Jak stosować TSADAXIN
Treść ulotki
ZADAXIN 1.6 mg/ml powder for injectable solution
Thymosin alpha 1
Read this leaflet carefully before you start to use 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 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 may 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 ZADAXIN is and what it is used for.
- 2. What you need to know before you use ZADAXIN.
- 3. How to use ZADAXIN.
- 4. Possible side effects.
- 5. How to store ZADAXIN.
- 6. Contents of the pack and other information.
1. What is ZADAXIN and what is it used for
ZADAXIN is an adjuvant medicine (i.e. it increases its effectiveness) for anti-
influenza vaccination in individuals with a compromised immune system.
2. What you need to know before you take ZADAXIN
Do not take ZADAXIN
- If you are allergic to the active substance or to any of the other ingredients of this medicine (listed in section 6).
- If you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).
Warnings and precautions
Consult your doctor or pharmacist before taking ZADAXIN.
The product should be used with caution in subjects predisposed to hypersensitivity
reactions, or who have had allergic reactions previously. In the case of
subjects affected by autoimmune diseases, the administration of ZADAXIN must be
evaluated on a case-by-case basis.
Children and adolescents
Do not use ZADAXIN in children and adolescents.
Other medicines and ZADAXIN
Tell your doctor or pharmacist if you are taking, have recently taken, or might
take any other medicine.
Since the product acts on the functions of white blood cells (lymphocytes), ZADAXIN
should be administered with caution simultaneously with other medicinal
products with immunomodulatory effects.
ZADAXIN with food, beverages and alcohol
To date, no interactions of the product with food, beverages and alcohol are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are
breastfeeding, do not take this medicine.
Driving and operating machinery
ZADAXIN has no effect on the ability to drive and operate machinery.
3. How to take ZADAXIN
Take this medicine following exactly the instructions of your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
ZADAXIN is a medicine for subcutaneous or intramuscular injections.
The contents of each vial (1.6 mg) must be reconstituted with 1 ml of the diluent (sterile water for injectable preparations) provided. The resulting solution must be
transparent without visible particles. The solution must be used within 24 hours of
reconstitution.
ZADAXIN must not be mixed with other medicines.
Adults
Inject the contents of one vial, by intramuscular or subcutaneous route, twice a week, for a period of four weeks, starting from the date of the first
influenza vaccination (time 0). Repeat the treatment, using the same dose and
frequency of administration, starting from the second influenza vaccination,
i.e. during the period from the eighth to the twelfth week.
The recommended weekly dose is 900 micrograms per 1 m of body surface area.
The following table shows the values of the body surface area as a function of the
height and weight of the subject.
| HEIGHT (cm) | z n IDEAL WEIGHT (kg) | SURFACE AREA (m2) | DOSE (mg) | |||
| Males | Females | Males | Females | Males | Females | |
| e 155 | 53.8 | 50.3 | 1.51 | 1.47 | 1.36 | 1.32 |
| 160 | 57.5 | 54.0 | 1.59 | 1.55 | 1.43 | 1.40 |
| g 165 | 61.3 | 57.8 | 1.67 | 1.63 | 1.51 | 1.47 |
| 170 | 65.0 | 61.5 | 1.75 | 1.71 | 1.58 | 1.54 |
| A 175 | 68.8 | 65.3 | 1.83 | 1.79 | 1.65 | 1.61 |
| 180 | 72.5 | 69.0 | 1.91 | 1.87 | 1.72 | 1.69 |
| 185 | 76.3 | 72.8 | 2.00 | 1.96 | 1.80 | 1.76 |
If you take more ZADAXIN than you should,
contact a doctor or the nearest hospital. In case of overdose, the patient must be
hospitalized for observation, and must receive appropriate treatment.
If you forget to take ZADAXIN,
do not take a double dose to make up for the missed dose.
If you stop taking ZADAXIN
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everyone will experience them.
The administration of ZADAXIN may occasionally cause temporary pain at the injection site; no other clinically relevant reactions are known.
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:
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 ZADAXIN
Keep this medicine out of the sight and reach of children.
Store in a refrigerator between +2 and +8 °C.
Do not use the medicine after the expiry date which is stated on the pack. The expiry date
refers to the last day of that month.
