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INTRODUCTION ABOUT SYNFLORIX INJECTION
SYNFLORIX INJECTION contains Pneumococcal Polysaccharide Serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F) conjugated with protein D which is derived from Non-Typeable H. influenzae as a carrier protein, tetanus toxoid carrier protein, and diphtheria toxoid carrier protein.
SYNFLORIX INJECTION is used in infants and children (from 6 weeks up to 5 years) to manage the diseases caused by specific streptococcus pneumoniae serotypes, such as invasive disease (sepsis, meningitis, bacteremic pneumonia, pleural empyema, and bacteraemia), pneumonia, and acute otitis media.
Sepsis is a life-threatening condition developed due to the extreme response of the body to the infection, which is characterised by symptoms such as confusion, dizziness, and diarrhoea. Meningitis is the infection of the membranes covering the brain, which is characterised by symptoms such as fever, headache, and stiff neck.
Pleural empyema is a lung infection that causes pus formation in the membrane covering the lungs and is characterised by symptoms such as chest pain, dry cough, and fever. Bacteraemia is an infection of the blood that is characterised by symptoms such as fever, chills, and low blood pressure.
Pneumonia is an infection occurring in the air sacs of one or both lungs that is characterised by symptoms such as fever, chills, and shortness of breath. Acute otitis media is an infection occurring in the middle ear, which is characterised by symptoms such as pain in the ears, headache, and fever.
SYNFLORIX INJECTION is not recommended for use if you are allergic to pneumococcal polysaccharide serotypes. It should be used with caution in patients with chronic liver disease and chronic kidney disease. It is not recommended for use in adults, including pregnant and nursing women. This vaccine is recommended for use only in children (up to 5 years old). It is also not recommended for use in adults, including elderly patients (above 65 years). Consult your doctor before receiving it.
The common side effects associated with the use of SYNFLORIX INJECTION are appetite loss, drowsiness, reactions at the sign of injection (pain, redness, swelling, induration), fever (38°C or higher), or irritability. Contact your doctor or a nearby hospital if any of the conditions worsen or persist.
USES OF SYNFLORIX INJECTION
Prevent the diseases caused by specific streptococcus pneumoniae serotypes in infants and children such as:
- invasive disease (sepsis, meningitis, bacteraemia pneumonia, pleural empyema, and bacteraemia)
- pneumonia
- acute otitis media
HOW SYNFLORIX INJECTION WORKS
SYNFLORIX INJECTION helps to manage diseases caused by specific streptococcus pneumoniae serotypes. The pneumococcal polysaccharide vaccine stimulates the production of certain neutralising antibodies that bind to the virus and manage it from infecting cells, thus protecting from the infection that may be caused by specific streptococcus pneumoniae serotypes in the future.
DIRECTIONS FOR USE
SYNFLORIX INJECTION will be given to you only by a doctor or a nurse and will be injected into a muscle as an intramuscular injection in the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in children. Your doctor will determine the correct dose and duration for you depending on your age, body weight, and disease condition.
SIDE EFFECTS OF SYNFLORIX INJECTION
COMMON
- appetite loss
- drowsiness
- reactions at the sign of injection such as pain, redness, swelling, induration
- fever (38°C or higher)
- irritability
UNCOMMON
- diarrhoea
- vomiting
- nausea
- reactions at the sign of injection such as severe bruise, bleeding, nodule formation, itching
- headache
- fever (39°C or higher)
- diffuse swelling of the limb where the injection is given (involving the adjacent joint sometimes)
- unusual crying
- rashes
- temporary cessation of breathing
RARE
- convulsions with or without fever
- signs of allergic reactions such as allergic dermatitis (swelling of the skin), atopic dermatitis (itchy inflamed skin), eczema (peculiar red rashes)
- itchy welts
Stop receiving SYNFLORIX INJECTION and contact your doctor if you experience any of the following side effects:
- signs of life-threatening allergic reaction such as swelling of face, shortness of breath, and severe rashes
HOW TO MANAGE SIDE EFFECTS
Diarrhea
Drink lots of fluids, such as water to keep yourself hydrated. Try to avoid taking any medicine on your own to manage diarrhoea and consult your doctor if the symptom gets worse.
