Ganciclovir medac: detailed information

Package leaflet: Information for the user

Ganciclovir medac 500 mg powder for concentrate for solution for infusion

Ganciclovir (as sodium ganciclovir)
Equivalent medicinal product
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Never give it to others. It may be harmful to other people, even if their symptoms are the same as yours.
If any adverse reaction occurs, including any not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Ganciclovir medac is and what it is used for
What you need to know before using Ganciclovir medac
How to use Ganciclovir medac
Possible side effects
How to store Ganciclovir medac
Contents of the pack and other information

1. What Ganciclovir medac is and what it is used for

What Ganciclovir medac is
Ganciclovir medac contains the active substance ganciclovir, which belongs to a group of medicines
called antivirals.
What Ganciclovir medac is used for
Ganciclovir medac is used to treat diseases caused by a virus known as cytomegalovirus (CMV) in adult and adolescent patients aged 12 years and older who have a weakened immune system, as well as for the prevention of CMV infections following organ transplantation or during chemotherapy in adults and children from birth.

The virus can affect any part of the body, including the retina, a layer lining the back of the eye – meaning that the virus can cause vision problems.
The virus can affect anyone, but poses a particular risk for individuals with a weakened immune system. In these individuals, CMV can cause serious illness. Immunosuppression may be due to other medical conditions (such as AIDS) or to medications (such as chemotherapy or immunosuppressants).

2. What you need to know before using Ganciclovir medac

Do not use Ganciclovir medac:

if you are allergic to ganciclovir, valganciclovir, or any of the other ingredients of this medicine (listed in section 6);
if you are breastfeeding (see subsection “Breastfeeding”). Do not use Ganciclovir medac if either of the above situations applies to you. If you have any doubts, consult your doctor, pharmacist, or nurse before using Ganciclovir medac.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before using Ganciclovir medac:

if you are allergic to aciclovir, valaciclovir, penciclovir, or famciclovir – these are other medicines used to treat viral infections;
if you have a low number of white blood cells, red blood cells, or platelets – your doctor will perform blood tests before and during treatment;
if you have previously experienced blood cell count problems due to medications;
if you have kidney problems – your doctor will need to give you a lower dose and monitor your blood cell counts more frequently during treatment;
if you are undergoing radiotherapy. If any of the above situations apply to you (or if you have any doubts), consult your doctor, pharmacist, or nurse before using Ganciclovir medac.

Be aware of side effects
Ganciclovir medac may cause serious side effects that must be reported to your doctor immediately. Pay attention to the serious side effects listed in section 4 and inform your doctor if you experience any of them during treatment with Ganciclovir medac. Your doctor may instruct you to stop taking Ganciclovir medac, and urgent medical intervention may be required.

Tests and monitoring
During treatment with Ganciclovir medac, your doctor will perform regular blood tests to ensure the dose you are receiving is appropriate for you. During the first 2 weeks, these blood tests will be performed more frequently than thereafter.

Children and adolescents
Information on the safety and efficacy of Ganciclovir medac for the treatment of CMV disease in children under 12 years of age is limited. Newborns and infants treated with Ganciclovir medac for prevention of CMV disease will undergo regular blood tests.

Other medicines and Ganciclovir medac
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking any of the following medicines:

imipenem/cilastatin – used to treat bacterial infections;
pentamidine – used to treat parasitic or lung infections;
flucytosine, amphotericin B – used to treat fungal infections;
trimethoprim, trimethoprim/sulfamethoxazole, dapsone – used to treat bacterial infections;
probenecid – used to treat gout;
mycophenolate mofetil, cyclosporine, tacrolimus – used after organ transplantation;
vincristine, vinblastine, doxorubicin – used to treat cancer;
hydroxyurea – used to treat a condition called polycythaemia, sickle cell anaemia, and cancer;
didanosine, stavudine, zidovudine, tenofovir, or other medicines used to treat HIV;
adefovir or any other medicine used to treat hepatitis B.
If any of the above situations apply to you (or if you have any doubts), consult your doctor or pharmacist before using Ganciclovir medac.

Pregnancy, breastfeeding, and fertility
Pregnancy
Ganciclovir medac must not be used in pregnant women unless the benefits to the mother outweigh the potential risks to the fetus.
If you are pregnant or suspect you may be pregnant, do not use this medicine unless specifically instructed by your doctor, as Ganciclovir medac could be harmful to the fetus.

Contraception
You must not become pregnant during treatment with this medicine, as it could be harmful to the fetus.

Women
If you are a woman able to become pregnant, you must use an effective method of contraception during treatment with Ganciclovir medac and for at least 30 days after stopping Ganciclovir medac.

