Alpivab - patient leaflet, side effects, dosage

A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE

Name and address of the manufacturer(s) responsible for batch release

Seqirus Vaccines Ltd

Gaskill Road

Speke

Liverpool

L24 9GR

UNITED KINGDOM

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE

Medicinal product subject to medical prescription.

C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION

V

• Periodic Safety Update Reports

The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines webportal.

The marketing authorisation holder shall submit the first periodic safety update report for this product within 6 months following authorisation.

CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT

Risk Management Plan (RMP)

The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed subsequent updates of the RMP.

An updated RMP should be submitted:

• At the request of the European Medicines Agency;
• Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being reached.

PARTICULARS TO APPEAR ON THE OUTER PACKAGING

CARTON

• 1. NAME OF THE MEDICINAL PRODUCT

Alpivab 200 mg concentrate for solution for infusion peramivir

• 2. STATEMENT OF ACTIVE SUBSTANCE(S) 1 mL concentrate contains 10 mg peramivir (anhydrous basis). Each 20 mL vial contains 200 mg peramivir.

Keep out of the sight and reach of children.

• 7. OTHER SPECIAL WARNING(S), IF NECESSARY

• 8. EXPIRY DATE

EXP

• 9. SPECIAL STORAGE CONDITIONS

Do not refrigerate or freeze.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

BioCryst Ireland Limited

Atlantic Avenue

Westpark Business Campus Shannon

V14 YX01

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE 2D barcode carrying the unique identifier included.

PC:

SN:

NN:

PARTICULARS TO APPEAR ON THE IMMEDIATE PACKAGING VIAL LABEL

• 1. NAME OF THE MEDICINAL PRODUCT

Alpivab 200 mg concentrate for solution for infusion peramivir

• 2. STATEMENT OF ACTIVE SUBSTANCE(S) 1 mL concentrate contains 10 mg peramivir (anhydrous base). Each 20 mL vial contains 200 mg peramivir.

EXP

9. SPECIAL STORAGE CONDITIONS

Do not refrigerate or freeze.

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER

BioCryst Ireland Limited

Atlantic Avenue

Westpark Business Campus

Shannon

V14 YX01

Ireland

Justification for not including Braille accepted.

17. UNIQUE IDENTIFIER – 2D BARCODE

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

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

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 reco 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 avai

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 ye

Side effects were similar to adults but

Common , may affect up to 1 in 10

• 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. This 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:

Manufacturer

Seqirus Vaccines Limited

Gaskill Road, Speke

Liverpool

L24 9GR

UK

This leaflet was last revised in {MM/YYYY }

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

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:

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

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

• 3. 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 (PA 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.

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

• 5. 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.

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

• 7. 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.

• 8. Discard any unused diluted solution of Alpivab after 24 hours.