ELECTROLYTE Infusion Solution 153 PE Bottle 10 x 500 ml

Electrolyte Infusion Solution 153. Indications: This solution replaces fluid and salts lost from the circulatory system. It can also be used in cases where your blood is slightly acidic. It is also used for short-term blood replacement. The solution can also be used as a carrier solution for other salts and medications.

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


PACKAGE LEAFLET: INFORMATION FOR THE USER

Electrolyte Infusion Solution 153, Total cations/anions 153 mEq/L each.
Infusion solution for intravenous use.

Read the entire package leaflet carefully before you start using this medicine because it contains important information. This medicine is available without a prescription. However, to achieve the best possible treatment outcome, Electrolyte Infusion Solution 153 must be used correctly.

• Keep the package leaflet. You may want to read it again later.
• Ask your doctor or pharmacist if you need more information or advice.
• 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 ELECTROLYTE INFUSION SOLUTION 153 AND WHAT IS IT USED FOR?
2. WHAT SHOULD YOU CONSIDER BEFORE USING ELECTROLYTE – INFUSION SOLUTION 153?
3. HOW IS ELECTROLYTE – INFUSION SOLUTION 153 TO BE USED?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. HOW SHOULD ELECTROLYTE – INFUSION SOLUTION 153 BE STORED?
6. PACKAGE CONTENTS AND FURTHER INFORMATION

1. WHAT IS ELECTROLYTE INFUSION SOLUTION 153 AND WHAT IS IT USED FOR?

Electrolyte Infusion Solution 153 is an infusion solution administered into a vein. This solution replaces fluid and salts lost from the circulatory system. It can also be used in cases where your blood is slightly acidic. It is also used for short-term blood replacement. The solution can also be used as a carrier solution for other salts and medications.

2. WHAT SHOULD YOU KNOW BEFORE USING ELECTROLYTE INFUSION SOLUTION 153?

Electrolyte Infusion Solution 153 must not be used if there is too much fluid in your circulatory system. The addition of electrolyte concentrates may result in further contraindications due to their chemical and physical properties.

Warnings and precautions:
Special care is required when using Electrolyte Infusion Solution 153 if you:

• have high potassium –%%% or sodium levels in the blood
• suffer from illnesses where you must not consume too much salt, such as mild or moderate impaired heart function (heart failure), fluid retention in the tissues (generalized edema), fluid retention in the...
• suffer from kidney dysfunction with a tendency towards elevated potassium levels in the blood.

If any of the above applies to you, your doctor will carefully consider whether this solution is suitable for you. While you are receiving Electrolyte Infusion Solution 153, your body fluid levels and blood salt concentrations will be monitored to ensure they remain within the normal range. For further warnings, see the section "The following information is intended for healthcare professionals."

Using Electrolyte Infusion Solution 153 with other medicines:
Please tell your doctor if you are taking/using any other medicines, including those obtained without a prescription. Your doctor is aware of the interactions that can occur when Electrolyte Infusion Solution 153 is combined with other medicines. They will take great care to ensure that the infusion you receive is correctly dosed. Some medicines cannot be mixed with Electrolyte Infusion Solution 153. Doctors will only add medication if they are certain it can be safely mixed with Electrolyte Infusion Solution 153.

Pregnancy and breastfeeding:
Please inform your doctor if you are pregnant or breastfeeding. Your doctor will decide whether this solution is suitable for you if you are pregnant. No adverse effects of Electrolyte Infusion Solution 153 on pregnancy or breastfed infants are expected when used as directed.

Driving and operating machinery:
Not applicable.

3. HOW TO USE ELECTROLYTE INFUSION SOLUTION 153?

Dosage:
Your doctor will determine how much solution you should receive. The daily dose can be up to 40 ml of solution per kg of body weight.

Method of administration:
Intravenous use. This medicine is administered via a venous drip.

Rate of administration:
Your doctor will also determine how quickly the solution is infused. The rate depends on your body weight and your condition.

Duration of treatment:
Your doctor will determine the duration of treatment for which you receive this solution.

If you have received more electrolyte infusion solution than you should:
Because your dose is controlled by a doctor or nurse, it is unlikely that you will receive too much solution. However, if you accidentally receive too much, or if the solution is given too quickly, you may experience symptoms such as:

• Overhydration (e.g., tissue swelling due to fluid accumulation),
• Disruptions of the water and salt balance,
• Hyperosmolarity
• Induction of an alkalotic metabolic state.

In case of an overdose, the infusion will be stopped immediately and appropriate corrective treatment initiated.

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

4. POSSIBLE SIDE EFFECTS

Like all medicines, Electrolyte Infusion Solution 153 can cause side effects, although not everybody gets them. When the contraindications, dosage recommendations, and instructions are followed, no side effects are known.

Reporting of side effects:
If you get 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 Electrolyte Infusion Solution 153

Electrolyte infusion solution 153 must not be used after the expiry date printed on the container and outer packaging. The expiry date refers to the last day of the month indicated. Keep this medicine out of the sight and reach of children. Once opened, the solution must be used immediately; any remaining solution must be discarded. Use only clear solutions in undamaged containers!

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Electrolyte Infusion Solution 153 contains:
1 L of infusion solution contains the following active ingredients: Sodium chloride 5.26 g, Potassium chloride 0.37 g, Calcium chloride dihydrate 0.37 g, Magnesium chloride hexahydrate 0.3 g, Sodium acetate trihydrate 6.8 g (corresponding mmol/L: Na+ 140, K+ 5, Ca2+ 2.5, Mg2+ 1.5, Cl- 104.5, Acetate ions 50). The other ingredients are water for injections and 36% hydrochloric acid. Sterile and pyrogen-free. pH: 5.0–7.0. Theoretical osmolarity: 303 mmol/L. Titration acidity: < 3.5 mmol/L to pH 7.4.

What Electrolyte Infusion Solution 153 looks like and contents of the pack:
Electrolyte Infusion Solution 153 is available in the following pack sizes: 1 x 250 ml, 10 x 250 ml, 1 x 500 ml, 10 x 500 ml, 1 x 1000 ml, 6 x 1000 ml, 10 x 1000 ml. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Serumwerk Bernburg AG,
Hallesche Landstraße 105 b,
06406 Bernburg (Saale), Germany .

ELECTROLYTE Infusion Solution 153 PE Bottle 10 x 500 ml