Vominil 10mg, for dogs and cats, 25ml

Vominil 10 mg/ml solution for injection for dogs and cats.

COMPOSITION:
Each ml contains:
Active substance:
Maropitant 10 mg
(as maropitant citrate monohydrate)
Excipients:
n-Butanol 22 mg
Clear, colourless to almost colourless solution for injection.

TARGET SPECIES:
Dogs and cats.

INSTRUCTIONS FOR USE:
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 nausea and vomiting in the perioperative period and to improve recovery from general anaesthesia after the use of morphine, an opioid µ-receptor agonist.
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.

CONTRAINDICATIONS:
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

SPECIAL WARNINGS:
Special warnings:
Vomiting may be associated with serious, severely debilitating conditions, including gastrointestinal obstruction, therefore appropriate diagnostic evaluations should be performed.
Good veterinary practice recommends that antiemetics be used in combination with other veterinary and supportive measures, such as dietary control and rehydration therapy, while addressing the underlying causes of vomiting.
The veterinary medicinal product is not recommended for use against vomiting due to motion sickness.
Dogs:
Although maropitant has been shown to be effective in both the treatment and prevention of chemotherapy-induced emesis, it has been observed to be more effective when used preventively. For this reason, it is recommended to administer the antiemetic before the administration of the chemotherapeutic agent.
Cats:
The efficacy of maropitant in reducing nausea has been demonstrated in studies using a model (xylazine-induced nausea).

Special precautions for safe use in the target species:
The safety of the veterinary medicinal product has not been established in dogs less than 8 weeks of age or in cats less than 16 weeks of age and in pregnant or lactating bitches or cats.
Use only according to the benefit-risk assessment by the responsible veterinarian.
Maropitant is metabolised in the liver and should therefore be used with caution in patients with liver disease. As maropitant accumulates in the body during the 14-day treatment period due to metabolic saturation, close monitoring of liver function and any adverse events should be implemented during long-term treatment.
The veterinary medicinal product should be used with caution in animals suffering from/predisposed to cardiac disease, as maropitant has affinity for Ca and K ion channels. An increase of approximately 10% in the QT interval of the ECG was observed in a study in healthy Beagle dogs administered 8 mg/kg orally, however, such an increase is unlikely to be of clinical significance. Due to the frequent occurrence of transient pain during subcutaneous injection, appropriate animal restraint measures should be applied. Injecting the veterinary medicinal product at refrigerated temperature may reduce pain on injection.

Special precautions to be taken by the person administering the veterinary medicinal product to animals:
This product may cause skin sensitization. People with known hypersensitivity to maropitant should administer the veterinary medicinal product with caution. Wash the skin immediately after exposure with plenty of water. If symptoms such as a rash occur following accidental exposure, seek medical advice and show the doctor this warning.
This veterinary medicinal product may be irritating to the eyes. Avoid contact with eyes. In case of accidental contact of the product with eyes, rinse with plenty of fresh water. If symptoms occur, seek medical advice.
Maropitant is a neurokinin-1 (NK.1) receptor antagonist acting on the central nervous system. Accidental self-injection or ingestion may result in nausea, dizziness and drowsiness. Care should be taken to avoid accidental self-injection. In case of self-injection or accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician. Wash hands after use.

Pregnancy and lactation:
Use only according to the benefit-risk assessment by the responsible veterinarian as no conclusive reproductive toxicity studies have been performed 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 for Ca channels.

Maropitant is highly bound to plasma proteins and may compete with other highly bound medicinal products.

Overdose:
Apart from transient injection site reactions following subcutaneous administration, maropitant was well tolerated in young dogs and cats injected daily at doses up to 5 mg/kg (5 times the recommended dose) for 15 consecutive days (3 times the recommended duration of administration).

No data are available on overdose in adult cats.

Major incompatibilities:
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products in the same syringe.

Adverse events:
Dogs and cats:
Very common (> 1 animal/10 animals treated): pain at the injection site*.

Very rare (<1 animal/10,000 animals treated, including isolated reports): anaphylactic-type reaction, allergic oedema, urticaria, erythema, collapse, dyspnoea, pale mucous membranes, lethargy, neurological disorders (e.g. ataxia, convulsions, seizures, muscle tremors).
*May occur when injected subcutaneously. Moderate to severe injection reactions are observed in approximately one third of cats.

Reporting of adverse events is important. It allows the continued monitoring of the safety of a veterinary medicinal product. If you notice any side effects, even those not already listed in this package leaflet, or you think that the product has not had an effect, please contact your veterinary surgeon first. You can also report adverse events to the Marketing Authorisation Holder or the local representative of the Marketing Authorisation Holder using the contact details provided at the end of this leaflet or via the national reporting system: fannacovigilenta@ansvsa.ro, icbmv@icbmv.ro.

Dosage for each species, route of administration and methods of administration:
For subcutaneous or intravenous use.
The veterinary medicinal product should be injected subcutaneously or intravenously, once daily, at a dose of 1 mg/kg body weight (1 ml/10 kg body weight) for up to 5 consecutive days. Administration of the veterinary medicinal product by the intravenous route should be carried out in a single bolus without mixing the veterinary medicinal product with any other fluids.
To ensure the correct dosage, body weight should be determined as accurately as possible. The rubber stopper can be safely punctured up to 100 times.

Recommendations for correct administration:
To prevent vomiting, the veterinary medicinal product should be administered more than 1 hour in advance. The duration of effect is approximately 24 hours and, for this reason, treatment may be given the night before the administration of an agent that may cause emesis, e.g. chemotherapy.

Since the pharmacokinetic variation is large and maropitant accumulates in the body after repeated daily administration, lower doses than those recommended may be sufficient for some individuals even when the dose is repeated.

For administration by subcutaneous injection, see also “Special precautions for safe use in target species”.

Precautions

special storage conditions:
Keep out of the sight and reach of children.
Do not freeze.
Do not use this veterinary medicinal product after the expiry date which is stated on the label and carton.
The expiry date refers to the last day of that month.
Expiry time after first opening the immediate packaging: 28 days.

Special precautions for disposal:
Medicinal products should not be disposed of via wastewater or household waste.
Use waste disposal systems for unused veterinary medicinal products or waste materials derived from such products, in accordance with local requirements and applicable national collection systems. These measures should help protect the environment.
Ask your veterinarian or pharmacist how to dispose of medicines no longer required.

Classification of veterinary medicinal products:
Veterinary medicinal product subject to prescription.

SIZE:
25 ml bottle.