Sodium Chloride 0.9% W/V And Glucose 5% W/V Iv Infusion Bp
6/445634/0714
PACKAGE LEAFLET: INFORMATION FOR THE USER
B. Braun Melsungen AG ■ 34209 Melsungen, Germany
= Sodium Chloride 0.9% w/v and Glucose 5% w/v IV Infusion BP
Solution for Infusion
Sodium Chloride, Glucose
Read all of this leaflet carefully before you start using this medicine.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you. Do not pass it on to others.
• If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Sodium Chloride 0.9% w/v and Glucose 5% w/v IV Infusion BP is and what it is used for
2. Before you are given this medicine
3. How to use this medicine
4. Possible side effects
5. How to store this medicine
6. Further information
1. WHAT SODIUM CHLORIDE 0.9% W/V AND GLUCOSE 5% W/V IV INFUSION BP IS AND WHAT IT IS USED FOR
This medicine contains normal salt and glucose (also called grape sugar or dextrose). It is given to you as a venous drip (infusion).
It will be given to you
• to maintain your fluid and salt levels especially if your blood has become too alkaline in combination with low chloride blood levels (hypochloraemic alkalosis)
• if you are lacking water and salt
• if you have lost chloride
• as a partial calorie source to meet your energy requirements.
It may also be used to dilute or dissolve medicines that are to be given to you by a venous drip.
2. BEFORE YOU ARE GIVEN THIS MEDICINE.
You should not receive this medicine
if you suffer from any of the following:
• excess water in your body tissues (hyperhydration), associated with swelling of the limbs
• abnormally high levels of electrolytes in your body fluids and tissues due to loss of water (hypertonic dehydration)
• uncorrected low blood potassium levels
• your blood has become too acidic (metabolic acidosis)
• abnormally high blood sugar level that only responds to high insulin doses or intolerance to glucose
• water on the lungs or in your brain
• heart failure (decompensated cardiac insufficiency)
Special care will be taken with this medicine
if you suffer from any of the following:
• abnormally high levels of sodium or chloride in your blood
• disorders where restriction of sodium intake is indicated, such as
- heart failure
- severe kidney problems
- swelling of the limbs, too much water in your body tissues (generalised oedema)
- lung disease or congestion of, or water on the lungs (pulmonary oedema)
- high blood pressure (hypertension)
- eclampsia (see section 'pregnancy and breast-feeding')
If you suffer from acute stroke or if your blood sugar levels are too high, your doctor will take special care with you: He/she will correct your blood sugar level before you receive this solution.
While you are given this medicine your water balance, salt levels (especially potassium) and blood sugar levels will be monitored by your doctor. After major operations or severe injuries (post-traumatic and postoperative conditions) you may not be able to metabolise glucose properly (impaired glucose tolerance). Then your blood sugar level will be regularly monitored. If you suffer from diabetes mellitus, your doctor will carefully monitor your blood sugar level and modify your insulin requirements.
If your blood sodium levels are chronically low, your doctor will take into account that your blood sodium levels must not increase too fast.
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.
Taking or using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Your doctor will adjust a your dosage if you receive cortisone. Cortisone may cause an accumulation of sodium and fluid in your body.
Pregnancy and breast-feeding
Pregnancy
If you think you are likely to be pregnant, tell your doctor immediately. Your doctor will give you this medicine only with caution. 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.
If you receive this medicine during labour, the blood glucose level of your child may be altered.
Blood glucose levels will be carefully monitored.
Breast-feeding
If you are breast-feeding, tell your doctor immediately. This medicine can be given while you are breast feeding.
Fertility Not relevant
Driving and using machines
This medicine has no influence on the ability to drive or use machines.
3. HOW TO USE THIS MEDICINE
The medicine will be administered to you by infusion (a drip) through a vein.
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 condition and other therapies needed. 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.
