Glyceryl Trinitrate 5mg/Ml Sterile Concentrate
h
Hospira
PACKAGE LEAFLET:
INFORMATION FOR THE USER
Glyceryl Trinitrate 5 mg/ml Sterile Concentrate
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 any further questions, ask your doctor or pharmacist.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
1. What Glyceryl Trinitrate Sterile Concentrate is and what it is used for
2. Before Glyceryl Trinitrate Sterile Concentrate is used
3. How Glyceryl Trinitrate Sterile Concentrate is used
4. Possible side effects
5. How Glyceryl Trinitrate Sterile Concentrate is stored
6. Further information
1. WHAT GLYCERYL TRINITRATE STERILE CONCENTRATE IS AND WHAT IT IS USED FOR
Glyceryl Trinitrate Sterile Concentrate is a vasodilator (a medicine that widens the blood vessels).
Glyceryl trinitrate is used for the control of blood pressure during operations or to improve blood flow during and after heart operations. It can also be given to you after you have had a heart attack or to control angina attacks (sudden pains in the chest) when other medicines have not worked.
2. BEFORE GLYCERYL TRINITRATE STERILE CONCENTRATE IS USED
Glyceryl Trinitrate Sterile Concentrate should not be used
if you have shown signs of hypersensitivity (severe allergy) to glyceryl trinitrate or medicines of the same group (organic nitrates) in the past
if you have low blood pressure or a low blood volume (e.g. if you have had severe blood loss)
if you suffer from increased intracranial pressure (high pressure within the skull) if you have had a 'bleed' on the brain
if you have inflammation of the outer lining of the heart or compression of the heart due to the collection of fluid around the heart
• if you are very anaemic (low iron content or low levels of blood cells in your blood)
• if you have low oxygen levels in your blood
• if you are taking sildenafil (Viagra) or similar medicines used for the treatment of erection problems in men or high blood pressure in the arteries of the lungs that can lead to heart failure (pulmonary arterial hypertension)
• if you have angina pectoris (pain or uncomfortable feeling in the chest) that is caused by a specific heart disease called hypertrophic obstructive cardiomyopathy (insufficient heart blood flow due to obstruction).
If possible, tell your doctor if you think any of the above applies to you before this medicine is used.
Special care needs to be taken with Glyceryl Trinitrate Sterile Concentrate
• if you are undernourished
• if your thyroid is not working properly
• if you have a low body temperature
• if you have severe liver or kidney problems
• if you have an eye condition called 'closed angle glaucoma' or you have a higher than normal risk of getting it
If possible, tell your doctor if you think any of the above applies to you before this medicine is used.
The use of this medicine is not recommended in children or the elderly.
Taking/using other medicines
Special care is needed if you are taking/using other medicines as some could interact with glyceryl trinitrate. For example:
• it is important that glyceryl trinitrate and sildenafil (a medicine taken to correct erectile dysfunction in men) are not used together because they can cause blood pressure to fall too low
• medicines used to treat high blood pressure
• tricyclic anti-depressants, medicines used to treat depression
• morphine-like painkillers.
Please tell or remind your doctor if you are taking medicines or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or breast-feeding. Your doctor will only use this medicine if the expected benefits outweigh any potential risk to your baby.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines
Do not drive or use machines if you experience any side effect (e.g. dizziness) which may lessen your ability to do so. (see also section 4 - possible side effects)
Important information about some of the ingredients of Glyceryl Trinitrate Sterile Concentrate
This medicinal product contains small amounts of ethanol (alcohol), less than 100 mg per dose.
Glyceryl Trinitrate 5 mg/ml Sterile Concentrate
The following information is intended for medical or healthcare professionals only
Further to the information included in section 3, practical information on the preparation/handling of the medicinal product is provided here.
Incompatibilities
Glyceryl Trinitrate Sterile Concentrate 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.
No other drug should be admixed with this medicinal product.
Instructions for use and handling
Glyceryl Trinitrate Sterile Concentrate is a concentrated, potent drug which must be diluted in Dextrose (5%) Injection BP or Sodium Chloride (0.9%) Injection BP prior to its infusion.
Glyceryl Trinitrate Sterile Concentrate must be mixed under aseptic conditions immediately after opening.
Admixtures are prepared by replacing a given volume of infusion vehicle with an equal volume of the product to produce the final infusion solution.
Example of admixture preparation.
