ARX-METHOTREXATE 2.5 methotrexate 2.5 mg tablet blister pack

Država: Avstralija

Jezik: angleščina

Source: Department of Health (Therapeutic Goods Administration)

Kupite ga zdaj

Prenos Navodilo za uporabo (PIL)
15-05-2023
Prenos Javno poročilo o oceni (PAR)
15-05-2023

Aktivna sestavina:

methotrexate, Quantity: 2.5 mg

Dostopno od:

Cipla Australia Pty Ltd

Farmacevtska oblika:

Tablet

Sestava:

Excipient Ingredients: calcium hydrogen phosphate; lactose monohydrate; sodium starch glycollate type A; microcrystalline cellulose; purified talc; magnesium stearate

Pot uporabe:

Oral

Enote v paketu:

30 tablets

Tip zastaranja:

(S4) Prescription Only Medicine

Terapevtske indikacije:

Antineoplastic chemotherapy,Treatment of breast cancer, gestational choriocarcinoma and in patients with chorioadenoma destruens and hydatidiform mole. Palliation of acute and subacute lymphocytic leukaemia. Greatest effect has been observed in palliation of acute lymphoblastic (stem cell) leukaemias. In combination with corticosteroids, methotrexate may be used for induction of remission. The drug is now most commonly used for the maintenance of induced remissions. Methotrexate is also effective in the treatment of the advanced stages (III and IV, Peters Staging System) of lymphosarcoma, particularly in children and in advanced cases of mycosis fungoides.,Psoriasis chemotherapy,(See Warnings box and section 4.4 Special warnings and precautions for use),Because of the high risk attending to its use, Methotrexate is only indicated in the symptomatic control of severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, but only when the diagnosis has been established, as by biopsy and / or after dermatologic consultations.,Rheumatoid Arthritis Chemotherapy,(See Warnings box and section 4.4 Special warnings and precautions for use),Management of severe, recalcitrant, active rheumatoid arthritis in adults not responding to or intolerant of an adequate trial of NSAIDs and one or more disease modifying drugs. Aspirin, NSAIDs and/or low dose steroids may be continued, although the possibility of increased toxicity with concomitant use of NSAIDs including salicylate has not been fully explored (see sections 4.4 Special warnings and precautions for use and 4.5 Interactions with other medicines and other forms of interactions).,Steroids may be reduced gradually in patients who respond to methotrexate.,Combined use of methotrexate with gold, penicillamine, hydroxychloroquine, sulfasalazine or cytotoxic agents has not been studied and may increase the incidence of adverse effects. Rest and physiotherapy as indicated should be continued.

Povzetek izdelek:

Visual Identification: Yellow, circular, biconvex uncoated tablets plain on both sides; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius

Status dovoljenje:

Registered

Datum dovoljenje:

2023-05-15

Navodilo za uporabo

                                CIPTREXATE
1
CIPTREXATE
CONSUMER MEDICINE INFORMATION (CMI) SUMMARY
The full CMI on the next page has more details. If you are worried
about taking this medicine, speak to your doctor or
pharmacist.
WARNING: Important safety information is provided in a boxed warning
in the
full CMI
. Read before taking this medicine.
1.
WHY AM I TAKING CIPTREXATE?
Ciptrexate contains the active ingredient methotrexate. Ciptrexate is
used to treat certain types of cancers, severe psoriasis or
rheumatoid arthrtis when the condition does not improve with other
medicines.
For more information, see Section 1. Why am I taking Ciptrexate? in
the full CMI.
2.
WHAT SHOULD I KNOW BEFORE I TAKE CIPTREXATE?
Do not take if you have ever had an allergic reaction to Ciptrexate or
any of the ingredients listed at the end of the CMI.
TALK TO YOUR DOCTOR IF YOU HAVE ANY OTHER MEDICAL CONDITIONS, TAKE ANY
OTHER MEDICINES, OR ARE PREGNANT OR PLAN TO BECOME
PREGNANT OR ARE
BREASTFEEDING.
For more information, see Section 2. What should I know before I take
Ciptrexate? in the full CMI.
3.
WHAT IF I AM TAKING OTHER MEDICINES?
Some medicines may interfere with Ciptrexate and affect how it works.
A list of these medicines is in Section 3. What if I am taking other
medicines? in the full CMI.
4.
HOW DO I TAKE CIPTREXATE?
The dose of medicine given to you will depend on the condition being
treated, your medical condition, your age, your size and
how well your kidneys and liver are working.
More instructions can be found in Section 4. How do I take Ciptrexate?
in the full CMI.
5.
WHAT SHOULD I KNOW WHILE TAKING CIPTREXATE?
THINGS YOU
SHOULD DO
•
Remind any doctor, dentist or pharmacist you visit that you are taking
Ciptrexate.
•
You and your partner must use a reliable method of contraception
(birth control pills or condom)
while taking Ciptrexate and for at least 6 months after you stop
treatment.
•
Discuss with your doctor how much water or fluids you should have as
not enough fluid intake can
increase the side effects of this medicine.
•
Remind 
                                
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