Dectova

Package leaflet: Information for the patient

Dectova 10 mg/mL solution for infusion

zanamivir
This medicinal product is subject to additional monitoring. This will allow for rapid identification of new safety information. You can help by reporting any side effects you experience while taking this medicine. See the end of section 4 for information on how to report side effects.
Please read this leaflet carefully before you are given this medicine, as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of 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 administered
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 influenza (infection with influenza A or B virus). It is used when
other treatments for influenza are not suitable.
Adults and children from 6 months of age onwards can be treated with Dectova.

2. What you should know before being given Dectova

Do not use Dectova

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

Warnings and precautions
Severe allergic or skin reactions
Severe allergic or skin reactions may occur after administration of Dectova. Symptoms may include swelling of the skin or throat, difficulty breathing, skin rashes with blisters or peeling of the skin (see also 'Allergic or skin reactions' in section 4).
Sudden changes in behaviour, hallucinations and seizures
During treatment with Dectova, changes in behaviour such as confusion and unresponsiveness may occur. Some people may also experience hallucinations (seeing, hearing or feeling things that do not exist) or seizures which may lead to loss of consciousness. These symptoms may occur in people with influenza who are not given Dectova. Therefore, it is not known whether Dectova plays a role in causing these symptoms.
If you are immunocompromised (have a weakened immune system)
If your immune system is not functioning properly, your doctor may monitor you more closely to ensure that the treatment is effective. If necessary, your doctor may switch you to an alternative treatment.
If you notice any of the symptoms listed above:
➔ inform 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, if you think you may be pregnant, or if you are planning to have a baby, please consult your doctor before this medicine is administered.
Driving and using machines
Dectova is unlikely to affect your ability to drive or use machines.
Dectova contains sodium
This medicine contains 70.8 mg of sodium (a main component of table salt) per vial. This corresponds to 3.54% of the maximum recommended daily intake of sodium for an adult.

3. How Dectova is administered

How much Dectova is administered
Your doctor will decide the correct dose of Dectova for you. The amount you are given is based on your age,
body weight, and blood test results (to check how well your kidneys are working).
The dose may be increased or decreased depending on how you respond to treatment.

Adults
The recommended dose is 600 mg twice daily for 5–10 days.
If your kidneys are not working properly, your doctor will decide whether to reduce your dose.

Children
Your doctor will determine the correct dose of Dectova.

When and how Dectova is administered
Dectova should be administered as soon as possible, usually within 6 days of the onset of flu symptoms.
A doctor or nurse will administer Dectova as an intravenous infusion (drip) into a vein. It is usually given in the arm over approximately 30 minutes or more.

If you have any doubts about the use of Dectova, consult the doctor or nurse administering the medicine to you.

If you are given more Dectova than you should be
It is unlikely that you will be given an excessive amount of this medicine, but if you think you have received too high a dose of Dectova, inform your doctor or nurse immediately.

4. Possible side effects

Like all medicines, Dectova can cause side effects, although not everyone experiences them.
Severe allergic and skin reactions may occur with Dectova, but there is insufficient information to estimate how likely they are. Contact your doctor or nurse immediately if you notice any of the following serious side effects:

• very severe skin reactions such as: a rash with blister-like formations resembling small targets (erythema multiforme), or a widespread rash with blisters and peeling of the skin, particularly around the mouth, nose, eyes, and genitals (Stevens-Johnson syndrome), or extensive peeling of the skin over a large part of the body surface (toxic epidermal necrolysis)
• severe allergic reactions, including symptoms such as itchy rash, swelling of the face, throat or tongue, difficulty breathing, feeling dizzy or light-headed, and vomiting.

Common side effects
These may affect up to 1 in 10 people:

• diarrhoea
• liver damage (hepatocellular damage)
• skin rash. Common side effects that may be detected by blood tests include:
• increased levels of liver enzymes (increased aminotransferases).

Uncommon side effects
These may affect up to 1 in 100 people:

• itching, irregular skin rash (urticaria). Uncommon side effects that may be detected by blood tests include:
• increased levels of liver or bone enzymes (elevated alkaline phosphatase).

Side effects for which the frequency is unknown
There is insufficient information to estimate how often these side effects occur:

• behaving strangely
• seeing, hearing or feeling things that are not real
• confused thoughts
• seizures
• being less alert or not responding to loud sounds or being easily startled.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Dectova

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial after Exp.
Dectova vials are for single use only. Any unused solution must be discarded.

6. Package contents and other information

What Dectova contains
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.
The other ingredients are sodium chloride, water for injections.

