Santiola Injection is used for the treatment and control of liver fluke in cattle and sheep. It is also targets the larval stage of nasal bots, stomach worm and large mouthed bowel worms in sheep. It can be used to treat Barbers pole worm and hookworm in cattle

Active Ingredient: Closantel

Target Species: Cattle, sheep

Administration Method: Subcutaneous injection (under the skin)

Treats and Controls: Liver fluke in sheep and cattle, larval stage nasal bots in sheep

Withdrawal Time: 77 days for animals intended for meat and offal, not permitted for use on animals producing milk for human consumption.

Dosage For Cattle: 2.5 ml per 50 kg of bodyweight.

Dosage for sheep: 1 ml per 10 kg of bodyweight.

Always read the label and all enclosed information for Santiola Injection before administering to animals!

Key Features of Santiola Injection:

• When used in the treatment of culling cows they can grow up to 10 kg heavier
• Treated herds can produce an extra 1-3% more calves
• Calves whose mothers have been treated are on average 20 kg heavier at the time of weaning
• Fluke egg laying is reduced for 13 weeks, this is longer than any other flukicide
• Fluke egg hatchability is highly reduced

• Weakened calves
• Reduced weight at the time of weaning caused by both the poor quality and quantity of the milk being produced
• Poor feed conversion
• On occasion, anaemia, loss of weight and even death in animals younger than 2 years old.

• Weakened or incapacitated cows, especially in later stages of pregnancy.
• Lower fertility rates which leads an increase in culls
• Sale weight of cull cows reduced
• Production of milk is greatly reduced
• Reduction in the nutritional value of the milk
• Lower conception rates
• Slower growth in heifers
• Delay in the onset of first oestrus in the herd
• Poor reproductive performance from bulls

Click here to Download Data Sheet

Health Products Regulatory Authority

1 NAME OF THE VETERINARY MEDICINAL PRODUCT
Santiola 50 mg/ml solution for injection for cattle and sheep

2 QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml contains
Active substance:
Closantel 50 mg (equivalent to closantel sodium dihydrate 54.375 mg )

Excipients:
For the full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM
Solution for injection
Clear light yellow to yellow or brown yellow solution.

4 CLINICAL PARTICULARS

4.1 Target Species
Cattle and sheep

4.2 Indications for use, specifyingthe target species
For treatment of the following trematodes (fluke), gastro-intestinal nematodes and arthropods if sensitive to closantel.

Sheep
Trematodes Fasciola hepatica(adult)
Fasciola gigantica (adult and 8 weeks immature)
Nematodes Haemonchus contortus(adult and immature)
Oesophagostomum columbianum (adult and immature)
Gaigeria pachyscelis(adult and immature)
Chabertia ovina (adult and immature)
Arthropods Oestrus ovis (1st , 2 nd and 3 rd instar)

Cattle
Trematodes Fasciola hepatica (adult)
Fasciola gigantica(adult and 8 week immature)
Nematodes Haemonchus placei (adult and immature)
Bunostomum phlebotomum (adult and immature)
Oesophagostomum radiatum (adult and immature)
Arthropods Hypoderma bovis(dermal stages)
Hypoderma lineatum (dermal stages)

4.3 Contraindications
Do not use in cases of hypersensitivity to the active substance or to any of the excipients.

4.4 Special warnings for each target species
Do not exceed the stated dose.
Care should be taken to ensure that all injection procedures are correctly carried out and body weights accurately assessed.
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.
- Underdosing, which may be due to underestimation of body weight, misadministration of the product, or lack of calibration of the dosing device.
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 another pharmacological class and having a different mode of action should be used. 

4.5 Special precautions for use

Special precautions for use in animals
Safe and efficacious use of this product at a dose of 2.5 mg/kg is dependent on accurate species level parasitological diagnosis of risks at farm level. Where this is unavailable, the dose rate of 5 mg/kg must be used.

Special precautions to be taken by the person administering the veterinary medicinal product to animals Wash hands after administration.
Take care to avoid accidental self-administration.

Other precautions
Closantel is toxic to dung fauna.
To reduce the risk for the dung fauna, treated and untreated animals should be grazed on the same field.
In order to reduce the risk to aquatic organisms, treated animals should be kept out of water for at least 48 hours after treatment. 4.6 Adverse reactions (frequency and seriousness)
The solution contains polyvidone.
This substance may in very rare cases induce hyperacute anaphylactic reactions in cattle.

