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Drug Details

Pandemrix suspension and emulsion for emulsion for injection

• Presentation
  Suspension and emulsion for emulsion for injection. The suspension is a colourless light opalescent liquid. The emulsion is a whitish homogeneous liquid.
• Description
  After mixing, 1 dose (0.5 ml) contains: Split influenza virus, inactivated, containing antigen* equivalent to: A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms** * propagated in eggs ** haemagglutinin AS03 adjuvant composed of squalene (10.69 milligrams), DL-?-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 milligrams) The suspension and emulsion, once mixed, form a multidose vaccine in a vial. Excipients: the vaccine contains 5 micrograms thiomersal
• Indications
  

  Prophylaxis of influenza caused by A (H1N1)v 2009 virus.

  Pandemrix should be used in accordance with Official Guidance.

• Adult Dosage
  

  Posology

  The dose recommendations take into account the safety and immunogenicity data from clinical studies in healthy subjects

  No data are available in children aged less than 6 months.

  Adults aged 18 years and older:

  One dose of 0.5 ml at an elected date.

  Immunogenicity data obtained at three weeks after one dose of Pandemrix (H1N1)v suggest that a single dose may be sufficient.

  If a second dose is administered there should be an interval of at least three weeks between the first and the second dose.

  Children and adolescents aged 10-17 years

  Dosing may be in accordance with the recommendations for adults.

  Children aged from 6 months to 9 years

  One dose of 0.25 ml at an elected date.

  There is a further immune response to a second dose of 0.25 ml administered after an interval of three weeks.

  Children aged less than 6 months

  Vaccination is not currently recommended in this age group.

  It is recommended that subjects who receive a first dose of Pandemrix should complete the vaccination course with Pandemrix.

  Method of administration

  Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or anterolateral thigh (depending on the muscle mass).

• Contra Indications
  

  History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this vaccine.

  Immunisation should be postponed in subjects with a severe febrile illness or acute infection.

• Special Precautions
  

  The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)v-like strains.

  Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than anaphylactic reaction) to the active substance, to any of the excipients, to thiomersal and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate).

  As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.

  Pandemrix should under no circumstances be administered intravascularly.

  There are no data with Pandemrix using the subcutaneous route. Therefore, healthcare providers need to assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit outweighs the risk of bleedings.

  Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient.

  A protective immune response may not be elicited in all vaccinees.

  There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1)v in children aged less than 6 months. Vaccination is not recommended in this age group.

  In children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with an interval of 3 weeks between doses there was an increase in the rates of injection site reactions and general symptoms after the second dose. In particular rates of fever (axillary temperature 38°C) increased considerably after the second dose. Therefore, monitoring of temperature and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are recommended in young children (e.g. up to approximately 6 years of age) after each dose of Pandemrix.

  There are no safety, immunogenicity or efficacy data to support interchangeability of Pandemrix with other (H1N1)v vaccines.

• Interactions
  

  Data obtained on co-administration of Pandemrix (H1N1)v with non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. The immune response to Fluarix was satisfactory.

  Co-administration was not associated with higher rates of local or systemic reactions compared to administration of Pandemrix alone.

  Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal influenza vaccines (with injections made into opposite limbs).

  Data obtained on the administration of a non-adjuvanted seasonal influenza vaccine (Fluarix, a split virion vaccine) three weeks before a dose of Pandemrix (H1N1)v in healthy adults over 60 years of age, did not suggest any significant interference in the immune response to Pandemrix (H1N1)v. Therefore the data indicate that Pandemrix may be administered three weeks after the administration of non-adjuvanted seasonal influenza vaccines.

  There are no data on co-administration of Pandemrix with other vaccines.

  If co-administration with another vaccine is considered, immunisation should be carried out on separate limbs. It should be noted that the adverse reactions may be intensified.

  The immunological response may be diminished if the patient is undergoing immunosuppressant treatment.

