Nitroglycerin Bioindustria Lim

Package leaflet: Information for the user

NITROGLICERINA Bioindustria L.I.M. 50 mg/50 ml concentrate for solution for infusion

nitroglycerin
Equivalent medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

1. What NITROGLICERINA Bioindustria L.I.M. is and what it is used for
2. What you need to know before using NITROGLICERINA Bioindustria L.I.M.
3. How to use NITROGLICERINA Bioindustria L.I.M.
4. Possible side effects
5. How to store NITROGLICERINA Bioindustria L.I.M.
6. Contents of the pack and other information

1. What NITROGLICERINA Bioindustria L.I.M. is and what it is used for

NITROGLICERINA Bioindustria L.I.M. contains nitroglycerin, a vasodilator used in the treatment of certain heart diseases. This medicine dilates blood vessels and improves blood circulation.

NITROGLICERINA Bioindustria L.I.M. is indicated for the treatment of:

• unstable angina, variant angina, and Prinzmetal's angina (chest pain caused by reduced blood flow to the heart, which may occur at rest or during exertion);
• acute left ventricular failure (sudden inability of the heart to pump sufficient blood to meet the body's needs), which may occur after acute myocardial infarction (death of heart cells due to prolonged lack of oxygen supply);
• pulmonary edema and pre-pulmonary edema (accumulation of fluid in the lungs that hinders breathing);
• hypertensive crisis (sudden and severe increase in blood pressure).

2. What you need to know before using NITROGLICERIN Bioindustria L.I.M.

Do not use NITROGLICERIN Bioindustria L.I.M.

• if you are allergic to nitroglycerin or to any of the other ingredients of this medicine (listed in section 6).
• NITROGLICERIN Bioindustria L.I.M. must not be used in case of: Shock and cardiogenic shock (reduction in blood flow reaching the organs and tissues of the body);
• Low blood pressure during acute myocardial infarction (death of heart cells due to prolonged lack of oxygen supply);
• Severe hypotension (blood pressure below 90 mm Hg);
• Severe hypovolemia (significant reduction in the amount of circulating blood in the body);
• Increased intracranial pressure, head trauma or cerebral haemorrhage (rupture of a blood vessel in the brain);
• Heart failure due to obstruction, e.g. from aortic or mitral stenosis (narrowing of heart valves), constrictive pericarditis (thickening of the membrane surrounding the heart), obstructive hypertrophic cardiomyopathy (thickening of the heart obstructing blood flow);
• Toxic pulmonary oedema (fluid accumulation in the lungs following exposure to toxic substances);
• Severe anaemia (reduction in the number of red blood cells or amount of haemoglobin, a protein in red blood cells that carries oxygen in the blood);
• Closed-angle glaucoma (a disease causing increased pressure in the eye and vision problems);
• Concomitant use of phosphodiesterase inhibitors and soluble guanylate cyclase stimulators (medicines used for impotence and high blood pressure in the lungs), see
• “Other medicines and NITROGLICERIN Bioindustria L.I.M.”.

Warnings and precautions
Talk to your doctor, pharmacist or nurse before using NITROGLICERIN Bioindustria L.I.M.
This medicine will only be administered in a hospital setting and by specialized medical personnel, who will monitor your blood pressure, heart rate (number of heartbeats per minute) and your general condition.
In severe cases, careful monitoring of central venous pressure (indicating the volume of blood returning to the heart), pulmonary pressure (pressure in the vessels carrying blood from the heart to the lungs), cardiac output (amount of blood pumped by the heart) and electrocardiogram (a test recording the heart's electrical activity) will be performed.
During treatment, especially at the beginning, flushing (sudden sensation of intense heat in the face, neck and chest, often accompanied by sweating and skin redness), headache and postural hypotension (reduction in blood pressure following sudden change from sitting or lying down to standing) may occur; see “Possible side effects” and “If you use more NITROGLICERIN Bioindustria L.I.M. than you should”.
For individuals engaged in sports, the use of medicines containing ethyl alcohol may lead to positive results in anti-doping tests, depending on the alcohol concentration limits established by certain sports federations.
Other medicines and NITROGLICERIN Bioindustria L.I.M.
Inform your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines.
Tell your doctor if you are taking the following medicines:

