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Cycloprost

Main information

  • Trade name:
  • Cycloprost 5 mg/ml Solution for Injection
  • Available from:
  • Listow Limited
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
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Documents

Localization

  • Available in:
  • Cycloprost 5 mg/ml Solution for Injection
    United Kingdom
  • Language:
  • English

Other information

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Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Expired
  • Authorization number:
  • 41687/4005
  • Last update:
  • 21-12-2016

Summary of Product characteristics

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Revised: October 2012

AN: 00754/2012

SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Cycloprost 5mg/ml Solution for injection.

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each ml of product contains:

Active Substance(s): mg

Dinoprost 5.00

Excipients:

Phenol 2.50

For a full list of excipients, see section 6.1

3. PHARMACEUTICAL FORM

Solution for injection.

Clear, colourless solution.

4. CLINICAL PARTICULARS

4.1 Target species

Cattle

4.2 Indications for use, specifying the target species

Cycloprost is indicated for its luteolytic effect on corpora lutea in cattle. This

luteolytic action of Cycloprost may be utilised as follows. 1. To improve control

of the time of oestrus in cycling cattle. 2. To control breeding in cattle. 3. To

induce parturition in cattle. 4. Synchronisation of recipient cattle for embryo

transplantation. 5. To induce abortion in cattle. 6. To treat cattle which have a

functional corpus luteum but do not express behavioural oestrus (sub-oestrus or

silent heat). 7. For treatment of chronic metritis and pyometra in cattle. 8. For

treatment of ovarian luteal cysts.

4.3 Contraindications

Do not administer by the intravenous route.

Animals should not be treated if they suffer from either acute or sub acute

disorders of the vascular system, gastrointestinal tract or respiratory system.

Page 1 of 4

Revised: October 2012

AN: 00754/2012

4.4 Special Warnings for each target species

No special warnings.

4.5 Special precautions for use

i. Special precautions for use in animals

Cycloprost is ineffective when administered prior to day 5 after ovulation.

Observe aseptic precautions during use.

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

medicinal product to animals

Prostaglandins of the F

2 a type can be absorbed through the skin and may

cause bronchospasm or miscarriage.

Care should be taken when handling the product to AVOID SELF-

INJECTION OR SKIN CONTACT.

In case of accidental self-injection, seek medical advice immediately and

show the package leaflet or the label to the physician.

Women of child-bearing age, asthmatics and persons with bronchial or

other respiratory problems should avoid contact with, or wear disposable

plastic gloves when administering, the product.

Accidental spillage on the skin should be washed off immediately with

soap and water. Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Side-effects are infrequently observed and are of a transitory nature as the

compound is rapidly metabolised in the tissues.

In cattle, salivation, tremor, restlessness and mild diarrhoea can occur for 15 - 30

minutes. The side-effects disappear within one hour after the administration of

PGF

2 µ

4.7 Use during pregnancy, lactation or lay

Pregnancy status should be determined prior to injection since Dinoprost has

been demonstrated to result in abortion or parturition induction when

administered at sufficiently high doses to cattle.

If pregnant the unlikely possibility of uterine rupture should be borne in mind,

especially if cervical dilation does not occur.

4.8 Interaction with other medicinal products and other forms of interaction

None known.

Page 2 of 4

Revised: October 2012

AN: 00754/2012

4.9 Amounts to be administered and administration route

Administer by intramuscular injection.

A single injection is usually sufficient, but on occasions where a response is not

observed, a second administration of 5 ml Cycloprost may be administered 10-12

days after the first injection.

Oestrus control )

Controlled breeding )

Induction of parturition )

Induction of abortion ) 25 mg (5 ml)

Treatment of sub-oestrus )

Treatment of metritis/pyometra )

Treatment of ovarian luteal cysts )

Embryo Transplantation - Two 5 ml (25 mg) injections given at an interval of 10 -

12 days.

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

Not applicable.

4.11 Withdrawal period

Milk- Zero hours

Meat- 1 day.

Animals must not be slaughtered for human consumption during treatment.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Prostaglandins

ATC Vet Code: QG02AD01

5.1 Pharmacodynamic properties

Dinoprost is the synthetically produced nature-identical prostaglandin

(PGF

2 a ). It is a natural luteolytic hormone and is also involved in uterine

contraction at the time of parturition. The luteolytic action of PGF

2 a is used to

control the oestrus cycle in dairy cattle and therefore it is a useful aid in the

management and treatment of reproductive conditions in dairy cattle.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Phenol,

Sodium Acetate Trihydrate,

Sodium Hydroxide,

Page 3 of 4

Revised: October 2012

AN: 00754/2012

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: 21 days.

6.4 Special precautions for storage

Do not store above 25 C.

Protect from light.

Following withdrawal of the first dose, use the product within 21 days

Discard unused material.

6.5 Nature and composition of immediate packaging

10 ml and 30 ml clear colorless Type II glass vials with bromobutyl rubber bungs

with an aluminium overseal.

Not all pack sizes may be marketed.

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

41687/4005

9. DATE OF FIRST AUTHORISATION

Date: 9 th January 2001

10. DATE OF REVISION OF THE TEXT

Date: October 2012

Page 4 of 4

There are no safety alerts related to this product.

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