Detonervin 10 mg/mL Solution for Injection for Horses and Cattle

New Zealand - English - Ministry for Primary Industries

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Active ingredient:
detomidine hydrochloride
Available from:
Le Vet Beheer B.V.
Composition:
detomidine hydrochloride 10 g/litre
Authorization number:
A011449
Authorization date:
2019-09-23

TEXT LABEL: DETONERVIN 10 mg/mL SOLUTION FOR INJECTION FOR HORSES AND CATTLE

Immediate Container Label: Ancillary Panel

Text appearing above the Header and below the Footer lines is not included in the label

12 Sept 2019 Version 4 1 | P a g e

5 mL Bottle:

RESTRICTED VETERINARY MEDICINE

WARNING - KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

DETONERVIN 10 mg/mL

SOLUTION FOR INJECTION

FOR HORSES AND CATTLE

10 mg/mL Detomidine hydrochloride

Analgesic / sedative for cattle and horses.

5 mL

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

WITHHOLDING PERIODS:

Cattle: Meat: Zero (0) days; Milk: Zero (0) days

Horses: Meat: Zero (0) days

STORAGE: Store below 25

C (Air conditioning). Protect from light. Do not freeze.

Distributed By:

Kahu Veterinary Equipment Ltd

ACVM No. A11449

Batch:

Expiry:

TEXT LABEL: DETONERVIN 10 mg/mL SOLUTION FOR INJECTION FOR HORSES AND CATTLE

Immediate Container Label: Ancillary Panel

Text appearing above the Header and below the Footer lines is not included in the label

12 Sept 2019 Version 4 2 | P a g e

20 mL Bottle:

RESTRICTED VETERINARY MEDICINE

WARNING - KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

DETONERVIN 10 mg/mL

SOLUTION FOR INJECTION

FOR HORSES AND CATTLE

10 mg/mL Detomidine hydrochloride

Analgesic / sedative for cattle and horses.

20 mL

TEXT LABEL: DETONERVIN 10 mg/mL SOLUTION FOR INJECTION FOR HORSES AND CATTLE

Immediate Container Label: Ancillary Panel

Text appearing above the Header and below the Footer lines is not included in the label

12 Sept 2019 Version 4 3 | P a g e

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

DIRECTIONS FOR USE

Dosage and Administration

Horses and cattle intramuscular (IM) or slow intravenous (IV).

Dose (mL/100 kg)

Effect

Effect Begins (mins)

Duration of Action

(hrs)

0.1 – 0.2

Easy to handle

3 - 5

0.3 – 1.0

0.2 – 0.4

Easy to handle

3 - 5

0.5 – 1.0

0.4 – 0.8

Prolonged effect

2 - 5

0.5 – 2.0

0.8 – 1.5

Strong effect

1 - 5

2.0 – 6.0

WITHHOLDING PERIODS:

Cattle: Meat: Zero (0) days; Milk: Zero (0) days

Horses: Meat: Zero (0) days

Disposal:

Dispose of empty container by wrapping with paper and putting in garbage.

Storage:

Store below 25

C (Air conditioning). Protect from light. Do not freeze

Discard 28 days after first broaching vial.

Registered to Le Vet Beheer B.V., The Netherlands

Distributed By:

Kahu Veterinary Equipment Ltd

Unit 7B, 23 Ash Road, Wiri Auckland 2104, New Zealand

Ph: 0800 524 883

ACVM No. A11449

Batch:

Expiry:

TEXT LABEL: DETONERVIN 10 mg/mL SOLUTION FOR INJECTION FOR HORSES AND CATTLE

Folding Carton: Main Panel

Text appearing above the Header and below the Footer lines is not included in the label

12 Sept 2019 Version 4 4 | P a g e

RESTRICTED VETERINARY MEDICINE

WARNING - KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

DETONERVIN 10 mg/mL

SOLUTION FOR INJECTION

FOR HORSES AND CATTLE

10 mg/mL Detomidine hydrochloride

Analgesic / sedative for cattle and horses.

5 mL [20 mL]

TEXT LABEL: DETONERVIN 10 mg/mL SOLUTION FOR INJECTION FOR HORSES AND CATTLE

Carton: Ancillary Panels

Text appearing above the Header and below the Footer lines is not included in the label

12 Sept 2019 Version 4 5 | P a g e

READ THE ENCLOSED LEAFLET BEFORE USING THIS PRODUCT.

DIRECTIONS FOR USE

Dosage and Administration

Horses and cattle intramuscular (IM) or slow intravenous (IV).

