FAQs - Healthcare Professionals
  1. Administration With Other Vaccines
  2. Adverse Effects
  3. Antibiotics
  4. Breast Feeding
  5. Egg Protein Content(ovalbumin)
  6. Children
  7. Interchangeable Vaccines
  8. Constituents
  9. Contraindications
  10. Damaged Vaccine Syringes
  11. Expiry Date
  12. Flu
  13. Frequency Of Vaccination
  14. Immunity
  15. Latex
  16. Launch
  17. What other vaccines are available from Abbott Healthcare Products Ltd?
  18. Pregnancy
  19. Storage And Stability
  20. Subunit Vaccine
  21. Vaccine Strains
  22. Influvac and Thiomersal
  23. Differences between Influvac desu,Influvac and Imuvac

1) Administration With Other Vaccines

Influvac Desu, Influvac and Imuvac are inactivated vaccines. They can be given at the same time as other vaccines. Immunisation should be carried out on separate limbs. Adverse reactions may be intensified1.

Ref:

1. Influvac Desu, Influvac and Imuvac SPCs (www.medicines.org.uk)

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2) Adverse Effects

Please refer all enquiries concerning adverse events to Influvac Desu, Influvac or Imuvac by phone to Abbott on 0800 121 8267.

To view a full list of adverse effects, please see Influvac Desu, Influvac and Imuvac SPCs section 4.8 (www.medicines.org.uk

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3) Antibiotics

We are not aware of any interactions between influenza vaccine and antibiotics.

The vaccine may contain traces of gentamicin. This antibiotic is used during the manufacturing process.

Our SPC states that use of our vaccines in patients hypersensitive to any of the active substances or excipients including gentamicin is contraindicated1

We are not aware of any cross-reactivity between penicillin and gentamicin. Therefore patients sensitive to penicillin should be able to receive influenza vaccine.

Ref:

1. Influvac Desu, Influvac and Imuvac SPCs (www.medicines.org.uk)

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4) Breast Feeding

Influvac Desu, Influvac and Imuvac may be used during breastfeeding.

Ref:

1. Influvac Desu, Influvac and Imuvac SPCs (www.medicines.org.uk)

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5) Egg Protein Content (Ovalbumin)

Can Influvac Desu, Influvac or Imuvac be given to patients hypersensitive (allergic) to chicken?

Influvac Desu, Influvac and Imuvac should not be given to patients hypersensitive (allergic) to chicken protein or eggs. The ovalbumin content of the vaccine is not more than 0.1mcg per 0.5ml dose (ie. 0.2 mcg per ml)1

Ref:

1. Data on file RM27496

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6) Children

Can Influvac Desu, Influvac or Imuvac be used in young children?

Yes in children from 6 months of age. See below for details.

Administration of Influvac Desu, Influvac and Imuvac in children

Children less than 6 months: No experience exists of Influvac Desu, Influvac or Imuvac being used in children under 6 months of age.

Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25 ml or 0.5ml may be given. The dose given should be in accordance with existing national recommendations.

Adults and children from 36 months: 0.5ml

Immunisation should be intramuscular or deep subcutaneous injection.

The UK Department of Health (Green Book) recommends that children aged 6 months to less than 9 years who have not received influenza vaccine before should receive a second dose of vaccine at least four weeks later.

Administration of 0.25mls of Influvac Desu and Imuvac (see section 23)

Administration of 0.25mls of Influvac

The Influvac 0.5ml syringe is not graduated. For administration of a 0.25ml dose from a syringe:

Eject the air from the syringe.

Push the front side of the plunger exactly to the edge of the hub (the knurled polypropylene ring); a volume of 0.25 ml of the vaccine remains in the syringe, suitable for administration.

Syringe Image

Refs:

1. Department of Health. Green Book Chapter 19, updated August 2012

2. Data on file. RM27367.

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7) Interchangeable vaccines

The trivalent seasonal influenza vaccines are interchangeable, as quoted in the “Green Book, Chapter 19 (updated August 2012) page 1991.

Therefore if a child needs two doses of Influenza seasonal vaccine four weeks apart, then two different brands of seasonal flu vaccines could be used.

