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Health Products Regulatory Authority

Summary of Product Characteristics

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Doramax 5 mg/ml Pour-on Solution for Cattle

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml contains:
Active substance
Doramectin  5.0 mg
Excipients
For a full list of excipients, see section 6.1

3 PHARMACEUTICAL FORM
Pour-on solution.
Clear, colourless solution.

4 CLINICAL PARTICULARS
4.1 Target Species
Cattle

4.2 Indications for use, specifying the target species
For treatment of infestations of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle.

Gastrointestinal roundworms (adults and fourth stage larvae)
Ostertagia ostertagi (inc. inhibited larvae)
O. lyrata1
Haemonchus placei
Trichostrongylus axei
T. colubriformis
Cooperia oncophora
C. punctata1
C. surnabada1 (syn. mcmasteri)
Bunostomum phlebotomum1
Oesophagostomum radiatum
Trichuris spp1 

Lungworms (adults and fourth stage larvae)
Dictyocaulus viviparus

Eyeworms (adults)
Thelazia spp

Warbles (parasitic stages)
Hypoderma bovis,
H. lineatum

Biting lice
Damalinia (Bovicola) bovis 

Sucking lice
Haematopinus eurystemus,
Linognathus vituli,
Solenopotes capillatus

Mange mites
Psoroptes bovis,
Sarcoptes scabiei,
Chorioptes bovis

Horn fly
Haematobia irritans

Duration of activity
Following product administration, efficacy against re-infection with the following parasites persists for the period indicated:

Species                                              Days
Ostertagia ostertagi                               35
Cooperia oncophora                              28
Dictyocaulus viviparus                           42
Linognathis vituli                                    49
Oesophagostomum radiatum                21
Damalinia (Bovicola) bovis                    42
Trichostrongylus axei                            28
Solenopotes capillatus                          35

The product also controls horn flies (Haematobia irritans) for at least 42 days after treatment.

4.3 Contraindications
The product has been formulated for topical application specifically for cattle.
It should not be administered to other species as severe adverse reactions, including fatalities in dogs, may occur.
Do not use in cases of hypersensitivity to the active substance or any of the excipients. See section 4.5.i.

4.4 Special warnings for each target species
For external use only.
Care should be taken to avoid the following practices because they increase the risk of development of resistance and could ultimately result in ineffective therapy:
- too frequent and repeated use of anthelmintics from the same class, over an extended period of time.
- under dosing, which may be due to underestimation of bodyweight, misadministration of the product, or lack of calibration of a dosing device (if any).
Suspected clinical cases of resistance to anthelmintics should be further investigated using appropriate tests (e.g. faecal egg count reduction test).
Where the results of the test(s) strongly suggest resistance to a particular anthelmintic, an anthelmintic belonging to a different pharmacological class and having a different mode of action should be used.
Do not apply to areas of skin that are contaminated with mud or manure.
Therapeutic efficacy for internal and external parasites is not affected by heavy rainfall (2 cm in 1 hour) either before (20 minutes) or after (20 and 40 minutes) treatment.
The influence of extreme weather conditions on efficacy is unknown.

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/tortoise.
Care should be taken to avoid ingestion of spilled product or access to containers by these other species.
To avoid secondary reactions due to death of Hypodermalarvae in the oesophagus or the spine, it is recommended to administer the product at the end of the period of warble fly activity and before the larvae reach their resting sites. Consult your veterinary surgeon on the correct timing of treatment.

Special precautions to be taken by the person administering the veterinary medicinal product to animals Persons with known hypersensitivity to the active substance should avoid contact with the product.
Do not smoke or eat while handling the product.
Wash hands after use.
The product may be irritating to human skin and eyes and users should be careful not to apply it to themselves or to other persons.
Operators should wear rubber gloves and boots with a waterproof coat when applying the product. Protective clothing should be washed after use.
If accidental skin contact occurs, wash the affected area immediately with soap and water. If accidental eye exposure occurs, flush the eyes immediately with water and get medical attention.
Use only in well ventilated areas or outdoors.
Highly Flammable - Keep away from heat, sparks, open flame or other sources of ignition.

Other precautions
Doramectin is very toxic to dung fauna and aquatic organisms and may accumulate in sediments.
The risk to aquatic ecosystems and dung fauna can be reduced by avoiding too frequent and repeated use of doramectin (and products of the same anthelmintic class) in cattle.
The risk to aquatic ecosystems will be reduced by keeping treated cattle away from water bodies for two to five weeks after treatment.

4.6 Adverse reactions (frequency and seriousness)
In rare cases small skin lesions may occur at the administration 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).

4.7 Use during pregnancy, lactation or lay
Do not use in non-lactating dairy cows, including pregnant heifers, within 60 days prior to calving.

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

4.9 Amounts to be administered and administration route
A single treatment of 1 ml (5 mg doramectin) per 10 kg bodyweight, equivalent to 500 µg/kg bodyweight, applied topically along the mid-line of the back in a narrow strip between the withers and tail head.
To ensure administration of a correct dose, bodyweight should be determined as accurately as possible; accuracy of the dosing device should be checked.
If animals are to be treated collectively rather than individually, they should be grouped according to their bodyweight and dosed accordingly, in order to avoid under- and over- dosing.

4.10 Overdose (symptoms, emergency procedures, antidotes), if necessary
Overdoses up to 5 times the label recommended dose resulted in no clinical signs that could be attributed to treatment with Doramectin.

