RevitaCAM Spray for Dogs

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RevitaCAM is a new formulation for the tried and trusted drug meloxicam, used to relieve pain and inflammation in dogs. This new formulation is provided as a liquid in a small, spray bottle. A metered dose of the medication is sprayed onto the gums or inside the lips at the side of the mouth. It is not necessary to open the dog's mouth, just to lift the lips at the side of the mouth to expose the gums. The correct dose is easily administered with the fine, low volume spray. Treatment is given once daily for as long as directed by the vet. It is usual to give a double dose on the first day of treatment.

Dose rate for RevitaCAM:

Body weight range (kg)
No. of sprays/treatment
Pump size (µl)
Dose volume (µl)
Total dose meloxicam (mg)*
Maintenance dosage range meloxicam delivered (mg/kg)*
2.1-3.5
1
50
50
0.25
0.1-0.12
3.6-5.0
2
50
100
0.50
0.1-0.14
5.1-7.5
3
50
150
0.75
0.1-.015
7.6-10.0
2
100
200
1.00
0.1-0.13
10.1-15.0
3
100
300
1.50
0.1-0.15
15.1-25.0
2
215
430
2.15
0.1-0.14
25.1-35.0
3
215
645
3.23
0.1-0.13
35.1-45.0
4
215
860
4.30
0.1-0.12
45.1-55.0
5
215
1075
5.38
0.1-0.12
55.1-70.0
6
215
1290
6.45
0.1-0.12

 

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Qualitative and quantitative composition

Each ml contains:

Active substance: Meloxicam 5mg

Excipients: Ethyl alcohol 150mg

For full list of excipients see Pharmaceutical Particulars

Pharmaceutical form

Oromucosal spray

Yellow colloidal dispersion

Clinical particulars

Target species

Dogs

Indications for use

Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders in dogs.

Contra-indications

Do not use in pregnant or lactating animals.

Do not use in animals suffering from gastrointestinal disorders such as irritation and haemorrhage, impaired hepatic, cardiac or renal function and haemorrhagic disorders.

Do not use in case of hypersensitivity to the active substance or any of the excipients.

Do not use in dogs less than 6 weeks of age.

This product is for dogs and should not be used in cats as it is not suitable for use in this species.

Special warnings for each target species

None

Special precautions for use

Special precautions for use in animals

If adverse reactions occur, treatment should be discontinued and the advice of the veterinarian should be sought.

Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.

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

Wash hands after administration of the product.

People with known hypersensitivity to Non Steroidal Anti-inflammatory Drugs (NSAIDs) should avoid contact with the veterinary medicinal product.

Avoid direct contact between the product and skin, if accidental exposure occurs wash hands immediately with soap and water.

Adverse reactions (frequency and seriousness)

Typical adverse drug reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, apathy and renal failure have occasionally been reported. These side effects occur generally within the first treatment week and are in most cases transient and disappear following termination of the treatment but in very rare cases may be serious or fatal.

In some dogs sneezing, coughing/gagging or drooling may be observed immediately after treatment administration.

Use during pregnancy, lactation or lay

The safety of the veterinary medicinal product has not been established during pregnancy and lactation (see contraindications).

Interaction with other medicinal products and other forms of interaction

Other NSAIDs, diuretics, anticoagulants, aminoglycoside antibiotics and substances with high protein binding may compete for binding and thus lead to toxic effects. RevitaCAM must not be administered in conjunction with other NSAIDs or glucocorticosteroids.

Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such veterinary medicinal products should be observed for at least 24 hours before commencement of treatment. The treatment-free period, however, should take into account the pharmacological properties of the products used previously.

Amounts to be administered and administration route

Store the vial in an upright position.

Shake gently before use.

To prime the pump depress at least 10 times prior to first use or until a fine spray appears. If RevitaCAM is not used for two days or more, re-prime with one or more sprays or until a fine spray appears.

Immediately after administration of the spray use a moist paper towel or tissue to clean the tip of the pump.

In case of pump failure, wipe nozzle and then re-prime the pump as described above.

Initial treatment is a single dose of 0.2mg meloxicam/kg body weight on the first day. Treatment should be continued once daily by application of the the spray to the oral mucosa (at 24 hour intervals) at a maintenance dose of 0.1 mg meloxicam/kg body weight (see dosing table).

To administer RevitaCAM, the dog's top lip should be grasped and gently pulled away exposing the gums. The mouth should not be opened any wider than necessary to facilitate application. The mist should be directed to the back and towards the gums and/or inner cheek, mucosal surfaces. The pump should be depressed fully, ensuring no mist escapes from the mouth. Allow the pump to fully reflate before administering consecutive sprays.

RevitaCAM is presented in 6ml, 11ml and 33ml glass vials containing pumps which deliver volumes of 50µl, 100µl and 215µl respectively. Care should be taken to select the correct size vial depending on the bodyweight of the dog.

