Vaxigrip

Vaxigrip

vaccine, influenza

Manufacturer:

Sanofi Pasteur

Distributor:

Zuellig
Full Prescribing Info
Contents
Flu vaccine (split virion, inactivated).
Description
Active substances: Influenza virus (inactivated, split) of the following strains*: A/Michigan/45/2015 (H1N1)pdm09-like strain (A/Michigan/45/2015, NYMC X-275) 15 micrograms HA**, A/Switzerland/8060/2017 (H3N2)-like strain (A/Brisbane/1/2018, NYMC X-311) 15 micrograms HA**, B/Colorado/06/2017-like strain (B/Maryland/15/2016, NYMC BX-69A) 15 micrograms HA** For one 0.5 ml dose.
*Propagated in fertilised hens' eggs from healthy chicken flocks
**Haemagglutinin
This vaccine complies with the WHO (World Health Organisation) recommendations (Southern Hemisphere) for the 2019 season.
The other ingredients are: Thiomersal and a buffer solution containing sodium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate, potassium chloride, water for injections.
Action
Pharmacotherapeutic group: Influenza vaccine. ATC code: J07BB02.
Indications/Uses
VAXIGRIP is a vaccine.
VAXIGRIP helps to protect against influenza (flu). VAXIGRIP should be used according to official recommendations.
When a person receives the vaccine VAXIGRIP, the immune system (the body's natural defence system) will produce its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu.
Flu is a disease that can spread rapidly and is caused by different types of virus strains that can change every year. This is why the patient may need to be vaccinated every year. The greatest risk of catching flu is during the coldest months. If the patient was not vaccinated in the autumn, it is still possible to do it until spring since the patient runs the risk of catching flu until then. The doctor will be able to recommend the best time to be vaccinated.
VAXIGRIP is intended to protect the patient against three strains of virus contained in the vaccine after about 2 to 3 weeks following the injection.
The incubation period for flu is a few days, so if the patient is exposed to flu immediately before or after vaccination, patient could still develop the illness.
This vaccine will not protect the patient against the common cold, even though some of the symptoms are similar to flu.
Dosage/Direction for Use
How to use VAXIGRIP: Adults receive one 0.5 ml dose.
Use in children and adolescents: Children aged 36 months and older receive 0.5 ml dose.
Children aged 6 months to 35 months receive one 0.25 ml dose.
If this is required by national recommendations, a 0.5 ml dose may be given.
If the child is aged less than 9 years and has not been previously vaccinated against flu, a second dose should be given after at least 4 weeks.
The doctor will administer the recommended dose of the vaccine as an injection into the muscle or deep under the skin.
For any further questions on the use of this product, ask the doctor or pharmacist.
If patient used more VAXIGRIP than he/she should: In some cases, more than the recommended dose was used.
In these cases, when side effects were reported, the information was in line with what is described in Side Effects.
Contraindications
To make sure that VAXIGRIP is suitable for the patient, it is important to tell the doctor or pharmacist if any of the points below apply.
If there is anything that the patient dose not understand, ask the doctor or pharmacist to explain.
Do not use VAXIGRIP: If patient is allergic (hypersensitive) to: the active substances or any of the other ingredients of this vaccine (see Description), or any component that may be present in very small amounts such as eggs (ovalbumin or chicken proteins), neomycin, formaldehyde or octoxinol-9.
If patient has an illness with a high or moderate temperature or an acute illness, the vaccination should be postponed until after the patient has recovered.
Special Precautions
Talk to the doctor or pharmacist before using VAXIGRIP.
Patient should tell the doctor before vaccination if he/she: Has a poor immune response (immunodeficiency or taking medicines affecting the immune system), has bleeding problems or bruise easily.
The doctor will decide if the patient should be vaccinated.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection.
Therefore tell the doctor or nurse if the patient has fainted with a previous injection.
If, for any reason, the patient has to have a blood test within the days following the flu vaccination, please tell the doctor. This is because false positive blood test results have been observed in a few patients who had recently been vaccinated.
As with all vaccines, VAXIGRIP may not fully protect all persons who are vaccinated.
VAXIGRIP contains potassium and sodium: This medicine contains less than 1 mmol potassium (39 mg) and sodium (23 mg) per dose, i.e. essentially 'potassium-free' and 'sodium-free'.
Driving and using machines: VAXIGRIP has no or negligible influence on the ability to drive and use machines.
Use In Pregnancy & Lactation
If patient is pregnant or breast-feeding, may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before using this medicine.
Flu vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third semester, compared with the first trimester; however, data from worldwide use of inactivated influenza vaccines do not indicate any adverse foetal and maternal outcomes attributable to the vaccine.
VAXIGRIP may be used during breast-feeding.
The doctor or pharmacist will be able to decide if patient should receive VAXIGRIP.
Side Effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Allergic reactions: See a doctor immediately if patient experience severe allergic reactions: that may lead to medical emergency with low blood pressure, rapid, shallow breathing, rapid heart rate and weak pulse, cold, clammy skin, dizziness, that may lead to collapse (shock); swelling most often situated on the head and neck, including the face, lips, tongue, throat or any other part of the body and which may cause difficulty in swallowing or breathing (angioedema).
See a doctor if patient experience allergic reactions that may affect: The skin: such as itching, hives, rash, redness, areas of itchy, red, swollen, and cracked skin (dermatitis atopic), flushing.
The eyes: such as excess of blood in the white of the eye (ocular hyperaemia), redness and irritation of the eye (conjunctivitis allergic).
The throat and the nose: such as throat irritation, sore throat, allergic irritation inside the nose, runny nose, sneezing, stuffy nose, sinus or throat.
