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ZEDBAC 500 MG POWDER FOR SOLUTION FOR INFUSION

Active substance(s): AZITHROMYCIN DIHYDRATE

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Package leaflet: information for the user

Zedbac

500mg powder for solution
for infusion
Azithromycin (as dihydrate)
Read all of this leaflet carefully before you
start using 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,
pharmacist or nurse.
If you get any side effects talk to your doctor,
• pharmacist
or nurse. This includes any possible
side effects not listed in this leaflet.
What is in this leaflet:
1 What Zedbac is and what it is used for
2 What you need to know before you use Zedbac
3 How to use Zedbac
4 Possible side effects
5 How to store Zedbac
6 Contents of the pack and other information

1. What Zedbac is and
what it is used for
Zedbac belongs to a group of antibiotics called
macrolides. It is used to treat localized infections
caused by bacteria in many different parts of
the body.
Which diseases are treated with Zedbac?
Zedbac is indicated for treatment of
serious infections or when oral treatment
cannot be used. It is used for treatment of
pneumonia (lung infection), and pelvic infections
(infection of the reproductive organs) caused by
susceptible organisms.

2. What you need to know before you
use Zedbac
Do not use Zedbac
if you are allergic to azithromycin or any of the
• ingredients
of this medicine (listed in section 6).
if you are allergic (hypersensitive) to any
• other
macrolide antibiotic (such as
erythromycin or clarithromycin) or ketolide
(macrolide derivatives)
if you are taking any ergot derivatives such
• as
ergotamine (used to treat migraine) as
these medicines should not be taken together
with Zedbac.
Warnings and precautions
Talk to your doctor, pharmacist or nurse before
using Zedbac
have an allergic reaction such as red
• orif you
white spots on the skin, itching and skin
irritation, swelling of the skin, larynx (throat)
or tongue, and difficulty in breathing, in which
case you should stop treatment with Zedbac
• if you have or have had kidney problems
if you have or have had liver problems: your
• doctor
may need to monitor your liver function
or stop the treatment
if you have or have had an abnormal heart
• rhythm
in particular problems such as long QT
syndrome (shown on an electro-cardiogram or
ECG machine)
if you feel heart palpitations or have an
• abnormal
heartbeat, or get dizzy or faint when
taking Zedbac, in which case you should inform
your doctor immediately
if you develop diarrhoea or loose stools
• during
or after treatment. In some cases there
is the possibility of developing a serious
intestinal inflammation known as
pseudomembranous colitis. Do not take any
medicine to treat your diarrhoea without first
checking with your doctor
Other important precautions:
Fungal infections may occur while you take
• azithromycin
• In rare cases severe allergic reactions may occur
Medicines known as ergot derivatives e.g.
• ergotamine
or dihydroergotamine (medicines
used for migraines or reducing blood flow)
should not be taken together with Zedbac
Care must be also taken if you suffer from
• neurological
or psychiatric diseases
This medicine shall not be used to treat infected
• burn
wounds
Worsening of symptoms has been observed in
• patients
with myasthenia gravis receiving
azithromycin.

Other medicines and Zedbac
Tell your doctor, pharmacist or nurse if you are
taking, have recently taken or might take any
other medicines.
Medicines can interact with each other or with
other substances causing unexpected drug
reactions or in some cases may cause a decrease
or increase of the expected effect. Therefore, you
should inform your doctor about all the medicines
you are taking or have taken, in particular:
ergot derivatives such as ergotamine (used to
• treat
migraine)
• digoxin (used to treat heart failure)
warfarin or any similar medicine to prevent
• blood
clots
ciclosporin (used to suppress the immune
• system
to prevent and treat rejection of a
transplanted organ or bone marrow)
• terfenadine (for hay fever or a skin allergy)
nelfinavir (used for the treatment of HIV
• infection
(AIDS))
zidovudine (for HIV). Zedbac may reduce the
• blood
levels of zidovudine and should therefore
be taken at least 1-2 hours before or after
zidovudine
• rifabutin (for HIV or tuberculosis)
• theophylline (for breathing problems)
You should not take Zedbac with antacids (used
for indigestion).
Pregnancy, breast-feeding and fertility
Please contact your doctor or pharmacist before
taking any medicine.
If you are pregnant or breast-feeding, think you
may be pregnant or planning to have a baby, ask
your doctor or pharmacist for advice before using
this medicine.
Driving and using machines
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 Zedbac.
Zedbac contains sodium
This medicinal product contains 7.31mmol
(168.2mg) sodium per vial. To be taken into
consideration by patients on a controlled
sodium diet.

