WATER FOR INJECTION POLPHARMA

Package leaflet: Information for the user

Aqua pro injectione Polpharma
solvent for the preparation of parenteral medicines
Aqua ad iniectabile
Please read the entire leaflet carefully before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If you experience any adverse reactions, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

1. What Aqua pro injectione Polpharma is and what it is 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. Contents of the pack and other information

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

Aqua pro injectione Polpharma, also known as water for injections, is used for dissolving and diluting medicines administered parenterally (by injections and infusions).

2. Important information before using Aqua pro injectione Polpharma

When not to use Aqua pro injectione Polpharma
There are no contraindications for the use of Aqua pro injectione Polpharma.
Warnings and precautions
Before starting treatment with Aqua pro injectione Polpharma, consult your doctor.
Due to the risk of intravascular hemolysis (breakdown of red blood cells),
water must not be administered intravenously in volumes exceeding 50 ml without adding a substance
that increases osmolarity (content of osmotically active substances) to a value equal to at least half
of the normal plasma osmolarity. For example, intravenous infusion may be administered 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
Injectable water is not compatible with oily injection solutions.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child,
she should consult a doctor or pharmacist before using this medicine.
There are no contraindications for the use of injectable water during pregnancy and breastfeeding.
Driving and operating machinery
Injectable water does not affect the ability to drive or operate machinery.

3. How to use Aqua pro injectione Polpharma

This medicine should always be used according to the doctor's instructions. In case of doubts, consult
your doctor.
This medicine should be administered only by qualified medical personnel.
Use in children and adults
This medicine should be used according to the instructions provided in the leaflet of the medicine which is to be diluted
or dissolved.
Use of a higher than recommended dose of Aqua pro injectione Polpharma
If the patient suspects having received too high a dose of the medicine, this should be reported to the doctor immediately.
In patients with impaired water balance (e.g. occult renal insufficiency, alcoholism, disease states characterized by increased release of antidiuretic hormone), administration of large amounts of water may lead to water intoxication, which is characterized by symptoms such as restlessness, inability to concentrate, loss of appetite, headache, apathy, nausea and vomiting.
If corrective measures are not taken immediately, seizures and loss of consciousness may occur.
In mild cases, complete discontinuation of water administration quickly leads to symptom resolution and correction of serum sodium concentration. In severe cases, intravenous infusions of 3% sodium chloride solution or 25% mannitol solution, approximately 100 mL, repeated doses, are required.
If you have any further questions regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Intravenous administration of water for injections alone may lead to intravascular hemolysis.
The possibility of other adverse reactions depends on the properties of the added medicinal products.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl

Adverse reactions can also be reported to the responsible entity.
Reporting adverse reactions allows the collection of additional information on the safety of using the medicine.

5. How to store Aqua pro injectione Polpharma

Keep this medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the container following: EXP.
The expiry date refers to the last day of the stated month.
Do not store above 25°C. Store in the original packaging.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Aqua pro injectione Polpharma contains
The active substance 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 contents of the pack
Aqua pro injectione Polpharma is a colourless, transparent liquid.
The pack contains 100 polyethylene ampoules with a capacity of 5 ml or 10 ml, packed in a cardboard box.

Marketing Authorisation Holder and Manufacturer
Zakłady Farmaceutyczne POLPHARMA S.A.
ul. Pelplińska 19, 83-200 Starogard Gdański
tel. +48 22 364 61 01