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Oxytobel 10 IU/ml Solution for Injection 50ml

Item Number: OXYTOBEL

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Description

Oxytobel 10 IU/ml Solution for Injection 50ml. In the mare, cow, sow, ewe, goat, bitch and cat the product is indicated for Obstetric use (stimulation of uterine contraction to facilitate parturition in the presence of a fully dilated cervix, promotion of involution of the post partum uterus, aid in the control of post partum haemorrhage).


Data Sheets

Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats Species:Cats, Cattle, Dogs, Goats, Horses and other equidae, Sheep Therapeutic indication:Pharmaceuticals: Hormones and therapeutically related products: Pituitary hormones

Active ingredient:Oxytocin

Product:Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats

Product index:Oxytobel 10 IU/ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats

Cattle - milk:Zero hours

Cattle - meat:Zero days

Sheep - meat:Zero days

Qualitative and quantitative composition

1 ml contains:

Active substance:

Oxytocin 16.6 µg

(equivalent to 10 IU Oxytocin)

Pharmaceutical form

Clear colourless solution for injection.

Clinical particulars

Target species

Horses (mares), cattle (cows), pigs (sows), sheep (ewes), goats (nanny), dogs (bitches) and cats (queen)

Indications for use, specifying the target species

In the mare, cow, sow, ewe, nanny, bitch and queen the product is indicated for:

∙ Obstetric use (stimulation of uterine contraction to facilitate parturition in the presence of a fully dilated cervix, promotion of involution of the post-partum uterus, aid in the control of post-partum haemorrhage).

∙ Promotion of milk let-down in cases of agalactia.

Contraindications

Do not use in cases of obstructive dystocia and/or in cases of non-dilatation of the uterine cervix.

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

Special warnings for each target species

Adrenaline at physiological levels markedly reduces the effect of Oxytocin on the uterus or mammary gland. For this reason the animal should not be frightened when complete Oxytocin effect is desired to cause either milk "let-down" or uterine contractions.

Special precautions for use in animals

When the veterinary medicinal product is used as an aid in parturition cervical dilation must be confirmed prior to administration to prevent risk of foetal death and possible uterine rupture.

Special precautions to be taken by the person administering the veterinary medicinal product to animals

Pregnant or lactating women should avoid handling the product as it could cause smooth muscle (e.g. uterine) contraction.

When administering the product, care should be taken to avoid accidental self-injection.

In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.

Adverse reactions (frequency and seriousness)

None.

Use during pregnancy, lactation or lay

The product is indicated for use, as appropriate, during parturition and lactation. Do not use during pregnancy except at the time of parturition.

Interaction with other medicinal products and other forms of interaction

This veterinary medicinal product maybe used concurrently with antibiotics in the treatment of endometritis.

Stimulation of β-adrenergic receptors may reduce oxytocin’s effects on the uterus and mammary gland.

If sympathomimetic agents or other vasoconstrictors are used concurrently with oxytocin, post-partum hypertension may result.

Amounts to be administered and administration route

Administered by subcutaneous or intramuscular injection.

Mare & Cow 4 – 6 ml

Sow 1 – 3 ml

Ewe & Nanny 1 – 2 ml

Bitch & Queen 0.25 – 1 ml

For treatment of agalactia the stated higher dosage level should be used.

The product may be administered by slow intravenous injection at dose rates one third of the above.

Enhanced dose rates will not result in proportionally increased pharmacological effects.

Overdose (symptoms, emergency procedures, antidotes), if necessary

Excessive doses of the veterinary medicinal product may delay parturition by producing uncoordinated uterine contractions which interfere with the progress of the foetus especially in multiple pregnancies.

Treatment of overdose is palliative and there are no specific antidotes.

Withdrawal period(s)

Meat and offal: zero days.

Milk: zero hours.

Pharmacological particulars

Pharmacotherapeutic group: Systemic hormonal preparations; Posterior pituitary lobe hormones; Oxytocin.

