How to use GLUCOSA PHYSAN 10% SOLUTION FOR INFUSION
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This page provides general information and does not replace a doctor’s consultation. Always consult a doctor before taking any medication. Seek urgent medical care if symptoms are severe.
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Introduction
Package Leaflet: Information for the User
Glucosa Physan 10%, Solution for Infusion
Anhydrous Glucose
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
- Keep this leaflet, you may need to read it again.
- If you have any further questions, ask your doctor, pharmacist, or nurse.
- If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.
Contents of the Package Leaflet
- What is Glucosa Physan 10% and what is it used for.
- What you need to know before you start using Glucosa Physan 10%.
- How to use Glucosa Physan 10%.
- Possible side effects.
- Storage of Glucosa Physan 10%.
- Contents of the pack and further information.
1. What is Glucosa Physan 10% and what is it used for
Glucosa Physan 10% belongs to the group of solutions for parenteral nutrition intended for the supply of water and energy.
It is indicated for the treatment of hypertonic dehydration (vomiting, diarrhea, profuse sweating, gastrointestinal fistulas), as an energy supplement in parenteral nutrition, in carbohydrate metabolism disorders (hypoglycemia, insulin coma, hepatic coma, acetonemic vomiting), and as a vehicle for the administration of compatible medications.
2. What you need to know before you start using Glucosa Physan 10%
Do not use Glucosa Physan 10%:
If you are allergic to anhydrous glucose or any of the other components of this medicine (listed in section 6).
- If you have been diagnosed with hypotonic dehydration, loss of salts, or decreased urine volume.
- In the first 24 hours after a head injury.
- In states of hyperglycemia.
- In states of hyperhydration, generalized edema.
- If you have hyperlactacidemia.
- If you have significant glucose tolerance disorders, including hyperosmolar coma.
Warnings and Precautions
Consult your doctor, pharmacist, or nurse before starting to use Glucosa Physan 10%.
- Blood glucose concentration should be carefully monitored in cases of intracranial hypertension.
- In case of having suffered acute ischemic attacks (decreased or absent circulation in arteries), since hyperglycemia has been related to an increase in ischemic cerebral damage and difficulty in recovery.
- In case of shock and acid-base balance disorders, patients should be treated by administering electrolytes before the administration of glucose solutions. In patients with sodium deficiency, the administration of sodium-free solutions can cause peripheral circulatory collapse and oliguria (scant urine excretion).
- It is recommended that regular controls of blood glucose, serum electrolytes, water balance, and acid-base balance be performed, as frequent and massive administration of parenteral glucose solutions can cause fluid overload (hyperhydration) and significant ionic depletions. In this case, it will be necessary to administer electrolyte supplements.
- To avoid hypokalemia produced during prolonged parenteral feeding with glucose, potassium may be added to the glucose solution as a safety measure.
- If you have malnutrition, you may have a vitamin B1 deficiency. This vitamin is essential for glucose metabolism, so if necessary, this deficiency should be corrected first.
- If you have diabetes. In this case, glucose solutions can be used as long as you have initially received appropriate treatment (insulin). Blood glucose should be regularly monitored in diabetic patients and insulin requirements modified.
- Do not administer blood simultaneously using the same infusion equipment due to the risk of pseudoagglutination and/or hemolysis.
- If administered continuously in the same infusion site, thrombophlebitis (inflammation of the veins) may occur.
- Special attention should be paid if used in elderly patients, as they may have affected liver and/or kidney function.
- Do not administer intramuscularly.
Glucose solutions for intravenous infusion are generally isotonic. However, in the body, glucose solutions can become extremely hypotonic physiologically due to the rapid metabolism of glucose.
Depending on the tonicity of the solution, the volume and rate of infusion, and the patient's initial clinical condition and ability to metabolize glucose, intravenous glucose administration can cause electrolyte disturbances, the most important of which is hyperosmolar hyponatremia.
