Fluarix

Maa: Uusi-Seelanti

Kieli: englanti

Lähde: Medsafe (Medicines Safety Authority)

Aktiivinen ainesosa:

Influenza virus A/California/7/2009 (H1N1) - like strain 30 µg/mL (A/Christchurch/16/2010 (NIB-74xp) (15 µg HA)); Influenza virus A/Hong Kong/4801/2014 (H3N2) - like strain 30 µg/mL (A/Hong Kong/4801/2014, NYMC X-263B (15 µg HA)); Influenza virus B/Brisbane/60/2008 - like strain 30 µg/mL (B/Brisbane/60/2008 (15 µg HA))

Saatavilla:

GlaxoSmithKline NZ Limited

INN (Kansainvälinen yleisnimi):

Influenza virus A/California/7/2009 (H1N1) - like strain 30 µg/mL (A/Christchurch/16/2010 (NIB-74xp) (15 µg HA))

Lääkemuoto:

Suspension for injection

Koostumus:

Active: Influenza virus A/California/7/2009 (H1N1) - like strain 30 µg/mL (A/Christchurch/16/2010 (NIB-74xp) (15 µg HA)) Influenza virus A/Hong Kong/4801/2014 (H3N2) - like strain 30 µg/mL (A/Hong Kong/4801/2014, NYMC X-263B (15 µg HA)) Influenza virus B/Brisbane/60/2008 - like strain 30 µg/mL (B/Brisbane/60/2008 (15 µg HA)) Excipient: Commercial light duty detergent D-alpha-Tocopheryl acid succinate Dibasic sodium phosphate dodecahydrate Formaldehyde Gentamicin sulfate Magnesium chloride hexahydrate Monobasic potassium phosphate Potassium chloride Sodium chloride Sodium deoxycholate Sucrose Water for injection

Kpl paketissa:

Syringe, without fixed needle, 0.5 mL

luokka:

Prescription

Prescription tyyppi:

Prescription

Valmistaja:

GlaxoSmithKline Biologicals (Dresden)

Käyttöaiheet:

Fluarix is indicated for prophylaxis against influenza in adults and children older than six months of age.

Tuoteyhteenveto:

Package - Contents - Shelf Life: Syringe, without fixed needle and separate needle supplied - 0.5 mL - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, without fixed needle - 0.5 mL - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, with fixed needle - 0.5 mL - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, 0.5mL - 10 dose units - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, single dose, - 0.5 mL - 12 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Valtuutus päivämäärä:

1993-11-19

Pakkausseloste

FLUARIX
®
1
FLUARIX
®
_Inactivated Split Influenza Vaccine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some of the
common questions about FLUARIX
vaccine. It does not contain all the
available information. It does not
take the place of talking to your
doctor or pharmacist.
All medicines and vaccines have
risks and benefits. Your doctor has
weighed the possible risks of you or
your child having FLUARIX against
the expected benefits.
IF YOU HAVE ANY CONCERNS ABOUT
RECEIVING FLUARIX TALK TO YOUR
DOCTOR, NURSE OR PHARMACIST.
KEEP THIS LEAFLET WITH THE VACCINE.
You may need to read it again.
WHAT FLUARIX IS USED
FOR
FLUARIX is used to help prevent
certain types of influenza. The
vaccine works by causing the body to
produce its own protection
(antibodies) against three different
types of influenza virus.
Each year new types of influenza
virus can appear, so every year
FLUARIX is changed to contain
fragments of the new types of virus.
Therefore, influenza vaccination is
recommended every year.
PLEASE NOTE THAT FLUARIX WILL
ONLY PROTECT YOU AGAINST THE THREE
TYPES OF INFLUENZA VIRUS USED TO
MAKE THE VACCINE. IT WILL NOT
PROTECT YOU FROM INFLUENZA CAUSED
BY OTHER TYPES OF INFLUENZA VIRUS OR
FROM INFECTIONS WITH OTHER AGENTS
CAUSING FLU-LIKE SYMPTOMS (SUCH AS
THE COMMON COLD).
FLUARIX cannot give you or your
child influenza because the viruses in
the vaccine have been killed.
Influenza is an infectious illness and
is spread by small droplets from the
nose, throat or mouth of an infected
person. The most common
symptoms of influenza include fever,
sore throat, runny nose, coughing,
general aches and pains, headache,
weakness and tiredness. Most people
recover completely within a week.
The risk of serious complications (eg.
pneumonia and death) is greater in
very young, very old and chronically
ill persons.
FLUARIX can be used in adults and
children older than 6 months of age.
PLEASE TALK TO YOUR DOCTOR IF YOU
HAVE ANY QUESTIONS.
BEFORE YOU ARE GIVEN
FLUARIX
_WHEN YOU OR YOUR CHILD _
_MUST

Valmisteyhteenveto

1
NEW ZEALAND DATA SHEET
FLUARIX
®
_Inactivated split influenza vaccine _
FLUARIX is an inactivated and purified split influenza vaccine,
prepared in embryonated
eggs.
The antigen composition and strains for the approaching influenza
season are determined
by the World Health Organisation (WHO). This corresponds to the
following types and
subtypes for the 2016 season:
A/California/7/2009 (H1N1) - like virus
A/Hong Kong/4801/2014 (H3N2) - like virus
B/Brisbane/60/2008 - like virus
PRESENTATION
Each 0.5 mL vaccine dose contains 15 mcg haemagglutinin of each of the
recommended
strains (total of 45 mcg haemagglutinin). The vaccine preparation also
contains alpha
tocopheryl acid succinate, sodium chloride, magnesium chloride,
potassium chloride,
potassium phosphate monobasic, sodium phosphate dibasic dodecahydrate,
polysorbate
80, and octoxinol 10 in water for injections. Residual amounts of
ovalbumin ≤0.05 mcg
and formaldehyde ≤5 mcg, but also traces of gentamicin sulfate,
hydrocortisone, and
sodium deoxycholate from the manufacturing process may be present.
Fluarix meets the WHO requirements for biological substances and
influenza vaccines.
INDICATIONS
Fluarix is indicated for prophylaxis against influenza in adults and
children older than six
months of age. Because of the possibility of increased morbidity and
mortality from
complications of influenza, vaccination is especially recommended for
the following:
•
Persons over 60 years of age,
•
Persons who suffer from diseases of the cardiovascular system,
metabolic diseases
(diabetes), cystic fibrosis, chronic respiratory diseases, and chronic
renal insufficiency,
and
•
Persons with congenital or acquired immune deficiency.
Vaccination can be recommended for individuals exposed to increased
risk of infection
because of their occupation, such as medical personnel. In addition,
prevention of disease
in the workforce could lead to substantial economic benefits.
Fluarix should be administered before the beginning of the influenza
season or as required
by the ep