Anidulafungin sandoz
PolandTable of Contents
Package leaflet: Information for the patient
Anidulafungin Sandoz, 100 mg, powder for solution for infusion
Anidulafunginum
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 further questions, ask your doctor, pharmacist, or nurse.
- If you experience any side effects, including any not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.
Contents of the leaflet
- What Anidulafungin Sandoz is and what it is used for
- Important information before using Anidulafungin Sandoz
- How to use Anidulafungin Sandoz
- Possible side effects
- How to store Anidulafungin Sandoz
- Contents of the pack and other information
1. What Anidulafungin Sandoz is and what it is used for
Anidulafungin Sandoz contains the active substance anidulafungin and is prescribed for adults
and children and adolescents aged 1 month up to but not including 18 years for the treatment of
fungal infection of the blood or internal organs, known as invasive candidiasis. This infection is
caused by fungal (yeast) cells called Candida.
Anidulafungin Sandoz belongs to a group of medicines called echinocandins. Medicines in this
group are used to treat serious fungal infections.
Anidulafungin Sandoz inhibits the normal process of fungal cell wall formation.
In the presence of this medicine, fungal cell walls are incomplete or damaged, causing them to
become fragile or unable to grow.
2. Information before using Anidulafungin Sandoz
When not to use Anidulafungin Sandoz
if the patient is allergic to anidulafungin, other echinocandins (e.g. caspofungin acetate) or
any of the other ingredients of this medicine (listed in section 6).
Warnings and precautions
Before starting treatment with Anidulafungin Sandoz, discuss this with your doctor, pharmacist
or nurse.
Your doctor may decide to monitor:
liver function, especially carefully in patients who have experienced liver function disorders
during treatment;
symptoms of allergic reactions (such as itching, wheezing, skin rash) in patients receiving
anaesthetic medicines during treatment with Anidulafungin Sandoz;
symptoms related to infusion reactions, such as rash, urticaria, itching, redness;
shortness of breath/difficulty breathing, dizziness or faintness.
Children and adolescents
Anidulafungin Sandoz must not be used in patients under 1 month of age.
Anidulafungin Sandoz and other medicines
Tell your doctor or pharmacist about all medicines the adult patient or child is currently taking,
has recently taken, or plans to take.
Pregnancy and breastfeeding
The effect of Anidulafungin Sandoz in pregnant women is unknown. Therefore, its use during
pregnancy is not recommended. Women of childbearing age should use effective contraception.
If a patient becomes pregnant while taking Anidulafungin Sandoz, contact your doctor immediately.
The effect of Anidulafungin Sandoz in breastfeeding women is unknown. Before starting
Anidulafungin Sandoz during breastfeeding, consult your doctor or pharmacist.
Before taking any medicine, consult your doctor or pharmacist.
Anidulafungin Sandoz contains fructose and sodium
Anidulafungin Sandoz contains 100 mg of fructose per vial.
If an adult patient (or child) has previously been diagnosed with hereditary fructose intolerance,
a rare genetic disorder, the adult patient (or child) must not take this medicine. In patients with
hereditary fructose intolerance, the body cannot break down the fructose contained in this medicine,
which may lead to severe adverse reactions. Inform your doctor before taking this medicine if the
adult patient (or child) has hereditary fructose intolerance or should avoid sweet foods or drinks due
to nausea, vomiting or unpleasant adverse effects such as bloating, stomach cramps or diarrhoea.
This medicine contains less than 1 mmol (23 mg) of sodium per vial, meaning the medicine is considered "sodium-free".
3. How to use Anidulafungin Sandoz
Anidulafungin Sandoz is always prepared and administered by a doctor or other medical personnel (more information on how to prepare the medicine can be found at the end of this leaflet, in the section intended exclusively for healthcare professionals).
In adults, treatment starts with a loading dose of 200 mg given on the first day. This is followed by a daily maintenance dose of 100 mg.
