Consumer medicine information

Polyvalent Snake Antivenom (Australia - PNG)

Black snake antivenom; Taipan antivenom; Death adder antivenom; Tiger snake antivenom; Brown snake antivenom

BRAND INFORMATION

Brand name

Polyvalent Snake Antivenom (Australia, Papua New Guinea)

Active ingredient

Black snake antivenom; Taipan antivenom; Death adder antivenom; Tiger snake antivenom; Brown snake antivenom

Schedule

S4

 

Consumer medicine information (CMI) leaflet

Please read this leaflet carefully before you start using Polyvalent Snake Antivenom (Australia - PNG).

What is in this leaflet

This leaflet answers some common questions about Polyvalent Snake 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 Polyvalent Snake 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 Polyvalent Snake Antivenom is used for

What it is used for

Polyvalent Snake Antivenom is given to those people who become ill after being bitten by an unidentified snake, except in Victoria and Tasmania.

If the type of snake is known, it is much better to use the appropriate antivenom for that snake; the size of the injection will be smaller and less likely to cause side effects.

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 is essential to use an appropriate amount of antivenom to counteract the effects of the poison.

How it works

Polyvalent Snake Antivenom is an injection designed to help neutralise the effect of the poison (venom) of most snakes that are encountered in Australia and in Papua New Guinea.

It is made by immunising horses against the venoms of the king brown snake, taipan, death adder, tiger snake and brown snake and then collecting that part of the horse’s blood which neutralises the poisons of these snakes.

The antivenom for all these snakes is purified and made into an injection for people who may need it after being bitten by a poisonous snake.

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

Before you are given Polyvalent Snake Antivenom

When you must not be given it

As Polyvalent Snake Antivenom consists of antivenom to several snakes, it is a very large injection. It should not be used if the type of snake which caused the bite is known, as the specific antivenom for that snake will be just as effective, and less likely to cause side effects than the large volume Polyvalent Snake Antivenom injections.

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 bite.

However as Polyvalent Snake Antivenom can be an emergency life-saving product, 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.
  1. you have, or have had any medical conditions, especially the following:
  • asthma
  • hayfever.
  1. you have ever received injections containing horse serum (snake bite and other antivenoms).
  2. you had an anti-tetanus injection before 1974.
  3. 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 Polyvalent Snake Antivenom.

How Polyvalent Snake Antivenom is given

How much is given

The dose for both adults and children is one vial (40,000 units). The dose can be repeated as necessary.

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

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

How it is given

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

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

After having Polyvalent 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.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well after having Polyvalent Snake 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 or pharmacist if you notice any of the following and they worry you:

  • local reaction around the injection site such as redness, itchiness, tenderness, pain or discomfort, warmth, burning or stinging, swelling or the formation of hard lumps or scars
  • chills
  • aching muscles, muscle tenderness or weakness, not caused by exercise
  • stomach pain or discomfort
  • headache
  • nausea, vomiting and diarrhoea.

These side effects are usually mild.

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.

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 Polyvalent Snake Antivenom

Polyvalent Snake 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 Polyvalent Snake Antivenom.

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

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

Product description

What it looks like

Polyvalent Snake Antivenom is supplied in a vial.

Ingredients

Active ingredients:

  • 1,000 units of Brown Snake Antivenom
  • 3,000 units of Tiger Snake Antivenom
  • 6,000 units of Death Adder Antivenom
  • 12,000 units of Taipan Antivenom
  • 18,000 units of Black Snake Antivenom.

Other ingredients:

  • sodium chloride
  • phenol
  • water for injections.

This product also contains substances from horse blood.

Polyvalent Snake Antivenom and its packaging components do not contain natural rubber latex.

Name and Address of Sponsor

Polyvalent Snake 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 74899.

This leaflet was prepared in July 2019

Published by MIMS December 2019

BRAND INFORMATION

Brand name

Polyvalent Snake Antivenom (Australia, Papua New Guinea)

Active ingredient

Black snake antivenom; Taipan antivenom; Death adder antivenom; Tiger snake antivenom; Brown snake antivenom

Schedule

S4

 

1 Name of Medicine

Polyvalent Snake Antivenom (equine) containing the following active ingredients:
Black snake antivenom; Taipan antivenom; Death adder antivenom; Tiger snake antivenom; Brown snake antivenom.

6.7 Physicochemical Properties

Not applicable.