Dose (mL/100 kg)

Effect

Effect Begins (mins)

Duration of Action

(hrs)

0.1 – 0.2

Easy to handle

3 - 5

0.3 – 1.0

0.2 – 0.4

Easy to handle

3 - 5

0.5 – 1.0

0.4 – 0.8

Prolonged effect

2 - 5

0.5 – 2.0

0.8 – 1.5

Strong effect

1 - 5

2.0 – 6.0

WITHHOLDING PERIODS:

Cattle: Meat: Zero (0) days

Milk: Zero (0) days

Horses: Meat: Zero (0) days

STORAGE: Store below 25

C (Air conditioning). Protect from light. Do not freeze.

Discard 28 days after first broaching vial.

Registered to Le Vet Beheer B.V., The Netherlands

Distributed By:

Kahu Veterinary Equipment Ltd

Unit 7B, 23 Ash Road, Wiri Auckland 2104, New Zealand

Ph: 0800 524 883

ACVM Registration No. A11449

See www.foodsafety.govt.nz for registration conditions

Batch:

Expiry:

TEXT LABEL: DETONERVIN 10 mg/mL SOLUTION FOR INJECTION FOR HORSES AND CATTLE

Leaflet

Text appearing above the Header and below the Footer lines is not included in the label

12 Sept 2019 Version 4 6 | P a g e

RESTRICTED VETERINARY MEDICINE

WARNING - KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

DETONERVIN 10 mg/mL

SOLUTION FOR INJECTION

FOR HORSES AND CATTLE

Injectable sedative and analgesic for use in horses and cattle.

Sterile Solution 10 mg/mL

Composition

Detomidine hydrochloride

10 mg

Methylparahydroxybenzoate

1 mg

Sodium chloride

5.9 mg

Aq. ad inject

1 mL

Indications

For slight analgesia and sedation in horses and cattle, to facilitate physical examinations and

treatments, such as minor surgical interventions. DETONERVIN may be used for:

Examinations e.g. endoscopy, rectal palpation, gynaecological examinations, x-ray

examinations

Minor surgical procedures e.g. treatment of wounds, removal of skin tumours and

hoof care

Treatment and medication e.g. use of nasogastric tubes and shoeing

Castration

In painful procedures detomidine should be used in combination with an analgesic or a local

anaesthetic.

DIRECTIONS FOR USE

Contraindications

As the safety of DETONERVIN during pregnancy and lactation has not been adequately

documented, its use is not recommended during the last month of pregnancy.

Because of possible interactions, it is recommended that sympathomimetic amines (e.g.

adrenaline, dobutamine) and intravenous potentiated sulphonamides should not be

administered to horses sedated with DETONERVIN.

DETONERVIN should not be used in animals with cardiac diseases (with pre-existing

bradycardia and risk of atrioventricular block) or respiratory, liver or kidney insufficiencies.

TEXT LABEL: DETONERVIN 10 mg/mL SOLUTION FOR INJECTION FOR HORSES AND CATTLE

Leaflet

Text appearing above the Header and below the Footer lines is not included in the label

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Side Effects

Harmful side effects have not been observed. The sympathomimetic properties of

DETONERVIN in large doses include effects such as piloerections and slight sweating of short

duration.

Partial transient penile prolapse in stallions and geldings and mild transient ruminal tympany

in cattle may be seen particularly at Detomidine HCl doses >40 µg/kg bodyweight. Very

rarely horses may exhibit signs of colic due to transitory intestinal status.

Dosage and Administration

Horses and cattle intramuscular (IM) or slow intravenous (IV) administration.

Dose

Effect

Effect

Begins

(mins)

Duration of

Action (hrs)

Other Effects

µg/kg

mL/100 kg

10 – 20

0.1 – 0.2

Easy to handle

3 – 5

0.3 – 1.0

Slight teetering

20 - 40

0.2 – 0.4

Easy to handle

3 – 5

0.5 – 1.0

Slight teetering

40 - 80

0.4 – 0.8

Prolonged

effect

2 – 5

0.5 – 2.0

Teetering,

sweating,

piloerection,

muscle spasms

80 -

0.8 – 1.5

Strong effect

1 - 5

2.0 – 6.0

Strong teetering,

piloerection,

sweating

It is recommended to wait 15 minutes after DETONERVIN administration before starting the

planned procedure.

Tissue tolerance to DETONERVIN is good.

WITHHOLDING PERIODS

It is an offence for users of this product to cause residues exceeding the relevant MRL in

the Food Notice: Maximum Residue Levels of Agricultural Compounds.

