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HARTMANNS SOLUTION COMPOUND SODIUM LACTATE INTRAVENOUS INFUSION BP

Active substance(s): CALCIUM CHLORIDE DIHYDRATE / POTASSIUM CHLORIDE / SODIUM CHLORIDE / SODIUM LACTATE 60% W/V

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NTS085F 150X210 30/04/13 13:40 Page1

PACKAGE LEAFLET: INFORMATION FOR THE USER
GB
HARTMANN’S SOLUTION
(Compound Sodium Lactate Intravenous Infusion B.P.)
Sodium chloride, potassium chloride, calcium chloride dihydrate, sodium lactate 60%
Read all of this leaflet carefully before being given 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 Hartmann’s solution is and what it is used for
2. What you need to know before you are given Hartmann’s solution
3. How Hartmann’s solution is given
4. Possible side effects
5. How to store Hartmann’s solution
6. Contents of the pack and other information
1. WHAT HARTMANN’S SOLUTION IS AND WHAT IT IS USED FOR
Hartmann’s solution is a clear solution of sodium chloride, potassium
chloride, calcium chloride dihydrate and sodium lactate 60% in water. The
solution is stored in a sealed plastic container.
Sodium, potassium, calcium and chloride ions are important for
maintaining the correct balance of fluid in and around the body’s cells and
tissues, and are involved in nerve signals and muscle contractions.
Hartmann’s solution may be given for a variety of reasons:
-to help restore fluid levels and the normal salt balance
-to correct for low blood pressure or decreased blood volume
-to treat metabolic acidosis, a condition where there is increased acid in
the body.
The solution may be given alone but may be given with other medicines
added.
You will be given Hartmann’s solution in hospital by a doctor or nurse.
2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN
HARTMANN’S SOLUTION
You MUST NOT be given this solution if you have:
• increased levels of sodium, potassium, calcium or chloride in the blood.
These conditions can be detected in blood tests
• severe kidney disease and you are passing little or no urine
• suffered heart failure
• increased blood volume or fluid retention (water intoxication, or excess
water content in the body)
• severe metabolic acidosis or lactic acidosis, when you have increased
acid in the body
• metabolic alkalosis, when you have less acid in the body than normal
• severe liver disease or cannot breakdown lactate
• swelling caused by fluid retention
• heart disease which is being treated with the medicine digitalis
• a requirement to take additional medicines which may lead to increased
potassium levels in the body, such as diuretics (water pills)
Warnings and precautions
Talk to your doctor or nurse before being given Hartmann’s solution if you:
• have heart, kidney or liver disease, or swelling caused by fluid retention
• have high blood pressure
• have any condition which causes increased levels of Vitamin D
• have or have had kidney stones
• have any condition which may lead to increased potassium levels in the
blood, such as extensive tissue destruction as occurs with severe burns, or
acute dehydration
• have pre-eclampsia of pregnancy
• are very young or elderly.
Other medicines and Hartmann’s solution
Tell your doctor if you are taking or have recently taken any other
medicines.

In particular, please tell your doctor if you are taking any of the following:
• digitalis (for heart disease). You must not be given Hartmann’s solution
if you are taking digitalis
• the water tablets spironolactone, triamterene, amiloride, potassium
canrenoate (diuretics used in congestive heart failure)
• thiazide diuretics
• medicines for treatment of high blood pressure (ACE inhibitors and
angiotensine II inhibitor)
• corticosteroids, used to treat inflammation
• tacrolimus and ciclosporin (medicines used to prevent tissue rejection
after transplantation)
• Vitamin D
• salicylates, barbiturates and lithium
• adrenaline and the stimulants dexamphetamine sulphate,
phenfluramine hydrochloride
• biphosphonates (for the treatment of bone disorders, and menopausal
symptoms)
• the antibiotic tetracycline and some fluoroquinolones
• carbenoxolone used to treat ulcers
• pseudoephedrine used to treat sinus or nasal congestion from colds,
hayfever, allergies
• fluoride (used to prevent dental caries).
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, or think you may be pregnant, ask
your doctor for advice before being given this medicine.
The solution should be used with care during pregnancy and breastfeeding. Breastfeeding mothers should be aware that calcium will pass into
breast-milk.
Driving and using machines
The solution has no effect on your ability to drive or use machines.
3. HOW HARTMANN’S SOLUTION IS GIVEN
The solution will be given to you in hospital.
You will receive the solution by infusion into a vein, probably in your arm,
administered by a doctor or nurse. The amount and rate at which the
infusion is given depends on your requirements, such as your age, weight
and clinical condition. Your doctor will decide on the correct volume for
you to receive.
Your doctor will check your response to the treatment by the relief of your
symptoms, and will probably take samples of blood and urine for
laboratory testing.
If your levels of potassium could be raised, the level of this salt in your
blood will be carefully checked.
Your doctor will monitor you carefully if you have heart or lung disease
and you need to be given high volumes of the solution.
Levels of potassium in Hartmann's solution are not high enough to treat
severely low blood potassium.

