سعر تراكتوسيل Tractocile 7.5مجم/مل فيال 0.9مل 2026
Tractocile 7.5mg/ml i.v. vial 0.9 mlدواعي استعمال تراكتوسيل
- تأخير الولادة المبكرة الوشيكة لدى الحوامل البالغات مع انقباضات رحمية منتظمة، وتوسع عنق الرحم 1-3 سم، وعمر حمل من 24 حتى 33 أسبوعاً مكتملاً، ومعدل نبض جنيني طبيعيالفئة: Pregnant adult women (>=18 years), 24-33 completed weeksEuropean Medicines Agency (EMA)
- To delay imminent pre-term birth in pregnant adult women with regular uterine contractions (>=30 s, >=4 per 30 min), cervical dilation 1-3 cm (0-3 cm in nulliparas) with effacement >=50%, gestational age 24 to 33 completed weeks and normal foetal heart ratePopulation: Pregnant adult women (>=18 years), 24-33 completed weeksEuropean Medicines Agency (EMA)
معلومات الدواء
التفاصيل الكاملةالآثار الجانبيةSide effects
- Maternal adverse reactions in trials were generally mild (48% of patients). Very common: nausea (14%). Common: headache, dizziness, hyperglycaemia, tachycardia, hypotension, hot flush, vomiting, injection site reaction. Uncommon: insomnia, pruritus, rash, pyrexia. Rare: allergic reaction, uterine haemorrhage, uterine atony. Post-marketing: dyspnoea and pulmonary oedema, particularly with other tocolytics and/or multiple pregnancy. No specific neonatal adverse reactions identified in trials.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
- Maternal adverse reactions in trials were generally mild (48% of patients). Very common: nausea (14%). Common: headache, dizziness, hyperglycaemia, tachycardia, hypotension, hot flush, vomiting, injection site reaction. Uncommon: insomnia, pruritus, rash, pyrexia. Rare: allergic reaction, uterine haemorrhage, uterine atony. Post-marketing: dyspnoea and pulmonary oedema, particularly with other tocolytics and/or multiple pregnancy. No specific neonatal adverse reactions identified in trials.International label, same product · European Medicines Agency (EMA)
موانع الاستعمالContraindications
- عمر حمل أقل من 24 أو أكثر من 33 أسبوعاً مكتملاً؛ تمزق الأغشية المبكر بعد 30 أسبوعاً؛ نبض جنيني غير طبيعي؛ نزف رحمي قبل الولادة يستدعي الولادة الفورية؛ الارتعاج أو ما قبل الارتعاج الشديد؛ وفاة الجنين داخل الرحم؛ الاشتباه في عدوى داخل الرحم؛ المشيمة المنزاحة؛ انفصال المشيمة؛ فرط الحساسية.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
- Gestational age below 24 or over 33 completed weeks; premature rupture of membranes >30 weeks; abnormal foetal heart rate; antepartum uterine haemorrhage requiring immediate delivery; eclampsia or severe pre-eclampsia requiring delivery; intrauterine foetal death; suspected intrauterine infection; placenta praevia; abruptio placentae; any other maternal or foetal condition in which continuing pregnancy is hazardous; hypersensitivity to atosiban or excipients.International label, same product · European Medicines Agency (EMA)
تحذيرات واحتياطاتWarnings & precautions
- If premature rupture of membranes cannot be excluded, balance the benefit of delaying delivery against the risk of chorioamnionitis.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
- Limited experience in multiple pregnancy and at 24-27 weeks; benefit in these subgroups is uncertain.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
- As an oxytocin antagonist it may theoretically facilitate uterine relaxation and postpartum bleeding: monitor blood loss after delivery.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
- If premature rupture of membranes cannot be excluded, balance the benefit of delaying delivery against the risk of chorioamnionitis.International label, same product · European Medicines Agency (EMA)
- Limited experience in multiple pregnancy and at 24-27 weeks; benefit in these subgroups is uncertain.International label, same product · European Medicines Agency (EMA)
- As an oxytocin antagonist it may theoretically facilitate uterine relaxation and postpartum bleeding: monitor blood loss after delivery.International label, same product · European Medicines Agency (EMA)
