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Document last updated on the eMC: Fri 12 September 2008
Enzira Suspension for injection, pre-filled
syringe/Influenza vaccine (split virion, inactivated) PH.
Eur.
Table of Contents
1. NAME OF THE MEDICINAL PRODUCT
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
3. PHARMACEUTICAL FORM
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
4.2 Posology and method of administration
4.3 Contraindications
4.4 Special warnings and precautions for use
4.5 Interaction with other medicinal products and other forms
of interaction
4.6 Pregnancy and lactation
4.7 Effects on ability to drive and use machines
4.8 Undesirable effects
4.9 Overdose
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
5.2 Pharmacokinetic properties
5.3 Preclinical safety data
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
6.2 Incompatibilities
6.3 Shelf life
6.4 Special precautions for storage
6.5 Nature and contents of container
6.6 Special precautions for disposal and other handling
7. MARKETING AUTHORISATION HOLDER
8. MARKETING AUTHORISATION NUMBER(S)
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
10. DATE OF REVISION OF THE TEXT
1. NAME OF THE MEDICINAL PRODUCT
Enzira® Suspension for injection, pre-filled syringe
Influenza vaccine (split virion, inactivated) Ph. Eur.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Split influenza virus*, inactivated with β-Propiolactone, containing
antigens equivalent to:
A/Brisbane/59/2007 (H1N1) - like strain
(A/Brisbane/59/2007 IVR-148)
15 micrograms
HA**
A/Brisbane/10/2007 (H3N2) - like strain
(A/Uruguay/716/2007 NYMC X-175C)
15 micrograms
HA**
B/Florida/4/2006 - like strain (B/Florida/4/2006) 15 micrograms
HA**
per 0.5 ml dose.
* propagated in fertilised hens' eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO recommendation (Northern
Hemisphere) and EU decision for the 2008/2009 season.
For a full list of excipients, see section 6.1.
3. PHARMACEUTICAL FORM
Suspension for injection in a pre-filled syringe.
Clear to slightly opaque liquid with some sediment that resuspends upon
shaking.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Prophylaxis of influenza, especially in those who run an increased risk of
associated complications.
The use of Enzira should be based on official recommendations.
4.2 Posology and method of administration
Posology
Adults and children from 36
months:
0.5 ml
Children from 6 months to 35
months:
Clinical data are limited. Dosages
of 0.25 ml or 0.5 ml have been
used.
For children who have not previously been vaccinated, a second dose
should be given after an interval of at least 4 weeks.
Method of administration
Immunisation should be carried out by intramuscular or deep
subcutaneous injection.
For instructions for preparation, see section 6.6.
4.3 Contraindications
Hypersensitivity to the active substances, to any of the excipients (see
section 6.1), to eggs and/or chicken proteins.
Enzira does not contain more than 1 µg ovalbumin per dose.
The vaccine may contain residues of the following substances: neomycin,
polymyxin.
Immunisation shall be postponed in patients with febrile illness or acute
infection.
4.4 Special warnings and precautions for use
As with all injectable vaccines, appropriate medical treatment and
supervision should always be readily available in case of an anaphylactic
event following administration of the vaccine.
Enzira should under no circumstances be administered intravascularly.
Antibody response in patients with endogenous or iatrogenic
immunosuppression may be insufficient.
4.5 Interaction with other medicinal products and
other forms of interaction
Enzira may be given at the same time as other vaccines. Immunisation
should be carried out on separate limbs. It should be noted that the
adverse reactions may be intensified.
The immunological response may be diminished if the patient is
undergoing immunosuppressant treatment.
Following influenza vaccination, false positive results in serological tests
using the ELISA method to detect antibodies against HIV1, Hepatitis C
and especially HTLV1 have been observed. The Western Blot technique
disproves the false-positive ELISA test results. The transient false
positive reactions could be due to the IgM response to the vaccine.
4.6 Pregnancy and lactation
Pregnancy
The limited data from vaccination in pregnant women do not indicate
that adverse fetal and maternal outcomes were attributable to the
vaccine. The use of this vaccine may be considered from the second
trimester of pregnancy. For pregnant women with medical conditions that
increase their risk of complications from influenza, administration of the
vaccine is recommended, irrespective of their stage of pregnancy.
Lactation
Enzira may be used during lactation.
4.7 Effects on ability to drive and use machines
The vaccine is unlikely to produce an effect on the ability to drive and
