Imidacloprid and Moxidectin Spot-on Solution (for Cats)

For Animal Use Only - For External Use Only

Generic Name: Imidacloprid and Moxidectin Spot-on Solution (for Cats)

Brand Name: —

Active Ingredients

Imidacloprid, Moxidectin

Description

This product is a yellow to yellowish-brown liquid.

Pharmacological Action

Antiparasitic drug

Pharmacodynamics

Imidacloprid is a new-generation chloronicotinyl insecticide with high affinity for the post-synaptic nicotinic acetylcholine receptors in the central nervous system of insects. It inhibits acetylcholine activity, leading to paralysis and death of parasites. It is effective against adult fleas and flea larvae at all stages, and also kills flea larvae in the environment.

Moxidectin has a mechanism of action similar to abamectin and ivermectin, exerting a good anthelmintic effect on internal and external parasites, especially nematodes and arthropods. Its anthelmintic mechanism is to promote the release of the neurotransmitter γ-aminobutyric acid (GABA), increase its binding affinity with post-synaptic receptors, and open chloride channels. Moxidectin also has selective and high affinity for glutamate-mediated chloride channels, thereby interfering with neuromuscular signal transmission, causing flaccid paralysis and subsequent death of parasites. Its site of action is the inhibitory interneurons and excitatory motor neurons in nematodes, and the neuromuscular junctions in arthropods.

The combination of the two ingredients produces a synergistic effect.

Pharmacokinetics

After the first administration, imidacloprid is rapidly distributed over the cat's body surface on the same day and remains on the body surface throughout the dosing interval. The plasma concentration of moxidectin in cats reaches the peak 1 ～ 2 days after administration, and it is distributed throughout the body and slowly metabolized and excreted within one month.

Indications

For the prevention and treatment of internal and external parasitic infections in cats, including:

1. Prevention and treatment of flea infestations (Ctenocephalides felis);
2. Treatment of ear mite infestations (Otodectes cynotis);
3. Treatment of gastrointestinal nematode infestations (adults, immature adults and L4 larvae of Toxocara cati and Ancylostoma tubaeforme);
4. Prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis);
5. Adjuvant treatment of flea-induced allergic dermatitis.

Dosage and Administration

Based on the product, for external use only. Single dose: 0.1 ml per kg body weight for cats, administered once a month for prevention or treatment. To prevent licking, apply only to the skin on the back of the cat's neck and behind the skull.

Specific Administration for Different Indications

Flea infestations: A single dose prevents reinfestation for 4 weeks. Flea pupae already present in the environment may hatch in 6 weeks or longer, and the duration of use depends on the local climate. Environmental treatment should be combined with the use of this product to interrupt the natural flea life cycle.

Ear mite infestations: A single dose; a veterinary examination and evaluation 30 days after administration will determine whether a second dose is needed.

Heartworm disease prevention: For cats living in or traveling through Dirofilaria immitis endemic areas, administer monthly year-round, or start one month before the mosquito (intermediate host for heartworm larvae) activity season and continue until one month after the end of mosquito activity. For a consistent regimen, it is recommended to administer on the same day each month. When replacing other heartworm prevention products with this product, the first dose should be given within one month after the last administration of the previous product.

Adverse Reactions

This product may cause transient pruritus. Animals may occasionally (incidence: 1/10,000 ＜ rate ＜ 10/10,000) develop hair matting, erythema or vomiting, which resolve without treatment. Allergic reactions may also occasionally occur in animals using this product.

If an animal licks the application site after administration, extremely rare cases (incidence ＜ 1/10,000) of transient neurological signs may occur, such as excitement, tremors, ophthalmic signs (mydriasis, diminished pupillary reflex, nystagmus), respiratory abnormalities, salivation and vomiting; extremely rare cases of short-term behavioral changes, such as inactivity, excitement and anorexia, may also occur.

Precautions

1. Contraindicated in cats under 9 weeks of age, and in cats hypersensitive to this product or its excipients. The safety of this product in pregnant and lactating cats has not been evaluated; use only on the advice of a veterinarian.
2. The use of this product in cats under 1 kg body weight requires veterinary advice.
3. For cats living in or traveling through heartworm endemic areas, it is recommended to test cats over 6 months of age for heartworm infection before use. If infection is confirmed, treat according to current scientific protocols, as the use of this product in cats with adult heartworm infection may cause severe adverse events, including death.
4. Prevent Collies, Old English Sheepdogs and related breeds from oral licking of this product.
5. The use of this product in sick or debilitated cats requires veterinary advice.
6. Do not use this product in dogs.
7. Avoid contact of the drug in the applicator tube with the eyes and mouth of the treated or other animals during use. Prevent mutual licking between treated animals. Do not touch or trim the hair until the drug is dry.
8. Occasional contact with water (once or twice) during the dosing period will not significantly affect the efficacy, but frequent shampooing or immersion in water may reduce efficacy.
9. Keep this product out of the reach of children.
10. Store below 30℃ and do not use beyond the expiration date.
11. Do not administer this product if you are hypersensitive to it.
12. During administration, avoid contact of the product with the skin, eyes and mouth; do not eat, drink or smoke. Wash hands thoroughly after administration. In case of skin contact, rinse immediately with soap and water; in case of eye contact, rinse immediately with clean water. Seek medical attention with this leaflet if symptoms persist.
13. No specific antidote is available for this product at present; oral activated charcoal may aid in detoxification in case of accidental ingestion.
14. The solvent in this product may stain leather, fabrics, plastics, painted surfaces and other materials. Prevent contact between these materials and the application site until the site is dry.
15. Prevent this product from entering surface water.
16. Dispose of unused product and packaging materials in an environmentally safe manner in accordance with local regulations.

