Vistide

Country: Եվրոպական Միություն

language: անգլերեն

source: EMA (European Medicines Agency)

active_ingredient:

cidofovir

MAH:

Gilead Sciences International Limited

ATC_code:

J05AB12

INN:

cidofovir

therapeutic_group:

Antivirals for systemic use

therapeutic_area:

Cytomegalovirus Retinitis

therapeutic_indication:

Vistide is indicated for the treatment of cytomegalovirus retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Vistide should be used only when other agents are considered unsuitable.,

leaflet_short:

Revision: 21

authorization_status:

Withdrawn

authorization_date:

1997-04-23

PIL

19
B. PACKAGE LEAFLET
Medicinal product no longer authorised
20
PACKAGE LEAFLET: INFORMATION FOR THE USER
VISTIDE 75 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION
Cidofovir
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.
-
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, even
if their symptoms are the same as yours.
-
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
IN THIS LEAFLET:
1.
What Vistide is and what it is used for
2.
Before you use Vistide
3.
How to use Vistide
4.
Possible side effects
5.
How to store Vistide
6.
Further information
1.
WHAT VISTIDE IS AND WHAT IT IS USED FOR
VISTIDE IS USED TO TREAT AN EYE INFECTION CALLED CMV RETINITIS IN
PATIENTS WITH AIDS (ACQUIRED
IMMUNODEFICIENCY SYNDROME).
Vistide will not cure CMV retinitis but may improve your condition
by delaying progression of the disease.
The safety and efficacy of Vistide has not been demonstrated in
diseases other than CMV retinitis in
patients with AIDS.
Vistide must be administered by a healthcare professional (doctor or
nurse) in a hospital setting.
WHAT IS CMV RETINITIS?
CMV retinitis is an eye infection caused by a virus named
cytomegalovirus (CMV). CMV attacks the
retina of the eye and may cause loss of vision, and eventually lead to
blindness. Patients with AIDS
are at high risk of developing CMV retinitis or other forms of CMV
disease such as colitis (an
inflammatory bowel disease). Treatment for CMV retinitis is necessary
to reduce the potential for
blindness.
Vistide is an antiviral medicine which blocks the replication of CMV
by interfering with viral DNA
production.
2.
BEFORE YOU USE VISTIDE
DO NOT USE VISTIDE
•
IF YOU ARE ALLERGIC _(HYPERSENSITIVE)_
to cidofovir or any of the other ingredients of Vistide.
•
IF YOU HAVE EVER HAD KIDNEY DISEASE.
•
IF

SPC

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal product no longer authorised
2
1.
NAME OF THE MEDICINAL PRODUCT
Vistide 75 mg/ml concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains 75 mg cidofovir anhydrous. Each vial contains 375
mg/5 ml cidofovir anhydrous as
the active substance.
Excipients:
Each vial contains approximately 2.5 mmol (or 57 mg) sodium per vial
(5 ml) as a constituent of the
excipients.
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear solution.
The formulation is adjusted to pH 7.4.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vistide is indicated for the treatment of CMV retinitis in adults with
acquired immunodeficiency
syndrome (AIDS) and without renal dysfunction. Vistide should be used
only when other agents are
considered unsuitable.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The therapy should be prescribed by a physician experienced in the
management of HIV infection.
Before each administration of Vistide, serum creatinine and urine
protein levels should be
investigated. Vistide must be administered with oral probenecid and
intravenous saline as described
below (see section 4.4 for appropriate recommendations, and under
section 6.6 for information on
obtaining probenecid).
Posology
_Adults:_
Induction treatment.
The recommended dose of cidofovir is 5 mg/kg body weight (given as an
intravenous infusion at a constant rate over 1 hour) administered once
weekly for two consecutive
weeks.
Maintenance treatment.
Beginning two weeks after the completion of induction treatment, the
recommended maintenance dose of cidofovir is 5 mg/kg body weight
(given as an intravenous
infusion at a constant rate over 1 hour) administered once every two
weeks.
Suspension of maintenance treatment with cidofovir should be
considered in accordance with local
recommendations for the management of HIV infected patients.
_Elderly population:_
The safety and efficacy of Vistide have not been e