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
Can be used during pregnancy and lactation. See section 4.11.

4.8 Interactionwith other medicinal productsand otherforms of interaction
None known.

4.9 Amounts to be administeredand administration route Route of administration:
Cattle: subcutaneous route 
Sheep: subcutaneous route

To ensure administration of a correct dose, body weight should be determined as accurately as possible. When large volumes have to be injected (more than 20 ml), divide the total volume equally over both neck sides.
Do not exceed 20 broachings per vial.
If more than 20 broachings are required, use of a draw off needle is recommended.
If treatment is to be repeated, a minimum of 11 week interval must be observed in order to avoid accumulation of residues.

Dose:
Cattle
2.5 mg/kg BW (1 ml/20 kg BW)      Adults      Immatures
Fasciola hepatica Fasciola                 x
gigantica Haemonchus placei            x
Bunostomum phlebotomum               x                x
Oesophagostomum radiatum             x

5.0 mg/kg BW (1 ml/10 kg BW)      Adults       Immatures
Fasciola hepatica Fasciola                  x
gigantica Haemonchus placei              x
Bunostomum phlebotomum                 x          From 8 weeks
Oesophagostomum radiatum               x               x
Hypoderma bovis                                 x               x
Hypoderma lineatum               Dermal Stage        x

Sheep
2.5 mg/kg BW (1 ml/20 kg BW)       Adults         Immatures
Haemonchus contortus                       x                 x
Gaigeria pachyscelis                           x                 x
Oestrus ovis                         1 st , 2 nd and 3 rd instar 

5.0 mg/kg BW (1 ml/10 kg BW)                                            Adults          Immatures
Fasciola hepatica                                                                      x
Fasciola gigantica                                                                      x               From 8 weeks
Haemonchus contortus(+ BZ-resistant strains)                         x                   x        
Oesophagostomum columbianum                                             x                   x
Chabertia ovina                                                                          x                   x
 
Because of its long half-life, closantel will protect for several weeks against re-infections with the following nematodes: 
Cattle
Residual Activity                    Dose (mg/kg)                 Protection Period
Haemonchus placei                     2.5                      4 weeks
                                                     5                         6 weeks
Bunostomum phlebotomum         5                         3 weeks
Oesophagostomu radiatum          5                         2 weeks

Sheep
Residual Activity                    Dose (mg/kg)                   Protection Period
Haemonchus contortus                         2.5                                2 weeks
                                                              5                                   7 weeks
Gaigeria pachyscelis                             5                                   3 weeks
                                                              5                                    8 weeks
Oestrus ovis                                          5                                    8 weeks
 

4.10 Overdose (symptoms, emergency procedures,antidotes), if necessary
Symptoms of acute overdosage are decreased vision or blindness, anorexia, incoordination and general weakness.

4.11 Withdrawal period(s)

Cattle: meat and offal: 77 days
Sheep: meat and offal: 77 days
Not authorised for use in cattle producing milk for human consumption including during the dry period.
Do not use during the last trimester of pregnancy in heifers which are intended to produce milk for human consumption.
Not authorised for use in ewes producing milk for human consumption including during the dry period.
Do not use within 1 year prior to the firstlambing in ewes intended to produce milk for human consumption.

5 PHARMACOLOGICAL or IMMUNOLOGICAL PROPERTIES

Pharmacotherapeutic group:
anthelmintics, phenol derivatives, including salicylanilides

ATCvet code:
QP52AG09

5.1 Pharmacodynamic properties
The product contains the salicylanilide closantel, a synthetic antiparasitic agent with high efficacy against liver fluke (Fasciola gigantica and Fasciola hepatica), haematophagous nematodes (Bunostomum phlebotomum,Chabertia ovina, Gaigeria pachyscelis, Haemonchus contortus – including benzimidazole-resistant strains,  Haemonchus placei,Oesophagostomum columbianum, and Oesophagostomum radiatum) and larval stages of some arthropods (Hypoderma bovis,Hypoderma lineatum, and Oestrus ovis) in sheep and cattle.
Closantel is an uncoupler of mitochondrial oxidative phosphorylation resulting in inhibition of ATP synthesis.
This induces a marked change in the energy metabolism and finally leads to death of the parasite.

