Calcium gluconate 10% solution for injection 10ml ampoules

Kraj: Wielka Brytania

Język: angielski

Źródło: MHRA (Medicines & Healthcare Products Regulatory Agency)

Składnik aktywny:

Calcium gluconate

Dostępny od:

hameln pharma Ltd

Kod ATC:

B05BB01

INN (International Nazwa):

Calcium gluconate

Dawkowanie:

100mg/1ml

Forma farmaceutyczna:

Solution for injection

Droga podania:

Intravenous

Klasa:

No Controlled Drug Status

Typ recepty:

Valid as a prescribable product

Podsumowanie produktu:

BNF: 09050101; GTIN: 5016386000386 5016386055508

Ulotka dla pacjenta

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

Charakterystyka produktu

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