Dosage for Revitacam

Body weight range (kg)

No. of sprays/treatment

Pump size (µl)

Dose volume (µl)

Total dose meloxicam (mg)*

Maintenance dosage range meloxicam delivered (mg/kg)*

2.1-3.5

1

50

50

0.25

0.1-0.12

3.6-5.0

2

50

100

0.50

0.1-0.14

5.1-7.5

3

50

150

0.75

0.1-.015

7.6-10.0

2

100

200

1.00

0.1-0.13

10.1-15.0

3

100

300

1.50

0.1-0.15

15.1-25.0

2

215

430

2.15

0.1-0.14

25.1-35.0

3

215

645

3.23

0.1-0.13

35.1-45.0

4

215

860

4.30

0.1-0.12

45.1-55.0

5

215

1075

5.38

0.1-0.12

55.1-70.0

6

215

1290

6.45

0.1-0.12

* For the initial treatment of a single dose of 0.2mg meloxicam/kg body weight, the above maintenance doses should be doubled.

For longer term treatment, once a clinical response has been observed (after ≥ 4 days), the dose of the product can be adjusted to the lowest effective individual dose reflecting that the degree of pain and inflammation associated with chronic musculo-skeletal disorders may vary over time.

A clinical response is normally seen within 3-4 days. Treatment should be discontinued after 10 days at the latest if no clinical improvement is apparent.

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

In the case of overdose symptomatic treatment should be initiated.

Withdrawal period(s)

Not applicable

Pharmacological particulars

Pharmacotherapeutic group: Antiinflammatory and antirheumatic products, non-steroids (oxicams)

ATCvet Code: QM01AC06

Pharmacodynamic properties

Meloxicam is a non-steroidal anti-inflammatory drug (NSAID) of the oxicam class which acts by inhibition of prostaglandin synthesis, thereby exerting anti-inflammatory, analgesic, anti-exudative and antipyretic effects. It reduces leukocyte infiltration into the inflamed tissue. To a minor extent it also inhibits collagen-induced thrombocyte aggregation. In vitro and in vivo studies demonstrated that meloxicam inhibits cyclooxygenase-2 (COX-2) to a greater extent than cyclooxygenase-1 (COX-1).

Pharmacokinetic properties

Absorption

Meloxicam is completely absorbed following oromucosal administration and maximal plasma concentrations are obtained after approximately 4.5 hours. When the product is used according to the recommended dosage regime, steady state concentrations of meloxicam in plasma are reached on the second day of treatment.

Distribution

There is a linear relationship between the dose administered and plasma concentration observed in the therapeutic dose range. Approximately 97% of meloxicam is bound to plasma proteins. The volume of distribution is 0.3 l/kg.

Metabolism

Meloxicam is predominantly found in plasma and is also a major biliary excretion product whereas urine contains only traces of the parent compound. Meloxicam is metabolised to an alcohol, an acid derivative and to several polar metabolites. All major metabolites have been shown to be pharmacologically inactive.

Elimination

Meloxicam is eliminated with a half-life of 24 hours. Approximately 75% of the administered dose is eliminated via faeces and the remainder via urine.

Pharmaceutical particulars

List of Excipients

Ethyl alcohol

Polycarbophil

Boric Acid

Potassium chloride

Hydrochloric acid

Sodium hydroxide

Water, purified

Major incompatibilities

None known

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 2 years

Shelf-life after first opening the immediate packaging: 6 months

Special precautions for storage

This veterinary medicinal product does not require any special storage conditions

Nature and composition of immediate packaging

Glass vial (6ml, 11ml and 33 ml) containing appropriate size pump ( 50µl, 100µl and 215µl )

Not all pack sizes may be marketed

Special precautions for the disposal of unused veterinary medicinal product or waste material 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

Marketing Authorisation Holder (if different from distributor)

Abbott Laboratories Limited

Abbott House

Vanwall Business Park

Vanwall Road

Maidenhead

Berkshire

SL6 4XE

Marketing authorisation number

6ml EU/2/12/138/001.

11ml EU/2/12/138/002.

33ml EU/2/12/138/003.

Date of the first authorisation or date of renewal

February 2012

Date of revision of the text

February 2012

Any other information

Nil

Legal category

POM-V

GTIN (Global Trade Item No)

6 ml (01)007 47222001322

11ml (01)007 47222001339

13ml (01)007 47222001346

Need help or advice? Contact us:

  • Freephone: 0800 084 2608
  • Mon - Fri: 8:30am - 7:00pm
  • Sat: 10:00am - 3:00pm
  • Email: support@viovet.co.uk

All prices include VAT where applicable.

Information regarding the safe use of all licensed medication supplied in the UK can be found on the Veterinary Medicine Directorate website. Follow this link and then search for the brand name of the product to find the official Summary of Product Characteristics for that product. Unlicensed medication, such as herbal supplements, will not be found here and there is no such formal recognition of any scientifically proven therapeutic effects from any unlicensed medication.

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