SUMMARY OF PRODUCT CHARACTERISTICS
1.
Name of the Veterinary Medicinal Product
Savlon Veterinary Antiseptic Concentrate
2.
Qualitative and Quantitative Composition
%w/v
Active Constituents
Chlorhexidine Gluconate Solution
Equivalent to Chlorhexidine Gluconate
Cetrimide Solution 40% w/v
equivalent to Cetrimide
Other Constituents
Isopropyl alcohol (antimicrobial preservative)
Sunset Yellow (E110) (colouring agent)
3.
1.56
15.0
3.14
0.10
Pharmaceutical Form
Cutaneous solution.
4.
Pharmacological Properties
Savlon Veterinary Antiseptic Concentrate is an anti-microbial preparation with
cleansing properties.
Pharmacodynamics
Chlorhexidine – at relatively low concentrations, the action of chlorhexidine is
bacteriostatic, whilst at higher concentrations the action is rapidly bactericidal, the
actual levels varying, somewhat, from species to species. Chlorhexidine inhibits
some viruses and is active against some fungi. The mechanisms of antimicrobial
action of chlorhexidine consist of a series of cytological and physiological changes,
some of which are reversible, which culminate in the death of the cell. The
sequence is: rapid attraction towards the bacterial cell, specific and strong
absorption to certain phosphate containing compounds on the bacterial surface,
overcoming the bacterial cell wall exclusion mechanisms, attraction towards the
cytoplasmic membrane, leakage of low molecular weight cytoplasmic components
e.g. K+ ions and inhibition of certain membrane bound enzymes e.g. adenosyl
triphosphatase which produce microbiostasis, and precipitation of the cytoplasm by
formation of complexes with phosphate entities such as adenosine triphosphate
and nucleic acids.
Cetrimide – this is a quaternary ammonium antiseptic, and has the typical actions
and uses of a cationic surfactant. Greatest activity is seen at the neutral or slightly
alkaline pH. The three possible modes of action for cetrimide are: protein
denaturation, enzyme inactivation and membrane damage.
At relatively low concentrations, the action of cetrimide is bacteriostatic, whilst at
higher concentrations the action is bactericidal. Protein denaturation is found to be
associated with high concentrations, whereas leakage of cytoplasmic contents and
cell lysis are found at low concentrations. Cetrimide has variable antifungal activity
and is effective against some viruses.
Pharmacokinetics
Because of their cationic nature, both chlorhexidine and cetrimide bind strongly to
skin surfaces, mucosae and tissues and are therefore poorly absorbed.
Radio-labelled chlorhexidine studies in rat, dog, marmoset and rhesus monkey
have indicated that chlorhexidine is very poorly absorbed, urinary excretion
following oral administration of [14C]-chlorhexidine being less than 2% of the dose
and biliary excretion being minimal. The one major component found in faeces is
chlorhexidine. These data indicate a very low absorption (<1%) and there is no
reason to suspect that any other species will differ in this respect. Following single
oral dosing in rodents (up to 50 mg/kg), excretion studies detected residual [ 14C]
material in the liver and kidneys but not in other tissues. Whole body
autoradiography in rats and mice showed that shortly after oral administration the
alimentary tract was heavily labelled, while at later times radiolabelled material was
still detectable in the liver, kidney and mucosal surfaces. More than 90% of the
material found in the liver was readily extractable indicating that it was not
irreversibly bound to proteins. Following oral dosing of chlorhexidine in pregnant
rats, less than 0.03% of the administered dose was found in pooled foetal tissue
during a 24 hour study period.
The absorption, distribution and excretion of orally administered [ 14C]-cetrimide in
the rat have been investigated. Intestinal absorption was found to be low, only
very small amounts of radioactivity being found in the blood, bile and tissues.
Approximately 92% of the administered dose was excreted in the faeces and 1%
excreted in the urine within 3 days of administration. There was evidence that
cetrimide was metabolised to some extent.
5.
Clinical Particulars
5.1
Target Species
All species.
5.2
Indications for Use
Savlon Veterinary Antiseptic Concentrate is a general purpose liquid
antiseptic for use in veterinary practice and on the farm. It combines
outstanding broad-spectrum antibacterial activity with useful cleansing
(detergent) properties. The cleansing action is particularly useful in the
treatment of wounds and burns where contamination with dirt or foreign
matter is an extra complication.
5.3
Contra-indications
For external use only.
Avoid contact with eyes.
