Patient leaflet - Glyceryl Trinitrate Macure 1 mg/ml solution for infusion
1. What Glyceryl Trinitrate Macure is and what it is used for
The active substance in Glyceryl Trinitrate Macure solu-tion for infusion is glyceryl trinitrate, which is a vasodila-tor (a medicine that widens the blood vessels). This means that your heart does not have to work so hard and it con-sumes less oxygen. The supply of oxygen to the heart is also improved.
Glyceryl Trinitrate Macure solution for infusion is used to treat the following conditions:
- severe and prolonged chest pain associated with acute myocardial infarction or unstable angina pectoris.
- left ventricular cardiac insufficiency and pulmonary con-gestion associated with myocardial infarction.
- hypertensive conditions (conditions that cause high blood pressure) associated with open heart surgery and other surgical procedures
- so-called hypertensive crisis
- in surgical procedures, to achieve a controlled hypoten-sion.
2. What you need to know before you are given Glyceryl Trinitrate Macure solution for infusion
Do not use Glyceryl Trinitrate Macure solution for infusion
- if you are allergic to glyceryl trinitrate, other nitro com-pounds or any of the other ingredients of this medicine (listed in section 6).
- if you are suffering from an acute circulatory distur-bance (shock, fainting)
- if you have been diagnosed with exceptionally low blood pressure
- if you suffer from severe hypovolaemia (reduced cir-culating blood volume or the total fluid volume in your body)
- if you have severe anaemia
- if you have certain heart-related problems, such as car-diogenic shock (the heart cannot pump enough blood to the tissues), cardiac insufficiency caused by aortic or mitral stenosis, hypertrophic obstructive cardiomyopa-thy (illness of the heart muscle), constrictive pericarditis (a type of inflammation of the pericardial sac) or cardiac tamponade (build-up of fluid in the pericardial sac)
- if you have a condition associated with increased intra-cranial pressure
- if you are taking medicines used for the treatment of erection problems, such as sildenafil, vardenafil or tada-lafil (these products may increase the blood pres-sure lowering effect of Glyceryl Trinitrate Macure to a life-threatening extent).
Warnings and precautions
Talk to your doctor or nurse before using Glyceryl Trini-trate Macure solution for infusion.
Tell your doctor if any of the following applies or has ap-plied to you:
- if you have left ventricular cardiac insufficiency caused by acute myocardial infarction
- if you experience a drop in blood pressure when you stand up (orthostatic hypotension)
Despite continuous steady administration, development of tolerance against the effects of glyceryl trinitrates has been observed. The tolerance disappears within 24 hours of the end of the infusion.
Glyceryl Trinitrate Macure must not be administered to pa-tients who are taking phosphodiesterase inhibitor-contain-ing products (e.g., sildenafil, vardenafil, tadalafil). Patients
who receive Glyceryl Trinitrate Macure must be warned not to take phosphodiesterase inhibitor-containing prod-ucts.
Materials made of polyethylene (PE), polytetrafluoreth-ylene (PTFE) or glass are suitable for infusing Glyceryl Trinitrate Macure. However, use of infusion materials made of polyvinyl chloride (PVC) should be avoided since glycer-yl trinitrate binds to PVC.
Children
The safety and efficacy of this medicinal product in chil-dren has not yet been established.
Other medicines and Glyceryl Trinitrate Macure
Tell your doctor or pharmacist if you are using, have re-cently used or might use any other medicines. Concurrent use of the product with the following medi-cines, drug groups or substances may potentiate the blood pressure lowering effects of glyceryl trinitrate:
- beta-blockers
- other vasodilators (products that expand blood vessels)
- calcium channel antagonists
- ACE inhibitors
- neuroleptics
- tricyclic antidepressants
alcohol.
The blood pressure lowering effect of Glyceryl Trinitrate Macure solution for infusion will increase if used together with phosphodiesterase inhibitors (e.g., sildenafil, vardena-fil or tadalafil) (see section Do not use Glyceryl Trinitrate Macure solution for infusion). This may lead to life-threat-ening cardiovascular complications. Patients who have re-cently taken phosphodiesterase inhibitors (e.g., sildenafil, vardenafil, tadalafil) must not be treated with Glyceryl Trini-trate Macure solution for infusion.
