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(Inclusive of all taxes) *This product cannot be returned for a refund or exchange. * Mkt: Glaxosmithkline Pharmaceuticals Ltd * Country of Origin: India * Delivery charges if applicable will be applied at checkout



INTRODUCTION

SYNFLORIX contains Pneumococcal Polysaccharide conjugate Vaccine (PPV) 10 which belongs to the group of medicine called killed vaccine. It helps to give protection against pneumonia (infections of the lungs), meningitis (infection of the covering of the brain and spinal cord), sepsis and bacteremia (infection of the blood cells), acute otitis media (ear infection) and other pneumococcal infections caused by 10 conjugate types of the bacteria Streptococcus pneumoniae in children aged between 6 weeks-5 years.

Vaccines are generally given to boost the immune system and protect from harmful infections. Vaccination against Pneumococcal infections using SYNFLORIX offers immune protection to your child against the 10 pneumococcal types included in the vaccine. PPV-10 enhances your body’s natural defense system by increasing the production of antibodies that help to protect against pneumococcal infections.

SYNFLORIX is not meant for self-administration. It should be given to your child only by a healthcare professional in the muscles of arms or legs. The most common side effects of this vaccine are injection site reactions (such as pain, redness and swelling) and fever. Contact your doctor if they bother your child. Before taking this medicine, inform your doctor if your child has a poor immune system or seizure disorders.

Prophylactic anti-pyretic therapy is recommended for children having seizure disorders and in those who receive whole cell pertussis vaccine concomitantly. This medicine should be used with extreme caution in prematurely born infants (born before 28 weeks) because they may not tolerate any other medical interventions. Consult your doctor before vaccination.

USES OF SYNFLORIX

  • Protects against pneumonia, meningitis, bacteremia, ear infection and other pneumococcal infections in children (aged between 6 weeks-5 years)

HOW SYNFLORIX WORKS

Pneumococcal polysaccharide conjugate vaccine (PPV)-10 is a killed vaccine. It promotes active immunization against the 10-conjugate polysaccharides types of Pneumococci in the body. It acts by enhancing the body’s natural defense system by stimulating the production of antibodies that are required to protect against pneumococcal infections.

DIRECTIONS FOR USE

SYNFLORIX will be given to you only by a doctor or nurse into the muscles (intramuscular injection) of the thighs or upper arm. Your doctor will decide the number of doses, dose intervals and frequency depending upon your child’s age, body weight and health condition.

SIDE EFFECTS OF SYNFLORIX

SERIOUS

  • allergic reactions (such as skin rash, hives, swelling of the face, lips, tongue and/or throat and neck leading to difficulty in breathing)

COMMON

  • injection site reactions (such as pain, redness, swelling or hardness)
  • fever
  • feeling sleepy or irritable
  • loss of appetite

RARE

  • fits
  • collapse
  • periods of unconsciousness
  • paleness or bluish skin discoloration

HOW TO MANAGE SIDE EFFECTS

Injection site pain and soreness:

Try to rest and relax. Do not frequently move the injected area. Keep an ice pack on the injected site as it may calm the redness, swelling and soreness. If the symptom still persists, consult your doctor.

Loss of appetite:

Eat when you are hungry. Try to eat smaller meals. Snack only when you're hungry. Always try to have a nutritious snack that is high in calories and protein, such as dried fruit and nuts.

WARNING & PRECAUTIONS

PREGNANCY

SYNFLORIX is intended for use only in children and therefore not recommended for use in pregnant women.

BREASTFEEDING

SYNFLORIX is intended for use only in children and therefore not recommended for use in breastfeeding women.

ALLERGY

Do not use this medicine if your child is allergic to PPV-10.

LUNGS

SYNFLORIX should be taken with caution in children with breathing problems or respiratory immaturity. Consult your doctor for advice.

