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Date: Thursday, March 28, 2024 20:07

Release 3.314
NASYM lyophilisate and solvent for suspension for injection or nasal spray for cattle
 
Species: Cattle
Therapeutic indication: Immunological veterinary medical products: For cattle
Active ingredient: Vaccine Antigens
Product:NASYM lyophilisate and solvent for suspension for injection or nasal spray for cattle
Product index: NASYM
Cattle - meat: Zero days
Incorporating:
Presentation
Lyophilisate and solvent for suspension for injection or nasal spray. Lyophilisate: Whitish freeze-dried lyophilisate. Solvent: Homogenous-clear solution.
Uses
Active immunisation of cattle to reduce virus shedding and respiratory clinical signs caused by bovine respiratory syncytial virus infection.
Onset of immunity: 21 days after administration of one dose by the nasal route. 21 days after the second dose of the two dose intramuscular vaccination schedule.
Duration of immunity: 2 months after nasal vaccination. 6 months after intramuscular vaccination.
Dosage and administration
Each dose of 2ml contains:
Lyophilisate (Active substance): Live attenuated bovine respiratory syncytial virus (BRSV), strain Lym-56...104.7-6.5 CCID50*Cell Culture Infective Dose 50%
Solvent: Phosphate buffer solution.
Nasal or intramuscular use. Reconstitute the vaccine with the corresponding volume of solvent:
Number of doses in vial of lyophilisate
Volume of solvent to be used
5 doses
10ml
25 doses
50ml
1. Peel the top off the aluminium cap on the vial containing the solvent and withdraw 10ml
2. Inject the 10ml of solvent into the vial containing the lyophilisate (freeze-dried powder)
3. Shake until the freeze-dried powder is in suspension. The 5 dose vial is now ready to use.
4. For the 25 dose vial, once the freeze-dried powder is in suspension, withdraw all the suspension obtained from the vaccine vial and inject it into the vial containing the remaining solvent.
5. Shake well before use. The reconstituted vaccine is a slightly yellowish homogenous suspension.
Avoid contamination during reconstitution and use. Use only sterile needles and syringes for administration.
For nasal use, spray the required volume of the vaccine into the animal's nostrils (1ml in each nostril) using an intranasal applicator (droplet size: 25-220 μm). It is recommended to use a new applicator for each animal.
The following doses and administration methods should be used:
Cattle from 9 days of age:
Primary vaccination (nasal use): Spray 1 ml into each nostril (so the total volume administered is 2 ml)
Revaccination: One intramuscular injection of 2 ml should be given 2 months after the primary vaccination and then every 6 months after the last revaccination.
Cattle from 10 weeks of age:
Primary vaccination (intramuscular injection): One intramuscular injection of 2 ml should be given followed by a second intramuscular injection of 2 ml given 4 weeks later.
Revaccination: One intramuscular injection of 2 ml should be given 6 months after completion of the primary vaccination scheme and then every 6 months after the last revaccination.
Contra-indications, warnings, etc
Do not use in case of hypersensitivity to the active substance or any of the excipients. Vaccinate healthy animals only.
In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician.
The safety of the veterinary medicinal product has not been established during pregnancy and lactation.
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.
Adverse reactions (frequency and seriousness)
Slight alteration of faecal consistency may be commonly observed post-vaccination.
Calves may uncommonly display a peak in temperature of at least 1.7°C two days after vaccination that resolves the next day without treatment.
Anaphylactic type reactions which may be serious (including fatal) have been reported very rarely. In case of such reactions, appropriate symptomatic treatment should be administered.
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 treated)
-uncommon (more than 1 but less than 10 animals in 1,000 treated)
-rare (more than 1 but less than 10 animals in 10,000 treated)
-very rare (less than 1 animal in 10,000 animals treated, including isolated reports)
No adverse reactions other than those described above occurred following the administration of an overdose.
Withdrawal period: Zero days.
Pharmaceutical precautions
Pharmacotherapeutic group: Immunological for Bovidae, Cattle, Live viral vaccines, bovine respiratory syncytial virus (BRSV). ATCvet code: QI02AD04.
To stimulate active immunity against bovine respiratory syncytial virus.
Reduction of respiratory clinical signs (but not a reduction of virus shedding) is observed 5 days after nasal vaccination. Full immunity is established from 21 days after nasal vaccination.
Excipients:
Lyophilisate: Dextran, Sucrose, Gelatin, NZ amine, Sorbitol, Potassium dihydrogen phosphate, Dipotassium phosphate.
Solvent: Potassium dihydrogen phosphate, Disodium phosphate dodecahydrate, Sodium chloride, Potassium chloride, Water for injections.
Do not mix with any other veterinary medicinal product except with the solvent supplied for use with the veterinary medicinal product.
Shelf life of the veterinary medicinal product as packaged for sale: 24 months
Shelf life after reconstitution according to directions: use immediately
Shelf life of the solvent: 5 years
Lyophilisate: Store and transport refrigerated (2°C - 8°C). Do not freeze. Protect from light.
Solvent: Store below 25°C. Do not freeze. Protect from light.
Legal category
Legal category: POM-V
Packaging quantities
Lyophilisate (vaccine): 10 ml type I glass vials of 5 or 25 doses sealed with a bromobutyl rubber stopper and aluminium cap.
Solvent: Polyethylene (PET) vials of 10ml or 50ml sealed with a bromobutyl rubber stopper and aluminium cap.
Cardboard box with 1 lyophilisate vial of 5 doses and 1 vial of 10 ml solvent.
Cardboard box with 1 lyophilisate vial of 25 doses and 1 vial of 50ml solvent.
Cardboard box with 10 lyophilisate vials of 5 doses.
Cardboard box with 10 vials of 10 ml solvent.
Cardboard box with 10 lyophilisate vials of 25 doses.
Cardboard box with 10 vials of 50 ml solvent.
Not all pack sizes may be marketed.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Laboratorios Hipra, S.A., Avda. la Selva, 135, 17170 Amer (Girona), Spain.
Further information
Nil
Marketing Authorisation Number
UK(GB): Vm 17533/5008
UK(NI): EU/2/19/241/001-004
Significant changes
GTIN
GTIN description:NASYM + DIS PET 5DS
GTIN:8427711196334
GTIN description:NASYM + DIS PET 25DS
GTIN:8427711196280