Phenylephrine 100 micrograms/ml solution for injection/infusion

国: アイルランド

言語: 英語

ソース: HPRA (Health Products Regulatory Authority)

有効成分:

Phenylephrine hydrochloride

から入手可能:

Laboratoire AGUETTANT

ATCコード:

C01CA06

INN（国際名）:

Phenylephrine hydrochloride

投薬量:

100 microgram(s)/millilitre

医薬品形態:

Solution for injection/infusion

治療領域:

phenylephrine

認証ステータス:

Marketed

承認日:

2020-02-28

情報リーフレット

PACKAGE LEAFLET: INFORMATION FOR THE PATIENT
PHENYLEPHRINE 100 MICROGRAMS/ML
SOLUTION FOR INJECTION/INFUSION
(REFERRED TO AS “PHENYLEPHRINE” 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 is and what it is used for
2. What you need to know before you are given Phenylephrine
3. How Phenylephrine is given
4. Possible side effects
5. How to store Phenylephrine
6. Contents of the pack and other information
1. WHAT PHENYLEPHRINE 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
YOU WILL NOT RECEIVE PHENYLEPHRINE:
- 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:
- 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 vessels disease, such as arteriosclerosis
(hardening and thickening of the walls of the blood vessels);
- if you suffer from a particular condition which may lead to a
poor blo

製品の特徴

Health Products Regulatory Authority
24 January 2022
CRN00CHWT
Page 1 of 6
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Phenylephrine 100 micrograms/ml solution for injection/infusion
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each ml of solution for injection contains phenylephrine hydrochloride
equivalent to 100 micrograms (0.1 mg) phenylephrine.
Each 20 ml vial contains phenylephrine hydrochloride equivalent to
2000 micrograms (2 mg) phenylephrine.
Excipients with known effect:
Each ml of solution for injection contains 3.9 mg equivalent to 0.17
mmol of sodium.
Each 20 ml vial contains 78 mg equivalent to 3.4 mmol of sodium.
For full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Solution for injection/infusion
Clear colourless solution
pH: 4.5 – 5.5
Osmolality: 270 – 330 mOsm/kg
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment of hypotension during spinal, epidural or general
anaesthesia.
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 obtained. One bolus dose should not
exceed 100 micrograms.
_ _
_Continuous infusion:_
Initial dose is 25 to 50 micrograms/min. Doses can be increased up to
100 micrograms/min or reduced in order to maintain
systolic blood pressure close to the normal value.
Doses between 25 and 100 micrograms/min have been considered
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.
_Elderly:_
_ _
Treatment of the elderly should be carried out with care.
Health Products Regulatory Authority
24 January 2022
CRN00CHWT
Page 2 of 6
_ _
_Paediatric population_
The safety and efficacy of phenylephrine in children have not been
established. No data are available.
Method of administration:
Intravenous bolus injection or intravenous infusion.