Half-Strength Compound Sodium Lactate Intravenous Infusion
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132M;920R/436474R/0714
PACKAGE LEAFLET:
INFORMATION FOR THE USER
B. Braun Melsungen AG • 34209 Melsungen, Germany
“ Half-Strength Compound
Sodium Lactate Intravenous Infusion
Sodium chloride, potassium chloride, calcium chloride, sodium lactate
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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 Half-Strength Compound Sodium Lactate Intravenous Infusion 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 HALF-STRENGTH COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION IS AND WHAT IT IS USED FOR
This medicine is a solution for infusion, that is administered to you in the form of a vein drip. It contains a combination of different salts and sodium lactate.
It will be given to you by infusion when you are lacking water and salts.
2. BEFORE YOU ARE GIVEN THIS MEDICINE
YOU SHOULD NOT RECEIVE THIS MEDICINE
if you have any of the following:
- swelling of the limbs because of to too much water in your body tissues (hyperhydration)
- dehydration due to abnormally low levels of electrolytes (salts) in your body fluids and tissues (hypotonic dehydration)
- abnormally high levels of lactate in your blood due to problems with your liver, heart or blood circulation, beriberi, or glycogen storage disease or anti-diabetic therapy
- severe kidney disease
- severe liver disease
The container contains a significant volume of air. To avoid risk of air embolism, this product must not be administered by pressure infusion.
SPECIAL CARE SHOULD BE TAKEN WITH THIS MEDICINE if you have or have had any of the following:
- abnormally high levels of sodium in your blood (hypernatraemia)
- beriberi
- kidney problems
- heart or circulatory disease
- liver disease
- sarcoidosis
- glycogen storage disease (a disease where your body cannot handle carbohydrates properly)
- abnormally low body temperature (hypothermia)
- lung disease or congestion of or water on the lungs (pulmonary oedema) Special care will be taken to avoid excessive doses which may lead to high levels of alkali in your blood.
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, because:
- your doctor should know how to adjust the amount of Half-Strength Compound Sodium Lactate Intravenous Infusion you have to receive.
- Half-Strength Compound Sodium Lactate Intravenous Infusion can stop some medicines from working properly.
Especially your doctor should know if you are taking any of the following:
- digoxin (Digitalis preparations)
- thiazide diuretics (a special kind of medicines increasing your urine flow)
- medicines for the treatment of diabetes
- medicines for the treatment of HIV
- medicines lowering your salt and fluid excretion (salt-retaining steroids)
PREGNANCY AND BREAST-FEEDING Pregnancy
If you think you are likely to be pregnant, tell your doctor immediately. This medicine can be given while you are pregnant if your doctor considers it necessary.
Breast-feeding
If you are breast-feeding, tell your doctor immediately. This medicine can be given while you are breast-feeding if your doctor considers it necessary.
DRIVING AND USING MACHINES
This medicine has no influence on the ability to drive and use machines.
3. HOW TO USE THIS MEDICINE
The amount of the medicine that you will be given will be determined by your doctor and will depend on your age, weight and clinical condition. While you receive this medicine your electrolyte (salt) levels and water balance will be monitored routinely.
The normal maximum dosage for an adult is 40 ml/kg body weight/day. Children will receive a reduced dosage dependent upon their age.
The medicine will be administered to you by infusion through a vein.
IF YOU RECEIVE MORE OF THIS MEDICINE THAN YOU SHOULD (OVERDOSE)
It is unlikely that this happens as your infusion will be controlled by a doctor or nurse.
BIBRAUN
Schwarz 210x297 mm 132/436474/0714 Latus: 2186 GroBbritannien Font size 9
132M;920R/436474R/0714
Yet if overdose occurs, you may experience disorders of fluid balance and serum electrolytes, swelling and heart or circulation disorders. Symptoms that may occur after overdose are described below under 4. Possible side effects.
Further, excessive administration of lactate may lead to a so-called metabolic alkalosis (high level of alkali in the blood).
Symptoms of metabolic alkalosis are shortness of breath and muscle weakness.
In patients with low calcium level, high muscle tension, twitching, and cramps may occur and in epileptic patients seizures may become more frequent or severe.
Excess intake of lactate may also lead to feelings of anxiety.
The therapy to normalise your condition will be determined by your doctor. It may include stopping of the infusion and administration of suitable medicines to treat the symptoms observed.
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, Half-Strength Compound Sodium Lactate Intravenous Infusion can cause side effects although not everybody gets them.
If any of the following happen, tell your doctor immediately or go to the casualty department at your nearest hospital:
- difficulty in breathing
- sudden severe chest pain
- slowing or quickening of your heart beat
- high (hypertension) or low (hypotension) blood pressure
- bad fainting attacks, convulsions (fits) or collapse
- weakness, paralysis, motor disturbances (of muscle movements), spasm or twitching
- very marked numbness, swelling or heaviness of your limbs
- cold skin or grey pallor
- difficulty in swallowing
- confusion
Tell your doctor if you notice any of the following side effects:
- nausea (feeling sick) or vomiting (being sick)
- diarrhoea or pain in your abdomen
- pain or tenderness at the injection site
- dry mouth or feeling thirsty
- sweating or feeling feverish
- headaches, dizziness
- restlessness, anxiety
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.
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.
This medicine is for single use only. Discard any unused medicine.
This medicine does not require any special storage conditions within EU countries (climatic zone 2).
This medicine should be clear in appearance. Do not use if it is cloudy or if the container has been damaged.
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. FURTHER INFORMATION
What Half-Strength Compound Sodium Lactate Intravenous Infusion contains
- The active substances are sodium chloride, potassium chloride, calcium chloride and sodium lactate.
1000 ml of the solution contain
Calcium chloride dehydrate 0.14 g
- The other ingredient is water for Injections
What Half-Strength Compound Sodium Lactate Intravenous Infusion looks like and contents of the pack
This medicine is a solution for infusion, that is, a solution for administration through a cannula placed into a vein.
It is a clear colourless sterile solution of the aforementioned substances in water.
It is supplied in polyethylene plastic bottles holding 500 ml or 1000 ml of solution.
It is available in the pack sizes:
10 x 500 ml 10 x 1000 ml
Marketing authorisation holder
B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen, Germany
Manufacturer
B. Braun Melsungen AG Carl-Braun-Strasse 1 34212 Melsungen, Germany or
B. Braun Medical S.A.
Carretera de Terrassa 121
08191 Rubi, Barcelona, Spain
This leaflet was last approved in June 2014.
By reporting side effects you can help provide more information on the safety of this medicine.
5. HOW TO STORE THIS MEDICINE
Keep your medicine out of the reach and sight of children. Your medicine could harm them.
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.
B. Braun Melsungen AG
34209 Melsungen Germany
Schwarz 210x297 mm 132/436474/0714 Latus: 2186 GroRbritannien Font size 9