• vasodilators, used to dilate blood vessels;
• antihypertensives, for lowering blood pressure;
• diuretics that lower blood pressure by increasing urine elimination; indomethacin, an anti-inflammatory and painkiller used for muscle, bone and joint pain;
• alteplase, which dissolves blood clots;
• sildenafil, vardenafil and tadalafil, used for impotence and high blood pressure in the lungs;
• riociguat, used for high blood pressure in the lungs.

Nitroglycerin may alter test results for monitoring cholesterol and triglycerides (blood fats).
NITROGLICERIN Bioindustria L.I.M. and alcohol
Alcohol worsens the low blood pressure caused by nitroglycerin.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor, pharmacist or nurse before using this medicine.
Pregnancy
Your doctor will prescribe NITROGLICERIN Bioindustria L.I.M. only if clearly needed, especially during the first three months of pregnancy.
Breastfeeding
It is not known whether nitroglycerin is excreted in breast milk; therefore, if you are breastfeeding, your doctor will prescribe NITROGLICERIN Bioindustria L.I.M. only if strictly necessary.
Fertility
Studies conducted in rats have not indicated any adverse effects on fertility.
Driving and using machines
Not applicable.
NITROGLICERIN Bioindustria L.I.M. 50 mg/50 ml concentrate for solution for infusion
contains propylene glycol
This medicine contains 52.5 mg of propylene glycol per vial, equivalent to 1.05 mg/1 ml.
If you are pregnant or breastfeeding, do not take this medicine unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.
If you have liver or kidney disease, do not take this medicine unless otherwise advised by your doctor. Your doctor may perform additional monitoring during treatment.

3. How to use NITROGLICERINA Bioindustria L.I.M.

This medicine will be administered to you by a doctor or a nurse. If you have any doubts, consult your
doctor, pharmacist, or nurse.
The recommended dose ranges from 0.5 to 6 mg/hour.
The doctor will determine the dose and method of intravenous administration (continuous drop-by-drop infusion or using an automatic device) based on the severity of your condition.
If you use more NITROGLICERINA Bioindustria L.I.M. than you should
If an excessive dose of nitroglycerin is administered, hypotension (low blood pressure) may occur, leading to tachycardia (increased heart rate), cold and pale skin, headache, dizziness (sensation of movement or spinning), confusion, visual disturbances, nausea, vomiting with abdominal pain associated with watery diarrhea, palpitations (awareness of heartbeat), syncope (sudden and transient loss of consciousness), and cardiovascular collapse (inability of the heart and blood vessels to deliver blood to organs and tissues).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur during treatment.

Rare (may affect up to 1 in 1,000 people)

• methaemoglobinaemia (reduced ability of haemoglobin to carry oxygen in the blood);
• paradoxical bradycardia (unexpected and opposite-to-desired reduction in heart rate).

Very rare (may affect up to 1 in 10,000 people)

• cyanosis (bluish or greyish discolouration of the skin and mucous membranes).

Not known (frequency cannot be estimated from the available data)

• dizziness (sensation of movement or spinning);
• headache;
• tachycardia (increased heart rate);
• palpitations (awareness of heartbeat);
• postural hypotension (drop in blood pressure following sudden change from sitting or lying to standing position);
• nausea;
• digestive disturbances;
• rash (skin eruption);
• blurred vision;
• hot flushes (sudden feeling of intense heat in the face, neck and chest, often accompanied by sweating and skin redness);
• hyperkalaemia (increased potassium levels in the blood);
• hyponatraemia (decreased sodium levels in the blood).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You can also report side effects directly via the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioniavverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NITROGLICERINA Bioindustria L.I.M.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after "Exp.".
The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What NITROGLICERINA Bioindustria L.I.M. contains
NITROGLICERINA Bioindustria L.I.M. 50 mg/50 ml concentrate for solution for infusion

• The active substance is nitroglycerin. Each vial contains 50 mg of nitroglycerin.
• The other components are: propylene glycol, glucose, water for injections.

