TranexamicAcid OBGYN

Tranexamic Acid in Gynaecology & Obstetrics
Prof. Surendra Nath Panda, M.S. Dept. of Obstetrics and Gynecology M.K.C.G.Medical College, Berhampur.
Blood The essence of Life
STOP BLOOD LOSS
STOP
BLOOD LOSS
LIFE GOES ON
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Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002
Women are always at Risk of Loosing Blood

PPH DUB APH FROM MENARCHEE TO MENOPAUSE IN NORMALCY OR PREGNANCY IN HEALTH OR DISEASE HOW TO STOP IT? DUB CX DUB
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Events in Hemostasis
1) Vasoconstriction 2) Platelet plug formation 3) Blood clotting
4) Fibrinolysis
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Events in Haemostasis
COAGULATION:
Prothrombin Fibrinogen Clot
Thrombin Fibrin
forms
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Events in Haemostasis
FIBRINOLYSIS:
Plasminogen
Plasmin
dissolves
Clot
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COAGULATION AND FIBRINOLYSIS
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Presenting Tranexamic Acid
COAGULATION TRANEXAMIC Tranexamic AND FIBRINOLYSIS ACID Acid
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Tranexamic Acid

Synthetic amino acid, first introduced in Sweden in1969. Chemically it is Tranexamic-stereo isomer of 1, 4, aminomethylcyclohexane carboxylic acid. Formula C8H15NO2. Molecular Wt.-157. Prevents fibrinolysis and breakdown of clot.
It is a competitive inhibitor of plasminogen activation. At very high concentration, it is also a non competitive inhibitor of Plasmin.
It is also a very weak inhibitor of thrombin.

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Tranexamic Acid
Mechanism of Action
Tranexamic acid inhibits conversion of plasminogen to plasmin, hence prevents breakdown of clot. Increases collagen synthesis which preserves the fibrin matrix and increases the tensile strength of the clot These actions of Tranexamic acid help in stabilizing the clot
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Tranexamic Acid
Pharmacokinetics

Absorption after oral administration is 30-50% Food has no influence on absorption Presystemic metabolism ~ nil Plasma half-life ~ 1.4h Is able to cross the blood-aqueous barrier in the eyes. Can also cross the damaged blood-brain barrier Rapidly diffuses into joint fluid and the synovial membrane.
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Tranexamic Acid
Pharmacokinetics Plasma protein binding is negligible Undergoes negligible metabolism in the body. Mainly eliminated unchanged in the urine. Excretion occurs by glomerular filtration via the kidneys. Passes through the placenta and its concentration in the cord blood may reach that of maternal blood.
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Tranexamic Acid
Clinical Pharmacology
The antifibrinolytic effect of Tranexamic acid is related mainly to a reversible complex formation with plasminogen, which prevents its activation to plasmin. Tranexamic acid is 7 to 10 times more potent than Epsoilon-aminocaproic acid [EACA]. Tranexamic acid produces a considerably higher and more sustained antifbrinolytic activity in tissues than does EACA.
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Tranexamic Acid
Clinical Pharmacology Adverse effects- are rare and mainly limited to

Nausea, Vomiting & Diarrhea, Allergy and occasionally an Orthostatic reaction. There is a theoretical risk of an increased thrombotic tendency, like deep vein thrombosis, during prolonged treatment as with any fibrinolysis inhibitors.
Contraindications: Severe renal insufficiency Hematuria

