Kabipac sodium chloride 9 mg/ml solution for infusion
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What KABIPAC SODIUM CHLORIDE 9 MG/ML is and what it is used for
- 2. WHAT YOU NEED TO KNOW BEFORE STARTING TO USE KABI PAC SODIUM CHLORIDE 9 MG/ML
- 3. HOW TO USE KABIPAC SODIUM CHLORIDE 9 MG/ML
- 4. Possible adverse effects
- 5. Storage of KABIPAC SODIUM CHLORIDE 9 MG/ML
- 6. PACKAGE CONTENTS AND ADDITIONAL INFORMATION
Package leaflet: Information for the user
Introduction
PACKAGE LEAFLET: INFORMATION FOR THE USER
KabiPac Sodium chloride 9 mg/ml solution for infusionSodium chloride
Read the entire patient information leaflet carefully before you start using this medicine, as it contains important information for you:
the same symptoms as you, as it may harm them.
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Package leaflet contents:
- What KabiPac Sodium Chloride 9 mg/ml is and what it is used for
- What you need to know before using KabiPac Sodium Chloride 9 mg/ml
- How to use KabiPac Sodium Chloride 9 mg/ml
- Possible side effects
- Storage of KabiPac Sodium Chloride 9 mg/ml
- Package contents and additional information
1. What KABIPAC SODIUM CHLORIDE 9 MG/ML is and what it is used for
KabiPac Sodium Chloride 9 mg/ml is an intravenous infusion solution supplied in 100 ml bottles containing 50 ml or 100 ml of solution, 250 ml bottles containing 100 ml or 250 ml of solution, and 500 ml and 1000 ml bottles.
It belongs to the group of medicines called electrolyte solutions.
It is used for electrolyte replacement in cases of dehydration with salt losses, in states of hypovolemia (reduced blood volume), mild alkalosis, and as a vehicle for the administration of drugs and electrolytes.
2. WHAT YOU NEED TO KNOW BEFORE STARTING TO USE KABI PAC SODIUM CHLORIDE 9 MG/ML
- Do not use KabiPac Sodium Chloride 9 mg/ml if you are allergic to the active substance or to any of the other components of KabiPac Sodium Chloride 9 mg/ml.
- If you have ever been diagnosed or found to have high blood pressure, edema, kidney or liver disease, or suffer from any heart disorder.
- If you have hypernatremia (increased blood sodium concentration), hyperchloremia (increased blood chloride concentration), hypokalemia (decreased blood potassium), or acidosis (pH below the normal range).
- In states of hyperhydration (fluid overload).
Warnings and precautions
Your doctor may request blood tests to monitor your condition, as the balance of water and electrolytes in the body must be controlled.
Regular blood electrolyte monitoring should be performed during prolonged therapy, particularly if you have acid-base imbalance, cardiac, hepatic and/or renal disorders, or if you are being treated with corticosteroids or adrenocorticotropic hormone.
This medicine should be administered with caution if you suffer from hypertension, pre-eclampsia (symptoms preceding seizures and drop in blood pressure in pregnant women), aldosteronism (a pathological condition due to excessive aldosterone production), or other conditions associated with sodium retention.
KabiPac Sodium Chloride 9 mg/ml should be administered with caution in premature infants and full-term neonates.
If administered continuously at the same infusion site, pain, fever, infection, and phlebitis (inflammation of the veins) may occur.
Use of KabiPac Sodium Chloride 9 mg/ml with other medicines
Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription, as it may be necessary to interrupt treatment or adjust the dose of one or more of them.
Before mixing with other medicines, compatibility tables should be checked, pH considered, and ions monitored.
Administration of sodium chloride increases renal excretion of lithium, leading to a reduction in its therapeutic effect.
It should be administered with caution in patients treated with corticosteroids or adrenocorticotropic hormone, as they may retain water and sodium.
Pregnancy and breastfeeding
Consult your doctor or pharmacist before using any medicine.
Provided administration is correct and controlled, adverse effects are not expected during pregnancy and breastfeeding.
To date, relevant epidemiological data are not available; therefore, it is recommended that, if used during these periods, it should be done with caution.
Driving and use of machines
Not applicable, due to the characteristics of its use.
3. HOW TO USE KABIPAC SODIUM CHLORIDE 9 MG/ML
Follow exactly the administration instructions for KabiPac Sodium Chloride 9 mg/ml provided by your doctor. Consult your doctor or pharmacist if you have any doubts.
