POLYVALENT SNAKE ANTIVENOM (AUSTRALIA

País: Austrália

Língua: inglês

Origem: Department of Health (Therapeutic Goods Administration)

Ingredientes ativos:

Death adder antivenom, Quantity: 6000 U; Brown snake antivenom, Quantity: 1000 U; Black snake antivenom, Quantity: 18000 U; Tiger snake antivenom, Quantity: 3000 U; Taipan antivenom, Quantity: 12000 U

Disponível em:

Seqirus Pty Ltd

Forma farmacêutica:

Injection, concentrated

Composição:

Excipient Ingredients: phenol; sodium chloride; water for injections

Via de administração:

Intravenous

Unidades em pacote:

40000U X 1

Tipo de prescrição:

(S4) Prescription Only Medicine

Indicações terapêuticas:

For the treatment in Papua New Guinea and in all states except Victoria and Tasmania who exhibit manifestations of systemic envenoming and the snake has not been identified. In Tasmania, Tiger snake antivenom should be used rather than polyvalent whilst in Victoria a combination of Tiger snake antivenom and brown snake antivenom is the preferred treatment.

Resumo do produto:

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

Status de autorização:

Registered

Data de autorização:

2000-07-21

Folheto informativo - Bula

Polyvalent Snake Antivenom
1
POLYVALENT SNAKE ANTIVENOM (AUSTRALIA – PAPUA
NEW GUINEA)
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 POLYVALENT SNAKE ANTIVENOM?
Polyvalent Snake Antivenom contains the active ingredients brown snake
antivenom, tiger snake antivenom, death adder
antivenom, taipan antivenom and black snake antivenom. Polyvalent
Snake Antivenom is given to people who have become ill
from venom after being bitten by an unidentified snake in Papua New
Guinea or in all Australian states except Victoria and
Tasmania.
For more information, see Section 1. Why am I using Polyvalent Snake
Antivenom?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN POLYVALENT SNAKE 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 Polyvalent Snake Antivenom?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Polyvalent Snake 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 POLYVALENT SNAKE ANTIVENOM GIVEN?
•
Your doctor will prescribe Polyvalent Snake Antivenom if you suffer
from the effects of venom from an unidentified snake
bite in Papua New Guinea or in all Australian states except Victoria
and Tasmania.
•
The dose for both adults and children is one vial (40,000 units). The
dose can be repeated as necessary.
More instructions can be found in Section 4. How is Polyvalent Snake
Antivenom given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN POLYVALENT SNAKE 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 Polyvalent Snake Antiv

Características técnicas

POLYVALENT SNAKE ANTIVENOM (AUST R 74899)
PRODUCT INFORMATION
Version 7.0
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION – POLYVALENT
SNAKE ANTIVENOM (AUSTRALIA – PAPUA NEW
GUINEA) INJECTION
1
NAME OF THE MEDICINE
POLYVALENT
SNAKE
ANTIVENOM
(equine)
containing
the
following
active
ingredients:
Black snake antivenom
Taipan antivenom
Death adder antivenom
Tiger snake antivenom
Brown snake antivenom
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
POLYVALENT SNAKE ANTIVENOM contains antibodies to the venom of the
following
snakes:
King brown or mulga snake
(
_Pseudechis australis_
)
Mainland tiger snake
(
_Notechis scutatus_
)
Eastern brown snake
(
_Pseudonaja textilis_
)
Common death adder
(
_Acanthophis antarcticus_
)
Coastal taipan
(
_Oxyuranus scutellatus_
)
The antivenom is prepared from the plasma of horses immunised with the
venom of the
snakes. The amount of antivenom has been standardised to neutralise
_in vitro_
the average
yield of venom from each snake. The minimum amount of each antivenom
is as follows:
Black snake antivenom
18,000 units
Taipan antivenom
12,000 units
Death adder antivenom
6,000 units
Tiger snake antivenom
3,000 units
Brown snake antivenom
1,000 units
Total
40,000 units
Each 1 mL of 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 dependent thus it varies from batch to
batch. Please refer
to the product volume printed on the carton.
POLYVALENT SNAKE ANTIVENOM (AUST R 74899)
PRODUCT INFORMATION
Version 7.0
Page 2 of 9
3
PHARMACEUTICAL FORM
POLYVALENT SNAKE ANTIVENOM is a concentrated injection for intravenous
use. 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 in Papua New Guinea and in all
Australian states except
Victoria and Tasmania who exhibit manifestations of systemic snake
envenoming and the
snake has n