Label: TEPADINA- thiotepa injection, powder, for solution

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Unapproved drug for use in drug shortage

Drug Label Information

Updated 12/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Thiotepa

    The following information is intended for medical or healthcare professionals only.

    PREPARATION GUIDE

    Read this guide prior to the preparation and administration of TEPADINA®.

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  • 1. PRESENTATION

    TEPADINA® is supplied as 100 mg powder for concentrate for solution for infusion.

    TEPADINA® must be reconstituted and diluted prior to administration.

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  • 2. SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING

    General

    Procedures for proper handling and disposal of anticancer medicinal products should be considered. All transfer procedures require strict adherence to aseptic techniques, preferably employing a vertical laminar flow safety hood.

    As with other cytotoxic compounds, caution need to be exercised in handling and preparation of TEPADINA® solutions to avoid accidental contact with skin or mucous membranes. Topical reactions associated with accidental exposure to thiotepa may occur. In fact, the use of gloves is recommended in preparing the solution for infusion. If thiotepa solution accidentally contacts the skin, immediately the skin must be thoroughly washed with soap and water. If thiotepa accidentally contacts mucous membranes, they must be flushed thoroughly with water.

    Calculation of dose of TEPADINA®

    TEPADINA® is administered at different doses in combination with other chemotherapeutic medicinal products in patients prior to conventional haematopoietic progenitor cell transplantation (HPCT) for haematological diseases or solid tumours.

    TEPADINA® posology is reported, in adult and paediatric patients, according to the type of HPCT (autologous or allogeneic) and disease.

    Posology in adults

    AUTOLOGOUS HPCT

    Haematological diseases

    The recommended dose in haematological diseases ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/day (8.10 mg/kg/day) as a single daily infusion, administered from 2 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 900 mg/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.

    LYMPHOMA

    The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 300 mg/m2/day (8.10 mg/ kg/day) as a single daily infusion, administered from 2 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 900 mg/m2 (24.32 mg/kg), during the time of the entire conditioning treatment.

    CNS LYMPHOMA

    The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before autologous HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.

    MULTIPLE MYELOMA

    The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.

    Solid tumours

    The recommended dose in solid tumours ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/ m2/day (6.76 mg/kg/day) divided in one or two daily infusions, administered from 2 up to 5 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 800 mg/m2 (21.62 mg/kg), during the time of the entire conditioning treatment.

    BREAST CANCER

    The recommended dose ranges from 120 mg/m2/day (3.24 mg/kg/day) to 250 mg/m2/day (6.76 mg/ kg/day) as a single daily infusion, administered from 3 up to 5 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 800 mg/m2 (21.62 mg/kg), during the time of the entire conditioning treatment.

    CNS TUMOURS

    The recommended dose ranges from 125 mg/m2/day (3.38 mg/kg/day) to 250 mg/m2/day (6.76 mg/ kg/day) divided in one or two daily infusions, administered from 3 up to 4 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.

    OVARIAN CANCER

    The recommended dose is 250 mg/m2/day (6.76 mg/kg/day) as a single daily infusion, administered in 2 consecutive days before autologous HPCT, without exceeding the total maximum cumulative dose of 500 mg/m2 (13.51 mg/kg), during the time of the entire conditioning treatment.

    GERM CELL TUMOURS

    The recommended dose ranges from 150 mg/m2/day (4.05 mg/kg/day) to 250 mg/m2/day (6.76 mg/ kg/day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 750 mg/m2 (20.27 mg/kg), during the time of the entire conditioning treatment.

    ALLOGENEIC HPCT

    Haematological diseases

    The recommended dose in haematological diseases ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 3 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 555 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.

    LYMPHOMA

    The recommended dose in lymphoma is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.

    MULTIPLE MYELOMA

    The recommended dose is 185 mg/m2/day (5 mg/kg/day) as a single daily infusion before allogeneic HPCT, without exceeding the total maximum cumulative dose of 185 mg/m2 (5 mg/kg), during the time of the entire conditioning treatment.