Withdrawal Period

Not required.

Specifications

0.4 ml: Imidacloprid 40 mg + Moxidectin 4 mg

0.8 ml: Imidacloprid 80 mg + Moxidectin 8 mgStorage

Seal and store in a tightly closed container.

Shelf Life

36 months.

Executive Standard

Announcement No. 765 of the Ministry of Agriculture and Rural Affairs of the People's Republic of China

Manufacturer

Imidacloprid and Moxidectin Spot-on Solution (for Dogs)

For Animal Use Only - For External Use Only

Generic Name: Imidacloprid and Moxidectin Spot-on Solution (for Dogs)

Brand Name: —

Ingredients

Imidacloprid, Moxidectin

Description

This product is a yellow to yellowish-brown liquid.

Pharmacological Action

Antiparasitic drug

Pharmacodynamics

Imidacloprid is a new-generation chloronicotinyl insecticide with high affinity for the post-synaptic nicotinic acetylcholine receptors in the central nervous system of insects. It inhibits acetylcholine activity, leading to paralysis and death of parasites. It is effective against adult fleas and flea larvae at all stages, and also kills flea larvae in the environment.

Moxidectin has a mechanism of action similar to abamectin and ivermectin, exerting a good anthelmintic effect on internal and external parasites, especially nematodes and arthropods. Its anthelmintic mechanism is to promote the release of the neurotransmitter γ-aminobutyric acid (GABA), increase its binding affinity with post-synaptic receptors, and open chloride channels. Moxidectin also has selective and high affinity for glutamate-mediated chloride channels, thereby interfering with neuromuscular signal transmission, causing flaccid paralysis and subsequent death of parasites. Its site of action is the inhibitory interneurons and excitatory motor neurons in nematodes, and the neuromuscular junctions in arthropods.

The combination of the two ingredients produces a synergistic effect.

Pharmacokinetics

After the first administration, imidacloprid is rapidly distributed over the dog's body surface on the same day and remains on the body surface throughout the dosing interval. The plasma concentration of moxidectin in dogs reaches the peak 4 to 9 days after administration, and it is distributed throughout the body and slowly metabolized and excreted within one month.

Indications

For the prevention and treatment of internal and external parasitic infections in dogs, including:

Prevention and treatment of flea infestations (Ctenocephalides felis);

Treatment of louse infestations (Trichodectes canis);

Treatment of ear mite infestations (Otodectes cynotis), sarcoptic mange (Sarcoptes scabiei var. canis) and demodicosis (Demodex canis);

Treatment of angiostrongylus and gastrointestinal nematode infestations (adults, immature adults and L4 larvae of Toxocara canis, Ancylostoma caninum and Uncinaria stenocephala; adults of Toxascaris leonina and Trichuris vulpis);

Prevention of heartworm disease (L3 and L4 larvae of Dirofilaria immitis);

Treatment of circulating microfilariae (Dirofilaria immitis);

Adjuvant treatment of flea-induced allergic dermatitis.

Dosage and Administration

Based on the product, for external use only. Single dose: 0.1 ml per kg body weight for dogs, administered once a month for prevention or treatment. To prevent licking, apply the product to the dog's back skin from between the two shoulder blades to the rump, and divide the dose into 3 ～ 4 application sites.

Specific Administration for Different Indications

Flea infestations: A single dose prevents reinfestation for 4 weeks. Flea pupae already present in the environment may hatch in 6 weeks or longer, and the duration of use depends on the local climate. Environmental treatment should be combined with the use of this product to interrupt the natural flea life cycle.

Louse infestations: A single dose; a veterinary examination and evaluation 30 days after administration will determine whether a second dose is needed.

Ear mite infestations: A single dose; remove loose ear debris from the external ear canal before administration. A veterinary examination and evaluation 30 days after administration will determine whether a second dose is needed.

Sarcoptic mange: Administer once every 4 weeks for 2 consecutive doses.

