BROWN SNAKE ANTIVENOM (equine) 1000U injection vial

Kraj: Australia

Język: angielski

Źródło: Department of Health (Therapeutic Goods Administration)

Składnik aktywny:

Brown snake antivenom, Quantity: 1000 U

Dostępny od:

Seqirus Pty Ltd

Forma farmaceutyczna:

Injection, concentrated

Skład:

Excipient Ingredients: phenol; sodium chloride; water for injections

Droga podania:

Intravenous

Sztuk w opakowaniu:

1000 x 1

Typ recepty:

(S4) Prescription Only Medicine

Wskazania:

For the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a snake of the genus Pseudonaja. This genus includes the Eastern brown snake, the dugite and the gwardar (Western brown snake).

Podsumowanie produktu:

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 autoryzacji:

Registered

Data autoryzacji:

2000-07-21

Ulotka dla pacjenta

Brown Snake Antivenom
1
BROWN 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 BROWN SNAKE ANTIVENOM?
Brown Snake Antivenom contains the active ingredient brown snake
antivenom (equine). Brown Snake Antivenom is given to
those people who become ill from venom after being bitten by an
eastern brown, dugite or gwardar (western brown) snake
.
For more information, see Section 1. Why am I using Brown Snake
Antivenom?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN BROWN 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 Brown Snake Antivenom?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Brown 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 BROWN SNAKE ANTIVENOM GIVEN?
•
Your doctor will prescribe Brown Snake Antivenom if you suffer from
the effects of venom from an eastern brown, dugite
or gwardar (western brown) snake.
•
The dose for both adults and children is one vial (1,000 units). The
dose can be repeated as necessary.
More instructions can be found in Section 4. How is Brown Snake
Antivenom given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN BROWN 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 Brown 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 ras

Charakterystyka produktu

Brown Snake Antivenom
(AUST R 74897)
Product Information
P a g e 1 | 9
AUSTRALIAN PRODUCT INFORMATION – BROWN SNAKE ANTIVENOM SOLUTION FOR
INJECTION
1
NAME OF THE MEDICINE
BROWN SNAKE ANTIVENOM (equine) as active ingredient.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
BROWN SNAKE ANTIVENOM is prepared from the plasma of horses immunised
with the venom of
the eastern brown snake (_Pseudonaja textilis_). Each vial contains
1,000 units of antivenom which
has been standardised to neutralise _in vitro_ the average yield of
venom from the brown snake.
The product also contains 2.2 mg phenol, 8 mg sodium chloride and
water for injections to 1.0 mL.
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
BROWN SNAKE ANTIVENOM is a concentrated solution for intravenous
injection. 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 snake of the genus _Pseudonaja_. This genus includes the eastern
brown snake, the dugite and the
gwardar (western brown snake).
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
BROWN SNAKE ANTIVENOM is the appropriate treatment, the contents of
one vial (1,000 units)
should be administered slowly by intravenous infusion after dilution
with Hartmann’s Solution or
0.9% w/v sodium chloride. Once diluted, BROWN SNAKE ANTIVENOM should
be used immediately.
Do not store diluted antivenom.
The dose is the same for adults and children.
The antivenom should be diluted 1 in 10, although a dilution of 1 in 5
may be more appropriate for
patients at risk of fluid overload. Seek expert