Veterinary Descriptions

Trade name product

A trade name product is an agricultural compound containing one or more active ingredient(s) normally mixed with non-active ingredients (such as surfactants, solvents, diluents, suspending agents) intended for application with or without dilution before use and which is labeled with directions for use.

 

The regulation of animal remedies is usually of trade name products (rather than the active ingredients) since the way products are formulated and used generally determines the level of risk.

 

Agricultural compounds

These are substances used in the management of agricultural plants or animals, and include such things as poisons for possums, animal growth regulators and plant compounds as well as veterinary medicines.

 

Agricultural compounds fall into three classes:

• 1). Veterinary medicines are substances or biological compounds used for the direct management of animals. These include things such as anaesthetics, antibiotics and vaccines.

•  

• 2). Plant compounds are used for direct management of plants in an agricultural context. These include herbicides, fungicides and plant growth regulators.

•  

• 3). Vertebrate toxic agents are poisons intended to kill vertebrate pests. This group includes compounds such as 1080, cyanide and brodifacoum.

 

These substances must be imported, manufactured, labeled, used and sold in specified ways.

 

A range of compounds and substances are conditionally exempt from registration if they are used in accordance with conditions specified in the Agricultural Compounds and Veterinary Medicines Regulations 2001. These include non-prescription first aid preparations, homeopathic compounds that make no specific therapeutic claims, and fertilisers

 

Veterinary medicine

Any substance, mixture of substances, or biological compound used or intended for use in the direct management of an animal (ACVM Act 1997). The term is commonly used to describe substances dispensed by veterinarians in promote good health or control or treat disease in animals. 

 

Animal remedy

A term commonly used to describe any substance that is administered to an animal with a view to promoting good health or controlling or treating disease in animals. 

 

Prescription

In relation to veterinary medicines, a prescription is a written directive authorised by a practicing veterinarian for the dispensing of a medicine and it includes directions on how it should be administered.

Anthelmintic

A product that is destructive to worms, which may be nematodes, flukes or tapeworms.

 

Anticoccidial

A substance that is destructive to coccidia, which are a type of one-celled parasite in the intestine.

Product name

The brand name

 

ACVM license number

The number that legally describes the product with the agricultural compounds and veterinary medicine group.

 

OTC/PAR Class        This description is outdated but is a useful reference as it describes in broad terms the usage criteria that products meet. It is familiar to many farmers and Vets.

Products are now registered with “Conditions of registration” and these are numbered on products and the details can be found on the New Zealand Food Safety Authority Website. These detail conditions of use, advertising etc.

However

OTC  (over the counter)

Over the counter. These are sold without restrictions on sale or purchase.

 

PAR class

A PAR is a Prescription Animal Remedy.  It may be sold and used only with the authorisation or prescription of a practicing veterinarian. In other words, a PAR product must not be used unless a registered practicing veterinarian specifically authorises its use by the person who uses it. 

 

PARs are graded as follows:

o   PARI or PAR Class 1

o   PARII or PAR Class 2

o   PARIII or PAR Class3

 

The grading reflects the degree of veterinary control that is required for their use.

o   PAR Class 1 – To be administered only by a veterinarian or under and in accordance with the authority r prescription of a veterinary surgeon

o   PAR Class 2 – To be administered only by a veterinarian or in the presence and under the direct control of a veterinarian

o   PAR Class 3 – To be administered only by a veterinarian.

 

Composition / Description and presentation

A description of the appearance of the product, the active ingredient, the form it is in (i.e. solution, suspension, tablet), its concentration and pack size)

 

New Zealand agent, distributor or manufacturer

The Company’s name is given.

 

Usage information

 

Ethical use of animal remedies

 

The Agricultural Compounds and Veterinary Medicines (ACVM) Act in 1997 imposes controls on the way in which animal remedies are used in New Zealand., For example farmers can no longer buy some animal remedies over the counter and the use of prescription animal remedies is controlled by veterinarians . 

