Active ingredients: Progesterone (Hydroxyprogesterone caproate)
PLEYRIS 25 mg powder for solution for injection
Indications Why is Pleyris used? What is it for?
PLEYRIS contains the active ingredient progesterone. Progesterone is a sex hormone naturally produced by the female body. The drug acts on the wall of the uterus, promoting the onset and continuation of pregnancy.
PLEYRIS is indicated for women in whom an inability to use or intolerance to vaginal preparations has been observed and who require progesterone supplementation when being treated with assisted reproductive technology (ART).
Contraindications When Pleyris should not be used
Do not use PLEYRIS
- If you are allergic (hypersensitive) to progesterone or any of the other ingredients of this medicine (listed in section 6)
- If you suffer from vaginal bleeding (other than that related to your normal menstrual cycle) that has not been evaluated by your doctor
- If you have a miscarriage and your doctor suspects there is tissue residue in the uterus
- If you have been pregnant outside the womb (ectopic pregnancy)
- If you have or have suffered from severe liver problems
- If you have known or suspected cancer of the breast or reproductive tract
- If you have or have had in the past blood clots in the lower limbs, lungs, eyes or other parts of the body
- If you have porphyrias (a group of inherited or acquired disorders due to an "alteration of the activity of certain enzymes"
- If during pregnancy you suffered from jaundice (yellowing of the eyes and skin caused by liver problems), severe itching and / or skin blisters
- If you are under the age of 18.
Precautions for use What you need to know before taking Pleyris
Take special care with PLEYRIS
If you experience any of the following symptoms during treatment, tell your doctor immediately as treatment may need to be stopped. Also tell your doctor if your symptoms appear a few days after taking your last dose.
- Heart attack (chest pains or back pain and / or intense, throbbing pain in one or both arms, sudden shortness of breath, sweating, dizziness, light-headedness, nausea, palpitations)
- Stroke (severe headache or vomiting, dizziness, syncope or changes in vision or speech, weakness or numbness in an arm or leg).
- Blood clots in the eyes or other parts of the body (pain in the eyes or pain and swelling in the ankles, feet and hands)
- Aggravation of depressive symptoms
- Severe headaches, vision changes.
Before starting treatment with PLEYRIS
Tell your doctor if you have suffered or are suffering from any of the following before starting treatment with PLEYRIS.
- Liver problems (mild or moderate)
- Epilepsy
- Migraine
- Asthma
- Heart or kidney problems
- Diabetes
- Depression
In this case it will be kept under observation during the treatment
Interactions Which drugs or foods can change the effect of Pleyris
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines, including non-prescription medicines and herbal medicines.
- Carbamazepine (used to treat convulsions / seizures)
- Rifampicin (antibiotic)
- Griseofulvin (antifungal drug)
- Phenytoin and phenobarbital (used as part of the treatment of epilepsy)
- Herbal products containing St. John's wort.
- Ciclosporin (drug used to treat some types of inflammation and after organ transplantation)
- Antidiabetic drugs
- Ketoconazole (antifungal drug)
Do not administer Lubion concomitantly with any other injectable medicine.
Warnings It is important to know that:
Pregnancy and breastfeeding
Ask your doctor or pharmacist for advice before using any medicine.
- PLEYRIS can be used during the first three months of pregnancy
- This medicine should not be taken while breastfeeding.
Driving and using machines
Do not drive or use any tools or machines if you feel sleepy or dizzy while using Lubion.
Dose, Method and Time of Administration How to use Pleyris: Posology
Always use this medicine exactly as your doctor has told you. PLEYRIS should only be used under the supervision of a physician experienced in the treatment of fertility disorders.
How much PLEYRIS should you use and for how long?
The recommended dose is one injection of 25 mg per day (equivalent to the contents of one vial and 1 ml of solvent) usually until 12 weeks after pregnancy confirmation (ie 10 weeks of treatment) is reached.
How PLEYRIS should be given
PLEYRIS can be administered under the skin (by subcutaneous injection) for doses of 25 mg or into the muscle (intramuscularly) for doses of 25 mg.
Subcutaneous administration of 25 mg of PLEYRIS should be performed after adequate advice and training by the doctor or a healthcare professional.
Before proceeding with the injection of PLEYRIS, you will receive instructions and advice on:
- Practical exercises of subcutaneous injections
- Where to inject the medicine
- How to prepare the solution for injection
- How to give the medicine.