Cattle: Meat: Zero (0) days

Milk: Zero (0) days

Horses: Meat: Zero (0) days

NOTE

A risk/benefit assessment should be undertaken by a veterinarian before using this product

in animals suffering from liver or renal disease or shock.

The safe handling of horses and cattle can be improved with DETONERVIN. Although the

animal is easy to handle under DETONERVIN sedation, normal restricting methods are

recommended. Local anaesthetics can be used when required.

When the DETONERVIN effect begins, the animal may lurch and lower the head rapidly. This

must be kept in mind when the handling place is chosen.

If cattle lie down, avoid ruminal bloat and aspiration of feed or saliva by maintaining in

sternal recumbency during and following treatment with head and neck lowered.

TEXT LABEL: DETONERVIN 10 mg/mL SOLUTION FOR INJECTION FOR HORSES AND CATTLE

Leaflet

Text appearing above the Header and below the Footer lines is not included in the label

12 Sept 2019 Version 4 8 | P a g e

Fasting prior to DETONERVIN sedation is not necessary. Water and feed should not be given

to the animal until the effect is over.

When using DETONERVIN extra fuss should be avoided.

FIRST AID:

If swallowed, DO NOT induce vomiting. If poisoning occurs, contact a doctor or

Poisons Information Centre. Phone New Zealand 0800 764 766 (0800 POISON).

HANDLING PRECAUTIONS:

This material may be harmful to humans if swallowed, inhaled or

absorbed through the skin, and may affect the central nervous system following repeated

oral exposure to high doses. Avoid ingestion, inhalation of vapours or mists, and skin

contact. Wash hands and exposed skin before meals and after use.

DISPOSAL: Dispose of empty container by wrapping with paper and putting in garbage.

STORAGE: Store below 25

C (Air conditioning). Protect from light. Do not freeze.

Discard 28 days after first broaching vial.

Presentation

: DETONERVIN is supplied in a 5 mL or 20 mL glass vial.

Registered to Le Vet Beheer B.V., The Netherlands

Distributed By:

Kahu Veterinary Equipment Ltd

Unit 7B, 23 Ash Road, Wiri Auckland 2104, New Zealand

Ph: 0800 524 883

ACVM Registration No. A11449

See www.foodsafety.govt.nz for registration conditions

Ref No A11449-02

Public Record of Delegate Decision

For granting an application for registration under section 21 of the Agricultural Compounds and Veterinary

Medicines Act 1997

Product details

Trade name

Detonervin 10 mg/mL Solution for Injection for Horses and Cattle

Ref No

A11449-02

Applicant

Le Vet Beheer B.V.

Application type

NEW PRODUCT

Date of Delegate

Decision

16 September 2019

Registration

Expiry Period

This registration will expire 5 years from the date of this Delegate’s Decision.

Protected

Confidential

Information

Status

Protected CI - New Registration - Non-innovative Trade Name Product

Summary of reasons for the Decision to grant the Application

Chemistry/Manufacturing: Chemistry and manufacturing information conformed to MPI requirements and was

sufficient to confirm the identity and quality of the product.

The product data sheet is complete, accurate and current.

The manufacturer has the appropriate approval. Manufacturing specifications conformed to MPI requirements and

were sufficient to show that the product could be consistently manufactured to those specifications.

Stability trials and data conformed to MPI requirements and were sufficient to assess.

Efficacy: Efficacy data conformed to MPI requirements and were sufficient to assess.

Safety: Safety data conformed to MPI requirements and were sufficient to assess.

Residues: Residue data conformed to MPI requirements and were sufficient to assess.

Trade: The product has been assessed in regard to the impact its use may have on trade in primary produce.

Public health: Due to the nature of the product and how it is intended to be used there were no additional public

health matters that needed to be addressed over and above those covered under the Hazardous Substances and

New Organisms Act 1996.

Recommendation to Register

On the basis of the above information, the product as approved, and when imported, manufactured, sold or used

in accordance with the conditions listed below, is not likely to cause unacceptable risks to:

public health

trade in primary produce

animal welfare or

Ref No A11449-02

agricultural security.

In balance, there are sufficient benefits to warrant this product to be registered.

When used in accordance with this approval, the product is not likely to cause residues in primary produce, food

or food-related products that would breach domestic food residue standards.

The assessed label content is adequate to provide sufficient consumer information to allow the product to be used

appropriately and safely and meets labelling requirements.

Delegate’s decision

Being satisfied of the matters above, and under delegated authority pursuant to the Agricultural Compounds and

Veterinary Medicines Act 1997, this application for registration is granted, under section 21(1)(d) under the

conditions as listed on the Register.

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