Calmino Vet 380 mg/ml + 60 mg/ml + 50 mg/ml Solution for Infusion for Cattle, Sheep and Pigs
Boric Acid, Calcium Gluconate Monohydrate, Magnesium Chloride Hexahydrate
Last verified
Veterinary medicinal product: solution for infusion. Distribution category: POM-V (Veterinary Medicines Regulations 2013, Schedule 3). Active substance: Boric Acid, Calcium Gluconate Monohydrate, Magnesium Chloride Hexahydrate.1
In short: questions and answers
- Does Calmino Vet 380 mg/ml + 60 mg/ml + 50 mg/ml Solution for Infusion for Cattle, Sheep and Pigs need a prescription?
- Prescription only. As stated in the registration decision.1
- Which animals is Calmino Vet 380 mg/ml + 60 mg/ml + 50 mg/ml Solution for Infusion for Cattle, Sheep and Pigs for?
- Cattle, Pigs, Sheep.1
- What is the active substance in Calmino Vet 380 mg/ml + 60 mg/ml + 50 mg/ml Solution for Infusion for Cattle, Sheep and Pigs?
- Boric Acid, Calcium Gluconate Monohydrate, Magnesium Chloride Hexahydrate. ATCvet code: QA12AX.13
- What is the withdrawal period of Calmino Vet 380 mg/ml + 60 mg/ml + 50 mg/ml Solution for Infusion for Cattle, Sheep and Pigs according to the leaflet?
- Cattle, meat: 0 days; Pigs, meat: 0 days; Sheep, meat: 0 days; Cattle, milk: 0 days; Sheep, milk: 0 days.3
- Dispensing
- Prescription only1
POM-V: Prescription Only Medicine - Veterinarian. Supplied only on a prescription written by a veterinary surgeon who has assessed the animal.12
Supplied only on a veterinarian's prescription. As stated in the registration decision.
- Active substance
- Boric Acid, Calcium Gluconate Monohydrate, Magnesium Chloride Hexahydrate
- ATCvet code
- QA12AX3
- Manufacturer
- Marketing authorisation holder: Interchemie Werken De Adelaar Eesti AS
Withdrawal period
Summary of product characteristics
Composition
Each ml contains:
Active substances:
Calcium gluconate for injection 380 mg (equivalent to 34.0 mg or 0.85 mmol of Ca2+)
Magnesium chloride hexahydrate 60 mg (equivalent to 7.2 mg or 0.30 mmol of Mg2+)
Boric acid 50 mg
Excipients:
| Qualitative composition of excipients and other constituents |
|---|
| Water for injections |
Clear, colourless to yellowish brown solution.
pH of the solution 3.0 – 4.0
Osmolality 2040 – 2260 mOsm/kg
Pharmacological properties
4.1 ATCvet code:
QA12AX Pharmacotherapeutic group: Calcium, combinations with vitamin D and/or other drugs
4.2 Pharmacodynamics
The product brings calcium and magnesium to the animal. The parenteral administration increases rapidly the plasmatic concentration of these ions for the treatment of hypocalcemia.
Calcium
Calcium is an essential mineral in the body. Only free ionized calcium in the blood is biologically active and regulates calcium metabolism. Free calcium participates in many functions in the body, e.g. release of hormones and neurotransmitters, impulse transmission, blood coagulation and formation of action potentials in sensitive membranes as well as muscle contraction.
Magnesium
Magnesium, also an essential mineral, is a co-factor in a number of enzymatic processes and transmission mechanisms being important in the formation of impulses and their transmission in nerve and muscle cells. During neuromuscular transmission of motor end plates impulses of magnesium decreases the release of acetylcholine. Magnesium ion can influence the release of transmitters in central nervous system and in vegetative ganglia. Magnesium causes delay of impulse transmission in heart muscle. Magnesium also stimulates the secretion of parathyroid hormone and therefore regulates serum calcium levels.
This veterinary medicinal product contains calcium in an organic compound (as calcium gluconate) and magnesium in form of magnesium chloride as active substances. By the addition of boric acid, calcium borogluconate is formed, which increases its solubility and tissue tolerability.
4.3 Pharmacokinetics
After parenteral administration, calcium and magnesium are rapidly distributed. The rate of protein binding are around 50% for calcium and 30 to 50 % for magnesium. Calcium is mainly excreted via feces and magnesium via kidney.
Target species
Cattle, sheep, pigs.
Indications
Treatment of acute hypocalcaemia complicated by deficiency of magnesium.
Dosage
For slow intravenous (iv) infusion, recommended over a period of 20 – 30 minutes. The smaller volumes (less than 50 ml) should be administered by a sterile syringe or syringe infusion pump.
Cattle
Administer 14 – 20 mg Ca2+ (0.34 – 0.51 mmol Ca2+) and 2.9 – 4.3 mg Mg2+ (0.12 – 0.18 mmol Mg2+) per one kg bodyweight corresponding to 0.4 – 0.6 ml of product per 1 kg bodyweight.
Sheep, calf, pig
Administer 10 – 14 mg Ca2+ (0.26 – 0.34 mmol Ca2+) and 2.2 – 2.9 mg Mg2+ (0.09 – 0.12 mmol Mg2+) per one kg bodyweight corresponding to 0.3 – 0.4 ml of product per 1 kg bodyweight.
The specified dosages are standard. The dose should always be adapted to the existing deficit and condition of the circulatory system.
The second treatment may be administered not earlier than 12 hours after the first administration. The administration can be repeated twice at 24-hour intervals, if the hypocalcaemic condition is persisting.
Contraindications
Do not use in cases of hypercalcaemia and hypermagnesemia.
