Medicinal product no longer authorised

PACKAGE LEAFLET:

Acticam 5 mg/ml solution for injection for dogs and cats

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

Ecuphar NV Legeweg 157-i
B-8020 Oostkamp
Belgium
NAME OF THE VETERINARY MEDICINAL PRODUCT

Acticam 5 mg/ml solution for injection for dogs and cats. Meloxicam.

longer
STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)

Meloxicam 5 mg/ml.
Ethanol anhydrous 150 mg/ml.
INDICATION(S)

Dogs:
product
Alleviation of inflammation and pain in both acute and chronic musculo-skeletal disorders. Reduction of post-operative pain and inflammation following orthopaedic and soft tissue surgery.

Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery.
CONTRAINDICATIONS

Do not use in pregnant or lactating animals.
dicinal
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 cases of hypersensitivity to the active substance or to any of the excipients. Do not use in animals less than 6 weeks of age nor in cats of less than 2 kg.

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ADVERSE REACTIONS

M
Typical adverse reactions of NSAIDs such as loss of appetite, vomiting, diarrhoea, faecal occult blood, lethargy and renal failure have occasionally been reported. In very rare cases elevated liver enzymes have been reported. In dogs, in very rare cases, haemorrhagic diarrhoea, haematemesis and gastrointestinal ulceration have been reported. In dogs, 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 very rare cases anaphylactoid reactions may occur and should be treated symptomatically.
If adverse reactions occur, treatment should be discontinued and the advice of a veterinarian should be sought.

The frequency of adverse reactions is defined using the following convention:
authorised
- very common (more than 1 in 10 animals treated displaying adverse reaction(s))
- common (more than 1 but less than 10 animals in 100 animals treated)
- uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
- rare (more than 1 but less than 10 animals in 10,000 animals treated)
- very rare (less than 1 animal in 10,000 animals treated, including isolated reports).
  
  If you notice any side effects, even those not already listed in this package leaflet or you think that the medicine has not worked, please inform your veterinary surgeon.
TARGET SPECIES

Dogs and cats.
DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION

Dogs: single administration of 0.2 mg meloxicam/kg body weight (i.e. 0.4 ml/10 kg). Cats: single administration of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg).

Dogs
no
Musculo-skeletal disorders: single subcutaneous injection.
Reduction of post-operative pain (over a period of 24 hours): single intravenous or subcutaneous injection before surgery, for example at the time of induction of anaesthesia.

Cats:
Reduction of post-operative pain after ovariohysterectomy and minor soft tissue surgery: single subcutaneous injection before surgery, for example at the time of induction of anaesthesia.

Avoid introduction of contamination during use.
ADVICE ON CORRECT ADMINISTRATION

Medicinal
Particular care should be taken with regard to the accuracy of dosing.
WITHDRAWAL PERIOD(S)

Not applicable.
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: 28 days.
Do not use this veterinary medicinal product after the expiry date which is stated on the carton and the
vial after EXP. The expiry date refers to the last day of that month.
SPECIAL WARNING(S)

authorised
For post-operative pain relief in cats, safety has only been documented after thiopental/halothane anaesthesia.

Special precautions for use in animals:

If side effects occur, treatment should be discontinued and the advice of a veterinarian should be sought.
Avoid use in any dehydrated, hypovolaemic or hypotensive animal, as there is a potential risk of increased renal toxicity.
Any oral follow-up therapy using meloxicam or other NSAIDs should not be administered in cats, as appropriate dosage regimens for such follow-up treatments have not been established.

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

Accidental self-injection may give rise to pain. People with known hypersensitivity to meloxicam should avoid contact with the veterinary medicinal product.
In case of accidental self-injection, seek medical advice immediately and show this package insert or the label to the physician.

Pregnancy and lactation:

no
See section “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. Acticam must not be administered in conjunction with other NSAIDs or glucocorticosteroids. Concurrent administration of potential nephrotoxic drugs should be avoided. In animals at anaesthetic risk (e.g. aged animals) intravenous or subcutaneous fluid therapy during anaesthesia should be taken into consideration. When anaesthesia and NSAID are concomitantly administered, a risk for renal function cannot be excluded.
Medicinal
Pre-treatment with anti-inflammatory substances may result in additional or increased adverse effects and accordingly a treatment-free period with such drugs should be observed for at least 24 hours
before commencement of treatment. The treatment-free period, however, should take into account the
pharmacokinetic properties of the products used previously.

Overdose (symptoms, emergency procedures, antidotes):

In the case of over dosage symptomatic treatment should be initiated. Incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY

authorised
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.
DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED

…

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OTHER INFORMATION