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Tranexamic Acid
Pregnancy And Lactation
Pregnancy:Tranexamic acid crosses over to the foetus. It is not known whether a reduction of the normally high fibrinolytic activity in the foetus and neonate is harmful.
Lactation:Tranexamic acid is secreted in the mother's milk. This concentration is only a hundredth of the corresponding serum levels and the drug may be given during lactation without risk to the child.
Ref: Collin Dollery. Tranexamic Acid. In 'Therapeutic Drugs. 2nd edition. 1999.pgT150-T153
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Tranexamic Acid
Uses in OBGYN
To Prevent / reduce blood loss in: Dysfunctional Uterine Bleeding IUD Menorrhagia. Conization / Amputation of Cervix. Post Partum Hemorrhage. Ante Partum Hemorrhage. During/After Abdominal/Vaginal Surgery Available in both Oral and Inj. (IV) forms
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Dysfunctional Uterine Bleeding
Most common menstrual disorder. Can affect any women from menarche to menopause. Often the first clinical diagnosis for any excessive menstrual bleedings. Diagnosis has to be confirmed by a process of exclusion of pathological causes.
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Types of DUB
OVULATION PHASE CHANGE
SHORTENED F P
END. HIST
MENSTRUAL PATERN
POLYMENORRHAGIA MENORRHAGIA OLIGOMENORRHOEA MENORRHAGIA
NORMAL NORMAL
NORMAL NORMAL
LONG F P
SHORT L P
ABNORMAL COR.LUT
PERSISTENT COR. LUT
DEFICIENT SEC. END.

WELL DEV. SEC. END
PRE MENS. SPOTTING MENORHAGIA

PROLONGED CYCLES
LONG L P
SHORT CYCLES
ANOVULATION (Insufficient follicles)

ANOVULATION (Polycystic Ovaries)
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DEFICIENT PRO. END.

PRO. / HYPERPLASTIC
POLYMENORRHAGIA MENORRHAGIA
OLIGOMENORRHOEA METROPATHIA HAEMORRHAGICA
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PROL. CYCLES
Dysfunctional Uterine Bleeding-WHY?
Exact pathophysiology still not known. Basis of excessive bleeding?

Endocrine abnormality: -estrogen - progesterone imbalance (usually estrogen dominance). Deficiency in clotting mechanism. Altered prostaglandin synthesis in favor of E2 than F2.
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D U B - Management Options
D&C (ES+H)
CONSERVATIVE
MEDICAL
SPONTANEOUS CURE
RECURENCE / FAILURE
CURE
H-Hysteroscopy ES-Endometrial Sampling
D & C / H+ES
-SURGERY-HYSTERCTOMY -ENDOMETRIAL ABLATION

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Medical Treatment for DUB
HORMONES
Es+Pr (COCP) Progestogens
Norethisterone?
MPA
ANTIFIBRINOLYTICS
TRANEXAMIC ACID (TA) Epsilon Amino Caproic Acid
LNG IUS Danazol GnRHa Estrogen Androgens + Estrogen
NSAIDs
Mefenamic acid (MA) Naproxen,Ibuprofen, Aspirin
Ethamsylate
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SERMS Radiotherapy ??
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Evidence Based Medicine

(E B M) Evidence-Based Medical Treatment for DUB may be Grade A - based on randomized controlled trials. Grade B - based on other robust. experimental or observational studies. Grade C - based on more limited evidence but the advice relies on expert opinion and has the endorsement of respected authorities.
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COC Pills

Combined oral contraceptives (COCs) can be used to reduce menstrual blood loss (A) [RCOG, 1998]. They are thought to reduce blood loss by inducing regular shedding of a thinner endometrium. In one small randomized trial, the COC reduced menstrual blood loss by 43% and was as effective as mefenamic acid, naproxen, and low dose danazol [Iyer et al. 2001]. The effectiveness of the COC at reducing menstrual blood loss is supported by other non-randomized and noncontrolled studies [RCOG, 1998]. The COC is a reasonable first choice for women who also require contraception. In addition, it may reduce associated dysmenorrhoea [Wilson et al. 2001].
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LNG IUS
A progestogen releasing intrauterine device is an effective treatment for menorrhagia (A) It reduces menstrual blood loss by up to 90% Its main advantages are relief of dysmenorrhoea, effective contraception, and long-term control of menorrhagia following insertion [Sturridge and Guillebaud, 1996]. Satisfaction and quality of life ratings are high, although there is a lack of data comparing it to other established treatments. It is much cheaper over 5 years compared to other treatments, although it becomes expensive if removed before that time limit. The main disadvantages are intermenstrual bleeding and breast tenderness in the first few months following insertion. Expulsion rates range from 3.3-5.9% within 12 months [Lethaby et al. 2001e].
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NASIDs

