VOCABRIA INJECTION

Land: Israel

Språk: engelska

Källa: Ministry of Health

Aktiva substanser:

CABOTEGRAVIR

Tillgänglig från:

GLAXO SMITH KLINE (ISRAEL) LTD

Läkemedelsform:

PROLONGED RELEASE SUSPENSION FOR INJECTION

Sammansättning:

CABOTEGRAVIR 200 MG / 1 ML

Administreringssätt:

I.M

Receptbelagda typ:

Required

Tillverkad av:

VIIV HEALTHCARE UK LIMITED, UK

Terapeutiska indikationer:

Vocabria injection is indicated, in combination with rilpivirine injection, for the 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

Tillstånd datum:

2022-06-06

Bipacksedel

PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’
REGULATIONS (PREPARATIONS) - 1986
The medicine is dispensed according to a physician’s prescription
only
Vocabria Injection
Prolonged-release suspension for injection
Each vial contains:
cabotegravir 200 mg/mL
The 2 mL vial contains - 400 mg cabotegravir
The 3 mL vial contains - 600 mg cabotegravir
For the list of the inactive and allergenic ingredients in the
medicine, see 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 Injection is indicated, in combination with rilpivirine
injection, for the
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.
Therapeutic group:
Vocabria Injection contains the active ingredient cabotegravir.
Cabotegravir belongs
to a group of anti-retroviral medicines called
integrase inhibitors (INIs)
.
Vocabria Injection 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.
Vocabria Injection is always given in combination with another
injection of an anti-
retroviral medicine called rilpivirine injection. Refer to the
rilpivirine patient leaflet for
information on that medicine.
2.
BEFORE USING THE MEDICINE
Do not use the medicine If:
• you are hypersensitive (allergic) to the active ingredient
(cabotegra

Produktens egenskaper

1
1.
NAME OF THE MEDICINAL PRODUCT
Vocabria Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
400 mg
Each vial contains 400 mg cabotegravir in 2 mL (200mg/ml).
600 mg
Each vial contains 600 mg cabotegravir in 3 mL (200mg/ml).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Prolonged-release suspension for injection.
White to light pink suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Vocabria_ _injection is indicated, in combination with rilpivirine
injection, for the 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).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Vocabria should be prescribed by physicians experienced in the
management of HIV infection.
Each injection should be administered by a healthcare professional.
Vocabria injection is indicated for the treatment of HIV-1 in
combination with rilpivirine injection,
therefore, the prescribing information for rilpivirine injection
should be consulted for recommended
dosing.
PRIOR TO STARTING VOCABRIA INJECTION, HEALTHCARE PROFESSIONALS SHOULD
HAVE CAREFULLY SELECTED
PATIENTS WHO AGREE TO THE REQUIRED 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.
FOLLOWING DISCONTINUATION OF VOCABRIA AND RILPIVIRINE INJECTION, IT IS
ESSENTIAL TO ADOPT AN
ALTERNATIVE, FULLY SUPPRESSIVE ANTIRETROVIRAL REGIMEN NO LATER THAN
ONE MONTH AFTER THE FINAL
INJECTION OF VOCABRIA WHEN DOSED MONTHLY AND NO LATER THAN TWO MONTHS
AFTER THE FINAL INJECTION
OF VOCABRIA WHEN DOSED EVERY 2 MONTHS (SEE SECTION 4.4).
The healthcare provider and patient may decide to use cabotegravir
tablets as an ora