Your doctor will determine the most appropriate dose according to your needs. Generally, intravenous drop-by-drop administration is recommended, based on your age, body weight, clinical condition, fluid and electrolyte balance, and acid-base balance.
Recommended dosage:
For adults, elderly, and adolescents: 500 ml to 3000 ml every 24 hours
For infants and children: 20 ml to 100 ml per kg of body weight every 24 hours
Generally, a drop-by-drop administration rate of 120–180 ml/hour is recommended, at a speed of 40–60 drops/minute.
It must be administered by intravenous route.
If you use more KabiPac Sodium Chloride 9 mg/ml than you should
In case of overdose, hyperhydration (excess water), hypernatremia (excess sodium), hyperchloremia (excess chloride), and related manifestations such as metabolic acidosis (blood pH lower than normal), cardiac overload, and edema formation may occur. Administration should be discontinued and symptomatic treatment initiated.
If you are not hospitalized, go immediately to the nearest hospital or contact the Toxicology Information Service. Telephone: 91 562 04 20.
4. Possible adverse effects
Like all medicines, KabiPac Sodium chloride 9 mg/ml may produce adverse effects, although not everyone experiences them.
If administered continuously at the same infusion site, pain, fever, infection, phlebitis extending from the injection site, extravasation, and hypervolemia may occur.
When used as a vehicle for the administration of other medicinal products, the nature of the added medicinal products will determine the likelihood of other adverse reactions.
In case of adverse reactions, the infusion should be discontinued.
If you experience any adverse effects, consult your doctor or pharmacist, including any adverse effects not listed in this leaflet.
5. Storage of KABIPAC SODIUM CHLORIDE 9 MG/ML
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container.
No special storage conditions are required.
Do not use KabiPac Sodium Chloride 9 mg/ml if the solution is not clear and contains precipitates.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. PACKAGE CONTENTS AND ADDITIONAL INFORMATION
Composition of KabiPac Sodium Chloride 9 mg/ml
The active substance is sodium chloride. Each 100 ml of solution contains 0.9 g of sodium chloride.
- The only excipient is water for injections.
Ionic composition:
Sodium 154 mmol/l (154 mEq/l)
Chloride 154 mmol/l (154 mEq/l)
Theoretical osmolarity: 308 mOsm/l.
pH: 4.5 - 7
Appearance of the product and package contents
KabiPac Sodium Chloride 9 mg/ml is a sterile, pyrogen-free, clear, colorless solution free from visible particles. It is supplied in polyethylene bottles with the following capacities and pack sizes:
1 bottle of 50 ml
1 bottle of 100 ml
1 bottle of 100/250 ml
1 bottle of 250 ml
1 bottle of 500 ml
1 bottle of 1000 ml
40 bottles of 100 ml
10 bottles of 500 ml
20 bottles of 50 ml
20 bottles of 250 ml
20 bottles of 100/250 ml
10 bottles of 1000 ml
40 bottles of 50 ml
Only certain package sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
Fresenius Kabi España S.A.U
C/ Marina 16-18,
08005 - Barcelona (Spain)
Manufacturers:
Labesfal – Laboratorios Almiro, S.A.
Zona Industrial do Lagedo,
3465-157 Santiago de Besteiros (Portugal)
Fresenius Kabi Deutschland GmbH Werk Friedberg
Freseniusstraße 1
D-61169 Friedberg, Germany
Fresenius Kabi Polska SP Z.O.O.
Sienkiewicza, 25 (Kutno)
P-99-300 Poland
Fresenius Kabi Italy S.r.l.
Via Camagre, 41
I – 37063 Isola della Scala – Verona, Italy
Fresenius Kabi España S.A.U.
C/ Dr. Ferran, 4
08339 Vilassar de Dalt (Barcelona), Spain
"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/"
Date of most recent review of this package leaflet: April 2021.
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This information is intended for healthcare professionals only:
This medicine must always be administered by trained personnel. It is administered by intravenous infusion via a central or peripheral vein.
The solution must be clear, free from particles and without precipitates. Do not administer if otherwise.
The contents of each container are intended for single use only; any unused portion must be discarded.
Use aseptic techniques when administering the solution and when preparing mixtures.
Before adding medications to the solution or administering it simultaneously with other medicinal products, compatibility must be verified.
Discard after single use.
Discard partially used containers.
Do not reconnect partially used containers.