Triumeq

Nazione: Nuova Zelanda

Lingua: inglese

Fonte: Medsafe (Medicines Safety Authority)

Principio attivo:

Abacavir sulfate 702mg equivalent to Abacavir 600 mg;  ; Dolutegravir sodium 52.6mg equivalent to Dolutegravir 50 mg;  ;  ;  ; Lamivudine 300mg;  

Commercializzato da:

GlaxoSmithKline NZ Limited

INN (Nome Internazionale):

Abacavir sulfate 702 mg (equivalent to Abacavir 600 mg)

Dosaggio:

50mg/600mg/300mg

Forma farmaceutica:

Film coated tablet

Composizione:

Active: Abacavir sulfate 702mg equivalent to Abacavir 600 mg   Dolutegravir sodium 52.6mg equivalent to Dolutegravir 50 mg       Lamivudine 300mg   Excipient: Magnesium stearate Mannitol Microcrystalline cellulose Opadry purple 85F90057 Povidone Sodium starch glycolate

Tipo di ricetta:

Prescription

Prodotto da:

Piramal Enterprises Limited

Indicazioni terapeutiche:

Triumeq is indicated for the treatment of Human Immunodeficiency Virus (HIV) infection in adults and adolescents from 12 years of age who are antiretroviral treatment-na?ve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents (dolutegravir, abacavir or lamivudine) in Triumeq.

Dettagli prodotto:

Package - Contents - Shelf Life: Bottle, HDPE Bottle with Child-Resistant Closure - 30 tablets - 36 months from date of manufacture stored at or below 30°C protect from moisture

Data dell'autorizzazione:

2015-02-04

Foglio illustrativo

TRIUMEQ
1
TRIUMEQ
_Film-coated tablets _
_50 mg dolutegravir (as dolutegravir sodium) / 600 mg abacavir (as
abacavir sulfate) / 300 mg lamivudine _
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING TRIUMEQ, WHICH CONTAINS ABACAVIR, MAY DEVELOP A
HYPERSENSITIVITY
REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF
TREATMENT
WITH TRIUMEQ IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE
ON WHETHER
YOU SHOULD STOP TAKING TRIUMEQ IF:
1)
YOU GET A SKIN RASH OR
2)
YOU GET ONE OR MORE SYMPTOMS FROM AT LEAST TWO OF THE FOLLOWING
GROUPS:

FEVER

SHORTNESS OF BREATH, SORE THROAT OR COUGH

NAUSEA OR VOMITING OR DIARRHOEA OR ABDOMINAL PAIN

SEVERE TIREDNESS OR ACHINESS OR GENERALLY ILL FEELING
IF YOU HAVE HAD A HYPERSENSITIVITY (ALLERGIC) REACTION TO TRIUMEQ
TABLETS, NEVER TAKE
TRIUMEQ, OR ANY OTHER MEDICINAL PRODUCT CONTAINING ABACAVIR (KIVEXA,
TRIZIVIR &
ZIAGEN) AGAIN AS YOU MAY DEVELOP A LIFE THREATENING REACTION WHICH CAN
BE FATAL.
THERE IS AN ALERT CARD INCLUDED IN THE TRIUMEQ PACK, TO REMIND YOU AND
MEDICAL STAFF
ABOUT ABACAVIR HYPERSENSITIVITY. THIS CARD SHOULD BE REMOVED FROM THE
PACK AND
KEPT WITH YOU AT ALL TIMES. SEE MORE DETAILS UNDER BEFORE YOU TAKE
TRIUMEQ.
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take TRIUMEQ. This
leaflet answers some common
questions about TRIUMEQ
(dolutegravir/abacavir/lamivudine).
It does not contain all of 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 expected benefits of you taking
TRIUMEQ against the risks this
medicine could have for you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT IS TRIUMEQ
USED FOR?
TRIUMEQ contains three active
ingredients that are used to treat HIV
infection in adults and children over
12 years old weighing 40 kg or more
who have never received treatment
for HIV or are infected

Scheda tecnica

1
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
TRIUMEQ dolutegravir 50 mg, abacavir 600 mg and lamivudine 300 mg
film-coated tablets.
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
TRIUMEQ is supplied as film-coated tablets each containing 50 mg of
dolutegravir (as
dolutegravir sodium), 600 mg of abacavir (as abacavir sulfate) and 300
mg of lamivudine.
Each film-coated tablet contains 50 mg of dolutegravir (as
dolutegravir sodium), 600 mg of
abacavir (as abacavir sulphate) and 300 mg of lamivudine.
For the full list of excipients, see section 6.1 List of excipients.
Data Sheets for TIVICAY(dolutegravir), ZIAGEN (abacavir), 3TC
(lamivudine) and KIVEXA
(abacavir and lamivudine) contain additional information.
3.
PHARMACEUTICAL FORM
Film-coated tablet.
Purple, film-coated, oval, biconvex tablets, debossed with ‘572
Trı’ on one side.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
TRIUMEQ is indicated for the treatment of Human Immunodeficiency Virus
(HIV) infection
in adults and adolescents from 12 years of age who are antiretroviral
treatment-naïve or are
infected with HIV without documented or clinically suspected
resistance to any of the three
antiretroviral agents (dolutegravir, abacavir or lamivudine) in
TRIUMEQ.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSE
Therapy should be initiated by a physician experienced in the
management of HIV infection.
The recommended dose of TRIUMEQ in adults and adolescents weighing at
least 40 kg is
one tablet once daily, taken with or without food.
Because TRIUMEQ is a fixed dose tablet, it should not be prescribed
for patients requiring
dose adjustment:
•
Adults or adolescents weighing <40 kg
•
Children <12 years of age
•
Patients with creatinine clearance <30 mL/min
•
Patients with mild hepatic impairment
2
•
Patients resistant to integrase inhibitors
SPECIAL POPULATIONS
Elderly
There are limited data available on the use of dolutegravir, abacavir
and lamivudine in
patients aged 65 years and over. However, there is no evidence that
elderly patients require
a different