    LEUKEMIA

    The recommended dose ranges from 185 mg/m2/day (5 mg/kg/day) to 481 mg/m2/day (13 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 2 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 555 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.

    THALASSEMIA

    The recommended dose is 370 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 370 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.

    Posology in paediatric patients

    AUTOLOGOUS HPCT

    Solid tumours

    The recommended dose in solid tumours ranges from 150 mg/m2/day (6 mg/kg/day) to 350 mg/m2/day (14 mg/kg/day) as a single daily infusion, administered from 2 up to 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 1050 mg/m2 (42 mg/kg), during the time of the entire conditioning treatment.

    CNS TUMOURS

    The recommended dose ranges from 250 mg/m2/day (10 mg/kg/day) to 350 mg/m2/day (14 mg/kg/ day) as a single daily infusion, administered for 3 consecutive days before autologous HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 1050 mg/m2 (42 mg/kg), during the time of the entire conditioning treatment.

    ALLOGENEIC HPCT

    Haematological diseases

    The recommended dose in haematological diseases ranges from 125 mg/m2/day (5 mg/kg/day) to 250 mg/m2/day (10 mg/kg/day) divided in one or two daily infusions, administered from 1 up to 3 consecutive days before allogeneic HPCT depending on the combination with other chemotherapeutic medicinal products, without exceeding the total maximum cumulative dose of 375 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.

    LEUKEMIA

    The recommended dose is 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.

    THALASSEMIA

    The recommended dose ranges from 200 mg/m2/day (8 mg/kg/day) to 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.

    REFRACTORY CYTOPENIA

    The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 3 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 375 mg/m2 (15 mg/kg), during the time of the entire conditioning treatment.

    GENETIC DISEASES

    The recommended dose is 125 mg/m2/day (5 mg/kg/day) as a single daily infusion, administered for 2 consecutive days before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.

    SICKLE CELL ANAEMIA

    The recommended dose is 250 mg/m2/day (10 mg/kg/day) divided in two daily infusions, administered before allogeneic HPCT, without exceeding the total maximum cumulative dose of 250 mg/m2 (10 mg/kg), during the time of the entire conditioning treatment.

    Reconstitution

    TEPADINA® must be reconstituted with 10 ml of sterile water for injections.
    Using a syringe fitted with a needle, aseptically withdraw 10 ml of sterile water for injections.
    Inject the content of the syringe into the vial through the rubber stopper.
    Remove the syringe and the needle and mix manually by repeated inversions.
    Only clear colourless solutions, without any particulate matter, must be used.

    Further dilution in the infusion bag

    The reconstituted solution is hypotonic and must be further diluted prior to administration with 500 ml sodium chloride 9 mg/ml (0.9 %) solution for injection (1000 ml if the dose is higher than 500 mg) or with an appropriate volume of sodium chloride 9 mg/ml (0.9 %) in order to obtain a final TEPADINA®concentration between 0.5 and 1 mg/ml.

    Administration

    TEPADINA® infusion solution should be inspected visually for particulate matter and opalescence prior to administration. Solutions containing a precipitate should be discarded.

    It is recommended that the infusion solution be administered to patients using an infusion set equipped with a 0.2 µm in-line filter.

    TEPADINA® should be aseptically administered as a 2 - 4 hours infusion under room temperature and normal light conditions.

    Prior to and following each infusion, the indwelling catheter line should be flushed with approximately 5 ml sodium chloride 9 mg/ml (0.9 %) solution for injection.

    Disposal

    TEPADINA® is for single use only.
    Any unused product or waste material should be disposed of in accordance with local requirements.

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  • PACKAGE LEAFLET: INFORMATION FOR THE USER

    TEPADINA® 100 mg
    powder for concentrate for solution for infusion
    Thiotepa

    Read all of this leaflet carefully before you start using this medicine.

