SUMMARY CMI

Taipan 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 Taipan Antivenom?

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

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

2. What should I know before being given Taipan 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 Taipan Antivenom? in the full CMI.

3. What if I am taking other medicines?

Some medicines may interfere with Taipan 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 Taipan Antivenom given?

Your doctor will prescribe Taipan Antivenom if you suffer from the effects of venom from a taipan snake bite
The dose for both adults and children is one to three vials (12,000 – 36,000 units) depending on the severity of the effects from the venom. The dose can be repeated as necessary

More instructions can be found in Section 4. How is Taipan Antivenom given? in the full CMI.

5. What should I know while being given Taipan Antivenom?

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

6. Are there any side effects?

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

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, clammy skin, a rapid, weak pulse, dizziness, weakness and fainting
• pinkish, itchy swellings on the skin 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

Taipan Antivenom

Active ingredient(s): taipan antivenom (equine)

Consumer Medicine Information (CMI)

This leaflet provides important information about using Taipan 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 Taipan Antivenom.

Where to find information in this leaflet:

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

1. Why am I using Taipan Antivenom?

Taipan Antivenom contains the active ingredient taipan antivenom (equine). Taipan Antivenom is an injection. Antivenoms are designed to help neutralise the effects of the poison (venom) after a snake bite.

Taipan Antivenom is used to treat people who become ill after being bitten by a taipan.

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

Warnings

Taipan Antivenom should not be given if:

You do not have any ill effects from the taipan snake bite, although it can be an emergency life-saving product and should not be withheld from anyone who needs it. 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)
• 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 Taipan Antivenom.

4. How is Taipan Antivenom given?

How much is given

The dose for both adults and children is one to three vials (12,000 – 36,000 units) depending on the severity of the effects from the venom. The dose can be repeated as necessary.

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

When is Taipan Antivenom given

Taipan Antivenom should only be given when you become ill after being bitten by a taipan.

How Taipan Antivenom is given

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

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

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

5. What should I know while being given Taipan 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 most 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.

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 Taipan Antivenom contains

What Taipan Antivenom looks like

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

AUST R 74898

Who distributes Taipan Antivenom

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

This leaflet was prepared in July 2021.

Published by MIMS December 2021

1 Name of Medicine

Taipan Antivenom (equine).

2 Qualitative and Quantitative Composition

Taipan Antivenom is prepared from the plasma of horses immunised with the venom of the coastal taipan snake (Oxyuranus scutellatus). Each vial contains 12,000 units of antivenom which has been standardised to neutralise in vitro, the average yield of venom from the taipan. 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.

3 Pharmaceutical Form

Taipan Antivenom is a concentrated injection for intravenous use available as vials containing 12,000 units of antivenom 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 taipan.

4.2 Dose and Method of Administration

When there is evidence of systemic envenoming and it has been established that Taipan Antivenom is the appropriate treatment, the contents of one vial (12,000 units) should be administered slowly by intravenous infusion after dilution with Hartmann's Solution or 0.9% w/v sodium chloride. Once diluted, Taipan Antivenom should be used immediately. Do not store diluted antivenom.
The dose is the same for adults and children.
If severe defibrination is present at the onset of treatment, at least 3 vials of antivenom should be given as initial treatment.
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. It should not be administered by the intramuscular route.
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).
The patient should receive the antivenom in an intensive care unit if possible and always in a setting where resuscitation facilities are immediately available.
If the patient has received adequate first aid treatment, the splint and pressure bandage should not be removed until antivenom is available for infusion, as removal can precipitate significant effects of systemic envenoming.
The aim of antivenom therapy is to neutralise the venom. Sufficient antivenom must be given to neutralise further venom migrating from the bite site. Deterioration in the patient's condition may indicate that treatment is inadequate and more may be required. Children may become critically ill and may need more antivenom. Patients with severe systemic envenoming may require up to 8 vials to control the effects. It should be remembered that such high doses of this product contain large amounts of horse protein.
The patient must be monitored for at least 6 hours after antivenom is administered.
Before starting the infusion of antivenom, adrenaline should be prepared ready to 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 horse serum, 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.
Taipan 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.

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.
In many cases of snake bite, little venom is injected and significant envenoming does not occur. With Taipan, however, the majority of patients will develop systemic envenoming. If a significant amount of venom has been introduced, clinical or laboratory evidence of envenoming is usually present within 2 hours but can be delayed, particularly if efficient first aid has been instituted with immobilisation and a firm pressure bandage.
Removal of the bandage and splint will often precipitate the systemic effects of the venom in patients who have been bitten.
Suspected cases of snake bite should be observed for at least 12 hours after being bitten or after removal of the bandage, prior to discharge, and preferably in an intensive care setting. Such patients must be regularly monitored for signs of neuromuscular impairment, coagulopathy, myolysis, renal impairment and other abnormalities.
A diagnosis of systemic envenoming should be based on clinical and, where possible, laboratory evidence.
The venom detection kits can be helpful in detecting and identifying specific venom at the bite site or in urine and can enable the selection of the appropriate monovalent antivenom. Tests of blood are less reliable.
As this product is prepared from animal serum, severe allergic reactions may follow, including anaphylactic shock. Adrenaline must be available during antivenom therapy and prepared ready for use prior to antivenom administration. Anaphylactoid reactions may be 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 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 Antivenom prior to infusion, although care should be taken to avoid fluid overload (also 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.
Severe cases of systemic envenoming should be managed in an intensive care unit.
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 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, but can be expected to occur in at least 5% of patients receiving horse serum for the first time.

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 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 reactions.

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 the Taipan 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

Taipan Antivenom should be protected from light and stored at 2-8°C. Do not freeze.

6.5 Nature and Contents of Container

Taipan Antivenom is available as1 x 12,000 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