Land: Storbritannien
Språk: engelska
Källa: MHRA (Medicines & Healthcare Products Regulatory Agency)
Calcium gluconate
hameln pharma Ltd
B05BB01
Calcium gluconate
100mg/1ml
Solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 09050101; GTIN: 5016386000386 5016386055508
PATIENT INFORMATION LEAFLET CALCIUM GLUCONATE INJECTION 10% 1. What Calcium Gluconate Injection 10% is and what it is used for Calcium is found naturally in the body and is necessary for the normal function of muscles and nerves. It is needed to make the heart work properly and for blood to clot. Calcium Gluconate Injection 10% is used: • to replace LOW levels of calcium in the BODY • in the treatment of HEART ATTACKS • in NEONATAL TETANY (a condition affecting the muscles of newly born babies and young infants) • in the treatment of lead and fluoride POISONING • to prevent low calcium levels from blood TRANSFUSIONS 2. What you need to know before you use Calcium Gluconate Injection 10% DO NOT USE CALCIUM GLUCONATE INJECTION 10%: • if you are ALLERGIC to Calcium Gluconate Injection 10% or any of the other ingredients in this injection (listed in section 6) • if you have HIGH LEVELS of CALCIUM in your URINE • if you have HIGH LEVELS of CALCIUM in your BLOOD (for example as a result of HYPERPARATHYROIDISM (overactivity of the parathyroid gland), EXCESSIVE levels of VITAMIN D, a TUMOUR, IMPAIRED KIDNEY FUNCTION, OSTEOPOROSIS due to a lack of mobility, SARCOIDOSIS or so-called MILK-ALKALI SYNDROME) • if you have SEVERE kidney disease • if you have kidney disease AND require REPEATED or PROLONGED treatment • if you are receiving treatment with DIGITALIS MEDICINES unless you have an extremely low blood calcium level with life-threatening symptoms, which can only be treated by an immediate injection of calcium • if you are a CHILD (less than 18 years of age) AND require REPEATED or PROLONGED treatment WARNINGS AND PRECAUTIONS: TALK TO YOUR DOCTOR, PHARMACIST OR NURSE BEFORE USING CALCIUM GLUCONATE INJECTION 10%: • if you suffer from DEPOSITION of CALCIUM in the kidneys (nephrocalcinosis) • if you have SARCOIDOSIS Important information about your medicine ► Your doctor or nurse will give you the injection ► If this injection causes you any problems talk to your doctor, nurse or pharmacist Läs hela dokumentet
OBJECT 1 CALCIUM GLUCONATE INJECTION BP Summary of Product Characteristics Updated 04-Jan-2016 | hameln pharmaceuticals ltd 1. Name of the medicinal product Calcium Gluconate Injection BP. 2. Qualitative and quantitative composition 9.5% of Calcium Gluconate in 10ml Each 1 ml of solution contains 95 mg calcium gluconate, equivalent to 0.22 mmol calcium. Each 10 ml of solution contains 950 mg of calcium gluconate, equivalent to 2.2 mmol calcium. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Sterile Injection. 4. Clinical particulars 4.1 Therapeutic indications PROPERTIES: Calcium is an essential body electrolyte. It is necessary for the functional integrity of nerve and muscle and is essential for the muscle contraction, cardiac function and coagulation of the blood. Calcium homeostasis is mainly regulated by three endocrine factors: parathyroid hormone is secreted in response to a fall in plasma calcium concentration and acts by accelerating calcium transfer from bone and by increasing its intestinal absorption and its renal reabsorption; calcitonin lowers plasma calcium by decreasing bone resorption and by increasing renal excretion of the ion; vitamin D stimulates intestinal absorption of calcium and decreases its renal excretion. INDICATIONS: Parenteral administration of calcium is indicated where the pharmacological action of a high calcium ion concentration is required, as for example, in acute hypocalcaemia, cardiac resuscitation and some cases of neonatal tetany. Intravenous injections of calcium have been used in the treatment of the acute colic of lead poisoning, and as an adjunct in the treatment of acute fluoride poisoning. Also, for the prevention of hypocalcaemia in exchange transfusions. 4.2 Posology and method of administration The normal concentration of calcium in plasma is within the range of 2.25 -2.75 mmol or 4.5-5.5 mEq per litre. Treatment should be aimed at restoring or maintaining this level. During therapy, serum calcium levels should be monitored closely. Acute Läs hela dokumentet