SELESYN 100 MCG Oral solution

Зміст інструкції

1. selesyn 100 micrograms oral solution (50 micrograms/ml)
2. selesyn 500 micrograms oral solution (50 micrograms/ml)
   1. WHAT IS SELESYN ORAL SOLUTION AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING SELESYN ORAL SOLUTION
   3. HOW TO USE SELESYN ORAL SOLUTION
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE SELESYN ORAL SOLUTION
   6. PACKAGE CONTENTS AND OTHER INFORMATION
3. selesyn 100 micrograms injectable solution (50 micrograms/ml)
4. selesyn 500 micrograms injectable solution (50 micrograms/ml)
   1. WHAT IS SELESYN INJECTABLE SOLUTION AND WHAT IS IT USED FOR
   2. BEFORE USING SELESYN INJECTABLE SOLUTION
   3. HOW TO USE SELESYN INJECTABLE SOLUTION
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE SELESYN INJECTABLE SOLUTION
   6. FURTHER INFORMATION

selesyn 100 micrograms oral solution (50 micrograms/ml)

100 micrograms of selenium in every 2 ml of oral solution

selesyn 500 micrograms oral solution (50 micrograms/ml)

500 micrograms of selenium in every 10 ml of oral solution
Active ingredient: Sodium selenite pentahydrate

Read this leaflet carefully before using this medicinebecause 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 pass it on to others, even if they have the same symptoms as you, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. WHAT IS SELESYN ORAL SOLUTION AND WHAT IS IT USED FOR

selesyn oral solution is a medicine that belongs to the group of mineral supplements. Sodium selenite pentahydrate, the active ingredient of the oral solution, provides a source of selenium, an essential trace element in the diet, which allows metabolism to function efficiently.
Your doctor has recommended this medicine because tests performed to measure selenium levels in your blood have revealed a deficiency of this element, which cannot be corrected by taking selenium from normal food sources.

2. WHAT YOU NEED TO KNOW BEFORE USING SELESYN ORAL SOLUTION

Do not use selesynoral solution

• if you are allergic to the active ingredient or to any of the other ingredients of this medicine (listed in section 6)
• if you have selenosis (selenium poisoning).

Warnings and precautions
There are no particular warnings or precautions for the use of selesyn oral solution.

Other medicines and selesynoral solution
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicine.
Care must be taken not to mix or take the solution at the same time as
reducing agents (e.g. vitamin C).
selesyn oral solution and vitamin C must be administered at least 4 hours apart.

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect you are pregnant or are planning to become pregnant, or if you are breastfeeding
with breast milk, ask your doctor or pharmacist for advice before using this medicine.
Pregnancy:
No data are available regarding the use of selesyn oral solution in pregnant women.
No adverse effects of sodium selenite on pregnancy or the fetus are expected, provided it is
used in cases of proven selenium deficiency.
Breastfeeding:
Selenium is excreted in breast milk. However, it is not expected that the doses administered to
correct selenium deficiency in breastfeeding women will have adverse effects on the infant.
Fertility
No data are available regarding the effect on fertility.

Driving and operating machinery
This medicine does not interfere with the ability to drive vehicles or operate machinery.

3. HOW TO USE SELESYN ORAL SOLUTION

Use this medicine following the doctor's instructions exactly. If you have any doubts, consult your doctor or pharmacist.
selesyn oral solution is exclusively for single use.
The recommended dose is:

• 100 – 200 micrograms of selenium (equivalent to 1 or 2 vials of selesyn 100 mcg oral solution, or 2 – 4 ml of selesyn 500 mcg oral solution).

If blood test results indicate the need to take a higher amount of selenium, your doctor may increase the dose to 500 micrograms of selenium (equivalent to 5 vials of selesyn 100 mcg oral solution, or 1 drinkable bottle of selesyn 500 mcg oral solution).

