Aciclovir 250mg/10ml concentrate for solution for infusion vials

국가: 영국

언어: 영어

출처: MHRA (Medicines & Healthcare Products Regulatory Agency)

유효 성분:

Aciclovir sodium

제공처:

Pfizer Ltd

ATC 코드:

J05AB01

INN (국제 이름):

Aciclovir sodium

복용량:

25mg/1ml

약제 형태:

Solution for infusion

관리 경로:

Intravenous

수업:

No Controlled Drug Status

처방전 유형:

Valid as a prescribable product

제품 요약:

BNF: 05030201; GTIN: 5015997119654

환자 정보 전단

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PACKAGE LEAFLET: INFORMATION FOR THE USER
ACICLOVIR 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
(STERILE CONCENTRATE)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.
•
Keep this leaflet. You may need to read it again.
•
If you have any further questions, ask your doctor or pharmacist.
•
If any of the side effects gets serious, or if you notice any side
effects not listed in this
leaflet, please tell your doctor.
IN THIS LEAFLET
:
1.
What Aciclovir Sterile Concentrate is and what it is used for
2.
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.
Further information
1.
WHAT ACICLOVIR STERILE CONCENTRATE IS AND WHAT IT IS USED
FOR
Aciclovir Sterile Concentrate is an anti-viral medicine. It is used:
•
to treat severe genital herpes
•
to prevent or treat
_Herpes simplex_
infections (may appear as cold sores around the lips or
as blisters on any part of the skin including the genitals) in
patients whose immune system
is not working properly
•
to treat
_Herpes simplex_
infections in very young babies or in infants up to 3 months of age
•
to treat
_Varicella zoster_
viral infections (e.g. shingles)
•
to treat herpes encephalitis (inflammation of the brain following
infection with herpes)
2.
BEFORE YOU USE ACICLOVIR STERILE CONCENTRATE
DO NOT USE ACICLOVIR STERILE CONCENTRATE
•
if you are allergic to aciclovir or valaciclovir or any of the other
ingredients of this
medicine (listed in Section 6)
Do not use Aciclovir Sterile Concentrate if the above applies to you.
If you are not sure, talk
to your doctor or pharmacist before using Aciclovir Sterile
Concentrate.
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before having Aciclovir Sterile
Concentrate if:
•
if you have kidney problems
•
if you are over 65 years of age
If you are not sure if the above apply to you, talk to your doctor or
pharmacist before using
Aciclovir Sterile Concentrat

제품 특성 요약

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