AQUA AD injections

Aqua ad injectabilia Deltamedica, liquid. Active ingredient: Water for injection. Indications: Solvent for dissolving and diluting medications, according to the instructions in the package leaflet of the respective medication.

For risks and side effects, read the package leaflet and ask your doctor or pharmacist.


PACKAGE LEAFLET: INFORMATION FOR THE USER

Aqua ad injectabilia Deltamedica, liquid
. Active ingredient: Water for injection.

Read the entire package leaflet carefully before you start using this medicine because it contains important information. Always use this medicine exactly as described in this package leaflet or exactly as your doctor or pharmacist has told you.

• Keep the package leaflet. You may want to read it again later.
• Ask your pharmacist if you need more information or advice.
• If your symptoms worsen or do not improve, you should definitely see a doctor.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What this leaflet contains:

1. WHAT IS AQUA AD INJECTABILIA DELTAMEDICA AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING AQUA AD INJECTABILIA DELTAMEDICA?
3. HOW IS AQUA AD INJECTABILIA DELTAMEDICA TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD AQUA AD INJECTABILIA DELTAMEDICA BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS AQUA AD INJECTABILIA DELTAMEDICA AND WHAT IS IT USED FOR?

Solvent for dissolving and diluting medications, according to the instructions in the package leaflet of the respective medications.

2. WHAT SHOULD YOU KNOW BEFORE USING AQUA AD INJECTABILIA DELTAMEDICA?

Aqua ad injectabilia Deltamedica must not be used:
If the indications for use are observed, there are no product-specific contraindications. Furthermore, the contraindications for the added medications must be considered.

Warnings and precautions:
Please talk to your doctor or pharmacist before using Aqua ad injectabilia Deltamedica. Larger quantities of electrolyte-free solutions should not be administered. Aqua ad injectabilia Deltamedica does not contain salts or other dissolved substances. It must not be injected alone (without additives) as it can lead to the breakdown of red blood cells (hemolysis) and the dilution of salts dissolved in the blood. The warnings for the added medications must be observed. When mixing with other medications and during any other handling, care must be taken to avoid the risk of contamination with bacteria or other pathogens. Use must occur immediately after opening or after piercing the rubber stopper.

Use of Aqua ad injectabilia Deltamedica with other medications:
Inform your doctor or pharmacist if you are using, have recently used, or intend to use any other medications. When the indications are followed, there are no known interactions specific to this product with other medications. The interactions of any added active ingredients must be considered.

Pregnancy, breastfeeding, and fertility:
If you are pregnant or breastfeeding, or if you suspect you may be pregnant or are planning to become pregnant, ask your doctor or pharmacist for advice before using this medicine. Use during pregnancy and breastfeeding depends on the specific diluted medication.

Driving and operating machinery:
The ability to actively participate in road traffic and operate machinery is not affected by the administration of Deltamedica injectable water. However, the effects of any added active ingredients should be taken into account.

3. HOW TO USE DELTAMEDICA INJECTIVE WATER

Always use this medicine exactly as described in this leaflet or exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Unless otherwise prescribed, the dosage depends on the instructions for the medicine to be dissolved or diluted.

Method of administration:
For dissolving and diluting medicines. Deltamedica injectable water is not intended for intravenous use alone and must only be injected or infused intravenously after the addition of osmotically active substances. Mixtures must be prepared under sterile conditions. From a microbiological point of view, solutions mixed under uncontrolled and unvalidated conditions must be used immediately. The user is responsible for the storage time and conditions of the ready-to-use solution. Only clear and colorless liquids from undamaged containers may be used as carrier or diluent solutions.

Duration of use:
The duration of use depends on the clinical requirements.

If you have used more Aqua ad injectabilia Deltamedica than you should:
If Aqua ad injectabilia Deltamedica has been administered accidentally, disturbances in fluid and electrolyte balance must be corrected according to the relevant laboratory parameters. If massive hemolysis occurs, intensive care measures must be initiated immediately. The signs and symptoms of an overdose also depend on the type of active ingredient added. In case of an overdose, the infusion should be stopped.

If you forget to use Aqua ad injectabilia Deltamedica:
Do not use a double dose to make up for a forgotten dose.

If you stop using Aqua ad injectabilia Deltamedica
: No further questions.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. POSSIBLE SIDE EFFECTS:

Like all medicines, this medicine can cause side effects, although not everybody gets them. When the indications are followed, there are no product-specific side effects. The likelihood of potential side effects depends on the added active ingredients.

Reporting of side effects:
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Federal Institute for Drugs and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger Allee 3, D-53175 Bonn, Germany, website: www.bfarm.de. By reporting side effects, you can help provide more information on the safety of this medicine.

5. HOW TO STORE AQUA AD INJECTABILIA DELTAMEDICA?

This medicine does not require any special storage conditions. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and the container after ###EXP:###/###EXP:###. The expiry date refers to the last day of that month. Do not use the solution if the container or cap is damaged. Solutions containing visible solid particles must not be administered. Administer immediately after connecting the infusion set. Containers that have already been used must not be reconnected, even if they are only partially empty. Disinfect rubber stoppers before piercing. Preservative-free. Therefore, intended for single use only. Discard any opened container.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Aqua ad injectabilia Deltamedica contains:
The active ingredient is: Water for injections. The other ingredient is: No other ingredients.

What Aqua ad injectabilia Deltamedica looks like and contents of the pack:
Clear, colorless liquid. It is sterile and pyrogen-free. It is available in packs containing:

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Deltamedica GmbH,
Ernst-Wagner-Weg 1-5,
72766 Reutlingen, Germany.

AQUA AD injections