Metaraminol 10mg/1ml solution for injection ampoules

Χώρα: Ηνωμένο Βασίλειο

Γλώσσα: Αγγλικά

Πηγή: MHRA (Medicines & Healthcare Products Regulatory Agency)

Δραστική ουσία:

Metaraminol tartrate

Διαθέσιμο από:

Torbay Pharmaceuticals

Φαρμακολογική κατηγορία (ATC):

C01CA09

INN (Διεθνής Όνομα):

Metaraminol tartrate

Δοσολογία:

10mg/1ml

Φαρμακοτεχνική μορφή:

Solution for injection

Οδός χορήγησης:

Intravenous

Kατηγορία:

No Controlled Drug Status

Τρόπος διάθεσης:

Valid as a prescribable product

Περίληψη προϊόντος:

BNF: 02070200; GTIN: 05060131263427

Αρχείο Π.Χ.Π.

OBJECT 1
METARAMINOL 10MG/ML SOLUTION FOR INJECTION OR
INFUSION
Summary of Product Characteristics Updated 22-Jul-2016 | Torbay &
South Devon 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 98.3 micromol (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 (0.05
- 0.5 mL), followed by an infusion of
15 - 100 mg (1.5 - 10 mL) in 500 mL of infusion liquid.
Particular care should be taken to use the correct dose when injecting
undiluted metaraminol.
_Intravenous Infusion:_ 15 - 100 mg (1.5 - 10.0 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 agents, therefore
particular caution should be taken in
this age group.
4.3 Contraindications
Metaraminol Injection should not be used concurrently with
cyclopropane or halothane anaesthesia,
unless clinical circumstances demand it.
Metaramino