Tranquigel

Main information

  • Trade name:
  • Tranquigel 35 mg/ g Oral Gel for Dogs and Horses
  • Pharmaceutical form:
  • Oral gel
  • Prescription type:
  • POM-V - Prescription Only Medicine – Veterinarian
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Tranquigel 35 mg/g Oral Gel for Dogs and Horses
    United Kingdom
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • Dogs, Horses
  • Therapeutic area:
  • Neurological Agent sedative

Status

  • Source:
  • VMD - Veterinary Medicines Directorate
  • Authorization status:
  • Authorized
  • Authorization number:
  • 41821/4044
  • Authorization date:
  • 21-11-2017
  • Last update:
  • 19-01-2018

Summary of Product characteristics: dosage, interactions, side effects

Issued: November 2017

AN: 00391/2016

SUMMARY OF PRODUCT CHARACTERISTICS

1.

NAME OF THE VETERINARY MEDICINAL PRODUCT

Tranquigel 35 mg/g oral gel for dogs and horses

(AT, BE, BG, CY, CZ, DE, EL, FR, HR, HU, LU, NL, PT, RO, SI, SK, UK)

Tranquigel vet 35 mg/g oral gel for dogs and horses

(IS, NO, SE, PL)

2.

QUALITATIVE AND QUANTITATIVE COMPOSITION

1 gram contains:

Active substances:

Acepromazine (as acepromazine maleate)

35.0 mg

Excipient(s):

Methyl parahydroxybenzoate (E 218)

1.04 mg

Propyl parahydroxybenzoate

0.104 mg

For the full list of excipients, see section 6.1.

3.

PHARMACEUTICAL FORM

Oral gel.

Clear, viscous, orange-yellow gel.

4.

CLINICAL PARTICULARS

4.1

Target species

Dogs and horses.

4.2

Indications for use, specifying the target species

For sedation of dogs and horses

4.3

Contraindications

Do not use in cases of hypotension, post-traumatic shock or hypovolemia.

Do not use in animals in a state of severe emotional excitation.

Do not use in animals suffering from hypothermia.

Do not use in animals with haematological disorders/coagulopathies or anaemia.

Do not use in animals with heart and or lung failure.

Do not use in animals with epilepsy.

Do not use in neonates.

Do not use in cases of hypersensitivity to the active substance or to any of the

excipients.

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Issued: November 2017

AN: 00391/2016

4.4

Special warnings for each target species

Dogs

None

Horses

Sedation lasts for approximately six hours, although the actual time and depth of

sedation are very dependent on the status of the individual animal.

Increasing the dosage above that recommended results in prolonged action and side

effects but no greater sedation.

4.5

Special precautions for use

Special precautions for use in animals:

This veterinary medicinal product should be used with caution and with reduced

dosage in the case of hepatic disease or in debilitated animals.

Acepromazine has negligible analgesic effects. Painful activities should be avoided

when handling tranquillized animals, unless treated with appropriate analgesics.

After administration of this veterinary medicinal product, animals should be kept in a

calm place and sensorial stimuli should be avoided as far as possible.

Dogs

Use of this veterinary medicinal product in dogs less than 17.5 kg bodyweight should

be based on a careful benefit: risk assessment by the responsible veterinarian.

Owing to limitations of the dosing- device in delivering small doses use in small (less

than 17,5 kg) dogs is not recommended for light sedation in sensitive individuals and

breeds.In dogs with the ABCB1-1Δ (also called MDR1) mutation, acepromazine

tends to cause more profound and prolonged sedation. In these dogs the dose

should be reduced by 25%-50%. In some dogs, particularly Boxers and other short-

nosed breeds, spontaneous fainting or syncope may occur, due to sinoatrial block

caused by excessive vagal tone, and an attack may be precipitated by

acepromazine, so a low dose should be used. Where there is a history of this type of

syncope, or if it is suspected because of excessive sinus arrhythmia, it may be

advantageous to control the dysrhythmia with atropine given just before the

acepromazine.

