Metaraminol 10mg/ml Solution for Injection or Infusion
Country: United Kingdom
Language: English
Source: myHealthbox
Patient Information leaflet
(PIL)
25-04-2024
Summary of Product characteristics
(SPC)
25-04-2024
Active ingredient:
metaraminol
Available from:
South Devon Healthcare NHS Foundation Trust
ATC code:
C01CA09
INN (International Name):
metaraminol
Dosage:
10mg/ml
Pharmaceutical form:
Solution for injection or infusion
Administration route:
Intravenous use
Units in package:
Pack size of 10 ampoules in an outer carton
Prescription type:
POM - Prescription Only Medicine
Manufactured by:
South Devon Healthcare NHS Foundation Trust
Therapeutic group:
Adrenergic and dopaminergic agent
Therapeutic indications:
For the treatment of acute hypotension due to loss of vasoconstrictor tone as may occur during spinal anaesthesia and as an adjunct to accepted remedial procedures.
Authorization status:
Authorised
Authorization date:
2015-07-06
Patient Information leaflet
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Summary of Product characteristics
Metaraminol 10mg/mL Solution for Injection or Infusion
Summary of Product Characteristics Updated 14Sep2015 | Torbay Pharmaceuticals, South Devon Healthcare NHS
Foundation Trust
1. Name of the medicinal product
Metaraminol 10mg/mL Solution for Injection or Infusion.
2. Qualitative and quantitative composition
Each 1 mL of solution contains 10mg of metaraminol (as tartrate).
Excipients of known effect:
Sodium chloride
Sodium metabisulfite
Each 1 mL of solution contains 98.4 mmol (2.26 mg) sodium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Solution for injection or infusion.
Glass ampoule containing a clear colourless solution with pH of 3.2 to 4.5 and osmolarity of 305mOsm/litre.
4. Clinical particulars
4.1 Therapeutic indications
For the treatment of acute hypotension due to loss of vasoconstrictor tone as may occur during spinal anaesthesia and
as an adjunct to accepted remedial procedures.
4.2 Posology and method of administration
_Method of Administration_
For intravenous use.
_Posology_
_Direct intravenous injection in grave emergencies: _0.5 5 mg (0.050.5 ml), followed by an infusion of 15100 mg (1.510
ml) in 500 ml of infusion liquid.
Particular care should be taken to use the correct dose when injecting undiluted metaraminol.
_Intravenous Infusion:_ 15100 mg (1.510.0 ml) in 500 ml Sodium Chloride Injection or Dextrose 5% Injection, adjusting
the rate of infusion to maintain the blood pressure at the desired level. Higher concentrations of Metaraminol have been
used when appropriate to the circumstances.
_Children:_ Metaraminol should not be used in children under 12 years of age.
_Use in the elderly: _The dosage may not require modification for elderly patients; however, geriatric patients may be
more sensitive to sympathomimetic
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