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Date: Tuesday, May 7, 2024 23:16

Release 4.100
Nobivac® Pi Lyophilisate and Solvent for Suspension for Injection for Dogs
 
Species: Dogs
Therapeutic indication: Immunological veterinary medical products: For dogs
Active ingredient: Vaccine Antigens
Product:Nobivac® Pi Lyophilisate and Solvent for Suspension for Injection for Dogs
Product index: Nobivac® Pi
Incorporating:
Qualitative and quantitative composition
1 dose of 1 ml contains:
Active substance:
Live attenuated canine parainfluenza virus (CPi) strain Cornell: ≥ 5.5 log10 and ≤ 7.3 log10 TCID50*.
* TCID50 = median Tissue Culture Infective Dose
Solvent:
Nobivac Solvent (Phosphate buffered diluent).
For the full list of excipients, see the Pharmaceutical Particulars section.
Pharmaceutical form
Lyophilisate and solvent for suspension for injection.
Lyophilisate: off-white or cream-coloured pellet.
Solvent: clear colourless solution.
Reconstituted product: off-pink or pink suspension.
Clinical particulars
Target species
Dogs
Indications for use
For active immunisation of dogs from the age of 8 weeks onwards to reduce clinical signs of canine para-influenza infection and to reduce viral shedding.
Onset of immunity: 4 weeks after vaccination.
Duration of immunity: has not been demonstrated, but an anamnestic response is produced in dogs given a revaccination one year after basic vaccination.
Contraindications
None.
Special warnings for each target species
A protective antibody titre is not accomplished in all vaccinated dogs.
As maternally derived passive antibodies can interfere with the response to vaccination in very young animals, a final dose at 10 weeks of age or older is recommended.
Special precautions for use
Vaccinate only healthy dogs.
Sterile equipment should be used for administration.
Operator warnings
In the case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
Adverse reactions
In very rare cases, some dogs may show discomfort during injection.
In very rare cases, a diffuse swelling, up to 5mm in diameter, may be observed at the site of injection; occasionally this swelling may be hard and painful and last for up to 3 days post injection.
In very rare cases, hypersensitivity reactions may occur. In the event of an anaphylactic reaction appropriate treatment such as adrenaline should be administered without delay.
The frequency of adverse reactions is defined using the following convention:
- very common (more than 1 in 10 animals displaying adverse reactions during the course of one treatment)
- common (more than 1 but less than 10 animals in 100 animals)
- uncommon (more than 1 but less than 10 animals in 1,000 animals)
- rare (more than 1 but less than 10 animals in 10,000 animals)
- very rare (less than 1 animal in 10,000 animals, including isolated reports).
Use during pregnancy or lactation
Nobivac Pi has been shown to be safe for use in pregnant bitches that have been vaccinated before pregnancy with the Pi vaccine of the Nobivac series.
Interactions
Safety and efficacy data (viral excretion) are available which demonstrate that this vaccine can be mixed and administered with the inactivated vaccines of the Nobivac series against canine leptospirosis caused by all or some of the following serovars: L. interrogans serogroup Canicola serovar Canicola, L. interrogans serogroup Icterohaemorrhagiae serovar Copenhageni, L. interrogans serogroup Australis serovar Bratislava, and L. kirschneri serogroup Grippotyphosa serovar Bananal/Liangguang.
The product information of the relevant Nobivac vaccines should be consulted before administration of the mixed product. When mixed with Nobivac leptospirosis vaccines at annual revaccination, it has been established that there is no interference with the anamnestic response induced by the injectable canine parainfluenza virus component.
After administration with one of the leptospirosis vaccines, a mild and transient increase in body temperature (≤ 1°C) may occur for a few days after vaccination, with some pups showing less activity and/or a reduced appetite. A small transient swelling (≤ 4 cm), which can occasionally be firm and painful on palpation, may be observed at the site of injection. Any such swelling will either have disappeared or be clearly diminished by 14 days post-vaccination.
After mixed administration of an overdose of Nobivac Pi and an overdose of the leptospirosis vaccines of the Nobivac series, transient local reactions such as diffuse to firm swellings from 1 to 5 cm in diameter may be observed, usually these will persist no longer than 5 weeks, however some may take a little longer to completely disappear.