Mefenamic acid is an effective treatment for reducing heavy menstrual blood loss (A) [RCOG, 1998]. Although mefenamic acid has been studied the most, it is likely that other nonsteroidal anti-inflammatory drugs (NSAIDs) are as effective [Lethaby et al. 2001a]. NSAIDs are thought to act by reducing uterine prostaglandin levels, which are elevated in women with excessive menstrual bleeding. NSAIDs reduce menstrual blood loss by 20-50% [RCOG, 1998]. Comparative studies show that they are less effective than tranexamic acid or danazol, but are as effective as other medical treatments [Duckitt, 2000; Lethaby et al. 2001a]. They reduce associated dysmenorrhoea [Zhang and Li Wan Po, 1998; Wilson and Farquhar, 2000].
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Tranexamic Acid
Tranexamic acid is an effective treatment for reducing heavy menstrual blood loss (A) [RCOG, 1998]. It reduces menstrual blood loss by 40-50% [Lethaby et al. 2001b]. Being a plasminogen activator inhibitor, its use is rational as an increase in the level of plasminogen activators is found in the endometrium of women with heavy menstrual bleeding compared to those with normal menstrual loss.
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Tranexamic Acid
Comparative studies show it to be more effective in reducing menstrual blood loss [RCOG, 1998; Duckitt, 2000; Lethaby et al. 2001b]. than
nonsteroidal anti-inflammatory drugs, luteal phase oral progestogens, and ethamsylate
It has not been compared to the combined oral contraceptive pill or the levonorgestrel intrauterine system. It is well tolerated, with no significant increase in reported adverse events compared to placebo or other treatments [Lethaby et al. 2001b]. There is no evidence of an increased incidence of thrombogenic disease (e.g. deep vein thrombosis) [RCOG, 1998; Lethaby et al. 2001b].
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Danazol
Danazol inhibits secretion of pituitary gonadotrophins and also has androgenic, antioestrogenic, and anti-progestogenic activity. It reduces excessive menstrual bleeding by up to 80% [NZ, 1998; RCOG, 1999]. It is poorly tolerated, due to androgenic side effects of weight gain, hirsutism, acne, mood changes, and occasionally deepening of the voice, which may be irreversible. It should generally only be used selectively, following specialist advice [NZ, 1998; RCOG, 1998].
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Ethamsylate
Ethamsylate is thought to reduce capillary bleeding by correcting abnormal platelet function. There is some evidence that it may achieve small reductions in menstrual blood loss, but this is unlikely to be clinically significant [RCOG, 1998; Duckitt, 2000]. Ethamsylate, at currently recommended doses, is not an effective treatment for menorrhagia (A) [RCOG, 1998].
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GnRHa
Gondadotrophin releasing hormone analogues initially stimulate pituitary secretion of gonadotrophins and then rapidly inhibit secretion due to pituitary down-regulation. This results in anovulation, markedly reduced oestrogen levels, and amenorrhoea. They are poorly tolerated and cannot be used long-term. They should only be used selectively following specialist advice [RCOG, 1998]. Some are licensed for endometrial thinning prior to intrauterine surgery or for reduction of size of uterine fibroids and associated bleeding before surgery.
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Progestogens (oral)
Several reviews have highlighted the lack of good trial data and the likely poor efficacy of commonly used regimes [EHCB, 1995; NZ, 1998; RCOG, 1998; Duckitt, 2000; Lethaby et al. 2001c]. Low dose, luteal phase administration of norethisterone is not an effective treatment for menorrhagia (A) [RCOG, 1998]. Luteal phase progestogens (taken from Day 15 or 19 to Day 26 of the cycle) have not been studied in placebo-controlled trials, but comparative studies indicate that they are inferior to other medical treatments [Lethaby et al. 2001c]. Progestogen treatment for 21 days of each cycle reduces menstrual blood loss by about 90%, but is poorly tolerated. In one study, only 22% of women were willing to continue treatment [RCOG, 1998; Duckitt, 2000; Lethaby et al. 2001c]. Norethisterone 15 mg daily for 10 days is licensed to arrest menstrual bleeding, and may be useful for some women who present with heavy, prolonged bleeding [BNF 41, 2001
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Progestogens (long-acting)
