Quadracel

Država: Nova Zelandija

Jezik: angleščina

Source: Medsafe (Medicines Safety Authority)

Aktivna sestavina:

Diphtheria toxoid, adsorbed 15 Lf U; Pertactin 3ug; Pertussis filamentous haemagglutinin 20ug; Pertussis fimbriae 2+3 5ug; Pertussis toxoid, adsorbed 20ug; Polio virus type 1 40 DAgU (Mahoney); Polio virus type 2 8 DAgU (M E F 1); Polio virus type 3 32 DAgU (Saukett); Tetanus toxoid, adsorbed 5 Lf U

Dostopno od:

Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics

INN (mednarodno ime):

Diphtheria toxoid, adsorbed 15 Lf U

Farmacevtska oblika:

Suspension for injection

Sestava:

Active: Diphtheria toxoid, adsorbed 15 Lf U Pertactin 3ug Pertussis filamentous haemagglutinin 20ug Pertussis fimbriae 2+3 5ug Pertussis toxoid, adsorbed 20ug Polio virus type 1 40 DAgU (Mahoney) Polio virus type 2 8 DAgU (M E F 1) Polio virus type 3 32 DAgU (Saukett) Tetanus toxoid, adsorbed 5 Lf U Excipient: Aluminium phosphate Formaldehyde Glutaral Neomycin Phenoxyethanol Polymyxin B Polysorbate 80 Water for injection

Enote v paketu:

Vial, glass, 1x0.5ml, 0.5 mL

Razred:

Prescription

Tip zastaranja:

Prescription

Izdeluje:

Sanofi Pasteur Limited

Terapevtske indikacije:

QUADRACEL is indicated for primary immunisation of children from the age of 2 months to 12 months against diphtheria, tetanus, pertussis and poliomyelitis. QUADRACEL is also indicated for the fourth dose for children from 15 months to six years of age who have been immunised previously with three doses of diphtheria, tetanus, pertussis and polio vaccines.

Povzetek izdelek:

Package - Contents - Shelf Life: Syringe, glass, 10x0.5ml - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 1x0.5ml - 1 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 5x0.5ml - 5 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, glass, 10x0.5ml - 10 dose units - 36 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze)

Datum dovoljenje:

2000-07-05

Navodilo za uporabo

QUADRACEL®
1
QUADRACEL
®
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 or pharmacist.
1.
WHY DOES MY CHILD NEED QUADRACEL?
Quadracel is a vaccine. It is used to help prevent whooping cough
(pertussis), tetanus, diphtheria and polio, in infants and
children.
For more information, see Section 1. Why does my child need Quadracel?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE MY CHILD IS GIVEN QUADRACEL?
Do not use if your child ever had an allergic reaction to Quadracel or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOUR CHILD HAS OR HAD ANY OTHER MEDICAL
CONDITIONS OR IS TAKING OTHER MEDICINES.
For more information, see Section 2. What should I know before my
child is given Quadracel? in the full CMI.
3.
WHAT IF MY CHILD IS TAKING OTHER MEDICINES?
Some medicines may interfere with Quadracel and affect how it works.
A list of these medicines is in Section 3. What if my child is taking
other medicines? in the full CMI.
4.
HOW QUADRACEL IS GIVEN?
Quadracel is given by a doctor or nurse as an injection into muscle.
More instructions can be found in Section 4. How is Quadracel given?
in the full CMI.
5.
WHAT SHOULD I KNOW AFTER MY CHILD IS GIVEN QUADRACEL?
THINGS YOU
SHOULD DO
•
Keep an updated record of vaccinations.
•
Keep follow-up appointments with your doctor or clinic.
LOOKING AFTER
YOUR MEDICINE
Quadracel is usually stored in the doctor’s surgery or clinic, or at
the pharmacy. However, if you need to
store Quadracel:
•
keep in the fridge between 2-8°C. Do not freeze.
For more information, see Section 5. What should I know after my child
is given Quadracel? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Common side effects include local reaction around the injection site
(redness, swelling, and tenderness), vomiting, fever, crying,
decreased eating, diarrhoea, fussiness, decreased activity,
sleepiness, listlessness. Serious side effects include abscess at the

Lastnosti izdelka

Property of the Sanofi group - strictly confidential
quad-ccdsv7-dsv5-01dec22
Page 1
NEW ZEALAND DATA SHEET
1
QUADRACEL
® (0.5 ML SUSPENSION FOR INJECTION)
Pertussis Vaccine-Acellular and Diphtheria and Tetanus Toxoids
(Adsorbed) Combined with
Inactivated Poliovirus Types 1, 2 and 3 (Vero Cell).
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial of Quadracel contains:
Diphtheria toxoid
≥ 30 IU (15 Lf)
Tetanus toxoid
≥ 40 IU (5 Lf)
Pertussis toxoid (PT)
20 microgram
Pertussis filamentous haemagglutinin (FHA)
20 microgram
Pertactin (PRN)
3 microgram
Pertussis fimbriae 2 + 3 (FIM)
5 microgram
Poliovirus inactivated type 1, Vero (Mahoney)
40 D-antigen Units
Poliovirus inactivated type 2, Vero (MEF-1)
8 D-antigen Units
Poliovirus inactivated type 3, Vero (Saukett)
32 D-antigen Units
Absorbed on 1.5 mg Aluminium phosphate (0.33 mg aluminium)
This product does not contain thiomersal.
The manufacture of this product includes exposure to bovine materials.
No evidence exists that
any case of vCJD (considered to be the human form of bovine spongiform
encephalopathy) has
resulted from the administration of any vaccine product.
Diphtheria toxoid is a cell-free preparation of diphtheria toxin
detoxified with formaldehyde.
Tetanus toxoid is prepared by detoxification of tetanus toxin with
formaldehyde.
Each of the three strains of poliovirus is individually grown in Vero
cells cultivated on
microcarriers. The single virus harvest is concentrated and purified,
then inactivated with
formaldehyde to produce the type 1, 2 or 3 monovalent. Monovalents of
each type are then
combined in appropriate quantities to produce a trivalent concentrate.
The 5 component pertussis antigens, pertussis toxoid (PT), pertussis
filamentous haemagglutinin
(FHA), pertactin (PRN) and pertussis fimbriae 2 + 3 (FIM), contained
in Quadracel are the same
as those in TRIPACEL or PEDIACEL. TRIPACEL consists of an acellular
pertussis vaccine
combined with diphtheria and tetanus toxoids (DTPa), and has lesser
amounts of PT and FHA,
while Quadracel has pe