ACICLOVIR 25 MG/ML CONCENTRATE FOR SOLUTION FOR INFUSION – patient leaflet, side effects, dosage

1. What Aciclovir Sterile Concentrate is and what it is used for

Aciclovir 25 mg/ml concentrate for solution for infusion contains aciclovir. This belongs to a group of medicines called antivirals. It works by stopping the growth of viruses. Aciclovir Sterile Concentrate can be used in patients with a working immune system to:

• treat recurring chicken-pox and shingles
• treat severe first cases of genital herpes

In patients with an impaired immune system (which means their bodies are less able to fight infections) to:

• treat primary and recurring chickenpox and shingles
• treat and stop cold sores and genital herpes
• prevent herpes simplex infections

It can also be used to:

• treat inflammation of the brain caused by the virus responsible for cold sore infection and genital herpes

• treat herpes simplex infections in very young babies or in infants up to 3 months of age

  1. 2.

     What you nee

     d to know before you use Aciclovir Sterile Concentrate iclovir Sterile Concentrate if:

     Do not use Ac

     • if you are ingredien Warnings and

       allergic (hypersensitive) to aciclovir or valaciclovir or any of the other ts (listed in section 6).

       precautions

Talk to your do

ctor, pharmacist or nurse before using Aciclovir Sterile Concentrate if: e kidney problems

• if you hav

• if you are

  over 65 years of age

• your imm If you are not s

  une system is weakened

  ure if the above apply to you, talk to your doctor, pharmacist or nurse

before using A Other medici

ciclovir Sterile Concentrate.

nes and Aciclovir Sterile Concentrate

Tell your doctor medicines. Thi medicines.

, pharmacist or nurse if you are using or have recently used any other s includes medicines obtained without a prescription, including herbal

In particular tel medicines:

l your doctor, pharmacist or nurse if you are taking any of the following

• probenec

  id, used to treat gout

• cimetidin

  e, used to treat stomach ulcers

• tacrolimu transplan

  s, cyclosporin or mycophenolate mofetil, used to stop your body rejecting ted organs

• theophylli

  ne (a medicine used to treat some breathing disorders) medicine used for bipolar disorder)

• lithium (a

Pregnancy, b

reast-feeding and fertility

If you are preg doctor or phar The active sub are breast-feed Concentrate. Driving and u

nant or think you may be pregnant or are planning to have a baby, ask your macist for advice before using this medicine.

stance in Aciclovir Sterile Concentrate can pass into breast milk. If you ing, you must check with your doctor before you take Aciclovir Sterile

sing machines

Some side effe and react. Mak

cts such as feeling drowsy or sleepy may impair your ability to concentrate e sure you are not affected before you drive or operate machinery.

Aciclovir Sterile Concentrate contains s

odium

This medicine contains 26.7 mg sodium (m vial of 10 ml solution. This is equivalent to 1 dietary intake of sodium for an adult. This medicine contains 53.4 mg sodium (m vial of 20 ml solution. This is equivalent to 2 dietary intake of sodium for an adult. This medicine contains 106.8 mg sodium ( vial of 40 ml solution. This is equivalent to 5 dietary intake of sodium for an adult.

ain component of cooking/table salt) in each .34% of the recommended maximum daily

ain component of cooking/table salt) in each .67% of the recommended maximum daily

main component of cooking/table salt) in each .34% of the recommended maximum daily

1. 3.

   How to take Aciclovir Sterile Co

   ncentra

   te

   How your medicine is given

   You will never be expected to give a person who is trained to do so. Aciclovir Sterile Concentrate will be This is where the drug is slowly giv

   yourself

   this medicine. It will

   always be given to you by

   given t en to yo

   o you as a continuo u over a period of ti

   us infusion into your vein. me. You may be given

   fluids to ensure you do not become The dose you will be given, the freq

   dehydr uency a

   ated.

   nd the duration of t

   he dose will depend on:

   • the type of infe

     ction you have d body size

   • your weight an
   • your age.

Your doctor may a

djust the dose of Aci

clovir Sterile Concent

rate if:

• you have kidney problems.

People over 65 years of age or with kid

ney problems:

It is very important while you are takin

g Aciclovir Sterile Concentrate that you

drink water regularly during the day. This

will help to reduce side effects that can

affect the kidney or nervous system. Your d

octor will closely monitor you for signs of

these. Nervous system side effects might in

clude feeling confused or agitated, or feeling

unusually sleepy or drowsy.

