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1. Name of the medicinal product

Abacavir Mylan 300 mg Film-coated Tablets

2. Qualitative and quantitative composition

Each film-coated tablet contains 300 mg of abacavir.

For the full list of excipients, see section 6.1.

3. Pharmaceutical form

Film-coated tablet (tablet).

Yellow, capsule shaped, biconvex, film-coated tablet (approximately 18.5 x 7.3 mm), debossed with 'H' on one side with a score line and 'A' and '26' separated by a score line on the other side.

The tablet can be divided into equal doses.

4. Clinical particulars

4.1 Therapeutic indications

Abacavir Mylan is indicated in antiretroviral combination therapy for the treatment of Human Immunodeficiency Virus (HIV) infection in adults, adolescents and children (see sections 4.4 and 5.1).

The demonstration of the benefit of abacavir is mainly based on results of studies performed with a twice daily regimen, in treatment-naïve adult patients on combination therapy (see section 5.1).

Before initiating treatment with abacavir, screening for carriage of the HLA-B*5701 allele should be performed in any HIV-infected patient, irrespective of racial origin (see section 4.4). Abacavir should not be used in patients known to carry the HLA-B*5701 allele.

4.2 Posology and method of administration

Posology

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

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

The recommended dose of abacavir is 600 mg daily. This may be administered as either 300 mg (one tablet) twice daily or 600 mg (two tablets) once daily (see sections 4.4 and 5.1).

Children (weighing less than 25 kg):

Dosing according to weight bands is recommended for abacavir tablets.

Children weighing ≥ 20 kg to < 25 kg: The recommended dose is 450 mg daily. This may be administered as either one 150 mg (one half of a tablet) taken in the morning and 300 mg (one whole tablet) taken in the evening, or 450 mg (one and a half tablets) taken once daily.

Children weighing 14 to < 20 kg: The recommended dose is 300 mg daily. This may be administered as either 150 mg (one half of a tablet) twice daily or 300 mg (one whole tablet) once daily.

Children less than three months of age: The clinical experience in children aged less than three months is limited and are insufficient to propose specific dosage recommendations (see section 5.2).

Abacavir may also be available as a 20 mg/ml oral solution for the treatment of children over three months of age and weighing less than 14 kg and for those patients for whom the tablets are inappropriate.

Patients changing from the twice daily dosing regimen to the once daily dosing regimen should take the recommended once daily dose (as described above) approximately 12 hours after the last twice daily dose, and then continue to take the recommended 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 abacavir is necessary in patients with renal dysfunction. However, abacavir 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.

Method of administration

For oral use.

Abacavir Mylan can be taken with or without food.

To ensure administration of the entire dose, the tablet(s) should ideally be swallowed without crushing.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

4.4 Special warnings and precautions for use