Read the following instructions on preparing and administering Lubion.
The self-administration of the drug is divided into the following phases:
A. Preparing the injection
B. Checking the package
C. Aspiration of solvent (water for injections)
D. Mixing the water for injections with the powder
E. Filling the syringe
F. Changing the injection needle
G. Elimination of air bubbles
H. Injection for subcutaneous administration
I. Disposal of used components.
Below is a detailed description of each individual phase.
IMPORTANT: Each vial is for single use only. The solution should be used immediately after complete dissolution of the powder.
It must not be kept.
A. Preparing the injection
The PLEYRIS powder must be dissolved before it can be injected. It is important to ensure maximum cleanliness. Begin by washing your hands thoroughly, drying them with a clean towel. Choose a clean area to prepare the medicine:
- One vial containing PLEYRIS powder
The following components are not supplied with the medicine. The supply of these components is by the doctor or pharmacist.
- A syringe
- A large needle (usually a green 21G needle for mixing the solution with PLEYRIS powder and for intramuscular administration)
- A short fine needle (usually a gray 27G needle; for subcutaneous injection)
- Water for injections (solvent to be added to PLEYRIS powder)
- Two alcohol swabs
- A sharps disposal container (for the safe disposal of needles, vials, etc.)
B. Checking the package
- The Vial of PLEYRIS, the syringe and the needles are all equipped with protective caps.
- Check that all caps are firmly in place. If not, or if they are damaged, do not use them
- Make sure that the expiry date printed on the vial of PLEYRIS and water for injections is still valid. Do not use the products if they have expired.
C. Aspiration of solvent (water for injections)
- Open the pack of water for injections by following the instructions on the leaflet supplied with the product or the instructions provided by your doctor
- Take the syringe out of the package and hold it in one hand
- Remove the green 21G thick needle from the package, without removing the cap
- Attach the needle to the syringe, then remove the needle cap
- Holding the syringe in one hand, take the water for injections and draw up 1 ml of solvent following the manufacturer's or doctor's instructions.
- Put the syringe back carefully on the work area taking care not to touch the needle
D. Mixing the water for injections with the powder
- Remove the plastic cap from the top of the PLEYRIS vial by gently pushing it upwards.
- Rub the rubber top with an alcohol swab and let it dry
- Push the green 21G thick needle through the central rubber part of the top of the PLEYRIS vial
- Firmly press the plunger down to inject all of the solution onto the powder
- Remove the syringe with the needle, place it carefully on the work area taking care not to touch the needle
- When the powder is well absorbed in the solvent, shake the vial vigorously to help dissolve the powder.
E. Filling the syringe
- Make sure the powder has dissolved (the dissolving process takes about 1 minute)
- The solution should be clear and colorless
- If the solution is cloudy or does not dissolve completely, do not use it and repeat the procedure with another vial of PLEYRIS.
- Never use running water or any other liquid other than that provided by your doctor or pharmacist
- Make sure the plunger is at the bottom of the syringe, then slowly push the green 21G needle again through the central rubber part of the top of the PLEYRIS vial.
- With the needle still inserted, turn the vial upside down. The needle should hold the vial by itself
- Make sure the tip of the needle is below the liquid level
- Gently pull the plunger to draw all of the mixture into the syringe
- Pull the needle out of the vial.
F. Changing the injection needle
This step is only necessary for subcutaneous administration. If the doctor is giving an intramuscular administration, he will proceed with the preparation of the dose and the administration of the injection.
- Attach the cap to the green 21G thick needle, then pull the thick needle out of the syringe
- Put the needle together with the container of water for injections in the sharps container provided
- Remove the gray 27G fine needle from the package, without removing the cap
- Attach the gray 27G fine needle to the syringe, then remove the needle cap.
G. Elimination of air bubbles
- Holding the syringe upright with the gray 27G fine injection needle pointing towards the ceiling, slightly retract the plunger and tap the syringe to make it easier for air bubbles to rise upwards.
- Slowly press the plunger until all the air is eliminated from the syringe and a drop of solution comes out of the tip of the fine gray 27G needle.
For all intramuscular injections, your doctor or any other healthcare professional will inject according to the following instructions.
