Bayer
Profender 15/3 mg for small dogs 1 tablet

For dogs suffering from, or at risk from, mixed parasitic infections

Some countries require a prescription to be issued for the sale of this drug.

Profender 15 mg/3 mg modified-release Tablets for Small Dogs

2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each tablet of Profender contains:

Active substances:

Profender Tablets for Small Dogs:    3 mg Emodepside; 15 mg Praziquantel

For the full list of excipients, see section 6.1.

3. PHARMACEUTICAL FORM

Modified-release tablets.
Brown, bone-shaped tablets with a score mark on each side.
The tablets can be divided into equal halves.

4. CLINICAL PARTICULARS

4.1 Target species

Dogs.

4.2 Indications for use, specifying the target species

For dogs suffering from, or at risk from, mixed parasitic infections caused by roundworms and tapeworms of the following species:

Roundworms (Nematodes):
Toxocara canis (mature adult, immature adult, L4 and L3)
Toxascaris leonina (mature adult, immature adult and L4) Ancylostoma caninum (mature adult and immature adult)
Uncinaria stenocephala (mature adult and immature adult) Trichuris vulpis (mature adult, immature adult and L4)

Tapeworms (Cestodes): Dipylidium caninum
Taenia spp.
Echinococcus multilocularis (mature adult and immature) Echinococcus granulosus (mature adult and immature)

4.3 Contraindications

Do not use in puppies under 12 weeks of age or weighing less than 1 kg.

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

4.4 Special warnings for each target species

Parasite resistance to any particular class of anthelmintic may develop following frequent, repeated use of an anthelmintic of that class.

4.5 Special precautions for use

Special precautions for use in animals

Administer only to fasted dogs. For example: Overnight fasting if the dog is to be treated in the morning. No food should be given until 4 hours after treatment.

When D. caninum infection is present, concomitant treatment against intermediate hosts such as fleas and lice should be considered to prevent reinfection.

No studies have been performed with severely debilitated dogs or individuals with seriously compromised kidney or liver function. Therefore, the veterinary medicinal product should only be used in such animals according to a benefit/risk assessment by the responsible veterinarian.

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

In the interests of good hygiene, wash your hands after administering the tablets to the dog. In case of accidental ingestion, especially in the case of children, seek medical advice immediately and show the package leaflet or the label to the physician.

Echinococcosis represents a hazard for humans. As Echinococcosis is a notifiable disease to the World Organisation for Animal Health (OIE), specific guidelines on the treatment and follow-up, and on the safeguard of persons, need to be obtained from the relevant competent authority.

4.6 Adverse reactions (frequency and seriousness)

Transient mild digestive tract disorders (e.g. hypersalivation, vomiting) were observed in very rare cases.
Transient mild neurological disorders (e.g. tremors, incoordination) were observed in very rare cases. Non compliance with fasting requirements tended to be a feature of those cases. In addition, signs of neurological disorders may be more severe (e.g. convulsion) in mdr1 mutant (-/-) Collies, Shelties and Australian Shepherds.
Specific antidotes are not known.

The frequency of adverse reactions is defined using the following convention:
very common (more than 1 in 10 animals displaying adverse reactions 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).

4.7 Use during pregnancy or lactation

Can be used during pregnancy and lactation.

4.8 Interaction with other medicinal products and other forms of interaction

Emodepside is a substrate for P-glycoprotein. Co-treatment with other drugs that are P-glycoprotein substrates/inhibitors (for example, ivermectin and other antiparasitic macrocyclic lactones, erythromycin, prednisolone and cyclosporine) could give rise to pharmacokinetic drug interactions. The potential clinical consequences of such interactions have not been investigated.

4.9 Amounts to be administered and administration route

Dosage and Treatment Schedule

Profender is to be administered at a minimum dose of 1 mg/kg body weight emodepside and 5 mg/kg body weight praziquantel, according to the following dosage table.

A single administration per treatment is effective.

