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RETROVIR 10 MG/ML IV CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance(s): ZIDOVUDINE

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1

10 mg/ml IV Concentrate for Solution for Infusion
zidovudine

10000000139504

10000000139504

The following information is intended for
medical or healthcare professionals only:

RETROVIR® IV FOR INFUSION 10 mg/ml
zidovudine
DOSAGE AND ADMINISTRATION
INFORMATION ONLY
Please refer to the Summary of Product
Characteristics for further information
Pharmaceutical form
Concentrate for solution for infusion.
Retrovir IV for Infusion is a clear, nearly colourless, sterile
aqueous solution with a pH of approximately 5.5.
Posology and method of administration
The required dose of Retrovir IV for Infusion must
be administered by slow intravenous infusion of the
diluted product over a one-hour period.
Retrovir IV for Infusion must NOT be given
intramuscularly.
Dilution: Retrovir IV for Infusion must be diluted prior
to administration (see Instructions for use and handling).
Dosage in adults
A dose for Retrovir IV for Infusion of 1 or 2 mg
zidovudine/kg bodyweight every 4 hours provides
similar exposure (AUC) to an oral dose of 1.5 or 3.0 mg
zidovudine/kg every 4 hours (600 or 1200 mg/day
for a 70 kg patient).
The current recommended oral dose of Retrovir is
250 or 300 mg twice daily. This current dose is used
as part of a multi-drug treatment regimen.
Patients should receive Retrovir IV for Infusion only
until oral therapy can be administered.
Dosage in children
Limited data are available on the use of Retrovir IV
for Infusion in children. A range of intravenous
dosages between 80-160 mg/m2 every 6 hours
(320-640 mg/ m2/day) have been used. Exposure
following the 120 mg/m2 dose every 6 hours
approximately corresponds to an oral dose of
180 mg/m2 every 6 hours. An oral dose of Retrovir of
360 to 480 mg/m2 per day approximately corresponds
to an intravenous dose of 240-320 mg/m2/day.

Dosage in the prevention of maternal-foetal
transmission
Although the optimal dosage schedule has not
been identified the following dosage regimen
has been shown to be effective. Pregnant women
(over 14 weeks of gestation) should be given
500 mg/day orally (100 mg five times per day) until
the beginning of labour. During labour and delivery
Retrovir should be administered intravenously at
2 mg/kg bodyweight given over one hour followed
by a continuous intravenous infusion at 1 mg/kg/h
until the umbilical cord is clamped.
The newborn infants should be given 2 mg/kg
bodyweight orally every 6 hours starting within
12 hours after birth and continuing until 6 weeks old
(e.g. a 3 kg neonate would require a 0.6 ml dose of
oral solution every 6 hours). Infants unable to receive
oral dosing should be given Retrovir intravenously
at 1.5 mg/kg bodyweight infused over 30 minutes
every 6 hours.
In case of planned caesarean, the infusion should be
started 4 hours before the operation. In the event of
false labour, the Retrovir infusion should be stopped
and oral dosing restarted.
Dosage adjustments in patients with
haematological adverse reactions
Substitution of zidovudine should be considered in
patients whose haemoglobin level or neutrophil count
fall to clinically significant levels. Other potential
causes of anaemia or neutropenia should be excluded.
Retrovir dose reduction or interruption should be
considered in the absence of alternative treatments.
Dosage in the elderly
Zidovudine pharmacokinetics have not been studied
in patients over 65 years of age and no specific
data are available. However, since special care is
advised in this age group due to age-associated
changes such as the decrease in renal function
and alterations in haematological parameters,
appropriate monitoring of patients before and
during use of Retrovir is advised.

Information for the patient

1 What Retrovir is and what it is
used for

10 mg/ml IV Concentrate for Solution for
Infusion
zidovudine
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 or
pharmacist.
If you get any side effects talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.

