Read this leaflet carefully before you start taking this medicine.  (DOWNLOAD)

 Keep this leaflet. You may need to read it again before, during or after use of this medicine. • If you have any further questions, ask your health care provider. 

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm  them, even if their symptoms are the same as yours. 
• If any of the side effects become serious, or if you notice any side effects not listed in this  leaflet, please inform your health care provider. 

In this leaflet: 

1. What 5% Dextrose and Normal Saline Infusion is and what it is used for. 2. What you need to know before you take 5% Dextrose and Normal Saline Infusion 3. How to take 5% Dextrose and Normal Saline Infusion 
2. Possible side effects 
3. How to store 5% Dextrose and Normal Saline Infusion 
4. Contents of the pack and other information 

 

1. WHAT 5% DEXTROSE AND NORMAL SALINE INFUSION IS AND WHAT IT IS USED  FOR 

5% DEXTROSE AND NORMAL SALINE INFUSION is a solution that contains sodium and  chloride ions and glucose, which are fundamental for the body and it is administered  intravenously.  

5% DEXTROSE AND NORMAL SALINE INFUSION is available in glass bottles with  volumes of 500 and 1000 ml with or without sets. It is used to treat or prevent deprivation of  water and salt in the body (dehydration). In addition, it meets a portion of the energy  requirement of the body. Particularly, it is preferred as preoperative and postoperative care  as a drug that can initiate renal functions.  

5% DEXTROSE AND NORMAL SALINE INFUSION is also used to dilute before  intravenous administration some concentrated drugs suitable for intravenous administration. 

2. WHAT YOU NEED TO KNOW BEFORE YOU USE 5% DEXTROSE AND NORMAL  SALINE INFUSION 

5% DEXTROSE AND NORMAL SALINE INFUSION is a safe drug in many patients.  However, if you have problems in your heart, kidneys, liver or lungs, if you are diabetic or if  you have swelling (edema) in your body related to excessive salt accumulation in your body,  your doctor can decide not to administer this drug to you.  

DO NOT USE 5% DEXTROSE AND NORMAL SALINE INFUSION under following  conditions:  

In case you have had allergic reaction when you took drugs containing the same active  substances or inactive ingredients with 5% DEXTROSE AND NORMAL SALINE, that is, if  you have experienced sudden stopping of breath, wheezing, skin rashes, itching or swelling  in your body, DO NOT USE this drug. 

In addition, if you are allergic against corn products, DO NOT USE THIS DRUG.  If you are not sure if you are allergic, consult your doctor. 

USE 5% DEXTROSE AND NORMAL SALINE INFUSION CAREFULLY under the  following conditions: 

This drug must be administered to you carefully if you have any of the following: • Congestive cardiac insufficiency, 

• Significant renal failure, 
• Obstruction of the urinary tract, 
• Swelling (edema) in your body or extremities, particularly if you are in immediate postoperative period or if you are elderly. 

If you have the following conditions, this drug must be administered to you carefully: • If you are diabetic, 

• If you are intolerant against carbohydrates for any reason. 

If this drug will be administered to you through an electronic pump, 

• It must be ensured that the operation of the pump stops before complete emptying of the  bottle. 

Administration of this drug requires changing of the pipes (sets) every 24 hours.  Furthermore, this drug must be used only if the bottle is intact and the contained solution is  clear. 

Please consult your doctor if these warnings are valid for you, even at any time in the past. 

Use of 5% DEXTROSE AND NORMAL SALINE INFUSION with foods or drinks  5% DEXTROSE AND NORMAL SALINE INFUSION is a drug administered intravenously;  and it does not interact with foods and drinks in relation with the route of its administration. 

Pregnancy  

Consult your doctor or pharmacist before using this drug.  

Do not use 5% DEXTROSE AND NORMAL SALINE INFUSION during pregnancy unless  specifically recommended by your doctor.  

In case you become aware that you are pregnant during treatment, immediately consult your  doctor or pharmacist.  

Lactation  

Consult your doctor or pharmacist before using this drug.  

If you are breastfeeding your baby, inform your doctor about this. Do not use 5% DEXTROSE AND NORMAL SALINE INFUSION during pregnancy unless specifically  recommended by your doctor.  

Driving and use of machines  

5% DEXTROSE AND NORMAL SALINE INFUSION has no effects on driving or using  machines. 

Taking other medicines  

If you plan to take, currently taking or have taken recently any other drugs also including  OTCs, vaccines or herbal drugs please inform your doctor.  

5% DEXTROSE AND NORMAL SALINE INFUSION is incompatible with some drugs. The  drugs known to be incompatible must not be added to the solution, and other solutions must  be preferred to dilute such drugs. The following are drugs known to be incompatible: 

• Ampicilin sodium 
• Mitomycin 
• Amphotericin B 
• Erythromicin lactobinate 

With the purpose of minimizing the potential incompatibility risk with any other drugs that  might be added to the solution, the healthcare personnel will check if there is any turbidity or  sedimentation right after mixing, just before administration and with certain intervals during  administration. 

The solution should not be administered from the same set together with blood.  

5% DEXTROSE AND NORMAL SALINE INFUSION must be used carefully in patients using  carbenoxolone (used to protect the gastric surface in peptic ulcer), corticosteroids (a drug  used intravenously in allergic conditions, through the respiratory route in allergic respiratory  track diseases and topically on the skin in various allergic conditions) or corticotrophin (a  hormone secreted by the brain and used as a drug in case of deficiency). 