Safety and efficacy data are available which demonstrate that this vaccine can be mixed and administered with the inactivated vaccine of the Nobivac series against rabies or the inactivated vaccine against rabies and leptospirosis, where applicable. After administration with the rabies containing vaccines transient local reactions such as diffuse to firm swellings from 1 to 4 cm in diameter may be observed for up to 3 weeks after vaccination. The swellings may be painful for up to 3 days post dosing.
Safety data are available which demonstrate that this vaccine can be administered at the same time but not mixed with the inactivated vaccine of the Nobivac series against Bordetella bronchiseptica.
When this vaccine is administered in association with the inactivated vaccine of the Nobivac series against Bordetella bronchiseptica, the demonstrated antibody response data of this vaccine are the same as when this vaccine is administered alone.
When Nobivac Pi is used with any of the other Nobivac vaccines referred to above, the minimum vaccination age for each vaccine must be taken into account such that at the time of vaccination, the dogs are at or older than the oldest minimum vaccination age for the individual vaccines.
No information is available on the compatibility of this vaccine when used with any other veterinary medicinal product except the products mentioned above. 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
One ml solvent or 1ml (1 dose) of inactivated vaccine (as specified in section 4.8) must be used to reconstitute the freeze-dried Nobivac Pi vaccine.
One ml (1ml) of reconstituted vaccine should be given by subcutaneous injection.
Vaccination schedule:
- Basic vaccination:
• Before the age of 12 weeks:
Two vaccinations, each with a single dose: the first vaccination from the age of 8 weeks onwards and the second vaccination 2 - 4 weeks later.
• From the age of 12 weeks onwards:
Single vaccination, with one dose per animal.
- Revaccination:
Every year with a single dose.
Overdose
Not different from a single dose. In some dogs the swelling may be more painful or may be observed for a longer period.
Withdrawal periods
Not applicable.
Pharmacological particulars
Immunological properties:
Pharmacotherapeutic group: Live viral vaccine for dogs
ATCvet code: QI07AD08.
Pharmaceutical particulars
Excipients
Vaccine: Sorbitol, Gelatin, Pancreatic digest of casein, Disodium phosphate dehydrate, Water for injections.
Solvent: Disodium phosphate dihydrate, Potassium dihydrogen phosphate. Water for injections.
Major incompatibilities
Do not mix with any other vaccine except the diluent supplied with the product or with the lepto and/or rabies vaccines of the Nobivac series (where these products and their combined use are authorised).
Shelf life
Shelf-life of the veterinary medicinal product as packaged for sale:
2 years at 2 – 8°C (after storage by the manufacturer for 29 months at -20°C).
Shelf-life after dilution or reconstitution according to directions: Use within 30 minutes.
Shelf life of the solvent: 4 years.
Special precautions for storage
Vaccine:
Store in a refrigerator (2 – 8°C).
Do not freeze.
Protect from light.
Care should be taken to avoid prolonged or repetitive exposure to high ambient temperatures following withdrawal from the refrigerator prior to use.
Solvent:
Store below 25°C if stored independently from the vaccine.
Immediate packaging
Vaccine:
Vial of hydrolytical class type I (Ph. Eur.) glass closed with a halogenobutyl rubber stopper and a colour coded aluminium cap.
Solvent:
Vial of hydrolytical class type I (Ph. Eur.) glass closed with a halogenobutyl rubber stopper and a colour coded aluminium cap.
Pack sizes: Carton or plastic box with 5, 10, 25 or 50 single dose vials.
Solvent may be packed together with the vaccine or separately.
Not all pack sizes may be marketed
Disposal
Dispose of waste material by boiling, incineration or immersion in an appropriate disinfectant approved for use by the competent authorities.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 01708/4632
Significant changes
Date of the first authorisation or date of renewal
31 January 2002.
Date of revision of the text
25 February 2022.
Any other information
For animal treatment only. Keep out of the sight and reach of childen.
Legal category
Legal category: POM-V
GTIN
GTIN description:Nobivac Pi 10x1ds:
GTIN:8713184143426
GTIN description:Nobivac Pi 50x1ds:
GTIN:8713184143433