Aciclovir accord

Package leaflet: Information for the patient

Aciclovir Accord, 25 mg/ml, concentrate for solution for infusion
Aciclovirum
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm others, even if their symptoms are the same.
• If any adverse reactions occur in the patient, including any adverse reactions not listed in this leaflet, inform the doctor or nurse immediately. See section 4.

Table of contents of the leaflet

1. What Aciclovir Accord is and what it is used for
2. Important information before using Aciclovir Accord
3. How to use Aciclovir Accord
4. Possible side effects
5. How to store Aciclovir Accord
6. Contents of the pack and other information

1. What Aciclovir Accord is and what it is used for

Aciclovir Accord contains the active substance called aciclovir. It belongs to a group of medicines known as antiviral agents and prevents the multiplication of viruses.
Aciclovir Accord may be used for:

• treatment and prevention of herpes simplex virus infections. Aciclovir Accord is mainly used in patients with weakened immunity due to bone marrow transplantation or treatment of acute leukaemia;
• treatment of shingles in patients with weakened immunity and treatment of severe shingles in patients with normal immunity, caused by varicella-zoster virus (Varicella zoster);
• treatment of severe genital herpes infections;
• treatment of herpes encephalitis;
• treatment of herpes virus infection in newborns.

2. Important information before using Aciclovir Accord

When not to use Aciclovir Accord:

• if the patient is allergic to aciclovir or to any of the other ingredients of this medicine (listed in section 6).

Do not use Aciclovir Accord if any of the above applies to the patient. If in doubt, talk to a doctor or pharmacist before using Aciclovir Accord.

Warnings and precautions

Talk to your doctor or pharmacist before starting Aciclovir Accord if:

• the patient has impaired kidney function,
• the patient is aged over 65 years.

If it is not known whether any of the above apply to the patient, speak to a doctor or pharmacist before using Aciclovir Accord. It is important to drink plenty of water while taking aciclovir.

Aciclovir Accord and other medicines

Tell your doctor about all medicines the patient is currently taking, has recently taken, or plans to take, including over-the-counter medicines and herbal remedies.

In particular, inform your doctor or pharmacist if the patient is taking any of the following medicines:

• probenecid, used in the treatment of gout;
• cimetidine, used in the treatment of stomach ulcers;
• tacrolimus, cyclosporine, or mycophenolate mofetil, used to prevent rejection of transplanted organs;
• lithium;
• theophylline.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or is planning to have a baby, she should consult a doctor or pharmacist before using this medicine.

Driving and using machines

Aciclovir Accord is usually administered to hospitalised patients. Therefore, information regarding driving and operating machinery does not apply.

Aciclovir Accord contains sodium

This medicine contains:

• 26.7 mg of sodium (the main component of table salt) in each 10 ml vial. This corresponds to 1.41% of the maximum recommended daily dietary intake of sodium for adults.
• 53.4 mg of sodium (the main component of table salt) in each 20 ml vial. This corresponds to 2.82% of the maximum recommended daily dietary intake of sodium for adults.
• 106.8 mg of sodium (the main component of table salt) in each 40 ml vial. This corresponds to 5.65% of the maximum recommended daily dietary intake of sodium for adults.

3. How to use Aciclovir Accord

Method of administration
The patient will never administer this medicine to themselves. It is always administered to the patient by a person appropriately trained for this purpose.
Before administration, this medicine will be diluted.
Aciclovir Accord is administered as a continuous intravenous infusion. The medicine is given slowly over a certain period of time.
The dose administered, frequency of administration, and duration of treatment will depend on:

• the type of infection the patient has,
• the patient's body weight,
• the patient's age.

The usual dose of Aciclovir Accord in adults is 5 mg/kg or 10 mg/kg administered every 8 hours.
In children aged 3 months to 12 years, the doctor will calculate the dose based on body surface area.
For the treatment of herpes simplex infection in newborns, the recommended dose is 20 mg/kg administered every 8 hours for 14–21 days.
In elderly patients with impaired kidney function, the doctor may reduce the dose by decreasing the frequency of infusions.
The doctor may adjust the dose of Aciclovir Accord if:

• the patient has impaired kidney function. If the patient has impaired kidney function, it is important to drink plenty of fluids during treatment with Aciclovir Accord. If this applies to the patient, consult a doctor before administering Aciclovir Accord.

Administration of a higher than recommended dose of Aciclovir Accord
If it is suspected that the patient has received an overdose of Aciclovir Accord, inform the doctor or nurse immediately.
If the patient has received an overdose of Aciclovir Accord, they may:

• experience confusion or agitation;
• have hallucinations (see or hear things that are not real);
• have seizures;
• lose consciousness (coma).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The following side effects may occur with this medicine:
Allergic reactions (in up to 1 in 10,000 people)
If a patient experiences an allergic reaction, treatment with Aciclovir Accord must be stopped immediately and the patient should seek medical advice without delay.
Symptoms may include:

• rash, itching or hives on the skin;
• swelling of the face, lips, tongue or other parts of the body;
• shortness of breath, wheezing or difficulty breathing;
• fever (high body temperature) of unknown cause and feeling faint, especially when standing.

Other possible side effects include:
Common (affects up to 1 in 10 people)

• nausea or vomiting;
• itchy rash resembling hives;
• skin reaction following exposure to light (photosensitivity);
• itching;
• swelling, redness and tenderness at the injection site;
• increased liver enzyme activity.