use machines.
4.8 Undesirable effects
Adverse reactions observed from clinical trials
The safety of trivalent inactivated influenza vaccines is assessed in open
label, uncontrolled clinical trials performed as annual update
requirements, including at least 50 adults aged 18 – 60 years of age and
at least 50 elderly aged 61 years or older. Safety evaluation is performed
during the first three days following vaccination.
The following undesirable effects have been observed during clinical trials
with the following frequencies: Very common (>1/10), common (
1/100, <1/10), uncommon ( 1/1,000, <1/100), rare ( 1/10,000,
<1/1,000), very rare (<1/10,000), including isolated reports.
Organ class
Nervous
system
disorders
Common
Very
common
>1/10
1/100,
<1/10
Headache*
Uncommo
n
Rare
Very rare
<1/10,00
1/1,000, 1/10,000, 0
<1/1,000
<1/100
Skin and
subcutaneous
tissue
disorders
Sweating*
Musculoskeleta
l and
connective
tissue
disorders
Myalgia,
arthralgia*
General
disorders and
administration
site conditions
Fever,
malaise,
shivering,
fatigue.
Local
reactions:
redness,
swelling,
pain,
ecchymosis,
induration*
* These reactions usually disappear within 1-2 days without treatment
Adverse reactions reported from post-marketing surveillance for
trivalent influenza vaccines
Adverse reactions reported from post marketing surveillance for trivalent
influenza vaccines are, next to the reactions which have also been
observed during the clinical trials, the following:
Blood and lymphatic system disorders
Transient thrombocytopenia, transient lymphadenopathy
Immune system disorders
Allergic reactions, in rare cases leading to anaphylactic shock,
angioedema
Nervous system disorders
Neuralgia, paraesthesia, convulsions
Neurological disorders, such as encephalomyelitis, neuritis and GuillainBarré syndrome
Vascular disorders
Vasculitis associated in very rare cases with transient renal involvement
Skin and subcutaneous tissue disorders
Generalised skin reactions including pruritus, urticaria or non-specific
rash
4.9 Overdose
Overdosage is unlikely to have any untoward effects.
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Influenza vaccine, ATC Code: J07B B02
Seroprotection is generally obtained within 2 to 3 weeks. The duration of
postvaccinal immunity to homologous strains or to strains closely related
to the vaccine strains varies but is usually 6 to 12 months.
5.2 Pharmacokinetic properties
Not applicable.
5.3 Preclinical safety data
Not applicable.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Sodium chloride
Anhydrous disodium phosphate
Sodium dihydrogen phosphate dihydrate
Potassium chloride
Potassium dihydrogen phosphate
Calcium chloride
Water for injection
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not
be mixed with other medicinal products.
6.3 Shelf life
1 year.
6.4 Special precautions for storage
Store in a refrigerator (2°C to 8°C). Do not freeze.
Keep the syringe in the outer carton in order to protect from light.
6.5 Nature and contents of container
0.5 ml suspension in pre-filled syringe (Type I glass) with plunger
stopper (chlorobutyl rubber) with attached needle in pack sizes of 1 or
10.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other
handling
The vaccine should be allowed to reach room temperature before use.
Shake before use. After shaking, the vaccine should appear as a
homogenous suspension. The vaccine must be inspected visually prior to
administration and should not be used if there is any variation of physical
appearance (see section 3).
Enzira is presented as a single use syringe and any remaining contents
should be disposed of in compliance with local rules for the disposal of
products of this nature.
When a 0.25 ml dose is indicated, the pre-filled syringe should be held in
an upright position and half the volume should be eliminated. To do so,
depress the plunger to the half dose marking on the glass syringe barrel,
the remaining volume should be injected.
7. MARKETING AUTHORISATION HOLDER
CSL Biotherapies GmbH
Emil-von-Behring-Strasse 76
35041 Marburg
Germany
8. MARKETING AUTHORISATION NUMBER(S)
PL 22236/0001
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
19 April 2005
10. DATE OF REVISION OF THE TEXT
June 2008
http://emc.medicines.org.uk/emc/assets/c/html/DisplayDoc.asp?DocumentID=20
070
SUPPORTING INFORMATION
Patient Information Leaflet:
Enzira suspension for injection, pre-filled syringe
Alternative format PIL:
Enzira suspension for injection, pre-filled syringe (new window)
Medicine Guide:
Enzira (new window)
Enzira suspension for injection, pre-filled syringe
In this leaflet:
PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
ENZIRA® Suspension for injection, pre-filled syringe
Influenza vaccine (split virion, inactivated) Ph. Eur.
Read all of this leaflet carefully before you are given this vaccination.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

