Aciclovir 1g/40ml solution for infusion vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Aciclovir sodium

Available from:

Pfizer Ltd

ATC code:

J05AB01

INN (International Name):

Aciclovir sodium

Dosage:

25mg/1ml

Pharmaceutical form:

Solution for infusion

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 05030201; GTIN: 5015997120711

Summary of Product characteristics

OBJECT 1
ACICLOVIR 25 MG/ML CONCENTRATE FOR SOLUTION FOR
INFUSION
Summary of Product Characteristics Updated 24-Feb-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Aciclovir 25 mg/ml Concentrate for Solution for Infusion.
2. Qualitative and quantitative composition
Each ml contains 25 mg aciclovir as aciclovir sodium.
Each vial of 10 ml of solution contains 250 mg aciclovir (sodium salt
formed _in situ_)
Each vial of 20 ml of solution contains 500 mg aciclovir (sodium salt
formed _in situ_)
Each vial of 40 ml of solution contains 1 g aciclovir (sodium salt
formed _in situ_)
Excipients: 1 ml of solution contains 2.67 mg of sodium (approximately
0.116 mmol).
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Concentrate for solution for infusion (sterile concentrate).
A clear, colourless or almost colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Aciclovir 25 mg/ml Concentrate for Solution for Infusion is indicated
for the treatment of severe initial
genital herpes in the immunocompromised and the non-immunocompromised.
Aciclovir 25 mg/ml Concentrate for Solution for Infusion is indicated
for the prophylaxis and treatment of
Herpes simplex infections in immunocompromised patients.
Aciclovir 25 mg/ml Concentrate for Solution for Infusion is indicated
for the treatment of _Varicella _
_zoster_ infections.
Aciclovir 25 mg/ml Concentrate for Solution for Infusion is indicated
for the treatment of herpes
encephalitis.
Aciclovir 25 mg/ml Concentrate for Solution for Infusion is indicated
for the treatment of Herpes simplex
infections in the neonate and infant up to 3 months of age.
4.2 Posology and method of administration
Posology
A course of treatment with Aciclovir 25 mg/ml Concentrate for Solution
for Infusion usually lasts 5 days,
but the duration of treatment may be adjusted according to the
patient's condition and response to therapy.
Treatment for herpes encephalitis usually lasts 10 days. Treatment for
neonatal herpes infections usually
lasts for 14 days for mu