Tuesday, April 26, 2011

For Kidney Dialysis - Interferon Alfa-2b Pre Filled Syringe and Vial

Interferon Alpha-2b



Methods & Procedures of Subcutaneous Injection
A subcutaneous injection is administered into the subcutis, where there are abundant lymphatic systems. There Interferon Alfa-2b (SHAFERON) can be more easily absorbed and utilized, hence the body immune system will be better boosted up and better curative effects will be achieved. The detailed injection procedures are as below:
1     Resume the product to normal temperature: Take SHAFERON pre-filled syringe out from the fridge 30 min before injection, in order for it to resume to normal temperature.
SHAFERON should be stored under 2-8 centigrade, protect from light.)
2     Choose injection site:
Ø   The outer area of the upper arm;
Ø   Abdomen, except the area right around the navel (a 2-inch circle);
Ø   The front of the thigh, midway to the outer side, 4 inches below the top of the thigh to 4 inches above the knee.
3     Disinfection: select a site and cleanse the area (about 2 inches) with a fresh cotton ball soaked in 2% iodine. Wait for the site to dry and then cleanse the site again with a fresh alcohol pad (or cotton ball) soaked in 70% alcohol. After the site is dry, injection can be given.
Disinfection with only alcohol pad is also acceptable.
4     Discharge Air: Take out the pre-filled syringe from the pack, remove the rubber cap, hold the syringe with the needle facing upward, then tap the syringe gently to bring the air bubble to the top. Then push the plunger slightly until one drop of the medication is pushed out. Take care to push the plunger tenderly so that to ensure accuracy of dose injected and also avoid waste of medication.
5    Injection



5.1    Injection with your family member’s help:
At the outer area of the upper arm or the front of the thigh: flat the skin with your thumb and forefinger of one hand, use the other hand to hold the syringe at 45° to your skin and then insert the needle in one quick motion with the needle bevel facing upwards. The whole needle shall be inserted into the skin. Pull back the plunger to check for blood; if there is no backflow blood, and then slowly push the plunger to inject the medication.



At the abdomen: choose abdomen which is beyond 5 cm of the navel as the injection site, grab the skin firmly with your thumb and forefinger, and use the other hand to hold the syringe at 45° to your skin and then insert the needle in one quick motion with the needle bevel facing upwards (for patients with standard or higher than standard weight, it is recommended to inject the medication with needle facing vertically to the skin). The whole needle shall be inserted into the skin. Pull back the plunger to check for blood; if there is no backflow blood, and then slowly push the plunger to inject the medication.
5.2   Methods for Self-Injection:
When you are conducting self-injection at the outer area of your upper arm, it is recommended that you raise your arm and let your hand stay naturally at your waist (sitting posture and standing posture are both okay). Then use your other hand to hold the syringe at 45° to your skin and then insert the needle in one quick motion with the bevel facing upwards. The whole needle shall be inserted into the skin. Pull back the plunger to check for blood; if there is no backflow blood, and then slowly push the plunger to inject the medication.
Note: For self-injection at the abdomen and the front of your thigh, the method is the same with that of “Injection with your family member’s help”.
6     Completion of Injection
Let the needle stay inside your skin for 3~5 seconds so that the medication will diffuse. Then pull out the needle quickly, and gently hold a sterilized cotton pad /ball to the injection site. Do not rub.
7     Post-Injection
After injection is completed, recap the needle and put it away in a special container for proper disposal.
Note:
1.   Please inquire your doctor or nurse if you are not very clear about the procedures.
2.   It is highly recommended that SHAFERON should reach room temperature at the time of injection.
3.   After the discharge of air, there should be no air bubble inside the syringe.
4.   You should insert & pull out the needle quickly and do NOT change the angle.
5.   For patients who need regular injection, it is recommended to rotate injection sites regularly.
6.   When you are pressing on the injection point gently, do NOT rub.
  
