Glucosaline Grifols solution for infusion
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Glucosalina Grifols Infusion Solution
Glucose, Sodium Chloride
Read this entire leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet as you may need to read it again.
- If you have any questions, consult your doctor or nurse.
- If you experience any adverse reactions, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.
Leaflet Contents
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What Glucosalina Grifols is and what it is used for
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What you need to know before using Glucosalina Grifols
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How to use Glucosalina Grifols
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Possible side effects
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How to store Glucosalina Grifols
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Contents of the container and other information
1. What Glucosalina Grifols is and what it is used for
Glucosalina Grifols belongs to the group of intravenous solutions that affect electrolyte balance.
Glucosalina Grifols is indicated for:
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States of dehydration (loss of body water) with moderate electrolyte losses
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Disorders of carbohydrate metabolism
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Mild states of alkalosis
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As a vehicle for the administration of drugs and electrolytes.
2. What you need to know before using Glucosalina Grifols
Do not use Glucosalina Grifols
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if you are allergic to the active substances or to any of the other components of this medicine (listed in section 6)
- if you have states of hyperhydration (excess fluid in the body)
- in cases of generalized edema (accumulation of fluid in body tissues) or ascitic cirrhosis (chronic progressive liver disease with fluid accumulation)
- if you have hyperglycemia (high blood glucose levels)
- if you have hypernatremia (high blood sodium levels)
- if you have hyperchloremia (high blood chloride levels)
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in states of hyperosmolar coma (loss of consciousness due to increased solute concentration in the blood)
- in states of hyperlactacidemia (presence of lactic acid in the blood)
- in severe cases of cardiac, hepatic, or renal failure (impaired function of the heart, liver, or kidneys, respectively)
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during the first 24 hours after a head injury.
Warnings and precautions
Consult your doctor or nurse before starting to use Glucosalina Grifols.
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Frequent and massive administration of glucose-saline solutions may cause fluid overload (hyperhydration), disturbances in acid-base balance, and significant ionic depletions, including hypomagnesemia (low blood magnesium levels), hypokalemia (low blood potassium levels), and hypophosphatemia (low blood phosphate levels). In such cases, electrolyte supplementation may be required. For this reason, regular monitoring of blood glucose, serum electrolytes, water balance, and acid-base equilibrium is recommended.
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Isotonic glucose-saline solutions may become physiologically hypotonic in the body due to the rapid metabolism of glucose (see section 3).
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Depending on the volume and rate of infusion, your initial clinical condition, and your ability to metabolize glucose, intravenous administration of glucose-saline may cause electrolyte disturbances such as hyponatremia (low blood sodium levels).
Hyponatremia:
If you are a patient with non-osmotic release of vasopressin (antidiuretic hormone) (e.g., in critical conditions, pain, postoperative stress, infections, burns, and central nervous system disorders), if you suffer from heart, liver, or kidney disease, or if you are exposed to vasopressin agonists (see next subsection), you are at special risk of developing acute hyponatremia following administration of hypotonic solutions.
Acute hyponatremia may cause acute hyponatremic encephalopathy (cerebral edema), characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema are at special risk of suffering severe, irreversible, and potentially fatal brain damage.
Children, women of reproductive age, and patients with reduced cerebral compliance (e.g., in cases of meningitis, intracranial hemorrhage, and cerebral contusion) are at special risk of severe and potentially fatal cerebral edema caused by acute hyponatremia.
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To prevent hypokalemia occurring during prolonged infusions with glucose-saline solutions, it is recommended as a safety measure to add potassium to the solution.
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Blood glucose concentration should be carefully monitored during episodes of intracranial hypertension.
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You should exercise special caution if you have suffered acute ischemic attacks (reduced or absent blood flow in arteries), as hyperglycemia has been associated with increased cerebral ischemic damage and impaired recovery.
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Be especially careful if you have any of the following conditions: hypertension, cardiac failure, peripheral or pulmonary edema, renal dysfunction, preeclampsia (symptoms preceding seizures and drop in blood pressure in pregnant women), or other conditions associated with sodium retention.
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Administration of solutions containing glucose may cause vitamin B1 deficiency, especially in cases of malnutrition.
