DOPAMINE 40 MG/ML STERILE CONCENTRATE
Active substance: DOPAMINE HYDROCHLORIDE
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If possible, tell your doctor if any of the above applies to you before this medicine is used.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dopamine 40 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. 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 Dopamine Sterile Concentrate is and what it is used for 2. Before Dopamine Sterile Concentrate is used 3. How Dopamine Sterile Concentrate is used 4. Possible side effects 5. How Dopamine Sterile Concentrate is stored 6. Further information
Special care needs to be taken with Dopamine Sterile Concentrate
if you have diabetes if you have kidney or liver problems if you have a history of blood circulation problems (you will be monitored for any changes in colour or temperature of your fingers or toes) If possible, tell your doctor if any of the above applies to you before this medicine is used.
Taking/using other medicines
Special care is needed if you are taking/ using other medicines as some could interact with dopamine, for example: anaesthetics (dopamine should not be used with cyclopropane and halogenated hydrocarbon anaesthetics) alpha- and beta-blockers, e.g. propranolol (medicines which are often used for treating blood pressure and heart disorders) monoamine oxidase inhibitors (antidepressant medicines) phenytoin (a medicine used to treat epilepsy) If possible, please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
1. WHAT DOPAMINE STERILE CONCENTRATE IS AND WHAT IT IS USED FOR
Dopamine is a medicine that stimulates the heart and has effects on the blood vessels.
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.
Dopamine Sterile Concentrate can be used:
to treat low blood pressure or shock (reduction of blood flow through the body tissues) after a heart attack, blood poisoning, trauma (injury) or kidney failure in combination with other treatments where low blood pressure occurs after open heart surgery in congestive heart failure (heart failure due to a build up of fluid/blood)
Driving and using machines
Do not drive or use machines if you experience any side effect (e.g. dizziness or difficulty seeing in bright light) which may lessen your ability to do so.
Important information about some of the ingredients of Dopamine Sterile Concentrate
This medicinal product contains sodium metabisulphite which, rarely, may cause severe hypersensitivity (severe allergy) reactions and bronchospasm (breathing difficulties). This medicinal product contains less than 1 mmol (23 mg) sodium per ampoule, i.e. essentially sodium free.
2. BEFORE DOPAMINE STERILE CONCENTRATE IS USED Dopamine Sterile Concentrate should not be used
if you have a tumour that causes an increase in blood pressure if you have an overactive thyroid gland if you have irregular or rapid heartbeats if you have shown signs of hypersensitivity (severe allergy) to dopamine or sodium metabisulphite in the past
3. HOW DOPAMINE STERILE CONCENTRATE IS USED
This medicine will be diluted before it is given to you. It will be given as an infusion (drip) into a vein.
Dose
If your blood volume is low, you may be given a transfusion of blood or a plasma expander before dopamine is given.
Dopamine 40 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
Dopamine Sterile Concentrate should not be added to any alkaline intravenous solutions, i.e. sodium bicarbonate. Any solution which exhibits physical or chemical incompatibility through a colour change or precipitate should not be administered. It is suggested that admixtures containing gentamicin sulphate, cephalothin sodium, cephalothin sodium neutral or oxacillin sodium should be avoided unless all other viable alternatives have been exhausted. Admixtures of ampicillin and dopamine in 5% glucose solution are alkaline and incompatible and result in decomposition of both drugs. They should not be admixed. Admixtures of dopamine, amphotericin B in 5% glucose solution are incompatible as a precipitate forms immediately on mixing.
Instructions for use and handling
For single use Discard any unused contents Do not use if the solution is discoloured
Q63040
Your doctor will work out the correct dose of dopamine for you and how often it must be given. The dose will depend upon your medical condition and your size. The rate of administration will be carefully controlled and adjusted according to your response. During treatment your heart rate, blood pressure and urine output will be measured to check how you are responding.
5. HOW DOPAMINE 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.
If you are given too much or too little Dopamine 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.
Storage
The ampoules should be kept in the outer carton, in order to protect from light, and stored at, or below, 30C. Prepared infusions should be used immediately, however, if this is not possible they can be stored for up to 48 hours provided they have been prepared in a way to exclude microbial contamination.
4. POSSIBLE SIDE EFFECTS
Like all medicines, dopamine can cause side effects, although not everybody gets them.
Visible signs of deterioration
Only clear, colourless or pale yellow solutions should be used. Opaque, cloudy or discoloured solutions should be discarded.
