Package Leaflet: Information for the User
Viaflo Hartmann (Lactated Ringer's) in 5% Glucose Solution for Infusion
Glucose, sodium chloride, potassium chloride, calcium chloride dihydrate, and sodium lactate
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Contents of the Package Leaflet:
This medicine is called “Viaflo Hartmann (Lactated Ringer's) in 5% Glucose Solution for Infusion”, but will be referred to as “Viaflo Hartmann (Lactated Ringer's) in 5% Glucose” throughout this leaflet.
Viaflo Hartmann (Lactated Ringer's) in 5% Glucose is a solution containing the following substances in water:
Glucose is one of the body's sources of energy. This solution provides 200 kilocalories per liter. Sodium, potassium, calcium, chlorides, and lactate are chemical substances (electrolytes) found in the blood.
Viaflo Hartmann (Lactated Ringer's) in 5% Glucose is used as a source of carbohydrates (sugar) in the following situations:
Viaflo Hartmann (Lactated Ringer's) in 5% Glucose must not be given to you if you have any of the following conditions
Warnings and precautions
Viaflo Hartmann (Lactated Ringer's) in 5% Glucose is a hypertonic solution (concentrated). Your doctor will take this into account when calculating how much solution to administer to you.
Consult your doctor or nurse before starting to use Viaflo Hartmann (Lactated Ringer's) in 5% Glucose if you have or have had any of the following conditions:
Intensive monitoring of your blood potassium levels is required.
This can increase the risk of low sodium levels in the blood and may cause headache, nausea, seizures, lethargy, coma, brain inflammation, and death. Brain inflammation increases the risk of death and brain damage. People at higher risk of brain inflammation are:
When you are being administered this solution, your doctor may take blood and urine samples to monitor:
Although Viaflo Hartmann (Lactated Ringer's) in 5% Glucose contains potassium, it does not contain enough to treat very low potassium levels in plasma (severe potassium deficiency)
Calcium chloride can be harmful if injected into tissues. Therefore, Viaflo Hartmann (Lactated Ringer's) in 5% Glucose must not be injected into muscle (intramuscular injection). Your doctor will take this into account to avoid the solution penetrating into the tissues around the veins.
Viaflo Hartmann (Lactated Ringer's) in 5% Glucose must not be administered with the same needle used for a blood transfusion. Red blood cells may be damaged or clumped.
Since Viaflo Hartmann (Lactated Ringer's) in 5% Glucose contains lactate (a substance present in the body), it may make the blood too alkaline (metabolic alkalosis).
Viaflo Hartmann (Lactated Ringer's) in 5% Glucose contains sugar (glucose) and may cause high blood sugar levels (hyperglycemia). If this occurs, your doctor may:
This is particularly important if you have diabetes.
Children
Viaflo Hartmann in 5% Glucose should be administered with caution in children. Newborns, especially premature and low-birth-weight infants, are at higher risk of developing high or low blood sugar levels (hypoglycemia or hyperglycemia), which can lead to complications.
Your doctor should consider whether you are receiving parenteral nutrition (nutrition received through infusion into a vein). During prolonged treatment with Viaflo Hartmann (Lactated Ringer's) in 5% Glucose, you will need extra nutrition.
Other medicines and Viaflo Hartmann (Lactated Ringer's) in 5% Glucose
Tell your doctor or nurse if you are using or have recently used or might use any other medicines.
It is particularly important that you inform your doctor if you are taking:
These medicines may cause your body to retain sodium and water, leading to:
The following medicines may increase the potassium level in your blood. This effect can be life-threatening. It is more likely that you will experience an increase in blood potassium levels if you have kidney disease.
(Note that these medicines may be included in some combination medicines)
Some medicines act on the hormone vasopressin. These may include:
Other medicines that may affect or be affected by Viaflo Hartmann (Lactated Ringer's) in 5% Glucose are:
Using Viaflo Hartmann (Lactated Ringer's) in 5% Glucose with food and drinks
Ask your doctor or nurse what you can eat or drink.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, or think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before using this medicine.