PFS subcutaneous injection system interferon with higher clinical compliance



Beijing Kawin Technology Share-Holding Co., Ltd. (Kawin Technology) was established by Beijing Kawin Bio-Tech Co., Ltd. Located in Beijing BDA area (known as ‘Pharmaceutical Valley’), Kawin Technology is a High-Tech Enterprise recognized by Beijing Municipal Science & Technology Committee. Based on its advanced biotechnology platforms, Kawin is committed to become a professional company that provides all-round solutions in the two major fields of Hepatology and Neurology.
 Endeavoring to provide highest quality and most convenient Interferon
Ø  Provide most convenient dosage form – pre-filled syringe, increases patient compliance
     l Interferon Alfa-2b (SHAFERON) adopts 27G needle, which significantly decreases pain
     feeling.



l   Safe & convenient for patients to carry out self-injection at home or on trips.



 Ø  Best administration method – subcutaneous injection, improves clinical efficacy



l  With a short needle, Interferon Alfa-2b (SHAFERON) is most suitable for subcutane



l  Interferon Alfa-2b (SHAFERON) will be easily absorbed in lymphatic system through subcutaneously injection, and therefore enhancing bioavailability;



l  Through subcutaneous injection, Interferon Alfa-2b (SHAFERON) has longer half-life and its efficacy will last longer.
Ø  Best administration time – in the evening, reduces the impact of adverse reactions [3]



l  Administration of Interferon Alfa-2b (SHAFERON) is more appropriate in the afternoon or evening. Since body resistance is stronger in the evening, the impact of adverse reactions will be reduced.
References
[1] Supplied by BG, Germany.
[2] J Clin Pharmacol, pharmacokinetics of interferon α2b in healthy volunteers 1987; 27:432-435;
[3] Wang Boying, et al, Impact of α Interferon on body temperature in patients with chronic hepatitis, J Norman Bethune University of Medical Science, 2000, 26 (1): 69-70.
Ø  Most convenient dosage form – pre-filled syringe, increases patient compliance
Ø  Best administration method – subcutaneous injection, improves clinical efficacy
Ø  Best administration time – in the evening, reduces the impact of adverse reactions
Brief Prescribing for:



Indication
Recommended dosage and administration
Chronic hepatitis B
3-6MIU once daily or three times a week, administered subcutaneously, continuously for 6 months.
Acute and chronic hepatitis C
3-6MIU once daily or three times a week, administered subcutaneously, continuously for 12 months.
Blood diseases
Chronic myelogenous leukemia: 3-5MIU/m2 once daily administered subcutaneously, also can be administered simultaneously with chemotherapy medicines such as hydroxycarbamide or Ara-C. All patients with complete hematological responses should continue injection every other day. The cytogenetic changes may be achieved in 9-10 months.
Hairy cell leukemia: 2-8MIU/m2 administered once daily, continuously for not less than 3 months. The response is achieved usually after 1-2 months of treatment.
Carcinoma
Renal cell carcinoma: 6MIU administered subcutaneously three times a week, continuously for 8 weeks, simultaneously with chemotherapy.
Multiple myeloma: 3-5MIU/m2 administered subcutaneously three times a week, simultaneously with chemotherapy such as VMCP.
Malignant melanoma: 6MIU administered subcutaneously three times a week, continuously for 1 month, simultaneously with chemotherapy.
Non-Hodgkin's Lymphoma: 3-5MIU/m2 administered subcutaneously three times a week, simultaneously with chemotherapy such as CHVP; 8-12 weeks as one treatment course, The treatment should be maintained for 12 months unless patient’s illness is exacerbated rapidly or severe intolerance occurs.
Dermatology
Herpes zoster: 1MIU administered subcutaneously once daily, continuously for 6 days. And taking acycloguanosine orally at the same time.
Condylomata acuminata: 1-3MIU administered subcutaneously each day, continuously for 4 weeks. Another method is 1MIU injected intralesionally each time, while simultaneously treating with laser or electrotherapeutics.



Preparation:
1.  Interferon Alfa-2b 3MIU/Ml Pre-filled Syringe (SHAFERON) - BFAD Reg. No: BR-771
2.  Interferon Alfa-2b 5MIU/Ml Pre-filled Syringe (SHAFERON) - BFAD Reg. No: BR-770
3.  Interferon Alfa-2b 6MIU/Ml Pre-filled Syringe (SHAFERON) - BFAD Reg. No: BR-769
4.  Interferon Alfa-2b 1MIU/Ml Vial (SHAFERON) - BFAD Reg. No: BR-768
5.  Interferon Alfa-2b 3MIU/Ml Vial (SHAFERON) - BFAD Reg. No: BR-767

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