BLACK SNAKE ANTIVENOM (equine) 18000U injection vial

देश: ऑस्ट्रेलिया

भाषा: अंग्रेज़ी

स्रोत: Department of Health (Therapeutic Goods Administration)

सक्रिय संघटक:

Black snake antivenom, Quantity: 18000 U

थमां उपलब्ध:

Seqirus Pty Ltd

फार्मास्यूटिकल फॉर्म:

Injection, concentrated

रचना:

Excipient Ingredients: sodium chloride; phenol; water for injections

प्रशासन का मार्ग:

Intravenous

पैकेज में यूनिट:

18 000u X 1

प्रिस्क्रिप्शन प्रकार:

(S4) Prescription Only Medicine

चिकित्सीय संकेत:

For the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a king brown or mulga snake. Although the antivenom is effective in the management of patients who are bitten by other members of the genus Pseudechis, including the red-bellied or common black snake, Tiger snake antivenom is the preferred treatment.

उत्पाद समीक्षा:

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

प्राधिकरण का दर्जा:

Registered

प्राधिकरण की तारीख:

2000-07-21

सूचना पत्रक

Black Snake Antivenom
1
BLACK SNAKE 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 BLACK SNAKE ANTIVENOM?
Black Snake Antivenom contains the active ingredient black snake
antivenom (equine). Black Snake Antivenom is given to
people who become ill from venom after being bitten by a king brown
snake or mulga snake
.
For more information, see Section 1. Why am I using Black Snake
Antivenom?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN BLACK 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 Black Snake Antivenom?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Black 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 BLACK SNAKE ANTIVENOM GIVEN?
•
Your doctor will prescribe Black Snake Antivenom if you suffer from
the effects of venom from a bite from a king brown
snake or mulga snake.
•
The dose for both adults and children is one vial (18,000 units). The
dose can be repeated as necessary.
More instructions can be found in Section 4. How is Black Snake
Antivenom given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN BLACK 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 Black Snake Antivenom? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Common side effects may include: allergic reactions, hives, rash,
fever, chills and headache.
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

उत्पाद विशेषताएं

BLACK SNAKE ANTIVENOM (AUST R 74894) PRODUCT INFORMATION
Version 7.0
Page 1 of 8
AUSTRALIAN PRODUCT INFORMATION – BLACK SNAKE
ANTIVENOM INJECTION
1
NAME OF THE MEDICINE
Black snake antivenom (equine) as active ingredient.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BLACK SNAKE ANTIVENOM is prepared from the plasma of horses immunised
with
the venom of the king brown snake (
_Pseudechis australis_
) also known as the mulga snake.
The king brown snake is a member of the genus
_Pseudechis_
, known as black snakes.
Each vial contains 18,000 units of antivenom which has been
standardised to neutralise
_in _
_vitro_
the average yield of venom from the king brown snake. Each 1 mL of the
product
also contains phenol 2.2 mg, sodium chloride 8 mg and water for
injections to 1.0 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.
3
PHARMACEUTICAL FORM
BLACK SNAKE ANTIVENOM is a concentrated injection (18000U) for
intravenous
use. It is 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 king brown or mulga snake. Although the
antivenom is effective in
the management of patients who are bitten by other members of the
genus
_Pseudechis_
,
including the red-bellied or common black snake, Tiger Snake Antivenom
is the preferred
treatment (see
S
ECTION
5.1
–
P
HARMACODYNAMIC
P
ROPERTIES
).
4.2
DOSE AND METHOD OF ADMINISTRATION
A proportion of people bitten by snakes have symptoms that are so mild
that antivenom is
not necessary. When there is evidence of systemic envenoming and it
has been
established that BLACK SNAKE ANTIVENOM is the appropriate treatment,
the contents
of one vial (18,000 units) should be administered slowly by
intravenous infusion after
dilution with Har