Ovarelin 50 ug/ml, solution for injection for cattle

Ireland - English - HPRA (Health Products Regulatory Authority)

Active ingredient:
Gonadorelin
Available from:
Ceva Santé Animale
ATC code:
QH01CA01
INN (International Name):
Gonadorelin
Dosage:
50 microgram(s)/millilitre
Pharmaceutical form:
Solution for injection
Prescription type:
POM: Prescription Only Medicine as defined in relevant national legislation
Therapeutic group:
Cattle
Therapeutic area:
gonadorelin
Therapeutic indications:
Hormone
Authorization status:
Authorised
Authorization number:
VPA10815/004/001
Authorization date:
2007-12-07

Read the complete document

Health Products Regulatory Authority

12 April 2019

CRN008S2G

Page 1 of 5

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT

Ovarelin 50 ug/ml, solution for injection for cattle

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Composition for 1 ml:

Active substance(s):

Quantity:

Gonadorelin (as diacetate tetrahydrate)

50.0 µg

Excipient:

Benzyl alcohol (E1519)

15.0 mg

For the 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: cows, heifers.

4.2 Indications for use, specifying the target species

Induction and synchronisation of oestrus and ovulation in combination with prostaglandin F

(PGF

) or analogue with or

without progesterone as part of Fixed Time Artificial Insemination (FTAI) protocols.

Treatment of delayed ovulation (repeat breeding).

A repeat breeder cow or heifer is generally defined as an animal that has been inseminated at least 2 or often 3 times without

becoming pregnant, despite having regular normal œstrus cycles (every 18 -24 days), normal œstrus behaviour and no clinical

abnormalities of the reproductive tract.

4.3 Contraindications

Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species

The response of dairy cows to synchronisation protocols may be influenced by the physiological state at the time of treatment,

which includes age of the cow, body condition and interval from calving.

Responses to treatment are not uniform either across herds or across cows within herds.

Where a period of progesterone treatment is included in the protocol, the percentage of cows displaying oestrus within a

given period is usually greater than in untreated cows and the subsequent luteal phase is of normal duration.

4.5 Special precautions for use

Special precautions for use in animals

Not applicable.

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12 April 2019

CRN008S2G

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Special precautions to be taken by the person administering the veterinary medicinal product to animals

Gonadorelin is a Gonadotropin Releasing Hormone (GnRH) analogue which stimulates the release of sex hormones. The effects

of accidental exposure to GnRH analogues in pregnant women or in women with normal reproductive cycles are unknown;

therefore it is recommended that pregnant women should not administer the product, and that women of child-bearing age

should administer the product with caution. Care should be taken when handling the product to avoid self-injection. In cases of

accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Care should be taken to avoid skin and eye contact. In cases of skin contact, rinse immediately and thoroughly with water as

GnRH analogues can be absorbed through the skin. In cases of accidental contact with eyes, rinse thoroughly with plenty of

water. People with known hypersensitivity (allergy) to GnRH analogues should avoid contact with the veterinary medicinal

product.

4.6 Adverse reactions (frequency and seriousness)

None.

4.7 Use during pregnancy, lactation or lay

Laboratory studies in rats and rabbits have not produced any evidence of a teratogenic or embryotoxic effects.

Observations in pregnant cows receiving the product in early pregnancy have not shown evidence of negative effects on

bovine embryos.

Inadvertent administration to a pregnant animal is unlikely to result in adverse effects.

4.8 Interaction with other medicinal products and other forms of interactions

None known.

4.9 Amounts to be administered and administration route

Intramuscular use.

100 µg of gonadorelin (as diacetate) per animal in a single injection.

i.e. 2 ml of the product per animal.

Judgement on the protocol to be used should be made by the veterinarian responsible for treatment, on the basis of the

treatment objectives of the individual herd or cow. The following protocols have been evaluated and could be used:

Induction and synchronisation of oestrus and ovulation in combination with aprostaglandin F2α (PGF2α) or analogue:

- Day 0: First injection of gonadorelin (2 ml of the product)

- Day 7: Injection of prostaglandin (PGF2 α) or analogue

- Day 9: Second injection of gonadorelin (2 ml of the product) should be done.

The animal should be inseminated within 16-20 hours after the last injection of the product or at observed oestrus if sooner.

Induction and synchronisation of oestrus and ovulationin combination with a prostaglandin F2α (PGF2α) or analogue

and a progesterone releasing intravaginal device:

The following FTAI protocols have been commonly reported in the literature:

-Insert progesterone releasing intravaginal device for 7 days

-Inject gonadorelin (2 ml of the product) at the progesterone device insertion.

