Noromectin Paste (ivermectin)

Please Note: This product is for equine (horse) use only. It is not suitable for human consumption. Always follow veterinary advice.

Noromectin Paste is administered orally with a syringe. Noromectin contains ivermectin which eradicates worms and other parasites from horses, donkeys, ponies, mares and foals. For best results all equine that are either stabled together or graze together should be treated at the same time.

Active Ingredients: Ivermectin

Target Species: Horses, Donkeys, Ponies, Mares, Foals.

Treats and Controls: Worms and a range of internal parasites.

Administration Method: Paste is delivered into the mouth at the back of the tongue. Delivery is via a syringe. 

Withdrawal time: Withdrawal period is 34 days

Dosage: Each syringe contains 140 mg of ivermectin which treats 700 kg of body mass. The syringe shaft is divided into sections that are effective to treat 100 kg of body weight each. A horse weighing 200 kg would require two sections. The same syringe may be used to treat other horses only if they are running together or housed in close proximity. The weight of the horse should be accurately calculated. Noromectin paste should be administered into an empty mouth, between the front and back teeth. Release the paste and tilt the horse head back to aid swallowing. All equine in the same area should be treated at the same time for maximum efficiency and successful eradication of parasite infestation.

Features of Noromectin Paste

• Easy to administer
• Contains 140 mg of Ivermectin
• One syringe can treat 700 kg of body weight
• Treats a wide range of parasites.

Click here to Download Data Sheet

Health Products Regulatory Authority 

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Noromectin 1.87% Oral Paste for Horses

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substance
Ivermectin 1.87% w/w (18.7 mg/g)

Excipient(s)
For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM
Oral Paste
A white homogenous paste.

4 CLINICAL PARTICULARS
4.1 Target Species
Horses.

4.2 Indications for use, specifying the target species
For the treatment of the following parasites of horses:

Roundworms in the stomach and intestines
Large strongyles
Strongylus vulgaris adults and 4th larval (arterial) stages
Strongylus edentatus adults and 4th larval (tissue) stages
Strongylus equinus adults
Small strongyles, adults
Cyathostomum catinatum
Cyathostomum peteratum
Cylicocyclus ashworthi
Cylicocyclus elongatus
Cylicocyclus insigne
Cylicocyclus leptostomum
Cylicocyclus nassatus
Cylicocyclus radiatus
Cylicostephanus asymetricus
Cylicostephanus bidentatus
Cylicostephanus calicatus
Cylicostephanus goldi
Cylicostephanus longibursatus
Cylicostephanus minutus
Cylicodontophorus bicornatus
Gyalocephalus capitatus

Hairworms
Trichostrongylus axei adult

Pinworms
Oxyuris equi adult and immature Ascarids Parascaris equorum adult and 3rd and 4th stage

Intestinal threadworms
Strongyloides westeriadult

Neck threadworms
Onchocerca spp (microfilariae)

Lungworms
Dictyocaulus arnfieldi adult and immature

Stomach bots Gasterophilus spp oral and gastric larval stages

Ivermectin is not effective against encysted larval stages of the small strongyles. 

4.3 Contraindications
Do not use in horses known to be hypersensitive to the active ingredient or to any other ingredients.
Do not use in dogs or cats as severe adverse reactions may occur. See also 4.11

4.4 Special warnings for each target species
The veterinary medicinal product has been formulated specifically for use in horses only.
Dogs and cats may be adversely affected by the concentration of ivermectin in the veterinary medicinal product if they are allowed to ingest spilled past or have access to used syringes.
As with all anthelmintics, a veterinary surgeon should establish appropriate dosing programmes and stock management to achieve adequate parasite control and reduce the likelihood of anthelmintic resistance developing.

4.5 Special precautions for use
Special Precautions for use in animals:
Avermectins may not be well tolerated in all non-target species (cases of intolerance with fatal outcome are reported in dogs, especially Collies, Old English Sheepdogs and related breeds or crosses, and also in turtles / tortoises).

Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Do not smoke or eat while handling the veterinary medicinal product.
Wash hands after use.
Avoid eye contact.

4.6 Adverse reactions (frequency and seriousness)
Some horses carrying heavy infection of Onchocerca microfilariae have experienced oedema and pruritus following dosing, assumed to be the result of death of large numbers of microfilariae.
These signs resolve within a few days but symptomatic treatment may be advisable.
Frequent and repeated use may lead to the development of resistance.

4.7 Use during pregnancy, lactation or lay
The veterinary medicinal product can be administered at any stage of pregnancy.
Ivermectin passes readily into milk.
When administering to lactating females, residues of ivermectin could be present in the maternal milk.
No studies have been reported on the effect of ingestion of milk on the development of newborn foals.
Do not use in mares producing milk for human consumption.