Use in children and adolescents
In children, the doctor will prescribe a dose of 2 µg/kg of body weight per day at the beginning of therapy and a maintenance dose of 1 µg/kg of body weight per day.
To measure a dose less than 1 ml of oral solution for the child, pour about 5 ml of oral solution into the measuring cup and draw up the required volume with the supplied pipette. For example, for a 1-year-old child weighing 10 kg, the maintenance dose is 10 µg equal to 0.2 ml of oral solution.
Blood tests will be performed periodically, which will be used to determine selenium levels in the blood and monitor the success of treatment.
The following table shows the maximum daily doses for children in case of prolonged administration:
Age (years) Maximum tolerable intake level (µg selenium/day)
1-3 60
4-6 90
7-10 130
11-14 200
15-17 250

Dosage in patients with impaired renal or hepatic function
Your doctor will not prescribe a different dose if you suffer from kidney or liver disorders.
Method of administration:
selesyn oral solution is intended for self-administration.
Selenase 100 micrograms, oral solution
Detach a single-dose vial from the blister pack and open it by rotating the cap. Squeeze directly into the mouth the contents of the entire vial. In the case of a drinkable bottle, unscrew the screw cap and pour the contents directly into the mouth.
Selenase 500 micrograms, oral solution
Before use, the drinkable bottle must be prepared for use.

Figure 1:
To open the bottle, first rotate the screw cap clockwise while pushing down, to open the bottle with the integrated tip of the cap.
Figure 2:
Then rotate the cap counterclockwise.
Figure 3:
If you need to take 500 micrograms of selenium, pour the entire contents of the bottle into your mouth. If the doctor has prescribed a dose of less than 500 micrograms of selenium, pour the required dose in milliliters into the graduated measuring cup provided, carefully squeezing the bottle. Then close the bottle tightly.
Hold the liquid in your mouth for about 30 - 60 seconds before swallowing.
Duration of treatment:
Blood tests will be performed periodically, which will be used to determine selenium levels in the blood and monitor the success of treatment. Treatment with selesyn oral solution will end as soon as selenium levels return to normal values.
There is no limit to the administration of selesyn oral solution in the supplemental dose (100 micrograms of selenium per day is equivalent to 1 vial).

If you use more selesyn oral solution than you should
If you use more selesyn oral solution than you should, the following symptoms may occur:

• acute (short-term): garlic odor on the breath, fatigue, nausea, diarrhea, and abdominal pain, or
• chronic (long-term), with possible effects on the growth of nails and hair, as well as possible onset of peripheral polyneuropathy (a disorder affecting a nerve or nerve pathway that may be associated with numbness or tingling). If you forget to use selesyn oral solutionDo not use a double dose to make up for the missed dose. If you stop treatment with selesyn oral solutionThere are no special instructions in case of stopping treatment with selesyn oral solution. If you have any doubts about the use of selesyn oral solution, ask your doctor or pharmacist .

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.
If selesyn oral solution is used correctly, no side effects, so-called adverse reactions, have been reported.
However, if taken in excessive quantities, the medicine may cause the symptoms listed above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please inform your
doctor or pharmacist. You can also report side effects directly through the
national reporting system at
http://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 SELESYN ORAL SOLUTION

Keep this medicine out of the sight and reach of children.
Do not store selesyn oral solution at a temperature above 25° C.

• selesyn 100 micrograms, oral solution Use selesyn 100 micrograms, oral solution, immediately after opening the vial.
• selesyn 500 micrograms, oral solution Use selesyn 500 micrograms, oral solution, immediately after opening the drinkable bottle.

