50, 100 and 200 mg / mL infusion solution
glucose

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.

In this leaflet you will find information about:
1. What Glucos Fresenius Kabi is and what it is used for
2. What you need to know before you use Glucos Fresenius Kabi
3. How to use Glucos Fresenius Kabi
4. Possible side effects
5. How to store Glucos Fresenius Kabi
6. Contents of the pack and other information

1. What Glucos Fresenius Kabi is and what it is used for

Glucose Fresenius Kabi solution for infusion is a clear solution of glucose in water for intravenous infusion (slow injection ), also called drip into a vein.

Glucose Fresenius Kabi 50 and 100 mg/ml are used when the body has lost a lot of water ( dehydration ).

All strengths can be given when intravenous nutrition is needed, usually in combination with amino acid ( protein ) solutions, vitamins, and lipid (fat) emulsions.

This leaflet covers three different strengths. These solutions will be collectively referred to as Glucos Fresenius Kabi in this leaflet.

2. What you need to know before you use Glucos Fresenius Kabi

Do not use Glucos Fresenius Kabi

  • if you are allergic to glucose or any of the other ingredients of this medicine (listed in section 6).

Or if you have one or more of the following:

  • Untreated diabetes , diabetic coma.
  • Other known glucose hypersensitivity.
  • Unconsciousness due to high blood sugar (hyperosmolar coma ).
  • High blood sugar ( hyperglycaemia ).
  • Low levels of potassium in the blood ( hypokalaemia ).
  • Too much acid in the body (metabolic acidosis ).
  • Untreated excretion of large amounts of urine ( diabetes insipidus ).
  • Renal impairment without the possibility of haemofiltration or dialysis .
  • Bleeding in the brain or spine.
  • Alcohol withdrawal ( deliruim tremens ) if the patient is already dehydrated.
  • Acute state of shock and collapse.
  • Acute heart failure .
  • Fluid accumulation in the lungs ( pulmonary edema ).
  • Too much fluid in the body (hyperhydration).
  • Not enough fluid in the body, with low blood pressure ( hypotonic dehydration ).

Warnings and cautions

Talk to your doctor or nurse before using Glucos Fresenius Kabi.

Blood sugar, electrolytes (especially serum potassium and phosphate ), and fluid balance should be checked regularly.

Healthcare professionals will monitor you when infusing large volumes if you have too much or not enough fluid in your body, severely impaired kidney, heart, and lung function, and/or decreased urine production.

Glucose tolerance may decrease if you have impaired kidney function or diabetes. Healthcare professionals will monitor your glucose levels and electrolytes during administration if you are diabetic or have impaired kidney function. Your needs for insulin and/or potassium may change. Your doctor will check these.

If you are malnourished, infusion of carbohydrates can trigger a thiamine deficiency syndrome ( vitamin B 1 ). This is especially true if the cause of malnutrition is:

  • alcohol abuse,
  • anorexia ,
  • fasting for a long time,
  • if you are pregnant and have severe nausea and / or vomiting.

Your doctor may decide to give you extra vitamin B 1 before and during the administration of one of glucose.

Use of glucose solution is not recommended if:

  • the supply of blood to a part of the brain decreases ( acute ischemic stroke ) because high blood sugar has been reported to increase brain damage and impair healing.
  • you have suffered a head injury in the last 24 hours.

Blood sugar levels will be closely monitored by medical staff in case of high blood pressure in the brain.

Particular caution will be exercised if you have a disease or condition that can cause high levels of vasopressin, a hormone that regulates the amount of fluid in your body. 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 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 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

Tell your doctor or nurse if you have recently taken or might take any other medicines.

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
  • medicines for pain and inflammation (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 also increase the risk of low sodium levels are diuretics ( diuretics ) and epilepsy drugs, such as oxcarbazepine.

Pregnancy and breastfeeding

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. Glucose is considered safe when used as recommended.

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 has no or negligible effect on the ability to drive and use machines.

3. How to use Glucos Fresenius Kabi

Glucos Fresenius Kabi will be given to you by a doctor or nurse. It will be given to you as a drip into a vein ( intravenous infusion ) or as an injection under the skin depending on the strength of Glucos Fresenius Kabi used.

