In addition to the standard labelling requirements, labels on non-prescription injectable products must also carry the following information, as applicable.

2. Product name

2.1. Calcium, magnesium, glucose and phosphorus solutions for the treatment of metabolic diseases in sheep and cattle

Use of the phrase ‘four in one’ or ‘4 in 1’ in the product name for products containing calcium, magnesium, glucose and phosphorus may be used, provided that only the:

  • calcium, phosphorus and magnesium content are declared as active constituents, as per the example below:
    • Active constituents – per 500 mL
    • Calcium (as the gluconate) – 12.50 g
    • Phosphorus (as the hypophosphite) – 6.00 g
    • Magnesium (as the hypophosphite) – 2.35 g
    • Also contains:
    • Glucose (as dextrose monohydrate) – [x] g
  • treatment of hypocalcaemia (parturient paresis or milk fever) and related metabolic diseases (transit paresis, transit tetany) in sheep and cattle are claimed in the indications for use. The claim may also include the treatment of hypomagnesaemia (grass tetany or lactation tetany), provided that directions are given for initial treatment with a magnesium salt solution, as well as with the product making the claim. The claim should not include any indication for hypoglycaemia (pregnancy toxaemia or ketosis or acetonaemia).

4. Statement of claims for use

4.1. Intravenous injections (non-prescription)

For all non-prescription products (excluding remedies for metabolic diseases – see below) that are intended for intravenous administration, the following statement must appear as part of the ‘Statement of claims for use’ and immediately below the ‘Dosage and administration’ subheading.

For intravenous (IV) use by or under the direction of a veterinarian.
Click to view label presentation

The statement should appear in bold-face, sans-serif letters as shown. For print size and style requirements, refer to the Printing and legibility requirements.

 

4.2. Calcium, magnesium, glucose and phosphorus solutions for the treatment of metabolic diseases in sheep and cattle

For injectable solutions of calcium, magnesium, glucose and/or phosphorus for the treatment of metabolic diseases in sheep and cattle, the following statement must appear as part of the ‘Statement of claims for use’ and immediately below the ‘Dosage and administration’ subheading.

Use of this product intravenously may be hazardous to the animal and advice from a veterinarian should be sought.
Click to view label presentation

The statement should appear in bold-face, sans-serif letters as shown. For print size and style requirements, refer to the Printing and legibility requirements.

 

6.5. Dosage and administration

6.5.1. Intravenous injections (non-prescription)

For all non-prescription products (excluding remedies for metabolic diseases – see below) that are intended for intravenous administration, the following statement must appear as part of the ‘Statement of claims for use’ and immediately below the ‘Dosage and administration’ subheading.

For intravenous (IV) use by or under the direction of a veterinarian.
Click to view label presentation

The statement should appear in bold-face, sans-serif letters as shown. For print size and style requirements, refer to the Printing and legibility requirements.

 

6.5.2. Calcium, magnesium, glucose and phosphorus solutions for the treatment of metabolic diseases in sheep and cattle

For injectable solutions of calcium, magnesium, glucose and/or phosphorus for the treatment of metabolic diseases in sheep and cattle, the following statement must appear as part of the ‘Statement of claims for use’ and immediately below the ‘Dosage and administration’ subheading.

Use of this product intravenously may be hazardous to the animal and advice from a veterinarian should be sought.
Click to view label presentation

The statement should appear in bold-face, sans-serif letters as shown. For print size and style requirements, refer to the Printing and legibility requirements.

 

6.6. General directions

6.6.1. Subcutaneous injections (non-prescription)

For non-prescription products intended for subcutaneous administration to food-producing animals, the following directions should appear with the ‘Caution’ statement under the subheading ‘General directions’.

Caution: avoid carcass damage
1. Sterilise all injection apparatus by boiling (or equivalent) before use. Avoid use of strong disinfectants on apparatus.
2. Maintain cleanliness at all times.
3. Keep needles sharp and clean. Replace frequently.
4. Use shortest needle possible, certainly not exceeding 15 mm.
5. As far as possible, avoid injection of animals during wet weather or under dusty conditions.
6. This product should be injected only under the skin.
7. If possible, inject high on the neck behind the ear.
Click to view label presentation

The ‘Caution’ statement should appear in bold-face, sans-serif letters in sentence case. For print size and style requirements, refer to the Printing and legibility requirements.

 

Note:

  • Items 4, 5 and 7 may not be appropriate for calcium borogluconate and other metabolic disease remedies, or for other injections of relatively large volume.
  • Item 7 may not be appropriate for products administered to poultry.

6.6.2. Intramuscular injections (non-prescription)

For non-prescription products intended for intramuscular administration to food-producing animals, the following directions should appear with the ‘Caution’ statement under the subheading ‘General directions’.

Caution: avoid carcass damage
1. Sterilise all injection apparatus by boiling before use. Avoid use of strong disinfectants on apparatus.
2. Maintain cleanliness at all times.
3. Keep needles sharp and clean. Replace frequently.
4. Use needles of appropriate gauge and length.
5. As far as possible, avoid injection of animals during wet weather or under dusty conditions.
6. This product should be injected only into muscle tissue.
7. If possible, inject into muscle tissue on side of neck.
Click to view label presentation

The ‘Caution’ statement should be in bold-face sanserif letters in sentence case. For print size and style requirements, refer to the Printing and legibility requirements.

 

Note:

  • We suggest you replace Item 7 for injectable iron compounds for preventing piglet anaemia – because of insufficient bulk of cervical muscle in newborn piglets – with:
Injections may be made into the muscles of the hind leg. This product is not to be administered to piglets after the first 4 weeks of life.
  • Item 7 may not be appropriate for products administered to poultry.

6.6.3. Combined intramuscular or subcutaneous injections (non-prescription)

For non-prescription products intended to be administered either intramuscularly or subcutaneously to food-producing animals, the following directions should appear with the ‘Caution’ statement under the subheading ‘General directions’.

Caution: avoid carcass damage
1. Sterilise all injection apparatus by boiling before use. Avoid use of strong disinfectants on apparatus.
2. Maintain cleanliness at all times.
3. Keep needles sharp and clean. Replace frequently.
4. Use needles of appropriate gauge and length. For subcutaneous administration, use shortest needle possible, certainly not exceeding 15 mm.
5. As far as possible, avoid injection of animals in wet weather or under dusty conditions.
6. Intramuscular injections should be made into muscle tissue on the side of the neck. Subcutaneous injections should be made under the skin, high on the neck behind the ear.
Click to view label presentation

The ‘Caution’ statement should be in bold-face, sans-serif letters in sentence case. For print size and style requirements, refer to the Printing and legibility requirements.

 

Note:

  • Item 6 may need to be modified to delete the reference to injection on the neck for products administered to poultry.