Men
If you are a man whose partner is able to become pregnant, you must use a barrier method of contraception (e.g. condom) during treatment with Ganciclovir medac and for at least 90 days after stopping Ganciclovir medac.
If you or your partner become pregnant during treatment with Ganciclovir medac, inform your doctor immediately.

Breastfeeding
Do not use Ganciclovir medac if you are breastfeeding. If your doctor prescribes treatment with Ganciclovir medac, you must stop breastfeeding before starting this medicine, as Ganciclovir medac may pass into breast milk.

Fertility
Ganciclovir medac may affect fertility. In men, Ganciclovir medac may temporarily or permanently stop sperm production. If you are planning a pregnancy, talk to your doctor or pharmacist before using Ganciclovir medac.

Driving and using machines
During treatment with Ganciclovir medac, you may feel drowsy, dizzy, confused, or experience tremors, lose your balance, or have seizures. If this happens, do not drive and do not operate tools or machinery.

Ganciclovir medac contains sodium
Ganciclovir medac contains 46 mg of sodium per 500 mg dose. This information should be considered by patients on a low-sodium diet.

3. How to use Ganciclovir medac

Use this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, please consult your doctor or pharmacist.

Use of this medicine
Ganciclovir medac will be administered to you by a doctor or nurse through a tube inserted into a vein. This method of administration is called intravenous infusion and usually takes about one hour.

The required amount of Ganciclovir medac varies from patient to patient. Your doctor will calculate the dose to be administered based on:

body weight (in children, height may also be considered)
age
kidney function
blood cell count
the reason for which you are using this medicine

The frequency and duration of administration of Ganciclovir medac may also vary.

Normally, treatment starts with one or two infusions per day.
In the case of two infusions per day, this regimen will continue for up to 21 days.
Afterwards, your doctor may prescribe one infusion per day.

Patients with kidney or blood problems
If you have kidney or blood problems, your doctor may advise you to receive a lower dose of Ganciclovir medac and may monitor your blood cell count more frequently during treatment.

If you use more Ganciclovir medac than you should
If you suspect that the dose of Ganciclovir medac you have received exceeds the recommended amount, speak to your doctor or go to hospital immediately. If you have been given an overdose, you may experience the following symptoms:

stomach ache, diarrhoea or vomiting
tremor or seizures
blood in the urine
kidney or liver problems
changes in blood cell counts.

If you stop treatment with Ganciclovir medac
Do not stop treatment with Ganciclovir medac without first talking to your doctor.
If you have any doubts about how to use this medicine, consult your doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. With this medicine, you may experience the following side effects:

Serious side effects
Inform your doctor immediately if you notice any of the following serious side effects:

your doctor may advise you to stop taking Ganciclovir medac, and urgent medical treatment may be required.

Very common (may affect more than 1 in 10 people)

low white blood cell count, with signs of infection such as sore throat, mouth ulcers, or fever
low red blood cell count, with signs including breathlessness, feeling tired, palpitations, or paleness.

Common (may affect up to 1 in 10 people)

blood infection (sepsis), with signs such as fever, chills, palpitations, confusion, and difficulty speaking
low platelet count, with signs including increased tendency to bleed or bruise, blood in urine or stools, or bleeding gums. Bleeding may be severe
markedly low blood cell count
pancreatitis, with signs including severe stomach pain spreading to the back
seizures

Uncommon (may affect up to 1 in 100 people)

failure of the bone marrow to produce blood cells
hallucinations, such as hearing or seeing things that are not real
unusual thoughts or feelings, loss of contact with reality
impaired kidney function

Rare (may affect up to 1 in 1,000 people)

severe allergic reaction, with signs possibly including skin redness and itching, swelling of the throat, face, lips, or mouth, difficulty swallowing or breathing.

Inform your doctor immediately if you notice any of the above-listed side effects.

Other side effects
If you notice any of the following side effects, inform your doctor, pharmacist, or nurse:

Very common: may affect more than 1 in 10 people

fungal infections (candidiasis) and oral thrush
upper respiratory tract infection (e.g., sinusitis, tonsillitis)
loss of appetite
headache
cough
breathlessness
diarrhoea
nausea or vomiting
abdominal pain
eczema
feeling tired
fever

Common: may affect up to 1 in 10 people

influenza
urinary tract infection, with signs including fever, more frequent urination, pain when passing urine
skin and subcutaneous tissue infection
mild allergic reaction, with signs possibly including red, itchy skin
weight loss
feeling depressed, anxious, or confused
sleep disorders
sensation of weakness and numbness in hands or feet, possibly affecting balance
altered sense of touch, tingling, tickling, itching, or burning sensation
altered sense of taste
chills
eye inflammation (conjunctivitis), eye pain, or vision problems
ear pain
low blood pressure, which may cause dizziness or fainting
difficulty swallowing
constipation, flatulence, indigestion, stomach ache, abdominal bloating
mouth ulcers
abnormal laboratory tests for liver and kidney function
night sweats
itching, skin rash
hair loss
back pain, muscle or joint pain, muscle spasms
dizziness, weakness, or general malaise
skin reaction at the injection site, such as inflammation, pain, and swelling.

