Micafungin reig jofre

Package leaflet: Information for the user

Micafungin Reig Jofre, 50 mg, powder for solution for infusion concentrate
Micafungin Reig Jofre, 100 mg, powder for solution for infusion concentrate
Micafunginum
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your doctor or pharmacist.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Leaflet contents:

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

1. What Micafungin Reig Jofre is and what it is used for

Micafungin Reig Jofre contains the active substance micafungin. Micafungin Reig Jofre is called an antifungal medicine because it is used to treat infections caused by fungal cells.
Micafungin Reig Jofre is used to treat fungal infections caused by fungi or yeast-like organisms called Candida. Micafungin Reig Jofre is effective in treating systemic infections (those that have spread throughout the body). It acts by interfering with the formation of a component of the fungal cell wall. An intact cell wall is essential for the normal development and growth of fungal cells. Micafungin Reig Jofre damages the fungal cell wall, thereby preventing further development and growth of fungi.
Your doctor may prescribe Micafungin Reig Jofre in the following cases, when no other appropriate antifungal treatment is available (see section 2):

• Treatment of adults, adolescents, and children, including newborns, with a serious fungal infection called invasive candidiasis (a systemic infection of the body);
• Treatment of adults and adolescents aged ≥ 16 years with fungal infection of the oesophagus (oesophageal candidiasis) where intravenous administration is appropriate;
• Prevention of Candida infections in patients undergoing allogeneic haematopoietic stem cell transplantation or in patients expected to develop neutropenia (reduction in the number of neutrophils; a type of white blood cell) lasting 10 or more days.

2. Important information before using Micafungin Reig Jofre

When not to use Micafungin Reig Jofre

• if the patient is allergic to micafungin, other echinocandins ( Ecalta or Cancidas ), or any of the other components of this medicine (listed in section 6).

Warnings and precautions
Long-term treatment with micafungin in rats has led to liver damage and, as a consequence, to liver tumors. The potential risk of developing liver tumors in humans is unknown. Before starting treatment, the doctor will assess the benefits and risks of using Micafungin Reig Jofre. Inform the doctor if the patient has severe liver diseases (e.g. liver failure or hepatitis) or if abnormal liver function test results have been observed. Liver function will be closely monitored during treatment. Discuss this with the doctor or pharmacist before starting Micafungin Reig Jofre.

• if the patient is allergic to any medication.
• if the patient has hemolytic anemia (anemia caused by the breakdown of red blood cells) or hemolysis (breakdown of red blood cells).
• if the patient has kidney diseases (e.g. kidney failure or abnormal kidney function test results). In such cases, the doctor may order closer monitoring of kidney function.

Micafungin may also cause a severe inflammatory condition and (or) skin and mucous membrane rashes (Stevens-Johnson syndrome, toxic epidermal necrolysis).
Micafungin Reig Jofre and other medicines
Inform the doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient plans to use.
It is especially important to inform the doctor about the use of amphotericin B deoxycholate or itraconazole (antifungal antibiotics), sirolimus (an immunosuppressive medicine), or nifedipine (a calcium channel blocker used in the treatment of high blood pressure). The doctor may decide to adjust the dosage of these medicines.
Micafungin Reig Jofre with food and drink
Since Micafungin Reig Jofre is administered intravenously (into a vein), there are no restrictions regarding food and drink.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Micafungin Reig Jofre should not be used during pregnancy unless absolutely necessary. Breastfeeding should not be continued during treatment with Micafungin Reig Jofre.
Driving and operating machinery
It is unlikely that micafungin will affect the ability to drive or operate machinery. However, dizziness may occur in some individuals during treatment with this medicine, and if so, the patient should not drive or operate any equipment or machinery. Inform the doctor if the patient experiences any symptoms that could impair the ability to drive or operate machinery.
Micafungin Reig Jofre contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, meaning the medicine is considered "sodium-free".

3. How to use Micafungin Reig Jofre

Micafungin Reig Jofre must be prepared and administered by a doctor or other medical personnel.
Micafungin Reig Jofre should be given once daily as a slow intravenous infusion (into a vein).
The daily dose is determined by the treating physician.

Use in adults, adolescents aged ≥ 16 years, and elderly patients

• For the treatment of invasive Candida infections, the usual dose is 100 mg once daily in patients weighing more than 40 kg and 2 mg/kg body weight once daily in patients weighing 40 kg or less.
• For the treatment of Candida esophagitis, the daily dose is 150 mg in patients weighing more than 40 kg and 3 mg/kg body weight once daily in patients weighing 40 kg or less.
• For prophylaxis of invasive Candida infections, the usual dose is 50 mg once daily in patients weighing more than 40 kg and 1 mg/kg body weight once daily in patients weighing 40 kg or less.