If you are given more Aciclovir Sterile C

oncentrate than you should

If you think you have been given too much

Aciclovir Sterile Concentrate, talk to your

doctor or nurse straight away.

If you have been given more aciclovir than you should you may:

• feel confused or agitated
• have hallucinations (seeing or hearing things that aren’t there)
• have fits
• become unconscious (coma).

• Possible side effects

  Like all medicines, this medicine can cause side effects, although not ev The following side effects may happen with this medicine: Allergic reactions (may affect up to 1 in 10,000 people) If you have an allergic reaction, stop taking Aciclovir Sterile Conc

  erybody gets them.

  entration and see a doctor straight away. The signs may include:

• bumpy rash, itching or hives on your skin
• swelling of your face, lips, tongue or other parts of your body (angioedema)
• shortness of breath, wheezing or trouble breathing If any of the following happen, tell your doctor immediately (may affect up to 1 in 10,000 people):
• unexplained fever and feeling faint, especially when standing up
• changes in your blood cells e.g. anaemia and/or reduced white blood cells and/or lowered platelet levels (leading to unexplained bruising). Your doctor may take blood samples to monitor for these

• a severe form of rash with itchy pink-red blotches, which may blister

  (erythema multiforme)

• a rare disorder of the blood clotting system called thrombotic thrombocytopenic purpura, which may give you bruising, headaches, hallucinations and also blood clots in the kidneys if you have a compromised immune system

• a severe form of anaemia called haemolytic uraemic syndrome, which may make you look pale and feel tired due to anaemia, and give you bruising and kidney problems if you have a compromised immune system

  The following information is intended for medical or healthcare professionals only: Please refer to the Summary of Product Characteristics (SPC) for complete prescribing information.

  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

For intravenous infusion only

Aciclovir 25 mg/ml Concentrate for Solution for Infusion 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 Concentrate for solution for Infusion 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 Concentrate for solution for Infusion to an infusion solution the mixture should be shaken to ensure thorough mixing.

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 solution (100 mg aciclovir) added to 20 ml of infusion fluid.

When diluted in accordance with the recommended schedules, Aciclovir 25 mg/ml

Concentrate for Solution for Infusion 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) Aciclovir 25mg/ml Concentrate for Solution for Infusion contains no preservative. Should any visible turbidity or crystallisation appear in the solution before or during infusion, the preparation should be discarded.

  Other side effe Common (ma

  cts include:

  y affect up to 1 in 10 people)

  • inflammat

    ion along the vein used for the infusion

  • feeling or

    being sick

  • itchy, bum

    py, hive-like rash

  • skin react

    ion after exposure to light (photosensitivity)

  • itching

  • swelling,

    redness and tenderness at the site of infusion

  • increases

    in liver related enzymes which may be detected through a blood test in blood urea and creatinine which may be detected through a blood test

  • increases

Uncommon (

may affect up to 1 in 100 people)

• noseblee platelets

  ds and bruising more easily than usual as a result of a decrease in blood

• decrease looking p

  d energy, weakness, shortness of breath, light-headedness, palpitations, ale (anaemia)

• a decreas leave a p

  e in the number of white blood cells found in blood (leukopenia). This may atient more prone to infection

• reduced n Very rare (ma

  umbers of blood platelets (thrombocytopenia)

  y affect up to 1 in 10,000 people)

• sweating
• headache

• feeling di

  zzy

• abdomina

  l pain

• diarrhoea

  or stomach pains

• feeling ve

  ry tired (fatigue)

• fever

• inflamma

  tion at the injection site

• feeling ag

  itated or confused (psychosis)

• shaking o

  r tremors

• hallucinat

  ions (seeing or hearing things that aren’t there) res)

• fits (seizu

• feeling un

  usually sleepy or drowsy

  • unsteadiness when walking and lack

    of coordination (ataxia)

  • difficulty speaking or hoarseness (dys

    arthria)

  • inability to think or judge clearly or co

    ncentrate

  • unconsciousness (coma)
  • difficulty breathing

  • disturbances of behaviour and speec

    h and bodily movements

  • inflammation of the liver (hepatitis)

  • yellowing of your skin and whites of yo

    ur eyes (jaundice)

  • kidney problems or failure where you pain in your lower back, the kidney are

    pass little or no urine (including blood in urine), a of your back or just above your hip (renal pain) ncephalopathy) which is evident by an altered