Description of the appearance of NITROGLICERINA Bioindustria L.I.M. and contents of the pack
NITROGLICERINA Bioindustria L.I.M. 50 mg/50 ml concentrate for injectable solution
Pack containing 1 glass vial of 50 ml.
Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A. (Bioindustria L.I.M. S.p.A.)
Via De Ambrosiis 2, 15067 Novi Ligure (AL) – Italy

The following information is intended exclusively for healthcare professionals

Therapeutic indications
Unstable angina, variant angina, Prinzmetal's angina. Acute left ventricular failure,
with or without preceding acute myocardial infarction, particularly when associated with elevated filling pressure
and reduced cardiac output. Acute pulmonary edema and pre-pulmonary edema. Hypertensive crisis.
Posology and method of administration
The recommended dosage ranges from 0.5 to 6 mg/hour of nitroglycerin for continuous intravenous infusion.
These dosages rarely need to be exceeded, even up to 6 mg/hour.
The infusion solution is prepared by appropriately diluting nitroglycerin according to the
table below and administered via an automated infusion device or by gravity drip, following the infusion table instructions (1 ml corresponds to approximately 20 drops from a standard infusion set).
Dilution table

Infusion table

Paediatric population
The safety and efficacy of NITROGLYCERIN BIOINDUSTRIA LIM have not yet been established.

Method of administration
For instructions on dilution of the medicinal product prior to administration, see “Incompatibilities” and “Special precautions for disposal and handling”.

Special warnings and precautions for use
Headache may occur immediately after administration of nitroglycerin due to cerebral vasodilation that may be induced; this tends to disappear during treatment (see section 4.8).
Signs and symptoms related to potential overdose may include dizziness, confusion, weakness, increased heart rate, hypotension, nausea, vomiting, and methaemoglobinaemia (see “Possible side effects” and “If you use more NITROGLYCERIN BIOINDUSTRIA LIM than you should”).
In addition, nitroglycerin may induce bradycardia, skin flushing, and exfoliative dermatitis (see “Possible side effects”).

Interference with laboratory tests
Nitrates may interfere with the Zlatkis/Zak colorimetric assay, causing a false result of decreased plasma cholesterol.
The propylene glycol content (E1520) may interfere with tests using glycerol oxidase enzyme methodology for triglyceride quantification, leading to falsely elevated results.

Overdose
Administration of fluids is recommended, and if necessary, alpha-adrenergic agonists and methylene blue. Methylene blue must not be used in case of G-6-PD deficiency.

Incompatibilities
Nitroglycerin is compatible with isotonic saline solution, 4–30% glucose solution, Ringer’s solution, and protein-containing solutions. No incompatibilities with other infusion solutions are known. Dilution must be performed only in glass infusion containers.
Nitroglycerin tends to rapidly migrate into many plastic materials; therefore, dilution of the concentrate for infusion solution must be carried out exclusively in glass infusion containers.

Nitroglycerin contained in the final infusion solution may be absorbed by the PVC commonly used in standard administration sets, with losses ranging from 40% to 80% of the total amount; the absorption rate is inversely proportional to the infusion rate. For this reason, polyethylene administration sets are recommended, as they result in significantly lower losses of nitroglycerin.
Infusion solutions containing nitroglycerin must not come into contact with PVC tubing, as loss of active substance may reach up to 80%, depending on the flow rate. Literature data indicate that the use of polyethylene infusion sets results in significantly reduced loss of nitroglycerin from the solution. It is recommended to verify the compatibility of the infusion set material with nitroglycerin before each use.

