ACICLOVIR 25 MG/ML STERILE CONCENTRATE

Active substance: ACICLOVIR

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PACKAGE LEAFLET:
INFORMATION FOR THE USER
Aciclovir 25 mg/ml Sterile Concentrate
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 Aciclovir Sterile Concentrate is and what it is used for
2. Before you use Aciclovir Sterile Concentrate
3. How to use Aciclovir Sterile Concentrate
4. Possible side effects
5. How to store Aciclovir Sterile Concentrate
6. Further information

1. WHAT ACICLOVIR STERILE CONCENTRATE IS AND WHAT IT IS
USED FOR
Aciclovir Sterile Concentrate is an anti-viral medicine. It is used:
• to treat severe genital herpes
• to prevent or treat Herpes simplex infections (may appear as
cold sores around the lips or as blisters on any part of the skin
including the genitals) in patients whose immune system is not
working properly
• to treat Herpes simplex infections in very young babies or in
infants up to 3 months of age
• to treat Varicella zoster viral infections (e.g. shingles)
• to treat herpes encephalitis (inflammation of the brain following
infection with herpes)

2. BEFORE YOU USE ACICLOVIR STERILE CONCENTRATE
Do not use Aciclovir Sterile Concentrate

• if you have shown signs of hypersensitivity (severe allergy) to
aciclovir or valaciclovir in the past
Tell your doctor if the above applies to you before this medicine is
used.

Take special care with Aciclovir Sterile Concentrate

• if you have any nervous system problems such as convulsions or
hallucinations
• if you had a nervous system side effect after treatment with an
anti-cancer medicine in the past
• if you have serious problems with your liver
• if you have any problems with your kidneys
• if tests show that you are hypoxic (have a low amount of oxygen
reaching your body tissues)
• if blood tests have shown that you have abnormal amounts of
electrolytes in your blood
Tell your doctor if any of the above applies to you before this
medicine is used.
It is important that while you are being treated with aciclovir you do
not become dehydrated. Before you are given this medicine your
doctor will check to make sure you are passing urine, are receiving
enough fluid and are not dehydrated. The doctor will also check if
you are taking any other medicine which could harm your kidneys.
These checks are particularly important in patients whose kidneys
may not be working properly.

Taking/using other medicines

Special care is needed if you are taking/using other medicines
as some could interact with Aciclovir Sterile Concentrate, for
example:









probenecid (a medicine used in the treatment of gout)
cimetidine (a medicine used to reduce stomach acid)
theophylline (a medicine used to treat some breathing disorders)
mycophenolate mofetil (a medicine used to prevent transplant
rejection)
lithium (a medicine used for manic-depressive disorder)
drugs which may affect the kidneys e.g. ciclosporin, tacrolimus
(medicines used to prevent transplant rejection)
interferon (used for treating multiple sclerosis)
intrathecal methotrexate (methotrexate injected into the spine) for
cancer treatment

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 decide if you should receive this
medicine.
Ask your doctor or pharmacist for advice before taking any
medicine.

Driving and using machines

This medicine may impair your ability to drive; if affected do not drive
or operate machinery.

Important information about some of the ingredients of
Aciclovir Sterile Concentrate

This medicinal product contains 3.3 mmol sodium (75 mg) per
700 mg dose. To be taken into consideration by patients on a
controlled sodium diet.

Aciclovir 25 mg/ml Sterile Concentrate
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.

Incompatibilities
Aciclovir sodium is reported to be incompatible with solutions of
amifostine, amsacrine, aztreonam, diltiazem hydrochloride, dobutamine
hydrochloride, dopamine hydrochloride, fludarabine phosphate,
foscarnet sodium, idarubicin hydrochloride, meropenem, morphine
sulphate, ondansetron hydrochloride, pethidine hydrochloride,
piperacillin sodium - tazobactam sodium, sargramostim and vinorelbine
tartrate.
Do not use bacteriostatic water for injection containing parabens or
benzyl alcohol.
Biologic or colloidal fluids (e.g. blood products, protein containing
solutions) are incompatible with aciclovir sodium.

