infusion solution, glucose solution, sodium chloride, sodium acetate trihydrate

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

– Save this information, you may need to read it again.

– If you have any further questions, ask your doctor or nurse.

– If you get any side effects, talk to your doctor or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about:
1. What Glucos Fresenius Kabi 50 mg/ml buffer is and what it is used for
2. What you need to know before using Glucos Fresenius Kabi 50 mg/ml buffer
3. How to use Glucos Fresenius Kabi 50 mg/ml buffered
4. Possible side effects
5. How to store Glucos Fresenius Kabi 50 mg/ml buffered
6. Contents of the pack and other information

What Glucos Fresenius Kabi 50 mg / ml buffered is and what it is used for

Glucose Fresenius Kabi 50 mg/ml buffered contains electrolytes (salts) and glucose (sugar). It is used to treat dehydration and imbalance in electrolyte levels, and as an energy supplement in the form of glucose. Dehydration and/or electrolyte imbalance can occur during, for example, surgery or injury.

What you need to know before using Glucos Fresenius Kabi 50 mg / ml buffered

Do not use Glucos Fresenius Kabi 50 mg / ml buffered

  • 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 Glucos Fresenius Kabi 50 mg/ml buffered if

  • 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 make sure that blood is not supplied via the same tube as Rehydrex with glucose, as this may cause the blood to clot.

The amount 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 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 lead to headaches, nausea, cramps, listlessness, coma, swelling of 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 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 Glucos Fresenius Kabi 50 mg / ml buffered

Tell your doctor if you have recently taken or might take any other medicines if you are taking digitalis glycosides (used to treat heart failure and heart rhythm disorders).

It is especially important that you tell your doctor if you are taking 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 
  • painkillers and anti-inflammatory drugs (so-called non-steroidal anti-inflammatory drugs ( NSAIDs ))
  • drugs similar to or enhancing the effect of vasopressin, such as desmopressin (used to treat increased thirst and urination), terlipressin (used to treat esophageal bleeding) and oxytocin (used to initiate labor).

Other drugs that increase the risk of low levels of sodium in the blood ( hyponatremia ) also include diuretics ( diuretics ) in general 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

Glucose Fresenius Kabi 50 mg/ml buffered has no or negligible effect on the ability to drive and use machines.

Glucose Fresenius Kabi 50 mg / ml buffered 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.
  • 50 g glucose per 1000 ml. This should be considered for patients with diabetes .

How to use Glucos Fresenius Kabi 50 mg / ml buffered

Glucos Fresenius Kabi 50 mg/ml buffered 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 medicines that increase its effects).

If you use more Glucos Fresenius Kabi 50 mg / ml buffered than you should

Glucos Fresenius Kabi 50 mg/ml buffered is given by healthcare professionals, 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).

If you have any further questions on the use of this product, ask your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, 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)

  • Superhydration (too much fluid in the body), electrolyte imbalance
  • Tissue damage (due to the drug accidentally ending up outside the blood vessel).
  • Headache, nausea, cramps, listlessness and vomiting. This can be caused by low levels of sodium 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”).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.

5. How to store Glucos Fresenius Kabi 50 mg / ml buffered

Instructions for storage of the medicine after opening can be found in the section intended for healthcare professionals.

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is 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 colorless/yellowish or if the container is damaged.

Medicines should not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

6. Contents of the packaging and other information

Content declaration

The active substances are

1 ml 1000 ml
Glucose monohydrate equivalent anhydrous glucose 50 mg 50 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  (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 contents of the pack

Infusion solution

Clear, colorless to yellowish, hypertonic, sterile, and pyrogen-free solution. pH: approx. 6. Osmolality: approx. 440 mOsm / kg water. Energy value: about 840 kJ (200 kcal) / 1000 ml, carbohydrate content: 50 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

Marketing Authorisation Holder

Fresenius Kabi AB, Uppsala, Sweden

Manufacturer 

Fresenius Kabi Norge AS, Halden, Norway

Muhammad Nadeem

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