  • damage or malfunction of the brain (e

    mental state

Not known (frequency cannot b

e estim

ated from the av

ailable data)

• thirst

• low blood pressure (you may

  feel dizz molysis

  y when you stand u )

  p)

• rupture of red blood cells (hae

• problems with small blood ve

  ssels (le

  ukocytoclastic vasc

  ulitis)

• tingling or numbness

Reporting of side effects

If you get any side e side effects not liste

ffects, talk to your doct d in this leaflet. You can

or or pharmacist. This i also report side effect

ncludes any possible s directly via the Yellow

Card Scheme at: w Google Play or App

ww.mhra.gov.uk/yellow le App Store. By reporti

card or search for MHR ng side effects you can

A Yellow Card in the help provide more

information on the s

afety of this medicine.

1. 5.

   How to store Aciclovir Sterile Concentra

   te

   Keep this medicine out of the sight and rea

   ch of children.

   Do not use this medicine after the expiry da

   te which is stated on the label and carton after

   “EXP”. The expiry date refers to the last da

   y of that month.

   Storage

   Do not store above 25ºC. Do not refrigerate

   or freeze.

   Visible signs of deterioration

   Do not use this medicine if you notice visible particles in it.

   1. 6.

      Contents of the pack and other information

      What Aciclovir Sterile Concentrate contains

      • The active substance is aciclovir. Each millilitre (ml) of sterile conc 25 milligrams (mg) of aciclovir (as aciclovir sodium).

        entrate contains

      • The other ingredients are: sodium hydroxide (see section 2 “Aciclo Sterile Concentrate contains sodium”) and Water for Injections. S hydroxide and/or hydrochloric acid are used to adjust the pH of th What Aciclovir Sterile Concentrate looks like and contents of the

        vir odium e solution.

        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

Hospira UK Limited, Walton Oaks, Walton-On-The-Hill, Dorking Road, Tadworth, Surrey, KT20 7NS, UK Manufacturer

Pfizer Service Company BV, Hermeslaan 11, 1932 Zaventem, Belgium

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Belgium: Aciclovir Hospira 25 mg/ml concentraat voor oplossing voor infusie Denmark: Aciclovir Pfizer

Finland: Aciclovir Pfizer

Ireland: Aciclovir 25 mg/ml concentrate for solution for infusion Luxembourg: Aciclovir Hospira 25 mg/ml solution à diluer pour perfusion Netherlands: Aciclovir Hospira 25 mg/ml concentraat voor oplossing voor infusie Portugal: Faulviral

Sweden: Aciclovir Pfizer

United Kingdom Aciclovir 25 mg/ml concentrate for solution for infusion (Northern Ireland):

This leaflet was last revised in 09/2025

Ref: gxAC 13_0

-----------------------------------------------------------------------------------------------------------

Aciclovir 25 mg/ml

PAA239241

Package leaflet: Information for the user Aciclovir 25 mg/ml concentrat

e

for solution for infusion (Sterile Concentrate)

Aciclovir sodium Read all of this leaflet carefully before you start using this medicine because it contains importa information for you.

nt

• Keep this leaflet. You may need to read it again.

• If you have any further questions, ask your docto

  r,

  pharmacist or nurse.

• If you get any side effects, talk to your doctor, pha

  rmacist not listed

  or nurse. This includes any possible side effects in this leaflet. See section 4.

What is in this leaflet

1. 1.

   What Aciclovir Sterile Concentrate is and what it i

   s used

   for

2. What you need to know before you use Aciclovir

Sterile

Concentrate

1. 3. How to use Aciclovir Sterile Concentrate
2. 4. Possible side effects
3. 5. How to store Aciclovir Sterile Concentrate
4. 6. Contents of the pack and other information
5. 1.

   What Aciclovir Sterile Concentrate is and wh

   at it is

   used for

Aciclovir 25 mg/ml concentrate for solution for infusi contains aciclovir. This belongs to a group of medici called antivirals. It works by stopping the growth of v

on

nes

iruses.

Aciclovir Sterile Concentrate can be used in patients a working immune system to:

with

• treat recurring chicken-pox and shingles
• treat severe first cases of genital herpes

In patients with an impaired immune system (which

their bodies are less able to fight infections) to:

means

• treat primary and recurring chickenpox and shing

  les

• treat and stop cold sores and genital herpes
• prevent herpes simplex infections

It can also be used to:

• treat inflammation of the brain caused by the viru

  s

  responsible for cold sore infection and genital her

  pes

• treat herpes simplex infections in very young bab

  ies or in

  infants up to 3 months of age

• What you need to know before you use Acic Sterile Concentrate

  lovir

Do not use Aciclovir Sterile Concentrate if:

• if you are allergic (hypersensitive) to aciclovir o

  r

  valaciclovir or any of the other ingredients (list

  ed in

  section 6).

