Pursuant to section 14(1) of the Agricultural Compounds and Veterinary Medicines Act 1997, the Director-General of the
New Zealand Food Safety Authority gives notice that a decision has been made, under section 29(1) of the Agricultural Compounds and Veterinary Medicines Act 1997, to reassess the following registered trade name products:
Trade Name Reference Formulation Type Active Ingredients General Use Claim
Benestermycin A007917 Oily suspension Framycetin 20g/L
Penicillin benethamine 56g/L
Penethamate hydroiodide 20g/L Intramammary antiobiotic for dry cow treatment.
Cloxagel-200 A004733 Oily suspension Neomycin sulphate 20g/L
Cloxacillin sodium 20g/L Intramammary treatment for mastitis in the lactating cow
Depomycin A004257 Aqueous liquid Dihydrostreptomycin 200g/L
Penicillin G procaine 200g/L Injectable suspension for the treatment of infections caused by bacteria sensitive to penicillin and streptomycin in horses, cattle, sheep, pigs, dogs and cats.
Hydropen A005377 Aqueous liquid Dihydrostreptomycin 250g/L
Penicillin G procaine 200g/L For the treatment and control
of infections caused by penicillin/streptomycin sensitive organisms in horses, cattle, sheep, pigs, dogs and cats. Injectable.
Kefamast Dry Cow A006740 Oily suspension Dihydrostreptomycin 55.56g/kg
Cephalexin 55.56g/kg For the treatment of mastitis at drying off and to assist new infections occurring during the dry period. Intramammary dry cow treatment.
Kefamast Lactating Cow A006741 Oily suspension Dihydrostreptomycin 55.56g/kg Cephalexin 55.56g/kg For the treatment of mastitis in lactating cows. Intramammary treatment.
Nafpenzal DC A003160 Cerate Dihydrostreptomycin 44.7g/L
Procain penicllin G 97.5g/L Nafcillin sodium 40.6g/L Intramammary for prevention of bovine, ovine, caprine mastitis caused by bacteria sensitive to penicillin, streptomycin or nafcillin.
Nafpenzal MC A003159 Cerate Dihydrostreptomycin 44.7g/L
Benzyl penicillin 60g/L
Nafcillin sodium 40.6g/L Intramammary suspension for the treatment of bovine mastitis caused by bacteria sensitive to penicillin, depomycin or nafcillin.
Neoboitic P Pump A001811 Aqueous liquid Neomycin sulphate 55g/L
Hysine methylbromide 0.263g/L Oral Antibiotic medicant for swine and aid in the control of scours and fluid loss in baby pigs caused by neomycin sensitive organisms.
Neomix Concentrate A001350 Powder Neomycin sulphate 715g/kg Oral. For the treatment of bacterial enteritis caused by organisms susceptible to neomycin in cattle, pigs and poultry.
Neomycin Penicllin 100/200 A003775 Aqueous liquid Neomycin 100g/L
Penicillin G procaine 200g/L Aqueous suspension for intramuscular injection for infections caused by penicllin-neomycin sensitive organisms in horses, cattle, sheep, pigs, dogs and cats.
Pen-mycin 250/250 A006821 Aqueous liquid Dihydrostreptomycin 250g/L
Penicllin G procaine 250g/L Injectable for the treatment of general infections caused by organisms sensitive to penicillin and/or streptomycin in cats, dogs, sheep, cattle, horses and pigs.
Penmycin LA A007152 Aqueous liquid Dihydrostreptomycin 250g/L
Penicllin G procaine 150g/L
Penicillin G benzathene 150g/L Injection for the treatment of general infections caused by organisms sensitive to penicillin and/or streptomycin in cats, dogs, horses, cattle and pigs.
Phoenix Pink Scour Tablets A006478 Bolus Streptomycin sulphate 48.2g/kg
Sulphapyridine 244.6g/kg Sulphamerazine 243.1g/kg
Sulfadiazine 243.1g/kg For the treatment of bacterial enteritis in calves, sheep and goats.
Scourban Plus A003622 Aqueous liquid Streptomycin 7.6g/L
Neomycin sulphate 181g/L Sulfadiazine 28.4g/L Sulphaguanidine 21.31g/L, Sulphamethazine 21.31g/L For the prevention and treatment of intestinal infections in horses, cattle, goats, pigs, sheep, dogs and cats. Oral antibiotic.
Strepcin A003141 Aqueous liquid Dihydrostreptomycin 250g/L
Penicllin G procaine 250g/L Injection for the treatment of general infections caused by organisms sensitive to penicillin and/or streptomycin in horses, cats, dogs, cattle, sheep and pigs.
Strepcin High Potency Milking Cow A007090 Oily suspension Dihydrostreptomycin 134.2g/kg
Penicillin G procaine 210g/kg Intramammary for the treatment of mastitis in cows.
Strepcin L.A. A006484 Aqueous liquid Dihydrostreptomycin 250g/L
Penicllin G procaine 100g/L
Penicillin G benzathene 100g/L Injectable for the treatment of general infections caused by organisms sensitive to penicillin and/or streptomycin in horses, cats, dogs, cattle, sheep and pigs.
Strepcin Super Strength Dry Cow A000367 Oily suspension Dihydrostreptomycin 152g/kg
Penicillin G procaine 250g/kg Intramammary for use in cows at drying off.
Ubro Yellow A000595 Oily suspension Dihydrostreptomycin 30g/kg
Framycetin sulphate 10g/L
Penethamate hydriodide 30g/L
Prednisolone 1g/L For the routine treatment of clinical mastitis in cows. Intramammary treatment.
Virbac Scour Mixture A004526 Aqueous liquid Neomycin sulphate 10g/L
Hyoscine hydrobromide 0.044g/L
Kaolin 105g/L
Pectin 7.2g/L
Potassium sulphate 8.4g/L
Sulfadiazine 21.3g/L Sulphaquanidine 21.3g/L Sulphamethazine 21.3g/L Aids in the treatment of bacterial scours in cattle, sheep and goats.
Reason for Reassessment: An expert panel was established to examine the impact of using antimicrobials in animals and horticulture and the development of antibiotic resistance in human pathogens. Based on the advice in the expert report, NZFSA indicated that it would reassess relevant veterinary medicines containing antimicrobials in the aminoglycoside class, taking into consideration the recommendations stated in the advice.
NZFSA considers the report to give rise to significant new information on a matter related to the use of the veterinary medicines containing antimicrobials in the aminoglycoside class (section 29(1)(a) of the Agricultural Compounds and Veterinary Medicines Act 1997).
Any person may make a written submission to the director-general concerning any of these reassessments.
Under sections 16 and 17 of the Agricultural Compounds and Veterinary Medicines Act 1997, a written submission:
(a) must state in full the reasons for making the submission;
(b) may state any decision sought on the reassessment; and
(c) must be received by the director-general no later than 30 working days after the date of notification in the New Zealand Gazette.
A copy of every submission will be forwarded to the applicant for its information.
The following address is:
(a) where submissions on these reassessments are to be sent;
(b) where requests for copies of the public information relating to these reassessments can be sent;
(c) where public information relating to these reassessments can be viewed; and
(d) the director-general’s address for service:
ACVM Group, New Zealand Food Safety Authority, Level 5, South Tower, 68–86 Jervois Quay, Wellington 6011. Postal Address: PO Box 2835, Wellington 6140.
Dated at Wellington this 30th day of April 2009.
MAREE ZINZLEY, Programme Manager (Operations) (acting under delegated authority), New Zealand Food Safety Authority.