Alpivab
Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Fuljett ta 'informazzjoni
(PIL)
09-12-2020
Karatteristiċi tal-prodott
(SPC)
09-12-2020
Rapport ta 'Valutazzjoni Pubblika
(PAR)
09-12-2020
Ingredjent attiv:
Peramivir
Disponibbli minn:
Biocryst
Kodiċi ATC:
J05AH03
INN (Isem Internazzjonali):
peramivir
Grupp terapewtiku:
Antivirals for systemic use
Żona terapewtika:
Influenza, Human
Indikazzjonijiet terapewtiċi:
Alpivab is indicated for the treatment of uncomplicated influenza in adults and children from the age of 2 years.
Sommarju tal-prodott:
Revision: 2
L-istatus ta 'awtorizzazzjoni:
Withdrawn
Data ta 'l-awtorizzazzjoni:
2018-04-13
Fuljett ta 'informazzjoni
21
B. PACKAGE LEAFLET
Medicinal Product no longer authorised
22
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
ALPIVAB 200 MG CONCENTRATE FOR SOLUTION FOR INFUSION
peramivir
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 pharmacist.
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 Alpivab is and what it is used for
2.
What you need to know before you are given Alpivab
3.
How Alpivab is given
4.
Possible side effects
5.
How to store Alpivab
6.
Contents of the pack and other information
1.
WHAT ALPIVAB IS AND WHAT IT IS USED FOR
Alpivab contains the active substance peramivir which belongs to a
group of medicines called
neuraminidase inhibitors. These medicines prevent the influenza virus
from spreading inside the body.
Alpivab is used to treat adults and children aged from 2 years with
influenza that is not severe enough
to require hospitalisation.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ALPIVAB
YOU MUST NOT RECEIVE ALPIVAB
if you are allergic to peramivir or any of the other ingredients of
this medicine (listed in section
6)
WARNINGS AND PRECAUTIONS
Talk to your doctor or pharmacist before you are given Alpivab if you
have reduced kidney function.
Your doctor may have to adjust your dose.
Tell your doctor immediately if you experience serious skin or
allergic reactions after Alpivab is
given. Symptoms may include skin or throat swelling, difficulty
breathing, blistering rash or peeling
skin. See section 4.
Tell your doctor immediately if you experience abnormal beha
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Karatteristiċi tal-prodott
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
Medicinal Product no longer authorised
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
Alpivab 200 mg concentrate for solution for infusion
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 20 mL vial of concentrate contains 200 mg peramivir.
1 mL concentrate for solution for infusion contains 10 mg peramivir
(anhydrous base).
Excipients with known effect
Each mL of concentrate contains 0.154 millimole (mmol) sodium, which
is 3.54 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Concentrate for solution for infusion.
Clear, colourless, solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Alpivab is indicated for the treatment of uncomplicated influenza in
adults and children from the age
of 2 years (see sections 4.4 and 5.1).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Posology
Alpivab should be administered as a single intravenous dose within 48
hours of the onset of symptoms
of influenza.
The recommended single intravenous dose of peramivir depends on age
and body weight as shown in
Table 1.
TABLE 1: PERAMIVIR DOSE BASED ON AGE AND BODY WEIGHT
AGE AND BODY WEIGHT
RECOMMENDED SINGLE DOSE
Children aged from 2 years and <50 kg
12 mg/kg
Children aged from 2 years and ≥50 kg body weight
600 mg
Adults and adolescents (13 years and older)
600 mg
_Elderly _
No dose adjustment is required based on age (see sections 4.4 and
5.2).
Medicinal Product no longer authorised
3
_ _
_Renal impairment _
The dose should be reduced for adults and adolescents (13 years and
older) with absolute glomerular
filtration rate (GFR) below 50 mL/min as shown in Table 2 (see
sections 4.4 and 5.2).
TABLE 2: PERAMIVIR DOSE FOR ADULTS AND ADOLESCENTS (FROM 13 YEARS AND
50 KG) BASED ON ABSOLUTE
GFR
ABSOLUTE GLOMERULAR F
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