Do not use this medicine if the vial or the drinkable bottle is damaged or if the
solution is cloudy.
Discard any unused content.
Do not use this medicine after the expiry date which is stated on the label applied to the vial
or the drinkable bottle, and on the carton after “exp.”. The expiry date refers to the last day of
that month.
Do not dispose of any medicine in 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 contains selesynoral solution
The active ingredient is:
Sodium selenite pentahydrate
The other ingredients are:
Sodium chloride, hydrochloric acid, water for injections

• selesyn 100 mcg oral solution: Each 2 ml vial of oral solution contains 100 micrograms of selenium in the form of 333 micrograms of sodium selenite pentahydrate, corresponding to 50 micrograms/ml.
• selesyn 500 mcg oral solution: Each 10 ml drinkable bottle of oral solution contains 500 micrograms of selenium in the form of 1,665 micrograms of sodium selenite pentahydrate, corresponding to 50 micrograms/ml. Description of the appearance of selesynoral solution and package contentsDescription of the appearance of selesyn oral solution: selesyn oral solution is a clear and colorless solution.

Package contents:

• selesyn 100 micrograms oral solution: Plastic vials (LDPE), each containing 2 ml of oral solution. Pack sizes: 10, 20, 50, 60, 90 and 100 vials.
• selesyn 500 micrograms oral solution: Drinkable bottles with plastic closure (LDPE) with a polypropylene screw cap, each containing 10 ml of oral solution, a measuring cup and a dosing pipette. Pack sizes: 10, 20 and 50 bottles.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
biosyn Arzneimittel GmbH
Schorndorfer Strasse 32
70734 Fellbach
Germany

This medicinal product is authorized in the Member States of the European Economic Area with the
following denominations:
NL: selenase drank 100 µg, drank 50 µg/ml
selenase drank 500 µg, drank 50 µg/ml
HU: selesyn 100 mikrogramm, belsöleges oldat
selesyn 500 mikrogramm, belsöleges oldat
IE: selesyn 100 micrograms/2 ml, oral solution (50 micrograms/ml)
selesyn 500 micrograms/10 ml, oral solution (50 micrograms/ml)
IT: selesyn 100 mcg soluzione orale
selesyn 500 mcg soluzione orale
PT: selenase solução oral 100 microgramas
selenase solução oral 500 microgramas
SK: selenase perorálny roztok 100 µg, perorálny roztok 50 µg/ml
selenase perorálny roztok 500 µg, perorálny roztok 50 µg/ml
UK: selenase 100 micrograms, oral solution (50 micrograms/ml)
selenase 500 micrograms, oral solution (50 micrograms/ml)

selesyn 100 micrograms injectable solution (50 micrograms/ml)

100 micrograms of selenium per 2 ml of injectable solution

selesyn 500 micrograms injectable solution (50 micrograms/ml)

500 micrograms of selenium per 10 ml of injectable solution
Active ingredient: Sodium selenite pentahydrate

Read this leaflet carefully before using this medicine.

• 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. Do not give it to other people, even if their symptoms are the same as yours, as it could be harmful.
• If any of the side effects gets worse, or if you notice any side effect not listed in this leaflet, tell your doctor or pharmacist.

Contents of this leaflet:

• 1. What selesyn injectable solution is and what it is used for
• 2. Before using selesyn injectable solution
• 3. How to use selesyn injectable solution
• 4. Possible side effects
• 5. How to store selesyn injectable solution
• 6. Further information

1. WHAT IS SELESYN INJECTABLE SOLUTION AND WHAT IS IT USED FOR

selesyn soluzione iniettabile is a medicine that belongs to the group of mineral supplements. Sodium selenite pentahydrate, the active ingredient of the injectable solution, provides a source of selenium, an essential trace element in the diet, which allows metabolism to function efficiently.
Your doctor has recommended this medicine because tests performed to measure selenium levels in your blood have revealed a deficiency of this element, which cannot be corrected by taking selenium from normal food sources.

2. BEFORE USING SELESYN INJECTABLE SOLUTION

Do not use selesyninjectable solution

• if you are allergic (hypersensitive) to pentahydrate sodium selenite or any of the excipients of selesyn injectable solution.
• if you have selenosis (selenium poisoning). Take particular care with selesyninjectable solutionThere are no particular warnings or precautions for the use of selesyn injectable solution.

Taking selesyninjectable solution with other medicines
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines, including those available without a prescription.
Care must be taken not to mix the solution with reducing agents (e.g. vitamin C).

Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before using any medicine.
Pregnancy:
No data are available regarding the use of selesyn injectable solution in pregnant
women. No adverse effects of sodium selenite on pregnancy or the fetus are expected,
provided it is used in cases of proven selenium deficiency.
Breastfeeding:
Selenium is excreted in breast milk. However, it is not expected that the doses administered to
correct selenium deficiency in breastfeeding women will have adverse effects on the infant.

Driving and using machines
This medicine does not interfere with the ability to drive vehicles or use machines.

Important information about some excipients of selesyninjectable solution
selesyn injectable solution contains less than 1 mmol of sodium (23 mg) per ml, therefore it is
substantially “sodium-free”.

3. HOW TO USE SELESYN INJECTABLE SOLUTION

Always use selesyn injectable solution exactly as your doctor has instructed. If you have
any doubts, consult your doctor or pharmacist.
selesyn injectable solution is for single use only.
The usual daily dose is:

• 100 – 200 micrograms of selenium (equivalent to 1 or 2 vials of selesyn 100 mcg injectable solution, or 2 – 4 ml of selesyn 500 mcg injectable solution).

If blood test results indicate the need to take a larger amount
of selenium, your doctor may increase the dose to up to 500 micrograms of selenium (equivalent to 5
vials of selesyn 100 mcg injectable solution, or 1 vial of selesyn 500 mcg injectable
solution).
Method of administration:
selesyn injectable solution will be administered to you exclusively by a nurse or a doctor.
selesyn injectable solution is administered as an intramuscular injection (into the
muscle) or intravenously (into a vein).
Duration of treatment:
Blood samples will be taken periodically, which will be used to determine selenium levels
in the blood and monitor the success of the treatment. Treatment with selesyn
injectable solution will end as soon as selenium levels return to normal.
Dosage in children
In children, the doctor will prescribe a dose of 2 µg/kg of body weight per day at the start of
therapy and a maintenance dose of 1 µg/kg of body weight per day. Blood samples will be taken
periodically, which will be used to determine selenium levels in the
blood and monitor the success of the treatment.
The following table shows the maximum daily doses for children in case of
long-term administration:
Age (years) Maximum tolerable intake level (µg selenium/day)
1-3 60
4-6 90
7-10 130
11-14 200
15-17 250
Dosage in patients with impaired renal or hepatic function:
Your doctor will not prescribe a different dose if you suffer from kidney or liver disorders.

If you use more selesyninjectable solution than you should
If you use more selesyn injectable solution than you should, the following symptoms may occur:

• acute (short-term): garlic odor on the breath, fatigue, nausea, diarrhea, and abdominal pain, or
• chronic (long-term), with possible effects on the growth of nails and hair, as well as possible onset of peripheral polyneuropathy (a condition affecting a nerve or nerve pathway that may be associated with numbness or tingling). If you forget to use selesyninjectable solutionDo not use a double dose to make up for a missed injection. If you stop using selesyninjectable solutionThere are no special instructions in case of discontinuation of treatment with selesyn injectable solution. If you have any questions about the use of selesyn injectable solution, ask your doctor or pharmacist .

4. POSSIBLE SIDE EFFECTS

Like all medicines, selesyn injectable solution can cause side effects, although not everyone will experience them.
Frequency not known (cannot be estimated based on available data):
following intramuscular administration, you may feel pain at the site where the nurse or
doctor administered selesyn injectable solution.
However, if taken in excessive quantities, the medicine may give rise to the symptoms listed above.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, please
consult your doctor or pharmacist. You can also report side effects directly
through the national reporting system at
http://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 SELESYN INJECTABLE SOLUTION

Keep Selesyn injectable solution out of the reach and sight of children.
The nurse or doctor will administer this medicine to you immediately after opening the vials or
flasks.
The nurse or doctor will not administer this medicine to you if the vial or flask is damaged or if the solution is cloudy.
This medicine does not require any particular storage conditions.
Do not use Selesyn injectable solution after the expiry date which is stated on the label
applied to the vial or glass flask, and on the carton after “exp.”. The expiry date refers to the last day of the month.

