Aciclovir Azevedos 250 mg Powder for solution for infusion

Țară: Irlanda

Limbă: engleză

Sursă: HPRA (Health Products Regulatory Authority)

Ingredient activ:

Aciclovir sodium

Disponibil de la:

Laboratórios Azevedos - Indústria Farmacêutica S.A

Codul ATC:

J05AB; J05AB01

INN (nume internaţional):

Aciclovir sodium

Dozare:

250 milligram(s)

Forma farmaceutică:

Powder for solution for infusion

Tip de prescriptie medicala:

Product subject to prescription which may not be renewed (A)

Zonă Terapeutică:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

Statutul autorizaţiei:

Marketed

Data de autorizare:

2017-10-06

Prospect

Room temperature
Refrigerator
(15ºC – 25ºC)
(2ºC – 8ºC)
Sodium Chloride Intravenous Infusion (0.9% w/v)
24 hours
24 hours
Sodium Chloride (0.18% w/v) and Glucose
12 hours
Do not refrigerate
(4% w/v) Intravenous Infusion
or freeze
Sodium Chloride (0.45% w/v) and Glucose
(2.5% w/v) Intravenous Infusion
24 hours
8 hours
Compound Sodium Lactate Intravenous Infusion
Do not store
12 hours
(Hartmann's Solution) – after reconstituted with
below 25ºC
purified water
Compound Sodium Lactate Intravenous Infusion
Do not store
8 hours
(Hartmann's Solution) - after reconstituted with
below 25ºC
Sodium Chloride (0.9% w/v) 1. WHAT ACICLOVIR IS AND WHAT IT IS USED FOR
Aciclovir 250 mg powder for solution for
infusion contains a medicine called aciclovir.
This belongs to a group of medicines called
antivirals. It works by killing or stopping the
growth of viruses.
Aciclovir can be used to:
• treat recurrent chickenpox and shingles in
people whose immune system works well
• treat primary and recurrent chickenpox
and shingles in people whose immune
systems work less well, which means
their bodies are less able to fight
infections
• treat severe cases of genital herpes
• treat and stop cold sores and genital
herpes in people whose immune systems
work less well, which means their bodies
are less able to fight infections
• treat serious virus infections in children up
to 3 months of age. This can rarely be
caused by the virus responsible for cold
sore infection and genital herpes
• treat inflammation of the brain. This can
rarely be caused by the virus responsible
for cold sore infection and genital herpes. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ACICLOVIR DO NOT USE ACICLOVIR
• if you are allergic to aciclovir or
valaciclovir or any of the other ingredients
of this medicine (listed in Section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before
taking Aciclovir if:
• you have kidney problems
• you are over 65 years of age
• your immune system is weak.
If you are not sure if the abo

Caracteristicilor produsului

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aciclovir Azevedos 250 mg Powder for solution for infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains 250 mg of aciclovir (as aciclovir sodium).
One ml of reconstituted solution contains 25 mg of aciclovir.
Excipients with known effect: sodium hydroxide.
For the full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Powder for solution for infusion.
Homogenous solid white powder.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Aciclovir Azevedos is indicated for the treatment_ of Herpes simplex_
infections in immunocompromised patients and
severe initial genital herpes in the non-immunocompromised.
Aciclovir Azevedos is indicated for the prophylaxis_ of Herpes
simplex_ infections in immunocompromised patients.
Aciclovir Azevedos is indicated for the treatment of_ Varicella
zoster_ infections.
Aciclovir Azevedos is indicated for the treatment of herpes
encephalitis.
Aciclovir Azevedos 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
Route of administration: Slow intravenous infusion over 1 hour.
A course of treatment with Aciclovir Azevedos usually lasts 5 days,
but this 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 14 days for mucocutaneous
(skin-eye-mouth) infections and 21 days for disseminated or
central nervous system disease.
The duration of prophylactic administration of Aciclovir Azevedos is
determined by the duration of the period at risk.
The required dose of aciclovir for infusion should be administered by
slow intravenous infusion over a one-hour period.
After reconstitution aciclovir for infusion may be administered by a
controlled-rate infusion pump. Alternatively, the
reconstituted solution may be further diluted to give an aciclovir
concentration of not great