Chiromas indications
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
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
See also:
- Chiromas Quadrivalent suspension, for intramuscular injection
- Fluzone Quadrivalent suspension for intramuscular injection
Medically reviewed by Drugs.com. Last updated on Jun 26, 2019.
- For intramuscular use only
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.
Medical Disclaimer
More about Chiromas (influenza virus vaccine, inactivated)
- Side Effects
- During Pregnancy
- Drug Interactions
- 5 Reviews
- Drug class: viral vaccines
- FDA Alerts (1)
Consumer resources
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Other Formulations
- Fluzone injection
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- Influenza Prophylaxis
Chiromas interactions
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.
Chiromas (N†=2569-2572) Percentage | Fluzone (N†=1258-1260) Percentage | |||||
---|---|---|---|---|---|---|
Any | Moderate‡ | Severe§ | Any | Moderate‡ | Severe§ | |
| ||||||
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.
- Blood and Lymphatic System Disorders: Thrombocytopenia, lymphadenopathy
- Immune System Disorders: Anaphylaxis, other allergic/hypersensitivity reactions (including urticaria, angioedema)
- Eye Disorders: Ocular hyperemia
- Nervous System Disorders: Guillain-Barré syndrome (GBS), convulsions, febrile convulsions, myelitis (including encephalomyelitis and transverse myelitis), facial palsy (Bell's palsy), optic neuritis/neuropathy, brachial neuritis, syncope (shortly after vaccination), dizziness, paresthesia
- Vascular Disorders: Vasculitis, vasodilatation/flushing
- Respiratory, Thoracic and Mediastinal Disorders: Dyspnea, pharyngitis, rhinitis, cough, wheezing, throat tightness
- Skin and Subcutaneous Tissue Disorders: Stevens-Johnson syndrome
- General Disorders and Administration Site Conditions: Pruritus, asthenia/fatigue, pain in extremities, chest pain, chills
- Gastrointestinal Disorders: Vomiting, nausea, diarrhea
- Musculoskeletal and Connective Tissue Disorders: Arthralgia
Chiromas contraindications
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.
An influenza vaccine in Spain.
List of Chiromas substitutes (brand and generic names) | Sort by popularity |
Unit description / dosage (Manufacturer) | Price, USD |
Celvapan (Romania) | |
Injectable; Injection; Influenza Vaccine (Baxter) | |
Daronrix (Czech Republic) | |
Evagrip (Greece) | |
Flu-Imune (United States) | |
Fluarix Quadrivalent | |
Fluarix Tetra (Hongkong) | |
Fluarix Tetra vaccine / inj 0.5 mL x 10 x 1's (GlaxoSmithKline) | |
Flucelvax Quadrivalent 2016-2017 Formula | |
Fluvaccin (Sweden) | |
Fluzone High-Dose | |
Fluzone Highdose | |
Fluzone Quadrivalent 2016-2017 Formula | |
Gripavac (Spain) | |
Grippe-Impfstoff | |
Injectable; Injection; Influenza Vaccine | |
Grippeimpfstoff | |
Injectable; Injection; Influenza Vaccine | |
Imovax Gripe (Argentina) | |
Inflexal S | |
Injectable; Injection; Influenza Vaccine | |
Inflexal V (Hongkong) | |
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 | |
Influenza Vaccine (Philippines) | |
Influenzinum C | |
Injectable; Injection; Influenza Vaccine | |
Influpozzi (Italy) | |
Influsplit SSW (Germany) | |
Injectable; Injection; Influenza Vaccine (Gsk) | |
Influvac Plus | |
Injectable; Injection; Influenza Vaccine | |
Influvirus (Italy) | |
Isiflu (Venezuela) | |
Isiflu V (Italy) | |
Isiflu Zonale (Argentina) | |
Isigrip Zonale (Italy) | |
Miniflu (Italy) | |
Nasalflu (Switzerland) | |
Nilgrip (Argentina) | |
Pandemrix (Romania) | |
Injectable; Injection; Influenza Vaccine (Glaxo smithkline biologicals) | |
Prodigrip (Spain) | |
Sandovac (Austria) | |
Injectable; Injection; Influenza Vaccine (Novartis) | |
Vacciflu (Austria, Netherlands) | |
See 55 substitutes for Chiromas |
Reviews
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Information checked by Dr. Sachin Kumar, MD Pharmacology