Special precautions for disposal and handling
The medicinal product must be diluted before intravenous infusion. For dilution instructions, refer to the section “Dosage and method of administration”. It is recommended to use glass infusion containers and polyethylene administration sets (see “Incompatibilities”).
Any unused medicinal product and waste materials derived from such medicinal product should be disposed of in accordance with local regulations.

For further information, please consult the Summary of Product Characteristics.

Package leaflet: information for the user

NITROGLICERINA Bioindustria L.I.M. 5mg/1.5 ml concentrate for solution for infusion

Nitroglycerin
Generic medicine
Please read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet

1. What NITROGLICERINA Bioindustria L.I.M. is and what it is used for
2. What you need to know before you use NITROGLICERINA Bioindustria L.I.M.
3. How to use NITROGLICERINA Bioindustria L.I.M.
4. Possible side effects
5. How to store NITROGLICERINA Bioindustria L.I.M.
6. Contents of the pack and other information

1. What NITROGLICERINA Bioindustria L.I.M. is and what it is used for

NITROGLICERINA Bioindustria L.I.M. contains the active substance nitroglycerin, a vasodilator, used in the treatment of certain heart diseases, and belongs to a group of medicines called organic nitrates.
This medicine works by dilating blood vessels and improving blood circulation.
NITROGLICERINA Bioindustria L.I.M. is indicated for the treatment of:

• chest pain caused by heart problems, unstable angina, variant angina, and Prinzmetal's angina;
• conditions involving reduced heart function, such as acute left ventricular failure due to various causes and characterized by high blood pressure;
• swelling due to fluid accumulation around the lungs (pulmonary edema and pre-pulmonary edema);
• rapid increase in blood pressure (hypertensive crisis).

2. What you should know before using NITROGLICERIN Bioindustria L.I.M.

Do not use NITROGLICERIN Bioindustria L.I.M.

• if you are allergic to nitroglycerin or to similar molecules (related organic nitrates) or to any of the other ingredients of this medicine (listed in section 6);
• if you suffer from a condition causing a severe drop in blood pressure (severe hypotension);
• if you have a reduced blood volume due to blood loss or loss of body fluids (severe hypovolemic states);
• if you have a disease affecting the eye leading to damage of the optic nerve (closed-angle glaucoma);
• if you have fluid accumulation in the lungs caused by medications or toxic substances (toxic pulmonary edema);
• if you are taking medicines for erectile dysfunction (e.g., sildenafil). The combination of nitroglycerin with these medicines may cause a sudden and severe drop in blood pressure.
• if you are taking riociguat, a medicine used to treat pulmonary hypertension (see section “Other medicines and NITROGLICERIN Bioindustria L.I.M.”);
• if you suffer from serious circulatory disorders such as acute circulatory failure, cardiogenic shock, or cardiocirculatory collapse;
• if you have acute myocardial infarction;
• if you are pregnant or breastfeeding (see section “Fertility, pregnancy and breastfeeding”).

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using NITROGLICERIN Bioindustria L.I.M.:

• if you have suffered a head injury (cranial trauma) and have bleeding in the brain (cerebral hemorrhage);
• if you are pregnant or breastfeeding (see section “Fertility, pregnancy and breastfeeding”). This medicine will be administered to you only in a hospital setting and by specialized medical personnel, who will monitor your blood pressure, heart rate (cardiac frequency), blood volume, pressure (systolic pulmonary arterial pressure, left ventricular filling pressure), and perform an electroencephalogram. Use this medicine with extreme caution if you have head problems such as cranial trauma and cerebral hemorrhage.

Other medicines and NITROGLICERIN Bioindustria L.I.M.
Inform your doctor, pharmacist, or nurse if you are taking, have recently taken, or might take any other medicine.
Use particular caution and inform your doctor if you are taking the following medicines, as they may increase the effect of nitroglycerin:

• medicines containing ethanol (alcohol), as they may enhance the action of nitroglycerin;
• medicines used to dilate blood vessels (vasodilators);
• medicines used to lower blood pressure (antihypertensives);
• medicines used to increase urine elimination (diuretics). Use particular caution and inform your doctor if you are taking indomethacin, a medicine used to relieve inflammation, as it may reduce the effectiveness of nitroglycerin. The use of nitroglycerin with riociguat, a soluble guanylate cyclase stimulator, is contraindicated because concomitant use may cause hypotension (see section “Do not use NITROGLICERIN Bioindustria L.I.M.”).

