nfusion solution

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 100 mg/ml with Na 40 + K 20 is and what it is used for
2. What you need to know before you use Glucos Fresenius Kabi 100 mg/ml with Na 40 + K 20
3. How to use Glucos Fresenius Kabi 100 mg/ml with Na 40 + K 20
4. Possible side effects
5. How to store Glucos Fresenius Kabi 100 mg/ml with Na 40 + K 20
6. Contents of the pack and other information

What Glucos Fresenius Kabi 100 mg / ml with Na 40 + K 20 is and what it is used for

Glucose Fresenius Kabi 100 mg/ml with Na 40 + K 20 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.

The active substances contained in Glucos Fresenius Kabi 100 mg/ml with Na 40 + K 20 may also be approved for the treatment of other conditions not mentioned in this product information. Ask your doctor, pharmacist, or other healthcare professional if you have any further questions, and always follow their instructions.

What you need to know before using Glucos Fresenius Kabi 100 mg / ml with Na 40 + K 20

Do not use Glucos Fresenius Kabi 100 mg / ml with Na 40 + K 20

  • if you are allergic to the active substances 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 100 mg/ml with Na 40 + K 20 if

  • you have diabetes
  • you have severe heart failure
  • you have severe renal impairment in combination with an increased amount of fluid in the body (swelling, edema ) and that your urine volume decreases or if you have no urine production

Other medicines and Glucos Fresenius Kabi 100 mg / ml with Na 40 + K 20

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

Some medicines may increase the risk of side effects due to low levels of sodium in the blood. These medicines include:

  • diuretics ( diuretics ),
  • medicines for pain and / or inflammation (also called non-steroidal anti-inflammatory drugs ( NSAIDs ))
  • drugs to treat psychosis
  • drugs to treat depression (selective serotonin reuptake inhibitors)
  • drugs with morphine-like effects ( opioids )
  • certain medicines for epilepsy ( antiepileptics )
  • a hormone called oxytocin (causes the uterus to contract)
  • certain anti-cancer drugs ( chemotherapy )

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.

There are no known risks when using Glucos Fresenius Kabi 100 mg/ml with Na 40 + K 20 during pregnancy and lactation.

Driving and using machines

Glucose Fresenius Kabi 100 mg/ml with Na 40 + K 20 has no known effects on the ability to drive or use machines.

You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened attention. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.

3. How to use Glucos Fresenius Kabi 100 mg / ml with Na 40 + K 20

Glucos Fresenius Kabi 100 mg/ml Na 40 + K 20 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 age, your weight, and your condition.

If you get more Glucos Fresenius Kabi 100 mg / ml with Na 40 + K 20

Glucos Fresenius Kabi 100 mg/ml with Na 40 + K 20 is given by healthcare professionals, so it is unlikely that you will receive a larger dose than you should.

  • An overdose can lead to (increased urinary excretion) and elevated blood sugar levels.

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 concomitant inflammation of a superficial blood vessel).

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

  • low sodium levels in the blood ( hyponatremia )
  • swelling of the brain which can cause brain damage (hyponatremic encephalopathy )

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 100 mg / ml with Na 40 + K 20

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 label after EXP. The expiration date is the last day of the specified month. The remaining solution is broken packaging must be discarded.

No special storage instructions.

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

1000 ml
Glucose monohydrate equivalent anhydrous glucose 100 g
Sodium chloride 1.0 g
Sodium acetate 3H 2 O 3.1 g
Potassium chloride 1.5 g
Magnesium chloride 6H 2 O 300 mg

Electrolyte content: 1000 ml
Na + 40 mmol
K + 20 mmol
Mg2 + 1.5 mmol
Cl- about 45 mmol
Ac- 23 mmol

Osmolality: about 750 mosm / kg water

pH: about 5

Energy value: approx. 1680 kJ (400 kcal) / 1000 ml

Carbohydrate content: 100 g / 1000 ml

Buffer capacity: From pH 5 to 7 7 mmol NaOH / 1000 ml are needed, from pH 5 to 4 about 13 mmol HCl / 1000 ml are needed.

The other ingredients are hydrochloric acid (for pH adjustment) and water for injections.

What the medicine looks like and contents of the pack

Glucos Fresenius Kabi 100 mg/ml with Na 40 + K 20; is an infusion solution and is available in the following containers and pack sizes:

Plastic containers (Excel)

9×1000 ml

Plastic container (Pharmaflex)

4 x 2000 ml

Plastic container (Freeflex)

10×1000 ml

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Fresenius Kabi AB, 751 74 Uppsala, Sweden

Manufacturer

Fresenius Kabi Norge AS, Svinesundsveien 80, 1788 Halden, Norway

Muhammad Nadeem

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