VETIVEX 11- sodium lactate, sodium chloride, potassium chloride, and calcium chloride injection, solution

VETIVEX 11 by

Drug Labeling and Warnings

VETIVEX 11 by is a Animal medication manufactured, distributed, or labeled by Dechra Veterinary Products, Dechra Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Solution for infusion for cattle, horses, dogs and cats

PACKAGE LEAFLET FOR:

Marketing authorisation holder:

Dechra Limited, Dechra House, Jamage Industrial Estate, Talke Pits, Stoke-on-Trent, Staffordshire, ST7 1XW, United Kingdom

Manufacturer responsible for batch release:

Terumo BCT Limited, Old Belfast Road, Millbrook, Larne, Co. Antrim, BT40 2SH, Northern Ireland

Name of the veterinary medicinal product:

Vetivex 11 solution for infusion for cattle, horses, dogs and cats

Statement of the active substances and other ingredients:

1 ml contains:

Active substances:
Sodium lactate	3.17 mg
Sodium chloride	6.00 mg
Potassium chloride	0.40 mg
Calcium chloride dihydrate	0.27 mg

Sodium: 131 mmol/litre, Potassium: 5 mmol/litre, Calcium: 2 mmol/litre, Bicarbonate (as lactate): 29 mmol/litre, Chloride: 111 mmol/litre. Solution for infusion. Clear, colourless solution.

Indications:

For the treatment of dehydration and metabolic acidosis in cattle, horses, dogs and cats.

May be used to correct volume depletion (hypovolaemia) resulting from gastrointestinal disease or shock.

Contraindications:

Lactate-containing solutions will not be utilised effectively in animals with hepatic impairment and it is undesirable to use this product in animals with metabolic alkalosis.

Adverse reactions:

Excessive infusion rates can cause restlessness, moist lung sounds, tachycardia, tachypnoea, nasal discharge, coughing, vomiting and diarrhoea. If you notice any serious effects or other effects not mentioned in this package leaflet, please inform your veterinary surgeon.

Target species:

Cattle, horses, dogs and cats.

Dosage for each species, route and method of administration:

Intravenous use.

The volume and rate of infusion will depend upon the clinical condition, existing deficits of the animal, maintenance needs and continuing losses. Generally aim to correct hypovolaemia by 50% initially (ideally over 6 hours but faster if necessary) and reassess by clinical examination.

Deficits are generally in the range of 50 ml/kg (mild) to 150 ml/kg (severe). An infusion rate of 15 ml/kg/hour is recommended in the absence of shock (range 5-75 ml/kg/hour).

In shock, high initial infusion rates, up to 90 ml/kg/hour, are needed. High infusion rates should not be continued for longer than 1 hour unless renal function and urine output are restored. The maximum infusion rate should be decreased in the presence of cardiac, renal and pulmonary disease.

Advice on correct administration:

Directions for use:

Remove the pack from the protective overwrap by tearing downwards from the serrated edge. Remove the port plug protecting the sterile giving port.

Insert the administration set fully to produce a leak-proof connection and suspend the bag from an infusion stand. An air inlet is not required.

Prime and regulate the administration set in accordance with the manufacturer's instructions. If the administration set becomes blocked, do not pump solution back into the pack, replace equipment.

Use of the Combi port (5000 ml Combi):

The Combi port permits two bags to be connected in sequence so volumes greater than 5 litres may be administered during a single infusion. Each Combi port is protected by a snap off cover. This should be removed from each of two Combi bags. One spike from each end of a double spike connector unit should be pushed firmly through the Combi port rubber septum of each of the bags. Suspend the bags (one higher than the other) from an infusion stand. To insert the administration set into the giving port of the lower bag, continue through section 'Directions for use' above.

Withdrawal period:

Cattle and horses: Meat and offal/milk – zero days/hours.

Special storage precautions:

Keep out of the sight and reach of children.

Do not store above 25°C.