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In patients with diabetes mellitus, glucose-containing solutions may be used provided appropriate initial treatment (insulin) is administered. Likewise, these solutions should be used with caution in patients with Addison's disease or carbohydrate intolerance.
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You should exercise special caution if the solution is administered continuously at the same injection site due to the risk of thrombophlebitis.
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This medicine should be used with caution if your heart, liver, and/or kidneys are not functioning properly, especially if you are elderly.
Other medicines and Glucosalina Grifols
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Certain medicines may interact with Glucosalina Grifols. In such cases, it may be necessary to adjust the dose or discontinue treatment with one of the medicines.
It is important that you inform your doctor if you are taking any of the following medicines:
- Insulin or oral antidiabetics (biguanides, sulfonylureas), as intravenous administration of glucose-containing solutions in patients treated with these medicines may lead to reduced therapeutic efficacy of the latter (antagonistic action).
- Corticosteroids: Intravenous administration of glucose-saline solution in patients treated with systemic corticosteroids with glucocorticoid activity (cortisol) may lead to increased plasma glucose levels due to the hyperglycemic effect of these agents. As for corticosteroids with mineralocorticoid activity, they should be administered with caution due to their capacity to retain water and sodium.
- Digitalis glycosides (digoxin), as intravenous administration of a glucose-containing solution concomitant with therapy using these medicines may increase digitalis activity, increasing the risk of toxicity. This is due to hypokalemia that may result from glucose administration if potassium is not added to the solution.
- Lithium carbonate, as administration of sodium chloride accelerates renal excretion of lithium, leading to reduced therapeutic effect of the latter.
- Medicines that increase the effect of antidiuretic hormone (such as chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxy-N-methamphetamine, ifosfamide, antipsychotics, narcotics, NSAIDs (non-steroidal anti-inflammatory drugs), cyclophosphamide, desmopressin, oxytocin, vasopressin, terlipressin): Intravenous administration of a glucose-saline solution together with these medicines, which reduce water excretion in urine, increases the risk of hospital-acquired hyponatremia (see previous subsection and sections 3 and 4).
- Diuretics in general and antiepileptic drugs such as oxcarbazepine, which increase the risk of hyponatremia.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.
During pregnancy, your doctor will decide whether glucose-saline solution is appropriate, as it should be used with caution in this case.
Excessive administration of glucose-containing solutions during pregnancy may cause hyperglycemia, hyperinsulinemia (high blood insulin levels), and acidosis in the fetus, and therefore may be harmful to the newborn.
This medicine should be administered with special caution in pregnant women during labor, especially if administered in combination with oxytocin, due to the risk of hyponatremia (see previous subsections and section 4).
There is no evidence suggesting that Glucosalina Grifols may cause adverse effects in the neonate during breastfeeding. However, caution is recommended during this period.
Driving and using machines
There is no indication that this medicine may affect the ability to drive or operate machinery.
3. How to use Glucosalina Grifols
Glucosalina Grifols is supplied as a solution for intravenous administration.
This medicine will be administered in a hospital setting by qualified healthcare personnel.
Your doctor will determine the duration of your treatment with Glucosalina Grifols.
The dosage may be adjusted at the physician's discretion, with the infusion rate always adapted to the patient's clinical needs according to age, body weight, clinical condition, blood glucose levels, and fluid, electrolyte, and acid-base balance. In general, it is recommended to administer the solution at an average rate of 40 to 80 drops per minute (120–240 mL/h). In adults, the usual daily dose is 40 mL/kg of body weight, and the maximum daily dose of 3000 mL should not be exceeded.
You may require monitoring of fluid balance, serum glucose, serum sodium, and other electrolytes before and during administration, particularly if you have non-osmotic vasopressin release (syndrome of inappropriate antidiuretic hormone secretion, SIADH) or are concurrently receiving vasopressin agonist medications, due to the risk of hyponatremia. Monitoring of serum sodium is especially important when physiologically hypotonic solutions are administered. This medication may become hypotonic after administration due to the rapid metabolism of glucose in the body (see sections 2 and 4).
If you receive more Glucosalina Grifols than you should
If the glucosaline solution is not administered correctly and under proper control, signs of overdose may occur, such as fluid overload, electrolyte disturbances, and acid-base imbalances.
If these conditions are not met and symptoms of intoxication occur, administration should be discontinued and symptomatic treatment initiated.
