Profender - Patient leaflet, side effects, dosage

B. PACKAGE LEAFLET

[Single-dose pipettes]

PACKAGE LEAFLET

Profender 30 mg / 7.5 mg spot-on solution for small cats

Profender 60 mg / 15 mg spot-on solution for medium cats

Profender 96 mg / 24 mg spot-on solution for large cats

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

Marketing authorisation holder :

Vetoquinol S.A.

Magny-Vernois

70200 Lure

France

Manufacturer responsible for batch release :

KVP Pharma + Veterinär Produkte GmbH

Projensdorfer Str. 324

24106 Kiel

Germany

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Profender 30 mg / 7.5 mg spot-on solution for small cats

Profender 60 mg / 15 mg spot-on solution for medium cats

Profender 96 mg / 24 mg spot-on solution for large cats

Praziquantel / Emodepside

STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Active substances:

Profender contains 21.4 mg/ml emodepside and 85.8 mg/ml praziquantel.

Each unit dose (pipette) of Profender contains:

	Volume	Emodepside	Praziquantel
Profender for Small Cats (> 0.5 – 2.5 kg)	0.35 ml	7.5 mg	30 mg
Profender for Medium Cats (> 2.5 – 5 kg)	0.70 ml	15 mg	60 mg
Profender for Large Cats (> 5 — 8 kg)	1.12 ml	24 mg	96 mg

Excipients:

5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)

• 4. INDICATIONS

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

Roundworms (Nematodes)

Toxocara cati (mature adult, immature adult, L4 and L3)

Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic transmission to the offspring

Toxascaris leonina (mature adult, immature adult and L4)

Ancylostoma tubaeforme (mature adult, immature adult and L4)

Tapeworms (Cestodes)

Dipylidium caninum (mature adult and immature adult)

Taenia taeniaeformis (adult)

Echinococcus multilocularis (adult)

Lungworms

Aelurostrongylus abstrusus (adult)

• 5. CONTRAINDI­CATIONS

Do not use in kittens under 8 weeks of age or weighing less than 0.5 kg.

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

• 6. ADVERSE REACTIONS

Salivation and vomiting may occur in very rare cases. Mild and transient neurological disorders such as ataxia or tremor may occur in very rare cases. These effects are thought to occur as a result of the cat licking the application site immediately after treatment. In very rare cases following administration of Profender transient alopecia, pruritus and/or inflammation were observed at the application site.

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

• – 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.

• 7. TARGET SPECIES

Cats

• 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

For external use only.

Dosage and Treatment Schedule

The recommended minimum doses are 3 mg emodepside / kg body weight and 12 mg praziquantel / kg body weight, equivalent to 0.14 ml Profender / kg body weight.

Body Weight of Cat (kg)	Pipette size to be used	Volume (ml)	Emodepside (mg/kg bw)	Praziquantel (mg/kg bw)
>0.5 – 2.5	Profender for Small Cats	0.35 (1 pipette)	3 – 15	12 – 60
>2.5 – 5	Profender for Medium Cats	0.70 (1 pipette)	3 – 6	12 – 24
>5 – 8	Profender for Large Cats	1.12 (1 pipette)	3 – 4.8	12 – 19.2
>8	Use an appropriate combination of pipettes

For the treatment of roundworms and tapeworms a single administration per treatment is effective.

For the treatment of queens to prevent lactogenic transmission of Toxocara cati (L3 larvae) to the offspring, a single administration per treatment approximately seven days prior to expected parturition is effective.

For the lungworm Aelurostrongylus abstrusus , two treatments administered two weeks apart are effective.

• 9. ADVICE ON CORRECT ADMINISTRATION

Remove one pipette from package. Hold pipette in upright position, twist and pull off cap and use the opposite end of the cap to break the seal.

Part the fur on the cat’s neck at the base of the skull until the skin is visible. Place the tip of the pipette on the skin and squeeze firmly several times to empty the contents directly onto the skin. Application on the base of the skull will minimise the ability of the cat to lick the product off. Apply only to the skin surface and on intact skin.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

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.

• 12. SPECIAL WARNINGS

Special warnings for each target species:

Shampooing or immersion of the animal in water directly after treatment may reduce the efficacy of the product. Treated animals therefore should not be bathed until the solution has dried.

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

Special precautions for use in animals:

Apply only to the skin surface and on intact skin. Do not administer orally or parenterally.

Avoid the treated cat or other cats in the household licking the site of application while it is wet.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a benefit-risk assessment for these animals.

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

Do not smoke, eat or drink during application.

Avoid direct contact with application area while it is wet. Keep children away from treated animals during that time.

Wash hands after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

If the product accidentally gets into eyes, they should be thoroughly flushed with plenty of water.

If skin or eye symptoms persist, or in case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Care should be taken not to allow children to have prolonged intensive contact (for example, by sleeping) with treated cats during the first 24 hours after application of the product.

The solvent in this product may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

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

Pregnancy and lactation:

Profender can be used during pregnancy and lactation.