Continued use of long-acting progestogens renders most women amenorrhoeic and therefore could be considered for use in menorrhagia (C) [RCOG, 1998]. However, there is no trial data available on their use in the treatment of menorrhagia and they are not licensed for this indication. Medroxyprogesterone acetate (MPA) is available as a depot injection for contraception. It may cause unpredictable, irregular spotting and bleeding in the first few months of use, and may cause heavy bleeding in 1-2% of women. However, after using it for a year, 45-50% of women are amenorrhoeic [RCOG, 1998]. MPA may be an option for women who require contraception but who are unable or unwilling to use the combined oral contraceptive pill or the levonorgestrel intrauterine system.
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EBM
Treatment of Menorrhagia during menstruation: randomized controlled trial of Ethamsylate, Mefenamic acid, and Tranexamic acid
John Bonnar, Professor and Head of Department, Brian L Sheppard, Associate Professor of Human Reproduction Trinity College Department of Obstetrics and Gynaecology, Trinity Centre for Health Sciences, St James' Hospital and The Coombe Women's Hospital, Dublin
BMJ. 1996;313:579-582
Objective: To compare the efficacy and acceptability of Ethamsylate, Mefenamic acid, and Tranexamic acid for treating Menorrhagia.
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EBM
Design: Randomized controlled trial. Setting: A university department of obstetrics and gynaecology. Subjects: 76 women with dysfunctional uterine bleeding. Interventions: Treatment for five days from day 1 of menses during three consecutive menstrual periods. 27 patients were randomised to take ethamsylate 500 mg six hourly, 23 patients to take mefenamic acid 500 mg eight hourly, and 26 patients to take tranexamic acid 1 g six hourly Main outcome measures: Menstrual loss measured by the alkaline haematin method in three control menstrual periods and three menstrual periods during treatment; duration of bleeding; patient's estimation of blood loss; sanitary towel usage; the occurrence of dysmenorrhoea; and unwanted events.
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EBM
Results
Fig 1--Mean menstrual blood loss of 27 patients during three pretreatment (control) cycles and three cycles during treatment with ethamsylate, 23 patients during three pretreatment cycles and three cycles during treatment with mefenamic acid, and 26 patients during three pretreatment cycles and three cycles during treatment with tranexamic acid. Bars are SD
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EBM
Results
Fig 2--Mean menstrual blood loss during three control and three treatment cycles in patients treated with ethamsylate (no reduction in blood loss), mefenamic acid (20% reduction in blood loss), and tranexamic acid (54% reduction in blood loss). Bars are SD
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EBM
Conclusions: Tranexamic acid given during menstruation is a safe and highly effective treatment for excessive bleeding. Patients with dysfunctional uterine bleeding should be offered medical treatment with Tranexamic acid before a decision is made about surgery.
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Antifibrinolytics for heavy menstrual bleeding (Cochrane Review conclusions)
Antifibrinolytic therapy causes a greater reduction in objective measurements of heavy menstrual bleeding when compared to placebo or other medical therapies (NSAIDS, oral luteal phase progestagens and ethamsylate). This treatment is not associated with an increase in side effects compared to placebo, NSAIDS, oral luteal phase progestagens or ethamsylate. Flooding and leakage and sex life is significantly improved after tranexamic acid therapy when compared with oral luteal progestogens but no other measures of quality of life were assessed. No study has used resource cost as an outcome. There are no data available within randomised controlled trials which record the frequency of thromboembolic events.
From- The Cochrane Library, Issue 3, 2002. Oxford: Lethaby A, Farquhar C, Cooke
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Evidence-Based Treatment for DUB
Effective treatments for Menorrhagia:
Tranexamic acid Non-steroidal anti-inflammatory drugs Combined oral contraceptives Cyclical (21 days) progestogens The Levo Norgestrel releasing intrauterine system (LNG IUS / Mirena)
Inappropriate management is being applied even though effective medical treatments exist (above) and have a rational basis for their use. Increased use of effective treatments will improve patient choice and provide an alternative to surgery.
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Reduction in Menstrual Blood Loss by Drugs

