Description of VeroPol IPV VACCINE SSI
Description of VeroPol (IPV VACCINE SSI)
1 NAME OF THE MEDICINAL PRODUCT
VeroPol
Solution for injection, prefilled syringe.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Per dose = 0.5 ml:
Poliovirus type 1, inactivated 40 DU
Poliovirus type 2, inactivated 8 DU
Poliovirus type 3, inactivated 32 DU
Poliovirus type 1 (Brunhilde), type 2 (MEF-1) and type 3 (Saukett), propagated in Vero cells, are purified and inactivated.
For a full list of excipients, see 6.1
3 PHARMACEUTICAL FORM
Solution for injection, pre-filled syringe.
The vaccine appears as a bright orange to red solution.
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Primary and booster immunisation of infants from the age of 2 months, children, adolescents and adults against poliomyelitis.
4.2 Posology and method of administration
VeroPol should be administered intramuscularly. The vaccine may also be administered subcutaneously in certain circumstances (see 4.4).
The vaccine must not be administered intravascularly.
For primary immunisation a vaccination series of 2-3 doses of 0.5 ml is administered, which is initiated at the earliest at 2 months of age with an interval of 1-2 months according to national recommendations regarding vaccination programme.
The first booster immunisation should be administered at the earliest 6 months after the primary vaccination series. For booster vaccination 1 dose of 0.5 ml is administered.
The need to routinely administer additional booster doses has not been established.
Administration of additional booster doses should take place in accordance with national recommendations for polio immunisation.
4.3 Contraindications
As with other vaccines, vaccination should be postponed in subjects suffering from an acute severe febrile illness.
VeroPol should not be administered to subjects with known hypersensitivity to the active substances or to any of the excipients.
4.4 Special warnings and precautions for use
As with all injectable vaccines, appropriate medical treatment and supervision should always readily be available in the case of rare anaphylactic events following the administration of the vaccine.
It may be expected that in patients receiving immunosuppressive treatment or patients with immunodeficiency, an adequate immune response may not be elicited.
As with any vaccine, a protective immune response may not be elicited in all vaccinees.
As with any injectable vaccine, VeroPol must be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following intramuscular administrations. The vaccine may be administered by subcutaneous injection in such cases.
VeroPol should under no circumstances be administered intravascularly.
The potential risk of apnoea and the need for respiratory monitoring for 48–72h should be considered when administrating the primary immunisation series to very premature infants (born ≤ 28 weeks of gestation) and particularly for those with a previous history of respiratory immaturity.
As the benefit of vaccination is high in this group of infants, vaccination should not be withheld or delayed.
Formaldehyde is used during the manufacturing process and trace amounts may be present in the product. Caution should be taken in individuals with known hypersensitivity to formaldehyde.
4.5 Interaction with other medicinal products and other forms of interaction
With exception of immunosuppressive treatment (see Special warnings and precautions for use) there is no known interaction with other medicinal products.
VeroPol can be administered concomitantly with other vaccines but different injection sites must be used.
4.6 Pregnancy and lactation
Pregnancy
There are no or limited data from the use of inactivated poliovirus in pregnant women.
There are no animal data with respect to effects on pregnancy, foetal development, parturition and post-natal development. The potential risk for humans is unknown.
As with other inactivated vaccines, harm to the fetus is not anticipated.
VeroPol should only be used during pregnancy if immediate protection is needed.
Lactation
The effect on breastfed infants of administration of VeroPol to their mothers has not been studied.
However it is not anticipated that vaccination of the breastfeeding mother with inactivated poliovaccine is harmful to the infant.
4.7 Effects on ability to drive and use machines
VeroPol has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects
Between 1 and 10% of the vaccinees can expect to experience side effects, most frequently as reactions on the injection site, fever and general malaise. Local reaction at the injection site in the way of redness, tenderness and swelling can occur within the first 48 hours after injection and last for 1–2 days. The appearance and seriousness of the local reactions is dependent on the injection site and the route of administration.
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Blood and lymphatic system disorders
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Rare (≥1/10,000 to <1/1,000)
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Lymphadenopathy
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Immune system disorders
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Very rare (<1/10,000)
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Hypersensitivity, including anaphylactic reaction
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Nervous system disorders
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Very rare (<1/10,000)
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Febrile convulsions
Headache
Drowsiness
Vasovagal syncope
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Skin and subcutaneous tissue disorders
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| Common (≥1/100 to <1/10) |
Skin rash
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Very rare (<1/10,000)
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Urticaria
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Musculoskeletal and connective tissue disorders
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Very rare (<1/10,000)
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Temporary arthralgia and myalgia |
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General disorders and administration site conditions
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| Common (≥1/100 to <1/10) |
General malaise
Tenderness, redness and swelling at the injection site Fever ≥ 38°C
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Rare (≥1/10,000 to <1/1,000)
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High fever ≥ 40°C
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Apnoea in very premature infants (born ≤ 28 weeks of gestation) (see Special warnings and precautions for use).
4.9 Overdose
Not relevant, since the vaccine is filled in a single-dose container.
5 PHARMACOLOGICAL PROPERTIES
5.0 Therapeutic classification
ATC code: J 07 BF 03, Poliomyelitis, trivalent, inactivated
5.1 Pharmacodynamic properties
The vaccine administered in a primary series and as a booster dose, stimulates the production of antibodies against poliovirus 1, 2 and 3.
Protective antibody levels against poliomyelitis can be expected shortly after the second or third vaccination of the primary vaccination series.
This has been demonstrated in two studies.
In one study 407 infants were vaccinated with the IPV from SSI in a combined vaccine at 3, 5 and 12 months of age. All infants but one obtained protection against all poliovirus types after the second vaccination. All infants were protected after the third dose.
In another study 817 infants were vaccinated with the IPV from SSI in a combined vaccine at 2, 3½, 5, and 16 months of age, protection against all three poliovirus types was obtained in all infants but one after three vaccinations. All infants were protected after completion of the schedule.
Clinical data on antibody levels obtained after primary immunisation of adults is not available.
Clinical data on long-term persistence of antibody levels is not available for VeroPol.
5.2 Pharmacokinetic properties
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5.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of single and repeated dose toxicity.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Medium 199 (contains phenolsulphonphthalein as pH indicator).
6.2 Incompatibilities
The vaccine must not be mixed with other medicinal products.
6.3 Shelf life
36 months.
6.4 Special precautions for storage
Store in a refrigerator (2°C – 8°C).
Do not freeze.
Vaccine that has been frozen should not be used.
Store in the original package in order to protect from light.
6.5 Nature and contents of container
Pre-filled single dose glass syringes of 0.5 ml (type I glass).
Pack sizes: 1 x 0.5 ml, 5 x 0.5 ml, 10 x 0.5 ml, 20 x 0.5 ml.
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
The vaccine should appear as a bright orange to red solution.
The vaccine should not be used if it appears yellow.
Any unused product or waste material should be disposed of in accordance with local requirements.
Last revised 7 February 2012