NOAH Compendium

Printed from NOAH Compendium (http://www.noahcompendium.co.uk). (c) Copyright NOAH Compendium 2017. All Rights Reserved.
Date: Friday, November 24, 2017 3:25

Release 3.9
Medesedan 10mg/ml Solution for Injection for Horses and Cattle
 
Species: Horses and other equidae, Cattle
Therapeutic indication: Pharmaceuticals: Neurological preparations: Analgesics
Active ingredient: Detomidine Hydrochloride
Product:Medesedan 10mg/ml Injection for Horses and Cattle
Product index: Medesedan 10mg/ml Injection for Horses and Cattle
Cattle - milk: 12 hours
Cattle - meat: 2 days
Withdrawal notes: Horse: Meat and offal - 2 days
Presentation
Clear, colourless solution for injection containing 10 mg/ml detomidine hydrochloride (equivalent to 8.36mg detomidine).
Each ml also contains 1.0 mg methyl parahydroxybenzoate (E218).
Uses
For the sedation and slight analgesia of horses and cattle, to facilitate physical examinations and treatments, such as minor surgical interventions.
Detomidine can be used for:
Examinations (e.g. endoscopy, rectal and gynaecological examinations, X-rays).
Minor surgical procedures (e.g. treatment of wounds, dental treatment, tendon treatment, excision of skin tumours, teat treatment).
Before treatment and medication (e.g. stomach tube, horse shoeing).
For premedication prior to administration of injection - or inhalation anaesthetics. See SPECIAL WARNINGS section before use.
Dosage and administration
For intravenous (IV) and intramuscular (IM) use. The product should be injected slowly. Onset of effect is more rapid following intravenous use.
Medesedan Dosage Guide
Dosage in mcg/kg
Dosage in ml/100 kg
Level of sedation
Commencement of effect (min)
Duration of effect (hrs)
   