2 Qualitative and Quantitative Composition

Polyvalent Snake Antivenom contains antibodies to the venom of the following snakes:
King brown or mulga snake (Pseudechis australis); Mainland tiger snake (Notechis scutatus); Eastern brown snake (Pseudonaja textilis); Common death adder (Acanthophis antarcticus); Coastal taipan (Oxyuranus scutellatus).
The antivenom is prepared from the plasma of horses immunised with the venom of the snakes. The amount of antivenom has been standardised to neutralise in vitro the average yield of venom from each snake. The minimum amount of each antivenom is as follows:
Black snake antivenom 18,000 units; Taipan antivenom 12,000 units; Death adder antivenom 6,000 units; Tiger snake antivenom 3,000 units; Brown snake antivenom 1,000 units.
Total 40,000 units.
Each 1 mL of 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 dependent thus it varies from batch to batch. Please refer to the product volume printed on the carton.

3 Pharmaceutical Form

Polyvalent Snake Antivenom is a concentrated injection for intravenous use. It is a light straw coloured, slightly viscous, transparent solution in a glass vial.

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

The venoms of some snakes from Australia and Papua New Guinea contain neurotoxins which can cause respiratory paralysis, and coagulants (except in the death adder) which convert prothrombin to thrombin, which in turn produces a secondary afibrinogenaemia with resultant haemorrhage. The venoms of some snakes also contain a myolytic toxin which can cause renal failure.
Although the amount of antivenom in each dose of Polyvalent Snake Antivenom will neutralise the average yield of venom from each snake in vitro, the actual amount needed in clinical practice may be considerably more, particularly if treatment is delayed and the effects of the venom are already evident.

Clinical trials.

No data available.

5.2 Pharmacokinetic Properties

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

5.3 Preclinical Safety Data

Genotoxicity.

No data available.

Carcinogenicity.

No data available.

4 Clinical Particulars

4.1 Therapeutic Indications

For the treatment of patients in Papua New Guinea and in all Australian states except Victoria and Tasmania who exhibit manifestations of systemic snake envenoming and the snake has not been definitely identified. In Tasmania, Tiger Snake Antivenom should be used rather than polyvalent antivenom whilst in Victoria a combination of Tiger Snake Antivenom and Brown Snake Antivenom is the preferred treatment.
Polyvalent Snake Antivenom should not be used when the snake has been identified, as appropriate monovalent antivenom provides similar neutralisation of the venom without introducing the larger amounts of equine protein present in the polyvalent product.

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 Polyvalent 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.
In many cases of snake bite, little venom is injected and significant systemic envenoming does not occur. 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 (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.
To minimise the amounts of equine protein administered, the appropriate monovalent antivenom should be used wherever possible for an identified snake (see Section 4.1 Therapeutic Indications). However, if the appropriate monovalent antivenom is not available or in insufficient quantity, Polyvalent Snake Antivenom may be useful, as it contains components against five venom immunotypes. Seek expert advice in the case of an identified snake, where supply of monovalent antivenom is an issue.

Use in the elderly.

No data available.

Paediatric use.

See Section 4.2 Dose and Method of Administration.

Effects on laboratory tests.

No data available.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

No data available.
There is limited but inconclusive information on the safety of the product in pregnant women. It is advisable to carefully weigh the risks of untreated envenoming against the expected benefits and potential risks of antivenom administration.
No information is available on the use of the product during lactation. It is advisable to carefully weigh the risks of untreated envenoming against the expected benefits and potential risks of antivenom administration.

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.

Common: allergic reactions including anaphylactic shock and delayed serum sickness.

Nervous system disorders.

Common: headache.

Gastrointestinal disorders.

Uncommon: abdominal pain, vomiting, nausea and diarrhoea.

Skin and subcutaneous tissue disorders.

Common: urticaria, rash.

Musculoskeletal and connective tissue disorders.

Uncommon: myalgia.

General disorders and administration site conditions.

Common: pyrexia, chills. Uncommon: local injection site reactions, chest pain.

Reporting suspected adverse effects.

Reporting suspected adverse reactions after registration of the medicinal product is important. It allows continued monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals are asked to report suspected adverse reactions at www.tga.gov.au/reporting-problems.

4.2 Dose and Method of Administration

A proportion of people bitten by snakes have symptoms that are so mild that antivenom is not necessary. When there is evidence of systemic envenoming and the snake has not been identified, the contents of one vial (40,000 units) of Polyvalent Snake Antivenom should be administered slowly by intravenous infusion after dilution with Hartmann's solution or 0.9% w/v sodium chloride. Once diluted, Polyvalent 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 for patients at risk of fluid overload. 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 sooner than adults and may need more antivenom. Patients with severe systemic envenoming may require several vials of antivenom to control the effects, particularly if coagulopathy is present. Amounts as high as 6 vials have been used in the treatment of severe systemic envenoming; 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.
Polyvalent Snake Antivenom contains no antimicrobial preservative. Use in one patient on one occasion only and discard any residue.

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.

4.9 Overdose

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

7 Medicine Schedule (Poisons Standard)

S4.

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

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

6.5 Nature and Contents of Container

Polyvalent Snake Antivenom is available as 1 x 40,000 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.

Summary Table of Changes