GnRH (TRIPTORELIN) Is this the future of PCT ?

[SouthernCharm]

how do u reconstitute? BW?

[jklooking]

how do u reconstitute? BW?

Yes.

[russianstar]

yABADABBADOO

[Gamer2Be08]

How long does it last reconstituted?

[jklooking]

How long does it last reconstituted?

Wouldn't matter, really. It's a single dose and you would just reconstituted it the minute or two before you decide to dose it.

JK

[ironmanZVW]

RS, If I'm running a 12 week cycle (hopefully) then when would be the best time to take a dose of trip. Right smack in the middle of it?

[JayJo]

Hope my GnRH arrives soon, so i can start my next cycle!

[TheDarkHalf]

I'm definitely going to be trying this during my upcoming PCT in a few weeks. Can someone advise me how I should run my PCT with this?

I was thinking 100mcg shot on day 1....then running HCGen followed by bridge. Serm necessary or no?

Cycle is 6 weeks of hella @ 100 and 6 weeks of katana @ 300

[jklooking]

I'm definitely going to be trying this during my upcoming PCT in a few weeks. Can someone advise me how I should run my PCT with this?

I was thinking 100mcg shot on day 1....then running HCGen followed by bridge. Serm necessary or no?

Cycle is 6 weeks of hella @ 100 and 6 weeks of katana @ 300

100mcg is the dose. HCGen, good. I'm not sure if you need it immediately th way the GnRH works on the receptors. I'll find out. Serm... maybe. Keep one handy. You shouldn't, but its your body.

[jklooking]

PAMORELIN
Suspension for injection

Triptorelin

PHARMACEUTICAL FORM AND FORMULATION

With freeze-dried vial contains:
Triptorelin pamoate
equivalent to 3.75 mg 11.25 mg
triptorelin

Each vial contains:
Water for injection 2.0 ml 2.0 ml

THERAPEUTIC INDICATIONS
LHRH agonist analogue indicated for the treatment of:

• Prostate cancer metastasis.
• Endometriosis.
• Breast cancer.
• Precocious puberty.

Mechanism of action: Triptorelin is a synthetic decapeptide analog of gonadotropin-releasing hormone (GnRH). It is a potent inhibitor of gonadotropin secretion when given continuously in therapeutic doses by deleting, in consequence, testicular and ovarian functions.

In prostate cancer, the administration quarterly PAMORELIN ® 11.25 mg may cause an initial increase in blood levels of LH and FSH, which follows the initial increase in the rate of testosterone. The maintenance of treatment results in decreased levels of LH and FSH leading to testosterone to castrate levels within 20 days and during the period in which the product is administered.

In a study in patients with prostate cancer demonstrated the pharmacodynamic bioequivalence between the two products by comparing quarterly PAMORELIN ® 11.25 mg of triptorelin with monthly PAMORELIN ® 3.75 mg administered once a month for three consecutive months.

After administration of PAMORELIN ® 11.25 mg quarterly or monthly PAMORELIN ® 3.75 mg, castration was reached on 19.98 ± 6.19 or 2.19 ± 0.94 respectively. Testosterone levels on re-injection of 3.75 mg PAMORELIN ® 28, 56 and 84 were identical to those presented by patients who received 11.25 mg PAMORELIN ® Quarterly: plasma testosterone (1) (ng / ml) and number of patients castrated after a single administration of PAMORELIN ® Quarterly PAMORELIN ® 11.25 mg and 3.75 mg once in three months.

Day 28 Day 56 Day 84

PAMORELIN ® 0.25 ± 0.06 0.24 ± 0.02 0.23 ± 0.01
Quarterly 11.25 mg (36/37) (36/36) (38/38)

PAMORELIN ® 0.27 ± 0.08 0.25 ± 0.05 0.24 ± 0.03
3.75 mg (20/20) (20/20) 20/20)

(A) Mean ± standard deviation.

Pharmacokinetics: After intramuscular injection of 11.25 mg PAMORELIN ® quarterly in patients with prostate cancer, there is a peak plasma triptorelin about three hours after administration.

Later, after a phase of progressive reduction during the first month, circulating concentrations of triptorelin at least remain constant until day 90. Testosterone castration level reached approximately 20 days after administration and remains below this level throughout the period of release of active ingredient, which corresponds to the equilibrium level of the active plasma.