التداخلات الدوائيةDrug interactions
- Cytochrome P450 substrates/inhibitorsCYP450-mediated interactions unlikely: atosiban is not a CYP substrate and does not inhibit CYP enzymes in vitro.European Medicines Agency (EMA)
- Labetalol, betamethasoneNo clinically relevant interaction found in studies in healthy female volunteers.European Medicines Agency (EMA)
- Other tocolytics (calcium channel blockers, beta-mimetics)Increased risk of pulmonary oedema, especially in multiple pregnancy; use with caution.European Medicines Agency (EMA)
- Cytochrome P450 substrates/inhibitorsCYP450-mediated interactions unlikely: atosiban is not a CYP substrate and does not inhibit CYP enzymes in vitro.European Medicines Agency (EMA)
- Labetalol, betamethasoneNo clinically relevant interaction found in studies in healthy female volunteers.European Medicines Agency (EMA)
- Other tocolytics (calcium channel blockers, beta-mimetics)Increased risk of pulmonary oedema, especially in multiple pregnancy; use with caution.European Medicines Agency (EMA)
الحمل والرضاعةPregnancy & breastfeeding
- Use only when pre-term labour has been diagnosed between 24 and 33 completed weeks. Embryo-foetal toxicity studies showed no toxic effects. Atosiban crosses the placenta (foetal/maternal ratio 0.12 at term). In a placebo-controlled study, foetal/infant deaths were higher with atosiban (5.2% vs 1.7%), mostly at 20-24 weeks with unequal subgroup distribution; no difference above 24 weeks.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
- If the woman is breast-feeding an earlier child, stop breast-feeding during treatment (oxytocin release may counteract tocolysis). Small amounts of atosiban pass into breast milk.نشرة دولية لنفس المنتج · European Medicines Agency (EMA)
- Use only when pre-term labour has been diagnosed between 24 and 33 completed weeks. Embryo-foetal toxicity studies showed no toxic effects. Atosiban crosses the placenta (foetal/maternal ratio 0.12 at term). In a placebo-controlled study, foetal/infant deaths were higher with atosiban (5.2% vs 1.7%), mostly at 20-24 weeks with unequal subgroup distribution; no difference above 24 weeks.International label, same product · European Medicines Agency (EMA)
- If the woman is breast-feeding an earlier child, stop breast-feeding during treatment (oxytocin release may counteract tocolysis). Small amounts of atosiban pass into breast milk.International label, same product · European Medicines Agency (EMA)
كيف يعمل الدواءHow it works
- أتوسيبان: ببتيد مُخلّق مضاد تنافسي للأوكسيتوسين البشري على مستوى المستقبلات؛ يقلل تواتر الانقباضات وتوتر الرحم؛ ويرتبط أيضاً بمستقبلات الفازوبريسين.مضاد لمستقبلات الأوكسيتوسين (ببتيد مُخلّق)
- Atosiban: Synthetic peptide competitive antagonist of human oxytocin at receptor level; reduces frequency of contractions and uterine tone; also binds the vasopressin receptor (EU SmPC).
تابع أسعار الأدوية أول بأول
بننشر كل يوم أسعار أدوية اتغيرت والبدائل الأرخص
المثائل (1)
كل المثائل والبدائلنفس المادة الفعالة والتركيز. اسأل الصيدلي قبل الاستبدال.
| الدواء | السعر | الفرق عن الأصلي |
|---|---|---|
| تراكتوسيل 7.5مجم/مل 5ملTractocile 7.5mg/ml i.v. conc. vial 5 mlmultipharma · 7.5 mg/mlالأرخص | السعر630ج.م630ج.م للوحدة | الفرق عن الأصليأغلى 460ج.م (270.6%) |
المعرّفات
- تصنيف ATC
- مراجع علمية للمادة الفعالة
- AtosibanPubChem (يفتح في نافذة جديدة)
أدوية ذات صلة
منتجات أخرى من multipharma
- ACTONEL 35MG ONCE-A-WEEK 2 F.C. TAB. (N/A)قرص مغلف121.5ج.م
- ALOXI 0.25MG/5ML VIAL FOR I.V.محلول للحقن (فيال)1,101ج.م
- ارانيسب 10 مكجم 4 سرنجات معبأة للحقنمحلول للحقن في سرنجة معبأة مسبقاً1,383ج.م
- ارانيسب 100مكجم 4 سرنجاتمحلول للحقن في سرنجة معبأة مسبقاً13,587ج.م
- ارانيسب 15 مكجم سرنجة معبأةمحلول للحقن في سرنجة معبأة مسبقاً250ج.م
- ارانيسب 150 مكجم 4 سرنجات معبأةسرنجة معبأة مسبقاً للحقن19,407ج.م
المصادر
- السعر: قوائم أسعار الأدوية المنشورة في مصر.
- European Medicines Agency (EMA)
- PubChem
تعليقات
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