  Warnings and precautions

  Talk to your doctor, pharmacist or nurse befor Aciclovir Sterile Concentrate if:

  e using

  • if you have kidney problems
  • if you are over 65 years of age
  • your immune system is weakened

If you are not sure if the above apply to you, ta doctor, pharmacist or nurse before using Acicl

lk to your ovir Sterile

Concentrate.

Other medicines and Aciclovir Sterile Concentr

ate

Tell your doctor, pharmacist or nurse if you are recently used any other medicines. This includ obtained without a prescription, including herb

using or have es medicines al medicines.

In particular tell your doctor, pharmacist or nur taking any of the following medicines:

se if you are

• probenecid, used to treat gout
• cimetidine, used to treat stomach ulcers

• tacrolimus, cyclosporin or mycophenolat

  e mofetil, used

  to stop your body rejecting transplanted

  organs

• theophylline (a medicine used to treat so

  me breathing

  disorders)

• lithium (a medicine used for bipolar diso

  rder)

Pregnancy, breast-feeding and fertility

If you are pregnant or think you may be pregn planning to have a baby, ask your doctor or ph advice before using this medicine.

ant or are armacist for

The active substance in Aciclovir Sterile Conc pass into breast milk. If you are breast-feeding check with your doctor before you take Aciclo

entrate can , you must vir Sterile

Concentrate.

Driving and using machines

Some side effects such as feeling drowsy or s impair your ability to concentrate and react. M are not affected before you drive or operate m

leepy may ake sure you achinery.

Aciclovir Sterile Concentrate contains sodium

This medicine contains 26.7 mg sodium (main of cooking/table salt) in each vial of 10 ml solu equivalent to 1.34% of the recommended max dietary intake of sodium for an adult.

component tion. This is imum daily

This medicine contains 53.4 mg sodium (main of cooking/table salt) in each vial of 20 ml solu equivalent to 2.67% of the recommended max dietary intake of sodium for an adult.

component tion. This is imum daily

This medicine contains 106.8 mg sodium (mai of cooking/table salt) in each vial of 40 ml solu equivalent to 5.34% of the recommended max dietary intake of sodium for an adult.

n component tion. This is imum daily

3. How to take Aciclovir Sterile Concentra

te

How your medicine is given

You will never be expected to give yourself thi

s medicine. It

will always be given to you by a person who is

trained to do

so.

Aciclovir Sterile Concentrate will be given to y

ou as

a continuous infusion into your vein. This is w

here the drug

is slowly given to you over a period of time. Yo

u may be

given fluids to ensure you do not become deh

ydrated.

The dose you will be given, the frequen of the dose will depend on:

• itchy, bumpy, hive-like rash cy and the duration

  tired due to anaemia, and gi problems if you have a com

  ve you bruising and kidney promised immune system

• the type of infection you have

  Other side effects include:

• your weight and body size

  Common (may affect up to 1 in 10

  people)

• your age.

• inflammation along the vein

  used for the infusion

Your doctor may adjust the dose of Acic Concentrate if:

lovir Sterile

• feeling or being sick
• you have kidney problems.

• skin reaction after exposure

  to light (photosensitivity)

• itching

People over 65 years of age or with kidn

ey problems:

• swelling, redness and tende

  rness at the site of infusion zymes which may be st

It is very important while you are tak Sterile Concentrate that you drink w

ing Aciclovir ater regularly

• increases in liver related en

  detected through a blood te

during the day. This will help to reduce s can affect the kidney or nervous system closely monitor you for signs of these. N effects might include feeling confused o unusually sleepy or drowsy.

ide effects that

• increases in blood urea and

  creatinine which may be st

. Your doctor will ervous system side r agitated, or feeling

detected through a blood te

Uncommon (may affect up to 1 in

100 people)

• nosebleeds and bruising mo

  re easily than usual as od platelets

  a result of a decrease in blo

If you are given more Aciclovir Sterile Conce

ntrate than you should

• decreased energy, weaknes

  s, shortness of breath,

If you think you have been given too mu Concentrate, talk to your doctor or nurs If you have been given more aciclovir tha

ch Aciclovir Sterile e straight away.

light-headedness, palpitatio

ns, looking pale (anaemia) f white blood cells found may leave a patient more

• a decrease in the number o

n you should you may:

in blood (leukopenia). This prone to infection

• feel confused or agitated

• have hallucinations (seeing or hea

  ring things that

  • reduced numbers of blood p

    latelets

aren’t there)

(thrombocytopenia)

• have fits

  Very rare (may affect up to 1 in 10

  ,000 people)

• become unconscious (coma).