3. How to use Zedbac
Always use this medicine exactly as your doctor or
pharmacist has told you. Check with your doctor
or pharmacist if you are not sure.
Your doctor will determine the dose and
treatment duration which are suitable for you.
The following information describes the doses most
commonly used in adults for the treatment of
pneumonia (lung infection) and pelvic infections.
Pneumonia
500mg administered as a single intravenous daily
dose for at least two days, followed by oral
administration of azithromycin. The appropriate
timing of the switch to oral therapy should be
done at the discretion of your doctor.
Pelvic infections
500mg administered as a single intravenous daily
dose for one or two days, followed by oral
administration of azithromycin. The appropriate
timing of the switch to oral therapy should be
done at the discretion of your doctor.
Method and route of administration
Zedbac is intended to be administered by
intravenous infusion.
This medicine should be reconstituted and diluted
according to the instructions, and should be
administered as an intravenous infusion over at
least 60 minutes.
Average duration of treatment
The duration of your treatment will depend on the
severity of your infection. Your doctor will inform
you about it.
Special patient groups
Zedbac is not recommended for use in children
and growing adolescents.


The following information is intended for healthcare professionals only:
Zedbac should be reconstituted and diluted according to the
instructions and should be administered as an intravenous
infusion over at least 60 minutes.
It should not be administered as an intravenous bolus or an
intramuscular injection.
Zedbac as powder for solution for infusion is supplied in
single dose vials.

Phase 1: Preparation of reconstituted solution
This medicinal product should be prepared under aseptic
conditions.
The initial reconstituted solution is prepared by adding
4.8ml of sterile water for injections to the 10ml vial initial
content using a standard 5ml syringe (non-automated) and
shaking the vial until all the drug is dissolved. Each ml of

reconstituted solution contains azithromycin dihydrate
equivalent to 100mg azithromycin (100 mg/ml).
The reconstituted solution must be further diluted
prior to administration.

Phase 2: Dilution of reconstituted solution
To provide azithromycin at a concentration of 1.0mg/ml:
Transfer 5ml of the azithromycin solution prepared in phase
1 (100mg/ml) to 500ml of the appropriate diluents
described overleaf.
To provide azithromycin at a concentration of 2.0mg/ml:
Transfer 5ml of the azithromycin solution prepared in phase
1 (100mg/ml) to 250ml of the appropriate diluents
described overleaf.

Patients with kidney or liver problems:
You should tell your doctor if you have kidney or
• liver
problems as your doctor may need to alter
the normal dose.
No dose adjustment is needed for elderly patients.
If you have any further questions about the use of
this medicine, ask your doctor, pharmacist or nurse.

Reporting of side effects
If you get any side effects, talk to your doctor or
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 (www.mhra.gov.uk/yellowcard).
By reporting side effects you can help provide
more information on the safety of this medicine.

4. Possible side effects

5. How to store Zedbac

Like all medicines, this medicine can cause side
effects, although not everybody gets them.
The following side effects have been reported:
• Very common (affects more than 1 user in 10)
• Common (affects 1 to 10 users in 100)
• Uncommon (affects 1 to 10 users in 1,000)
• Rare (affects 1 to 10 users in 10,000)
• Very rare (affects less than 1 user in 10,000)
Not known - frequency cannot be estimated
• from
available data
Very common side effects
• diarrhoea, stomach cramps, feeling sick, wind
Common side effects
• headache, dizziness
• numbness or pins and needles
• taste disturbance, loss of appetite
• visual disturbances, deafness
• vomiting, indigestion
• skin rash and /or itching
• joint pain
low numbers of lymphocytes (type of white
• blood
cells), higher number of eosinophils
(type of white blood cells)
• low blood bicarbonate
• tiredness/fatigue
Uncommon side effects
• yeast infections of the mouth and vagina (thrush)
low numbers of leukocytes (type of white blood
• cells),
low number of neutrophils (type of white
blood cells)
• allergic reactions of various severity
• generalized blistering skin rash
• skin more sensitive to sunlight than normal
• urticaria
• feeling nervous
reduced sense of touch or sensation
• (hypoesthesia)
• dizziness
• sleepiness or sleeplessness (insomnia)
• poor hearing or ringing in the ears
• heart palpitations, chest pain
• constipation
inflammation of the liver (hepatitis), changes in
• liver
enzymes
• general loss of strength
• swelling
• general discomfort
abnormal laboratory test values
• (e.g.
blood or liver tests)
vomiting (with or without blood) associated
• with
abdominal pain
Rare side effects
• agitation
• vertigo
• changes in liver function
Side effects with frequency not known:
• diarrhoea
reduction in the number of platelets (important
• cells
in blood clotting), anaemia
• allergic reactions
aggression, anxiety, convulsions (fits) or
• fainting,
feeling hyperactive
loss of smell or altered sense of smell,
• loss
of taste
abnormal heartbeat, including fast and
• irregular
heartbeat, muscle weakness
• low blood pressure
• inflammation of the pancreas (pancreatitis)
• tongue discolouration, severe skin reaction
liver failure, liver necrosis, yellowing of the
• skin
or eyes (jaundice), skin redness
• kidney failure, kidney inflammation
• abnormal electrocardiogram (ECG)
stomach pain associated with diarrhoea
• and
fever
• bruising and bleeding
tiredness/fatigue associated with dark
• coloured
urine
• localized muscle weakness
Local injection site reactions (inflammation/pain)
have been reported with the intravenous
administration of azithromycin.