Concurrent use with dihydroergotamine may increase the blood level of dihydroergotamine and increase its effect. Concurrent use with acetyl salicylic acid may potentiate the blood pressure lowering effects of glyceryl trinitrate. Non-steroidal anti-inflammatory drugs (except small doses of acetyl salicylic acid as antithrombotic medication) may diminish the therapeutic response to glyceryl trinitrate. Caution must be exercised when using a sapropterin-con-taining medicinal product concurrently with Glyceryl Trini-trate Macure solution for infusion.
If intravenous tissue plasminogen activator (tPA infusion) is administered concomitantly with the glyceryl trinitrate infu-sion, the plasma clearance of tPA may be accelerated due to increased hepatic blood flow.
The use of heparin and glyceryl trinitrate solution can lead to a partial loss of action of heparin when both medicinal products are given simultaneously by intravenous route. Please tell your doctor if you have any other illnesses or al-lergies.
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Glyceryl Trinitrate Macure solution for infusion should not be used during pregnancy unless considered necessary by your doctor.
Glyceryl trinitrate is excreted into breast milk. Your doctor will decide whether you should discontinue breastfeeding or discontinue treatment with Glyceryl Trinitrate Macure, taking into account the benefit of breastfeeding for the child and the benefit of the treatment for you. Driving and using machines
Glyceryl Trinitrate Macure may affect the patient’s reac-tivity to an extent that their ability to drive or to operate machinery is impaired. The probability of this effect is in-creased in combination with alcohol.
Glyceryl Trinitrate Macure solution for infusion contains glucose.
The product contains approximately 51 mg/ml glucose monohydrate. This should be taken into account if you have diabetes.
3. How to use Glyceryl Trinitrate Macure solution for infusion
Glyceryl Trinitrate Macure solution for infusion is admin-istered in hospital. The treatment must be administered under continuous careful monitoring of the cardiac and circulatory function by clinical means or direct pressure measurements.
The dosage is individual and depends on the clinical re-sponse. Your doctor has determined the suitable dose and duration of treatment for you and your condition. If you are given more Glyceryl Trinitrate Macure solution for infusion than you should
As the medicinal product is administered in hospital, over-dose is not likely to occur. Symptoms of overdose may in-clude severe drop in blood pressure, pallor, sweating, weak pulse, palpitations, feeling of dizziness, headache, weak-ness, giddiness, nausea, vomiting and diarrhoea. If you suspect that you have received an overdose of the medicinal product, inform the doctor or nursing staff im-mediately.
If you have any questions concerning the use of this medi-cine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, al-though not everybody gets them.
The most common adverse effects of glyceryl trinitrates include excessive drop in blood pressure, particularly when standing up, tachycardia and headache. Occurrence of headache is associated with the dose administered. Head-ache becomes less frequent as the treatment continues. The following adverse effects may occur during the use of Glyceryl Trinitrate Macure:
Very common: may affect more than 1 in 10 people
- headache.
Common: may affect up to 1 in 10 people
- dizziness (including dizziness when standing up)
- drowsiness
- tachycardia
- drop in blood pressure when standing up (orthostatic hypotension)
- weakness.
Uncommon: may affect up to 1 in 100 people
- enhanced angina pectoris symptoms
- acute circulatory collapse (sometimes accompanied by bradyarrhythmia and syncope)
- nausea, vomiting
- allergic skin reactions.
Rare: may affect up to 1 in 1,000 people
- restlessness
- syncope
- visual disturbances.
Very rare: may affect up to 1 in 10,000 people
- heartburn.
Not known: frequency cannot be estimated from the avail-able data
- heart palpitation
- drop in blood pressure, redness
- exfoliative dermatitis.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via Yellow Card Scheme Website: www.mhra.gov.uk/yellow-card or search for MHRA Yellow Card in the Google Play or Apple App Store
By reporting side effects you can help provide more infor-mation on the safety of this medicine.
5. How to store Glyceryl Trinitrate Macure solution for infusion
Keep this medicine out of the sight and reach of children. This medicine does not require any special temperature storage conditions. Keep the vial in the outer carton in or-der to protect from light.