120 100 80
Percent
97
97
Ethymsylate Norethisterone
TA
MA
60 50 40 30 15 5
NASID (MA)
COCP
60 40 20 0
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Tranexamic Acid
Danzol GNRha LNG IUS
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Hormonal Treatment for DUB

Problems:
Treatment has to be individualized. Not suitable for all ages and all types. Response is erratic and unpredictable. SIDE EFFECTS So discontinuation and noncompliance. Failures are common. Cost effectiveness? Surgery is often resorted to.
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Final Verdict on Tranexamic Acid

EBM
It is the most effective and acceptable of the drug therapies currently available for DUB. It induces a reduction in menstrual blood loss of around 50% in the majority of patients. However, Tranexamic acid is ineffective in around 15% of patients, and Its acceptability is compromised in approximately 20-30% of patients, due to the side effects.
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Guidelines and Statements From Governmental Agencies and Professional Associations were also reviewed
United Kingdom Cochrane Menstrual Disorders and Subfertility Group (Cochrane Collaboration) Disorders of the Menstrual Cycle (Royal College of Obstetricians and Gynaecologists, UK) Menorrhagia (Prodigy, UK) North Essex Guidelines For The Management Of Menorrhagia In Primary Care (Equip, UK) The Initial Management of Menorrhagia (Royal College of Obstetricians and Gynaecologists, UK) The Management of Menorrhagia in Secondary Care (Royal College of Obstetricians and Gynaecologists, UK)
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United States Abnormal Vaginal Bleeding (American College of Radiology) Menstrual disorders (American Board of Family Practice) Surgical Alternatives to Hysterectomy for Abnormal Uterine Bleeding (Minnesota Health Technology Advisory Committee, US) Canada Guidelines for the Management of Abnormal Uterine Bleeding (The Society of Obstetricians and Gynaecologists of Canada)
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Australia IMB - Guidelines For Referral (Medicine Australia) New Zealand Guidelines for the Management of Heavy Menstrual Bleeding (New Zealand Guidelines Group) Recommended Medical Investigations and Treatment for Heavy Menstrual Bleeding (New Zealand Guidelines Group)
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Treatment for Menorrhagia (DUB) Current Recommendation

Does not need contraception / prefers non hormonal treatment
TA 1G TDS / M A 500mg TDS / Both, from 1st day of period for days of heavy flow (Not more than 4 days)
If blood flow is reduced to an acceptable level , continue treatment indefinitely.
Use for 3 months
If blood flow is not reduced to an acceptable level or unacceptable side effects, review and try other modalities.
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Treatment for Menorrhagia (DUB) Current Recommendation

Needs contraception / prefers hormonal treatment
COC Pills
+TA
Review after 3 months. Add MA if necessary.
LNG IUS +TA
21 days Cyclical MPA / Long Acting TA Progestogens
Review after 3 months.

