Dienosis

White to off-white, round, flat faced bevelled edge tablets debossed with "NC" on one side and "22" on other side.
Each tablet contains 2 mg dienogest.
Excipient(s) with known effect: Each tablet contains 62.8 mg lactose monohydrate.
Excipients/Inactive Ingredients: Lactose monohydrate, Microcrystalline cellulose, Potato starch, Crospovidone, Povidone, Talc, Magnesium stearate.

Pharmacotherapeutic group: Progestogens. ATC code: G03D.
Pharmacology: Pharmacodynamics: Mechanism of action: Dienogest acts on endometriosis by reducing the endogenous production of estradiol and thereby suppressing the trophic effects of estradiol on both the eutopic and ectopic endometrium. When given continuously, dienogest leads to a hypoestrogenic, hypergestagenic endocrine environment causing initial decidualization of endometrial tissue followed by atrophy of endometriotic lesions. Additional properties, like immunologic and antiangiogenic effects, seem to contribute to the inhibitory action of dienogest on cell proliferation.
Pharmacodynamics effects: Dienogest is a nortestosterone derivative with no androgenic but rather an antiandrogenic activity of approximately one third of that of cyproterone acetate. Dienogest binds to the progesterone receptor of the human uterus with only 10% of the relative affinity of progesterone. Despite its low affinity to the progesterone receptor, dienogest has a strong progestogenic effect in vivo. Dienogest has no significant androgenic, mineralocorticoid or glucocorticoid activity in vivo.
Clinical efficacy and safety: Data on efficacy: Superiority of Dienogest 2 mg tablets over placebo with regard to reduction of endometriosis-associated pelvic pain (EAPP) and clinically meaningful reduction of pain compared to baseline were demonstrated in a 3-month study including 102 patients on Dienogest 2 mg tablets. EAPP was measured on a Visual Analog Scale (VAS) (0-100 mm). After 3 months of treatment with Dienogest 2 mg tablets, a statistically significant difference compared to placebo (△=12.3 mm; 95% CI: 6.4-18.1; p<0.0001) and a clinically meaningful reduction of pain compared to baseline (mean reduction = 27.4 mm ± 22.9) were demonstrated.
After 3 months of treatment, reduction of EAPP by 50% or more without relevant increase of concomitant pain medication was achieved in 37.3% of patients on Dienogest 2 mg tablets (placebo: 19.8%); a reduction of EAPP by 75% or more without relevant increase of concomitant pain medication was achieved in 18.6% of patients on Dienogest 2 mg tablets (placebo: 7.3%).
The open-label extension to this placebo-controlled study showed a continued improvement of endometriosis-associated pelvic pain for a treatment duration of up to 15 months (mean reduction at end of treatment = 43.2 ± 21.7 mm).
In addition, efficacy on endometriosis-associated pelvic pain was shown in a 6-month comparative trial of Dienogest 2 mg tablets versus the GnRH analogue leuprorelin acetate (LA) including 120 patients on Dienogest 2 mg tablets. EAPP was measured on a VAS (0-100 mm). A clinically meaningful reduction of pain compared to baseline was observed in both treatment groups (Dienogest 2 mg tablets: 47.5 ± 28.8 mm, LA: 46.0 ± 24.8 mm). Non-inferiority versus LA based on a pre-defined non-inferiority margin of 15 mm was demonstrated (p<0.0001).
Three studies including a total of 252 patients who received a daily dose of 2 mg dienogest demonstrated a substantial reduction of endometriotic lesions after 6 months of treatment.
A randomized, double-blind, parallel-group study (n=20 to 23 per dose group) investigated pharmacodynamics effects of four dienogest doses (0.5, 1.0, 2.0, or 3.0 mg/day) for a maximum of 72 days. Ovulations were observed in 14% and 4% of women of the 0.5 mg and 1 mg groups, respectively. No ovulation occurred in the 2 mg and 3 mg groups. In the 2 mg group, ovulation was confirmed in 80% of women within 5 weeks after cessation of therapy. Dienogest 2 mg tablets 2 mg tablets has not been tested for contraceptive efficacy in larger studies.
The efficacy of Dienogest 2 mg tablets 2 mg tablets was demonstrated in the treatment of endometriosis related symptoms (pelvic pain, dysmenorrhea, and dyspareunia) in a 12-month study with 111 female adolescents (after menarche between 12 and 18 years of age).
Data on safety: Endogenous estrogen levels are only moderately suppressed during treatment with Dienogest 2 mg tablets.
Bone mineral density (BMD) was assessed in 21 adult patients before and after 6 months of treatment and there was no reduction in mean BMD. In a 12-months study involving 111 female adolescents, 103 had BMD measurements. The mean relative change in BMD of the lumbar spine (L2-L4) from baseline was -1.2%. In a subset of the patients with decreased BMD a follow-up measurement was performed 6 months after end of treatment and showed an increase in BMD towards baseline levels.
No significant impact on standard laboratory parameters, including hematology, blood chemistry, liver enzymes, lipids, and HbA1C was observed during treatment with Dienogest 2 mg tablets 2 mg tablets for up to 15 months (n=168).
Pharmacokinetics: Absorption: Orally administered dienogest is rapidly and almost completely absorbed. Peak serum concentrations of 47 ng/ml are reached at about 1.5 hours after single ingestion. Bioavailability is about 91%. The pharmacokinetics of dienogest are dose-proportional within the dose range of 1-8 mg.
Distribution: Dienogest is bound to serum albumin and does not bind to sex hormone binding globulin (SHBG) or corticoid binding globulin (CBG). 10% of the total serum drug concentrations are present as free steroid, 90% are non-specifically bound to albumin. The apparent volume of distribution (Vd/F) of dienogest is 40 l.
Metabolism/Biotransformation: Dienogest is completely metabolized by the known pathways of steroid metabolism, with the formation of endocrinologically mostly inactive metabolites. Based on in vitro and in vivo studies, CYP3A4 is the major enzyme involved in the metabolism of dienogest. The metabolites are excreted very quickly so that in plasma unchanged dienogest is the dominating fraction.
The metabolic clearance rate from serum Cl/F is 64 ml/min.
Elimination/Excretion: Dienogest serum levels decrease in two phases. The terminal disposition phase is characterized by a half-life of approximately 9-10 hours. Dienogest is excreted in form of metabolites which are excreted at a urinary to fecal ratio of about 3:1 after oral administration of 0.1 mg/kg. The half-life of urinary metabolites excretion is 14 hours. Following oral administration approximately 86% of the dose administered is eliminated within 6 days, the bulk of this amount excreted within the first 24 h, mostly with the urine.
Steady-state conditions: Pharmacokinetics of dienogest are not influenced by SHBG levels. Following daily ingestion drug serum levels increase about 1.24 fold reaching steady-state conditions after 4 days of treatment. The pharmacokinetics of dienogest after repeated administration of Dienogest 2 mg tablets can be predicted from single dose pharmacokinetics.
Toxicology: Preclinical safety data: Preclinical data reveal no special risks for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential and toxicity to reproduction. However, it should be borne in mind that sex steroids can promote the growth of certain hormone-dependent tissues and tumors.

Treatment of endometriosis.

Method of administration: For oral use.
Dosage Regimen: Tablet-taking can be started on any day of the menstrual cycle.
The dosage of Dienosis is one tablet daily without any break, taken preferably at the same time each day with some liquid as needed. Tablets must be taken continuously without regard to vaginal bleeding. When a pack is finished the next one should be started without interruption.
The efficacy of Dienogest 2 mg tablets may be reduced in the event of missed tablets, vomiting and/or diarrhoea (if occurring within 3-4 hours after tablet taking). In the event of missed tablet(s), the woman should take one tablet only, as soon as she remembers, and should then continue the next day to take the tablet at her usual time. A tablet not absorbed due to vomiting or diarrhoea should likewise be replaced by one tablet.
If a short acting, e.g. oral, hormonal treatment was prescribed before starting treatment with dienogest, treatment may be started on the first day of menstrual bleeding after cessation of treatment.
If a long-acting, i.e. injectable, hormonal treatment was administered before starting treatment with dienogest, then dienogest may be started once metabolism/excretion of the previously administered drug is expected to complete.
There is no experience with Dienogest 2 mg tablets treatment for more than 15 months in patients with endometriosis.
Additional information on special populations: Paediatric population: Dienogest 2 mg tablets is not indicated in children prior to menarche.
The efficacy of Dienogest 2 mg tablets has been demonstrated in the treatment of endometriosis-associated pelvic pain in adolescent patients (12-18 years), with an overall favorable safety and tolerability profile.
The use of Dienogest 2 mg tablets in adolescents over a treatment period of 12 months was associated with a mean decrease in Bone Mineral Density (BMD) in the lumbar spine of 1.2%. After cessation of treatment, BMD increased again in these patients.
Loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if BMD decrease in this population will reduce peak bone mass and increase the risk for fracture in later life.
Therefore, the treating physician should weigh the benefits of Dienogest 2 mg tablets against the possible risks of use in each individual adolescent patient (see Precautions, Pharmacology: Pharmacodynamics under Actions). If clinically warranted, BMD may be monitored and the results used in the risk-benefit assessment of use of Dienogest 2 mg tablets.
Geriatric population: There is no relevant indication for the use of Dienogest 2 mg tablets in the geriatric population.
Patients with hepatic impairment: Dienogest 2 mg tablets is contraindicated in patients with present or past severe hepatic disease (see Contraindications).
Patients with renal impairment: There are no data suggesting the need for a dosage adjustment in patients with renal impairment.

