GLYCERYL TRINITRATE-HAMELN INJECTION 1MGML

Country: Singapore

Language: English

Source: HSA (Health Sciences Authority)

Active ingredient:

Glyceryl Trinitrate (GTN on glucose 1.96% w/w)

Available from:

ZYFAS PHARMA PTE LTD

ATC code:

C01DA02

Pharmaceutical form:

INFUSION, SOLUTION

Composition:

Glyceryl Trinitrate (GTN on glucose 1.96% w/w) 1.000 MG/ML

Administration route:

INTRAVENOUS

Prescription type:

Prescription Only

Manufactured by:

Siegfried Hameln GmbH

Authorization status:

ACTIVE

Authorization date:

2016-10-20

Summary of Product characteristics

GLYCERYL TRINITRATE-HAMELN 1 MG/ML Injection
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Glyceryl Trinitrate-hameln 1 mg/ml Injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
1 ml solution contains 1 mg glyceryl trinitrate (GTN).
Amount of active substance per pack size:
TOTAL VOLUME
TOTAL GTN CONTENT
CONTAINER
10 ml
10 mg
ampoule
50 ml
50 mg
vial
For excipients, see 6.1.
3.
PHARMACEUTICAL FORM
Solution for infusion
The product is a clear and colourless solution.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
_SURGERY:_
Glyceryl Trinitrate-hameln 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-hameln
may
be
used
to
treat
unresponsive congestive heart failure secondary to acute
myocardial infarction.
_UNSTABLE ANGINA:_
Glyceryl Trinitrate-hameln may be used to treat unstable
angina, which is refractory to treatment with beta blockers
and sublingual nitrates.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
POSOLOGY
_Adults_
The dose of Glyceryl Trinitrate-hameln should be adjusted
to meet the individual needs of the patient.
The recommended dosage range is 10-200 micrograms/
min but up to 400 micrograms/min may be necessary dur-
ing some surgical procedures.
_Paediatric population_
The safety and efficacy of Glyceryl Trinitrate-hameln has
not yet been established in children.
_Elderly population_
There
is
no
evidence
that
a
posology
adjustment
is
required in the elderly.
_Patients with renal and hepatic impairment_
Additional dose adjustments in patients with severe hepatic
insufficiency or severe renal failure may be necessary and
require additional monitoring.
USE IN SURGERY
A starting dose of 25 micrograms/min is recommended for
the control of hypertension, or to produce hypotension dur-
ing surgery. This may be increased by incr