IBET 1.5 мг/2 мл Инъекционный раствор

Содержание инструкции

1. IBET 1.5 mg/2 ml injectable solution, 4 mg/2 ml injectable solution
   1. What IBET is and what it is used for
   2. What you need to know before taking IBET
   3. How to take IBET
   4. Possible side effects
   5. How to store IBET
   6. Package Contents and Other Information

IBET 1.5 mg/2 ml injectable solution, 4 mg/2 ml injectable solution

Betamethasone disodium phosphate

Read this leaflet carefully before you start 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 or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What IBET is and what it is used for

IBET contains the active ingredient betamethasone disodium phosphate, a synthetic hormone that belongs to the
group of corticosteroids.
Corticosteroids are hormones produced by the adrenal glands that, by acting against inflammation,
reduce pain, swelling, heat, and redness.
This medicine is a solution contained in a vial. Treatment with IBET must be
initiated and carried out under strict medical supervision.
IBET is used:

• to treat severe allergies, such as anaphylactic reactions (characterized by skin rashes, itching, swelling of the face, throat with difficulty breathing and a sudden drop in blood pressure) that can occur after taking medication or after a blood transfusion;
• to treat severe breathing difficulties due to asthma (asthmatic status);
• if you have reduced adrenal function (adrenal insufficiency), for example, you have a disease called Waterhouse-Friderichsen syndrome, suffer from Addison's disease or Simmonds' disease, have undergone surgery in which the adrenal glands have been removed (adrenalectomized) or have taken medications containing cortisone for long periods;
• in case of shock due to burns, trauma or surgery;
• for the treatment of diseases affecting the joints, such as tennis elbow and periarthritis of the shoulder joint;
• in case of cerebral edema, a serious condition due to rapid swelling of brain tissue;
• in case of heart attack;
• to treat blood problems (acute exacerbation of hemopathies);

2. What you need to know before taking IBET

Do not take IBET if:

• you are allergic to the active ingredient, to other corticosteroid medicines or to any of the other ingredients of this medicine (listed in section 6);
• you have widespread infections;
• you are pregnant or breastfeeding, unless specifically indicated by your doctor (see section “pregnancy and breastfeeding”).

Vaccinations with live attenuated vaccines should be avoided during treatment with IBET.

Warnings and precautions
Tell your doctor if you have (currently) or have had (in the past) any of the following conditions, or if you have been
subjected to any of the following treatments:

• intestinal diseases, such as ulcerative colitis or diverticulitis;
• surgery on the intestine (intestinal anastomoses);
• stomach or duodenal ulcer (peptic ulcer);
• steroid-induced myopathy;
• congestive heart failure;
• kidney disease;
• high blood pressure (hypertension);
• severe muscle weakness (myasthenia gravis) or muscle problems after taking other corticosteroids;
• weakening of the bones (osteoporosis);
• eye infection due to a virus (herpes simplex), as it may cause corneal perforation;
• blurred vision or other visual disturbances;
• pus collection (abscess) or infection that causes abscesses;
• emotional instability or psychotic tendencies, such as feelings of unjustified happiness (euphoria), mood or personality changes, insomnia, severe depression (feeling of sadness), as these conditions may worsen;
• tuberculosis (active or latent) or a positive tuberculin test;
• decreased thyroid gland function (hypothyroidism);
• severe liver disease (e.g. cirrhosis);
• reduced heart function (congestive heart failure);
• diabetes;
• increased eye pressure with possible worsening of vision (glaucoma);
• you suffer from epilepsy;
• if you have reduced blood coagulation (hypoprothrombinemia) and need to use acetylsalicylic acid (e.g. aspirin);
• during prolonged therapy and with high doses, if an alteration of the electrolyte balance occurs, it is advisable to adjust the intake of sodium and potassium.

Other important information about IBET
IBET may have an effect on the immune system. This compromises its ability to
fight infections. If your immune system is altered:

• you need protection from agents that cause disease;
• there may be a greater risk of infection. If you are developing an infection, it may be more difficult to detect during treatment with IBET.

Treatment with IBET may have a negative effect on the way calcium is metabolized
in your bones, as it increases the elimination of calcium with urine. For this reason, you should
discuss with your doctor the risk of osteoporosis (loss of bone mass with increased risk of fractures
), especially if there are family members with a history of bone fractures, if
you do not exercise regularly, if you are a woman in or post-menopause or if you are elderly.
During therapy with IBET:

• you should not come into contact with people affected by measles and chickenpox if you are taking high doses of this medicine. If this happens, contact your doctor;
• you may have adrenal insufficiency. This occurs when the adrenal gland does not produce enough cortisol (a hormone). In such cases, therapy needs to be adjusted accordingly;
• you may have an alteration of electrolytes in the blood, especially sodium and potassium. In these cases, the doctor may associate other therapeutic measures with your treatment, for example the administration of mineral salts (e.g. sodium chloride) or hormones called mineralocorticoids.

