Table of Contents
Wildlife Pharmaceuticals specialises in the local and international distribution of scheduled veterinary medicines
Each ml contains: Midazolam HCl 50 mg
Preservative: Methylparaben 0,1 % m/v
CATEGORY AND CLASS OF MEDICINE
C 1.4.1 Sedative hypnotic
PHARMACOKINETIC AND PHARMACODYNAMIC PROPERTIES
No pharmacokinetic studies have been done in wildlife animals. The pharmacokinetics of midazolam in domestic animals shows variation between species and routes of administration.
In dogs, the elimination half-life is variable (0,46 hours following IV administration to 1,6 hours following IM administration) with a high clearance rate (10-28 ml/kg/min). In horses, the elimination half-life is 3,6 hours following IV administration and 6,8 hours following IM administration with a high clearance rate of 10,4 – 10,6 ml/min/kg. In sheep, the elimination half-life of midazolam following IV administration is 0,78 hours with a clearance of 21,2 ml/min/kg. Midazolam is metabolised in the liver and the metabolites are excreted in the urine. Elimination of midazolam occurs in a biphasic manner and consists of an initial rapid redistribution phase, followed by a slower terminal phase.
Aqueous midazolam preparations produce little tissue irritation when injected. Following injection into an environment of relatively neutral tissue pH, the chemical structure of midazolam shifts to a completely ring-closed form, which makes the medicine highly lipophilic. This lipophilic form is rapidly absorbed from the injection site and easily penetrates the CNS.
SEDOLAM 50 is indicated for sedation and induction of anaesthesia in wildlife animals. Controlled clinical trials with SEDOLAM 50 have only been conducted in blesbok.
The rapid onset of action following IV administration of SEDOLAM 50 may lead to paradoxical excitation or serious cardiorespiratory depression.
The safety of SEDOLAM 50 in pregnant and lactating wildlife animals has not been established. Reproduction toxicology and teratological studies in domestic animal species has shown that midazolam is neither embryotoxic nor teratogenic and exerts no influence on the fertility and post-natal development of animals. Studies in rats showed no adverse effects on reproductive parameters during gestation and/or lactation.
SEDOLAM 50 residue studies have not been conducted in wildlife animals. Human and predator consumption of carcasses from animals treated with SEDOLAM 50 is not advised.
DOSAGE AND DIRECTIONS FOR USE
SEDOLAM 50 dosing is dependent on species, body mass and the condition of the wildlife animal being treated. Administration by IV injection is recommended. Refer to the table for SEDOLAM 50 dosing.
SIDE EFFECTS AND SPECIAL PRECAUTIONS FOR USE
No severe side effects have been reported in wildlife animals. Administration of SEDOLAM 50 in combination with ketamine may result in respiratory depression and vomiting. Special precautions should be taken when SEDOLAM 50 is administered IV as abnormal excitement has been reported.
Due to its high concentration, accidental exposure to SEDOLAM 50 could have serious effects on humans. Veterinarians are advised to take the following precautions when handling SEDOLAM 50:
Do not work with the product when unaccompanied.
Avoid using the product in devices where the solution is pressurised e.g. blowpipes.
Wear gloves when handling the product.
Discard used needles in an appropriate sharps container immediately after use.
In the event of topical exposure, rinse the affected area with copious amounts of water. Monitor for signs of toxicity including impaired level of consciousness, ataxia and dysarthria.
Should accidental injection occur, administer the antidote (flumazenil) and seek medical attention immediately. Severe exposure may result in respiratory depression, hypotension and hypothermia. Monitor the airways and initiate CPR if needed.
KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT
Symptoms of overdosing include increased depth of sedation and/or prolonged recovery. The sedative effect of SEDOLAM 50 will be accentuated by concomitantly administered CNS depressants, particularly opioids.
A clear, colourless solution free from visible particulates.
SEDOLAM 50 is supplied in a 10 ml amber glass vial with a grey rubber stopper and a white plastic cap. Each vial is contained in an outer carton.
Store at or below 25 °C.
Protect from light.
KEEP OUT OF REACH OF CHILDREN AND UNINFORMED PERSONS.
NAME AND BUSINESS ADDRESS OF HOLDER OF CERTIFICATE OF REGISTRATION
Wildlife Pharmaceuticals (Pty) Ltd. 38 Wilkens Street, Rocky Drift, White River,1240, South Africa.
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