Ref:

1. Department of Health. Green Book Chapter 19, updated August 2012

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8) Constituents

The constituents of Influvac Desu, Influvac and Imuvac for the 2013/2014 season as recommended by the World Health Organisation are as follows:

Active constituents Influvac Desu, Influvac and Imuvac:

  • A/California/7/2009 (H1N1) pdm09-derived strain used (NYMC X-181)
  • A/Victoria/361/2011 (H3N2) –like strain used (NYMC X-223A) derived from A/Texas/50/2012
  • B/Massachusetts/2/2012-derived strain used (NYMC BX-51B)

California/7/2009 (H1N1) like virus is antigenically and genetically similar to the pandemic A (H1N1) virus.

Other constituents:

Influvac Desu, Influvac and Imuvac

  • Potassium dihydrogen phosphate
  • Disodium phosphate dihydrate
  • Sodium chloride
  • Potassium chloride
  • Calcium chloride dihydrate
  • Magnesium chloride hexahydrate
  • Water for injections

Residue or traces of:

  • Formaldehyde
  • Cetyltrimethylammonium bromide
  • ovalbumin
  • chicken proteins
  • Polysorbate 80
  • Gentamicin

Ref:

1. Influvac Desu, Influvac and Imuvac SPCs (www.medicines.org.uk) & WHO

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9) Contraindications

Which patients should not be vaccinated?

Allergy to eggs or chicken protein

Patients hypersensitive (allergic) to eggs or chicken protein should not be vaccinated with Influvac Desu, Influvac or Imuvac.

Allergy to gentamicin or any other constituent of the vaccine.

As Influvac Desu, Influvac and Imuvac may contain minimal amounts of gentamicin, they should not be used in patients hypersensitive to this antibiotic. Patients who are allergic to any of the ingredients or to any of the components that could be present in trace amounts, should not receive Influvac Desu, Influvac or Imuvac. Please also see Question 8 Constituents.

Febrile Illness: Vaccination should be postponed in patients with febrile illness or acute infection

Ref:

1. Influvac Desu, Influvac and Imuvac SPCs (www.medicines.org.uk)

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10) Damaged Vaccine Syringes

What should I do if Influvac Desu, Influvac or Imuvac syringes arrive damaged?

Where at all possible the damaged syringe(s) should be carefully packaged and returned to:-

Quality Assurance Dept
Abbott Healthcare Products Ltd
Mansbridge Rd
SOUTHAMPTON SO18 3JD

Please enclose a short summary of the problem, your name and address and account number. Please also say whether you would like credit or the stock replaced.

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11) Expiry Date

Can Influvac Desu, Influvac or Imuvac be used beyond its expiry date?

The shelf-life is 12 months provided that the vaccine has been stored correctly. Use of any vaccine after its expiry date is not recommended.

In addition the vaccines contain appropriate quantities of the A and B virus strains that are recommended by the WHO. These strains vary from year to year and therefore vaccines from previous years may not contain the current recommended virus strains.

Please also see 19) Storage and Stability

Ref:

1. Influvac Desu, Influvac and Imuvac SPCs (www.medicines.org.uk)

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12) Flu

Can Influvac Desu, Influvac or Imuvac cause the flu?

Influvac Desu, Influvac and Imuvac contain inactivated viral components and thus cannot cause influenza.

Influenza-like symptoms can be caused by many respiratory infections (including the common cold) and Influvac Desu, Influvac and Imuvac will not prevent these.

The incubation period for the flu is a few days, so if a patient is exposed to the flu immediately before or after vaccination, the illness could still develop.

Ref:

1. Department of Health. Green Book Chapter 19, updated August 2012

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13) Frequency Of Vaccination

Is vaccination with Influvac Desu, Influvac or Imuvac needed each year?

The vaccination is needed each year for optimal protection against influenza.

Annual vaccination is required because the influenza virus will vary each year. Therefore the immunity induced by previous vaccination will not give optimum protection to new virus strains.

Each year the World Health Organisation (WHO) recommends which antigens should be included in the influenza vaccines.

Influvac Desu, Influvac and Imuvac comply with the WHO recommendations.

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14) Immunity

How soon after vaccination will protection against influenza be achieved?

Some antibodies will be produced after around 2 days, whilst protective antibody levels are achieved within 2-3 weeks. The duration of immunity varies but is usually 6-12 months. The ideal time for vaccination is between September and early November. Immunity can be expected to last through the winter.

The incubation period for the flu is a few days, so if a patient is exposed to the flu immediately before or after vaccination, the illness could still develop.

Influenza-like symptoms can be caused by many respiratory infections (including the common cold) and Influvac Desu, Influvac and Imuvac will not prevent these.