Large breeds: it has been noted that large breeds of dogs are particularly sensitive to

acepromazine and the minimum dose possible should be used in these breeds.

Acepromazine should be used cautiously as a restraining agent in aggressive dogs

as it may make the animal more prone to startle and react to noises or other sensory

inputs.

Horses

In stallions, the lowest dose range is indicated to minimise prolapse of the penis.

Use of this veterinary medicinal product in horses less than 100 kg bodyweight

should be based on a careful benefit: risk assessment by the responsible

veterinarian.

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Issued: November 2017

AN: 00391/2016

Special precautions to be taken by the person administering the veterinary medicinal

product to animals:

Acepromazine may cause sedation. Care should be taken to avoid accidental

ingestion. Replace cap immediately after use. While replacing the cap a “click” must

be heard to ensure proper closure. Keep the broached oral syringe in the original

carton and make sure that the carton is closed properly. Keep the package out of

sight and reach of children at all times. In case of accidental ingestion, seek medical

advice immediately and show the package leaflet or the label to the physician but DO

NOT DRIVE as sedation can occur.

Wash hands and exposed skin thoroughly after use.

People with sensitive skin or in continuous contact with the veterinary medicinal

product are advised to wear impermeable gloves.

Avoid contact with eyes.

If accidental eye contact occurs, flush gently with running water for 15 minutes and

seek medical advice if any irritation persists.

4.6

Adverse reactions (frequency and seriousness)

Dogs

Hypotension, tachycardia, increase of respiratory rate, arrhythmia, miosis, lacrimation

and ataxia. Contradictory clinical signs of aggressiveness and generalised CNS

stimulation may occur.

Horses

Since acepromazine decreases sympathetic nervous system tone, a transient drop in

blood pressure may occur after administration.

Inhibition of temperature regulation.

The following reversible changes are possible in the haemogram:

- transient decrease in erythrocyte count and haemoglobin concentration;

- transient decrease in thrombocyte and leukocyte counts.

Because acepromazine may increase prolactin secretion, the administration of

acepromazine may lead to disturbances in fertility.

Penile prolapse may occur due to the relaxation of the retractor penis muscles.

Retraction of the penis must be visible within two to three hours. If this does not take

place, it is advised to contact a veterinary surgeon. Lack of retraction is of particular

concern in breeding stallions. Administration of acepromazine has caused

paraphimosis (the foreskin does not return to the normal position) sometimes in

sequel to priapism (persistent erection).

Contradictory clinical signs of aggressiveness and generalised CNS stimulation may

occur.

Prolapse of the nictitating membrane (third eyelid) has also been cited as a possible

adverse effect in horses.

4.7

Use during pregnancy and lactation

The safety of this veterinary medicinal product during pregnancy and lactation has

not been studied in the target species; use only accordingly to the benefit-risk

assessment by the responsible veterinarian.

Please see also Section 4.6 relating to disturbances in fertility in mares.

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Issued: November 2017

AN: 00391/2016

4.8

Interaction with other medicinal products and other forms of interaction

Acepromazine potentiates the action of centrally depressant drugs.

Simultaneous administration, or administration to animals recently treated with

organophosphates or procaine hydrochloride (a local anaesthetic) should be avoided,

since these molecules enhance the toxic effects of acepromazine.

Since acepromazine decreases sympathetic nervous system tone, simultaneous

treatment with blood pressure lowering products should not take place.

Antacids may cause a decrease in the gastrointestinal absorption of acepromazine

after oral administration.

Opiates and adrenaline may enhance the hypotensive effects of acepromazine.

4.9

Amounts to be administered and administration route

For oral use.

Dogs

Light sedation: 0.5 – 1.0 mg acepromazine / kg body weight (corresponding to 0.14 –

0.29 g of product per 10 kg bodyweight)

Deeper sedation: 1.0 – 2.0 mg acepromazine /kg body weight (corresponding to 0.29

– 0.57 g of product per 10 kg bodyweight)

Horses

Moderate sedation: 0.150 mg acepromazine / kg body weight (corresponding to

0.43 g of product per 100 kg bodyweight)

Deeper sedation: 0.225 mg acepromazine / kg body weight (corresponding to 0.64 g

of product per 100 kg bodyweight)

The above dosage information is provided as a guideline and should be adapted to

each patient, taking into account the various factors (e.g. temperament, breed,

nervousness etc.) that may affect the sensitivity to sedatives.

