Vocabria

Valsts: Eiropas Savienība

Valoda: angļu

Klimata pārmaiņas: EMA (European Medicines Agency)

Aktīvā sastāvdaļa:

Cabotegavir sodium, Cabotegravir

Pieejams no:

ViiV Healthcare B.V.

ATĶ kods:

J05AX

SNN (starptautisko nepatentēto nosaukumu):

cabotegravir

Ārstniecības grupa:

Antivirals for systemic use

Ārstniecības joma:

HIV Infections

Ārstēšanas norādes:

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

Produktu pārskats:

Revision: 8

Autorizācija statuss:

Authorised

Autorizācija datums:

2020-12-17

Lietošanas instrukcija

65
B. PACKAGE LEAFLET
66
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
VOCABRIA 400 MG PROLONGED-RELEASE SUSPENSION FOR INJECTION
cabotegravir
This medicine is subject to additional monitoring. This will allow
quick identification of new safety
information. You can help by reporting any side effects you may get.
See the end of section 4 for how
to report side effects.
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor or nurse.
-
If you get any side effects, talk to your doctor or nurse. This
includes any possible side effects
not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Vocabria is and what it is used for
2.
What you need to know before you are given Vocabria
3.
How Vocabria injections are given
4.
Possible side effects
5.
How to store Vocabria
6.
Contents of the pack and other information
1.
WHAT VOCABRIA_ _IS AND WHAT IT IS USED FOR
Vocabria injection contains the active ingredient cabotegravir.
Cabotegravir belongs to a group of anti-
retroviral medicines called
_integrase inhibitors (INIs)_
.
Vocabria injection is used to treat HIV (human immunodeficiency virus)
infection in adults aged 18
years and over, who are also receiving another antiretroviral medicine
called rilpivirine and whose
HIV-1 infection is under control.
_ _
Vocabria injections do not cure HIV infection; they keep 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 package leaflet for information on that
medicine.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN VOCABRIA
DO NOT RECEIVE A VOCABRIA INJECTION:

if you are
ALLERG

Produkta apraksts

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
This medicinal product is subject to additional monitoring. This will
allow quick identification of
new safety information. Healthcare professionals are asked to report
any suspected adverse reactions.
See section 4.8 for how to report adverse reactions.
1.
NAME OF THE MEDICINAL PRODUCT
400 mg
Vocabria 400 mg prolonged-release suspension for injection
600 mg
Vocabria 600 mg prolonged-release suspension for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
400 mg
Each vial contains 400 mg cabotegravir in 2 mL.
600 mg
Each vial contains 600 mg cabotegravir in 3 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
3
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