Zantac 50mg/2ml solution for injection ampoules

Ország: Egyesült Királyság

Nyelv: angol

Forrás: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktív összetevők:

Ranitidine hydrochloride

Beszerezhető a:

GlaxoSmithKline UK Ltd

ATC-kód:

A02BA02

INN (nemzetközi neve):

Ranitidine hydrochloride

Adagolás:

25mg/1ml

Gyógyszerészeti forma:

Solution for injection

Az alkalmazás módja:

Intravenous; Intramuscular

Osztály:

No Controlled Drug Status

Recept típusa:

Valid as a prescribable product

Termék összefoglaló:

BNF: 01030100; GTIN: 5000123106684

Betegtájékoztató

INFORMATION FOR HEALTHCARE PROFESSIONALS
ZANTAC
®
INJECTION 50 MG/2 ML
RANITIDINE HYDROCHLORIDE
PLEASE REFER TO THE SUMMARY OF PRODUCT CHARACTERISTICS (SPC) FOR
FURTHER
DETAILS ON THIS PRODUCT.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Ranitidine hydrochloride HSE 56 mg/2 ml equivalent to ranitidine 50
mg/2 ml.
Each ampoule contains 2.9 mg (0.09 mmol) of sodium and 0.6 mg (0.015
mmol) of
potassium.
For the full list of excipients, see SPC section 6.1.
PHARMACEUTICAL FORM
Injection (Aqueous solution)
A clear colourless to pale yellow liquid, practically free from
particles
POSOLOGY AND METHOD OF ADMINISTRATION
(See SPC section 5.2 Pharmacokinetic properties – Other special
populations.)
Posology

Adults (including elderly)/adolescents (12 years and over)
Zantac Injection may be given as a slow (over 2 minutes) intravenous
injection up to
a maximum of 50 mg, after dilution to a volume of 20 ml per 50 mg
dose, which may
be repeated every 6 to 8 hours; or as an intermittent intravenous
infusion at a rate of
25 mg per hour for two hours; the infusion may be repeated at 6 to 8
hour intervals,
or as an intramuscular injection of 50 mg (2 ml) every 6 to 8 hours.
Prophylaxis of haemorrhage from stress ulceration or recurrent
haemorrhage:
In the prophylaxis of haemorrhage from stress ulceration in seriously
ill patients or
the prophylaxis of recurrent haemorrhage in patients bleeding from
peptic ulceration,
parenteral administration may be continued until oral feeding
commences. Patients
considered to be still at risk may then be treated with Zantac Tablets
150 mg twice
daily.
In the prophylaxis of upper gastro-intestinal haemorrhage from stress
ulceration in
seriously ill patients a priming dose of 50 mg as a slow intravenous
injection followed
by a continuous intravenous infusion of 0.125-0.250 mg/kg/hr may be
preferred.
Prophylaxis of Mendleson’s syndrome:
In patients considered to be at risk of developing acid aspiration
syndrome, Zantac
Injection 50 mg may be given intramuscularly or by slow intravenous
injecti

Termékjellemzők

OBJECT 1
ZANTAC INJECTION 50MG/2ML
Summary of Product Characteristics Updated 26-Oct-2015 |
GlaxoSmithKline UK
1. Name of the medicinal product
Zantac Injection 50 mg/2ml
2. Qualitative and quantitative composition
Ranitidine Hydrochloride HSE 56.0 mg/2ml equivalent to Ranitidine 50.0
mg/2ml.
Each ampoule contains 2.9 mg (0.09 mmol) of sodium and 0.6 mg (0.015
mmol) of potassium.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Injection (Aqueous solution)
A clear colourless to pale yellow liquid, practically free from
particles.
4. Clinical particulars
4.1 Therapeutic indications
Adults:
Zantac Injection is indicated for the treatment of duodenal ulcer,
benign gastric ulcer, post - operative
ulcer, reflux oesophagitis, Zollinger - Ellison Syndrome and the
following conditions where reduction of
gastric secretion and acid output is desirable:
The prophylaxis of gastrointestinal haemorrhage from stress ulceration
in seriously ill patients, the
prophylaxis of recurrent haemorrhage in patients with bleeding peptic
ulcers and before general
anaesthesia in patients considered to be at risk of acid aspiration
(Mendelson's Syndrome), particularly
obstetric patients during labour. For appropriate cases, Zantac
tablets are also available.
Children (6 months to 18 years):
Zantac Injection is indicated for the short term treatment of peptic
ulcer and the treatment of gastro-
oesophageal reflux, including reflux oesophagitis and symptomatic
relief of gastro-oesophageal reflux
disease.
4.2 Posology and method of administration
(See section 5.2 Pharmacokinetic properties – Other special -
populations)
Posology
Adults (including elderly) / Adolescents (12 years and over)
Zantac Injection may be given either as a slow (over 2 minutes)
intravenous injection up to a maximum of
50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may
be repeated every 6 to 8 hours; or
as an intermittent intravenous infusion at a rate of 25 mg per hour
for two hours; the infusion may be
repeated at 6 to 8 hour in