CONTRAINDICATIONS

PAMORELIN ® is contraindicated in patients with known hypersensitivity to LHRH agonist analogues or any of the components of the formula.

GENERAL PRECAUTIONS

It may be useful to check regularly, plasma testosterone levels, which should never be greater than 1 nanogram / ml.

The therapeutic response can be assessed by examination escintigráfico bone level and / or CT, at the prostate in addition to clinical examination and a rectal examination, should be resorted to ultrasound and / or CT.

RESTRICTIONS OF USE DURING PREGNANCY AND LACTATION

Not applicable.

ADVERSE REACTIONS

Side effects are most frequently observed in 35%, hot flashes, decreased libido and impotence in 6%.

These events are due to decreased plasma levels of testosterone which is a consequence of the pharmacological action of the drug.

These effects also occur with other GnRH analogues.

In some patients it is possible that this treatment is initiated, a transient increase in plasma testosterone rates may cause exacerbation of urinary symptoms, bone pain of metastatic origin and symptoms associated with spinal cord compression caused by metastases.

There has also allergic reactions such as rash or pruritus (3-4%), hypertension crisis that tends to normalize spontaneously (less than 3%) pain at the site of injection (2%) and single cases of gastrointestinal disorders and gynecomastia

DRUG INTERACTIONS AND OTHER GENDER

Have not been observed with the most frequently used drugs.

CHANGES IN THE LABORATORY TEST RESULTS

The answer to PAMORELIN ® should be monitored by measuring serum testosterone levels and prostate-specific antigen. In clinical trials, most subjects had increased levels of testosterone during the first week of treatment, falling to castrate levels at the end of the first month. Once achieved, castration levels of testosterone were maintained until the patients received monthly injection.

PRECAUTIONS IN RELATION TO EFFECTS OF CARCINOGENESIS, MUTAGENESIS, teratogenesis and ON FERTILITY

Animal toxicology studies have not shown specific toxicity of the molecule.

The observed effects are related to the pharmacological properties of the product on the endocrine system.

Local tolerance studies in dogs after IM administration of the active and / or excipients separately, have revealed gross changes as induration or discoloration histopathologic zonal level compatible with a granulomatous inflammatory reaction.

After four months there has been no histologic evidence of local reaction to the presence of a foreign body.

However, in men there was none of these changes, reducing the most common manifestations of pain at the injection site, itching.

The resorption of the microspheres is complete at 120 days.

There have been no reported interactions between PAMORELIN ® and other products. In the absence of relevant data and as a precaution, not be given together with drugs hiperprolactinemiantes, since hyperprolactinemia reduces the rate of pituitary GnRH receptors.

DOSE AND ROUTE OF ADMINISTRATION

A deep intramuscular injection PAMORELIN ® 3.75 mg every four weeks for three months.

A deep intramuscular injection PAMORELIN ® 11.25 mg every three months.

MANIFESTATIONS AND MANAGEMENT OF OVERDOSE OR ACCIDENTAL INGESTION

There has been no reported cases of overdose.

PRESENTATIONS

PAMORELIN ® comes in:

Cardboard box with PVC pouch containing a lyophilized vial with 3.75 mg of triptorelin pamoate, with a syringe, a needle and a vial with 2 ml of water injection.

Cardboard box with PVC pouch containing a lyophilized vial with 11.25 mg of triptorelin pamoate, with a syringe, a needle and a vial with 2 ml of water injection.

STORAGE RECOMMENDATIONS

Keep in a cool, dry place. No refrigeration required. The product should be used immediately after reconstitution.

LEGENDS OF PROTECTION

Literature exclusively for physicians. Its sale requires a prescription. Keep out of reach of children.
Read instructions annex. Do not administer
during pregnancy and lactation. This medication should be administered only by
medical specialists in oncology and
experience in cancer chemotherapy.

Made in Switzerland by:
Debio Recherche Pharmaceutique, S. A.

Conditioned by:
Laboratories Manuell, S. A.

Distributed by:

Rowfarma DE MEXICO, S. R. L. C. V.
Insurgentes Sur No. 664, Piso 11
Col. del Valle 03100 Mexico, D. F.
Tel: 52 (55) 5543-3414 Ext. 225
Fax: 52 (55) 5523-4250
Reg No. 123M97, SSA
IEAR-053300601022380/RM2005