Ország: Új-Zéland
Nyelv: angol
Forrás: Medsafe (Medicines Safety Authority)
Neisseria meningitidis Group A polysaccharide 10ug (conjugated to tetanus toxoid); Neisseria meningitidis Group C polysaccharide 10ug (conjugated to tetanus toxoid); Neisseria meningitidis Group W135 polysaccharide 10ug (conjugated to tetanus toxoid); Neisseria meningitidis Group Y polysaccharide 10ug (conjugated to tetanus toxoid)
Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics
0.5 mL
Solution for injection
Active: Neisseria meningitidis Group A polysaccharide 10ug (conjugated to tetanus toxoid) Neisseria meningitidis Group C polysaccharide 10ug (conjugated to tetanus toxoid) Neisseria meningitidis Group W135 polysaccharide 10ug (conjugated to tetanus toxoid) Neisseria meningitidis Group Y polysaccharide 10ug (conjugated to tetanus toxoid) Excipient: Sodium acetate Sodium chloride Tetanus toxoid Water for injection
Prescription
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.
Package - Contents - Shelf Life: Vial, glass, Glass vial (0.5 ml volume) closed with rubber stopper and flip-off seal - 1 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, Glass vial (0.5 ml volume) closed with rubber stopper and flip-off seal - 10 dose units - 48 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)
2021-01-27
MenQuadfi 1 MENQUADFI® 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-135 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 to affect you Olvassa el a teljes dokumentumot
Property of the Sanofi group - strictly confidential menq-ccdsv4-5-dsv6-14mar24 Page 1 of 27 NEW ZEALAND DATA SHEET 1 PRODUCT NAME MenQuadfi® (meningococcal (groups A, C, Y, W) polysaccharide tetanus toxoid conjugate vaccine) solution for injection 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. 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. Primary Vaccination • Individuals 12 months of age and older receive a single dose. Property of the Sanofi group - strictly confidential menq-ccdsv4-5-dsv6-14mar24 Page 2 of 27 Booster Vaccination • MenQuadfi may be given as a single booster dose to adolescents and adults who have previously been primed with meningococcal vaccine at least 4 years prior (see Section 5.1 Pharmacodynamic Properties). Refer to official recommendations for further in Olvassa el a teljes dokumentumot