Dizziness Or Drowsiness
Lie down until the drowsiness passes and get up slowly. Get a lot of rest. Walk slowly and carefully. Take plenty of fluids. Avoid drinking coffee, alcohol, or smoking. Consult your doctor if the condition gets worsened.
Nausea And Vomiting
Stick to simple meals. Avoid eating rich or spicy food. Get a lot of rest. Avoid drinking coffee, alcohol, or smoking. Consult your doctor if the symptom gets worse.
WARNING & PRECAUTIONS
PREGNANCY
ContraindicatedSYNFLORIX INJECTION is not recommended to be used in adults including pregnant women. Consult your doctor before receiving the medicine.
BREASTFEEDING
ContraindicatedSYNFLORIX INJECTION is not recommended to be used in adults including breastfeeding women. Consult your doctor before receiving the medicine.
KIDNEY
Use with CautionSYNFLORIX INJECTION should be used with caution in patients with chronic kidney disease. Consult your doctor before receiving it.
LIVER
Use with CautionSYNFLORIX INJECTION should be used with caution in patients with chronic liver disease. Consult your doctor before receiving it.
ALLERGY
ContraindicatedSYNFLORIX INJECTION is not recommended for use if you are allergic to pneumococcal polysaccharide serotypes or any other ingredients of this medicine.
USE IN PEDIATRICS
ContraindicatedSYNFLORIX INJECTION is recommended for use only in children (up to 5 years). Consult your doctor before receiving it.
USE IN GERIATRICS
ContraindicatedSYNFLORIX INJECTION is not recommended for use in adults including elderly patients (above 65 years). Consult your doctor before receiving it.
OTHERS
Before receiving SYNFLORIX INJECTION, inform your doctor if you:
- have a severe illness with high fever
- have thrombocytopenia (low blood platelet count) or any coagulation disorder
- have impaired immune responsiveness due to any genetic defect, Human Immunodeficiency Virus (HIV) infection, or other causes
- have sickle cell disease (a disease that affects the shape of red blood cells and impairs their function)
- have a history of fainting with other injections
INTERACTIONS
A. Drug-Drug Interactions:
Before receiving SYNFLORIX INJECTION, inform your doctor, if you are taking/ receiving any of the following medicines or vaccines:
- DTPa-HBV-IPV/Hib (vaccine used to manage diphtheria, tetanus, whooping cough, polio, Haemophilus influenzae type B, hepatitis B)
- diphtheria-tetanus-acellular pertussis vaccine (vaccine used to manage diphtheria, tetanus, and whooping cough)
- hepatitis B vaccine (vaccine used to manage hepatitis)
- inactivated polio vaccine (vaccine used to manage polio)
- haemophilus influenza type b vaccine (vaccine used to manage haemophilus influenza type B)
- measles-mumps-rubella vaccine (vaccine used to manage measles, mumps, and rubella)
- varicella vaccine (vaccine used to manage chicken pox)
- meningococcal serogroup C conjugate vaccine conjugated with CRM197 and TT (vaccine used to manage meningococcal infections)
- meningococcal serogroups A. C, W-135 and Y tetanus toxoid conjugate vaccine (vaccine used to manage meningococcal infections)
- rotavirus vaccine (vaccine used to manage infections caused by rotavirus)
Overdosage:
SYNFLORIX INJECTION will be given to you only by a doctor or nurse in a hospital, so it is unlikely to receive an overdose. No cases of overdosage have been reported yet. However, if you experience any unusual symptoms, consult your doctor immediately or visit the nearby hospital.
SYNOPSIS
| Drug | : | Pneumococcal Polysaccharide Vaccine (PPV) |
| Pharmacological Category | : | Vaccine |
| Therapeutic Indication | : | Prevent the diseases caused by specific Streptococcus Pneumoniae Serotypes |
| Dosage Forms | : | Injection |
MORE INFORMATION
- Keep the medicine out of reach of children
- Store SYNFLORIX INJECTION at room temperature
FAQs ABOUT SYNFLORIX INJECTION
Q: What is SYNFLORIX INJECTION used for?
A: SYNFLORIX INJECTION is used in infants and children (from 6 weeks up to 5 years) to manage the diseases caused by specific streptococcus pneumoniae serotypes, such as invasive disease (sepsis, meningitis, bacteraemia pneumonia, pleural empyema, and bacteraemia), pneumonia, and acute otitis media. Consult your doctor before receiving SYNFLORIX INJECTION.