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Dokument = 210 x 297 mm (DIN A4) 2 Seiten
GIF EP GB___6
Sodium Chloride 0.9% w/v and Glucose 5% w/v IV Infusion BP 6/445634/0714 Standort: Melsungen + Rubi
Latus
2893
Font size: 9 pt.
G 111718
Children
Children will receive a reduced dosage dependent upon their age, weight and clinical condition. Thus the individual daily requirements of fluid, electrolytes and energy of your child will be taken into account.
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.
For example heart failure or kidney failure Other special patient groups
Special care will be taken if you have an impaired glucose tolerance (e.g. after surgery, severe injury, diabetes, organ failure etc.). In those cases your blood glucose level will be monitored while you receive this solution.
If you received more Sodium Chloride 0.9% w/v and Glucose 5% w/v IV Infusion BP than you should
It is unlikely that this happens as your infusion will be controlled by a doctor or nurse.
Symptoms
An overdose may lead to hyperhydration (excess fluid in the body), which will be followed by
• increased skin tension
• congestion of your blood
• swelling
• water on the lungs and in your brain
• disorders of your salt and acid-base balance.
It may also lead to
• high blood sugar values.
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, Sodium Chloride 0.9% w/v and Glucose 5% w/v IV Infusion BP can cause side effects although not everybody gets them. Side effects may be associated to the technique of administration including febrile response, infection at the site of injection, local pain or reaction, vein irritation, venous thrombosis or phlebitis.
If you notice any side effects, please tell your doctor or pharmacist. 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 THIS MEDICINE
Keep this medicine out of the reach and sight of children.
Do not use this medicine after the expiry date which is stated on the label and the outer carton. The expiry date refers to the last day of that month.
This medicine is for single use only. After use discard container and any unused medicine.
Do not reconnect partially used containers.
This medicine does not require any special storage conditions.
Only to be used if solution is clear and colourless and the container and its closure are undamaged.
Any unused product or waste material should be disposed of in accordance with local requirements.
6. FURTHER INFORMATION_
What Sodium Chloride 0.9% w/v and Glucose 5% w/v IV Infusion BP contains
• The active substances are sodium chloride and glucose.
1000 ml of the solution contain
Sodium chloride 9.0 g
Glucose 50.0 g (as glucose monohydrate)
• The other ingredient is water for Injections
Energy: 835 kJ/l A 200 kcal/l
Theoretical osmolarity: 586 mOsm/l
Acidity (titration to pH 7.4): < 0.5 mmol/l
pH: 3.5 - 5.5
What Sodium Chloride 0.9% w/v and Glucose 5% w/v IV Infusion BP looks like and contents of the pack
It is a clear colourless sterile solution of sodium chloride and glucose in water.
It is supplied in
• polyethylene plastic bottles; contents 500 ml or 1000 ml available in packs of
1 x 500 ml, 10 x 500 ml 1 x 1000 ml, 10 x 1000 ml
Marketing authorisation holder
B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen, Germany
Postal address:
B. Braun Melsungen AG 34209 Melsungen, Germany Tel: +49-(0)-5661-71-0 Fax: +49-(0)-5661-4567
Manufacturer
B. Braun Melsungen AG Carl-Braun-StraBe 1 34212 Melsungen, Germany
or
B. Braun Medical S.A.
Carretera de Terrassa 121 08191 Rubi, Barcelona, Spain
This leaflet was last revised in May 2014.
The following information is only intended for health-care professionals:
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.
Hypertonic solutions should be administered in a large peripheral or central vein to diminish the risk of causing irritation.
Important information about the container:
The plastic container contains a significant volume of air.
To avoid risk of air embolism, all air must be expelled before starting a pressure infusion.
Dosage:
Partial coverage of energy requirements, i. e. substitution of the obligatory daily glucose requirements, is only possible with the maximum dose stated above.
BBRAUN
B. Braun Melsungen AG
34209 Melsungen Germany
445634_Sodium_EP_GIF_A4_GB_6.indd 2 11.07.14 08:54