Acute toxicity studies performed with Dienogest 2 mg tablets did not indicate a risk of acute adverse effects in case of inadvertent intake of a multiple of the daily therapeutic dose. There is no specific antidote. 20-30 mg dienogest per day (10 to 15 times higher dose than in Dienogest 2 mg tablets) over 24 weeks of use were very well tolerated.

Dienogest 2 mg should not be used in the presence of any of the conditions listed as follows, which are partially derived from information on other progestogen-only preparations. Should any of the conditions appear during the use of Dienogest 2 mg tablets treatment must be discontinued immediately.
Presence or risk of venous thromboembolism (VTE): Venous thromboembolism - current VTE (on anticoagulants) or history of (e.g. deep venous thrombosis [DVT] or pulmonary embolism [PE]).
Known hereditary or acquired predisposition for venous thromboembolism, such as APC-resistance, (including Factor V Leiden), antithrombin-III-deficiency, protein C deficiency, protein S deficiency.
Major surgery with prolonged immobilisation (see Precautions).
A high risk of venous thromboembolism due to the presence of multiple risk factors (see Precautions).
Presence or risk of arterial thromboembolism (ATE): Arterial thromboembolism - current arterial thromboembolism, history of arterial thromboembolism (e.g. myocardial infarction) or prodromal condition (e.g. angina pectoris).
Cerebrovascular disease - current stroke, history of stroke or prodromal condition (e.g. transient ischaemic attack, TIA).
Known hereditary or acquired predisposition for arterial thromboembolism, such as hyperhomocysteinaemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant).
History of migraine with focal neurological symptoms.
A high risk of arterial thromboembolism due to multiple risk factors (see Precautions) or to the presence of one serious risk factor such as: diabetes mellitus with vascular symptoms; severe hypertension; severe dyslipoproteinaemia.
Arterial and cardiovascular disease, present or in history (e.g. myocardial infarction, cerebrovascular accident, ischemic heart disease).
Diabetes mellitus with vascular involvement.
Presence or history of severe hepatic disease as long as liver function values have not returned to normal.
Presence or history of liver tumors (benign or malignant).
Known or suspected sex hormone-dependent malignancies.
Undiagnosed vaginal bleeding.
Hypersensitivity to the active substance or to any of the excipients.

