Ascor L 500

Country: New Zealand

Language: English

Source: Medsafe (Medicines Safety Authority)

Active ingredient:

Ascorbic acid 500 mg/mL;  ;  

Available from:

Centre for Advanced Medicine

INN (International Name):

Ascorbic acid 500 mg/mL

Dosage:

500 mg/mL

Pharmaceutical form:

Solution for injection

Composition:

Active: Ascorbic acid 500 mg/mL     Excipient: Disodium edetate dihydrate Nitrogen Sodium bicarbonate Sodium hydroxide Water for injection

Units in package:

Vial, glass, 50mL,

Class:

General sale

Prescription type:

General sale

Manufactured by:

Hebei Welcome Pharmaceutical Co. Ltd

Therapeutic indications:

Ascor L 500 is indicated for ascorbic acid deficiency. Parenteral ascorbic acid supplementation may be necessary in the treatment of scurvy for patients with gastric disorders, for patients with extensive injuries, for surgical patients and others only if their needs cannot be met from normal dietary sources or in patients who cannot take oral vitamins. Acute ascorbic acid deficiency may be associated with extensive injuries and other states of extreme stress. Vitamin C requirements are also significantly increased in certain diseases and conditions such as tuberculosis, hyperthyroidism, peptic ulcer, neoplastic disease and lactation.

Product summary:

Package - Contents - Shelf Life: Vial, glass, 50mL -   - 24 months from date of manufacture stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Authorization date:

2005-10-20

Summary of Product characteristics

NEW ZEALAND DATASHEET
1 PRODUCT NAME
ASCOR L 500
®
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ascorbic acid 500 mg/ml
3 PHARMACEUTICAL FORM
Ascor L 500
®
(Ascorbic Acid Injection, USP) is a sterile, nonpyrogenic solution of
ascorbic acid
prepared with the aid of sodium bicarbonate in water for injection.
Ascorbic Acid is an essential
water-soluble vitamin. Ascor L 500
®
is a clear solution in an amber glass vial. Each ml contains
500 mg of ascorbic acid, and edetate disodium 0.025% (w/v).
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Ascor L 500
®
is indicated for ascorbic acid deficiency. Parenteral ascorbic acid
supplementation
may be necessary in the treatment of scurvy for patients with gastric
disorders, for patients with
extensive injuries, for surgical patients and others only if their
needs cannot be met from normal
dietary sources or in patients who cannot take oral vitamins. Acute
ascorbic acid deficiency may
be
associated
with
extensive
injuries
and
other
states
of
extreme
stress. Vitamin
C
requirements are also significantly increased in certain diseases and
conditions such as
tuberculosis, hyperthyroidism, peptic ulcer, neoplastic disease,
pregnancy and lactation.
4.2 Dose and method of administration
Ascor L 500
®
(Ascorbic Acid Injection, USP) is usually injected intramuscularly or
subcutaneously.
The solution has a pH of 5.5 to 7.0 and is not usually irritating to
the tissues. The solution also
may be injected intravenously, but a higher percentage of the drug
will be excreted in the urine
than
when
the
subcutaneous
or
intramuscular
route
is
employed. When
administered
intravenously, Ascor L 500
®
should be slowly infused with large volume solutions. Ascor L 500
®
should be added to such solutions shortly before venoclysis; any of
the mixture remaining after
administration should be discarded.
It is difficult to establish an exact dosage of ascorbic acid suitable
for the treatment of
deficiencies. In general, therapeutic doses should substantially
exceed the recommended daily
dietary a