If any of the following happen, tell your doctor immediately:
severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint pain or poor circulation in your fingers or toes (you may notice a change in skin colour) pain or swelling at the injection site during or immediately after the injection severe palpitations These are serious side effects. You may need urgent medical attention.
6. FURTHER INFORMATION What Dopamine Sterile Concentrate contains
The active substance is dopamine hydrochloride. Each millilitre (ml) of concentrate contains 40 milligrams (mg) of dopamine hydrochloride. The other ingredients are sodium metabisulphite and Water for Injections. See section 2 for further information about sodium metabisulphite.
If any of the following happen, tell your doctor as soon as possible:
irregular, rapid or slow heart beats chest pain shortness of breath low blood pressure (you may feel dizzy or faint, particularly when standing up or getting out of bed) feeling or being sick headache dilation of the pupil of the eye (mydriasis) which may cause difficulty seeing in bright light goose pimples
What Dopamine Sterile Concentrate looks like and contents of the pack
Dopamine Sterile Concentrate is a clear, colourless or pale yellow concentrate for solution for infusion which comes in glass containers called ampoules. It may be supplied in packs containing: 5 x 200 mg/5 ml ampoules 50 x 200 mg/5 ml ampoules Not all packs may be marketed.
Marketing authorisation holder and manufacturer
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK This leaflet was last approved in 10/2008
Dopamine may lead to changes in your blood chemistry. Your doctor may take blood samples to monitor for these. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Preparation of infusion solutions
Suggested dilution Aseptically transfer Dopamine Sterile Concentrate into the IV solution as shown in the following table: Strength of Concentrate 200 mg/5 ml 200 mg/5 ml 200 mg/5 ml 200 mg/5 ml Volume of concentrate (ml) 5 5 10 20 IV Solution Volume (ml) 500 250 250 500 Final Concentration (microgram/ml) 400 800 1600 1600
Dopamine hydrochloride can be diluted with: Sodium chloride (0.9%) solution Dextrose (5%), sodium chloride (0.45%) solution Sodium Lactate Intravenous Infusion, Compound (Hartmanns Solution for Injection)
In use storage precautions
Following dilution in the recommended diluents chemical and physical in-use stability has been demonstrated for 48 hours at a temperature not above 25C. 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 2-8C unless dilution has taken place in controlled and validated aseptic conditions.
45165/17/08
Q63040
PACKAGE LEAFLET: INFORMATION FOR THE USER
Dopamine 40 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. 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 Dopamine Sterile Concentrate is and what it is used for 2. Before Dopamine Sterile Concentrate is used 3. How Dopamine Sterile Concentrate is used 4. Possible side effects 5. How Dopamine Sterile Concentrate is stored 6. Further information
Special care needs to be taken with Dopamine Sterile Concentrate
if you have diabetes if you have kidney or liver problems if you have a history of blood circulation problems (you will be monitored for any changes in colour or temperature of your fingers or toes) If possible, tell your doctor if any of the above applies to you before this medicine is used.
Taking/using other medicines
Special care is needed if you are taking/ using other medicines as some could interact with dopamine, for example: anaesthetics (dopamine should not be used with cyclopropane and halogenated hydrocarbon anaesthetics) alpha- and beta-blockers, e.g. propranolol (medicines which are often used for treating blood pressure and heart disorders) monoamine oxidase inhibitors (antidepressant medicines) phenytoin (a medicine used to treat epilepsy) If possible, please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
1. WHAT DOPAMINE STERILE CONCENTRATE IS AND WHAT IT IS USED FOR
Dopamine is a medicine that stimulates the heart and has effects on the blood vessels.
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.
Dopamine Sterile Concentrate can be used:
to treat low blood pressure or shock (reduction of blood flow through the body tissues) after a heart attack, blood poisoning, trauma (injury) or kidney failure in combination with other treatments where low blood pressure occurs after open heart surgery in congestive heart failure (heart failure due to a build up of fluid/blood)
Driving and using machines
Do not drive or use machines if you experience any side effect (e.g. dizziness or difficulty seeing in bright light) which may lessen your ability to do so.
Important information about some of the ingredients of Dopamine Sterile Concentrate
This medicinal product contains sodium metabisulphite which, rarely, may cause severe hypersensitivity (severe allergy) reactions and bronchospasm (breathing difficulties). This medicinal product contains less than 1 mmol (23 mg) sodium per ampoule, i.e. essentially sodium free.