Description of the appearance of Dectova and contents of the pack
Dectova is a clear, colourless infusion solution. It is supplied in a 26 mL transparent glass vial
with a rubber stopper and an aluminium seal with a plastic 'flip-off' cap.
Each pack contains 1 vial.

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

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
GlaxoSmithKline Pharmaceuticals s.a./n.v. GlaxoSmithKline Trading Services Limited
Tél/Tel: + 32 (0) 10 85 52 00 Tel: +370 80000334

България Luxembourg/Luxemburg
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Pharmaceuticals s.a./n.v.
Teл.: +359 80018205 Belgique/Belgien
Tél/Tel: + 32 (0) 10 85 52 00

Česká republika Magyarország
GlaxoSmithKline, s.r.o. GlaxoSmithKline Trading Services Limited
Tel: + 420 222 001 111 Tel.: +36 80088309
[email protected]

Danmark Malta
GlaxoSmithKline Pharma A/S GlaxoSmithKline Trading Services Limited
Tlf: + 45 36 35 91 00 Tel: +356 80065004
[email protected]

Deutschland Nederland
GlaxoSmithKline GmbH & Co. KG GlaxoSmithKline BV
Tel.: + 49 (0)89 36044 8701 Tel: + 31 (0)33 2081100
[email protected]

Eesti Norge
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AS
Tel: +372 8002640 Tlf: + 47 22 70 20 00

Ελλάδα Österreich
GlaxoSmithKline Μονοπρόσωπη A.E.B.E. GlaxoSmithKline Pharma GmbH
Τηλ: + 30 210 68 82 100 Tel: + 43 (0)1 97075 0
[email protected]

España Polska
GlaxoSmithKline, S.A. GSK Services Sp. z o.o.
Tel: + 34 900 202 700 Tel.: + 48 (0)22 576 9000
[email protected]

France Portugal
Laboratoire GlaxoSmithKline GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tél: + 33 (0)1 39 17 84 44 Tel: + 351 21 412 95 00
[email protected] [email protected]

Hrvatska România
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Trading Services Limited
Tel: +385 800787089 Tel: +40 800672524

Ireland Slovenija
GlaxoSmithKline (Ireland) Limited GlaxoSmithKline Trading Services Limited
Tel: + 353 (0)1 4955000 Tel: +386 80688869

Ísland Slovenská republika
Vistor hf. GlaxoSmithKline Trading Services Limited
Sími: + 354 535 7000 Tel: +421 800500589

Italia Suomi/Finland
GlaxoSmithKline S.p.A. GlaxoSmithKline Oy
Tel: + 39 (0)45 7741 111 Puh/Tel: + 358 (0)10 30 30 30

Κύπρος Sverige
GlaxoSmithKline Trading Services Limited GlaxoSmithKline AB
Τηλ: +357 80070017 Tel: + 46 (0)8 638 93 00
[email protected]

Latvija United Kingdom (Northern Ireland)
GlaxoSmithKline Trading Services Limited GlaxoSmithKline Trading Services Limited
Tel: +371 80205045 Tel: + 44 (0)800 221441
[email protected]

This medicinal product has been authorised under "exceptional circumstances".
This means that, for scientific reasons, it has not been possible to obtain complete information about this
medicinal product.
The European Medicines Agency will review any new information on this medicinal product annually, and this patient information leaflet will be updated if necessary.

Further sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/

The following information is intended exclusively for healthcare professionals:

7. INFORMATION FOR HEALTHCARE PROFESSIONALS

Preparation of Dectova

• The volume of Dectova and the total infusion volume will depend on the patient's age, weight, and renal function (see section 4.2 of the SmPC).
• The dose may be infused as supplied or diluted in 9 mg/mL (0.9%) sodium chloride solution for injection to achieve a concentration equal to or greater than 0.2 mg/mL.
• Each vial is for single use only; once the seal has been broken, any remaining volume must 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 9 mg/mL (0.9%) sodium chloride solution for injection to be used for the infusion.
• Using a sterile needle and syringe, withdraw and discard an amount of 9 mg/mL (0.9%) sodium chloride solution for injection (equal to the volume of Dectova) from the infusion bag.
• Infusion bags may contain an additional amount of 9 mg/mL (0.9%) sodium chloride solution for injection, which may also be removed if considered necessary.
• Using a sterile needle and syringe, withdraw the required volume of Dectova from the vial and add it to the infusion bag.
• Discard any unused portion of the vial.
• The infusion bag should be gently mixed to ensure thorough mixing.
• If refrigerated, the infusion bag must be removed from the refrigerator and brought to room temperature before use.