Dectova – Package Leaflet: InfoCons – Consumer Protection presents, in an accessible format, the official package leaflet of the medicine Dectova, as authorised in the European Union and published in the Union Register of medicinal products.
Before anything else
Read all of this leaflet carefully before you are given 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 get any side effects , talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
ℹ️ 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 (influenza A or B virus infection ). It is used when other flu treatments are not suitable.
Adults and children aged 6 months or more can be tr eated 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, bliste ring 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 are immunocompromised (have a weakened immune system) Your doctor may monitor you more closely if your immune system is not working properly to ensure the treatment is working. Your doctor may switch you to an alternative treatment where appropriate.
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 test s (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 m g 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 w ho 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 : o a skin rash, which may blister, and looks like small targets ( erythema multiforme) o a widespread rash with blisters and peeling skin, particularly occurring around the mouth, nose, eyes and genitals ( Stevens -Johnson syndrome ) o extensive peeling of the sk in on much of the body surface ( toxic epidermal necrolysis ).
- severe allergic reactions, including features such as itchy rash, swelling of the face, th roat 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 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 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) in 20 mL .
Other ingredients are sodium chloride and water for injection s.
What Dectova looks like and contents of the pack
Dectova is a clear, colourless solution for infusion. 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.
Marke ting 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 any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien GlaxoSmithKline Pharmaceuticals s.a./n.v.
Tél/Tel: + 32 (0) 10 85 52 00 Lietuva GlaxoSmithKline Trading Services Limited Tel: +370 80000334 България GlaxoSmithKline Trading Services Limited Teл.: +359 80018205 Luxembourg/Luxemburg GlaxoSmithKline Pharmaceuticals s.a./n.v.
Belgique/Belgien Tél/Tel: + 32 (0) 10 85 52 00 Česká republika GlaxoSmithKline , s.r.o.
Tel: + 420 222 001 111 [email protected] Magyarország GlaxoSmithKline Trading Services Limited Tel.: +36 80088309 Danmark GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00 [email protected] Malta GlaxoSmithKline Trading Services Limited Tel: +356 80065004 Deutschland GlaxoSmithKline GmbH & Co. KG Tel.: + 49 (0)89 36044 8701 [email protected] Nederland GlaxoSmithKline BV Tel: + 31 (0)33 2081100 Eesti GlaxoSmithKline Trading Services Limited Tel: +372 8002640 Norge GlaxoSmithKline AS Tlf: + 47 22 70 20 00 Ελλάδα GlaxoSmithKline Μονοπρόσωπη A.E.B.E.
Τηλ: + 30 210 68 82 100 Österreich GlaxoSmithKline Pharma GmbH Tel: + 43 (0)1 97075 0 [email protected] España GlaxoSmithKline, S.A.
Tel: + 34 900 202 700 [email protected] Polska GSK Services Sp. z o.o.
Tel.: + 48 (0)22 576 9000 France Laboratoire GlaxoSmithKline Tél: + 33 (0)1 39 17 84 44 [email protected] Portugal GlaxoSmithKline – Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00 [email protected] Hrvatska GlaxoSmithKline Trading Services Limited Tel: +385 800787089 România GlaxoSmithKline Trading Services Limited Tel: +40 800672524 Ireland GlaxoSmithKline (Ireland) Limited Tel: + 353 (0)1 4955000 Slovenija GlaxoSmithKline Trading Services Limited Tel: +386 80688869 Ísland Vistor hf.
Sími: +354 535 7000 Slovenská republika GlaxoSmithKline Trading Services Limited Tel: +421 800500589 Italia GlaxoSmithKline S.p.A.
Tel: + 39 (0)45 7741 111 Suomi/Finland GlaxoSmithKline Oy Puh/Tel: + 358 (0)10 30 30 30 Κύπρος GlaxoSmithKline Trading Services Limited Τηλ: +357 80070017 Sverige GlaxoSmithKline AB Tel: + 46 (0)8 638 93 00 [email protected] Latvija GlaxoSmithKline Trading Services Limited Tel: +371 80205045 United Kingdom (Northern Ireland) GlaxoSmithKline Trading Services Limited Tel: + 44 (0)800 221441 [email protected] This leaflet was last revised i n {month YYYY} .
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 European Medicines Agency will review any new information on this medicine every year and this leaflet will be updated as necessary.
Other sources of information Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu
🩺 Information 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, w ithdraw 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.
📄 Package Leaflet – official source
This article reproduces the information in the official package leaflet, as authorised in the European Union. You can consult the original document here: Product information Dectova (PDF, ec.europa.eu).
You can check this medicine at any time in the Union Register of medicinal products (EU number EU/1/18/1349).
⚠️ Important: This article is for information purposes only and does not replace medical advice or the package leaflet inside the medicine box. Read the leaflet carefully before use. For any questions about your treatment, talk to your doctor or pharmacist. If you experience side effects, tell your doctor or pharmacist and report them through your national reporting system.