4.8 Interaction with other medicinal products and other forms of interactions
None known.

4.9 Amounts to be administered and administration route
The veterinary medicinal product is administered orally at a single dose rate of 200 μg/kg of bodyweight.
One syringe division of paste should be administered per 100 kg bodyweight (based on the recommended dosage of 200 μg/kg (0.2 mg/kg).
Each syringe delivers 140 mg ivermectin, sufficient to treat 700 kg of bodyweight. horses weight should be accurately determined for the correct use of the paste.
The animal's mouth should be free from food to ensure swallowing.
The tip of the syringe barrel should be inserted at the interdental space (the gap between the front and back teeth). Immediately elevate the horse's head for a few seconds to ensure swallowing.
Do not use the same syringe to treat more than one animal unless horses are running together or in direct contact with each other on the same premises.
For best results all horses in a yard or grazing together should be included in a regular parasite control programme, with particular attention being paid to mares, foals and yearlings, and treated at the same time.

Foals should be treated initially at 6-8 weeks of age and routine treatment repeated as appropriate.

Retreatment should be done according to the epidemiological situation, but not less than 30 days intervals. 

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Mild transitory signs (slowed pupillary light response and depression) have been seen at a higher dose of 1.8 mg/kg (9 times the recommended dose level).
Other signs seen at higher doses include mydriasis, ataxia, tremors, stupor, coma and death.
The less severe signs have been transitory.
Although no antidote has been identified, symptomatic therapy may be beneficial.

4.11 Withdrawal period(s)
Edible tissues: 34 days.
Not permitted in mares producing milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group:
Avermectins

ATC Vet Code:
QP 54AA01.

5.1 Pharmacodynamic properties
Ivermectin is a 22, 23-dihydro derivative of an avermectin (which is a fermentation product produced by Streptomyces avermitilis) and consists of 2 homologues: B1a and B1b.
It is a parasiticide with nemotocidal, insecticidal and acaricidal activity documented in a wide range of domesticated animals. Ivermectin is not effective in liver fluke and cestode infestations.
Avermectin bind selectively with glutamate-gated chloride ion channels, which occur in invertebrate nerve or muscle cells.
This leads to an increase of the cell membrane permeability to chloride ions of the nerve or muscle cells, causing irreversible neuromuscular blockade in the parasite, followed by paralysis and death.
Compounds of this class may also interact with other ligand-gated chloride channels, such as those gated by the neurotransmitter gamma-aminobutyric acid (GABA).
Ivermectin stimulates GABA liberation at presynaptic nerve terminations (in Nematodes) or the neuromuscular junctions (in Arthropodes), that leads to the paralysis and death of the relevant parasites.
Resistance to ivermectin in horses has not been reported, however it is possible that frequent and repeated use may lead to the development of resistance.

5.2 Pharmacokinetic particulars
After oral administration of the recommended dose to horses, the following parameters were observed: Cmax of 29 ng/ml, Tmax of 7 h, AUC of 1485 ng/ml.h and t½ of 55 h. Ivermectin is highly lipophilic and has good ability to penetrate to the location of parasites.
It is stored in and slowly released from fat after which it is converted by the liver to less lipid soluble metabolites by oxidative biotransformation.
The excretion route of the active substance occurs mainly in the bile and faeces.
Less than 2% is eliminated via urine. 

Ivermectin is highly protein bound and clearance is slow.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Hydroxypropyl Cellulose
Hydrogenated Castor Oil
Titanium Dioxide (E171)
Propylene Glycol
Water for Injections

6.2 Major incompatibilities
Not applicable.

6.3 Shelf-life
Shelf-life of the veterinary medicinal product as packaged for sale: 3 years
This is a unidose product.
Please dispose of after use.

6.4 Special precautions for storage
Do not store above 25°C.
Keep the container in the outer carton in order to protect from light.

6.5 Nature and composition of immediate packaging
Low-density polyethylene pre-filled syringes containing 7.49 g of product in cartons of 1,2 and 10 syringes.

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
EXTREMELY DANGEROUS TO FISH AND AQUATIC LIFE.
Do not contaminate surface waters or ditches with product or used container.
Any unused product or waste manerial should be disposed of in accordance with national requirements.
 

7 MARKETING AUTHORISATION HOLDER
Norbrook Laboratories (Ireland) Limited
Rossmore Industrial Estate
Monaghan
Ireland

8 MARKETING AUTHORISATION NUMBER(S)
VPA22664/062/001
 
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 06 April 2001
Date of last renewal: 21 March 2007

10 DATE OF REVISION OF THE TEXT
August 2019

Ivermectin is a semi-synthetic antiparasitic medication derived from avermectins, a class of highly active broad-spectrum antiparasitic agents isolated from the fermentation products of Streptomyces avermitilis. 

​Ivermectin itself is a mixture of two avermectins, comprising roughly 90% 5-O-demethyl-22,23-dihydroavermectin A1a (22,23-dihydroavermectin B1a) and 10% 5-O-demethyl-25-de(1-methylpropyl)-22,23-dihydro­-25-(1-methylethyl) avermectin A1a (22,23-dihydroavermectin B1b).