VALGANCICLOVIR TEVA

البلد: إسرائيل

اللغة: الإنجليزية

المصدر: Ministry of Health

العنصر النشط:

VALGANCICLOVIR AS HYDROCHLORIDE

متاح من:

TEVA ISRAEL LTD

ATC رمز:

J05AB14

الشكل الصيدلاني:

FILM COATED TABLETS

تركيب:

VALGANCICLOVIR AS HYDROCHLORIDE 450 MG

طريقة التعاطي:

PER OS

نوع الوصفة الطبية :

Required

المصنعة من قبل:

TEVA ISRAEL LTD, ISRAEL

المجال العلاجي:

VALGANCICLOVIR

الخصائص العلاجية:

Valganciclovir Teva is indicated for the induction and maintenance treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). Valganciclovir Teva is indicated for the prevention of CMV disease in CMV-negative patients who have received a solid organ transplant from a CMV-positive donor.

تاريخ الترخيص:

2021-10-31

نشرة المعلومات

PATIENT PACKAGE INSERT IN
ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS )PREPARATIONS( - 1986
The medicine is dispensed with
a doctor’s prescription only
VALGANCICLOVIR TEVA
®
Film-coated tablets
Composition:
Each film-coated tablet contains:
Valganciclovir (as hydrochloride) 450 mg
For the list of inactive ingredients in the
preparation see section 6 – “Further Information”.
READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE
USING THE MEDICINE. This leaflet contains concise
information about the medicine. If you have further
questions, refer to the doctor or pharmacist.
Keep this leaflet. You may need to read it
again.
THIS MEDICINE HAS BEEN PRESCRIBED TO TREAT
YOUR AILMENT. DO NOT PASS IT ON TO OTHERS. IT
MAY HARM THEM, EVEN IF IT SEEMS TO YOU THAT
THEIR MEDICAL CONDITION IS SIMILAR.
If you have any side effects, refer to the doctor or
pharmacist. This includes possible side effects
not detailed in this leaflet (see section 4).
This medicine is intended for the treatment of
adults over the age of 18.
1. WHAT IS THE MEDICINE INTENDED
FOR?
Valganciclovir Teva
®
is intended for the
treatment of cytomegalovirus infections of the
retina (CMV retinitis) in patients with acquired
immunodeficiency syndrome (AIDS).
Valganciclovir Teva
®
is intended for prevention
of cytomegalovirus (CMV) disease in patients
not infected with CMV who have received an
organ(s) donation from a person carrying the
virus.
THERAPEUTIC GROUP:
Valganciclovir Teva
®
belongs to a group of
medicines (antivirals) that directly act to
prevent proliferation of viruses. In the body,
valganiciclovir, the active ingredient of the
medicine, turns into ganciclovir.
Ganciclovir
prevents
a
virus
called
cytomegalovirus from multiplying and penetrating
healthy cells. In patients with a weakened
immune system, cytomegalovirus may cause
an infection in the body’s organs which can be
life-threatening.
2. BEFORE USING THE MEDICINE
Do not use the medicine if you are:
∙ Sensitive (allergic) to the active ingredient,
valganciclovir, or to any of the

خصائص المنتج

Valganciclovir Teva Tablets 450 mg SPC New Notification 122022 RC
SUMMARY OF PRODUCT CHARACTERISTICS
Valganciclovir Teva Film-Coated Tablets
1. Name of the medicinal product
Valganciclovir Teva 450 mg film-coated tablets
2. Qualitative and quantitative composition
Each film-coated tablet contains 450 mg of valganciclovir (as
hydrochloride)
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablets
Oval, pink film coated tablets, debossed "93" on one side and "5465"
on the
other side.
4. Clinical particulars
4.1 Therapeutic indications
Valganciclovir Teva is indicated for the induction and maintenance
treatment
of cytomegalovirus (CMV) retinitis in patients with acquired
immunodeficiency
syndrome (AIDS).
Valganciclovir Teva is indicated for the prevention of CMV disease in
CMV-
negative patients who have received a solid organ transplant from a
CMV-
positive donor.
4.2 Posology and method of administration
Posology
Caution – Strict adherence to dosage recommendations is essential to
avoid overdose (see sections 4.4 and 4.9).
Valganciclovir is rapidly and extensively metabolised to ganciclovir
after oral
dosing. Oral valganciclovir 900 mg b.i.d. is therapeutically
equivalent to
intravenous ganciclovir 5 mg/kg b.i.d.
Treatment of cytomegalovirus (CMV) retinitis
Adult patients
Induction treatment of CMV retinitis
For patients with active CMV retinitis, the recommended dose is 900 mg
valganciclovir (two Valganciclovir Teva 450 mg tablets) twice a day
for 21
days and, whenever possible, taken with food. Prolonged induction
treatment
may increase the risk of bone marrow toxicity (see section 4.4).
Maintenance treatment of CMV retinitis:
Following induction treatment, or in patients with inactive CMV
retinitis, the
recommended dose is 900mg valganciclovir (two Valganciclovir Teva 450
mg
tablets) once daily and, whenever possible, taken with food. Patients
whose
Valganciclovir Teva Tablets 450 mg SPC New Notification 122022 RC
retinitis worsens may repeat induction treatment; however,
c