Medolone 250 mg powder for solution for infusion

国: マルタ

言語: 英語

ソース: Medicines Authority

有効成分:

ACICLOVIR SODIUM

から入手可能:

Medochemie Limited 1-10 Constantinoupleos Street, 3011 Limassol, Cyprus

ATCコード:

J05AB01

INN（国際名）:

ACICLOVIR SODIUM 250 mg

医薬品形態:

POWDER FOR SOLUTION FOR INFUSION

構図:

ACICLOVIR SODIUM 250 mg

処方タイプ:

POM

治療領域:

ANTIVIRALS FOR SYSTEMIC USE

製品概要:

Licence number in the source country: NOT APPLICAPABLE

認証ステータス:

Authorised

承認日:

2020-11-23

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
MEDOLONE 250 MG POWDER FOR SOLUTION FOR INFUSION
aciclovir
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.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
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 Medolone is and what it is used for
2.
What you need to know before you use Medolone
3.
How to use Medolone
4.
Possible side effects
5.
How to store Medolone
6.
Contents of the pack and other information
1.
WHAT MEDOLONE IS AND WHAT IT IS USED FOR
Medolone contains a medicine called aciclovir. This belongs to a group
of medicines called antivirals.
It works by stopping the growth of viruses.
Medolone can be used to:
-
Treat recurring chicken-pox and shingles in people whose immune system
works well.
-
Treat severe first cases of genital herpes in people whose immune
system works well.
-
Treat primary and recurring chickenpox and shingles in people whose
immune systems work less
well, which means their bodies are less able to fight infections.
-
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.
-
Prevent herpes simplex infections in people whose immune systems work
less well, which means
their bodies are less able to fight infections.
-
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 USE MEDOLONE
DO NOT USE MEDOLONE:
-
If you are allergic to aciclovir, valaciclovir or any of the other
ingredients of this medicine (listed

製品の特徴

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Medolone 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.
Excipient with known effect: contains less than 1 mmol of sodium (23
mg) per dose.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder for solution for infusion.
White lyophilized powder.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Medolone is indicated:
-
For the treatment of
_Herpes simplex_
infections in immunocompromised patients and severe initial
genital herpes in non-immunocompromised patients.
-
For the prophylaxis of
_Herpes simplex_
infections in immunocompromised patients.
-
For the treatment of recurrent
_Varicella zoster_
infections in non-immunocompromised patients.
-
For the treatment of primary and recurrent
_Varicella zoster_
infections in immunocompromised
patients.
-
For the treatment of herpes encephalitis in immunocompromised and
non-immunocompromised
patients.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_Adults and adolescents _
Patients with
_Herpes simplex_
(except herpes encephalitis) or
_Varicella zoster_
infections should be
given aciclovir in doses of 5 mg/kg body weight every 8 hours provided
renal function is not impaired
(see Dosage in renal impairment).
Immunocompromised patients with
_Varicella zoster_
infections or patients with herpes encephalitis
should be given aciclovir in doses of 10 mg/kg body weight every 8
hours provided renal function is
not impaired (see Dosage in renal impairment).
In obese patients dosed with intravenous aciclovir based on their
actual body weight, higher plasma
concentrations may be obtained (see section 5.2). Consideration should
therefore be given to dosage
reduction in obese patients and especially in those with renal
impairment or the elderly.
_Paediatric population _
The dose of aciclovir for infants and children aged bet