Glyceryl trinitrate 50mg/10ml solution for infusion ampoules

国: イギリス

言語: 英語

ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)

有効成分:

Glyceryl trinitrate

から入手可能:

Pfizer Ltd

ATCコード:

C01DA02

INN（国際名）:

Glyceryl trinitrate

投薬量:

5mg/1ml

医薬品形態:

Solution for infusion

投与経路:

Intravenous

クラス:

No Controlled Drug Status

処方タイプ:

Valid as a prescribable product

製品概要:

BNF: ; GTIN: 5015997884651

情報リーフレット

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
GLYCERYL TRINITRATE 5 MG/ML STERILE CONCENTRATE
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

If any of the side effects gets serious, or if you notice any side
effects not
listed in this leaflet, please tell your doctor.
IN THIS LEAFLET:
1.
What Glyceryl Trinitrate Sterile Concentrate is and what it is used
for
2.
Before Glyceryl Trinitrate Sterile Concentrate is used
3.
How Glyceryl Trinitrate Sterile Concentrate is used
4.
Possible side effects
5.
How Glyceryl Trinitrate Sterile Concentrate is stored
6.
Further information
1.
WHAT GLYCERYL TRINITRATE STERILE CONCENTRATE IS
AND WHAT IT IS USED FOR
Glyceryl Trinitrate Sterile Concentrate is a vasodilator (a medicine
that widens the
blood vessels).
Glyceryl trinitrate is used for the control of blood pressure during
operations or to
improve blood flow during and after heart operations. It can also be
given to you
after you have had a heart attack or to control angina attacks (sudden
pains in the
chest) when other medicines have not worked.
2.
BEFORE GLYCERYL TRINITRATE STERILE CONCENTRATE IS
USED
GLYCERYL TRINITRATE STERILE CONCENTRATE SHOULD NOT BE USED

if
you have shown signs of hypersensitivity
(severe allergy) to glyceryl
trinitrate or medicines of the same group (organic nitrates) in the
past

if you have low blood pressure or a low blood volume (e.g. if you have
had
severe blood loss)

if you suffer from increased intracranial pressure (high pressure
within the
skull)

if you have had a ‘bleed’ on the brain

if you have inflammation of the outer lining of the heart or
compression of the
heart due to the collection of fluid around the heart

if you are very anaemic (low iron content or low levels of blood cells
in your
blood)

if you have low oxygen levels in your blood
2

if you are taking sildenafil (Viagra) or similar medicines use

製品の特徴

OBJECT 1
GLYCERYL TRINITRATE 5 MG/ML STERILE CONCENTRATE
Summary of Product Characteristics Updated 01-Mar-2017 | Hospira UK
Ltd
1. Name of the medicinal product
Glyceryl Trinitrate 5 mg/ml Sterile Concentrate.
2. Qualitative and quantitative composition
1 ml of solution contains 5 mg of glyceryl trinitrate. Each 5 ml and
10 ml ampoules contains 25 mg and
50 mg glyceryl trinitrate respectively.
For excipients, see 6.1
3. Pharmaceutical form
Concentrate for solution for infusion
Ampoules containing a clear, practically colourless solution.
4. Clinical particulars
4.1 Therapeutic indications
SURGERY: Glyceryl trinitrate is indicated for:
1. the rapid control of hypertension during cardiac surgery.
2. reducing blood pressure and maintaining controlled hypotension
during surgical procedures.
3. controlling myocardial ischaemia during and after cardiovascular
surgery.
UNRESPONSIVE CONGESTIVE HEART FAILURE: Glyceryl trinitrate may be used
to treat unresponsive
congestive heart failure secondary to acute myocardial infarction.
UNSTABLE ANGINA: Glyceryl trinitrate may be used to treat unstable
angina that is refractory to treatment
with beta-blockers and sublingual nitrates.
4.2 Posology and method of administration
Posology
_Adults _
The dose of glyceryl trinitrate should be adjusted to meet the
individual needs of the patient. The
recommended dose range is 10-200 microgram/min, although up to 400
microgram/min may be necessary
during some surgical procedures.
_Paediatric Population_
The safety and efficacy of glyceryl trinitrate has not yet been
established in children.
_Elderly Population_
There is no evidence that a posology adjustment is required in the
elderly.
_Surgery _
A starting dose of 25 microgram/min is recommended for the control of
hypertension, or to produce
hypotension during surgery. This may be increased by increments of 25
microgram/min at 5 minute
intervals until the blood pressure is stabilised. Doses between 10-200
microgram/min are usually
sufficient during surgery, although doses of up to 400 mic