1-NAMEANDADDRESS OF THE MARKETINGAUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
Bioveta, a. s., Komenského 212,
683 23 Ivanovice na Hané, Czech Republic
NAME OF THE VETERINARY MEDICINALPRODUCT
Biofel PCH emulsion for injectionfor cats
Vaccine against feline panleukopenia,calicivirus and herpesvirus infection
STATEMENT OF THEACTIVE SUBSTANCESAND OTHER INGREDIENTS
Composition – 1 ml (1 dose):
Active substances:
Virus panleucopeniae contagiosae felis

inactivatum                                  RP≥1
Calicivirus felis inactivatum          RP≥1
Herpesvirus felis inactivatum       RP≥ 1

*) RP= Relative potency (ELISAtest)compared with the reference serum obtained after vaccination of guinea pigs with a vaccine batch that has successfully passed the challenge test on the target species.
Excipients:

Thiomersal                             0.01%
Adjuvants:
Oil adjuvant (Emulsigen)        ad 1 ml
4.INDICATION

For active immunisation against feline panleukopenia, calicivirus and herpesvirus infection.
The onset of protective immunity against panleukopenia is established at 3 weeks after basic vaccination and the onsetof protective immunity against feline calicivirus and herpesvirus infection is established at 4 weeks after basic vaccination.
The duration of immunity is 12 months.
5.CONTRAINDICATIONS
Do not use in case of general febrile illness.
6.ADVERSE REACTIONS
An adequate local reaction (usually the size of a pea) may appear at the administration site, which disappears within 3 weeks.Vaccination may exceptionally cause hypersensitivity reactions. In such case,appropriate treatment should be initiated immediately.
If you notice any serious effects or other effects not mentioned in this packageleaflet, please inform your veterinary surgeon.
7.TARGET SPECIES
Cats.
8-DOSAGE FOR EACH SPECIES,
ROUTEAND METHODOFADMINISTRATION
Dose – 1 ml regardless of age, weightand breed of the individual, but not earlier than at 8 weeks of age.
Method of administration – subcutaneous,preferably in the region behind the shoulder blade.
Vaccination schedule:
Basic vaccination:Two administrations at an intervalof 3 weeks.
The first vaccination with one dose ofBiofel PCH in kittens from the age of
8 – 10 weeks and the second vaccination with one dose of Biofel PCHR from the age
of 3 months.Revaccination:
Further regular revaccination with Biofel PCHR is carried out in 12-month intervals.
9-ADVICE ON CORRECT ADMINISTRATION
The vial contents should be shaken well before use.

10.WITHDRAWALPERIOD
Not intended for food-producing animals.
11.SPECIALSTORAGE PRECAUTIONS
Keep out of the sight and reach of children.Store in a refrigerator (2 °C – 8 °C).Protect from light.
Protect from frost.
Shelf life after first opening the immediate packaging: 8 hours.
Do not use this veterinary medicinalproduct after the expiry date which is stated on the label.
12.SPECIALWARNINGS
Special warnings for each target species Vaccinate only clinically healthy individuals in good nutritional condition.Any antiparasitic treatment should precede the vaccination by at least 10 days.
Use during pregnancy, lactation or lay Vaccination of pregnant cats is recommended in the first half of pregnancy.
Interaction with other medicinal products and other forms of interactionNo information is available on the safety and efficacy of this vaccine when administered concurrently with other veterinary medicinal products.
Decision about using this vaccine beforeor after any other veterinary medicinal product must be based on considerationof individual cases.
Incompatibilities
Do not mix with other veterinary medicinal products.
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 withthe product may result in severe pain and swelling, particularly if injected into a jointor finger, and in rare cases can lead to loss of the affected finger if not given prompt medical attention.
If you are accidentally injected with this product, seek prompt medical advice evenif only a very small amount is injectedand 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 productcan 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.
13.SPECIALPRECAUTIONS FOR THE
DISPOSALOF UNUSED PRODUCT
OR WASTE MATERIALS, IFANY
Any unused veterinary medicinal productor waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
14.DATE ON WHICH THE PACKAGE LEAFLET WAS LASTAPPROVED
10.01.2021
15.OTHER INFORMATION
For animal treatment only.Veterinary medicinal product subject
to prescription.
Package size:
2 × 1 dose, 10 × 1 dose,
20 × 1 dose, 100 × 1 dose,
1 × 5 doses, 5 × 5 dose, 10 × 5 dosesNot all pack sizes may be marketed.
Imported by: Biovet Egypt Co.,Mansura
City, Egypt
Slaughterhouse district ofAl Wahda street,Neighborhood trees - Nasreddine St. No.5.
Reg. No.:xxx