RETROVIR 10 MG/ML IV CONCENTRATE FOR SOLUTION FOR INFUSION

Active substance: ZIDOVUDINE

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5

10 mg/ml IV Concentrate for Solution for Infusion
zidovudine

10000000130134

10000000130134

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

Information for the patient
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.

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)
• if you’re diabetic and using insulin.
➔ 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.
If you’re 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.

GSK-GBR-Barnard Castle-UKBAR

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
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.

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Retrovir
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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

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lower dose of Retrovir, depending on how well
your kidneys or liver are working.
➔ Ask your doctor or pharmacist for
advice.

4 Possible side effects
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:
• 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.
Your body shape may change
People taking combination therapy for HIV may
find that their body shape changes, because of
changes in fat distribution:
• Fat may be lost from the legs, arms or face.
• Extra fat may build up around the tummy
(abdomen), or on the breasts or internal
organs.

• Fatty lumps (sometimes called buffalo
hump) may appear on the back of the neck.
It is not yet known what causes these changes,
or whether they have any long-term effects on
your health. If you notice changes in your body
shape:
➔ Tell your doctor.
Lactic acidosis is a rare but serious side
effect
Some people taking Retrovir, or other medicines
like it (NRTIs), 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
• increased levels of sugar, fatty acids
(triglycerides) and cholesterol in the blood
• resistance to insulin (so if you’re diabetic,
you may have to change your insulin dose to
control your blood sugar).
These effects 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).

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
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: October 2014
Retrovir is a registered trade mark of the
ViiV Healthcare group of companies.
© 2014 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.

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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.
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.

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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.
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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