Use in children aged ≥ 4 months and adolescents under 16 years of age

• For the treatment of invasive Candida infections, the usual dose is 100 mg once daily in patients weighing more than 40 kg and 2 mg/kg body weight once daily in patients weighing 40 kg or less.
• For prophylaxis of invasive Candida infections, the usual dose is 50 mg once daily in patients weighing more than 40 kg and 1 mg/kg body weight once daily in patients weighing 40 kg or less.

Use in children and neonates under 4 months of age

• For the treatment of invasive Candida infections, the usual dose ranges from 4 mg/kg to 10 mg/kg body weight once daily.
• For prophylaxis of invasive Candida infections, the usual dose is 2 mg/kg body weight once daily.

Administration of a higher than recommended dose of Micafungin Reig Jofre
The doctor will determine the appropriate dose of Micafungin Reig Jofre based on the patient's response to treatment and overall health condition. If there is any doubt whether too high a dose of Micafungin Reig Jofre has been administered, contact a doctor or other medical personnel immediately.

Missed dose of Micafungin Reig Jofre
The doctor will decide on the need for continued treatment with Micafungin Reig Jofre based on the patient's response to treatment and overall health condition. If there is any doubt whether a dose of Micafungin Reig Jofre has been missed, contact a doctor or other medical personnel immediately.

If you have any further questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone will experience them.
If you experience an allergic reaction or a severe skin reaction (e.g. blistering and peeling of the skin), inform your doctor or nurse immediately.
Micafungin Reig Jofre may cause the following other side effects:

Common (may affect fewer than 1 in 10 people)

• abnormal blood test results (reduced number of white blood cells [leukopenia; neutropenia]); reduced number of red blood cells (anaemia)
• decreased potassium levels in the blood (hypokalemia); decreased magnesium levels in the blood (hypomagnesemia); decreased calcium levels in the blood (hypocalcemia)
• headache
• inflammation of the vein wall (at the injection site)
• nausea; vomiting; diarrhoea; abdominal pain
• abnormal liver function tests (increased alkaline phosphatase activity, increased aspartate aminotransferase activity, increased alanine aminotransferase activity)
• increased bilirubin levels in the blood (hyperbilirubinemia)
• rash
• fever
• chills

Uncommon (may affect fewer than 1 in 100 people)

• abnormal blood test results (reduced number of blood cells [pancytopenia]); reduced platelet count (thrombocytopenia); increased number of a type of white blood cells called eosinophils; decreased albumin levels in the blood (hypoalbuminemia)
• hypersensitivity
• increased sweating
• decreased sodium levels in the blood (hyponatremia); increased potassium levels in the blood (hyperkalemia); decreased phosphate levels in the blood (hypophosphatemia); anorexia (feeding difficulties)
• insomnia (sleep disturbances); anxiety; disorientation
• drowsiness; tremor; dizziness; taste disturbance
• rapid heartbeat; stronger heartbeat; irregular heartbeat
• high or low blood pressure; skin redness
• shortness of breath
• indigestion; constipation
• liver failure; increased liver enzyme activity (gamma-glutamyl transferase); jaundice (yellowing of the skin or whites of the eyes due to liver or blood disorders); reduced bile secretion into the intestine (cholestasis); enlarged liver; hepatitis
• itchy rash (urticaria); itching; skin redness (erythema)
• abnormal kidney function tests (increased blood creatinine levels; increased blood urea levels); worsening of kidney failure
• increased activity of an enzyme called lactate dehydrogenase
• venous thrombosis at the injection site; inflammation at the injection site; pain at the injection site; fluid retention in the body

Rare (may affect fewer than 1 in 1,000 people)

• anaemia caused by breakdown of red blood cells (haemolytic anaemia), breakdown of red blood cells (haemolysis)

Unknown frequency (cannot be estimated from available data)

• blood coagulation disorder
• shock (allergic)
• liver cell damage, which may also lead to death
• kidney disorders; acute kidney failure

Additional side effects observed in children and adolescents
The following reactions have been observed more frequently in children and adolescents than in adult patients:
Common (may affect fewer than 1 in 10 patients)

• reduced platelet count (thrombocytopenia)
• increased heart rate (tachycardia)
• high or low blood pressure
• increased bilirubin levels in the blood (hyperbilirubinemia); enlarged liver
• acute kidney failure; increased blood urea levels

Reporting of side effects
If any side effects occur, including any side effects not listed in this leaflet, tell your doctor or pharmacist. 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 authorisation holder.
Reporting side effects helps provide more information on the safety of the medicine.

