RED BACK SPIDER ANTIVENOM (equine) 500U injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Red-back spider antivenom, Quantity: 500 U

Available from:

Seqirus Pty Ltd

Pharmaceutical form:

Injection, solution

Composition:

Excipient Ingredients: phenol; water for injections; sodium chloride

Administration route:

Intravenous, Intramuscular

Units in package:

500U X 1

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

For the treatment of patients who exhibit manifestations of systemic envenoming following a bite by a red back spider.

Product summary:

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

Authorization status:

Licence status A

Authorization date:

2000-07-21

Patient Information leaflet

Red Back Spider Antivenom
1
RED BACK SPIDER 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 RED BACK SPIDER ANTIVENOM?
Red Back Spider Antivenom contains the active ingredient red-back
spider antivenom (equine). Red Back Spider Antivenom is
given to those people who become ill from venom after being bitten by
a red back spider.
For more information, see Section 1. Why am I using Red Back Spider
Antivenom?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN RED BACK SPIDER 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 Red Back Spider Antivenom?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Red Back Spider 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 RED BACK SPIDER ANTIVENOM GIVEN?
•
The dose for both adults and children is one vial (500 units). This
dose can be repeated as necessary.
More instructions can be found in Section 4. How is Red Back Spider
Antivenom given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN RED BACK SPIDER 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 Red Back Spider Antivenom? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Common side effects may include allergic reactions.
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, shortness of breath, wheezing or trouble breathing
•
Rapid shallow breathing, cold clam

Summary of Product characteristics

RED BACK SPIDER ANTIVENOM (AUST R 74893) PRODUCT INFORMATION
Version 7
Page 1 of 6
AUSTRALIAN PRODUCT INFORMATION – RED BACK SPIDER
ANTIVENOM SOLUTION FOR INJECTION
1
NAME OF THE MEDICINE
Red-back Spider Antivenom (equine) as active ingredient.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
RED BACK SPIDER ANTIVENOM is prepared from the plasma of horses
immunised with
the venom of the female red back spider
_(Latrodectus hasselti_
). Each vial contains 500 units of
antivenom which has been standardised to neutralise 5 mg of venom.
Each 1 mL of product
also contains 2.2 mg phenol, 8 mg sodium chloride and water for
injections to 1 mL. Each vial
contains ≤ 100 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
RED BACK SPIDER ANTIVENOM (500U) is a solution for injection available
as vials
containing 500 units of antivenom in aqueous solution. It is a
colourless to light straw coloured,
slightly viscous, transparent solution in a vial.
4
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
For the treatment of patients who exhibit manifestations of systemic
envenoming following a
bite by a red back spider (
_Latrodectus hasselti_
).
4.2 DOSE AND METHOD OF ADMINISTRATION
A large proportion of people bitten by red back spiders have symptoms
that are so mild that
antivenom is not necessary. When there is evidence of severe local
and/or systemic
envenoming by a red back spider, the contents of one vial (500 units)
should be given
intramuscularly. The dose is the same for both adults and children.
In cases of life threatening envenoming, the intravenous route may be
used. The antivenom is
first diluted 1:10 in Hartmann’s Solution or 0.9% w/v Sodium
Chloride. Seek expert advice
regarding dilution of antivenom to avoid fluid overload, as required.
NOTE: THE INTRAVENOUS
ROUTE IS MORE LIKELY TO PRECIPITATE ANAPHYLACTOID REACTIONS.
If the effects of the venom have not been comple