Kigtropin® AQ 30IU (10mg)/vial 1vial/kit.
Kigtropin® AQ is produced by Kigtropin bio ltd using the recombinant DNA technology and has the same acid sequence as human growth hormone produced naturally in the human body. Kigtropin® AQ human growth hormone is the first ready-to-use liquid recombinant growth hormone formulation in China and is supplied per pen with 30IU (10mg)cartridges.

Product Name
Kigtropin  HCG 5000IU/vial 10vial/kit
Human Chorionic Gonadotrophin for Injection

Composition
A preparation of Chorionic Gonadotrophin, which is a  sterile lyophilized form after adding appropriate excipient.The titer is 80%-125% of the labelled amount.

Indication
A. The diagnosis and treatment of puberty cryptorchidism.
B. Male infertility induced by pituitary dysfunction. It can be combined with HMG. Long-term gonadotropin dysfunction should be supplemented with testosterone.
C. Female anovulatory infertility induced by pituitary gonadotropin deficiency. It is often treated after clomiphene treatment is ineffective. The combined use with menotropin and post-menopausal gonadotropin could promote ovulation.
D. It is used for obtaining multiple oocytes in vitro fertilization and should combine with postmenopausal gonadotropin.
E. Female luteal phase defect.
F. Dysfunctional uterine bleeding, threatened abortion during early pregnancy, habitual abortion.

Dosage and Administration
For adult:
A. For gonadal dysfunction caused by male gonadotropin dysfunction, inject intramuscularly 1000-4000 units, twice or 3 times per week lasting for weeks or months. To promote sperm production, treatment should be continued for 6 months or more. If the sperm count is less than 5,000,000 / ml, the application should be combined with HMG for 12 months.
B. Ovulation promotion. For anovulatory female infertility or in vitro fertilization, inject intramuscularly 5000-10000 IU one day after the last treatment of gonadotropin of post-menopause or 5 to 7 days after treatment of
Clomiphene for consistent 3-6 treatment cycles. If no effect is shown, the drug should be withdrawal.
C. For luteal function defect, inject 1500 IU at 15 to 17 days after ovulation once every other day, for 5 times. The dose can be adjusted according to patients’ response. After pregnancy, the original dose should maintain for 7 to 10 gestational weeks.
D. For functional uterine bleeding. Inject intramuscularly 1000-3000 IU. For habitual abortion and pregnancy threatened abortion, inject 1000-5000 IU intramuscularly.
For children:
A. For determination of slow development of testicular function, inject intramuscularly 2000 IU, once a day, for 3 days.
B. For puberty cryptorchidism, inject intramuscularly 1000-5000 IU, 2-3 times per week. The drug withdraws once beneficial effects show. The total number of injections is not more than 10 times.

How Supplied
Packing material: injection vial + Medicinal halogenating butyl rubber plug; ampoule;
Pack: (1)1000 IU, 10 vials/box;
          (2)2000 IU, 10 vials/box;
           (3)5000 IU, 10 vials/box;
Storage Condition
Protect from light and keep tightly sealed in a cool place (store below 20 0C).

Shelf Life 24 months
Products are being developed, is expected in 2015 listed please wait !

Product Hightlights
Kigtropin EPO is an injectable recombinant human erythropoietin (EPO) that stimulates the production of red blood cells.
Kigtropin EPO is utilized as a replacement protein therapy to restore EPO to normal levels, stimulate red blood cell production and relieve the symptoms of anemia, thereby improving the quality of life for patients with renal disease and cancer in addition to reducing the need for continuous blood transfusions.
Our Kigtropin EPO products are available in four different strengths plus unique indications.
We were among the first to introduce a recombinant form of EPO in China.
Drug Names
Generic Name: Recombinant Human Erythropoietin Injection
Trade Name: Kigtropin EPO
Ingredients: Recombinant Human Erythropoietin, Human Serum Albumin
Character
Colorless and transparent liquid, pH 6.9±0.5

Pharmacology and Toxicology
1. Pharmacology
Erythropoietin is a glycoprotein which is excreted in the kidney and stimulates the division and differentiation of committed erythroid progenitors in the bone marrow. It can increase the production of CFU-E and BFU-E.

2. Toxicology
2.1 Acute toxicity: the LD50 of Kigtropin EPO in mice, rats and dogs by intravenous injection and the LD50 of Kigtropin EPO in 4-day-old rats are more than 20,000IU /kg.
2.2 Sub-acute and Chronic toxicity:
△ Rat: after continually intravenous or intraperitoneal administration of 80IU/kg/day for 4 weeks, 20IU/kg/day for 13 weeks or 10IU/kg/day continually for 52 weeks, polycythemia can be observed for overdosage and long-term therapy with Kigtropin EPO may result in fibrosis.
△ Dog: after intravenous administration of 200IU/kg/day continually for 4 weeks, 100IU/kg/day continually for 13 weeks and 20IU/kg/day continually for 52 weeks, polycythemia can be observed for overdosage and long-term therapy with Kigtropin EPO may result in fibrosis and construction change of kidney.

