SALACLAV POWDER FOR SOLUTION FOR INJECTION 1.2G/VIAL [SIN15043P]

Product Info

SALACLAV POWDER FOR SOLUTION FOR INJECTION 1.2G/VIAL

[SIN15043P]

Indication

4.1 Therapeutic indications

SALACLAV is indicated for short-term treatment of bacterial infections at the following sites:
Upper respiratory tract infections (including ENT) e.g. recurrent tonsillitis, sinusitis, otitis media.

Lower respiratory tract infections e.g. acute exacerbation of chronic bronchitis, lobar and bronchopneumonia.

Genito-urinary tract infections e.g. cystitis, urethritis, pyelonephritis.

Skin and soft tissue infections, e.g. boils, abscesses, cellulitis, wound infections.

Bone and joint infections e.g. osteomyelitis.

Other infections e.g. intra-abdominal sepsis.

SALACLAV intravenous is also indicated for prophylaxis against infection which may be associated with major surgical procedures such as gastrointestinal, pelvic, head and neck, cardiac, renal, joint replacement and biliary tract.

Susceptibility to SALACLAV will vary with geography and time (see Pharmacological Properties, Pharmacodynamics for further information – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Local susceptibility data should be consulted where available, and microbiological sampling and susceptibility testing performed where necessary.

Infections caused by amoxicillin-susceptible organisms are amenable to SALACLAV treatment due to its amoxicillin content. Mixed infections caused by amoxicillin -susceptible organisms in conjunction with SALACLAV-susceptible β-lactamase producing organisms may therefore be treated with SALACLAV.

Dosing

4.2 Posology and method of administration

Dosage for the treatment of infections

Adults and children over 12 years:
Usually 1.2 g eight hourly. In more serious infections, increase frequency to six-hourly intervals.

Children 3 months–12 years:
Usually 30 mg/kg * SALACLAV eight hourly. In more serious infections, increase frequency to six-hourly intervals.

Children 0–3 months:
30 mg/kg* SALACLAV every 12 hours in premature infants and in full term infants during the perinatal period, increasing to eight hours thereafter.
* Each 30 mg SALACLAV contains 25 mg amoxicillin and 5 mg clavulanate.

Adult dosage for surgical prophylaxis

The usual dose is 1.2 g SALACLAV intravenous given at the induction of anaesthesia. Operations where there is a high risk of infection, e.g. colorectal surgery, may require three, and up to four, doses of 1.2 g SALACLAV intravenous in a 24-hour period. These doses are usually given at 0, 8, 16 (and 24) hours. This regimen can be continued for several days if the procedure has a significantly increased risk of infection.

Clear clinical signs of infection at operation will require a normal course of intravenous or oral SALACLAV therapy post-operatively.

Dosage in renal impairment

Children
Similar reductions in dosage should be made for children.

Dosage in hepatic impairment

Dose with caution; monitor hepatic function at regular intervals.
Each 1.2 g vial of SALACLAV contains 1.0 mmol of potassium and 3.1 mmol of sodium (approx.).

Method of administration
SALACLAV may be administered either by intravenous injection or by intermittent infusion. It is not suitable for intramuscular administration.

For instructions on reconstitution and dilution of the medicinal product before administration, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

Contraindications

4.3 Contraindications

• Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 or to any penicillin antibiotic – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

• History of a severe immediate hypersensitivity reaction (e.g. anaphylaxis) to another betalactam agent (e.g. a cephalosporin, carbapenem or monobactam).

• History of jaundice/hepatic impairment due to amoxicillin/clavulanic acid (see section 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).