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ERYTHROMYCIN LACTOBIONATE FOR INTRAVENOUS INFUSION 1G

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Erythromycin Lactobionate
for Intravenous Infusion 1 g
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.
• If any of the side effects gets serious, or if you notice
any side effects not listed in this leaflet, please tell your
doctor.
In this leaflet:
1. What Erythromycin Lactobionate for Intravenous Infusion is and what
it is used for
2. Before you use Erythromycin Lactobionate for Intravenous Infusion
3. How to use Erythromycin Lactobionate for Intravenous Infusion
4. Possible side effects
5. How to store Erythromycin Lactobionate for Intravenous Infusion
6. Further information

1. WHAT ERYTHROMYCIN LACTOBIONATE FOR INTRAVENOUS
INFUSION IS AND WHAT IT IS USED FOR
Erythromycin lactobionate is an antibiotic (a medicine used to treat
infections caused by bacteria).
This medicine may be used to treat infections caused by a number
of different bacteria. It is used to treat infections of the nose, ear,
mouth, throat, chest (airways) and skin. It can also be used to
treat other infections such as sexually transmitted diseases, and
infections of the lining and valves of the heart. It may be used when
a patient cannot take penicillin to treat an infection.

2. BEFORE YOU USE ERYTHROMYCIN LACTOBIONATE FOR
INTRAVENOUS INFUSION
Do not use Erythromycin Lactobionate for Intravenous Infusion
• if you have shown signs of hypersensitivity (severe allergy) to
erythromycin in the past
Tell your doctor if the above applies to you before this medicine is
used.
This medicine must not be given as an intravenous injection (rapid
injection into a vein using a syringe). See section 3 for the correct
method of administration.

Take special care with Erythromycin Lactobionate for
Intravenous Infusion
• if you have any problems with your liver or kidneys
• if you have a disorder called myasthenia gravis
Tell your doctor if any of the above applies to you before this
medicine is used.

Taking/using other medicines
Erythromycin Lactobionate for Intravenous Infusion must not be
used at the same time as the following medicines:
• astemizole or terfenadine (anti-histamine medicines which can be
taken for allergic reactions e.g. hayfever)
• cisapride (medicine used for gut problems)
• pimozide (medicine used to treat schizophrenia)
• simvastatin or lovastatin (medicine used to lower your cholesterol)
Special care is needed if you are taking/using other medicines as
some could interact with erythromycin lactobionate, for example:

















penicillin (an antibiotic medicine)
digoxin (medicine for heart problems)
warfarin and acenocoumarol (medicines used to thin your blood)
carbamazepine, valproate, phenytoin and hexobarbitone
(medicines which can be used to treat epilepsy)
theophylline (used to treat asthma)
vinblastine (an anti-cancer medicine)
cyclosporin (used after receiving a transplant)
ergot (used for treatment of migraine or in obstetric procedures)
other statins such as atorvastatin (drugs used to lower your
cholesterol)
alfentanil (a painkiller usually used when receiving an
anaesthetic)
bromocriptine (a drug used in Parkinson’s disease, in acromegaly,
in benign breast disease and to suppress lactation)
midazolam and triazolam (sedative or calming drugs)
tacrolimus (used in severe eczema and after a transplant)
verapamil (used for particular heart conditions)
clozapine (used in psychiatric conditions)
medications causing specific changes on your EGC (heart trace)
(prolongation of the QT interval)

Please tell your doctor if you are taking or have recently taken
any other medicines, including medicines obtained without a
prescription.

Pregnancy and breast-feeding
Tell your doctor if you are pregnant, trying to become pregnant
or breast-feeding. Your doctor will only use this medicine if the
expected benefits outweigh any potential risk to your baby.
Ask your doctor or pharmacist for advice before taking any
medicine.

3. HOW TO USE ERYTHROMYCIN LACTOBIONATE FOR
INTRAVENOUS INFUSION
This medicine will be dissolved in Water for Injections and then
further diluted using a sodium chloride or glucose solution. It is then
given by infusion (drip) into a vein.

Erythromycin Lactobionate for Intravenous Infusion 1 g
The following information is intended for medical or healthcare
professionals only
Further to the information included in section 3, practical information on
the preparation/handling of the medicinal product is provided here.

Instructions for use and handling
For single use. Discard any unused contents.
Erythromycin lactobionate vials labelled as containing 1 gram of
erythromycin should be initially reconstituted by adding 20 ml of Sterile
Water for Injections without preservative, to provide a solution containing
50 mg per ml. No other diluent should be used to prepare this initial
solution. It is important to ensure that the product is completely dissolved
by vigorous shaking before transferring to infusion containers.
Prior to administration, the concentrated solution should be further diluted
in glass or flexible plastic containers of 0.9% sodium chloride injection. If,
for clinical reasons, 0.9% sodium chloride injection is not suitable, then
neutralised 5% glucose injection may be used. Neutralised 5% glucose
injection is prepared by the addition of 5 ml of sterile 8.4% w/v sodium
bicarbonate solution to each litre of 5% glucose injection. It is necessary to
buffer the glucose solution in this way because the stability of erythromycin
lactobionate is adversely affected below pH 5.5.
Q62994
4XXXXX

Copyright in this drawing, design and
specification or artwork vests in Hospira
UK Limited and must not be copied or
reproduced without the express prior
permission of Hospira UK Limited. Any
unauthorised act in relation to this work will
result in both civil and criminal liability.
Copyright © Hospira UK Limited October 2007

The infusion can either be given over 20 to 60 minutes (repeated
every 6 hours) or it may be given continuously over 24 hours.

