Cymevene 500mg powder for concentrate for solution for infusion vials

Negara: Inggris

Bahasa: Inggris

Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)

Bahan aktif:

Ganciclovir sodium

Tersedia dari:

Neon Healthcare Ltd

Kode ATC:

J05AB06

INN (Nama Internasional):

Ganciclovir sodium

Dosis:

500mg

Bentuk farmasi:

Powder for solution for infusion

Rute administrasi :

Intravenous

Kelas:

No Controlled Drug Status

Jenis Resep:

Valid as a prescribable product

Ringkasan produk:

BNF: 05030202; GTIN: 5000471004427

Selebaran informasi

1
uk-pil-cymevene-clean-171219-500mg-inf
PACKAGE LEAFLET: INFORMATION FOR THE USER
CYMEVENE 500 MG POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION
ganciclovir
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.
•
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, pharmacist or nurse.
This includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Cymevene is and what it is used for
2.
What you need to know before you use Cymevene
3.
How to use Cymevene
4.
Possible side effects
5.
How to store Cymevene
6.
Contents of the pack and other information
1.
WHAT CYMEVENE IS AND WHAT IT IS USED FOR
WHAT CYMEVENE IS
Cymevene contains the active substance ganciclovir. This belongs to a
group called anti-viral
medicines.
WHAT CYMEVENE IS USED FOR
Cymevene is used to treat diseases caused by a virus called
cytomegalovirus (CMV) in adults and
adolescent patients 12 years and older who have a weak immune system.
It is also used to prevent
CMV infection after an organ transplant or during chemotherapy in
adults and children from birth.
•
The virus can affect any part of the body. This includes the retina at
the back of the eye – this
means the virus can cause problems with eye sight.
•
The virus can affect anyone, but it is a particular problem in people
with a weak immune system.
In these people the CMV virus can lead to a serious disease. A weak
immune system may be
caused by other diseases (such as AIDS) or by medicines (such as
chemotherapy or
immunosuppressants).
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE CYMEVENE
DO NOT USE CYMEVENE IF:
•
you are allergic to ganciclovir, valganciclovir or any of the other
ingredients

Karakteristik produk

OBJECT 1
CYMEVENE 500 MG POWDER FOR CONCENTRATE FOR
SOLUTION FOR INFUSION
Summary of Product Characteristics Updated 19-Apr-2018 | Roche
Products Limited
1. Name of the medicinal product
Cymevene 500 mg powder for concentrate for solution for infusion.
2. Qualitative and quantitative composition
Each vial contains 500 mg of ganciclovir (as ganciclovir sodium).
After reconstitution with 10 mL of water for injections, each mL
provides 50 mg of ganciclovir.
Excipient(s) with known effect: approximately 43 mg (2 mEq) sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Powder for concentrate for solution for infusion (powder for
concentrate).
White to off-white solid cake.
4. Clinical particulars
4.1 Therapeutic indications
Cymevene is indicated in adults and adolescents ≥ 12 years of age
for the:
- treatment of cytomegalovirus (CMV) disease in immunocompromised
patients;
- prevention of CMV disease using pre-emptive therapy in patients with
drug-induced
immunosuppression (for example following organ transplantation or
cancer chemotherapy).
Cymevene is also indicated from birth for the:
- prevention of CMV disease using universal prophylaxis in patients
with drug-induced
immunosuppression (for example following organ transplantation or
cancer chemotherapy).
Consideration should be given to official guidance on the appropriate
use of antiviral agents.
4.2 Posology and method of administration
Posology
_TREATMENT OF CMV DISEASE_
_Adults and Paediatric Population ≥12 years of age with normal renal
function:_
- Induction treatment: 5 mg/kg given as an intravenous infusion over
one hour, every 12 hours for 14 - 21
days.
- Maintenance treatment: For immunocompromised patients at risk of
relapse maintenance therapy may
be given. 5 mg/kg given as an intravenous infusion over one hour, once
daily on 7 days per week or 6
mg/kg once daily on 5 days per week. The duration of maintenance
treatment should be determined on an
individual basis, local treatment guidelines should be consulted.
- Treatme