MSD NUFLOR 100 ml VET ONLY (S4)

PHARMACOLOGICAL ACTION

Florfenicol is a synthetic, broad spectrum antibiotic which acts by inhibiting bacterial protein synthesis at the ribosomal level. Florfenicol is active against a wide range of aerobic and anaerobic gram-negative and gram-positive bacteria isolated from domestic animals.

In vitro activity has been shown in cattle against Mannheimia haemolytica, Pasteurella multocida, Mycoplasma bovis, Histophilus somni, Escherichia coli, Salmonella spp., Moraxella spp., Klebsiella spp., Bacteroides spp., Fusobacterium spp.,Trueperella pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus uberis, Streptococcus zooepidemicus, Staphylococcus aureus, Staphylococcus epidermidis and Clostridium spp.

Laboratory tests have demonstrated that florfenicol has bactericidal activity against Mannheimia haemolytica, Pasteurella multocida and Histophilus somni.

In vitro testing has shown that florfenicol is active against the bacterial pathogens most commonly isolated in respiratory disease in pigs, including Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae.

In vitro testing has shown that in sheep, florfenicol has bactericidal activity against Mannheimia haemolytica and Pasteurella multocida. These organisms may be responsible for primary and secondary bronchopneumonia in sheep.

In vitro sensitivity does not necessarily imply in vivo efficacy.

INDICATIONS

Cattle: Nuflor®is indicated for the treatment of bovine respiratory disease, also called shipping fever or transit fever associated with bacteria susceptible to florfenicol, including Mannheimia haemolytica, Mycoplasma bovis and Pasteurella multocida and for the treatment of bovine interdigital phlegmon (foot rot, acute interdigital necrobacillosis and infectious pododermatitis) associated with Fusobacterium necrophorum and Prevotella melaninogenica.

Metaphylaxis: Nuflor® is indicated for the control of respiratory disease in cattle at high risk of developing BRD associated with Mannheimia haemolytica, Mycoplasma bovis, Pasteurella multocida and Histophilus somni.

Pigs: Nuflor® is indicated for the treatment of infections due to florfenicol-sensitive bacteria and for the treatment of respiratory infections caused by Actinobacillus pleuropneumoniae, Pasteurella multocida and Mycoplasma hyopneumoniae.

Sheep: Nuflor® is indicated for the treatment of ovine respiratory disease (ORD) associated with Mannheimia haemolytica and Pasteurella multocida.

CONTRAINDICATIONS

Do not use in cows producing milk for human consumption or in bulls intended for breeding purposes.

Do not administer to boars and ramsintended for breeding.

WARNINGS

Withdrawal period:

Cattle: Do not slaughter cattle for human consumption within 30 days after the last intramuscular treatment or within 44 days after the last subcutaneous treatment.

Pigs: Do not slaughter pigs for human consumption within 21 days after the last treatment.

Sheep: Do not slaughter sheep for human consumption within 37 days after the last treatment.

SAFETY IN PREGNANCY AND LACTATION

The safety of Nuflor® has not been established in cattle, pigs and sheep during pregnancy, lactation, lay or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methylpyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

DOSAGE AND DIRECTIONS FOR USE

Cattle: The recommended dose is 20 mg/kg body weight (1 mℓ/15 kg) by intramuscular injection. Administer a total of 2 injections 48 hours apart using a 16G needle. Alternatively, administer by a single subcutaneous injection at a dose rate of 40 mg/kg body weight.

Do not administer more than 10 mℓ at each site.

The injection should be given only in the neck.

Clinical response was evident in most treated animals within 24 hours of initiation of therapy.

Pigs: The recommended dose is 15 mg/kg body weight (1 mℓ/20 kg) by intramuscular injection into the neck muscle. Administer a total of 2 injections 48 hours apart using a 16G needle. The volume administered per site of injection should not exceed 10 mℓ.

Sheep: The recommended dose is 20 mg/kg (1 mℓ/15 kg) by intramuscular injection once daily for 3 consecutive days.

The injections must be alternated between either side of the neck.

SIDE EFFECTS AND SPECIAL PRECAUTIONS

Lowering of food consumption has been observed.

The effect of administering Nuflor® with other drug products is not known.

Microsomal enzyme inhibition may occur.

In swine, diarrhoea and/or perianal erythema/oedema may occur transiently following treatment. A transient reaction may occasionally occur with minor swelling at the injection site. These swellings disappear completely within 21 days.

SPECIAL PRECAUTIONS TO BE TAKEN BY THE PERSON ADMINISTERING NUFLOR® TO ANIMALS

Laboratory studies in rabbits and rats with the excipient N-methylpyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use Nuflor® with serious caution to avoid accidental self-injection.

KNOWN SIGNS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT

Gross over dosage of Nuflor® can result in anorexia, pyrexia, vomiting, diarrhoea and slight ataxia which resolve within 2 weeks. Treatment is symptomatic and supportive.

IDENTIFICATION

A clear, light yellow to straw-coloured solution.

PRESENTATION

Glass vials of 20 mℓ, 50 mℓ, 100 mℓ and 250 mℓ closed with grey bromobutyl rubber stoppers and sealed with aluminium caps, with or without flip-off caps. Placed in an outer carton.

Not all pack sizes may be marketed.

STORAGE

Store at orbelow 25 °C.
Do not refrigerate or freeze.
Store in the original package in order to protect from light.
Shelf life after first opening the container: Use the contents of the bottle within 28 days.
Do not use this veterinary medicinal product after the expiry date which is stated on the container label.
KEEP OUT OF REACH AND SIGHT OF CHILDREN, UNINFORMED PERSONS AND ANIMALS.
REGISTRATION NUMBER

96/21.1/1 (Act 101/1965)

Namibia Reg. No. V12/17.1.5/1183 NS2