Apex Meloxicam KG Oral Suspension for Dogs

New Zealand - English - Ministry for Primary Industries

Buy It Now

Active ingredient:
meloxicam
Available from:
Dechra Veterinary Products NZ Ltd
Composition:
meloxicam 1.5 g/litre
Authorization number:
A011682
Authorization date:
2019-08-08

Apex Meloxicam KG Oral Suspension For Dogs

Page 1 of 4

02 December 2019

[IMMEDIATE CONTAINER]

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

APEX Meloxicam KG

ORAL SUSPENSION FOR DOGS

Active Constituent: 1.5 mg/mL MELOXICAM

Meloxicam is a non-steroidal anti-inflammatory agent

used in the treatment of inflammation and to provide

analgesia for both acute and chronic musculoskeletal

disorders in dogs.

15 mL, 30 mL, 50 mL, 100 mL

[IMMEDIATE CONTAINER– Ancillary Panel]

READ ENCLOSED LEAFLET FOR FULL

INSTRUCTIONS

DIRECTIONS FOR USE:

Dosage and Administration: Shake well before use

DOGS: Initial dose: 0.2mg/kg bodyweight once only.

Maintenance dose: 0.1mg/kg bodyweight once daily.

FIRST AID: If poisoning occurs, contact a doctor or

Poisons Information Centre. Phone Australia 131 126;

Phone New Zealand 0800 764 766.

DISPOSAL: Dispose of container by wrapping with

paper and putting in garbage.

STORAGE: Store below 25

C (air conditioning).

Once opened discard after 6 months.

Protect from light.

Dechra Veterinary Products (Australia) Pty Ltd

2 Cal Close, Somersby, NSW 2550, Australia

Tel: 1300 015 825

APVMA Approval No. 87621/118819

In NZ: RVM

ACVM No. A011682

See www.foodsafety.govt.nz for registration conditions.

SAFETY DIRECTIONS: Pregnant women and people

with known hypersensitivity to NSAIDs should avoid

contact with meloxicam. Harmful if swallowed. May

irritate the eyes and skin, avoid contact with eyes and

skin. When using the product, wear disposable gloves.

Wash hands after use. If the medicine comes into

contact with the skin, the affected area should be rinsed

thoroughly.

Registered to: Dechra Veterinary Products NZ Ltd

Tel: 0800 479 838

Batch:

Expiry:

Apex Meloxicam KG Oral Suspension For Dogs

Page 2 of 4

02 December 2019

[CARTON]

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

APEX Meloxicam KG

ORAL SUSPENSION FOR DOGS

Active Constituent: 1.5 mg/mL MELOXICAM

Meloxicam is a non-steroidal anti-inflammatory agent

used in the treatment of inflammation and to provide

analgesia for both acute and chronic musculoskeletal

disorders in dogs.

15 mL, 30 mL, 50 mL, 100 mL

[CARTON – Ancillary Panels]

READ THE ENCLOSED LEAFLET FOR FULL

INSTRUCTIONS

DIRECTIONS FOR USE:

Dosage and Administration: Shake well before use.

This product may separate on storage/standing. This

product should be re-suspended immediately prior to

use by inverting/shaking the bottle 3-5 times. Once

opened discard after 6 months.

DOGS: Oral administration only, to be given with

food.

Initial Dose: 0.2mg/kg bodyweight given once only.

This equates to 1mL/7.5kg bodyweight once only, by

syringe.

Maintenance Dose: 0.1mg/kg bodyweight once daily.

This equates to 1mL/15kg bodyweight once daily by

syringe.

FIRST AID: If poisoning occurs, contact a doctor or

Poisons Information Centre. Phone Australia 131 126;

Phone New Zealand 0800 764 766.

DISPOSAL: Dispose of empty container by wrapping

with paper and putting in garbage.

STORAGE: Store below 25

C (air conditioning). Once

opened discard after 6 months. Protect from light.

Dechra Veterinary Products (Australia) Pty Ltd

2 Cal Close, Somersby, NSW 2550, Australia

Tel: 1300 015 825

APVMA Approval No. 87621/118819

NEW ZEALAND INFORMATION

RESTRICTED VETERINARY MEDICINE

ACVM Registration No: A011682

See www.foodsafety.govt.nz for registration conditions.

SAFETY DIRECTIONS: Pregnant women and people

with known hypersensitivity to NSAIDs should avoid

contact with meloxicam. Harmful if swallowed. May

irritate the eyes and skin, avoid contact with eyes and

skin. When using the product, wear disposable gloves.

Wash hands after use. If the medicine comes into

contact with the skin, the affected area should be rinsed

thoroughly.

Registered to: Dechra Veterinary Products NZ Ltd

Tel: 0800 479 838

Batch:

Expiry:

Apex Meloxicam KG Oral Suspension For Dogs

Page 3 of 4

02 December 2019

[LEAFLET]

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

APEX Meloxicam KG

ORAL SUSPENSION FOR DOGS

COMPOSITION:

Active Constituent: 1.5 mg /mL MELOXICAM

INDICATIONS: Meloxicam is a non-steroidal anti-

inflammatory agent used in the treatment of

inflammation and to provide analgesia for both acute

and chronic musculoskeletal disorders in dogs.