Use of this veterinary medicinal product for light sedation in dogs weighing less than

17.5 kg should be based on a careful benefit: risk assessment by the responsible

veterinarian. See section 4.5.

The 3 and 6 gram syringes have a dosage ring graduated every 0.25 gram.

The 10 and 12 gram syringes have a dosage ring graduated every 0.5 gram. The

most appropriate syringe should be chosen to ensure accurate dosing.

The following tables are intended as a guide to dispensing this veterinary medicinal

product at the recommended dose rates. Turn the dial ring anti-clockwise until the left

side of the ring lines up with the weight of the oral gel to be administered. Place the

pre-filled oral syringe in the animal's mouth and expel the required dose on the back

of the tongue of dogs or into the cheek pouch of horses.

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AN: 00391/2016

Dogs Tranquigel

Light Sedation

0.5 - 1.0 mg/kg body weight

Deeper Sedation

1.0 - 2.0 mg/kg body weight

Body weight

Dose of

gel

(gram)

Acepromazin

e

(mg)

Dose range

(mg/kg)

Dose of

gel

(gram)

Acepromazine

(mg)

Dose

range

(mg/kg)

10 kg – 17.5 kg

0.25

8.75

0.88 – 0.50

0.50

17.50

1.75 – 1.00

>17.5 kg – 20 kg

0.50

17.50

1.00 – 0.88

0.75

26.25

1.50 – 1.31

>20 kg – 25 kg

0.50

17.50

0.88 – 0.70

1.00

35.00

1.75 – 1.40

>25 kg – 30 kg

0.50

17.50

0.70 – 0.58

1.25

43.75

1.75 – 1.46

>30 kg – 40 kg

0.75

26.25

0.88 – 0.66

1.50

52.50

1.75 – 1.31

>40 kg – 50 kg

1.00

35.00

0.88 – 0.70

2.00

70.00

1.75 – 1.40

>50 kg – 60 kg

1.25

43.75

0.88 – 0.73

2.50

87.50

1.75 – 1.46

>60 kg – 70 kg

1.50

52.50

0.88 – 0.75

3.00

105.00

1.75 – 1.31

Horses Tranquigel

Moderate Sedation

0.150 mg/kg body weight

Deeper Sedation

0.225 mg/kg body weight

Body weight

Dose of

gel

(gram)

Acepromazine

(mg)

Dose range

(mg/kg)

Dose of

gel

(gram)

Acepromazine

(mg)

Dose range

(mg/kg)

100 kg – 150 kg

0.50

17.50

0.18 – 0.12

0.75

26.25

0.26 – 0.18

>150 kg – 200 kg

0.75

26.25

0.18 – 0.13

1.00

35.00

0.23 – 0.18

>200 kg – 250 kg

1.00

35.00

0.18 – 0.14

1.50

52.50

0.26 – 0.21

>250 kg – 300 kg

1.25

43.75

0.18 – 0.15

1.75

61.25

0.25 – 0.20

>300 kg – 350 kg

1.50

52.50

0.18 – 0.15

2.25

78.75

0.26 – 0.23

>350 kg – 400 kg

1.75

61.25

0.18 – 0.15

2.50

87.50

0.25 – 0.22

>400 kg – 500 kg

2.00

70.00

0.18 – 0.14

3.00

105.00

0.26 – 0.21

>500 kg – 600 kg

2.50

87.50

0.18 – 0.15

3.50

122.50

0.25 – 0.20

In dogs sedation usually sets in after 1 hour and lasts 8-12 hours, in horses sedations

sets in after 15-20 minutes and lasts for 6-7 hours. For longer use in dogs these

doses may be repeated once after 12 hours.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary

Overdose results in an earlier onset of the sedative symptoms and in a prolonged

effect. Toxic effects are ataxia, hypotension, hypothermia and central nervous system

(extrapyramidal) effects. Noradrenaline, but not adrenaline, can be used to

counteract the cardiovascular effects.