The reconstituted solution can be diluted with:
0.9 % sodium chloride
0.45 % sodium chloride
5% dextrose in water
Lactated Ringer’s solution
5% dextrose in 0.3% sodium chloride
5% dextrose in 0.45% sodium chloride
Concentrated solution after reconstitution (according to the
instructions) is chemically and physically stable during 24
hours, when stored below 25°C.
Diluted solutions, prepared according to the instructions,
are chemically and physically stable for 24 hours at or below
25°C, or for 7 days if stored under refrigeration (5°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 would normally not be longer than 24 hours at

Keep this medicine out of the sight and reach
of children.
Do not use this medicine after the expiry date,
which is stated on the carton and the vial after
EXP. The expiry date refers to the last day of
that month.
Keep the vial in the outer carton in order to
protect from light.
Concentrated solution after reconstitution
(according to the instructions) is chemically and
physically stable during 24 hours, when stored
below 25°C.
Diluted solutions, prepared according to the
instructions, are chemically and physically stable
for 24 hours at or below 25°C, or for 7 days if
stored under refrigeration (5°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
would normally not be longer than 24 hours at
2°C to 8°C, unless the reconstitution/dilution
has taken place in controlled and validated
aseptic conditions.
Do not use this medicine if you notice that the
visual appearance has changed (e.g. the solution
is not free from visible particles).
Any unused medicine must be discarded.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.

6. Contents of the pack and other
information
What Zedbac contains
The active substance is azithromycin (as
• dihydrate).
Each vial contains 500mg of
azithromycin (equivalent to 524.03mg
azithromycin dihydrate).

The other ingredients are: citric acid and sodium
• hydroxide
30% (for pH adjustment).
What Zedbac looks like and contents
of the pack
Zedbac is a free white powder, with small
aggregates, for solution for infusion. It comes in a
10ml glass single dose vial, colourless with
rubber stopper and sealed with aluminium/plastic
flip-off cap.
The appearance of the product after
reconstitution is a colourless and clear solution
and leaves no visible undissolved matter.
Zedbac is available in the following
pack sizes:
Pack with 1 vial.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
Aspire Pharma Limited
Bellamy House
Winton Road
Petersfield
Hampshire
GU32 3HA
United Kingdom
Manufacturer
Laboratório Reig Jofré, S.A.
Gran Capitán 10, 08970 Sant Joan Despí
Barcelona
Spain
or
Tecnimede – Sociedade Técnico-Medicinal S.A.
Quinta da Cerca - Caixaria
2565 - 187 Dois Portos
Portugal
This leaflet was last revised in 01/2015

1010009-P5.2

2°C to 8°C, unless the reconstitution / dilution has taken
place in controlled and validated aseptic conditions.
Parenteral administration drugs should be inspected
visually for particulates in suspension prior to
administration. If particulates in suspension are evident
in the reconstituted solution, it should be discarded.
Any unused medicine must be discarded.
Other intravenous substances, additives or other
medications should not be added to Zedbac or infused
simultaneously through the same intravenous line.

Artwork for:
Aspire Pharma Limited
Product name:
Zedbac Azithromycin 500mg powder UK version
Size:
PL/PA no:
Type: Leaflet
Artwork dimensions: 400mm x 140mm
Profile supplied:
Dimensions supplied
Date of first artwork: 7 July 2011
Reason for request: Text edits
Version no: 5.1
Date of revision:
13 January 2015
Colours:
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Font(s):
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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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