STONEFISH ANTIVENOM (Equine) 2000U injection vial

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Aktivna sestavina:

Stonefish antivenom, Quantity: 2000 U

Dostopno od:

Seqirus Pty Ltd

Farmacevtska oblika:

Injection, solution

Sestava:

Excipient Ingredients: phenol; sodium chloride; water for injections

Pot uporabe:

Intravenous, Intramuscular

Enote v paketu:

2000U X 1

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

For the treatment of patients who exhibit manifestations of systemic envenoming by stonefish antivenom.

Povzetek izdelek:

Visual Identification: Colourless to 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 dovoljenje:

Registered

Datum dovoljenje:

2000-07-21

Navodilo za uporabo

Stonefish Antivenom
1
STONEFISH 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 STONEFISH ANTIVENOM?
Stonefish Antivenom contains the active ingredient stonefish antivenom
(equine)]. Stonefish Antivenom is given to people
who become ill after being poisoned by a stonefish.
For more information, see Section 1. Why am I using Stonefish
Antivenom?
in the full CMI.
2.
WHAT SHOULD I KNOW BEFORE BEING GIVEN STONEFISH 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 Stonefish Antivenom?
in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Stonefish 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 STONEFISH ANTIVENOM GIVEN?
The dose is the same for both adults and children, and depends on the
number of puncture sites from the spines of the
stonefish:
•
for 1 - 2 punctures the dose is 1 vial (2,000 units)
•
for 3 - 4 punctures the dose is 2 vials (4,000 units)
•
for 5 or more punctures the dose is 3 vials (6,000 units).
The injection can be repeated as necessary.
More instructions can be found in Section 4. How is Stonefish
Antivenom given?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE BEING GIVEN STONEFISH 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 Stonefish Antivenom? in the full CMI.
6.
ARE THERE ANY SIDE EFFECTS?
Common side effects may include: allergic reactions, hives and rash.
Tell your doctor immediately if you notice any of the following:
•
sudden signs of allergy such as rash, itching or hives on the skin,
swelling of th

Lastnosti izdelka

Stonefish Antivenom Solution for Injection
(AUST R 74892)
Product Information
Page 1 of 7
AUSTRALIAN
PRODUCT
INFORMATION
–
STONEFISH
ANTIVENOM
SOLUTION
FOR
INJECTION
1
NAME OF THE MEDICINE
STONEFISH ANTIVENOM (equine) as the active ingredient.
2
QUALITATIVE AND QUANTITATIVE COMPOSITION
STONEFISH ANTIVENOM is prepared from the plasma of horses immunised
with the venom
of stonefish _(Synanceia verrucosa _and/or_ Synanceia horrida)_. Each
vial contains 2,000 units
of antivenom. 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
STONEFISH ANTIVENOM is a solution for injection. It is a colourless to
light straw coloured,
slightly viscous, transparent solution in a glass vial.
4
CLINICAL PARTICULARS
4.1
T
HERAPEUTIC INDICATIONS
For the treatment of patients who, following envenoming by a
stonefish, have systemic
manifestations or severe oedema and pain which do not respond to first
aid measures.
4.2
D
OSE AND METHOD OF ADMINISTRATION
The majority of people who stand on stonefish and whose feet are
pierced by their spines will
need antivenom for relief of the pain and oedema. However appropriate
first aid measures
recommended
by
local
guidelines
must
be
instituted
when
necessary
before
giving
antivenom.
The initial dose of antivenom depends on the number of visible
puncture sites:
•
1 - 2 punctures
1 vial
(2,000 units)
•
3 - 4 punctures
2 vials
(4,000 units)
5 or more punctures
3 vials
(6,000 units)
The dose is the same for both adults and children.
The antivenom should be given by intramuscular injection but may be
given by intravenous
infusion in extreme cases after diluting the antivenom 1:10 in an
intravenous solution such as
Hartmann’s Solution or 0.9% w/v Sodium Chloride. Seek expert advice
regarding dilution of
antivenom to avoid flu