 

The legislation is a response to world-wide concern about antibiotic resistance (in some types of disease-causing bacteria) and chemical residues (in animal products especially food). The Act ensures that sale and use of agricultural compounds and veterinary medicines are tightly regulated while still enabling high standards of animal health and welfare to be maintained. In other words, the regulations are designed to ensure the ethical use of animal remedies, so that there is minimal risk of unintended exposure of humans or animals to products that could potentially be harmful.

 

 

Expiry date

If correctly stored, the active ingredient in the product should stay fully active until the expiry date that is printed or stamped both on the pack and on the drug container itself. After this date there is no certainty that the product will be fully active, so the product should not be used after the expiry date. 

 

It’s important to check the expiry date especially when buying large quantities of animal remedy as the product may be on the shelf for some time.

 

Products that have not been stored correctly may have a shorter shelf life than indicated because of breakdown of the active ingredients.

 

Some products, for example some vaccines, should only be used soon after their container has been opened.  Any unused product must be disposed of appropriately. 

 

Products should be disposed of when the expiry date is reached. Many Quality Assurance programmes require that no expired veterinary medicines and animal remedies are retained.

 

Note that some animal remedies are chemically inert and as they do not break down over time no expiry date is shown.  

 

Disposal of unused and out-of-date remedies

Unused product and out of date product should be returned to the veterinary clinic or supplier from which it was obtained or otherwise disposed of in such a way that it cannot be accessed by humans or other animals. 

 

Route of administation

The route of administration is the way in which the product is given. This could be by mouth (orally) or injection (parenterally). If by injection it may be given by various routes, and the most common are subcutaneous (under the skin), into the muscle (intra-muscular) and into a vein (intravenous).

Storage

Most products should be stored in a cool dark place, as warmth and light can promote chemical reactions that could break down the active ingredient.

 

Any specific requirements for storage of an animal remedy (e.g. refrigeration) are printed on the packaging and on the product container.

 

The conditions must not be exceeded. For example, freezing should not replace refrigeration, or products like some vaccines will be degraded.

 

If some products are not stored in appropriate conditions there can be premature breakdown so the product becomes unfit for its purpose. This can happen well before the expiry date.

 

Off-label use

‘Off-label use’ refers to the use of a product in a manner and/or on a species of animal that was not assessed and approved when the product was registered.  The uses recommended by the registrant of the product are always shown on the label. Consequently, any use not listed on the label is an “off-label” use.

 

Registration generally allows off-label uses, provided the user takes proper precautions to avoid breaches in residue standards.  

 

In the case of veterinary medicines, the user must confirm by consulting a veterinarian that the intended off-label use is likely to be safe, appropriate, and will not cause breaches in residue standards.

 

When using a product in a species it is not registered for, there are default withholding periods. These are:

• Ruminants including deer: Meat 91 days, milk 35 days.

• Camelids: Meat 63 days.

• Rabbits: Meat 63 days.

• Pigs, horses: Meat 63 days.

• Birds: Meat 63 days, eggs 10 days.

 

These withholding periods do not apply to sustained-release formulations because the withholding period must apply to the time after the release period, not the time of administration.

 

Note that products manufactured to treat plants must be used only on plants, not on animals, and vice versa. 

 

Sterility

“Sterility” means free of contamination by microbes such as bacteria, fungi and viruses. All animal remedies are free of potentially harmful microbes, but not all products are completely sterile. 

 

Products intended for injection are completely sterile. The exception is live vaccines that contain a weakened form of the microbe that is to be protected against. 

 

Opening a container or any other break in the container of a sterile product can allow microbes to enter and proliferate. This can be very dangerous especially if the product is injected into an animal’s body, This is why it is important that some products such as vaccines are not retained for use once the seal of their container has been breached. 

 

The manufacturer’s instructions will indicate for how long a product can be retained for use after opening. 

