Description
Solution for injection, supplementing calcium and magnesium deficiencies for horses, cattle and swine
Active substance and excipient content 1 ml contains:
Active substances:
Magnesium gluconate 60 mg/ml
Calcium gluconate 60 mg/ml
Magnesium chloride hexahydrate 30 mg/ml
Calcium chloride hexahydrate 27 mg/ml
Excipient:
Phenol 2.6 mg
Therapeutic indications
Horses: laminitis, urticaria.
Cattle: post-calving paralysis in cows, calcium and magnesium disorders such as Downer cow syndrome, hypocalcaemias and subclinical hypomagnesaemias, acute hypomagnesaemic tetanies.
Swine: post-farrowing hypocalcaemia in sows, rickets.
Posology per each species, route and method of administration
Route of administration: intravenously.
horses, cattle – 0.5 – 1.0 ml / kg b.w.
swine – 2.0 – 5.0 ml / kg b.w.
Recommendations for proper administration
Inject slowly 25 – 50 ml/min.
Contraindications
Do not use in hyperparathyroidism and heavy renal insufficiency.
Do not use in hypermagnesaemia by impaired cardiac conductivity.
Do not use in the case of previous treatment with cardiac glycosides.
Adverse reactions
Unusually, in the case of high doses and in animals with bad general condition, it may cause hypercalcaemia in intravenous infusions. Bradycardia occurs at first, then the strength of the contraction is bigger and the heart rate increases with AV nodal reentrant tachycardia and extra systoles. Acute myocardial hypoxaemia occurs, then muscle tremor, anxiety, sweating and decreased arterial blood pressure leading to a collapse.
Any adverse reactions emerged after administration of the product or any observed symptoms not listed in the leaflet (including symptoms reported in humans following exposure to the product) should be reported to the competent veterinarian, Marketing Authorization Holder or the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products. The report form should be downloaded from https://www.urpl.gov.pl (Department of Veterinary Medicinal Products).
Withdrawal period
Horses, cattle, swine:
Edible tissues – zero days
Cattle:
Milk – zero hours.
Special precautions for storage
Keep out of the sight and reach of children.
Store at a temperature below +25°C. Protect from light. Do not freeze.
Do not use this veterinary medicinal product after the expiry date given on the label.
Durability after the first opening of the direct package – 28 days.
Special warnings
Special warnings per each target species:
In the case of high doses in intravenous infusions particularly in animals with bad general condition it may cause hypercalcaemia.
Special precautions for use in animals:
In order to avoid administration of too high dose, the bodyweight of an animal has to be determined with the highest possible accuracy. In order to identify the symptoms of over-dosage at a proper time, the heartbeat should be monitored during the infusion.
The preparation needs to be heated to the body temperature and injected slowly in the amount of 25-50 ml/min.
Special precautions to be taken by the persons administering the veterinary medicinal product to animals:
In the case of accidental self-injection, immediately seek medical advice and show the package leaflet or the label to the physician.
Pregnancy: No contraindications.
Lactation: No contraindications.
Interactions with other medicinal products and other forms of interaction:
Cardiac glycosides intensify the cardiotoxic effect of calcium ions. Beta-adrenomimetics and methylxanthines intensify the effect of calcium ions on the heart. Simultaneous oral administration of tetracyclines increases binding of calcium ions with proteins. Calcium salts administered orally reduce absorption of tetracyclines and fluorine compounds (a three-hour interval is necessary between administration of these drugs and calcium compounds). Vitamin D, parathormone and acidic pH of food increase absorption of calcium whereas calcitonin, glycocorticosteroids, excessive amounts of lipids, alkaline reaction of food, phytates (e.g. in cereals), oxalates (e.g. in spinach, rhubarb) and phosphates (milk and dairy products) reduce absorption of calcium. High doses of calcium administered in combination with cardiac glycosides (strophanthin derivatives and digoxins) intensify their effect and may lead to cardiac arrhythmias. Thiazide diuretics increase resorption of calcium and pose a risk of hypercalcaemia. High doses of calcium in combination with vitamin D may weaken the effect of verapamil and other calcium channel blockers. Overdose (symptoms, procedures concerning immediate help and antidotes):
Overdose leads to hypercalcemia and hypermagnesemia, as well as to increased urinary calcium and magnesium excretion. Symptoms of hypercalcaemia and/or hypermagnesaemia may include: nausea, vomiting, increased thirst, polyuria, dehydration and constipation. Long-lasting overdose leading to hypercalcaemia and/or hypermagnesaemia can cause vascular and organ calcification. Calcium supplementation in excess of 2000 mg/day, taken for several months constitutes a threshold and may be a cause of poisonings.
Abnormal heart rate is a sign of overdose. In that case, abandon administration of the product.
In the case of over-dosage one must immediately stop the treatment and supplement the fluid deficiency. In the case of long-term over-dosage oral and intravenous rehydration with NaCl solutions should be applied. At the same time (or also after rehydration) loop diuretics (e.g. furosemide) are applied in order to increase calcium excretion and prevent the increase in the fluid volume.
Thiazide diuretics should not be administered.
Pharmaceutical incompatibilities:
Since no studies of the conformity of this veterinary medicinal product have been conducted, this product must not be combined with other medicinal veterinary products.
Special precautions for the disposal of unused veterinary medicinal product or waste materials derived from the use of such products
Medicines should not be disposed of via wastewater or household waste.
Ask your veterinary surgeon how to dispose of medicines no longer required. These measures should help to protect the environment.
For animal treatment only.
Subject to medical prescription – prescription drug.
Shelf life 2 years
Available containers 250 ml
Marketing Authorization : 790/99
2016-04-20 SPC
31.08.2017 r.
