Patient leaflet - Dectova 10 mg / ml solution for infusion
what it is used for
Dectova contains zanamivir, which belongs to a group of medicines called antivirals.
Dectova is used to treat severe flu (influenza virus infection). It is used when other flu treatments are not suitable.
Adults and children aged
6 months or more can
be treated with Dectova.
2 What you need to know
before you are given Dectova
Do not use Dectova:
if you are allergic to zanamivir or any of the
other ingredients of this medicine (listed in section 6).
Warnings and precautions
Serious skin or allergic reactions
Serious skin or allergic reactions may occur after Dectova is given. Symptoms may include skin or throat swelling, difficulty breathing, blistering rash or peeling skin (see also ‘Serious skin or allergic reactions’ in section 4).
Sudden changes in behaviour, hallucinations and fits
During treatment with Dectova, changes in behaviour such as confusion and unresponsiveness may occur. Some people may also have hallucinations (seeing, hearing, or feeling things that are not there) or fits (seizures) which can lead to loss of consciousness. These symptoms also occur in people with flu who
are not being given Dectova. So it is not known if Dectova played a part in causing them.
If you notice any of the above symptoms:
➔ Tell a 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 breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given 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 sodium (main component of cooking/table salt) in each vial. This is equivalent to 3.54% of the recommended maximum daily intake of sodium for an adult.
3 How Dectova is given
How much Dectova is given
Your doctor will decide how much Dectova is right for you. The amount you are given is based 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 daily for 5 to 10 days.
If your kidneys are not working as well as they should, your doctor will decide on the reduced dose for you.
Children
Your doctor will decide on the correct dose of Dectova.
When and how Dectova is given
Dectova should be given as soon as possible, usually within 6 days of the symptoms of flu appearing.
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 on the use of Dectova, ask the doctor or nurse who is giving it you.
If you are given more Dectova than you should
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. Serious skin and allergic reactions may occur with Dectova, but there isn’t enough information to estimate how likely they are. Contact your doctor or nurse straight away if you notice any of the following serious side effects:
very severe skin reactions such as:
a skin rash, which may blister, and looks
like small targets (erythema multiforme)
a widespread rash with blisters and peeling
skin, particularly occurring around the mouth, nose, eyes and genitals (Stevens-Johnson syndrome)
extensive peeling of the skin on much of the
body surface (toxic epidermal necrolysis).
severe allergic reactions, including features
such as itchy rash, swelling of the face, throat or tongue, breathing difficulty, light headedness and vomiting.
Common side effects
These may affect up to 1 in 10 people
diarrhoea
- liver damage (hepatocellular injury)
- rash.
Common side effects that may show up in your blood tests:
increase in the level of liver enzymes (raised
aminotransferases).
Uncommon side effects
These may affect up to 1 in 100 people
- itchy, bumpy rash (hives).
Uncommon side effects that may show up in your blood tests:
increase in the level of liver or bone enzymes
(raised alkaline phosphatase).
Side effects where it is not known how likely they are to happen
There isn’t enough information to estimate how likely these side effects are:
- acting strangely
seeing, hearing or feeling things which are not
there
- confused thinking
- fits (seizures)
being less alert or not responding to loud
sounds or being shaken
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA
Yellow Card in the Google Play or Apple App Store. 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 which is stated on the carton and vial after EXP. Vials of Dectova are for single use only. Any unused solution should be discarded.
6 Contents of the pack
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).
Other ingredients are sodium chloride and water for injections.
What Dectova looks like and contents of the pack
Dectova is a clear, colourless solution for infusion containing 200 mg zanamivir (as hydrate) in 20 mL. It is supplied in a 26 mL clear glass vial with a rubber stopper and an aluminium over-seal with a plastic flip off cap.
There is 1 vial in each pack.
Marketing Authorisation Holder
GlaxoSmithKline UK Limited
79 New Oxford Street
London
WC1A 1DG
United Kingdom
Manufacturer
Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations)
Harmire Road
Barnard Castle
County Durham
DL12 8DT
UK
62000000098591
The following information is intended for healthcare professionals only:
- 7.
INFORMATION FOR HEALTHCARE
PROFESSIONALS
Dectova preparation
The volume of Dectova and total volume for
infusion will depend on the patient’s age, weight and renal function (see section 4.2 of the SmPC).
The dose can be infused as supplied or diluted
in sodium chloride 9 mg/mL (0.9%) solution for injection down to any concentration greater than or equal to 0.2 mg/mL.
Each vial is for single use only; once the seal
has been broken, the remaining volume must be discarded.
How to prepare the infusion for intravenous administration:
Use aseptic techniques throughout preparation
of the dose.
Calculate the required dose and volume of
Dectova.
Decide on the volume of sodium chloride
9 mg/mL (0.9%) solution for injection to be used for infusion.
Using a sterile needle and syringe, withdraw
and discard a volume of sodium chloride 9 mg/mL (0.9%) solution for injection (equal to the volume of Dectova) from the infusion bag.
Infusion bags may have a further overage of
sodium chloride 9 mg/mL (0.9%) solution for injection included – this can also be removed if considered necessary.
Using a sterile needle and syringe, withdraw
the volume of Dectova from the vial(s) and add to the infusion bag.
- Discard any unused portion of the vial.
The infusion bag should be gently manipulated
by hand to ensure it is mixed thoroughly.
If refrigerated, the infusion bag should be
removed from the refrigerator and brought up to room temperature before use.
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This leaflet was last revised in 02/2025.
Trademarks are owned by or licenced to the GSK group of companies.
© 2025 GSK group of companies or its licensor This medicine has been authorised under ‘exceptional circumstances’.
This means that for scientific reasons it has not been possible to get complete information on this medicine.
The Medicines & Healthcare products Regulatory Agency (MHRA) will review any new information on this medicine every year and this leaflet will be updated as necessary.
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62000000098591
7496
IMPORTANT and pre-press suitability.
GSK Market is responsible to advise SDC when changes required impact the following:
Formulation, Tablet embossing, Storage conditions and Shelf Life
NOTE TO MARKET
Local approvers must ensure that trade mark and copyright statements included in the brief comply with guidance provided by
Legal: Global Trade Marks.
Manufacturing Site Number:
62000000098591
Manufacturing Site(s):
GSK_BARNARD CASTLE_UNITED KINGDOM
JMF302
Product Market Trade Name:
DECTOVA
Approving Market(s):
United Kingdom-GBR
Material Spec: (Do NOT include version number):
N/A
N/A
Colour Standard Reference:
N/A
Material Type:
N/A N/A
9.0pt
9.0pt
Leading:
10.0pt
Horizontal Scale:
85%
Microtext:
N
2
BLACK 072
0
Additional Info (1):
N/A
Additional Info (2):
N/A
Additional Info (3):
N/A
200 mm Measuring Bar Artwork copyright is the property of the GSK Group of Companies. All suppliers providing a service to GSK for printed components of any description must ensure that they have a licence for all fonts / software used in conjunction with GSK artwork. The distribution and use of fonts / software without a licence constitutes an intellectual property infringement. GSK will not accept any liability for the breach of third party intellectual property rights by printed component suppliers. The GSK certification / audit process requires suppliers to declare that they do not use unlicensed fonts / software and may require the supplier to produce evidence of such licence to GSK.