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Dunlop's

Main information

  • Trade name:
  • Dunlop's 20% w/v PMD Solution for Injection
  • Available from:
  • Norbrook Laboratories Limited
  • Pharmaceutical form:
  • Solution for injection
  • Prescription type:
  • POM-VPS -Prescription Only Medicine – Veterinarian, Pharmacist, Suitably Qualified Person
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Dunlop's 20% w/v PMD Solution for Injection
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Sheep
  • Therapeutic area:
  • Mineral

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 02000/4206
  • Authorization date:
  • 23-05-2000
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Revised: July 2010

ATCVet code amended

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Dunlops 20% w/v PMD Solution for Injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance:

Contains Calcium Gluconate 16.6% w/v

Magnesium Hypophosphite Hexahydrate 5% w/v

Glucose Monohydrate 22.0% w/v

Each 400 ml contains:

5.92 g calcium (provided by calcium gluconate and calcium

borogluconate)

1.84 g magnesium (provided by magnesium hypophosphite

hexahydrate)

80 g glucose provided by glucose monohydrate.

Also contains 3.40% w/v boric aid.

Excipients:

Chlorocresol 0.1% w/v

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Solution for injection

A clear, pale yellow aqueous solution

4. CLINICAL PARTICULARS

4.1 Target species

Sheep

4.2 Indications for use, specifying the target species

For the treatment of hypocalcaemia complicated by deficiency of

magnesium with accompanying hypoglycaemia. In the treatment of

pregnancy toxaemia and other metabolic imbalances in periparturient

sheep

1

Revised: July 2010

ATCVet code amended

4.3 Contraindications

Not to be administered by intravenous or intramuscular routes

4.4 Special Warnings for each target species

No special warning.

4.5 Special precautions for use

i. Special precautions for use in animals

The solution should be warmed to body temperature before

administration.

ii. Special precautions to be taken by the person administering the

veterinary medicinal product to animals

Care should be taken to avoid accidental self-injection.

If accidental self-injection occurs, seek medical advice. Wash

hands after use.

4.6 Adverse reactions (frequency and seriousness)

None

4.7 Use during pregnancy, lactation or lay

Can be safely administered to pregnant and lactating animals

4.8 Interaction with other medicinal products and other forms of

interaction

None known

4.9 Amounts to be administered and administration route

The solution should be warmed to body temperature before

administration by subcutaneous injection only. Observe aseptic

precautions. Sites of administration should be massaged gently.

Sheep: 50 - 80 ml

4.10 Overdose (symptoms, emergency procedures, antidotes), if

necessary

Not applicable.

2

Revised: July 2010

ATCVet code amended

4.11 Withdrawal period

Meat – Zero days

Milk – Zero hours

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Mineral supplements, Calcium,

Calcium, combinations with other drugs

ATC Vet Code: QA12AX

5.1 Pharmacodynamic properties

Milk fever, characterised by hypocalcaemia is caused by an acute drop

in the level of calcium in the blood. At parturition hypophosphataemia

and hypomagnesaemia can also occur. When administered by

subcutaneous injection the product replenishes plasma concentrations

of calcium, phosphate and magnesium ions. Dextrose is included as

an energy source to coincide with the high turnover of energy during

lambing.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Chlorocresol

Sodium Bicarbonate (for pH adjustment)

Water for Injection

6.2 Incompatibilities

None known

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale:

Amber Glass Bottles 2 years.

Polypropylene Vials 2 years.

Shelf life after first opening the immediate packaging: 28 days

6.4 Special precautions for storage

(1) Following withdrawal of the first dose use the contents within 28

days. Discard unused material.

(2) Do not store above 25°C.

(3) Protect from light.

3

Revised: July 2010

ATCVet code amended

6.5 Nature and composition of immediate packaging

400 ml amber Type III glass bottles, with natural rubber wads and

aluminium screw caps or 400 ml polypropylene vials with bromobutyl

bungs and aluminium overseals

6.6 Special precautions for the disposal of unused veterinary medicinal

product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived

from such veterinary medicinal products should be disposed of in

accordance with local requirements.

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down, BT35 6JP

8. MARKETING AUTHORISATION NUMBER(S)

Vm

02000/4206

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

Date of first authorisation: 23 rd May 2000

10. DATE OF REVISION OF THE TEXT

July 2010

4

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