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AZITHROMYCIN 500 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): AZITHROMYCIN MONOHYDRATE

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PACKAGE LEAFLET: INFORMATION FOR THE USER
Azithromycin 500mg Powder for Solution for Infusion
(Azithromycin)
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 nurse.
 This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours.
 If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. See section 4.
In this leaflet:
1. What is Azithromycin 500 mg Powder for Solution for Infusion used for?
2. Before you are given Azithromycin 500 mg Powder for Solution for Infusion.
3. How Azithromycin 500 mg Powder for Solution for Infusion is given?
4. Possible side effects.
5. How to store Azithromycin 500 mg Powder for Solution for Infusion?
6. Further information.
1. What is Azithromycin 500mg Powder for Solution for Infusion used for?
Azithromycin is one of a group of antibiotics called macrolides.
This medicine is used to treat the following serious infections when these require
admission to hospital and when the infection is caused by micro-organisms that are
susceptible to azithromycin:



Pneumonia acquired outside of hospital
Infection of the internal female sex organs (Pelvic Inflammatory Disease)

This medicinal product is used when you require treatment by intravenous infusion (a
‘drip’).
This medicine is ready to be reconstituted (dissolved in liquid) to be given by infusion (a
‘drip’). See under “How Azithromycin500 mg Powder for Solution for Infusion is given.”
2. Before you are given Azithromycin 500mg Powder for Solution for Infusion
You should not be given this medicine if you:
• have ever had an allergic reaction to this medicinal product or any other macrolide
antibiotic such as erythromycin.
• are taking any ergot derivatives such as ergotamine (used to treat migraine).
You should take special care with this medicine if you:
• have kidney problems
• have liver problems
• have any heart conditions
• have diarrhoea
Tell your doctor or nurse BEFORE you are given this medicine. You may need to be
given another medicine instead.

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Taking other medicines
Tell your doctor or nurse BEFORE you are given this medicine if you are taking, or have
recently taken, any of the following medicines:
o Ergot derivatives such as ergotamine (to treat migraine)
o Nelfinavir (used in the treatment of HIV infection)
o Antacids (for indigestion)
o Rifabutin (to treat infections including tuberculosis)
o Warfarin or any similar medicine to prevent blood clots
o Ciclosporin (used following organ transplants)
o Digoxin,(used to treat heart conditions)
o Astemizole (for hay fever or allergies)
o Pimozide (for psychiatric disorders)
o Theophilline (for asthma or chronic obstructive pulmonary disease)
Please tell your doctor or nurse if you are taking or have recently taken any other
medicines, including medicines obtained without a prescription.
Pregnancy and breast-feeding
You should not be given this medicine if you are pregnant or are breast feeding unless
your doctor has specifically recommended it. Ask your doctor or pharmacist for advice
before taking any medicine.
Driving and using machines
However, side effects could occur which may influence your ability to drive or use
machines (see section 4). You are advised not to drive or use machines whilst taking
azithromycin.
Important information about some of the ingredients of this medicine
This medicinal product contains 114mg sodium per dose. To be taken into consideration
by patients on a controlled sodium diet.
3. How Azithromycin 500mg Powder for Solution for Infusion is given?
This medicine will be given to you by your doctor or nurse as an intravenous infusion (a
‘drip’).
It will be given either over 3 hours with a concentration of 1mg/ml, or over 1 hour with a
concentration of 2mg/ml.
Do not give this medicine in concentrations higher than 2mg/ml as it may result in pain
and discomfort at the infusion site.
This medicine should not be given over a period less than 1 hour.
Do not inject this medicine directly into a vein or muscle.
Pneumonia acquired outside of hospital:
Adults and the elderly: 500mg as an intravenous infusion once daily for at least two
days, followed by 500mg of oral azithromycin as a single daily dose to complete a 7-10
day treatment in total.
Pelvic Inflammatory Disease (infection of the internal female sex organs):