NITROGLICERIN Bioindustria L.I.M. and alcohol
Consumption of ethanol may enhance the effect of this medicine; therefore, avoid drinking alcoholic beverages during treatment with NITROGLICERIN Bioindustria L.I.M.
Fertility, pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor, pharmacist, or nurse before using this medicine.
If you are pregnant or breastfeeding, use NITROGLICERIN Bioindustria L.I.M. with caution, only when strictly necessary and under direct medical supervision.
Driving and using machines
NITROGLICERIN Bioindustria L.I.M. may impair your ability to drive or operate machinery, as it may cause nausea, dizziness, and a drop in blood pressure upon changing posture (postural hypotension).
If these effects occur, you should refrain from driving or operating machinery.
NITROGLICERIN Bioindustria L.I.M. 5 mg/1.5 ml concentrate for solution for infusion contains ethanol (alcohol) and propylene glycol
This medicine contains 33.3 vol% ethanol (alcohol), equivalent to 386 mg of ethanol per vial, which corresponds to 257 mg/ml.
The amount in mg of this medicine is equivalent to 10 ml of beer or 4 ml of wine per vial.
It may be harmful for alcoholics.
This should be taken into account in pregnant or breastfeeding women, children, and high-risk groups such as patients with liver disease or epilepsy.
The amount of alcohol in this medicine may alter the effects of other medicines.
The amount of alcohol in this medicine may impair your ability to drive or operate machinery.
This medicine contains 1040 mg of propylene glycol, which may cause symptoms similar to those caused by alcohol.

3. How to use NITROGLICERINA Bioindustria L.I.M.

This medicine will be administered to you by a doctor, pharmacist, or nurse through continuous intravenous infusion. If you have any doubts, consult your doctor, pharmacist, or nurse.
The recommended dose ranges from 0.5 to 6 mg/hour, depending on the patient's condition and needs, and must be given by continuous drip infusion or by using an automatic device.
Your doctor will determine the dose based on your age, weight, health status, and method of administration.
If you use more NITROGLICERINA Bioindustria L.I.M. than you should
If you think you have been given too high a dose of nitroglycerin, inform your doctor or nurse immediately, as this may cause excessive lowering of blood pressure (severe hypotension) accompanied by increased heart rate (reflex tachycardia).
In case of accidental ingestion/overdose of NITROGLICERINA Bioindustria L.I.M., contact your doctor immediately or go to the nearest hospital.
Depending on the situation, other cardiovascular supportive measures should be taken, such as elevating the patient’s legs and administering plasma substitutes.
If you have any questions about how to use this medicine, ask your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
In case of overdose, the side effects described in section 3 “If you use more NITROGLICERINA Bioindustria L.I.M. than you should” may occur.

The following side effects may occur:

Effects related to the blood
Rare: a condition in which an abnormal form of haemoglobin—the protein that carries oxygen to the body's tissues—accumulates in the blood (methaemoglobinaemia). This adverse effect has been associated with prolonged treatment or high-dose regimens.

