DUKORAL oral inactivated cholera vaccine liquid vial and buffer powder sachet

Nchi: Australia

Lugha: Kiingereza

Chanzo: Department of Health (Therapeutic Goods Administration)

Viambatanisho vya kazi:

Vibrio cholerae, Quantity: 31.25 billion organisms; Vibrio cholerae, Quantity: 1 mg

Inapatikana kutoka:

Seqirus Pty Ltd

Dawa fomu:

Oral Liquid, suspension

Tungo:

Excipient Ingredients: sodium chloride; dibasic sodium phosphate dihydrate; water for injections; monobasic sodium phosphate dihydrate

Njia ya uendeshaji:

Oral

Vitengo katika mfuko:

Single dose carton with 1 vial vaccine and 1 sachet granules, Two dose carton with 2 vaccine vials and 2 sachet granules

Dawa ya aina:

(S4) Prescription Only Medicine

Matibabu dalili:

Cholera caused by serogroup 01 Vibrio cholerae: Active immunisation of adults and children from two years of age, who will be visiting areas epidemic or endemic for cholera and who are at high risk of infection.

Bidhaa muhtasari:

Visual Identification: Carton containing one vial with 3mL whitish liquid and one sachet containing buffer powder.; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert

Idhini hali ya:

Registered

Idhini ya tarehe:

2003-09-09

Taarifa za kipeperushi

Dukoral®
1
DUKORAL®
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI below has more details. If you are worried about using
this medicine, speak to your doctor or pharmacist.
1.
WHY AM I TAKING DUKORAL®?
Dukoral® contains the active ingredients _Vibrio cholerae_ (cholera)
bacteria (inactivated) and cholera toxin B subunit
(recombinant). Dukoral® is a vaccine used to help prevent cholera.
For more information, see Section
1. Why am I taking Dukoral®? in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE DUKORAL®?
Do not use if you or your child have ever had an allergic reaction to
Dukoral® or formaldehyde or any of the ingredients listed
at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU OR YOUR CHILD 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 take
Dukoral®? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Dukoral® and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE DUKORAL®?
•
Follow all directions given to you by your doctor or pharmacist
carefully.
•
Avoid food and drink for 1 hour before and 1 hour after drinking the
vaccine. Food and drink taken during this time may
inactivate the vaccine.
More instructions can be found in Section 4. How do I take Dukoral®?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING DUKORAL®?
THINGS YOU OR
YOUR CHILD
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are using
Dukoral®.
•
Keep an updated record of your vaccinations.
•
Keep follow-up appointments with your doctor or clinic.
THINGS YOU OR
YOUR CHILD
SHOULD NOT DO
•
Do not have food or drink for 1 hour before and 1 hour after taking
Dukoral®.
•
Do not have an oral typhoid vaccine for 8 hours after taking
Dukoral®.
•
Do not have any other oral medicines for at least 1 hour before and 1
hour

Tabia za bidhaa

Dukoral PI
Page 1 of 15
AUSTRALIAN PRODUCT INFORMATION - DUKORAL
®
_ _
_[VIBRIO CHOLERAE]_
ORAL LIQUID SUSPENSION
1
NAME OF THE MEDICINE
_Vibrio cholerae _
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
DUKORAL
®
is provided as a whitish oral liquid suspension (vaccine) in a single
dose glass
vial with white to off-white effervescent powder (buffer), in an
accompanying sachet.
Each dose of vaccine suspension (3 ml) contains:
_ACTIVE INGREDIENTS _
- A total of 1.25 x 10
11
bacteria of the following strains:
_Vibrio cholerae_
O1 Inaba classic strain, heat inactivated
ca. 31.25 x 10
9
bacteria*
_Vibrio cholerae_
O1 Inaba El Tor strain, formalin inactivated
ca. 31.25 x 10
9
bacteria*
_Vibrio cholerae_
O1 Ogawa classic strain, formalin inactivated
ca. 31.25 x 10
9
bacteria*
_Vibrio cholerae_
O1 Ogawa classic strain, heat inactivated
ca. 31.25 x 10
9
bacteria*
*bacterial count before inactivation
- Recombinant cholera toxin B subunit
1mg
For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS.
3
PHARMACEUTICAL FORM
DUKORAL
®
is provided as a whitish oral liquid suspension (vaccine) in a single
dose glass
vial with white to off-white effervescent powder (buffer), in an
accompanying sachet.
The vaccine suspension is filled to a volume of 3 mL in vials (type I
glass) with a rubber
stopper (bromobutyl rubber) and a screw cap.
Dukoral PI
Page 2 of 15
4
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
DUKORAL
®
is indicated for use in the prevention of cholera caused by serogroup
O1
_Vibrio _
_cholerae_
. DUKORAL
®
can be used for active immunisation of adults and children
_from two _
_years of age,_
who will be visiting areas epidemic or endemic for cholera and who are
at high
risk of infection.
4.2
DOSE AND METHOD OF ADMINISTRATION
DOSAGE
Primary immunisation consists of 2 doses for adults and children over
the age of 6. Children
from 2 to 6 years of age should receive 3 doses. Doses are to be
administered at intervals of
at least 1 week. If more than 6 weeks elapse between doses, the
primary immunisation
cour