horse
cattle
 
10-20
0.1-0.2
Light
3-5
5-8
0.5-1
20-40
0.2-0.4
Moderate
3-5
5-8
0.5-1
When prolonged sedation and analgesia is required, doses of 40 to 80 μg/kg can be used. The duration of effect is up to 3 hours.
For combination with other product to intensify the sedation or for premedication prior to general anaesthesia, doses of 10 to 30 μg/kg can be used.
It is recommended to wait 15 minutes after the detomidine administration before starting the planned procedure.
The bodyweight of the animal to be treated should be determined as accurately as possible to avoid overdosing.
Advice on correct administration
In the absence of compatibility studies, this veterinary medicinal product should not be mixed with other veterinary medicinal products in the same syringe.
Contra-indications, warnings, etc
Do not use in animals with cardiac abnormalities or respiratory diseases.
Do not use in animals with liver insufficiency or renal failure.
Do not use in animals with general health problems (e.g. dehydrated animals).
Do not use in combinations with butorphanol in horses suffering from colic.
Do not use in the last trimester of pregnancy.
Adverse reactions
Injection of detomidine may cause the following side effects:
Bradycardia
Transient hypo- and/or hypertension.
Respiratory depression, rarely hyperventilation.
Increase in blood glucose
As with other sedatives, in rare cases paradoxical reactions (excitations) can develop.
Ataxia
Uterine contractions
In Horses: Cardiac arrhythmia, atrioventicular and sino-atrial block
In cattle: Inhibition of rumen motility, tympania, paralysis of the tongue.At doses above 40 μg/kg bodyweight, the following symptoms can also be observed: sweating, pilo-erection and tremor of muscles, transient penis prolapse in stallions and geldings and mild, transient tympania of rumen and increased salivation in cattle.
In very rare cases horses may show mild symptoms of colic following administration of alpha-2 sympathomimetics because substances of this class transiently inhibit the motility of the intestines. Detomidine should be prescribed with caution in horses which present with signs of colic or impaction.
A diuretic effect is usually observed within 45 to 60 minutes after treatment.
Special precautions for use in animals
As sedation begins, especially horses may start to sway and lower the head rapidly while they remain standing. Cattle and especially young cattle will try to lie down. To prevent injuries the location should therefore be chosen carefully. Especially for horses usual precautionary measures should be taken to prevent self-injury. To avoid ruminal bloat and aspiration of feed or saliva, cattle should be maintained in sternal recumbency during and following treatment and head and neck of recumbent cattle should be lowered.
Animals suffering from shock or liver or kidney disease should only be treated according to the benefit risk assessment by the responsible veterinarian. The product should not be used in animals suffering from cardiac diseases (with pre-existing bradycardia and risk of atrioventricular block), respiratory, liver or renal insufficiencies, shock or any other extraordinary stress conditions. Detomidine/butorphanol combination should not be used in horses with a history of liver disease or cardiac irregularities.
It is recommended that feed should be withheld for at least 12 hours prior to anaesthesia. Water or food should not be offered to treated animals until the drug effect has passed.
In painful procedures detomidine should be used only in combination with an analgesic or a local anaesthetic.
While waiting for sedation animals should remain in calm surroundings.
In case of sustained effect it is necessary to protect the animals from heat or cold.
User warnings
In the case of accidental oral intake or self-injection, seek medical advice immediately and show the package leaflet to the physician but DO NOT DRIVE as sedation and changes in blood pressure may occur.
Avoid skin, eye or mucosal contact.
Wash the exposed skin immediately after exposure with large amounts of water. Remove contaminated clothes that are in direct contact with skin. In the case of accidental contact of the product with eyes, rinse abundantly with fresh water. If symptoms occur, seek the advice of a physician. If pregnant women handle the product, special caution should be observed not to self-inject as uterine contractions and decreased foetal blood pressure may occur after accidental systemic exposure.
Advice to doctors
Detomidine is an alpha2-adrenoreceptor agonist, symptoms after absorption may involve clinical effects including dose-dependent sedation, respiratory depression, bradycardia, hypotension, a dry mouth, and hyperglycaemia, Ventricular arrhythmias have also been reported. Respiratory and haemodynamic symptoms should be treated symptomatically.
Use during pregnancy, lactation or lay
Do not use during the last trimester of pregnancy. Use only according to the benefit/risk assessment by the responsible veterinarian during the other months of pregnancy.
Interaction with other medicinal products and other forms of interaction
Concurrent use of other sedatives only after consultation of the warnings and precautions of the product concerned.
Detomidine should not be used in combination with sympathomimetic amines such as adrenaline, dobutamine and ephedrine.
The concurrent use of certain potentiated sulphonamides may cause cardiac arrhythmia with fatal outcome. Do not use in combination with sulphonamides. Detomidine in combination with other sedatives and anaesthetics should be used carefully because additive/synergistic effects may be possible. Where anaesthesia is induced with a combination of detomidine and ketamine, prior to maintenance with halothane, the effects of halothane may be delayed and care must be taken to avoid overdosage. When detomidine is used as a premedicant prior to general anaesthesia, the product may delay the onset of induction.
Overdose (symptoms, emergency procedures, antidotes)
In the event of an accidental overdose, cardiac arrhythmias, hypotension, delayed recovery and profound CMS and respiratory depression may occur. Should the effects of detomidine become life-threatening, general measures for circulatory and respiratory stabilisation and administration of an alpha2-adrenergic antagonist are recommended.
Withdrawal periods
Horse, cattle:
Meat and offal: 2 days
Milk: 12 hours
Pharmaceutical precautions
Keep out of the reach and sight of children. This veterinary medicinal product does not require any special storage conditions.
Do not use after the expiry date stated on the label and on the carton. Shelf-life after first opening the container: 28 days.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
Legal category
Legal category: POM-V
Packaging quantities
1 x 1 glass vial with 5 ml, 5 x 1 glass vial with 5 ml, 1 x 1 glass vial with 20 ml, 5 x 1 glass vial with 20 ml. Not all pack sizes may be marketed.
Marketing Authorisation Number
Vm 20916/4002
Significant changes
Marketing Authorisation Holder (if different from distributor)
CP-Pharma Handelsgesellschaft mbH, Ostlandring 13, 31303 Burgdorf, Germany