5.4
Undesirable Effects
Cetrimide is non-irritant and non-toxic to raw surfaces in the dilutions
normally used for local application. Occasionally individual animals may
show some sensitivity to cetrimide, but usually only following prolonged
application. Avoid accidental oral, rectal or intra-uterine administration.
Avoid contact with the brain, meninges or middle ear.
5.5
Special Precautions for Use
For external use only.
Avoid accidental oral, rectal or intra-vaginal/uterine administration.
Avoid contact with the brain, meninges or middle ear.
Instruments containing cemented glass components must not be immersed
in solutions of Concentrate and prolonged immersion of rubber appliances
is undesirable.
Syringes and needles which have been immersed in solutions of
Concentrate must be thoroughly rinsed in sterile water or saline before use.
Hypochlorite bleaches may cause brown stains to develop in fabrics which
have previously been in contact with solutions containing chlorhexidine
gluconate.
Where it is required to leave metal instruments stored in Savlon solutions
for more than eight hours, sodium nitrite 0.4% (4 x 1 g tablets in 1 litre)
should be added to prevent corrosion, and the solution should be changed
at weekly intervals.
5.6
Use During Pregnancy and Lactation
The product may be used in pregnant and lactating animals.
5.7
Interaction with other Medicaments and other forms of Interaction
Cetrimide, like all quatenary ammonium compounds, is incompatible with
soap and similar anionic compounds, with iodine and with alkali hydroxides.
5.8
Posology and Method of Administration
Dilute before use.
Recommended dilutions: Dilutions are with water, unless otherwise stated.
Distilled water is preferable to tap water. One stroke of the pump delivers
5 ml.
DILUTE 1 IN 100 (2 pump strokes made up to 1 litre)
Washing surgical equipment.
Storage of sterile instruments plus polythene and plastic tubing.
Cleansing hands before and after treatment of animals.
Routine antisepsis for minor operations.
Disinfection of floors and walls in broiler houses, pig units and other
livestock quarters.
Washing items of equipment, e.g. stalls, feeders, battery unit brooders,
water troughs and livestock transport, etc.
Cleansing protective clothing, e.g. overalls, boots.
DILUTE 1 IN 30 (3 pump strokes made up to 500 ml)
Skin disinfection
Emergency disinfection
of surgical instruments
(immerse for 2 mins)
Made up in 70% alcohol
Cleansing of rubber and plastic materials
Cleansing wounds, including those which are heavily contaminated.
5.9
Overdose (symptoms, emergency procedures, antidotes), If Necessary:
Cetrimide is non-irritant and non-toxic to raw surfaces in the dilutions
normally used for local application. Very occasionally, individual animals
may show some sensitivity to cetrimide, but usually following prolonged
application of solutions. Specific antidotes to accidental ingestion of
solutions containing cetrimide are mild soap and anionic surfactants.
5.10
Special Warnings for each Target Species
If signs of disease persist or appear, consult a veterinary surgeon or
veterinary practitioner.
5.11
Withdrawal Period
Meat/Milk – Nil.
5.12
Special Safety Precautions to be taken by the Person Administering the
Product to Animals
Irritating to the eyes. Wash splashes from the skin or eyes immediately with
plenty of water.
First Aid: If swallowed, wash out the mouth, drink plenty of milk or water,
seek medical advice. Show the container to the doctor.
Guide to the doctor: Avoid vomiting or gastric lavage if it is believed that a
concentrated solution has been ingested. Specific antidotes to accidental
ingestion of solutions containing cetrimide are mild soap and anionic
surfactants.
6.
Pharmaceutical Particulars
6.1
Incompatibilities (major)
None described.
6.2
Shelf Life
4 years.
6.3
Special Precautions for Storage
Do not store above 25°C.
Cork may protect certain Gram-negative organisms from the action of
antiseptics.
Solutions must always be stored in glass or rubber-stoppered bottles.
6.4
Nature and Contents of Container
Clear yellow, aqueous antiseptic solution, with a strong pine like odour
contained in 5 litre high density polyethylene containers with polyethylene
closures.
6.5
Special Precautions for the Disposal of Unused Product or Waste Material,
if any
None.
7.
Final Information
Name or Style and Permanent Address or Registered Place of Business of the
Holder of the Authorisation to Place the Product on the Market:
Schering-Plough Limited
Schering-Plough House
Shire Park
Welwyn Garden City
Hertfordshire AL7 1TW
UK
Legal Category:
GSL
Marketing Authorisation number: Vm 00201/4085
Version Number: 4
Date of Revision: 7/7/03
Date Renewal: 23/3/02