Carbetocin Injection 100mcg/ml

  1. Name of the medicinal product

Carbetocin 100 micrograms/ml solution for injection Taj Pharma

  1. Qualitative and quantitative composition

Carbetocin 100 micrograms/ml.

Oxytocic activity: approximately 50 IU of oxytocin/vial

For a full list of excipients, see section 6.1.

  1. Pharmaceutical form

Solution for injection.

A clear colourless solution.

  1. Clinical particulars

4.1 Therapeutic indications

Carbetocin is indicated for the prevention of uterine atony following delivery of the infant by Caesarean section under epidural or spinal anaesthesia

4.2 Posology and method of administration

Posology:

Withdraw 1 ml of Carbetocin containing 100 micrograms carbetocin and administer only by intravenous injection, under adequate medical supervision in a hospital.

Paediatric population

No data available

Method of administration

Carbetocin must be administered slowly, over 1 minute only after delivery of the infant by Caesarean section. It should be given as soon as possible after delivery, preferably before removal of the placenta. Carbetocin is intended for single use only. No further doses of carbetocin should be administered.

4.3 Contraindications

  • During pregnancy and labour before delivery of the infant.
  • Carbetocin must not be used for the induction of labour.
  • Hypersensitivity to carbetocin, oxytocin or to any of the excipients listed in section 6.1.
  • Hepatic or renal disease.
  • Cases of pre-eclampsia and eclampsia.
  • Serious cardiovascular disorders.
  • Epilepsy

4.4 Special warnings and precautions for use

Carbetocin is intended for use only at well-equipped specialist obstetrics units with experienced and qualified staff available at all times.

The use of carbetocin at any stage before delivery of the infant is not appropriate because its uterotonic activity persists for several hours after a single bolus injection. This is in marked contrast to the rapid reduction of effect observed after discontinuation of an oxytocin infusion.

In case of persistent uterine bleeding after administration of carbetocin the cause must be determined. Consideration should be given to causes such as retained placental fragments, inadequate emptying or repair of the uterus, or disorders of blood coagulation.

Carbetocin is intended for single administration only. It must be administered slowly over 1 minute. In case of persisting uterine hypotonia or atonia and the consequent excessive bleeding, additional therapy with oxytocin and/or ergometrine should be considered. There are no data on additional doses of carbetocin or on the use of carbetocin following persisting uterine atony after oxytocin.

Animal studies have shown carbetocin to possess some antidiuretic activity (vasopressin activity: <0,025 IU/vial) and therefore the possibility of hyponatraemia cannot be excluded, particularly in patients also receiving large volumes of intravenous fluids. The early signs of drowsiness, listlessness and headache should be recognised to prevent convulsions and coma.

In general, carbetocin should be used cautiously in the presence of migraine, asthma and cardiovascular disease or any state in which a rapid addition to extracellular water may produce hazard for an already overburdened system. The decision of administering carbetocin can be made by the physician after carefully weighing the potential benefit carbetocin may provide in these particular cases.

Specific studies have not been undertaken in gestational diabetes mellitus.

The efficacy of carbetocin has not been assessed following vaginal delivery.

4.5 Interaction with other medicinal products and other forms of interaction

During clinical trials, carbetocin has been administered in association with a number of analgesics, spasmolytics and agents used for epidural or spinal anaesthesia, and no drug interactions have been identified.

Specific interaction studies have not been undertaken.

Since carbetocin is closely related in structure to oxytocin, the occurrence of interactions known to be associated with oxytocin cannot be excluded:

Severe hypertension has been reported when oxytocin was given 3 to 4 hours following prophylactic administration of a vasoconstrictor in conjunction with caudal-block anaesthesia.

During combination with ergot-alkaloids, such as methylergometrine, oxytocin and carbetocin may enhance the blood pressure enhancing effect of these agents. If oxytocin or methylergometrine are administered after carbetocin there may be a risk of cumulative exposure.

Since it has been found that prostaglandins potentiate the effect of oxytocin, it is expected that this can also occur with carbetocin. Therefore, it is not recommended that prostaglandins and carbetocin be used together. If they are concomitantly administered, the patient should be carefully monitored.

Some inhalation-anesthetics, such as halothane and cyclopropane may enhance the hypotensive effect and weaken the effect of carbetocin on the uterus. Arrhythmias have been reported for oxytocin during concomitant use.

4.6 Fertility, pregnancy and lactation

Pregnancy

Carbetocin is contraindicated during pregnancy and must not be used for the induction of labour (see section 4.3).

Breastfeeding

No significant effects on milk let-down have been reported during clinical trials. Small amounts of carbetocin have been shown to pass from plasma into breast milk of nursing women (see section 5.2). The small amounts transferred into colostrum or breast milk after a single injection of carbetocin, and subsequently ingested by the infant are assumed to be degraded by enzymes in the gut.

4.7 Effects on ability to drive and use machines

Not relevant.

