Advertisement

Downlands

Main information

  • Trade name:
  • Downlands Calcium Borogluconate 20% w/v PMD Solution for Injection
  • Available from:
  • Norbrook Laboratories Limited
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
Advertisement

Documents

Localization

  • Available in:
  • Downlands Calcium Borogluconate 20% w/v PMD Solution for Injection
    United Kingdom
  • Language:
  • English

Other information

Advertisement

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 02000/4205
  • Last update:
  • 21-12-2016

Summary of Product characteristics

Advertisement

Revised: June 2010

ATCVet code amended

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Downlands Calcium Borogluconate 20% w/v PMD Solution for Injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Active Substance:

Contains Calcium Gluconate 16.6% w/v, Magnesium Hypophosphite

Hexahydrate 5.0% w/v, and Glucose Monohydrate 22.0% w/v

Each 400 ml contains:

5.92 g calcium (provided by calcium gluconate and calcium borogluconate) and

1.84 g magnesium (provided by magnesium hypophosphite hexahydrate)

80 g glucose provided by glucose monohydrate.

Also contains 3.40% w/v boric acid.

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 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

4.3 Contraindications

Not to be administered by intravenous or intramuscular routes

4.4 Special Warnings for each target species

No special warning.

Page 1 of 4

Revised: June 2010

ATCVet code amended

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.

4.11 Withdrawal period

Meat - Zero days

Milk – Zero hours

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Mineral supplements, Calcium, Calcium,

combinations with other drugs

ATCVet Code: QA12AX

Page 2 of 4

Revised: June 2010

ATCVet code amended

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 (Preservative)

Sodium Bicarbonate (for pH adjustment)

Water for Injections

6.2 Incompatibilities

None known

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 2 years

Shelf life after first opening the immediate packaging: 28 days

6.4 Special precautions for storage

(1) Once a vial has been broached the contents should be used within 28

days. Discard unused material.

(2) Do not store above 25°C.

(3) Protect from light.

6.5 Nature and composition of immediate packaging

Amber Type III bottles of 400 ml, with natural rubber wads and aluminium screw

caps.

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 products should be disposed of in accordance with local requirements.

Page 3 of 4

Revised: June 2010

ATCVet code amended

7. MARKETING AUTHORISATION HOLDER

Norbrook Laboratories Limited

Station Works

Newry

Co. Down

BT35 6JP

8. MARKETING AUTHORISATION NUMBER(S)

Vm

02000/4205

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 23 rd May 2000

10. DATE OF REVISION OF THE TEXT

June 2010

Page 4 of 4

There are no safety alerts related to this product.

There are no news related to this product.

Other products from the same company

Advertisement