1 mg / ml solution for infusion / concentrate for solution for infusion
glyceryl trinitrate
What Nitroglycerin Karo Pharma is and what it is used for
Nitroglycerin Karo Pharma contains glyceryl trinitrate and is a vasodilator with rapid effect for intravenous infusion ( injection into a vein). Nitroglycerin Karo Pharma is used for hypoxia in the heart muscle, heart failure, acute high blood pressure, and in operations to keep blood pressure at a low level in a controlled manner.
Glyceryl trinitrate contained in Nitroglycerin Karo Pharma may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professionals if you have any further questions, and always follow their instructions.
What you need to know before you get Nitroglycerin Karo Pharma
Your doctor will not give you Nitroglycerin Karo Pharma :
- if you are allergic to glyceryl trinitrate or any of the other ingredients of this medicine (listed in section 6)
- if you are taking medicines containing sildenafil (for impotence )
- if you have fluid in your pericardium ( pericardial tamponade )
- if you have pericarditis (constrictive pericarditis).
Warnings and cautions
When you are given this medicine, your doctor will take into account:
- if you have low blood pressure
- if you have any disease in the blood vessels of the brain
- if you have increased pressure in the brain
- if you have narrowing of the heart valves
- if you have anemia
- if you have myocardial thickening
- if you have a lack of oxygenation of the blood
- if you have impaired thyroid function.
Other medicines and Nitroglycerin Karo Pharma
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Nitroglycerin Karo Pharma should not be used in combination with agents containing sildenafil (eg used for impotence ). You may suffer from a severe drop in blood pressure, heart attack, and circulatory disorders that can cause permanent damage to the heart and brain.
Nitroglycerin Karo Pharma may affect the effectiveness of other medicines:
- heparin , a blood thinner
- vasodilators or antihypertensives
- alteplas, a medicine for blood clots.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
There is limited experience of use during pregnancy.
Breast-feeding
It is unknown whether Nitroglycerin Karo Pharma is excreted in human milk.
Driving and using machines
Because you may become dizzy when treated with Nitroglycerin Karo Pharma, your ability to react may be affected. You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
Nitroglycerin Karo Pharma contains alcohol (ethanol) and sodium
Alcohol ( ethanol ):
This medicine contains 94.4 mg alcohol ( ethanol ) per ml (12 vol% ethanol ). The amount in 1 ml of this medicine corresponds to 3 ml of beer or 1 ml of wine.
The low amount of alcohol in this medicine does not produce any noticeable effects.
Sodium:
This medicine contains less than 1 mmol (23 mg) sodium per dose, ie essentially ‘sodium-free’.
How Nitroglycerin Karo Pharma is given
A doctor or nurse will give you Nitroglycerin Karo Pharma in a vein ( intravenously ). Your doctor will decide the right dose for you and when and how to inject one.
If you take more Nitroglycerin Karo Pharma than you should
It is unlikely that your doctor or nurse will give you too much medicine. Your doctor and nurse will monitor your treatment.
Tell your healthcare provider if you experience any of the following symptoms, which may occur if you get too much Nitroglycerin Karo Pharma:
headache, agitation, reddening of the skin, cold sweats, vomiting, dizziness, fainting, arrhythmia, palpitations and drop in blood pressure.
This is unlikely to happen because you are receiving the medicine in a hospital.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common (may affect up to 1 in 10 people): headache, dizziness, palpitations, low blood pressure, flushing
Uncommon (may affect up to 1 in 100 people): nausea
Rare (may affect up to 1 in 1,000 people): methemoglobinemia (blood disease), fainting
How to store Nitroglycerin Karo Pharma
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and label after EXP. The expiration date is the last day of the specified month.
Contents of the package and other information
Content declaration
- The active substance is glyceryl trinitrate . 1 ml infusion solution and infusion concentrate contain 1 mg glyceryl trinitrate .
- The other ingredients are ethanol , hydrochloric acid , sodium chloride and water for injections.
What the medicine looks like and contents of the pack
10 ml in clear vials (glass, type I): pack of 10 vials.
50 ml in clear vials (glass, type I): pack of 1 vial.
Marketing Authorization Holder and Manufacturer
Manufacturer
Apoteket, Produktion & Laboratorier AB
Formvägen 5B
906 21 Umeå