Sterile Dopamine Concentrate Bp 800mg/ 5ml
PACKAGE LEAFLET: INFORMATION FOR THE USER
3. How Dopamine Concentrate is giveni3i7
Sterile Dopamine Concentrate BP 200mg/5ml and 800mg/5ml
Dopamine Hydrochloride
Read all of this leaflet carefully before you use Dopamine
Concentrate.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, please ask your doctor or nurse.
• If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
In this leaflet:
1. What Dopamine Concentrate is and what it is used for
2. Before you are given Dopamine Concentrate
3. How Dopamine Concentrate is given
4. Possible side effects
5. Storing Dopamine Concentrate 5. Further information
1. What Dopamine Concentrate is and what it is used for
Dopamine hydrochloride is one of a group of medicines that stimulate the heart and acts on blood vessels and the kidneys.
Dopamine Concentrate is used in the treatment of diseases of the heart muscle, kidney failure and poor blood flow. It is also used n the treatment of shock associated with heart attacks, trauma (injury), blood poisoning, open heart surgery and heart failure.
2. Before you are given Dopamine Concentrate
You should not be given Dopamine Concentrate if:
• you are allergic to Dopamine Hydrochloride or any of ingredients listed in section 6 of this leaflet
• you have a tumour in the adrenal glands known as phaeochromocytoma
• you have a fast and irregular heartbeat
Take special care with Dopamine Concentrate if:
• you are pregnant or breast-feeding.
f any of the above applies to you, please consult your doctor before you are given Dopamine Concentrate.
Taking with other medicines
Please tell your doctor or nurse if you are taking or have recently taken any other medicines, including those obtained without prescription.
Medicines that may interact with Dopamine Concentrate include:
• medicines used to treat depression such as amitriptyline
• phenytoin, a medicine used to treat fits
• dopexamine, a medicine used to increase blood flow
• ergotamine, a medicine used to treat headaches
• guanethidine, a medicine used to treat high blood pressure
• adrenergic blocking agents such as doxazosin
• Monoamine-Oxidase Inhibitors (MAOI), a type of medicine used to treat depression
• certain anaesthetics, such as halothane
• entacapone, a medicine used in Parkinson's disease
• doxapram, used as a respiratory stimulant.
If you have any doubts about whether this medicine should be administered to you, consult your doctor or nurse. Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant or are breast-feeding before you are given this medicine. Effects on the ability to drive and use machinery
There are no reported effects of Dopamine Concentrate on driving and using machinery.
Important information about some of the ingredients of this medicine
This medicine contains sodium metabisulphite which in rare cases may cause an allergic reaction, the symptoms of which nclude difficulty breathing, a red itchy rash and facial swelling. If you experience any of these side effects please tell your doctor or nurse immediately.
Your doctor will determine the dose you require and dilute the Dopamine Concentrate with a sterile solution. The doctor will then give the dopamine solution by intravenous infusion via a drip into as large a vein as possible.
Adults including the elderly
The rate of administration will be carefully controlled and adjusted according to your response. The dose will be gradually increased until the optimum dosage is achieved. During treatment your heart rate, blood pressure and urine output will be measured to check how you are responding.
Children
Use in children is not recommended.
If you are given too much Dopamine Concentrate
If you are at all concerned that you have been given too much of this medicine please tell your doctor immediately.
4. Possible side effects
Like all medicines, Dopamine Concentrate can cause side effects, although not everybody gets them.
One of the ingredients of this medicine may cause an allergic reaction (see section 2 of this leaflet 'Important information about some of the ingredients of this medicine'). Tell your doctor or nurse immediately if you experience any of the following symptoms:
• swelling of the face, lips or tongue
• wheezing or difficulty breathing
• rashes, red, raised lumps or itching
Other rare side effects include:
• body hair standing on end
• kidney problems
• high blood pressure.
Common side effects include:
• changes in the heartbeat
• chest pains
• breathing difficulties
• feeling sick (nausea)
• being sick (vomiting)
• fall in blood pressure
• narrowing of blood vessels.
If any of the side effects become serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or nurse.
5. Storing Dopamine Concentrate
Keep out of the reach and sight of children.
This product has an expiry date on the ampoule label. The doctor or nurse will check that the product has not passed this date. The expiry date refers to the last day of that month.
Do not use if the contents are discoloured.
This product must be protected from light. It should not be stored above 25°C.
6. Further Information
What Dopamine Concentrate contains
The active ingredient is dopamine hydrochloride
the other ingredients are sodium metabisulphite, water for
injections, hydrochloric acid and potassium hydroxide.
What Dopamine Concentrate looks like and the contents of the pack.
The injection is supplied in glass ampoules, each containing 5ml. The ampoules are supplied in packs of 10 ampoules. Marketing Authorisation Holder and Manufacturer
Martindale Pharmaceuticals Ltd.,
Bampton Road,
Harold Hill,
Romford Essex RM3 8UG
Product licence numbers: PL 0156/0087 PL 0156/0088
Sterile Dopamine Concentrate BP 200mg/5ml and 800mg/5ml Date of last revision: May 2008
Martindale AJL. Pharmaceuticals fVi
Bampton Road, Harold Hill, Romford, RM3 8UG, United Kingdom