Before starting Dienogest 2 mg tablets treatment, pregnancy must be excluded (see Use in Pregnancy & Lactation). During treatment, patients are advised to use non-hormonal methods of contraception (e.g. barrier method) if contraception is required.
Pregnancies that occur among users of progestogen-only preparations used for contraception (eg. minipill) are more likely to be ectopic than are pregnancies among users of combined oral contraceptives. Therefore, in women with a history of extrauterine pregnancy or an impairment of tube function, the use of Dienogest 2 mg tablets should be decided on only after carefully weighing the benefits against the risks.
As Dienogest 2 mg tablets is a progestogen-only preparation, it can be assumed that special warnings and special precautions for use of other progestogen-only preparations are also valid for the use of Dienogest 2 mg tablets although not all of the warnings and precautions are based on respective findings in the clinical studies with Dienogest 2 mg tablets.
If any of the conditions/risk factors mentioned as follows is present or deteriorates, an individual risk-benefit analysis should be done before Dienogest 2 mg tablets is started or continued.
Circulatory disorders: The use of any combined hormonal contraceptive (CHC) increases the risk of venous thromboembolism (VTE) compared with no use. Products that contain levonorgestrel, norgestimate or norethisterone are associated with the lowest risk of VTE. Other products such as dienogest may have up to twice this level of risk. The decision to use any product other than one with the lowest VTE risk should be taken only after a discussion with the woman to ensure she understands the risk of VTE with dienogest, how her current risk factors influence this risk, and that her VTE risk is highest in the first ever year of use. There is also some evidence that the risk is increased when a CHC is re-started after a break in use of 4 weeks or more.
In women who do not use a CHC and are not pregnant, about 2 out of 10,000 will develop a VTE over the period of one year. However, in any individual woman, the risk may be far higher, depending on her underlying risk factors.
Epidemiological studies in women who use low-dose (<50 μg ethinylestradiol) CHCs have found that out of 10,000 women, between 6 to 12 will develop a VTE in one year. It is estimated that out of 10,000 women who use a levonorgestrel-containing CHC, about 6 will develop a VTE in one year.
It is not yet known how the risk of VTE with CHCs that contain dienogest compares with the risk with levonorgestrel-containing CHCs.
Extremely rarely, thrombosis has been reported to occur in other blood vessels, e.g. hepatic, mesenteric, renal or retinal veins and arteries, in CHC users.
Tumors: A meta-analysis from 54 epidemiological studies reported that there is a slightly increased relative risk (RR=1.24) of having breast cancer diagnosed in women who are currently using oral contraceptives (OCs), mainly estrogen-progestogen preparations. The excess risk gradually disappears during the course of the 10 years after cessation of combined oral contraceptives (COC) use. Because breast cancer is rare in women under 40 years of age, the excess number of breast cancer diagnoses in current and recent COC users is small in relation to the overall risk of breast cancer. The risk of having breast cancer diagnosed in progestogen-only pill users is possibly of similar magnitude to that associated with COC. However, for progestogen-only preparations, the evidence is based on much smaller populations of users and so is less conclusive than that for COCs. These studies do not provide evidence for causation. The observed pattern of increased risk may be due to an earlier diagnosis of breast cancer in OC users, the biological effects of OCs or a combination of both. The breast cancers diagnosed in ever-users tend to be less advanced clinically than the cancers diagnosed in never-users.
In rare cases, benign liver tumors, and even more rarely, malignant liver tumors have been reported in users of hormonal substances such as the one contained in Dienogest 2 mg tablets. In isolated cases, these tumors have led to life-threatening intra-abdominal hemorrhages. A hepatic tumor should be considered in the differential diagnosis when severe upper abdominal pain, liver enlargement or signs of intra-abdominal hemorrhage occur in women taking Dienogest 2 mg tablets.
Changes in bleeding pattern: Dienogest 2 mg tablets treatment affects the menstrual bleeding pattern in the majority of women (see Adverse Reactions).
Uterine bleeding, for example in women with adenomyosis uteri or uterine leiomyomata, may be aggravated with the use of Dienogest 2 mg tablets. If bleeding is heavy and continuous over time, this may lead to anemia (severe in some cases). Discontinuation of Dienogest 2 mg tablets should be considered in such cases.
Changes in Bone Mineral Density (BMD): The use of Dienogest 2 mg tablets in adolescents (12 to 18 years) over a treatment period of 12 months was associated with a mean decrease in bone mineral density (BMD) in the lumbar spine of 1.2%. After cessation of treatment, BMD increased again in these patients.
Loss of BMD is of particular concern during adolescence and early adulthood, a critical period of bone accretion. It is unknown if BMD decrease in this population will reduce peak bone mass and increase the risk for fracture in later life (see Additional information on special populations: Paediatric population under Dosage & Administration and Pharmacology: Pharmacodynamics under Actions).
Therefore, the treating physician should weigh the benefits of Dienogest 2 mg tablets against the possible risks of use in each individual adolescent patient also taking into account the presence of significant risk factors for osteoporosis.
Adequate intake of calcium and Vitamin D, whether from the diet or from supplements, is important for bone health in women of all ages.
No BMD decrease was observed in adults (see Pharmacology: Pharmacodynamics under Actions).
Other conditions: Patients who have a history of depression should be carefully observed and the drug discontinued if the depression recurs to a serious degree.
Dienogest 2 mg tablets generally does not appear to affect blood pressure in normotensive women. However, if a sustained clinically significant hypertension develops during the use of Dienogest 2 mg tablets, it is advisable to withdraw Dienogest 2 mg tablets and treat the hypertension.
Recurrence of cholestatic jaundice and/or pruritus which occurred first during pregnancy or previous use of sex steroids necessitates the discontinuation of Dienogest 2 mg tablets.
Dienogest 2 mg tablets may have a slight effect on peripheral insulin resistance and glucose tolerance. Diabetic women, especially those with a history of gestational diabetes mellitus, should be carefully observed while taking Dienogest 2 mg tablets.
Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation whilst taking Dienogest 2 mg tablets.
Persistent ovarian follicles (often referred to as functional ovarian cysts) may occur during the use of Dienogest 2 mg tablets. Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain.
Medical examination: A complete medical history should be taken and a physical and gynecological examination should be performed prior to the initiation or reinstitution of the use of Dienogest 2 mg tablets, guided by the contraindications (see Contraindications) and warnings (see Precautions), and these should be repeated regularly during the use of Dienogest 2 mg tablets. The frequency and nature of these assessments should be adapted to the individual woman but should generally include special reference to blood pressure, breasts, abdomen and pelvic organs, and should also include cervical cytology.
Effects on ability to drive or use machines: Not known.

