Acix 500

Leaflet attached to the packaging: patient information

ACIX 500, 500 mg, powder for solution for infusion

Aciclovir

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, nurse, or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, tell your doctor, nurse, or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is ACIX and what is it used for

The powder for solution for infusion ACIX contains the active substance acyclovir - a synthetic antiviral drug that inhibits the multiplication of herpes viruses, including Herpes simplex(HSV) type 1 and 2, Varicella-zoster(VZV), Epstein-Barr virus (EBV), and cytomegalovirus (CMV).
Indications for use of ACIX
Herpes simplex encephalitis.
Severe primary genital herpes infections (Herpes simplex).
Chickenpox, shingles (infections with Varicella-zostervirus)
Skin and mucous membrane infections caused by herpes virus in people with congenital immunodeficiency or secondary immunodeficiency during immunosuppressive or cytostatic treatment.
Prevention of herpes simplex virus infections in people with reduced immunity, e.g. during intensive immunosuppressive treatment.
Herpes infection in newborns.

2. Important information before using ACIX

When not to use ACIX

If the patient is allergic to acyclovir, valacyclovir, or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Before starting treatment with ACIX, discuss it with your doctor.
The patient should drink plenty of fluids to maintain proper hydration.
In patients with renal impairment and in elderly patients, dose modification may be necessary due to the possibility of acyclovir accumulation in the body.
In patients receiving high doses of acyclovir intravenously, the doctor will recommend monitoring of renal function, especially in dehydrated patients or those with renal impairment.
Prolonged or repeated use of acyclovir in patients with significantly reduced immunity may lead to the selection of virus strains resistant to the drug.
The prepared solution should not be taken orally due to its highly alkaline pH (around 11.0).

ACIX and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to use.
Acylovir is excreted by the kidneys. If the patient receives acyclovir intravenously along with medicines that are excreted in the same way, the serum concentration of one or both of these medicines may increase. The doctor will closely monitor the patient's condition.
Probenecid and cimetidine reduce the excretion of acyclovir by the kidneys, but changing its dosage is not necessary.
During concomitant administration of acyclovir and mycophenolate mofetil (a medicine used to prevent transplant rejection), the total effect of these medicines on the patient's body increases.
Intravenous acyclovir in high doses may increase the toxicity of concomitantly used lithium.
During intravenous administration of acyclovir and concomitant use of medicines affecting renal function (such as cyclosporine and tacrolimus), caution is necessary. The doctor will recommend monitoring of renal function in the patient.
During concomitant use of acyclovir and theophylline, the doctor will monitor the theophylline concentration in the patient's blood.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before using this medicine.
The medicine can be used during pregnancy only if, in the doctor's opinion, the expected benefits of using acyclovir outweigh the risks to the fetus.
Acylovir passes into breast milk.
Caution is recommended when using acyclovir in breastfeeding women.

Driving and operating machinery

Acylovir in the form of intravenous infusions is usually administered to hospitalized patients, so information on the effect of the product on the ability to drive and operate machinery is not typically applicable. Additionally, there are no studies that would assess the impact of acyclovir on these activities.

ACIX contains sodium

The medicine contains 48.8 mg of sodium (the main component of common salt) in each vial, which corresponds to 2.4% of the maximum recommended daily sodium intake in the diet for adults.
The medicine can be diluted in a 0.9% NaCl solution. The sodium content from the diluent should be taken into account when calculating the total sodium content in the prepared dilution of the medicine. For accurate information on the sodium content in the solution used to dilute the medicine, refer to the patient information leaflet of the diluent used.

3. How to use ACIX

This medicine should always be used as directed by your doctor. If you are unsure, consult your doctor.
The dose of acyclovir per kilogram of body weight is the same for all patients.
The dose of acyclovir for children aged 3 months to 12 years is calculated based on body surface area to avoid underdosing.
In patients with normal renal function, the medicine is administered three times a day, every 8 hours.
The recommended dosing is presented below.
Table 1. Adults, children over 12 years, infants under 3 months, and newborns
a) Patients with normal immunity

b) Patients with reduced immunity

* In individual cases, depending on the type and duration of the disease, the medicine may be administered for a longer period.
Table 2. Children aged 3 months to 12 years
a) Patients with normal immunity

b) Patients with reduced immunity

* In individual cases, depending on the type and duration of the disease, the medicine may be administered for a longer period.
Dosing in patients with renal impairment
The dose of acyclovir depends on the degree of renal impairment. Proper hydration of the patient is essential.
Table 3.
Dosing in adults and adolescents with renal impairment

Table 4.
Dosing in infants and children with renal impairment

Dosing in elderly patients
Since renal impairment is more likely to occur in elderly patients, close monitoring of renal function is recommended. If necessary, the dose of ACIX should be modified according to Table 3.
When using high doses of acyclovir (e.g. during treatment of herpes simplex encephalitis), renal function should be monitored, especially in patients with renal impairment and those taking small amounts of fluids.
Method of preparing the infusion solution and method of administration -see "Information intended exclusively for healthcare professionals".

