Description
Nobivac Tricat Trio/FELV for suspension for injection, for cats.
Qualitative and quantitative composition
Per dose of 1 ml:
|
Active substances: (lyophilisate) |
||
|
live attenuated feline calicivirus, strain F9 |
= 4.6 log10 PFU1 | |
|
live attenuated feline herpes virus type 1, strain G2620A |
= 5.2 log10 PFU1 | |
|
live attenuated feline panleucopenia virus, strain MW-1 |
= 4.3 log10 CCID502 | |
|
1PFU: Plaque-Forming Units |
For a full list of excipients, see section “Pharmaceutical particulars”.
Pharmaceutical form
Lyophilisate and solvent for suspension for injection. Off-white lyophilisate.
Clinical particulars
Target species
Cats
Indications for use
Active immunisation of cats:
-to reduce the clinical signs caused by infection with feline calicivirus (FCV) and feline herpes virus type 1 (FHV),
-to prevent the clinical signs, leucopenia and virus excretion caused by infection with feline panleucopenia virus (FPLV). Onset of immunity: for FCV and FHV: 4 weeks; for FPLV: 3 weeks.
Duration of immunity for FCV and FHV: 1 year, for FPLV: 3 years.
Contra-indications
See section “Use during pregnancy”.
Special warnings for each target species
Maternal antibodies, which may persist up to the age of 9-12 weeks, can have a negative influence on the efficacy of vaccination. In the presence of maternal antibodies, vaccination may not completely prevent the clinical signs, leucopenia and virus excretion following an FPLV infection. In such cases where a relatively high level of maternally derived antibodies is expected, the vaccination schedule should be planned accordingly.
Special precautions for use
Only healthy animals should be vaccinated.
User warnings:
In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
A slight painful swelling may be observed at the injection site for 1-2 days. A slight transient rise in body temperature (up to 40°C) may occur for 1-2 days. In some cases sneezing, coughing, nasal discharge, and a slight dullness or reduced appetite may be observed for up to 2 days post vaccination. In very rare cases, the vaccine may cause hypersensitivity reactions (pruritus, dyspnoea, vomiting, diarrhoea and collapse).
Use during pregnancy, lactation or lay
Do not use during pregnancy or lactation, as the product has not been tested in pregnant or lactating queens. Live FPL virus can cause reproductive problems in pregnant queens and birth defects in the progeny.
Interactions
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 made on a case by case basis.
Amounts to be administered and administration route
Use 1 ml solvent to reconstitute the lyophilisate (= 1 single dose). Bring the vaccine to room temperature and administer 1 ml of the vaccine per animal by subcutaneous injection. Use sterile injection equipment, free from traces of disinfectants.
Vaccination schedule:
Basic vaccination: Two single dose inoculations, 3-4 weeks apart. The first inoculation can be given from the age of 8-9 weeks and the second inoculation from the age of 12 weeks. (See also section “Special warnings”).
Revaccination: A single dose (1 ml) according to the following schedule:
Revaccination against feline calicivirus and feline herpesvirus type 1 must be given every year (with vaccines containing the F9 and G2620 strains, where available). Revaccination against feline panleucopenia virus can be given every three years (with strain MW-1 as in Nobivac Tricat Trio, where available).
Overdose
At ten-fold overdose, a slight painful swelling may be observed at the injection site for 4-10 days. A slight transient rise in temperature (up to 40.8°C) may occur for 1-2 days. In some cases general discomfort, coughing, sneezing, transient lethargy and reduced appetite may be observed for a few days post vaccination.
Withdrawal periods
Not applicable.
Pharmacological particulars
ATCvet-code: QI06AD04. Pharmacotherapeutic group: Live viral vaccine for cats.
Immunological properties
To stimulate active immunity against feline calicivirus, feline herpesvirus type 1 (feline rhinotracheitis virus) and feline panleucopenia virus in cats.
Pharmaceutical particulars
Excipients
Lyophilisate: Disodium phosphate dehydrate, Hydrolised gelatine, Pancreatic digest of casein and Sorbitol. Solvent: Disodium phosphate dehydrate, Potassium dihydrogen phosphate and Water for injection.
Major incompatibilities
Do not mix with any other veterinary medicinal product.
Shelf life
Shelf life of the veterinary medicinal product as packed for sale:
Lyophilisate: 33 months and Solvent: 5 years.