DIRECTIONS FOR USE:

Contraindications: This product is contraindicated for

use in animals suffering from cardiac, hepatic or clinical

renal disease, or where there is suspicion of

gastrointestinal bleeding, ulceration, haemorrhagic

disorder or individual hypersensitivity to the product.

Precautions: Do not administer to pregnant bitches in

the last trimester, or to lactating bitches. As meloxicam

is an NSAID, use in animals less than six weeks of age

or in debilitated aged animals may involve an additional

risk. If use in such animals cannot be avoided careful

clinical management may be necessary. Meloxicam

should not be concurrently administered with

corticosteroids, other NSAIDs, aminoglycoside

antibiotics or anti-coagulation agents. Pre-treatment

with anti-inflammatory drugs may result in additional or

increased adverse effects and accordingly a treatment

free period should be observed for at least 24 hours

before commencement of meloxicam. The treatment

free period should however take into account the

pharmacokinetic properties of the drugs used

previously.

Side Effects: Meloxicam is an NSAID and as such

typical NSAID adverse reactions may occur with its use.

Typical adverse reactions of NSAIDs include loss of

appetite, vomiting, diarrhoea, melaena or occult faecal

blood, and lethargy. Symptomatic treatment may be

necessary. In most cases, gastrointestinal side effects

are transient and disappear following termination of

treatment, however in rare cases may be serious.

Owners should be advised to discontinue therapy and

contact their veterinarian if signs of intolerance are

observed.

Overdose: In case of overdosing symptomatic

treatment should be initiated.

Dosage and Administration:

Shake well before use. This product may separate on

storage/standing. This product should be resuspended

immediately prior to use by inverting/shaking the bottle

3-5 times.

DOGS: Oral administration only, to be given with

food. An initial dose of 0.2mg/kg bodyweight (this

equates to 1mL/7.5kg bodyweight by syringe) given

once is recommended, followed by a maintenance dose

of 0.1mg/kg bodyweight (this equates to 1mL/15kg

bodyweight by syringe) to be given daily. Duration of

therapy is at the discretion of the veterinarian and will

depend on condition being treated and response to

therapy. NSAID dosing should be undertaken with

attention to accuracy. The accompanying syringe has a

kg-bodyweight scale designed for the maintenance

dose (i.e. 0.1mg/kg bodyweight). Thus twice the volume

should be administered on the first day as the initial

dose. The top of this bottle has been designed to

facilitate attachment of the accompanying syringe. After

shaking the bottle remove the lid and insert the syringe

tip into the attachment in the top of the bottle. Invert the

bottle and syringe together and then pull back on the

plunger until the line on the plunger corresponds to the

dog’s bodyweight in kilograms on the syringe barrel.

Turn the bottle and syringe the right way up and

carefully disconnect the syringe and press the plunger

to administer dose onto the food. Rinse out syringe

after use.

General Directions: It is recommended that dogs

undergo a thorough clinical examination and

appropriate pathology testing before introduction of

NSAID therapy. During extended administration,

appropriate re-evaluation and pathology testing should

be undertaken periodically. Meloxicam is a member of

the oxicam family and they act by inhibiting

prostaglandin synthesis. Inhibition of leukocyte

infiltration of inflamed tissue and inhibition of bone and

cartilage destruction also occur. To a lesser extent

there is also inhibition of collagen induced thrombocyte

aggregation. Meloxicam exerts anti-inflammatory, anti-

exudative, analgesic and antipyretic effects.

First Aid: If poisoning occurs, contact a doctor or

Poisons Information Centre. Phone Australia 131 126;

Phone New Zealand 0800 764 766.

Disposal: Dispose of empty container by wrapping with

paper and putting in garbage.

Storage: Store below 25

C (air conditioning). Once

opened discard after 6 months. Protect from light.

Dechra Veterinary Products (Australia) Pty Ltd

2 Cal Close, Somersby NSW 2250, Australia

Tel: 1300 015 825

APVMA Approval No. 87621/118819

Apex Meloxicam KG Oral Suspension For Dogs

Page 4 of 4

02 December 2019

NEW ZEALAND INFORMATION

RESTRICTED VETERINARY MEDICINE

ACVM Registration No: A011682

See www.foodsafety.govt.nz for registration conditions.

SAFETY DIRECTIONS: Pregnant women and people

with known hypersensitivity to NSAIDs should avoid

contact with meloxicam. Harmful if swallowed. May

irritate the eyes and skin, avoid contact with eyes and

skin. When using the product, wear disposable gloves.

Wash hands after use. If the medicine comes into

contact with the skin, the affected area should be rinsed

thoroughly.

Registered to: Dechra Veterinary Products NZ Ltd

Tel: 0800 479 838

Ref No A11682-01

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

Apex Meloxicam KG Oral Suspension for Dogs

Ref No

A11682-01

Applicant

Dechra Veterinary Products NZ Limited

Application type

NEW PRODUCT

Date of Delegate

Decision

2 August 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 trials and data conformed to MPI requirements and were sufficient to assess.

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

Residues: It was not necessary to assess residues because this product is for use only in dogs.

Trade: Risks to trade are not applicable for this product.

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

agricultural security.

Ref No A11682-01

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.

Similar products

Search alerts related to this product

View documents history

Share this information