Warnings and Precautions for Use

Use of cefuroxime should be reserved for moderately serious or severe infections.

 

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.

 

Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with potent diuretics such as frusemide or aminoglycosides, as renal impairment has been reported with these combinations. Renal function should be monitored in these patients, the elderly, and those with pre-existing renal impairment (see 4.2 Posology and Method of Administration).

 

As with other antibiotics, prolonged use of cefuroxime may result in the overgrowth of Candida. Prolonged use may also result in the overgrowth of non-susceptible organisms (e.g. Candida, Enterococci,  and Clostridium difficile), which may require interruption of treatment.

 

As with other therapeutic regimens used in the treatment of meningitis, mild to moderate hearing loss has been reported in a few paediatric patients treated with cefuroxime sodium. Persistence of positive CSF cultures of Haemophilus influenzae at 18 to 36 hours has also been noted with cefuroxime sodium injection, as well as with other antibiotic therapies; however, the clinical relevance of this is not known
 
 
4.8               Undesirable Effects
 

Infections and infestations

Rare: Candida overgrowth from prolonged use.

 

Updated on 30 August 2006 SmPC

Reasons for updating

  • 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

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

Free text change information supplied by the pharmaceutical company

4.4. Special Warnings and Precautions for Use

Use of cefuroxime should be reserved for moderately serious or severe infections.

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.

Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with potent diuretics such as frusemide or aminoglycosides, as renal impairment has been reported with these combinations. Renal function should be monitored in these patients, the elderly, and those with pre-existing renal impairment (see 4.2 Posology and Method of Administration).

As with other antibiotics, prolonged use of cefuroxime may result in the overgrowth of non-susceptible organisms (e.g. Candida, enterococci, Clostridium difficile), which may require interruption of treatment..................

4.5 Interaction with Other Medicaments and other forms of Interaction

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

During intravenous administration admixture with other medications in solution should be avoided.

Cefuroxime has been shown to be compatible with metronidazole, azlocillin and xylitol.

Zinacef interferes with tests for glycosuria depending on copper reduction.

Sodium bicarbonate is not recommended for the dilution of Zinacef.

4.8 Undesirable effects

.......Immune system disorders
                                        Hypersensitivity reactions including
                                        Uncommon: Skin rash, urticaria and pruritus.

                                        Rare: Drug fever.

                                        Very rare: Interstitial nephritis, anaphylaxis, cutaneous vasculitis....................

Updated on 27 July 2006 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 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

4.4. Special Warnings and Special Precautions for Use

Use of cefuroxime should be removed for moderately serious or severe infections.

Special care is indicated in patients who have experienced an allergic reaction to penicillins or other beta-lactams.

Cephalosporin antibiotics at high dosage should be given with caution to patients receiving concurrent treatment with potent diuretics such as frusemide or aminoglycosides, as renal impairment has been reported with these combinations. Renal function should be monitored in these patients, the elderly, and those with pre-existing renal impairment (see 4.2 Posology and Method of Administration).

Prolonged use of anti-infective may result in the development of superinfection due to organisms resistant to that anti-infective.
As with other therapeutic regimens used in the treatment of meningitis, mild to moderate hearing loss has been reported in a few paediatric patients treated with cefuroxime sodium. Persistence of positive CSF cultures of Haemophilus influenzae at 18 to 36 hours has also been noted with cefuroxime sodium injection, as well as with other antibiotic therapies; however, the clinical relevance of this is not known.
 

4.8 Undesirable Effects

Adverse drug reactions are very rare (<1/10,000) and are generally mild and transient in nature.

The frequency categories assigned to the adverse reactions below are estimates, as for most reactions suitable data for calculating incidence are not available. In addition the incidence of adverse reactions associated with cefuroxime sodium may vary according to the indication.

Data from clinical trials were used to determine the frequency of very common to rare undesirable effects. The frequencies assigned to all other undesirable effects (i.e., those occurring at <1/1000) 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 1/10,

common 1/100 and <1/10,

uncommon 1/1000 and <1/100,

rare 1/10,000 and <1/1000,

very rare <1/10,000.

Infections and infestations

Rare: Candida overgrowth from prolonged use.

Blood and lymphatic system disorders

Common: Neutropenia, eosinophilia.

Uncommon: Leukopenia, decreased haemoglobin concentration, positive Coomb’s test.

Rare: Thrombocytopenia.

Very rare: Haemolytic anaemia.

Cephalosporins as a class tend to be absorbed onto the surface of red cell membranes and react with antibodies directed against the drug to produce a positive Coomb’s Test (which can interfere with cross matching of blood) and very rarely haemolytic anaemia.

Immune system disorders

Hypersensitivity reactions including

Uncommon: Skin rash, urticaria and pruritus.

Rare: Drug fever.

Very rare: Interstitial nephritis, anaphylaxis.

See also Skin and subcutaneous tissue disorders and Renal and urinary disorders.

Gastrointestinal disorders

Uncommon: Gastrointestinal disturbance.

Very rare: Pseudomembranous colitis.

Hepatobiliary disorders

Common: Transient rise in liver enzymes.

Uncommon: Transient rise in bilirubin.

Transient rises in serum liver enzymes or bilirubin occur, particularly in patients with pre-existing liver disease, but there is no evidence of harm to the liver.

Skin and subcutaneous tissue disorders

Very rare: Erythema multiforme, toxic epidermal necrolysis and Stevens Johnson Syndrome.

See also Immune system disorders.

Renal and urinary disorders

Very rare: Elevations in serum creatinine, elevations in blood urea nitrogen and decreased creatinine clearance ( See Warnings and Precautions).

See also Immune system disorders.

General disorders and administration site conditions

Common Injection site reactions which may include pain and thrombophlebitis
Pain at the intramuscular injection site is more likely at higher doses. However it is unlikely to be a cause for discontinuation of treatment.
 

6.6 Instructions for Use and Handling

Intravenous: Dissolve Zinacef in Water for Injections using at least 15 ml for 1.5g cefuroxime.

Intravenous infusion:

Dissolve 1.5g of cefuroxime sodium in 15 ml of Water for Injections. Add the reconstituted solution of cefuroxime sodium to 50 or 100 ml of a compatible infusion fluid (see information on Compatibility below)

These solutions may be given directly into the vein or introduced into the tubing of the giving set if the patient is receiving parenteral fluids.

Compatibility:

Cefuroxime sodium is compatible with the more commonly used i.v. infusion fluids. It will retain potency for up to 24h at room temperature in:

Sodium Chloride Injection 0.9% w/v

5% Dextrose Injection

0.18% w/v Sodium Chloride plus 4% Dextrose Injection

Compound Sodium Lactate Injection (Hartmann's Solution).

Dextran 40

Dextran 70

Intraperitoneal dialysis fluid (lactate)

The pH of 2.74% w/v Sodium Bicarbonate Injection considerably affects the colour of the solution and therefore this solution is not recommended for the dilution of Zinacef. However, if required, for patients receiving Sodium Bicarbonate Injection by infusion the Zinacef may be introduced into the tube of the giving set.

Updated on 1 November 2005 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

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

Updated on 13 October 2004 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 9 August 2004 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation

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

Updated on 3 July 2003 SmPC

Reasons for updating

  • Improved electronic presentation

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

Updated on 3 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

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