MSD MASTIPLAN 20 SYRINGES VET ONLY (S4)

Pharmacodynamic properties

Cefapirin is a first-generation cephalosporin which acts by inhibition of cell wall synthesis. It is bactericidal with a time dependent mechanism of action and is characterised by its broad therapeutic spectrum of activity.

In vitro activity has been demonstrated against common Gram-positive and Gram-negative bacteria including Escherichia coli, Klebsiella spp., Arcanobacterium pyogenes, Staphylococcus aureus, coagulase-negative Staphylococci, Streptococcus dysgalactiae, Streptococcus agalactiae, and Streptococcus uberis.

The following bacterial species: A. pyogenes, S. aureus, coagulase-negative Staphylococci,

S. uberis, S. dysgalactiae, S. agalactiae, E. coli, Klebsiella spp. and Mannheimia haemolytica isolated from field studies conducted in France, the United Kingdom, Germany, the Netherlands, Hungary, Italy and Spain proved to be susceptible to cefapirin.

Recently isolated South African strains of S. aureus, E. coli and several streptococcal species tested for susceptibility, provided evidence that local strains are not exhibiting resistance trends different from strains in the northern hemisphere.

An overview of the MIC50 and MIC90 values of common bacterial mastitis pathogens is presented in the table below:

Bacterial species isolated MIC50 (µg/mℓ) MIC90 (µg/mℓ)
Staphylococcus aureus 0,128 0,25
Coagulase-negative Staphylococci 0,128 0,25
Streptococcus uberis 0,032 0,25
Streptococcus dysgalactiae 0,032 0,064
Streptococcus agalactiae 0,25 0,25
Escherichia coli 8 16
Prednisolone exerts anti-inflammatory properties through the inhibition of the early and the late phases of inflammation. After intramammary application, prednisolone induces a reduction in the swelling and subsequent size of the infected quarter and promotes a return to normal temperature in infected animals.

Pharmacokinetic properties

After intramammary administration of Mastiplan LC, cefapirin and prednisolone are mainly excreted via milk during milking. The absorption of both cefapirin and prednisolone into the blood stream is fast and limited. The absorbed fractions of both cefapirin and prednisolone are mainly excreted in urine.

An overview of the concentrations of cefapirin and prednisolone in milk during treatment is presented in the table below:

Active substance Mean milk concentrations of active substances at milking relative to first treatment
0 1 2 3 4
Cefapirin (µg/mℓ) 0 27,0 ± 6,2 31,2 ± 7,9 40,0 ± 8,8 34,6 ± 6,5
Prednisolone (µg/mℓ) 0 182,0 ± 61,7 100,8 ± 51,0 283,7 ± 129,8 101,5 ± 38,8
INDICATIONS

For the treatment of clinical mastitis in lactating dairy cows caused by the following cefapirin sensitive organisms:

Staphylococci (including S. aureus and coagulase-negative Staphylococci),
Streptococci (including S. agalactiae, S. dysgalactiae and S. uberis),
Coliforms (including E. coli).
CONTRA-INDICATIONS

Do not use in case of hypersensitivity of the animal to the cephalosporin antibiotics or other ß-lactam antibiotics.

PREGNANCY AND LACTATION

Mastiplan LC can be used during pregnancy and lactation and in breeding animals.

Laboratory studies in mice, rats, rabbits, and hamster have not produced any evidence of teratogenic, foetotoxic or maternotoxic effects.

There is no evidence of reproductive toxicity (including teratogenicity) in cattle.

Since no specific studies have been performed in the target animal species, use only according to the benefit/risk assessment by the responsible veterinarian during pregnancy and in breeding animals.

INTERACTIONS

None known.

DOSAGE AND DIRECTIONS FOR USE

The treatment consists of intramammary administration of 1 syringe per infected quarter every 12 hours, with a maximum of 4 treatments.

Before infusion, the udder should be milked out completely.

The teat and its orifice should be thoroughly cleaned and disinfected with the cleaning towel provided.

Care should be taken to avoid contamination of the syringe nozzle.

Either break the top of the cap and gently insert about 5 mm or remove the whole cap and gently insert the total length of the nozzle into the teat canal.

Infuse the total content of the syringe into the affected quarter.

WITHDRAWAL PERIODS

Meat and offal: 3 days (72 hours).

Milk: 120 hours (10 milkings).

SIDE EFFECTS AND SPECIAL PRECAUTIONS

Special precautions for use in animals

Do not use the cleaning towels on teats that have visible, non-healed cuts or wounds.

Special precautions to be taken by the person administering Mastiplan LC to animals

Penicillins and cephalosporins may cause hypersensitivity (allergy) following injection, inhalation, ingestion or skin contact. Hypersensitivity to penicillins may lead to cross sensitivity to cephalosporins and vice versa. Allergic reactions to these substances may occasionally be serious.

Do not handle Mastiplan LC if you know you are sensitised to penicillins or cephalosporins or if you have been advised not to work with such preparations. Handle this product with great care to avoid exposure, taking all recommended precautions.

If you develop symptoms following exposure, such as skin rash, you should seek medical advice and show the doctor this warning. Swelling of the face, lips or eyes, or difficulty breathing are more serious symptoms and require urgent medical attention.

Wash hands after using the wipes and wear protective gloves if skin irritation, due to isopropyl alcohol, is known or suspected.

The syringe must only be used once.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF TREATMENT PER SPECIES

Not applicable.

IDENTIFICATION

Off-white or yellow to pink homogenous ointment.

PRESENTATION

Container of 1 laminated aluminium foil sachet of 4 x 10 mℓ polyethylene syringes and 4 cleaning towels.

Container of 1 laminated aluminium foil sachet of 20 x 10 mℓ polyethylene syringes and 20 cleaning towels.

STORAGE INSTRUCTIONS

Store at or below 25 °C in a cool, dry place.
Store in the original package in order to protect from light.
Do not use Mastiplan LC 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

09/16.1/17 (Act 101/1965)

Namibia Reg. No. V22/16.1/1506 NS2

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 THIS PACKAGE INSERT

21 April 2020