Trinitrina concentrate for solution for infusion

Maa: Armenia

Kieli: englanti

Lähde: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Aktiivinen ainesosa:

nitroglycerin

Saatavilla:

FISIOPHARMA S.R.L.

ATC-koodi:

C01DA02

INN (Kansainvälinen yleisnimi):

nitroglycerin

Annos:

5mg/1,5ml

Lääkemuoto:

concentrate for solution for infusion

Kpl paketissa:

(10) ampoules 1.5ml

Prescription tyyppi:

Prescription

Valtuutuksen tilan:

Registered

Valtuutus päivämäärä:

2023-04-05

Pakkausseloste

PACKAGE LEAFLET: INFORMATION FOR THE USER
TRINITRINA 5 MG/1.5 ML CONCENTRATE FOR SOLUTION FOR INFUSION
Nitroglycerin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.

Keep this leaflet. You may need to read it again.

If you have any further questions, ask your doctor or nurse.

If you get any side effects talk to your doctor or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET:
1. What Trinitrina is and what it is used for
2. What you need to know before you take Trinitrina
3. How to use Trinitrina
4. Possible side effects
5. How to store Trinitrina
6. Contents of the pack and other information
1. WHAT TRINITRINA IS AND WHAT IT IS USED FOR
Trinitrina contains the active substance nitroglycerin, which belongs
to a group of vasodilator
medicines, used to treat certain heart diseases. This medicine works
by widening the blood vessels
and improving blood flow.
Trinitrina is indicated for the treatment of:

chest pain caused by heart problems, such as unstable angina, variant
angina, and Prinzmetal's
angina.

problems with impaired heart function, such as acute left ventricular
failure due to various
causes and characterised by high blood pressure.

swelling due to accumulation of fluid around the lungs (pulmonary
oedema and pre-
pulmonary oedema).

rapid rise in blood pressure (hypertensive crisis).
2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE TRINITRINA
DO NOT USE TRINITRINA

If you are allergic to nitroglycerin, any other similar medicines
(organic nitrates) or any of the
other ingredients of this medicine (listed in section 6).

If you have severe blood circulation problems due to impaired heart
function (shock,
cardiogenic shock).

If you have had an acute heart attack characterised by low blood
pressure.

If you have very low blood pressure (severe hypotension, < 90 mmHg
systolic pressure).

If you have decreased volume of circulating bloo

Valmisteyhteenveto

Summary of Product Characteristics
TRINITRINA 5MG/1.5ML CONCENTRATE FOR SOLUTION FOR INFUSION
SUMMARY OF PRODUCT CHARACTERISTICS
1. NAME OF THE MEDICINAL PRODUCT
TRINITRINA 5 mg/1.5 ml concentrate for solution for infusion.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
One 1.5 ml ampoule contains:
_Active ingredient: _nitroglycerin 5 mg
For excipients see section 6.1
3. PHARMACEUTICAL FORM
Concentrate for solution for infusion.
4. CLINICAL PARTICULARS
4.1. THERAPEUTIC INDICATIONS
Unstable
angina,
variant
angina,
Prinzmetal
angina.
Acute
left
ventricular
failure
following or not following acute myocardial infarction, particularly
with high filling
pressure and minute-reduced flow rate. Acute pulmonary oedema and
pulmonary pre-
oedema. Hypertensive crisis.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
The dosage should be determined according to the individual needs of
each patient
and according to the response of the parameters to be monitored.
Depending on the
experience reported, the dosage is between 0.5 and 6 mg/hour of
nitroglycerin for
continuous intravenous infusion.
In rare cases these dosages must be exceeded, reaching up to 6
mg/hour. The
solution for intravenous infusion is prepared by diluting
nitroglycerin according to the
table below, and infused using an automatic device or drop by drop,
according to the
infusion table (1 ml corresponds to approximately 20 drops of a normal
infusion).
Dilution table
Number of ampoules
(Mass of active ingredient)
1
(5 mg)
2
(10 mg)
Ampoule solution
1.5 ml
3 ml
Diluting solution (ml)
250
500
Final volume of solution ready
for use (ml)
251.5
503
Final concentration of
nitroglycerin (mg/ml)
[20 drop concentration of a
normal infusion]
0.02
Infusion table
Desired quantity
of NTG per hour
No. drops
per minute
0.50 mg
6-7
0.75 mg
10
1.00 mg
13-14
1.25 mg
17
1.50 mg
20-21
2.00 mg
26-27
Summary of Product Characteristics
2.50 mg
34
3.00 mg
41
3.50 mg
47-48
4.00 mg
53
4.50 mg
59-60
5.00 mg
68
5.50 mg
74-75
6.00 mg
82
4.3 CONTRAINDICATIONS
·
shock
·
cardiogenic shock, unless adequ