  Following influenza vaccination, false-positive serology test results may be obtained by the ELISA method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, HTLV-1. In such cases, the Western blot method is negative. These transitory false-positive results may be due to IgM production in response to the vaccine.

• Adverse Drug Reactions
  

  • Clinical trials

  Adverse reactions reported are listed according to the following frequency:

  Very common (1/10)

  Common (1/100 to <1/10)

  Uncommon (1/1,000 to <1/100)

  Rare (1/10,000 to <1/1,000)

  Very rare (<1/10,000)

  Clinical studies have evaluated the incidence of adverse reactions listed below in approximately 5,000 subjects 18 years old and above who received formulations containing A/Vietnam/1194/2004 (H5N1).

  Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

  Blood and lymphatic system disorders

  Common: lymphadenopathy

  Psychiatric disorders

  Uncommon: insomnia

  Nervous system disorders

  Very common: headache

  Uncommon: paraesthesia, somnolence, dizziness

  Gastrointestinal disorders

  Uncommon: gastro-intestinal symptoms (such as diarrhoea, vomiting, abdominal pain, nausea)

  Skin and subcutaneous tissue disorders

  Common: ecchymosis at the injection site, sweating increased

  Uncommon: pruritus, rash

  Musculoskeletal and connective tissue disorders

  Very common: arthralgia, myalgia

  General disorders and administration site conditions

  Very common: induration, swelling, pain and redness at the injection site, fever, fatigue

  Common: shivering, influenza like illness, injection site reactions (such as warmth, pruritus)

  Uncommon: malaise

  Additional data on reactogenicity are available from clinical studies in healthy subjects of various age groups from 6 months of age upwards who received Pandemrix (H1N1)v. The available data are as follows:

  Adults

  A clinical study evaluated the reactogenicity of Pandemrix (H1N1)v in healthy adults aged 18-60 (N=120) and above 60 years (N=120) who received either one or two doses of vaccine. The frequency of adverse reactions was similar between age groups, except for redness (more common in subjects aged >60 years) and shivering and sweating (more common in subjects aged 18-60 years). In the subjects aged 18-60 years, no increase in reactogenicity was observed after the second dose compared to the first dose. In the subjects aged >60 years, arthralgia was reported with a higher frequency after the second dose.

  In another clinical study that evaluated reactogenicity in healthy adults aged 18-60 years who received two 0.5 ml doses (21 days apart) of Pandemrix (H1N1)v, there were higher rates of most general solicited symptoms (such as fatigue, headache, arthralgia, shivering, sweating and fever) after the second dose compared to the first dose.

  Children aged 10-17 years

  In clinical studies that evaluated the reactogenicity in children 10 to 17 years of age who received either two 0.5 ml doses (adult dose) or two 0.25 ml doses (half adult dose) (21 days apart) of Pandemrix (H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:

   

  Adverse reactions	10-17 years
  	Half adult dose		Adult dose
  	Post dose 1 N=118	Post dose 2 N=117	Post dose 1 N=98	Post dose 2 N=93
  Pain	73.7%	68.4%	92.9%	96.8%
  Redness	22.9%	31.6%	21.4%	28.0%
  Swelling	30.5%	25.6%	41.8%	53.8%
  Shivering	20.3%	16.2%	14.3%	26.9%
  Sweating	7.6%	6.8%	5.1%	7.5%
  Fever>38°C	1.7%	5.1%	3.1%	9.7%
  Fever>39°C	1.7%	1.7%	0.0%	1.1%
  Arthralgia	9.3%	15.4%	26.5%	34.4%
  Myalgia	22.0%	23.1%	34.7%	47.3%
  Fatigue	28.0%	27.4%	40.8%	51.6%
  Gastrointestinal	11.0%	12.0%	6.1%	6.5%
  Headache	35.6%	35.0%	41.8%	53.8%

  Children aged 3-9 years

  In clinical studies that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table:

   

