Oral electrolyte products for the treatment of horses in exercise
Guideline Number 71
December 2010
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Background
This guideline was published on 8 December 2010 to establish arrangements whereby low-risk equine electrolyte products may be registered with reduced cost.
See the announcement of the guideline, and the the consultation process by which it was developed.
1. Purpose
The purpose of this model is to set out the regulatory requirements and provide a model (template) for the registration of a class of veterinary chemical products termed orally-applied dry soluble powder equine electrolyte products, including parameters for:
- permissible constituents
- chemistry and manufacture
- use pattern and allowable therapeutic claims
- labelling, including instructions for use and handling
- containers
For the purposes of this document electrolytes are minerals that are dissolved in the blood and cellular fluids including sodium, potassium, chloride, calcium, magnesium, and phosphate as electrically charged salts or ‘ions’. Electrolytes or ‘body salts’ are involved in nerve transmission, muscle contraction processes, metabolic processes, and water balance. Electrolytes are lost in sweat, tears, digestive secretions, urine and droppings.
Equine electrolyte products require registration where they are represented as being suitable for, supplied or used to treat diseases or conditions in horses resulting from a deficiency of electrolytes, and/or to improve or modify the health, production, performance or behaviour of an animal.
Equine electrolyte products are usually administered in the horse’s feed, or may e administered in the drinking water. In some situations, for example to ensure that the recipient has consumed the entire dose intended for administration, aqueous solutions can be administered directly into the mouth using a delivery device appropriate for this purpose. In certain cases it may be considered necessary to administer the electrolyte product by stomach tube1.
If an electrolyte product conforms to this model, a person may apply to the Australian Pesticides and Veterinary Medicines Authority (APVMA) to register the product by reference to the model. Application must be made under Category 10 - modules 1 and 11.4 will be applicable. Further information on making a Category 10 application can be obtained from the APVMA’s Veterinary Manual of Requirements and Guidelines (MORAG) (see also Section 7 below).
An application for registration of an electrolyte product according to this model does not require the submission of any data, apart from any data specified in this document. Such applications also do not require the nomination of an appropriate reference product as the model sets the parameters within which the APVMA is satisfied.
If the electrolyte product contains bicarbonate or citrate ions, makes any claims other than those specified herein, or does not comply with this model in any other way, additional data, modular fees and timeframes will apply.
It is important to note that certain stockfood supplements, including certain electrolyte products, are excluded from the requirements of registration. This model is only applicable to those electrolyte products that are required to be registered by the APVMA. Further detail regarding electrolyte products that do and do not require registration is included in Section 2 ‘Determining the Requirement to Register Electrolyte Products’ below.
1 Administration of electrolyte products by stomach tube is associated with a number of potentially serious adverse effects and should only be undertaken by or under the direct supervision of an appropriately qualified veterinarian.
2. Determining the requirement to register electrolyte products
Electrolyte products for use in animals DO NOT require registration if:
- the product is presented in whole food or in a food premix for voluntary ingestion; or as a block or a lick for voluntary ingestion; or with directions to administer in the feed for voluntary ingestion (not administered as a drench or by stomach tube); and
- the only claim on the label consists of the words ‘to supplement diets where levels may be low’, or words to that effect 2; and
- the product is formulated in such a way that after following the label directions for use the intended recipient receives between 25% and 100% of the daily requirement of each electrolyte (from all sources for maintenance, growth and exercise) as recommended by the US National Research Council of the US National Academy of Sciences (the ‘NRC’).
Such products are excluded by Regulation 8 of the Agricultural and Veterinary Chemicals Code Regulations 1995 from the operation of the veterinary chemical product definition provided by Section 5 of the Agricultural and Veterinary Chemicals Code 1994 (the Agvet Code).
The words “For Animal Treatment Only” should not be included on the label of excluded stockfood supplements that do not require registration with the APVMA.
Electrolyte products for use in animals DO require registration if:
- the product is to be administered parenterally, or enterally via a stomach tube or directly into the animal’s mouth for the direct or indirect prevention or treatment of a disease or condition caused by an electrolyte deficiency; or
- where any claim in relation to the product is made beyond ‘to supplement diets where levels may be low’ (or words to that effect – see footnote 2), such as a claim to prevent or treat a disease or condition caused by an electrolyte deficiency or to improve and/or modify the health, production, performance or behaviour of an animal.
