5.7 mg / mL injection , suspension 
betamethasone

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your doctor, pharmacist, or nurse.
  • This medicine has been prescribed for you only. Do not give it to others. It can harm them, even if they show signs of illness similar to yours.
  • If you get any side effects, talk to your doctor, pharmacist or nurse. This also applies to any side effects not mentioned in this information. See section 4.

This leaflet contains information about: 
1. What Celeston Biphas is and what it is used for 
2. What you need to know before you use Celeston Biphas 
3. How to use Celeston Biphas 
4. Possible side effects 
5. How to store Celeston steak 6. Contents of the pack 
and other information 

1. What Celeston bifas is and what it is used for

Celeston biphas is a drug that contains betamethasone, a corticosteroid, in two different forms. Through this combination, the drug has both a rapid effect at the beginning of the treatment and a long-lasting effect, which means that the intervals between the injections can be extended.

Celeston biphas is used in the treatment of various forms of inflammation and allergies , for example in asthma , severe allergic conditions, anaphylactic reactions (shock-sensitive hypersensitivity reactions), reactions after transfusions , rheumatoid arthritis , skin diseases, as protection in connection with operations in cases where the body’s own levels are insufficient, in case of fluid accumulation ( edema ) in the brain, as well as in false croup ( pseudo-croup ).

2. What you need to know before using Celeston bifas

Do not use Celeston bifas

  • if you are allergic to betamethasone acetate, betamethasone sodium phosphate or any of the other ingredients of this medicine (listed in section 6).
  • if you have a fungal infection in your blood.
  • if you have a local viral or bacterial infection, such as tuberculosis or gonorrhea .

Consult your doctor or pharmacist if you are unsure before using Celeston bifas.

Warnings and cautions

Talk to your doctor, pharmacist or nurse before using Celeston bifas:

  • if you have osteoporosis
  • if you have recently had bowel surgery
  • if you have a psychosis
  • if you have stomach ulcers or ulcers on the duodenum one
  • if you have tuberculosis
  • if you have diabetes
  • if you have high blood pressure
  • if you have heart failure
  • if you have an infection

Tell your doctor if you have or are planning to get vaccinated.

Doctors should be consulted in case of stress such as fever or in stressful situations, as the dose may need to be increased.

Contact a doctor if you experience blurred vision or other visual disturbances.

Children

Used with caution when treating children.

Other medics and Celeston bifas

Celeston biphas may affect or be affected by other medicines, for example:

  • rifampicin (used to treat certain infections )
  • phenobarbital, phenytoin and carbamazepine (used to treat or prevent epileptic seizures)
  • ephedrine (can be used to treat asthma )

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

Some medicines may increase the effects of Celeston biphas and your doctor may want to monitor you closely if you are taking these medicines (eg some HIV medicines: ritonavir, cobicistat).

Pregnancy and breastfeeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

The use of Celeston biphas is not recommended if you are pregnant or breast-feeding.

Celeston bifas passes into breast milk but probably does not affect the breast-fed baby.

Driving and using machines

Celeston bifas does not affect your ability to drive or use machines.

Celeston biphas contains sodium

Celeston biphas contains less than 1 mmol sodium (23 mg) per dose , ie essentially ‘sodium-free’.

3. How to use Celeston biphas

Celeston bifas is given to you by a doctor or other healthcare professional.

Celeston biphas is injected into a muscle, joint or skin.

Dos en

  • Your doctor will decide on a dose and decide how many treatments you should have. It depends on your illness and how good an effect you get from the treatment.

If you use more Celeston than you should

As this medicine is given by a doctor or nurse, it is unlikely that you will receive too much.

If you have any further questions on the use of this product, ask your doctor, pharmacist or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects , although not everybody gets them.

Stop using Celeston biphas and contact a doctor immediately if you get any of the following symptoms:

  • Signs of an allergic reaction (rare). Symptoms of an allergic reaction may include swelling of the face, tongue or throat, difficulty swallowing, hives and difficulty breathing.

Other side effects:

Common (may affect up to 1 in 10 people)

  • thin skin
  • osteoporosis, muscle wasting (decrease in muscle mass)
  • inhibition of one’s own corticosteroid secretion as well as fat accumulations on the torso and face, skin changes, fluid accumulations in the body (so-called Cushing-like symptoms), worsening diabetes or outbreaks of diabetes that have been dormant, growth inhibition in children
  • low potassium levels in the blood, impaired excretion of sodium in the urine
  • activation of infection , such as tuberculosis that has been dormant

Uncommon (may affect up to 1 in 100 people)

  • blood clot
  • glaucoma , posterior cataract
  • reduced or increased pigmentation , abscess (with topical treatment)
  • activation of mental disorders
  • joint instability
  • increased blood pressure inside the skull

Rare (may affect up to 1 in 1,000 people)

  • spasm of the trachea
  • stomach ulcers , ulcers on the intestine
  • allergic, sometimes anaphylactic (shock type) hypersensitivity s

Has been reported (may occur in unknown number of users)

  • high blood pressure , heart failure
  • seizures, increased pressure in the skull with swelling of the optic nerve papilla in the fundus, dizziness, headache
  • inflammation of the pancreas, stretched abdomen, sore inflammation of the esophagus
  • skin haemorrhages and bruises, reddening of the skin, increased sweating
  • muscle weakness, steroid-related muscle disease
  • menstrual disorders
  • negative nitrogen balance due to degradation of the protein s
  • insomnia

Has been reported (may occur in unknown number of users):

  • Dimsyn

Other rare side effects reported spontaneously are: edema , impaired wound healing, tendon rupture, impaired response to skin tests, skin reactions (allergic inflammation of the skin) and hiccups.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information.P

5. How to store Celeston steak

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton after EXP and on the ampoule or vial after EXP. The expiration date is the last day of the specified month.

Do not store above 25 ° C.

Completed liquid should be used immediately.

6. Contents of the packaging and other information

Content declaration

  • The active substances are betamethasone acetate and betamethasone sodium phosphate. 1 ml contains 5.7 mg betamethasone.
  • The other ingredients are sodium edetate, sodium dihydrogen phosphate dihydrate, disodium phosphate dihydrate, benzalkonium chloride and water for injections.

What the medicine looks like and contents of the pack

Celeston Biphase 5.7 mg / ml is a suspension for injection .

Celeston biphas is supplied in packs of 5 ampoules x 1 ml and 5 ampoules x 2 ml and vials, 5 ml.

Your doctor will decide on a dose and decide how many treatments you should have. It depends on your illness and how good an effect you get from the treatment.

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

Merck Sharp & Dohme BV

Box 581

2003 PC Haarlem

Netherlands

Muhammad Nadeem

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