BIOLOGICAL THERAPIES FOLIC ACID 5mg/1ml Injection vial

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

folic acid, Quantity: 5 mg/mL

Available from:

Orthomolecular Medisearch Laboratories Pty Ltd Trading As Biological Therapies

INN (International Name):

Folic acid

Pharmaceutical form:

Injection

Composition:

Excipient Ingredients: water for injections; sodium hydroxide; disodium edetate

Administration route:

Intramuscular, Subcutaneous, Intravenous

Units in package:

10 x 1mL, 6 x 1mL, 1 x 1mL

Prescription type:

(S4) Prescription Only Medicine

Therapeutic indications:

1. Megaloblastic anaemia where the anaemia has been proven to be due to folate deficiency only. 2. Prevention of folic acid deficiency in pregnancy and lactation.

Product summary:

Visual Identification: Yellow coloured, clear solution.; Container Type: Vial; Container Material: Glass Type I Coloured; Container Life Time: 12 Months; Container Temperature: Store at 2 to 8 degrees Celsius

Authorization status:

Registered

Authorization date:

2006-01-19

Patient Information leaflet

BIOLOGICAL THERAPIES FOLIC ACID 5 MG IN 1 ML INJECTION
_FOR INTRAMUSCULAR, SUBCUTANEOUS OR INTRAVENOUS INJECTION _
CONSUMER MEDICINE INFORMATION
_Biological Therapies Folic Acid 5 mg in 1 mL Injection Version ID:
NMcmi39s1907 _
_page 1 of 3 _
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about Biological Therapies
Folic Acid Injection. It does not contain
all the available information. It does not
take the place of talking to your doctor
or pharmacist.
All medicines have risks and benefits.
Your doctor has weighed the risks of
giving Folic Acid Injection against the
benefits they expect it will have for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR PHARMACIST.
KEEP THIS LEAFLET WITH THE MEDICINE.
You may need to read it again.
WHAT BIOLOGICAL
THERAPIES FOLIC ACID
INJECTION IS USED FOR
Folic Acid Injection contains the active
ingredient folic acid; (2_S_)-2-[[4-[[(2-
amino-4-oxo-1,4-dihydropteridin-6-
yl)methyl]amino]benzoyl]amino]
pentanedioic acid (a member of the
Vitamin B group). Once administered,
folic acid is converted to folate in the
body.
Folate Deficiency:
Folic Acid Injection may be prescribed if
you have a diagnosed folate deficiency
and are unable to absorb sufficient
folate through oral intake. Oral intake
may be insufficient in; malabsorption
disorders, alcoholism, gastrointestinal
diseases, pregnancy and lactation,
haemolytic anaemia, exfoliative
dermatitis and chronic infection.
For use in Pregnancy and Lactation:
Without folate, cells cannot divide
normally. This is especially important
for all rapidly dividing cells in the body,
such as the cells in a developing baby
(foetus). Your doctor may prescribe
Folic Acid Injection to prevent folate
deficiency in pregnancy or lactation,
particularly if you have a problem that
decreases your folate levels.
Megaloblastic Anaemia:
Anaemia occurs when red blood cells
cannot carry enough oxygen to meet
the needs of the body’s cells. Folate is
needed to make red blood cells grow
properly, without it t

Summary of Product characteristics

AUSTRALIAN PRODUCT INFORMATION
BIOLOGICAL THERAPIES FOLIC ACID 5 MG IN 1 ML INJECTION
FOR INTRAMUSCULAR, SUBCUTANEOUS OR INTRAVENOUS INJECTION
Biological Therapies
page 1 of 5
Product Information: FA5 - pi39s1901
AUST R 106972
1. NAME OF THE MEDICINE
Folic acid
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Biological Therapies Folic Acid Injection contains folic acid adjusted
to pH with sodium hydroxide in water for injections. Disodium
edetate 2 mg/mL is used as a stabiliser. Each 1 mL solution contains 5
mg of folic acid as an active ingredient.
The total sodium content in undiluted Biological Therapies Folic Acid
Injection 5 mg in 1 mL is approximately 1.0 mg/mL, the pH range
8 to 11.
Folic acid,
(2_S_)-2-[[4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]
benzoyl]amino]pentanedioic acid, is prepared
synthetically. Folates are complex organic compounds present in liver,
yeast and natural sources.
For the full list of excipients, see Section 6.1 List of Excipients.
3. PHARMACEUTICAL FORM
Biological Therapies Folic Acid Injection is a yellow colour and is a
clear solution.
4. CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Folate deficiency may exist that is unable to be corrected by oral
intake and in these cases parenteral administration may be
preferable. Oral intake may be insufficient in: malabsorption
disorders, gastrointestinal pathologies, pregnancy and lactation,
alcoholism, haemolytic anaemia, exfoliative dermatitis and chronic
infection.
Specific indications may include:
1.
Megaloblastic anaemia where the anaemia has been proven to be due to
folate deficiency only.
2.
Prevention of folic acid deficiency in pregnancy and lactation.
4.2 DOSE AND METHOD OF ADMINISTRATION
Biological Therapies Folic Acid Injection is used for parenteral folic
acid therapy, and may be administered, usually by intramuscular, or
less commonly by intravenous or subcutaneous injection. Although
Biological Therapies Folic Acid Injection can be given undiluted for
intramuscular or subcutaneous use, it must be diluted befor