Abbott Heathcare - Influvac and Imuvac

FAQs

Administration With Other Vaccines
Adverse Effects
Antibiotics
BCG
Breast Milk
Chicken Allergy
Children
Children - Second Dose
Constituents
Contraindications
Damaged Vaccine Syringes
Dose
Expiry Date
Flu
Frequency Of Vaccination
Immunity
Latex
Launch
Other Abbott Healthcare Vaccines
Pregnancy
Shelf-Life
Storage And Stability
Subunit Vaccine
Vaccine Strains

1) Administration With Other Vaccines

Can Influvac or Imuvac be given at the same time as other vaccines?

Influvac and Imuvac are both inactivated vaccines. Thus Influvac and Imuvac can be given at the same time as other vaccines, except BCG.

Vaccine should be given in different limbs. It should be noted that adverse reactions may be intensified.

Influvac and Imuvac are not live vaccines.

Appropriate literature concerning the other vaccine should be consulted (especially for BCG vaccine) for example the relevant Summary of Product Characteristics (SPC), The Green Book¹

Ref

1.Salisbury D. Immunisation against infectious disease. London: Department Health, 2006. PublicationsPolicyAndGuidance/DH_079917

2) Adverse Effects

Please refer all enquiries concerning adverse events to Influvac or Imuvac to the Medical Information Department at Abbott Healthcare Products Ltd on 02380 467000, or e-mail: medinfo.shl@solvay.com

The following reactions are the most common:
Headache*, sweating*, myalgia, arthralgia*.

Local reactions: redness, swelling, pain, ecchymosis, induration*.
Systemic reactions: fever, malaise, shivering, fatigue.

*These reactions usually disappear within 1-2 days without treatment.

Please see Influvac or Imuvac Summary of Product Characteristics (SPC) for details of uncommon and rare adverse events (www.medicines.org.uk)
.

3) Antibiotics

Can Influvac or Imuvac be given to a patient taking antibiotics?

We are not aware of any reported interactions between Influvac or Imuvac and antibiotics.

The vaccine does contain small amounts of gentamycin. This antibiotic is used in the early phase of production. The vaccine purification process removes this antibiotic. Minor traces may however be present. Caution should therefore be exercised in patients hypersensitive to this antibiotic and other aminoglycosides.

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

4) BCG

Can Influvac or Imuvac be given at the same time as BCG vaccine?

Influvac and Imuvac should not be given at the same time as BCG vaccination.

No further immunisation should be given in the arm used for BCG vaccination for at least three months because of the risk of regional lymphadenitis.¹

Ref

1. Salisbury D. Immunisation against infectious disease. London: Department of Health 2006. PublicationsPolicyAndGuidance/DH_079917

5) Breast Milk

Can Influvac or Imuvac be given to a breast feeding mother?

Yes. The vaccines contain inactivated virus, and any antibodies passed from the mother to the baby should not cause a harmful effect.

6) Chicken Allergy

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

Influvac and Imuvac should not be given to patients hypersensitive (allergic) to chicken protein or eggs.

7) Children

Can Influvac or Imuvac be used in young children?

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

Administration of Influvac and Imuvac in children

Dosage is as follows:

Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25ml or 0.5ml have been used.

For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks.

No experience exists of Influvac or Imuvac being used in children under 6 months of age.

Adults and Children from 36 months: 0.5ml

Immunisation should be by intramuscular or deep subcutaneous injection.

The Centers for Disease Control and Prevention, July 2009 recommends that children less than 9 years who have not been previously vaccinated should receive a second dose after an interval of at least 4 weeks.¹

The UK Department of Health (Green Book) recommends that children who have not been previously vaccinated and are aged 6 months to 12 years should receive a second dose after a 4-6 week interval.²

Administration of 0.25ml dose of Influvac or Imuvac

The Influvac and Imuvac 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.

Refs

1. Centers for Disease Control and Prevention. Seasonal Influenza Vaccine Dosage and Administration. http://www.cdc.gov/flu/about/qa/vaxadmin.htm accessed July 2010.

2. Salisbury D. Immunisation against infectious disease. London: Department Health 2006 PublicationsPolicyAndGuidance/DH_079917

8) Children - Second Dose of Influvac or Imuvac

Which children should receive a second dose?

For children who have not previously been vaccinated, a second dose of Influvac or Imuvac should be given after an interval of at least 4 weeks. See also question 7.

Do both doses have to be Influvac or Imuvac?

No information is available on the efficacy of using two different brands of influenza vaccine given 4-6 weeks apart to induce immunity in children. Thus it is recommended that both doses should be Influvac or Imuvac.