  Adverse reactions	3-5 years				6-9 years
  	Half adult dose		Adult dose		Half adult dose		Adult dose
  	Post dose 1 N=60	Post dose 2 N=56	Post dose 1 N=53	Post dose 2 N=52	Post dose 1 N=65	Post dose 2 N=63	Post dose 1 N=57	Post dose 2 N=57
  Pain	60.0%	55.4%	75.5%	84.6%	63.1%	65.1%	94.7%	96.5%
  Redness	26.7%	41.1%	28.3%	34.6%	23.1%	33.3%	24.6%	33.3%
  Swelling	21.7%	28.6%	34.0%	30.8%	23.1%	25.4%	28.1%	45.6%
  Shivering	13.3%	7.1%	3.8%	9.6%	10.8%	6.3%	7.0%	22.8%
  Sweating	10.0%	5.4%	1.9%	7.7%	6.2%	7.9%	1.8%	7.0%
  Fever>38°C	10.0%	14.3%	5.7%	32.6%	4.6%	6.4%	1.8%	12.3%
  Fever>39°C	1.7%	5.4%	0.0%	3.8%	0.0%	3.2%	0.0%	1.8%
  Diarrhoea	5.0%	5.4%	1.9%	5.8%	NA	NA	NA	NA
  Drowsiness	23.3%	17.9%	15.1%	28.8%	NA	NA	NA	NA
  Irritability	20.0%	26.8%	18.9%	26.9%	NA	NA	NA	NA
  Loss of appetite	20.0%	17.9%	15.1%	32.7%	NA	NA	NA	NA
  Arthralgia	NA	NA	NA	NA	15.4%	14.3%	14.0%	22.8%
  Myalgia	NA	NA	NA	NA	16.9%	17.5%	22.8%	28.1%
  Fatigue	NA	NA	NA	NA	27.7%	20.6%	35.1%	49.1%
  Gastrointestinal	NA	NA	NA	NA	13.8%	7.9%	15.8%	14.0%
  Headache	NA	NA	NA	NA	21.5%	20.6%	42.1%	45.6%

  NA= not available

  Children aged 6-35 months

  In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v there was an increase in injection site reactions and general symptoms after the second dose compared to the first dose particularly in rates of axillary fever (>38°C). The per-dose frequency of the following adverse reactions was as shown in the table: 

  Adverse reactions	Half adult dose		Adult dose
  	Post dose 1 N=104	Post dose 2 N=104	Post dose 1 N=53	Post dose 2 N=52
  Pain	35.6%	41.3%	58.5%	51.9%
  Redness	18.3%	32.7%	32.1%	44.2%
  Swelling	11.5%	28.8%	20.8%	32.7%
  Fever (>38°C) axillary	6.8%	41.4%	7.6%	46.1%
  Fever (>39°C) axillary	1.0%	2.9%	1.9%	17.3%
  Drowsiness	16.3%	33.7%	20.8%	42.3%
  Irritability	26.9%	43.3%	22.6%	51.9%
  Loss of appetite	17.3%	39.4%	20.8%	50.0%

  • Post-marketing surveillance

  Pandemrix (H1N1)v

  In addition to the adverse reactions reported in the clinical trials, the following have been reported during post-marketing experience with Pandemrix (H1N1)v:

  Immune system disorders

  Anaphylaxis, allergic reactions

  Nervous system disorders

  Febrile convulsions

  Skin and subcutaneous tissue disorders

  Angioedema, generalised skin reactions, urticaria

  Trivalent seasonal influenza vaccines

  From Post-marketing surveillance with trivalent seasonal influenza vaccines, the following adverse reactions have also been reported:

  Rare:

  Neuralgia, transient thrombocytopenia.

  Very rare:

  Vasculitis with transient renal involvement.

  Neurological disorders, such as encephalomyelitis, neuritis and Guillain Barré syndrome.

  This medicinal product contains thiomersal (an organomercuric compound) as a preservative and therefore, it is possible that sensitisation reactions may occur.