5.2 Pharmacokinetic particulars
Closantel is rapidly absorbed into the systemic circulation with peak plasma levels at 24-48 hours after dosing.
In plasma, closantel is bound 99% to albumin.
As a result, tissue distribution is very limited.
On average, tissue levels are 15 times lower than plasma levels.
The elimination half-life of closantel from plasma and tissues is approximately 2 to 4 weeks in sheep and 9 to 21 days in cattle. The drug is poorly metabolised and the main excretion route is in the faeces via the bile. Urinary excretion is negligible.

Environmental properties
Closantel has the potential to adversely affect non-target organisms. Following treatment, excretion of potentially toxic levels of closantel may take place over a period of several weeks. Faeces containing closantel excreted onto pasture by treated animals may reduce the abundance of dung feeding organisms which may impact on the dung degradation.
Closantel may affect aquatic organisms (aquatic invertebrates, sediment dwellers and fish).

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Propylene glycol (E1520)
Povidone K 12
Citric acid monohydrate
Sodium hydroxide
Water for injections

6.2 Major incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products. 

6.3 Shelf-life
Shelf life of the veterinary medicinal product as packaged for sale: 2 years.
Shelf life after first opening the immediate packaging: 28 days.

6.4 Special precautions for storage
Store below 30 °C.
Store in the original container in order to protect from light.
Once opened, store below 25 °C.

6.5 Nature and composition of immediate packaging
Container or pack size: 1 or 4 type I amber glass vials.
Closure: bromobutyl rubber.
Contents of each vial: 250 ml solution.
Not all pack sizes may be marketed.

6.6 Special precautions for the disposal of unusedveterinary medicinal products or waste materials derived from the use of such products
Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal product should be disposed of in accordance with local requirements.
The product should not enter water courses as this may be dangerous for fish and other aquatic organisms.

7 MARKETING AUTHORISATION HOLDER
KRKA, d.d., Novo mesto
Šmarješka cesta 6
8501 Novo mesto
Slovenia

8 MARKETING AUTHORISATION NUMBER(S)

VPA10774/048/001


9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 2 nd February 2018

10 DATE OF REVISION OF THE TEXT

 Cattle Injectables
Injectables should be given according to the manufacturer’s instructions at the recommended injection site.
• Always use a clean, sterile syringe and needle. If using a multiple injection gun, ensure the needle is disinfected between injections, e.g. with an automatic sterilisation system.
• If the site to be injected is dirty, clean the skin and swab with an alcohol-impregnated wipe or cotton wool.
• Before injecting, check the expiry date and read the instructions of the product to be used. Some products need to be shaken before use.
• Use the correct-sized needle according to the size of the animal and site of injection.
• Ensure the animal is adequately restrained before attempting the injection.
• Take care to ensure it is given subcutaneously and not intramuscularly. Raise a fold of skin at the injection site (mainly neck but some are ear) recommended by the product manufacturer and inject carefully into the space created.
• If a large dose is to be delivered, it may be advisable to split the dose between two injection sites. After the injection, briefly massage the site to improve the dispersal of the injected material.
• Dispose of the needle and syringe in appropriate clinical waste and sharps containers.

Sheep Subcutaneous injections
Subcutaneous injections need to be administered with care to ensure the product is placed under the skin and not into the fleece or muscle.
The sheep needs to be well restrained, and the skin ‘tented’ away from the underlying muscle.
The preferred injection site is 10–15 cm (4–6 inches) below the ear on the side of the neck (see diagram below). Usually a 1.6 cm (5/8 inch) needle is ideal.
After administration, the site should be gently massaged.

Delivery Information

Delivery Service

Here at Agridirect we have joined forces with DPD to ensure all packages are delivered promptly and safely to you. We ship to all mainland countries within the EU. Deliveries take place Monday to Friday excluding bank holidays. Once your order has been dispatched from our warehouse you will be notified by email. If there is a delay with your order for any reason you will be contacted immediately. 

Due to Brexit we are temporarily unable to ship to the UK. Shipping to Northern Ireland will remain in place.

Delivery Times

Some products have an extended delivery time, this is noted on the products.

Delivery Rates

A selection of the products we sell are only licensed for sale within the Republic Of Ireland and can not be shipped outside of the country. These products are noted as only being available within the Republic of Ireland on the individual product pages.

There may be an addition charge on certain bulky items. This charge will be clearly marked on an applicable products and will be explained on the checkout page before payment has been made.

Agridirect 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 loss of value of 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 which occur 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 here.

2) To print off your return label click here 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 here.

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.