Do not use this medicine after the expiry date which is stated on the carton and the label after EXP. The expiry date refers to the last day of that month.
After first opening and dilution chemical and physical in-use stability has been demonstrated for 24 hours at 5 °C and 25 °C. From a microbiological point of view, the product must be used immediately after opening. If not used immediately, in-use storage times and conditions prior to use are the re-sponsibility of the user.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.
6. Contents of the pack and other information
What Glyceryl Trinitrate Macure contains
- The active substance is glyceryl trinitrate. 1 ml of solu-tion contains 1 mg of glyceryl trinitrate.
The other ingredients are glucose monohydrate, water for injections and hydrochloric acid (for pH adjustment).
What Glyceryl Trinitrate Macure looks like and contents of the pack
Description of the product: Clear, colourless solution, free from visible particles.
Colourless glass vial, closed with bromobutyl rubber stop-per with an aluminium cap with a polypropylene disc. Pack size: 1 x 50 ml and 10 x 50 ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Macure Pharma UK Ltd.
3 Waterhouse Square, 138-142 Holborn
London, EC1N 2SW, United Kingdom
Manufacturer
Solupharm Pharmazeutische Erzeugnisse GmbH Industriestr. 3
D-34212 Melsungen
Germany
This leaflet was last revised in September 2024.
The following information is intended for healthcare professionals only:
Glyceryl Trinitrate Macure 1 mg/ml solution for infusion Posology and method of administration
The posology is individual and is determined according to clinical response and systolic blood pressure. The haemodynamic effects of glyceryl trinitrate adminis-tered by infusion are often very strong. Therefore, its use requires hospital conditions as well as continuous moni-toring of the cardiac and circulatory function. In normoten-sive patients, the systolic blood pressure should not drop more than 10–15 mmHg, in hypotensive patients not more than 5 mmHg, and the pulse rate should not increase more than 5/min unless the clinical picture is clearly improved at the same time.
An intravenous infusion is started at a low rate, 10–20 mi-crograms/min. The drop rate may be increased accord-ing to the response by about 10–20 micrograms/min with 5–10-minute intervals. An effective response is usual-ly achieved at an infusion rate of 50–100 micrograms/min (3–6 mg/h).
The solution for infusion is sterile but not preserved. The vial is not intended for multiple uses. Glyceryl Trinitrate Ma-cure solution for infusion must remain under aseptic condi-tions as soon as opened.
The medicinal product should be visually inspected prior to use. Only clear solutions free from particles should be used.
Once opened, the medicinal product should be used im-mediately. Any remaining contents should be discarded. Glyceryl Trinitrate Macure solution for infusion can be ad-ministered undiluted using an infusion pump, or diluted into physiological saline solution, 5–30 % glucose solution or Ringer-lactate solution.
Solutions for infusion with a glyceryl trinitrate concentra-tion of 100 micrograms/ml are usually recommended. This is prepared by removing 50 ml of liquid from an infusion bottle of 500 ml and adding one vial (50 ml) of Glyceryl Trinitrate Macure solution for infusion. Higher concentra-tions may also be used in the solutions, but it is recom-mended not to exceed the concentration 133 micrograms/ ml.
Materials made of polyethylene (PE), polytetrafluoreth-ylene (PTFE) or glass are suitable for administering Glyc-eryl Trinitrate Macure solution for infusion. However, use of infusion materials made of polyvinyl chloride (PVC) should be avoided since glyceryl trinitrate binds to PVC. Shelf life and storage
This medicine does not require any special temperature storage conditions. Keep the vial in the outer carton in or-der to protect from light.
After first opening and dilution chemical and physical in-use stability has been demonstrated for 24 hours at 5 °C and 25 °C.
From a microbiological point of view, the product must be used immediately after opening. If not used immediately, in-use storage times and conditions prior to use are the re-sponsibility of the user.
This medicinal product must not be used after the expiry date which is stated on the carton and the label. Incompatibilities
Glyceryl Trinitrate Macure solution for infusion can be mixed with physiological saline solution, 5–30 % glucose solution or Ringer-lactate solution.
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