INFANRIX PENTA 0.5mL injection syringe

Χώρα: Αυστραλία

Γλώσσα: Αγγλικά

Πηγή: Department of Health (Therapeutic Goods Administration)

Δραστική ουσία:

Hepatitis B surface antigen recombinant, Quantity: 20 microgram/mL; Pertactin, Quantity: 16 microgram/mL; Poliovirus, Quantity: 16 DAgU; Pertussis filamentous haemagglutinin, Quantity: 50 microgram/mL; Diphtheria toxoid, Quantity: 30 IU; Tetanus toxoid, Quantity: 40 IU; Pertussis toxoid, Quantity: 50 microgram/mL; Poliovirus, Quantity: 80 DAgU; Poliovirus, Quantity: 64 DAgU

Διαθέσιμο από:

GlaxoSmithKline Australia Pty Ltd

INN (Διεθνής Όνομα):

Diphtheria toxoid,Hepatitis B surface antigen recombinant,Pertactin,Pertussis filamentous haemagglutinin,Pertussis toxoid,Poliov

Φαρμακοτεχνική μορφή:

Injection, suspension

Σύνθεση:

Excipient Ingredients: aluminium phosphate; aluminium hydroxide hydrate; polymyxin B sulfate; water for injections; sodium chloride; neomycin sulfate; glucose monohydrate; ascorbic acid; polysorbate 80; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; Biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium

Οδός χορήγησης:

Intramuscular

Μονάδες σε πακέτο:

1 x pre-filled syringe, 10 x pre-filled syringe

Τρόπος διάθεσης:

(S4) Prescription Only Medicine

Θεραπευτικές ενδείξεις:

INDICATIONS: Infanrix Penta is indicated for immunisation of infants from the age of 6 weeks against diphtheria, tetanus, pertussis, hepatitis B and poliomyelitis. Infanrix Penta may also be used as a booster dose at 18 months of age if boosting with hepatitis B and poliomyelitits, as well as diphtheria, tetanus and pertussis is required.

Περίληψη προϊόντος:

Visual Identification: Turbid liquid, white deposit, colourless supernatant.; Container Type: Syringe; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Καθεστώς αδειοδότησης:

Licence status A

Ημερομηνία της άδειας:

2007-01-08

Φύλλο οδηγιών χρήσης

INFANRIX
®
PENTA
1
INFANRIX
®
PENTA
_Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B
and Inactivated Poliovirus Vaccine _
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
Please read this leaflet carefully
before your child is given
INFANRIX PENTA.
This leaflet answers some common
questions about INFANRIX PENTA.
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 risks of your child
having INFANRIX PENTA against
the benefits they expect it will have.
IF YOU HAVE ANY CONCERNS ABOUT
YOUR CHILD RECEIVING INFANRIX
PENTA, ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET WITH THE VACCINE.
You may need to read it again.
WHAT INFANRIX
PENTA IS USED FOR
INFANRIX PENTA is a vaccine
used in infants from the age of 6
weeks to prevent five diseases;
diphtheria, tetanus, pertussis
(whooping cough), hepatitis B and
poliomyelitis (polio). The vaccine
works by causing the body to
produce its own protection
(antibodies) against these diseases.
Diphtheria, tetanus, and pertussis are
all serious life-threatening diseases
caused by bacterial infection.
Hepatitis B and poliomyelitis are
infectious diseases caused by viral
infection.
DIPHTHERIA
Diphtheria mainly affects the airways
and sometimes the skin. Generally
the airways become inflamed
(swollen) causing severe breathing
difficulties and sometimes
suffocation. The bacteria also release
a toxin (poison), which can cause
nerve damage, heart problems, and
death. The risk of serious
complications and death is greater in
the very young and elderly.
TETANUS (LOCKJAW)
Tetanus bacteria enter the body
through wounded skin. Wounds that
are especially prone to infection are
burns, fractures, deep wounds or
wounds contaminated with soil, dust,
horse manure or wood splinters. The
bacteria release a toxin (poison),
which can cause muscle stiffness,
painful muscle spasms, fits and
death. The spasms can be strong
enou