TAIPAN ANTIVENOM (equine) 12000U injection vial

Land: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

Taipan antivenom, Quantity: 12000 U

Fáanlegur frá:

Seqirus Pty Ltd

Lyfjaform:

Injection, concentrated

Samsetning:

Excipient Ingredients: sodium chloride; phenol; water for injections

Stjórnsýsluleið:

Intravenous

Einingar í pakka:

12000U X 1

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

For the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a taipan.

Vörulýsing:

Visual Identification: Light straw coloured, slightly viscous, transparent solution in a glass vial; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 3 Years; Container Temperature: Store at 2 to 8 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

2000-07-21

Upplýsingar fylgiseðill

Taipan Antivenom
1
TAIPAN ANTIVENOM
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 AM I USING TAIPAN ANTIVENOM?
Taipan Antivenom contains the active ingredient taipan antivenom
(equine). Taipan antivenom is given to people who become
ill from venom after being bitten by a taipan snake.
For more information, see Section 1. Why am I using Taipan Antivenom?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN TAIPAN ANTIVENOM?
TALK TO YOUR DOCTOR 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 being
given Taipan Antivenom?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Taipan Antivenom 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 IS TAIPAN ANTIVENOM GIVEN?
Your doctor will prescribe Taipan Antivenom if you suffer from the
effects of venom from a taipan snake bite
The dose for both adults and children is one to three vials (12,000
– 36,000 units) depending on the severity of the effects
from the venom. The dose can be repeated as necessary
More instructions can be found in Section 4. How is Taipan Antivenom
given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN TAIPAN ANTIVENOM?
THINGS YOU
SHOULD DO
Tell your doctor if you experience any side effects.
For more information, see Section 5. What should I know while being
given Taipan Antivenom? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Common side effects may include: allergic reactions, rash, hives,
headache, fever and chills.
If you experience the following serious side effects, tell your doctor
immediately:
•
sudden signs of allergy such as rash, itching or hives on the skin,
swelling of the face, lips, tongue or other parts of the
body, sho

Vara einkenni

TAIPAN ANTIVENOM (AUST R 74898)
PRODUCT INFORMATION
Version 7
Page 1 of 7
AUSTRALIAN
PRODUCT
INFORMATION
–
TAIPAN
ANTIVENOM INJECTION
1
NAME OF THE MEDICINE
TAIPAN ANTIVENOM (equine)
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
TAIPAN ANTIVENOM is prepared from the plasma of horses immunised with
the venom of
the coastal taipan snake (
_Oxyuranus scutellatus_
). Each vial contains 12,000 units of antivenom
which has been standardised to neutralise
_in vitro_
, the average yield of venom from the taipan.
Each 1 mL of the product also contains 2.2 mg phenol, 8 mg sodium
chloride and water for
injections to 1 mL in an aqueous solution. Each vial contains ≤ 170
mg per mL of plasma protein
of equine origin.
The product volume is potency dependant thus it varies from batch to
batch. Please refer to the
product volume printed on the carton.
3
PHARMACEUTICAL FORM
TAIPAN ANTIVENOM is a concentrated injection for intravenous use
available as vials
containing 12,000 units of antivenom in aqueous solution. It is a
light straw coloured, slightly
viscous, transparent solution in a glass vial.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of patients who exhibit manifestations of systemic
envenoming following a
bite by a taipan.
4.2 DOSE AND METHOD OF ADMINISTRATION
When there is evidence of systemic envenoming and it has been
established that TAIPAN
ANTIVENOM is the appropriate treatment, the contents of one vial
(12,000 units) should be
administered slowly by intravenous infusion after dilution with
Hartmann’s Solution or 0.9%
w/v sodium chloride. Once diluted, TAIPAN ANTIVENOM should be used
immediately. Do
not store diluted antivenom.
The dose is the same for adults and children.
If severe defibrination is present at the onset of treatment, at least
3 vials of antivenom should be
given as initial treatment.
The antivenom should be diluted 1 in 10, although a dilution of 1 in 5
may be more appropriate
to avoid fluid overload in patients that are at risk (e.g. small
children). Seek expert advice
reg