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.

Overdose (symptoms, emergency procedures, antidotes) :

Salivation, vomiting and trembling were observed occasionally when the product was administered at up to 10 times the recommended dose in adult cats and up to 5 times the recommended dose in kittens. These symptoms were thought to occur as a result of the cat licking the application site. The symptoms were completely reversible.

There is no known specific antidote.

Incompatibili­ties:

None known.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS

Profender should not be allowed to enter water courses as emodepside has shown harmful effects on aquatic organisms.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

• 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.

• 15. OTHER INFORMATION

Not all pack sizes may be marketed.

[Multi-dose bottle]

PACKAGE LEAFLET

Profender 85.8 mg/ml / 21.4 mg/ml spot-on solution for cats

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

Marketing authorisation holder :

Vetoquinol S.A.

Magny-Vernois

70200 Lure

France

Manufacturer responsible for batch release :

KVP Pharma + Veterinär Produkte GmbH

Projensdorfer Str. 324

24106 Kiel

Germany

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

Profender 85.8 mg/ml / 21.4 mg/ml spot-on solution for cats

Praziquantel/E­modepside

• 3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS

Active substances:

Profender contains 21.4 mg/ml emodepside and 85.8 mg/ml praziquantel.

Excipients:

• 5.4 mg/ml butylhydroxyanisole (E320; as antioxidant)

• 4. INDICATIONS

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

Roundworms (Nematodes)

Toxocara cati (mature adult, immature adult, L4 and L3)

Toxocara cati (L3 larvae) – treatment of queens during late pregnancy to prevent lactogenic

transmission to the offspring

Toxascaris leonina (mature adult, immature adult and L4)

Ancylostoma tubaeforme (mature adult, immature adult and L4)

Tapeworms (Cestodes)

Dipylidium caninum (mature adult and immature adult)

Taenia taeniaeformis (adult)

Echinococcus multilocularis (adult)

Lungworms

Aelurostrongylus abstrusus (adult)

• 5. CONTRAINDI­CATIONS

Do not use in kittens under 8 weeks of age or weighing less than 0.5 kg.

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

• 6. ADVERSE REACTIONS

Salivation and vomiting may occur in very rare cases. Mild and transient neurological disorders such as ataxia or tremor may occur in very rare cases. These effects are thought to occur as a result of the cat licking the application site immediately after treatment. In very rare cases following administration of Profender transient alopecia, pruritus and/or inflammation were observed at the application site.

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

• – 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.

• 7. TARGET SPECIES

Cats

• 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

For external use only.

Dosage and Treatment Schedule

The recommended minimum doses are 3 mg emodepside / kg body weight and 12 mg praziquantel / kg body weight, equivalent to 0.14 ml Profender / kg body weight.

Either calculate the exact dose based on the individual body weight, or use the following dose volumes recommended for the different weight ranges:

Body Weight of Cat (kg)	Volume (ml)	Emodepside (mg) (mg/kg bw)		Praziquantel (mg) (mg/kg bw)
>0.5 – 2.5	0.35	7.5	3 – 15	30	12 – 60
>2.5 – 5	0.70	15	3 – 6	60	12 – 24
>5 – 8	1.12	24	3 – 4.8	96	12 – 19.2
>8	Appropriate combination of volumes

For the treatment of roundworms and tapeworms a single administration per treatment is effective.

For the treatment of queens to prevent lactogenic transmission of Toxocara cati (L3 larvae) to the offspring, a single administration per treatment approximately seven days prior to expected parturition is effective.

For the lungworm Aelurostrongylus abstrusus , two treatments administered two weeks apart are effective.

• 9. ADVICE ON CORRECT ADMINISTRATION

Take the adapter, remove protective cover from the spike and insert spike into the central area of the stopper (1). Remove screw cap (2). Take a standard disposable 1 ml syringe with luer nozzle and connect it to the adapter (3). Then turn bottle up-side down, and withdraw the necessary volume (4).

Replace screw cap after use. Part the fur on the cat’s neck at the base of the skull until the skin is

visible. Place the tip of the syringe on the skin and empty the contents directly onto the skin (5).

Application on the base of the skull will minimise the ability of the cat to lick the product off. Apply only to the skin surface and on intact skin.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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.

Shelf life after first opening the immediate container: 3 months

• 12. SPECIAL WARNING(S)

Special warnings for each target species:

Shampooing or immersion of the animal in water directly after treatment may reduce the efficacy of the product. Treated animals therefore should not be bathed until the solution has dried.

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

Special precautions for use in animals :

Apply only to the skin surface and on intact skin. Do not administer orally or parenterally.

Avoid the treated cat or other cats in the household licking the site of application while it is wet.

There is limited experience on the use of the product in sick and debilitated animals, thus the product should only be used based on a benefit-risk assessment for these animals.

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

Do not smoke, eat or drink during application.

Avoid direct contact with application area while it is wet. Keep children away from treated animals during that time.

Wash hands after use.