    -
    Keep this leaflet. You may need to read it again.
    -
    If you have any further questions, ask your doctor.
    -
    If any of the side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

    In this leaflet:

    1. What TEPADINA® is and what it is used for
    2. Before you use TEPADINA®
    3. How to use TEPADINA®
    4. Possible side effects
    5. How to store TEPADINA®
    6. Further information

    1. WHAT TEPADINA® IS AND WHAT IT IS USED FOR

    TEPADINA® contains the active substance thiotepa, which belongs to a group of medicines called alkylating agents.

    TEPADINA® is used to prepare patients for bone marrow transplantation. It works by destroying bone marrow cells. This enables the transplantation of new bone marrow cells (haematopoietic progenitor cells), which in turn enable the body to produce healthy blood cells. TEPADINA® can be used in adults and children.

    2. BEFORE YOU USE TEPADINA®

    Do not use TEPADINA®

    -
    if you are allergic (hypersensitive) to thiotepa,
    -
    if you are pregnant or think you may be pregnant (see below),
    -
    if you are breast-feeding,
    -
    if you are receiving yellow fever vaccination, live virus and bacterial vaccines.

    Take special care with TEPADINA®

    You should tell your doctor if you have:

    -
    liver or kidney problems,
    -
    heart or lung problems,
    -
    seizures/fits (epilepsy) or have had them in the past (if treated with phenytoin or fosphenytoin).

    You will have to take regular blood tests during treatment to check your blood cell counts.

    You will have to use anti-infectives to prevent and manage infections.

    TEPADINA® may cause another type of cancer in the future. Your doctor will discuss this risk with you.

    Pregnancy and breast-feeding

    You must tell your doctor if you are or think you may be pregnant before you receive TEPADINA® . You must not use TEPADINA® during pregnancy.

    Both women and men using TEPADINA® must use effective contraceptive methods during treatment.

    It is not known whether this medicinal product is excreted in breast milk. As a precautionary measure, women must not breast-feed during treatment with TEPADINA® .

    TEPADINA® can impair male and female fertility. Male patients should seek for sperm preservation before therapy is started and should not father while treated and during the year after cessation of treatment.

    Using other medicines

    Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

    3. HOW TO USE TEPADINA®

    Your doctor will calculate the dose according to your body surface or weight and your disease.

    How TEPADINA® is given

    TEPADINA® is administered by a qualified healthcare professional as an intravenous infusion (drip in a vein) after dilution of the individual vial. Each infusion will last 2 - 4 hours.

    Frequency of administration

    You will receive your infusions every 12 or 24 hours. The duration of treatment can last up to 3 days. Frequency of administration and duration of treatment depend on your disease.

    4. POSSIBLE SIDE EFFECTS

    Like all medicines, TEPADINA® can cause side effects, although not everybody gets them.

    The most serious side effects of TEPADINA® therapy or the transplant procedure may include

    -
    decrease in circulating blood cell counts (intended effect of the medicine to prepare you for your transplant infusion)
    -
    infection
    -
    liver disorders including blocking of a liver vein
    -
    the graft attacks your body (graft versus host disease)
    -
    respiratory complications

    Your doctor will monitor your blood counts and liver enzymes regularly to detect and manage these events.

    Side effects of TEPADINA® may occur with certain frequencies, which are defined as follows:

    • very common: affects more than 1 user in 10
    • common: affects 1 to 10 users in 100
    • uncommon: affects 1 to 10 users in 1,000
    • rare: affects 1 to 10 users in 10,000
    • very rare: affects less than 1 user in 10,000
    • not known: frequency cannot be estimated from the available data.

