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Date: Friday, April 26, 2024 6:36

Release 5.192
Fevaxyn® Pentofel Solution for Injection for Cats
 
Species: Cats
Therapeutic indication: Immunological veterinary medical products: For cats
Active ingredient: Vaccine Antigens
Product:Fevaxyn® Pentofel Solution for Injection for Cats
Product index: Fevaxyn Pentofel
Incorporating:
Presentation
Per dose of 1ml (single dose syringe):
Active components
Relative
Potency
Inactivated feline panleucopenia virus, strain CU4
≥ 8.50
Inactivated feline calicivirus, strain 255
≥ 1.26
Inactivated feline rhinotracheitis virus, strain 605
≥ 1.39
Inactivated Chlamydophila felis, strain Cello
≥ 1.69
Inactivated feline leukaemia virus, stain 61E
≥ 1.45
Adjuvants
Ethylene/maleic anhydride (EMA-31)
Neocryl
Emulsigen SA
10mg
30mg
50mg
Uses
For the active immunisation of healthy cats 9 weeks or older against Feline Panleukopenia and Feline Leukaemia viruses and against respiratory diseases caused by Feline Rhinotracheitis virus, Feline Calicivirus and Chlamydophila felis.
Dosage and administration
1ml. Subcutaneous use.
The contents of the single dose syringe should be shaken well and administered aseptically by subcutaneous injection. When administering the product, care must be taken to attach the enclosed sterile needle aseptically to the syringe before use.
Primary 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.
Contra-indications, warnings, etc
Special warnings
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 retested 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.
Special precautions for use in animals
In case of an anaphylactoid reaction, adrenaline should be administered intramuscularly.
Pregnancy
The safety of the vaccine in pregnant queens has not been investigated. Vaccination of pregnant queens is not recommended.
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. A decision to use this vaccine before or after any other veterinary medicinal product therefore needs to be decided on a case by case basis.
Incompatibilities
Do not mix with any other veterinary medicinal product.
Adverse reactions
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, pruritus or hair loss at the injection site may be observed.
Anaphylactic reactions with oedema, pruritus, respiratory and cardiac distress, severe gastrointestinal signs (including haematemesis and haemorrhagic diarrhoea) or shock have been seen during the first hours after vaccination in very rare cases.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
Administration of an overdose of the product has shown no adverse reactions other than those noted with use of a single dose.
If you notice any serious effects or other effects not mentioned in this leaflet, please inform your veterinary surgeon.
User Warnings
To the user: This veterinary medicinal 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 veterinary medicinal 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 veterinary medicinal 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.
Withdrawal period
Not applicable.
Pharmaceutical precautions
Store and transport refrigerated (2°C - 8°C). Protect from light. Do not freeze.
Keep out of the sight and reach of children.
For animal treatment only
Legal category
Legal category: POM-V
Packaging quantities
10 x 1 ml presentation: Box containing 10 single dose prefilled syringes and 10 sterile needles.
20 x 1 ml presentation: Box containing 20 single dose prefilled syringes and 20 sterile needles.
25 x 1 ml presentation: Box containing 25 single dose prefilled syringes and 25 sterile needles.
Not all pack sizes may be marketed.
Further information
Disposal
Any unused product or waste material derived from such veterinary medicinal products should be disposed of in accordance with national requirements.
Marketing Authorisation Number
UK(GB): Vm 42058/5027
UK(NI): EU/2/96/002/001-003
Significant changes
GTIN
GTIN description:25 x 1 dose:
GTIN:08714015015936