4.8 Undesirable effects

The adverse events observed with carbetocin during the clinical trials were of the same type and frequency as the adverse events observed with oxytocin when administered after Caesarean section under spinal or epidural anaesthesia.

System Organ Class Very common

≥ 1/10

Common

≥ 1/100 and < 1/10

Blood and lymphatic system disorders Anaemia
Nervous system disorders Headache, tremor Dizziness
Vascular disorders Hypotension, flushing
Respiratory, thoracic and mediastinal disorders Chest pain, dyspnoea
Gastrointestinal disorders Nausea, abdominal pain Metallic taste, vomiting
Skin and subcutaneous tissue disorders Pruritus
Musculosceletal and connective tissue disorders Back pain
General disorders and administration site conditions Feeling of warmth Chills, pain

In the clinical trials sweating and tachycardia were reported as sporadic cases.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme, website: www.mhra.gov.uk/yellowcard

4.9 Overdose

Overdosage of carbetocin may produce uterine hyperactivity whether or not due to hypersensitivity to this agent.

Hyperstimulation with strong (hypertonic) or prolonged (tetanic) contractions resulting from oxytocin overdose can lead to uterine rupture or postpartum haemorrhage.

Overdosage of oxytocin may lead to hyponatraemia and water intoxication in severe cases, especially when associated with excessive concomitant fluid intake. As carbetocin is an analogue of oxytocin, the possibility of a similar event cannot be excluded.

Treatment of overdosage of carbetocin consists of symptomatic and supportive therapy. When signs or symptoms of overdosage occur oxygen should be given to the mother. In cases of water intoxication it is essential to restrict fluid intake, promote diuresis, correct electrolyte imbalance, and control convulsions that may eventually occur.

  1. Pharmacological properties

5.1 Pharmacodynamic properties

Pharmacotherapeutic group: Oxytocin and analogues

ATC code: H01BB03

The pharmacological and clinical properties of carbetocin are those of a long acting oxytocin agonist.

Like oxytocin, carbetocin selectively binds to oxytocin receptors in the smooth muscle of the uterus, stimulates rhythmic contractions of the uterus, increases the frequency of existing contractions, and raises the tone of the uterus musculature.

On the postpartum uterus, carbetocin is capable of increasing the rate and force of spontaneous uterine contractions. The onset of uterine contraction following carbetocin is rapid, with a firm contraction being obtained within 2 minutes.

A single 100 micrograms intravenous dose of carbetocin administered after the delivery of the infant is sufficient to maintain adequate uterine contraction that prevents uterine atony and excessive bleeding comparable with an oxytocin infusion lasting for several hours.

5.2 Pharmacokinetic properties

Carbetocin shows a biphasic elimination after intravenous administration with linear pharmacokinetics in the dose range of 400 to 800 micrograms. The terminal elimination half-life is approximately 40 minutes. Renal clearance of the unchanged form is low, with <1% of the injected dose excreted unchanged by the kidney.

In 5 healthy nursing mothers, plasma carbetocin concentrations were detectable by 15 min and peaked at a maximum of 1035 ± 218 pg/ml within 60 min. Peak concentrations in milk were approximately 56 times lower than in plasma at 120 min

5.3 Preclinical safety data

Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicology and genotoxicity. A reproductive toxicity study in rats, with daily drug administration from parturition to day 21 of lactation, showed a reduction in offspring body weight gain. No other toxic effects were observed. The indication did not warrant studies on fertility or embryotoxicity.

Carcinogenicity studies have not been performed with carbetocin due to the single dose nature of the indication

  1. Pharmaceutical particulars

6.1 List of excipients

L-methionine, Succinic acid, Mannitol, Sodium hydroxide for pH adjustment, Water for injections

6.2 Incompatibilities

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

6.3 Shelf life

3 years.

Shelf life after first opening the container:

After first opening the vial: the solution should be used immediately.

6.4 Special precautions for storage

Keep vials in the outer carton, in order to protect from light. Store below 30°C. Do not freeze.

6.5 Nature and contents of container

Type I glass vials (2R) with type 1 bromobutyle stoppers with aluminium crimp cap containing 1 ml of solution for injection.

Packs of 5 vials

6.6 Special precautions for disposal and other handling

Carbetocin is for intravenous use only.

Only clear solutions practically free from particles should be used.

Any unused product or waste material should be disposed of in accordance with local requirements.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com


Carbetocin Injection 100mcg/ml

 

Package leaflet: Information for the patient

Carbetocin 100 micrograms/ml solution for injection Taj Pharma

Read all of this leaflet carefully before you are given an injection of Carbetocin because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor, midwife or nurse.
  • If you get any side effects, tell your doctor, midwife or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

  1. What Carbetocin is and what it is used for
  2. What you need to know before you are treated with Carbetocin
  3. How Carbetocin is given to you
  4. Possible side effects
  5. How Carbetocin is stored
  6. Contents of the pack and other information

 

  1. What Carbetocin is and what it is used for

Carbetocin is used to treat women who have just had a baby by caesarean section. In some women, after a caesarean, the womb (uterus) doesn’t contract (shrink)

quickly enough. This makes it more likely that they’ll bleed more than normal. Carbetocin makes the womb contract and so reduces the risk of bleeding.

