Ipol

Land: Neuseeland

Sprache: Englisch

Quelle: Medsafe (Medicines Safety Authority)

Wirkstoff:

Polio virus type 1 29 DAgU (Mahoney by parallel line method (equiv to 40 DAgU by sigmoid method)); Polio virus type 2 7 DAgU (MEF1 by parallel line method (equiv to 8 DAgU by sigmoid method)); Polio virus type 3 26 DAgU (Saukett by parallel line method (equiv to 32 DAgU by sigmoid method))

Verfügbar ab:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (Internationale Bezeichnung):

Polio virus type 1 40 DAgU (Mahoney)

Darreichungsform:

Suspension for injection

Zusammensetzung:

Active: Polio virus type 1 29 DAgU (Mahoney by parallel line method (equiv to 40 DAgU by sigmoid method)) Polio virus type 2 7 DAgU (MEF1 by parallel line method (equiv to 8 DAgU by sigmoid method)) Polio virus type 3 26 DAgU (Saukett by parallel line method (equiv to 32 DAgU by sigmoid method)) Excipient: Formaldehyde Phenoxyethanol Polysorbate 80 Water for injection

Einheiten im Paket:

Syringe, 1, 0.5 mL

Klasse:

Prescription

Verschreibungstyp:

Prescription

Hergestellt von:

Sanofi Pasteur SA

Anwendungsgebiete:

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: · The primary vaccination of immunocompromised individuals of all ages (see PRECAUTIONS), and household contacts of such individuals (when vaccination is indicated) · unvaccinated or inadequately vaccinated (*) adults, particularly if at increased risk of exposure to live poliovirus, including: · Travellers to areas or countries where poliomyelitis is epidemic or endemic; · Laboratory workers handling specimens which may contain polioviruses; · Health care workers in close contact with patients who may be excreting polioviruses. (*) Such as those who had not completed a primary series of vaccination or not received a booster dose since infancy.

Produktbesonderheiten:

Package - Contents - Shelf Life: Syringe, 1 - 0.5 mL - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Syringe, 10x0.5ml - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Berechtigungsdatum:

1997-04-07

Gebrauchsinformation

IPOL
_®_
1
IPOL
®
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,

Fachinformation

ipol-ccdsv6-dsv5-31jan24
Page 1
NEW ZEALAND DATA SHEET
1
IPOL (0.5 ML SUSPENSION FOR INJECTION)
IPOL Inactivated Poliomyelitis Vaccine (VERO), poliovirus, 0.5mL
suspension for injection
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
IPOL (inactivated poliomyelitis vaccine), is a clear, colourless
sterile suspension of three strains
of poliovirus: Type 1 (Mahoney), Type 2 (MEF-I) 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 0.5mL immunising dose of trivalent vaccine is formulated
to contain:
Poliovirus type 1 (Mahoney)
1
………………….…………. 29 D-antigen units
2
Poliovirus type 2 (MEF-1)
1
………………………….…….7 D-antigen units
2
Poliovirus type 3 (Saukett)
1
…………………….………….26 D-antigen units
2
1
Cultivated on Vero cells
2
These antigen quantities are strictly the same as those previously
expressed as 40-8-32 D-antigen
units, for virus type 1, 2 and 3 respectively, when measured by
another suitable immunochemical
method.
Contains phenylalanine.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Suspension for Injection
IPOL is a clear, colourless sterile suspension.
ipol-ccdsv6-dsv5-31jan24
Page 2
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:
•
The primary vaccination of im