ATCvet code: QH01BB02

Pharmacodynamic properties

Oxytocin is a hormone of the posterior lobe of the hypophysis. It influences the rhythmic contraction of the oxytocin sensitive smooth muscle apparatus. Of special significance is the increase of strength and frequency of the uterine contractions at the beginning of labour.

In the lactating cow the myoepithelial cells, which cover the alveoli of the mammary glands, are contracted by the influence of oxytocin and the milk is passed into the milkducts.

The veterinary medicinal product is a sterile, aqueous, protein-free injectable solution of synthetic oxytocin which corresponds chemically as well as pharmacologically with naturally occurring oxytocin.

Pharmacokinetic particulars

Following injection, oxytocin has a rapid onset of activity as physiological effects are usually detected within minutes following administration. Oxytocin is cleared very fast, as its mean half-life of distribution is about 2 minutes while its half-life of elimination is around 12 minutes.

Pharmaceutical particulars

List of excipients

Chlorobutanol Hemihydrate

Acetic Acid, Glacial

Ethanol 96 %

Water for Injections

Major Incompatibilities

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

Shelf life

Shelf-life of the veterinary medicinal product as packaged for sale: 18 months

Shelf-life after first opening the immediate packaging: 7 days

Special precautions for storage

Keep the container in the outer carton in order to protect from light.

Store in a refrigerator (2°C – 8°C).

Once opened do not store above 25°C.

Special precautions for the disposal of unused veterinary medicinal product 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.

Marketing Authorisation Holder (if different from distributor)

Bela-Pharm GmbH & Co. KG

Lohner Straße 19

D - 49377 Vechta Germany

Marketing Authorisation Number

Vm 41816/4000

Significant changes

Date of the first authorisation or date of renewal

06 August 2014

Date of revision of the text

January 2019

Any other information

Legal category

Legal category:POM-V

GTIN

GTIN description:Oxytobel 10 IU/ ml solution for injection for Horses, Cattle, Pigs, Sheep, Goats, Dogs and Cats

GTIN:5391510234845

Delivery

Shipping charges mainland UK zone1

ValueWeightDelivery Charge
Over £49.00Any WeightFREE
Under £49.00No weight limit£4.50
Under £49.00Under 250g£2.99

Most orders are despatched the same day and standard delivery is 3 to 5 working days from despatch. FAST Expedited options are available.

NB: Orders placed with faster delivery must be placed before 13:00 to ensure same day dispatch (excluding weekends and bank holidays). Please also check on the product page that the items ordered show 'In Stock' otherwise your order will be delayed until the stock becomes available, which in most cases will only be 24hrs.

Estimated "Usually shipped in" information is shown against most products

Overseas orders

Postage outside of the UK is from £4.50

Prescription Items

Prescription items will be sent on receipt of a valid signed and dated prescription.

Pick up

We offer a pickup service for orders placed over the phone.

Please ring us on 01833 641112 for more information.

Refrigerated Items

Refrigerated items will be sent by carrier or Royal Mail with coolpacks unless you pay for a premium for a refrigerated delivery. We will contact you prior to despatch for your instructions.

Returns

We want you to be completely satisfied with any purchase. If not any item* can be returned to us within 14 days of receipt for exchange or refund Please give us a ring for a returns number on 01833 641112 or alternatively email [email protected] to obtain a returns number.

*Due to legal requirements medicines may not be returned except to correct an error in despatch or in response to an "official recall". If an item is believed to be faulty it should be returned for inspection and it may be necessary to forward it to the manufacturers for testing before replacements or refunds can be authorised. This does not infringe legal rights. Please contact our customer services for a "Returns Number" which must appear on the outside of the package or it will not be accepted. We advise customers to use an insured method of shipping and to retain proof of despatch. We may refuse returns on products specially obtained or manufactured to order. Items must be returned unsoiled and unused and sent adequately packed and carriage paid.

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