infusion 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, pharmacist or nurse.
  • 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. See section 4.

In this leaflet you will find information about:
1. What Glucosel is and what it is used for
2. What you need to know before using Glucosel
3. How to use Glucosel
4. Possible side effects
5. How to store Glucosel
6. Other information

1. What Glucose is and what it is used for

Glucose is a solution given into a vein via a drip ( intravenous infusion ).

The solution is intended to supply the body with energy in the form of glucose and to supply salts during parenteral nutrition (nutrition is supplied directly into the blood circulation), ie in situations where you cannot eat or drink normally. The solution can also be given after surgeries to ensure the basic need for fluids, energy, and salts.

Glucose can also be used as a supplement to enteral nutrition (nutrition is supplied directly to the stomach or intestine, for example via a tube).

It should be noted that this solution is only part of parenteral nutrition. Full parenteral nutrition should also include amino acids, vitamins, fatty acids, and trace elements.

2. What you need to know before using Glucose

Do not use Glucose

  • If you have abnormally high blood sugar levels that require high doses , your insulin should be kept under control
  • if you have severe diabetes mellitus with complications, even unconsciousness
  • if you have severely disturbed kidney function with massive fluid loss ( diabetes insipidus )
  • if you have very severe kidney failure that is not treated with dialysis (a treatment method by which the blood is purified from slag products and excess fluid artificially).
  • if you have cerebral haemorrhage or spinal haemorrhage
  • if you have delirium tremens (a state of confusion caused by alcoholism and which occurs at the beginning of abstinence and is characterized by various symptoms including hallucinations, tremors, irritability, insomnia, etc.), if associated with dehydration
  • if you have abnormally high levels of salt in your blood (especially potassium )
  • if you have circulatory collapse ( shock ), lack of oxygen in tissues are
  • if you have accumulation of acidic substances in your blood
  • if you are allergic to active substances or any of the other ingredients of this medicine (listed in section 6)

Warnings and cautions

Administration of glucose solutions is not recommended if you have recently had a stroke.

Glucose is used with caution if:

  • you have diabetes mellitus (diabetes)
  • you do not tolerate carbohydrates
  • your blood volume is too large
  • you have impaired kidney or heart function
  • you have problems with fluid balance in the brain (for example due to meningitis , bleeding in the skull or brain damage)
  • you have a disease or condition that can cause high levels of vasopressin , a hormone that regulates the amount of fluid in the body, for example if you
    • have acute and severe illness or injury
    • has recently undergone surgery
    • have a brain disease
    • taking certain medicines (see section Other medicines and Glucose).

These conditions can increase the risk of low sodium levels in the blood which can cause headaches, nausea, cramps, listlessness, coma, and swelling in the brain.

If you suffer from any of these conditions, your doctor will carefully determine if this solution can be given to you.

For adequate control of your blood sugar level, you may need insulin. Then the potassium content in your blood should also be monitored and corrected if necessary, as insulin can affect the potassium content in the blood.

Your doctor will make sure that the infusion is not stopped suddenly but gradually, especially if you have diabetes or other illness which results in a reduced ability to maintain a normal blood sugar level.

Normally, your blood sugar and serum electrolytes (salts in the blood), fluid balance, and acid-base balance will be checked. Your doctor will decide how often the check-ups should be performed. It depends i.a. on your condition and how many doses you get.

Children

Children may need additional carbohydrates and/or fats to fully meet their energy needs.

Other drugs and Glucose

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Tell your doctor:

  • If you use certain heart medications, digitalis preparations (cardiac glycosides). There is a risk that the effect of digitalis preparations is intensified after a sudden cessation of potassium , which can lead to digitalis poisoning.
  • If you use a certain type of diuretic (potassium-sparing diuretics ) that reduces the excretion of potassium , as the potassium content in your blood can rise sharply above normal. This can sometimes lead to severe heart rhythm disorders. Therefore, the level of potassium in your blood is closely monitored during and after treatment with Glucose.
  • If you are taking medicines that may increase the risk of side effects are due to low sodium levels in the blood. These drugs include:
    • certain anti-cancer drugs
    • selective serotonin reuptake inhibitors (used to treat depression)
    • certain drugs for the treatment of psychotic diseases (antipsychotics)
    • morphine-like drugs ( opioids )
    • medicines for pain and / or inflammation (so-called non-steroidal anti-inflammatory drugs, NSAIDs )
    • certain medicines for epilepsy
    • oxytocin (used to initiate labor, during caesarean section or to control bleeding after childbirth, miscarriage or abortion)
    • diuretics .