-Inject a prostaglandin (PGF2α) or analogue 24 hours prior to device removal

-FTAI 56 hours after removal of the device, or

-Inject gonadorelin (2 ml of the product) 36 hours after progesterone releasing intravaginal device removal and FTAI 16 to 20

hours later.

Health Products Regulatory Authority

12 April 2019

CRN008S2G

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Treatment of delayed ovulation (repeat-breeding):

GnRH is injected during oestrus.

To improve the pregnancy rates, the following timing of injection and insemination should be followed:

- injection should be performed between 4 and 10 hours after oestrus detection

- an interval of at least 2 hours between the injection of GnRH and artificial insemination is recommended

- artificial insemination should be carried out in accordance with the usual field recommendations, i.e., 12 to 24 hours after

oestrus detection.

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

After single administration of up to 5 times recommended dose or one to three daily administrations of recommended dose,

no measurable signs of either local or general clinical intolerance are observed.

4.11 Withdrawal period(s)

Meat and offal:

​zero days

Milk:

​zero hours

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group: Gonadotropin-releasing hormones

ATCvet code: QH01CA01

5.1 Pharmacodynamic properties

Gonadorelin (as diacetate) is a synthetic hormone physiologically and chemically identical to the Gonadotropin Releasing

Hormone (GnRH) synthesized in mammalian species.

Gonadorelin stimulates the synthesis and release of the pituitary gonadotropins, luteinizing hormone (LH) and follicle

stimulating hormone (FSH). Its action is mediated by a specific plasma membrane receptor. Only 20% GnRH receptor

occupancy is required to induce 80% of the maximum biological response. The binding of GnRH to its receptor activates

protein kinase C (PKC) and also mitogen-activated protein kinase (MAPK) cascades which provide an important link for the

transmission of signals from the cell surface to the nucleus allowing synthesis of the gonadotropin hormones.

In repeat breeding animals, one of the most prominent findings is the delayed and smaller preovulatory LH surge leading to

delayed ovulation. Injection of GnRH during oestrus increases the spontaneous LH peak and prevents delay in ovulation in

repeat breeding animals.

5.2 Pharmacokinetic particulars

Absorption

After intramuscular administration of 100 µg of gonadorelin (as diacetate) to the animal, absorption of GnRH is rapid. The

maximum concentration (Cmax) of 120.0 ± 34.2 ng / litre is obtained after 15 min (Tmax). Concentrations of GnRH decreased

rapidly in plasma.

The absolute bioavailability of gonadorelin (IM versus IV) was estimated to be around 89%.

Distribution

24 hours after intramuscular administration of 100 µg of radiolabelled gonadorelin(as diacetate), the greatest amounts of

radioactivity in tissues were measured in the main organs of excretion: liver, kidney and lungs.

8 or 24 hours after the administration, gonadorelin shows an extensive plasma protein binding of 73%.

Metabolism

Gonadorelin is a naturally occurring peptide which is rapidly broken down into inactive metabolites.

Elimination

After intramuscular administration of gonadorelin to the dairy cow, the principal excretion route is milk followed by urine and

faeces. A high percentage of the administered dose is excreted as carbon dioxide in expired air.

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12 April 2019

CRN008S2G

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6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Benzyl alcohol (E1519)

Potassium dihydrogen phosphate

Dipotassium phosphate

Sodium chloride

Water for injections

6.2 Major incompatibilities

In the absence of compatibility studies this veterinary medicinal product must not be mixed with any other veterinary medicinal

products.

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

Do not store above 25°C.

Keep the container in the outer carton in order to protect from light.

6.5 Nature and composition of immediate packaging

Material of the primary container:

Colourless glass vial type I (4 ml).

Colourless glass vial type II (10, 20 and 50 ml).

Chlorobutyl stopper.

Pack sizes:

Box containing 1 glass vial of 4 ml

Box containing 1 glass vial of 10 ml

Box containing 1 glass vial of 20 ml

Box containing 1 glass vial of 50 ml

Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unused veterinary medicinal products 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

Ceva Santé Animale

10, avenue de La Ballastière

33500 Libourne

France

8 MARKETING AUTHORISATION NUMBER(S)

VPA10815/004/001

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12 April 2019

CRN008S2G

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9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 07 December 2007

Date of last renewal: 27 January 2012

10 DATE OF REVISION OF THE TEXT

April 2019

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