SUMMARY CMI

Sea 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 Sea Snake Antivenom?

Sea Snake Antivenom contains the active ingredient sea snake antivenom (equine). Sea Snake Antivenom is given to people who become ill from venom after being bitten by a sea snake.

For more information, see Section 1. Why am I using Sea Snake Antivenom? in the full CMI.

2. What should I know before being given Sea 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 I use Sea Snake Antivenom? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Sea 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 Sea Snake Antivenom given?

• 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 Sea Snake Antivenom given? in the full CMI.

5. What should I know while being given Sea Snake Antivenom?

For more information, see Section 5. What should I know while being given Sea Snake Antivenom? in the full CMI.

6. Are there any side effects?

Common side effects may include: allergic reactions, headache, rash, hives, fever and chills.

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.
• chest pain.
• high temperature.

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

Sea Snake Antivenom

Active ingredient: sea snake antivenom (equine)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Sea Snake 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 Sea Snake Antivenom.

Where to find information in this leaflet:

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

1. Why am I using Sea Snake Antivenom?

Sea snake Antivenom contains the active ingredient sea snake antivenom (equine). Sea Snake Antivenom is an injection designed to help neutralise the effect of the poison (venom) of the sea snake.

Sea Snake Antivenom is given to people who become ill after being bitten by sea snake. Not everyone who is bitten needs the antivenom, as some people have only very mild effects from the bite or none at all. However, some people can become very ill after being bitten, and in these people, it may be important to use an appropriate amount of antivenom to counteract the effects of the venom.

2. What should I know before being given Sea Snake Antivenom?

Warnings

Sea Snake Antivenom should not be given if:

• You do not have any ill effects from the sea snake bite.

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

Check with your doctor if you:

• Have allergies to any other medicines or any other substances such as foods, preservatives or dyes
• have any other medical conditions especially the following: asthma, hayfever,
• take any medicines for any other condition.
• received injections containing horse serum (including snake bite and other antivenoms, and anti-tetanus injections before 1974)
• received injection of Sea Snake Antivenom.

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 Sea Snake Antivenom.

4. How is Sea Snake Antivenom given?

How much is given

The dose for both adults and children is one vial (1,000 units). The dose can be repeated as necessary.

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

When is Sea Snake Antivenom given

• Sea Snake Antivenom should be only given to those people who become ill after being bitten by a sea snake.

How is Sea Snake Antivenom given

This medicine is diluted and given slowly as a drip into a vein.

Once diluted Sea Snake Antivenom should be used immediately. Diluted antivenom should not be stored.

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

5. What should I know while being given Sea Snake 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 in 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.

Less serious 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 Sea snake Antivenom contains

What Sea Snake Antivenom looks like

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

AUST R 74901.

Who distributes Sea Snake Antivenom

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

This leaflet was prepared in June 2021.

Published by MIMS December 2021

1 Name of Medicine

Sea Snake Antivenom (equine).

2 Qualitative and Quantitative Composition

Sea Snake Antivenom is prepared from the plasma of horses immunised with the venom of the sea snake (Enhydrina schistosa). Each vial contains 1,000 units of antivenom. Each 1 mL of the product also contains 2.2 mg phenol, 8 mg sodium chloride and water for injections to 1 mL in an aqueous solution. 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.
Sea Snake Antivenom has been shown to be effective not only against the venom of Enhydrina schistosa but, to a varying degree, against the venoms of a wide variety of sea snakes present in northern Australian waters.

3 Pharmaceutical Form

Sea Snake Antivenom is a concentrated injection for intravenous use available as vials containing 1,000 units in aqueous solution. 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 sea snake.

