Ziagen 20mgml oral solution

Država: Velika Britanija

Jezik: engleski

Izvor: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktivni sastojci:

Abacavir sulfate

Dostupno od:

ViiV Healthcare UK Ltd

ATC koda:

J05AF06

INN (International ime):

Abacavir sulfate

Doziranje:

20mg/1ml

Farmaceutski oblik:

Oral solution

Administracija rute:

Oral

Razred:

No Controlled Drug Status

Tip recepta:

Valid as a prescribable product

Proizvod sažetak:

BNF: 05030100; GTIN: 5000123109203

Uputa o lijeku

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
ZIAGEN 20 MG/ML ORAL SOLUTION
Abacavir
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.
IMPORTANT - HYPERSENSITIVITY REACTIONS
ZIAGEN CONTAINS ABACAVIR
(which is also an active substance in medicines such as
KIVEXA
,
TRIUMEQ
and
TRIZIVIR
). Some people who take abacavir may develop a
HYPERSENSITIVITY REACTION
(a serious
allergic reaction), which can be life-threatening if they continue to
take abacavir. containing products.
YOU MUST CAREFULLY READ ALL THE INFORMATION UNDER ‘HYPERSENSITIVITY
REACTIONS’ IN THE PANEL IN
SECTION 4
.
The Ziagen pack includes an
ALERT CARD
, to remind you and medical staff about abacavir
hypersensitivity.
DETACH THIS CARD AND KEEP IT WITH YOU AT ALL TIMES
.
WHAT IS IN THIS LEAFLET
1.
What Ziagen is and what it is used for
2.
What you need to know before you take Ziagen
3.
How to take Ziagen
4.
Possible side effects
5.
How to store Ziagen
6.
Contents of the pack and other information
1.
WHAT ZIAGEN IS AND WHAT IT IS USED FOR
ZIAGEN IS USED TO TREAT HIV (HUMAN IMMUNODEFICIENCY VIRUS) INFECTION
.
Ziagen contains the active ingredient abacavir. Abacavir belongs to a
group of anti-retroviral
medicines called
_nucleoside analogue reverse transcriptase inhibitors (NRTIs)_
.
Ziagen does not completely cure HIV infection; it reduces the amount
of virus in your body, and keeps
it at a low level. It also increases the CD4 cell count in your blood.
CD4 cells are a type of white blood
cell that are important in helping your body to fight infection.
Not everyone respon

Svojstava lijeka

OBJECT 1
ZIAGEN 20 MG/ML ORAL SOLUTION
Summary of Product Characteristics Updated 07-Mar-2018 | ViiV
Healthcare UK Ltd
1. Name of the medicinal product
Ziagen 20 mg/ml oral solution
2. Qualitative and quantitative composition
Each ml of oral solution contains 20 mg of abacavir (as sulfate).
Excipients with known effect:
Sorbitol (E420) 340 mg/ml
Methyl parahydroxybenzoate (E218) 1.5 mg/ml
Propyl parahydroxybenzoate (E216) 0.18 mg/ml
For the full list of excipients see section 6.1.
3. Pharmaceutical form
Oral solution
The oral solution is clear to slightly opalescent yellowish, aqueous
solution which may turn into a brown
colour over time
4. Clinical particulars
4.1 Therapeutic indications
Ziagen is indicated in antiretroviral combination therapy for the
treatment of Human Immunodeficiency
Virus (HIV) infection in adults, adolescents and children (see
sections 4.4 and 5.1).
The demonstration of the benefit of Ziagen is mainly based on results
of studies performed in treatment-
naïve adult patients on combination therapy with a twice daily
regimen (see section 5.1).
Before initiating treatment with abacavir, screening for carriage of
the HLA-B*5701 allele should be
performed in any HIV-infected patient, irrespective of racial
origin(see section 4.4). Abacavir should not
be used in patients known to carry the HLA-B*5701 allele.
4.2 Posology and method of administration
Ziagen should be prescribed by physicians experienced in the
management of HIV infection.
Ziagen can be taken with or without food.
Ziagen is also available as a tablet formulation.
_Adults, adolescents and children (weighing at least 25 kg): _
The recommended dose of Ziagen is 600 mg daily (30 ml). This may be
administered as either 300 mg
(15 ml) twice daily or 600 mg (30 ml) once daily (see sections 4.4 and
5.1).
_Children (weighing less than 25 kg): _
_Children from one year of age_: The recommended dose is 8 mg/kg twice
daily or 16 mg/kg once daily, up
to a maximum total daily dose of 600 mg (30 ml).
_Children from three months to one year of ag