Aciclovir Azevedos 250 mg Powder for solution for infusion

Main information

  • Trade name:
  • Aciclovir Azevedos 250 mg Powder for solution for infusion
  • Dosage:
  • 250 milligram(s)
  • Pharmaceutical form:
  • Powder for solution for infusion
  • Prescription type:
  • Product subject to prescription which may not be renewed (A)
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Aciclovir Azevedos 250 mg Powder for solution for infusion
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic area:
  • Nucleosides and nucleotides excl. reverse transcriptase inhibitors; aciclovir

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization status:
  • Authorised
  • Authorization number:
  • PA1852/003/001
  • Authorization date:
  • 06-10-2017
  • Last update:
  • 21-02-2019

Patient Information leaflet: composition, indications, side effects, dosage, interactions, adverse reactions, pregnancy, lactation

Room temperature

Refrigerator

(15ºC – 25ºC)

(2ºC – 8ºC)

Sodium Chloride Intravenous Infusion (0.9% w/v)

24 hours

24 hours

Sodium Chloride (0.18% w/v) and Glucose

12 hours

Do not refrigerate

(4% w/v) Intravenous Infusion

or freeze

Sodium Chloride (0.45% w/v) and Glucose

(2.5% w/v) Intravenous Infusion

24 hours

8 hours

Compound Sodium Lactate Intravenous Infusion

Do not store

12 hours

(Hartmann's Solution) – after reconstituted with

below 25ºC

purified water

Compound Sodium Lactate Intravenous Infusion

Do not store

8 hours

(Hartmann's Solution) - after reconstituted with

below 25ºC

Sodium Chloride (0.9% w/v)

1. What Aciclovir is and what it is

used for

Aciclovir 250 mg powder for solution for

infusion contains a medicine called aciclovir.

This belongs to a group of medicines called

antivirals. It works by killing or stopping the

growth of viruses.

Aciclovir can be used to:

treat recurrent chickenpox and shingles in

people whose immune system works well

treat primary and recurrent chickenpox

and shingles in people whose immune

systems work less well, which means

their bodies are less able to fight

infections

treat severe cases of genital herpes

treat and stop cold sores and genital

herpes in people whose immune systems

work less well, which means their bodies

are less able to fight infections

treat serious virus infections in children up

to 3 months of age. This can rarely be

caused by the virus responsible for cold

sore infection and genital herpes

treat inflammation of the brain. This can

rarely be caused by the virus responsible

for cold sore infection and genital herpes.

2. What you need to know before

you are given Aciclovir

Do not use Aciclovir

if you are allergic to aciclovir or

valaciclovir or any of the other ingredients

of this medicine (listed in Section 6).

Warnings and precautions

Talk to your doctor or pharmacist before

taking Aciclovir if:

you have kidney problems

you are over 65 years of age

your immune system is weak.

If you are not sure if the above apply to you,

talk to your doctor or pharmacist before

taking Aciclovir. It is important that you drink

plenty of water while taking Aciclovir.

Other medicines and Aciclovir

Tell your doctor or pharmacist if you are

taking, have recently taken or might take

any other medicines. This includes

medicines obtained without a prescription,

including herbal medicines.

In particular tell your doctor or pharmacist if

you are taking any of the following medicines:

probenecid, used to treat gout

cimetidine, used to treat stomach ulcers

tacrolimus, ciclosporin or mycophenolate

mofetil, used to stop your body rejecting

transplanted organs

lithium, used in the treatment of manic-

depressive disorders

theophylline, used in the treatment of

certain respiratory diseases.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think

you may be pregnant or are planning to

have a baby, ask your doctor or pharmacist

for advice before taking this medicine.

Driving and using machines

Side effects such as feeling drowsy or sleepy

may impair your ability to concentrate and

react. Make sure you are not affected

before you drive or operate machinery.

Aciclovir contains sodium

This medicine contains less than 1 mmol

sodium (23 mg) per dose, i.e. essentially

“sodium-free”.

