IPOL inactivated poliomyelitis vaccine 0.5mL injection

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

Poliovirus, Quantity: 17 DAgU; Poliovirus, Quantity: 20 DAgU; Poliovirus, Quantity: 5 DAgU

Disponível em:

Sanofi-Aventis Australia Pty Ltd

Forma farmacêutica:

Injection, suspension

Composição:

Excipient Ingredients: sodium hydroxide; hydrochloric acid; formaldehyde solution; phenoxyethanol; glucose monohydrate; purified water; polysorbate 80; ascorbic acid; sodium chloride; aminobenzoic acid; adenosine phosphate; dl-alpha-tocopheryl phosphate disodium; magnesium sulfate; monobasic potassium phosphate; deoxyribose; calcium chloride dihydrate; iron trinitrate; potassium chloride; magnesium sulfate heptahydrate; potassium nitrate; sodium selenite; monobasic sodium phosphate; dibasic sodium phosphate heptahydrate; adenine sulfate; adenosine triphosphate disodium; cholesterol; glutathione; guanine hydrochloride; hypoxanthine; phenolsulfonphthalein; ribose; sodium acetate; thymine; uracil; xanthine; sodium pyruvate; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; hydroxyproline; isoleucine; asparagine; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine;

Via de administração:

Subcutaneous

Unidades em pacote:

1 x 0.5mL

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

Ipol is indicated for active immunisation of infants, children and adults for the prevention of poliomyelitis. Ipol should be offered to patients who have refused OPV or in whom OPV is contraindicated. Ipol is also indicated for: 1) the primary vaccination of immunocompromised individuals of all ages, and household contacts of such individuals (when vaccination is indicated); (2) unvaccinated or inadequately vaccinated(*) adults, particularly if at increased risk of exposure to live polio virus, including: - Travellers to areas or countries where poliomyelitis is epidemic or endemic: - Laboratory workers handling specimens which may contain polio virus; - Health care workers in close contact with patients who may be excreting polioviruses. (*) such as those who may not have completed a primary series of vaccination or not received a booster dose since infancy. IDICATIONS AS AT 9 JUNE 2003: Ipol is indicated for active immunisation of infants, children and adults for the prevention of poliomyelitis. Recommen

Resumo do produto:

Visual Identification: Colourless clear solution .; Container Type: Syringe; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Status de autorização:

Registered

Data de autorização:

1994-06-29

Folheto informativo - Bula

IPOL
®
I
p
o
l
®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this vaccine, speak to your doctor or pharmacist.
1.
WHY DO I NEED IPOL?
Ipol is a vaccine. It is used to prevent poliomyelitis ('polio') in
infants, children and adults.
For more information, see Section 1. Why do I or my child need Ipol?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I AM GIVEN IPOL?
Do not use if you or your child ever had an allergic reaction to Ipol
or any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU OR YOUR CHILD HAS ANY OTHER MEDICAL
CONDITIONS, OR TAKE ANY OTHER MEDICINES.
TALK TO YOUR DOCTOR IF YOU ARE PREGNANT OR PLAN TO BECOME PREGNANT OR
ARE BREASTFEEDING.
For more information, see Section 2. What should I know before I am
given Ipol? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Ipol and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW IS IPOL GIVEN?
Ipol is given by a doctor or nurse as an injection into the tissue
below the skin of the upper arm, or into the thigh in infants and
small
children, although your doctor may choose to inject it elsewhere.
More instructions can be found in Section 4. How is Ipol given? in the
full CMI.
5.
WHAT SHOULD I KNOW AFTER I AM GIVEN IPOL?
THINGS YOU
SHOULD DO
•
Keep an updated record of vaccinations.
•
Keep follow-up appointments with your doctor or clinic.
LOOKING AFTER
YOUR VACCINE
Ipol is usually stored in the doctor’s surgery or clinic, or at the
pharmacy. However, if you need to store Ipol:
•
keep in fridge between 2-8°C. Do not freeze.
For more information, see Section 5. What should I know after I am
given Ipol? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Common side effects include local reactions around the injection site
(such as redness, swelling, pain or discomfort, rash or the
formation of hard lumps), fever, agitation, sleepiness, i

Características técnicas

ipol-ccdsv5-piv3-08nov21
Page 1 of 10
AUSTRALIAN PRODUCT INFORMATION – IPOL INACTIVATED
POLIOMYELITIS VACCINE (POLIOVIRUS)
1
NAME OF THE MEDICINE
Poliovirus (inactivated)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ipol is a clear, colourless sterile suspension of three strains of
poliovirus: Type 1 (Mahoney),
Type 2 (MEF-1) and Type 3 (Saukett). The viruses are grown in cultures
of VERO cells, a
continuous line of monkey kidney cells, by the microcarrier technique.
The viruses are
concentrated, purified and made non infectious by inactivation with
formaldehyde.
Each sterile 0.5 mL immunising dose of trivalent vaccine is formulated
to contain:
•
Poliovirus inactivated type 1 (Mahoney)
40D Antigen Units
•
Poliovirus inactivated type 2 (MEF-1)
8D Antigen Units
•
Poliovirus inactivated type 3 (Saukett)
32D Antigen Units
Traces of neomycin, streptomycin sulfate and polymyxin B sulfate used
in vaccine
production may be present.
Contains phenylalanine.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Suspension for Injection
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Ipol is indicated for active immunisation of infants, children and
adults for the prevention of
poliomyelitis. Recommendations for the use of live and inactivated
poliovirus vaccines are
described in the national immunisation guidelines.
1.
GENERAL RECOMMENDATIONS.
It is recommended that all infants, unimmunised
children and adolescents not previously immunised be vaccinated
routinely against
paralytic poliomyelitis.
_IPOL SHOULD BE OFFERED TO PATIENTS WHO HAVE REFUSED OPV, OR _
_IN WHOM OPV IS CONTRAINDICATED._
2.
IPOL IS ALSO INDICATED FOR:
ipol-ccdsv5-piv3-08nov21
Page 2 of 10
•
The primary vaccination of immunocompromised individuals of all ages
(see Section
4.4 Special warnings and precautions for use),
and household contacts of such
individuals (when vaccination is indicated)
•
Unvaccinated or inadequately vaccinated (*) adults, particularly if at
increased risk of
exposure to live poliovir