5% DEXTROSE AND NORMAL SALINE INFUSION solutions must be used by adding  potassium in sufficient amount in fasting patients with good renal functions particularly is the  patient is under treatment with digitalis-type drugs.  

If you are currently using any prescribed drug or OTC, or if you have used them recently,  please inform your doctor or pharmacist about these. 

3. HOW TO TAKE 5% DEXTROSE AND NORMAL SALINE INFUSION Instructions for proper use and dosage/application intervals:  

Your doctor will decide the amount of this drug that you need and the time of application.  S/he will consider your age, body weight and the reason for the administration of this drug will also be considered. Follow these instructions unless otherwise is recommended by your  doctor.  

Do not forget to take your drug in a timely manner.  

Your doctor will inform you about the period of your treatment with 5% DEXTROSE AND  NORMAL SALINE. Do not stop the treatment earlier, because if you do, you will not obtain  the expected results. 

Route and method of administration:  

This drug is administered to your vein through a proper plastic pipe (set).  

Different age groups  

Use in children:  

The dosage and the size of the administration for children will be decided by the doctor that  recommends the administration. 

Use in the elderly:  

Since decrease of the liver, renal and cardiac functions are more frequent in the elderly and  the frequency of co-morbidities or using other drugs concomitantly is also higher, dose  selection generally requires more attention by choosing the possible lowest limit of the dose  range.  

Since this drug is largely eliminated through the kidneys, the risk of adverse effects of the  drug will increase where the renal functions are impaired. Since the decrease in renal  functions is greater in the elderly, care must be given in the selection of dosage and renal  functions must be monitored during treatment. 

Conditions of special use:  

Renal/ hepatic impairment  

Your doctor can prefer not to use this drug on you in cases of renal or liver insufficiency,  depending on the severity of your condition; if s/he decides to use the drug, s/he will follow  you up carefully.  

If you have the impression that the effects of 5% DEXTROSE AND NORMAL SALINE  INFUSION is too powerful or too weak, consult your doctor or pharmacist.  In case you had used 5% DEXTROSE AND NORMAL SALINE INFUSION in an amount  more than you should:  

Consult a doctor or a pharmacist if you had used 5% DEXTROSE AND NORMAL SALINE  INFUSION in an amount more than you should.  

In case you forget to take 5% DEXTROSE AND NORMAL SALINE:  Do not take double dosage to balance the skipped dosage. 

Possible effects related to the termination of the treatment with 5% DEXTROSE AND  NORMAL SALINE:  

None 

4. POSSIBLE SIDE EFFECTS 

Like all drugs, 5% DEXTROSE AND NORMAL SALINE INFUSION can cause adverse  effects in individuals who are sensitive to the contents.  

In case you encounter any of the following, stop using 5% DEXTROSE AND NORMAL  SALINE INFUSION and inform your doctor immediately or apply to the emergency  room of the nearest hospital:  

Widespread or local (urticaria) wheezing, sense of compression on your chance, drop of  blood pressure, fever, feeling of being unwell, gastric pain or tremors/ flu-like signs.  

These are all very serious adverse effects. 

Having any of the above means that you are seriously allergic against 5% DEXTROSE AND  NORMAL SALINE. Emergent medical intervention or hospitalization can be necessary.  

All these very serious adverse effects are seen rather rarely. 

Inform your doctor immediately or apply to the emergency room of the nearest hospital in case you encounter any of the following: 

• Fluid accumulation in the body, swelling (edema) and congestive (related to fluid accumulation) heart failure becoming more severe 
• Decrease in the fluid amount in your body and water deficiency in your body (dehydration) • Decrease in the amounts of substances called ions in your body (including potassium, magnesium, phosphate, etc.) 
• Increase in your blood sugar (hyperglycemia) 
• Shifting the body fluids to the acidic side (acidosis) 
• Headache 
• Vertigo 
• Irritability 
• Excessive excitability 
• Contractions 
• Coma and death 
• Palpitation (tachycardia) 
• Increase of blood pressure 
• Increase in the volume of the circulating blood (hypervolemia) 
• Fluid accumulation in lungs (edema) 
• Slowing down of breathing 
• Respiratory arrest 
• Nausea, vomiting, diarrhea, abdominal cramps, thirst, reducing of saliva amount
• Reducing of sweating 
• Fasciculation and hardening of muscles 
• Renal failure 
• Increase in urinary output 
• Fever, fatigue 
• Extravasation in application site 
• Pain, redness and swelling in the application site 
• Inflammation in the application site 
• Irritation in the application site 
• Inflammation in the application site starting from the application site and spreading • Formation of clots in the veins starting from the application site 
• Inflammation in the application site 
• Hardness, redness or swelling starting from the application site and spreading` 

All of the above are serious adverse effects that might require emergent medical  intervention.  

In case you encounter any adverse effects not mentioned in these PATIENT  INFORMATION LEAFLET, please inform your doctor or pharmacists. 

5. HOW TO STORE 5% DEXTROSE AND NORMAL SALINE INFUSION • Keep this medicine out of the sight and reach of children. 

• Store below 30°C.  
• Do not use 5% Dextrose and Normal Saline Infusion after the expiry date which is stated on  the carton and label after ‘EXP’. The expiry date refers to the last day of that month. 

6. FURTHER INFORMATION. 

Each ml of 5% Dextrose and Normal saline contains 5% Dextrose and 0.9 Sodium Chloride 

What 5% DEXTROSE AND NORMAL SALINE INFUSION looks like and contents of the  pack 

500ml transparent liquid placed in a LDPE Infusion bottle