Download NovoSeven®RT (Room Temperature) stable

NovoSeven®RT (Room Temperature) stable
NovoSeven®RT can be stored in or out of the refrigerator
UP TO 25°C
• NovoSeven®RT is convenient to store and transport, as it does not
require refrigeration
• It can be stored at room temperature (up to 25°C) or in the refrigerator for
up to 2 years
0
1
2
YEAR
YEARS
Injection volumes are 40% smaller
• A higher concentration of NovoSeven®RT (1 mg = 1 ml reconstituted product)
makes injection volumes 40% smaller for equivalent doses compared with the
original formulation
Original formulation
NovoSeven®RT has a dedicated solvent for reconstitution
New formulation
40% Lower volume
NovoSeven®RT vials
Round-number vial sizes
• NovoSeven®RT is supplied in round-number vials of 1, 2 and 5 mg
- These replace the original formulation vials of 1.2 mg, 2.4 mg & 4.8 mg
- The new vial sizes make it easier to calculate doses
- The vials are colour-coded and match the corresponding solvent vials
1 mg
2 mg
5 mg
• NovoSeven®RT is available in two dosing regimens:
Solvent vials
- 90 µg/kg administered as multiple doses
- 270 µg/kg administered as a single dose (Adults ≥ 18yrs in Australia)
• Dosing varies by type of bleeding episode and indication; see the
Prescribing Information for details
Example of reduced infusion volume
Example of simplified dose calculation
Treatment
Single-dose
270 µg/kg
Treatment
Multiple dose 90 µg/kg
70 kg person
Dose 18.9 mg
Original
formulation
31.5
ml
(0.6 mg/ml)
NovoSeven® RT
18.9
40 kg person
Original
formulation
Dose
3.6 mg
Total volume after
reconstitution
6.0 ml
ml
(1 mg/ml)
NovoSeven® RT
3.6
3.6
mg
ml
Ordering Made Easier With Separate Drug And Infusion Kits
• The ordering process is similar to the original formulation of NovoSeven®
• Drug and solvent for NovoSeven®RT are packaged together
• Reconstitution and administration devices are supplied separately which allows
orders to be tailored to meet patient or hospital needs. One infusion set is
needed per dose.
Portable, Durable Travel Case Keeps Supplies Together
• The NovoSeven®RT Travel Case keeps together all the supplies needed for
treatment of a single bleed away from home
• Patients have the confidence that their treatment is always at hand, even away
from home
eptacog alfa (activated) (bhk)
CLIENT
DESCRIPTION
vibe WT
Novo Nordisk
Summary Haemophilia
v0537
CODE
KNIFE
DIMENSIONS
COLOURS
21.01.09
PROCESS
CYAN
vibe integrated creative
DATE
210mm x 297mm
PROCESS
MAGENTA
PROCESS
YELLOW
PROCESS
BLACK
PANTONE
280 C
S u i t e 4 0 4 · L e v e l 4 · 1 2 C e n t u r y C i r c u i t · N o r w e s t B u s i n e s s C e n t r e · B a u l k h a m H i l l s N S W 2 1 5 3 · T 0 2 8 8 5 0 5 4 5 5 · F 0 2 8 8 5 0 6 1 6 6 · W w w w. i m s g r o u p . c o m . a u
MINIMUM PRODUCT INFORMATION* - NovoSeven®RT (eptacog alfa (activated) (bhk))
Active Ingredient: Each pack contains a single use glass vial of 1.0 mg (50,000IU), 2.0 mg (100,000IU) or 5.0 mg (250,000IU) recombinant coagulation
factor VIIa (rFVIIa) lyophilised powder and a solvent vial. Reconstitute each vial of NovoSeven RT with the specified volume of solvent provided. Do not
use water for injections. The specified volume of Histidine solvent required is as follows: 1.0 mg vial + 1.1 mL solvent, 2.0 mg vial + 2.1 mL solvent , 5.0
mg vial + 5.2 mL solvent. After reconstitution each vial contains 1.0 mg/mL rFVIIa. Storage: Store lyophilised NovoSeven RT below 25o C. Reconstituted
NovoSeven RT should be used immediately. If storage is necessary, hold at 2-8o C for not more than 24 hours (not in syringe). Indications: Control of
bleeding and surgery prophylaxis in patients with inhibitors to coagulation factors FVIII or FIX; congenital FVII deficiency; or Glanzmann’s Thrombasthenia. See full Product Information/Data Sheet for restrictions on use. Contraindications: Known hypersensitivity to NovoSeven, any of the components
