ACTIMENTIN Powder for oral suspension Ref.[51179] Active ingredients: Amoxicillin Clavulanic acid

Posology

Duration of therapy should be appropriate to the indication and should not exceed 14 days without review.

ACTIMENTIN 600 BD is recommended for dosing at 90/6,4 mg/kg/day in two divided doses at 12 hourly intervals for 10 days, in children aged 3 months and older. There is no experience in paediatric patients weighing >40 kg or in adults. There are no clinical data in children under 3 months of age.

ACTIMENTIN 600 BD does not contain the same amount of clavulanic acid (as the potassium salt) as any of the other suspensions containing a combination of amoxicillin and potassium clavulanate. Therefore, these suspensions should not be substituted for ACTIMENTIN 600 BD, as they are not interchangeable.

Special populations

Hepatic impairment

There are insufficient data on which to base a dosage recommendation.

Renal impairment

There are no dosing recommendations for ACTIMENTIN 600 BD in patients with renal impairment.

Method of administration

ACTIMENTIN 600 BD should be taken immediately before a meal.

For instructions on reconstitution of ACTIMENTIN 600 BD before administration, see section 6.6.

Symptoms and signs of overdose

Gastrointestinal symptoms (nausea, vomiting and diarrhoea) as well as disturbance of the fluid and electrolyte balances may be evident with overdosage.

Amoxicillin crystalluria, in some cases leading to renal failure, has been observed (see section 4.4).

Convulsions may occur in patients with impaired renal function or in those receiving high doses.

Treatment of overdose

Gastrointestinal symptoms may be treated symptomatically, with attention to the water/electrolyte balance. ACTIMENTIN 600 BD can be removed from the circulation by haemodialysis.

Dry powder: 2 years.

Reconstituted suspensions: 7 days stored at 2°C–8°C. Discard unused suspension after 7 days.

Dry powder: store at or below 25°C. Store in the original container in order to protect from moisture.

Reconstituted suspensions: store at 2°C–8°C, in original container. Do not freeze.

ACTIMENTIN 600 BD is available as 30 ml, 50 ml, 70 ml or 100 ml oral suspension. It is filled in amber type III glass bottles, with a nominal volume of 60 ml (for 30 ml oral suspension), 100 ml (for 50 ml or 70 ml oral suspension) or 150 ml (for 100 ml oral suspension). Bottles are closed with HDPE or PP white screw caps containing a liner (or sealing disk). The bottles are packed together with a dosing device; either:

• a 6 ml PE/PS syringe (with CE marking 0373) or
• a 5 ml PS spoon (with CE marking 0373) or
• a 5 ml PP cup (with CE marking 0546).

The glass bottles and dosing device are packed into outer cartons.

Not all pack sizes may be marketed.

For reconstitution, tap the bottle until all the powder flows freely. Add approximately ⅔ of the total amount of water for reconstitution (see table below) and shake vigorously to suspend powder. Add remainder of the water and again shake vigorously.

After reconstitution, invert and shake bottle well before each use.

Table 2. Reconstitution instructions:

The reconstituted solution is off-white to yellowish coloured homogeneous suspension with strawberry odour.