6. FURTHER INFORMATION

What selesyn injectable solution containsinjectable solution
The active ingredient is:
Sodium selenite pentahydrate
The excipients are:
Sodium chloride, hydrochloric acid, water for injections

• selesyn 100 micrograms injectable solution: Each 2 ml vial of injectable solution contains 100 micrograms of selenium in the form of 333 micrograms of sodium selenite pentahydrate, corresponding to 50 micrograms/ml.
• selesyn 500 micrograms injectable solution: Each 10 ml vial of injectable solution contains 500 micrograms of selenium in the form of 1,665 micrograms of sodium selenite pentahydrate, corresponding to 50 micrograms/ml. Description of the appearance of selesyninjectable solution and contents of the packDescription of the appearance of selesyn injectable solution selesyn injectable solution is a clear and colorless solution.

Contents of the pack:

• selesyn 100 micrograms injectable solution: glass vials containing each 2 ml of injectable solution. Pack sizes: 5, 10 and 50 vials.
• selesyn 500 micrograms injectable solution: Vials, each containing 10 ml of injectable solution, are made of transparent glass closed with chlorobutyl rubber stoppers of metallic blue color and aluminum cap with PP disc in natural color, or closed with bromobutyl rubber stoppers of grey color and aluminum cap with grey PP disc. Pack sizes: 2 and 10 vials.

It is possible that not all pack sizes are marketed.

Marketing authorization holder and manufacturer
biosyn Arzneimittel GmbH
Schorndorfer Strasse 32
70734 Fellbach
Germany

This medicinal product is authorised in the Member States of the European Economic Area with the
following designations:
NL: selenase oplossing voor injectie 100 µg, oplossing voor injectie 50 µg/ml
selenase oplossing voor injectie 500 µg, oplossing voor injectie 50 µg/ml
CZ: selenase injekční roztok 500 µg, injekční roztok 50 µg/ml
HU: selesyn 100 mikrogramm, oldatos injekció
selesyn 500 mikrogramm, oldatos injekció
IE: selesyn 100 micrograms/2 ml, solution for injection (50 micrograms/ml)
selesyn 500 micrograms/10 ml, solution for injection (50 micrograms/ml)
IT: selesyn 100 mcg soluzione iniettabile
selesyn 500 mcg soluzione iniettabile
PT: selenase solução injectável 100 microgramas
selenase solução injectável 500 microgramas
SK: selenase injekčný roztok 100 µg, injekčný roztok 50 µg/ml
selenase injekčný roztok 500 µg, injekčný roztok 50 µg/ml
UK: selenase 100 micrograms, solution for injection (50 micrograms/ml)
selenase 500 micrograms, solution for injection (50 micrograms/ml)

Further information for personnel administering the medicinal product
When preparing a solution for infusion with selesyn injectable solution as
a supplement, it is necessary to ensure that the pH does not fall below 7.0 and that the solution is not
mixed with reducing agents (e.g. vitamin C), because elemental selenium precipitate may form.
For safety reasons, it is recommended to avoid nonspecific precipitation after mixing infusion solutions with selesyn injectable solution.
Elemental selenium is not soluble in aqueous medium and has no bioavailability.
When selesyn injectable solution is administered as a supplement to solutions for
total parenteral nutrition, a daily dose of 100
micrograms of selenium must be ensured (1 vial of selesyn 100 mcg injectable solution). There are no predetermined intervals to be observed for the possible administration of a supplementary dose of selesyn
injectable solution (100 micrograms of selenium per day = 1 vial of selesyn 100 mcg injectable
solution).
Selenium levels in whole blood or serum should be determined to monitor the success
of therapy.
selesyn injectable solution can be mixed with 0.9% NaCl.
This medicinal product does not require any special storage conditions.
The shelf life of selesyn injectable solution in unopened vials or ampoules is 4 years.
Dispose of any unused content.