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Zalcal

Main information

  • Trade name:
  • Zalcal 20 CMD Solution for Injection
  • Available from:
  • Listow Limited
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Zalcal 20 CMD Solution for Injection
    United Kingdom
  • Language:
  • English

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 41687/4011
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Revised: October 2012

AN: 00838/2012

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Zalcal 20 CMD Solution for Injection

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each 400 ml vial contains :

Active Substance:

Contains: Calcium Borogluconate 20% w/v

Magnesium Hypophosphite Hexahydrate 5% w/v

Glucose Monohydrate 22% w/v

Each 400ml contains:

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

1.84g magnesium (provided by magnesium hypophosphate hexahydrate)

80g glucose as glucose monohydrate

Also contains 3.40% w/v boric acid.

Excipient:

Chlorocresol 0.10% 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

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Revised: October 2012

AN: 00838/2012

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.

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 (s)

Meat - Zero days

Milk- Zero hours

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Revised: October 2012

AN: 00838/2012

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

Water for injection

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 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

(2) Do not store above 25°C.

(3) Protect from light.

6.5 Nature and composition of immediate packaging

400 ml amber Type III glass bottle, with natural rubber wads and aluminium screw

caps

400 ml natural polypropylene vial with Bromobutyl bung with aluminium overseals.

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Revised: October 2012

AN: 00838/2012

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

Listow Limited

9 Belgrave Square

London

SW1x 8PH

8. MARKETING AUTHORISATION NUMBER

Vm

: 41687/4011

9. DATE OF FIRST AUTHORISATION

Date: 23 May 2000

10. DATE OF REVISION OF THE TEXT

Date: October 2012

Page 4 of 4

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There are no news related to this product.

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