Such products are considered to be represented as being suitable for, supplied or used for a purpose commensurate with the definition of a veterinary chemical product provided by Section 5 of the Agvet Code.
The registration model set out in this document relates only to those products requiring registration and which conform to the parameters set out below.
2 Claims considered by the APVMA to be to the effect of ‘to supplement diets where levels may be low’ are set out in the Guideline for Stockfeed Supplement Products Containing Vitamins, Minerals or Amino Acids and Containing Only ‘Nutritional Messages’ (PDF, 105kb) which is published in Volume 4 of Vet MORAG.
3. Use pattern parameters
The products to which this model applies may only be for the purposes set out below. Labelling requirements, including allowable claims and instructions for use, are set out in Section 5 of this model.
3.1 Target animal species
Healthy horses suitable for exercise and work.
3.2 Uses of the class of products
Exercising horses have an absolute requirement to dissipate the heat generated by muscular activity. One of the most important mechanisms of heat dissipation in the horse is by evaporative cooling following sweating. Equine sweat is a hypertonic electrolyte solution and significant quantities of both fluid and electrolytes are lost in sweat.
Equine electrolyte products are used to aid replacement of the electrolytes lost in sweat and when provided in conjunction with freely available water allow the horse to rehydrate and replace water lost in sweat.
Quantitatively, the most significant electrolytes lost by horses in sweat include sodium (present at 3.0 - 3.7 g/L), potassium (present at 1.2 - 2.0 g/L) and chloride (present at 5.3 - 6.2 g/L). Equine sweat also contains relatively low levels of calcium (0.08 - 0.3 g/L), magnesium (0.024 - 0.14 g/L), and phosphate (<0.01 - 0.3 g/L).
3.3 Dose Rate
Fluid and electrolyte loss in sweat during exercise is related to the speed and duration of work, the environmental conditions (temperature and humidity) and the training status and fitness of a horse.
The dose rates set out in Section 5 (Labelling Requirements) of this model for the heavy sweat and moderate sweat formulations discussed in Section 4.3.1 (Formulation) have been determined in cognisance of the NRC recommendations for the replacement of sweat losses as estimated by bodyweight loss during exercise.
The dose rates set out in this model are considered to be appropriate and safe. However as noted in Section 5 (Labelling Requirements), veterinary or nutritionist advice should be sought on the appropriate use of electrolytes and to ensure that daily electrolyte intakes from the diet and electrolyte products match the daily requirements of each horse. This is reflected in the required label instruction and is consistent with normal industry practice.
4. Chemistry and manufacture parameters
The products to which this model applies may contain only the constituents set out in Sections 4.1 and 4.2 below. The concentration of any constituents must not exceed any limits specified below. Where no limits are specified the allowable concentration of those constituents may be at the manufacturer’s discretion.
4.1 Active constituents
Equine electrolyte products to which this model applies may contain the following active constituents:
| EQUINE ELECTROLYTE ACTIVE CONSTITUENTS | AUSTRALIAN APPROVED NAME and STANDARD | ELECTROLYTE(S) PROVIDED |
|---|---|---|
| AMMONIUM CHLORIDE | Ammonium chloride BP | Chloride |
| CALCIUM CARBONATE | Calcium carbonate BP | Calcium |
| CALCIUM PHOSPHATE | Calcium hydrogen phosphate BP Calcium hydrogen phosphate anhydrous BP Calcium phosphate BP |
Calcium Phosphate |
| MAGNESIUM CARBONATE | Magnesium carbonate USP | Magnesium |
| MAGNESIUM OXIDE | Magnesium oxide USP | Magnesium |
| MAGNESIUM SULFATE | Magnesium sulfate BP | Magnesium |
| POTASSIUM CHLORIDE | Potassium chloride BP | Potassium Chloride |
| POTASSIUM PHOSPHATE | Potassium phosphate - dibasic trihydrate USP Potassium phosphate - monobasic USP |
Potassium Phosphate |
| SODIUM CHLORIDE | Sodium chloride BP | Sodium Chloride |
| SODIUM PHOSPHATE | Sodium phosphate – dibasic USP Sodium phosphate - dibasic anhydrous USP Sodium phosphate - dibasic dihydrate USP Sodium phosphate – dibasic dodecahydrate USP Sodium phosphate - dibasic monohydrate USP Sodium phosphate - monobasic USP Sodium phosphate – tribasic USP |
Sodium Phosphate |
Note: BP means the British Pharmacopoeia; USP means the United States Pharmacopeia
4.2 Non-active constituents
Equine electrolyte products to which this model applies may contain non-active constituents that fulfil a variety of functions such as improving the physical characteristics of the formulation, or enhancing its attractiveness.
