Sodium Chloride 0.45% W/V And Glucose 5% W/V Iv Infusion Bp
84/445554/0714
Package leaflet: Information for the patient
B. Braun Melsungen AG ■ 34209 Melsungen, Germany
S Sodium Chloride 0.45% w/v = and Glucose 5 % w/v Intravenous Infusion BP
Sodium Chloride, Glucose
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
• Keep this leaflet. 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 includes any possible side effects not listed in this leaflet.
What is in this leaflet:
1. What Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) is and what it is used for
2. What you need to know before you use Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %)
3. How to use Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %)
4. Possible side effects
5. How to store Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %)
6. Contents of the pack and other information
1. What Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) is and what it is used for
Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) is a infusion solution, which will be given to you as a venous infusion (drip) by your doctor.
It will be given to you
• if you are dehydrated and lose water (hypertonic dehydration)
You are given this medicine to provide you partial with carbohydrates if you are unable to eat and drink normally, especially if your energy needs are high or if you need restriction of fluid intake.
This solution may also be used to dissolve or dilute medicines that are to be given to you by a venous infusion (drip).
2. What you need to know before you use Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %)
Do not use Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %):
• if you are allergic to sodium chloride or glucose or any of the other ingredients of this medicine (listed in section 6).
• if you have excessively high body fluid level (hyperhydration)
• if you have fluid and sodium deficit (hypotonic dehydration)
• Head trauma (first 24 hours)
• if you have abnormally high blood sugar level that only responds to high insulin doses or intolerance to glucose
Warnings and precautions
This medicine must not be used to treat fluid deficits without adequate administration of salts, since this may markedly reduce the salt concentration in your blood. A lack of salts can lead to problems with your heart and damage your brain.
Special care should be taken if you have abnormally low level of sodium or potassium in the blood. Then an adequate supply of salts (in particular potassium and sodium) will be ensured.
In diabetic patients, the amount of infused glucose has to be taken into account and insulin requirements may be modified.
You should not normally receive this medicine if you suffer or have recently suffered from stroke except your doctor considers it essential for your recovery.
Your levels of blood sugar, electrolytes (especially potassium) and acid-base and water balance will be checked to make sure that these are correct before and during infusion.
After major operations or severe injuries (post-traumatic and postoperative conditions or in the presence of tissue oxygen deficiency, high blood acidity or organ failure) you may not be able to metabolise glucose properly (impaired glucose tolerance). Then your blood sugar level will be regularly monitored.
Please note:
If this solution is used to dilute or dissolve medicines that are to be given to you by a venous drip, your doctor will take into account the safety information of the additive.
Other medicines and Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %)
Tell your doctor if you are using, have recently used or might use any other medicines.
Your doctor will adjust your dosage if you receive cortisone. Cortisone may cause an accumulation of sodium and fluid in your body.
Pregnancy and, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.
Pregnancy
Your doctor will decide carefully whether or not you should receive this solution if you are pregnant.
Thus special care will be taken if you have a specific disorder that may occur during pregnancy, called eclampsia, with the following symptoms: high blood pressure, cramps, swelling.
Blood sugar levels will be checked regularly.
Breast-feeding
This medicine can be given while you are breast feeding.
Driving and using machines
Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) has no influence on the ability to drive and use machines.
3. How to use Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %)
Dosage
Adults
The amount of the medicine that you will be given will be determined by your doctor and will depend on your age, weight, clinical and biological (acid-base-balance) condition and concomitant therapy. Thus your individual requirements of fluid, electrolytes and energy will be taken into account.
The normal maximum dosage for an adult is 40 ml/kg body weight/day.
The maximum infusion rate is 5 ml per kg body weight per hour.
Elderly patients
Basically the same dosage as for adults applies. But your doctor will take caution if you are suffering from other diseases often seen with advanced age.
Other special patient groups
If you have an impaired glucose tolerance (e.g. after surgery, severe injury, organ failure, tissue oxygen deficiency etc.) the dosage should be adjusted to keep the blood glucose level close to normal values.
In those cases your blood glucose level will be monitored while you receive this solution.
Use in children and adolescents m
Children will receive a dosage dependent upon their age, weight and clinical and biological (acid-base-balance) condition and concomitant therapy. Thus the individual daily requirements of fluid and glucose of your child will be taken into account.
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Format = 210 x 297 mm (A4) 2 Seiten
Latus
1202
GB___84
Sodium Chloride 0.45% w/v and Glucose 5 % w/v 84/445554/0714 EP - GIF
Standort Melsungen + Rubi
Fpnt size: 9 pt.
G 080992
If you received more Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) than you should
It is unlikely that this occurs because your doctor will determine your m daily doses.
Symptoms
An overdose may lead to excess fluid in the body (hyperhydration), electrolyte imbalances (especially hypokalaemia and hyponatraemia), acid-base imbalances, and high blood sugar (hyperglycaemia).
Clinical symptoms of water intoxication may also occur, such as nausea, vomiting, spasms.
Treatment
The therapy to normalise your condition will be determined by your doctor. It may include stopping of the infusion, supervision of blood salt level and administration of suitable medicines to treat the symptoms observed (e.g. diuretics, insulin). In extreme situations you may also need dialysis. If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not everybody gets them.
If the product is used as directed, no side effects are to be expected.
Yet if you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in the package leaflet. You can also report side effects directly via the Yellow Card Scheme at: www. mhra.gov.uk/yellowcard.
By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %)
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 carton labels. The expiry date refers to the last day of that month.
This medicinal product does not require any special storage conditions. Only to be used if solution is clear and colourless up to faintly straw-coloured and the container and its closure are undamaged.
This medicine is for single use only. After use discard container and any unused medicine.
Containers once opened must be used immediately and must not stored for later use.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.
6. Contents of the pack and other information
What Sodium Chloride 4.5 mg/ml (0.45%) and Glucose 50 mg/ml (5 %) contains
The active substance are sodium chloride and glucose.
1000 ml of the solution contain Sodium chloride Glucose monohydrate equivalent to anhydrous glucose
Energy
Theoretical osmolarity:
Acidity (titration to pH 7.4): pH:
The other ingredient is water for injections.
What Chloride 4.5 mg/ml (0.45%) and Glucose 25 mg/ml (2.5 %) looks like and contents of the pack
It is a clear, colourless up to faintly straw-coloured aqueous solution of sodium chloride and glucose in water.
It is supplied in
• Polyethylene (LDPE) bottles, contents: 500 ml, 1000 ml available in packs of 10 x 500 ml, 10 x 1000 ml
Marketing Authorisation Holder and Manufacturer
B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen Germany
Postal address:
34209 Melsungen Germany
Phone: +49-5661-71-0 Fax: +49-5661-71-4567
This leaflet was last revised in May 2014.
The following information is intended for healthcare professionals only:
Method of administration:
The solution should not be administered through the same infusion equipment simultaneously, before or after an administration of blood because of the possibility of pseudo-agglutination.
Shelf life after dilution:
From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 °C, unless dilution has taken place in controlled and validated aseptic conditions.
In patients with chronic hypernatraemia, the serum sodium concentration should not be lowered faster than at a rate of 0.5 mmolxl-1xh-1.
B. Braun Melsungen AG
34209 Melsungen Germany
445554_Sodium_4.5_nd_Glucose_50_GIF_A4_GB_84.indd 2 11.07.14 07:33