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Review after 6 months. If flow still unacceptable reassess.
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Treatment for Menorrhagia (IUD) Current Recommendation

Has an non hormonal IUCD T A 1G TDS alone / with / or M A 500mg TDS, from 1st day of period for days of heavy flow (Not more than 4 days) If blood flow is reduced to an acceptable level , continue treatment indefinitely.
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If flow is not reduced to an acceptable level or unacceptable side effects, remove IUCD & suggest alternative contraception.
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Tranexamic Acid for DUB Summary

Tranexamic Acid in doses of 1G TDS/QDS is a very safe and effective alternative. Adding Mefenamic Acid 500mg TDS will further improve the results specially in patients having dysmenorhea as well. It should be used as primary / first line of treatment particularly where the cycle is regular or contraception is not desired. It can also be used along with OCP / MPA where cycle control /contraception is required.
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Tranexamic Acid in Conization
Post operative heavy bleeding after knife conization occurs in about 15% of cases, requiring extra measures. High concentration of Plasminogen has been observed in Cx. Tranexamic Acid, is a logical solution in such patients. In doses of 1.5G/day for 12 days post operatively, double blind studies have shown a 70% reduction in blood loss.
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Tranexamic Acid in APH & PPH
Bleeding from placental sites usually result from the structural weakness & defects in the placental blood vessels. Tranexamic acid in doses of 1G (IV/Oral) TDS, by prtomoting stable coagulation at the site of bleeding, can be of help in Placenta Previa (2nd half of pregnancy). Abruptio Placentae. Persistent Post Partum Hemorrhage
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Blood The essence of Life
STOP BLOOD LOSS WITH

TRANEXAMIC ACID
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52
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TranexamicAcid OBGYN

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Tranexamic Acid in Gynaecology & Obstetrics

Blood The essence of Life

STOP BLOOD LOSS

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Women are always at Risk of Loosing Blood

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Prothrombin Fibrinogen Clot

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

COAGULATION AND FIBRINOLYSIS

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

COAGULATION TRANEXAMIC Tranexamic AND FIBRINOLYSIS ACID Acid

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

It is also a very weak inhibitor of thrombin.

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Clinical Pharmacology Adverse effects- are rare and mainly limited to

Contraindications: Severe renal insufficiency Hematuria

Dysfunctional Uterine Bleeding

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

DEFICIENT SEC. END.

PRE MENS. SPOTTING MENORHAGIA

ANOVULATION (Insufficient follicles)

DEFICIENT PRO. END.

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Dysfunctional Uterine Bleeding-WHY?

Exact pathophysiology still not known. Basis of excessive bleeding?

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

-SURGERY-HYSTERCTOMY -ENDOMETRIAL ABLATION

Medical Treatment for DUB

LNG IUS Danazol GnRHa Estrogen Androgens + Estrogen

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Evidence Based Medicine

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Antifibrinolytics for heavy menstrual bleeding (Cochrane Review conclusions)

Evidence-Based Treatment for DUB

Effective treatments for Menorrhagia:

Reduction in Menstrual Blood Loss by Drugs

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Hormonal Treatment for DUB

Final Verdict on Tranexamic Acid

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Treatment for Menorrhagia (DUB) Current Recommendation

If blood flow is reduced to an acceptable level , continue treatment indefinitely.

Use for 3 months

Treatment for Menorrhagia (DUB) Current Recommendation

LNG IUS +TA

21 days Cyclical MPA / Long Acting TA Progestogens

Review after 3 months.

Review after 6 months. If flow still unacceptable reassess.

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Treatment for Menorrhagia (IUD) Current Recommendation

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Tranexamic Acid for DUB Summary

Tranexamic Acid in Conization

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Tranexamic Acid in APH & PPH

Blood The essence of Life

STOP BLOOD LOSS WITH

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

Tranexamic Acid in Gynaecology and Obstetrics- Prof.S.N.Panda, 21-12-2002

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