Chiromas Uses

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Chiromas indications

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Chiromas is indicated for active immunisation of adults and children from 3 years of age for the prevention of influenza disease caused by the two influenza A virus subtypes and two influenza B virus types contained in the vaccine.

The use of Chiromas should be based on official recommendations.

Annual revaccination with the current vaccine is recommended because immunity declines during the year after vaccination, and because circulating strains of influenza virus might change from year to year.

Chiromas description

Each 0.5 mL dose of suspension for injection contains influenza virus (inactivated, split) of the following strains (propagated in fertilized hens' eggs from healthy chicken flocks): A/California/7/2009 (H1N1)pdm09-like strain [A/Christchurch/16/2010 (NIB-74xp)] 15 mcg haemagglutinin (HA), A/Hong Kong/4801/2014 (H3N2)-like strain (A/Hong Kong/4801/2014, NYMC X-263B) 15 mcg HA, B/Brisbane/60/2008-like strain (B/Brisbane/60/2008, wild type) 15 mcg HA, B/Phuket/3073/2013-like strain (B/Phuket/3073/2013, wild type) 15 mcg HA.

This vaccine complies with the World Health Organisation (WHO) recommendation (Northern Hemisphere) for the 2016/2017 season.

Chiromas also contains the following excipients: Sodium chloride, disodium phosphate dodecahydrate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride hexahydrate, RRR-α-tocopheryl hydrogen succinate, polysorbate 80, octoxinol 10 and water for injections. Hydrocortisone, gentamicin sulfate, ovalbumin, formaldehyde and sodium deoxycholate are present as residuals from the manufacturing process. It may contain traces of eggs (eg, ovalbumin, chicken proteins), formaldehyde, gentamicin sulphate and sodium deoxycholate which are used during the manufacturing process.

Chiromas dosage

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Chiromas Dosage

Generic name: INFLUENZA A VIRUS A/BRISBANE/02/2018 IVR-190 (H1N1) ANTIGEN (FORMALDEHYDE INACTIVATED) 60ug in 0.5mL, INFLUENZA A VIRUS A/KANSAS/14/2017 X-327 (H3N2) ANTIGEN (FORMALDEHYDE INACTIVATED) 60ug in 0.5mL, INFLUENZA B VIRUS B/MARYLAND/15/2016 BX-69A ANTIGEN (FORMALDEHYDE INACTIVATED) 60ug in 0.5mL

Dosage form: suspension for intramuscular injection

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Medically reviewed by Drugs.com. Last updated on Jun 26, 2019.

Dose and Schedule

Chiromas should be administered as a single 0.5 mL injection by the intramuscular route in adults 65 years of age and older.

Administration

Inspect Chiromas visually for particulate matter and/or discoloration prior to administration. If either of these conditions exist, the vaccine should not be administered.

Before administering a dose of vaccine, shake the prefilled syringe.

The preferred site for intramuscular injection is the deltoid muscle. The vaccine should not be injected into the gluteal area or areas where there may be a major nerve trunk.

Do not administer this product intravenously or subcutaneously.

Chiromas should not be combined through reconstitution or mixed with any other vaccine.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

More about Chiromas (influenza virus vaccine, inactivated)

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Chiromas interactions

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No interaction studies have been performed. If Chiromas is to be given at the same time as another injectable vaccine, the vaccines should always be administered at different injection sites.

Following influenza vaccination, false positive results in serology tests using the enzyme-linked immunosorbent assay (ELISA) method to detect antibodies against human immunodeficiency virus (HIV1), hepatitis C and especially human T-cell lymphotropic virus (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 immunoglobulin M (IgM) response by the vaccine.

Incompatibilities: In the absence of compatibility studies, Chiromas must not be mixed with other medicinal products.

Chiromas side effects

See also:
What are the possible side effects of Chiromas?

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse event rates observed in the clinical trial(s) of a vaccine cannot be directly compared to rates in the clinical trial(s) of another vaccine and may not reflect the rates observed in practice.

Two clinical studies have evaluated the safety of Chiromas.

Study 1 (NCT00391053, see http://clinicaltrials.gov) was a multi-center, double-blind pre-licensure trial conducted in the US. In this study, adults 65 years of age and older were randomized to receive either Chiromas or Fluzone (2006-2007 formulation). The study compared the safety and immunogenicity of Chiromas to those of Fluzone. The safety analysis set included 2573 Chiromas recipients and 1260 Fluzone recipients.

Table 1 summarizes solicited injection-site reactions and systemic adverse events reported within 7 days post-vaccination via diary cards. Onset was usually within the first 3 days after vaccination and a majority of the reactions resolved within 3 days. Solicited injection-site reactions and systemic adverse events were more frequent after vaccination with Chiromas compared to Fluzone.