Effects related to the nervous system

• Dizziness (vertigo)
• Headache (cephalalgia)
• Confusion

Effects related to the eye

• Blurred vision

Effects related to the heart

• Increased heart rate (tachycardia)
• Awareness of heartbeat (palpitations)
• Decreased heart rate (paradoxical bradycardia)
• Fainting (syncope)

Effects related to blood circulation

• Drop in blood pressure, even after sudden change from sitting or lying position to standing (postural hypotension)

Effects related to the mouth, stomach and intestine

• Nausea
• Digestive disturbances
• Vomiting

Effects related to the skin

• Skin rash
• Skin redness
• Skin rash with peeling

Effects related to the whole body

• Hot flushes with skin irritation and redness (erythema)
• Weakness
• Sweating
• Bluish discoloration of the skin due to lack of oxygen (cyanosis) (very rare frequency)
• Pallor (very rare frequency)

Effects related to the site of administration

• Burning sensation
• Skin irritation and redness (erythema)

Nitroglycerin causes headache (cephalalgia), which may be severe and persistent, due to dilation of cerebral blood vessels: this usually occurs at the beginning of treatment and disappears after a few days without discontinuing therapy.

Dizziness, confusion, weakness, increased heart rate, and other manifestations caused by low blood pressure (hypotension), such as nausea, vomiting, excessive sweating (diaphoresis), pallor, and fainting (lipotimia), are generally related to drug overdose.

Only rarely can nitroglycerin induce a decrease in heart rate (bradycardia) and signs of increased vagus nerve activity (hypervagotonia).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
http://www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store NITROGLICERINA Bioindustria L.I.M.

No special storage conditions regarding temperature are required.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp.".
The expiry date refers to the last day of that month.
The expiry date applies to the medicine in its original, unopened packaging, correctly stored.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Pack contents and other information

What NITROGLICERINA Bioindustria L.I.M. contains
NITROGLICERINA Bioindustria L.I.M. 5mg/1.5ml concentrate for solution for infusion

• The active substance is nitroglycerin. Each vial contains 5 mg of nitroglycerin.
• The other components are: ethanol, propylene glycol.

Description of the appearance of NITROGLICERINA Bioindustria L.I.M. and pack contents
NITROGLICERINA Bioindustria L.I.M. 5mg/1.5ml concentrate for injectable solution
Packaging: 10 vials of 1.5 ml each.

Marketing Authorization Holder and Manufacturer
Bioindustria Laboratorio Italiano Medicinali S.p.A.
(Bioindustria L.I.M. S.p.A.)
Via De Ambrosiis 2, 15067 Novi Ligure (AL) – Italy

Package leaflet: information for the physician

NITROGLICERIN Bioindustria L.I.M. 5mg/1.5 ml concentrate for solution for infusion

Nitroglycerin
Equivalent medicinal product
The following information is intended exclusively for physicians or healthcare professionals
Therapeutic indications
Unstable angina, variant angina, Prinzmetal's angina.
Acute left ventricular failure, following or unrelated to acute myocardial infarction, particularly with elevated filling pressure and reduced cardiac output.
Acute pulmonary edema and pre-pulmonary edema.
Hypertensive crisis.
Dosage and method of administration
Dosage
The infusion solution is prepared by appropriately diluting nitroglycerin according to the table below and administered via an automated device or drop by drop as indicated in the infusion table (1 ml corresponds to approximately 20 drops from a standard infusion set).
Dilution table

Infusion table

Administration method
The medicinal product must always be diluted before intravenous infusion. The dilutions to be used, reported in the section "Dosage and administration", must be carried out in glass infusion containers (see section "Incompatibilities").

Incompatibilities
Nitroglycerin is compatible with infusion solutions commonly used in clinical practice, such as physiological saline, 4–30% glucose solutions, Ringer's solution, and protein-containing solutions. No incompatibilities with other infusion solutions are currently known. Dilution must be performed exclusively in glass infusion containers.

Nitroglycerin tends to rapidly migrate into many plastic materials. Therefore, the dilution of injectable nitroglycerin for intravenous infusion solution must be carried out exclusively in glass infusion containers.

Nitroglycerin contained in the final infusion solution may be absorbed by the PVC commonly used in standard administration sets, with losses ranging from 40% to 80% of the total amount; the absorption rate is inversely proportional to the infusion rate. For this reason, the use of polyethylene tubing, in which nitroglycerin losses are very low, is recommended.

For further information, please refer to the Summary of Product Characteristics.