VAXELIS DTPa5-HB-IPV-Hib vaccine suspension for injection in 0.5 mL vial

Land: Australien

Språk: engelska

Källa: Department of Health (Therapeutic Goods Administration)

Aktiva substanser:

Tetanus toxoid, Quantity: 40 IU; Diphtheria toxoid, Quantity: 20 IU; Poliovirus, Quantity: 80 DAgU; Pertussis fimbriae 2 + 3, Quantity: 5 microgram; Haemophilus influenza type B polyribose ribitol phosphate, Quantity: 3 microgram; Pertussis toxoid, Quantity: 20 microgram; Pertussis filamentous haemagglutinin, Quantity: 20 microgram; hepatitis B surface antigen, Quantity: 10 microgram; Pertactin, Quantity: 3 microgram

Tillgänglig från:

Maxx Pharma Pty Ltd

Läkemedelsform:

Injection, suspension

Sammansättning:

Excipient Ingredients: aluminium; water for injections; dibasic sodium phosphate; monobasic sodium phosphate

Administreringssätt:

Intramuscular

Enheter i paketet:

10

Receptbelagda typ:

(S4) Prescription Only Medicine

Terapeutiska indikationer:

VAXELIS (DTPa5-HB-IPV-Hib) is indicated for primary and booster vaccination in infants and toddlers from the age of 6 weeks, against diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and invasive diseases caused by Haemophilus influenzae type b (Hib).,The use of Vaxelis should be in accordance with official recommendations.

Produktsammanfattning:

Visual Identification: cloudy, white to off-white suspension; 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

Bemyndigande status:

Registered

Tillstånd datum:

2022-03-23

Bipacksedel

Vaxelis
™
1
VAXELIS™
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the later pages has more details. If you are worried
about having your child receive this vaccine, speak to your
child’s doctor or nurse.
This medicine is new or being used differently. Please report side
effects. See the full CMI for further details.
1.
WHY IS MY CHILD RECEIVING VAXELIS?
Vaxelis is a vaccine given to help protect your child against
diphtheria, tetanus (lockjaw), pertussis (whooping cough), hepatitis
B, polio and Hib (_Haemophilus influenzae_ type b).
For more information, see Section 1. Why is my child receiving
Vaxelis? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE MY CHILD RECEIVES VAXELIS?
Do not use if your child has had shortness of breath or swelling of
the face after a previous dose of Vaxelis, has ever had an
allergic reaction to Vaxelis or any of the ingredients listed at the
end of the CMI, has suffered from a severe reaction affecting
the brain (encephalopathy) within 7 days of a prior dose of a
pertussis vaccine or has an uncontrolled condition or severe
illness affecting the brain and nervous system (uncontrolled
neurologic disorder) or uncontrolled epilepsy.
TALK TO YOUR DOCTOR IF YOUR CHILD HAS OR HAS HAD ANY OTHER MEDICAL
CONDITIONS OR IS TAKING ANY OTHER MEDICINES.
For more information, see Section 2. What should I know before my
child receives Vaxelis? in the full CMI.
3.
WHAT IF MY CHILD IS TAKING OTHER MEDICINES?
Some medicines may interfere with Vaxelis 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 WILL MY CHILD RECEIVE VAXELIS?
Vaxelis is given by your child’s doctor or nurse as an injection
into the muscle.
More instructions can be found in Section 4. How will my child receive
Vaxelis? in the full CMI.
5.
WHAT SHOULD I DO AFTER MY CHILD RECEIVES VAXELIS?
THINGS YOU
SHOULD DO
Tell your child’s doctor or nurse immediately after your child
receives the vaccine and if your child has
•
difficulty i

Produktens egenskaper

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