DECTOVA 10 mg/ml SOLUTION FOR INFUSION

Introduction

Package Leaflet: Information for the Patient

Dectova 10 mg/ml Solution for Infusion

zanamivir

This medicinal product is subject to additional monitoring, which will allow for quick identification of new safety information. You can help by reporting any side effects you may get. The last section of section 4 will tell you 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 nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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. Storage of 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(infection caused by influenza A or B virus). It is used when other treatments for flu are not suitable.

Treatment with Dectova can be given to adults and children from 6 months of age and older.

2. What you need to know before you are given Dectova

Do not give Dectova:

• if you are allergicto zanamivir or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or nurse before you start using Dectova.

Severe skin and allergic reactions

Severe skin and allergic reactions can occur after giving Dectova. Symptoms can include swelling of the skin or throat, difficulty breathing, skin rash with blisters or peeling of the skin (see also “Severe skin and allergic reactions” in section 4).

Sudden changes in behavior, hallucinations, and seizures

During treatment with Dectova, changes in behavior such as confusion or lack of response have been observed. Some people may also have hallucinations (seeing, hearing, or feeling things that are not real) or seizures (fits) that can lead to loss of consciousness. These symptoms also occur in people with flu who are not being treated with Dectova. Therefore, it is not known if Dectova was the cause.

If you have a weakened immune system

If your immune system is not working properly, your doctor may monitor you more closely to make sure the treatment is working. Your doctor may switch you to an alternative treatment when they consider it necessary.

If you experience any of these symptoms:

• Tell your doctor or nurse immediately.

Other medicines and Dectova

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

Driving and using machines

Dectova should not affect your ability to drive or use machines.

Dectova contains sodium

This medicine contains 70.8 mg of sodium (main component of cooking/table salt) per vial. This is equivalent to 3.54% of the maximum recommended daily intake of sodium for an adult.

3. How Dectova is given

How much Dectova is given

Your doctor will decide the correct dose of Dectova for you. The amount given will depend on your age, body weight, and the results of your blood tests (to check how well your kidneys are working).

Your dose may be increased or decreased depending on how well you respond to treatment.

Adults

The recommended dose is 600 mg twice a day for 5 to 10 days.

If your kidneys are not working as well as they should, your doctor will decide on a reduced dose for you.

Use in children

Your doctor will decide on the correct dose of Dectova.

How and when to give Dectova

Dectova should be given as soon as possible, usually within 6 days of the onset of flu symptoms.

A doctor or nurse will give you Dectova as an infusion (drip) into a vein. It is usually given into your arm over about 30 minutes.

If you have any questions about the use of Dectova, ask your doctor or nurse.

If you are given too much Dectova

It is unlikely that you will be given too much, but if you think you have been given too much Dectova, tell your doctor or nurse immediately.

4. Possible side effects

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

Severe skin and allergic reactions can occur with Dectova,but there is not enough information to estimate how often this happens. Tell your doctor or nurse immediately if you experience any of the following serious side effects:

• severe skin reactions such as:

• a skin rash that can form blisters that look like small targets (erythema multiforme)
• a widespread rash with blisters and peeling of the skin, especially around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome)
• widespread peeling of the skin in large areas of the body (toxic epidermal necrolysis)
• • severe allergic reactions, including symptoms such as skin rash with itching, swelling of the face, throat, or tongue, difficulty breathing, dizziness, and vomiting.

Common side effects

May affect up to 1 in 10people:

• diarrhea
• liver damage (hepatocellular injury)
• rash.

Common side effects that may appear in your blood tests are:

• increased levels of liver enzymes (elevated transaminases).

Uncommon side effects

May affect up to 1 in 100people:

• itching, irregular skin rash (hives).

Uncommon side effects that may appear in your blood tests are:

• increased levels of liver and bone enzymes (elevated alkaline phosphatase).

Side effects with frequency not known

There is not enough information to estimate how often these side effects happen:

• abnormal behavior
• seeing, hearing, and feeling things that are not real
• confused thoughts
• seizures (fits)
• being less alert or not responding to loud noises or being shaken.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through 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. Storage of Dectova

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 carton and vial after EXP.

The vials of Dectova are for single use only. Any unused solution should be discarded.

6. Contents of the pack and other information

Composition of Dectova

The active substance is zanamivir.

Each ml of Dectova contains 10 mg of zanamivir (as hydrate). Each vial contains 200 mg of zanamivir (as hydrate) in 20 ml.

Other ingredients are sodium chloride and water for injections.

Appearance and pack

Dectova is a clear and colorless solution for infusion. It is presented in a 26 ml clear glass vial with a rubber stopper and an aluminum seal with a plastic press-on cap.

There is one vial in each pack.

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk

Citywest Business Campus

Dublin 24

Ireland

Manufacturer

GlaxoSmithKline Manufacturing S.P.A

Strada Provinciale Asolana, 90

43056 San Polo di Torrile

Parma

Italy

You can ask for more information about this medicine from the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet:

This medicinal product has been authorised under “exceptional circumstances”. This means that due to the complexity of the disease, it has not been possible to obtain complete information on this medicinal product.

The European Medicines Agency will review any new information that may become available every year and this leaflet will be updated as necessary.

Other sources of information.

Detailed information on this medicinal product is available on the European Medicines Agency web site: http://www.ema.europa.eu/

This information is intended only for healthcare professionals:

1. INFORMATION FOR HEALTHCARE PROFESSIONALS

Preparation of Dectova

• The volume of Dectova and the total volume for infusion will depend on the patient's age, weight, and renal function (see section 4.2 of the Summary of Product Characteristics).
• The dose may be infused as provided or diluted to any concentration greater than or equal to 0.2 mg/ml, with a 9 mg/ml (0.9%) sodium chloride injection solution.
• Each vial is for single use only; once the seal has been broken, the remaining volume should be discarded.

How to prepare the infusion for intravenous administration:

• Use aseptic techniques throughout the preparation of the dose.
• Calculate the required dose and volume of Dectova.
• Determine the volume of the 9 mg/ml (0.9%) sodium chloride injection solution to be used for the infusion.
• Use a sterile needle and syringe to withdraw and discard the volume of the 9 mg/ml (0.9%) sodium chloride injection solution (equal to the volume of Dectova) from the infusion bag.
• Infusion bags may have an overfill of the 9 mg/ml (0.9%) sodium chloride injection solution, which may be removed if necessary.
• Use a sterile needle and syringe to withdraw the volume of Dectova from the vial(s) and add it to the infusion bag.
• Discard any unused portion of the vial.
• The infusion bag should be gently manipulated by hand to ensure it is well mixed.
• If refrigerated, the infusion bag should be removed from the refrigerator and allowed to come to room temperature before use.