AVAXIM inactivated hepatitis A vaccine 160U/ 0.5mL injection needle free syringe

국가: 오스트레일리아

언어: 영어

출처: Department of Health (Therapeutic Goods Administration)

유효 성분:

Hepatitis a virus antigen, Quantity: 320 AgU/mL

제공처:

Sanofi-Aventis Australia Pty Ltd

INN (국제 이름):

Hepatitis a virus antigen

약제 형태:

Injection, suspension

구성:

Excipient Ingredients: neomycin; polysorbate 80; formaldehyde; aluminium hydroxide hydrate; phenoxyethanol; hydrochloric acid; sodium hydroxide; ethanol absolute; glucose monohydrate; ascorbic acid; sodium chloride; calcium chloride dihydrate; ferric nitrate nonahydrate; potassium chloride; magnesium sulfate heptahydrate; monobasic potassium phosphate; dibasic sodium phosphate; adenine sulfate dihydrate; adenosine triphosphate disodium; adenosine phosphate; cholesterol; deoxyribose; glutathione; guanine hydrochloride monohydrate; sodium hypoxanthine; ribose; sodium acetate; thymine; uracil; sodium xanthine; dl-alanine; arginine hydrochloride; dl-aspartic acid; cysteine hydrochloride; cystine dihydrochloride; dl-glutamic acid; glutamine; glycine; histidine hydrochloride; isoleucine; hydroxyproline; dl-leucine; lysine hydrochloride; dl-methionine; dl-phenylalanine; proline; dl-serine; dl-threonine; dl-tryptophan; tyrosine disodium; dl-valine; Biotin; ergocalciferol; calcium pantothenate; choline chloride; folic acid; inositol; menadione; nicotinic acid; nicotinamide; aminobenzoic acid; pyridoxal hydrochloride; pyridoxine hydrochloride; riboflavine; thiamine hydrochloride; retinol acetate; dl-alpha-tocopheryl phosphate disodium

관리 경로:

Intramuscular

패키지 단위:

1 x 0.5mL syringe

처방전 유형:

(S4) Prescription Only Medicine

치료 징후:

AVAXIM is indicated for: Active immunisation against hepatitis A infections in adults and children 2 years and older who are or will be at increased risk of infection: - travellers to areas of moderate or high endemicity for hepatitis A. - visitors to rural and remote indigenous communities. - child day-care and pre-school personnel. - the intellectually disabled and their carers. -health care providers. - sewerage workers. - men who have sex with men. - injecting drug users. - patients with chronic liver disease. - haemophiliacs who may receive pooled plasma concentrates.

제품 요약:

Visual Identification: Whitish cloudy suspension.; Container Type: Syringe; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

승인 상태:

Registered

승인 날짜:

2012-05-23

환자 정보 전단

AVAXIM™
_Hepatitis A Virus (inactivated, adsorbed)_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about AVAXIM It does not
contain all the available information.
It does not take the place of talking to
your doctor.
All medicines, including vaccines,
have risks and benefits. Your doctor
has weighed the risks of you having
AVAXIM against the benefits they
expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT THIS
VACCINE, ASK YOUR DOCTOR, NURSE OR
PHARMACIST.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT AVAXIM IS USED
FOR
AVAXIM is a vaccine used to help
prevent Hepatitis A infection.
Hepatitis A is an infection caused by
a virus which is usually transmitted
in unclean food or drink. It may also
be transmitted by sharing needles and
some sexual practices.
The vaccine contains inactivated
virus and is injected into the body.
The body then produces its own
protection by making disease-
fighting substances (antibodies) to
fight the virus. The vaccine cannot
cause the infection. If a vaccinated
person comes into contact with live
virus the body is usually ready to
destroy it. However, as with all
vaccines, 100% protection against
hepatitis A cannot be guaranteed.
Avaxim will not protect against
hepatitis caused by other agents or
viruses (such as hepatitis B, hepatitis
C, or hepatitis E).
As with most vaccines, AVAXIM
may not protect every person.
AVAXIM is recommended in adults
and children aged 2 years and older.
BEFORE YOU ARE GIVEN
AVAXIM
_WHEN YOU MUST NOT BE GIVEN_
_IT_
You have had a severe reaction to a
previous injection of this vaccine.
DO NOT HAVE AVAXIM IF YOU HAVE
AN ALLERGY TO:
•
AVAXIM OR ANY OF THE
INGREDIENTS LISTED AT THE END OF
THIS LEAFLET
Symptoms of an allergic reaction
may include:
•
Shortness of breath, wheezing or
difficulty breathing
•
Swelling of the face, lips, tongue
or other parts of the body
•
Skin rash, itching or hives
DO NOT GIVE AVAXIM TO CHILDREN
UNDER 2 YEARS OF AGE.
The safety and efficacy of AVAXIM
in th

제품 특성 요약

ava-ccdsv10-piv4-22apr21
1
AUSTRALIAN PRODUCT INFORMATION – AVAXIM (HEPATITIS A
VIRUS) SUSPENSION FOR INJECTION
1
NAME OF THE MEDICINE
Hepatitis A virus (inactivated, adsorbed)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
Avaxim is a sterile suspension for injection containing
formaldehyde-inactivated hepatitis A
virus (GBM strain) adsorbed onto aluminium hydroxide hydrate.
Each 0.5mL dose contains:
ACTIVE INGREDIENT:
Hepatitis A virus*
............................................................... 160
antigen units**
* GBM strain cultured on MRC-5 human diploid cells. MRC-5 is a cell
line that was derived
from human embryonic lung tissue in the 1960s.
** In the absence of an international standardised reference, the
antigen content is expressed
using an in-house reference.
The manufacture of this product includes exposure to bovine derived
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.
Contains phenylalanine and residual neomycin.
For the full list of excipients, see Section 6.1 List of excipients.
3
PHARMACEUTICAL FORM
Suspension for injection.
Avaxim is a cloudy, whitish suspension.
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Avaxim is indicated for active immunisation against hepatitis A
infection in adults and
children 2 years and over.
ava-ccdsv10-piv4-22apr21
2
Vaccination against viral hepatitis A is recommended for individuals
who are or will be at
increased risk of infection:
•
travellers to areas of moderate or high endemicity for hepatitis A
•
visitors to rural and remote indigenous communities
•
child day-care and pre-school personnel
•
the intellectually disabled and their carers
•
health care providers
•
sewerage workers
•
men who have sex with men
•
injecting drug users
•
patients with chronic liver disease
•
haemophiliacs who may receive pooled plasma concentrates
4.2
DOSE AND METHOD OF ADMINISTRATION
The dose is 0.5 mL for each inject