Instructions for use and handling
Aciclovir 25 mg/ml Sterile Concentrate contains no preservative.
Dilution should therefore be carried out immediately before use under
full aseptic conditions and any unused solution should be discarded.
Refrigeration is not recommended as precipitation may occur.
For adults, it is recommended that infusion bags containing 100 ml
of infusion fluid are used, even when this would give an aciclovir
concentration substantially below 0.5% w/v. Thus one 100 ml
infusion bag may be used for any dose between 250 mg and 500 mg
aciclovir but a second bag must be used for doses between 500 and
1000 mg. Aciclovir 25 mg/ml Sterile Concentrate should not be diluted
to a concentration greater than 5 mg/ml (0.5% w/v) for administration
by infusion. After addition of Aciclovir 25 mg/ml Sterile Concentrate to
an infusion solution the mixture should be shaken to ensure thorough
mixing.
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3. HOW TO USE ACICLOVIR STERILE CONCENTRATE
This medicine will be diluted with a solution such as sodium chloride
0.9% before it is given to you. It will be given to you by a slow
infusion (drip) into a vein over a period of 1 hour. You may be given
fluids to ensure you do not become dehydrated.
If Aciclovir Sterile Concentrate accidentally gets into your eyes or
onto your skin, tell your doctor or nurse immediately so that it may
be washed away.

Dosage

The dose of medicine given to you and how often you are given it
will be determined by your doctor and will depend on your medical
condition, age, size and how well your kidneys are working.
Treatment with aciclovir usually lasts 5 - 7 days depending on how
quickly you get better. However, treatment for herpes encephalitis
and Herpes simplex in very young babies usually lasts for at least
10 days.
If aciclovir is being given to prevent a viral infection, it will be
given for the period your doctor thinks you are at risk of getting an
infection.

If you are given too much or too little Aciclovir Sterile
Concentrate

This medicine will be given to you in a hospital, under the supervision
of a doctor. 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 Aciclovir Sterile Concentrate 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.
• pain or swelling at the injection site during or immediately after
the injection
• convulsions or fits
• confusion or unusual and disordered thoughts (psychosis)
• hallucinations
• agitation
• trembling or shaking
• feeling unusually sleepy
• coma

If any of the following happen, tell your doctor as soon as
possible:

• blood in the urine
• inflammation (soreness, redness and swelling) of the skin near
the infusion site or along the vein used for the infusion
• sweating or fever
• thirst
• low blood pressure (you may feel dizzy when you stand up)
• headache
• abdominal pain
• feeling or being sick
• rash or hives
Aciclovir Sterile Concentrate may lead to changes in your blood cells
and liver and kidney function. 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 ACICLOVIR STERILE CONCENTRATE
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 label and carton after ‘EXP’. Where only a month and
year is stated, the expiry date refers to the last day of that month.

Storage

Do not store above 25°C. Do not refrigerate.

Visible signs of deterioration

This medicine should not be used if it has visible particles in it.

6. FURTHER INFORMATION
What Aciclovir Sterile Concentrate contains

The active substance is aciclovir. Each millilitre (ml) of sterile
concentrate contains 25 milligrams (mg) of aciclovir (as aciclovir
sodium).
The other ingredients are sodium hydroxide and Water for Injections.
Sodium hydroxide and/or hydrochloric acid are used to adjust the
pH of the solution.

What Aciclovir Sterile Concentrate looks like and contents of
the pack

Aciclovir Sterile Concentrate is a concentrate for solution for infusion
(sterile concentrate). This means it is a concentrated solution,
which is diluted then given as an infusion (drip). It comes in glass
containers called vials.
It may be supplied in packs containing:
• 5 x 250 mg/10 ml vials
• 5 x 500 mg/20 ml vials
• 1 x 1 g/40 ml vial
Not all pack sizes 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 09/2009

For children and neonates, where it is advisable to keep the volume of
infusion fluid to a minimum, it is recommended that dilution is on the
basis of 4 ml of sterile concentrate (100 mg aciclovir) added to 20 ml
of infusion fluid.
Aciclovir 25 mg/ml Sterile Concentrate when diluted in accordance with
the above schedule will give an aciclovir concentration not greater than
0.5% w/v.
When diluted as recommended, Aciclovir 25 mg/ml Sterile Concentrate
is known to be compatible with the infusion fluids listed below:



Sodium Chloride Intravenous Infusion 0.9% w/v
Sodium Chloride (0.18% w/v) and Glucose (4% w/v) Intravenous
Infusion
• Sodium Chloride (0.9% w/v) and Glucose (5% w/v) Intravenous
Infusion
• Sodium Chloride (0.45% w/v) and Glucose (2.5% w/v) Intravenous
Infusion
• Compound Sodium Lactate Intravenous Infusion (Hartmann’s
Solution)
After dilution, chemical and physical in-use stability has been
demonstrated for 12 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. When dilution is carried out under validated aseptic conditions, the
product may be stored for a maximum of 12 hours at room temperature,
below 25°C.
Should any visible turbidity or crystallisation appear in the solution
before or during infusion, the preparation should be discarded.

Q62936
4XXXXX

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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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