To obtain an admixture of glyceryl trinitrate at a concentration of 100 micrograms/ml add 10 ml (containing 50 mg glyceryl trinitrate) to 490 ml of infusion vehicle to give a final volume of 500 ml. HD4D52
3. HOW GLYCERYL TRINITRATE STERILE CONCENTRATE IS USED
The medicine will be diluted in a suitable infusion solution and given as an infusion (drip) into a vein. It must not be given by a bolus injection.
Dose
Your doctor will work out the correct dose of glyceryl trinitrate for you and how often it must be given.
The dose of medicine given to you will depend upon your medical condition. An initial dose will be given and depending on how your body reacts, this may be gradually increased.
The infusion rate is typically between 10 and 200 microgram/min.
Treatment should not last more than three days.
Your blood pressure and pulse may be measured often whilst you are being given this medicine.
Elderly: There is no evidence that a change in dose is required in the elderly.
If you are given too much or too little Glyceryl Trinitrate Sterile Concentrate
This medicine will be given to you in a hospital, under the supervision of a doctor. It is unlikely that you will be given too much or too little, however, tell your doctor or nurse if you have any concerns.
4. POSSIBLE SIDE EFFECTS
Like all medicines, glyceryl trinitrate can cause side effects, although not everybody gets them.
Common side effects:
• You may have headaches, abnormally fast, slow or irregular heartbeat, feel dizzy when standing up suddenly, weakness and feel sick whilst being given Glyceryl Trinitrate Sterile Concentrate.
irritation)
Other side effects:
• dizziness
• sleepiness
• chest pain
• heart failure
• vomiting
• heartburn
• allergic skin reactions (skin rash, redness, itch, burning sensation
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW GLYCERYL TRINITRATE STERILE CONCENTRATE IS STORED
Keep out of the reach and sight of children.
Expiry
This medicine must not be used after the expiry date which is stated on the ampoule and carton after 'EXP'. Where only a month and year is stated, the expiry date refers to the last day of that month.
Storage
The ampoules should be kept in the outer carton, in order to protect from light, and stored at, or below, 25°C.
Prepared infusions should be used immediately, however, if this is not possible they can be stored for up to 24 hours in a refrigerator. Storage for longer periods may be possible provided the infusion has been prepared in a way to exclude microbial contamination.
Visible signs of deterioration
Glyceryl Trinitrate Sterile Concentrate and the prepared infusion should be clear and practically colourless. Discoloured solutions should not be used.
6. FURTHER INFORMATION
What Glyceryl Trinitrate Sterile Concentrate contains
The active substance is glyceryl trinitrate. Each millilitre (ml) of solution contains 5 milligrams (mg) of glyceryl trinitrate.
The other ingredients are ethanol, propylene glycol and Water for Injections. See section 2 for further information regarding ethanol.
What Glyceryl Trinitrate Sterile Concentrate looks like and contents of the pack
Glyceryl Trinitrate Sterile Concentrate is a clear, practically colourless concentrate for solution for infusion which comes in glass containers called ampoules.
It may be supplied in packs containing:
• 5 x 25 mg/5 ml ampoules
• 5 x 50 mg/10 ml ampoules
Not all packs may be marketed.
Marketing authorisation holder and manufacturer
Hospira UK Limited Horizon, Honey Lane Hurley, Maidenhead SL6 6RJ UK
This leaflet was last revised in July 2016.
44800/25/16 —
A dosage of 100 micrograms/min can be obtained by giving 60 ml of this admixture per hour. This is equivalent to a drip rate of 20 standard drops per minute or 60 paediatric microdrops per minute. At this drip rate the mixture provides enough solution for an infusion time of 8 hours 20 minutes.
Compatible with commonly employed infusion solutions, Sodium Chloride (0.9%) Injection and Dextrose (5%) Injection.
Compatible with glass infusion bottles and rigid infusion packs made of polyethylene.
Open ampoules of glyceryl trinitrate should be used immediately and any unused portion discarded.
Do not use if the solution is discoloured.
In use storage precautions
Following dilution in either 0.9% sodium chloride or 5% dextrose injection solutions in glass containers, chemical and physical in-use stability has been demonstrated for 7 days at both 18°C and 4°C.
Following dilution in 5% dextrose solution in polycarbonate or polypropylene syringes at concentrations of 1 mg or 4 mg per ml protected from light, chemical and physical in-use stability has been demonstrated for 72 hours at room temperature.
However, from a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2-8°C, unless dilution has taken place in controlled and validated aseptic conditions.
HD4D52