SUMMARY CMI

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?

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 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.

For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.

FULL CMI

Stonefish Antivenom

Active ingredient: stonefish antivenom (equine)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Stonefish Antivenom. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Stonefish Antivenom.

Where to find information in this leaflet:

1. Why am I using Stonefish Antivenom?
2. What should I know before being given Stonefish Antivenom?
3. What if I am taking other medicines?
4. How is Stonefish Antivenom given?
5. What should I know while being given Stonefish Antivenom?
6. Are there any side effects?
7. Product details

1. Why am I using Stonefish Antivenom?

Stonefish Antivenom contains the active ingredient stonefish antivenom (equine). Stonefish Antivenom is an injection designed to help neutralise the effect of the poison (venom) of the stonefish.

Stonefish Antivenom is given to 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.

2. What should I know before being given Stonefish Antivenom?

Warnings

Always check the ingredients to make sure you can use this medicine.

Check with your doctor if you:

• have allergies to:
  - any other medicines
  - any other substances such as foods, preservatives or dyes.
• have any other medical conditions especially asthma, hayfever,
• have ever received injections containing horse serum (snake bite and other antivenoms).
• you had an anti-tetanus injection before 1974.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Check with your doctor if you are pregnant or intend to become pregnant.

Talk to your doctor if you are breastfeeding or intend to breastfeed.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Stonefish Antivenom.

4. How is Stonefish Antivenom 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.

When is Stonefish Antivenom given

Stonefish Antivenom should be only given to those people who become ill or have severe pain or swelling that does not respond to first aid measures after being stung by a stonefish.

How is Stonefish Antivenom given

Usually, 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.

5. What should I know while being given 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.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

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.

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Serious side effects

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

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

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor's prescription.

What Stonefish Antivenom contains

What Stonefish Antivenom looks like

Stonefish Antivenom is a light straw coloured, slightly viscous transparent solution in a glass vial.

AUST R 74892.

Who distributes Stonefish Antivenom

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

This leaflet was prepared in September 2021.

Published by MIMS December 2021

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