Hyponatremia:
Patients with non-osmotic release of vasopressin (e.g., in critical states, pain, postoperative stress, infections, burns, and CNS diseases), patients with heart, liver, and kidney diseases, and patients exposed to vasopressin agonists have a special risk of experiencing acute hyponatremia after infusion of hypotonic solutions.
Acute hyponatremia can cause acute hyponatremic encephalopathy (cerebral edema) characterized by headache, nausea, seizures, lethargy, and vomiting. Patients with cerebral edema have a special risk of suffering severe, irreversible, and potentially fatal brain damage.
Children, women of childbearing age, and patients with reduced cerebral distensibility (e.g., in case of meningitis, intracranial hemorrhage, and cerebral contusion) have a special risk of suffering severe and potentially fatal cerebral edema caused by acute hyponatremia.
Using Glucosa Physan 10% with other medicines
Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicine.
It is important that you inform your doctor if you use any of the following medicines:
- Insulin or oral antidiabetics (biguanides, sulfonylureas): Intravenous glucose administration in patients treated with insulin or oral antidiabetics can decrease their effectiveness (antagonistic action).
- Corticosteroids: Intravenous administration of glucose solutions in patients treated with systemic corticosteroids with glucocorticoid activity (cortisol) can lead to a significant increase in plasma glucose levels due to the hyperglycemic action of these latter. As for corticosteroids with mineralocorticoid activity, they should be administered with caution due to their ability to retain water and sodium.
- Digitalis glycosides (digoxin): If intravenous glucose administration coincides with treatment with digitalis glycosides (digoxin), an increase in digitalis activity can occur, with the risk of developing intoxication with these medicines. This is due to the hypokalemia that can be caused by glucose administration if potassium is not added to the solution.
In any case, the doctor should check the compatibility of the added medicines.
Medicines that potentiate the effect of vasopressin
The following medicines increase the effect of vasopressin, which reduces the renal excretion of water without electrolytes and increases the risk of hospital hyponatremia after inadequately balanced treatment with intravenous infusion solutions.
- Medicines that stimulate the release of vasopressin; e.g.: chlorpropamide, clofibrate, carbamazepine, vincristine, selective serotonin reuptake inhibitors, 3,4-methylenedioxymethamphetamine, ifosfamide, antipsychotics, narcotics
- Medicines that potentiate the action of vasopressin; e.g.: chlorpropamide, NSAIDs, cyclophosphamide
- Vasopressin analogs; e.g.: desmopressin, oxytocin, vasopressin, terlipressin
Other medicines that are known to increase the risk of hyponatremia are diuretics in general and antiepileptics such as oxcarbazepine.
Pregnancy, Breast-feeding, and Fertility
Glucosa Physan 10% should be administered with special caution in pregnant women during childbirth, especially if administered in combination with oxytocin, due to the risk of hyponatremia.
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using any medicine.
In case of pregnancy, your doctor will decide whether to use a 10% glucose solution, as it should be used with caution in this case. The administration of glucose intravenously during pregnancy can elevate glucose and insulin levels, as well as acidic components in the fetal blood.
There is no evidence to suggest that 10% glucose can cause adverse effects during the lactation period in the neonate. However, it is recommended to use with caution during this period.
Driving and Using Machines
Not applicable.
3. How to use Glucosa Physan 10%
Your doctor will indicate the most suitable dose for your needs. It is usually recommended to administer intravenously, drop by drop, according to your age, body weight, clinical situation, and metabolic state.
In adults, the maximum dose is 20 ml/kg body weight/day, and the maximum infusion rate is 2.5 ml/kg body weight/hour = 0.25 g/kg body weight/hour.
Use in Children
In children, the infusion rate depends on the child's age and weight and generally should not exceed 10-18 mg of glucose (0.1-0.18 ml of solution)/kg/min.
0-10 kg: 50 ml/kg/24h
10-20 kg: 500 ml + 25 ml/kg/24 h for weight above 10 kg.