Do not freeze.

Special warnings:

Special precautions for use in animals:

Do not use unless the solution is clear, free from visible particles, and the container is undamaged. A risk of thrombosis with intravenous infusion should be considered.

Maintain aseptic precautions.

The product should be warmed to approximately 37°C prior to administration in order to avoid hypothermia.

This product should be used with caution in animals with cardiac or renal impairment as sodium overload may occur.

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

None.

Use during pregnancy or lactation:

Use under veterinary supervision.

Interaction with other medicinal products and other forms of interaction:

This product in incompatible with methylprednisolone, and sodium lactate or sodium bicarbonate intravenous infusions. It is generally recommended that no agents should be added.

Overdose (symptoms, emergency procedures, antidotes):

Monitor fluid output.

Incompatibilities:

This product is incompatible with methylprednisolone, and sodium lactate or sodium bicarbonate intravenous infusions.

Special precautions for the disposal of unused product or waste materials:

Any unused veterinary medicinal product or waste materials derived from such veterinary medicinal products should be disposed of in accordance with local requirements.

Date on which the package leaflet was last approved:

24-04-2013

Other information:

UK: Vm 10434/4080 Prescription Only Medicine - Veterinarian

IE: VPA 10799/025/001 Prescription Only Medicine

For animal treatment only. To be supplied only on veterinary prescription. Polyvinylchloride infusion bag overwrapped with polypropylene.

Pack sizes: 250 ml, 500 ml, 1000 ml, 3000 ml, 5000 ml and 5000 ml Combi. Not all pack sizes may be marketed.

For any information about this veterinary medicinal product, please contact the local representative of the marketing authorisation holder.

SPL UNCLASSIFIED SECTION

Dechra Veterinary Products Limited, Sansaw Business Park, Hadnall, Shrewsbury, Shropshire, SY4 4AS, United Kingdom

LEAF/V11/7

PRINCIPAL DISPLAY PANEL - 5000 mL Container Label

5000 ml
Code V11E

VETIVEX™ 11
Solution for infusion for
cattle, horses, dogs
and cats

1 ml contains:
Active substances:
Sodium lactate 3.17 mg
Sodium chloride 6.00 mg
Potassium chloride 0.40 mg
Calcium chloride dihydrate 0.27 mg

Read the package leaflet before use.
For animal treatment only. To be supplied
only on veterinary prescription.
Keep out of the sight and reach
of children.

UK: Vm 10434/4080 POM-V

IE: VPA 10799/025/001 POM

V11E/3

Dechra

Lot:
EXP:

INGREDIENTS AND APPEARANCE

VETIVEX 11 
sodium lactate, sodium chloride, potassium chloride, and calcium chloride injection, solution

Product Information
Product Type	PRESCRIPTION ANIMAL DRUG	Item Code (Source)	NDC: 17033-480
Route of Administration	INTRAVENOUS

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
sodium lactate (UNII: TU7HW0W0QT) (lactic acid - UNII:33X04XA5AT, sodium cation - UNII:LYR4M0NH37)	sodium lactate	3.17 mg  in 1 mL
sodium chloride (UNII: 451W47IQ8X) (sodium cation - UNII:LYR4M0NH37, chloride ion - UNII:Q32ZN48698)	sodium chloride	6 mg  in 1 mL
potassium chloride (UNII: 660YQ98I10) (potassium cation - UNII:295O53K152, chloride ion - UNII:Q32ZN48698)	potassium chloride	0.4 mg  in 1 mL
calcium chloride (UNII: M4I0D6VV5M) (calcium cation - UNII:2M83C4R6ZB, chloride ion - UNII:Q32ZN48698)	calcium chloride	0.27 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17033-480-01	1000 mL in 1 CONTAINER
2	NDC: 17033-480-05	5000 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		03/20/2015

Labeler - Dechra Veterinary Products (362142734)

Registrant - Dechra Ltd (641097493)