In children and adolescents (aged 1 month to below 18 years), treatment starts with a loading dose of 3.0 mg/kg body weight (dose not exceeding 200 mg) on the first day. This is followed by a maintenance dose of 1.5 mg/kg body weight/day (dose not exceeding 100 mg).
The dose administered depends on the patient's body weight.
Anidulafungin Sandoz should be given once daily by slow intravenous infusion (drip infusion). In adults, the maintenance dose should be infused over at least 1.5 hours, and the loading dose over 3 hours.
In children and adolescents, the infusion duration may be shorter, depending on the patient's body weight.
The doctor will determine the duration of treatment, the daily dose, and will monitor the patient's response to treatment and their condition.
Treatment usually lasts for at least 14 days after the last day on which Candida fungi were detected in the patient's blood.
Taking more Anidulafungin Sandoz than prescribed
If the patient has any doubts whether they have received an excessive dose of Anidulafungin Sandoz, they should immediately contact their doctor or other medical personnel.
Missing a dose of Anidulafungin Sandoz
The medicine is administered under strict medical supervision, so missing a dose is unlikely. However, if the patient is unsure whether they received the dose, they should inform their doctor or pharmacist.
The doctor should not administer a double dose of the medicine.
Stopping Anidulafungin Sandoz treatment
Discontinuation of Anidulafungin Sandoz by the doctor should not cause any symptoms in the patient.
After stopping Anidulafungin Sandoz, the doctor may prescribe another medicine to continue treatment of the fungal infection or to prevent its recurrence.
If the original symptoms recur, the patient should immediately inform their doctor or healthcare professional.
If you have any further questions about the use of this medicine, please consult your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Some of these side effects will be observed by the doctor during monitoring of the patient's response to treatment and their condition.
Life-threatening allergic reactions, such as difficulty breathing with wheezing or worsening of existing rash, have been rarely reported during administration of anidulafungin.
If the patient experiences any of the following severe side effects, a doctor or healthcare professional must be informed immediately:
- Convulsions
- Sudden redness of the skin, especially of the face
- Rash, itching
- Hot flushes
- Urticaria
- Sudden contraction of muscles surrounding the airways, causing wheezing or coughing
- Difficulty breathing
Other side effects:
Very common side effects (may occur in more than 1 in 10 people)
- Low blood potassium levels (hypokalaemia)
- Diarrhoea
- Nausea
Common side effects (may occur in less than 1 in 10 people)
- Convulsions
- Headache
- Vomiting
- Changes in blood test results assessing liver function
- Rash, itching
- Changes in blood test results assessing kidney function
- Impaired bile flow from the gallbladder to the intestine (cholestasis)
- High blood sugar levels
- High blood pressure
- Low blood pressure
- Sudden contraction of muscles surrounding the airways, causing wheezing or coughing
- Difficulty breathing
Uncommon side effects (may occur in less than 1 in 100 people)
- Blood clotting disorders
- Sudden redness of the skin, especially of the face
- Hot flushes
- Abdominal pain
- Urticaria
- Pain at the injection site
Side effects with unknown frequency (frequency cannot be estimated from the available data)
- Life-threatening allergic reactions
Reporting of side effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform a doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring Adverse Drug Reactions 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 helps provide more information on the safety of the medicine.
5. How to store Anidulafungin Sandoz
Keep this medicine out of the sight and reach of children.
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.
Store in a refrigerator (2°C - 8°C).
Chemical and physical stability of the concentrate for infusion solution has been demonstrated for 24 hours at 25°C.
The infusion solution may be stored at 25°C (room temperature) for 48 hours (do not freeze) and should be administered at 25°C within 48 hours.
Due to microbiological concerns, the medicinal product should be used immediately.
Otherwise, the user is responsible for the storage conditions and duration prior to administration. The solution may be stored for no longer than 24 hours at 2°C to 8°C, provided reconstitution and dilution have been carried out under controlled and validated aseptic conditions.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures will help protect the environment.
