SUMMARY OF PRODUCT CHARACTERISTICS

Laurabolin 25 mg/ml, solution for injection

Each ml contain

active substance:

Nandrolone laurate 25 mg

equivalent to nandrolone 15 mg

Other substance:

Benzyl alcohol 10.4% w/v

For full list of excipients, see section 6.1

Solution for injection.

Light yellow oily solution.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs and cats.

4.2 Indications for use, specifying the target species

Nandrolone is a testosterone derivative which can be used in the supportive management of chronic renal failure.

4.3 Contra-indications

Laurabolin should not be used in pregnant animals.

4.4 Special warning for each target species

To be used with caution in known cases of hepatic impairment.

4.5 Special precautions for use

None.

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

Virilisation of the foetus may occur in pregnant women. Thus it is advisable that

pregnant women avoid using this product.

Avoid accidental self-injection of this product.

Wash hands after use.

4.6 Adverse reactions (frequency and seriousness)

Androgenic side effects may be seen in animals treated with Laurabolin, especially in entire female animals.

The product may cause a strong urine odour in cats.

4.7 Use during pregnancy or lactation

Laurabolin is contra-indicated in pregnant animals

4.8 Interaction with other medicinal products and other forms of interaction

None known

4.9 Amounts to be administered and administration route

Species Dosage

Dog 2-5 mg/kg

Cat 2-5 mg/kg

As with all hormone therapy there can be considerable variation in response to treatment; the above dosages may need to be adjusted according to clinical response. Treatment may be repeated every 21 days.

Administer by subcutaneous or intramuscular injection, observing usual aseptic precautions.

Swab the septum before removing each dose. Use a dry sterile needle and syringe and avoid introduction of contamination.

Further information:

The product may be used to continue treatment initiated with similarly acting oral preparations. Such preparations may also be used to continue therapy commenced with this product to allow more rapid termination of treatment if necessary.

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

No specific treatment or antidote recommended.

4.11 Withdrawal period

Not applicable

5. PHARMACOLOGICAL PROPERTIES

Nandrolone is a testosterone derivative which has very marked anabolic and anti-catabolic action whilst in the recommended therapeutic dosage it has negligible androgenic or progestagenic activity. It may therefore be used in both male and female with equally safe and potent activity. Positive effects on nitrogen, calcium and phosphorus metabolism are promoted, together with normalisation of tissue water/electrolyte balance.

Laurabolin is indicated whenever excessive tissue breakdown or extensive repair processes are proceeding, particularly in convalescence, new born animals, geriatrics, tendon and bone damage and after surgery. The effects of each treatment last approximately three weeks.

ATC Vet Code: QA14AB01

After release from the intramuscular or subcutaneous depot, it has been shown that the nandrolone ester enters the peripheral circulation and is immediately hydrolysed, releasing the active substance, nandrolone. The laurate ester of nandrolone has been compared with the phenylpropionate or decanoate esters. The T1/2 for the intra-muscular depot of nandrolone laurate in the rat is 243 hours compared with 130 hours for the decanoate, 25_hours for the phenylpropionate and 0.6 hours for nandrolone. This reflects the duration of action of the esters - 1 week for the phenylpropionate, 2-3 weeks for the decanoate and 3-4 weeks for the laurate.

Excretion and metabolic studies were carried out with nandrolone in rats. 3H nandrolone and/or its metabolites were not retained or stored in the body of rats. The biological half life of the radioactivity was 1-2 days. A pharmacokinetic study was performed in dogs. The nandrolone levels rose slowly after injection, reaching peak levels after an average of 5 days. Thereafter levels decreased steadily with an elimination half life of approximately 12 days. Twenty-one days after the injections, measurable levels of nandrolone were still present. There were no differences in pharmacokinetics between male and female animals. It should be noted that the dose of Laurabolin administered (1 mg/kg) was less than the range recommended in the data sheet/package insert: 2-5 mg/kg. The plasma levels after treatment would thus have a somewhat higher peak and slightly longer duration of action.

6 PHARMACEUTICAL PARTICULARS

Benzyl alcohol

Arachis oil

None known.

Shelf life of the veterinary medicinal product as packaged for sale: 36 months.

Shelf life after first opening the immediate packaging: 28 days.

Do not store above 25 °C. Protect from light. At low temperature the product may become viscous. Warming the product in the hand will return the contents to the normal state.

Keep the container in the outer carton.

Clear, Glass Type I (Ph.Eur) vials with halogenobutyl rubber stopper, closed with a colour coded aluminium cap. Package quantities: 10 ml vials.

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

Intervet UK Ltd

Walton Manor

Walton

Milton Keynes

Buckinghamshire

MK7 7AJ

8. MARKETING AUTHORISATION Number

Vm: 01708/4253

9. Date of first AUTHORISation

Date: 19 March 1993.

10. Date of Revision of text

Date: October 2014

APPROVED 9/10/14