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Adults and the elderly: 500mg as an intravenous infusion once daily, followed by
250mg of oral azithromycin as a single daily dose to complete a 7-10 day treatment in
total.
The doctor will decide when to change to treatment using oral azithromycin.
Children: The use of this medicine in children and adolescents under 16 years has not
been established.
If you have kidney problems:
Your doctor may need to reduce the dose of Azithromycin500mg Powder for Solution for
Infusion.
If you are given more Azithromycin 500mg Powder for Solution for Infusion than
you should
As you will be given Azithromycin 500mg Powder for Solution for Infusion by a doctor
or nurse, you are unlikely to be given the wrong dose. However, if you experience bad
side effects or think you have been given too much, tell your doctor immediately.
An antimicrobial agent with anaerobic activity should be administered in combination
with azithromycin if anaerobic microorganisms are suspected of contributing to the
infection.
The safety of intravenous azithromycin has not been assessed beyond the time frames
described in the clinical trials of use in patients with community-acquired pneumonia and
pelvic inflammatory disease.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets
them.
The following side effects are important and will require immediate action if you
experience them. You should stop taking azithromycin and see your doctor immediately if
the following symptoms occur:
Rare side effects affect fewer than 1 in 1,000 patients
 Swelling of the face, tongue and windpipe which can cause great difficulty in
breathing
 A sudden allergic reaction with shortness of breath, rash, wheezing and drop of
blood pressure
 Severe, extensive, blistering skin rash
 Watery and severe diarrhoea that may also be bloody
The following side effects may also occur:
Common – more than 1 in every 100 people taking this medicine:
 Local pain and inflammation at infusion site
 Stomach pain, diarrhoea, feeling sick, indigestion or heartburn, vomiting,
 Altered blood test results of liver function
Uncommon - less than 1 in every 100 but more than 1 in every 1000 people taking
this medicine:
 Headache, drowsiness

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Taste disturbance, flatulence (wind)
Skin rash and itching, oedema (build-up of fluid in the body tissues)
Yeast infections of the mouth and/or vagina.

Rare - less than 1 in every 1000 but more than 1 in every 10000 people taking this
medicine:
 Feeling weak, fatigue, dizziness, tingling sensations, fainting, discomfort,
nervousness, aggression, convulsions (fits), hyperactivity, deafness or ringing in
the ears (effects on hearing are usually reversible)
 A reduced number of cells in the circulation that fight infection leading to frequent
infections such as sore throuts, mouth ulcers, bleeding or bruising more easily than
normal
 Rapid or irregular heart beat, alterations in the electrical activity of the heart
 Loss of appetite, discoloration of tongue, constipation, loose stools, inflammation
of the pancreas causing pain in the abdomen and vomiting, hives, increased
sensitivity to sunlight
 Inflammation of the liver and jaundice (yellowing of the skin and the whites of the
eyes), liver failure (rarely life-threatening)
 Joint pain
 Kidney problems
 Visual problems
 Inflammation of the vagina (vaginitis)
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 this 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.
5. How to store Azithromycin 500mg Powder for Solution for Infusion?
For the unopened product with dry powder, this medicinal product does not require any
special storage precautions.
Once the vial has been reconstituted (dissolved in liquid) ready for use, the product is
stable for 24 hours when stored at temperatures lower than 30°C or for 7 days when
stored in a refrigerator between 2°C and 8°C. From a microbiological point of view, the
prepared solution should be used immediately. If the product is not used immediately, inuse storage times and conditions are the responsibility of the user.
Unused solution must be discarded. Medicines should not be disposed of via wastewater
or household waster. Any unused product or waste material should be disposed of in
accordance with local requirements.
Do not use Azithromycin 500mg Powder for Solution for Infusion after the expiry date
which is stated on the label. The expiry date refers to the last day of that month. Your
doctor or nurse will check that this date has not been passed.
The doctor or nurse responsible for giving you this medicine will ensure it has been
reconstituted (dissolved into liquid) correctly before giving it to you.
Keep out of the reach and sight of children.