  • sweating

4. Possible side effects

• headache
• feeling dizzy

Like all medicines, this medicine can ca although not everybody gets them.

use side effects,

• abdominal pain
• diarrhoea or stomach pains

The following side effects may happen

with this medicine:

• feeling very tired (fatigue)
• fever

Allergic reactions (may affect up to 1 If you have an allergic reaction, stop Sterile Concentration and see a doct

in 10,000 people) taking Aciclovir or straight away.

• inflammation at the injection

  site

• feeling agitated or confused

  (psychosis

  )

• shaking or tremors

The signs may include:

• hallucinations (seeing or he

  aring things that aren’t

• bumpy rash, itching or hives on yo

  ur skin

  there)

• swelling of your face, lips, tongue

  or other parts of your

• fits (seizures)

body (angioedema)

• feeling unusually sleepy or

  drowsy

• shortness of breath, wheezing or t

  rouble breathing

• unsteadiness when walking

  and lack of coordination

If any of the following happen, tell yo immediately (may affect up to 1 in 10

ur doctor

(ataxia)

,000 people):

• difficulty speaking or hoarse

  ness (dysarthria)

• unexplained fever and feeling faint,

  especially when

• inability to think or judge cle

  arly or concentrate

standing up

• unconsciousness (coma)

• changes in your blood cells e.g. a

  naemia and/or owered platelet sing). Your doctor r for these

• difficulty breathing

reduced white blood cells and/or l levels (leading to unexplained brui may take blood samples to monito

• disturbances of behaviour a

  nd speech and bodily

  movements

• inflammation of the liver (he

  patitis)

• a severe form of rash with itchy pi

  nk-red blotches, orme)

• yellowing of your skin and w

  hites of your eyes (jaundice) here you pass little or no

which may blister (erythema multif

• kidney problems or failure w

• a rare disorder of the blood clottin

  which is evident by an altere g system called ura, which may ucinations and also ve a compromised

  urine (including blood in urin the kidney area of your bac (renal pain)

  e), pain in your lower back, k or just above your hip

  thrombotic thrombocytopenic purp give you bruising, headaches, hall blood clots in the kidneys if you ha immune system

• damage or malfunction of th

  e brain (encephalopathy) d mental state

• a severe form of anaemia called h

  aemolytic uraemic ook pale and feel

  syndrome, which may make you l

  The following information is healthcare professionals on

  intended for medical or ly:

  Please refer to the Summar (SPC) for complete prescrib

  y of Product Characteristics ing information.

  Further to the information in information on the preparat product is provided here.

  cluded in section 3, practical ion/handling of the medicinal

  Incompatibilities

  Aciclovir sodium is reported solutions of amifostine, ams hydrochloride, dobutamine hydrochloride, fludarabine p idarubicin hydrochloride, m ondansetron hydrochloride, piperacillin sodium - tazoba vinorelbine tartrate.

  to be incompatible with acrine, aztreonam, diltiazem hydrochloride, dopamine hosphate, foscarnet sodium, eropenem, morphine sulphate, pethidine hydrochloride, ctam sodium, sargramostim and

  Do not use bacteriostatic w parabens or benzyl alcohol

  ater for injection containing .

  Biologic or colloidal fluids (e containing solutions) are inc

  .g. blood products, protein ompatible with aciclovir sodium.

  Instructions for use and han

  dling

  For intraveno

  us infusion on

  ly

  Aciclovir 25 m contains no p

  g/ml Concent reservative. D

  rate for Solution for Infusion ilution should therefore be ore use under full aseptic solution should be discarded.

  carried out im conditions an

  mediately bef d any unused

  Refrigeration

  is not recomm

  ended as precipitation may occur.

