VAXIGRIP PEDIATRIC USE (SOUTHERN HEMISPHERE)

Država: Indonezija

Jezik: indonezijščina

Source: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Aktivna sestavina:

INFLUENSAVACCIN

Dostopno od:

BIO FARMA - Indonesia

INN (mednarodno ime):

INFLUENSAVACCIN

Farmacevtska oblika:

CAIRAN INJEKSI

Enote v paketu:

DUS,1 PREFILLED SYRINGE @ 0,25 ML (1 DOSIS)

Izdeluje:

SANOFI PASTEUR - France

Datum dovoljenje:

2018-10-17

Lastnosti izdelka

VAXIGRIP
®
INACTIVATED INFLUENZA VACCINE
(SPLIT VIRION)
EFFECTS ON ABILITY TO DRIVE AND USE MACHINARY:
The vaccine is unlikely to produce an effect on the ability to drive
vehicles and use machines.
LIST OF EXCIPIENTS WITH KNOWN EFFECT:
Sodium (chloride, dihydrate disodium phosphate form), potassium
(chloride, monopotassium phosphate
form).
Please inform your doctor or pharmacist if you notice any other
undesirable effects not mentioned in
this leaflet.
USE WITH OTHER MEDICINAL PRODUCTS:
The immunological response may be diminished in case of
immunosuppressive treatment. Please inform
your doctor or pharmacist of any ongoing treatment, or if any other
medicinal products, even if non-
prescription, have been taken recently.
3. HOW TO USE VAXIGRIP
®
POSOLOGY:
Adult and children from 36 months: one 0.5 mL dose.
Children from 6 to 35 months: 0.25 mL dose.
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:
Intramuscular route, or deep subcutaneous injection.
The vaccine should be brought to room temperature before use.
Shake before use to obtain a uniform suspension.
ADMINISTRATION RATE AND TIME:
Due to the seasonal nature of influenza, it is recommended to perform
vaccination against influenza
every year, either at the beginning of autumn in temperate countries
or at the beginning of the risk
period in tropical countries.
4. WHAT ARE THE POSSIBLE UNDESIRABLE EFFECTS
As with all medicinal products, VAXIGRIP
®
may cause undesirable effects:
- local reactions: erythema (redness), swelling, pain, ecchymosis,
induration;
- systemic reactions: fever, malaise, shivering, fatigue, headaches,
sweating, joint and muscular
pain;
These reactions usually disappear within 1-2 days without treatment;
- rarely: neuralgia (pain located along the course of
the nerve), paraesthesia (a sensory
perception disorder where reactions to touch, pain, heat or movement
are affected), convulsions
and transient thrombocytopenia (an insufficient am