ZINACEF Powder for injection / infusion Ref.[6607] Active ingredients: Cefuroxime

Posology

Table 1. Adults and children ≥40 kg:

Table 2. Children <40 kg:

Renal impairment

Cefuroxime is primarily excreted by the kidneys. Therefore, as with all such antibiotics, in patients with markedly impaired renal function it is recommended that the dosage of Zinacef should be reduced to compensate for its slower excretion.

Table 3. Recommended doses for Zinacef in renal impairment:

Hepatic impairment

Cefuroxime is primarily eliminated by the kidney. In patients with hepatic dysfunction this is not expected to affect the pharmacokinetics of cefuroxime.

Method of administration

Zinacef should be administered by intravenous injection over a period of 3 to 5 minutes directly into a vein or via a drip tube or infusion over 30 to 60 minutes, or by deep intramuscular injection.

Intramuscular injections should be injected well within the bulk of a relatively large muscle and not more than 750 mg should be injected at one site. For doses greater than 1.5 g intravenous administration should be used. For instructions on reconstitution of the medicinal product before administration, see section 6.6.

750 mg, 1.5 g powder for solution for infusion (Monovial presentation).

For instructions on preparation of the medicinal product before administration, see section 6.6.

Overdose can lead to neurological sequelae including encephalopathy, convulsions and coma. Symptoms of overdose can occur if the dose is not reduced appropriately in patients with renal impairment (see sections 4.2 and 4.4).

Serum levels of cefuroxime can be reduced by haemodialysis or peritoneal dialysis.

Shelf life: Three years when stored below 25°C and protected from light.

Store below 25°C and protect from light.

After constitution, Zinacef should be stored at 2-8°C for no longer than 24 hours.

1. Moulded glass (type 1 or III) vials with bromobutyl or fluoro-resin laminated butyl rubber plug, overseal and flip-off cap containing either 250mg, 750mg or 1.5g Zinacef.
2. A bulk pack of 100 vials.
3. Monovial containing either 750mg or 1.5g Zinacef with transfer needle.

* Only the 1.5g injection pack is marketed (the infusion pack is not)

Instructions for constitution

Table 4. Additional volumes and concentrations which may be useful when fractional doses are required:

* Reconstituted solution to be added to 50 or 100 mL of compatible infusion fluid (see information on compatibility, below)
** The resulting volume of the solution of cefuroxime in reconstitution medium is increased due the displacement factor of the drug substance resulting in the listed concentrations in mg/mL.

Zinacef 750 mg and 1.5 g powder for solution for infusion (Monovial presentation)

Preparation of solution for intravenous infusion

The contents of the Monovial are added to small volume infusion bags containing 0.9% w/v Sodium Chloride Injection BP, or 5% Dextrose Injection, or another compatible fluid.

1. Peel off the removable top part of the label and remove the cap.
2. Insert the needle of the Monovial into the additive port of the infusion bag.
3. To activate, push the plastic needle holder of the Monovial down onto the vial shoulder until a “click” is heard.
4. Holding it upright, fill the vial to approximately two-thirds capacity by squeezing the bag several times.
5. Shake the vial to reconstitute the cefuroxime sodium.
6. With the vial uppermost, transfer the reconstituted cefuroxime sodium into the infusion bag by squeezing and releasing the bag.
7. Repeat steps 4 to 6 to rinse the inside of the vial. Dispose of the empty Monovial safely. Check that the powder has dissolved, and that the bag has no leaks.

Compatibility

1.5 g cefuroxime sodium constituted with 15 mL Water for Injection may be added to metronidazole injection (500 mg/100 mL) and both retain their activity for up to 24 hours below 25°C.

1.5 g cefuroxime sodium is compatible with azlocillin 1 g (in 15 mL) or 5 g (in 50 mL) for up to 24 hours at 4°C or 6 hours below 25°C.

Cefuroxime sodium (5 mg/mL) in 5% w/v or 10% w/v xylitol injection may be stored for up to 24 hours at 25°C.

Cefuroxime sodium is compatible with aqueous solutions containing up to 1% lidocaine hydrochloride.

Cefuroxime sodium is compatible with the following infusion fluids. It will retain potency for up to 24 hours at room temperature in:

0.9% w/v Sodium Chloride Injection BP
5% Dextrose Injection BP
0.18% w/v Sodium Chloride plus 4% Dextrose Injection BP
5% Dextrose and 0.9% w/v Sodium Chloride Injection BP
5% Dextrose and 0.45% Sodium Chloride Injection
5% Dextrose and 0.225% Sodium Chloride Injection
10% Dextrose Injection
10% Invert Sugar in Water for Injection
Ringer’s Injection USP
Lactated Ringer’s Injection USP
M/6 Sodium Lactate Injection
Compound Sodium Lactate Injection BP (Hartmann’s Solution).

The stability of cefuroxime sodium in 0.9% w/v Sodium Chloride Injection BP and in 5% Dextrose Injection is not affected by the presence of hydrocortisone sodium phosphate.

Cefuroxime sodium has also been found compatible for 24 hours at room temperature when admixed in IV infusion with:

Heparin (10 and 50 units/mL) in 0.9% w/v Sodium Chloride Injection BP; Potassium Chloride (10 and 40 mEqL) in 0.9% w/v Sodium Chloride Injection BP.

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.