Paramec %2®

Paramec %2®

Product Group:Parasiticides
Pharmaceutical Form:Solution for Injection
Active Ingredient:Ivermectin
Target Type:Cattle, Sheep
Package Form:50 - 100 - 250 ml

For Animal Use Only

For Animal Use Only

 

PARAMEC %2

Solution for Injection

Veterinary Endectocide

 

COMPOSITION

Paramec 2% Solution for Injection is an odorless, clear, colorless or light yellow sterile solution containing 20 mg of Ivermectin (22,23-dihydro-avermectin B1a at least 90% and 22,23-dihydroavermectin B1b at most 10%) in each 1 ml.

 

PHARMACOLOGICAL PROPERTIES

Paramec 2% Solution for Injection is an endectocide product used in the control of internal (Nematoda) and external (scabies, lice, nocra etc.) parasites in cattle and sheep. Ivermectin is an Avermectin derivative and is a macrocyclic lactone group compound obtained from Streptomyces Avermitilis cultures. Ivermectin is composed of at least 90% 5-o-demethyl-22,23-dihydroavermectin A1a [22-23 Dihydroavermectin B1a] and up to 10%  5-o-demethyl-25-de (1-methylpropyl)-22,23-dihydro-25-(1-methylethyl) avermectin A1a [22-23 Dihydroavermectin B1b] components. The ratio of components [H2B1a/(H2B1a+H2B1b]) is a minimum of 90%. Ivermectin keeps chlorine (CI-) channels open by increasing the secretion of Gamma Amino Butyric Acid (GABA) in the motoric ganglion synapses (nematodes) or neuromuscular endplates (arthropods) of parasites. It enables paralysis and death of the parasite by preventing the passage of motoric nerve impulses. On the other hand, Ivermectin kills parasites without harming the host animal, as it cannot cross the blood/brain barrier in mammals and cannot sufficiently penetrate the GABA-ergic nerves located in the central nervous system. The time to reach the maximum plasma concentration in subcutaneous administration is on average 1.3 days, the plasma elimination half-life is on average 3.5 days in sheep and 8 days in cattle. It is transported bound to plasma proteins. The volume of distribution is high. It penetrates all body fluids and tissues except cerebrospinal fluid. Since it is stored in adipose tissues and released and eliminated slowly, it has a lasting effect that varies between 2-4 weeks depending on the parasite species. It is excreted mainly with bile secretion and to a very small extent in the urine. More than 90% of the excreted substance is an unmetabolized parent compound.

AREA OF USE / INDICATIONS

Paramec 2% Solution for Injection is a broad-spectrum endectocide product used for the treatment and control of the following internal and external parasites in cattle and sheep.

In cattle;

Gastrointestinal Nematodes: Haemonchus placei, Ostertagia lyrata, Cooperia oncophora, C. punctata, C. pectinata, Trichostrongylus axei, T. colubriformis, Oesophagostomum radiatum, Bunostomum phlebotomum (adults, L4 larvae), Ostertagia ostertagi (adults, L4 larvae, inhibited L4 larvae), Nematoda helvetianus, N. spathiger, Strongyloides papillosus, Trichuris spp. (adults)

Lung Pinworms: Dictyocaulus viviparus (adult and L4 larvae)

Eye nematodes: Thelazia spp. (adult)

Nokra Factor Fly Larvae: Hypoderma bovis, H. lineatum

Scabies: Psoroptes ovis, Sarcoptes scabiei var. bovis

Lice: Linognathus vituli, Haematophinus eurysternus, Solenopotes capillatus

In sheep;

Gastrointestinal Nematodes: Haemonchus contortus, Ostertagia circumcincta (adults, L4 larvae, inhibited L4 larvae), Ostertagia trifurcata, Trichostrongylus axei, T. colubriformis, Cooperia curticei, Oesophagostomum columbianum, Nematodirus filicollins, L4 vitricollins, L4 vitricollina, T. venulosum, Trichuris ovis (adults)

Lung nematodes: Dictyocaulus filaria (adult and L4 larvae), Protostrongylus refescens (adult)

Scabies: Psoroptes ovis,

Nasal nematodes: Oestrus ovis

 

USAGE AND DOSAGE

Paramec 2% Solution for Injection is administered intramuscularly (IM) and subcutaneously (SC) in cattle and sheep. During the application, the rules of asepsis and antisepsis should be followed, and dry, sterile injection needles and injectors should be used.