Q: What happens if you take more SYNFLORIX INJECTION than your required dose?
A: SYNFLORIX INJECTION will be given to you only by a doctor or nurse in a hospital, so it is unlikely that you will receive an overdose. No cases of overdosage have been reported yet. However, if you experience any unusual symptoms, consult your doctor immediately or visit the nearby hospital.
Q: What side effects are seen with SYNFLORIX INJECTION?
A: The common side effects associated with the use of SYNFLORIX INJECTION are appetite loss, drowsiness, reactions at the sign of injection (pain, redness, swelling, induration), fever (38°C or higher), or irritability. Contact your doctor or a nearby hospital if any of the conditions worsen or persist.
Q: Who should avoid receiving SYNFLORIX INJECTION?
A: SYNFLORIX INJECTION is not recommended for use if you are allergic to pneumococcal polysaccharide serotypes. It is not recommended for use in adults, including pregnant and nursing women. It is also not recommended for use in adults, including elderly patients (above 65 years). Consult your doctor before receiving SYNFLORIX INJECTION.
Q: Is SYNFLORIX INJECTION safe to use in children and elderly patients?
A: SYNFLORIX INJECTION is recommended for use only in children (up to 5 years old). It is also not recommended for use in adults, including elderly patients (above 65 years). Consult your doctor before receiving SYNFLORIX INJECTION.
Q: How does SYNFLORIX INJECTION work?
A: SYNFLORIX INJECTION helps to manage diseases caused by specific streptococcus pneumoniae serotypes. The pneumococcal polysaccharide vaccine stimulates the production of certain neutralising antibodies that bind to the virus and manage it from infecting cells, thus protecting from the infection that may be caused by specific streptococcus pneumoniae serotypes in the future.
Q: What is the method of receiving SYNFLORIX INJECTION?
A: SYNFLORIX INJECTION will be given to you only by a doctor or a nurse and will be injected into a muscle as an intramuscular injection in the anterolateral aspect of the thigh in infants or the deltoid muscle of the upper arm in children. Your doctor will determine the correct dose and duration for you depending on your age, body weight, and disease condition.
Q: Is it safe to take an antipyretic before receiving SYNFLORIX INJECTION?
A: Taking antipyretics (medicines used to manage fever) as a management measure before or immediately after vaccine administration can help reduce the incidence and intensity of post-vaccination fever. Consult your doctor before receiving SYNFLORIX INJECTION.
Q: Is SYNFLORIX INJECTION safe to use in liver patients?
A: SYNFLORIX INJECTION should be used with caution in patients with chronic liver disease (liver diseases that have been prevailing in the body for a long time and are worsening with time). Consult your doctor before receiving SYNFLORIX INJECTION.
Q: Is SYNFLORIX INJECTION safe to use in kidney patients?
A: SYNFLORIX INJECTION should be used with caution in patients with chronic kidney disease (kidney diseases that have been prevailing in the body for a long time and are worsening with time). Consult your doctor before receiving SYNFLORIX INJECTION.
REFERENCES
1. J. Larry Jameson, A. S. Fauci, D. L. Kasper, S. L. Hauser, D. L. Longo, J. Loscalzo. Pneumococcal Infections. Harrison’s Principles of Internal Medicine. Twentieth Edition. 2018. Page – 1063.
2. Stefaan J. Vandecasteele, Sara Ombelet, Sophie Blumental, Willy E. Peetermans. The ABC of pneumococcal infections and vaccination in patients with chronic kidney disease. NIH National Library of Medicine. National Centre for Biotechnology Information. PMC PubMed Central. May 2015. [Assessed 18th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4440476/
3. Suvi Harmala, Constantinos Parisinos, Laura Shallcross, Alastair O’Brien, Andrew Hayward. Effectiveness of pneumococcal and influenza vaccines to prevent serious health complications in adults with chronic liver disease: a protocol for a systematic review. NIH National Library of Medicine. National Centre for Biotechnology Information. PMC PubMed Central. March 2018. [Assessed 18th August 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5857657/
4. GlaxoSmithKline Inc. SYNFLORIX. [Revised in November 2019] [Assessed 18th August 2022] https://ca.gsk.com/media/6260/synflorix.pdf
USEFUL DIAGNOSTIC TESTS
- Blood Test
- Urine Test
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