Dopamine hydrochloride Hikma

Package Leaflet: Information for the User

Dopamine Hydrochloride Hikma

40 mg/ml
Concentrate for solution for infusion
Dopamine hydrochloride
Generic medicine
Please read this leaflet carefully before using this medicine because it
contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet

1. What Dopamine Hydrochloride Hikma is and what it is used for
2. What you need to know before using Dopamine Hydrochloride Hikma
3. How to use Dopamine Hydrochloride Hikma
4. Possible side effects
5. How to store Dopamine Hydrochloride Hikma
6. Contents of the pack and other information

1. What Dopamine Hydrochloride Hikma is and what it is used for

Dopamine is a medicine that stimulates the heart and has effects on blood vessels.
Dopamine Hydrochloride Hikma may be used:

• to treat low blood pressure or a state of shock (reduced blood flow through body tissues) following a heart attack, blood poisoning, or trauma (injury)
• in combination with other treatments when low blood pressure occurs after open-heart surgery
• in the case of congestive heart failure (heart failure caused by accumulation of fluid/blood).

2. What you need to know before using Dopamine Hydrochloride Hikma

Do not use Dopamine Hydrochloride Hikma:

• if you are allergic to dopamine hydrochloride or to any of the other ingredients of this medicine (listed in section 6).
• if you have a tumour causing high blood pressure
• if you have an irregular or rapid heartbeat

If possible, inform your doctor if any of the conditions listed above apply to you before receiving this medicine.

Warnings and precautions

Talk to your doctor or nurse before you are given Dopamine Hydrochloride Hikma.

Special caution is needed with Dopamine Hydrochloride Hikma if you:

• have diabetes
• have kidney or liver problems
• have suffered from circulation problems (you will be monitored for possible changes in colour or temperature of your fingers or toes).
• have narrow-angle glaucoma
• have benign prostatic hyperplasia with urinary retention
• have an overactive thyroid gland

If possible, inform your doctor if any of the conditions listed above apply to you before receiving this medicine.

Other medicines and Dopamine Hydrochloride Hikma

Special care is needed if you are taking other medicines, as some may interact with dopamine, for example:

• anaesthetics (dopamine must not be used with cyclopropane or halogenated hydrocarbons)
• alpha- and beta-blockers, e.g. propranolol (medicines often used to treat blood pressure and heart conditions)
• monoamine oxidase inhibitors (antidepressant medicines)
• phenytoin (a medicine used to treat epilepsy)
• reserpine, cardiac glycosides, metoclopramide
• thyroid hormones
• antiarrhythmics

Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Pregnancy and breastfeeding

If you are pregnant, think you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before using this medicine.

Your doctor will use this medicine only if the expected benefits outweigh the potential risks to your baby.

Driving and using machines

Not applicable, as this medicine will be administered in a hospital setting.

Dopamine Hydrochloride Hikma contains sodium metabisulfite

This excipient may rarely cause severe hypersensitivity reactions (serious allergy) and bronchospasm (difficulty breathing).

This medicine contains less than 1 mmol of sodium (23 mg) per vial and is therefore essentially “sodium-free”.

3. How to use Dopamine Hydrochloride Hikma

This medicine will be diluted before it is administered to you. It will be given as an infusion (intravenous drip) into a vein.
Dose
If your blood volume is low, you may be given a blood transfusion or a plasma expander before dopamine is administered.
Your doctor will calculate the correct dose of dopamine for you and how often it should be given. The dosage will depend on your medical condition and body weight.
The rate of administration will be carefully monitored and adjusted according to your response. During treatment, your heart rate, blood pressure, and urine output will be measured to assess how you are responding to the treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although
not everyone gets them.
The most common reactions include:
Cardiac disorders: Ectopic heartbeats, fast heartbeat
(tachycardia), angina-related pain (anginal
pain), palpitations, low blood pressure
(hypotension), and narrowing of small arteries
(vasoconstriction).
Gastrointestinal disorders: Nausea and vomiting.
Nervous system disorders: Headache, anxiety, tremor.
Respiratory disorders: Difficulty in breathing (dyspnoea).
Renal and urinary disorders: Increased frequency of urination (polyuria).
Investigations: Increased serum glucose levels, increased BUN levels (Blood Urea Nitrogen).
Less common reactions include:
Biochemical abnormalities: Renal failure (azotemia).
Cardiac disorders: Aberrant conduction, slow heartbeat
(bradycardia), widened QRS complex, high blood pressure
(hypertension), fatal ventricular arrhythmias (irregular heartbeat) have been reported rarely.
Eye disorders: Marked dilation of the pupil (mydriasis).
Nervous system disorders: Erection of hairs (piloerection).
Serious or life-threatening reactions
Gangrene of extremities has occurred at high doses and at low doses in patients with
pre-existing vascular problems.
Dopamine may cause changes in the chemistry of your blood. Your doctor may take blood
samples to monitor these aspects.
Reporting of side effects
If you experience any side effect, including those not listed in this
leaflet, talk to your doctor or nurse. You can also report side effects
directly via the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili . Reporting side effects can
help provide more information on the safety of this medicine.

