Is PABAL RTS 100 mcg/ml registered in Tanzania?

PABAL RTS 100 mcg/ml is recorded with registration status “Registered/Compliant” in Tanzania, registration number TZ 20 H 0094, based on TMDA data.

Who manufactures PABAL RTS 100 mcg/ml?

PABAL RTS 100 mcg/ml is manufactured by Ferring.

What is the active ingredient in PABAL RTS 100 mcg/ml?

PABAL RTS 100 mcg/ml contains Carbetocin 100 mcg/ml, dosage form Solution for injection.

Registered Tanzania · TMDA

PABAL RTS 100 mcg/ml

Carbetocin 100 mcg/ml

TZ 20 H 0094 Solution for injection 100

What it does

Carbetocin is a synthetic hormone used to help with childbirth and certain reproductive issues.

Commonly used for: helping contractions during childbirth, reducing bleeding after delivery

Registration & product details

Registration no.

TZ 20 H 0094

Registration date

2025-03-16

Expiry date

2030-03-15

Status

Registered/Compliant

Active ingredient

Carbetocin 100 mcg/ml

Dosage form

Solution for injection

Strength

100

Pack size

Therapeutic class

Manufacturer / MAH

Ferring

Applicant / LTR

ferring Pharmaceuticals SA, Jordan

Country of origin

GERMANY

Manufacturer location

Wittland 11, 24109 Kiel, Germany

Source: Tanzania Medicines and Medical Devices Authority · fetched 2026-03-11 23:52:12 · updated 2026-09-14 03:00:45

Disclaimer: This information is sourced from Tanzania Medicines and Medical Devices Authority (Tanzania). Always consult a qualified healthcare professional before using any medication.

About this medicine

Carbetocin is a synthetic hormone used to help with childbirth and certain reproductive issues.

What it treats

helping contractions during childbirth
reducing bleeding after delivery

How it works

Carbetocin works by mimicking a natural hormone in the body that helps the uterus contract, making it useful during and after childbirth.

Who it's for

This medication is for women who are giving birth or have just given birth.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Carbetocin

BNF-referenced

Carbetocin is a synthetic analogue of oxytocin, primarily utilized in obstetrics to prevent uterine atony and control postpartum hemorrhage after cesarean sections. It enhances uterine contractions and increases uterine tone, facilitating the expulsion of the placenta and reducing the risk of excessive bleeding. Carbetocin is administered via slow intravenous injection, making it effective in acute situations following delivery.

Indications

Prevention of uterine atony after cesarean section

Dosage

Adults: 100 micrograms for 1 dose, to be given over 1 minute, administered as soon as possible after delivery, preferably before removal of placenta.

Mechanism of action

Carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. The oxytocin receptor content of the uterus is very low in the non-pregnant state and increases during pregnancy, reaching a peak at the time of delivery.

Pharmacodynamics

Carbetocin is primarily used to control postpartum hemorrhage, which is excessive bleeding that can occur after childbirth. Its pharmacological action mirrors that of oxytocin, as it triggers uterine contractions that are essential for the prevention of uterine atony, a condition where the uterus fails to contract effectively after delivery.

Pharmacokinetics

Carbetocin is administered intravenously, allowing for rapid onset of action. The drug is metabolized in the liver, and its clearance may be affected in patients with hepatic impairment. Specific pharmacokinetic parameters such as half-life and volume of distribution are not detailed in the provided resources, thus further literature may be necessary for a comprehensive understanding.

Contra-indications

Eclampsia
Epilepsy
Pre-eclampsia

Adverse effects

Anxiety
Chest pain
Chills
Dizziness
Feeling hot
Flushing
Headache
Hypotension
Nausea
Tachycardia
Hyponatraemia
Hyperglycaemia

Precautions

Asthma
Cardiovascular disease (avoid if severe)
Migraine
Intra-uterine growth restriction
Caution in patients with hepatic impairment
Caution in patients with renal impairment

Pregnancy

Carbetocin is indicated for the prevention of uterine atony following caesarean section and is used in the postpartum period.

Breast-feeding

Information regarding the safety of carbetocin during breastfeeding is not specifically provided.

Storage

Store below 25°C. Protect from light.

Formulations

{'name': 'Solution for injection', 'available_strengths': '100 micrograms/ml'}

BNF 85 (British National Formulary) p.924 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Carbetocin

PubChem CID 16681432

Molecular formula: C45H69N11O12S

Mechanism of action

Carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions, and increased uterine tone. The oxytocin receptor content of the uterus is very low in the non-pregnant state, and increases during pregnancy, reaching a peak at the time of delivery.

Pharmacodynamics

Carbetocin is a drug used to control postpartum hemorrhage, bleeding after giving birth. It is sold under the trade name Duratocin. It is an analogue of oxytocin, and its action is similar to that of oxytocin; it causes contraction of the uterus.

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.