VaxigripTetra

VaxigripTetra

vaccine, influenza

Manufacturer:

Sanofi Pasteur

Distributor:

Zuellig Pharma
Full Prescribing Info
Contents
Quadrivalent influenza vaccine (split virion, inactivated).
Description
The active substances are Influenza virus (inactivated, split) of the following strains*: A/Guangdong-Maonan/SWL1536/2019 (H1N1)pdm09-like strain (A/Guangdong-Maonan/SWL1536/2019, CNIC-1909) 15 micrograms HA**; A/Hong Kong/2671/2019 (H3N2) - like strain (A/Hong Kong/2671/2019, IVR-208) 15 micrograms HA**; B/Washington/02/2019 - like strain (B/Washington/02/2019, wild type) 15 micrograms HA**; B/Phuket/3073/2013 - like strain (B/Phuket/3073/2013, wild type) 15 micrograms HA**.
Per 0.5 ml dose: *propagated in fertilised hens' eggs from healthy chicken flocks.
**haemagglutinin.
This vaccine complies with the WHO (World Health Organization) recommendations (Flu vaccine for Northern hemisphere) and EU decision for the 2020/2021 season.
Excipients/Inactive Ingredients: The other ingredients are a buffer solution containing sodium chloride, potassium chloride, disodium phosphate dihydrate, potassium dihydrogen phosphate and water for injections.
Some components such as eggs (ovalbumin, chicken proteins), neomycin, formaldehyde or octoxinol-9 may be present in very small amounts (see Contraindications).
Action
Pharmacotherapeutic group: Influenza vaccine. ATC code: J07BB02.
VaxigripTetra is a vaccine. This vaccine administered to adult or child from 6 months of age helps to protect against influenza (flu).
When a person is given VaxigripTetra, the immune system (the body's natural defense system) will produce its own protection (antibodies) against the disease. When given during pregnancy the vaccine helps to protect the pregnant women but also helps to protect her baby from birth to less than 6 months of age through the transmission of protection from mother to baby during pregnancy (see also Precautions and Dosage & Administration).
None of the ingredients in the vaccine can cause flu.
The use of VaxigripTetra should be based on official recommendations.
Flu is a disease that can spread rapidly and is caused by different types of strains that can change every year. Due to this potential change in circulating strains on a yearly basis, as well as the duration of protection intended by the vaccine, vaccination is recommended every year. For Thailand the greatest risk of catching flu is during rainy season around June to September and in winter season in December to March of every year. The doctor will be able to recommend the best time to be vaccinated.
VaxigripTetra is intended to protect the adult or child against the four strains of virus contained in the vaccine about 2 to 3 weeks after the injection. In addition, if the adult or child is exposed to flu immediately before or after the vaccination, the adult or child could still develop the illness from flu as the incubation period for flu is a few days.
The vaccination will not protect the adult or child against the common cold, even though some of the symptoms are similar to flu.
Indications/Uses
For the prevention of influenza disease caused by two influenza A virus subtypes and two influenza B virus subtypes contained in the vaccine for active immunisation of adults, including pregnant women, and children from 6 months of age; passive protection of infants less than 6 months of age and born to women vaccinated during pregnancy.
Dosage/Direction for Use
Adults receive one 0.5 ml dose.
Use in children: Children from 6 months to 17 years of age receive one 0.5 ml dose.
If the child is less than 9 years old and has not been previously vaccinated against flu, a second dose of 0.5 ml should be given after at least 4 weeks.
If the patient is pregnant, one 0.5 ml dose given during pregnancy may protect the baby from birth to less than 6 months of age. Ask the doctor or pharmacist for more information.
How VaxigripTetra is given: The doctor or nurse will administer the recommended dose of the vaccine as an injection into the muscle or under the skin.
If the patient has any further questions on the use of this product, ask the doctor or pharmacist.
Overdosage
No information.
Contraindications
Do not use VaxigripTetra if the adult or child are allergic 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, chicken proteins), neomycin, formaldehyde or octoxinol-9.
If the adult or child has an illness with a high or moderate temperature or an acute illness, the vaccination should be postponed until after adult or child has recovered.