In case of accidental spillage onto skin, wash off immediately with soap and water.

If the product accidentally gets into eyes, they should be thoroughly flushed with plenty of water.

If skin or eye symptoms persist, or in case of accidental ingestion, seek medical advice immediately and show the package leaflet or the label to the physician.

Care should be taken not to allow children to have prolonged intensive contact (for example, by sleeping) with treated cats during the first 24 hours after application of the product.

The solvent in this product may stain certain materials including leather, fabrics, plastics and finished surfaces. Allow the application site to dry before permitting contact with such materials.

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

Pregnancy and lactation:

Profender can be used during pregnancy and lactation.

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.

Overdose:

Salivation, vomiting and neurological signs (tremor) were observed occasionally when the product was administered at up to 10 times the recommended dose in adult cats and up to 5 times the recommended dose in kittens. These symptoms were thought to occur as a result of the cat licking the application site. The symptoms were completely reversible.

There is no known specific antidote.

Incompatibili­ties:

None known.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS

Profender should not be allowed to enter water courses as emodepside has shown harmful effects on aquatic organisms.

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

• 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.

• 15. OTHER INFORMATION

Not all pack sizes may be marketed.

PACKAGE LEAFLET

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

Profender 50 mg/10 mg modified-release Tablets for Medium Dogs

Profender 150 mg/30 mg modified-release Tablets for Large Dogs

• 1. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER AND OF THE MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE

Marketing authorisation holder :

Vetoquinol S.A.

Magny-Vernois

70200 Lure

France

Manufacturer responsible for batch release :

KVP Pharma + Veterinär Produkte GmbH

Projensdorfer Str. 324

24106 Kiel

Germany

• 2. NAME OF THE VETERINARY MEDICINAL PRODUCT

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

Profender 50 mg/10 mg modified-release Tablets for Medium Dogs

Profender 150 mg/30 mg modified-release Tablets for Large Dogs Praziquantel / Emodepside

• 3. STATEMENT OF THE ACTIVE SUBSTANCES AND OTHER INGREDIENTS

  4.

  
  

  INDICATIONS

  
  

Each tablet of Profender contains:

	Emodepside	Praziquantel
Profender Tablets for Small Dogs	3 mg	15 mg
Profender Tablets for Medium Dogs	10 mg	50 mg
Profender Tablets for Large Dogs	30 mg	150 mg

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)

• 5. CONTRAINDI­CATIONS

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

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

• 6. ADVERSE REACTIONS

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 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.

• 7. TARGET SPECIES

Dogs.

• 8. DOSAGE FOR EACH SPECIES, ROUTE AND METHOD OF ADMINISTRATION

For oral use in dogs from 12 weeks of age and weighing at least 1 kg.

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 for
	small dogs 11' = 3 kg	medium dogs 1 = 10 kg	large dogs 1 = 30 kg
1 – 1.5	*/2
> 1.5 – 3	1
> 3 – 4.5	1*/2
> 4.5 – 6	2
> 6 – 10		1
> 10 – 15		1*/2
> 15 – 20		2
>20 – 30			1
> 30 – 45			1*/2
>45 – 60			2

• 9. ADVICE ON CORRECT ADMINISTRATION

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.

• 10. WITHDRAWAL PERIOD(S)

Not applicable.

• 11. SPECIAL STORAGE PRECAUTIONS

Keep out of the sight and reach of children.

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

Do not use this veterinary medicinal product after the expiry date which is stated on the carton or blister. The expiry date refers to the last day of that month.

• 12. SPECIAL WARNINGS

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.

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 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.

Pregnancy and lactation:

Profender can be used during pregnancy and lactation.

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.

Overdose (symptoms, emergency procedures, antidotes) :

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 frequency and intensity of such overdose symptoms and occasionally vomiting may occur. Specific antidotes are not known.

Incompatibili­ties:

Not applicable.

• 13. SPECIAL PRECAUTIONS FOR THE DISPOSAL OF UNUSED PRODUCT OR WASTE MATERIALS

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

Unused half tablets must not be stored for future use and should be disposed of in accordance with local requirements.

• 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.

• 15. OTHER INFORMATION

Pack sizes:

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

2 tablets 4 tablets 10 tablets 24 tablets 50 tablets

(1 blister strip) (1 blister strip) (1 blister strip) (3 blister strips with 8 tablets each) (5 blister strips with 10 tablets each)

Profender 50 mg / 10 mg modified-release Tablets for Medium Dogs

2 tablets 4 tablets 6 tablets 24 tablets 102 tablets

(1 blister strip) (1 blister strip) (1 blister strip) (4 blister strips with 6 tablets each) (17 blister strips with 6 tablets each)

Profender 150 mg / 30 mg modified-release Tablets for Large Dogs

– 2 tablets – 4 tablets – 24 tablets – 52 tablets

(1 blister strip) (1 blister strip) (6 blister strips with 4 tablets each) (13 blister strips with 4 tablets each)

Not all pack sizes may be marketed.

78