Phenylephrine 500micrograms/10ml solution for injection pre-filled syringes

Land: Verenigd Koninkrijk

Taal: Engels

Bron: MHRA (Medicines & Healthcare Products Regulatory Agency)

Werkstoffen:

Phenylephrine hydrochloride

Beschikbaar vanaf:

Aguettant Ltd

INN (Algemene Internationale Benaming):

Phenylephrine hydrochloride

Dosering:

50microgram/1ml

farmaceutische vorm:

Solution for injection

Toedieningsweg:

Intravenous

klasse:

No Controlled Drug Status

Prescription-type:

Valid as a prescribable product

Product samenvatting:

BNF: ; GTIN: 5060238380232 5060238380225

Bijsluiter

1
PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PHENYLEPHRINE 50 MICROGRAMS/ML, SOLUTION FOR INJECTION IN PRE-FILLED
SYRINGE
(REFERRED TO AS “PHENYLEPHRINE INJECTION” IN THIS LEAFLET)
PHENYLEPHRINE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU ARE GIVEN THIS MEDICINE
BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
-
Keep this leaflet. You may need to read it again.
-
If you have any further questions, ask your doctor, pharmacist or
nurse.
-
If you get any side effects, talk to your doctor, pharmacist or nurse.
This includes any
possible side effects not listed in this leaflet. See section 4.
_ _
WHAT IS IN THIS LEAFLET
1.
What Phenylephrine Injection is and what it is used for
2.
What you need to know before you are given Phenylephrine Injection
3.
How Phenylephrine Injection is given
4.
Possible side effects
5.
How to store Phenylephrine Injection
6.
Contents of the pack and other information
1.
WHAT PHENYLEPHRINE INJECTION IS AND WHAT IT IS USED FOR
This medicine belongs to a group of adrenergic and dopaminergic
agents.
It is used to treat low blood pressure during anaesthesia.
2.
WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN PHENYLEPHRINE INJECTION
YOU WILL NOT RECEIVE PHENYLEPHRINE INJECTION:
-
if you are allergic to phenylephrine hydrochloride or any of the other
ingredients of this
medicine (listed in section 6);
-
if you suffer from severe high blood pressure, or peripheral vascular
disease (poor blood
circulation);
-
if you are taking a Monoamine Oxydase inhibitor (MAO) (or within 2
weeks of their
withdrawal), that is used to treat depression (such as iproniazide,
nialamide);
-
if you suffer from severe overactive thyroid gland (hyperthyroidism).
WARNINGS AND PRECAUTIONS
Talk to your doctor, pharmacist or nurse before you are given
Phenylephrine Injection:
-
if you are elderly;
-
if you are diabetic;
-
if you suffer from arterial hypertension;
-
if you have an overactive thyroid gland (uncontrolled
hyperthyroidism);
-
if you have blood vessel disease, such as arteriosclerosis (hardening
and thickening

Productkenmerken

OBJECT 1
PHENYLEPHRINE 50 MICROGRAMS/ML, SOLUTION FOR
INJECTION IN PRE-FILLED SYRINGE
Summary of Product Characteristics Updated 26-Jan-2016 | Aguettant Ltd
1. Name of the medicinal product
PHENYLEPHRINE 50 micrograms/ml, solution for injection in pre-filled
syringe
2. Qualitative and quantitative composition
Each ml of solution for injection contains phenylephrine hydrochloride
equivalent to 50 micrograms (0.05
mg) phenylephrine.
Each 10 ml pre-filled syringe contains phenylephrine hydrochloride
equivalent to 500 micrograms (0.5
mg) phenylephrine.
Excipients with known effect:
This medicinal product contains sodium.
Each ml of solution for injection contains 3.68 mg equivalent to 0.160
mmol of sodium.
Each 10 ml pre-filled syringe contains 36.8 mg equivalent to 1.60 mmol
of sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection in pre-filled syringe. (Injection)
Clear colourless solution.
pH: 4.7 – 5.3
Osmolality: 270-300 mOsm/Kg
4. Clinical particulars
4.1 Therapeutic indications
Treatment of hypotension during spinal, epidural or general
anesthesia.
4.2 Posology and method of administration
Posology
_Adults_
_Intravenous bolus injection:_
Normal dose is 50 to 100 micrograms, which can be repeated until the
desired effect is attained. One
bolus dose should not exceed 100 micrograms.
_Continuous infusion:_
Initial dose is 25 to 50 micrograms/min. The doses may be increased or
decreased to maintain the systolic
blood pressure close to the normal value. Doses between 25 and 100
micrograms/min have been assessed
to be effective.
_Renal impairment_
Lower doses of phenylephrine may be needed in patients with impaired
renal function.
_Hepatic Impairment_
Higher doses of phenylephrine may be needed in patients with cirrhosis
of the liver.
_Older people:_
Treatment of the elderly should be carried out with care.
_Paediatric population_
The safety and efficacy of phenylephrine in children have not been
established. No data are available.
Method of administration:
Parenter