3. How to use Aciclovir

You will never be expected to give yourself

this medicine. It will always be given to you

by a person who is trained to do so.

Before the medicine is given to you it will be

diluted.

Aciclovir will be given to you as a continuous

infusion into your vein. This is where the

drug is slowly given to you over a period of

time.

The dose you will be given, the frequency

and the duration of the dose will depend on:

the type of infection you have

your weight

your age.

Your doctor may adjust the dose of Aciclovir

if you have kidney problems.

For people over 65 years of age or with

kidney problems, it is important you receive

plenty of fluids while you are being treated

with Aciclovir. This will help to reduce side

effects that can affect the kidneys or nervous

system. Your doctor will closely monitor you

for signs of these. Nervous system side

effects might include feeling confused or

agitated, or feeling unusually sleepy or

drowsy. Talk to your doctor before having

Aciclovir if any of the above applies.

If you are given too much Aciclovir

If you think you have been given too much

Aciclovir, talk to your doctor or nurse straight

away.

If you have been given too much Aciclovir

you may:

feel confused or agitated

have hallucinations (seeing or hearing

things that aren’t there)

have fits

become unconscious (coma).

PACKAGE LEAFLET: INFORMATION FOR THE USER

Aciclovir 250 mg

powder for solution for infusion

Aciclovir sodium

Read all of this leaflet carefully before you are given 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:

What Aciclovir is and what it is used for

What you need to know before you are given Aciclovir

How to use Aciclovir

Possible side effects

How to store Aciclovir

Contents of the pack and other information

4. Possible side effects

Like all medicines, this medicine can cause

side effects, although not everybody gets

them. 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 and see a doctor straight away.

The signs may include:

rash, itching or hives on your skin

swelling of your face, lips, tongue or other

parts of your body

shortness of breath, wheezing or trouble

breathing

unexplained fever (high temperature) and

feeling faint, especially when standing up.

Other side effects include:

Common (may affect up to 1 in 10 people)

feeling or being sick

itchy, hive-like rash

skin reaction after exposure to light

(photosensitivity)

itching

swelling, redness and tenderness at the

site of injection

increase in liver enzymes

increases in blood urea and creatinine

(that can determine kidney function, which

may be detected through a blood test).

Uncommon (may affect up to 1 in 100

people)

reduced numbers of red blood cells

(anaemia)

reduced numbers of white blood cells

(leukopenia)

reduced numbers of blood platelets (cells

that help the blood to clot)

(thrombocytopenia).

Very rare (may affect up to 1 in 10,000

people)

headache or feeling dizzy

diarrhoea or stomach pains

feeling tired

fever

effects on some blood urine tests

feeling weak

feeling agitated or confused

shaking or tremors

hallucinations (seeing or hearing things

that aren’t there)

fits

feeling unusually sleepy or drowsy

unsteadiness when walking and lack of

coordination

difficulty speaking

inability to think or judge clearly

unconsciousness (coma)

paralysis of part or all of your body

disturbances of behaviour, speech and

eye movements

stiff neck and sensitivity to light

inflammation of the liver (hepatitis)

yellowing of your skin and whites of your

eyes (jaundice)

kidney problems where you pass little or

no urine

pain in your lower back, the kidney area

of your back or just above your hip (renal

pain)

damage or malfunction of the brain

(encephalopathy) which is evident by an

altered mental state.

Reporting of side effects

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

pharmacist or nurse. This includes any

possible side effects not listed in this leaflet.

You can also report side effects directly via:

UK: the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard.

Ireland: HPRA Pharmacovigilance, Earlsfort

Terrace, IRL - Dublin 2; Tel: +353 1 6764971;

Fax: +353 1 6762517. Website: www.hpra.ie;

E-mail: medsafety@hpra.ie.

By reporting side effects you can help

provide more information on the safety of

this medicine.

5. How to store Aciclovir

Keep this medicine out of the sight and

reach of children.