Unless recommended otherwise by the veterinarian, it should be administered as 1 ml of Paramec 2% Injectable Solution/100 kg ca at a dose of 0.2 mg Ivermectin/kg ca in cattle and sheep.

 

The practical dose table is given below.

SHEEPCATTLE
Body Weight(kg)Dose (mL)Body Weight (kg)Dose (mL)
20 - 250.2550 - 1000.5 - 1
25 - 500.5100 - 2001 - 2
50 - 750.50 - 0.75200 - 4002 - 4

SPECIFIC CLINICAL INFORMATION AND WARNINGS FOR TARGET SPECIES

- A single treatment may not always be sufficient in cases of psoroptes ovis seen in sheep. In these cases, two injections 7 days apart are recommended. It is applied to the loose part of the skin in the armpit or armpit area of sheep, and to the shoulder and neck region of cattle, intramuscularly or to the loose part of the skin.

-Parasites and paraplegia occur when the larvae of hypoderma bovis are in the spinal cord and when the larvae die there. Applications performed during the periods when the larvae of Hypoderma lineatum are in the esophagus may cause salivation and the formation of secondary tympani as a result of the death of the larvae and require appropriate intervention. Therefore, the nocra treatment should be done at the end of the fly season.

- Permanent duration of action of Paramec 2% Solution for Injection against infective pinworm larvae varies between 2 and 4 weeks, depending on the nematode species.

- Regardless of the parasite, the application must cover all animals in the herd in order for the parasitic control to be successful.

- Parasitic developmental stages of target parasites, infestation intensity, climatic and pasture conditions, pasture schedules and other environmental factors should be taken into account in determining the application times and application frequency. Consult your veterinarian for the most appropriate and effective parasite control program for the area.

- In cattle that are fed into the barn, one application of Paramec 2% Solution for Injection is usually sufficient at the entrance to the fattening.

- It is necessary to apply several times a year to animals that graze continuously or occasionally in the pasture. Consult the veterinarian to determine the most appropriate application times and application frequencies according to the conditions of the region, the parasitic development stages of the target parasites, the transmission intensity and pasture schedules.

The best results can be obtained in the pasture season of that year, when 3 applications are made to the young animals that go out to the pasture for the first time, in the 3rd, 8th and 13th weeks following their emergence.

- Frequent and repeated use of ivermectin may cause resistance development. Care should be taken to administer the correct dose to minimize the risk of resistance development.

- In suspected clinical situations, ivermectin resistance should be investigated with appropriate tests (eg, fecal egg reduction test). Where tests support the development of resistance, a different anthelmintic product should be used.

- Macrocyclic lactone (ivermectin also falls into this class) resistance; Bay Teladorsagia spp. and for Cooperia spp. in cattle. Therefore, adequate epidemiological information should be provided in the use of this product to control and prevent further resistance development in susceptible nematodes.

Sheep scabies (Prosoptes ovis) is a highly contagious external parasite in sheep. Scabies can survive in sheep for up to 15 days. Therefore, great care must be taken to avoid re-infestation. It is important to treat all sheep that come into contact with infected sheep. Contact between treated, infected and untreated flocks should be avoided for at least seven days after treatment. In sheep, a single injection is not recommended for the treatment of sheep scabies, because even if clinical improvement can be seen, not all scabies will be eradicated.

Use in Pregnancy: It is safe for pregnant animals in the recommended use.

 

UNDESIRED EFFECTS

Temporary pain and swelling may occur at the injection site. These reactions resolve spontaneously without the need for any intervention.

 

DRUG INTERACTIONS

There are no studies on the incompatibility of ivermectin with other drugs. Therefore, it should not be used concurrently with other veterinary medicinal products. Paramec 2% Solution for Injection can be applied together with FMD and clostridial vaccines when applied by injection from different sites in cattle and sheep. Ivermectin injections for lungworms should not be administered at the same time as a vaccination. If ivermectin treatment is to be administered in vaccinated animals, treatment should be given 28 days before or after vaccination.

It should not be mixed with other medicinal products.