H. Injection for subcutaneous administration
- Your doctor or healthcare professional will have already shown you where to inject Lubion (eg belly or front of thigh)
- Open the alcohol swab and carefully clean the area of the skin where you want to inject, then let it dry
- Hold the syringe in one hand. With the other hand, lightly pinch the skin at the injection site area between the thumb and forefinger
- With a quick vertical motion, insert the thin gray 27G needle into the skin, so that the skin and needle form a right angle.
- Insert the thin gray 27G needle completely into the skin. Do not inject directly into a vein
- Inject the solution by exerting gentle pressure on the plunger in a slow, steady motion until the solution is completely injected under the skin. Inject all of the prescribed solution
- Release the skin and pull out the needle while keeping it vertical
- Clean the injection site with an alcohol swab in a circular motion.
I. Disposal of used components:
- Once you have finished your injection, put all needles, empty vials and syringes back into the sharps container.
- Any unused solution should be discarded.
Intramuscular administration by a physician or healthcare professional
The injection of PLEYRIS will be made on the lateral side of the thigh or on the buttock. The doctor or healthcare professional will clean the area of the skin where the injection will be given using an alcohol swab and allow it to dry. With a quick movement vertical will insert the larger needle into the muscle. They will inject the solution by exerting gentle pressure on the piston in a slow and steady motion until the solution is completely injected into the muscle. They will pull out the needle while keeping it upright and wipe the injection site with an alcohol swab.
If you forget to use PLEYRIS
Take the dose as soon as you remember, then proceed as before. Do not use a double dose to make up for a forgotten dose. Tell your doctor what happened.
If you stop taking PLEYRIS
Do not stop taking Lubion without first talking to your doctor or pharmacist. Stopping treatment with PLEYRIS abruptly can lead to increased anxiety, mood changes and an increased risk of convulsions (seizures).
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Overdose What to do if you have taken too much Pleyris
Tell your doctor or pharmacist. Symptoms of an overdose include sleepiness.
Side Effects What are the side effects of Pleyris
Like all medicines, Lubion can cause side effects, although not everybody gets them.
Very common side effects (affecting up to 1 in 10 patients treated):
- Pain, redness, itching, irritation or swelling at the injection site
- Uterine spasm
- Vaginal bleeding.
Common side effects (affecting between 1 in 10 and 1 in 100 patients treated):
- Ovarian hyperstimulation (symptoms include pain in the lower stomach, feeling thirsty and nauseous, in some cases with associated vomiting, passing small amounts of concentrated urine, and weight gain)
- Headache
- Swollen belly
- Stomach ache
- Constipation
- Vomiting and nausea
- Breast tenderness and / or breast pain
- Vaginal discharge
- Skin irritation associated with tingling or discomfort or itching on the vagina and surrounding area
- Hardening of the area around the injection site
- Bruise around the injection site
- Fatigue (excessive tiredness, exhaustion, lethargy).
Uncommon side effects (affecting between 1 in 100 and 1 in 1000 patients treated):
- Changes in mood
- Dizziness
- Insomnia
- Upset stomach and intestinal tract (including stomach discomfort and / or tension, aerophagia, painful spasms and retching)
- Skin rashes (including hot, red skin or raised itchy papules or wheals or dry, cracked, blistered, or swollen skin)
- Swelling and / or breast enlargement
- Feeling of heat
- General feeling of discomfort or "bad mood"
- Ache.
The disorders listed below, although not reported by patients in clinical trials with PLEYRIS, have been reported in conjunction with the use of other progestogens: depression, jaundice, insomnia, premenstrual-type syndrome and menstrual disorders, urticaria, acne, hirsutism, alopecia, weight gain and anaphylactoid reactions.
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.
Expiry and Retention
Keep this medicine out of the sight and reach of children.
Store below 25 ° C. Do not refrigerate or freeze.
Store in the original packaging to keep the product protected from light.
After first opening and reconstitution, the medicinal product should be used immediately.
Any remaining solution should be discarded.
Do not use this medicine after the expiry date which is stated on the label after "EXP": the expiry date refers to the last day of that month.
Do not use this medicine if you notice particles in the solution or if the solution is not clear.
Do not throw any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. This will help protect the environment.
Deadline "> Other information
What PLEYRIS contains
The active ingredient is progesterone. Each vial contains 25 mg of progesterone.
After reconstitution with 1 ml of water for injections, the reconstituted solution (1.119 ml) contains 25 mg of progesterone.
The other component is hydroxypropylbetadex.
