PHENYLIP phenylephrine hydrochloride 10 mg / 1 mL injection USP vial

Country: Ástralía

Tungumál: enska

Heimild: Department of Health (Therapeutic Goods Administration)

Virkt innihaldsefni:

phenylephrine hydrochloride, Quantity: 10 mg

Fáanlegur frá:

Cipla Australia Pty Ltd

Lyfjaform:

Injection

Samsetning:

Excipient Ingredients: water for injections; sodium chloride; sodium citrate dihydrate; citric acid monohydrate; sodium metabisulfite; hydrochloric acid; sodium hydroxide

Stjórnsýsluleið:

Intramuscular, Intravenous, Subcutaneous

Einingar í pakka:

25 x 1 mL vials

Gerð lyfseðils:

(S4) Prescription Only Medicine

Ábendingar:

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.

Vörulýsing:

Visual Identification: Clear colourless solution practically free from visible particles; Container Type: Vial; Container Material: Glass Type I Clear; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Leyfisstaða:

Registered

Leyfisdagur:

2019-10-15

Upplýsingar fylgiseðill

Phenylip*
1
PHENYLIP*
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about using this medicine, speak to your doctor or pharmacist.
1.
WHY AM I USING PHENYLIP?
Phenylip contains the active ingredient phenylephrine hydrochloride.
Phenylip is used to 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.
For more information, see Section 1. Why am I using Phenylip? in the
full CMI.
2.
WHAT SHOULD I KNOW BEFORE I USE PHENYLIP?
Do not use if you have ever had an allergic reaction to phenylephrine
hydrochloride or any of the ingredients listed at the end
of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE BREASTFEEDING. Your doctor will discuss the risks and
benefits of being given Phenylip during pregnancy and in
case of breastfeeding.
For more information, see Section 2. What should I know before I use
Phenylip? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Phenylip and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I USE PHENYLIP?
•
Phenylip can be given to you in three ways: a) as a slow injection or
infusion (drip) into a vein, b) as a deep injection into a
muscle; c) as an injection just under the skin. Sometimes it is
diluted before use and given with fluids into a vein.
•
Your doctor will determine how you will be given this medicine.
Phenylip must only be given by a doctor or nurse.
More instructions can be found in Section 4. How do I use Phenylip? in
the full CMI.
5.
WHAT SHOULD I KNOW WHILE USING PHENYLIP?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist, when you visit that you are
using Phenylip.
•
Tell your doctor if you are pregnant or intend to become pregnant.
THINGS YOU
SHO

Vara einkenni

1
AUSTRALIAN PRODUCT INFORMATION
PHENYLIP (PHENYLEPHRINE HYDROCHLORIDE) SOLUTION FOR INJECTION
1.
NAME OF THE MEDICINE
Australian approved name: 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 vial contains 10 mg of phenylephrine hydrochloride per one mL (1%
solution).
The 10 mg/ 1 mL vials contain an overfill to allow the withdrawal of
1.15 ± 0.05 mL (1.10 -
1.20 mL).
Excipient with known effect
Each vial of solution for injection contains 2.799 mg of sodium.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Solution for injection.
A clear, colourless, aqueous solution, practically free from visible
particulates.
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.
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 0.1 mg to 0.5 mg. Initial dose should
not exceed 0.5 mg.
2
Injections should not be repeated more often than every 10 to 15
minutes. A 5 mg intramuscular
dose should raise blood pressure for one to two hours. A 0.5 mg
intravenous dose should elevate
the pressure for about 15 minutes
_Severe hypotension and shock - including medicine-related hypotension
_
Blood volume depletion should always be corrected as fully as possible
before any vasopressor is
administered. When, as an emergency