Dectova

Negara: Uni Eropa

Bahasa: Inggris

Sumber: EMA (European Medicines Agency)

Bahan aktif:

Zanamivir

Tersedia dari:

GlaxoSmithKline Trading Services Limited

Kode ATC:

J05AH01

INN (Nama Internasional):

Zanamivir

Kelompok Terapi:

Antivirals for systemic use

Area terapi:

Influenza, Human

Indikasi Terapi:

Dectova is indicated for the treatment of complicated and potentially life-threatening influenza A or B virus infection in adult and paediatric patients (aged ≥6 months) when:The patient’s influenza virus is known or suspected to be resistant to anti-influenza medicinal products other than zanamivir, and/orOther anti-viral medicinal products for treatment of influenza, including inhaled zanamivir, are not suitable for the individual patient.Dectova should be used in accordance with official guidance.

Ringkasan produk:

Revision: 4

Status otorisasi:

Authorised

Tanggal Otorisasi:

2019-04-26

Selebaran informasi

23
B. PACKAGE LEAFLET
24
Package leaflet: Information for the patient
DECTOVA 10 MG/ML SOLUTION FOR INFUSION
zanamivir
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 ARE GIVEN 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 Dectova is and what it is used for
2.
What you need to know before you are given Dectova
3.
How Dectova is given
4.
Possible side effects
5.
How to store Dectova
6.
Contents of the pack and other information
1.
WHAT DECTOVA IS AND WHAT IT IS USED FOR
Dectova contains zanamivir, which belongs to a group of medicines
called antivirals.
Dectova
IS USED TO TREAT SEVERE FLU
(influenza A or B virus infection). It is used when other flu
treatments
are not suitable.
Adults and children aged 6 months or more can be treated with Dectova.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN DECTOVA
DO NOT USE DECTOVA:
•
IF YOU ARE ALLERGIC
to zanamivir or any of the other ingredients of this medicine (listed
in section 6).
WARNINGS AND PRECAUTIONS
Serious skin or allergic reactions
Serious skin or allergic reactions may occur after Dectova is given.
Symptoms may include skin or throat
swelling, difficulty breathing, blistering rash or peeling skin (see
also ‘
_Serious skin or allergic reactions_
’ in
section 4).
Sudden changes in behaviour, hallucinations and fits
During treatment with Dectova, changes in behaviour such as confusion
and unresponsiveness may occur.
Some people may also have hallucinations (seeing, hearing, or feeling
things that are not there) or fits
(seizures) wh

Karakteristik produk

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
Dectova 10 mg/mL solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each mL of solution contains 10 mg of zanamivir (as hydrate).
Each vial contains 200 mg of zanamivir (as hydrate) in 20 mL.
Excipients with known effect
Each vial contains 3.08 mmol (70.8 mg) sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
Clear, colourless.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Dectova is indicated for the treatment of complicated and potentially
life-threatening influenza A or B virus
infection in adult and paediatric patients (aged ≥6 months) when:
•
The patient’s influenza virus is known or suspected to be resistant
to anti-influenza medicinal
products other than zanamivir, and/or
•
Other anti-viral medicinal products for treatment of influenza,
including inhaled zanamivir, are not
suitable for the individual patient.
Dectova should be used in accordance with official guidance.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
_ _
Treatment with Dectova should commence as soon as possible and usually
within 6 days of the onset of
symptoms of influenza (see section 5.1).
_Adults _
The recommended dose is 600 mg twice daily for 5 to 10 days given by
intravenous infusion.
_Paediatric population _
3
Adolescents, children and infants should receive a weight-based dose
regimen for 5 to 10 days (Table 1).
TABLE 1: WEIGHT-BASED DOSE REGIMEN BY AGE FOR INFANTS, CHILDREN AND
ADOLESCENTS WITH NORMAL RENAL
FUNCTION
AGE RANGE
WEIGHT-BASED DOSE REGIMEN
6 months to < 6 years
14 mg/kg twice daily
≥
6 years to < 18 years
12 mg/kg twice daily up to a maximum dose of 600 mg
twice daily
_Elderly _
No dose adjustment is requ