Anupco


JECTOCAL 300

Solution for injection

COMPOSITION

Calcium Gluconate 279.24 mg – Boric acid 77.05 mg – Magnesium Chloride 40.0 mg – Caffeine anhydric 0.073 mg – Ephedrine hydrochloride 0.21 mg – Excipients up to 1 ml.

PHARMACOLOGICAL PROPERTIES

JECTOCAL 300 is a solution that can be used as a source of quickly available calcium- and magnesium ions.

Calcium has, among other things, essential functions in the formation of bones and teeth, the muscle contraction and heart funtion, neuromuscular excitability and transmission of nerve impulses, maintenance of cell membrane permeability and regulation of the acid-base balance, and in the clotting mechanisms of blood and milk. The normal calcium level in the blood of most animal species varies between 9-11 mg/ 100 ml (▒ 5 mEq/L). Approximately half of the calcium in the blood is present under active, ionised form. The other part is bound to proteins (▒ 40%), and a minor part is bound to other molecules. Calcium-ions occur mainly extra-cellularly.

Magnesium is an essential cofactor for many enzymes, particularly those involved in high-energy phosphate transfer and protein and DNA synthesis. It plays an important role in neurochemical transmission and muscular excitability, as well as in the central nervous and cardiovascular systems. It also plays part in the calcium metabolism, namely in the release and action of the parathyroid hormone, the metabolism of vitamin D in the liver and the exchange of calcium at the bone surface. It has a calcium inhibiting action in antagonizing the inflow of calcium in the cells and in this way avoiding an over-stimulation by ionised calcium. The normal magnesium level in blood varies between 2-2.9 mg/ 100 ml (0.75 -1.1 mmol/liter). Magnesium is an ionáthat occurs mainly intracellularly.

Calciumgluconate and boric acid form calciumborogluconate. After the intravenous infusion of calciumborogluconate and magnesiumchloride and immediate rise of the calcium and magnesium levels is obtained. The highest values are being observed at the end of the infusion period and these concentrations are usually much higher than the normal values. The degree of hypocalcaemia that is obtained (and eventually the co-related side effects) does not only depend on the dose, but also on the rate of administration and the initialácalcium level before treatment. Termination of the infusion is followed by a quick decrease within 3-24 hours to approximately the original pre-treatment blood levels. After administration the calcium is rapidly and mainly distributed in the extracellular fluid (distribution volume: 0.2 L/kg), while magnesium is mainly distributed intracellularly. Both ions are mainly excreted by the kidneys (glomerular filtration, tubular re-absorption), but also with faeces and milk.

INDICATIONS

Acute hypocalcaemia in cows and ewes (puerperal paresis, milk fever).

Acute hypocalcaemia in cattle (grass tetany).

CONTRA-INDICATIONS

Absolute contra-indication: cardio-vascular disorders

Relative contra-indications: hyperparathyroidia, renal insufficiency, acidosis, intoxication with heartglycosides.

DOSAGE AND MODE OF ADMINISTRATION

BY SLOW INTRAVENOUS ADMINISTRATION.

Adult cattle (500-600 kg): 500mlá(eq. 12.5 g calcium + 2.4 g magnesium)áor the whole bottle

Sheep: 1 ml/ kg b.w.

This product is not suitable for subcutaneous administration.

UNDESIRABLE EFFECTS

Following treatment and because of the temporary hypercalcaemia, observed side effects mostly involve theácardio-vascular system. An initial bradycardia evolving to a slight tachycardia and a strong pulse rate can be observed in the majority of animals during standard therapy. In some cases however, these symptoms may progress to a pronounced tachycardia, an irregular pulse (extrasystoles), and even death by heart failure (ventricular fibrillation, heart block).

Occurrence of severe side effects increases in case of too fast intravenous administration. Other toxic symptoms that may be seen during but also after infusion are: muscle tremor, increased salivation, lacrimation, grinding of teeth, frequent urination and defaecation, and central nervous disturbances varying from depression (anorexia, weakness, prostration) to agitation and terminal excitability.

SPECIAL PRECAUTIONS FOR USE AND WARNINGS

This product should be administered only by the intravenous route. If possible, the solution should be warmed up near to body temperature.áNecessary precautions should be taken in order to infuse as aseptically as possible. It is advised to perform a regular check to ensure absence of air within the infusion apparatus. The solution should be administered by slow intravenous injection, i.e. an infusion time of at least 5 minutes should be respected. It is advised to regularly control the heart function during the intravenous administration. In case of relapse after therapy, an interval of at least 6 hours should be respected between the first and the second treatment.

PACK SIZE

Vials with 500 ml solution.

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