6. Package contents and other information
What Anidulafungin Sandoz contains
- The active substance is anidulafungin. One vial contains 100 mg of anidulafungin. The prepared concentrate for infusion solution contains 3.33 mg/ml of anidulafungin, and the diluted infusion solution contains 0.77 mg/ml of anidulafungin.
- Other components: fructose, mannitol, polysorbate 80, (S)-lactic acid, sodium hydroxide (for pH adjustment), hydrochloric acid concentrated (for pH adjustment).
What Anidulafungin Sandoz looks like and contents of the pack
Anidulafungin Sandoz is a white or almost white disc or powder.
The medicine is available in cardboard boxes containing 1 vial with powder for preparation of concentrate for infusion solution.
Pack sizes: 1 vial
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sandoz GmbH
Biochemiestrasse 10
6250 Kundl, Austria
Manufacturers
PHARMIDEA SIA
Rūpnīcu iela 4, Olaine, Olaine novads
LV-2114, Latvia
Salutas Pharma GmbH
Otto-von-Guericke-Allee 1
Sachsen-Anhalt
39179 Barleben, Germany
LABORATORIOS ALCALÁ FARMA, S.L.
Avenida de Madrid, 82
Alcalá de Henares, 28802
Madrid, Spain
Lek Pharmaceuticals d.d.
Verovškova ulica 57
Ljubljana 1526
Slovenia
For further information about the medicine and its names in the European Economic Area countries,
please contact:
Sandoz Polska Sp. z o.o.
ul. Domaniewska 50 C
02-672 Warsaw
tel. 22 209 70 00
The following information is intended exclusively for healthcare professionals and refers solely to a single vial of Anidulafungin Sandoz.
The medicinal product Anidulafungin Sandoz must be dissolved in water for injections, and the resulting concentrate must be diluted ONLY with 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion. Compatibility of reconstituted Anidulafungin Sandoz with other medicines, excipients, or intravenous infusion solutions has not been established other than with 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion.
Reconstitution of the powder
The contents of each vial should be dissolved aseptically in 30 ml of water for injections to obtain a concentrate with a concentration of 3.33 mg/ml. Dissolution may take up to 5 minutes. The resulting concentrate should be clear, colourless, and practically free of visible particles. If solid particles or discoloration are observed after reconstitution, the solution must be discarded.
The prepared concentrate for infusion may be stored prior to dilution for up to 24 hours at a temperature not exceeding 25°C.
Dilution and infusion
Transfer the contents of the reconstituted vial(s) aseptically into an infusion bag (or bottle) containing 9 mg/ml (0.9%) sodium chloride solution for infusion or 50 mg/ml (5%) glucose solution for infusion to obtain a final infusion solution of anidulafungin at a concentration of 0.77 mg/ml. In children and adolescents, the volume of infusion solution required to administer the appropriate dose will vary depending on the patient's body weight. The table below shows the appropriate volumes for each dose.
Dilutions required for administration of Anidulafungin Sandoz product
| Dose | Number of vials with powder | Total volume of concentrate | Solution volume for dilutionA | Total volume of infusion solutionB | Infusion rate | Minimum infusion duration |
|---|---|---|---|---|---|---|
| 100 mg | 1 | 30 ml | 100 ml | 130 ml | 1.4 ml/min | 90 min |
| 200 mg | 2 | 60 ml | 200 ml | 260 ml | 1.4 ml/min | 180 min |
Or 9 mg/ml (0.9%) sodium chloride solution for infusion, or 50 mg/ml (5%) glucose solution for
infusion.
The concentration of the infusion solution is 0.77 mg/ml.
The infusion rate should not exceed 1.1 mg/min (corresponding to 1.4 ml/min, if reconstitution and
dilution were performed according to the instructions), see sections 4.2, 4.4 and 4.8.
Parenteral medicinal products should be inspected visually for particulate matter and discoloration prior
to administration, whenever solution and container permit. If particulate matter or discoloration is
observed, the solution should be discarded.
The medicinal product is for single use only. Any unused medicinal product and waste material should
be disposed of in accordance with local requirements.