It may be necessary to adjust the dose of IBET in case of stressful events (e.g. hospitalization,
after an accident or if you are subjected to greater physical exertion).

Children and adolescents
Children undergoing prolonged therapy must be closely monitored for
growth and development.
Children are particularly at risk of increased pressure inside the skull.

For athletes: the use of the drug without therapeutic need constitutes doping and
may still result in positive anti-doping tests.

Other medicines and IBET
Tell your doctor if you are taking or have recently taken or may take other
medicines, including over-the-counter medicines, as some medicines may
interact with your treatment.
Some medicines may increase the effects of IBET and your doctor may want to keep you under
close observation if you are taking these medicines (including some medicines for
the treatment of HIV: ritonavir, cobicistat).
IBET:

• reduces the effect of non-steroidal anti-inflammatory drugs (NSAIDs) and/or increases the risk of ulcers or bleeding of the stomach and intestines;
• reduces the effect of medicines containing salicylate;
• reduces the effect of medicines against diabetes, e.g. insulin;
• increases or decreases, depending on the individual, the blood-thinning effects of anticoagulant drugs; reduces the effect of drugs called anticholinesterases, used for example in the treatment of Alzheimer's disease (a disease characterized by progressive loss of intellectual abilities, starting with memory) or myasthenia gravis (a disease characterized by severe muscle weakness);
• may have an increased effect if administered together with cyclosporine (immunosuppressant) and/or increase the effect of the latter;
• reduces the effect of contrast agents used for radiographic examination to detect the bile ducts (cholecystography);
• may have a reduced effect if administered together with: phenytoin and phenobarbital (drugs used against epilepsy), ephedrine (a drug used for example in asthma) and rifampicin (a type of antibiotic);
• may cause excessive potassium loss in the blood if administered together with:
• medicines that increase urine production (diuretics) in particular furosemide and thiazide diuretics;
• amphotericin (antifungal);
• xanthines e.g. theophylline;
• may have an increased effect if administered together with:
• ritonavir (a medicine used against the HIV virus);
• ketoconazole (a medicine to fight fungal infections).

If you are taking any of the above medicines, your doctor may prescribe you another
medicine or adjust the dose of IBET or the other medicine.

Pregnancy, breastfeeding and fertility
Do not take IBET if you are pregnant or breastfeeding, unless specifically indicated by
your doctor. If you suspect or are planning a pregnancy, ask your doctor or pharmacist
for advice before taking this medicine.

Driving and operating machinery
It is unlikely that IBET will impair your ability to drive vehicles or operate machinery. However, if
you experience side effects such as dizziness, visual disturbances or changes in mental state, it is
best to avoid such activities.

IBET contains:

• sodium: this medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially ‘sodium-free’;
• sodium metabisulfite (E223). Rarely it may cause severe hypersensitivity reactions and bronchospasm.

3. How to take IBET

Take this medicine following the instructions of your doctor exactly, who will decide the
dose and frequency of administrations based on your condition. If you have any doubts, consult your doctor
or pharmacist.
The usual dose ranges from 1.5 to 4 mg per single administration. If necessary, this dose may be
repeated until an improvement in the clinical picture is obtained.
Depending on the severity of your condition, the usual dose may be increased to 10-15 mg
or more, in a single injection, and repeated up to 3-4 times a day.

Method of administration
IBET can be administered by intravenous injection (intravenous bolus), also in addition to the
normal fluids used for infusion, or into a muscle (intramuscular route).
The administration of IBET intravenously is reserved for medical personnel.
To administer IBET into a muscle, read and follow the instructions carefully at the end of
If you are using IBET for the treatment of diseases affecting the joints, such as tennis elbow and periarthritis of the shoulder joint, the injection must be performed near the site
where you have pain (local injection). Caution: do not use IBET directly into the tendons. If
you have had an infection in the joint where you are making the injection, the administration of IBET
should be avoided.
Use IBET according to your doctor's instructions. The doctor will discuss with you the necessary duration for the
treatment.

If you take more IBET than you should,contact your doctor immediately or go to the nearest
hospital.
IF YOU HAVE ANY DOUBTS ABOUT THE USE OF IBET, CONTACT YOUR DOCTOR OR PHARMACIST.

