DOPAMINA 40 mg /Ml Koncentrat Do Sporządzania Roztworu Infuzyjnego

Treść ulotki

1. Dopamina Cloridrato Hikma
2. Dopamina cloridrato
   1. What is Dopamina Cloridrato Hikma and what is it used for
   2. What you need to know before using Dopamina Cloridrato Hikma
   3. How to use Dopamina Cloridrato Hikma
   4. Possible side effects
   5. How to store Dopamina Cloridrato Hikma
   6. Package contents and other information

Dopamina Cloridrato Hikma

40 mg/ml
Concentrate for solution for infusion

Dopamina cloridrato

Generic medicine

Read this leaflet carefully before you use 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 any side effect occurs, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet

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

1. What is Dopamina Cloridrato Hikma and what is it used for

Dopamine is a medicine that stimulates the heart and has effects on blood vessels.
Dopamina Cloridrato Hikma can be used:

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

2. What you need to know before using Dopamina Cloridrato Hikma

Do not use Dopamina Cloridrato Hikma:

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

If possible, tell your doctor if any of the above conditions apply to you before taking this medicine.

Warnings and precautions
Talk to your doctor or nurse before you are given Dopamina
Cloridrato Hikma.
Special care must be taken with Dopamina Cloridrato Hikma:

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

If possible, tell your doctor if any of the above conditions apply to you before taking this medicine.

Other medicines and Dopamina Cloridrato Hikma
Special care should be taken if you are using other medicines because some
may interact with dopamine, for example:

• anaesthetics (dopamine should not be used with cyclopropane and halogenated hydrocarbons)
• alpha- and beta-blockers, e.g. propranolol (medicines that are often used to treat blood pressure and heart conditions).
• Monoamine oxidase inhibitors (anti-depressant 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, suspect you are pregnant or are planning a pregnancy, or if you
are breastfeeding, ask your doctor for advice before using this
medicine.
Your doctor will only use this medicine if the expected benefits outweigh the potential
risks to your baby.

Driving and using machines
Not applicable as the medicine will be administered in hospital.

Dopamina Cloridrato Hikma contains sodium metabisulphite
This excipient can rarely cause serious hypersensitivity reactions (severe allergy)
and bronchospasm (difficulty breathing).
This medicine contains less than 1 mmol of sodium (23mg) per vial, i.e. it is
essentially “sodium-free”.

3. How to use Dopamina Cloridrato Hikma

This medicine will be diluted before it is administered to you. It will be administered
as an infusion (intravenous drip) into a vein.
Dosage
If your blood volume is low, you may be given a blood transfusion or a plasma expander before dopamine is administered to you.
Your doctor will calculate the correct dose of dopamine for you and how often it will need to
be administered. The dosage will depend on your medical condition and your
weight.
The rate of administration will be carefully monitored and adjusted based on
your response. During treatment, your heart rate, blood pressure, and urine flow will be measured to check 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.
Not all people will experience them.
The most common reactions include:

Cardiovascular disorders: Ectopic heartbeats, fast heartbeat
(tachycardia), pain related to angina (anginal pain), palpitations, low blood pressure
(hypotension) and narrowing of the small arteries
(vasoconstriction).

Gastrointestinal disorders: Discomfort (nausea) and vomiting.

Nervous system disorders:
Headache, anxiety, tremor.

Respiratory disorders:Difficulty breathing (dyspnea).

Renal and urinary disorders: Increased frequency of urination (polyuria).

Diagnostic tests: increased glucose levels in the serum, increased
levels of BUN (Blood Urea Nitrogen).
Less common reactions include:

Biochemical anomalies: Renal failure (azotemia).

Cardiovascular disorders: Irregular rhythm conduction (aberrant
conduction), slow heartbeat (bradycardia),
widened QRS complex, high blood pressure
(hypertension), fatal ventricular arrhythmias (irregular
heartbeat) have been reported rarely.

Eye disorders: Wide dilation of the pupil (mydriasis).