Permitted non-active constituents are flavouring agents and those anti-caking and colouring agents listed in standards published by Food Standards Australia New Zealand as approved food additives (external site).
The maximum total concentration of all non-active constituents is 2%.
4.3 Formulated product details
The equine electrolyte products covered by this model are to be formulated as dry powders. They may be administered by addition to the feed or drinking water of the horse; or prepared as a ready-to-administer aqueous solution for direct administration to the horse.
4.3.1 Formulation
There are two formulation options permissible under this model:
- Heavy Sweat Formulations: This type of formulation must contain at least 70% w/w combined potassium and sodium chloride so that the ratio of potassium to sodium is 1.8-2.2:1.
- Moderate Sweat Formulations: This type of formulation must contain at least 70% w/w combined potassium and sodium chloride so that the ratio of potassium to sodium is 1:1.
These formulations may also contain any of the other constituents listed in Section 4.1 or allowed by Section 4.2 of this document.
Full details of the formulation must be included on the application form.4.3.2 Sites of product manufacture
The products registered by reference to this Model must have all steps of their manufacture carried out in premises that are licensed by the APVMA (Australian manufacturing sites) or recognised by the APVMA as being compliant with Good Manufacturing Practice (“GMP”) (overseas manufacturing sites).
Steps of manufacture include formulating, testing, filling, packaging and labelling. As part of GMP, product manufacturers must ensure the potency and purity of each product until the label expiry date by adequate testing or certification of incoming raw materials and appropriate batch release and expiry testing of formulated product.
The site of manufacture for the product must be included on the application form.
4.3.3 Shelf life
The maximum allowable shelf life for these products is 36 months when stored below 30°C (Room Temperature). Although the APVMA is satisfied that a shelf life of up to 36 months may be appropriate for products conforming to the parameters set out in this model, it is the registrant’s responsibility to be satisfied that the shelf life shown on the label is appropriate for products registered under this model. Registrants may specify a shorter shelf life where that is necessary.
4.3.4 Maximum pack size
The maximum allowable pack size for products registered under this model is 25kg.
Packaging details, including the size range, must be included on the application form.
5. Labelling requirements
The label on a container for the product must comply with APVMA’s Veterinary Labelling Code, which is published in Volume 5 of Vet MORAG. It must also contain the following elements (note: claims and instructions must be consistent with those outlined below in order for this model to apply).
Labels conforming to these requirements must be included with the application.
See the labelling requirements for oral electrolyte products for the treatment of horses in exercise (PDF, 40kb) | (RTF, 18kb).
6. Container requirements
A container for the product must meet all of the following criteria:
- be able to protect the product from the effects of microbial contamination, heat, light and moisture
- be impervious to, and incapable of chemical reaction with, its contents when under conditions of temperature and pressure that are likely to be encountered in normal service
- have sufficient strength and impermeability to prevent leakage of its contents during handling, transport and storage under normal handling conditions
- if it is intended to be opened more than once – be able to be securely and readily closed and reclosed
- have sufficient excess capacity to prevent it from breaking if its contents expand during handling, transport or storage
- enable all or any part of its contents to be removed or discharged in such a way that, with the exercise of no more than reasonable care, the contents cannot harm any person or have an unintended effect that is harmful to the environment.
Nothing in this model affects the operation of any other Australian law that applies in relation to containers for chemical products.
Details of containers must be included on the application form.
7. Other requirements
As discussed in Section 1, a person may apply to the APVMA to register a product by reference to this model by making an application under Category 10 (modules 1 and 11.4). The application must include all of the following:
- a covering letter clearly indicating that the application references the APVMA Oral Equine Electrolytes Model
- a completed application form
- the prescribed fee for modules 1 and 11.4
- two copies of the proposed product label
It should however be noted that it is not necessary for storage stability data, or other data to be submitted with the application. It is also not necessary to complete the application overview that is attached to the application form.
Further details regarding the making of a Category 10 application, including links to the application form and information about fees, can be obtained from the Category 10 description in Volume 2 of Vet MORAG.
Revision history
| Revision | Revision date | Description of revision |
|---|---|---|
| Edition 1 | December 2010 | First edition - publication to MORAG |