Phenylephrine 10mg/1ml solution for injection ampoules

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Phenylephrine hydrochloride

Beszerezhető a:

Kent Pharma (UK) Ltd

INN (nemzetközi neve):

Phenylephrine hydrochloride

Adagolás:

10mg/1ml

Gyógyszerészeti forma:

Solution for injection

Az alkalmazás módja:

Intravenous; Subcutaneous; Intramuscular

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: ; GTIN: 5060061160636

Betegtájékoztató

PACKAGE LEAFLET: INFORMATION FOR THE USER
PHENYLEPHRINE 10MG/ML SOLUTION FOR INJECTION OR INFUSION
(Referred to as Phenylephrine Injection in this leaflet)
PACKAGE LEAFLET: INFORMATION FOR THE HEALTHCARE PROFESSIONAL
PHENYLEPHRINE 10MG/ML SOLUTION FOR INJECTION OR INFUSION
The following information is intended for medical or healthcare
professionals only:
QUALITATIVE AND QUANTITATIVE COMPOSITION
Phenylephrine hydrochloride Ph Eur 1.0% w/v.
Each 1 ml ampoule contains 10 mg
phenylephrine.
THERAPEUTIC INDICATIONS
For the treatment of hypotensive states, e.g.
circulatory failure, during spinal anaesthesia or
drug-induced hypotension.
POSOLOGY AND METHOD OF ADMINISTRATION
For subcutaneous, intramuscular or slow
intravenous injection or by intravenous infusion.
Inspect visually for particulate matter and
discolouration prior to administration.
ADULTS:
Phenylephrine injection may be administered
subcutaneously or intramuscularly in a dosage of
2 to 5 mg with further doses of 1 to 10 mg if
necessary according to response, or in a dose of
100 to 500 micrograms by slow intravenous
injection as a 0.1% solution, repeated as
necessary after at least 15 minutes.
Alternatively, 10 mg in 500 ml of glucose 5%
injection or sodium chloride 0.9% injection may
be infused intravenously, initially at a rate of up to
180 micrograms per minute, reduced according
to response to 30-60 micrograms per minute.
SPECIAL CARE SHOULD BE TAKEN WITH
PHENYLEPHRINE INJECTION IF ANY OF THE
FOLLOWING APPLY TO YOU.
TELL YOUR DOCTOR IF YOU HAVE:
• any heart problems or disease, including
arrhythmias or angina
• a disease of your blood vessels, such as
arteriosclerosis or aneurysms
• diabetes mellitus
• closed-angle glaucoma (increased pressure
in the eye)
• you are pregnant or breast feeding.
TAKING OTHER MEDICINES
Please tell your doctor or nurse if you are
taking or have recently taken any other
medicines, including medicines obtained
without a prescription.
In particular, tell your doctor or nurse if you are
taking any of the following:
•

Termékjellemzők

OBJECT 1
PHENYLEPHRINE 10 MG/ML SOLUTION FOR INJECTION OR
INFUSION
Summary of Product Characteristics Updated 09-Feb-2017 | Beacon
Pharmaceuticals
1. Name of the medicinal product
Phenylephrine 10 mg/ml Solution for Injection or Infusion
2. Qualitative and quantitative composition
Phenylephrine hydrochloride Ph Eur 1.0% w/v
Each 1 ml ampoule contains 10 mg phenylephrine.
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Solution for injection, or concentrate for solution for injection or
infusion.
Clear, colourless, sterile, solution.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of hypotensive states, e.g. circulatory failure,
during spinal anaesthesia or drug-induced
hypotension.
4.2 Posology and method of administration
For subcutaneous, intramuscular or slow intravenous injection or by
intravenous infusion.
Whenever solution and container permit, parenteral drug products
should be inspected visually for
particulate matter and discolouration prior to administration.
ADULTS
Phenylephrine injection may be administered subcutaneously or
intramuscularly in a dosage of 2 to 5 mg
with further doses of 1 to 10 mg if necessary according to response,
or in a dose of 100 to 500
micrograms by slow intravenous injection as a 0.1% solution, repeated
as necessary after at least 15
minutes.
Alternatively, 10 mg in 500 ml of glucose 5% injection or sodium
chloride 0.9% injection may be infused
intravenously, initially at a rate of up to 180 micrograms per minute,
reduced according to response to 30-
60 micrograms per minute.
CHILDREN
100 micrograms/kg bodyweight subcutaneously or intramuscularly.
ELDERLY
There is no need for dosage reduction in the elderly.
4.3 Contraindications
Hypersensitivity to phenylephrine or to any of the excipients.
Patients taking monoamine oxidase inhibitors, or within 14 days of
ceasing such treatment.
Severe hypertension and hyperthyroidism.
4.4 Special warnings and precautions for use
Great care should be exercised in administering Phenylephrine
Injecti