Glycophos

国: ニュージーランド

言語: 英語

ソース: Medsafe (Medicines Safety Authority)

有効成分:

Sodium glycerophosphate pentahydrate 306.1 mg/mL (corresponds to sodium glycerophosphate anhydrous 216 mg/mL - )

から入手可能:

Fresenius Kabi New Zealand Limited

INN（国際名）:

Sodium glycerophosphate pentahydrate 306.1 mg/mL (corresponds to sodium glycerophosphate anhydrous 216 mg/mL - )

投薬量:

306.1 mg/mL

医薬品形態:

Concentrate for infusion

構図:

Active: Sodium glycerophosphate pentahydrate 306.1 mg/mL (corresponds to sodium glycerophosphate anhydrous 216 mg/mL - ) Excipient: Hydrochloric acid Water for injection

パッケージ内のユニット:

Vial, plastic, Polypropylene, 20 mLx10, 10 dose units

クラス:

General sale

処方タイプ:

General sale

製:

Dr Paul Lohmann GmbH KG

適応症:

GLYCOPHOS is indicated in adult patients, children, infants and neonates as a supplement in intravenous nutrition to meet the requirement of phosphate.

製品概要:

Package - Contents - Shelf Life: Ampoule, plastic, Polypropylene, 20 mL - 20 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze. 24 hours diluted stored at 2° to 8°C (Refrigerate, do not freeze) - Vial, plastic, Polypropylene, 20 mL - 10 dose units - 36 months from date of manufacture stored at or below 25°C. Do not freeze 24 hours opened stored at 2° to 8°C (Refrigerate, do not freeze) 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze)

承認日:

2003-06-30

情報リーフレット

Page 1 of 2
GLYCOPHOS
®
Concentrate for solution for infusion
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
before
using
Glycophos.
If
you
have any questions or are unsure
about
anything,
please
ask
the
doctor or pharmacist. Keep this
leaflet, you may need to read it
again.
_ _
WHAT
GLYCOPHOS
IS
USED FOR
Glycophos is a sterile concentrate
which
provides
the
body
with
phosphate
by
the
intravenous
route. 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
should
not
be
given
Glycophos if you:

Have an allergy to any of the
ingredients
contained
in
Glycophos as listed above and
at the end of this leaflet.

Are suffering from dehydration

Have high sodium levels in the
blood

Have high phosphate levels in
the blood

Have severe kidney problems

Are suffering from shock.
If you are not sure whether any of
these apply to you, check with the
doctor.
You should tell your doctor
BEFORE given Glycophos if the
answer to any of the following
questions is YES.

Are you pregnant or trying
to become pregnant?

Are you breastfeeding?

Do you have kidney
disease?
HOW TO TAKE
GLYCOPHOS
HOW MUCH TO TAKE
The dose of Glycophos which you
will require will be determined by
the
doc

製品の特徴

Page 1 of 4
NEW ZEALAND DATA SHEET
1.
PRODUCT NAME
Glycophos
®
306.1 mg/mL Infusion, concentrate
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 mL solution contains:
Sodium
glycerophosphate
pentahydrate
306.1
mg
(corresponds
to
sodium
glycerophosphate anhydrous 216 mg).
Glycophos
®
contains 1 mmol of glycerophosphate and 2 mmol of sodium per mL.
Osmolality: 2800mOsm/kg water.
pH: 7.4
For a full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Glycophos
®
is a sterile clear, colourless solution.
Infusion, concentrate.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Glycophos
®
is indicated in adult patients, children, infants and neonates as a
supplement in intravenous nutrition to meet the requirement of
phosphate.
4.2
DOSE AND METHOD OF ADMINISTRATION
_Dose _
_Adults: _
The
recommended
dosage
is
individual.
The
recommended
daily
dosage
of
phosphate during intravenous nutrition would normally be 10-20 mmol.
This can be
met by using 10-20 mL of Glycophos
®
added to the infusion solution or to the
admixture for which compatibility has been proved.
_Children, Infants and Neonates: _
The recommended dosage is individual. The recommended dose for
children,
infants and neonates is 1.0-1.5 mmol/kg body weight/day.
Method of administration
Intravenous Infusion.
Glycophos
®
must not be given undiluted. The infusion must be administered over a
period of at least 8 hours.
4.3 CONTRAINDICATIONS
Glycophos
®
should not be given to patients in a state of dehydration or with
hypernatraemia, hyperphosphataemia, severe renal insufficiency or
shock.
Page 2 of 4
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Glycophos
®
should be used with caution in patients with impaired renal function.
The phosphate status of all patients should be monitored regularly.
Glycophos
®
must not be given undiluted.
4.5 INTERACTION WITH OTHER MEDICINES AND OTHER FORMS OF INTERACTION
No interactions with other drugs have been observed, but a moderate
fall in serum
phosphate can be seen during carbohydrate infusions.
4.6 FERTILITY, PR