Calcium Gluconate Injection USP 1g/10ml
Calcium Gluconate Injection USP 5g/50ml
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
- Please tell your doctor or pharmacist, if you have any other medical conditions or have an allergy to any of the ingredients of this medicine
- Please tell your doctor or pharmacist, if you are taking any other medicines
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, pharmacist or nurse.
- If you get any side effects, talk to your doctor, pharmacist or nurse.
- This includes any possible side effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
- What Calcium Gluconate Injection 5G/50ML is and what it is used for
- What you need to know before you use Calcium Gluconate Injection 5G/50ML
- How to use Calcium Gluconate Injection 5G/50ML
- Possible side effects
- How to store Calcium Gluconate Injection 5G/50ML
- Contents of the pack and other information
1. WHAT CALCIUM GLUCONATE INJECTION 1G/10ML / 5G/50ML 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 5G/50ML 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 1G/10ML / 5G/50ML
Do NOT use Calcium Gluconate Injection 1G/50ML:
- if you are allergic to Calcium Gluconate Injection 5G/50ML 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 5G/50ML:
- if you suffer from the deposition of calcium in the kidneys (nephrocalcinosis)
- if you have sarcoidosis
- if you have kidney disease
- if you have heart disease
- if you have excessive levels of calcium in the
- urine
- if you are receiving adrenaline (epinephrine)
- if you are elderly
Children and Adolescents:
Children and adolescents (under the age of 18) should not be routinely administered Calcium Gluconate Injection 5G/50ML.
Other medicines and Calcium Gluconate Injection 5G/50ML:
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription. This is especially important with the following medicines as they may interact with your Calcium Gluconate Injection 5G/50ML:
- digoxin (a heart medicine)
- diuretics (water tablets)
- ceftriaxone (an antibiotic)
- adrenaline (epinephrine)
- magnesium
- calcium channel blockers
Pregnancy and breast-feeding:
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Driving and using machines:
You should not drive or use machinery if you are affected by the administration of Calcium Gluconate Injection 5G/50ML.
3. HOW TO USE CALCIUM GLUCONATE INJECTION 5G/50ML
Your nurse or doctor will give you the
injection.
Your doctor will decide the correct dosage for you and how and when the injection will be given. During treatment, your blood calcium levels will be monitored closely.
If you use more Calcium Gluconate Injection 5G/50ML than you should
Since the injection will be given to you by a doctor
or nurse, it is unlikely that you will be given too much. If you think you have been given too much, you feel sick, are sick, are constipated, have stomach pain, suffer muscle weakness, feel thirsty, are passing a lot of urine, feel confused or have bone pain you must tell the person giving you the injection immediately.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Side effects on the heart, circulation or other body functions may appear as symptoms of an excessively high blood calcium level after overdosing or too rapid injection into a vein.
The presence and frequency of such symptoms depend directly on the speed of injection and the dose administered.
The following side effects may be serious If any of the following side effects occur tell your doctor immediately:
Rare: may affect up to 1 in 1,000 people
- Severe, and in some cases, fatal, adverse reactions have been reported in pre-term and full-term neonates (aged <28 days) who had been treated with intravenous ceftriaxone and calcium. Precipitations of ceftriaxone-calcium salt have been observed in lung and kidneys post-mortem.
Not known: frequency cannot be estimated from the available data
- slow or irregular heartbeat
- drop in blood pressure (hypotension)
- circulatory collapse (possibly fatal)
Other side effects
Not known: frequency cannot be estimated from the available data
- widening of blood vessels
- hot flushes, mainly after the injection has been
- administered too rapidly
- feeling sick or being sick (vomiting)
- sensation of heat
- sweating
Side effects when Calcium Gluconate Injection 5G/50ML is used incorrectly
It has been reported that following leaking of the solution from a vein into the surrounding tissue (extravasation), calcium deposition in the soft tissue may occur. It may be followed by peeling and destruction of the skin.
If you think this injection is causing you any problems, or you are at all worried, talk to your doctor, nurse or pharmacist.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse: This includes any possible side effects not listed in this leaflet.
5. HOW TO STORE CALCIUM GLUCONATE INJECTION 5G/50ML
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the label and carton after ?Exp. date?. The expiry date refers to the last day of that month.
Your injection will be stored at less than 25?C and protected from light.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
What Calcium Gluconate Injection 5G/50ML contains
The active substance is calcium gluconate. Every 1 ml of solution contains 95 mg calcium gluconate in a sterile solution for injection.
The other ingredients are Calcium D Saccharate USP and Sterile Water for Injections EP.
What Calcium Gluconate Injection 5G/50ML looks like and contents of the pack
Calcium Gluconate Injection 5G/50ML is supplied in
10 ml clear glass ampoules. 10 ampoules supplied in each carton.
7. MANUFACTURED IN INDIA BY:
TAJ LIFE SCIENCES PVT. LTD.
Unit No. 214, Old Bake House,
Bake House Lane, Fort,
Mumbai-400001
at: Ahmedabad- Gujarat, INDIA.
Ho.NO.+91 8448 444 095
Toll Free Phone: (1800-222-434 / 1800-222-825)