After reconstitution, under sterile conditions, with the diluent (water for injections)
provided, ZADAXIN must be used only once and within 24 hours; any unused solution must be
discarded.
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. Contents of the pack and other information
What ZADAXIN contains
The active ingredient is thymosin alpha 1, also known as thymalfasin.
The other ingredients are: mannitol, sodium phosphate monobasic monohydrate, sodium phosphate
dibasic heptahydrate.
Description of the appearance of ZADAXIN and contents of the pack
| 190 | 80.0 | 76.5 | 2.08 | 2.04 | 1.87 | 1.83 |
Containers
Both the vial containing the lyophilized product and the vial containing the solvent are made of
neutral white glass, hydrolytic class I.
Packs
The packs of thymosin alpha-1 consist of a vial of lyophilized product
containing 1.6 mg of active ingredient and a vial of 1 ml of solvent (water for
injections).
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
SciClone Pharmaceuticals Italy S.R.L.
Via Lisbona, 11
00198 Rome
Italy
Manufacturer for all stages except for the diluent vial (water for injections)
Patheon Italia S.p.A.
Viale G. B. Stucchi, 110
20900 Monza (MB)
Italy
Manufacturer of water for injections, for primary packaging (including
sealing of the vials) and for controls.
Alfa Wassermann S.p.A.
Via E. Fermi, 1
65020 Alanno (PE)
Italy
Manufacturer of water for injections, for primary packaging (excluding
sealing of the vials) and vial controls.
Patheon Italia S.p.A.
Seconda traversa sinistra di Via Morolense, numero civico 5
03013 Ferentino (FR)
Italy
Control laboratory for sealing, packaging and release of vials.
Patheon Italia S.p.A.
Viale G. B. Stucchi, 110
20900 Monza (MB)
Italy
Sales distributor
Biofutura pharma S.p.A.
Via Pontina km 30,4
00040 Pomezia (RM)
Italy

- Kraj rejestracji
- Postać farmaceutycznaPowder and solvent for injectable solution, 1.6 MG/ML
- Wymaga receptyTak
- Producent
- Te treści mają charakter wyłącznie informacyjny i nie zastępują konsultacji lekarskiej.
- Zamienniki TSADAXINPostać farmaceutyczna: Granules, 800 MGSubstancja czynna: pidotimodProducent: POLICHEM S.R.L.Wymaga receptyPostać farmaceutyczna: Powder and solvent for intravesical suspension, 50 mlSubstancja czynna: BCG vaccineBez receptyPostać farmaceutyczna: Powder and solvent for intravenous infusion solution, 1 MGSubstancja czynna: tasonerminProducent: BELPHARMA S.A.Wymaga recepty
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TSADAXIN wymaga recepty w Włochy. Możesz skonsultować się z lekarzem online, aby sprawdzić, czy ten lek może być odpowiedni w Twojej sytuacji.
TSADAXIN jest produkowany przez SCICLONE PHARMACEUTICALS ITALY S.R.L.. Nazwy handlowe i opakowania mogą się różnić w zależności od dystrybutora.
Lekarze, tacy jak Lekarze rodzinni, Psychiatrzy, Dermatolodzy, Kardiolodzy, Endokrynolodzy, Gastroenterolodzy, Pulmonolodzy, Nefrolodzy, Reumatolodzy, Hematolodzy, Zakaźnicy, Alergolodzy, Geriatrzy, Pediatrzy, Onkolodzy, mogą ocenić, czy stosowanie TSADAXIN jest odpowiednie w Twoim przypadku, w zależności od sytuacji klinicznej i lokalnych przepisów. Możesz umówić konsultację online, aby omówić objawy i możliwe dalsze kroki.
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Możesz kupić TSADAXIN w Warszawie, Krakowie, Wrocławiu lub Gdańsku w każdej aptece, posiadając ważną receptę.
Aby uzyskać receptę, możesz skorzystać z Oladoctor:
Inne leki zawierające tę samą substancję czynną () to m.in. AXIL, BKG MEDAK, BEROMUN. Mogą one różnić się nazwą handlową lub postacią, ale zawierają ten sam składnik terapeutyczny. Przed zmianą lub rozpoczęciem nowego leku skonsultuj się z lekarzem.
