4. Possible side effects

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

Side effects with unknown frequency (frequency cannot be estimated based on available data)

• severe heart failure (congestive heart failure)
• adrenal insufficiency
• decrease in adrenal gland size (adrenal atrophy)
• disorders of the adrenal glands such as Cushing's Syndrome
• hyperadrenocorticism
• diabetes mellitus
• increased blood sugar levels
• excessive hair or beard growth
• increased eye pressure (glaucoma)
• opacity at the level of the posterior capsule of the lens (subcapsular cataract)
• increased eye tone
• perforation of an existing stomach and intestinal ulcer before starting treatment with IBET
• stomach and duodenal ulcer
• acute pancreatitis
• esophageal inflammation
• nausea
• incomplete healing
• severe allergic reaction
• urticaria
• skin inflammation due to allergy
• recurrence of tuberculosis
• infections caused by fungi or viruses
• reduction of potassium levels
• reduction of nitrogen levels in the blood
• reduction of proteins
• reduction of lymphocytes (white blood cells) in the blood
• reduced glucose tolerance
• weight gain or loss
• hiccups
• loss of bone tissue (osteoporosis)
• death of bone tissue (osteonecrosis)
• swelling from fluid retention (edema)
• increased appetite
• growth delay
• muscle diseases
• collagen diseases
• fracture
• tendon rupture
• increased pressure inside the skull
• swelling of the optic nerve head due to increased intracranial pressure (papilledema)
• blurred vision
• dizziness
• headache
• psychiatric disorders
• anxiety
• irritability
• menstrual cycle alterations
• thinning of the skin
• acne
• bruising
• skin erythema
• skin changes such as delayed wound healing
• excessive sweating
• high blood pressure

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. You can also report side effects directly through the
national reporting system at 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 IBET

Keep this medicine out of the sight and reach of children.
This medicine does not require any particular temperature for storage. Keep the
medicine in the original package to protect it from light.
Do not use this medicine after the expiry date which is reported on the packaging. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in the wastewater and household waste. Ask your pharmacist how
to eliminate medicines that you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What IBET contains
The active ingredient is betamethasone disodium phosphate.
One 1.5 mg vial contains: 1.975 mg betamethasone disodium phosphate equivalent to 1.5 mg betamethasone.
One 4 mg vial contains: 5.263 mg betamethasone disodium phosphate equivalent to 4 mg betamethasone.
The excipients are: phenol, sodium chloride, sodium metabisulfite (E223), sodium edetate, sodium hydroxide
(pH adjuster), water for injections.

Description of the appearance of IBET and package contents
IBET 1.5mg/2ml injectable solution is available in packs of 6 glass vials of 2 ml
each.
IBET 4mg/2ml injectable solution is available in packs of 3 glass vials of 2 ml each.

Marketing Authorisation Holder
Biopharma S.r.l., Via Paolo Mercuri n. 8, Rome, Italy

Manufacturer
ESSETI FARMACEUTICI srl, Via Campobello, 15 – 00071 Pomezia (Rome)
INSTRUCTIONS FOR INTRAMUSCULAR ADMINISTRATION OF IBET
Wash your hands thoroughly. Ensure that the accessories are well cleaned and placed on a clean
surface.
Place the following tools on the surface:

• 1 alcohol swab (not included in the package);
• 1 vial of IBET;
• 1 empty syringe (not included in the package).
• 1. PreparationTo open the vial, gently tap the top of the vial to remove any liquid residue present in the tip; position the vial as shown in Figure 1 and apply pressure with your thumb placed above the COLORED SPOT as shown in Figure 2. Using the syringe, draw up the solvent contained in the vial. Place the syringe on the surface and be careful not to touch the needle.
• 2. AdministrationSafety check: before administration, eliminate any air bubbles by holding the syringe vertically, with the needle pointing upwards, and gently tapping until the air bubbles collect at the top, then gently push the syringe plunger to expel the air, until liquid appears at the tip of the needle.

Inject the solution immediately after preparation.
To minimize skin irritation, choose a different injection site each day.
Clean the injection site with an alcohol swab. Firmly hold between your fingers the area where you
intend to give the injection and insert the needle at an angle between 45° and 90° with an arrow-like movement.
Inject all the solution, slowly pressing the plunger.
Immediately remove the needle and clean the injection area with an alcohol swab with a
circular motion.
Once the injection is finished, immediately dispose of the used needle and empty vials safely, preferably in a sharps container.