Ref:

1. Department of Health. Green Book Chapter 19, updated August 2012

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15) Latex

Does Influvac Desu, Influvac or Imuvac contain latex?

Product:

Influvac Desu, Influvac and Imuvac are contained in pre-filled syringes that have a rubber component. This is made only from synthetic rubber, and not latex.

Production:

During production, contact with rubber may occur (e.g. rubber rings are used to close-off containers during production). Direct contact of our product should not occur, but cannot be excluded.

Ref:

1. Data on file RM27495

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16) Launch

When were Influvac Desu, Influvac and Imuvac first launched?

Influvac Desu will be launched in 2013.

Influvac was first launched in 1962.

Imuvac was first launched in 2006.

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17) What other vaccines are available from Abbott Healthcare Products Ltd?

Aside from Influvac Desu, Influvac and Imuvac no other vaccines are produced by Abbott Healthcare Products Ltd.

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18) Pregnancy

The pregnancy section in the UK SPC has been updated, section 4.6 states:

“Inactivated influenza vaccines can be used in all stages of pregnancy. Larger datasets on safety are available for the second and third trimester, compared with the first trimester; however, data from worldwide use of influenza vaccine do not indicate any adverse foetal and maternal outcomes attributable to the vaccine”. The Influvac/Imuvac 2012/2013 SPCs state that its use should be based on official recommendations. (section 4.1)1

Refs:

1. Influvac Desu, Influvac and Imuvac SPCs (www.medicines.org.uk)

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19) Storage And Stability

How should Influvac,  Influvac Desu or Imuvac be stored?

The optimum temperature for storage is between 2-8oC, for a period no longer than twelve months.

Storage out of the fridge

Influvac Desu, Influvac and Imuvac should always be stored at 2-8oC, but in the event of accidental storage at higher temperatures, please contact the Abbott Medical Information Unit on 02380467000.

Storage below 2oC

In the event of accidental storage below 2oC, please contact Abbott Medical Information Unit on 02380467000.

The vaccines should not be frozen.

Store in original package in order to protect from light.

Ref:

1. Influvac Desu, Influvac and Imuvac SPCs (www.medicines.org.uk)

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20) Subunit Vaccine

What is meant by a subunit vaccine?

The different types of inactivated influenza vaccine are as follows:

  • Whole Virus Vaccines: The whole virus is used to induce immunity
  • Split-Virion Vaccines: The protein coat of the virus is split away from the virus core and is used to induce immunity
  • Sub-Unit Vaccines: The protein coat is further broken down and only the 'H' and 'N' antigens are used.

Ref:

1. Ellebedy AH. Vaccine 2009;27: D65-D68

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21) Vaccine Strains

Influvac Desu, Influvac and Imuvac contain appropriate quantities of the A and B virus strains that are recommended by the WHO. These strains vary from year to year. The strains that are present in Influvac Desu, Influvac and Imuvac for the 2013/2014 season will be:

  • A/California/7/2009 (H1N1) pdm09-derived strain used (NYMC X-181)
  • A/Victoria/361/2011 (H3N2) –like strain used (NYMC X-223A) derived from A/Texas/50/2012
  • B/Massachusetts/2/2012-derived strain used (NYMC BX-51B)

California/7/2009 (H1N1) like virus is antigenically and genetically similar to the pandemic A (H1N1) virus.

Ref:

1. WHO

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22) Influvac Desu, Influvac and Thiomersal

Influvac Desu, Influvac and Imuvac are thiomersal free.

Ref:

1. Influvac Desu, Influvac and Imuvac SPCs (www.medicines.org.uk)

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23) Differences between Influvac Desu,Influvac and Imuvac

Administration of 0.25mls

Influvac Desu and Imuvac have a mark on the barrel of the syringe. For administration of a 0.25ml dose from a single 0.5ml syringe, push the front side of the plunger exactly to the edge of the mark so that half of the volume is eliminated; a volume of 0.25mls of the vaccine remains in the syringe, suitable for administration. For administration of 0.25mls for Influvac , see section 6) Children

Needle Length

Needle length for Influvac is 25mm; for Influvac Desu and Imuvac it is 16mm. This had to be changed in order to ensure supply.

Needle Guard

The needle guard for Influvac is rigid but the needle guards for Influvac Desu and Imuvac are soft.

Both types of needle guard are latex free –See section 15 Latex

Labels on the syringes

There are minor changes to the size of the label with Influvac Desu and Imuvac compared to Influvac.

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