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PREFLUCEL SUSPENSION FOR INJECTION IN A PRE-FILLED SYRINGE

Active substance(s): INFLUENZA VACCINE (SPLIT VIRION INACTIVATED)

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Nanotherapeutics Bohumil, sro

Package Leaflet - UK

PACKAGE LEAFLET

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Package Leaflet - UK

Package leaflet: Information for the user
PREFLUCEL Suspension for injection in a pre-filled syringe
2012/2013 season
Influenza Vaccine (split virion, inactivated, prepared in cell cultures)
Read all of this leaflet carefully before you receive this vaccine 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 pharmacist.
If you get any of the side effects, talk to your doctor or pharmacist.This includes any possible
side effects not listed in this leaflet. See section 4.

What is in this leaflet
1.
2.
3.
4.
5.
6.

What PREFLUCEL is and what it is used for
What you need to know before you receive PREFLUCEL
How PREFLUCEL is given
Possible side effects
How to store PREFLUCEL
Contents of the pack and other information

1.

What PREFLUCEL is and what it is used for

PREFLUCEL is a vaccine. This vaccine helps to protect adults and elderly against influenza (flu). The
use of PREFLUCEL should be based on official recommendations.
When a person is given the vaccine PREFLUCEL, the immune system (the body’s natural defence
system) will produce its own protection (antibodies) against disease. None of the ingredients in the
vaccine can cause flu.
Flu is a disease that can spread rapidly and is caused by different types of strains that can change every
year. Therefore, this is why you might need to be vaccinated every year. The greatest risk of catching
flu is during the cold months between October and March. If you were not vaccinated in the autumn, it
is still sensible to be vaccinated up until the spring since you run the risk of catching flu until then.
Your doctor will be able to recommend the best time to be vaccinated.
PREFLUCEL will protect you against the three strains of virus contained in the vaccine from about 2
to 3 weeks after the injection.
The incubation period for flu is a few days, so if you are exposed to flu immediately before or after
your vaccination, you could still develop the illness.
The vaccine will not protect you against the common cold, even though some of the symptoms are
similar to flu.

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Package Leaflet - UK

What you need to know before you receive PREFLUCEL

You should not receive PREFLUCEL
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If you are allergic (hypersensitive) to the active substances, or any of the excipients or residues
(e.g. formaldehyde, benzonase, sucrose) of PREFLUCEL, see section 6.
If you have an illness with a higher temperature (fever) or an acute infection the vaccination
shall be postponed until after you have recovered.

Warnings and precautions
You should tell your doctor before vaccination if you have a poor immune response
(immunodeficiency or taking medicines affecting the immune system). Your doctor will decide if you
should receive the vaccine.
If, for any reason, you have a blood test within a few days following a flu vaccination, please tell your
doctor. This is because false positive blood test results have been observed in a few patients who had
recently been vaccinated.
As with all vaccines, PREFLUCEL may not fully protect all people who are vaccinated.
Anaphylaxis has been reported with PREFLUCEL. (see section 4 “Possible Side Effects”).
As with other intramuscular injections, PREFLUCEL should be given with caution in individuals with
bleeding disorders such as hemophilia or on anticoagulant therapy, to avoid the risk of hematoma
following the injection.
Other medicines and PREFLUCEL
Please tell your doctor or pharmacist if you are taking, have recently taken or might take any other
medicines.
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PREFLUCEL can be given at the same time as other vaccines by using separate limbs. It should
be noted that the side effects may be stronger.
The immunological response may decrease in case of immunosuppressant treatment, such as
corticosteroids, cytotoxic drugs or radiotherapy.
Do not mix with any other vaccine in the same syringe or vial.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask
your doctor or pharmacist for advice before taking PREFLUCEL.
The safety of PREFLUCEL in pregnancy and lactation has not been assessed in clinical trials.
Limited data from flu vaccinations in pregnant women do not indicate that the vaccine would have
harmful effects on the pregnancy or the baby. 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 the flu, administration of the vaccine is recommended, irrespective of their stage
of pregnancy.
The effects of PREFLUCEL vaccine on male fertility have not been assessed.
PREFLUCEL may be used during breastfeeding.
Driving and using machines
PREFLUCEL has no or negligible influence on the ability to drive and use machines.
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PREFLUCEL contains sodium.
This medicinal product contains less than 1 mmol sodium (23 mg) per 0.5 ml, i.e. essentially ‘sodiumfree’.
3.

How PREFLUCEL is given

The doctor will give PREFLUCEL as an injection into your upper arm (deltoid muscle).
The vaccine should never be given into a vein.
Adults from the age of 18 years and older will receive one injection of PREFLUCEL 0.5 ml.
Use in children
There is no information on the use of PREFLUCEL below 18 years of age.
4.

Possible side effects

Like all medicines, PREFLUCEL can cause side effects, although not everybody gets them.
Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects
not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
During clinical trials, the following side effects have been observed.
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Very common (affects more than 1 user in 10): headache*, muscle pain (myalgia), pain at
injection site*, generally feeling unwell (malaise), feeling tired (fatigue)

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Common (affects 1 to 10 user in 100): cough, pain in mouth and throat (oropharyngeal pain),
runny nose (rhinorrhoea), urge to vomit (nausea)*, vomiting*, sweating (hyperhidrosis),
increased blood pressure, joint pain (arthralgia)*, at the injection site: swelling, redness
(erythema), hardness (induration)*; systemic reactions: chills, fever (pyrexia)

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Uncommon (affects 1 to 10 users in 1,000): abnormal or reduced sensation (sensory
disturbance)*, red eyes (ocular hyperemia), mucus draining from the eye (eye discharge)*,
throat irritation, throat swelling (pharyngeal oedema), shortness of breath (dyspnoea), belly pain
(abdominal pain), itching (pruritus), skin redness (erythema), eye irritation, musculoskeletal
stiffness, at the injection site: itching (pruritus), minor bleeding (hemorrhage), warmth*;
systemic reaction: chest discomfort

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Rare (affects 1 to 10 users in 10, 000): allergic reactions, which can potentially lead to a
decrease of blood pressure, if untreated, may lead to shock. Doctors are aware of these
possibilities and have treatment available for use in such cases. Distortion of the sense of taste
(dysgeusia), difficulty swallowing (dysphagia)*, hives (urticaria), feeling faint (syncope), local
swelling (peripheral oedema)

*These reactions usually disappear within 1-2 days without treatment.

