Alpivab

Основна информация

  • Търговско наименование:
  • Alpivab
  • Използвай за:
  • Хората
  • Вид на лекарството:
  • алопатични наркотици

Документи

Локализация

  • Предлага се в:
  • Alpivab
    Европейски съюз
  • Език:
  • английски

Терапевтична информация

  • Терапевтична група:
  • Antivirals for systemic use,
  • Терапевтична област:
  • Influenza, Human
  • Терапевтични показания:
  • Alpivab is indicated for the treatment of uncomplicated influenza in adults and children from the age of 2 years.,
  • Каталог на резюме:
  • Revision: 1

Състояние

  • Източник:
  • EMA - European Medicines Agency
  • Статус Оторизация:
  • Authorised
  • Номер на разрешението:
  • EMEA/H/C/004299
  • Дата Оторизация:
  • 12-04-2018
  • EMEA код:
  • EMEA/H/C/004299
  • Последна актуализация:
  • 24-07-2019

Доклад обществена оценка

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© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.

EMA/120516/2018

EMEA/H/C/004299

Alpivab (peramivir)

An overview of Alpivab and why it is authorised in the EU

What is Alpivab and what is it used for?

Alpivab is an antiviral medicine that contains the active substance peramivir. It is used to treat

uncomplicated influenza (flu) in adults and children over 2 years. Uncomplicated means that the flu

has typical features (such as fever, aches, cough, sore throat and runny nose) and is not made worse

by other conditions.

How is Alpivab used?

Alpivab is available as a solution to be diluted for infusion (drip) into a vein. The medicine can only be

obtained with a prescription. Alpivab is given as an infusion lasting 15 to 30 minutes. The dose

depends on age and body weight and should be reduced in adults and adolescents over 13 years of

age with reduced kidney function. It is given once only, within 48 hours after symptoms start.

For more information about using Alpivab, see the package leaflet or contact your doctor or

pharmacist.

How does Alpivab work?

The active substance in Alpivab, peramivir, prevents the flu virus from spreading further by blocking

the activity of enzymes (proteins) on the surface of the virus called neuraminidases. Peramivir works

on neuraminidases of both influenza-A (the most common type) and influenza-B viruses.

What benefits of Alpivab have been shown in studies?

Alpivab was shown to reduce the length of time symptoms lasted in patients with influenza.

Alpivab was compared with placebo (a dummy treatment) in one main study of 296 adults with

influenza (mostly influenza A) treated within 48 hours of symptoms appearing. The main measure of

effectiveness was the length of time before symptoms (cough, sore throat, headache, blocked nose,

feverishness or chills, aches or pains of the muscle or joints and tiredness) got better. Symptoms took

around 2 and a half days (59 hours) to get better in patients taking Alpivab in comparison with just

under 3 and a half days (82 hours) in patients taking placebo.

Alpivab (peramivir)

EMA/120516/2018

Page 2/2

What are the risks associated with Alpivab?

The most common side effects with Alpivab (which may affect up to around 3 in 100 people) are a

decrease in the levels of neutrophils (a type of white blood cell) and nausea (feeling sick). Serious side

effects with Alpivab are anaphylaxis (a severe allergic reaction) and skin reactions, including erythema

multiforme (an allergic skin reaction) and Stevens-Johnson Syndrome (life-threatening reaction with

flu-like symptoms and painful rash affecting the skin, mouth, eyes and genitals).

For the full list of side effects and restrictions with Alpivab, see the package leaflet.

Why is Alpivab authorised in the EU?

Alpivab reduces the length of time flu symptoms last by one day on average. Although this difference

is not large, it may benefit some patients. There is a risk of severe allergic reactions, and although it is

not known exactly how often these reactions occur, they appear to be rare. The European Medicines

Agency decided that Alpivab’s benefits are greater than its risks and it can be authorised for use in the

What measures are being taken to ensure the safe and effective use of

Alpivab?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe

and effective use of Alpivab have been included in the summary of product characteristics and the

package leaflet.

As for all medicines, data on the use of Alpivab are continuously monitored. Side effects reported with

Alpivab are carefully evaluated and any necessary action taken to protect patients.

Other information about Alpivab

Alpivab received a marketing authorisation valid throughout the EU on 13 April 2018.

Further information on Alpivab can be found on the Agency’s website: ema.europa.eu/Find

medicine/Human medicines/European public assessment reports.

This overview was last updated in 04-2018.

Листовка за пациента: състав, показания, Нежелани лекарствени реакции, дозиране, взаимодействия, бременност, кърмене

B. PACKAGE LEAFLET

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

What Alpivab is and what it is used for

What you need to know before you are given Alpivab

How Alpivab is given

Possible side effects

How to store Alpivab

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

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 behaviour after Alpivab is given. Symptoms

may include confusion, difficulty thinking or hallucinations. See section 4.

Children and adolescents

Alpivab is not recommended in children aged under 2 years.

Other medicines and Alpivab

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines.

Live attenuated influenza vaccines should not be given until 48 hours after treatment with Alpivab.

This is because Alpivab may prevent these vaccines from working well enough.

Pregnancy and breast-feeding

Tell your doctor if you are pregnant or breast-feeding. Your doctor will advise on whether you can be

given Alpivab during pregnancy, or whether you are to stop breast-feeding for a short period after

getting Alpivab.

Driving and using machines

Alpivab is not likely to change your ability to drive and use machines.

Alpivab contains sodium

This medicine contains 212.4 mg sodium (main component of cooking/table salt) in each dose

consisting of 3 vials. This is equivalent to 10.6 % of the recommended maximum daily dietary intake

of sodium for an adult.

