Tivicay

Land: Nya Zeeland

Språk: engelska

Källa: Medsafe (Medicines Safety Authority)

Aktiva substanser:

Dolutegravir sodium 52.6mg equivalent to dolutegravir 50 mg;  ;  ;  

Tillgänglig från:

GlaxoSmithKline NZ Limited

INN (International namn):

Dolutegravir sodium 52.6 mg (equivalent to Dolutegravir 50 mg)

Dos:

50 mg

Läkemedelsform:

Film coated tablet

Sammansättning:

Active: Dolutegravir sodium 52.6mg equivalent to dolutegravir 50 mg       Excipient: Mannitol Microcrystalline cellulose Opadry yellow 85F92461 Povidone Sodium starch glycolate Sodium stearyl fumarate

Receptbelagda typ:

Prescription

Tillverkad av:

Glaxo Wellcome Manufacturing Pte Ltd

Terapeutiska indikationer:

TIVICAY is indicated for the treatment of human immunodeficiency virus (HIV) infection in combination with other antiretroviral agents in adults and children over 12 years of age and weighing 40 kg or more.

Produktsammanfattning:

Package - Contents - Shelf Life: Bottle, plastic, HDPE with PP child resistant closure - 30 tablets - 60 months from date of manufacture stored at or below 30°C

Tillstånd datum:

2014-02-12

Bipacksedel

TIVICAY Film Coated Tablets
1
TIVICAY FILM COATED TABLETS
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING TIVICAY?
TIVICAY contains the active ingredient dolutegravir. TIVICAY is used
to treat HIV (human immunodeficiency virus) infection in
adults and in children. For more information, see Section 1. Why am I
using TIVICAY? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE TIVICAY?
Do not use if you (or your child, if they are the patient) have ever
had an allergic reaction to dolutegravir or any of the ingredients
listed at the end of the CMI.
Do not use if taking the following medicines dofetilide or
pilsicainide (to treat heart conditions); or fampridine (to treat
multiple
sclerosis).
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I use
TIVICAY? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with TIVICAY and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE TIVICAY?

For children, your doctor will decide on the correct dose of TIVICAY
for your child, depending on their weight and age.

For adults, the usual dose of TIVICAY film coated tablets is 50 mg,
once a day.

For HIV infection that is resistant to other medicines similar to
TIVICAY, the usual dose of TIVICAY film coated tablets is 50 mg
taken twice a day.
More instructions can be found in Section 4. How do I use TIVICAY? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING TIVICAY?
THINGS YOU
SHOULD DO

Remind any doctor, dentist or pharmacist you visit that you are using
TIVICAY.

If you become pregnant while taking this medicine, tell your doctor
immediately.

Keep all of your doctor's appointments so that

Produktens egenskaper

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
TIVICAY
dolutegravir 50 mg film-coated tablets
TIVICAY film-coated tablets contain dolutegravir (as dolutegravir
sodium) which is an
integrase inhibitor active against Human Immunodeficiency Virus (HIV).
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TIVICAY is supplied as film-coated tablets each containing 52.6 mg of
dolutegravir sodium,
equivalent to 50 mg of dolutegravir free acid.
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Film-coated tablets.
Yellow, film-coated, round, biconvex tablets, debossed with ‘SV
572’ on one side and ‘50’
on the other side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TIVICAY is indicated for the treatment of human immunodeficiency virus
(HIV) infection in
combination with other antiretroviral agents in adults and children
over 12 years of age and
weighing 40 kg or more (see Section 4.4 Special warnings and
precautions for use).
4.2.
DOSE AND METHOD OF ADMINISTRATION
TIVICAY therapy should be initiated by a physician experienced in the
management of HIV
infection.
DOSE
Adults
_Patients infected with HIV-1 without resistance to the integrase
class _
The recommended dose of TIVICAY is 50 mg once daily.
_Patients infected with HIV-1 with resistance to the integrase class
(documented or clinically _
_suspected) _
The recommended dose of TIVICAY is 50 mg twice daily.
The decision to use dolutegravir
for such patients should be informed by the integrase resistance
pattern (see_ _section 5.1
Pharmacodynamic properties).
2
The following should be considered prior to initiating treatment with
TIVICAY 50 mg twice
daily:

Reduced virologic response was observed in patients treated with
TIVICAY 50 mg
twice daily with an INI-resistance Q148H/K/R mutation plus 2 or more
additional INI-
resistance mutations including, but not limited to G140A/C/S,
E138A/K/T, or L74I
(see section 5.1 Pharmacodynamic properties).
Adolescents
In patients who have not previously been treated with an integrase
inhi