VOCABRIA TABLETS

Država: Izrael

Jezik: engleski

Izvor: Ministry of Health

Aktivni sastojci:

CABOTEGRAVIR AS SODIUM

Dostupno od:

GLAXO SMITH KLINE (ISRAEL) LTD

Farmaceutski oblik:

FILM COATED TABLETS

Sastav:

CABOTEGRAVIR AS SODIUM 30 MG

Administracija rute:

PER OS

Tip recepta:

Required

Proizveden od:

VIIV HEALTHCARE UK LIMITED, UK

Terapijske indikacije:

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) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for: • oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting cabotegravir injection plus long acting rilpivirine injection. • oral therapy for adults who will miss planned dosing with cabotegravir injection plus rilpivirine injection.

Datum autorizacije:

2022-06-06

Uputa o lijeku

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Vocabria Tablets
Film-coated tablets
Each tablet contains:
cabotegravir (as sodium) 30 mg
For the list of the inactive and allergenic ingredients in the
medicine, see
section 2 - "Important information about some of the ingredients in
the medicine" and
section 6 – "Additional information".
Read the leaflet carefully in its entirety before using the medicine.
This leaflet contains
concise information about the medicine. If you have further questions,
refer to the
physician or pharmacist.
This medicine has been prescribed for you. Do not pass it on to
others. It may harm
them even if it seems to you that their medical condition is similar.
1.
WHAT IS THE MEDICINE INTENDED FOR?
Vocabria Tablets is 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) on a stable
anti-retroviral
regimen without present or past evidence of viral resistance to, and
no prior
virological failure with agents of the NNRTI and INI class, for:
• oral lead-in to assess tolerability of Vocabria and rilpivirine
prior to administration of
long acting cabotegravir injection plus long acting rilpivirine
injection.
• oral therapy for adults who will miss planned dosing with
cabotegravir injection plus
rilpivirine injection.
Therapeutic group:
Vocabria contains the active ingredient cabotegravir. Cabotegravir
belongs to a group
of anti-retroviral medicines called
integrase inhibitors (INIs)
.
Vocabria Tablets does not cure HIV infection; it keeps the amount of
virus in your body
at a low level. This helps maintain the number of CD4+ cells in your
blood. CD4+ cells
are a type of white blood cells that are important in helping your
body to fight infection.
Your physician will advise you to take Vocabria tablets before
administrati

Svojstava lijeka

Page 1 of 20
1.
NAME OF THE MEDICINAL PRODUCT
Vocabria Tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains cabotegravir sodium equivalent to 30 mg
cabotegravir.
Excipient with known effect
Each film-coated tablet contains 155 mg lactose (as monohydrate).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
White, oval, film-coated tablets (approximately 8.0 mm by 14.3
mm), 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) on a stable antiretroviral regimen without
present or past evidence of
viral resistance to, and no prior virological failure with agents of
the NNRTI and INI class (see
sections 4.2, 4.4 and 5.1) for:
•
oral lead-in to assess tolerability of Vocabria and rilpivirine prior
to administration of long
acting cabotegravir injection plus long acting rilpivirine injection.
•
oral therapy for adults who will miss planned dosing with cabotegravir
injection plus
rilpivirine injection.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vocabria should be prescribed by physicians experienced in the
management of HIV infection.
Vocabria tablets are indicated for the short-term treatment of HIV in
combination with rilpivirine
tablets, therefore, the prescribing information for rilpivirine
tablets should be consulted for
recommended dosing.
PRIOR TO STARTING VOCABRIA, HEALTHCARE PROFESSIONALS SHOULD CAREFULLY
SELECT PATIENTS WHO AGREE TO
THE REQUIRED MONTHLY INJECTION SCHEDULE AND COUNSEL PATIENTS ABOUT THE
IMPORTANCE OF ADHERENCE
TO SCHEDULED DOSING VISITS TO HELP MAINTAIN VIRAL SUPPRESSION AND
REDUCE THE RISK OF VIRAL REBOUND
AND POTENTIAL DEVELOPMENT OF RESISTANCE WITH MISSED DOSES (SEE SECTION
4.4).
The healthcare provider and patient may decide to use Vocabria tablets
as an or