Using a higher dose of ACIX than recommended

Overdose of intravenous acyclovir causes increased serum creatinine, blood urea nitrogen, and subsequent renal failure. It has also been reported to cause symptoms from the nervous system, such as disorientation, hallucinations, agitation, seizures, coma.
Hemodialysis significantly removes acyclovir from the blood and may be considered as a treatment method in case of overdose.

Missing a dose of ACIX

Do not take a double dose to make up for a missed dose.
If you have any further questions about using this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The frequency of the side effects listed is approximate, as in most cases exact data are not available. Moreover, the frequency of side effects may vary depending on the indication.
Common side effects (may occur in less than 1 in 10 people):
phlebitis, nausea and vomiting, itching, rash, urticaria, photosensitivity, transient elevation of liver enzymes in the blood, increased urea and creatinine levels in the serum (rapid increase in urea and creatinine levels in the blood may be related to the maximum concentration of the medicine in the plasma and the patient's hydration status, therefore the medicine should not be administered by intravenous injection, but by slow intravenous infusion over at least 60 minutes).
Uncommon side effects (may occur in less than 1 in 100 people):
anemia (reduced red blood cell count), thrombocytopenia (reduced platelet count), leukopenia (reduced white blood cell count).
Rare side effects (may occur in less than 1 in 10,000 people):
anaphylactic reactions (severe allergic reactions), headache, dizziness, agitation, confusion, tremors, ataxia, speech disorders, hallucinations, psychotic symptoms, seizures, somnolence, encephalopathy (non-inflammatory changes in the brain), coma, dyspnea, diarrhea, abdominal pain, transient elevation of bilirubin, jaundice, hepatitis, angioedema, renal impairment (reversible after fluid supplementation and/or dose reduction or discontinuation of the medicine), renal pain, in individual cases acute renal failure, fatigue, fever, local inflammation.

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the 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 authorization holder.
Reporting side effects will help to gather more information on the safety of this medicine.

5. How to store ACIX

Keep the medicine out of the sight and reach of children.
Store in a temperature below 25°C.
The prepared infusion solution should be stored for up to 48 hours in a temperature below 25°C.
Do not freeze.
Do not use this medicine after the expiry date stated on the packaging after: EXP.
The expiry date refers to the last day of the month stated.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the packaging and other information

What ACIX contains

The active substance of the medicine is acyclovir.
1 vial of ACIX 500 contains 500 mg of acyclovir in the form of sodium acyclovir salt (548.8 mg).

What ACIX looks like and what the pack contains

The pack contains 10 vials placed on a polystyrene tray, in a cardboard box.

Marketing authorization holder

Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria

Manufacturer

Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
39179 Barleben, Germany
To obtain more detailed information, contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
Sandoz logo

Date of last revision of the leaflet:

Information intended exclusively for healthcare professionals

The infusion solution should be prepared with aseptic precautions, immediately before use.
For dissolving the product and withdrawing the concentrated solution from the vial, it is recommended to use needles with a diameter of up to 0.8 mm.
The contents of the vial should be dissolved by adding 20 ml of water for injections or 0.9% sodium chloride solution. The resulting concentrated solution or its part should be immediately diluted (at least 100 ml, maximum 500 ml). The diluent should be 0.9% sodium chloride solution without any additional ingredients.
The ACIX 500 solution prepared according to the recommendations remains stable for up to 48 hours at a temperature below 25°C.
Do not use the solution if it becomes cloudy or crystals form during or after preparation.
Unused portions of the dry substance or solution should be discarded.

Method of administration

The prepared infusion solution should be administered by slow intravenous infusion over at least 60 minutes. Do not administer ACIX 500 as a rapid intravenous injection (bolus).
If ACIX 500 is administered using an infusion pump, the acyclovir concentration should be 2.5% (25 mg/ml).
Note: The pH of the concentrated ACIX solution is around 11. Do not administer orally.