Pharmacokinetics
After subcutaneous administration, absorption of erythropoietin is slow from the injection site. Increase of serum concentration of EPO can be observed 2 hours after administration and the peak concentration is achieved 18 hours post dosing. Bone marrow is the specific absorption organ and EPO is absorbed mainly in liver and kidney. It has been demonstrated that metabolism of EPO occurs mainly in liver, and by other pathways such as degradation in kidney, bone marrow and spleen. EPO is not mainly excreted in kidney and less than 10% non-degraded EPO is excreted in kidney of anemia patients treated with EPO.

Indications
Anemia associated with renal failure: including patients on hemodialysis (HD) and non-dialysis (ND).
Peri-operative red blood cell mobilization
Anemia associated with chemotherapy in cancer patients with non-myeloid malignancies. rhEPO is not indicated for the treatment of anemia due to other factors such as iron or folate deficiencies, hemolysis or gastrointestinal bleeding.

Dosage and Administration
Anemia of renal failure: rhEPO should be administrated under direct medical supervision. rhEPO may be administrated subcutaneously or intravenously, 2~3 times weekly. The dose should be adjusted according to anemia degree, age and other related factors. The following administration is suggested:

Therapy period: The recommended starting dose is 100~150IU/kg bodyweight weekly for HD patients, and 75~100IU/kg for ND patients. The dose may be increased by 15~30IU/kg 4 weeks after administration the increment of hematocrit (Hct) is less than 0.5vol% per week. The maximum increase dose should not exceed 30IU/kg/week and Hct should not exceed 36vol%, usually at 30~33%vol%.

Maintenance period: when Hct reaches 30~33vol％or hemoglobin (Hb) reaches 100-110g/L, the dose should be adjusted to two thirds of the therapeutic dose. Hct should be monitored every 2~4 weeks to prevent excessive erythropoiesis and keep Hct and Hb at proper level.

Peri-operative red blood cell mobilization: Elective surgery patients with Hb between 100~130g/L receive rhEPO 150IU/kg subcutaneously, 3 times weekly, starting 10 days prior to, and for 4 days after surgery. rhEPO can relieve anemia in and after surgery, reduce peri-operative transfusion requirements and correct anemia after surgery. Oral iron should be given at the same time in case of iron deficiency.

Anemia in cancer patients on chemotherapy: rhEPO treatment is not recommended for patients with serum endogenous EPO level more than 200mu/ml. It is demonstrated that for patients with lower baseline serum EPO level respond more vigorously to rhEPO than patients with higher baseline EPO levels. The recommended starting dose is 150IU/kg bodyweight, 3 times weekly by SC administration. The dose may be increased to 200IU/kg if transfusion requirements are not decreased or Hct is still lower after 8 weeks therapy. If the hematocrit exceeds 40%, the dose of Kigtropin EPO should be withheld until the hematocrit falls to 36%. The dose of Kigtropin EPO should be reduced by 25% when treatment is resumed and titrated to maintain the desired hematocrit. If the starting dose of Kigtropin EPO includes a very rapid hematocrit response (e.g., an increase of more than 4 percentage points in any 2-week period), the dose of Kigtropin EPO should be reduced.

Directions for use: Using aseptic techniques, attach a sterile needle to a sterile syringe, and withdraw into the syringe an appropriate volume of solution as an intravenous or subcutaneous injection.
Adverse reactions
Common reactions: headache, fever and fatigue occurred occasionally at the beginning of rhEPO therapy. Myalgia and arthralgia have been observed rarely. Most of these symptoms can be corrected by expectant treatments and the therapy can be continued. For those failed to be relieved, the therapy should be discontinued.

Allergic reactions: There have been no reports of serious allergic reactions or anaphylaxis associated with erythropoietin administration during clinical trials. Skin rashes and urticaria have been observed rarely and when reported have generally been mild and transient in nature. A low dose administration prior to the full dose treatment is recommended for the patients administered with Kigtropin EPO initially or those resume the treatment of Kigtropin EPO. Any abnormality should be treated appropriately and the Kigtropin EPO administration should be discontinued.

Cardio-cerebral vascular system: Increases in blood pressure, deterioration of hypertension, headache induced by hypertensive encephalopathy and spasm have been reported in clinical trials. Therefore, Blood pressure should be monitored carefully and if necessary, the dose of rhEPO should be adjusted/ terminated and hypotensive agents may be used.

Blood system: with the increase of Hct due to administration of rhEPO, the blood viscosity can be observed increasing. So measures should be taken to prevent from thrombosis.

1.0 ml solution for each vial, containing rhEPO 2000IU/ 3000IU/ 4000IU/ 10000IU

Storage
Store at 2-8℃. Avoid direct sunshine.

Shelf life   Two years.
Products are being developed, is expected in 2015 listed please wait !