2. BEFORE DOPAMINE STERILE CONCENTRATE IS USED Dopamine Sterile Concentrate should not be used
if you have a tumour that causes an increase in blood pressure if you have an overactive thyroid gland if you have irregular or rapid heartbeats if you have shown signs of hypersensitivity (severe allergy) to dopamine or sodium metabisulphite in the past
3. HOW DOPAMINE STERILE CONCENTRATE IS USED
This medicine will be diluted before it is given to you. It will be given as an infusion (drip) into a vein.
Dose
If your blood volume is low, you may be given a transfusion of blood or a plasma expander before dopamine is given.
Dopamine 40 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
Dopamine Sterile Concentrate should not be added to any alkaline intravenous solutions, i.e. sodium bicarbonate. Any solution which exhibits physical or chemical incompatibility through a colour change or precipitate should not be administered. It is suggested that admixtures containing gentamicin sulphate, cephalothin sodium, cephalothin sodium neutral or oxacillin sodium should be avoided unless all other viable alternatives have been exhausted. Admixtures of ampicillin and dopamine in 5% glucose solution are alkaline and incompatible and result in decomposition of both drugs. They should not be admixed. Admixtures of dopamine, amphotericin B in 5% glucose solution are incompatible as a precipitate forms immediately on mixing.
Instructions for use and handling
For single use Discard any unused contents Do not use if the solution is discoloured
Q63040
Your doctor will work out the correct dose of dopamine for you and how often it must be given. The dose will depend upon your medical condition and your size. The rate of administration will be carefully controlled and adjusted according to your response. During treatment your heart rate, blood pressure and urine output will be measured to check how you are responding.
5. HOW DOPAMINE 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.
If you are given too much or too little Dopamine 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.
Storage
The ampoules should be kept in the outer carton, in order to protect from light, and stored at, or below, 30C. Prepared infusions should be used immediately, however, if this is not possible they can be stored for up to 48 hours provided they have been prepared in a way to exclude microbial contamination.
4. POSSIBLE SIDE EFFECTS
Like all medicines, dopamine can cause side effects, although not everybody gets them.
Visible signs of deterioration
Only clear, colourless or pale yellow solutions should be used. Opaque, cloudy or discoloured solutions should be discarded.
If any of the following happen, tell your doctor immediately:
severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth or throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint pain or poor circulation in your fingers or toes (you may notice a change in skin colour) pain or swelling at the injection site during or immediately after the injection severe palpitations These are serious side effects. You may need urgent medical attention.
6. FURTHER INFORMATION What Dopamine Sterile Concentrate contains
The active substance is dopamine hydrochloride. Each millilitre (ml) of concentrate contains 40 milligrams (mg) of dopamine hydrochloride. The other ingredients are sodium metabisulphite and Water for Injections. See section 2 for further information about sodium metabisulphite.
If any of the following happen, tell your doctor as soon as possible:
irregular, rapid or slow heart beats chest pain shortness of breath low blood pressure (you may feel dizzy or faint, particularly when standing up or getting out of bed) feeling or being sick headache dilation of the pupil of the eye (mydriasis) which may cause difficulty seeing in bright light goose pimples
What Dopamine Sterile Concentrate looks like and contents of the pack
Dopamine Sterile Concentrate is a clear, colourless or pale yellow concentrate for solution for infusion which comes in glass containers called ampoules. It may be supplied in packs containing: 5 x 200 mg/5 ml ampoules 50 x 200 mg/5 ml ampoules Not all packs may be marketed.
Marketing authorisation holder and manufacturer
Hospira UK Limited, Queensway, Royal Leamington Spa, Warwickshire, CV31 3RW, UK This leaflet was last approved in 10/2008
Dopamine may lead to changes in your blood chemistry. Your doctor may take blood samples to monitor for these. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
Preparation of infusion solutions
Suggested dilution Aseptically transfer Dopamine Sterile Concentrate into the IV solution as shown in the following table: Strength of Concentrate 200 mg/5 ml 200 mg/5 ml 200 mg/5 ml 200 mg/5 ml Volume of concentrate (ml) 5 5 10 20 IV Solution Volume (ml) 500 250 250 500 Final Concentration (microgram/ml) 400 800 1600 1600
Dopamine hydrochloride can be diluted with: Sodium chloride (0.9%) solution Dextrose (5%), sodium chloride (0.45%) solution Sodium Lactate Intravenous Infusion, Compound (Hartmanns Solution for Injection)
In use storage precautions
Following dilution in the recommended diluents chemical and physical in-use stability has been demonstrated for 48 hours at a temperature not above 25C. 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 2-8C unless dilution has taken place in controlled and validated aseptic conditions.
45165/17/08
Q63040
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
