Calcium Gluconate 10% B.Braun Solution for Injection

Riik: Malaisia

keel: inglise

Allikas: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Toimeaine:

Calcium Gluconate for Injection

Saadav alates:

B.BRAUN MEDICAL INDUSTRIES SDN BHD

INN (Rahvusvaheline Nimetus):

Calcium Gluconate for Injection

Ühikuid pakis:

20 x 10 ml

Valmistatud:

B.BRAUN MELSUNGEN AG

Toote omadused

DIRECTIONS FOR USE
B. BRAUN MELSUNGEN AG ∙ 34209 MELSUNGEN, GERMANY
CALCIUM GLUCONATE 10 % B. BRAUN
SOLUTION FOR INJECTION
B|BRAUN
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Special warnings
In the exceptional case of intravenous administration of calcium
gluconate to patients receiving cardiac glycosides, adequate cardiac
monitoring is mandatory and emergency treatment of cardiac com-
plications such as serious arrhythmias must be available.
Calcium salts should only be used with caution and after careful
establishment of the indication in patients with nephrocalcinosis,
heart diseases, sarcoidosis (Boeck's disease), in patients receiving
epinephrine (see section 4.5), or in the elderly.
Renal
impairment
may
be
associated
with
hypercalcaemia
and
secondary hyperparathyroidism. Therefore, in patients with renal
impairment, parenteral calcium should be administered only after
careful assessment of the indication and the calcium-phosphate
balance should be monitored.
Precautions for use
Solutions
containing
calcium
should
be
administered
slowly
to
minimise peripheral vasodilation and cardiac depression.
Intravenous injections should be accompanied by heart rate or ECG
control because bradycardia with vasodilatation or arrhythmia can
occur when calcium is administered too quickly.
In paediatric patients, Calcium Gluconate 10 % B. Braun should not
be injected intramuscularly but only slowly intravenously.
Patients receiving calcium salts should be monitored carefully to
ensure
maintenance
of
correct
calcium
balance
without
tissue
deposition.
Plasma levels and urinary excretion of calcium should be monitored
when high-dose parenteral calcium is administered.
Calcium is insoluble in adipose tissue and may therefore cause
infiltration and subsequent abscess formation, tissue indurations and
necrosis if accidently injected into the adipose tissue.
After
perivascular
or
superficial
intramuscular
injection
local
irritation, possibly followed by skin ablation or tissue necrosis, may
occur (see section 4.8). Extravasation