More than 20 kg: 750 ml + 10 ml/kg/24h for weight above 20 kg.
(See also section 6).
If you have been given too much Glucosa Physan 10%:
In case of overdose, hyperglycemia, glucosuria, hyperhydration, or electrolyte disorders may appear. The administration will be suspended, and symptomatic treatment will be resorted to.
In case of overdose, consult the Toxicology Information Service. Telephone: 91 562 04 20.
4. Possible Side Effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Hyperglycemia, glucosuria (glucose in urine), or disturbances in fluid or electrolyte balance may occur if administered too quickly or if the fluid volume is excessive, or in cases of metabolic insufficiency.
On the other hand, the hyperglycemia resulting from rapid or excessive infusion should be monitored in severe cases of diabetes mellitus, and can be avoided by reducing the dose and infusion rate or by administering insulin.
A local reaction may occur at the injection site.
Whenever any of these adverse reactions occur, you should inform your doctor, who will assess whether or not to suspend the medication.
If used as a vehicle for the administration of other medicines, the nature of the added medicines will determine the likelihood of other adverse reactions.
If you notice any of these side effects or any other not mentioned in this leaflet, please tell your doctor or pharmacist.
Side Effects
Metabolic and nutritional disorders with hospital hyponatremia** of unknown frequency.
Nervous system disorders with hyponatremic encephalopathy** of unknown frequency.
** Hospital hyponatremia can cause irreversible brain damage and death due to the occurrence of acute hyponatremic encephalopathy.
Reporting of Side Effects
If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
5. Storage of Glucosa Physan 10%
Keep this medicine out of the sight and reach of children.
No special storage conditions are required.
Do not use this medicine after the expiry date which is stated on the label after EXP. The expiry date is the last day of the month stated.
Do not use this medicine if you notice visible signs of deterioration.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.
6. Contents of the Pack and Further Information
Composition of Glucosa Physan 10%
- The active substance is glucose. Each 100 ml of solution contains 10 g of anhydrous glucose (11 g as glucose monohydrate).
- The other components (excipients) are: water for injectable preparations, hydrochloric acid (for pH adjustment).
Theoretical osmolality: 556 mosm/l. Theoretical calories: 400 kcal/l.
pH: 3.5-6.5
Appearance of the Product and Contents of the Pack
Transparent solution, hypertonic, apyrogenic, and sterile.
Glucosa Physan 10% is a solution for intravenous infusion presented in 250 ml and 500 ml containers.
For single-dose containers:
Presented in glass vials: Type II glass and polypropylene (PP).
Also in bags: Polypropylene (PP) and polyvinyl chloride (PVC).
In the following capacities:
- Vial and Bag of 250 ml
- Vial and Bag of 500 ml
For Clinical Containers:
With the following presentations:
1.- Glass Vials:
- 24 vials of 250 ml
- 10 vials of 250 ml
- 10 vials of 500 ml
2.- PP Vials:
- 20 vials of 250 ml
- 24 vials of 250 ml
- 10 vials of 500 ml
20 vials of 500 ml
3.- PP and PVC Bags:
- 30 bags of 250 ml
- 20 bags of 500 ml
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder:
LAPHYSAN, S.A.U.
Anabel Segura, 11 Edificio A, Planta 4, Puerta D
28108 Alcobendas – Madrid, Spain
Manufacturer:
S.M. FARMACEUTICI SRL
Zona industriale
85050 TITO – POTENZA, Italy
or
SALF SPA LABORATORIO FARMACOLOGICO
Via Marconi 2
24069 Cenate Sotto (Bergamo), Italy
or
PARACELSIA INDUSTRIA FARMACEUTICA
Rua Antero de Quental, 639
P-4200-068 Porto, Portugal
or
LABORATORIOS BASI - INDUSTRIA FARMACÉUTICA, S.A. Parque Industrial Manuel Lourenço Ferreira, Nº 8 Nº 15 y Nº 16 3450-232 Mortágua – Portugal
Date of the Last Revision of this Leaflet: March 2019
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This information is intended only for healthcare professionals:
This medicine will always be administered by specialized personnel. It will be administered by infusion, through a central or peripheral vein.