In case of overdose or accidental ingestion, contact the Toxicology Information Service. Telephone: 915 620 420.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If the solution is administered correctly and under control, the only possible complications are those related to the intravenous administration technique, including fever, infection at the injection site, pain, reaction and/or irritation at the injection site, venous thrombosis, or phlebitis extending from the injection site, and extravasation.
To reduce the risk of thrombophlebitis (inflammation of a vein due to a blood clot), it is recommended to alternate the catheter insertion site (every 24–48 hours).
In patients with non-osmotic release of vasopressin, in patients with heart, liver, or kidney disease, and in patients treated with vasopressin agonists, the risk of developing acute hyponatremia after administration of hypotonic solutions is increased. Hospital-acquired hyponatremia may cause irreversible brain damage and death due to the development of cerebral edema (see sections 2 and 3).
Frequencies of the possible adverse effects described are not established, as there are no clinical studies available with this medicine.
If used as a vehicle for the administration of other medicines, the nature of the added medicines will determine the likelihood of additional adverse effects.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Glucosalina Grifols
No special storage conditions are required.
After opening the container, the solution should be used immediately.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the container. The expiry date is the last day of the month indicated.
Do not use this medicine if you notice that the solution is not clear or contains precipitates.
Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their containers to the SIGRE point (SIGRE symbol) at your pharmacy. If you are in doubt, ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.
6. Contents of the pack and other information
Composition of Glucosalina Grifols
The active substances are glucose and sodium chloride. Each 100 ml of solution contains 3.3 g of glucose (as monohydrate) and 0.3 g of sodium chloride.
The other components (excipients) are hydrochloric acid (for pH adjustment) and water for injections.
Appearance of the product and contents of the pack
Glucosalina Grifols is a clear, colourless perfusion solution supplied in 250 ml and 500 ml glass bottles and in flexible polypropylene bags (Fleboflex) of 250 ml, 500 ml, and 1000 ml.
Marketing Authorization Holder
LABORATORIOS GRIFOLS, S.A.
Can Guasch, 2
08150 Parets del Vallès, Barcelona (SPAIN)
Manufacturer
LABORATORIOS GRIFOLS, S.A.
Polígono Industrial Autopista. Passeig Fluvial, 24
08150 Parets del Vallès, Barcelona (SPAIN)
LABORATORIOS GRIFOLS, S.A.
Polígono Industrial Los Llanos. C/ Marte, 4
30565 Las Torres de Cotillas, Murcia (SPAIN)
Date of the most recent review of this summary: July 2018
Other sources of information
Detailed 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/)
This information is intended for healthcare professionals only:
Glucosalina Grifols is administered by intravenous infusion.
The contents of each Glucosalina Grifols container are intended for single use only.
Once the container has been opened, the solution should be administered immediately. Any unused portion must be discarded.
The solution should be clear and free from precipitates. Do not administer if otherwise.
Fleboflex bags:
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Check for leaks by firmly squeezing the bag. If any leaks are detected, discard the product.
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To connect the infusion set, remove the protective tab from the infusion port to expose the access membrane of the bag.
Aseptic technique must be maintained when administering the solution, especially when adding medications.
To add medications to the solution or to administer concomitantly with other drugs, compatibility must first be verified.
It has been reported that the glucosaline solution containing 3.3% glucose and 0.3% sodium chloride is incompatible with mitomycin due to the low pH of this solution.
In addition, incompatibilities have been observed between various isotonic glucosaline solutions and the following drugs: amoxicillin sodium, sodium heparin, sodium imipenem-cilastatin, and meropenem. However, these drugs may be compatible with this type of solution depending on various factors such as drug concentration (sodium heparin) or the time interval between reconstitution and administration (amoxicillin sodium, sodium imipenem-cilastatin, and meropenem).
Moreover, incompatibilities have been reported when certain drugs are diluted in glucose-containing solutions, including: sodium ampicillin, amrinone lactate, sodium amoxicillin/clavulanic acid, interferon alfa-2b, and procainamide hydrochloride. However, amrinone lactate or sodium amoxicillin/clavulanic acid may be directly injected into the injection site while these infusion solutions are being administered.
Incompatibilities have also been reported when certain drugs are diluted in chloride-containing solutions, including amsacrine and trimetrexate glucuronate.