3.

How Alpivab is given

Alpivab is given by a healthcare profesional as a single dose within 2 days of the start of influenza

symptoms. It is first diluted and then given into a vein by infusion (drip), over 15 to 30 minutes.

Adults and adolescents (13 years and older) receive 600 mg (3 Alpivab vials).

Children aged from 2 years weighing 50 kg or more receive 600 mg (3 Alpivab vials).

Children aged from 2 years weighing less than 50 kg receive 12 mg per kg body weight.

Patients with reduced kidney function may require a reduced dose.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediately

if any of the following side effects occur:

Rare,

may affect up to 1 in 1,000 people

severe skin rash with or without blisters and fever

Not known,

frequency cannot be estimated from the available data

very severe skin reactions, including Steven-Johnson syndrome and dermatitis exfoliative

These skin reactions are life-threatening rashes with fever and blisters and can effect the lining

of the mouth and genitals.

severe allergic reactions, including severe allergic shock reaction with features such as itchy

rash, swelling of the throat and tongue, breathing difficulty, lightheadedness and vomiting

Other side effects occur with the following frequencies:

Common

, may affect up to 1 in 10 people

low levels of a white blood cell type called neutrophils

blood tests showing increased levels of lactate dehydrogenase

nausea (feeling sick), vomiting

Uncommon

, may affect up to 1 in 100 people

decreased appetite

blood tests showing decreased levels of albumin, glucose, lactate dehydrogenase

blood tests showing increased levels of chloride, potassium, sodium, uric acid, protein total,

gamma-glutamyltransferase, creatine phosphokinase, urea, creatinine

sleeplessness

reduced sense of touch or sensation

abnormal sensation such as prickling, tingling and itchiness

blurred vision

prolonged time of the heart ventricle activity, measured in the ECG

upper abdominal pain, abdominal discomfort

inflammation of stomach lining

skin inflammation, eczema, rash, nettle-rash

joint pain

urobilin presented in the urine

increased level of urine ketone body

chest discomfort, fatigue

Not known

, frequency cannot be estimated from the available data

abnormal behaviour, delirium

liver disorder

blood test showing increased levels of alanine aminotransferase, aspartate aminotransferase

acute kidney injury, reduced kidney function

Children and Adolescents from 2 years

Side effects were similar to adults but also included the following:

Common

, may affect up to 1 in 10 people

rash on the injection site

fever

red ear drum

restlessness

itching

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. Th

s includes any possible side effects

not listed in this leaflet. You can also report side effects directly via the national reporting system

listed in Appendix V. By reporting side effects you can help provide more information on the safety of

this medicine.

5.

How to store Alpivab

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the label and carton after EXP. The

expiry date refers to the last day of that month.

Do not refrigerate or freeze.

Once diluted, administer the prepared Alpivab solution immediately; otherwise, store in a refrigerator

(2 °C – 8 °C) for up to 24 hours.

6.

Contents of the pack and other information

What Alpivab contains

The active substance is peramivir.

Each 20 mL vial contains 200 mg peramivir. 1 mL concentrate for solution for infusion contains

10 mg peramivir (anhydrous base).

The other ingredients are sodium chloride, water for injections, hydrochloric acid (for pH

adjustment), sodium hydroxide (for pH adjustment).

What Alpivab looks like and contents of the pack

Alpivab is a clear, colourless, sterile concentrate for solution for infusion. It is provided in a clear glass

vial with a coated rubber stopper, aluminium overseal and flip-off cap.

Each carton contains 3 vials.

Marketing Authorisation Holder

BioCryst Ireland Limited

Atlantic Avenue

Westpark Business Campus

Shannon

V14 YX01

Ireland

Tel: +353 1223 3541

E-mail: safety@biocryst.com

Manufacturer

Seqirus Vaccines Limited

Gaskill Road, Speke

Liverpool

L24 9GR

This leaflet was last revised in

MM/YYYY

Detailed information on this medicine is available on the European Medicines Agency web site:

http://www.ema.europa.eu.

------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Use aseptic technique during the preparation of Alpivab to prevent microbial contamination. There is

no preservative or antibacterial agent in the solution. Do not mix or co-infuse Alpivab with other

medicines administered into a vein.

Follow the steps below in the provided order to prepare a diluted solution of Alpivab:

Check the seal of each vial. Do not use if the seal opening is broken or missing.

Inspect the Alpivab concentrate. It must be colourless and without particulate matter.

If a patient receives 600 mg peramivir the required volume of Alpivab concentrate is 60 mL (3 vials

of 20 mL each). In the case of a 300 mg peramivir dose, 30 mL (1½ vials) of Alpivab concentrate

is needed and for a 200 mg dose, only 20 mL (1 vial). Fractions of a vial may be needed for

appropriate dose adjustments in children with a bodyweight of less than 50 kg.

Add the measured volume of Alpivab concentrate into the infusion container.

Dilute the required dose of Alpivab concentrate in sodium chloride 9 mg/mL (0.9 %) or 4.5 mg/mL

(0.45 %) solution for infusion, 5 % dextrose or Ringer lactate solution to a volume of 100 mL.

Administer the diluted solution via intravenous infusion over 15 to 30 minutes.

Once a diluted Alpivab solution has been prepared, administer immediately or store in a refrigerator

(2 °C to 8 °C) for up to 24 hours. If refrigerated, allow the diluted Alpivab solution to reach room

temperature, then administer immediately.

Discard any unused diluted solution of Alpivab after 24 hours.

No special requirements for disposal.

Any unused medicinal product or waste material should be disposed of in accordance with local

requirements.