FOR ANIMAL USE ONLY

MAXIMUNE 8

Reg. No. G4029 Act 36/1947

Newcastle Disease (NCD) is a controlled disease according to the Animal Diseases Act, Act 35/1984. Any occurrence or suspected occurrence of Newcastle Disease must be reported immediately to the local state veterinarian.
An inactivated oil emulsion vaccine for the immunization of healthy breeder replacement and breeder chickens against Newcastle Disease (ND) and healthy primed breeder replacement and breeder chickens against Infectious Bronchitis (IB), Infectious Bursal Disease (IBD) caused by the standard and variant types, and tenosynovitis and malabsorption (inclusive of feed passage and proventriculitis) caused by Avian Reovirus infection.

COMPOSITION

This vaccine contains inactivated Newcastle Disease virus (LaSota strain), Infectious Bronchitis virus (Massachusetts serotype, M-41 and H-52 strains), Infectious Bursal Disease virus of the standard serotype 1, (Lukert strain) and variant types (Delaware variant 1084A and Delaware variant 1084E strains) and inactivated Avian Reovirus (strain S1133, a tenosynovitis pathotype, strain 2408, a malabsorption pathotype and strain SS412, a proventriculitis and malabsorption pathotype) in an oil emulsion.

Minimum titre per 0,5 mℓ dose prior to inactivation is:
10^8,8 EID₅₀ Newcastle Disease virus......................................................... 0,03 mℓ

10^6,1 EID₅₀ Infectious Bronchitis virus, Massachusetts serotype, M-41 strain.....0,02 mℓ

10^6,1 EID₅₀ Infectious Bronchitis virus, Massachusetts serotype, H-52 strain..... 0,02 mℓ

10^5,10 EID₅₀ Infectious Bursal Disease virus, standard serotype 1, Lukert strain 0,015 mℓ

10^3,7 EID₅₀ Infectious Bursal Disease virus, Delaware variant 1084A strain....... 0,01 mℓ

10^4,84 EID₅₀ Infectious Bursal Disease virus, Delaware variant 1084E strain..... 0,01 mℓ

10^5,42 TCID₅₀ Avian Reovirus, S1133 strain................................................ 0,015 mℓ

10^5,67 TCID₅₀ Avian Reovirus, 2408 strain.................................................. 0,015 mℓ

10^5,26 TCID₅₀ Avian Reovirus, SS412 strain................................................ 0,015 mℓ

Maximum formaldehyde content (inactivant) is 0,37 mg / 0,5 mℓ dose

STORAGE

Store in a refrigerator at 2 – 7 °C.
Do not freeze.
The shelf-life of the unopened vaccine is 24 months, when stored at recommended conditions.
Storage contrary to label recommendations may cause loss of potency of the vaccine.
Protect from sunlight.
Improper storage of the vaccine may cause potency losses.

WARNINGS

Do not slaughter fowls for human consumption within 42 days after vaccination.
Vaccinate healthy chickens only.
This vaccine contains an oil based adjuvant and accidental self-injection may cause a severe local allergic reaction. Consult a physician and inform her/him that the vaccine contains a mineral oil.
Contains Gentamicin and Amphotericin B as preservatives.
Post vaccination reactions may occur and may include swellings or granulomas at the injection site.
Ensure that fowls that are marketed do not have reactions at the site of administration, as this will result in condemnations.
Vaccination of fowls in lay may result in a drop in egg production, due to the stress of handling during vaccination.
Destroy any unused vaccine by for example burning; dispose of all the vaccine containers when the vaccination is completed.
Keep out of reach of children, uninformed persons and animals.
Although this vaccine has been extensively tested under a large variety of conditions, failure thereof may ensue as a result of a wide range of reasons. If this is suspected, seek veterinary advice and notify the registration holder.

PRECAUTIONS

Observe aseptic precautions. Ensure that all vaccination equipment (needles, syringes etc.) is clean and sterile prior to use.
Do not contaminate with disinfectant or spirits.
Do not mix with other vaccines.
Use entire contents of bottles immediately after opening – do not store partially used vials for future use.
Do not use the contents of damaged bottles.
It is good vaccination practice when handling the vaccine to avoid contact with the eyes or mucous membranes, hands and clothing.
Wash and disinfect hands with a disinfectant after vaccination.

DIRECTIONS FOR USE: Use only as directed

MAXIMUNE 8 is recommended for the vaccination of healthy fowls of at least 18 weeks of age as an aid in the prevention of Newcastle Disease and Infectious Bronchitis.
Breeder vaccination provides maternal antibodies to progeny of breeder hens as an aid in the prevention of bursal disease caused by standard and variant types and tenosynovitis and malabsorption caused by reoviruses of the standard and SS412 types.
A priming vaccination with a live infectious bursal disease vaccine, tenosynovitis vaccine and bronchitis vaccine of the Massachusetts serotype is recommended at least four weeks in advance of the administration of the killed vaccine to provide optimum protection.
Shake the vaccine well before and during use.
Use aseptic technique.
Prior to use, allow the vaccine to gradually reach room temperature.
The dose is 0,5 mℓ per fowl and is administered via the subcutaneous route.
The preferred site is under the skin on the back of the neck, midway between the head and the body and in a direction away from the head. Do not inject near the head. Do not inject into the muscle tissue or the neck vertebrae.

PRESENTATION

500 mℓ plastic bottle containing 1 000 doses.

REGISTRATION HOLDER

Ceva Animal Health (Pty) Ltd
Reg No. 1973/016009/07
PO Box 7707
Halfway House
1685

MANUFACTURED BY

Ceva Biomune Co.
8906 Rosehill Road
Lenexa
Kansas 66215, USA
U.S. Vet Lic. No. 368