What is in this leaflet
1 What Retrovir is and what it is used for
2 What you need to know before you’re

given Retrovir
3 How Retrovir is given
4 Possible side effects
5 How to store Retrovir
6 Contents of the pack and other

information

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Retrovir is used to treat HIV (human
immunodeficiency virus) infection.
The active ingredient in Retrovir is zidovudine. Retrovir
is a type of medicine known as an anti-retroviral. It
belongs to a group of medicines called nucleoside
analogue reverse transcriptase inhibitors (NRTIs).
Retrovir does not get rid of HIV infection; it reduces
the amount of virus in your body, and keeps it at a low
level. Retrovir also increases the CD4 cell count in your
blood. CD4 cells are a type of white blood cells that
are important in helping your body to fight infection.
Retrovir is used, in combination with other medicines
(‘combination therapy’), to treat HIV in adults and
children. To control your HIV infection, and to stop
your illness getting worse, you must keep taking all
your medicines.
If you’re pregnant, your doctor may want you to take
Retrovir, to help prevent you passing HIV on to your
unborn baby. After the birth, your baby may be given
Retrovir to help prevent it from getting infected with HIV.
HIV infection is spread by sexual contact with someone
who’s got the infection, or by transfer of infected blood
(for example, by sharing injection needles).

2 What you need to know before
you’re given Retrovir

Don’t take Retrovir:
• if you’re allergic (hypersensitive) to zidovudine
or any of the other ingredients of Retrovir (listed
in Section 6)
• if you have a very low white blood cell count
(neutropenia) or a very low red blood cell count
(anaemia).
Retrovir for new-born babies
Retrovir must not be given to some new-born babies
with liver problems, including:
• some cases of hyperbilirubinaemia (increased
amounts in the blood of a substance called
bilirubin which may make the skin appear yellow)
• other problems which cause high levels of liver
enzymes in the blood.
Take special care with Retrovir
Some people taking Retrovir or combination therapy
for HIV are more at risk of serious side effects. You
need to be aware of the extra risks:
• if you have ever had liver disease (including
hepatitis B or C)
• if you’re seriously overweight (especially if
you’re a woman)
➔ Talk to your doctor if any of these applies
to you. You may need extra check-ups, including
blood tests, while you’re taking your medication. See
Section 4 for more information.
Look out for important symptoms
Some people taking medicines for HIV infection
develop other conditions, which can be serious. You need
to know about important signs and symptoms to look
out for while you’re taking Retrovir.
Please read the information in Section 4 of
this leaflet. If you have any questions about this
information or the advice given:
➔ Talk to your doctor.
Other medicines and Retrovir
Tell your doctor or pharmacist if you’re taking
any other medicines, or if you’ve taken any

recently, including herbal medicines or other
medicines you bought without a prescription.
Don’t take these medicines with Retrovir:
• stavudine, used to treat HIV infection
• ribavirin or injections of ganciclovir to treat viral
infections
• rifampicin, which is an antibiotic.
Some medicines can make it more likely that you’ll
have side effects, or make side effects worse
These include:
• sodium valproate, used to treat epilepsy
• aciclovir, ganciclovir or interferon, used to
treat viral infections
• pyrimethamine, used to treat malaria and
other parasitic infections
• dapsone, used to prevent pneumonia and treat
skin infections
• fluconazole or flucytosine, used to treat
fungal infections such as candida
• pentamidine or atovaquone, used to treat
parasitic infections such as PCP
• amphotericin or co-trimoxazole, used to treat
fungal and bacterial infections
• probenecid, used to treat gout and similar
conditions, and given with some antibiotics to
make them more effective
• methadone, used as a heroin substitute
• vincristine, vinblastine or doxorubicin, used
to treat cancer.
➔ Tell your doctor if you’re taking any of these.
A medicine that interacts with Retrovir
• phenytoin, used for treating epilepsy.
➔ Tell your doctor if you’re taking phenytoin. Your
doctor may need to monitor you while you’re
taking Retrovir.
Pregnancy
If you are pregnant, if you become pregnant, or if
you’re planning to become pregnant:
➔ Talk to your doctor about the risks and benefits
of taking Retrovir.
If pregnant women who are HIV-positive take
Retrovir, they are less likely to pass the HIV infection
on to their unborn babies.