Description of the appearance of PLEYRIS and contents of the pack
PLEYRIS is a white powder for solution for injection supplied in a colorless glass vial. Each pack contains 1, 7 or 14 vials.
Not all pack sizes may be marketed.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT -
PLEYRIS 25 MG POWDER FOR SOLUTION FOR INJECTION
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION -
Each vial contains 25 mg of progesterone.
After reconstitution with 1 ml of water for injections, the reconstituted solution (1.119 ml) contains 25 mg of progesterone.
For the full list of excipients, see section 6.1.
03.0 PHARMACEUTICAL FORM -
Powder for solution for injection
White freeze-dried powder.
04.0 CLINICAL INFORMATION -
04.1 Therapeutic indications -
PLEYRIS is indicated in adults to support the luteal phase as part of the assisted reproductive technology (ART) treatment program in infertile women who are unable to use or tolerate vaginal preparations.
04.2 Posology and method of administration -
Dosage
Adults
One injection of 25 mg per day from the day of egg retrieval, usually until 12 weeks of confirmed pregnancy is reached.
Since the indications for PLEYRIS are limited to women of childbearing potential, dosing recommendations for the pediatric and elderly population are not adequate.
PLEYRIS is administered by subcutaneous or intramuscular injection.
Special populations
Senior citizens
No clinical data have been acquired in patients over 65 years of age.
Renal and hepatic impairment
There is no experience on the use of PLEYRIS in patients with impaired hepatic or renal function.
Pediatric population
The safety and efficacy of PLEYRIS in children aged 0 to 18 have not yet been established.
There is no indication for a specific use of PLEYRIS in the pediatric or elderly population as a support in the luteal phase within the assisted reproductive technology (ART) treatment program in infertile women.
Method of administration
Treatment with Lubion should be started under the supervision of a physician experienced in the treatment of fertility disorders.
PLEYRIS is intended for use for intramuscular or subcutaneous administration. The powder must be reconstituted immediately prior to use with water for injections (not provided in the pack).
For instructions on reconstitution of the medicinal product before administration, see section 6.6.
Appearance of the reconstituted product: the solution should be clear and colorless.
Intramuscular administration
Choose a suitable area (quadriceps femoris of the right or left thigh). Swab the chosen area, make a deep injection (with the needle forming a 90 ° angle with the skin). The medicine should be injected slowly to minimize local tissue damage.
Subcutaneous administration
Choose an appropriate area (front of thigh, lower abdomen), swab the chosen area, pinch the skin firmly and insert the needle at a 45 ° to 90 ° angle. The medicine should be injected slowly to reduce local tissue damage to a minimum.
04.3 Contraindications -
PLEYRIS should not be used in people with any of the following conditions:
• Hypersensitivity to progesterone or to any of the excipients
• Undiagnosed vaginal bleeding
• Known suspected abortion or ectopic pregnancy
• Severe liver dysfunction or disease
• Known or suspected cancer of the breast or genital tract
• Active arterial or venous thromboembolism or severe thrombophlebitis or a previous history of these events
• Porphyria
• A history of idiopathic jaundice, severe itching or pemphigoid gravidarum.
04.4 Special warnings and appropriate precautions for use -
Treatment with PLEYRIS should be discontinued if any of the following conditions are suspected: myocardial infarction, cerebrovascular disorders, arterial or venous thromboembolism, thrombophlebitis or retinal thrombosis.
Caution is recommended in patients with mild to moderate hepatic dysfunction.
Patients with a history of depression should be closely monitored. Discontinuation of treatment should be considered if symptoms worsen.
Since progesterone can cause some degree of water retention, conditions that could be affected by this factor (eg epilepsy, migraine, asthma, cardiac or renal dysfunction) require careful observation.
A reduction in insulin sensitivity and consequently in glucose tolerance has been observed in a small number of patients on combined estrogen and progestogen therapy. The mechanism of this reduction is not known. progesterone diabetic patients should be closely monitored (see section 4.5).
The use of sex steroids could also increase the risk of retinal vascular lesions. In order to prevent these complications, it is recommended to use caution in patients over the age of 35, in smokers and in individuals with risk factors for atherosclerosis. treatment should be stopped in case of transient ischemic events, sudden severe headache or visual impairment related to papillary edema or retinal haemorrhage.
Abrupt discontinuation of progesterone dosage can cause mood changes, increased anxiety states and sensitivity to seizures.