4.11 Withdrawal period(s)
Meat and offal: 35 days.
Not permitted for use in lactating animals producing milk for human consumption.
Do not use in pregnant cows or heifers, which are intended to produce milk for human consumption, within 2 months of expected parturition.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES
Pharmacotherapeutic group:
macrocyclic lactones, avermectins

ATCvet Code:
QP 54AA03

5.1 Pharmacodynamic properties
Doramectin is a fermentation-derived antiparasitic agent, which belongs to the avermectin class, and is closely related structurally to ivermectin. Both compounds share a wide spectrum of antiparasitic activity and produce a similar paralysis in nematodes and parasitic arthropods.
Whilst it is not possible to assign a single mode of action to the avermectins, it is likely that the entire series share a common mechanism.
In parasitic organisms the effect is mediated through a specific avermectin-binding site.
The physiological response to avermectin binding is an increase in membrane permeability to chloride ions.
In invertebrate nervous tissue an influx of chloride ions into the excitatory motor neurone in nematodes or muscle cell of arthropods results in hyperpolarisation and the elimination of signal transmission with resulting paralysis.

5.2 Pharmacokinetic particulars
Maximum plasma concentration of Doramectin occurs in cattle approximately 9 days after topical administration of the product.
An (apparent) elimination half-life of around 10 days results in sustained Doramectin concentrations, which protect animals from parasitic infection and re-infection for extended periods following treatment.

5.3 Environmental properties
Like other macrocyclic lactones, doramectin has the potential to adversely affect non-target organisms.
Following treatment, excretion of potentially toxic levels of doramectin may take place over a period of several weeks. Faeces containing doramectin excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.

Doramectin is very toxic to aquatic organisms and may accumulate in sediments.

6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Cetostearyl
Octanoate
Trolamine
Isopropyl alcohol
Butylhydroxytoluene

6.2 Major incompatibilities
None known.

6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale:5 years
Shelf life after first opening the immediate packaging: 1 year

6.4 Special precautions for storage
This veterinary medicinal product does not require any special storage conditions.

6.5 Nature and composition of immediate packaging
The product will be supplied in: 1 L, 2.5 L, 3 L, 5 L, 6L (5L+1L) and 8L (5 L + 3 L) high-density polyethylene bottles with a tamper evident cap in a carton box. Not all pack sizes may be marketed

6.6 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products

Extremely dangerous for fish and aquatic life.
Do not contaminate ponds, waterways or ditches with the product or used container.
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.

7 MARKETING AUTHORISATION HOLDER
Chanelle Pharmaceuticals Manufacturing Limited
Loughrea
Co. Galway
Ireland

8 MARKETING AUTHORISATION NUMBER(S)
VPA10987/166/001

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 09 April 2021

10 DATE OF REVISION OF THE TEXT

Doramax Pour-On is a pour-on treatment for infestations of gastrointestinal roundworms, lungworms, eyeworms, warbles, sucking and biting lice, mange mites and hornfly in cattle. It contains the active ingredient Doramectin 0.5% w/v. Before using Doramax, always read the manufacturer's instructions carefully. 

Returns Policy

We’re sorry your purchase didn’t work out. But don’t worry; we have a great returns policy to help you out.

All purchases can be returned to us within 14 days of delivery, and returned goods must be received within 14 days from the date you informed us of the return.

Purchases may be opened for inspection but must not be used and must be repackaged securely in the original packaging if you wish to return it.

If we discover goods have been used or there has been a loss in value of the goods due to damage to the goods while in your care or whilst being returned to us, we will reduce the amount refunded, which may amount to the full cost of the product, to cover the loss of value of the goods.

All returns should be complete, which includes boxes, manuals, and accessories that may have been included with the order.

All returns must be packaged appropriately for shipping; we will not accept responsibility for damages or loss that occurs during shipping of a return product.

We accept no responsibility for goods damaged or lost while in transit to us. 

How do I return a product?

We have partnered with DPD to make your returns process easy and secure. Simply follow the steps below and bring your package to an official DPD pickup point.

1) All returns must be accompanied with a fully filled out returns form which can be downloaded returns form PDF.

2) To print off your return label click DPD Returns page or visit www.dpd.ie/returns and follow the on-screen instructions. Make sure and use your order number as your reference.

• Select “Continue as Guest”
• Select “Agridirect” from the drop-down menu
• Select your reason for returning
• Select the size of the package you wish to return
• Accept DPD’s terms and conditions
• Fill in your payment details
• Fill in your own details
• Follow the instructions to print off your label

3) Bring your package to a DPD pickup point. To find your nearest drop off point DPD pickup shops.

Once the returned product has been received into our warehouse and been fully inspected a refund will be issued.

If you choose not to use the DPD returns service we recommend that you use a method that can be tracked.

For the return of bulk products please contact us at sales@agridirect.ie

I have received a damaged product from you, what should I do?

First off, if you have received a damaged electrical product from us, do not plug it in. Any electrical products that are plugged in are deemed ‘as used and accepted’ and are not accepted as returns. All damages must be reported to us via phone or email within 24hours of receipt of goods. Please ensure you check your items upon delivery.

How do I begin the returns process?

If you wish to begin the return process, please email us at sales@agridirect.ie and ensure the following information is included in your email. Your name, phone number, Order id, the item you wish to return, reason for return and if the product is damaged we require photos of the product.

Once you have sent us all required information a member of our team will assess your claim and will contact you as soon as possible. Please hold off on returning products until a member of our team has called you to confirm.

Refunds

Once the returned product has been returned to us and fully inspected a refund will be issued.

Please Note: A typical timeline for a refund to show in your account is up to 10 working days from the date processed, depending on your bank.