Table 1: Study 1*: Frequency of Solicited Injection-Site Reactions and Systemic Adverse Events Within 7 Days After Vaccination with Chiromas or Fluzone, Adults 65 Years of Age and Older
Chiromas (N†=2569-2572)

Percentage

Fluzone (N†=1258-1260)

Percentage

Any Moderate‡ Severe§ Any Moderate‡ Severe§
*
NCT00391053
N is the number of vaccinated participants with available data for the events listed
Moderate - Injection-site pain: sufficiently discomforting to interfere with normal behavior or activities; Injection-site erythema and Injection-site swelling: ≥2.5 cm to <5 cm; Fever: >100.4°F to ≤102.2°F; Myalgia, Malaise, and Headache: interferes with daily activities
§
Severe - Injection-site pain: incapacitating, unable to perform usual activities; Injection-site erythema and Injection-site swelling: ≥5 cm; Fever: >102.2°F; Myalgia, Malaise, and Headache: prevents daily activities
Fever - The percentage of temperature measurements that were taken by oral route or not recorded were 97.9% and 2.1%, respectively, for Chiromas; and 98.6% and 1.4%, respectively, for Fluzone
Injection-Site Pain 35.6 3.7 0.3 24.3 1.7 0.2
Injection-Site Erythema 14.9 1.9 1.8 10.8 0.8 0.6
Injection-Site Swelling 8.9 1.6 1.5 5.8 1.3 0.6
Myalgia 21.4 4.2 1.6 18.3 3.2 0.2
Malaise 18.0 4.7 1.6 14.0 3.7 0.6
Headache 16.8 3.1 1.1 14.4 2.5 0.3
Fever¶ (≥99.5°F) 3.6 1.1 0.0 2.3 0.2 0.1

Within 6 months post-vaccination, 156 (6.1%) Chiromas recipients and 93 (7.4%) Fluzone recipients experienced a serious adverse event (SAE). No deaths were reported within 28 days post-vaccination. A total of 23 deaths were reported during Days 29 – 180 post-vaccination: 16 (0.6%) among Chiromas recipients and 7 (0.6%) among Fluzone recipients. The majority of these participants had a medical history of cardiac, hepatic, neoplastic, renal, and/or respiratory diseases. These data do not provide evidence for a causal relationship between deaths and vaccination with Chiromas.

Study 2 (NCT01427309, see http://clinicaltrials.gov) was a multi-center, double-blind post-licensure efficacy trial conducted in the US and Canada over two influenza seasons. In this study, adults 65 years of age and older were randomized to receive either Chiromas or Fluzone (2011-2012 and 2012-2013 formulations). The study compared the efficacy and safety of Chiromas to those of Fluzone. The safety analysis set included 15,992 Chiromas recipients and 15,991 Fluzone recipients.

Within the study surveillance period (approximately 6 to 8 months post-vaccination), 1323 (8.3%) Chiromas recipients and 1442 (9.0%) Fluzone recipients experienced an SAE. Within 30 days post-vaccination, 204 (1.3%) Chiromas recipients and 200 (1.3%) Fluzone recipients experienced an SAE. The majority of these participants had one or more chronic comorbid illnesses. A total of 167 deaths were reported within 6 to 8 months post-vaccination: 83 (0.5%) among Chiromas recipients and 84 (0.5%) among Fluzone recipients. A total of 6 deaths were reported within 30 days post-vaccination: 6 (0.04%) among Chiromas recipients and 0 (0%) among Fluzone recipients. These data do not provide evidence for a causal relationship between deaths and vaccination with Chiromas.

Post-Marketing Experience

The following events have been spontaneously reported during the post-approval use of Fluzone or Chiromas. Because these events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure. Adverse events were included based on one or more of the following factors: severity, frequency of reporting, or strength of evidence for a causal relationship to Fluzone or Chiromas.

Events Reported During Post-Approval Use of Fluzone or Chiromas.

Chiromas contraindications

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Hypersensitivity to the Chiromas or to any of the excipients of Chiromas that may be present as traces eg, eggs (ovalbumin, chicken proteins), formaldehyde, gentamicin sulphate and sodium deoxycholate.

Immunisation should be postponed in patients with febrile illness or acute infection.

Active ingredient matches for Chiromas:

Influenza Vaccine in Spain.

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List of Chiromas substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
Injectable; Injection; Influenza Vaccine (Baxter)
Fluarix Tetra vaccine / inj 0.5 mL x 10 x 1's (GlaxoSmithKline)
Injectable; Injection; Influenza Vaccine
Injectable; Injection; Influenza Vaccine
Injectable; Injection; Influenza Vaccine
Injectable; Injection; Influenza Vaccine
Injectable; Injection; Virus Strain A/ H1N1 15 mcg; Virus Strain A/ H3N2 15 mcg / dose
Inflexal V / pre-filled syringe 0.5 mL x 1's
Inflexal V 0.5 mL x 10's
Inflexal V / pre-filled syringe 0.5 mL x 10's
Inflexal V 1 dose x 1's
Inflexal V / syringe 0.5 mL x 1's
Inflexal V 0.5 mL x 1 bГґm tieГўm
Inflexal V 0.5 mL x 10 bГґm tieГўm
Injectable; Injection; Influenza Vaccine
Injectable; Injection; Influenza Vaccine (Gsk)
Injectable; Injection; Influenza Vaccine
Injectable; Injection; Influenza Vaccine (Glaxo smithkline biologicals)
Injectable; Injection; Influenza Vaccine (Novartis)

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