    Very common side effects

    -
    increased susceptibility to infection
    -
    whole-body inflammatory state (sepsis)
    -
    decreased counts of white blood cells, platelets and red blood cells (anaemia)
    -
    the transplanted cells attack your body (graft versus host disease)
    -
    dizziness, headache, blurred vision
    -
    uncontrolled shaking of the body (convulsion)
    -
    sensation of tingling, pricking or numbness (paraesthesia)
    -
    partial loss of movement
    -
    cardiac arrest
    -
    nausea, vomiting, diarrhoea
    -
    inflammation of the mucosa of the mouth (mucositis)
    -
    irritated stomach, gullet, intestine
    -
    inflammation of the colon
    -
    anorexia, decreased appetite
    -
    high glucose in the blood
    -
    skin rash, itching, shedding
    -
    skin colour disorder (do not confuse with jaundice - see below)
    -
    redness of the skin (erythema)
    -
    hair loss
    -
    back and abdominal pain, pain
    -
    muscle and joint pain
    -
    abnormal electrical activity in the heart (arrhythmia)
    -
    inflammation of lung tissue
    -
    enlarged liver
    -
    altered organ function
    -
    blocking of a liver vein (VOD)
    -
    yellowing of the skin and eyes (jaundice)
    -
    hearing impaired
    -
    lymphatic obstruction
    -
    high blood pressure
    -
    increased liver, renal and digestive enzymes
    -
    abnormal blood electrolytes
    -
    weight gain
    -
    fever, general weakness, chills
    -
    bleeding (haemorrhage)
    -
    nasal bleeding
    -
    general swelling due to fluid retention (oedema)
    -
    pain or inflammation at the injection site
    -
    eye infection (conjunctivitis)
    -
    decreased sperm cell count
    -
    vaginal bleeding
    -
    absence of menstrual periods (amenorrhea)
    -
    memory loss
    -
    delaying in weight and height increase
    -
    bladder disfunction
    -
    underproduction of testosterone
    -
    insufficient production of thyroid hormone
    -
    deficient activity of the pituitary gland
    -
    confusional state

    Common side effects

    -
    anxiety, confusion
    -
    abnormal bulging outward of one of the arteries in the brain (intracranial aneurysm)
    -
    creatinine elevated
    -
    allergic reactions
    -
    occlusion of a blood vessel (embolism)
    -
    heart rhythm disorder
    -
    heart inability
    -
    cardiovascular inability
    -
    oxygen deficiency
    -
    fluid accumulation in the lungs (pulmonary oedema)
    -
    pulmonary bleeding
    -
    respiratory arrest
    -
    blood in the urine (haematuria) and moderate renal insufficiency
    -
    inflammation of the urinary bladder
    -
    discomfort in urination and decrease in urine output (disuria and oliguria)
    -
    increase in the amount of nitrogen components in the blood stream (BUN increase)
    -
    cataract
    -
    inability of the liver
    -
    cerebral haemorrhage
    -
    cough
    -
    constipation and upset stomach
    -
    obstruction of the bowel
    -
    perforation of stomach
    -
    changes in muscle tone
    -
    gross lack of coordination of muscle movements
    -
    bruises due to a low platelet count
    -
    menopausal symptoms
    -
    cancer (second primary malignancies)
    -
    abnormal brain function

    Uncommon side effects

    -
    inflammation and exfoliation of the skin (erythrodermic psoriasis)
    -
    delirium, nervousness, hallucination, agitation
    -
    gastrointestinal ulcer
    -
    inflammation of the muscular tissue of the heart (myocarditis)
    -
    abnormal heart condition (cardiomyopathy)
    -
    male and female infertility

    If any of the side effects gets serious, or if you notice any side effects not mentioned in this leaflet, please tell your doctor or nurse.

    5. HOW TO STORE TEPADINA®

    Keep out of the reach and sight of children.

    Do not use TEPADINA® after the expiry date which is stated on the carton and vial label, after EXP. The expiry date refers to the last day of that month.

    Store and transport refrigerated (2 °C - 8 °C).
    Do not freeze.

    After reconstitution the product is stable for 8 hours when stored at 2 °C - 8 °C.

    After dilution the product is stable for 24 hours when stored at 2 °C - 8 °C and for 4 hours when stored at 25 °C. From a microbiological point of view, the product should be used immediately.

    Any unused product or waste material should be disposed of in accordance with local requirements.

