Consumer medicine information

What is in this leaflet

This leaflet answers some common questions about Stonefish Antivenom.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you having Stonefish Antivenom against the benefits they expect it will have.

If you have any concerns about this medicine, ask your doctor, nurse or pharmacist.

Keep this leaflet. You may need to read it again.

What Stonefish Antivenom is used for

What it is used for

Stonefish Antivenom is given to those people who become ill after being poisoned by a stonefish.

The stonefish has sharp spines along its back. Standing on a stonefish causes these spines to pierce the skin on the bottom of the foot. Poison from the stonefish goes into the foot along the spines and causes intense pain, severe damage to the foot and can cause serious illness.

The antivenom is given to neutralise the poison, prevent dangerous illness and to reduce the pain and swelling.

Before antivenom is given, first aid measures must be used.

Not everyone who is stung needs the antivenom, but the pain and swelling is usually so severe in those people who stand on stonefish that antivenom is usually required to control these effects. In these people it is essential to use an appropriate amount of antivenom to counteract the effects of the poison.

How it works

Stonefish Antivenom is an injection designed to help neutralise the effect of the poison (venom) of the stonefish.

It is made by immunising horses against the venom of the stonefish and then collecting that part of the horse’s blood which neutralises this poison.

The antivenom is purified and made into an injection for people who may need it after receiving a stonefish sting.

Ask your doctor if you have any questions about why this medicine has been given to you.

Before you are given Stonefish Antivenom

When you must not be given it

As there are sometimes unpleasant and dangerous reactions to the antivenom (see Side Effects), it should not be given to people who have no effects from the sting.

However as Stonefish Antivenom can be important in relieving the pain and other severe effects of the poison, it should not be withheld from anyone who needs it.

Before you are given it

Tell your doctor if:

1. you have allergies to:

• any other medicines
• any other substances such as foods, preservatives or dyes.

2. you have, or have had any medical conditions, especially the following:

• asthma
• hayfever.

3. you have ever had injections made from horse serum (snake bite and other antivenoms).
4. you had an anti-tetanus injection before 1974.
5. you are pregnant or you are breast feeding.
   Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you are given Stonefish Antivenom.

How Stonefish Antivenom is given

How much is 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.

Your doctor will take precautions to counteract any allergic reactions if they should happen.

How it is given

This medicine is usually injected into a muscle, or in severe cases may be diluted and given via a vein.

Stonefish Antivenom does not contain any antimicrobial preservative. It should be used once and any residue discarded.

After having Stonefish Antivenom

When medicines are produced in animals and injected into you, it is always possible that viruses or other substances could be present in the medicine and cause an illness. These could be viruses or other infectious agents which may not yet have been discovered. In the past, there have been no reports of this ever having happened with this product.

If you have any queries about any aspect of this medicine, or questions regarding information in this leaflet, discuss them with your doctor or pharmacist.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after having Stonefish Antivenom.

It may have unwanted side effects in some people. All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects.

As the injection is made from horse serum, side effects occur more commonly in those who have allergies, particularly if they have ever had injections before which were also prepared from horses. Allergic reactions can be treated by your doctor.

Ask your doctor or pharmacist to answer any questions you have.

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 the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing
• rapid, shallow breathing, cold, clammy skin, a rapid, weak pulse, dizziness, weakness and fainting
• pinkish, itchy swellings on the skin, also called hives or nettle rash
• fever, swelling, skin rash, joint pains and swelling of the glands in the neck armpit or groin, anytime up to two weeks after the injection.

These may be serious side effects. You may need urgent medical attention.

Tell your doctor or pharmacist if you notice anything that is making you feel unwell.

Other side effects not listed above may also occur in some people.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Storing Stonefish Antivenom

Stonefish Antivenom is usually stored in a doctor’s surgery, hospital or ambulance. However, if you need to store it:

• Keep it where children cannot reach it.
• Keep it in the original pack until it is needed.
• Keep it in the refrigerator, between 2°C and 8°C and protect it from light. Do not freeze Stonefish Antivenom.

Do not use Stonefish Antivenom after the expiry date printed on the pack.

Do not use Stonefish Antivenom if the packaging is torn or shows signs of tampering.