 

Abbreviations

b.w.                 bodyweight

C                     Celsius

cm.                  centimetres

g.                     grams

Gram –ve        Gram negative

Gram +ve       Gram positive

i/m.                  intramuscular, into muscle

i/mamm.          intra-mammary, into the udder through the teat canal

i/p.                   intra-peritoneal, into the abdominal cavity, into the abdomen

i.u.                   international unit of measure

i/v.                   intravenous, into a vein

kg.                   kilograms

L.                     litres

l.w.                   liveweight

mcg or µg        microgram, a ??? of a gram

mg.                  milligrams

mL.                  millilitres

mm.                 millimeters

orally               by mouth

ppm                 parts per million

s/c.                  subcutaneous, below the skin

sp                    species (singular)

spp                  species (plural)

topically           applied to the skin surface

w/v                  weight per volume

w/w                  weight per weight

CNS                central nervous system

NSAID non-steroidal anti-inflammatory

Tbsp                tablespoonful

Tsp                  teaspoonful

Dosage

Information on dosage may include the species of animal, the route and site of administration, the volume or weight of product to be given per kg body weight, the timing of treatments and the way in which they should be given.

 

Some animal remedies are not dose dependent and the same dose can be given to each animal in a group. However most should be given in a volume related to the body size of the animal, i.e. at an appropriate dose rate. The manufacturer’s recommended dose rates are determined by careful research and should be strictly followed. Giving too much to any animal can cause toxicity (poisoning) and is wasteful, and giving too little can encourage resistance and may be ineffective. 

 

Some remedies require a constant concentration in the animal’s body for a period of time so they may require daily administration or regular dosing for a certain period of time. Other remedies require repeat doses after a specified time, e.g. some vaccines require a priming dose and a booster several weeks later

 

 

 

Information and Legislation

 

Action

The chemical name of the product and its effect in the body, i.e. its pharmacological effect.

 

Indications

The reasons why the product might be given or the types of condition it might be used to treat, in other words, its preventive or remedial properties for relevant species

 

Contraindications

Circumstances in which the drug should not be used.  There are some predictable and untoward reactions to inappropriate use of some animal remedies. For example bloat remedies may be toxic to unweaned calves.

 

Toxicity/Antidote

This indicates the level of dosage that can be poisonous (toxic) and describes treatment or the antidote if relevant. The National Poisons Centre will advise (phone 0800 POISON or 0800 764 766).

 

 

Side effects

Adverse effects that may follow the recommended dose in the treated animal and an outline of the appropriate action to take.

 

Special precautions

Actions that should be taken to ensure the safety of humans and other animals when the product is being used

 

Withholding period

The withholding period is the time that must elapse between the last application of a veterinary medicine or chemical and consequent sale for processing for use by the meat, dairy, poultry or wool industries.

 

For any treated animal there may be different withholding periods for different products. For example when a cow has been treated with a pour-on remedy there may be different withholding periods for her milk, meat and bobby calves.

 

The container of all animal remedies clearly indicates the withholding period for that remedy. 

 

Most countries that import animal products have food safety standards that are strictly legally enforced and regularly audited with heavy penalties for farmers and processors if animal products exceed permitted concentrations.

 

First aid: Symptoms of poisoning

The effects of accidental poisoning of humans and actions to be taken if human poisoning occurs.

 

Other information
Any additional information that is considered relevant, including known drug interactions, need to avoid contamination of waterways, storage requirements. For some products, approved handlers may be required for large quantities (see ERMA website: erma.govt.nz).

 

Useful websites

 

New Zealand Food Safety Authority

The New Zealand Food Safety Authority protects and promotes public health and safety, and facilitates access to markets for New Zealand food and food related products.

 

The Agricultural Compounds and Veterinary Medicines (ACVM) group within the New Zealand Food Safety Authority (NAFSA) is responsible for the implementation of the ACVM Act. The ACVM group is responsible for approving veterinary medicines and other agricultural compounds used in the direct management of animals and plants.

 

Website: nzfsa.govt.nz

 

Environmental Risk Management Authority or ERMA

ERMA helps protect the environment and the health and safety of people and communities by helping prevent and managing the adverse effects of hazardous substances and new organisms.

 

Website: ermanz.govt.nz

 

Resistance

‘Resistance’ when used in relation to antibiotics or anthelmintics means that the active ingredient in the product is no longer fully effective against one or more of the target organisms, which may be nematode parasites (anthelmintic resistance) or bacterial species (antibiotic resistance). Factors that favour the development of resistant organisms include treatment of infected animals with doses that are too small or too frequent.