5. How to store Micafungin Reig Jofre

Keep this medicine out of the sight and reach of children.
Do not use Micafungin Reig Jofre after the expiry date stated on the vial and carton. The expiry date refers to the last day of the stated month.
Closed vials do not require storage under special conditions.
The prepared concentrate and diluted infusion solution should be administered immediately, as the medicine does not contain any preservatives to protect against bacterial contamination. This medicine may be prepared for use only by trained, professional medical personnel after carefully reading the entire instruction.
Do not use the diluted infusion solution if it becomes cloudy or if a precipitate appears.
To protect from light, the bottle (bag) containing the diluted infusion solution should be placed in a closed, opaque container.
The vial is intended for single use only. Any unused, prepared concentrate should be promptly discarded.

6. Contents of the packaging and other information

What Micafungin Reig Jofre contains

• The active substance is micafungin (as micafungin sodium). One vial contains 50 mg or 100 mg of micafungin (as micafungin sodium).
• The other ingredients are: lactose monohydrate, citric acid (for pH adjustment), and sodium hydroxide (for pH adjustment).

What Micafungin Reig Jofre looks like and contents of the pack
Micafungin Reig Jofre 50 mg or 100 mg is a white or almost white powder for concentrate solution for infusion. Micafungin Reig Jofre is supplied in a cardboard box containing 1 vial.

Marketing Authorisation Holder
Reig Jofre Sp. z o.o.
ul. Ostródzka 74N
03-289 Warsaw
e-mail: [email protected]
Telephone: +48 22 487 88 49
(marketing authorisation holder's logo)

Manufacturer
Laboratorio Reig Jofré S.A.
C/Gran Capitán 10
Sant Joan Despí
08970 Barcelona
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
France: Micafungine Reig Jofre 50 mg, poudre pour solution à diluer pour perfusion
Micafungine Reig Jofre 100 mg, poudre pour solution à diluer pour perfusion
Spain: Micafungina Sala 50 mg polvo para concentrado para solución para perfusión EFG
Micafungina Sala 100 mg polvo para concentrado para solución para perfusión EFG
Poland: Micafungin Reig Jofre
Portugal: Micafungina Reig Jofre 50 mg pó para concentrado para solução para perfusão
Micafungina Reig Jofre 100 mg pó para concentrado para solução para perfusão
Sweden: Micafungin Bioglan 50 mg pulver till koncentrat till infusionsvätska, lösning
Micafungin Bioglan 100 mg pulver till koncentrat till infusionsvätska, lösning
Italy: Micafungin Reig Jofre

Detailed information on this medicinal product is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products https://urpl.gov.pl/pl

Information intended exclusively for healthcare professionals:
The medicinal product Micafungin Reig Jofre must not be mixed or co-administered by intravenous infusion with other medicinal products, except those listed below. Under aseptic conditions and at room temperature, the medicinal product Micafungin Reig Jofre should be prepared as follows:

1. Remove the plastic cap from the vial and disinfect the stopper with alcohol.
2. Under aseptic conditions, slowly inject 5 mL of sodium chloride 9 mg/mL (0.9%) solution for infusion or glucose 50 mg/mL (5%) solution for infusion (drawn from a 100 mL bottle/bag) down the inner wall of each vial. Although foaming may occur, every effort should be made to minimize foam formation. To obtain the correct dose of the medicinal product Micafungin Reig Jofre in mg, prepare the concentrate using the appropriate number of vials (see table below).
3. Gently rotate the vial. DO NOT SHAKE! The powder will dissolve completely. The prepared concentrate should be used immediately. The vial is intended for single use only. Therefore, any prepared but unused concentrate must be discarded immediately.
4. Transfer the entire volume of the prepared concentrate from the vials into the bottle (bag) containing the infusion solution from which the diluent was originally withdrawn. The diluted infusion solution should be administered immediately. The reconstituted solution remains chemically and physically stable for 96 hours at 25°C and for 24 hours at 2–8°C, provided it is protected from light and has been diluted according to the instructions above.
5. Gently invert the bottle (bag) containing the infusion solution to ensure thorough mixing, and DO NOT SHAKE to avoid foam formation. Do not administer the solution if it is cloudy or contains precipitate.
6. The bottle (bag) containing the diluted infusion solution should be placed in a closed, opaque container to protect it from light.

Preparation of the infusion solution