Tsetrotid lyophilisate for injection for subcutaneous injection of a vial of 0.25 mg N7
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Active ingredients
Zetrorelix
Release form
Lyophilisate
Composition
Water, liposome-emulsion complex No. 3, (stearic acid, Neowax emulsion wax, glycerin, vegetable oil, anhydrous lanolin, propylene glycol, IT microcar, nimesulide, sodium hydroxide, Green Dock antioxidant), comfrey extract, bee venom, tea tree essential oil , rosehip extract, burdock extract, skullcap extract, golden whisker extract, sabelnik extract, chondroitin sulfate, formic alcohol, mummy, D-panthenol, DMR microcar, perfumery composition.
Pharmacological effect
Absorption and distributionAfter s / c injection cetrorelix is rapidly absorbed, bioavailability - 85%. Pharmacokinetic parameters after a single SC injection at a dose of 250 μg and repeated administration (within 14 days), respectively: Cmax - 4.17–5.92 ng / ml and 5.18–7.96 ng / ml; Tmax - 0.5-1.5 h and 0.5-2 h; AUC - 23.4-42 ng × h / ml and 36.7-54.2 ng × h / ml. When subcutaneous injection of cetrorelix in single doses (from 250 μg to 3 mg), as well as with daily administration for 14 days, linear kinetics of the drug. Vd is equal to 11.1 l / kg. Withdrawal After a single SC injection at a dose of 250 mcg and repeated administration (within 14 days), the T1 / 2 is 2.4-48.8 h and 4.1-179.3 h, respectively. Excreted by the kidneys. The total plasma and renal clearance is 1.2 ml / min × kg and 0.1 ml / min × kg respectively. The final T1 / 2 after IV and SC injection averages about 12 hours and 30 hours, respectively.
Pharmacokinetics
Composition1 bottle contains: Active substance: Cetrorelix (in the form of acetate) 250 mcg. Auxiliary substances: mannitol - 54.8 mg. Solvent: water d / and - 1 ml. Bottles of clear glass (1) complete with solvent (syringes 1 pcs.), Needles (1 needle No20 for the introduction of the solvent into the vial, 1 needle No27 for the s / c injection) and alcohol swabs (2 pcs.) - blister packs (7) - cardboard packs.
Indications
Prevention of diseases of the joints and spinal column in the presence of risk factors: physical inactivity, occupational mobility restrictions, hypothermia, and frequent colds. Prevention of age-related changes in the joints.
Contraindications
Treatment with Cetrotid can only be done by a gynecologist with clinical experience using this drug. After the first injection, clinical monitoring is required for 30 minutes to identify symptoms of a possible allergic or pseudo-allergic reaction to the drug being administered.At the same time, it is necessary to provide conditions and means for stopping such reactions. Cetrotid in a dose of 250 mcg (1 bottle) should be administered 1 time / day every 24 hours in the morning or evening. Administration of the drug in the morning: treatment with Cetrotide should be started on the 5th or 6th day of ovarian stimulation (approximately 96-120 h after the start of stimulation) with a gonadotropin preparation, recombinant or isolated from urine, and continue throughout the entire period of stimulation with gonadotropin, including the day of the introduction of an ovulatory dose of chorionic gonadotropin (CG). Introduction a in the evening: treatment with Cetrotid should begin on day 5 of ovarian stimulation (approximately 96-108 h after the onset of stimulation) with gonadotropin, recombinant or excreted from the urine, and continue throughout the whole period of stimulation with gonadotropin, including the evening preceding the day of ovulatory CG administration. . The rules for the preparation of injection solutions and the introduction of the drug The first injection should be done by a specialist doctor. After receiving appropriate instructions from the doctor about the symptoms that may indicate the occurrence of an allergic reaction, the consequences of such a reaction and the need to treat it, the patient can self-administer Tsetrotid. Cetrotid should be injected into the lower part of the anterior abdominal wall, preferably in the area around the navel . In order to avoid local irritation with repeated administration of the drug, the injection site should be changed daily. Cetrotide should be dissolved only with the help of the attached solvent. During the dissolution of the bottle must be gently rocked. To avoid the formation of bubbles, you should not use vigorous shaking to accelerate dissolution. Do not use the solution if it is opaque or contains undissolved particles. From the vial should be drawn into the syringe all its contents. This will allow you to enter a dose of tsetrorelix at least 230 mcg when using the drug Cetrotid 250 mcg and at least 2.82 mg when using the drug Cetrotid 3 mg. The solution should be injected immediately after its preparation. If you are self-administering Cetrotide, you should follow these recommendations: 1. Wash the hands. It is very important that the hands and all the devices necessary for the insertion are clean.Place on a clean surface that is necessary for injection (1 bottle, 1 syringe with solvent, 1 needle with yellow marking, 1 needle with gray marking and 2 swabs soaked in alcohol) .3. Open the snap-on lid on the bottle. Wipe the aluminum ring and the rubber stopper with one swab with alcohol. Remove the wrap from the needle with yellow markings. Remove the syringe with solvent from the packaging. Put the needle on the syringe with the solvent and remove the protective cap from it. Insert the needle into the center of the rubber stopper of the bottle. Inject the solution from the syringe into the vial, slowly pressing on the piston. Without removing the needle from the vial, you should gently rock the vial until the powder is completely dissolved. Avoid shaking vigorously so that bubbles do not form during dissolution. Draw the entire contents of the vial into the syringe. If a solution remains in the vial, you should turn the vial over and extend the needle so that its opening is immediately under the stopper. If you look at the inside of the cork from the side, you can control the movement of the needle and the liquid. It is very important to draw all the contents of the bottle into a syringe. Remove the needle from the syringe and place the syringe. Remove the wrap from the needle with gray markings. Put this needle on the syringe and remove the protective cap.9. Turn the syringe with the needle upwards and press on the plunger until all air bubbles come out of the syringe. Do not touch the needle or allow it to come into contact with any surface. The injection site is in the lower part of the anterior abdominal wall, preferably in the area around the navel. Take a second swab soaked in alcohol and rub the skin at the site of the intended injection. In one hand, hold the syringe, with the other hand, gently squeeze the skin surrounding the injection site and fix it tightly between the fingers.11. Take the syringe as you normally would with a pencil and insert the needle into the skin at a 45 ° angle. 12. After the needle is fully inserted, the skin should be released.13. Carefully pull the plunger back. If blood appears in the syringe, then you should act in accordance with paragraph 14. In the absence of blood, slowly inject the solution by pressing on the plunger. After the introduction of the entire solution, slowly remove the needle and gently press the swab soaked in alcohol onto the skin at the injection site.The needle should be removed from the skin at the same angle at which it was inserted. If blood appears in the syringe, remove the needle from the skin and lightly press the injection site with a swab. For repeated injection, this solution can not be used, so the contents of the syringe should be poured. Then, start the procedure from clause 1.15 first. The syringe and needles can be used only once. Immediately after use, they should be discarded (in order to avoid injury, protective caps should be put on the needles).
Precautionary measures
In case of allergic reactions, discontinue use and consult a doctor.
Use during pregnancy and lactation
Not contraindicated in pregnancy and lactation.
Dosage and administration
Apply the balm in circular motions on the problem area for 3-5 minutes until completely absorbed 2-3 times a day. If possible, provide warmth and rest to the joint. Duration of application is 3-5 weeks.
Side effects
No side effects have been identified.
special instructions
Contraindicated in case of individual intolerance to the components.