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Date: Saturday, May 21, 2022 7:08

Description: Ceva logo
Release 2.103
Spectam® Scour Halt oral solution 50 mg/ml
 
Species: Pigs, Sheep
Therapeutic indication: Pharmaceuticals: Antimicrobials: Oral preparations: Others
Active ingredient: Spectinomycin
Product:Spectam® Scour Halt oral solution 50 mg/ml
Product index: Spectam Scour Halt oral solution
Sheep - meat: See notes
Pig - meat: See notes
Withdrawal notes: Sheep Meat: 10 days from the last treatment; Pig Meat: 12 days from the last treatment
Qualitative and quantitative composition
per 100 ml
Active ingredients:
Spectinomycin 5.00g (as spectinomycin dihydrochloride pentahydrate)
Excipients:
Benzoic acid 0.10 g
Tartrazine (E102) 0.06 g
For the full list of excipients, see Pharmaceutical particulars.
Pharmaceutical form
Oral solution. A yellow viscous aqueous solution.
Clinical particulars
Target species
Pigs (piglets)
Sheep (lambs)
Indications for use
For the treatment and control of enteritis caused by strains of Escherichia coli sensitive to spectinomycin in piglets.
For the prevention of bacterial neonatal disease (e.g. watery mouth disease) in lambs which are at risk of colostrum deprivation.
Contraindications
Known hypersensitivity to the active ingredient.
Do not use in pigs over 4 weeks of age or over 7 kg bodyweight.
Use with caution in animals suffering from renal damage
Special warnings for each target species
None
Special precautions for use, including special precautions to be taken by the person administering the medicinal product to the animals
Special precautions for use in animals
Use of the product should be based on susceptibility testing of the bacteria isolated from the animal. If this is not possible, therapy should be based on local (regional, farm level) epidemiological information about susceptibility of the target bacteria.
Special precautions to be taken by the person administering the medicinal product to animals
Do not handle in case of known hypersensivity to spectinomycin.
In case of accidental splashing on to the skin or eyes, wash the affected area with plenty of clean running water.
Wash hands thoroughly after use.
Adverse reactions (frequency and seriousness)
None known
Use during pregnancy, lactation or lay
Not applicable.
Interaction with other medicinal products and other forms of interaction
None reported
Amounts to be administered and administration route
By oral administration.
To ensure a correct dosage, body weight should be determined as accurately as possible to avoid underdosing.
Piglets:
Piglets under 4.5 kg (10 lb) - 1 pump (1 ml) twice daily.
Piglets between 4.5 kg (10 lb) and 7.0 kg (15 lb) - 2 pumps (2 ml) twice daily.
Treatment may be continued twice daily for 3-5 days. If pigs do not improve within 48 hours, re-diagnosis is suggested
Lambs:
1 pump (1 ml) once only as soon as possible after birth.
Insert the doser in the bottle and push the piece of clear plastic tubing over the end of the pump spout. Press the plunger a few times to fill both the pump and plastic extension tube with medication.
The preparation should be administered well back on the tongue. Each pump of the plunger delivers 1 ml of solution containing 50 mg of spectinomycin. When not in use, remove the dosing pump from the bottle. Place the clear plastic tube in the neck of the bottle and press the plunger a few times to return any medication in the pump to the bottle. Before storing for future use, always rinse out the doser with water to prevent the pump parts from sticking.
Overdose (Symptoms, emergency procedures, antidotes)
Because the product is so poorly absorbed from the alimentary canal, it is difficult to overdose.
The symptoms of overdosage in piglets and lambs are not known. There is no known antidote to overdosage.
Withdrawal periods
Animals must not be slaughtered for human consumption during treatment.
Pigs may be slaughtered for human consumption only after 12 days from the last treatment.
Lambs may be slaughtered for human consumption only after 10 days from the last treatment.
Pharmacological particulars
Pharmacotherapeutic group: Antibacterials for systemic use, other antibacterials. ATCvet code: QJ01XX04
Spectinomycin is an aminocyclitol antimicrobial and has been shown to be produced by two kinds of fungi, Streptomyces flavopersicus and Streptomyces spectabilis. It is similar to the aminoglycosides, acting by binding to ribosomal 30s subunits of the bacteria.
In-vitro tests have shown spectinomycin to be effective against a range of Gram-negative and Gram-positive bacteria, although in the field its spectrum of action is for Gram-negative bacteria. Anaerobic organisms are generally resistant.
It has been demonstrated that spectinomycin is more bacteriostatic than bactericidal. The mechanism of action appears to be by inhibition of protein synthesis.
Spectinomycin is poorly absorbed from the alimentary canal. In the blood, protein binding is low at less than 10%. It is almost totally eliminated by renal glomerular filtration with 75% or more cleared in 4 hours.
Pharmaceutical particulars
List of excipients
Benzoic acid, Tartrazine (E102), Hypromellose, Purified water.
Major incompatibilities
None known.
Shelf-life
Shelf-life for veterinary medicine as packaged for sale: 3 years
Special precautions for storage
Do not store above 25°C
Nature and contents of container
Nature:
Container: White high density polyethylene.
Stopper: White Polypropylene.
Plunger device: Various parts consisting of polyacetal, polyethylene, polypropylene, styrene acrylonitrile, butadiene acrylonitrile rubber.
Lubricant: Polydimethylsiloxane.
Contents: 100 ml
Special precautions for the disposal of unused medicinal product or waste materials if any
Any unused product or waste material derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Marketing Authorisation Holder (if different from distributor)
Marketing Authorisation Number
UK: Vm 15052/4006
Significant changes
Date of the first authorisation or date of renewal
Renewed: 31st July 2002
Date of revision of the text
September 2011
Any other information
Nil
Legal category
Legal category: POM-V
GTIN
GTIN description:Spectam Scour Halt 100 ml
GTIN:03411110004302