Calcium preparation with phosphorus, magnesium and glucose, for injections for cattle, horses, swine and dogs
Active substance and excipient content
1 ml contains:
Calcium gluconate 60 mg
Calcium hypophosphite 22 mg
Magnesium chloride hexahydrate 30 mg
Glucose monohydrate 100 mg
Phenol 2.6 mg
Solution for injections indicated for use in horses, cattle, swine and dogs during calcium and magnesium deficiency. The product is used for treating clinical and subclinical hypocalcemia, hypomagnesemia and hypoglycemia, e.g. parturient paresis in cows, eclampsia in lactating dogs, postparturient hypocalcemia in sows.
Calmagluc is also applied while treating various allergies (urticaria in particular), as well as sub-acute and chronic calcium and magnesium disorders, such as Downer cow syndrome, and primarily subclinical hypomagnesemias. The product has been used for treatment of diseases emerging as a result of calcium and phosphate metabolic disturbances, such as rickets, osteomalacia and osteodystrophy. Further, it is administered while treating diseases with accompanying enhanced neuromuscular excitability, such as hypomagnesemic tetany in cattle, tetanus, tying-up in horses, as well as inflammations and poisonings with signs of increased vessel permeability, e.g. cerebral and pulmonary oedema, oedema disease in piglets, laminitis in horses (as an adjuvant).
Hyperparathyroidism and renal failure.
Hypermagnesemia, Myastenia gravis in dogs, slow conduction in cardiac muscle. Previous use of cardiac glycosides, beta adrenomimetic drugs and caffeine.
Calcium gluconate, magnesium chloride, calcium hypophosphite and glucose have a wide margin of safety, and any toxic effect results from administration of doses in excess of multiple therapeutic doses. In exceptional cases, after administering high doses of the product in animals with poor general health, hypercalcemia may occur during intravenous injections. Bradycardia develops; strength of single contraction increases, just as the contraction frequency with AV nodal reentrant tachycardia and additional contractions. Acute myocardial hypoxia occurs, followed by muscle tremor, anxiety, sweating, decreased blood pressure, leading to collapse. In order to promptly recognize overdose signs, heart rate should be monitored during infusion.
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 http://www.urpl.gov.pl (Department of Veterinary Medicinal Products).
Posology per each species, routes and methods of administration
To be administered intravenously or intramuscularly. In horses and dogs, only intravenous administration is allowed.
Depending on disease type, administer the product in cattle, horses, pigs and dogs as follows:
- Chronic and sub-acute, both primary and secondary metabolism of macro elements, as well as morphology disorders resulting from calcium and phosphate metabolic disturbances, such as rickets, osteomalacia and osteodystrophy – administer doses of 5 ml/kg b.w. intravenously or intramuscularly, once a day for 3-7 days. Extend treatment by using compound feeds with minerals.
- Acute disturbances with advanced hypocalcemia and hypomagnesemia, such as parturient paresis and hypomagnesemic tetany – administer doses of 0-1.5 ml/kg b.w. intravenously or intramuscularly, single administration, double administration, and in special cases triple administration, in 12-hour intervals.
- Diseases not directly related to calcium and phosphate metabolic disturbances and as an adjuvant in inflammations, allergies and poisonings (urticaria, laminitis, edemas, enhanced neuromuscular excitability) – administer doses of 3-0.5 ml/kg b.w., every second day for 6-14 days.
Recommendations for proper administration
When administered intravenously, heat to body temperature and inject slowly (25-50 ml/min for large animals, 15-30 ml/min for small animals). For example: 500 ml of the product in large animals should be administered for no less than 5-10 minutes.
Horses, cattle, pigs:
Edible tissues – zero days.
Milk – zero hours.
Dogs: not applicable.
Special precautions for storage
Keep out of the sight and reach of children.
Store below 25°C. Protect from light. Do not freeze.
The durability period after the first opening of the immediate container: 28 days.
Do not use this veterinary medicinal product after the expiry date stated on the label.
Special warnings for each target species:
Use caution with animals with poor general health in which excessive drug doses may cause myocardial hypoxia and decreased blood pressure leading to collapse.
Special precautions for use in animals:
When administered intravenously, heat to body temperature and inject slowly (25-50 ml/min for large animals, 15-30 ml/min for small animals).
For example: 500 ml of the product in large animals should be administered for no less than 5-10 minutes.
In order to avoid overdose, determine animal body weight as precisely as possible.
In order to ensure timely recognition of overdose signs, monitor heart rate during the infusion.
Special precautions to be taken by the person administering the veterinary medicinal product to animals:
Do not eat, drink or smoke while handling the veterinary medicinal product.
Use caution to avoid self-injection.
In case of accidental self-injection, seek medical advice immediately and show the package insert to the physician.
Wash hands after use.
Can be used during pregnancy.
Can be used during lactation.
Interaction with other medicinal products and other forms of interaction:
Cardiac glycosides intensify cardiotoxicity of calcium ions.
Beta-adrenomimetic drugs and methylxanthines intensify cardiac effect of calcium ions.
Simultaneous oral administration of tetracycline antibiotics enhances binding of calcium ions to proteins.
It is not recommended to mix Calmagluc with thiazide diuretics, glucocorticoids, bile acid sequestrants, oxalic acid and phytic acid, laxatives, e.g. paraffin oil.
Due to magnesium ion content, Calmagluc may display antagonistic activity to other calcium preparations. Magnesium decreases gastrointestinal absorption of theophylline, tetracycline antibiotics, iron preparations, fluorine compounds, oral anticoagulants and warfarin derivatives.
Diuretics, cisplatin, cycloserine, mineralocorticoids increase urinary magnesium excretion. Aminoglycosides, muscle relaxants and colistin used simultaneously with magnesium preparations may cause muscle paralysis. As a result of urine alkalinization, renal excretion of quinidine is decreased, thus posing the risk of overdose.
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 hypercalcemia and hypermagnesemia may include: nausea, vomiting, excessive thirst, polyuria, dehydration and constipation. Long-lasting overdose leading to hypercalcemia and/or hypermagnesemia can cause vascular and organ calcification 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.
Abnormal heart rate is a sign of overdose. In that case, abandon administration of the product.
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.
To be administered under veterinary supervision.
Available containers: 250 ml
For more information about this veterinary medicinal product, contact the Marketing Authorization Holder.
Biowet Puławy Sp z o. o.
Arciucha 2, 24-100 Puławy
Tel./fax: (81) 886 33 53, Tel: (81) 888 91 00
2015-08-05 Office for Registration of Medicinal Products decision