Body Weight (kg): Number of Profender tablets

1 – 1.5 kg: ½ tablet small dogs (1= 3 kg)
> 1.5 – 3 kg: 1 tablet small dogs (1= 3 kg)
> 3 – 4.5 kg: 1½ tablet small dogs (1= 3 kg)
> 4.5 – 6 kg: 2 tablets small dogs (1= 3 kg)
> 6 – 10 kg: 1 tablet medium dogs (1= 10 kg)
> 10 – 15 kg: 1½ tablet medium dogs (1= 10 kg)
> 15 – 20 kg: 2 tablets medium dogs (1= 10 kg)
> 20 – 30 kg: 1 tablet large dogs (1= 30 kg)
> 30 – 45 kg: 1½ tablet large dogs (1= 30 kg)
> 45 – 60 kg: 2 tablets large dogs (1= 30 kg)

Method of administration

For oral use in dogs from 12 weeks of age and weighing at least 1 kg. Profender tablets are meat flavoured and usually dogs will accept them without any food.
Administer only to fasted dogs. For example: Overnight fasting if the dog is to be treated in the morning. No food should be given until 4 hours after treatment.

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

Transient muscular tremors, incoordination and depression were occasionally observed when the veterinary product was administered at overdoses of up to 5 times the recommended dose. In mdr1 mutant (-/-) Collies the margin of safety appears lower compared to the normal dog population, with mild transient tremor and/or ataxia occasionally observed after twice the recommended dose, in dogs fasted as recommended.
The symptoms were completely self-resolving without any treatment. Feeding can increase the incidence and intensity of such overdose symptoms and occasionally vomiting may occur. Specific antidotes are not known.

4.11 Withdrawal period(s)

Not applicable.

5. PHARMACOLOGICAL PROPERTIES

Pharmacotherapeutic group: therapeutic antiparasitic agent.
ATCvet code: QP52AA51.

5.1 Pharmacodynamic properties

Emodepside is a semi-synthetic compound belonging to the new chemical group of depsipeptides. It is active against roundworms (ascarids, hookworms and whipworms). In this product, emodepside is responsible for the efficacy against Toxocara canis, Toxascaris leonina, Ancylostoma caninum, Uncinaria stenocephala and Trichuris vulpis.
It acts at the neuromuscular junction by stimulating presynaptic receptors belonging to the secretin receptor family which results in paralysis and death of the parasites.

Praziquantel is a pyrazinoisoquinoline derivative effective against tapeworms such as Dipylidium caninum, Taenia spp., Echinococcus multilocularis and Echinococcus granulosus.
Praziquantel is rapidly adsorbed via the surface of the parasites and acts primarily by changing the calcium (Ca++) permeability of the parasite membranes. This results in severe damage to the parasite integument, contraction and paralysis, disruption of metabolism and finally leads to the death of the parasite.

5.2 Pharmacokinetic particulars

After treatment with a dose of 1.5 mg emodepside and 7.5 mg praziquantel per kg bodyweight, geometric mean maximum plasma concentrations of 47 µg emodepside/l and 593 µg praziquantel/l were observed. Maximum concentrations were reached 2 hours after treatment for both active substances. Both active substances were then eliminated from the plasma with a half-life of 1.4 to 1.7 hours.
After oral application in the rat, emodepside is distributed to all organs. Highest concentration levels are found in the fat. Unchanged emodepside and hydroxylated derivatives are the major excretion products. The excretion of emodepside has not been investigated in dogs.
Studies in many different species show that praziquantel is rapidly metabolised in the liver. The main metabolites are monohydroxycyclohexyl derivatives of praziquantel. Renal excretion of metabolites predominates.

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Calcium hydrogen phosphate anhydrous Cellulose, microcrystalline Silica, colloidal anhydrous
Croscarmellose sodium
Magnesium stearate
Povidone
Artificial beef flavour

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

Shelf life of the veterinary medicinal product as packaged for sale: 3 years

6.4 Special precautions for storage

Store in the original package in order to protect from moisture.

From
1
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2.11 €
From
10
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2.04 €
From
20
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1.98 €
From
30
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1.92 €
From
40
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1.86 €
From
100
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1.80 €
2.11
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And receive your order
on Monday 27 November
AIR FREIGHT