5. How to store Dopamina Cloridrato Hikma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label and the carton after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Keep the vial in the outer packaging to protect the medicine from light.
Parenteral medicines should be inspected visually for particulate matter and discoloration prior to administration. Do not use the medicine if the injection solution is darker than a slight yellowish tint or otherwise discolored.

6. Package contents and other information

What Dopamina Cloridrato Hikma contains

• The active substance is dopamine hydrochloride.
• The other components are sodium metabisulfite, hydrochloric acid, sodium hydroxide and water for injectable preparations.

Appearance of Dopamina Cloridrato Hikma and contents of the pack
Dopamina Cloridrato Hikma is a clear solution ranging from colourless to pale yellow,
packaged in clear type I glass vials of 5 ml with a break point (OPC),
boxed in cardboard packaging.
Pack size: 10 vials
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Hikma Farmacêutica (Portugal) S.A.
Estrada do Rio da Mó, nº8, 8A and 8B
Fervença
2705-906 Terrugem SNT
Portugal

Manufacturer
Hikma Italia S.P.A.
Viale Certosa, 10
27100 Pavia
Italy

This medicinal product is authorized in the European Economic Area Member States under the following names:
Austria: Dopamin Hikma 40 mg/ml Konzentrat zur Herstellung einer Infusionslösung
Germany: Dopamine Hikma 40 mg/ml, Konzentrat zur Herstellung einer Infusionslösung
Italy: Dopamina Cloridrato Hikma
Portugal: Dopamina Hikma
Netherlands: Dopamine Hikma 40 mg/ml, Concentraat voor oplossing voor infusie
United Kingdom: Dopamine 40 mg/ml, Concentrate for solution for infusion

This summary of product characteristics was last revised on:

The following information is intended for healthcare professionals only:

• Incompatibilities

Dopamine Hydrochloride Hikma concentrate for solution for infusion must not be added to any alkaline intravenous solutions, e.g. sodium bicarbonate. Any solution showing physical or chemical incompatibility through a change in colour or formation of a precipitate must not be administered.
It is recommended to avoid mixtures containing gentamicin sulfate, sodium cephalothin, neutral sodium cephalothin or sodium oxacillin unless all other valid alternatives have been exhausted.
Mixtures of ampicillin and dopamine in 5% glucose solution are alkaline and incompatible, leading to degradation of both drugs. These must not be mixed.
Mixtures of dopamine and amphotericin B in 5% glucose solution are incompatible as they form a precipitate immediately upon mixing.

• Special precautions for disposal and handling

For single use only.
Any unused medicinal product or waste material must be disposed of in accordance with local regulations.
Parenteral medicines should be inspected visually for particulate matter and discoloration prior to administration. Do not use if the solution is darker than slightly yellow or otherwise discoloured.

Preparation of infusion solution
Recommended dilution
Aseptically transfer the sterile concentrate for infusion solution into the intravenous solution as shown in the following table:

| Concentrate concentration (mg/ml) | Volume of concentrate (ml) | Volume of intravenous solution (ml) | Final concentration (micrograms/ml) | |-----------------------------------|----------------------------|-------------------------------------|-------------------------------------| | 40 mg/ml | 5 | 500 | 400 | | 40 mg/ml | 5 | 250 | 800 |

Dopamine hydrochloride may be diluted with:

• Sodium Chloride 0.9% Solution for Injection
• Glucose 5% Solution for Injection
• Glucose 5% and Sodium Chloride 0.9% Solution for Injection
• Sodium Chloride 0.45% Solution
• Glucose 5% and Sodium Chloride 0.45% Solution
• Glucose 5% in Ringer's Lactate Solution
• Sodium Lactate 1/6 Molar Solution for Injection
• Ringer's Lactate Solution for Injection

Stability during use:
Chemical and physical in-use stability has been demonstrated for 24 hours at room temperature (< 25°C).
From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage time and conditions prior to use are the responsibility of the user and should normally not exceed 24 hours at 2°C - 8°C, unless dilution has taken place under controlled and validated aseptic conditions.