Ringer Lactat plastic infusion solution, 10x1000 ml

Upute za korištenje Ringer Lactat plastic infusion solution, 10x1000 ml

Important notes (compulsory information):

Ringer lactate solution, electrolytes, infusion solution. Applications: For liquid and electrolyte substitution with balanced acid base household and with slight acidosis, as a short-term intravasal volume replacement, in isoton dehydration, with hypoton dehydration, as a carrier solution for compatible electrolyte concentrates and medicines.

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


LEAFLET: INFORMATION FOR THE USER

Ringer lactate solution, electrolytes, infusion solution
Active ingredients: sodium chloride, potassium chloride, calcium chloride, sodium lactate

Read the entire leaflet carefully before starting using this medicine, because it contains important information. Always use this medicine as described in this leaflet as described in this leaflet or exactly as your doctor, pharmacist or medical personnel.

• Lift the package leaflet. You might want to read it again.
• Ask your pharmacist if you need more information or advice.
• If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. See section 4.
• If you do not feel better or even worse, contact your doctor.

What is in this leaflet:

1. What is Ringer Lactat solution and what is it used for?
2. What should you consider before using Ringer Lactat solution?
3. How is Ringer Lactat solution to apply?
4. WHAT SIDE EFFECTS ARE POSSIBLE?
5. How to keep the Ringer Lactat solution?
6. Content of the pack and further information

1. What is Ringer Lactat solution and what is it used for?

Ringer Lactat solution is an electrolytic solution and is used:

• for liquid and electrolyte substitution with balanced acid-base household and light acidosis,
• as a short-term intravasal volume replacement,
• with isoton dehydration,
• for hypotonous dehydration,
• as a carrier solution for compatible electrolyte concentrates and drugs.

2. What should you consider before using Ringer Lactat solution?

Ringer-lactate solution must not be used with too high amount of fluid in the body (hyperhydration states) and lactate metabolic disorders.

Warnings and Precautions:
Please talk to your doctor or pharmacist before Ringer Lactat solution is applied to you, especially:

• if you have an increased potassium content in the blood (hyperkalemia) to have,
• if you have an increased sodium content in the blood (hyperremia) to have,
• if you have an increased chloride content in the blood (hyperchloria) to have,
• if you have diseases that have a restrictive sodium supply (such as heart failure, generalized edema, pulmonary edema, hypertension, eclampsia, heavy renal insufficiency).

Caution is offered with impaired performance of kidneys with inclination to increased potassium content in the blood. Controls of electrolyte and fluid status are required.

Application of Ringer Lactat solution together with other medicines:
Inform your doctor or pharmacist if you apply other medicines, recently applied other medicines or intend to apply other medicines. Interactions with other medicines are not yet known. For incompatibilities see section "The following information is intended for medical professionals“.

Pregnancy and breast feeding period:
If you are pregnant or breastfeeding, or if you guessing to be pregnant or intend to become pregnant, ask your doctor or pharmacist for advice before applying this medicine. Caution is offered during pregnancy, especially in Eklampsie.

Driving and ability to operate machines:
Ringer Lactat solution has no influence on the ability to drive and the ability to serve machines.

3. How is Ringer Lactat solution to apply?

The medicine will be available from the doctor by means of infusion (Administration directly in the vein) applied. The dosage depends on your needs for fluid and electrolytes.

Maximum daily dose:
The maximum daily dose results from its fluid and electrolyte requirements. A fluid supply of 40 ml per kg body weight and day, corresponding to 5.24 mmol sodium per kg body weight and day and 0.21 mmol of potassium per kg body weight and day, should not be exceeded in adults.

Maximum infusion speed:
The maximum infusion rate depends on your clinical condition and normally will not exceed the values given below: 5 ml per kg body weight and hour or 1.7 drops per kg body weight and minute. The doctor decides on the duration of the application.

When a larger amount of Ringer Lactat solution has been applied than it should:
The symptoms of overdose are:

• Waisting,
• Disorders in the electrolyte balance,
• Hyperosmolarity,
• Induction of an alkalotic material changing position.

Therapy for overdose:

• Interruption of the supply of the solution,
• accelerated excretion over the kidneys,
• a corresponding negative accounting of the electrolytes.

If you have further questions about the application of this medicine, contact your doctor.

4. Which side effects are possible?

Like all medicines, this medicine can also have side effects, but they do not have to occur each other.

Rarely (1 to 10 treated from 10,000):
Fever reactions caused by the administration method, infections at the injection site, local pain or reactions, venous irritation, blood clots in the veins, venous inflammation outstanding from the injection site.

Frequency unknown (frequency based on the available data not estimable):
When using the solution, it can lead to increased chloride levels in the blood (hyperchloremia.

Message of side effects:
If you notice side effects, contact your doctor or pharmacist. This also applies to side effects that are not indicated in this leaflet. You can also effectively effect the Federal Institute for Medicines and Medical Devices, Dept. Pharmacovigilance, Kurt-Georg-Kiesinger-Allee 3, D-53175 Bonn, website: www.bfarm.de. By reporting side effects, you can help to provide more information about the security of this medicine.

5. How to keep the Ringer Lactat solution?

Keep this medicine inaccessible to children. You may not use this medicine after the expiry date specified on the outer carton or on the bottle label according to "usable until". The expiry date refers to the last day of the specified month. No special storage conditions are required for this medicine. You may not use this medicine if you notice the following: The solution is not clear and / or the container is damaged. The medicine is intended for unique application and immediate consumption. Solutions with the addition of drugs must not be stored. After infusion unrayed residual quantities are to be rejected and may under no circumstances be stored for later infusion. The medicine must not be disposed of in wastewater or budgetary waste. This measure helps protect the environment.

6. Content of the pack and further information

What is Ringer-Lactat solution:
1000 ml infusion solution Ethe active ingredients are: Sodium chloride 6.02 g, potassium chloride 0.41 g, calcium chloride dihydrate 0.26 g of sodium lactate 3.14 g as a sodium lactate solution (50%). The other ingredient is: water for injection purposes. Theoretical osmolarity: 279 mosm / l. pH value: 5.0 to 7.5. Titrationacidity up to pH 7.4: < 0.3 mmol / l. Molar concentration: sodium 131 mmol / l, potassium 5.5 mmol / l, calcium 1.8 mmol / l, chloride 112 mmol / l, lactate 28 mmol / l.

Like Ringer Lactat solution looks and content of the pack:
Ringer-lactate solution is a clear, tortured-free, colorless solution in plastic infusion bottles, available in the following packages: Content: 10 x 500 ml (N2), 10 x 1000 ml (N2). Not all pack sizes may be placed on the market.

Pharmaceutical entrepreneur and manufacturer:
BERLIN-CHEMIE AG
Glienicker Weg 125
12489 Berlin
Germany

This leaflet was recently revised in December 2014.

The following information is intended for medical professionals:
Due to the calcium content, incompatibilities with solutions may arise which contain inorganic phosphate, oxalate or carbonate / hydrogen carbonate. With regard to further incompatibilities, the information in the package leaflets of the drugs to be used must be observed. Further information see Fachinformation.

Source: Information of the leaflet
Status: 07/2016