TRELAVUE dolutegravir (as sodium) 50 mg/abacavir (as sulfate) 600 mg/lamivudine 300 mg tablet bottle

Država: Australija

Jezik: engleski

Izvor: Department of Health (Therapeutic Goods Administration)

Aktivni sastojci:

abacavir sulfate, Quantity: 702 mg (Equivalent: abacavir, Qty 600 mg); lamivudine, Quantity: 300 mg; dolutegravir, Quantity: 50 mg

Dostupno od:

ViiV Healthcare Pty Ltd

INN (International ime):

Abacavir sulfate,Dolutegravir,Lamivudine

Farmaceutski oblik:

Tablet, film coated

Sastav:

Excipient Ingredients: microcrystalline cellulose; sodium starch glycollate; povidone; magnesium stearate; purified water; mannitol; titanium dioxide; purified talc; iron oxide red; polyvinyl alcohol; macrogol 3350; iron oxide black

Administracija rute:

Oral

Jedinice u paketu:

30 tablets

Tip recepta:

(S4) Prescription Only Medicine

Terapijske indikacije:

TRELAVUE 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 TRELAVUE.

Proizvod sažetak:

Visual Identification: Purple, biconvex, film coated oval tablets (approximately 22 x 11 mm), debossed with 572 Tri on one face.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 36 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status autorizacije:

Registered

Uputa o lijeku

TRELAVUE
1
TRELAVUE
FILM-COATED TABLETS
_50 mg dolutegravir (as dolutegravir sodium) / 600 mg abacavir (as
abacavir sulfate) / 300 mg lamivudine _
CONSUMER MEDICINE INFORMATION
PATIENTS TAKING TRELAVUE, WHICH CONTAINS ABACAVIR, MAY DEVELOP A
HYPERSENSITIVITY
REACTION (SERIOUS ALLERGIC REACTION) WHICH CAN BE LIFE-THREATENING IF
TREATMENT
WITH TRELAVUE IS CONTINUED. CONTACT YOUR DOCTOR IMMEDIATELY FOR ADVICE
ON
WHETHER YOU SHOULD STOP TAKING TRELAVUE 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 TRELAVUE
TABLETS, NEVER
TAKE TRELAVUE, 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 TRELAVUE 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
TRELAVUE.
WHAT IS IN THIS LEAFLET?
Please read this leaflet carefully
before you take TRELAVUE. This
leaflet answers some common
questions about TRELAVUE
(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
TRELAVUE 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 TRELAVUE
USED FOR?
TRELAVUE contains three active
ingredients that are used to treat HIV
infection in adults and children over
12 years old: dolutegravir, abacavir,
and lamivudine. Dolutegravir
belongs to a gr