Cedora

AREA OF USE / INDICATIONS

 

Cattle: It is used for the treatment of internal and external parasites given below.

Gastrointestinal nematods:

Ostertagia ostertagi (adult; L3 larvae; L4 larvae, including hypobiosis)

Ostertagia lyrata (adult and L4 larvae)

Haemonchus placei (adult; L3 and L4 larvae)

Trichostrongylus spp. (adult, L4 larvae)

Cooperia spp. (adult and L4 larvae)

Oesophagostomum radiatum (adult; L3 and L4 larvae)

Nematodirus spp. (adult)

Bunostomum phlebotomum (adult; larvae L3 and L4)

Strongyloides papillosus (adult)

Trichuris spp.(adult)

Toxocara vitulorum (adult)

 

Lungworm nematods (adult and 4. stage larvae):

Dictyocaulus viviparus

 

Subcutaneous nematod:

Parafilaria Bovicola (adult)

 

Eye nematod:

Thelazia spp. (adult)

 

Warble fly (larval stage):

Hypoderma bovis

H. lineatum

Dermatobia hominis

Chrysomya bezziana

 

Mange:

Psoroptes ovis

Sarcoptes scabiei var. bovis

Chorioptes bovis

 

Lice:

Linognathus vituli

Haematopinus eurysternus

Solenopotes capillatus

 

Ticks:

Ornithodoros savignyi

Boophilus microplus

Boophilus decoloratus

 

Ivermectin can be used for control Damalinia bovis and Chorioptes bovis, but complete elimination may not be possible. Use of this product at the recommended dose can prevent re-infection for 14 days for Haemonchus placei, Cooperia oncophora, Cooperia pectinata and Trichostrongylus axei, 21 days for Ostertagia ostertagi and Oesophagostomum radiatum, and 28 days for Dictyocaulus viviparus.

Timing of treatment may vary according to epidemiological factors and characteristics of the business. The application program should be evaluated by the veterinarian.

For consistently effect, it is recommended to apply in the pasture animals at the 3^rd, 8^th and 13^th weeks after the pasture, and to treat all the animals.

 

Sheep: It is used for the treatment of the internal and external parasites given below.

- Gastrointestinal nematods:

Haemonchus contortus (adult, L3 larvae (including hypobiosis) and L4 larvae)

Teladorsagia (Ostertagia) circumcincta (adult, larvae L3 (including hypobiosis) and larvae L4)

Teladorsagia (Ostertagia) trifurcata (adult and larvae L4)

Trichostrongylus axei (adult)

Trichostrongylus colubriformis (adult, larvae L3 and L4)

Trichostrongylus vitrinus (adult)

Cooperia curticei (adult and larvae L4)

Oesophagostomum columbianum (adult, L3 and L4 larvae)

Oesophagostomum venulosum (adult)

Nematodirus filicollis (adult and L4 larvae)

Nematodirus spathiger (adult, L3 and L4 larvae)

Strongyloides papillosus (adult, L3 and L4 larvae)

Trichuris ovis (adult)

Chabertia ovina (adult, L3 and L4 larvae)

 

Lungworm nematods :

Dictyocaulus filaria (adult and L4 larvae)

Protostrongylus refescens (adult)

 

Mite:

Psoroptes ovis

Sarcoptes scabiei

 

Nose nematods:

Oestrus ovis (all larval stages)

 

Lite

Melophagus ovinus

 

USAGE AND DOSAGE

It is administered as a single dose, except for Psoroptes ovis treatment.

For correct dosage, the body weight of the animals should be measured as accurately as possible. The accuracy of the dosing device should be controlled.

If herd treatment is applied, animals should be grouped appropriately to avoid over or under dose. Application to wet or dirty animals is not recommended.

 

Cattle:

Dosage: 1 ml/50 kg body weight (200 µg/kg ivermectin body weight)

Application: It is applied subcutaneously to the front or back of the shoulder area, in accordance with the aseptic technique. It is recommended to use sterile, 1.4 x 15 mm (17G x ½ inch) needle.

 

Sheep:

Dosage: 0,5 ml/ 25 kg body weight (200 µg ivermektin /kg body weight)

Application: A single injection is applied, following aseptic precautions for gastrointestinal nematodes, lungworms and nasal nematode. It is recommended to use sterile, 1.4 x 15 mm (17G x ½ inch) needle.

Two doses are administered with an interval of 7 days for the treatment of Psoroptes ovis. Injections should be made in a different area.

0.10 ml product is applied for every 5 kg body weight for lambs weighing less than 20 kg. Syringes capable of delivering 0.10 ml of product are recommended for these animals.

SPECIAL CLINICAL INFORMATION AND SPECIAL WARNINGS FOR TARGET SPECIES

 

The following practices should be avoided because of the risk of resistance development and thus treatment failure.

- Very frequent and repeated use of the same group of anthelmintics within a certain period of time,

- Administering less than the required dose due to miscalculation of body weight, incorrect application of the product, or the delivery device being out of calibration resulting in the application of the wrong amount of product.

In case of the resistance to anthelmintics is suspected, further investigations with appropriate tests should be performed (such as the fecal egg count reduction test (FECRT)). If data show that resistance to a particular anthelmintic has developed, another product with a different pharmacological class and mode of action should be used.

Resistance to macrocyclic lactones including ivermectin has been reported in Teladorsagia in sheep, Ostertagia circumcinta in lambs, Ostertagia ostertagi and Cooperia in cattle. Therefore, this product should be used based on regional (farm or wider) epidemiological susceptibility data.