One case of multiple sclerosis was reported in a single male subject. First symptoms occurred 6 weeks
after vaccination.

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Package Leaflet - UK

How to store PREFLUCEL

Keep this medicine out of the sight and reach of children.
Do not use PREFLUCEL after the expiry date which is stated on the carton after EXP. The expiry date
refers to the last day of that month.
Store in a refrigerator (2°C – 8°C). Do not freeze.
Keep in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These measures will help protect the environment.
6.

Contents of the pack and other information

What PREFLUCEL contains
The active substances are influenza virus (inactivated, split) of the following strains*:
A/California/07/2009 (H1N1)
A/Victoria/361/2011 (A/H3N2)
B/Hubei-Wujiagang/158/2009 (B)

15 micrograms HA**
15 micrograms HA**
15 micrograms HA**
per 0.5 ml dose
* propagated in Vero cells (continuous cell line of mammalian origin)
** haemagglutinin

This vaccine complies with the WHO (World Health Organization) recommendations (Northern
Hemisphere) and EU decision for the 2012/2013 season.
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The other ingredients are:
Trometamol, Sodium Chloride, Water for Injections and Polysorbate 80

What PREFLUCEL looks like and contents of the pack
PREFLUCEL is supplied as a 0.5 milliliter suspension for injection in a pre-filled syringe. The
vaccine is a clear to opalescent suspension.
Pack sizes:
1 or 10 prefilled syringes with attached needle;
1 or 10 prefilled syringes without attached needle.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Nanotherapeutics Bohumil S.R.O.
Bohumil 138 28163,
Jevany,
Czech Republic
Manufacturer:
Baxter AG
Industriestrasse 67
A-1221 Wien
Austria

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This medicinal product is authorized in the Member States of the EEA under the following names:
Austria: PREFLUCEL Injektionssuspension in einer Fertigspritze
Belgium: PREFLUCEL suspension injectable en seringue préremplie, PREFLUCEL suspensie voor
injectie in een voorgevulde spuit, PREFLUCEL Injektionssuspension in einer Fertigspritze
Czech Republic: PREFLUCEL injekční suspenze v předplněné injekční stříkačce
Denmark: PREFLUCEL injektionsvæske, suspension, i fyldt injektionssprøjte
Finland: PREFLUCEL-injektioneste, suspensio, esitäytetyssä ruiskussa
Germany: PREFLUCEL Injektionssuspension in einer Fertigspritze
Ireland: PREFLUCEL suspension for injection in a pre-filled syringe
Italy: PREFLUCEL, sospensione iniettabile in siringa preriempita
Norway: PREFLUCEL injeksjonsvæske, suspensjon i en ferdigfylt sprøyte
Poland: PREFLUCEL zawiesine do wstrzykiwan w ampulko-strzykawce
Portugal: PREFLUCEL
Spain: PREFLUCEL Suspension inyectable en jeringa precargada
Sweden: Preflucel injektionsvätska, suspension i förfylld spruta
The Netherlands: PREFLUCEL 2012/2013, suspensie voor injectie 0,5 ml
The UK: PREFLUCEL suspension for injection in a pre-filled syringe
This leaflet was revised in 04/2016

The following information is intended for healthcare professionals only:
The vaccine should be allowed to reach room temperature before use.
Shake the prefilled syringe well prior to administration so that the vaccine suspension is thoroughly
mixed. After shaking PREFLUCEL is a clear to opalescent suspension. The vaccine should be inspected
visually for any foreign particulate matter and/or variation in physical appearance prior to
administration. In the event of either being observed, discard the vaccine.
Remove needle guard as follows:
1.
Hold the pre-filled syringe at the lower part of the needle guard fixed onto the glass recipient
(Fig. 1).
2.
Use the other hand to take the upper part of the needle guard between thumb and forefinger, and
twist to break the seal (tamper evident) (Fig. 2).
3.
Remove the detached part of the needle guard from the needle by a vertical movement (Fig. 3).

Fig. 1

Fig. 2

Fig. 3

Following removal of the needle guard, PREFLUCEL should be used immediately.

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To avoid loss of sterility and/or clogging of the needle, it should not be left without protection for
prolonged periods of time. Therefore, the needle guard should only be removed after shaking and
immediately prior to use.
Additional information for PREFLUCEL syringe without attached needle:
After removing the syringe cap, attach the needle immediately and remove the needle shield prior to
administration. Once the needle is attached, the vaccine must be administered immediately.
To minimize the risk of local adverse reactions care must be taken to avoid droplets of vaccine on the
tip or the external surface of the needle prior to injection. If alcohol is used at the injection site, it
should be allowed to dry completely before vaccination, and should not come in contact with the
vaccine.
PREFLUCEL must not be mixed with other medicinal products. PREFLUCEL may be given at the
same time as other vaccines. Immunization should be carried out on separate limbs.
Any unused product or waste material should be disposed of in accordance with local requirements.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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