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 pharmacist for advice before taking this medicine.

There are no known risks of treatment with this medicine during pregnancy or lactation when the treatment is carried out according to the instructions with close monitoring of blood tests (blood sugar, electrolyte values ​​in serum and fluid and acid-base balance ).

However, co-administration of a drug called oxytocin during childbirth may cause decreased levels of sodium in the blood (increase the risk of hyponatremia ).

Driving and using machines

This medicine does not affect your ability to drive or use machines.

3. How to use Glucose

Your doctor will decide which dose is right for you, depending on your age, body weight, and condition.

If you also need a blood transfusion, these will be given via a separate infusion set.

Your doctor may check the fluid balance as well as the glucose and electrolyte content (including sodium ) in your blood before and during treatment, especially if you have increased production of vasopressin (a hormone that regulates the amount of fluid in your body) and if you are on medications that act on the same way as vasopressin, as there is a risk of abnormally low sodium in the blood ( hyponatremia ). See also sections “Warnings and precautions”, “Other medicines and Glucose” and “Possible side effects”.

Adults:
The maximum daily dose is 40 ml per kg body weight and the infusion rate should not exceed 2.5 ml per kg body weight per hour.

Use in children:
For children over 2 years of age, the same dose as for adults can be used.
Glucose should not be used in children under 2 years of age.

In connection with infusion one, your blood sugar, fluid and salt levels, and urine excretion are checked regularly. Your doctor will assess how often this should be checked, depending on your condition.

If you take more glucose than you should

Because you are receiving Glucose under hospital supervision, it is unlikely that you will receive too much. If you still happen to get too much or if the infusion rate has been too fast, your doctor knows what action to take.
Symptoms that you have received too much glucose can be, for example, large amounts of urine, glucose in the urine, elevated blood sugar, and/or disturbances in the salt balance and acid-base balance. In severe cases, excessive amounts can lead to unconsciousness or liver damage.

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

4. Possible side effects

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

Common (may affect up to 1 in 10 people): concomitant inflammation and blood clots in blood vessels ( thrombophlebitis ).

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

  • Low sodium levels in the blood ( hyponatremia ).
  • Swelling in the brain that can cause brain damage.

Other side effects may be associated with the specific treatment and underlying diseases and may include:

  • Low blood potassium levels that may be associated with insulin therapy.
  • Low levels of potassium , magnesium and phosphate in the blood due to the fact that nutrition begins especially if you are malnourished.
  • Low blood sugar after abrupt discontinuation of glucose therapy and / or insulin therapy .

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 Glucose

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 container and the outer carton. The expiration date is the last day of the specified month.

Glucose must only be used if the solution is clear and the packaging is undamaged.

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

6. Other information

Content declaration

  • The active substances are:

1000 ml of the solution contains

Glucose monohydrate
(equivalent to 100.0 g glucose )
110.0 g
Sodium chloride 2.34 g
Potassium chloride 1.87 g
Magnesium chloride hexahydrate 0.51 g
Sodium dihydrogen phosphate dihydrate 1.56 g
Zinc acetate dihydrate 16.5 mg

The corresponding electrolyte concentrations are:

Sodium 50 mmol / l
Potassium 25 mmol / l
Magnesium 2.5 mmol / l
Zinc 0.075 mmol / l
Chloride 70 mmol / l
Dihydrogen phosphate 10 mmol / l
Acetate 0.15 mmol / l
  • The other ingredients are: water for injections and hydrochloric acid .

Characteristics:

Calorie value: 1680 kJ / l (400 kcal / l)
Osmolarity 710 mOsm / l
pH ca 3.5
Acidimetric titration (to pH 7) about 8 mmol / l

What the medicine looks like and contents of the pack

Glucose is an infusion solution, ie it is administered through a cannula or small tube placed in a vein. It is a clear, colorless to pale yellow solution.

Glucose is supplied in plastic bottles (uncolored polyethylene) containing 1000 ml.
Pack size: 10 plastic bottles.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:
B. Braun Melsungen AG
Carl-Braun-Strasse 1
34212 Melsungen, Germany

Postal address:
B. Braun Melsungen AG
34209 Melungen, Germany

Muhammad Nadeem

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