Patient Information Leaflet: Instructions for the User

EMOSINT 4 mcg/0.5 ml solution for injection, 20 mcg/1 ml solution for injection

Desmopressin acetate trihydrate
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. 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, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What EMOSINT is and what it is used for

EMOSINT contains desmopressin, a synthetic analogue of antidiuretic hormone (ADH).
EMOSINT is used for:

the treatment of mild and moderate haemophilia A and von Willebrand's disease (type 1), disorders characterized by impaired factor VIII activity (a protein that regulates blood coagulation);
preparation for surgical procedures in patients with mild and moderate haemophilia A and von Willebrand's disease (type 1).

2. What you need to know before using EMOSINT

Do not use EMOSINT

if you are allergic to desmopressin or to any of the other ingredients of this medicine (listed in section 6);
if you have von Willebrand disease type II B;
if you have blood vessel disorders;
if you have kidney problems (if you suffer from renal insufficiency).

Warnings and precautions
Talk to your doctor or pharmacist before using EMOSINT.
During treatment, fluid retention may occur, leading to hyponatremia (reduced sodium levels in the blood).
Therefore, fluid intake must be limited, especially if you have liver or kidney problems (hepatic or renal insufficiency).
Inform your doctor if:

you suffer from bronchial asthma,
you suffer from migraine and/or epilepsy,
you have heart failure (reduced heart function), if you have coronary artery disease (heart artery abnormalities), if you have high blood pressure, or if you are at risk of thrombotic events (blockage of a blood vessel).

During treatment, your doctor may, if necessary, prescribe tests to evaluate blood coagulation.
In case of repeated treatments with desmopressin, monitoring of urine output and blood electrolyte levels, particularly sodium, will be performed, especially in children and when other medicines that may reduce blood sodium levels are being used.
For athletes: using this medicine without a therapeutic need constitutes doping and may result in a positive anti-doping test.

Children and adolescents
EMOSINT may cause fluid retention and/or hyponatremia (reduced sodium levels in the blood), which may increase the risk of seizures. Higher risk applies to:

children under 2 years of age;
children affected by cystic fibrosis (a genetic disease causing abnormal mucus secretion);
children affected by conditions leading to inappropriate intake of large amounts of fluids, such as attention deficit hyperactivity disorder (ADHD) or Prader-Willi syndrome. In these cases, the doctor will recommend restricting fluid intake and performing blood and urine tests for at least 24 hours after administration.

Other medicines and EMOSINT
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Inform your doctor if you are being treated with:
Carbamazepine (a medicine used for epilepsy),
cyclophosphamide (a medicine used in the treatment of tumors and immune system disorders),
sulfonylureas, particularly chlorpropamide (medicines used for diabetes),
clofibrate (a medicine that reduces triglyceride levels in the blood),
antidepressants,
anti-inflammatory and pain-relieving medicines,
medicines for diabetes insipidus and urinary disorders.

Pregnancy, breastfeeding and fertility
If you are pregnant, think you might be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before taking this medicine.
Pregnancy
It is not known whether desmopressin crosses the placenta.
Desmopressin may stimulate uterine contractions and reduce blood flow.
Your doctor will prescribe EMOSINT only if clearly necessary and will monitor your blood pressure during treatment.
Breastfeeding
Desmopressin is excreted in breast milk. Your doctor will prescribe EMOSINT only if clearly necessary.
Fertility
Studies conducted in mice show harmful effects on sperm function, fertility, and embryonic development. These effects are dose-dependent and occur at high doses.

Driving and using machines
EMOSINT does not affect or has negligible influence on the ability to drive or operate machinery.

EMOSINT contains sodium
EMOSINT 4 mcg/0.5 ml injectable solution contains 4.5 mg of sodium (the main component of table salt) per vial. This corresponds to 0.22% of the maximum daily recommended dietary intake for an adult.
EMOSINT 20 mcg/1 ml injectable solution contains 9 mg of sodium (the main component of table salt) per vial. This corresponds to 0.44% of the maximum daily recommended dietary intake for an adult.

3. How to use EMOSINT

Use this medicine exactly as prescribed by your doctor. If you have any doubts, consult your doctor, pharmacist, or nurse.
The recommended dose is 0.3 mcg/kg body weight administered intravenously or subcutaneously.
The dose may be repeated at intervals of 12–24 hours depending on the type and severity of bleeding. During administration, your heart rate and blood pressure will be monitored. Adjusting the dosage may reduce the potential occurrence of adverse effects.
Use in children and adolescents
EMOSINT is not recommended in children under 2 years of age.
If you use more EMOSINT than you should
If you have administered an excessive dose of EMOSINT, stop using the medicine immediately.
An overdose increases the risk of fluid retention and hyponatremia (reduced sodium levels in the blood).
If you stop treatment with EMOSINT
If you have any doubts about using this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The adverse reactions associated with EMOSINT listed below have unknown frequency (frequency cannot be estimated from the available data):
• The side effects include:

facial flushing,
tachycardia (increased heart rate),
hypotension,
nausea,
uterine spasms (similar to pains occurring during menstruation) and vulvar pain,
headache,
abdominal pain,
severe allergic reactions (including anaphylactic reactions).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report side effects via
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 EMOSINT

Keep this medicine out of the sight and reach of children.
Store at 2°C - 8°C. Keep the vials in the outer packaging to protect the medicine from light.
Do not use this medicine after the expiry date which is stated on the label and on the outer packaging after "Exp.". The expiry date refers to the last day of that month.
Do not dispose of medicines 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 EMOSINT contains
The active substance is desmopressin acetate trihydrate.
One 0.5 ml vial contains 4 micrograms of desmopressin acetate trihydrate.
One 1 ml vial contains 20 micrograms of desmopressin acetate trihydrate.
The other components are: sodium chloride, hydrochloric acid, water for injections.

Description of the appearance of EMOSINT and contents of the package
EMOSINT is a clear, colourless solution. Do not use this medicine if you notice that the solution is
cloudy or contains deposits or shows any change in colour.
Lithographed cardboard box containing a thermoformed PVC blister with 10 vials of neutral borosilicate glass of type 1
EMOSINT desmopressin 10 vials 4 micrograms/0.5 ml
EMOSINT desmopressin 10 vials 20 micrograms/1 ml

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Kedrion S.p.A. – Loc. Ai Conti, 55051 Castelvecchio Pascoli, Barga (Lucca).
Manufacturer
BIOLOGICI ITALIA LABORATORIES S.r.l. – via Filippo Serpero 2, Masate (MI).

The following information is intended exclusively for physicians or healthcare professionals

Dosage
The recommended dose is 0.3 mcg/kg administered intravenously by infusion or subcutaneously.
The dose may be repeated at intervals of 12–24 hours depending on the type and severity of bleeding.

Paediatric population
EMOSINT is not recommended in children under 2 years of age (see section 4.4).

Method of administration

Intravenous use
EMOSINT must be diluted in 50–100 ml of physiological saline and administered by slow intravenous infusion over 20–30 minutes. During the infusion, pulse rate and blood pressure must be monitored.

Subcutaneous use
EMOSINT must not be diluted.

Overdose
In case of overdose, discontinue treatment, restrict fluid intake, and, if necessary, initiate symptomatic treatment.