Rocephin 250mg, 1g and 2g vials Ref.[2631] Active ingredients: Ceftriaxone

Rocephin may be administered by deep intramuscular injection, slow intravenous injection, or as a slow intravenous infusion, after reconstitution of the solution according to the directions given below.

Diluents containing calcium, (e.g. Ringer’s solution or Hartmann’s solution), should not be used to reconstitute ceftriaxone vials or to further dilute a reconstituted vial for IV administration because a precipitate can form. Precipitation of ceftriaxone-calcium can also occur when ceftriaxone is mixed with calcium-containing solutions in the same IV administration line. Therefore, ceftriaxone and calcium-containing solutions must not be mixed or administered simultaneously (see sections 4.3, 4.4 and 6.2).

Dosage and mode of administration should be determined by the severity of the infection, susceptibility of the causative organism and the patient’s condition. Under most circumstances a once-daily dose – or, in the specified indications, a single dose – will give satisfactory therapeutic results.

Adults and children 12 years and over

Standard therapeutic dosage: 1g once daily.

Severe infections: 2 – 4g daily, normally as a single dose every 24 hours.

The duration of therapy varies according to the course of the disease. As with antibiotic therapy in general, administration of Rocephin should be continued for a minimum of 48 to 72 hours after the patient has become afebrile or evidence of bacterial eradication has been obtained.

Acute, uncomplicated gonorrhoea: A single dose of 250mg intramuscularly should be administered. Simultaneous administration of probenecid is not indicated.

Peri-operative prophylaxis: Usually 1g as a single intramuscular or slow intravenous dose. In colorectal surgery, 2g should be given intramuscularly (dosages greater than 1g should be divided and injected at more than one site), or by slow intravenous infusion, in conjunction with a suitable agent against anaerobic bacteria.

Elderly

These dosages do not require modification in elderly patients provided that renal and hepatic function are satisfactory (see below).

Neonates, infants and children up to 12 years

The following dosage schedules are recommended for once daily administration:

Neonates

A daily dose of 20 – 50mg/kg body weight, not to exceed 50mg/kg. In the neonate, the intravenous dose should be given over 60 minutes to reduce the displacement of bilirubin from albumin, thereby reducing the potential risk of bilirubin encephalopathy (see section 4.4).

Infants and children of up to 12 years

Standard therapeutic dosage: 20 – 50mg/kg body weight once daily.

In severe infections up to 80mg/kg body weight daily may be given. For children with body weights of 50kg or more, the usual adult dosage should be used. Doses of 50mg/kg or over should be given by slow intravenous infusion over at least 30 minutes. Doses greater than 80mg/kg body weight should be avoided because of the increased risk of biliary precipitates.

Renal and hepatic impairment

In patients with impaired renal function, there is no need to reduce the dosage of Rocephin provided liver function is intact. Only in cases of pre-terminal renal failure (creatinine clearance < 10ml per minute) should the daily dosage be limited to 2g or less.

In patients with liver damage there is no need for the dosage to be reduced provided renal function is intact.

In severe renal impairment accompanied by hepatic insufficiency, the plasma concentration of Rocephin should be determined at regular intervals and dosage adjusted.

In patients undergoing dialysis, no additional supplementary dosing is required following the dialysis. Serum concentrations should be monitored, however, to determine whether dosage adjustments are necessary, since the elimination rate in these patients may be reduced.

In the case of overdose nausea, vomiting, diarrhoea, can occur. Ceftriaxone concentration can not be reduced by haemodialysis or peritoneal dialysis. There is no specific antidote. Treatment is symptomatic.

3 years.

For shelf life of diluted product see section 6.6.

Do not store above 25°C. Keep vial in the outer carton.

For shelf life of diluted product see section 6.6.

Rocephin 250mg and 1g: Type 1 Ph. Eur 15ml glass vial with teflonised rubber stopper and aluminium cap, containing a sterile, white to yellowish-orange crystalline powder. Packs of 1 vial.

Rocephin 2g: Type II Ph. Eur 50ml glass vial with teflonised rubber stopper and aluminium cap, containing a sterile, white to yellowish-orange crystalline powder. Packs of 1 vial.

Each gram of Rocephin contains approximately 3.6mmol sodium.

Instructions for use, handling and disposal

Preparation of solutions for injection and infusion

The use of freshly prepared solutions is recommended. These maintain potency for at least 6 hours at or below 25°C or 24 hours at 2-8°C. Protect from light.

Rocephin should not be mixed in the same syringe with any drug other than 1.06% Lidocaine Hydrochloride BP solution (for intramuscular injection only).

Intramuscular injection: 250mg Rocephin should be dissolved in 1ml of 1.06% Lidocaine Hydrochloride BP solution, or 1g in 3.5ml of 1.06% Lidocaine Hydrochloride BP solution. The solution should be administered by deep intramuscular injection. Dosages greater than 1g should be divided and injected at more than one site.

Solutions in Lidocaine should not be administered intravenously.

Intravenous injection: 250mg Rocephin should be dissolved in 5ml of Water for Injections BP or 1g in 10ml of Water for Injections BP. The injection should be administered over at least 2 – 4 minutes, directly into the vein or via the tubing of an intravenous infusion.

Intravenous infusion: 2g of Rocephin should be dissolved in 40ml of one of the following calcium-free solutions: Dextrose Injection BP 5% or 10%, Sodium Chloride Injection BP, Sodium Chloride and Dextrose Injection BP (0.45% Sodium Chloride and 2.5% Dextrose), Dextran 6% in Dextrose Injection BP 5%, Hydroxyethyl Starch 6 – 10% infusions. The infusion should be administered over at least 30 minutes.

The displacement value of 250mg of Rocephin is 0.194ml.

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