GLYCOPHOS sodium glycerophosphate (as hydrate) 4.32 g/20 mL concentrated solution for injection

Země: Austrálie

Jazyk: angličtina

Zdroj: Department of Health (Therapeutic Goods Administration)

Aktivní složka:

sodium glycerophosphate hydrate, Quantity: 6.122 g (Equivalent: sodium glycerophosphate, Qty 4.32 g)

Dostupné s:

Fresenius Kabi Australia Pty Ltd

Léková forma:

Injection, concentrated

Složení:

Excipient Ingredients: hydrochloric acid; water for injections

Podání:

Intravenous Infusion

Jednotky v balení:

20 x 20 mL ampoules

Druh předpisu:

Not scheduled. Not considered by committee

Terapeutické indikace:

Glycophos? is indicated in adult and paediatric patients as a supplement to parenteral nutrition to meet the daily requirements of phosphate.

Přehled produktů:

Visual Identification: Glycophos is a clear, colourless solution.; Container Type: Ampoule; Container Material: PP; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure

Stav Autorizace:

Registered

Datum autorizace:

2019-11-14

Informace pro uživatele

CMI - Glycophos
®
Concentrated Solution for Injection – July 2019
Page 1 of 2
GLYCOPHOS
®
Sodium glycerophosphate 4.32 g/20 mL ampoule
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about
Glycophos
®
. 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 you given Glycophos
®
against any benefits they expect it
will have for you.
PLEASE READ THIS LEAFLET CAREFULLY.
IF YOU HAVE ANY QUESTIONS OR ARE
UNSURE ABOUT ANYTHING, PLEASE
ASK YOUR DOCTOR OR PHARMACIST.
Keep this leaflet. You may need to
read it again.
WHAT IS GLYCOPHOS
®
USED FOR
Glycophos
®
is a sterile concentrate
solution which provides the body
with phosphate by the intravenous
route. It can be used in adults and
children. When the intake of
nutrients or food into the mouth or
directly into the gut is not possible,
or it is not enough to supply the
body’s needs, then intravenous
nutrients or foods can be given.
This is especially important for
people whose bodies are under
physical stress from illness or
recent surgery. During illness or
after surgery the body requires
nutrition or food.
It is usually given together with
fats, amino acids, glucose and
vitamins to provide a complete
intravenous diet.
BEFORE YOU ARE GIVEN
GLYCOPHOS
®
You must NOT use this product:
•
if you are allergic
(hypersensitive) to any of the
ingredients of Glycophos
®
•
if you are suffering from
dehydration
•
if you have high phosphate
levels in the blood
•
if you have high sodium levels
in the blood
•
if you have serious kidney
disease without access to
dialysis
•
if you are in acute shock
•
if you are in an unstable
condition, such as after serious
trauma, uncontrolled diabetes,
acute heart attack, stroke,
blood clot, metabolic acidosis
(a disturbance resulting in too
much acid in the blood), serious
infection (severe sepsis), coma
and if you don’t have enough
bod

Charakteristika produktu

AUSTRALIAN PRODUCT INFORMATION – GLYCOPHOS
®
(SODIUM GLYCEROPHOSPHATE)
Page 1 of 8
1.
NAME OF THE MEDICINE
Sodium glycerophosphate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Sodium glycerophosphate 4.32 g/20 mL ampoule.
Each 1 mL of Glycophos
®
contains 306.1 mg of sodium glycerophosphate hydrate, equivalent to
216 mg of sodium glycerophosphate.
Each 1 mL of Glycophos
®
corresponds to 1 mmol of phosphate and 2 mmol of sodium.
For the full list of excipients, see Section 6.1 List of Excipients._
_
3.
PHARMACEUTICAL FORM
Glycophos
®
Concentrated injection solution for infusion is a sterile, clear,
colourless solution
essentially free from visible particles.
Osmolality: 2760 mOsm/kg water
pH: 7.4
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glycophos
®
is indicated in adult and paediatric patients as a supplement to
parenteral nutrition to
meet the daily requirements of phosphate.
4.2 DOSE AND METHOD OF ADMINISTRATION
Method of administration
For intravenous infusion only. Glycophos
®
must not be given undiluted. The infusion duration
depends on the admixture; the infusion must be administered over a
period of at least 8 hours.
Dosage (dose and interval)
ADULTS
The recommended dosage should be individualized to each patient’s
phosphorus status and
needs. Approximately 15 mmol of phosphate is provided by a litre of
lipid emulsions or amino acid
solutions. This should be considered when supplementing phosphate from
Glycophos
®
. The
normal requirements during PN can be met by using 10 to 20 mL of
Glycophos
®
added to the
infusion solution or admixture for which compatibility has been
proven.
PAEDIATRIC POPULATION
The recommended dosage should be individualized to each patient’s
phosphorous status and
needs. The recommended dose for children, infants and neonates is 1.0
to 1.5 mmol/kg body
weight per day.
Page 2 of 8
Instructions for use
Glycophos
®
must not be given undiluted.
For single use in one patient only. Any excess infusion solution in an
opened package must be
discarded and must not be