14

Medicinal product no longer authorised

PACKAGE LEAFLET FOR:

RevitaCAM 5mg/ml oromucosal spray for Dogs

authorised

1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT

   
   

   Marketing authorisation holder:

   Zoetis Belgium SA, Rue Laid Burniat 1, 1348 Louvain-la-Neuve, BELGIUM

   
   

   Manufacturer for the batch release:

   Abbott Logistics B.V., Minervum 7201, Breda 4817 ZJ, THE NETHERLANDS

   
   

2. NAME OF THE VETERINARY MEDICINAL PRODUCT

   
   

   RevitaCAM 5 mg/ml oromucosal spray for Dogs Meloxicam

   
   

3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

   
   

   Meloxicam 5 mg/ml

   
   

   no

4. INDICATION(S)

   
   

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

   
   

5. CONTRAINDICATIONS

   
   

   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 to any of the excipients. Do not use in dogs less than 6 weeks of age.

   Medicinal

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

   
   

6. ADVERSE REACTIONS

   
   

   Typical adverse drug reactions of Non Sterioidal Anit-Inflammatory Drugs (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.

   
   

   The frequency of adverse reactions is defined using the following convention:

   • very common (more than 1 in 10 animals displaying adverse reaction(s) during the course of one treatment)

   • common (more than 1 but less than 10 animals in 100 animals)

   • uncommon (more than 1 but less than 10 animals in 1,000 animals )

   • rare (more than 1 but less than 10 animals in 10,000 animals)

   • very rare (less than 1 animal in 10,000 animals, including isolated reports).

   
   

   If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

   
   

   authorised

7. TARGET SPECIES

   
   

   Dogs

   
   

8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

   
   

   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 0.2 mg meloxicam/kg body weight on the first day. Treatment is to be continued once daily by oromucosal administration (at 24-hour intervals) at a maintenance dose of

   0.1 mg meloxicam/kg body weight (see dosing table).

   
   

   p

   
   

   oduct

   

   no

   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.

   
   

   

   r

   

   
   

   edicinal

   Remove Cap Insert pump into vial Gently shake vial

   
   

   

   M

   Prime pump by spraying into

   tissue

   

   

   Spray RevitaCAM into dog’s

   mouth

   Wipe pump with tissue to

   prevent clogging

   10 ml glass vial

   containing either 3ml or 6 ml	50 µl pump
   20 ml glass vial	containing either 3ml or 11ml	100µl pump
   50 ml glass vial	containing either 8 ml or 33 ml	215µl pump

   RevitaCAM is presented in:

   
   

   

   authorised

   Care should be taken to select the correct size vial depending on the weight of the dog.

   
   

   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	-	0.15
   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

   no

   * For the initial treatment of a single dose of 0.2 mg 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.

   
   

   Medicinal

9. ADVICE ON CORRECT ADMINISTRATION

   
   

   Particular care should be taken with regard to the accuracy of dosing. Please carefully follow the instructions of the veterinarian.

   
   

10. WITHDRAWAL PERIOD

    
    

    Not applicable.

    
    

11. SPECIAL STORAGE PRECAUTIONS

    
    

    Keep out of the sight and reach of children.

    This veterinary medicinal product does not require any special storage conditions. Shelf-life after first opening the container: 6 months.

    Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the

    vial.

12. SPECIAL WARNING(S)

    
    

    Special precautions for use in animals:

    authorised

    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 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.

    
    

    Use during pregnancy and lactation: See section "Contraindications".

    
    

    Interactions 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.

    no

    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.

    
    

    Overdose (symptoms, emergency procedures, antidotes):

    In case of overdose symptomatic treatment should be initiated.

    
    

13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

    
    

    Medicinal

    Medicines should not be disposed of via wastewater or household waste but in accordance with local requirements. Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.

    
    

14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

    
    

    Detailed information on this product is available on the website of the European Medicines Agency

    /.

    
    

15. OTHER INFORMATION

Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

België/Belgique/Belgien

Ecuphar nv/sa

Tél/Tel: +32 (0) 50 31 42 69

Lietuva

Zoetis Lietuva UAB Tel: +370 5 2683634

Република България

Zoetis Luxembourg Holding Sarl Teл: +359 2 8021933

authorised

Luxembourg/Luxemburg

Ecuphar nv/sa

Tél/Tel: +32 (0) 50 31 42 69

Česká republika

Zoetis Česká republika, s.r.o. Tel: +420 257 101 111

Magyarország Zoetis Hungary Kft. Tel: +361 224 5222

Danmark

Orion Pharma A/S Tlf: +45 86140000

Malta

Agrimed Limited Tel: +356 21 465 797

Deutschland

Ecuphar GmbH

Tel: +49 (0) 3834 835840

Nederland

Le Vet BV

Tel: +31 (0) 348 565858

Eesti

Zoetis Lietuva UAB Tel: +370 5 2683634

Norge

Orion Pharma AS Animal Health Tlf: +47 4000 4190

Ελλάδα

BIOVET Veterinary Equipment Tel: + 30 2310 325 328

Österreich

no

Vana GmbH

Tel: +43 1 728 03 67

España

Laboratorios Dr. ESTEVE, S.A. Tel: +34 93 446 6000

Polska

Zoetis Polska Sp. z o.o. Tel: +48 22 2234800

France

Axience SAS

Tél: +33 (0) 1 41 83 23 17

Portugal

ESTEVE FARMA, LDA Tel: +351 21 424 6010

Hrvatska

Medicinal

Zoetis Netherlands Holdings BV Tel: +385 1 644 1460

România

Zoetis România SRL Tel: +40 21 207 17 70

Ireland

Duggan Veterinary Supplies Tel: + 353 (0504) 43169

Slovenija

Zoetis Netherlands Holdings BV Tel: +385 1 644 1460

Ísland

Icepharma hf.

Sími: +354 540 80 00

Slovenská republika

Zoetis Luxembourg Holding Sarl, o.z. Tel: +421 2 5939 6190

Italia

Esteve S.p.A.

Tel: + 39 02 699.64.201

Suomi/Finland

Orion Pharma Eläinlääkkeet Puh/Tel: +358 (0) 10 4261

Κύπρος

BIOVET Veterinary Equipment Tel: + 30 2310 325 328

Sverige

Orion Pharma Animal Health Tel: +46 (0) 8 623 6440

Latvija

Medicinal

no

authorised

Zoetis Lietuva UAB Tel: +370 5 2683634

United Kingdom

Zoetis UK Limited

Tel: +44 (0) 845 300 8034