Warnings
If the patient has any further questions, ask the doctor, pharmacist or nurse.
This vaccine has been prescribed for adult or child only. Do not pass it on to others.
If the adult or child gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monoraph. See Side Effects.
Special Precautions
To make sure that VaxigripTetra is suitable for the adult or child, it is important to tell the doctor or pharmacist if any of the points as follows apply to the adult or child. If there is anything the patient does not understand, ask the doctor or pharmacist to explain.
Talk to the doctor, pharmacist or nurse before using VaxigripTetra.
The patient should tell the doctor before vaccination if he/she or the child has: a poor immune response (immunodeficiency or taking medicines affecting the immune system), bleeding problem or bruising easily.
The doctor will decide if the adult or child should receive the vaccine.
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell the doctor or nurse if the adult or child has fainted with a previous injection.
As with all vaccines, Vaxigrip Tetra may not fully protect all persons who are vaccinated.
Not all babies less than 6 months of age born to pregnant women vaccinated during pregnancy will be protected.
If, for any reason, the adult or child has a blood test within a few days following a 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.
VaxigripTetra 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: VaxigripTetra has no or negligible influence on the ability to drive or use machines.
Use in Children: VaxigripTetra is not recommended for use in children below 6 months of age.
Use In Pregnancy & Lactation
If the patient is pregnant or breast-feeding, thinks she may be pregnant or is planning to have a baby, ask the doctor or pharmacist for advice before using this vaccine.
Vaxigrip Tetra can be used in all stages of pregnancy.
Vaxigrip Tetra may be used during breast-feeding.
The doctor/pharmacist will be able to decide if the patient should receive VaxigripTetra.
Pregnancy: Pregnant women are at high risk of influenza complications, including premature labour and delivery, hospitalisation, and death; pregnant women should receive an influenza vaccine. One animal study did not indicate direct or indirect harmful effects with respect to pregnancy, embryo-fetal development or early post-natal development.
Lactation: VaxigripTetra may be used during breastfeeding. There are no fertility data available in Humans. One animal study did not indicate harmful effects on female fertility.
Side Effects
Like all medicines, this vaccine can cause side effects, although not everybody gets them.
Allergic reactions: See a doctor IMMEDIATELY if the adult or child experiences: 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). These side effects were not observed with VaxigripTetra but have been rarely reported with other vaccines given to prevent flu (may affect up to 1 in 1,000 people).
Swelling most apparent in 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).
Allergic reactions such as skin reactions that may spread throughout the body including itching, hives, rash, redness.
These side effects are rare (may affect up to 1 in 1,000 people) except itching (pruritus) that may be more frequent (may affect up to 1 in 100 people).
Other side effects reported in adults and elderly: Very common (may affect more than 1 in 10 people): Headache, muscle pain (myalgia), malaise (1), pain at the injection site.
(1) Common in elderly.
Common (may affect up to 1 in 10 people): Fever (2), shivering, reactions at the injection site: redness (erythema), swelling, hardness (induration).
(2) Uncommon in elderly.
Uncommon (may affect up to 1 in 100 people): Dizziness (3), diarrhea, nausea (4), fatigue, reactions at the injection site: bruising (ecchymosis), itching (pruritus), and warmth.
(3) Rare in adults. (4) Rare in elderly.
Hot flush: only seen in the elderly.
Swelling of the glands in the neck, armpit or groin (lymphadenopathy): only seen in adults.
Rare (may affect up to 1 in 1,000 people): Anomalies in the perception of touch, pain, heat and cold (paresthesia), sleepiness, increased sweating (hyperhidrosis), unusual tiredness and weakness (asthenia), flu-like illness.
Joint pain (arthralgia), discomfort at the injection site: only seen in adults.
Other side effects reported in children from 3 to 17 years of age: Very common (may affect more than 1 in 10 people): Headache, muscular pain (myalgia), malaise, shivering (5), reactions at the injection site: pain, swelling, redness (erythema) (5), hardness (induration) (5).
