Rehydrex with glucose 25 mg/ml solution for infusion, Glucose Solution, Sodium Chloride, Sodium Acetate Trihydrate
What Rehydrex With Glucose Is And What Rehydex Used For
Rehydrex with glucose contains electrolytes (salts) and glucose (sugar). Rehydex used to treat dehydration and imbalance in electrolyte levels and as an energy supplement in the form of glucose. Dehydration or electrolyte imbalance can occur during, for example, surgery or injury.
What You Need To Know Before Using Rehydrex With Glucose
Do Not Use Rehydrex With Glucose
- If you are allergic to glucose, sodium chloride, sodium acetate trihydrate, or any of the other ingredients of this medicine (listed in section 6).
Warnings And Cautions
Talk to your doctor or nurse before using Rehydrex with glucose
- You have diabetes
- You have severe kidney failure in combination with edema (swelling)
- Your urine volume decreases, or if you have no urine production
- You have severe heart failure
- You are severely malnourished
- You drink large amounts of alcohol
- You suffer from anorexia
- You have vomited a lot during pregnancy
- you get blood. Your doctor or nurse will ensure that blood is not supplied via the same tube as Rehydrex with glucose, which may cause the blood to clot.
The number of electrolytes in your blood can be checked with blood tests, especially if you need a lot of fluid quickly.
Particular caution will be exercised if you have a disease or condition that can cause high levels of vasopressin, a hormone that regulates the body’s fluid balance. You may have too much vasopressin in your body e.g. if:
- You have suffered from a sudden and serious illness
- You have pain
- You have undergone an operation
- You have an infection, burns, or a brain disease
- You have diseases that are associated with the heart, liver, kidneys, or central nervous system
- You are taking certain medicines.
This can increase the risk of low sodium levels in the blood, which can cause:
- Headaches
- Nausea
- Cramps
- Listlessness
- Coma
- Swelling in the brain, and death
- Swelling in the brain increases the risk of death and brain damage
The following patients are at increased risk for brain swelling:
- children
- women (especially those of childbearing potential )
- patients who have problems with fluid balance in the brain e.g. due to meningitis, skull bleeding, or brain damage.
Other Medicines And Rehydrex With Glucose
Tell your doctor if you are taking, have recently taken, or might take any other medicines if you are taking digitalis glycosides (used to treat heart failure and heart rhythm disorders). You must tell your doctor if you take medicines that affect the hormone et vasopressin. Such drugs may be:
- Diabetes medicine (chloropropamide)
- Cholesterol drugs (clofibrate)
- Epilepsy drug (carbamazepine)
- Amphetamine-like drugs
- Certain cancer drugs (vincristine, ifosfamide, cyclophosphamide)
- Selective serotonin reuptake inhibitors (used to treat depression)
- Antipsychotics
- Opioids (morphine-like drugs) used to treat severe pain
- Medicines for pain and inflammation (so-called non-steroidal anti-inflammatory drugs, NSAIDs )
- Drugs similar to or potentiating the effect of vasopressin, such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat oesophagal bleeding), and oxytocin (used to initiate labor).
Other drugs that increase the risk of low sodium levels in the blood ( hyponatremia ) include diuretics ( diuretics ) and epilepsy drugs such as oxcarbazepine.
Pregnancy, Breastfeeding, And Fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Rehydrex with glucose can be used during pregnancy and lactation.
This medicine should be given with special caution to pregnant women during childbirth, especially if it is combined with oxytocin (a hormone that can be used to induce pain and control bleeding) due to the risk of low sodium levels.
Driving And Using Machines
Rehydrex with glucose has no or negligible effect on the ability to drive and use machines.
Rehydrex With Glucose Contains Sodium And Glucose
- 70 mmol (or 1600 mg) sodium per 1000 ml. This should be taken into consideration for patients prescribed a low-salt diet.
- 25 g glucose per 1000 ml. This should be taken into consideration for patients with diabetes.
How To Use Rehydrex With Glucose
Rehydrex with glucose will be given to you by a doctor or nurse. It will be given to you as a drip into a vein ( intravenous infusion ).
Your doctor will determine the right dose for you and when and how it should be given. Dosage one is individual and depends on your clinical condition.
Before and after infusion one, the doctor will monitor the body’s fluid balance, the acid level in the blood and urine, and the electrolyte level (especially sodium ) in the blood (mainly in patients who have high levels of vasopressin or who are taking drugs that increase its effects).
If You Use More Rehydrex With Glucose Than You Should
Healthcare professionals give Rehydrex with glucose, so it is unlikely that you will receive a larger dose than you should.
- An overdose can lead to osmotic diuresis (increased urinary excretion), elevated blood sugar levels, and metabolic alkalosis (too low an acid level in the blood).
Ask your doctor or nurse if you have any further questions about using this product.
Possible Rehydex Side Effects:
This medicine can cause side effects like all medicines, although not everybody gets them.
Common (may affect up to 1 in 10 people)
- Thrombophlebitis (blood clot and inflammation at the injection site).
Has been reported (occurs in an unknown number of users)
- Super hydration (too much fluid in the body), electrolyte imbalance
- Tissue damage (due to the drug inadvertently ending up outside the blood vessel).
- Headache, nausea, cramps, listlessness, and vomiting. This can be caused by low sodium levels in the blood ( hyponatremia ). Low sodium levels can lead to brain damage and death due to swelling in the brain (see also “Warnings and Precautions”).
How To Store Rehydrex With Glucose
- Instructions for storing the medicine after opening can be found in the section intended for healthcare professionals.
- Keep this medicine out of sight and reach of children.
- Do not use this medicine after the expiry date stated on the sachet and carton after EXP. The expiration date is the last day of the specified month.
- Do not use this medicine if the solution is not clear and colourless/yellowish or if the container is damaged.
Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines that are no longer required. These measures will help to protect the environment.
Contents Of The Pack And Other Information
Content Declaration
The active substances are
| 1 ml | 1000 ml | |
| Glucose monohydrate equivalent to anhydrous glucose | 25 mg | 25 g |
| Sodium acetate trihydrate | 3.4 mg | 3.4 g |
| Sodium chloride | 2.6 mg | 2.6 g |
Electrolyte content:
| 1000 ml | ||
| Na + | 1600 mg | 70 mmol / 1000 ml |
| Cl- | about 1600 mg | 45 mmol / 1000 ml |
| CH 3 CO 2 – (acetate) | 1500 mg | 25 mmol / 1000 ml |
The other ingredients are hydrochloric acid ( pH adjustment) and water for injections.
What The Medicine Looks Like And The Contents Of The Pack
- Infusion solution:
- Clear, colourless to the yellowish, isotonic, sterile, and pyrogen-free solution
- pH:
- Approx. 6.
- Osmolality:
- Approx. 280 mOsm / kg water.
- Energy value:
- About 420 kJ (100 kcal) / 1000 ml
- Carbohydrate content:
- 25 g / 1000 ml.
- It is available in the following containers and pack sizes:
- Plastic containers (EXCEL)
- 12 x 500 ml
- 9 x 1000 ml
- Freeflex (polypropylene bag)
- 15 x 500 ml
- 20 x 500 ml
- 10 x 1000 ml
- Not all pack sizes may be marketed.
Marketing Authorization Holder And Manufacturer
Manufacturer
Fresenius Kabi Norge AS, Halden, Norway