Uncommon: may affect up to 1 in 100 people

feeling restless
tremors, shaking
deafness
irregular heartbeat
hives, dry skin
blood in urine
infertility in men; see section “Fertility”
chest pain

Side effects in children and adolescents
Low blood cell counts are more likely to occur in children, especially in neonates and infants.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ganciclovir medac

Keep this medicine out of the sight and reach of children.
This medicine does not require any special storage conditions.
Do not use this medicine after the expiry date stated on the carton and vial after "Exp".
The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Ganciclovir medac contains

The active substance is ganciclovir (as ganciclovir sodium)
The other ingredients are sodium hydroxide and hydrochloric acid (for pH adjustment)

Description of the appearance of Ganciclovir medac and contents of the pack
Ganciclovir medac is a powder for the preparation of a concentrate for solution for infusion, supplied in glass vials.
Each vial contains 546 mg of ganciclovir sodium, equivalent to 500 mg of ganciclovir.
Each pack contains 1 clear glass vial of 10 ml.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
medac pharma s.r.l
Via Viggiano 90
00178 Rome
Italy
Manufacturer
Quercus Labo bv
Wijmenstraat 21P,
9030 Mariakerke,
Belgium

The following information is intended for healthcare professionals only.

For complete prescribing information, refer to the Summary of Product Characteristics.
Route of administration
Attention:
Ganciclovir must be administered by intravenous infusion over 1 hour at a maximum concentration of 10 mg/ml. Rapid intravenous injection or bolus administration must be avoided due to the potential for increased toxicity of ganciclovir caused by excessively high plasma levels.
Intramuscular or subcutaneous injection must be avoided, as it may cause severe tissue irritation due to the high pH (~11) of ganciclovir solutions.
The recommended dosage, frequency, and infusion rate must not be exceeded.
Ganciclovir medac is a powder for solution for infusion. After reconstitution, Ganciclovir medac appears as a colorless solution, practically free from visible particles.
The infusion should be administered into a vein with adequate blood flow, preferably using a plastic cannula.
Care must be taken when handling Ganciclovir medac.
Since ganciclovir is considered potentially teratogenic and carcinogenic in humans, caution must be exercised during handling. Avoid inhalation or direct contact with the powder contained in the vials, as well as direct contact between the reconstituted solution and skin or mucous membranes. Ganciclovir medac solutions are alkaline (pH ~11). In case of contact, wash the affected area thoroughly with soap and water and rinse eyes abundantly with running water.
Preparation of the reconstituted concentrate
Reconstitution of the Ganciclovir medac lyophilized powder requires the use of aseptic techniques.

Remove the flip-off seal to expose the central portion of the rubber stopper. Withdraw 10 ml of water for injections using a syringe, then slowly inject it into the vial by inserting the needle through the center of the rubber stopper and directing it toward the vial wall. Do not use bacteriostatic water for injections containing parabens (para-hydroxybenzoates), as they are incompatible with Ganciclovir medac.
Gently swirl the vial to ensure complete dissolution of the medicinal product.
Gently rotate/gently agitate the vial for several minutes until a clear reconstituted solution is obtained.
Prior to dilution with a compatible solvent, carefully inspect the reconstituted solution to ensure the medicinal product is completely dissolved and practically free from visible particles. The color of reconstituted Ganciclovir medac solutions may vary from colorless to pale yellow.

Preparation of the final diluted infusion solution
Withdraw from the vial the volume of concentrate required according to the patient's weight using a syringe, and further dilute it in a suitable infusion solution. Add 100 ml of diluent to the reconstituted solution. Infusion concentrations exceeding 10 mg/ml are not recommended.
Solutions of sodium chloride, 5% dextrose, Ringer's solution, or Ringer's lactate are considered chemically and physically compatible with Ganciclovir medac.
Ganciclovir medac must not be mixed with other intravenous products.
The diluted solution should then be administered intravenously over 1 hour, as indicated in section 4.2. Intramuscular or subcutaneous administration must be avoided, as it may cause severe tissue irritation due to the high pH (~11) of the ganciclovir solution.
Disposal
For single use only. Unused medicine and waste materials derived from this medicine must be disposed of in accordance with local regulations.