Store in the original package.

For reconstituted solutions, chemical and

physical in-use stability has been

demonstrated for 12 hours at 25°C or in a

refrigerator (2ºC – 8ºC).

From a microbiological point of view, once

opened, the product should be used

immediately. If not used immediately, in-use

storage times and conditions prior to use

are the responsibility of the user and would

normally not be longer than 12 hours at

2-8°C, unless reconstitution has taken place

in controlled and validated aseptic conditions.

When diluted in accordance with the

recommended schedules, Aciclovir is known

to be compatible with the following infusion

fluids (see table below).

Do not use this medicine after the expiry

date which is stated on the carton after Exp.

The expiry date refers to the last day of that

month.

Do not throw away any medicines via

wastewater or household waste. Ask your

pharmacist how to throw away medicines

you no longer use. These measures will help

protect the environment.

6. Contents of the pack and other

information

What Aciclovir contains

The active substance is aciclovir. Each vial

contains 250 mg of aciclovir (as aciclovir

sodium). The other ingredient is sodium

hydroxide.

What Aciclovir looks like and contents of

the pack

Aciclovir is available in vials containing a

white powder, sealed with a stopper made

of bromobutyl rubber, a cap made of

aluminium and a plastic polypropylene lid.

Aciclovir is available in packs containing 1, 5

or 10 units.

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Laboratórios Azevedos –

Indústria Farmacêutica, S.A.

Estrada Nacional 117-2,

Alfragide

2614-503 Amadora,

Portugal

Manufacturer

Sofarimex –

Indústria Química e Farmacêutica, S.A.

Av. das Indústrias,

Alto do Colaride

2735-213 Cacém,

Portugal

This leaflet was last revised in 08/2017.

article code here 000000.00

For single use only.

Prepare immediately prior to use.

Reconstitution

Aciclovir should be reconstituted using the

following volumes of either Water for Injections or

Sodium Chloride Intravenous Injection (0.9% w/v)

to provide a solution containing 25 mg Aciclovir

per ml:

Volume of fluid

Volume following

for reconstitution

reconstitution

250 mg vial 10 ml

10.1 – 10.2 ml

From the calculated dose, determine the

appropriate number and strength of vials to be

used.

To reconstitute each vial add the recommended

volume of infusion fluid and shake gently until the

contents of the vial have dissolved completely.

The solution reconstituted with Water for

Injections or sodium chloride intravenous

injection (0.9% w/v) is stable for a period of 12

hours at temperature below 25ºC or in a

refrigerator (2ºC – 8ºC).

Administration

The required dose of Aciclovir should be

administered by slow intravenous infusion over a

one-hour period.

After reconstitution, Aciclovir may be

administered by a controlled-rate infusion pump.

Alternatively, the reconstituted solution may be

further diluted to give an aciclovir concentration

of not greater than 5 mg/ml (0.5% w/v) for

administration by infusion.

Add the required volume of reconstituted solution

to the chosen infusion solution, as recommended

below, and shake well to ensure adequate

mixing occurs.

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 reconstituted solution (100 mg

aciclovir) added to 20 ml of infusion fluid.

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 and 500 mg aciclovir (10 ml of reconstituted

solution) but a second bag must be used for

doses between 500 mg and 1000 mg.

Aciclovir when diluted in accordance with the

above schedule will give an aciclovir

concentration not greater than 0.5% w/v.

Since no antimicrobial preservative is included,

reconstitution and dilution must be carried out

under full aseptic conditions, immediately before

use, and any unused solution discarded.

Should any visible turbidity or crystallisation

appear in the solution before or during infusion,

the preparation should be discarded.

Discard any unused solution. Any unused

medicinal product or waste material should be

disposed of in accordance with local requirements.

The following information is intended for healthcare professionals only

When diluted in accordance with the recommended schedules, Aciclovir is known to be compatible

with the following infusion fluids:

AZEVENDOS Aciclovir 250 mg PIL

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