The mouth: such as numbness or pins and needles sensation (paresthesia oral), rash (oral mucosal eruption).
Breathing: such as asthma, difficulty breathing (dyspnoea).
These allergic reactions were reported as uncommon (may affect up to 1 in 100 people) to rare (may affect up to 1 in 1,000 people).
Other side effects reported: Very common (may affect more than 1 in 10 people) in adults and elderly: Headache, Muscle pain, Malaise(1), Pain at the injection site.
Common (may affect up to 1 in 10 people) in adults and elderly: Shivering, fever(1); Reactions at the injection site: redness, hardness, swelling.
Uncommon (may affect up to 1 in 100 people) in adults and elderly: Swelling of the glands in the neck, armpit or groin(1); Unusual weakness(1), tiredness, sleepiness(2), dizziness(2), increased sweating(1); Joint pain(1); Feeling sick (nausea), diarrhoea; Reactions at the injection site: bruising, itching, warmth, discomfort.
Rare (may affect up to 1 in 1,000 people) in adults and elderly: Numbness or pins and needles sensation (paresthesia), decrease sensitivity (hypoesthesia)(3); Vomiting, decreased appetite, abdominal pain; Signs of flu-like illness(3); Reactions at the injection site: peeled off skin (exfoliation), allergy.
(1)Less frequent in elderly, (2) Less frequent in adults, (3)In adults, (4)In elderly.
Very common (may affect more than 1 in 10 people) in children and adolescents from 3 to 17 years of age: Headache; Muscle pain; Malaise, shivering(6); Reactions at the injection site: pain, redness, swelling, hardening(5).
Common (may affect up to 1 in 10 people) in children and adolescents from 3 to 17 years of age: Fever, shivering(5); Reactions at the injection site: bruising(5), hardening(6).
Uncommon (may affect up to 1 in 100 people) in children and adolescents from 3 to 17 years of age: Swelling of the glands in neck, armpit or groin(5), unusual weakness(6), tiredness, dizziness(6), crying(5); Diarrhoea(5), abdominal pain(5); Reactions at the injection site: bruising(6), itching, warmth(6), discomfort(6).
Very common (may affect more than 1 in 10 people) in children from 6 to 35 months of age: Headache(7), unusual crying(8), irritability(8), drowsiness(8); Muscular pain(7); Fever, loss of appetite(8); Reactions at the injection site: tenderness, redness, hardness, bruising, swelling.
Common (may affect up to 1 in 10 people) in children from 6 to 35 months of age: Vomiting(8), diarrhoea; Shivering(7).
(5)In 3 to 8 years old (6)in 9 to 17 years old (7)In 24 to 35 months old (8)In 6 to 23 months old
The frequency of the following side effects is not known (cannot be estimated from the available data) in the whole population except in the population for which the side effect is listed previously: Swelling of the glands in the neck, armpit or groin; Numbness or pins and needles sensation (paraesthesia); Pain situated on the nerve route (neuralgia)(9); Convulsions; Neurological disorders that may result in stiff neck, confusion, numbness, pain and weakness of the limbs, loss of balance, loss of reflexes, paralysis of part or all the body (encephalomyelitis, neuritis(9), Guillain-Barre Syndrome(9)); Blood vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems; Temporary reduction in the number of certain blood elements called platelets; a low number of these can result in excessive bruising or bleeding (transient thrombocytopenia).
(9)Not reported in children from 6 to 35 months old
Most side effects usually occurred within the 3 days following vaccination, disappeared within 3 days without treatment. The intensity of these side effects was mild to moderate.
This vaccine contains thiomersal (an organomercuric compound) as a preservative and therefore allergic reactions (hypersensitivity) may occur.
Reporting of side effects: If the patient get any side effects, talk to the doctor or pharmacist. This includes any possible side effects not listed in this monograph. By reporting side effects than can help provide more information on the safety of this medicine.
Drug Interactions
Tell the doctor or pharmacist if the patient is taking or has recently taken any other vaccines or any other medicines.
VAXIGRIP can be given at the same time as other vaccines by using separate limbs. In this case, the side effects may be intensified.
The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.
Caution For Usage
As with all injectable vaccines, appropriate medical treatment and supervision should be readily available in case of an anaphylactic reaction following the administration of the vaccine.
The vaccine should be brought to room temperature before use.
Shake before use.
Any opened multidose vial remaining after a vaccination session should be discarded in accordance with WHO recommendations.(1)
For each dose taken and for each patient, a new sterile syringe fitted with a new sterile needle is used.
Between different removals and in any case within 5 minutes maximum after removal of the last dose, the vial should be placed back into the refrigerator to keep the product at the required storage temperature, i.e. between 2°C and 8°C (never in the freezer).
In any case, when in storage period, the vial should be stored according to the conditions described in the manufacturer's instructions for use.
It should not be mixed with other medicinal products in the same syringe.
This vaccine is not to be injected directly into a blood vessel.
See also How to use VAXIGRIP under Dosage and Administration.
(1) French Regulatory Agency (ANSM) approved the following recommendations: After removal of the first dose, the vaccine contained in the vial must imperatively be used within 7 days.
A partially used vial must be destroyed immediately if: sterile removal has not been strictly carried out, there is any suspicion that a partially used vial has been contaminated, there is a visible sign of contamination, such as a change in the appearance or the presence of particles in suspension.
Storage
Store in a refrigerator (2°C-8°C). Do not freeze.
Keep the vial in the outer carton in order to protect from light.
Do not throw away any medicines via wastewater or household waste. Ask the pharmacist how to throw away any medicines no longer used. These measures will help protect the environment.
ATC Classification
J07BB01 - influenza, inactivated, whole virus ; Belongs to the class of influenza viral vaccines.
Presentation/Packing
Inj (multidose vial) 0.5 mL x 10 doses x 1's, 10's.
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