Febrivac^® DE

SPC

Summary of Product Characteristics 

1. Name of the Immunological Veterinary Medicinal Product
FEBRIVAC DE VET

2. Qualitative and Quantitative Composition

3. Pharmaceutical Form
Lyophilisate and aqueous suspension, for subcutaneous injection after reconstitution

4. Immunological Properties
ATC vet code:  QI 20 CH

FEBRIVAC DE stimulates the active immunity against mink distemper virus and mink parvovirus.

5. Clinical Particulars

5.0 Target species
Mink

5.1 Indication for use
Active immunisation against virus enteritis and distemper infections in mink.

Distemper vaccine:
It is necessary to use a live vaccine against distemper to ensure development of an active immunity through the reliable replication of the vaccine virus in the vaccinated animal.
Although a certain degree of immunity is reached within a short period of vaccination, complete immunity is only attained between 10 and 20 days after vaccination.

A single vaccination of young animals will result in a sufficient level of immunity for 12 months. Administration of a booster dose 6 months after initial vaccination will increase the protective effect and result in a uniform level of immunity in the animal population.
The presence of maternal antibodies in the young has an adverse affect on the outcome of vaccination. So the kits of minks vaccinated against distemper should only be vaccinated from the age of 10 weeks onwards. If they are vaccinated before this age they must be given a booster vaccination to ensure they develop immunity.

Virus enteritis vaccine:
Virus enteritis is an acute infectious disease of primarily mink kits, although it can affect older animals. The disease is caused by a parvovirus, an antigen closely related to both the feline and the canine parvovirus.
The incubation time is, on the average, approximately 5 - 7 days. The first symptoms are anorexia followed by diarrhoea with an irritated and sloughing intestinal epithelium in mink pups and less pronounced in older animals.
Outbreaks of virus enteritis infections in mink farms can have catastrophic consequences.

FEBRIVAC DE
The vaccination by FEBRIVAC DE produces a good development of immunity of the stock. At the earliest kits should be primarily vaccinated between the 8th and 12th weeks of life, since the active immunisation can be affected by maternal antibodies. Breeding animals vaccinated four weeks before mating are protected for one year and should be boostered annually.

5.2 Contra-indications
Do not use for
- Vaccination of clinically ill or weakened animals after transportation or housing.
- Vaccination of pregnant females (only possible as metaphylactical vaccination)

5.3 Undesirable Effects
- Loss may increase in animals latently infected by distemper virus, after metaphylactic  vaccination.
- Infectious plasmocytosis (Aleutian Disease) may become active by vaccination against distemper. Increased losses in infected animals after vaccination at the age of 6 to 12 weeks can be provoked.

5.4 Special precautions for use
- The vaccine should not be applied after expiration of shelf live.
- Do not freeze
- Easier reconstitution of FEBRIVAC DIST by a diluent temperature (FEBRIVAC ENT) at +12 °C to +15 °C.
- Reconstituted vaccine should be used up within 1 hour while stored very cold (+2 °C to
- +8 °C) and protected from light.
- When vaccinating animals aged less than 10 weeks, maternal antibodies can disturb active immunization against distemper. For that reason a second monovalent vaccination with
- FEBRIVAC DIST should be given after 4 - 6 weeks.

5.5 Pregnancy and lactation
Not applicable.

5.5 Interactions with other veterinary medicinal products and other forms of interactions
No information is available on the safety and efficacy from the current use of FEBRIVAC DE with any other vaccines. It is therefore recommended that no other vaccines should be administered within 14 days before and after vaccination with this product.
- Development of immunity is affected by passive vaccination with distemper antiserum up to two weeks before injection.
- Application of immunosuppressively acting drugs 14 days before and 14 days after vaccination against distemper, should be avoided.

5.7 Dosage and Administration
The freeze-dried distemper vaccine FEBRIVAC DIST is reconstituted, immediately before use, by the inactivated suspension of FEBRIVAC ENT.
Basic immunization for pup and adult mink:
Dose: 1 ml, subcutaneous
Puppies of unvaccinated females should be vaccinated at an age between 4 – 6 weeks.
Puppies of vaccinated females (puppies with maternal antibodies) should be vaccinated at an age of 8-9 weeks.
Breeding animals are vaccinated annually before mating.

5.8 Overdose
No side effects were observed after administration of a double dose.

5.9 Special precautions for each subspecies
Not relevant

5.10 Withdrawal Period
Not applicable.

5.11 Special warnings for personnel handling the vaccine
In the case of accidental self-injection seek medical advice immediately.

6. Pharmaceutical Particulars

6.1 Incompatibilities
Possible interactions with vaccines from other manufacturers have not been investigated.
Do not mix with any other vaccines.

6.2 Shelf-life
18 months
The vaccine FEBRIVAC DIST can be stored for at least 18 months.
The vaccine FEBRIVAC ENT can be stored for at least 24 months.
Reconstituted vaccine should be used within one hour.

6.3 Storage
Protected from light, at +2?C to +8?C.

6.4 Nature and content of containers
Cardboard box with 2 vials of 100 or 250 ml with rubber stopper and aluminium cap.
The frieze-dried vaccine FEBRIVAC DIST is contained in glass vial. FEBRIVAC ENT as vaccine suspension is contained in a plastic vial.

6.5 Name and address of the license holder and manufacturer
Impfstoffwerk Dessau-Tornau GmbH
Streetzer Weg 15 a
D-06862 Rodleben
Germany

Name and Address of the Distributor
NordVacc Läkemedel Danmark
filial af NordVacc Läkemedel AB
Tolbodgade 18
1253 København K

6.7 Special precautions for the disposal of unused product or waste materials
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant in accordance with national requirements.

7. Additional information