Viaflo Hartmann (Lactated Ringer's) in 5% Glucose can be used safely during pregnancy and breastfeeding. Your doctor will monitor your blood electrolyte levels and fluid levels.
Calcium can pass to the fetus through the placenta and, after birth, through breast milk.
However, if another medicine is added to the infusion solution during pregnancy or breastfeeding, you should:
Driving and using machines
Ask your doctor or pharmacist before driving or using machinery.
Viaflo Hartmann (Lactated Ringer's) in 5% Glucose will be administered to you by a doctor or nurse.
Your doctor will decide how much you need and when you should receive it. This will depend on your age, weight, physical condition, and the reason for treatment. The amount you receive may also be influenced by other treatments you are receiving.
DO NOT receive Viaflo Hartmann (Lactated Ringer's) in 5% Glucose if there are particles floating in the solution or if the container is damaged in any way.
Viaflo Hartmann (Lactated Ringer's) in 5% Glucose is usually administered through a plastic tube attached to a needle inserted into a vein. A vein in the arm is usually used to administer the infusion. However, your doctor may administer the medication in another way.
Before and during the infusion, your doctor will monitor:
Any unused remainder of the solution must be discarded. DO NOT receive Viaflo Hartmann (Lactated Ringer's) in 5% Glucose from a bag that has been partially used.
If you receive more Viaflo Hartmann (Lactated Ringer's) in 5% Glucose than you should
If you receive too much Viaflo Hartmann (Lactated Ringer's) in 5% Glucose solution or if you receive it too quickly, you may experience the following symptoms:
If you notice any of these symptoms, inform your doctor immediately. The infusion will be stopped and you will receive treatment based on the symptoms.
If a medication has been added to Viaflo Hartmann (Lactated Ringer's) in 5% Glucose before excessive administration, the medication may also cause symptoms. You should read the list of possible symptoms in the medication's package insert.
If you interrupt the infusion of Viaflo Hartmann (Lactated Ringer's) in 5% Glucose
Your doctor will decide when you should stop receiving this infusion.
If you have any further questions about the use of this product, ask your doctor or nurse.
Like all medications, Viaflo Hartmann (Lactated Ringer's) with 5% Glucose may cause adverse effects, although not all people will experience them.
If you experience any of the following symptoms, inform your doctor or nurse immediately.
The following symptoms may be signs of a severe or life-threatening hypersensitivity reaction (allergy) called anaphylactic shock:
Low sodium levels in the blood that can be acquired during hospitalization (nosocomial hyponatremia) and related neurological disorder (acute hyponatremic encephalopathy). Hyponatremia can cause irreversible brain damage and death due to cerebral edema/inflammation (see also section 2 "Warnings and Precautions").
Some reactions may be due to the administration technique:
Other adverse effects reported with similar products (other solutions containing sodium lactate) include:
If a medication has been added to the infusion solution, it may also cause adverse effects. These adverse effects will depend on the added medication. You should read the list of possible symptoms in the package insert of the added medication.
If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this package insert.
Reporting Adverse Effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es.
By reporting adverse effects, you can contribute to providing more information on the safety of this medication.
Keep this medication out of sight and reach of children.
This medication does not require special storage conditions.
DO NOT use this medication after the expiration date stated on the bag after CAD. The expiration date is the last day of the month indicated.
DO NOT receive Viaflo Hartmann (Lactated Ringer's) in 5% Glucose if there are particles floating in the solution or if the container is damaged in any way.
Composition of Viaflo Hartmann (Lactated Ringer's) in 5% Glucose
The active ingredients are:
The only excipient is water for injectable preparations
Appearance of the Product and Package Contents
Viaflo Hartmann (Lactated Ringer's) in 5% Glucose is a clear, particle-free solution. It is presented in polyolefin/polyamide (Viaflo) plastic bags. Each bag is packaged in a sealed protective plastic overbag.