4.2 Dose and Method of Administration

A large proportion of people bitten by sea snakes have minimal or no effects from the bite and antivenom is unnecessary. When there is evidence of systemic envenoming from a sea snake, the contents of one vial (1,000 units) should be administered slowly by intravenous infusion after dilution with Hartmann's solution or normal saline. Once diluted, Sea 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 to avoid fluid overload in patients that are at risk (e.g. small children). Seek expert advice, regarding dilution of antivenom to avoid fluid overload, as required.
In cases of severe envenoming, when myalgia, muscle weakness, trismus, ptosis and ophthalmoplegia are present, an initial dose of 3,000 to 4,000 units should be given and up to 10,000 units may be required altogether. In less severe cases a total of 3,000 units will control most patients.
In the past, some authorities have advocated premedication with 0.25 mL of 1:1,000 adrenaline subcutaneously and intravenous antihistamine to reduce the chance of anaphylactic shock, particularly in those patients who are known to be at risk, but such use is controversial (see Section 4.4 Special Warnings and Precautions for Use).
If the patient has the affected limb immobilised, the splint and pressure bandage should not be removed until the patient is in a unit where full resuscitation measures and antivenom are available.
Severe cases of systemic envenoming should be managed in an intensive care unit if possible and always in a setting where resuscitation facilities are immediately available.
The patient must be monitored for at least 6 hours after the conclusion of the antivenom infusion.
Before starting the infusion of antivenom, adrenaline should be prepared ready for use, as anaphylactic reactions can occur rapidly (see Section 4.4 Special Warnings and Precautions for Use).
Should an anaphylactic reaction occur, suspend administration of antivenom and implement treatment measures immediately according to an appropriate protocol or guideline.
As delayed serum sickness is relatively common following the use of large volumes of foreign protein, patients who have received antivenom should be advised of the symptoms of serum sickness and warned to seek urgent medical attention if such symptoms develop.
It may occasionally be necessary to treat both envenoming and anaphylaxis simultaneously.
Sea Snake Antivenom contains no antimicrobial preservative. Use in one patient on one occasion only and discard any residue.

4.3 Contraindications

There are no absolute contraindications, but the product should not be used unless there is clear evidence of systemic envenoming with the potential for serious toxic effects.
See Section 4.4 Special Warnings and Precautions for Use for use of Sea Snake 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.
Most cases of sea snake bites are painless with no local swelling. A row of small teeth marks may be seen. Intense pain from underwater trauma is more likely to be due to a fish than a sea snake.
Up to two-thirds of those bitten by a sea snake have little or no effect from the bite. Severely envenomed patients often develop symptoms soon after the bite, but in some, the potentially dangerous effects may be delayed for several hours. It is therefore essential to observe all those who have been bitten by a sea snake for at least 12 hours, prior to discharge. Such patients must be regularly monitored for signs of neuromuscular impairment, coagulopathy, myolysis, renal impairment and other abnormalities.
If the limb has been immobilised and a firm bandage applied, removal of the bandage and splint may precipitate the systemic effects of the venom. The bandage and splint should not be removed until the patient is in hospital with appropriate antivenom treatment available. As immobilisation causes local retention of the venom, the requisite period of observation of the patient for a minimum of 12 hours commences when the splint and bandage are removed.
Severe cases of systemic envenoming should be managed in an intensive care unit, if possible and always in a setting where resuscitation facilities are immediately available.
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 may be more likely to occur in those who are atopic or 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 skin testing to determine patients who may have an allergic reaction are not satisfactory and should not be undertaken.
Antivenoms may bind complement and produce an anaphylactoid reaction in patients who have had no previous contact with equine protein. The risk of such a reaction can be reduced by adequate dilution of the antivenom prior to infusion, although care should be taken to avoid fluid overload (see Section 4.2 Dose and Method of Administration).
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.
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 a similar animal protein. Patients who have received antivenom 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 effect of this medicine on the 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 postapproval use of all Seqirus snake 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.

Nervous system disorders.

Gastrointestinal disorders.

Skin and subcutaneous tissue disorders.

Musculoskeletal and connective tissue disorders.

General disorders and administration site conditions.

Reporting suspected adverse effects.

4.9 Overdose

For information on the management of overdose, contact the Poisons Information Centre on 131 126 (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

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

6.5 Nature and Contents of Container

Sea Snake Antivenom is available as 1 x 1,000 units in 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