Foscarnet sodium hexahydrate Tillomed 24 mg/ml solution for infusion

국가: 아일랜드

언어: 영어

출처: HPRA (Health Products Regulatory Authority)

유효 성분:

Foscarnet Sodium Hexahydrate

제공처:

Tillomed Pharma GmbH

ATC 코드:

J05AD01

INN (국제 이름):

Foscarnet Sodium Hexahydrate

약제 형태:

Solution for infusion

치료 영역:

foscarnet

승인 상태:

Not marketed

승인 날짜:

2022-08-12

환자 정보 전단

PACKAGE LEAFLET
PACKAGE LEAFLET: INFORMATION FOR THE USER
FOSCARNET SODIUM HEXAHYDRATE TILLOMED 24 MG/ML SOLUTION FOR INFUSION
foscarnet sodium hexahydrate
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 Foscarnet Tillomed is and what it is used for
2.
What you need to know before you use Foscarnet Tillomed
3.
How to use Foscarnet Tillomed
4.
Possible side effects
5.
How to store Foscarnet Tillomed
6.
Contents of the pack and further information
1.
WHAT FOSCARNET TILLOMED IS AND WHAT IT IS USED FOR
Foscarnet Tillomed contains a medicine called foscarnet sodium
hexahydrate. This belongs
to a group of medicines called antivirals. It works by stopping
viruses from multiplying in
number.
Foscarnet Tillomed is used to treat the following infections in AIDS
patients:
•
A life-threatening or vision threatening eye infection called CMV
retinitis caused by a
virus in people with AIDS which leads to a loss of vision and
eventually blindness. The
virus is called cytomegalovirus (CMV) and the infection is known as
CMV retinitis.
Foscarnet Tillomed stops the infection from getting worse but it
cannot repair the
damage that has already happened.
•
Herpes Simplex Virus (HSV). Foscarnet Tillomed 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 USE FOSCARNET TILLOMED
DO NOT USE FOSCARNET TILLOMED :
- if you are allergic (hypersensitive) to foscarnet sodium hexahydrate
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 you

제품 특성 요약

Health℃Products℃Regulatory℃Authority
12℃August℃2022
CRN009TDG
Page℃1℃of℃11
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Foscarnet℃sodium℃hexahydrate℃Tillomed℃24℃mg/ml℃solution℃for℃infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each℃ml℃of℃solution℃for℃infusion℃contains℃24℃mg℃foscarnet℃sodium℃hexahydrate.
Each℃250℃ml℃bottle℃contains℃6000℃mg℃foscarnet℃sodium℃hexahydrate℃
Each℃bottle℃of℃250℃ml℃contains℃1375℃mg℃(60℃mmol)℃sodium℃as℃a℃constituent℃of℃the℃active℃substance.℃
For℃the℃full℃list℃of℃excipients,℃see℃section℃6.1.
3 PHARMACEUTICAL FORM
Solution℃for℃infusion
Clear℃and℃colourless℃solution,℃practically℃free℃from℃particles℃
pH:℃Between℃7.2℃and℃7.6
Osmolality:℃Between℃240℃mOsmol/℃kg℃and℃300℃mOsmol/℃kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Foscarnet℃Tillomed℃should℃only℃be℃used℃in℃patients℃with℃acquired℃immunodeficiency℃syndrome℃(AIDS).℃
-℃Life℃threatening℃or℃eye-threatening℃disease℃caused℃by℃cytomegalovirus℃(CMV).℃Treatment℃with℃Foscarnet℃Tillomed℃should℃only
be℃given℃if℃cytomegalovirus℃has℃been℃detected.
-℃For℃acute,℃mucocutaneous℃infections℃caused℃by℃aciclovir-resistant℃herpes℃viruses℃(HSV).℃Foscarnet℃Tillomed℃therapy℃should℃be
given℃if℃there℃are℃no℃medically℃acceptable℃therapeutic℃alternatives.℃Due℃to℃the℃risk℃profile℃of℃the℃active℃ingredient,℃a℃strict℃
indication℃is℃required.
If℃there℃is℃a℃relapse,℃the℃aciclovir℃resistance℃must℃be℃reviewed.
The℃generally℃accepted℃guidelines℃for℃the℃appropriate℃use℃of℃medicines℃to℃treat℃cytomegalovirus℃or℃herpes℃simplex℃infections℃in
HIV-infected℃patients℃must℃be℃followed.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
For℃intravenous℃application.
_ _
_Posology_
CMV INFECTION: