NITROCINE 1MG/ML SOLUTION FOR INFUSION

Active substance: GLYCERYL TRINITRATE

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Abreißperforation

®

1 mg/ml

Solution for Infusion

CIA76976A_MU_3 10/112 1135

glyceryl trinitrate

CIA76976A_MU_3_GI_MON_Nitrocine_GBR.indd 1

diastolic volume and preload. The net effect is a
lowering of myocardial oxygen consumption.
Sys­ emic vascular resistance, pulmonary vascular
t
and arterial pressure are also reduced by glyceryl
trinitrate and there is a net reduction in afterload.
Glyceryl trinitrate improves the myocardial
oxy­ en supply by redistributing blood flow along
g
collateral channels from epicardial to endocardial
regions.
Dosage
Use as directed by your physician.
Adults:
The dose of Nitrocine® should be adjusted to
meet the individual needs of the patient.
The recommended dosage range is 10-200mcg/min
but up to 400mcg/min may be necessary during some
surgical procedures.
Children:
The safety and efficacy of Nitrocine® has not yet
been established in children.
Elderly:
There is no evidence that a posology adjustment is
required in the elderly.
Surgery:
A starting dose of 25mcg/min is recommended
for the control of hypertension, or to produce
hypotension during surgery. This may be increased
by increments of 25mcg/min at 5 minute in­ er­­
t vals
until the blood pressure is stabilized. Doses between
10-200mcg/min are usually sufficient
du­ ing surgery, although doses of up to 400mcg/min
r
have been required in some cases.
The treatment of perioperative myocardial
ischa­ mia maybe started with a dose of 15-20mcg/
e
min, with subsequent increments of 10-15mcg/min
until the required effect is obtained.
Unresponsive congestive heart failure:
The recommended starting dose is 20-25mcg/min.
This may be decreased to 10mcg/min, or increased

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Nitrocine

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Aesica Id.-No.

GBR/IRL

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external Id.-No.

CIA76976A_MU_3

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Dimensions

140 x 520 mm

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Operator

Sorek

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Creation Date

25.06.2014

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Edition No.

01

Patient Information Leaflet

nitrocine

®

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

1 mg/ml

Solution for Infusion
glyceryl trinitrate

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 further questions, please 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
• In this leaflet Nitrocine 1 mg/ml w/v Solution for
Infusion will be called Nitrocine.
In this leaflet:
1. What Nitrocine is for
2. Before you are given Nitrocine
3. How you will be given Nitrocine
4. Possible side effects
5. How to store Nitrocine
6. Further information.

1. What Nitrocine is for

Abreißperforation

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
4
 0789 Monheim, Germany

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.
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 volume
of infusion vehicle with an equal volume of Nitrocine®
to produce the final infusion solution. For example
to obtain an admixture of glyceryl trinitrate at a
concentration of 100mcg/ml, add 50 ml Nitrocine®
solution (containing 50 mg glyceryl trinitrate) to 450
ml of infusion vehicle to give a final volume of 500
ml. For different concentrations, refer to summary of
product characteristics.
Example:
If a dosage of 100mcg/min is required, this can be
obtained using an admixture of glyceryl trinitrate
containing 100mcg/ml by giving 60 ml of the ad­
mixture per hour. This is equivalent to a drip rate
of 60 paediatric microdrops/minute, or 20 standard
drops/minute. At this drip rate, the infusion will last
for 8 hours and 20 minutes.
Prepared admixtures should be given by intravenous
infusion or with the aid of a syringe pump to ensure
a constant rate of infusion. During Nitrocine®
administration there should be close haemodynamic
monitoring of the patient.

CIA76976A_MU_3 10/112 1135

nitrocine

User information leaflet
nitrocine® 1mg/ml
solution for infusion
glyceryl trinitrate
Presentation
Nitrocine® is a solution for infusion and is available in
10 ml ampoules containing 10 mg glyceryl trinitrate
or 50 ml vials containing 50 mg glyceryl trinitrate.
In both cases, each ml of solution contains 1 mg
glyceryl trinitrate.
Nitrocine® also contains glucose anhydrous,
propylene glycol, water for injection and
hydrochloric acid for pH adjustment.
Nitrocine® is an isotonic sterile solution.
Uses
Surgery:
Nitrocine® 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:
Nitrocine® may be used to treat unresponsive con­­
gestive heart failure secondary to acute myocar­ ial
d
infarction.
Unstable angina:
Nitrocine® may be used to treat unstable angina
which is refractory to treatment with beta blockers
and sublingual nitrates.
Pharmacological actions
Glyceryl trinitrate reduces the tone of vascular
smooth muscle, with a more marked effect on
the venous capacitance vessel than on the arterial
vessels. This reduces venous return to the heart
and lowers elevated filling pressure. The lowering
of filling pressure reduces the left ventricular end

Nitrocine belongs to a group of medicines called
‘nitrates’. These are used to widen your blood
vessels and reduce the workload of your heart.
Nitrocine is usually used in emergency
situations to:
• Rapidly control high blood pressure during
surgery, especially heart surgery
• Treat unstable angina. (Angina attacks feel like a
tight pain in your chest, neck or arm and are a
sign that your heart is not getting enough oxygen
for the amount of work it is doing)
• Treat heart failure following a heart attack.
It is very important that your doctor treats these
conditions as quickly and effectively as possible,
as left untreated the consequences could be fatal.

2. Before you are given Nitrocine
Do not use Nitrocine if:
• You are allergic to glyceryl trinitrate or to any of
the other ingredients in Nitrocine (See section 6)
• You are allergic to any other nitrates
• You are taking medicines for failure to achieve
an erection such as Viagra. Using Nitrocine with
these medicines could cause a severe drop in
blood pressure and could lead to collapse and
unconsciousness, and may be fatal
• You suffer from low blood pressure
• You suffer from low blood volume
• You suffer from severe anaemia (low iron levels
in your blood)
• You have ever had a serious head injury, cerebral
haemorrhage (bleeding in the brain) or a disease
which is accompanied by increased pressure on
the brain
• You have or had heart conditions
If any of the above applies to you talk to your
doctor.
Check with your doctor before using
Nitrocine if:
• You have an underactive thyroid gland
• You have any diseases of the liver or kidneys
• You have hypothermia (very low body
temperature)
• You are malnourished (severe lack of food)
• You are pregnant or breastfeeding.
Taking other medicines
• Do not take Nitrocine with medicines
for failure to achieve an erection such
as Viagra. Using Nitrocine with these
medicines could cause a severe drop in
blood pressure and could lead to collapse
and unconsciousness, and may be fatal.

Tell your doctor if you are taking any of the
following medicines:
• Medicines which reduce blood pressure
(e.g. beta-blockers, calcium channel blockers,
vasodilators)
• Tricyclic anti-depressants (used to treat
depression)
• Neuroleptics (used to treat anxiety)
• Any other medicine, including medicines
obtained without a prescription.
• Non-steroidal anti-inflammatory drugs except
acetyl salicylic acid.
• Sapropterine containing medicines.
If any of the above applies to you, talk to your
doctor before you are given Nitrocine.
Using Nitrocine with food and drink
Do not drink alcohol whilst using Nitrocine as it
can cause your blood pressure to drop. This may
make you may feel dizzy or faint.
Pregnancy and breast-feeding
If you are pregnant, trying to become pregnant
or breast feeding, tell your doctor before you are
given Nitrocine.

3. How you will be given Nitrocine
Important:
Your doctor will choose the dose that
is right for you. Your medicine will be
administered by a doctor in hospital. It will
be given via a drip into your bloodstream
and may be diluted or undiluted.
Nitrocine is not suitable for children.
Adults
• The usual dose is between 10 micrograms and
200 micrograms per minute, but sometimes as
much as 400 micrograms per minute may be
needed

25.06.14 11:11

Abreißperforation

• The exact dose that the doctor will give you
depends on the condition you are being treated
for. As a guide:
To control high blood pressure during
surgery:
• 25 micrograms per minute will be given as a
starting dose
• This may be increased by 25 micrograms per
minute at 5 minute intervals until your blood
pressure is stabilised
• Doses up to 400 micrograms per minute may
occasionally be needed.
To control myocardial ischaemia during and
after cardiovascular surgery:
15-20 micrograms per minute will be given as a
starting dose
Depending on your response, the dose may be
increased by increments of 10-15 micrograms per
minute until the desired effect is obtained.
To treat unstable angina:
• 10 micrograms per minute will be given as a
starting dose
• Depending on your response, the dose may be
increased or decreased by 10 micrograms every
30 minutes until the desired effect is achieved.
Treat heart failure following a heart attack:
• 20-25 micrograms per minute will be given as a
starting dose
• Depending on your needs, the doctor may
decrease the dose by 10 micrograms per minute
or give you a further 20-25 micrograms per
minute until the required effect is obtained.
While you are being given Nitrocine, the doctor
may monitor your heart rate and breathing to make
sure that the medicine is working properly.

If you are given more Nitrocine than you
should
This is unlikely as Nitrocine will be injected slowly by
a doctor who will monitor your heart continuously
during treatment. If any problem occurs, Nitrocine
can be stopped and any symptoms of overdosage
treated urgently.
If you have any further questions about this
medicine, ask your doctor.

4. Possible side effects
Like all medicines, Nitrocine can cause side effects,
although not everybody gets them.
Common side effects:
• You may have headaches, abnormally fast, slow
or irregular heart beat, feel dizzy when stand
up suddenly, weakness and feel sick whilst being
given Nitrocine.
Other side effects:
• dizziness
• sleepiness
• chest pain
• heart failure
• vomiting
• heartburn
• allergic skin reactions (skin rash, redness, itch,
buring sensation, irriation)
If any of the side effects gets serious, please tell
your doctor immediately.

Marketing Authorisation Holder

5. How to store Nitrocine
Keep out of the reach and sight of children.
Do not use Nitrocine after the expiry date shown
on the label. The expiry date refers to the last day
of that month.
Nitrocine is for single use only.
Unopened, this medicinal product does not require
any special storage conditions.
When opened, Nitrocine must be used immediately.
If it has to be diluted, the mixed product should
also be used immediately.
Medicines should not be disposed of via wastewater
or household waste. Return all unused medicine to
your pharmacist.
Your doctor or nurse will make sure your medicine
is correctly stored and disposed of.

6. Further information
What Nitrocine contains
The active ingredient in Nitrocine is glyceryl
trinitrate. Each 1 ml of solution contains 1 mg
glyceryl trinitrate.
The other ingredients are glucose, propylene glycol,
water for injection and hydrochloric acid for pH
adjustment.
What Nitrocine looks like
Nitrocine 1mg/ml Solution for Infusion is an
isotonic sterile solution. It is supplied in packs of
10 ampoules, each containing 10 mg glyceryl
trinitrate in 10 ml solution, or in a single glass
vial containing 50 mg glyceryl trinitrate in 50 ml
solution.

In UK
UCB Pharma Ltd, 208 Bath Road, Slough,
Berkshire, SL1 3WE, UK.
In Ireland
UCB (Pharma) Ireland Ltd, United Drug House,
Magna Drive, Magna Business Park, Citywest Road,
Dublin 24, Ireland
Manufacturer
Aesica Pharmaceuticals GmbH,
Alfred-Nobel-Strasse 10,
D-40789 Monheim,
Germany.
This leaflet was last updated 06/2014

If this leaflet is difficult to
read and you would like it in a
different format, please contact
the Marketing Authorisation
Holder in your country.

CIA76976A_MU_3 10/112 1135

CIA76976A_MU_3_GI_MON_Nitrocine_GBR.indd 2

Abreißperforation

Note:

Aesica Pharmaceuticals GmbH
Packaging Technology & Artwork Services
Alfred-Nobel-Straße 10
4
 0789 Monheim, Germany

Artwork Studio checks and approves technical accuracy and pre-press
suitability of this artwork only. Ensure the artwork has been thoroughly
checked for textual accuracy and has been approved as such!

Nitrocine

Print Colours

Aesica Id.-No.

GBR/IRL

black

external Id.-No.

CIA76976A_MU_3

Dispatched to

Dimensions

140 x 520 mm

Artwork Information

Operator

Sorek

Fontsize Bodytext

Creation Date

25.06.2014

Technical Changes

Product Name

Techn. Colours

Artwork Studio

Date

Operator

Schlüter

Manufacturing Site

7,5 pt

Linespacing

Approver

PT Approval

8,3 pt

Amended by

Modific. Date
Edition No.

01

Vials of Nitrocine® are for single use only and should
not be regarded as multi-dose containers.
Children:
The safety and efficacy of Nitrocine has not yet
been established in children.
Contraindications, warnings, etc.
Contraindications:
Nitrocine should not be used in the following cases:
known hypersensitivty to the active substance,
other nitro compounds or to any the excipients,
acute circulatory failure, cardiogenic shock,
severe anaemia, closed angle glaucoma, severe
hypotension, severe hypovolemia, hypertrophic
obstructive cardiomyopathy, aortic and mitral
stenosis, constrictive pericarditis, cardiac tamponade,
conditions with increased intracranial pressue.
Nitrocine® must not be given to patients taking
phosphodiesterase 5 in­ ibitors, e.g. sildenafil due to
­ h
poten­ ially life threatening potentiation of hypotension
t
by sildenafil.
Beta blockers, calcium antagonists, vasodilators, ACE
inhibitors, diuretics, antihypertensives and alcohol may
also exacerbate the hypotensive effects of Nitrocine®.
This might also occur with neuroleptics and tricyclic
anti depressants.
Simultaneous intravenous infusions of tissue
plasminogen activator (tPA) may accelerate plasma
clearance of tPA.
Nitrocine may increase the blood level of
dihydroergotamine and its affects. Nitrocine
administered with heparin may lead to partial loss
of action of heparin. Concurrent administration of
nitrocine with salicylic acid may potentiate the blood
pressure lowering effects of Nitrocine.
Precautions:
Nitrocine must used only with particular caution and
under medical supervision low filling pressures, aortic/
mistral stenosis, orthostatic dysfuction. Tolerance and
cross tolerance to other nitro compounds has been