Do not use in cases of calcinosis in cattle and sheep.
Do not use following administration of high doses of vitamin D3.
Do not use in cases of chronic kidney insufficiency or in cases of circulatory or cardiac disorders.
Do not use in cattle suffering septicaemic processes in the course of acute mastitis in cattle.
Do not administer inorganic phosphate solutions simultaneously or shortly after the infusion.
Adverse reactions
Cattle, sheep, pigs
Undetermined frequency (cannot be estimated from the available data): Hypercalcaemia1, Bradycardia2tachycardia3, Agitation, Muscle tremor, Hypersalivation, Tachypnoea, General illness4
1 Transient.
2 Initially.
3 Increase in heart rate following initial bradycardia may indicate overdose. In this case, stop the infusion immediately.
4 Delayed undesirable effects may appear in form of disturbances of the general state of health and symptoms of hypercalcaemia up to 6 – 10 hours after administration and must not be diagnosed as recurring hypocalcaemia.
Reporting adverse events is important. It allows continuous safety monitoring of a veterinary medicinal product. Reports should be sent, preferably via a veterinarian, to either the marketing authorisation holder or the national competent authority via the national reporting system. See package leaflet for respective contact details.
Warnings
Special precautions for use in the target species:
The medicinal product must be administered only slowly intravenously.
The solution should be warmed to body temperature before administration.
During the infusion, the heart rate, rhythm and circulation must be monitored. In case of symptoms of overdosing (cardiac arrhythmia, fall in blood pressure, agitation), the infusion should be stopped immediately.
Special precautions to be taken by the person administering the veterinary medicinal product to animals
This veterinary medicinal product contains boric acid, and should not be administered by pregnant women, users of childbearing age, and users trying to conceive. In case of accidental self-injection, seek medical advice immediately and show the package leaflet or the label to the physician.
This veterinary medicinal product can cause slight skin and eye-irritation due to the low pH of the product formulation.
Avoid contact with skin and eyes.
Wear protective gloves and glasses.
When the veterinary medicinal product comes into contact with the skin or eyes, rinse immediately with water.
Special precautions for the protection of the environment:
Not applicable.
3.11 Special restrictions for use and special conditions for use, including restrictions on the use of antimicrobial and antiparasitic veterinary medicinal products in order to limit the risk of development of resistance
Not applicable.
Use during pregnancy, lactation or lay
The safety of the product has not been established during pregnancy and lactation. Use only according to the benefit/risk assessment by the responsible veterinarian.
Interactions
Calcium increases the effects of heart glycosides.
Calcium amplifies the cardiac effects of β-adrenergic medicinal products and methylxanthines.
Glucocorticoids increase the renal excretion of calcium by way of vitamin D-antagonism.
Overdose
When the intravenous administration is performed too rapidly, hypercalcaemia and/or hypermagnesemia with cardiotoxic symptoms such as initial bradycardia with subsequent tachycardia, cardiac arrhythmia and in severe cases ventricular fibrillation with cardiac arrest may occur.
Additional symptoms of hypercalcaemia are: motor weakness, muscle tremors, increased excitability, agitation, sweating, polyuria, fall in blood pressure, depression and coma.
Symptoms of hypercalcaemia may persist 6 – 10 hours after the infusion and must not be incorrectly diagnosed as symptoms of hypocalcaemia.
Special warnings
In case of acute hypomagnesaemia, the administration of a solution with a higher concentration of magnesium may be necessary.
Withdrawal period
Cattle, pigs, sheep:
Meat and offal: zero days.
Cattle, sheep:
Milk: zero hours.
Incompatibilities
In the absence of compatibility studies, this veterinary medicinal product must not be mixed with other veterinary medicinal products.
Immediate packaging
Graduated polypropylene bottle, closed with a bromobutyl rubber stopper and secured with an aluminium cap or flip-off cap with polypropylene cover.
Package size: 500 ml.
Multipack size: 12 x 500 ml in a cardboard box.
Not all pack sizes may be marketed.
Storage
This veterinary medicinal product does not require any special storage conditions.
Shelf life
Shelf life of the veterinary medicinal product as packaged for sale: 3 years. Shelf life after first opening the immediate packaging: use immediately.
Disposal of unused product
5.5 Special precautions for the disposal of unused veterinary medicinal products or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Use take-back schemes for the disposal of any unused veterinary medicinal product or waste materials derived thereof in accordance with local requirements and with any national collection systems applicable to the veterinary medicinal product concerned.
Additional information
Vm 51467/4000
8 DATE OF FIRST AUTHORISATION
18 November 2019
9 DATE OF LAST REVISION OF THE SUMMARY OF THE PRODUCT CHARACTERISTIC
December 2025
10 CLASSIFICATION OF VETERINARY MEDICINAL PRODUCTS
Veterinary medicinal product subject to prescription.
Find more product information by searching for the ‘Product Information Database’ on www.gov.uk.
Approved: 31 March 2026
Registration holder
Interchemie Werken De Adelaar Eesti AS
Regulations
- Veterinary Medicines Regulations 2013 (SI 2013/2033), Schedule 32
Sources
- VMD Product Information Database: Calmino Vet 380 mg/ml + 60 mg/ml + 50 mg/ml Solution for Infusion for Cattle, Sheep and Pigs, 51467/4000
- The Veterinary Medicines Regulations 2013, Schedule 3 (categories of veterinary medicinal products)
- Summary of Product Characteristics: Calmino Vet 380 mg/ml + 60 mg/ml + 50 mg/ml Solution for Infusion for Cattle, Sheep and Pigs