    6. FURTHER INFORMATION

    What TEPADINA® contains

    -
    The active substance is thiotepa. One vial contains 100 mg thiotepa. After reconstitution, each ml contains 10 mg thiotepa (10 mg/ml).
    -
    TEPADINA ® does not contain any other ingredients.

    What TEPADINA® looks like and contents of the pack

    TEPADINA® is a white crystalline powder supplied in a glass vial containing 100 mg thiotepa.
    Each carton contains 1 vial.

    Marketing Authorisation Holder
    ADIENNE S.r.l.
    Via Broseta 64/B
    24128 Bergamo
    Italy

    +39 035 19964047
    adienne@adienne.com

    Manufacturer
    RIEMSER Arzneimittel AG
    7 An der Wiek
    17493 Greifswald
    Insel Riems
    Germany

    For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

    België/Belgique/Belgien
    Eurocept International B.V.
    Trapgans 5
    NL-1244 RL, Ankeveen
    Tél/Tel: +31-35 5283 957
    info@eurocept.nl

    Luxembourg/Luxemburg
    Eurocept International B.V.
    Trapgans 5
    NL-1244 RL, Ankeveen
    Tél/Tel: +31-35 5283 957
    info@eurocept.nl

    България
    S&D Chemicals (Bulgaria) Ltd.
    36, Dragan Tzankov blvd.
    World Trade Center bl.B, офис 502
    София BG 1057
    Teл.: +359- (0) 2 971 21 30
    info@sndchemicals.bg

    Magyarország
    Medical Maximum
    Hegedus Gy. u. 93/D 8/3.
    H-1133 Budapest
    Tel.: + 36- (6) 302 510 086
    sales@med-max.com

    Česká republika
    CSC Pharmaceuticals Handels GmbH
    Gewerbegebiet Klein-Engersdorf
    Gewerbestrasse 18-20
    A-2102 Bisamberg
    Tel: +43- (0) 2 262 606-0
    office@csc-pharma.com

    Malta
    ADIENNE S.r.l.
    Via Broseta 64/B
    I-24128 Bergamo
    Tel: +39-035 199 64047
    adienne@adienne.com

    Danmark
    Eurocept International B.V.
    Trapgans 5
    NL-1244 RL, Ankeveen
    Tlf: +31-35 5283 957
    info@eurocept.nl

    Nederland
    Eurocept International B.V.
    Trapgans 5
    NL-1244 RL, Ankeveen
    Tel: +31-(0)35 5283 957
    info@eurocept.nl

    Deutschland
    RIEMSER Arzneimittel AG
    An der Wiek 7
    D - 17493 Greifswald - Insel Riems
    Tel: +49- (0) 38 351 76-0
    info@riemser.de

    Norge
    Eurocept International B.V.
    Trapgans 5
    NL-1244 RL, Ankeveen
    Tlf: +31-35 5283 957
    info@eurocept.nl

    Eesti
    RIEMSER Arzneimittel AG
    An der Wiek 7
    D - 17493 Greifswald - Insel Riems
    Tel: +49-(0) 38 351 76-0
    info@riemser.de

    Österreich
    Amomed Pharma
    Nikolsdorfergasse 1/15
    A- 1050 Wien
    Tel: + 43- (0) 1 545 01 13 0
    office@amomed.com

    Ελλάδα
    aVIPHARMA International S.A.
    Μεσογείων 43
    GR-151 26 Μαρούσι-Αθήνα
    Τηλ: +30-210 6194 170
    info@avipharma.gr

    Polska
    IMED POLAND Sp. z o.o.
    314, Pulawska Str.
    02-819 Warsaw
    Tel: +48 - (0) 22 663 43 10
    imed@imed.com.pl

    España
    ADIENNE SPAIN S.L.
    Passeig del Canal 5, Local 4
    E-08980 Sant Feliu de Llobregat - Barcelona
    Tel: +34 93.666.25.61
    adiennespain@adienne.com

    Portugal
    ADIENNE S.r.l.
    Via Broseta 64/B
    I-24128 Bergamo
    Tel: +39-035 199 64047
    adienne@adienne.com