Retrovir and similar medicines may cause side effects
in unborn babies; if it does, these effects won’t show
up until after the baby has been born. Even so, the
benefit of protecting your baby from getting HIV is
greater than the risk of your baby getting side effects.
If you’ve taken Retrovir while you were
pregnant, your baby may be given extra check-ups
(which may include blood tests), to make sure it’s
developing normally.
Breast-feeding
Women who are HIV-positive must not breast-feed,
because HIV infection can be passed on to the baby
in breast milk.
A small amount of the ingredients in Retrovir can also
pass into your breast milk.
If you are breast-feeding, or thinking about
breast-feeding:
➔ Talk to your doctor immediately.
Driving and using machines
Retrovir can make you dizzy and have other side
effects that make you less alert.
➔ Don’t drive or operate machinery unless
you’re feeling well.
You will need regular blood tests
For as long as you’re taking Retrovir, your doctor will
arrange regular blood tests to check for side effects.
There’s more information about these side effects in
Section 4 of this leaflet.
Stay in regular contact with your doctor
Retrovir helps to control your condition, but it is not
a cure for HIV infection. You need to keep taking it
every day to stop your illness getting worse. You may
still develop other infections and illnesses linked to
HIV infection.
➔ Keep in touch with your doctor, and don’t
stop taking Retrovir without your doctor’s
advice.
Protect other people
HIV infection is spread by sexual contact with
someone who has the infection, or by transfer of
infected blood (for example, by sharing injection

GSK-GBR-Barnard Castle-UKBAR

needles). You can still pass on HIV when taking this
medicine, although the risk is lowered by effective
antiretroviral therapy.
Discuss with your doctor the precautions needed to
avoid infecting other people.
Retrovir IV vials contain latex
The rubber stopper of the IV vials contains latex.
➔ Tell your doctor if you are allergic to latex.

United Kingdom-GBR; ViiV Healthcare
Retrovir

3 How Retrovir is given

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Your doctor will give you this medicine by infusing
it into a vein (a drip). It is diluted before use and is
given slowly over a one-hour period. It is usually
only given for short periods of time (up to 2 weeks)
while you or your child are unable to take Retrovir
by mouth.
How much Retrovir will you be given?
Adults and adolescents over 12 years old:
The dose of Retrovir you receive will depend on your
weight. The usual dose is 1 mg or 2 mg for each kg
of bodyweight every four hours.
Children:
Your doctor will decide on the correct dose of Retrovir
for your child, depending on the size of the child.
Pregnancy, childbirth and newborn babies:
You should not normally take Retrovir during the
first 14 weeks of your pregnancy. After week 14, the
usual dose is 500 mg given as 100 mg five times per
day taken by mouth each day until you start to go
into labour. During the labour and birth, your doctor
may give you injections of Retrovir, until your baby’s
umbilical cord has been clamped. Your new-born
baby may also be given Retrovir to help prevent it
from getting infected with HIV.
People with kidney or liver problems:
If you have severe kidney or liver problems, you may
be given a lower dose of Retrovir, depending on how
well your kidneys or liver are working.
➔ Ask your doctor or pharmacist for advice.

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4 Possible side effects
During HIV therapy there may be an increase in weight
and in levels of blood lipids and glucose. This is partly
linked to restored health and life style, and in the
case of blood lipids sometimes to the HIV medicines
themselves. Your doctor will test for these changes.
Treatment with zidovudine (Retrovir) often causes
a loss of fat from legs, arms and face (lipoatrophy).
This loss of body fat has been shown to be not fully
reversible after discontinuation of zidovudine. Your
doctor should monitor for signs of lipoatrophy. Tell
your doctor if you notice any loss of fat from your
legs, arms, and face. When these signs occur, Retrovir
should be stopped and your HIV treatment changed.
Like all medicines, this medicine can cause side
effects, but not everyone gets them. Some side effects
may show up in your blood tests, and may not appear
until 4 to 6 weeks after you start taking Retrovir. If
you get any of these effects, and if they are severe,
your doctor may advise you to stop taking Retrovir.
As well as the effects listed below, other conditions
can develop during combination therapy for HIV.
➔ It is important to read the information in ‘Other
possible side effects of combination therapy for HIV’.
Very common side effects
These may affect more than 1 in 10 people taking
Retrovir:
• headaches
• feeling sick (nausea).
Common side effects
These may affect up to 1 in 10 people taking
Retrovir:
• being sick (vomiting)
• diarrhoea
• stomach pains
• feeling dizzy
• aching muscles
• generally feeling unwell.
Common side effects that may show up in your
blood tests are:
• a low red blood cell count (anaemia) or low white
blood cell count (neutropenia or leucopenia)

