VOCABRIA cabotegravir (as sodium) 30 mg film-coated tablet, bottle

Negara: Australia

Bahasa: Inggris

Sumber: Department of Health (Therapeutic Goods Administration)

Bahan aktif:

cabotegravir, Quantity: 30 mg (Equivalent: cabotegravir sodium, Qty mg)

Tersedia dari:

ViiV Healthcare Pty Ltd

Bentuk farmasi:

Tablet, film coated

Komposisi:

Excipient Ingredients: titanium dioxide; magnesium stearate; hypromellose; lactose monohydrate; microcrystalline cellulose; sodium starch glycollate type A; macrogol 3350

Rute administrasi :

Oral

Unit dalam paket:

30

Jenis Resep:

(S4) Prescription Only Medicine

Indikasi Terapi:

VOCABRIA tablets are indicated in combination with rilpivirine tablets for the short-term treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) and have no known or suspected resistance to either cabotegravir or rilpivirine (see sections 4.2 DOSE AND METHOD OF ADMINISTRATION and 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials) for: ? oral lead in to assess tolerability of cabotegravir prior to administration of cabotegravir prolonged-release suspension for injection plus rilpivirine prolonged-release suspension for injection. ? oral therapy for adults who will miss planned dosing with cabotegravir prolonged-release suspension for injection.

Ringkasan produk:

Visual Identification: White, oval, film-coated, tablets, debossed with SV CTV on one side; Container Type: Bottle; Container Material: HDPE; Container Life Time: 48 Months; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure

Status otorisasi:

Registered

Tanggal Otorisasi:

2021-02-16

Selebaran informasi

VOCABRIA TABLETS
V
O
C
A
B
R
I
A
T
A
B
L
E
T
S
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.
▼
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY AM I TAKING VOCABRIA TABLETS?
VOCABRIA TABLETS contain the active ingredient cabotegravir. VOCABRIA
TABLETS are used to treat Human Immunodeficiency
Virus (HIV) infection in adults.
For more information, see Section 1. Why am I taking VOCABRIA TABLETS?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE VOCABRIA TABLETS?
Do not use VOCABRIA TABLETS if you have ever had an allergic reaction
to cabotegravir or any of the ingredients listed at the end
of the CMI.
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 take
VOCABRIA TABLETS? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with VOCABRIA TABLETS and affect how they
work.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE VOCABRIA TABLETS?
•
VOCABRIA TABLETS should be taken once a day and must always be taken
with another HIV medicine (rilpivirine). You should
also follow the instructions for rilpivirine carefully.
•
Take VOCABRIA TABLETS for as long as your doctor tells you. Don't stop
unless your doctor advises you to.
More instructions can be found in Section 4. How do I take VOCABRIA
TABLETS? in the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING VOCABRIA?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
VOCABRIA TABLETS.
•
Have regular blood tests and stay in regular contact with your doctor.
•
Continue to protect people as VOCABRIA TABLETS may not stop you
passing HIV infection on to others.
THINGS Y

Karakteristik produk

1
This medicinal product is subject to additional monitoring in
Australia. This will allow
quick identification of new safety information. Healthcare
professionals are asked to report
any suspected adverse events at www.tga.gov.au/reporting-problems.
AUSTRALIAN PRODUCT INFORMATION
VOCABRIA (CABOTEGRAVIR) FILM-COATED TABLETS
1
NAME OF THE MEDICINE
Cabotegravir (as cabotegravir sodium)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
VOCABRIA tablet contains 30 mg cabotegravir (as cabotegravir sodium).
Cabotegravir is a white to almost white solid.
LIST OF EXCIPIENTS WITH KNOWN EFFECT
VOCABRIA tablets contain lactose monohydrate.
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
VOCABRIA tablets are white, oval, film-coated, tablets, debossed with
‘SV CTV’ on one side
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
VOCABRIA tablets are indicated in combination with rilpivirine tablets
for the short-term
treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in
adults who are
virologically suppressed (HIV-1 RNA <50 copies/mL) and have no known
or suspected
resistance to either cabotegravir or rilpivirine (see sections 4.2
DOSE AND METHOD OF
ADMINISTRATION and 5.1 PHARMACODYNAMIC PROPERTIES, Clinical trials)
for:
•
oral lead in to assess tolerability of cabotegravir prior to
administration of
cabotegravir prolonged-release suspension for injection plus
rilpivirine prolonged-
release suspension for injection.
•
oral therapy for adults who will miss planned dosing with cabotegravir
prolonged-
release suspension for injection.
4.2
DOSE AND METHOD OF ADMINISTRATION
VOCABRIA should be prescribed by a physician experienced in the
management of HIV
infection.
VOCABRIA is indicated for the treatment of HIV-1 in combination with
rilpivirine, therefore,
the product information for rilpivirine should be consulted for
recommended dosing.
▼

2
Prior to starting VOCABRIA tablets, healthcare professionals should
carefully select patients
who agree to the required inject