The bag sizes are
The bags are packaged in cardboard boxes. Each cardboard box contains one of the following quantities:
Not all packaging sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Baxter S.L.
Pouet de Camilo 2, 46394 Ribarroja del Turia (Valencia)
Manufacturer:
Bieffe Medital S.A.
Ctra. de Biescas, Senegüé
22666 Sabiñanigo (Huesca)
Spain
Baxter SA
Boulevard René Branquart, 80
7860 Lessines
Belgium
Date of the Last Revision of this Package Insert: April 2018
Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
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This information is intended only for healthcare professionals
Handling and Preparation
Parenteral solutions should be visually inspected for particles and discoloration before administration when the solution and container permit. Do not administer unless the solution is clear and the container is intact.
Do not remove the bag from its overbag until it is ready for use. The inner bag maintains the sterility of the product. Administer immediately after connecting the infusion equipment.
Do not connect plastic containers in series. This type of use can produce gas embolisms due to residual air being dragged from the primary container before the liquid contained in the secondary container is completely administered. The pressurization of intravenous solutions in flexible plastic containers to increase flow rates can lead to a gas embolism if the residual air in the container is not fully evacuated before administration. The use of an intravenous administration set with a ventilation filter in the open position could cause a gas embolism. This type of intravenous administration set with a ventilation filter in the open position should not be used with flexible plastic containers.
The solution is for intravenous administration using a sterile administration set and aseptic technique. The set must be primed with the solution to prevent air from entering the system.
Added medications can be introduced before or during the infusion through the injection point.
It is essential that the mixing of products is done under extreme aseptic conditions. Solutions containing added medications should be used immediately and not stored
The addition of other medications or the use of an incorrect administration technique can cause the appearance of febrile reactions due to the possible introduction of pyrogens. In case of an adverse reaction, the infusion should be interrupted immediately.
Discard after a single use.
Discard partially used containers.
Do not reconnect partially used bags.
Use sterile material for preparation and administration.
Warning: Added medications may be incompatible. Check the compatibility of the added medication with the solution and container before use (see below the section 5 "Incompatibilities of Added Medications")
To add medication before administration
Precaution: do not store bags with added medication.
To add medication during administration
Before use, the physical and chemical stability of any added medication must be established in the pH of the Viaflo Hartmann (Lactated Ringer's) in 5% Glucose solution in the Viaflo container.
From a microbiological point of view, the diluted product must be used immediately unless the addition of medications has been carried out under controlled and validated aseptic conditions. If it is not used immediately, the conditions and storage times used before use are the responsibility of the user
Ceftriaxone should not be mixed with solutions containing calcium, including Viaflo Hartmann (Lactated Ringer's) in 5% Glucose
As with all parenteral solutions, added medications may be incompatible; therefore, the compatibility of added medications with Viaflo Hartmann (Lactated Ringer's) in 5% Glucose must be verified before addition.
After adding a medication, the incompatibility of the added medication with Viaflo Hartmann (Lactated Ringer's) in 5% Glucose should be visible by a change in color and/or precipitate, insoluble complexes, or the appearance of crystals. The package insert of the medication to be added or any other relevant source should be consulted.
Before adding a medication, verify that it is soluble and/or stable in water at the pH range of Viaflo Hartmann (Lactated Ringer's) in 5% Glucose (pH 4.0 - 6.5) is appropriate.
When adding medications to Viaflo Hartmann (Lactated Ringer's) in 5% Glucose, aseptic technique must be used. Mix the solution well when added medications have been introduced. Do not store solutions with added medications.
The following list of incompatible medications with Viaflo Hartmann (Lactated Ringer's) in 5% Glucose serves as a guide (non-exhaustive list):
concentration of 2%-3% stable for 4 hours
concentration >3% should be administered within 1 hour
Medications known to be incompatible should not be used.