Daronrix
pandemic influenza vaccine (whole virion, inactivated, adjuvanted)
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted)
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This vaccine has been prescribed for you. Do not pass it on to others.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
What Daronrix is and what it is used for
Before you receive Daronrix
How Daronrix is given
Possible side effects
How to store Daronrix
Further information
Daronrix is a vaccine used in adults aged 18 to 60 years to prevent influenza (flu) in an officially declared pandemic. The vaccine works by causing the body to produce its own protection (antibodies) against the disease.
Pandemic flu is a type of influenza that occurs every few decades and which spreads rapidly to affect most countries and regions around the world. The symptoms of pandemic flu are similar to those of “ordinary” flu but are usually more severe.
if you have previously had any allergic reaction to Daronrix, or any ingredient (including eggs, chicken protein, gentamicin sulphate (antibiotic)) contained in this vaccine. The active substances and other ingredients in Daronrix are listed at the end of the leaflet. Signs of an allergic reaction may include itchy skin rash, shortness of breath and swelling of the face or tongue. However, in a pandemic situation, it may be appropriate to give the vaccine, provided that facilities for resuscitation are immediately available in case of need.
if you have a severe infection with a high temperature (over 38°C). A minor infection such as a cold should not be a problem, but talk to your doctor first.
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription or have recently received any other vaccine.
If you take any medicines that reduce immunity to infections or have any other type of treatment (such as radiotherapy) that affects the immune system, Daronrix can still be given but your response to the
vaccine may be poor.
There is no information on the use of Daronrix in pregnant women. Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are pregnant. Please tell your doctor if you are pregnant.
Daronrix may be used during lactation.
After administration of Daronrix, it is unlikely that side effects would unable you to drive or use machines.
Thiomersal (preservative) is present in this product, and it is possible that you may experience an allergic reaction.
Adults from the age of 18 to 60 years will receive two injections of Daronrix, the first injection will be administered at an elected date, the second at least three weeks after the first injection.
There is no information on the use of Daronrix below 18 years of age. Your doctor needs to assess the benefits and potential risks of giving you the vaccine if you are below the age of 18 years.
The doctor will give Daronrix as an injection into your upper arm muscle. The vaccine should never be given into a vein.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Like all medicines, Daronrix can cause side effects, although not everybody gets them.
Very common (more than 1 per 10 doses of vaccine):
Headache
Fatigue
Pain and redness at the injection site
Common (less than 1 per 10 but more than 1 per 100 doses of vaccine):
Increased sweating, bruising
Aching muscles, joint pain
Swelling at the injection site, hard lump
Shivering, fever
Uncommon (less than 1 per 100 but more than 1 per 1000 doses of vaccine):
Sore nose and throat and discomfort when swallowing, runny nose
Itching at the injection site
These reactions usually disappear within 1-2 days without treatment.
Other side effects which have occurred in the days or weeks after vaccination with ordinary flu vaccines include:
Uncommon (less than 1 per 100 but more than 1 per 1000 doses of vaccine):
Generalised skin reactions such as itching, hives or rash
Rare (less than 1 per 1000 but more than 1 per 10,000 doses of vaccine):
Severe stabbing or throbbing pain along one or more nerves
Pins and needles
Fits
Low blood platelet count
Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead to collapse, coma and death
Very rare (less than 1 per 10,000 doses of vaccine):
Narrowing or blockage of blood vessels with kidney problems
Inflammation of the brain and spinal column
Painful swelling in the arms or legs
Temporary inflammation of the nerves, causing pain, weakness and paralysis in the extremities and often progressing to the chest and face.
Do not be alarmed by this list of possible side effects. It is possible that you have no side effects from vaccination.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Do not use Daronrix after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in a refrigerator (2°C - 8°C).
Store in the original package in order to protect from light. Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
The active substances are:
Whole virion influenza vaccine of pandemic strain, inactivated, containing antigen* equivalent to:
A/Vietnam/1194/2004 (H5N1)*** 15 micrograms** per 0.5 ml dose
* propagated in eggs
** haemagglutinin
*** adjuvanted by aluminium phosphate 0.45 milligrams Al3+
and aluminium hydroxide, hydrated 0.05 milligrams Al3+
The other ingredients are: sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, thiomersal, water for injections
Daronrix is a white, slightly milky liquid and is presented in a pre-filled syringe (0.5 ml) for 1 dose in pack sizes of 1 and 10 with or without needles
Not all pack sizes may be marketed.
GlaxoSmithKline Biologicals s.a. Rue de l’Institut 89
B-1330 Rixensart Belgium
Sächsisches Serumwerk Dresden (SSW) Zirkusstraße 40
D-01069 Dresden Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
GlaxoSmithKline Pharma A/S Tlf: + 45 36 35 91 00
GlaxoSmithKline GmbH & Co. KG Tel: + 49 (0)89 360448701
GlaxoSmithKline Eesti OÜ Tel: +372 667 6900
GlaxoSmithKline Pharma GmbH. Tel: + 43 1 970 75-0
GlaxoSmithKline A.E.B.E Tηλ: + 30 210 68 82 100
GSK Commercial Sp. z o.o. Tel.: + 48 (22) 576 9000
Smith Kline & French Portuguesa, Produtos Farmacêuticos, Lda.
Tel: + 351 21 412 95 00
Laboratoire GlaxoSmithKline Tél: + 33 (0) 1 39 17 84 44
GlaxoSmithKline (GSK) SRL Tel: + 40 (0)21 3028 208
GlaxoSmithKline (Ireland) Ltd Tel: + 353 (0)1 4955000
GlaxoSmithKline S.p.A. Tel:+ 39 04 59 21 81 11
GlaxoSmithKline Cyprus Ltd
Τηλ: + 357 22 89 95 01
GlaxoSmithKline Latvia SIA Tel: + 371 7312687
GlaxoSmithKline Lietuva UAB Tel. +370 5 264 90 00
Daronrix has been authorised under “Exceptional Circumstances”.
This means that for scientific reasons, it has not been possible to obtain complete information on this medicinal product.
The European Medicines Agency (EMEA) will review any new information on the medicine every year and this leaflet will be updated as necessary.