Gabapentin mesilate Ibi

GABESATO MESILATO IBI
100 mg/5 ml powder and solvent for solution for infusion
Equivalent medicine
Please read this leaflet carefully before taking this medicine, as 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. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any side effects, including those not listed in this leaflet, contact your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Gabesato mesilato Ibi is and what it is used for
2. What you need to know before taking Gabesato mesilato Ibi
3. How to take Gabesato mesilato Ibi
4. Possible side effects
5. How to store Gabesato mesilato Ibi
6. Contents of the pack and other information

1. What Gabesato mesilato Ibi is and what it is used for

Gabesato mesilato Ibi contains the active substance gabesato mesilato, which belongs to the category of protease inhibitors—substances that break down certain proteins in the body.
Gabesato mesilato Ibi is used to treat acute inflammatory processes of the pancreas (acute pancreatitis), a gland associated with the digestive system.

2. What you should know before taking Gabesato mesilato Ibi

Do not take Gabesato mesilato Ibi

• if you are allergic to the active substance.

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before taking Gabesato mesilato Ibi.
During administration, the infusion rate should be adjusted so as not to exceed 2.5 mg/kg per hour (see "How to administer Gabesato mesilato Ibi"). This medicine may make the blood thinner and thereby reduce blood coagulation, possibly increasing the risk of bleeding.

Other medicines and Gabesato mesilato Ibi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with Gabesato mesilato Ibi are known.
If receiving concomitant therapy with other parenteral medicines, gabesato mesilato must be administered separately.

Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.

Pregnancy
During confirmed or suspected pregnancy, it is advisable to keep the dosage of gabesato mesilato at the lowest effective levels and only use it when indicated by life-threatening conditions for the mother.

Breastfeeding
There are no data available regarding the excretion of this medicine in human breast milk.

Driving and using machines
Not applicable, as gabesato mesilato is administered only in a hospital setting.

3. How to take Gabesato mesilato Ibi

Gabesato mesilato Ibi is administered by a doctor or nurse in a hospital setting
as an intravenous infusion.
If you have any doubts, consult your doctor, pharmacist, or nurse.
Treatment is initiated with 1–3 vials per day via intravenous infusion. Your doctor
will adjust the dosage according to clinical improvement.
For instructions on how to administer the medicine, see below “How to administer
Gabesato mesilato Ibi”.
If you take more Gabesato mesilato Ibi than you should
Symptoms of overdose are not known.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.

Rarely may occur

• Shock with decreased blood pressure, feeling of pressure in the chest (precordial oppression), and difficulty breathing (dyspnea). In such cases, treatment will be immediately discontinued.
• Phlebitis (inflammation of the vein) with pain, redness or swelling at the injection site. In such cases, the dose will be reduced, and if symptoms persist, treatment will be discontinued.
• Headache
• Reduced time for blood clot formation (reduced partial thromboplastin time)
• Tendency to bleed
• Low blood pressure (hypotension)
• Nausea
• Vomiting
• Diarrhea
• Skin rash
• Itching
• Facial flushing (facial congestion)

In these cases, the dose will be reduced and, if symptoms persist, treatment will be permanently discontinued.

Following the instructions reported in this leaflet reduces the risk of side effects.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, please contact your doctor or pharmacist. You may also report side effects directly through the national reporting system at www.agenziafarmaco.gov.it/it/responsabili.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Gabesato mesilato Ibi

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the packaging after "Exp". The expiry date refers to the last day of that month. The date refers to the product in its original, unopened packaging, correctly stored.
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. Contents of the pack and other information

What Gabesato mesilato Ibi contains
Vial:
The active substance is gabesato mesylate. Each vial contains 100 mg of gabesato mesylate.
Solvent ampoule:
Contains: water for injections.

Description of the appearance of Gabesato mesilato Ibi and contents of the pack
Powder and solvent for solution for infusion.
Carton pack containing 1 vial of 100 mg powder + 1 solvent ampoule of 5 ml.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
Istituto Biochimico Italiano Giovanni Lorenzini S.p.A., Via Fossignano, 2 – 04011 Aprilia (LT).

Manufacturer
Powder vial
GiPharma S.r.l., Strada Crescentino - 13040 Saluggia (VC).
Solvent ampoule
Istituto Biochimico Italiano G. Lorenzini S.p.A., Via Fossignano 2 – 04011 Aprilia (LT).

The following information is intended exclusively for physicians or healthcare professionals

How to administer Gabesato mesilato Ibi
Begin treatment with 1–3 vials per day (100–300 mg of gabesato mesylate) by intravenous drop-by-drop infusion at a rate not exceeding 8 ml/minute, and subsequently reduce the dosage according to clinical improvement. If necessary, the above dosage may be increased by 1–3 vials within the same day.
Introduce the supplied solvent into the vial containing the lyophilized powder. The resulting solution is stable for 24 hours at room temperature and for 5 days when refrigerated (3°C). The resulting solution must be further diluted in 500 ml of Ringer's solution or 5% glucose solution.
It is advisable to administer the solution by slow intravenous infusion, adjusting the rate so that it does not exceed 2.5 mg of gabesato mesylate per kg of body weight per hour.