SUMMARY OF PRODUCT CHARACTERISTICS

1. NAME OF THE VETERINARY MEDICINAL PRODUCT

Fevaxyn Quatrifel Suspension for injection for cats

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Per dose of 1 ml (single dose syringe):

Active components	Relative Potency (R.P.)
Inactivated feline panleucopenia virus, strain CU4 Inactivated feline calicivirus, strain 255 Feline rhinotracheitis virus, strain 605 Inactivated Chlamydophila felis, strain Cello	8.50 – 12.25 1.26 – 2.40 1.39 – 2.10 1.69 – 3.50
Adjuvants
Ethylene/maleic anhydride (EMA-31) Neocryl Emulsigen SA	10mg 30mg 50mg

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Suspension for injection.

4. CLINICAL PARTICULARS

Cats

For the active immunisation of healthy cats and kittens against feline infectious enteritis (panleucopaenia), to reduce respiratory disease due to feline rhinotracheitis virus and calicivirus (cat flu) and pneumonia due to Chlamydophila felis.

4.3 Contraindications

Do not use in unhealthy cats

4.4 Special warnings for each target species

None

4.5 Special precautions for use

None

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 leaflet 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.

Vaccinated cats may develop post-vaccinal reactions including transient fever, listlessness and temporary swellings at the injection site, which usually disappear within 2 days.

In the event of an allergic reaction, immediate treatment should be given using adrenaline, corticosteroid or antihistamine.

4.7 Use during pregnancy, lactation or lay

Do not use during pregnancy.

4.8 Interaction with other medicinal products and other forms of interaction

No information is available on the safety and efficacy of this vaccine when used with any other veterinary medicinal product except those containing inactivated feline leukaemia virus. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be made on a case by case basis.

The contents of a prefilled syringe should be shaken well and administered by subcutaneous injection using aseptic techniques.

Cats aged 8 weeks and older:	For an initial vaccination course, two doses are required, injected at an interval of 3 - 4 weeks.
Booster Vaccination:	Boost annually with a single dose of vaccine.

Administration of an overdose of the product has shown no adverse reactions other than those noted with use of a single dose.

4.11 Withdrawal period

Not applicable.

5. IMMUNOLOGICAL PROPERTIES

For the active immunisation of healthy cats and kittens against feline infectious enteritis (panleucopaenia), to reduce respiratory disease due to feline rhinotracheitis virus and calicivirus (cat flu) and pneumonitis due to Chlamydophila felis.

ATC Vet Code: QI06AL02

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Eagles Earles Minimal Essential Medium with Hepes buffer and Lactalbumin hydrolysate

Do not mix with any other veterinary medicinal product.

24 months.

Use all contents of syringe immediately.

6.4 Special precautions for storage

Store and transport refrigerated (2 °C – 8 °C).

Do not freeze.

Protect from light.

6.5 Nature and composition of immediate packaging

The product is presented in 3 ml disposable polypropylene syringes containing one 1 ml dose. The syringes are sealed with rubber tips.

Syringes are supplied in packs of 10, 20 or 25 syringes.

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 products or waste materials derived from such veterinary medicinal products should be disposed of in accordance with the national requirements.

7. MARKETING AUTHORISATION HOLDER

Zoetis UK Limited

5th Floor, 6 St. Andrew Street

London

EC4A 3AE

8. MARKETING AUTHORISATION NUMBER

Vm 42058/4068

9. DATE OF FIRST AUTHORISATION

08 September 1995

10. DATE OF REVISION OF THE TEXT

May 2015

Approved: 26 June 2015