Pregnancy: There are limited data from the use of dienogest in pregnant women. Animal studies and data from women exposed to dienogest during pregnancy reveal no special risks on pregnancy, embryonic/fetal development, birth or development after birth for humans (see also Pharmacology: Toxicology: Preclinical safety data under Actions). However, Dienogest 2 mg tablets should not be administered to pregnant women because there is no need to treat endometriosis during pregnancy.
The increased risk of VTE during the postpartum period should be considered when re-starting dienogest 2 mg tablets (see Precautions).
Lactation: Treatment with Dienogest 2 mg tablets during lactation is not recommended. Physiochemical properties and animal data indicate excretion of dienogest in breast milk.
A decision must be made whether to discontinue breast-feeding or to abstain from Dienogest 2 mg tablets therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Based on available data, ovulation is inhibited in the majority of patients during treatment with Dienogest 2 mg tablets. However, Dienogest 2 mg tablets is not a contraceptive.
Dienogest 2 mg tablets was not studied for contraceptive efficacy, but DNG 2 mg has been shown in a study involving 20 women to inhibit ovulation after 1 month of treatment. If contraception is required a non-hormonal method should be used (see Precautions).
Based on available data, the menstrual cycle returns to normal within 2 months after cessation of treatment with Dienogest 2 mg tablets.

Undesirable effects are more common during the first months after start of intake of Dienogest 2 mg tablets, and subside with duration of treatment. The following undesirable effects have been reported in users of Dienogest 2 mg tablets.
The most frequently reported undesirable effects during treatment that were considered at least possibly related to Dienogest 2 mg tablets were headache (9.0%), breast discomfort (5.4%), depressed mood (5.1%), and acne (5.1%).
The table, the frequencies of adverse drug reactions (ADRs) by MedDRA system organ classes (MedDRA SOCs) reported with Dienogest 2 mg tablets are summarized in the table as follows. Within each frequency grouping, undesirable effects are presented in order of decreasing frequency. Frequencies are defined as common (2:1/100 to <1/10) and uncommon (2:1/1000 to <1/100).* The frequencies are based on pooled data of four clinical trials including 332 patients (100.0%). (See table.)

