Introduction

FDAH

Company name: Fort Dodge Animal Health

Address: Flanders Road

Hedge End

Southampton SO30 4QH

Telephone: 01489 781711

Fax: 01489 788306

Statement of active substances

Per dose of 1ml

Active components
Inactivated Feline Panleucopenia Virus (CU4 strain)	R.P. 9.50–12.25
Inactivated Feline Calicivirus (255 strain)	R.P. 1.65–2.15
Inactivated Feline Rhinotracheitis Virus (605 strain)	R.P. 1.60–2.10
Inactivated Feline Chlamydia psittaci (Cello strain)	R.P. 2.00–2.30
Inactivated Feline Leukaemia Virus (61E strain)	R.P. 1.45–2.00
Adjuvants
Ethylene/Maleic Anhydride (EMA) Neocryl XK-62 Emulsigen SA	10mg 30mg 50mg

Marketing authorisation holder and Manufacturer

Fort Dodge Laboratories Ireland

Finiskin Industrial Estate

Sligo, Ireland

Target species, dosage for each species, method and route of administration, advice on correct administration

The contents of the pre-filled syringe should be shaken well and administered aseptically by subcutaneous injection.

Basic vaccination of cats 9 weeks and older: two doses at an interval of 3 to 4 weeks. An additional dose is recommended for kittens living in high-risk FeLV environments whose first dose was administered before 12 weeks of age.

Revaccination

One vaccination annually.

Indications, contra-indications, undesirable effects

For the active immunisation of healthy cats 9 weeks and older against Feline Panleucopenia Virus, and Feline Leukaemia and against respiratory diseases caused by Feline Rhinotracheitis Virus, Feline Calicivirus and Feline Chlamydia psittaci .

Only healthy cats should be vaccinated. Vaccination of pregnant queens is not recommended.

A small percentage of vaccinated cats may develop post-vaccinal reactions including transient fever, vomiting, anorexia and/or depression, which usually disappear within 24 hours.

A local reaction with swelling, pain pruritis or hair loss at the injection site may be occasionally observed. In very rare cases an anaphylactoid reaction with oedema, pruritis, respiratory and cardiac distress, severe gastrointestinal signs or shock have been seen during the first few hours after vaccination. In the case of an anaphylactoid reaction, adrenaline should be administered intramuscularly.

If you notice any other side effects, please inform your veterinary surgeon. No information is available on the safety and efficacy of the current use of this vaccine with any other. Therefore it is recommended that no other vaccines should be administered within fourteen days before or after vaccination with this product.

Vaccination of FeLV positive cats is of no benefit. Vaccination does not affect the course of FeLV infection in cats already infected with FeLV at the time of vaccination, implying that such cats will excrete FeLV irrespective of vaccination; consequently, these animals will constitute a hazard to susceptible cats in their environment. It is therefore recommended that cats with a significant risk of having been exposed to FeLV be tested for FeLV antigen prior to vaccination. Test negative animals can be vaccinated, while test positive cats should be isolated from other cats and re-tested within 1-2 months. Cats positive at the second testing should be considered as being permanently infected with FeLV and should be handled accordingly. Cats negative at second testing can be vaccinated since, in all likelihood, they have overcome the FeLV infection.

Withdrawal Period

Not applicable.

Special storage conditions

Store at +2°C - +8°C (in a refrigerator).

Special warning(s)

To the user

This product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given.

If you are accidentally injected with this product, seek prompt medical advice even if only a very small amount is injected and take the package insert with you.

If pain persists for more than 12 hours after medical examination, seek medical advice again.

To the physician

This product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.

Special precautions for the disposal of unused medicinal product or waste material, if any

Any unused product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Date on which the package insert was last revised

July 2003

Other information

FOR ANIMAL TREATMENT ONLY.

KEEP OUT OF THE REACH OF CHILDREN.

For any information about this veterinary medicinal product please contact the local representative of the marketing authorisation holder:

United Kingdom

Tel. 01489 781711