of NovoSeven, to mouse, hamster or bovine proteins. Precautions: Maintain vigilance for untoward coagulation/thrombosis. Thrombogenic potential or
induction of DIC is possible in conditions associated with circulating tissue factor. FVII deficient patients should be monitored for prothrombin time and
FVII coagulant activity before and after administration of NovoSeven. Risk of potential interaction with coagulation factor concentrates is unknown –
avoid simultaneous use of prothrombin complex concentrates. Do not mix with infusion solutions or administer NovoSeven by infusion. Adverse
Reactions: (Clinical Trials) fever, haemorrhage, fibrinogen plasma decreased, haemarthrosis, hypertension. (Post marketing) (each <1/10000) DIC,
myocardial infarction, CVA and cerebral ischaemia, arterial and venous thrombotic events. Development of inhibitors for FVII has been reported in a
small number of patients after treatment with rFVIIa. Dosage and Administration: The following is a guide only. Please review full Product
Information/Data Sheet for country- and age-specific dosage information. Duration of self-administered treatment should not exceed 24 hours. Administered as i.v. bolus injection over 2 - 5 minutes. Patients with inhibitors to factors VIII or IX: Control of Bleeding: 35-120 µg/kg every 2-3 hours until
control achieved, then every 3-12 hours if necessary. In mild to moderate bleeding episodes two dosing regimens can be recommended: (i) 2 to 3
injections of 90 µg/kg body weight administered at three-hour intervals; or (ii) in adults (>18 years) one single injection of 270 µg/kg body weight.
Bleeding Prophylaxis: patients with a high bleeding frequency defined as 4 or more bleeding episodes/month can be treated with a once-daily dose of
90 µg/kg body weight for up to 3 months to reduce bleeding frequency. Surgical Prophylaxis: 35-120 µg/kg every 2-3 hours for 1-2 days, then every 2-6
hours if necessary. FVII deficiency: 15-30µg/kg body weight every 4-6 hours until haemostasis is achieved. Dose and frequency of injections should be
individually titrated. Glanzmann’s Thrombasthenia: 80-120 µg/kg body weight at maximum intervals of 2.5 hours. At least three doses are
recommended to secure effective haemostasis. The prophylaxis of invasive/surgical procedures may require a more prolonged use of NovoSeven.
Dosing in Children: No general differentiation in dosing between children and adults required but due to faster clearance, higher doses of rFVIIa may
be needed in children to achieve similar plasma concentrations as in adult.
Australia: Before prescribing, please review full Product Information.
PBS Information: NovoSeven is not listed on the PBS
NovoSeven® is funded by the National Blood Authority for the control of bleeding in patients with haemophilia with inhibitors and for
patients with rare bleeding disorders. Please refer to the National Blood Authority for details.
Further information is available from Novo Nordisk Customer Care Centre (Australia) 1800 668 626. Novo Nordisk Pharmaceuticals Pty Ltd. ABN 40
002 879 996. Level 3, 21 Solent Circuit, Baulkham Hills NSW 2153. www.novonordisk.com.au
New Zealand: NovoSeven® is a prescription medicine and is not listed on the Pharmaceutical Schedule. Special funding conditions do apply. Before
prescribing, please review full Data Sheet.
Further information is available from Novo Nordisk Customer Care Centre (New Zealand) 0800 733 737. Novo Nordisk Pharmaceuticals Ltd. PO Box
51268 Pakuranga, Auckland, New Zealand. www.novonordisk.co.nz
® Registered trademarks of Novo Nordisk A/S
eptacog alfa (activated) (bhk)
CLIENT
DESCRIPTION
vibe WT
Novo Nordisk
Summary Haemophilia
v0537
CODE
KNIFE
DIMENSIONS
COLOURS
210mm x 297mm
DATE
21.01.09
PROCESS
BLACK
vibe integrated creative
S u i t e 4 0 4 · L e v e l 4 · 1 2 C e n t u r y C i r c u i t · N o r w e s t B u s i n e s s C e n t r e · B a u l k h a m H i l l s N S W 2 1 5 3 · T 0 2 8 8 5 0 5 4 5 5 · F 0 2 8 8 5 0 6 1 6 6 · W w w w. i m s g r o u p . c o m . a u