Sedastart vet.

1 x 10 ml

Liquid for injection, solution

Active substance

Medetomidine (Medetomidine hydrochloride) : 1 mg/ml

ATC code

QN05CM91 Medetomidine

QN05CM Other hypnotics and sedatives

QN05C Hypnotics and sedatives

QN05 Psycholeptics

QN Nervous system

Species

Dog and Cat

Indications

In dogs and cats:

Sedation to facilitate handling. Premedication prior to general anaesthesia.

In cats:

In combination with ketamine for general anaesthesia for minor surgical procedures of short duration.

Dose to be administered and administration route

The veterinary medicinal product is intended for:

Dogs: Intramuscular or intravenous use.

Cats: Intramuscular use.

Use of an appropriately graduated syringe is recommended to ensure accurate dosing when administering small volumes

Dogs:

For sedation, the veterinary medicinal product should be administered at the rate of 750 μg medetomidine hydrochloride i.v. or 1000 μg medetomidine hydrochloride i.m. per square meter of body surface. Use the table below to determine the correct dosage on the basis of body weight:

Maximal effect is obtained within 15-20 minutes. Clinical effect is dosedependent, lasting from 30-180 minutes.

Dosages in ml and corresponding amount of medetomidine hydrochloride in μg/kg bw):

Body weight [kg]	i.v. – Injection [ml]	corresp. to [μg/kg bw]	i.m. – Injection [ml]	corresp. to [μg/kg bw]
1	0.08	80.0	0.10	100.0
2	0.12	60.0	0.16	80.0
3	0.16	53.3	0.21	70.0
4	0.19	47.5	0.25	62.5
5	0.22	44.0	0.30	60.0
6	0.25	41.7	0.33	55.0
7	0.28	40.0	0.37	52.9
8	0.30	37.5	0.40	50.0
9	0.33	36.7	0.44	48.9
10	0.35	35.0	0.47	47.0
12	0.40	33.3	0.53	44.2
14	0.44	31.4	0.59	42.1
16	0.48	30.0	0.64	40.0
18	0.52	28.9	0.69	38.3
20	0.56	28.0	0.74	37.0
25	0.65	26.0	0.86	34.4
30	0.73	24.3	0.98	32.7
35	0.81	23.1	1.08	30.9
40	0.89	22.2	1.18	29.5
50	1.03	20.6	1.37	27.4
60	1.16	19.3	1.55	25.8
70	1.29	18.4	1.72	24.6
80	1.41	17.6	1.88	23.5
90	1.52	16.9	2.03	22.6
100	1.63	16.3	2.18	21.8

For premedication, the veterinary medicinal product should be administered at a dosage of 10-40 µg medetomidine hydrochloride per kg body weight, corresponding to 0.1 – 0.4 ml product per 10 kg body weight. The exact dose depends on the combination of drugs used and the dosage(s) of the other drug(s). The dose should furthermore be adjusted to the type of surgery, length of procedure and patient temperament and weight. Premedication with medetomidine will significantly reduce the dosage of the induction agent required and will reduce volatile anaesthetic requirements for maintenance anaesthesia. All anaesthetic agents used for induction or maintenance of anaesthesia should be administered to effect. Before using any combinations, product literature for the other products should be observed. See also section 4.5.

Cats:

For moderate-deep sedation and restraint of cats the veterinary medicinal product should be administered at a dosage of 50 – 150 μg medetomidine hydrochloride / kg bw (corresp. to 0.05 – 0.15 ml product / kg bw).

For anaesthesia the veterinary medicinal product should be administered at a dosage of 80 μg medetomidine hydrochloride / kg bw (corresp. to 0.08 ml product / kg bw) and 2.5 to 7.5 mg ketamine / kg bw. Using this dosage anaesthesia occurs within 3 – 4 minutes and is apparent for 20 – 50 minutes.

For longer lasting procedures administration has to be repeated by using ½ of the initial dose (i.e. 40 μg medetomidine hydrochloride (corresp. to 0.04 ml product / kg bw) and 2.5 – 3.75 mg ketamine / kg bw) or 3.0 mg ketamine / kg bw alone. Alternatively, for longer lasting procedures anaesthesia may be extended by use of the inhalation agents isoflurane or halothane, with oxygen or oxygen/nitrous oxide. See section 4.5

Adverse reactions

Target species: Cats and dogs.

Rare (1 to 10 animals / 10,000 animals treated):	Pulmonary oedema^a
Very rare (<1 animal / 10,000 animals treated, including isolated reports):	Bradycardia, Hypertension^b , Death^c , Respiratory depression^d , Cyanosis Vomit^e , Hyperaesthesia, Polyuria, Hypothermia, Muscle tremor, Hyperglycaemia^f
Undetermined frequency (cannot be estimated from the available data)	Heart block 1st degree, Heart block 2nd degree, Extrasystole, Vasconstriction of coronary artery, Decreased cardiac output, Injection site pain

^a Especially in cats.

^b Blood pressure will increase initially after administration and then return to normal, or slightly below normal

^c from circulatory failure with severe congestion of the lungs, liver, or kidney has been reported.

^d In circulatory and respiratory depression manual ventilation and an oxygen supplement may be indicated

^e Some dogs and most cats will vomit within 5-10 minutes of injection. Cats may also vomit on recovery.

^f In individual cases reversible hyperglycaemia due to depression of insulin secretion.

Atropine may increase the cardiac rate. Dogs with a body weight of less than 10 kg may show the undesirable effects mentioned above more often. Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See the package leaflet for respective contact details.