Patient leaflet - Prevomax
B. PACKAGE LEAFLET
PACKAGE LEAFLET:
Prevomax 10 mg/ml solution for injection for dogs and cats
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1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE, IF DIFFERENT
Marketing authorisation holder :
Dechra Regulatory B.V.
Handelsweg 25
5531 AE Bladel
The Netherlands
Manufacturer responsible for batch release :
Produlab Pharma B.V.
Forellenweg 16
4941 SJ Raamsdonksveer
The Netherlands
Eurovet Animal Health B.V.
Handelsweg 25
5531 AE Bladel
The Netherlands
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2. NAME OF THE VETERINARY MEDICINAL PRODUCT
Prevomax 10 mg/ml solution for injection for dogs and cats Maropitant
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3. STATEMENT OF THE ACTIVE SUBSTANCE(S) AND OTHER INGREDIENT(S)
1 ml contains:
Active substance:
Maropitant 10 mg
Excipients:
Benzyl alcohol (E1519) 11.1 mg
A clear, colourless to light yellow solution.
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4. INDICATION(S)
Dogs
- For the treatment and prevention of nausea induced by chemotherapy.
- For the prevention of vomiting except that induced by motion sickness.
- For the treatment of vomiting, in combination with other supportive measures.
- For the prevention of perioperative nausea and vomiting and improvement in recovery from general anaesthesia after use of the p-opiate receptor agonist morphine.
Cats
- For the prevention of vomiting and the reduction of nausea, except that induced by motion sickness.
- For the treatment of vomiting, in combination with other supportive measures.
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5. CONTRAINDICATIONS
None.
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6. ADVERSE REACTIONS
Pain at injection site may occur when injected subcutaneously.
In cats, moderate to severe response to injection is very commonly observed (in approximately one third of cats).
In very rare cases, anaphylactic type reactions (allergic oedema, urticaria, erythema, collapse, dyspnoea, pale mucous membranes) may occur.
The frequency of adverse reactions is defined using the following convention:
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– very common (more than 1 in 10 animals treated displaying adverse reaction(s))
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– common (more than 1 but less than 10 animals in 100 animals treated)
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– uncommon (more than 1 but less than 10 animals in 1,000 animals treated)
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– rare (more than 1 but less than 10 animals in 10,000 animals treated)
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– 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.
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7. TARGET SPECIES
Dogs and cats.
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8. DOSAGE FOR EACH SPECIES, ROUTE(S) AND METHOD OF ADMINISTRATION
For subcutaneous or intravenous use in dogs and cats.
Prevomax solution for injection should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg of maropitant/kg body weight (1 ml/10 kg body weight). Treatment may be repeated for up to five consecutive days. Intravenous administration of Prevomax should be given as a single bolus without mixing the product with any other fluids.
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9. ADVICE ON CORRECT ADMINISTRATION
To prevent vomiting, Prevomax solution for injection should be administered more than 1 hour in advance. The duration of effect is approximately 24 h and therefore treatment can be given the night before administration of an agent that may cause emesis, e.g. chemotherapy.
Due to the frequent occurrence of transient pain during subcutaneous injection, appropriate animal restraining measures may have to be applied. Injecting the product at refrigerated temperature may reduce pain at injection.
As the pharmacokinetic variation is large and maropitant accumulates in the body after once daily repeated administration, lower doses than recommended might be sufficient in some individuals and when repeating the dose.
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10. WITHDRAWAL PERIOD(S)
Not applicable.
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11. SPECIAL STORAGE PRECAUTIONS
Keep out of the sight and reach of children.
Do not freeze.
Shelf life after first opening the vial: 56 days.
Do not use this veterinary medicinal product after the expiry date which is stated on the label of the vial after EXP. The expiry date refers to the last day of that month.
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12. SPECIAL WARNING(S)
Special warnings for each target species:
Vomiting can be associated with serious, severely debilitating conditions and the cause should be investigated. Products such as Prevomax should be used in conjunction with other supportive measures such as dietary control and fluid replacement therapy, as recommended by your veterinary surgeon.
Maropitant is metabolised in the liver and therefore should be used with caution in dogs and cats with liver disease. Prevomax should be used with caution in animals suffering from or with predisposition for heart diseases.
The use of Prevomax solution for injection against vomiting due to motion sickness is not recommended.
Dogs:
Although maropitant has been demonstrated to be effective in both the treatment and prevention of emesis induced by chemotherapy, it was found more efficacious if used preventively. Therefore, it is recommended to administer the veterinary medicinal product prior to administration of the chemotherapeutic agent.
Cats:
The efficacy of maropitant in reduction of nausea in cats was demonstrated in studies using a model (xylazine-induced nausea).
Special precautions for use in animals :
The safety of maropitant has not been established in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, or in pregnant or lactating dogs and cats. The responsible veterinarian should make a benefit-risk assessment before using the veterinary medicinal product in dogs less than 8 weeks of age, or in cats less than 16 weeks of age, or in pregnant or lactating bitches and cats.
Special precautions to be taken by the person administering the veterinary medicinal product to animals :
People with known hypersensitivity to maropitant should administer the veterinary medicinal product with caution.
Wash hands after use. In case of accidental self-injection seek medical advice immediately and show the package leaflet or the label to the physician. Maropitant has been shown to be a potential eye irritant, and in the case of accidental eye exposure, flush the eyes with plenty of water and seek medical attention.
Pregnancy and lactation :
Use only according to the benefit-risk assessment by the responsible veterinarian, because conclusive reproductive toxicity studies have not been conducted in any animal species.
Interaction with other medicinal products and other forms of interaction:
The veterinary medicinal product should not be used concomitantly with Ca-channel antagonists as maropitant has affinity to Ca-channels.
Maropitant is highly bound to plasma proteins and may compete with other highly bound drugs.
Overdose (symptoms, emergency procedures, antidotes) :
Apart from transient reactions at the injection site following subcutaneous administration, maropitant was well tolerated in dogs and young cats injected daily with up to 5 mg/kg (5 times the recommended dose) for 15 consecutive days (3-times the recommended duration of administration). No data have been presented on overdoses in adult cats.
Incompatibilities :
Prevomax must not be mixed with other veterinary medicinal products in the same syringe as its compatibility with other products has not been tested.
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13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS, IF ANY
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
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14. DATE ON WHICH THE PACKAGE LEAFLET WAS LAST APPROVED
Detailed information on this veterinary medicinal product is available on the website of the European Medicines Agency.
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15. OTHER INFORMATION