This vaccination has been prescribed for yourself, 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 Enzira is and what it is used for

2. Before you are given Enzira

3. How to use Enzira

4. Possible side effects

5. How to store Enzira

6. Further information
Go to top of the page
1. WHAT ENZIRA IS AND WHAT IT IS USED FOR
Enzira is a suspension for injection in a pre-filled syringe. It contains a vaccine which stimulates
the immune system to produce antibodies against influenza. The vaccine is used for prevention
of influenza especially in those who run an increased risk of developing complications. The use
of Enzira should be based on official recommendations. Full effect of the vaccine is generally
achieved 2-3 weeks after the vaccination and the protection is usually maintained for 6 to 12
months.
Go to top of the page
2. BEFORE YOU ARE GIVEN ENZIRA
Do not use Enzira

If you are hypersensitive (allergic) to any of the ingredients of Enzira or to eggs and/or
chicken proteins which includes ovalbumin, or the antibiotics neomycin or polymyxin.

If you have previously had an allergic reaction to this vaccine.

If you have a high fever or an acute infection.
Take special care with Enzira
Enzira will not work well if you suffer from a disease that lowers your immunity.
Inform your doctor if you have any known allergy or have previously had problems with
vaccinations.
The vaccine should not be injected directly into a blood vessel.
Taking other medicines
Please inform your doctor or pharmacist if you are taking or have recently taken any medicines,
including medicines obtained without a prescription. Enzira will not work well if you are taking
medications that lower your immunity.
Pregnancy and breast-feeding
The experience from vaccinations in pregnant women is limited. If you are pregnant, ask your
doctor for advice before being vaccinated. The vaccine may be given when you are breastfeeding.
Driving and using machines
Enzira is unlikely to produce an effect on your ability to drive and use machinery.
Important information about some of the ingredients of Enzira
Enzira does not contain more than 1 µg ovalbumin per dose (0.5 ml).
This medicine contains potassium, less than 1 mmol (39 mg) per dose, i.e. essentially
“potassium free”.
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially
“sodium free”.
Go to top of the page
3. HOW TO USE ENZIRA
The vaccine is administered by deep injection (subcutaneously) under your skin or into a muscle
(intramuscularly) by a doctor or a nurse:

Adults and children from 36 months: 0.5 ml

Children from 6 months to 35 months: 0.25 ml or 0.5 ml

Children who have not previously been vaccinated: a second dose is given after
an interval of at least 4 weeks.
Other vaccinations can be given at the same time, provided that different injection sites are
used. It should be noted that the adverse reactions may be intensified.
Go to top of the page
4. POSSIBLE SIDE EFFECTS
Like all vaccines, Enzira can have side effects, although not everybody gets them.
The following undesirable effects have been reported in clinical studies:
Common side effects (in more than 1 out of 100 but fewer than 1 out of 10 vaccinees):

