VIMCO emulsion for injection for ewes and female goats

VIMCO emulsion for injection for ewes and female goats.

Uses
Ewes: For active immunisation of healthy ewes in flocks with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis (reduction of udder lesions, somatic cell count and S. aureus count) caused by Staphylococcus aureus.
Female Goats: For active immunisation of healthy female goats in herds with recurring mastitis problems, to reduce the incidence of sub-clinical mastitis caused by Staphylococcus aureus and/or Coagulase-Negative Staphylococci; when clinical mastitis caused by Coagulase-Negative Staphylococci* however occurs, the severity of clinical signs (udder and milk aspect) is reduced. (*Determination of the CNS species has not been performed)
The onset of immunity in ewes is 6 weeks
The onset of immunity in goats has not been established (see Pharmaceutical Precautions Section)
The duration of immunity in ewes and goats has not been established
Dosage and administration
Intramuscular use for ewes and adult female goats
Administration: Give one dose (2ml) by deep intramuscular injection in the neck muscles at 5 weeks before the expected parturition date and 3 weeks after the first dose administer a second dose.
Allow the vaccine to reach a temperature of 15 - 250C before administration.
Shake before use
Minimum age of vaccination; 8 months
The basic vaccination scheme is to be repeated prior to each lactation
One 2ml dose contains:
Active Substance: Inactivated Staphylococcus aureus, SP140 CP**8 strain, expressing Biofilm components > 8.98 SaCC*
*Staphylococcus aureus Cell Count in log10
** CP: capsular polysaccharide
Adjuvant: Liquid paraffin 18.2mg
Excipient: Benzyl alcohol 21mg
Contra-indications, warnings, etc
Contraindications: None
Special warnings for each target species; Vaccinate healthy animals only. Immunisation has to be considered as one component in a complex mastitis control program that addresses all important udder health factors (e.g. milking technique, dry-off and breeding management, hygiene, nutrition, housing, bedding, animal comfort, air and water quality, health monitoring) and other management practices.
Special precautions to be taken by the person administering the veterinary medicinal product to animals; This veterinary medicinal product contains mineral oil. Accidental injection/self injection may result in severe pain and swelling, particularly if injected into a joint or finger, and in rare cases could result in the loss of the affected finger if prompt medical attention is not given. If you are accidentally injected with this veterinary medicinal product, seek prompt medical advice even if only a very small amount is injected and take the package leaflet with you. If pain persists for more than 12 hours after medical examination, seek medical advice again.
To the physician; This veterinary medicinal product contains mineral oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may result in ischaemic necrosis and even the loss of a digit. Expert, PROMPT, surgical attention is required and may necessitate early incision and irrigation of the injected area, especially where there is involvement of finger pulp or tendon.
Adverse Reactions (frequency and seriousness)
Very common adverse reactions - slight swelling at the injection site of less than 2 cm in diameter which disappears within 12 days at most
Common adverse reactions - Swelling at the injection site higher than 5cm in diameter which resolves within 3 days at most. Transient increase in body temperature of up to 1.80C between the first 4 hours and 3 days after injection during clinical studies, which spontaneously resolves within some days without compromising health status.
Post Authorisation Pharmacovigilance Reporting
Anaphylactic-type reactions which might be life-threatening and/or cause abortion occurred very rarely. Under these circumstances, appropriate and rapid symptomatic treatment should be administered.
Mild apathy, anorexia and/or recumbency occurred very rarely after administration of the vaccine.
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 every 100 treated)
-uncommon (more than 1 but less than 10 animals in every 1,000 treated)
-rare (more than 1 but less than 10 animals in every 10,000 treated)
-very rare (less than 1 animal in every 100,000 animals treated, including isolated reports)
Use during pregnancy, lactation or lay; Can be used during pregnancy and lactation
Interaction with other medicinal products and other forms of interaction; 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.
Overdose symptoms; Transient increase in body temperature of about 10C in some animals up to 1.80C may occur in the first 24-48 hours after injection of a 2-fold dose. Hard spots up to 5cm in diameter which disappear within 7-9 days may be observed after injection of a 2-fold dose.
Withdrawal Period - Zero days
Pharmaceutical precautions
Pharmacotherapeutic group: Inactivated bacterial vaccines.
ATC vet code: Q103AB
To stimulate active immunisation against Staphylococcus aureus in ewes
To stimulate active immunisation against Staphylococcus aureus and/or Coagulase Negative Staphylococci in female goats
The full immunisation scheme in goats induces a serological response from 3 weeks after vaccination. The relevance of these antibody levels to the protection afforded by the vaccine has not been determined experimentally.
Do not mix with any other veterinary medicinal product.
Shelf Life: Shelf life of the veterinary medicinal product as packaged for sale: 18 months. Shelf life after first opening the immediate packaging: 10 hours.
Special precautions for storage: Store and transport refrigerated (2 - 80C). Protect from light. Do not freeze. Once broached use by 10 hours stored at +15°C to 25°C.
Special precautions for disposal of unused product: Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements
Legal category
Legal category:POM-V
Packaging quantities
Nature and composition of immediate packaging; 10ml, 50ml and 100ml Type I colourless glass and Polyethylene (PET) vials, closed with rubber stoppers and aluminium caps.
Pack Sizes:
Cardboard box with 1 glass vial of 5 doses (10ml)
Cardboard box with 1 glass vial of 25 doses (50ml)
Cardboard box with 1 glass vial of 50 doses (100ml)
Cardboard box with 1 PET vial of 5 doses (10ml)
Cardboard box with 1 PET vial of 25 doses (50ml)
Cardboard box with 1 PET vial of 50 doses (100ml)
Not all pack sizes may be marketed.