  For adults, it i

  s recommend

  ed tha

  t infusion bags con

  taining

  100 ml of infusio

  n fluid are

  used, even when this wo

  uld give an aciclovir con

  centration s

  ubstantially below 0.5%

  w/v. Thus one 100 ml infu

  sion bag ma

  y be used for any dose b

  etween

  250 mg and 500

  mg aciclov

  ir but a second bag must

  be used for doses betwe

  en 500 and

  1000 mg. Aciclovir 25 mg/ml

  Concentrate for solution for

  Infusion should not be diluted to a concentration greater t

  han 5 mg/ml (0.5%w/v) for administration by infusion. A

  fter addition of Aciclovir 25 mg/ml

  Concentrate for solution for

  Infusion to an infusion solution the mixture should be shak

  en to ensure thorough mixing.

  For children and neonates, volume of infusion fluid to a that dilution is on the basis o added to 20 ml of infusion fl

  where it is advisable to keep the minimum, it is recommended f 4 ml of solution (100 mg aciclovir) uid.

  When diluted in accordance schedules, Aciclovir 25 mg/ Infusion is known to be com listed below:

  with the recommended ml Concentrate for Solution for patible with the infusion fluids

  • Sodium Chloride Intrave

    nous 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 Lact

    ate Intravenous Infusion

    (Hartmann’s Solution)

    Aciclovir 25mg/ml Co contains no preserva

    ncentrate for Solution for Infusion tive.

    Should any visible tur solution before or dur discarded.

    bidity or crystallisation appear in the ing infusion, the preparation should be

Not known (frequency cannot be estimated from the available data)

• thirst

• low blood pressure (you may feel dizzy when you

  stand up)

• rupture of red blood cells (haemolysis)

• problems with small blood vessels (leukocytoc

  lastic

  vasculitis)

• tingling or numbness

Reporting of side effects

If you get any side effects, talk to your doctor or pha This includes any possible side effects not listed in t leaflet. You can also report side effects directly via t Yellow Card Scheme at: www.mhra.gov.uk/yellowca search for MHRA Yellow Card in the Google Play or App Store. By reporting side effects you can help pr more information on the safety of this medicine.

rmacist. his

he

rd or

Apple ovide

5. How to store Aciclovir Sterile Concentrate

Keep this medicine out of the sight and reach of chil

dren.

Do not use this medicine after the expiry date which on the label and carton after “EXP”. The expiry date the last day of that month.

is stated refers to

Storage

Do not store above 25ºC. Do not refrigerate or freez

e.

Visible signs of deterioration

Do not use this medicine if you notice visible particle

s in it.

6. Contents of the pack and other information

What Aciclovir Sterile Concentrate contains

• The active substance is aciclovir. Each millilitr

  e (ml)

  of sterile concentrate contains 25 milligrams ( aciclovir (as aciclovir sodium).

  mg) of

• The other ingredients are: sodium hydroxide (s

  ee

  section 2 “Aciclovir Sterile Concentrate contains and Water for Injections. Sodium hydroxide an hydrochloric acid are used to adjust the pH of the

  sodium”) d/or

  solution.

What Aciclovir Sterile Concentrate looks like and con the pack

tents of

Aciclovir Sterile Concentrate is a concentrate for sol

ution for

infusion (sterile concentrate). This means it is a conc solution, which is diluted then given as an infusion (d comes in glass containers called vials.

entrated rip). It

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

Hospira UK Limited, Walton Oaks, Walton-On-The-

Hill,

Dorking Road, Tadworth, Surrey, KT20 7NS, UK

Manufacturer

Pfizer Service Company BV, Hermeslaan 11, 1932 Zaventem, Belgium

This medicine is authorised in the Member Sta European Economic Area and in the United Ki (Northern Ireland) under the following names:

tes of the

ngdom

Belgium: Aciclovir Hospira 25 mg/m

l concentraat e

voor oplossing voor infusi Denmark: Aciclovir Pfizer Finland: Aciclovir Pfizer Ireland: Aciclovir 25 mg/ml conce

ntrate for

solution for infusion Luxembourg: Aciclovir Hospira 25 mg/m

l solution à

diluer pour perfusion Netherlands: Aciclovir Hospira 25 mg/m

l concentraat e

voor oplossing voor infusi Portugal: Faulviral

Sweden: Aciclovir Pfizer United Kingdom Aciclovir 25 mg/ml conce (Northern Ireland): solution for infusion

ntrate for

This leaflet was last revised in 09/2025

Ref: gxAC 13_0

Aciclovir 25 mg/ml concentrate for solution for infusion (Sterile Concentrate) Aciclovir sodium

PAA239210