Uncommon (affects up to 1 in 100 people)

• reduced number of red blood cells (anaemia);
• reduced number of white blood cells (leukopenia);
• reduced number of platelets (cells that help blood to clot; thrombocytopenia).

Very rare (affects up to 1 in 10,000 people)

• headache or dizziness;
• diarrhoea or abdominal pain;
• feeling tired;
• fever;
• effects on certain blood and urine test results;
• weakness;
• agitation or confusion;
• chills or shivering;
• hallucinations (seeing or hearing things that are not real);
• seizures;
• unusual drowsiness;
• loss of balance while walking and lack of coordination;
• difficulty speaking;
• inability to think logically or assess situations;
• loss of consciousness (coma);
• weakness or paralysis of part or all of the body;
• disturbances in behaviour, speech or eye movement;
• neck stiffness and sensitivity to light;
• hepatitis (liver inflammation);
• yellowing of the skin and whites of the eyes (jaundice);
• kidney problems associated with passing little or no urine;
• pain in the lower back, kidney area or over the hip (kidney pain).

Reporting of side effects
If you experience any side effects, including any not listed in this leaflet, tell your doctor or nurse.
Side effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the Marketing Authorisation Holder. Reporting side effects helps provide more information on the safety of this medicine.

5. How to store Aciclovir Accord

Keep this medicine out of the sight and reach of children.
Store below 25°C.
Do not use this medicine after the expiry date stated on the label and carton after: EXP.
The expiry date refers to the last day of the stated month.
Discard any unused solution.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Aciclovir Accord contains

• The active substance is aciclovir.

Each ml of concentrate contains 25 mg of aciclovir as aciclovir sodium salt.
Each 10 ml vial of concentrate contains 250 mg of aciclovir as aciclovir sodium salt.
Each 20 ml vial of concentrate contains 500 mg of aciclovir as aciclovir sodium salt.
Each 40 ml vial of concentrate contains 1 g of aciclovir as aciclovir sodium salt.

• The other components are sodium hydroxide and/or hydrochloric acid, concentrated; water for injections. Sodium hydroxide and/or hydrochloric acid are used to adjust the pH of the solution.

What Aciclovir Accord looks like and contents of the pack
This medicine is a concentrate for solution for infusion. It is supplied as a clear, colourless or almost colourless solution in a glass vial. It is a concentrated solution which must be diluted before being administered by infusion (intravenous drip).
The pH value is 10.7–11.7.
Vials made of colourless glass type I with a capacity of 10 ml, 20 ml or 50 ml (with fill volumes of 10 ml, 20 ml and 40 ml, respectively), closed with a rubber stopper and an aluminium flip-off seal.
Pack sizes: 1, 5 or 10 vials.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Accord Healthcare Polska Sp. z o.o.
ul. Taśmowa 7
02-677 Warsaw
Poland
Manufacturer/Importer
LABORATORI FUNDACIÓ DAU
C/ C, 12-14 Pol. Ind. Zona Franca,
08040 Barcelona
Spain
Accord Healthcare Polska Sp. z o.o.
ul. Lutomierska 50
95-200 Pabianice
Poland
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000, Malta
This medicinal product is authorised for marketing in the European Economic Area countries under the following names:

Information intended exclusively for medical professionals

For single use only. Any unused portion of the solution must be discarded. Any unused medicinal product or waste material should be disposed of in accordance with local regulations.

Based on the calculated dose, determine the appropriate number and size of vials required.

Administration method

The required dose of aciclovir should be administered as a slow intravenous infusion lasting at least one hour.

Aciclovir Accord may be administered using an infusion pump with controlled infusion rate. Additionally, Aciclovir Accord may be further diluted so that the concentration of aciclovir in the intravenous infusion does not exceed 5 mg/ml (0.5% w/v).

Add the required volume of Aciclovir Accord to the selected infusion solution according to the recommendations below and shake vigorously to ensure complete mixing.

In children and neonates, when minimal infusion volume is indicated, it is recommended to perform dilution such that 4 ml of solution (100 mg aciclovir) is added to 20 ml of infusion solution.

In adults, infusion bags containing 100 ml of infusion solution are recommended, even if this results in an aciclovir concentration considerably below 5 mg/ml (0.5% w/v). Thus, one 100 ml infusion bag may be used for any dose between 250 mg and 500 mg aciclovir (10 ml to 20 ml of solution), whereas a second bag must be used for doses from 500 mg to 1000 mg.

After dilution according to the recommended regimen, aciclovir is pharmaceutically compatible with the following infusion solutions and remains stable for up to 24 hours at room temperature (below 25°C):

• Sodium chloride 0.45% w/v and 0.9% w/v infusion solution
• Sodium chloride 0.18% w/v and glucose 4% w/v infusion solution
• Sodium chloride 0.45% w/v and glucose 2.5% w/v infusion solution
• Multicomponent sodium lactate infusion solution (Hartmann's solution)

Dilution according to the above regimen ensures an aciclovir concentration not exceeding 5 mg/ml (0.5% w/v).

Due to the absence of antimicrobial preservatives, the medicinal product should be diluted under aseptic conditions immediately before use, and any unused solution must be discarded.

If cloudiness or crystallization occurs before or during infusion, the solution must be discarded.

Compatibility has been demonstrated with polypropylene (PP) syringes, non-polyvinyl chloride (PVC) intravenous administration sets, and non-polyvinyl chloride (PVC) infusion bags.