• an increase in the level of liver enzymes
• an increased amount in the blood of bilirubin
(a substance produced in the liver) which may
make your skin appear yellow.
Uncommon side effects
These may affect up to 1 in 100 people taking
Retrovir:
• skin rash (red, raised or itchy skin)
• feeling breathless
• fever (high temperature)
• general aches and pains
• wind (flatulence)
• weakness.
Uncommon side effects that may show up in your
blood tests are:
• a decrease in the number of cells involved in
blood clotting (thrombocytopenia), or in all kinds
of blood cells (pancytopenia).
Rare side effects
These may affect up to 1 in 1000 people taking
Retrovir:
• lactic acidosis (excess lactic acid in the blood; see
the next section, ‘Other possible side effects of
combination therapy for HIV’)
• liver disorders, such as jaundice, enlarged liver or
fatty liver
• inflammation of the pancreas
• chest pain; disease of the heart muscle
• fits (convulsions)
• feeling depressed or anxious; not being able to
sleep (insomnia); not being able to concentrate;
feeling drowsy
• indigestion; loss of appetite; taste disturbance
• changes in the colour of your nails, your skin, or
the skin inside your mouth
• a flu-like feeling — chills, sweating and cough
• tingly feelings in the skin (pins and needles)
• passing urine more often
• enlarged breasts in men.
A rare side effect that may show up in your blood
tests is:
• a decrease in the number of a type of red blood
cell (pure red cell aplasia).

Very rare side effects
A very rare side effect that may affect up to 1 in
10,000 people taking Retrovir, and may show up in
blood tests is:
• a failure of the bone marrow to produce new
blood cells (aplastic anaemia).
If you get any side effects
➔ Talk to your doctor or pharmacist.
This includes any possible side effects not listed
in this leaflet.
Other possible side effects of combination
therapy for HIV
Some other conditions may develop during HIV
treatment.
Old infections may flare up
People with advanced HIV infection (AIDS) have
weak immune systems, and are more likely to
develop serious infections (opportunistic infections).
When these people start treatment, they may find
that old, hidden infections flare up, causing signs
and symptoms of inflammation. These symptoms
are probably caused by the body’s immune system
becoming stronger, so that the body starts to fight
these infections.
In addition to the opportunistic infections,
autoimmune disorders (a condition that occurs when
the immune system attacks healthy body tissue)
may also occur after you start taking medicines for
the treatment of your HIV infection. Autoimmune
disorders may occur many months after the start of
treatment. If you notice any symptoms of infection or
other symptoms such as muscle weakness, weakness
beginning in the hands and feet and moving
up towards the trunk of the body, palpitations,
tremor or hyperactivity, please inform your doctor
immediately to seek necessary treatment.
If you get any symptoms of infection while you’re
taking Retrovir:
➔ Tell your doctor immediately. Don’t take other
medicines for the infection without your doctor’s
advice.

Lactic acidosis is a rare but serious side effect
Some people taking Retrovir develop a condition
called lactic acidosis, together with an enlarged
liver. Lactic acidosis is caused by a build-up of lactic
acid in the body. It is rare; if it happens, it usually
develops after a few months of treatment. It can be
life-threatening, causing failure of internal organs.
Lactic acidosis is more likely to develop in people
who have liver disease, or in obese (very overweight)
people, especially women.
Signs of lactic acidosis include:
• deep, rapid, difficult breathing
• drowsiness
• numbness or weakness in the limbs
• feeling sick (nausea), being sick (vomiting)
• stomach pain.
During your treatment, your doctor will monitor you
for signs of lactic acidosis. If you have any of the
symptoms listed above, or any other symptoms that
worry you:
➔ See your doctor as soon as possible.
You may have problems with your bones
Some people taking combination therapy for HIV
develop a condition called osteonecrosis. With this
condition, parts of the bone tissue die because of
reduced blood supply to the bone.
People may be more likely to get this condition:
• if they have been taking combination therapy for
a long time
• if they are also taking anti-inflammatory
medicines called corticosteroids
• if they drink alcohol
• if their immune systems are very weak
• if they are overweight.
Signs of osteonecrosis include:
• stiffness in the joints
• aches and pains (especially in the hip, knee or
shoulder)
• difficulty moving.
If you notice any of these symptoms:
➔ Tell your doctor.
Other effects may show up in tests
Combination therapy for HIV can also cause:

• increased levels of lactic acid in the blood,
which on rare occasions can lead to lactic acidosis
This effect may show up in the blood tests you’ll
have while you’re taking Retrovir.
Reporting of side effects
If you get any side effects, talk to your doctor or
pharmacist. 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 Retrovir
Retrovir IV vials should be stored in the original
outer carton and should be kept out of the sight and
reach of children.
Don’t take this medicine after the expiry date shown
on the carton.
Retrovir IV should not be stored above 30 °C (86 °F).