Before starting treatment with PLEYRIS, the patient and her partner should be evaluated by a physician for underlying causes of infertility or complications in pregnancy.
04.5 Interactions with other medicinal products and other forms of interaction -
Drugs known to induce the cytochrome P450-3A4 system in the liver (eg rifampicin, carbamazepine, griseofulvin, phenobarbital, phenytoin or St. John's wort (herbal products containing Hypericum perforatum) may increase the rate of elimination and consequently reduce the bioavailability of progesterone.
Conversely, ketoconazole and other cytochrome P450-3A4 inhibitors could decrease the elimination rate and consequently increase the bioavailability of progesterone.
Since the action of progesterone may affect diabetic control, an adjustment of the antidiabetic dosage may be necessary (see section 4.4).
Progesterone may inhibit the metabolism of cyclosporine by inducing increased concentrations of cyclosporine in plasma and the risk of toxicity.
The effect of concomitant use of injectable drugs on progesterone exposure of PLEYRIS has not been evaluated. Concomitant use with other drugs is not recommended.
04.6 Pregnancy and breastfeeding -
Fertility
PLEYRIS is used in the treatment of some forms of infertility (see section 4.1 for complete information).
Pregnancy
PLEYRIS is indicated as a support of the luteal phase as part of the assisted reproductive technology (ART) treatment program in infertile women.
Data on the risk of congenital abnormalities, including reproductive system abnormalities in male or female infants, following intrauterine exposure in pregnancy, are limited and inconclusive. The observed rates of congenital abnormalities, miscarriage and ectopic pregnancies in the clinical trial they were found to be comparable to the event rate described in the general population, but the excessively low value of the total exposure does not allow any conclusions to be drawn.
Feeding time
Progesterone is secreted in breast milk. PLEYRIS should therefore not be used during breastfeeding.
04.7 Effects on ability to drive and use machines -
PLEYRIS has mild or moderate effects on the ability to drive or use machines. Progesterone can cause sleepiness and / or dizziness. Therefore, caution is recommended for those who drive and use machines.
04.8 Undesirable effects -
The most frequently reported adverse drug reactions during treatment with PLEYRIS in the clinical trial setting are administration site reactions, breast and vulvo-vaginal disorders.
The table below shows the main adverse drug reactions in women treated with Lubion in the pivotal clinical study. Data are expressed by system organ class (SOC) and frequency.
* Reactions at the administration site, such as irritation, pain, itching and swelling.
Effects by class
The following conditions, although not reported by patients in clinical trials with PLEYRIS, have been described in association with the use of other drugs belonging to this class of medicines.
04.9 Overdose -
High doses of progesterone can cause drowsiness.
Treatment of overdose consists of discontinuation of PLEYRIS therapy associated with the initiation of adequate symptomatic and supportive therapy.
05.0 PHARMACOLOGICAL PROPERTIES -
05.1 "Pharmacodynamic properties -
Pharmacotherapeutic group: sex hormones and modulators of the genital system; progestogens; pregnene derivatives, ATC code: G03DA04.
Progesterone is a natural steroid secreted by the ovary, placenta and adrenal glands. In the presence of adequate levels of estrogen, progesterone transforms a proliferative endometrium into a secretory endometrium. Progesterone is necessary in increasing endometrial receptivity for the purpose of "implantation of an embryo. Once the implantation of the embryo has taken place, the action of progesterone favors the maintenance of pregnancy."
Clinical efficacy and safety
The rates of developmental pregnancies following 10-week luteal phase support treatment with PLEYRIS 25 mg / day (N = 318) in patients in whom an embryo transfer was observed in the phase III clinical trial were equal to 29.25% (95% CI: 24.25 - 34.25).
Pediatric population
The European Medicines Agency has waived the obligation to submit the results of studies with PLEYRIS in all subsets of the pediatric population for the authorized indications.
05.2 "Pharmacokinetic properties -
Absorption
Serum progesterone concentrations were increased following subcutaneous (SC) administration of 25 mg of Lubion in 12 healthy postmenopausal female subjects. One "hour after administration of a single sc dose the mean Cmax was 50.7 ± 16.3 ng / ml. The serum progesterone concentration decreased after monoexponential decay and twelve hours after administration the mean concentration reported a value of 6.6 ± 1.6 ng / ml. The trough concentration in serum, 1.4 ± 0.5 ng / ml, was reached at the observation interval of 96 hours. Pharmacokinetic analysis demonstrated linearity of the three SC doses tested (25 mg, 50 mg and 100 mg).
