Tecovirimat SIGA

País: Unión Europea

Idioma: inglés

Fuente: EMA (European Medicines Agency)

Ingredientes activos:

Tecovirimat

Disponible desde:

SIGA Technologies Netherlands B.V.

Código ATC:

J05AX24

Designación común internacional (DCI):

tecovirimat monohydrate

Grupo terapéutico:

Antivirals for systemic use

Área terapéutica:

Poxviridae Infections; Cowpox; Monkeypox; Vaccinia; Smallpox

indicaciones terapéuticas:

Tecovirimat SIGA is indicated for the treatment of the following viral infections in adults and children with body weight at least 13 kg:- Smallpox- Monkeypox- CowpoxTecovirimat SIGA is also indicated to treat complications due to replication of vaccinia virus following vaccination against smallpox in adults and children with body weight at least 13 kg (see sections 4.4 and 5.1).Tecovirimat SIGA should be used in accordance with official recommendations.

Resumen del producto:

Revision: 2

Estado de Autorización:

Authorised

Fecha de autorización:

2022-01-06

Información para el usuario

24
B. PACKAGE LEAFLET
25
PACKAGE LEAFLET: INFORMATION FOR THE USER
TECOVIRIMAT SIGA 200 MG HARD CAPSULES
tecovirimat
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 TAKING 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 pharmacist.
-
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
-
If you get any side effects, talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Tecovirimat SIGA is and what it is used for
2.
What you need to know before you take Tecovirmat SIGA
3.
How to take Tecovirimat SIGA
4.
Possible side effects
5.
How to store Tecovirimat SIGA
6.
Contents of the pack and other information
1.
WHAT TECOVIRIMAT SIGA IS AND WHAT IT IS USED FOR
Tecovirimat SIGA contains the active ingredient tecovirimat.
Tecovirimat SIGA is used to treat viral infections, such as smallpox,
mpox and cowpox in adults and
children weighing at least 13 kg.
Tecovirimat SIGA is also used to treat complications from smallpox
vaccines.
Tecovirimat SIGA works by stopping the virus from spreading. This will
help your own body to build
up protection against the virus until you are better.
2.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE
TECOVIRIMAT SIGA
DO NOT TAKE TECOVIRIMAT SIGA
-
if you are allergic to Tecovirimat SIGA or any of the other
ingredients of this medicine (listed in
section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before taking Tecovirimat SIGA.
-
if your immune system does not work properly (immunodeficiency) or you
are taking medicines
that weaken the immune syst

Ficha técnica

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
Tecovirimat SIGA 200 mg hard capsules
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each hard capsule contains tecovirimat monohydrate equivalent to 200
mg tecovirimat.
Excipient(s) with known effect
Each capsule contains 31.5 mg lactose (as monohydrate) and 0.41 mg
sunset yellow (E110).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Hard capsule (capsule)
Opaque gelatin capsules with an orange body and black cap, containing
white to off-white powder.
The body is printed with “SIGA” and the SIGA logo (a curved
triangle with letters in it) followed by
“®” in white ink. The cap is printed with “ST-246
®
” in white ink. The capsules are 21.7 millimeters
long and 7.64 millimeters in diameter.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Tecovirimat SIGA is indicated for the treatment of the following viral
infections in adults and children
with body weight at least 13 kg:
o
Smallpox
o
Mpox
o
Cowpox
Tecovirimat SIGA is also indicated to treat complications due to
replication of vaccinia virus
following vaccination against smallpox in adults and children with
body weight at least 13 kg
(see sections 4.4 and 5.1).
Tecovirimat SIGA should be used in accordance with official
recommendations.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Tecovirimat treatment should be initiated as soon as possible after
diagnosis (see section 4.1).
_ _
_Adults and children of at least 13 kg _
The recommended doses are described in Table 1.
3
TABLE 1:
RECOMMENDED DOSE BY BODY WEIGHT
BODY WEIGHT
DOSAGE
NUMBER OF CAPSULES
13 kg to less than 25 kg
200 mg every 12 hours for 14 days
One Tecovirimat 200 mg capsule
25 kg to less than 40 kg
400 mg every 12 hours for 14