4.11 Withdrawal period(s)

Not authorised for use in horses intended for human consumption?

5.

PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: Nervous system, psycholeptics, antipsychotics,

phenothiazines with aliphatic side-chain, acepromazine.

ATCvet code: QN05AA04

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Issued: November 2017

AN: 00391/2016

5.1

Pharmacodynamic properties

Acepromazine is a phenothiazine derivative with neuroleptic activity. Phenothiazines

inhibit the post-synaptic dopamine receptors in the central nervous system and can

inhibit the dopamine release.

Besides this, phenothiazines have an anticholinergic effect and they can antagonise

the alpha-adrenergic receptors and thus decrease the tone of the sympathetic

nervous system.

5.2

Pharmacokinetic particulars

In dogs the bioavailability after oral administration is approximately 20%. Sedation

usually sets in after 1 hour and lasts up to 8-12 hours. As the gastro-intestinal

absorption is variable, dose adjustment is necessary per patient.

In horses bioavailability after oral administration is approximately 20-50%. Sedation

usually sets in after 15-20 minutes after administration with a peak effect after 30-60

minutes and lasts up to 6-7 hours.

In both target species acepromazine is extensively distributed throughout the body

tissues and the plasma protein binding is more than 99%. Acepromazine is

metabolised in the liver, with urine as the main route of excretion of unconjugated

and conjugated metabolites.

6.

PHARMACEUTICAL PARTICULARS

6.1

List of excipients

Methyl parahydroxybenzoate (E 218)

Propyl parahydroxybenzoate

Hydroxyethylcellulose

Ethanol 96%

Maleic acid (for pH adjustment)

Sodium hydroxide (for pH adjustment)

Water, purified

6.2

Major incompatibilities

None applicable

6.3

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 3 years.

Shelf-life after first opening the immediate packaging: 56 days (8 weeks).

6.4

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions.

6.5

Nature and composition of immediate packaging

White LLDPE (linear low-density polyethylene) pre-filled oral syringe of different sizes:

4 ml containing 3 gram, 8 ml containing 6 gram, 14 ml containing 10 gram and 14 ml

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Issued: November 2017

AN: 00391/2016

containing 12 gram. The 3 and 6 gram syringes have a dosage ring graduated every

0.25, 0.5 and 1 gram. The 10 and 12 gram syringes have a dosage ring graduated

every 0.5 and 1 gram. The syringes are tightly closed with a LLDPE cap. Each pre-

filled oral syringe is packed in a cardboard box.

Pack sizes:

Box with 1 pre-filled oral syringe of 3 gram

Box with 1 pre-filled oral syringe of 6 gram

Box with 1 pre-filled oral syringe of 10 gram

Box with 1 pre-filled oral syringe of 12 gram

Multi-pack with 12 boxes each containing 1 pre-filled oral syringe of 3 gram

Multi-pack with 12 boxes each containing 1 pre-filled oral syringe of 6 gram

Multi-pack with 12 boxes each containing 1 pre-filled oral syringe of 10 gram

Multi-pack with 12 boxes each containing 1 pre-filled oral syringe of 12 gram

Not all pack sizes may be marketed.

6.6

Special precautions for the disposal of unused veterinary medicinal

product or waste materials derived from the use of such products

Any unused veterinary medicinal product or waste materials derived from such

veterinary medicinal products should be disposed of in accordance with local

requirements.

7.

MARKETING AUTHORISATION HOLDER

Le Vet Beheer B.V.

Wilgenweg 7

3421 TV Oudewater

The Netherlands

8.

MARKETING AUTHORISATION NUMBER

Vm 41821/4044

9.

DATE OF FIRST AUTHORISATION

21 November 2017

10.

DATE OF REVISION OF THE TEXT

November 2017

Approved: 21 November 2017

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