    France
    RIEMSER Arzneimittel AG
    An der Wiek 7
    D - 17493 Greifswald - Insel Riems
    Tél: +49 (0) 38 351 76-0
    info@riemser.de

    România
    Romfarmachim S.A. Foreign Trade Co.
    Intrarea Costache Negri no.11, Sector 5
    București 050554 - RO
    Tel: + 40- (0) 21 3166284
    romfarmachim@rdsmail.ro

    Ireland
    ADIENNE S.r.l.
    Via Broseta 64/B
    I-24128 Bergamo
    Tel: +39-035 199 64047
    adienne@adienne.com

    Slovenija
    Medis, d.o.o.
    Brnčičeva 1
    SI-1001 - Ljubljana
    Tel: +386- (0) 1 561 21 19
    info@medis.si

    Ísland
    Eurocept International B.V.
    Trapgans 5
    NL-1244 RL, Ankeveen
    Sími: +31-35 5283 957
    info@eurocept.nl

    Slovenská republika
    CSC Pharmaceuticals Handels GmbH
    Gewerbegebiet Klein-Engersdorf
    Gewerbestrasse 18-20
    A-2102 Bisamberg
    Tel: +43-(0)2 262 606-0
    office@csc-pharma.com

    Italia
    ADIENNE S.r.l.
    Via Broseta 64/B
    I-24128 Bergamo
    Tel: +39-035 199 64047
    adienne@adienne.com

    Suomi/Finland
    Eurocept International B.V.
    Trapgans 5
    NL-1244 RL, Ankeveen
    Puh/Tel: +31-35 5283 957
    info@eurocept.nl

    Κύπρος
    aVIPHARMA International S.A.
    Μεσογείων 43
    GR-151 26 Μαρούσι-Αθήνα
    Τηλ: +30-210 6194 170
    info@avipharma.gr

    Sverige
    Eurocept International B.V.
    Trapgans 5
    NL-1244 RL, Ankeveen
    Tel: +31-35 5283 957
    info@eurocept.nl

    Latvija
    PEAN Ltd.
    Duntes 12/22
    Rīga LV 1005
    Tel: + 371- 67392500
    pean@mailbox.riga.lv

    United Kingdom
    ADIENNE S.r.l.
    Via Broseta 64/B
    I-24128 Bergamo
    Tel: +39-035 199 64047
    adienne@adienne.com

    Lietuva
    UAB Armila
    Ateities 10
    LT 08303 Vilnius
    Tel: +370- (0) 5 2777596
    info@armila.com

    This leaflet was last approved in:

    Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu

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  • PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton

    TEPADINA® 100 mg

    Powder for concentrate for solution for infusion

    Thiotepa
    1 vial

    Intravenous use, after reconstitution and dilution.

    ADIENNE
    PHARMA & BIOTECH

    PRINCIPAL DISPLAY PANEL - 100 mg Vial Carton
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  • INGREDIENTS AND APPEARANCE
    TEPADINA 
    thiotepa injection, powder, for solution
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:53964-002
    Route of Administration INTRAVENOUS DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    THIOTEPA (THIOTEPA) THIOTEPA 100 mg
    Product Characteristics
    Color WHITE Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:53964-002-02 1 in 1 BOX
    1 1 in 1 VIAL, GLASS
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG FOR USE IN DRUG SHORTAGE 04/05/2011
    Labeler - ADIENNE SA (486304103)
    Establishment
    Name Address ID/FEI Business Operations
    IDT Australia Limited 753286384 API MANUFACTURE(53964-002)
    Establishment
    Name Address ID/FEI Business Operations
    THYMOORGAN PHARMAZIE GmbH 319029989 MANUFACTURE(53964-002), ANALYSIS(53964-002)
    Establishment
    Name Address ID/FEI Business Operations
    LABOR L+S AG 313710642 ANALYSIS(53964-002)
    Establishment
    Name Address ID/FEI Business Operations
    BioChem GmbH 318354230 ANALYSIS(53964-002)
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