OTHERS

Before taking this vaccine, inform your doctor if your child:

  • have serious infection with fever
  • has any bleeding problems
  • has a poor immune system (due to immunosuppressive therapy, genetic defect or HIV infection)
  • have seizure disorders
  • have problems in spleen
  • have sickle cell disease

INTERACTIONS

Tell your doctor about all the medicines you use, including non-prescription and prescription medicines and herbal supplements.

SYNOPSIS

Drug :   Pneumococcal Polysaccharide Vaccine (PPV) 10
Pharmacological Category :   Killed vaccine
Therapeutic Indication :   Pneumococcal infections
Dosage Forms :   Injection

MORE INFORMATION

Store in a refrigerator (between 2-8°C) and keep out of reach of children. Do not freeze.

FAQs ABOUT SYNFLORIX

Will SYNFLORIX cause fever after vaccination?

Although, this medicine is used to protect from various bacterial infections, it may cause a mild fever and discomfort in few infants, due to the presence of inactivated conjugate polysaccharide types of Pneumococci. This is usually mild and disappears with time. However, if your child experiences any severe fever or other unusual symptom contact your doctor.

Can SYNFLORIX be received along with influenza vaccine?

Yes. It can be given at the same time as influenza vaccine, but different syringes and different injection sites should be used. Most children respond well to both the vaccines and so they can be used to offer protection against both the infections simultaneously.

My child has fever. Can SYNFLORIX be taken during fever?

No. It should not be taken if your child is in fever or having other infection. You must wait until your child’s condition becomes normal before taking this medicine.

Can SYNFLORIX be used in adults?

No. This vaccine is intended for use only in children (6 weeks-5 years).

REFERENCES

1. Aditi Sinha, Surjit Singh. Immunization and Immunodeficiency. Ghai Essentials Pediatrics. 8th Edition. CBS Publishers and Distributors Pvt Ltd. Page – 199-200.

2. GlaxoSmithKline.  Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Pneumococcal Vaccine (Synflorix™) When Administered to Children Who Are at an Increased Risk of Pneumococcal Infection. NIH U.S. National Library of Medicine ClinicalTrials.gov. [Revised on July 2019] [Accessed 9th January 2021] https://clinicaltrials.gov/ct2/show/NCT01746108

3. Anita H. J. van den Biggelaar, William S. Pomat, Geraldine Masiria, Sandra Wana, Birunu Nivio, Jacinta Francis, Rebecca Ford, Megan Passey, Lea-Ann Kirkham, Peter Jacoby, Deborah Lehmann, Peter Richmond and 10v13v PCV Trial Team. Immunogenicity and Immune Memory after a Pneumococcal Polysaccharide Vaccine Booster in a High-Risk Population Primed with 10-Valent or 13-Valent Pneumococcal Conjugate Vaccine: A Randomized Controlled Trial in Papua New Guinean Children. NCBI; PMC US National Library of Medicine, National Institute of Health. February 2019. [Accessed 9th January 2021]. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6466212/

4. GlaxoSmithKline Biologicals s.a. Health Products Regulatory Authority (HPRA). [Accessed 9th January 2021] http://www.hpra.ie/docs/default-source/vaccine-pils/synflorix_pil_08_2020.pdf?sfvrsn=2

5. GlaxoSmithKline. SYNFLORIX® Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed. [Revised on September 2016] [Accessed 9th January 2021] https://au.gsk.com/media/367258/synflorix_cmi_au_008_approved.pdf

6. Synflorix Pneumococcal polysaccharide conjugate vaccine (adsorbed). European Medical Agency (EMA). [Revised on November 2017] [Accessed 9th January 2021] https://www.ema.europa.eu/en/documents/overview/synflorix-epar-summary-public_en.pdf

PRODUCT DETAILS

    Net Qty
    1
    Ingredient
    PNEUMOCOCCAL POLYSACCHARIDE VACCINE(PPV) 1MCG
    Hsn Code
    30022019
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