Even if clinical improvement is observed, a single dose is not recommended for the treatment of pseudoptic mange in sheep because not all agents can be eliminated. Psotoptis ovis is a highly contagious external parasite. After treatment, due care should be taken to avoid re-infestation of treated animals, as agents can survive for an additional 15 days. It is important to treat all animals in contact with infected sheep. Contact between treated animals and non-treated animals should be avoided for at least 7 days after the last treatment.

Because ivermectin is highly bound to plasma proteins, it should be used with caution in animals with diseases or nutritional deficiencies with low plasma protein levels.

Avermectins may not be well tolerated in non-target species. Fatal cases of intolerance have been reported in dogs, particularly Collies, Bobtails, Old English Sheepdogs, and close or cross breeds, as well as turtles.

Do not combine with lungworm vaccines. If the product is to be administered to vaccinated animals, it should be administered 28 days before or after vaccination.

Excretion of nematode eggs may continue for some time after treatment.

In cattle, it is recommended to apply the product in the final stage of warble flies, before they reach these areas, in order to avoid secondary reactions caused by the death of Hypoderma larvae in the esophagus and spine. The death of the Hypoderma lineatum in the peri-esophageal tissue can cause salivation and tympania. Death of Hypoderma bovis while in the spinal canal can cause paresis or paralysis.

Clean the vial before each use.

Use in pregnancy and lactation: This product can be used in pregnant cattle and sheep. The product has no adverse effects on fertility.

 

ADVERSE EFFECTS

Discomfort may observe in some animals after subcutaneous administration. In cattle, this situation manifests itself in the form of jumping and rolling. Behaviors usually return to normal within 15 minutes of administration. Solidification and swelling may occur at the injection site. These reactions are temporary and disappear within 1-4 weeks.

Allergic and anaphylactic reactions may occur very rarely. These reactions may also be accompanied by nervous symptoms such as ataxia, convulsions and/or tremor.

 

DRUG INTERACTIONS

Do not combine with lungworm vaccines. If the product is administered to vaccinated animals, it should be administered 28 days before or after vaccination.

Do not mix with the other medicinal products.

 

SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE

Clinical symptoms of ivermectin toxicity in cattle are ataxia and depression (20 times the recommended dose). There is no antidote. In case of overdose, symptomatic treatment should be applied. No indication of toxicity was observed in applications up to 3 times the recommended dose. At 100 times the recommended dose, ataxia, bilateral mydriasis, dyspnea and somnolence were observed in pigs, which did not result in death.

Overdose in sheep can cause ataxia and depression. No systemic toxic effects were observed at twice the recommended dose. In case of overdose, symptomatic treatment can be applied.

 

WITHDRAWAL PERIODS

Meat: 49 days for cattle, 42 days for sheep. Do not use in cattle and sheep producing milk for human consumption. It is not used within 60 days before birth in pregnant cows and sheep whose milk will be offered for human consumption.

 

CONTRAINDICATIONS

Do not use intravenously and intramuscularly.

Do not use in animals known to be sensitive to the components.

Do not use in cats and dogs due to possible serious side effects

 

GENERAL WARNINGS

Consult your veterinarian before use and in case of unexpected effects.

Keep out of reach of children.

 

 

 

PRECAUTIONS TO BE TAKEN BY THE ADMINISTRATOR AND WARNINGS FOR VETERINARY SURGEON

Do not consume anything, including cigarettes, while applying the product. Wash hands after use. Take necessary precautions to prevent accidental injection as it causes irritation and pain at the injection site. In case of accidental self-injection, consult a doctor with the product label and leaflet. Do not contact the product. In case of contact, wash the area with plenty of soap and water. In case of contact with eyes, rinse with plenty of running water.

 

STORAGE CONDITIONS AND SHELF LIFE

Before and after opening, it should be stored under 25 ᵒC, in the original packages, without freezing and refrigerating. Protect from sunlight. Shelf life is 2 years. It should be consumed within 28 days, after opening.

 

DISPOSAL AFTER USE AND WARNINGS FOR NON-TARGET SPECIES

HIGHLY TOXIC TO FISH AND AQUATIC LIFE. The product or used product containers should never be disposed of in or near water sources.

The product is highly toxic to aquatic organisms and dung beetles. Cattle must not have direct access to ponds, streams or ditches within 14 days of treatment. Long-term effects on dung beetles cannot be neglected due to continuous or repeated use. Therefore, repeating treatments on a pasture during a seasonal period should only be done on the advice of a veterinarian.

Used or leftover product should be disposed of in accordance with the relevant legislation.

 

COMMERCIAL PRESENTATION FORM

20 ml and 100 ml type 2 colorless glass vials in cardboard boxes.

 

PLACE AND CONDITIONS OF SALE

Sold with Veterinary Surgeon’s prescription in pharmacies and veterinary surgeries.

 

APPROVAL DATE OF LEAFLET: 28.04.2025

 

MARKETING AUTHORIZATION DATE AND NO: 27.04.2001 – 010/0943

 

MARKETING AUTHORIZATION HOLDER

Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.

Malıköy Başkent OSB Mah. 26. Cad. No:34/A Sincan/Ankara-Türkiye

 

MANUFACTURER COMPANY

FDN İLAÇ SAN. VE TİC. LTD. ŞTİ.

Büyükkayacık OSB Mah. İnsu Sokak No:3 Selçuklu/Konya-Türkiye

 

 

Made in Turkiye