ZIAGEN Oral solution Ref.[6072] Active ingredients: Abacavir

Ziagen should be prescribed by physicians experienced in the management of HIV infection.

Ziagen can be taken with or without food.

Ziagen is also available as a tablet formulation.

Adults, adolescents and children (weighing at least 25 kg)

The recommended dose of Ziagen is 600 mg daily (30 ml). This may be administered as either 300 mg (15 ml) twice daily or 600 mg (30 ml) once daily (see sections 4.4 and 5.1).

Children (weighing less than 25 kg)

Children from one year of age: The recommended dose is 8 mg/kg twice daily or 16 mg/kg once daily, up to a maximum total daily dose of 600 mg (30 ml).

Children from three months to one year of age: The recommended dose is 8 mg/kg twice daily. If a twice daily regimen is not feasible, a once daily regimen (16 mg/kg/day) could be considered. It should be taken into account that data for the once daily regimen are very limited in this population (see sections 5.1 and 5.2).

Children less than three months of age: the experience in children aged less than three months is limited (see section 5.2).

Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recomended once daily dose (as described above) approximately 12 hours after the last twice daily dose, and then continue to take the recomended once daily dose (as described above) approximately every 24 hours. When changing back to a twice daily regimen, patients should take the recommended twice daily dose approximately 24 hours after the last once daily dose.

Special populations

Renal impairment

No dosage adjustment of Ziagen is necessary in patients with renal dysfunction. However, Ziagen is not recommended for patients with end-stage renal disease (see section 5.2).

Hepatic impairment

Abacavir is primarily metabolised by the liver. No definitive dose recommendation can be made in patients with mild hepatic impairment (Child-Pugh score 5-6). In patients with moderate or severe hepatic impairment, no clinical data are available, therefore the use of abacavir is not recommended unless judged necessary. If abacavir is used in patients with mild hepatic impairment, then close monitoring is required, including monitoring of abacavir plasma levels if feasible (see sections 4.4 and 5.2).

Elderly

No pharmacokinetic data are currently available in patients over 65 years of age.

Single doses up to 1200 mg and daily doses up to 1800 mg of Ziagen have been administered to patients in clinical studies. No additional adverse reactions to those reported for normal doses were reported. The effects of higher doses are not known. If overdose occurs the patient should be monitored for evidence of toxicity (see section 4.8), and standard supportive treatment applied as necessary. It is not known whether abacavir can be removed by peritoneal dialysis or haemodialysis.

2 years.

After first opening the container: 2 months.

Do not store above 30°C.

Ziagen oral solution is supplied in high density polyethylene bottles with child-resistant closures, containing 240 ml of oral solution.

The pack also includes a polyethylene syringe-adapter and a 10 ml oral dosing syringe comprised of a polypropylene barrel (with ml graduations) and a polyethylene plunger.

A plastic adapter and oral dosing syringe are provided for accurate measurement of the prescribed dose of oral solution. The adapter is placed in the neck of the bottle and the syringe attached to this.

The bottle is inverted and the correct volume withdrawn.

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