Emagel

Package leaflet: Information for the user

EMAGEL 35 g/l infusion solution

Polygeline
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 pharmacist.
• This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
• If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Emagel is and what it is used for

Emagel contains the active substance poligeline, which is a medicine belonging to the category of
plasma substitutes (the liquid part of the blood); these agents act by increasing the fluid volume in the circulating blood.
Emagel is used in the treatment of severe hypovolemia (reduced blood volume) in situations where the use of dextran 80-85 is contraindicated.
If you do not feel better or feel worse, speak to your doctor.

2. What you should know before using EMAGEL

Do not use EMAGEL

• If you are allergic to polygeline or to any of the other ingredients of this medicine (listed in section 6), as anaphylactic/anaphylactoid reactions have been observed.
• If you have hypercalcaemia (increased calcium concentration in the blood).
• If you are undergoing digitalis therapy (used in certain heart diseases).

The use of Emagel is subject to certain restrictions in that the physician,
considering its infusion necessary, must adopt special precautions:

• in all cases where an increase in intravascular blood volume and its related consequences (e.g. increased cardiac output, increased blood pressure), an increase in interstitial fluid volume (fluid between cells), or blood dilution may represent a specific risk for you. Examples of such conditions include: uncompensated heart failure (a condition in which the heart cannot pump an adequate amount of blood to meet the body's needs), high blood pressure, oesophageal varices (dilated veins in the oesophagus), pulmonary oedema (fluid accumulation in the lungs), predisposition to bleeding, absence of urine production due to kidney problems or issues affecting structures following the kidney;
• in all patients in whom there is an increased risk of histamine release (e.g. patients with a history of allergic or allergy-like reactions, or patients with a history of histamine response).

In the latter case, Emagel may be administered only after adequate preventive measures have been taken (see "Warnings and precautions").
Warnings and precautions
Consult your doctor or nurse before EMAGEL is administered to you.
Infusion must be immediately discontinued if intolerance reactions occur.
Mild forms of such reactions may be managed by administering antihistamine medications. In the case of severe reactions, follow current guidelines for modern shock therapy.
If you belong to the category of patients with an increased risk of histamine release [e.g. if you have experienced allergic or allergy-like reactions, if you have a clinical history of allergic diseases such as asthma, or if you are at risk of histamine-induced reactions due to a cumulative effect from concomitant use of histamine-releasing drugs such as anaesthetics, muscle relaxants, analgesics, ganglion-blocking agents (which block nerve impulse transmission), and anticholinergics (which block a hormone called acetylcholine)], this medicine may be administered only after adequate preventive measures have been taken, such as administration of anti-H1 and anti-H2 antihistamines.
In general, the administration of red blood cells (blood cells) or coagulation factors should be considered—no later than—when haematocrit levels (percentage of blood cells in blood) fall below 25% by volume.
In general, the use of hydro-electrolyte solutions should be evaluated and monitored based on blood levels of potassium, calcium, and pH (blood acidity) to avoid undesirable accumulation of salts or dangerous interference with cardiac, renal, pulmonary, or central nervous system function.
Infusion of Emagel may cause a transient increase in erythrocyte sedimentation rate (ESR), a laboratory test.
Only clear solutions from intact, undamaged vials should be used. Since Emagel does not contain preservatives, there is a risk of secondary contamination of vials that have been opened and handled with non-sterile equipment (needles and cannulae). This naturally precludes its use.
Emagel solution remains clear even at low temperatures, close to freezing point. However, for physiological reasons, the solution should be infused at body temperature.
For technical reasons, a residual air volume is present in the containers. Therefore, when using plastic infusion bottles, infusion pressure should be monitored, as there is a risk of gas embolism (presence of gas bubbles in circulating blood).
Other medicines and EMAGEL
Inform your doctor if you are taking, have recently taken, or might take any other medicines.