(5)Common in children from 9 to 17 years of age.
Common (may affect up to 1 in 10 people): Fever, bruising (ecchymosis) at the injection site.
Uncommon (may affect up to 1 in 100 people) in children from 3 to 8 years of age: 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): only seen in one child of 3 years of age.
Moaning, restlessness.
Dizziness, diarrhea, vomiting, upper abdominal pain, joint pain (arthralgia), fatigue, warmth at the injection site.
Uncommon (may affect up to 1 in 100 people) in children from 9 to 17 years of age: Diarrheoa, itching (pruritus) at the injection site.
Other side effects reported in children from 6 to 35 months of age: Very common (may affect more than 1 in 10 people): Vomiting (1), muscular pain (myalgia) (2), irritability (3), appetite lost (3), generally feeling unwell (malaise) (2), fever.
(1) Uncommon in children from 24 to 35 months of age. (2) Rare in children less than 24 months of age.
(3) Rare in children from 24 to 35 months of age.
Reactions at the injection site: pain/tenderness, redness (erythema).
Headache: only seen in children from 24 months of age.
Drowsiness, unusual crying: only seen in children less than 24 months of age.
Common (may affect up to 1 in 10 people): Shivering: only seen in children 24 months and older.
Reactions at the injection site: hardness (induration), swelling, bruising (ecchymosis).
Uncommon (may affect up to 1 in 100 people): Diarrhoea, hypersensitivity.
Rare (may affect up to 1 in 1,000 people): Flu-like illness, reactions at the injection site: rash, pruritus (itching).
In children from 6 months to 8 years of age who receive 2 doses, side effects were similar after the first and after the second dose. Fewer side effects may happen after the second dose in children from 6 to 35 months of age.
When seen, side effects generally happen in the first 3 days after the vaccination and go away by themselves in 1 to 3 days after they start. The intensity of observed side effects was mild.
Side effects were generally less frequent in elderly than in adults and children.
The following side effects have been reported after administration of Vaxigrip. These side effects may occur with VaxigripTetra: pain situated on the nerve route (neuralgia), 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, Guillain-Barré syndrome); blood vessel inflammation (vasculitis) which may result in skin rashes and in very rare cases in temporary kidney problems.
Reporting of side effects: If the adult or child gets any side effects, talk to the doctor, pharmacist or nurse. This includes any possible side effects not listed in this monograph. By reporting side effects the patient can help provide more information on the safety of this medicine.
Drug Interactions
Tell the doctor or pharmacist if the adult or child is receiving, has recently received or might receive any other vaccines or any other medicines.
VaxigripTetra can be given at the same time as other vaccines by using separate limbs.
The immunological response may decrease in case of immunosuppressant treatment, such as corticosteroids, cytotoxic drugs or radiotherapy.
Following influenza vaccination, false positive results in serology tests using the ELISA method to detect antibodies against HIV1, Hepatitis C and especially HTLV1 have been observed. The Western Blot technique disproves the false-positive ELISA test results. The transient false positive reactions could be due to the IgM response by the vaccine.
Caution For Usage
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of an anaphylactic reaction following the administration of the vaccine.
The vaccine should be allowed to reach room temperature before use.
Shake before use. Inspect visually prior to administration.
The vaccine should not be used if foreign particles are present in the suspension.
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 Dosage & Administration.
Storage
Store in a refrigerator (2°C - 8°C). Do not freeze. Keep the syringe 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 medicines no longer used. These measures will help protect the environment.
ATC Classification
J07BB02 - influenza, inactivated, split virus or surface antigen ; Belongs to the class of influenza viral vaccines.
Presentation/Packing
Susp for inj (pre-filled syringe) 0.5 mL (colourless opalescent liquid) x 1's.
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