After multiple dosing of 25 mg / day with subcutaneous administration, steady-state concentrations were achieved over 2 days of treatment with PLEYRIS. Trough values of 4.8 ± 1.1 ng / ml were observed with AUC of 346.9 ± 41.9 ng * hr / mL on day 11.
Distribution
In humans, 96% to 99% progesterone is bound to serum proteins such as albumin (50-54%) or transcortin (43-48%) and the remainder is free in plasma. Due to its lipid solubility, progesterone passes from the bloodstream to its target cells by passive diffusion.
Biotransformation
Progesterone is metabolised primarily by the liver to a large extent by conversion into pregnanediols and pregnenolones. The pregnanediols and pregnenolones are conjugated in the liver to the glucuronide and sulfate metabolites. The metabolites of progesterone which are excreted in the bile can be deconjugated and further metabolized in the intestine by reduction, dehydroxylation and epimerization.
Elimination
Progesterone is eliminated by the kidney and biliary.
05.3 Preclinical safety data -
Rabbits were treated with 6.7 mg / kg / day of PLEYRIS for 7 consecutive days by SC injection. and i.m. No relevant effects attributed to treatment with s.c. injectable progesterone. it was observed on local, macroscopic and histopathological examination.
Upon examination of the injection site, animals treated with the solvent and progesterone administered im for 7 days experienced a mild local reaction such as hematoma and redness with associated hardening of the muscle. A higher incidence of edema was observed in animals treated with PLEYRIS These signs have been related to local tissue necrosis and a macrophage response to histopathological examination. Moderate fibrosis has been associated with
Intramuscular administration of PLEYRIS after a post-treatment observation period of 7 days. However, no significant or extensive histological changes were found.
A longer-term study was performed with the administration of Lubion at 1 mg / kg / day s.c. or at 4 mg / kg / day i.m. In the context of this research, no toxicologically important clinical signs were found and the minor signs observed were generally similar to those identified in the solvent-treated group. Histopathological examination of the injection sites after 28 days of treatment indicated minor alterations, generally similar to those seen in animals treated with the solvent. After the post-treatment observation period (14 days) there were no changes associated with the injection of PLEYRIS.
Other preclinical studies have found no effects other than those that may be attributable to the known hormone profile of progesterone, however it should be borne in mind that sex hormones such as progesterone may promote the growth of hormone-dependent tumors and tissue proliferations.
The active substance progesterone poses an environmental risk to the aquatic environment, in particular to fish.
06.0 PHARMACEUTICAL INFORMATION -
06.1 Excipients -
Hydroxypropylbetadex
06.2 Incompatibility "-
This medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
06.3 Period of validity "-
48 months
After first opening and reconstitution, the reconstituted solution should be used immediately. Any remaining solution should be discarded.
06.4 Special precautions for storage -
Store below 25 ° C. Do not refrigerate or freeze.
Store in the original package to keep the medicine protected from light.
For storage conditions after reconstitution of the medicinal product, see section 6.3.
06.5 Nature of the immediate packaging and contents of the package -
Colorless type I glass vial with bromobutyl rubber stopper, aluminum cap and flip-off seal. Each pack contains 1, 7 or 14 vials. Not all pack sizes may be marketed.
06.6 Instructions for use and handling -
The reconstituted solution is for single use only.
IMPORTANT: Each vial of lyophilized PLEYRIS must be reconstituted with 1 ml of water for injections before use. The complete dissolution process for PLEYRIS takes approximately 1 minute. The vial must be shaken vigorously to facilitate reconstitution.
After reconstitution the solution is clear and colorless.
The reconstituted solution should not be administered if it contains particles or if it is discolored.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
07.0 HOLDER OF THE "MARKETING AUTHORIZATION" -
IBSA Farmaceutici Italia Srl, Via Martiri di Cefalonia 2, 26900 Lodi
08.0 MARKETING AUTHORIZATION NUMBER -
"25 mg powder for solution for injection" 1 glass vial AIC 041348018
"25 mg powder for solution for injection" 7 glass vials AIC 041348020
"25 mg powder for solution for injection" 14 glass vials AIC 041348032
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION -
22/11/2013
10.0 DATE OF REVISION OF THE TEXT -
January 2017