VPT-Pool/Technik/ABV_SOP_Vorgaben/Freigabefeld/Freigabefeld_Aesica_08/2011

described. The material of PVC/PU may induce a loss of
the active due to adsorption.
The solution contains glucose, this should be
considered for diabetes mellitus patients.
Nitrocine should be used in caution in patients
with hypoxaemia and methemoglobinemia.
Pregnancy and lactation:
There is no, or inadequate, evidence of safety of the
drug in human pregnancy or lactation, but it has been
in widespread use for many years without apparent ill
consequence, animal studies having shown no hazard. If
drug therapy is needed in pregnancy, this product can be
used if there is no safer alternative.
Adverse effects:
Severe hyptension responses have been reported
for organic nitrates and include nausea, vomiting,
restlessness, pallor and excessive perspiration.
Other possible adverse reactions include headache,
dizziness, tachycardia, enhanced angina pectoris
symptoms, orthostatic hypotension, circulatory
collapse, nausea, vomiting, heartburn, allergic skin
reactions and skin dermatitis, dermatitis exfoliative,
asthenia, pruritus, burning, erythema and irriatation.
Reporting of side effects
If you get any side effects talk to your doctor or
pharmacist. This includes any possible side effects not
listed in this leaflet. You can also report side effects
directly via the national reporting system:
UK
The Yellow Card Scheme
Website: www.mhra.gov.uk/yellowcard
Ireland
Pharmacovigilance Section · Irish Medicines Board
Kevin O’Malley House · Earlsfort Centre
Earlsfort Terrace · IRL - Dublin 2
Tel: +353 1 6764971 · Fax: +353 1 6762517
Website: imbpharmacovigilance@imb.ie
By reporting side effects you can help provide more
information on the safety of this medicine.

Overdose:
Mild overdose usually results in hypotension and
tachycardia. If arterial systolic blood pressure
drops below 90 mmHg and if heart rate increases
10 % above its initial value, the infusion should be
discontinued to allow a return to pretreatment levels.
If hypotension persists, or in more severe cases,
this may be reversed by elevating the legs, supply
oxygen, expand plasma volume and/or treatment with
hypertensive agents.
Pharmaceutical precautions
Chemical and physical in-use stability of the admixture
has been demonstrated for 24hrs
at 25°C in suitable containers.
From a microbiological point of view, the admixture
should be used immediately. If not used immediately,
in-use storage conditions prior to use are the
responsibility of the user and would not normally
be longer than 24 hours at 2 to 8°C, unless
dilution has taken place in controlled and validated
aseptic conditions.
Open ampoules or vials should be used immediately
and any unused drug discarded.
Compatibility:
Nitrocine® is incompatible with polyvinylchloride
(PVC) and severe losses of glyceryl trinitrate (over
40 %) may occur if this material is used. Contact
with polyvinylchloride bags should be avoided.
Polyurethane also induces a loss of the active
ingredient. Nitrocine® is compatible with glass
in­usion bottles and with rigid infusion packs made of
f
polyethy­lene. Nitrocine® may also be infused slowly using
a syringe pump with a glass or plastic syringe.
This product does not require any special storage
conditions.
Keep out of the reach and sight of children.
Legal category
POM

Package quantities
Ampoules: each pack contains 10 x 10 ml ampoules
of Nitrocine®
Bottles: each pack contains 1 x 50 ml vial of Nitrocine®
Product licence number
PL 00039/0747
Product authorisation numbers
Nitrocine® 1mg/ml solution for infusion, 10 ml
ampoule
PA 891/13/1
Nitrocine® 1mg/ml solution for infusion, 50 ml vial
PA 891/13/2
Name and address of marketing
au­thorisation holder
In UK
UCB Pharma Limited,
208 Bath Road, Slough, Berkshire, SL1 3WE,
United Kingdom
In Ireland
UCB (Pharma) Ireland Ltd,
United Drug House,
Magna Drive,
Magna Business Park, Citywest Road,
Dublin 24, Ireland
Distributed in Republic of Ireland by
United Drug Distribution Group Limited
Magna Drive, Citywest Road
Dublin 24 ,Ireland
Name and address of
manufacturer
Aesica Pharmaceuticals GmbH
Alfred-Nobel-Strasse 10
Monheim D 40789, Germany
Date of preparation
06/2014

CIA76976A_MU_3 10/112 1135

25.06.14 11:11

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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