AQUAVAC STREP SA

FOR ANIMAL USE ONLY

AQUAVAC STREP SA

Emulsion for Injection Vaccine

Reg. No. G4435 (Act 36/1947)

INDICATIONS

For active immunisation of susceptible fish species to reduce mortality and disease due to Streptococcus caused by Streptococcus agalactiae.

Onset of immunity demonstrated from 3 weeks after vaccination at a water temperature of

28 °C. Duration of immunity demonstrated for at least 30 weeks after a single vaccination.

In the field it has been observed that the food conversion rate is significantly improved in vaccinated fish under disease pressure.

COMPOSITION

Per 1 mℓ of vaccine:

Active substance: 1,36 x 108 bacterial cells of Streptococcus agalactiae TI 513.

Excipients: Phosphate buffer and ISA 763A VG as adjuvant.

STORAGE

  • Store in a refrigerator between 2 °C and 8 °C.
  • Do not freeze.
  • Protect from light.
  • Opened bottles should be used promptly within 5 hours and should not be stored.
  • Do not use AquaVac Strep Sa after the expiry date which is stated on the container label.

WARNINGS

  • Withdrawal period: None.
  • Vaccinate healthy fish only.
  • No information is available on the compatibility of AquaVac Strep Sa with any vaccines.
  • Do not mix with any other veterinary medicinal product.
  • AquaVac Strep Sa should not be used in brood-stock.
  • Do not over- or under-dose the vaccine.
  • Do not use within 2 weeks of antimicrobial treatment.
  • 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

Special precautions for each target species

  • AquaVac Strep Sa has been tested for safety and efficacy in Tilapia (Oreochromis spp.) as a representative species.
  • Observe aseptic precautions. Ensure that all vaccination equipment (containers, syringes and needles) is clean and sterile prior to and during use. Use sterile equipment when administering the vaccine.
  • Do not use disinfectants or antiseptics to sterilise any equipment.
  • Adhere to the vaccination programme to obtain optimum results.
  • Do not eat, drink or smoke whilst handling the product.
  • Destroy any unused vaccine and dispose of all the empty vaccine containers and disposable equipment after use in accordance with National Environmental Management: Waste Act, 2008 (Act No. 59 of 2008).
  • Do not contaminate rivers, dams or any water sources with containers or waste.

Special precautions for use, including special precautions to be taken by the person administering AquaVac Strep Sa to animals.

  • Personal protective equipment consisting of e.g., needle protector should be used when handling AquaVac Strep Sa.
  • In case of accidental self-injection, seek medical advice immediately and show the package insert or label to the physician.

To the user:

This product contains oil. Accidental injection or 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 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:

AquaVac Strep Sa contains oil. Even if small amounts have been injected, accidental injection with this product can cause intense swelling, which may, for example, 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.

DOSAGE AND DIRECTIONS FOR USE – USE ONLY AS DIRECTED.

  • Shake the vaccine well before use.
  • Inject 0,05 mℓ intraperitoneally in fish of minimum 15 gram.
  • Ensure the needle penetrates through the muscle wall and ideally deposits the vaccine into the visceral fatty area. For example, in barramundi (Lates calcarifer) and Tilapia (Oreochromis spp.) of 15 gram this is between and just before the tip of the pelvic fins. To ensure the needle does not penetrate important internal organs such as the liver, stomach, and spleen.
  • Sterile injection equipment should be used.
  • For injection, fish should be anaesthetised.
  • Food should be withheld for a period of 1 day prior to vaccination.
  • Avoid stress in the period prior to and after vaccination.

ADVERSE REACTIONS

A small population of treated animals may show very minor lesions.

PRESENTATION

PET bottles closed with a rubber stopper and sealed with a coded aluminium cap.

Pack sizes of 50 mℓ (1 000 doses), 100 mℓ (2 000 doses), 250 mℓ (5 000 doses), 500 mℓ (10 000 doses) or 1 000 mℓ (20 000 doses).

Not all pack sizes may be marketed.

REGISTRATION HOLDER

Intervet South Africa (Pty) Ltd.

20 Spartan Road

Spartan

1619, RSA

Tel: +27 (0)11 923 9300

E-mail: msdahza@msd.com

www.msd-animal-health.co.za

DATE OF PUBLICATION OF PACKAGE INSERT

24 July 2020

Zimbabwe Registration number: 2023/80.23.17/9832
Pharmacological classification: 802317 Vaccines (Other species)
Vaccines Categories for distribution: P.P.(Vet)