• Emagel may be mixed with common infusion solutions [saline solutions, glucose solutions (containing sugars), Ringer's solution (a solution used to increase blood volume), etc.], as well as with muscle relaxants, barbiturates (sedatives), circulatory agents, corticosteroids, vitamins, tetanus antitoxin, penicillin-group and tetracycline-group antibiotics.
• Histamine-mediated reactions may occur as a result of a cumulative effect from concomitant use of histamine-releasing drugs [such as anaesthetics, muscle relaxants, analgesics, ganglion-blocking agents (which block nerve impulse transmission), and anticholinergics (which block a hormone called acetylcholine)]. Due to its calcium ion content, however, it should not be mixed with citrated stored blood (to prevent coagulation). There are no such concerns regarding the combination of Emagel with adequately heparinized blood (blood containing heparin, an anticoagulant).

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor before using this medicine.
Emagel has been widely used during pregnancy. Regarding the course of pregnancy, fetal health, and neonatal condition, no harmful effects have been observed (category A).
Nevertheless, particular caution should generally be exercised when body fluid or volume substitutes are administered during or immediately after pregnancy.
Driving and using machines
No interference with the ability to drive vehicles or operate machinery has been reported.
EMAGEL contains:

• Sodium chloride: This medicine contains 1671 mg (72.71 mmol) of sodium per 500 ml, equivalent to 83.5% of the maximum daily intake of sodium recommended by the WHO.
• EMAGEL is considered high in sodium. This should be taken into account in individuals with impaired renal function or those on a low-sodium diet.
• Potassium chloride: This medicine contains 2.69 mmol of potassium per 500 ml. This should be taken into account in patients with impaired renal function or those on a low-potassium diet.

3. How to use EMAGEL

Use this medicine exactly as directed by your doctor. If you have any doubts, consult your doctor.
The solution is ready for infusion and is administered intravenously.
The amount and duration of the infusion depend on the individual needs of each case.
Typically, in adults, 500 ml are administered over 1-2 hours (approximately 40-60 drops per minute).
In cases of severe shock, rapid infusion of 500 ml under pressure within 5-10 minutes may be required.
Repeated infusions of Emagel, up to a total amount of several liters within a few days, are well tolerated.
Use in children
In children, the usual dose is 10 ml/kg.
If you use more EMAGEL than you should
The need to administer large doses of Emagel requires careful monitoring of circulatory parameters. A possible blood dilution effect may affect coagulation potential and blood cells, although normalization occurs rapidly, at the latest within 24 hours.
If you have any questions about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Occasional transient skin reactions (urticaria, rashes), low blood pressure, increased or decreased heartbeat, nausea/vomiting, breathing difficulties, increased body temperature and/or chills may occur during or after infusion of plasma substitutes (liquid part of the blood).
Rarely, severe hypersensitivity reactions have been observed, severe enough to progress to shock.
In such cases, the countermeasures to be taken depend on the nature and severity of the adverse reaction.
The occurrence of an adverse reaction should prompt immediate discontinuation of the infusion, along with simultaneous initiation of appropriate therapeutic measures based on the nature and severity of the reaction.
It has been demonstrated that histamine release is the main cause of infusion-related adverse reactions associated with Emagel.
The rate of infusion may promote the occurrence of histamine-induced reactions.
See also the sections "Warnings and precautions" and "Other medicines and EMAGEL".
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store EMAGEL

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The shelf life refers to the product in its original, unopened packaging, correctly stored.
Do not store above 25°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What EMAGEL contains

• The active substance is polygeline. 1000 ml of Emagel contain 35 g of polygeline (corresponding to a nitrogen content of 6.3 g).
• The other components are: sodium chloride; potassium chloride; calcium chloride; and water for injections.

The corresponding electrolyte concentration is: sodium ion 145 (mmol/l); potassium ion 5.1 (mmol/l); calcium ion 6.25 (mmol/l); chloride ion 145 (mmol/l).

Description of the appearance of EMAGEL and contents of the pack
Infusion solution.
500 ml vial.

Marketing Authorization Holder
Piramal Critical Care B.V.
Rouboslaan 32 (ground floor)
2252 TR, Voorschoten
The Netherlands

Manufacturers
Piramal Critical Care B.V.
Rouboslaan 32 (ground floor)
2252 TR, Voorschoten
The Netherlands