NITROCINE 1 Mg/Ml Solution for Infusion
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Patient Information leaflet
(PIL)
19-04-2024
Summary of Product characteristics
(SPC)
19-04-2024
Active ingredient:
GLYCERYL TRINITRATE
Available from:
UCB (Pharma) Ireland Limited
INN (International Name):
GLYCERYL TRINITRATE
Dosage:
1 Mg/Ml
Pharmaceutical form:
Solution for Infusion
Prescription type:
Product subject to prescription which may not be renewed (A)
Authorization status:
Authorised
Authorization date:
0000-00-00
Patient Information leaflet
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Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
40789 Monheim, Germany
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Technical Changes
Product Name
Nitrocine
Print Colours
Techn. Colours
Aesica Id.-No.
4015108 GBR/IRL
BLACK
external Id.-No.
Dimensions
140 x 520 mm
Operator
Sorek
Creation Date
31.01.2012
Amended by
Sorek
Modific. Date
28.02.2012
Edition No.
02
VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011
UNRESPONSIVE CONGESTIVE HEART FAILURE:
The recommended starting dose is 20-25mcg/min.
This may be decreased to 10mcg/min, or increased
in steps of 20-25mcg/min every 15-30 minutes until
the desired effect is obtained.
UNSTABLE ANGINA:
An initial dose of 10mcg/min is recommended with
increments of 10mcg/min being made at approximately
30 minute intervals according to the needs of the
patient. Patients with severe anginal syndromes must
be treated with a posology of 33-133µg/min.
For patients in a hypertensive crisis: infuse 33-
133µg/min while constantly monitoring blood
pressure and heart rate.
ADMINISTRATION
Refer to compatibilities at the end of this leaflet.
Nitrocine
®
can be administered undiluted by
slow intravenous infusion using a syringe pump
incorporating a glass or rigid plastic syringe.
Alternatively, Nitrocine may be administered
intravenously as an admixture using a suitable
vehicle such as Sodium Chloride Injection B.P. or
Dextrose Injection B.P. In case of dilution, Nitrocine
must be mixed under aseptic conditions immediately
after opening.
ADMIXTURE PREPARATION:
Admixtures are prepared by replacing a given v
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Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Nitrocine 1 mg/ml solution for infusion, ampoule
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Ampoules containing 10 mg glyceryl trinitrate in 10 ml (1 mg/ml).
For a full list of excipients see Section 6.1.
3 PHARMACEUTICAL FORM
Solution for infusion
Clear colourless and odourless isotonic sterile solution.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
_Surgery_
Nitrocine is indicated for:
_Unresponsive congestive heart failure:_
Nitrocine may be used to treat unresponsive congestive heart failure secondary to acute myocardial infarction.
_Unstable angina:_
Nitrocine 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
_Adults_
The dose of Nitrocine should be adjusted to meet the individual needs of the patient.
The recommended dosage range is 10 - 200 mcg/min but up to 400 mcg/min may be necessary during some surgical
procedures.
_Elderly_
There is no evidence that a posology adjustment is required in the elderly
_Paediatric population_
The safety and efficacy of Nitrocine has not yet been established in children.
_Surgery_:
A starting dose of 25 mcg/min is recommended for the control of hypertension, or to produce hypotension during
surgery. This may be increased by increments of 25 mcg/min at 5 minute intervals until the blood pressure is stabilized.
Doses between 10 - 200 mcg/min are usually sufficient during surgery, although doses of up to 400 mcg/min have been
required in some cases.
The treatment of perioperative myocardial ischaemia may be started with a dose of 15 - 20 mcg/min, with subsequent
increments of 10 - 15 mcg/min until the required effect is obtained.
1. The rapid control of hypertensi
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