NTS085F-04/2013

NTS085F 150X210 30/04/13 13:40 Page2

If you are given solutions by infusion for a long period of time, your doctor
will also provide you with suitable intravenous feeding.
If you are given more solution than you should
It is unlikely you will be given too much solution as your doctor or nurse
will be checking your response to the treatment. If too much solution is
given or if it is infused too quickly, the levels of potassium, sodium,
calcium and lactate in the body may become too high. If you are concerned
about the volume of solution given, or are worried about any effects you
notice, talk to your doctor or nurse.
If you have any further questions on the use of this medicine, ask your
doctor or nurse.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicine can cause side effects, although not
everybody gets them.
The infusion should be stopped immediately if you experience an adverse
reaction.
If you are given the solution for a long time, you may notice the following:
• irritation, swelling, redness and tenderness at the site of injection. You
may get inflammation of the vein and blood clots in the vein.
Very common side effects are:
• symptoms of an allergic reaction such as urticaria (hives), skin redness,
rash, itching, swelling of the face, lips, throat or tongue, respiratory
symptoms such as nasal congestion, difficulty in breathing, wheezing,
coughing, sneezing
• upset levels of electrolytes (salts) in your body giving symptoms such as
muscle weakness, swelling, prickling sensation in hands and feet, low or
high blood pressure, shortness of breath, confusion, nausea
• if you have heart disease or fluid accumulation in your lungs you may
experience water intoxication, or excess water content in the body and
heart failure
Common side effects are:
• chest tightness
• chest pain with a decrease or increase in heart rate
• feelings of anxiety
Uncommon side effects are:
• panic attacks and seizure, caused by increases of lactate levels in the
blood.

The other ingredient is water for injections.
What Hartmann’s solution looks like and contents of the pack
Hartmann’s solution is a clear, colourless solution. The solution is
packaged in a plastic bag or flexible container with an integral infusion set
for direct connection to a catheter. It is available in sizes of 250ml, 500ml
and 1000ml.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Maco Pharma (UK) Ltd
8th Floor
Regal House
70 London Road
Twickenham
Middlesex TW1 3QS
United Kingdom
Manufacturer
Maco Productions SAS
Rue Lorthiois
59420 Mouvaux
France
Distributor in Ireland
Technopharm Limited
Pharmapark
Chapelizod
Dublin 20
This medicinal product is authorised in the Member States of the EEA
under the following names:
France: RINGER LACTATE MACOPHARMA, solution pour perfusion
Ireland: Hartmann’s solution - Compound Sodium Lactate Intravenous
Infusion B.P.
Luxembourg: RINGER LACTATE MACOPHARMA, solution pour
perfusion
The Netherlands: Ringer Lactaat MacoPharma, oplossing voor
intraveneuze infusie
United Kingdom: Hartmann’s solution - Compound Sodium Lactate
Intravenous Infusion B.P.
This leaflet was last revised in 04/2013.

If you get any side effects, talk to your doctor or nurse. This includes any
possible side effects not listed in this leaflet.

PL 12580/0020

5. HOW TO STORE HARTMANN’S SOLUTION

For information on CD,
please contact the Royal National
Institute of Blind People.
Central phone number:
(+44) 0800 198 5000.

Keep this medicine out of the sight and reach of children.
Do not store above 25°C. Store in the outer container, in order to protect
from light.
Do not use this medicine after the expiry date which is stated on the label
after EXP. The expiry date refers to the last day of that month.
The solution should only be used if it is clear and the container is not
damaged. It should be used immediately on removal from the overwrap.
Any unused solution in the bag must be discarded.
Do not throw away any medicines via wastewater or household waste. The
doctor or nurse will dispose of this medicine. These measures will help to
protect the environment.
6. CONTENTS OF THE PACK AND OTHER INFORMATION

What Hartmann’s solution contains
The active substances are sodium chloride, potassium chloride, calcium
chloride dihydrate and sodium lactate 60%. Each litre of solution contains
6g sodium chloride, 0.4g potassium chloride, 0.27g calcium chloride
dihydrate and 5.16g sodium lactate 60%.
NTS085F-04/2013

PA 931/9/1-4

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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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