Demodicosis: Administer once every 4 weeks for 2 to 4 consecutive months to effectively prevent and treat canine demodicosis and significantly improve clinical signs. Severe infestations may require longer and more frequent treatment; the product can be administered once a week for an extended period based on veterinary examination. In all cases, treatment should continue until skin scales return to normal for at least 2 consecutive months. Discontinue use in dogs with no improvement or no reduction in mite count after 2 months of treatment, and switch to other medications under veterinary guidance. Since demodicosis is a multifactorial disease, underlying conditions should be treated if possible.

Angiostrongylus infestations: A single dose; a veterinary examination and evaluation 30 days after administration will determine whether a second dose is needed. Routine monthly administration in endemic areas can prevent angiostrongylus larva migrans and overt angiostrongylus infestations.

Heartworm disease prevention: Same as the prevention regimen for cats (administer monthly year-round or according to mosquito activity season; administer on the same day each month; replace other products within one month).

Circulating microfilariae: Administer once a month for 2 consecutive doses.

Adverse Reactions

1. This product may cause transient pruritus. Animals may occasionally (incidence: 1/10,000 ＜ rate ＜ 10/10,000) develop hair matting, erythema or vomiting, which resolve without treatment. Local allergic reactions may also occasionally occur in animals using this product.
2. If an animal licks the application site after administration, extremely rare cases (incidence ＜ 1/10,000) of transient neurological signs may occur, such as excitement, tremors, ophthalmic signs (mydriasis, diminished pupillary reflex, nystagmus), respiratory abnormalities, salivation and vomiting; extremely rare cases of short-term behavioral changes, such as inactivity, excitement and anorexia, may also occur.
3. Field trials show that heartworm-positive dogs with microfilaremia are at risk of developing severe respiratory signs (cough, tachypnea and dyspnea), which may require immediate veterinary treatment. Gastrointestinal signs (vomiting, diarrhea, anorexia) and lethargy are also common adverse reactions in these dogs after using this product.

Precautions

1. Contraindicated in dogs under 7 weeks of age, and in dogs hypersensitive to this product or its excipients. The safety of this product in pregnant and lactating bitches has not been evaluated; use only on the advice of a veterinarian.
2. The use of this product in dogs under 1 kg body weight requires veterinary advice.
3. Do not use in dogs with Class 4 heartworm disease, as the safety of this product in this population has not been evaluated; safety has only been assessed in dogs with Class 1 or 2 heartworm disease in laboratory studies and a small number of dogs with Class 3 heartworm disease in field trials. A risk assessment is required before use in dogs with obvious or severe heartworm disease signs.
4. Although overdose studies have shown that the use of this product in dogs with adult heartworm infection may be safe, this product has no therapeutic effect on adult Dirofilaria immitis. Therefore, it is recommended to test dogs aged 6 months and above living in heartworm endemic areas for adult heartworm infection before use. A veterinarian will determine whether adulticidal therapy is needed. The safety of administering this product on the same day as adulticidal drugs has not been evaluated.
5. This product contains moxidectin (a macrolide); special care should be taken to prevent oral licking of this product in Collies, Old English Sheepdogs and related breeds when using this product.
6. The use of this product in sick or debilitated dogs requires veterinary advice.
7. Do not use this product in cats.
8. Avoid contact of the drug in the applicator tube with the eyes and mouth of the treated or other animals during use. Prevent mutual licking between treated animals. Do not touch or trim the hair until the drug is dry.
9. Occasional contact with water (once or twice) during the dosing period will not significantly affect the efficacy, but frequent shampooing or immersion in water may reduce efficacy.
10. Keep this product out of the reach of children.
11. Store below 30℃ and do not use beyond the expiration date.
12. Do not administer this product if you are hypersensitive to it.
13. During administration, avoid contact of the product with the skin, eyes and mouth; do not eat, drink or smoke. Wash hands thoroughly after administration. In case of skin contact, rinse immediately with soap and water; in case of eye contact, rinse immediately with clean water. Seek medical attention with this leaflet if symptoms persist.
14. No specific antidote is available for this product at present; oral activated charcoal may aid in detoxification in case of accidental ingestion.
15. The solvent in this product may stain leather, fabrics, plastics, painted surfaces and other materials. Prevent contact between these materials and the application site until the site is dry.
16. Prevent this product from entering surface water.
17. Dispose of unused product and packaging materials in an environmentally safe manner in accordance with local regulations.

Withdrawal Period

Not required.

Specifications

0.4 ml: Imidacloprid 40 mg + Moxidectin 10 mg

1.0 ml: Imidacloprid 100 mg + Moxidectin 25 mg

2.5 ml: Imidacloprid 250 mg + Moxidectin 62.5 mg

4.0 ml: Imidacloprid 400 mg + Moxidectin 100 mg

Storage

Seal and store in a tightly closed container.

Shelf Life

36 months.

Executive Standard

Announcement No. 765 of the Ministry of Agriculture and Rural Affairs of the People's Republic of China

Manufacturer