Telzir 50mgml oral suspension

国家: 英国

语言: 英文

来源: MHRA (Medicines & Healthcare Products Regulatory Agency)

有效成分:

Fosamprenavir calcium

可用日期:

ViiV Healthcare UK Ltd

ATC代码:

J05AE07

INN（国际名称）:

Fosamprenavir calcium

剂量:

50mg/1ml

药物剂型:

Oral suspension

给药途径:

Oral

类:

No Controlled Drug Status

处方类型:

Valid as a prescribable product

產品總結:

BNF: 05030100; GTIN: 5000123111978

资料单张

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
TELZIR 50 MG/ML ORAL SUSPENSION
Fosamprenavir
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING 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 pharmacist.
•
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 PHARMACIST. THIS
INCLUDES ANY POSSIBLE
SIDE EFFECTS NOT LISTED IN THIS LEAFLET. SEE SECTION 4.
WHAT IS IN THIS LEAFLET:
1.
WHAT TELZIR IS AND WHAT IT IS USED FOR
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE TELZIR
3.
HOW TO TAKE TELZIR
4.
POSSIBLE SIDE EFFECTS
5. HOW TO STORE TELZIR
6.
CONTENTS OF THE PACK AND OTHER INFORMATION
1.
WHAT TELZIR IS AND WHAT IT IS USED FOR
TELZIR IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION.
Telzir is a type of medicine known as an anti-retroviral. It is taken
with low doses of another
medicine, ritonavir, which boosts the level of Telzir in the blood.
Telzir belongs to a group of
anti-retroviral medicines called
_protease inhibitors_
. Protease is an enzyme produced by HIV which
enables the virus to multiply in white blood cells
_(CD4 cells)_
in your blood. By stopping protease
from working, Telzir stops HIV multiplying and infecting more CD4
cells
Telzir with low doses of ritonavir is used in combination with other
anti-retroviral medicines
(‘combination therapy’) to treat adults, adolescents and children
aged over 6 years infected with
HIV.
HIV can become resistant to anti-HIV medicines. To avoid this
happening, and to stop your illness
getting worse, it is very important that you keep taking all your
medicines exactly as prescribed.
Telzir will not stop you passing on HIV. HIV infection is spread by
sexual contact with someone
who’s got the infection, or by transfer of infected blood (for
example by sharing needles).
2.
WHAT

产品特点

OBJECT 1
TELZIR ORAL SUSPENSION
Summary of Product Characteristics Updated 31-Jan-2018 | ViiV
Healthcare UK Ltd
1. Name of the medicinal product
Telzir 50 mg/ml oral suspension
2. Qualitative and quantitative composition
Each ml of oral suspension contains 50 mg fosamprenavir as
fosamprenavir calcium (equivalent to
approximately 43 mg amprenavir).
Excipients:
Methyl parahydroxybenzoate (E218) 1.5 mg/ml
Propyl parahydroxybenzoate (E216) 0.2 mg/ml
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Oral suspension
The suspension is white to off-white in colour.
4. Clinical particulars
4.1 Therapeutic indications
Telzir in combination with low dose ritonavir is indicated for the
treatment of Human Immunodeficiency
Virus Type 1 (HIV-1) infected adults, adolescents and children of 6
years and above in combination with
other antiretroviral medicinal products.
In moderately antiretroviral experienced adults, Telzir in combination
with low dose ritonavir has not
been shown to be as effective as lopinavir / ritonavir. No comparative
studies have been undertaken in
children or adolescents.
In heavily pretreated patients the use of Telzir in combination with
low dose ritonavir has not been
sufficiently studied.
In protease inhibitor (PI) experienced patients, the choice of Telzir
should be based on individual viral
resistance testing and treatment history (see section 5.1).
4.2 Posology and method of administration
Telzir must only be given with low dose ritonavir as a pharmacokinetic
enhancer of amprenavir and in
combination with other antiretroviral medicinal products. The Summary
of Product Characteristics of
ritonavir must therefore be consulted prior to initiation of therapy
with Telzir.
Therapy should be initiated by a physician experienced in the
management of HIV infection.
Fosamprenavir is a pro-drug of amprenavir and must not be administered
concomitantly with other
medicinal products containing amprenavir.
The importance of complying with the full recommended dosing regimen
should be stressed