Shelf life after reconstitution according to directions: use within 30 minutes.
Special precautions for storage
Lyophilisate: Store in a refrigerator (2°C to 8°C). Protect from light.
Solvent: can be kept below 25°C if stored separately from the lyophilisate. Do not freeze.
Immediate packaging
Lyophilisate: 1 dose vial of glass type I (Ph.Eur.) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Solvent: 1 dose vial of glass type I (Ph.Eur.) closed with a halogenobutyl rubber stopper and sealed with a coded aluminium cap.
Pack sizes: Carton boxes with 5, 10, 25 or 50 doses of vaccine and solvent.
++ Nobivac FeLV
Presentation
The inactivated vaccine contains 102 microgram per ml of purified p45 FeLV-envelope antigen, obtained by genetic recombination of a strain of E. coli. The antigenic suspension is adjuvanted with 0.1 ml of a 3% aluminium hydroxide gel and with 10 microgram purified extract of Quillaja saponaria.
Uses
For active immunisation of healthy cats to prevent persistent feline leukaemia virus viraemia and any associated clinical signs. The onset of protection begins 2 weeks after immunisation and the duration of protection lasts one year after the primary vaccination course.
Dosage and administration
Shake the vial before use. Administer via the subcutaneous route 1 dose of Nobivac FeLV according to the following protocol.
Basic vaccination scheme
A first injection in cats from minimum 8 weeks of age.
A second injection in cats 3 to 4 weeks later.
Revaccination scheme
Annual revaccination.
Nobivac FeLV can be used to reconstitute 1 dose (1 vial) of cat vaccines in the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain) immediately prior to use by the addition of the contents of 1 vial (1 ml) Nobivac FeLV.
Contra-indications, warnings, etc
Since no data have been generated, do not use to vaccinate females during pregnancy and lactation.
Transient mild skin thickening or nodule formation, approximately 5-10 mm in size, may be observed at the injection site and disappear within 2 to 6 weeks without treatment. Occasionally systemic reactions (hyperthermia, anorexia, lethargy) may occur within one or two days after vaccine administration.
Where Nobivac FeLV has been used to reconstitute cat vaccines in the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain) prior to inoculation, a small, painless nodule at the site of vaccination is frequently observed. It can persist for up to 18 days post inoculation. Occasionally the nodule may be painful for up to 6 days after injection. A transient rise in body temperature or lameness may occur and last for up to 3 days post vaccination. In some cases, a slight dullness or reduced appetite may be observed for up to 1 day post vaccination.
In the rare event of hypersensitivity reaction following vaccination, administer an antihistamine, corticosteroid or adrenaline without delay and by the most immediate route.
No undesirable effects have been seen after the administration of an overdose of Nobivac FeLV except those indicated above.
The vaccine should be administered in accordance with the usual aseptic conditions for vaccination.
Vaccinate only healthy animals.
It is recommended that animals be treated for intestinal parasites at least 10 days prior to vaccination.
Safety and /or efficacy data are available which demonstrate that this vaccine can be mixed with cat vaccines in the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain).
Do not mix with other medicinal products except cat vaccines in the Nobivac range containing feline calicivirus (F9 strain), feline rhinotracheitis virus (G2620A strain) and/or feline panleucopenia virus (MW-1 or Bristol strain).
Nobivac FeLV has been developed by genetic engineering technology which allows for the production of the single specific antigen responsible for the stimulation of full immunity to all components of FeLV disease. This antigen is sub-group A FeLV p45 which is the specific fraction of the envelope glycoprotein gp70 involved in the immune process. In field conditions, only sub-group A of FeLV is infective and once established in the cat’s body it leads to the production of sub-groups B, C and FOCMA. By concentrating only sub-group A p45 in the vaccine, full protection is achieved with no danger of infection or immuno-suppression resulting from the inclusion of other viral components in the vaccine.
Operator warnings
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Withdrawal period
Not applicable.
For animal treatment only. Keep out of the reach and sight of children.
Pharmaceutical precautions
Store and transport in the original package at a temperature of 4°C ± 2°C and away from light.
Do not freeze.
Keep container in the outer carton.
Any unused product or waste material should be disposed of in accordance with national requirements.
Legal category
POM-V
Packaging Quantities
Cardboard boxes containing 10 or 50 single dose vials of vaccine.
Delivery
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