Reaction around the injection site (such as redness, pain, swelling), unusual purplish
patches on the skin, hardening of skin at injection site,

Fever, feeling generally unwell, chills, tiredness,

Headache, dizziness,

Sweating,

Muscle pain or joint pain.
Most of these reactions usually disappear within 1 to 2 days without treatment.
In addition to the reactions which have been observed during clinical trials, the following
adverse reactions have been reported after the introduction of trivalent influenza vaccines to the
market:

Severe stabbing or throbbing nerve pain,

Numbness or a pricking sensation in the arms or legs,

Fits,

Inflammation of the brain or spinal cord, inflammation of nerves, or Guillain-Barré
syndrome, which causes extreme weakness and paralysis,

Transient blood coagulation disorder increasing the risk of bleeding or bruising
(reduction in blood platelets),

Temporary swelling of glands in the neck, armpit and groin (lymph nodes),

Allergic reactions (in rare cases leading to anaphylactic shock) such as skin rash or
hives, itchiness, swelling of the face, lips, tongue, throat or other parts of the body,
tightness of the chest, wheezing, collapse,

Blood vessel inflammation with transient kidney involvement and little or no urine
passed.
If any of the following happen, contact your doctor immediately or go to the
Emergency Department at your nearest hospital:

A sudden allergic reaction (such as skin rash or hives, itchiness, swelling of the face,
lips, tongue, throat or other parts of the body),

Shortness of breath, wheezing or trouble breathing,

Fits,

Little or no urine passed.
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.
Go to top of the page
5. HOW TO STORE ENZIRA
Keep out of the reach and sight of children.
Do not use Enzira after the expiry date which is stated on the label and carton.
Store in a refrigerator (2°C to 8°C). Do not freeze.
Keep the syringe in the outer carton in order to protect from light.
Go to top of the page
6. FURTHER INFORMATION
What Enzira contains
The active substance is:
Split influenza virus*, inactivated with β-Propiolactone, containing antigens equivalent to:
A/Brisbane/59/2007 (H1N1) – like strain
15 micrograms HA**
(A/Brisbane/59/2007 IVR-148)
A/Brisbane/10/2007 (H3N2) – like strain
15 micrograms HA**
(A/Uruguay/716/2007 NYMC X-175C)
B/Florida/4/2006 – like strain
15 micrograms HA**
(B/Florida/4/2006)
per 0.5 ml dose.
* propagated in fertilised hens' eggs from healthy chicken flocks
** haemagglutinin
This vaccine complies with the WHO recommendation (Northern Hemisphere) and EU decision
for the 2008/2009 season.
Other ingredients are:
sodium chloride, anhydrous disodium phosphate, sodium dihydrogen phosphate dihydrate,
potassium chloride, potassium dihydrogen phosphate, calcium chloride and water for injections.
What Enzira looks like and contents of the pack
Enzira contains 0.5 ml of suspension for injection in a pre-filled syringe with plunger stopper
(chlorobutyl rubber) with attached needle in pack sizes of 1 or 10.
The suspension is a clear to slightly opaque liquid with some sediment that resuspends upon
shaking.
Marketing Authorisation Holder and Manufacturer
CSL Biotherapies GmbH
Emil-von-Behring-Strasse 76
35041 Marburg
Germany
Distributors:
Wyeth Pharmaceuticals Ltd.
Huntercombe Lane South
Taplow
Maidenhead
Berkshire
SL6 0PH
UK
Wyeth Pharmaceuticals Ltd.
Plaza 254
Blanchardstown Corporate Park 2
Ballycoolin
Blanchardstown
Dublin 15
Ireland