In situations where stocks are short and there is no alternative but to use more than one brand of influenza vaccine it is not anticipated that there would be any particular problems whether Influvac or Imuvac was given as the first or second dose.

9) Constituents

The constituents of Influvac and Imuvac for the 2010/2011 season as recommended by the World Health Organisation are as follows:

Active constituents Influvac and Imuvac:

an A/California/7/2009 (H1N1)-like virus
an A/Perth/16/2009 (H3N2)-like virus
a B/Brisbane/60/2008-like virus

Other constituents:

Influvac and Imuvac

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

Residue or traces of:

Formaldehyde
Cetyltrimethylammonium bromide
Polysorbate 80
Gentamicin
Sucrose

(Data on file)

10) 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 or Imuvac.

Allergy to gentamicin or any other constituent of the vaccine.

As 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 or Imuvac. Please also see Question 9 Constituents.

Allergy to Feathers

Influvac and Imuvac are not contraindicated in patients hypersensitive to feathers.

Febrile illness

Vaccination should be postponed in patients with febrile illness.

11) Damaged Vaccine Syringes

What should I do if 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.

12) Dose

What dose of Influvac or Imuvac should be given?

Adults and Children from 36 months: 0.5ml

Children from 6 months to 35 months: Clinical data are limited. Dosages of 0.25ml or 0.5ml have been used.

For children who have not previously been vaccinated, a second dose should be given after an interval of at least 4 weeks. (See Question 8: Children - Second dose).

No experience exists of Influvac and Imuvac being used in children under 6 months of age.

Immunisation should be by intramuscular or deep subcutaneous injection.

Please see Question 7 Children, for details on how to administer a 0.25ml dose.

13) Expiry Date

Can 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 either 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 Storage and Stability

14) Flu

Can Influvac or Imuvac cause the flu?

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 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.

15) Frequency Of Vaccination

Is vaccination with 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.

Both Influvac and Imuvac comply with the WHO recommendations.

16) 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 and Imuvac will not prevent these.

17) Latex

Does Influvac or Imuvac contain latex?

Product:

Influvac and Imuvac are contained in pre-filled syringes that have a rubber component. This is made only from synthetic rubber, and not latex. The needle guard contains no latex. It is made from polypropylene mixed with 1-2% titanium oxide dye.

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.

18) Launch

When were Influvac and Imuvac first launched?

Influvac was first launched in 1962.

Imuvac was first launched in 2006.

19) Other Vaccines Available From Abbott Healthcare Products Ltd

What other vaccines are available from Abbott Healthcare Products Ltd?

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

20) Pregnancy

Can Influvac or Imuvac be given to a pregnant woman?

Influvac and Imuvac use may be considered from the second trimester of pregnancy.

Influvac and Imuvac SPC section 4.6 states

‘that limited data from vaccinations in pregnant women do not indicate that adverse foetal and maternal outcomes were due to the vaccine. For pregnant women with medical conditions that increase their risk of complications from influenza, administration of the vaccine is recommended, irrespective of their stage of pregnancy’.

The Department of Health recommendation for influenza immunisation for the 2010/11 season provides new advice for pregnant women:

‘There is good evidence that all pregnant women are at increased risk from complications if they contract the H1N1 swine influenza virus. In light of this, pregnant women in clinical risk groups will continue to be offered the seasonal influenza vaccine as usual. But in addition, those pregnant women who are not in a clinical risk group and who have not already received a dose of H1N1 swine influenza vaccine will also be offered the trivalent seasonal influenza vaccine’.

Ref

1. Influvac and Imuvac SPCs

2. Department of Health (Interim Chief Medical Officer) The influenza immunisation programme 2010/11 accessed 28th May 2010 dh_116506.pdf

21) Shelf-Life

Can Influvac and Imuvac be used beyond its expiry date?

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

Please also see Questions 24 Storage and Stability

22) Storage And Stability

How should Influvac or Imuvac be stored?

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

Storage out of the fridge

Influvac and Imuvac should always be stored at 2-8^oC, but in the event of accidental storage at higher temperatures, please contact the Abbott Customer Care Centre on 0800 358 7468.

Storage below 2^oC

Storage below 2^oC causes the haemagglutinin component to become unstable, and loose its potency. The vaccines should not be used if they have been stored below 2^oC.

The vaccines should not be frozen.

23) 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.

Sub-Unit Vaccines are less likely to cause unwanted reactions than whole virus vaccines and split-virion vaccines.

Ref 1
Beyer WEP. Clin Drug Invest 1998; 15(1): 1-12

24)Vaccine Strains

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 and Imuvac for the 2010/11 season are:

an A/California/7/2009 (H1N1)-like virus
an A/Perth/16/2009 (H3N2)-like virus
a B/Brisbane/60/2008-like virus