Manufacturer
Glaxo Wellcome Operations, Harmire Road,
Barnard Castle, County Durham DL12 8DT
Other formats:
To listen to or request a copy of this leaflet in Braille,
large print or audio please call, free of charge:

0800 198 5000 (UK Only)

Please be ready to give the following information:
Product name
Retrovir IV
Reference number
35728/0005
This is a service provided by the Royal National
Institute of Blind People.
Leaflet date: December 2015.
Retrovir is a registered trade mark of the
ViiV Healthcare group of companies.
© 2015 ViiV Healthcare group of companies.
All rights reserved.

6 Contents of the pack and other
information

What Retrovir contains
The active substance is zidovudine.
The other ingredients are: water for injections,
sodium hydroxide and/or hydrochloric acid.
What Retrovir looks like and contents of the
pack
Retrovir IV for Infusion 10 mg/ml is a clear, sterile
aqueous solution containing 10 mg of the active
ingredient, zidovudine, per ml.
Retrovir IV for Infusion 10 mg/ml is packed in
20 ml vials.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder
ViiV Healthcare UK Ltd, 980 Great West Road,
Brentford, Middlesex TW8 9GS

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0139504

Dosage in renal impairment
In patients with severe renal impairment the recommended IV dosage is 1 mg/kg
3 - 4 times daily. This is equivalent to the current recommended oral daily
dosage for this patient group of 300-400 mg allowing for oral bioavailability
of 60-70%. Haematological parameters and clinical response may influence the
need for subsequent dosage adjustment. For patients with end-stage renal disease
maintained on haemodialysis or peritoneal dialysis, the recommended dose is
100 mg every 6-8 hrs (300 mg – 400 mg daily).
Dosage in hepatic impairment
Data in patients with cirrhosis suggest that accumulation of zidovudine
may occur in patients with hepatic impairment because of decreased
glucuronidation.
Dosage reductions may be necessary but, due to the large variability in
zidovudine exposures in patients with moderate to severe liver disease, precise
recommendations cannot be made. If monitoring of plasma zidovudine levels
is not feasible, physicians will need to monitor for signs of intolerance, such as
the development of haematological adverse reactions (anaemia, leucopenia,
neutropenia) and reduce the dose and/or increase the interval between doses
as appropriate.
Overdose
Symptoms and signs: Dosages as high as 7.5 mg/kg by infusion every four
hours for two weeks have been administered to five patients. One patient
experienced an anxiety reaction while the other four had no untoward effects.
No specific symptoms or signs have been identified following acute oral
overdose with zidovudine, apart from those listed as undesirable effects such
as fatigue, headache, vomiting, and occasional reports of haematological
disturbances.
Following a report where a patient took an unspecified quantity of zidovudine
with serum levels consistent with an overdose of greater than 17 grams there
were no short term clinical, biochemical or haematological sequelae identified.
Treatment: Patients should be observed closely for evidence of toxicity and
given the necessary supportive therapy.
Haemodialysis and peritoneal dialysis appear to have a limited effect on
elimination of zidovudine but enhances the elimination of the glucuronide
metabolite.
Shelf life and special precautions for storage
3 years when not stored above 30°C.
Instructions for use and handling
Dilution: Retrovir IV for Infusion must be diluted prior to administration. Since
no antimicrobial preservative is included, dilution must be carried out under
full aseptic conditions, preferably immediately prior to administration, and any
unused portion of the vial should be discarded.

GSK-GBR-Barnard Castle-UKBAR
United Kingdom-GBR; ViiV Healthcare
Retrovir
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The required dose should be added to and mixed with Glucose Intravenous
Infusion 5% w/v to give a final zidovudine concentration of either 2 mg/ml or
4 mg/ml. These dilutions are chemically and physically stable for up to 48 hours
at both 5°C and 25°C.
Should any visible turbidity appear in the product either before or after dilution
or during infusion, the preparation should be discarded.

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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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