Tenofovir disoproxil tablets (Teva)

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245 mg;  

Dostopno od:

Teva Pharma (New Zealand) Limited

INN (mednarodno ime):

Tenofovir disoproxil succinate 300.6 mg (equivalent to tenofovir disoproxil 245 mg)

Odmerek:

245 mg

Farmacevtska oblika:

Film coated tablet

Sestava:

Active: Tenofovir disoproxil succinate 300.6mg equivalent to tenofovir disoproxil 245 mg   Excipient: Croscarmellose sodium Indigo carmine aluminium lake Lactose Macrogol 3350 Magnesium stearate Microcrystalline cellulose Polyvinyl alcohol Pregelatinised maize starch Purified talc Purified water Titanium dioxide

Tip zastaranja:

Prescription

Izdeluje:

Zhejiang Jiuzhou Pharmaceutical Co. Limited

Terapevtske indikacije:

Tenofovir disoproxil tablets in combination with other antiretroviral agents are indicated for the treatment of HIV-infected adults and paediatric patients 12 years of age and older.

Povzetek izdelek:

Package - Contents - Shelf Life: Bottle, HDPE, with HDPE canister containing silica gel, closed with a PP child-resistant cap - 30 tablets - 60 months from date of manufacture stored at or below 25°C

Datum dovoljenje:

2016-08-05

Navodilo za uporabo

CONSUMER MEDICINE INFORMATION
TENOFOVIR DISOPROXIL TABLETS (TEVA)
Tenofovir disoproxil tablets 245 mg
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully before you start taking Tenofovir
disoproxil
tablets (Teva).
This leaflet answers some common questions about Tenofovir disoproxil
tablets (Teva). It does not contain all the available information. It
does not
take the place of talking to your doctor or pharmacist.
All medicines have risks and benefits. Your doctor has weighed the
risks of
you using Tenofovir disoproxil tablets (Teva) against the benefits
they expect
it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR
PHARMACIST.
Keep this leaflet with the medicine. You may need to read it again.
WHAT TENOFOVIR DISOPROXIL TABLETS (TEVA) IS USED FOR
Tenofovir disoproxil tablets (Teva) is an antiviral medication used to
treat two
different viruses; Chronic Hepatitis B (CHB) and Human
Immunodeficiency
Virus (HIV) Infection.
Tenofovir disoproxil tablets (Teva) is a type of medicine called a HBV
polymerase inhibitor and a nucleotide analog reverse transcriptase
inhibitor
(NRTI).
HOW TENOFOVIR DISOPROXIL TABLETS (TEVA) WORK IN THE TREATMENT OF CHB
Tenofovir disoproxil tablets (Teva) are used to treat CHB (an
infection with
hepatitis B virus [HBV]) in adults and paediatric patients aged 12
years and
older and weighing at least 35 kg.
Tenofovir disoproxil tablets (Teva) work by interfering with the
normal working
of
enzymes (HBV
DNA polymerase) that are essential for HBV to reproduce
itself. Tenofovir disoproxil tablets (Teva) may help lower the amount
of
hepatitis B virus in your body by lowering the ability of the virus to
multiply and
infect new liver cells and can improve the inflammation and scar
tissue caused
by the hepatitis B virus in your liver.
Lowering the amount of virus in your body may reduce the chance of
developing cirrhosis, liver failure and liver cancer.
We do not know how long Tenofovir disoproxil tablets (Teva) may help
treat
your hepatitis. Sometimes

Lastnosti izdelka

Version 1.3
1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Tenofovir disoproxil tablets (Teva) 245 mg
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains tenofovir disoproxil succinate 300.6 mg
equivalent to tenofovir disoproxil 245
mg.
Excipient with known effect:
lactose
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Light blue, almond shaped, film coated tablets with dimensions of
approximately 17.0 mm x 10.5
mm.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tenofovir disoproxil tablets in combination with other antiretroviral
agents are indicated for the
treatment of HIV- infected adults and paediatric patients 12 years of
age and older.
Tenofovir disoproxil tablets are indicated for the treatment of
chronic hepatitis B in adults and in
paediatric patients 12 years of age and older.
4.2
DOSE AND METHOD OF ADMINISTRATION
_ADULTS: _
The recommended dose is one tablet once daily taken orally with or
without food.
_PAEDIATRIC PATIENTS (≥ 12 YEARS OF AGE AND ≥ 35 KG): _
The recommended dose for paediatric patients
(12 years of age and older), who weigh ≥ 35 kg, is one tablet once
daily taken orally with or without
food.
The safety and efficacy of tenofovir disoproxil in patients under the
age of 12 years have not been
established.
Tenofovir disoproxil tablets must not be administered to children
under 12, until
further data become available.
_ELDERLY: _
No data are available on which to make a dose recommendation for
patients over the age
of 65 years. The safety and efficacy of tenofovir disoproxil has not
been established in patients over
the age of 65 years. Caution should be exercised when administering
Tenofovir disoproxil tablets to
elderly patients until further data become available describing the
disposition of tenofovir disoproxil
in these patients. The greater frequency of decreased hepatic, renal
or cardiac function in these
patients, presence of any concomitant illnesses or the need for
treatment with other medicinal
products concomitantly with Tenofovir dis