The active ingredient in Carbetocin is carbetocin. It is similar to a substance called oxytocin, which is naturally produced by the body to make the womb contract during childbirth.

  1. What you need to know before you are treated with Carbetocin

Carbetocin must not be given until after the baby has been delivered.

Before giving Carbetocin, your doctor needs to know about any medical conditions you may have. You should also tell your doctor about any new symptoms that develop while you are being treated with Carbetocin.

Carbetocin must not be used

  • if you are allergic to carbetocin or any of the ingredients of Carbetocin (see Section 6)
  • if you have any disease of the liver or kidneys
  • if you have pre-eclampsia (high blood pressure in pregnancy) or eclampsia (toxaemia of pregnancy)
  • if you have any serious heart disease
  • if you have epilepsy
  • if you ever have had an allergic reaction to oxytocin (sometimes given as a drip or injection during or after labour)

If any of these apply to you, tell your doctor.

Doctors need to take special care when using Carbetocin

  • if you get migraines
  • if you have asthma
  • if you have problems with your heart or your circulation (such as high blood pressure)
  • if you have any other medical condition If any of these apply to you, tell your doctor.

Children: Not relevant

Other medicines and Carbetocin

Tell your doctor if you are taking, or have recently taken, any other medicines – including medicines obtained without a prescription.

Pregnancy and breast-feeding

Carbetocin must not be used during pregnancy, but may be given after delivery by Caesarean section.

Small amounts of carbetocin have been shown to pass from the nursing mother’s blood into the breast milk, but it is assumed to be degraded in the infant’s bowels.

  1. How Carbetocin is given to you

Carbetocin is given as an injection into one of your veins, immediately after your baby has been delivered by caesarean section under an epidural or spinal anaesthetic. The dose is one vial (100 micrograms).

If someone is given too much Carbetocin

If you are accidently given too much Carbetocin, your womb may contract strongly enough to become damaged or to bleed heavily. You may also suffer drowsiness, listlessness and headache, caused by water building up in your body. You will be treated with other medication, and possibly surgery.

  1. Possible side effects

Like all medicines, Carbetocin can have side effects, but not everybody gets them.

The most common side effects may affect at least 10 of every 100 women treated with Carbetocin. They include:

  • nausea
  • pain in the stomach
  • itching
  • flushing (red skin)
  • feeling warm
  • low blood pressure
  • heachaches
  • shakiness

Other side effects, which may affect between 1 and 10 of every 100 women, include:

  • vomitting
  • dizziness
  • pain in the back or chest
  • a metallic taste in the mouth
  • anaemia
  • breathlessness
  • chills

Infrequently some women might experience rapid heartbeat or sweating.

Carbetocin may cause a build up of water in the body which can lead to drowsiness, listlessness and headache.

Reporting of side effects

If you get any side effects, talk to your doctor, midwife or nurse. This includes any possible side effects not listed in this leaflet.

  1. How Carbetocin is stored

Carbetocin vials are stored in the outer carton in order to protect from light. Store below 30ºC. Do not freeze.

Only clear solutions practically free from particles should be used.

Carbetocin must not be used after the expiry date printed on the carton and vial. Carbetocin should be kept out of sight and reach of children.

Contents of the pack and other information

What Carbetocin contains

The active substance is carbetocin. Each millilitre contains 100 micrograms of carbecotin. The other ingredients are L-methionine, succinic acid, mannitol, sodium hydroxide and water for injections.

What Carbetocin looks like and contents of the pack

Carbetocin is clear colourless solution for injection, ready for intravenous injection, supplied in packs of five vials of 1ml.

Carbetocin should be used only in well equipped specialist obstetrics units.

  1. Contents of the pack and other information

What Carbetocin contains 

The active substance is carbetocin. Each millilitre contains 100 micrograms of

carbecotin. The other ingredients are L-methionine, succinic acid, mannitol, sodium

hydroxide and water for injections.

What Carbetocin looks like and contents of the pack

Solution for injection, ready for intravenous injection, supplied in packs of five vials of 1ml.

Carbetocin should be used only in well equipped specialist obstetrics units.

  1. Manufactured in India by:
    TAJ PHARMACEUTICALS LTD.
    Mumbai, India
    Unit No. 214.Old Bake House,
    Maharashtra chambers of Commerce Lane,
    Fort, Mumbai – 400001
    at:Gujarat, INDIA.
    Customer Service and Product Inquiries:
    1-800-TRY-FIRST (1-800-222-434 & 1-800-222-825)
    Monday through Saturday 9:00 a.m. to 7:00 p.m. EST
    E-mail: tajgroup@tajpharma.com