Your doctor will decide the right dose for you and when and how it should be given. Your doctor will consider your age, weight, physical condition, and what other treatments you are receiving.

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 than you should

Glucos Fresenius Kabi is given by healthcare professionals, so it is unlikely that you will receive a larger dose than you should. If you accidentally overdose, the administration one will be canceled and you will receive treatment depending on the symptoms.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If the dosing recommendations are exceeded, osmotic diuresis (increased urine production) which may lead to dehydration may occur.

Other possible side effects include:

Has been reported (occurs in an unknown number of users)

  • Increased urine production ( polyuria ).
  • High blood sugar ( hyperglycemia ), dehydration and electrolyte imbalance, e.g. low levels of potassium ( hypokalaemia ), magnesium ( hypomagnesaemia ) and phosphate ( hypophosphataemia ) in the blood.
  • Side effects are related to administration techniques including fever, injection site infection , local pain or reaction, venous irritation, inflammation of the vein where the solution is given ( venous thrombosis or phlebitis ), accidental administration of the solution outside the vein (extravasation, which may damage tissue ) or too much fluid in the body ( hypervolemia ) and fluid retention ( edema ) caused by overdose.
  • 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”).

High blood sugar (hyperglycemia), urinary glucose ( glucosuria ), and fluid in the lungs ( pulmonary edema ) may occur if the solution is administered too quickly.

You can be monitored by healthcare professionals during treatment. If any side effects get worse, your doctor or nurse will help you. If side effects are of concern to you, talk to a doctor or nurse.

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

Freeflex infusion bag

50 mg / ml: Do not store above 25 ° C

100 mg / ml: No special precautions for storage.

200 mg / ml: No special storage instructions.

Kabipac infusion bottle

No special storage instructions.

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 you see visible particles 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 substance is glucose 50 mg / ml, 100 mg / ml or 200 mg / ml (as glucose monohydrate).
  • The other ingredients are hydrochloric acid ( pH adjustment, only 50 mg / ml and 100 mg / ml), sodium hydroxide ( pH adjustment, only 50 mg / ml and 100 mg / ml), water for injections.

What the medicine looks like and contents of the pack

Glucos Fresenius Kabi 50 mg/ml and 100 mg/ml are clear, colorless, and sterile solutions without electrolytes and visible particles.

50 mg / ml is isotonic , 100 mg / ml is hypertonic .

Glucos Fresenius Kabi 200 mg/ml is a clear, colorless to pale yellow, hypertonic, and sterile solution without electrolytes and visible particles.

It is available in the following containers and pack sizes:

Glucos Fresenius Kabi 50 mg / ml

Freeflex (polypropylene bag) with injection port for needle, alternatively Freeflex + with injection port for luer cap:

40 x 50 ml 40 x 100 ml 20 x 250 ml 15 x 500 ml 10 x 1000 ml
60 x 50 ml 50 x 100 ml 30 x 250 ml 20 x 500 ml
65 x 50 ml 55 x 100 ml 35 x 250 ml
70 x 50 ml 60 x 100 ml 40 x 250 ml

KabiPac (polyethylene bottle):

10 x 100 ml 10 x 250 ml 10 x 500 ml 10 x 1000 ml
40 x 100 ml 20 x 250 ml 20 x 500 ml
30 x 250 ml 30 x 500 ml

Glucos Fresenius Kabi 100 mg / ml

Freeflex (polypropylene bag) with injection port for the needle, alternatively Freeflex + with injection port for Luer cap:

15 x 500 ml 10 x 1000 ml
20 x 500 ml

KabiPac (polyethylene bottle):

10 x 100 ml 10 x 250 ml 10 x 500 ml 10 x 1000 ml
40 x 100 ml 20 x 250 ml 20 x 500 ml
30 x 250 ml 30 x 500 ml

Glucos Fresenius Kabi 200 mg / ml

Freeflex (polypropylene bag) with injection port for the needle:

15 x 500 ml 10 x 1000 ml
20 x 500 ml

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi AB, Uppsala,

Manufacturer 

Fresenius Kabi Norge AS, Halden, Norway or

Fresenius Kabi Deutschland GmbH, Friedberg, Germany or

Fresenius Kabi France, Louviers Cedex, France or

Fresenius Kabi Polska Sp. z oo, Kutno, Poland

Muhammad Nadeem

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