Foscavir 6g/250ml solution for infusion bottles

Страна: Великобритания

Язык: английский

Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)

Активный ингредиент:

Foscarnet sodium

Доступна с:

Clinigen Healthcare Ltd

код АТС:

J05AD01

ИНН (Международная Имя):

Foscarnet sodium

дозировка:

24mg/1ml

Фармацевтическая форма:

Solution for infusion

Администрация маршрут:

Intravenous

класс:

No Controlled Drug Status

Тип рецепта:

Valid as a prescribable product

Обзор продуктов:

BNF: 05030202; GTIN: 5014162007123

тонкая брошюра

PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSCAVIR
®
24 mg/ml Solution for Infusion
foscarnet
M088729-05 UK
READ ALL OF THIS LEAFLET CAREFULLY
BEFORE YOU START HAVING 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 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 or nurse. This includes any
possible side effects not listed in this
leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1. What Foscavir is and what it is
used for
2. What you need to know before you
have Foscavir
3. How to have Foscavir
4. Possible side effects
5. How to store Foscavir
6. Contents of the pack and other
information
1. WHAT FOSCAVIR IS AND WHAT IT IS
USED FOR
Foscavir contains a medicine called
foscarnet. This belongs to a group of
medicines called anti-virals. It works
by stopping viruses from multiplying in
number.
Foscavir is used to treat the following
infections that are caused by viruses:
• An eye infection caused by a virus
in people with AIDS. The virus is
called cytomegalovirus (CMV) and the
infection is known as CMV retinitis.
Foscavir stops the infection from
getting worse but it cannot repair the
damage that has already happened.
• Herpes Simplex Virus (HSV). Foscavir
is given to people with HSV who
have a weakened immune system.
It is given to people who have not
got better from HSV after having a
medicine called aciclovir.
2. WHAT YOU NEED TO KNOW BEFORE
YOU HAVE FOSCAVIR
DO NOT HAVE FOSCAVIR:
• If you are allergic (hypersensitive)
to foscarnet or any of the other
ingredients of this medicine (listed in
section 6).
If you are not sure, talk to your doctor or
nurse before having Foscavir.
WARNINGS AND PRECAUTIONS
Talk to your doctor or nurse before you
have Foscavir.
Check with your doctor or nurse before
having Foscavir if:
• You h

Характеристики продукта

OBJECT 1
FOSCAVIR 24 MG/ML SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 05-Oct-2017 | Clinigen
Healthcare Ltd
1. Name of the medicinal product
Foscavir 24 mg/ml Solution for Infusion
2. Qualitative and quantitative composition
Foscarnet trisodium hexahydrate 24 mg/ml.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for infusion.
Clear and colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
Foscavir is indicated for induction and maintenance therapy of
cytomegalovirus (CMV) retinitis in
patients with AIDS.
Foscavir is also indicated for the treatment of mucocutaneous Herpes
Simplex Virus (HSV) infections,
clinically unresponsive to aciclovir in immunocompromised patients.
The safety and efficacy of Foscavir
for the treatment of other HSV infections (e.g. retinitis,
encephalitis); congenital or neonatal disease; or
HSV in immunocompetent individuals has not been established.
The diagnosis of aciclovir unresponsiveness can be made either
clinically by treatment with intravenous
aciclovir (5–10 mg/kg t.i.d) for 10 days without response or by _in
vitro_ testing.
Foscavir is not recommended for treatment of CMV infections other than
retinitis or HSV or for use in
non-AIDS or non-immunocompromised patients.
4.2 Posology and method of administration
METHOD OF ADMINISTRATION: Foscarnet should be administered by the
intravenous route only, either by a
central venous line or in a peripheral vein.
When peripheral veins are used, the solution of foscarnet 24 mg/ml
must be diluted. Individually
dispensed doses of foscarnet should be aseptically transferred and
diluted with equal parts of 0.9%
sodium chloride (9 mg/ml) or 5% dextrose (50 mg/ml) by the hospital
pharmacy. The diluted solutions
should be used as soon as possible after preparation but can be stored
for up to 24 hours if kept
refrigerated.
The solution of foscarnet 24 mg/ml may be given without dilution via a
central vein.
ADULTS: Induction therapy for CMV retinitis: Foscavir is administere