Nervous system disorders:
Hair erection (piloerection).
Serious or life-threatening reactions
Gangrene of the extremities has occurred at high doses and low doses in patients with
pre-existing vascular problems.
Dopamine can lead to changes in its blood chemistry. Your doctor may
take blood samples to monitor these aspects.

Reporting of side effects
If you experience any side effects, including those not listed in this
leaflet, tell your doctor or nurse. You can also report side effects
directly through the national reporting system at
http://www.agenziafarmaco.gov.it/it/responsabili . By reporting side effects you 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 on the
pack after EXP. The expiry date refers to the last day of the month.
Do not store above 25°C.
Store the vial in the outer packaging to protect the medicine from light.
Parenteral drug products must be visually inspected for particulate matter and discoloration before administration. Do not use the medicine if
the injection solution is darker than a slight yellow color or if
it is discolored in any other way.

6. Package contents and other information

What Dopamina Cloridrato Hikma contains

• The active ingredient is dopamine hydrochloride
• The other ingredients are sodium metabisulfite, hydrochloric acid, sodium hydroxide and water for injections.

Appearance of Dopamina Cloridrato Hikma and package contents
Dopamina Cloridrato Hikma is a clear solution from colorless to pale yellow
packaged in clear type I glass vials of 5ml with a snap-off (OPC) point,
packaged in cardboard boxes.
Packaging: 10 vials
Not all packs may be marketed.

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

Manufacturer
Hikma Italia S.P.A.
Viale Certosa, 10
27100 Pavia
Italy
This medicinal product is authorised in the Member States of the European Economic Area
under the following names:
Austria: Dopamin Hikma 40 mg/ml Concentrate for the preparation of an
infusion solution
Germany: Dopamine Hikma 40 mg/ml, Concentrate for the preparation of an
infusion solution
Italy: Dopamina Cloridrato Hikma
Portugal: Dopamina Hikma
Netherlands: Dopamine Hikma 40 mg/ml, Concentrate for solution for infusion
United Kingdom: Dopamine 40 mg/ml, Concentrate for solution for infusion
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The following information is reserved for healthcare professionals:

• Incompatibilities

Dopamina Cloridrato Hikma concentrate for solution for infusion must not be
added to any alkaline intravenous solutions, e.g. sodium bicarbonate. Any
solution that shows physical or chemical incompatibility through a change of
color or the formation of a precipitate must not be administered.
It is recommended to avoid mixtures containing gentamicin sulfate, cefalothin sodium,
cefalothin sodium neutral or oxacillin sodium unless all other valid alternatives
have been exhausted.
Mixtures of ampicillin and dopamine in 5% glucose solution are alkaline and
incompatible and lead to the decomposition of both drugs. They must not
be mixed.
Mixtures of dopamine, amphotericin B in 5% glucose solution are
incompatible because they form a precipitate upon mixing.

• Special precautions for disposal and handling

For single use only.
Any unused medicine or waste material should be disposed of in
accordance with local regulations.
Parenteral medicines should be visually inspected for particulate matter and discoloration before administration. Do not use if the solution is
darker than a slightly yellow color or discolored in any other way.

Preparation of the infusion solution
Suggested dilution
Aseptically transfer the sterile concentrate for solution for infusion into the
intravenous solution as shown in the following table:
Concentration of
concentrate
(mg/ml)
Final
Concentration
(micrograms/ml)
40 mg/ml 5 500 400
Volume of
concentrate
(ml)
Volume of intravenous
solution
(ml)
40 mg/ml 5 250 800
Dopamine hydrochloride can 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 Lactate Solution
• Sodium Lactate 1/6 Molar Solution for Injection
• Ringer Lactate Solution for Injection

Stability during use:
Chemical and physical stability during use has been demonstrated for 24 hours at room
temperature (< 25ºC).
From a microbiological point of view, the product must be used immediately. If
not used immediately, the storage times during use and the
conditions before use are the responsibility of the user and should not
normally exceed 24 hours at 2º - 8ºC, unless the dilution has taken place
in a controlled environment and in validated aseptic conditions.