 

SYMPTOMS OF OVERDOSE, PRECAUTIONS AND ANTIDOTE

The tolerance limit is wide (calf-lamb up to 5 times, adults 10-20 times). In overdose, central nervous system symptoms such as mydriasis, various degrees of depression, muscle relaxation, paresis, ataxia, decreased tongue and lip tone, drooling, lying on the floor, and coma are seen. There is no known antidote.

 

WITHDRAWAL WARNINGS FOR FOOD-PRODUCING ANIMALS

During the treatment and after the last drug administration, cattle should not be sent to slaughter until 49 days and sheep until 42 days after. It cannot be used in sheep and cows producing milk for human consumption. It cannot be used in pregnant cows and sheep whose milk will be offered for human consumption during 60 days before delivery.

 

CONTRAINDICATIONS

In cases of cuticol myiasis caused by Hypoderma species in cattle, complications such as paraplegia, meteorismus and anaphylactic shock may develop if the pesticide is applied while the larvae are in winter waiting for areas and the larvae die in the spinal canal and esophagus. Therefore, it should not be used during the spinal cord migration of Hypoderma larvae. Do not administer by the intravenous (IV) route.

It should not be used in animals known to be sensitive to the active substance and excipients.

 

GENERAL PRECAUTIONS

Read the leaflet before use. Keep out of reach of children. Consult your veterinarian in case of unexpected effects and before use. Do not use products past the expiry date.

 

PRECAUTIONS TO BE TAKEN BY THE APPLICANT AND WARNINGS FOR PHYSICIANS

Paramec 2% Solution for Injection should be administered in accordance with the rules of asepsis-antisepsis. Use sterile syringes in application. The appropriate volume of vials should be selected for the number and type of animals to be treated, depending on the dose of use. It is recommended not to puncture the stopper more than 20 times after the first use. It is recommended to use automatic injectors in herd treatment. During the application, do not eat, drink or smoke. Hands should be washed after applying the medicine. In case of accidental injection, seek medical advice and show the label or leaflet to your doctor. The product may cause local irritation and/or pain at the injection site. Avoid direct contact with the product. People with hypersensitivity to Ivermectin should not come into contact with the drug.

 

STORAGE CONDITIONS AND SHELF LIFE

Store at room temperature (15 ˚C - 25 ˚C) in its own package. Protect from direct sunlight, do not refrigerate or freeze. Shelf life is 2 years from the date of manufacture. Opened products should be used within 28 days from the first use, provided that they are kept at a temperature of 15 ˚C - 25 ˚C

 

END DISPOSAL AND WARNINGS FOR NON-TARGET SPECIES

Since Ivermectin is toxic to fish and other aquatic organisms, care should be taken not to mix used medicine bottles with water. For this reason, medicine bottles to be destroyed should not be thrown into streams, lakes, etc. water sources. It should not be used in dogs, especially Collie breeds, due to its lethal effect. Bottles should not be buried in the ground or thrown into the garbage can. The medicine whose shelf life has expired, which has been opened or kept for a long time without complying with the storage conditions, should be destroyed together with its inner packaging (bottle).

 

TRADE DRESS

Paramec 2% Solution for Injection is enclosed in a cardboard box in 50 mL and 100 mL clear type II glass vials with 20 mm gray bromobutyl rubber stopper and 20 mm brown flip-off cap, 250 mL clear type II glass vials with 32 mm gray bromobutyl rubber stopper and 32 mm It is offered for sale plastered with a brown flip-off cover.

 

PLACE AND CONDITIONS OF SALE

Sold in veterinary offices and pharmacies with a veterinarian's prescription.

APPROVAL DATE OF THE PROSPECTUS

T.R. MINISTRY OF AGRICULTURE AND FORESTRY MARKETING AUTHORIZATION DATE AND NO: 06.03.2019-028/0044

 

MARKETING AUTHORIZATION HOLDER

Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.

Malıköy Başkent OSB Mah. 26. Cad. No: 34/A - Sincan - ANKARA - TÜRKİYE

 

MANUFACTURER COMPANY

Pİ FARMA İLAÇ SAN. VE TİC. A.Ş.

Malıköy Başkent OSB Mah. 26. Cad. No: 34/A - Sincan - ANKARA - TÜRKİYE

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