Product description

What it looks like

Stonefish Antivenom is supplied in a vial.

Ingredients

Active ingredient:

• 2,000 units of Stonefish Antivenom.

Other ingredients:

• sodium chloride
• phenol
• water for injections

This product contains substances from horses’ blood.

The vial and all associated components do not contain natural rubber latex.

Name and Address of Sponsor

Stonefish Antivenom is sponsored by:

Seqirus Pty Ltd,
ABN 26 160 735 035
63 Poplar Road
Parkville 3052
Victoria
Australia

The Australian Registration Number is AUST R 74892.

This leaflet was prepared in August 2019.

Published by MIMS November 2019

1 Name of 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 dependent 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 Therapeutic 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 Dose 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 fluid overload, as required.

Note.

4.3 Contraindications

There are no absolute contraindications, but the product should not be used unless there is clear evidence of stonefish envenoming with severe effects.
See Section 4.4 Special Warnings and Precautions for Use for the use of Stonefish Antivenom in patients with a known allergy.

4.4 Special Warnings and Precautions for Use

When medicinal products prepared from animal plasma are administered, infectious diseases due to the transmission of infective agents cannot be totally excluded. This applies to pathogens of hitherto unknown origin. This possibility must always be considered and should be conveyed, whenever possible, to patients who may receive the product. Historically there have been no known recorded cases of transmission of viruses by this product.
Appropriate first aid measures recommended by local guidelines must be instituted when necessary before giving antivenom.
As this product is prepared from animal plasma, severe allergic reactions may follow, including anaphylactic shock. Adrenaline must be available during antivenom therapy and prepared ready for use prior to antivenom administration. Anaphylactic reactions are more likely to occur in those who are atopic or who have previously received equine serum. This would include patients who have previously received equine Tetanus Antitoxin (prior to 1974 in Australia). In the past, some authorities have advocated premedication with subcutaneous adrenaline and intravenous antihistamine, particularly in those patients who are known to be at risk, but such use is controversial.
The results of initial skin testing to determine patients who may have an allergic reaction to antivenom are not satisfactory and should not be undertaken.
Should anaphylaxis occur, suspend administration of antivenom and implement treatment measures immediately according to an appropriate protocol or guideline. Further administration of antivenom should be considered in the light of the relative problems of envenoming and anaphylaxis.
Severe cases of envenoming should be managed in an intensive care unit, if possible.
Delayed serum sickness can occur following the use of animal derived antivenoms. The most common manifestations include fever, cutaneous eruptions, arthralgia, lymphadenopathy and albuminuria. Less commonly, arthritis, nephritis, neuropathy and vasculitis can occur. The condition can appear days or weeks after the use of antivenom but can occur as soon as 12 hours after a second injection of horse protein. Patients should be advised of the symptoms of serum sickness and warned to seek urgent medical attention if such symptoms develop.
The incidence of serum sickness is greater with larger volumes of antivenom.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The following adverse reactions, presented below according to system organ class and frequency, have been identified during post-approval use of Seqirus antivenoms. Adverse event frequencies are defined as follows.
Very common: ≥ 1/10; common: ≥ 1/100 and < 1/10; uncommon: ≥ 1/1000 and < 1/100; rare: ≥ 1/10,000 and < 1/1000; and very rare: < 1/10,000.

Immune system disorders.

Skin and subcutaneous tissue disorders.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Clinical trials.

5.2 Pharmacokinetic Properties

No specific information is available on absorption, distribution, metabolism or excretion of antivenom.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

See Section 2 Qualitative and Quantitative Composition.

6.2 Incompatibilities

Incompatibilities were either not assessed or not identified as part of the registration of this medicine.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

Stonefish Antivenom should be protected from light and stored between 2 to 8°C. Do not freeze.

6.5 Nature and Contents of Container

Stonefish Antivenom is available as 1 x 2,000 units in a clear glass vial.
The vial and all associated components do not contain natural rubber latex.

6.6 Special Precautions for Disposal

In Australia, any unused medicine or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Not applicable.

7 Medicine Schedule (Poisons Standard)

S4.

Summary Table of Changes