The solution must be transparent and not contain precipitates. Do not administer otherwise. The contents of each vial, bottle, or bag are for a single infusion; the unused fraction must be discarded.
Use an aseptic method to administer the solution and in case of preparation of mixtures.
Before adding medicines to the solution or administering them simultaneously with other medicines, it should be checked that there are no incompatibilities.
It may be necessary to monitor the water balance, blood glucose, serum sodium, and other electrolytes before and during administration, especially in patients with increased non-osmotic release of vasopressin (syndrome of inappropriate antidiuretic hormone secretion, SIADH) and in patients receiving concomitant medication with vasopressin agonists due to the risk of hyponatremia.
Monitoring of serum sodium is especially important when administering physiologically hypotonic solutions. Glucosa Physan 10% solution for infusion can become extremely hypotonic after administration due to glucose metabolism in the body.
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- Country of registration
- Dosage formINJECTABLE INFUSION, 10,000 mg glucose monohydrate/100 ml
- ATC codeB05BA03
- Active substance
- Prescription requiredYes
- Manufacturer
- This information is for reference only and does not constitute medical advice. Always consult a doctor before taking any medication. Oladoctor is not responsible for medical decisions based on this content.
- Alternatives to GLUCOSA PHYSAN 10% SOLUTION FOR INFUSIONDosage form: INJECTABLE INFUSION, 50 g glucoseActive substance: carbohydratesManufacturer: Fresenius Kabi España, S.A.U.Prescription requiredDosage form: INJECTABLE PERFUSION, 11 gActive substance: carbohydratesManufacturer: Fresenius Kabi España, S.A.U.Prescription requiredDosage form: INJECTABLE INFUSION, Glucose Monohydrate 5.5 gActive substance: carbohydratesManufacturer: Fresenius Kabi España, S.A.U.Prescription required
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Frequently Asked Questions
GLUCOSA PHYSAN 10% SOLUTION FOR INFUSION requires a prescription in Spain. You can check with a doctor online whether this medicine may be appropriate for your situation.
The active ingredient in GLUCOSA PHYSAN 10% SOLUTION FOR INFUSION is carbohydrates. This information helps identify medicines with the same composition but different brand names.
GLUCOSA PHYSAN 10% SOLUTION FOR INFUSION is manufactured by Laphysan S.A.U.. Pharmacy brands and packaging may differ depending on the distributor.
Doctors such as Family doctors, Psychiatrists, Dermatologists, Cardiologists, Endocrinologists, Gastroenterologists, Pulmonologists, Nephrologists, Rheumatologists, Hematologists, Infectious disease physicians, Allergists, Geriatricians, Paediatricians, Oncologists may assess whether GLUCOSA PHYSAN 10% SOLUTION FOR INFUSION is appropriate, depending on your situation and local regulations. You can book an online consultation to discuss your symptoms and possible next steps.
Spain has a well-developed healthcare infrastructure across major cities such as Madrid, Barcelona, Valencia, and Seville. Pharmacies are widely available and operate under strict regulations, ensuring access to prescribed medications.
You can buy GLUCOSA PHYSAN 10% SOLUTION FOR INFUSION in Madrid, Barcelona, Seville, or Valencia at any local pharmacy with a valid prescription.
To obtain a prescription, you can use Oladoctor:
Other medicines with the same active substance (carbohydrates) include DEXTROSE FRESENIUS KABI 50% SOLUTION FOR INFUSION, FREEFLEX GLUCOSA 10% SOLUTION FOR INFUSION, FREEFLEX GLUCOSA 5% SOLUTION FOR INFUSION. These may have different brand names or formulations but contain the same therapeutic ingredient. Always consult a doctor before switching or starting a new medicine.
