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HALF-STRENGTH COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM LACTATE

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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
- 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:
1. WHAT HALF-STRENGTH COMPOUND SODIUM - digoxin (Digitalis preparations)
LACTATE INTRAVENOUS INFUSION IS AND WHAT IT IS - thiazide diuretics (a special kind of medicines increasing your urine flow)
- medicines for the treatment of diabetes
USED FOR
This medicine is a solution for infusion, that is administered to you in the - medicines for the treatment of HIV
form of a vein drip. It contains a combination of different salts and sodi- - medicines lowering your salt and fluid excretion (salt-retaining steroids)
um lactate.
PREGNANCY AND BREAST-FEEDING
It will be given to you by infusion when you are lacking water and salts.
Pregnancy
If you think you are likely to be pregnant, tell your doctor immediately.
2. BEFORE YOU ARE GIVEN THIS MEDICINE
This medicine can be given while you are pregnant if your doctor considers it necessary.
YOU SHOULD NOT RECEIVE THIS MEDICINE
Breast-feeding
if you have any of the following:
- swelling of the limbs because of to too much water in your body tissues 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.
(hyperhydration)
- dehydration due to abnormally low levels of electrolytes (salts) in your DRIVING AND USING MACHINES
body fluids and tissues (hypotonic dehydration)
This medicine has no influence on the ability to drive and use machines.
- abnormally high levels of lactate in your blood due to problems with your
liver, heart or blood circulation, beriberi, or glycogen storage disease or 3. HOW TO USE THIS MEDICINE
anti-diabetic therapy
The amount of the medicine that you will be given will be determined by
- severe kidney disease
your doctor and will depend on your age, weight and clinical condition.
- severe liver disease
While you receive this medicine your electrolyte (salt) levels and water balThe container contains a significant volume of air. To avoid risk of air ance will be monitored routinely.
embolism, this product must not be administered by pressure infusion.
The normal maximum dosage for an adult is 40 ml/kg body weight/day.
SPECIAL CARE SHOULD BE TAKEN WITH THIS MEDICINE
Children will receive a reduced dosage dependent upon their age.
if you have or have had any of the following:
The medicine will be administered to you by infusion through a vein.
- abnormally high levels of sodium in your blood (hypernatraemia)
- beriberi
IF YOU RECEIVE MORE OF THIS MEDICINE THAN YOU SHOULD (OVER- kidney problems
DOSE)
- heart or circulatory disease
It is unlikely that this happens as your infusion will be controlled by a doc- liver disease
tor or nurse.
- sarcoidosis

B|BRAUN
Schwarz
210x297 mm
132/436474/0714
Lätus: 2186
Großbritannien
Font size 9

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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

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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.
By reporting side effects you can help provide more information on the
safety of this medicine.

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
Sodium chloride
3.0 g
Sodium lactate
1.61 g
Potassium chloride
0.20 g
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 Rubí, Barcelona, Spain
This leaflet was last approved in June 2014.

5. HOW TO STORE THIS MEDICINE

B|BRAUN

Schwarz
210x297 mm
132/436474/0714
Lätus: 2186
Großbritannien
Font size 9

B. Braun Melsungen AG
34209 Melsungen
Germany

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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.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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