Revised: April 2010
AN: 02040/2009
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE VETERINARY MEDICINAL PRODUCT
Fevaxyn iCHP
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active substances:
Inactivated feline panleucopenia virus
Inactivated feline calicivirus
Inactivated feline rhinotracheitis virus
per 1 ml dose
RP*: 9.50 -12.25
RP*: 1.63 - 2.15
RP*: 1.60 - 2.10
*RP = relative protection.
Adjuvants:
Ethylene/Maleic anhydride (EMA) 31
Neocryl A640
Emulsigen SA
Excipients:
10 mg
30 mg
50 mg
q.s. 1 ml
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Suspension for injection.
4.
CLINICAL PARTICULARS
4.1 Target species
Cats.
4.2 Indications for use, specifying the target species
To stimulate the production of serum neutralising antibodies against
feline infectious enteritis (panleucopenia) and respiratory disease due to
feline rhinotracheitis virus and calicivirus (cat flu).
4.3 Contraindications
Do not use in unhealthy cats.
4.4 Special warnings
None.
Revised: April 2010
AN: 02040/2009
4.5 Special precautions for use
i
Special precautions for use in animals
None.
ii
Special precautions to be taken by the person administering the
veterinary medicinal product to animals
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.
4.6 Adverse reactions (frequency and seriousness)
Vaccinated cats may develop post-vaccinal reactions including transient
fever 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 in pregnant animals.
Revised: April 2010
AN: 02040/2009
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.
4.9 Amounts to be administered and administration route
The contents of a pre-filled syringe should be shaken well and
administered by subcutaneous or intramuscular injection.
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.
4.10 Overdose (symptoms, emergency procedures, antidotes), if
necessary
No adverse reactions exceeding those discussed in section 4.6 were
recorded following administration of an overdose.
4.11 Withdrawal period(s)
Not applicable.
5.
IMMUNOLOGICAL PROPERTIES
To stimulate active immunity against feline infectious enteritis
(panleucopenia) virus and prevent respiratory disease due to feline
rhinotracheitis virus and feline calicivirus (cat flu).
ATCVet Code:
6.
QI06AA04
PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Eagles Earles Minimal Essential Medium with Hepes buffer and
Lactalbumin hydrolysate.
6.2 Incompatibilities
Do not mix with any other veterinary medicinal product.
Revised: April 2010
AN: 02040/2009
6.3 Shelf life
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
Pfizer Limited
Ramsgate Road
Sandwich
Kent
CT13 9NJ
8.
MARKETING AUTHORISATION NUMBER(S)
Vm 00057/4318
9.
DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
Date of first authorisation: 08-Sep-1995
Date of renewal of the authorisation: 08-Sep-2005
10. DATE OF REVISION OF THE TEXT
April 2010