Nchi: Australia
Lugha: Kiingereza
Chanzo: Department of Health (Therapeutic Goods Administration)
Meningococcal polysaccharide group W135, Quantity: 10 microgram; Meningococcal polysaccharide group C, Quantity: 10 microgram; Meningococcal polysaccharide group A, Quantity: 10 microgram; Meningococcal polysaccharide Group Y, Quantity: 10 microgram
Sanofi-Aventis Australia Pty Ltd
Injection, solution
Excipient Ingredients: sodium acetate; Tetanus toxoid; sodium chloride; water for injections
Intramuscular
10 vials per pack, 1 vial per pack
(S4) Prescription Only Medicine
MenQuadfi is indicated for active immunisation for the prevention of invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y.,The use of MenQuadfi should be in accordance with official recommendations.
Visual Identification: Clear, sterile, preservative-free solution; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 48 Months; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Registered
2020-10-29
MENQUADFI ® M e n Q u a d f i ® CONSUMER MEDICINE INFORMATION (CMI) SUMMARY The full CMI on the next page has more details. If you are worried about using this medicine, speak to your doctor, nurse or pharmacist. ▼ This medicine is new or being used differently. Please report side effects. See the full CMI for further details 1. WHY AM I USING MENQUADFI? MenQuadfi is a vaccine. It is used to help protect you or your child against infections caused by a bacteria (germs) called “Neisseria meningitides” types A, C, W and Y. MenQuadfi can be given to children (12 months of age and above), adolescents, adults and the elderly. For more information, see Section 1. Why am I using MenQuadfi? in the full CMI. 2. WHAT SHOULD I KNOW BEFORE I USE MENQUADFI? Do not use if you have ever had an allergic reaction to MenQuadfi or any of the ingredients listed at the end of the CMI. TALK TO YOUR DOCTOR, NURSE OR PHARMACIST IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME PREGNANT OR ARE BREASTFEEDING. For more information, see Section 2. What should I know before I use MenQuadfi? in the full CMI. 3. WHAT IF I AM TAKING OTHER MEDICINES? Some medicines may interfere with MenQuadfi and may affect how it works. Tell your doctor nurse or pharmacist if you are taking, have recently taken or might take any other vaccines or medicines, including medicines obtained without a prescription. For more information, see Section 3. What if I am taking other medicines? in the full CMI. 4. HOW DO I USE MENQUADFI? MenQuadfi is given by your doctor, nurse or pharmacist. More instructions can be found in Section 4. How do I use MenQuadfi? in the full CMI. 5. WHAT SHOULD I KNOW AFTER USING MENQUADFI? THINGS YOU SHOULD DO • CALL YOUR DOCTOR, NURSE OR PHARMACIST STRAIGHT AWAY IF YOU: • NOTICE SIGNS OF ALLERGIC REACTION WHICH INCLUDE RASH, ITCHING, DIFFICULTY BREATHING, SHORTNESS OF BREATH OR SWELLING OF THE FACE, LIPS, THROAT OR TONGUE. DRIVING OR USING MACHINES • MENQUADFI IS NOT LIKELY T Soma hati kamili
Property of the Sanofi group - strictly confidential menq-cccdsv4-piv3-19jan23 Page 1 of 28 This medicinal product is subject to additional monitoring in Australia. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events at www.tga.gov.au/reporting-problems. AUSTRALIAN PRODUCT INFORMATION – MENQUADFI ® (MENINGOCOCCAL (GROUPS A, C, Y, W) POLYSACCHARIDE TETANUS TOXOID CONJUGATE VACCINE) SOLUTION FOR INJECTION 1 NAME OF THE MEDICINE Meningococcal (Groups A, C, Y, W) Polysaccharide Tetanus Toxoid Conjugate Vaccine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 0.5 mL dose of vaccine contains: • Meningococcal polysaccharide* Group A 10.0 microgram/dose • Meningococcal polysaccharide* Group C 10.0 microgram/dose • Meningococcal polysaccharide* Group Y 10.0 microgram/dose • Meningococcal polysaccharide* Group W-135 10.0 microgram/dose * Each of the four polysaccharides is conjugated to tetanus toxoid (approximately 55 microgram/dose) MenQuadfi is a sterile solution of _Neisseria meningitidis _ ( _N. meningitidis_ ) purified capsular polysaccharides of groups A, C, W-135, and Y, individually conjugated to tetanus toxoid protein prepared from cultures of _Clostridium tetani_ . No preservative or adjuvant is added during manufacture. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Solution for injection. MenQuadfi is a clear, colourless, sterile, preservative-free solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS MenQuadfi is indicated for active immunisation for the prevention of invasive meningococcal disease caused by _Neisseria meningitidis_ serogroups A, C, W and Y. ▼ Property of the Sanofi group - strictly confidential menq-cccdsv4-piv3-19jan23 Page 2 of 28 The use of MenQuadfi should be in accordance with official recommendations. 4.2 DOSE AND METHOD OF ADMINISTRATION MenQuadfi should be administered as a 0.5 mL single dose injection by the intramuscular route only Soma hati kamili