Aqua pro iniectione Polpharma

Leaflet attached to the packaging: information for the user

Aqua pro injectione Polpharma

Solvent for the preparation of parenteral medicines
Aqua ad iniectabile

You should read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What is Aqua pro injectione Polpharma and what is it used for
• 2. Important information before using Aqua pro injectione Polpharma
• 3. How to use Aqua pro injectione Polpharma
• 4. Possible side effects
• 5. How to store Aqua pro injectione Polpharma
• 6. Package contents and other information

1. What is Aqua pro injectione Polpharma and what is it used for

Aqua pro injectione Polpharma, i.e., water for injections, is used to dissolve and dilute medicines administered parenterally (in injections and infusions).

2. Important information before using Aqua pro injectione Polpharma

When not to use Aqua pro injectione Polpharma

There are no contraindications to the use of Aqua pro injectione Polpharma.

Warnings and precautions

Before starting to take Aqua pro injectione Polpharma, you should discuss it with your doctor.
Due to the risk of intravascular hemolysis (red blood cell breakdown), water should not be administered intravenously in quantities exceeding 50 ml without the addition of a substance that increases osmolality (the content of osmotically active substances) to a value of at least half the normal osmolality of serum. For example, an intravenous infusion can be performed only after mixing with at least an equal volume of isotonic 0.9% sodium chloride solution or 5% glucose solution.

Aqua pro injectione Polpharma and other medicines

Water for injections should not be mixed with oily injection solutions.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, suspects that she may be pregnant, or plans to have a child, she should consult a doctor or pharmacist before using this medicine.
There are no contraindications to the use of water for injections during pregnancy and breastfeeding.

Driving and operating machinery

Water for injections does not affect the ability to drive vehicles and operate machinery.

3. How to use Aqua pro injectione Polpharma

This medicine should always be taken according to the doctor's recommendations. In case of doubts, you should consult a doctor.
The medicine should be administered only by qualified medical personnel.

Use in children and adults

The medicine should be used in accordance with the recommendations given in the leaflet of the medicine to be diluted or dissolved.

Using a higher dose of Aqua pro injectione Polpharma than recommended

If the patient suspects that they have received too high a dose of the medicine, they should inform their doctor.
In patients with water balance disorders (e.g., hidden renal failure, alcoholism, conditions characterized by increased release of antidiuretic hormone), the administration of large amounts of water may cause water poisoning, which is characterized by symptoms of restlessness, inability to concentrate, lack of appetite, headaches, apathy, nausea, and vomiting.
If no corrective measures are taken immediately, seizures and loss of consciousness may occur.
In mild cases, complete cessation of water administration quickly leads to the disappearance of symptoms and normalization of serum sodium levels. In severe disorders, intravenous infusions of 3% sodium chloride solution or 25% mannitol solution in a volume of about 100 ml, in repeated doses, are necessary.
In case of any further doubts related to the use of this medicine, you should consult a doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although they may not occur in everyone.
Intravenous administration of water for injections alone poses a risk of intravascular hemolysis.
The possibility of other side effects depends on the properties of the added medicinal products.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, you should tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store Aqua pro injectione Polpharma

The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the specified month.
Do not store above 25°C. Store in the original packaging.
Medicines should not be disposed of via wastewater or household waste containers. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Aqua pro injectione Polpharma contains

The active substance of the medicine is water for injections (Aqua ad iniectabilia).
Each ampoule contains 5 ml or 10 ml of water for injections.

What Aqua pro injectione Polpharma looks like and what the package contains

Aqua pro injectione Polpharma is a colorless, transparent liquid.
The package contains 100 polyethylene ampoules with a capacity of 5 ml or 10 ml, packed in a cardboard box.

Marketing authorization holder and manufacturer

Polpharma S.A. Pharmaceutical Works
ul. Pelplińska 19, 83-200 Starogard Gdański
phone: +48 22 364 61 01

Date of the last update of the leaflet: