10 mg / mL infusion solution 
zanamivir

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, 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 also applies to any side effects not mentioned in this information. See section 4.

In this leaflet you will find information about: 
1. What Dectova is and what it is used for 
2. What you need to know before you are given Dectova 
3. How to give Dectova 
4. Possible side effects 
5. How to store Dectova 6. Contents of the pack 
and other ingredients 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 ( flu virus infection ). It is used when other treatments for influenza are not suitable.

Adults and children from 6 months of age 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 cautions

Severe skin reactions or allergic reactions

Severe skin reactions or allergic reactions may occur after Dectova has been given. Symptoms may include swelling of the skin or throat, difficulty breathing, rash with blisters, or scaly skin (see also “ Severe skin reactions or allergic reactions”  in section 4).

Sudden behavioral changes, hallucination,s, and seizures

During treatment with Dectova, behavioral changes, such as confusion and incontestability, may occur. Some people may also have hallucinations (seeing, hearing, or feeling things that are not there) or seizures that can lead to unconsciousness. These symptoms also occur in people with the flu who have not received Dectova. Therefore, it is not known whether Dectova contributes to their occurrence.

If you get 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 breastfeeding

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 taking this medicine.

Driving and using machines

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

Dectova contains sodium

This medicine contains 70.8 mg of sodium (the main ingredient in table salt/table salt) in each vial. This corresponds to 3.54% of the highest recommended daily intake of sodium for adults.

How to give Dectova

How much Dectova you are given

Your doctor will decide how much Dectova is right for you. The amount you are given is based on your age and body weight as well as the results of blood tests (which show how well your kidneys are working).

Dose one may need to 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 do not work as well as they should, your doctor will lower your dose.

Children

Your doctor will decide which dose of Dectova is appropriate.

When and how Dectova is given

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 in the arm for about 30 minutes.

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

If you take more Dectova then you should

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

4. Possible side effects

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

Severe skin reactions and allergic reactions may occur with Dectova, but there is not enough information to estimate how likely they are. Contact a doctor or nurse immediately if you notice any of the following serious side effects:

  • very serious skin reactions such as:
    • rash, possibly with blisters, which look like small targets (erythema multiforme)
    • a widespread rash with blisters and scaly skin, especially around the mouth, nose, eyes, and genitals ( Stevens-Johnson syndrome )
    • extensive skin detachment on large parts of the body surface ( toxic epidermal necrolysis ).
  • severe allergic reactions, with symptoms such as itchy rash, swelling of the face, throat, or tongue, difficulty breathing, dizziness, and vomiting.

Common side effects are

These can occur in up to 1 in 10 users:

  • diarrhea
  • liver damage (liver cell damage)
  • rash.

Common side effects that may show up in blood tests:

  • elevated liver enzyme values ​​(elevated aminotransferases).

Uncommon side effects are

These can occur in up to 1 in 100 users:

  • itchy, raised rash (hives).

Uncommon side effects that may show up in blood tests are:

  • elevated liver or skeletal enzyme levels (elevated alkaline phosphatase).

Side effects that occur in an unknown number of users:

There is insufficient information to estimate the likelihood of these side effects :

  • abnormally behaving
  • see, hear or feel things that are not there
  • confused thoughts
  • seizures
  • decreased attention or no reaction to loud noises or shaking.

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 with Dectova are for single use only. The remaining solution must be discarded.

6. Contents of the packaging and other information

Content declaration

The active substance is zanamivir.

One ml of Dectova contains 10 mg of zanamivir (as hydrate). One vial contains 200 mg zanamivir (as hydrate).

The other ingredients are sodium chloride and water for injections.

What the medicine looks like and the contents of the pack

Dectova is a clear, colorless 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, aluminum seal, and a plastic snap cap.

Each pack contains 1 vial.

Marketing Authorisation Holder

GlaxoSmithKline Trading Services Limited

12 Riverwalk 

Citywest Business Campus

Dublin 24

Ireland

Manufacturer

Glaxo Operations UK Limited (under the name Glaxo Wellcome Operations)

Harmire Road

Barnard Castle

Durham County

DL12 8DT

UK

or

GlaxoSmithKline Manufacturing SPA

Strada Provinciale Asolana, 90

43056 San Polo di Torrile

Parma

Italy

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / Belgien GlaxoSmithKline Pharmaceuticals sa / nvTel: + 32 (0) 10 85 52 00 LithuaniaGlaxoSmithKline Lithuania UABTel: + 370 5 264 90 00info.lt@gsk.com
BulgariaThe GlaxoSmithKlein ЕООДTel .: + 359 2 953 10 34 Luxembourg / LuxemburgGlaxoSmithKline Pharmaceuticals sa / nvBelgium / BelgiumTel: + 32 (0) 10 85 52 00
Czech Republic GlaxoSmithKline, sroTel: + 420 222 001 111cz.info@gsk.com HungaryGlaxoSmithKline Kft.Tel .: + 36 1 225 5300
Denmark GlaxoSmithKline Pharma A / STel: + 45 36 35 91 00dk-info@gsk.com Malta GlaxoSmithKline (Malta) LimitedTel: + 356 21 238131
Germany GlaxoSmithKline GmbH & Co. KGTel .: + 49 (0) 89 36044 8701produkt.info@gsk.com The Netherlands GlaxoSmithKline BVTel: + 31 (0) 3 2081100
EestiGlaxoSmithKline Eesti OÜTel: + 372 6676 900estonia@gsk.com  NorwayGlaxoSmithKline ASTel: + 47 22 70 20 00
GreeceGlaxoSmithKline Aονοπρόσωπη AEBE:Ηλ: + 30 210 68 82 100 AustriaGlaxoSmithKline Pharma GmbHTel: + 43 (0) 1 97075 0at.info@gsk.com
SpainGlaxoSmithKline, SATel: + 34 900 202 700es-ci@gsk.com PolandGSK Services Sp. z ooTel .: + 48 (0) 22 576 9000
FranceGlaxoSmithKline LaboratoryTel: + 33 (0) 1 39 17 84 44diam@gsk.com PortugalGlaxoSmithKline – Pharmaceutical Products, Lda.Tel: + 351 21 412 95 00FI.PT@gsk.com
CroatiaGlaxoSmithKline dooTel: + 385 1 6051 999 RomaniaGlaxoSmithKline (GSK) SRLTel: + 4021 3028 208
IrelandGlaxoSmithKline (Ireland) LimitedTel: + 353 (0) 1 4955000 SloveniaGlaxoSmithKline dooTel: + 386 (0) 1 280 25 00medical.x.si@gsk.com
IcelandVistor hf.Phone: + 354 535 7000 Slovak RepublicGlaxoSmithKline Slovakia sroTel: + 421 (0) 2 48 26 11 11recepcia.sk@gsk.com
ItalyGlaxoSmithKline SpATel: + 39 (0) 45 7741 111 Finland / FinlandGlaxoSmithKline OyPuh / Tel: + 358 (0) 10 30 30 30Finland.tuoteinfo@gsk.com
LatviaGlaxoSmithKline Latvia SIATel: + 371 67312687lv-epasts@gsk.com United KingdomGlaxoSmithKline UK LtdTel: + 44 (0) 800 221441customercontactuk@gsk.com

This medicinal product has been authorized under “Exceptional Authorization” rules.

This means that it has not been possible to obtain complete information on this medicine for scientific reasons.

Every year, the European Medicines Agency reviews all new information that may have emerged about this medicine and updates this Summary of Product Characteristics when necessary.

Muhammad Nadeem

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