Nitronal 5mg/5ml solution for infusion ampoules

Country: Միացյալ Թագավորություն

language: անգլերեն

source: MHRA (Medicines & Healthcare Products Regulatory Agency)

active_ingredient:

Glyceryl trinitrate

MAH:

Beaumont Pharma Ltd

ATC_code:

C01DA02

INN:

Glyceryl trinitrate

dosage:

1mg/1ml

pharmaceutical_form:

Solution for infusion

administration_route:

Intravenous

class:

No Controlled Drug Status

prescription_type:

Valid as a prescribable product

leaflet_short:

BNF: 02060100; GTIN: 5013675000560

PIL

PACKAGE LEAFLET: INFORMATION FOR THE USER
GLYCERYL TRINITRATE
Read all of this leaflet carefully before you start taking this
medicine.
– Keep this leaflet. You may need to read it again.
– If you have any further questions, ask your doctor or pharmacist.
– This medicine has been prescribed for you. Do not pass it on to
others. It may harm them,
even if their symptoms are the same as yours.
–
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet,
please tell your doctor or pharmacist.
223050025/10 GI Nitronal / 148 x 320 / LC 7954 / England / fub
Nitronal
®
1 mg/ml solution for infusion
In this leaflet:
1. What Nitronal
®
is and what it is used for
2. Before you take Nitronal
®
3. How to take Nitronal
®
4. Possible side effects
5. How to store Nitronal
®
6. Further information
1. WHAT NITRONAL
®
IS AND WHAT IT IS USED FOR
Nitronal
®
contains glyceryl trinitrate (GTN). GTN belongs to a group of
medicines called nitrates,
which relax the muscle around blood vessels and make the heart’s
work easier.
Nitronal
®
is a medicine which is only used in hospitals. It is used in three
conditions:
–
in heart failure
–
in angina
–
to lower the blood pressure during surgery.
All patients given Nitronal
®
are monitored very carefully.
2. BEFORE YOU TAKE NITRONAL
®
Do not take Nitronal
®
if you
–
are ALLERGIC (hypersensitive) to NITRATES or ANY OF THE OTHER
INGREDIENTS of Nitronal
®
(see list
of ingredients in Section 6). An allergic reaction may include rash,
itching, difficulty breathing
or swelling of the face, lips, throat or tongue.
–
are taking VIAGRA (sildenafil) or similar products for the treatment
of erectile dysfunction or
hypertension of arterial lung vessels. If you take these products and
Nitronal
®
, a severe and
possibly dangerous fall in blood pressure can occur. This would result
in collapse, uncon-
sciousness and could be fatal.
–
are suffering from:
–
acute circulatory failure
–
shock
–
low blood pressure
–
a condition c

SPC

OBJECT 1
NITRONAL
Summary of Product Characteristics Updated 08-May-2018 | Intrapharm
Laboratories Limited
1. Name of the medicinal product
Nitronal
®
2. Qualitative and quantitative composition
Glyceryl trinitrate 1 mg/ml.
3. Pharmaceutical form
Solution for infusion.
4. Clinical particulars
4.1 Therapeutic indications
(1) Unresponsive congestive heart failure, including that secondary to
acute myocardial infarction.
(2) Refractory unstable angina pectoris and coronary insufficiency,
including Prinzmetal's angina.
(3) Control of hypertensive episodes and / or myocardial ischaemia
during and after cardiac surgery. For
the induction of controlled hypotension for surgery.
4.2 Posology and method of administration
For intravenous use. Nitronal® should be administered by means of a
micro-drip set infusion pump or
similar device which permits maintenance of constant infusion rate.
_Adults and the elderly _- the dose should be titrated against the
individual clinical response.
(1) Unresponsive congestive heart failure. The normal dose range is
10-100 micrograms / minute
administered as a continuous intravenous infusion with frequent
monitoring of blood pressure and heart
rate. The infusion should be started at the lower rate and increased
cautiously until the desired clinical
response is achieved. Other haemodynamic measurements are extremely
important in monitoring
response to the drug: These may include pulmonary capillary wedge
pressure, cardiac output and
precordial electrocardiogram depending on the clinical picture.
(2) Refractory unstable angina pectoris. An initial infusion rate of
10-15 micrograms / minute is
recommended; this may be increased cautiously in increments of 5-10
micrograms until either relief of
angina is achieved, headache prevents further increase in dose, or the
mean arterial pressure falls by more
than 20 mm Hg.
(3) Use in surgery. An initial infusion rate of 25 micrograms / minute
is recommended; this should be
increased gradually until the desired systolic arterial pressure is
attained. T