NEOSYNEPHRINE 1% phenylephrine hydrochloride 10mg/1mL injection USP ampoule

Страна: Австралія

мова: англійська

Джерело: Department of Health (Therapeutic Goods Administration)

Активний інгредієнт:

phenylephrine hydrochloride, Quantity: 10 mg/mL

Доступна з:

Pfizer Australia Pty Ltd

Фармацевтична форма:

Injection, solution

Склад:

Excipient Ingredients: water for injections; sodium citrate dihydrate; sodium metabisulfite; nitrogen; sodium chloride; citric acid

Адміністрація маршрут:

Intramuscular, Intravenous, Subcutaneous

Одиниць в упаковці:

25 x 1 mL

Клас:

Medicine Registered

Тип рецепту:

(S4) Prescription Only Medicine

Терапевтичні свідчення:

INDICATIONS AS AT 01 JAN 1991 : Phenylephrine hydrochloride is intended for the maintenance of an adequate level of blood pressure during spinal and inhalation anesthesia and for the treatment of vascular failure in shock, shock-like states, and drug-induced hypotension, of hypersensitivity. It is also employed to overcome paroxysmal supraventricular tachycardia, to prolong spinal anesthesia, and as a vasoconstrictor in regional analgesia.

Огляд продуктів:

Visual Identification: Clear colourless solution; Container Type: Ampoule; Container Material: Glass Type I Clear; Container Life Time: 5 Years; Container Temperature: Store below 25 degrees Celsius

Статус Авторизація:

Registered

Дата Авторизація:

1991-09-10

інформаційний буклет

NEO-SYNEPHRINE
TM
CMI
page 1
NEO-SYNEPHRINE
TM
_(NEE-O-SIN-EH-FRIN) _
Phenylephrine Hydrochloride
1% Injection (
_Fen-nel-EF-reen Hi-dro-KLOR-ide)_
CONSUMER MEDICINE INFORMATION
_Date of Dispensing_
_Consumer Name _
_ _
_Pharmacist Name _
_Consumer Address _
_Pharmacist Address _
WHAT IS IN THIS LEAFLET
This leaflet answers some
common questions about NEO-
SYNEPHRINE
TM
.
It does not contain all of 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 associated with giving you
NEO-SYNEPHRINE
TM
against the
benefits they expect it will have for
you.
IF YOU HAVE ANY CONCERNS ABOUT
TAKING THIS MEDICINE, TALK TO YOUR
DOCTOR, PHARMACIST OR NURSE.
Keep this leaflet while you are
being given NEO-SYNEPHRINE
TM
.
You may need to read it again.
WHAT NEO-
SYNEPHRINE
TM IS
USED FOR
NEO-SYNEPHRINE
TM
is used to
help increase your blood pressure
and slow down your heart, for
example, during surgery or in
states of shock. It does this by
causing constriction (narrowing) of
your blood vessels.
It belongs to a group of medicines
called vasoconstrictors.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY NEO-
SYNEPHRINE
TM
HAS BEEN
PRESCRIBED FOR YOU.
Your doctor may have prescribed it
for another reason.
This medicine is not addictive.
This medicine is available only with
a doctor’s prescription.
BEFORE YOU ARE
GIVEN NEO-
SYNEPHRINE
TM
_WHEN YOU MUST NOT BE _
_GIVEN IT _
YOU MUST NOT BE GIVEN NEO-
SYNEPHRINE
TM
IF YOU ARE
ALLERGIC TO:
•
PHENYLEPHRINE
•
SODIUM METABISULFITE
•
ANY OF THE INGREDIENTS LISTED
AT THE END OF THIS LEAFLET.
Symptoms of an allergic reaction
may include:
•
shortness of breath, wheezing
or difficulty breathing
•
swelling of the face, lips, tongue
or other parts of the body
•
rash, itching or hives on the
skin.
You must not be given NEO-
SYNEPHRINE
TM
if you have:
•
very high blood pressure.
•
a very fast heart beat
(palpitations)
IF YOU ARE NOT SURE WHETHER YOU
SHOULD START TA

Характеристики продукта

Version: pfpneosi10619
Page 1 of 9
AUSTRALIAN PRODUCT INFORMATION –
NEO-SYNEPHRINE
™ (PHENYLEPHRINE
HYDROCHLORIDE)
1.
NAME OF THE MEDICINE
Phenylephrine hydrochloride
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenylephrine hydrochloride is a synthetic sympathomimetic agent. It
is a white or almost
white crystalline powder, freely soluble in water and alcohol.
Each ampoule contains 10 mg of phenylephrine hydrochloride per one mL
(1% solution) as
well as 3.5 mg of sodium chloride for isotonicity, 4 mg of sodium
citrate dihydrate and 1 mg
of citric acid as buffering agents, 2 mg of sodium metabisulfite as an
antioxidant and water
for injections. . It is for use in one patient on one occasion only.
Discard any residue.
EXCIPIENT WITH KNOWN EFFECT:
•
Sodium metabisulfite
For the full list of excipients, see section 6.1 List of excipients.
3.
PHARMACEUTICAL FORM
Solution for injection.
NEO-SYNEPHRINE
™
, brand of phenylephrine hydrochloride injection, is a vasoconstrictor
and pressor drug chemically related to adrenaline and ephedrine.
NEO-SYNEPHRINE
™
is a
clear, colorless, aqueous solution, free from visible particulates, in
sterile form for parenteral
injection.
It has a pH of between 4.5 and 6.5.
NEO-SYNEPHRINE
TM
contains no antimicrobial preservative.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Phenylephrine hydrochloride is intended for the maintenance of an
adequate level of blood
pressure during spinal and inhalation anaesthesia and for the
treatment of vascular failure in
shock, shock-like states, and drug-induced hypotension, or
hypersensitivity. It is also
employed to overcome paroxysmal supraventricular tachycardia, to
prolong spinal
anaesthesia, and as a vasoconstrictor in regional analgesia.
Version: pfpneosi10619
Page 2 of 9
4.2 DOSE AND METHOD OF ADMINISTRATION
DOSAGE
_MILD OR MODERATE HYPOTENSION: _
_Subcutaneously or Intramuscularly: _
Usual dose, from 2 mg to 5 mg. Range, from 1 mg to 10 mg. Initial dose
should not exceed 5
mg.
_Intravenously: _
Usual dose, 0.2 mg. Range, from 0.