Aciclovir 25mg/ml concentrate for solution for infusion

Страна: Ирландия

Язык: английский

Источник: HPRA (Health Products Regulatory Authority)

Активный ингредиент:

Aciclovir sodium

Доступна с:

Pfizer Healthcare Ireland

код АТС:

J05AB; J05AB01

ИНН (Международная Имя):

Aciclovir sodium

дозировка:

25 milligram(s)/millilitre

Фармацевтическая форма:

Concentrate for solution for infusion

Тип рецепта:

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

Терапевтические области:

Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

Статус Авторизация:

Marketed

Дата Авторизация:

1999-01-22

тонкая брошюра

Page
1
of
7
PACKAGE LEAFLET: INFORMATION FOR THE USER
ACICLOVIR 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
(STERILE CONCENTRATE)
ACICLOVIR SODIUM
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any possible
side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Aciclovir Sterile Concentrate is and what it is used for
2.
What you need to know before you use Aciclovir Sterile Concentrate
3.
How to use Aciclovir Sterile Concentrate
4.
Possible side effects
5.
How to store Aciclovir Sterile Concentrate
6.
Contents of the pack and other information
1.
WHAT ACICLOVIR STERILE CONCENTRATE IS AND WHAT IT IS USED FOR
Aciclovir 25 mg/ml concentrate for solution for infusion contains
aciclovir. This belongs to a group of
medicines called antivirals. It works by stopping the growth of
viruses.
Aciclovir Sterile Concentrate can be used in patients with a working
immune system to:
•
treat recurring chicken-pox and shingles
•
treat severe first cases of genital herpes
In patients with an impaired immune system (which means their bodies
are less able to fight
infections) to:
•
treat primary and recurring chickenpox and shingles
•
treat and stop cold sores and genital herpes
•
prevent
_herpes simplex_
infections
It can also be used to:
•
treat inflammation of the brain caused by the virus responsible for
cold sore infection and genital
herpes
•
treat
_herpes simplex_
infections in very young babies or in infants up to 3 months of age
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE ACICLOVIR STERILE CONCENTRATE
DO NOT USE ACICLOVIR STERILE CONCENTRATE IF:
•
if you are allergic (hypersensitive) to aciclovir or valaciclovir or
any of the other ingredients
(listed in section 6).
WARNINGS AND PRECAUTIONS
Tal

Характеристики продукта

Health Products Regulatory Authority
21 September 2021
CRN00C3HY
Page 1 of 9
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aciclovir 25mg/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_)
Excipient with known effect:
Each vial of 10 ml of solution contains 26.7 mg sodium.
Each vial of 20 ml of solution contains 53.4 mg sodium.
Each vial of 40 ml of solution contains 106.8 mg sodium.
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:
NON-IMMUNOCOMPROMISED PATIENTS
IMMUNOCOMPROMISED PATIENTS
Severe initial genital herpes
Herpes simplex infection
Recurrent _varicellazoster_ virus infection
Primary and recurrent _varicellazoster_ infection
Prophylaxis of herpes simplex infection
Herpes simplex encephalitis
​
Herpes simplex in neonates and infants up to 3 months of age
​
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The required dose of Aciclovir 25 mg/ml Concentrate for Solution for
Infusion should be administered by slow intravenous
infusion over 1 hour.
A course of treatment with Aciclovir 25 mg/ml Concentrate for Solution
for Infusion 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 usually lasts 14 days for mucocutaneous
(skin-eye-mouth) infections and 21 days for
dissemination or central nervous system disease.
The duration of prophylactic administrat