Dose
Your doctor will work out the correct dose of erythromycin
lactobionate for you and how often it must be given.
The dose of medicine given to you will depend upon your medical
condition, your age, your body weight and how well your liver and
kidneys are working. Your doctor will tell how well your liver and
kidneys are working from blood and urine samples.

If you are given too much or too little Erythromycin
Lactobionate for Intravenous Infusion
This medicine will be given to you by a doctor or nurse. It is unlikely
that you will be given too much or too little, however, tell your doctor
or nurse if you have any concerns.

4. POSSIBLE SIDE EFFECTS
Like all medicines, erythromycin can cause side effects, although
not everybody gets them.

If any of the following happen, tell your doctor immediately:
• severe allergic reaction - you may experience a sudden itchy rash
(hives), swelling of the hands, feet, ankles, face, lips, mouth or
throat (which may cause difficulty in swallowing or breathing), and
you may feel you are going to faint
• painful rash
• blistering of the skin, mouth, throat, genitals or eyes
• skin peeling/shedding
These are serious side effects. You may need urgent medical
attention.

If any of the following happen, tell your doctor as soon as
possible:
• changes in the normal heartbeat may occur giving rise to
palpitations
• severe abdominal pain with or without vomiting (this may be
pancreatitis – inflammation of the pancreas)
• abdominal discomfort and cramp, nausea, vomiting and
diarrhoea. The diarrhoea may be mild or severe, may have blood
in it and may develop some days after stopping the erythromycin
(pseudomembranous colitis)
• temporary deafness
• a rash which is not painful
• itching
• pain, swelling, redness or tenderness at the site of the injection
If erythromycin is given for a long time you may be more likely to
get another infection.
Erythromycin may lead to blood abnormalities. Your doctor may take
blood samples to monitor for these.
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, please tell your doctor.

5. HOW TO STORE ERYTHROMYCIN LACTOBIONATE FOR
INTRAVENOUS INFUSION
Keep out of the reach and sight of children

Expiry
This medicine must not be used after the expiry date which is stated
on the vial and carton after ‘EXP’. Where only a month and year is
stated, the expiry date refers to the last day of that month.

Storage
The vials should be kept in the outer carton, in order to protect from
light, and stored at, or below, 25°C.
Unused portions of opened vials must not be stored for later use.
Prepared injections or infusions should be used immediately,
however, if this is not possible they can be stored for up to 24 hours
at, or below, 25°C before administration.

6. FURTHER INFORMATION
What Erythromycin Lactobionate for Intravenous Infusion
contains
The active substance is erythromycin. After reconstitution each
millilitre (ml) of solution contains 50 milligrams (mg) of erythromycin
(as erythromycin lactobionate).
There are no other ingredients.

What Erythromycin Lactobionate for Intravenous Infusion
looks like and contents of the pack
Erythromycin Lactobionate for Intravenous Infusion is a white
powder for concentrate for solution for infusion which comes in
glass containers called vials.
It may be supplied in packs containing:
• 1 x 1 g vial
• 10 x 1 g vial
Not all packs may be marketed.

Marketing authorisation holder and manufacturer responsible
for batch release in Europe
Hospira UK Limited, Queensway, Royal Leamington Spa,
Warwickshire, CV31 3RW, UK

Manufacturer
Hospira Australia Pty Ltd, Lexia Place, Mulgrave, Victoria 3170,
Australia
This leaflet was last approved in
08/2008.


It is recommended that a clarifying filter is used to minimise the particulate
levels in resultant infusions.
For continuous intravenous infusion the concentrated solution should be
diluted to a concentration of 1 mg per ml. If required, solution strengths up
to 5 mg/ml (0.5% solution) may be used, but should not be exceeded.
For intermittent intravenous infusion the appropriate daily dose can be
given as 4 doses once every 6 hours. The erythromycin concentration
should not exceed 5 mg per ml and the infusion should be administered
over 60 minutes, as a rapid infusion is more likely to be associated with
arrhythmias or hypotension. A longer period of infusion should be used
in patients with risk factors or previous evidence of arrhythmias. Not
less than 100 ml of diluent should be used for preparing intermittent
intravenous solutions.

In use storage precautions
After reconstitution/dilution, chemical and physical in-use stability has
been demonstrated for 24 hours at 25°C.
From a microbiological point of view, the product should be used
immediately. If not used immediately, in-use storage times and conditions
prior to use are the responsibility of the user and should not be longer
than 24 hours at a temperature not exceeding 25°C.
Q62994
4XXXXX

Copyright in this drawing, design and
specification or artwork vests in Hospira
UK Limited and must not be copied or
reproduced without the express prior
permission of Hospira UK Limited. Any
unauthorised act in relation to this work will
result in both civil and criminal liability.
Copyright © Hospira UK Limited October 2007

Expand Transcript

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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