Click on icon to see table/diagram/image

*The most appropriate MedDRA term (version 11.0) to describe a certain adverse reaction is listed. Synonyms or related conditions are not listed, but should be taken into account as well.
Uterine bleeding irregularities: Menstrual bleeding patterns were assessed systematically using patient diaries and were analysed using the WHO 90 days reference period method. During the first reference period (i.e. first 90 days of treatment with Dienogest 2 mg tablets): The following bleeding patterns were observed (n=290; 100%): Amenorrhea (1.7%), infrequent bleeding (27.2%), frequent bleeding (13.4%), irregular bleeding (35.2%), prolonged bleeding (38.3%), normal bleeding, i.e. none of the previous categories (19.7%). During the fourth reference period the following bleeding patterns were observed (n=149; 100%): Amenorrhea (28.2%), infrequent bleeding (24.2%), frequent bleeding (2.7%), irregular bleeding (21.5%), prolonged bleeding (4.0%), normal bleeding, i.e. none of the previous categories (22.8%). 13 Changes in menstrual bleeding patterns were only occasionally reported as adverse event by the patients (see previous table).

Note: The prescribing information of concomitant medications should be consulted to identify potential interactions.
Effects of other medicaments on Dienogest 2 mg tablets: Progestins including dienogest are metabolized mainly by the cytochrome P450 3A4 system (CYP3A4) located both in the intestinal mucosa and in the liver. Therefore, inducers or inhibitors of CYP3A4 may affect the progestogen drug metabolism.
An increased clearance of sex hormones due to enzyme induction may reduce the therapeutic effect of Dienogest 2 mg tablets and may result in undesirable effects e.g., changes in the uterine bleeding profile.
A reduced clearance of sex hormones due to enzyme inhibition may increase the exposure to dienogest and may result in undesirable effects.
Substances increasing the clearance of sex hormones (diminished efficacy by enzyme-induction), e.g.: Phenytoin, barbiturates, primidone, carbamazepine, rifampicin, and possibly also oxcarbazepine, topiramate, felbamate, griseofulvin and products containing St. John's wort.
Enzyme induction can already be observed after a few days of treatment. Maximum enzyme induction is generally seen within a few weeks. After the cessation of drug therapy enzyme induction may be sustained for about 4 weeks.
The effect of the CYP 3A4 inducer rifampicin was studied in healthy postmenopausal women. Co-administration of rifampicin with estradiol valerate/dienogest tablets led to significant decreases in steady state concentrations and systemic exposures of dienogest.
The systemic exposure of dienogest at steady state, measured by AUC(0-24h), was decreased by 83%.
Substances with variable effects on the clearance of sex hormones: When co-administered with sex hormones, many HIV/HCV protease inhibitors and non-nucleoside reverse transcriptase inhibitors can increase or decrease plasma concentrations of the progestin. These changes may be clinically relevant in some cases.
Substances decreasing the clearance of sex hormones (enzyme inhibitors): Dienogest is a substrate of cytochrome P450 (CYP) 3A4.
Strong and moderate CYP3A4 inhibitors such as azole antifungals (e.g itraconazole, voriconazole, fluconazole), verapamil, macrolides (e.g clarithromycin, erythromycin), diltiazem and grapefruit juice can increase plasma concentration of the progestin.
In a study investigating the effect of CYP3A4 inhibitors (ketoconazole, erythromycin) on the combination of Estradiol valerate/dienogest, steady state dienogest plasma levels were increased. Co-administration with the strong inhibitor ketoconazole resulted in a 2.86-fold increase of AUC(0-24h) of dienogest at steady state was increased 1.62-fold. The clinical relevance of these interactions is unknown.
Effects of Dienogest 2 mg tablets on other medicinal products: Based on in vitro inhibition studies, a clinically relevant interaction of Dienogest 2 mg tablets with the cytochrome P450 enzyme mediated metabolism of other medicaments is unlikely.
Drug-food interactions: A standardized high fat meal did not affect the bioavailability of Dienogest 2 mg tablets.
Other forms of interactions: The use of progestins may influence the results of certain laboratory tests, including biochemical parameters of liver, thyroid, adrenal and renal function, plasma levels of (carrier) proteins, e.g. lipid/lipoprotein fractions, parameters of carbohydrate metabolism and parameters of coagulation and fibrinolysis. Changes generally remain within the normal laboratory range.

Incompatibilities: None.
Instructions for use/handling: None.

Shelf life: 3 years.
Special precautions for storage: Store below 30°C. Protect from light.

Oestrogens, Progesterones & Related Synthetic Drugs

G03DB08 - dienogest ; Belongs to the class of pregnadien derivative progestogens used in progestogenic hormone preparations.

POM