Zadaxin
Italy
Table of Contents
Patient Information Leaflet
ZADAXIN 1.6 mg/ml powder and solvent for injectable solution
Thymosin alpha 1
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 or pharmacist.
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 may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.
Contents of this leaflet:
- What ZADAXIN is and what it is used for.
- What you need to know before using ZADAXIN.
- How to use ZADAXIN.
- Possible side effects.
- How to store ZADAXIN.
- Package contents and other information.
1. What ZADAXIN is and what it is used for
ZADAXIN is an adjuvant (i.e. it enhances the effectiveness) of influenza vaccination in individuals with a compromised immune system.
2. What you should know before taking ZADAXIN
Do not take ZADAXIN
- If you are allergic to the active substance or to any of the other components of this medicinal product (listed in section 6).
- If you are pregnant or breastfeeding (See section “Pregnancy and breastfeeding”).
Warnings and precautions
Talk to your doctor or pharmacist before taking ZADAXIN.
This product should be used with caution in individuals predisposed to hypersensitivity reactions or who have previously experienced allergic reactions. In patients with autoimmune diseases, administration of ZADAXIN should be evaluated on a case-by-case basis.
Children and adolescents
Do not use ZADAXIN in children and adolescents.
Other medicines and ZADAXIN
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Since this product affects the functions of white blood cells (lymphocytes), ZADAXIN should be administered with caution when used concomitantly with other immunomodulatory medicinal products.
ZADAXIN with food, beverages and alcohol
As of today, no interactions between this product and food, beverages or alcohol are known.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding with breast milk, do not take this medicinal product.
Driving and using machines
ZADAXIN has no effect on the ability to drive or operate machinery.
3. How to take ZADAXIN
Take this medicine exactly as instructed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
ZADAXIN is a medicine for subcutaneous or intramuscular injection.
The contents of each vial (1.6 mg) must be reconstituted with 1 ml of the provided solvent (sterile water for injectable preparations). The resulting solution should be clear and free of visible particles. The solution must be used within 24 hours after reconstitution.
ZADAXIN must not be mixed with other medicines.
Adults
Inject the contents of one vial by intramuscular or subcutaneous administration twice weekly 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 administration schedule, starting from the second influenza vaccination, i.e., between the eighth and twelfth week.
The recommended weekly dose is 900 micrograms per 1 m² of body surface area.
The following table shows body surface area values according to the subject's height and weight.
| HEIGHT (cm) | IDEAL WEIGHT (kg) | SURFACE AREA (m2) | DOSE (mg) | |||
| Male | Female | Male | Female | Male | Female | |
| 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 |
| 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 |
| 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 |
| 190 | 80.0 | 76.5 | 2.08 | 2.04 | 1.87 | 1.83 |
If you take more ZADAXIN than you should
Contact a doctor or the nearest hospital. In case of overdose, the patient should be admitted for observation and 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 using ZADAXIN
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.
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 effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at the following website:
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 ZADAXIN
Keep this medicine out of the sight and reach of children.
Store in a refrigerator between +2 and +8 °C.
Do not use this medicine after the expiry date stated on the carton. The expiry date refers to the last day of that month.
After reconstitution, under sterile conditions, with the solvent provided (water for injections), ZADAXIN must be used only once and within 24 hours; any unused solution must be discarded.
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 ZADAXIN contains
The active substance is thymosin alpha 1, also known as thymalfasin.
The other components are: mannitol, monobasic sodium phosphate monohydrate, dibasic sodium phosphate heptahydrate.
Description of the appearance of ZADAXIN and contents of the pack
Containers
Both the vial containing the lyophilized product and the ampoule containing the solvent are made of white neutral glass, hydrolytic class I.
Packaging
The packages of thymosin alpha-1 consist of one vial of lyophilized product containing 1.6 mg of active substance and one ampoule of 1 ml solvent (water for injectable preparations).
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
SciClone Pharmaceuticals Italy S.R.L.
Via Ombrone, 14
00198 Rome
Italy
Manufacturer for all steps except the solvent ampoule (water for injectable preparations)
Patheon Italia S.p.A.
Viale G. B. Stucchi, 110
20900 Monza (MB)
Italy
Manufacturer of water for injectable preparations, for primary packaging (including ampoule depyrogenation) and controls
Alfasigma S.p.A.
Via E. Fermi, 1
65020 Alanno (PE)
Italy
Manufacturer of water for injectable preparations, for primary packaging (excluding ampoule depyrogenation) and ampoule controls
Patheon Italia S.p.A.
Seconda traversa sinistra di Via Morolense, number 5
03013 Ferentino (FR)
Italy
Control site for depyrogenation, cartoning and release of ampoules
Patheon Italia S.p.A.
Viale G. B. Stucchi, 110
20900 Monza (MB)
Italy
Marketing Licensee
A. MENARINI Industrie Farmaceutiche Riunite s.r.l.
Via Sette Santi, 3 - Florence