Daronrix

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Whole virion, inactivated, containing antigen*: A/Vietnam/1194/2004 (H5N1)* produced in eggs

Available from:

GlaxoSmithKline Biologicals S.A.

ATC code:

J07BB01

INN (International Name):

pandemic influenza vaccine (whole virion, inactivated, adjuvanted)

Therapeutic group:

Vaccines

Therapeutic area:

Influenza, Human; Immunization; Disease Outbreaks

Therapeutic indications:

Prophylaxis of influenza in an officially declared pandemic situation. Pandemic influenza vaccine should be used in accordance with official guidance.

Authorization status:

Withdrawn

Authorization date:

2007-03-21

Patient Information leaflet

37
B. PACKAGE LEAFLET
38
PACKAGE LEAFLET: INFORMATION FOR THE USER
DARONRIX, SUSPENSION FOR INJECTION IN PRE-FILLED SYRINGE
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted)
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START RECEIVING THIS
VACCINE.
-
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.
IN THIS LEAFLET
:
1.
What Daronrix is and what it is used for
2.
Before you receive Daronrix
3.
How Daronrix is given
4.
Possible side effects
5.
How to store Daronrix
6.
Further information
1.
WHAT DARONRIX IS AND WHAT IT IS USED FOR
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.
2.
BEFORE YOU RECEIVE DARONRIX
DARONRIX SHOULD NOT BE GIVEN:
•
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.
TAKE SPECIAL CARE WITH DARONRIX:
•
if you have a severe infection with a high temperature (over 38°C). A
minor infection suc

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Daronrix, suspension for injection in pre-filled syringe
Pandemic influenza vaccine (whole virion, inactivated, adjuvanted)
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
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 Al
3+
and aluminium hydroxide, hydrated
0.05 milligrams Al
3+
This vaccine complies with the WHO recommendation and EU decision for
the pandemic.
Excipients:
Thiomersal
50 micrograms
For a full list of excipients see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
Turbid white suspension.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Prophylaxis of influenza in an officially declared pandemic situation.
Pandemic influenza vaccine
should be used in accordance with official guidance. (see sections 4.2
and 5.1)
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Daronrix has been evaluated with a haemagglutinin content of 15 µg HA
per dose in adults aged 18-60
years following a 0, 21 day schedule.
Adults from the age of 18 to 60 years will receive two doses of
Daronrix, the first administered at an
elected date, the second at least three weeks after the first dose for
maximum efficacy.
No data have been generated with Daronrix below 18 years of age.
Therefore health care providers
need to assess the benefits and potential risks of administering the
vaccine in that population.
For pregnant women, see section 4.6.
3
For further information, see section 5.1.
Immunisation should be carried out by intramuscular injection.
4.3
CONTRAINDICATIONS
History of an anaphylactic reaction (i.e. life-threatening) to any of
the constituents or trace residues
(e.g. eggs, chicken protein, gentamicin sulphate) of this vaccine.
However, in a pandemic situation, it
may be appropriate to give the vaccine, provided that facilitie