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6. Further information
This medicinal product contains
The active ingredient is azithromycin. Each vial contains 500mg azithromycin as
monohydrate.
The other ingredients are citric acid monohydrate and sodium hydroxide.
What Azithromycin 500mg Powder for Solution for Infusion looks like and contents
of the pack.
This medicinal product is a white to almost white powder, and is presented in a 14 ml
glass vial with a rubber stopper and aluminium/polypropylene flip-off seal, packaged in a
carton.
Marketing Authorisation holder:
PLIVA Pharma Limited, Ridings Point, Whistler Drive, Castleford, West Yorkshire,
WF10 5HX, United Kingdom
Manufacturer:
Teva Operations Poland Sp. z.o.o., ul. Mogilska 80, 31-546 Kraków; Poland
This leaflet was last revised in: April 2015
PL 10622/0306
Prescriber Information
Azithromycin 500 mg Powder for Solution for Infusion
The following information is intended for medical or healthcare professionals only
(Please note this is a Prescriber Information Leaflet NOT the Summary of Product
Characteristics (SPC). For full details regarding this product please refer to the SPC).
Administration
This medicinal product is administered as an intravenous infusion over 3 hours with a
concentration of 1 mg/ml, or over 1 hour with a concentration of 2 mg/ml. Higher
concentrations should be avoided as all tested subjects receiving infusion concentrations
higher than 2 mg/ml experienced local reactions at the infusion site.
The azithromycin infusion time should not be shorter than 60 minutes.
Azithromycin should not be given as a bolus or intramuscular injection.
Incompatibilities
This medicinal product must not be mixed or co-administered with other medicinal products
except those mentioned under the ‘Infusion concentrate may be diluted with’ subheading
below.
Instructions for preparation of infusion
Step 1
Prepare the initial solution infusion concentrate by adding 4.8 ml of sterile water for injection
to the injection vial of Azithromycin 500 mg Powder for Solution for Infusion. Shake the vial
until all of the powder is dissolved. One ml of the reconstituted solution contains 100 mg
azithromycin. A clear and colourless solution is obtained.

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Step 2
Dilute the resulting 5 ml infusion concentrate further with a compatible infusion solution to
obtain the final solution for infusion containing azithromycin with a concentration of 1 mg/ml
or 2 mg/ml (see Table 1 below).
Table 1 Preparation of final infusion solution
Concentration of final infusion
solution (mg/ml)
1 mg/ml
2 mg/ml

Quantity of diluent
500 ml
250 ml

Infusion concentrate may be diluted with
0.9 % sodium chloride
0.45% sodium chloride
5 % glucose
5 % glucose in 0.45% sodium chloride with 20mEq KCL
5 % glucose in 0.3% sodium chloride
5 % glucose in 0.45 sodium chloride
4% glucose, 0.18% sodium chloride and 0.15% potassium chloride
Before administration, the reconstituted and diluted solutions should be inspected visually for
particulate matter. Only clear solutions free from particles should be used. If the solution
contains particulate matter, it should be discarded.
This product is for single use only. Unused product must be discarded. Any unused product or
waste material should be disposed of in accordance with local requirements.
Special precautions for storage
This medicinal product does not require any special storage conditions.
For storage conditions of the reconstituted and diluted medicinal product, see below.
Chemical and physical in-use stability for reconstituted concentrate has been demonstrated for
24 hours at 25°C or 7 days in refrigerator at 2-8°C.
After reconstitution and dilution, the mixed solution is chemically and physically stable for 24
hours at 30°C or 7 days in refrigerator (at 2-8°C).
However, from a microbiological point of view, unless the method of opening/ reconstitution/
dilution precludes the risk of microbial contamination, the product should be used
immediately.
If the product is not used immediately, in-use storage times and conditions are the
responsibility of the user.

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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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